Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
To assess the effects of acupuncture for overweight or obese people.
Background
Description of the condition
Overweight and obesity are defined as abnormal or excessive fat accumulation that presents a risk to health (WHO 2010). The fundamental cause of obesity and overweight is an energy imbalance between intake and expenditure of calories. The problem of overweight and obesity was labelled as a global epidemic in the World Health Organization (WHO) report ten years ago. Evidence is now emerging to suggest that the prevalence of the global epidemic ‐ "globesity" ‐ is increasing at an alarming rate in all countries (WHO 2010).
In the European region, prevalence has tripled in many countries since the 1980s (WHO 2008). In the African region, overweight and obesity have increased alarmingly since the early 1990s (WHO 2010). The prevalence of obesity in the Western Pacific region is well above 20% in most communities (WHO 2002). In 2008, Colorado was the only one state of the US which had a prevalence less than 20% while other 32 states had a prevalence of 25% or more (CDC 2009a). In the South‐East Asia region, data suggests that obesity is growing rapidly in affluent urban populations (WHO 2004). WHO further projects have shown that by 2015, approximately 2.3 billion adults will be overweight and more than 700 million will be obese (WHO 2006).
This is not only happening in the adult population but also in children and adolescents. According to the latest estimates from the International Obesity Task Force (IOTF), at least 155 million school‐age children worldwide are overweight. Around 30 to 45 million within that population are classified as obese ‐ accounting for 2% to 3% of the world's children aged 5 to 17. A further 22 million children are also affected according to previous IOTF global estimates based on WHO data for children less than five years of age (IOTF 2002). More than 75% of overweight and obese children live in low‐ and middle‐income countries (WHO 2010).
These global increases in overweight and obesity are attributable to a number of factors including: a global shift in diet towards increased intake of energy‐dense foods that are high in fat and sugars, a trend towards decreased physical activity due to the increasingly sedentary lifestyle and work, changing modes of transportation, and increasing urbanization. To assess the level of overweight and obesity, the WHO recommended using the body mass index (BMI), which is defined as the weight in kilograms divided by the square of the height in meters (kg/m2). At present, the WHO defines overweight as a BMI ≥ 25, and obesity as a BMI ≥ 30. The range of 18.50 to 24.99 of BMI is considered as normal. For the Asia‐Pacific region, the WHO recommended lower ranges (WHO 2000). BMI cut‐points provide a benchmark for individual assessment, but must be regarded as a rough guide for adults (WHO 2006). The BMI criteria used for children and teens are different from those used for adults.
In addition to the BMI, there are other measurements, such as waist circumference and waist‐to‐hip ratio (WHR) and body fat composition in identifying individuals at increased risk from obesity‐related illness.
Obesity has physical, psychological, and social consequences in adults and children (CDC 2009b). It increases risk of premature death and debilitating complaints which have an adverse effect on quality of life. It is also a major risk factor for non‐communicable diseases (NCDs) such as non‐insulin‐dependent diabetes mellitus (NIDDM), cardiovascular diseases (CVD) and cancer (WHO 2004). It may also result in many psychological disorders. Besides, overweight and obesity and their associated health problems lead to economic burdens to many societies. Obesity has already accounted for 2% to 8% of healthcare costs in several parts of the European region (WHO 2008); in the U.S in 2008, an estimate of the medical costs of obesity for 2010 reached $147 billion or 123 billion EUR (CDC 2009c).
Effective weight management is an important goal for every overweight and obese person. Presently, treatments for obesity suggested by the WHO are dietary management, physical activity, behavior modification, pharmacological treatment, surgery, traditional medicine and other treatments. Dietary restriction is the most conventional way for managing weight; adding physical activity and exercise to diet is more effective than either method alone in promoting fat loss; behavior treatment is regarded as an essential component of any adequate obesity‐treatment program. But all these three treatments have a common limitation: they show short term effects only. The concept of long‐term drug treatment has emerged as an adjunct to other weight‐loss therapies and as a way of helping to maintain body weight over time. However, its long‐term use has raised safety concerns in recent years. Weight management drugs do not cure obesity, so weight regain is expected when medication is discontinued. Furthermore, drugs for weight management have not yet been recommended for routine use but should be used under medical supervision. Bariatric surgery is considered to be the most effective way of reducing weight and may result in a sustained weight loss (WHO 2004). However, serious complications can occur, so patients should be selected carefully (Marielle 2008).
Currently, there are an increasing number of people who turn to complementary and alternative medicine (CAM). Although the use of acupuncture in the treatment of obesity is relatively new, it has become one of the most widely used therapies (Cho 2009).
Description of the intervention
Acupuncture originated in China thousands of years ago, constituting an integral part of Traditional Chinese Medicine (TCM). TCM, a traditional medical system, represents the wisdom of the Chinese people as well as a great treasure house of China. Its profound effects appear irreplaceable in maintaining good health for the Chinese people. TCM holds a unique view of the world and the human body which is different from Western medicine concepts. It has the 'concept of holism' and 'treatment according to syndrome differentiation'. From the viewpoint of TCM, a sound body is considered as a delicate balance between the two opposing, complementary and inseparable forces, Yin and Yang. The concept of Yin and Yang is rooted in the ancient Chinese philosophy: Yin represents cold, slow, weak, dark, or passive aspects, while Yang represents hot, excited, strong, bright, or active aspects. A major theory is that health is achieved by maintaining a balance of Yin and Yang and disease is caused by an imbalance of Yin and Yang (NCCAM 2009). TCM practitioners make a comprehensive analysis of a patient's condition by using four diagnostic methods: observing, hearing and smelling, asking and interviewing, and touching and palpating as well as applying individual or combined therapies.
As a part of TCM, acupuncture has been practiced in China for more than 5000 years and has gained popularity among Chinese people. Over the last few decades, its popularity has grown significantly in the world, spreading first throughout Asia and later to Europe and the Americas. After thousands of years of improvement and development, today's acupuncture techniques are quite different from ancient times. The term 'acupuncture', in modern times, describes the practice of stimulating the specific points on the human body by penetrating the skin with thin, solid, metallic needles that are manipulated by the hands and electrical stimulation.
Adverse effects of the intervention
It has been reported that acupuncture is associated with local pain, inflammation, or occasional infection after the treatment of overweight and obesity (Lacey 2003). Relatively few complications have been reported from the treatment using acupuncture in general (NCCAM 2009). However, adverse effects of using acupuncture need to be assessed systematically.
How the intervention might work
Up to now, the mechanism of acupuncture has not been clearly explained. According to Western medicine, the effects of acupuncture are probably the results of stimulating the nervous system to release chemicals which may in turn release other neurotransmitters or hormones producing the desired effects. This theory is supported by the basic research work which has shown acupuncture's effect on adrenocorticotropin (ACTH), insulin, thyroid hormones, growth stimulating hormone, beta‐endorphin, white blood cell production and plasma cholesterol levels. It is also believed that acupuncture may work on an electromagnetic bio‐information system (AMFI 2007).
In TCM, acupuncture regulates the balance of Yin and Yang, removes blockages of Qi (vital force) and Blood as well as dredging the meridian to restore and maintain the healthy condition. Being different from the common Western understandings, Qi and Blood are the fundamental substances that maintain the life activities of the human body. The meridian system is a distribution network for Qi and Blood, linking different areas of the body and making the body an organic whole. Its pathways make up a comprehensive yet complex body map that supplies vital energy to every part of the body. Acupoints are the specific sites through which the Qi of the internal organs and meridians is transported to the body surface. They are classified into three categories: acupoints of the fourteen meridians, extraordinary points and Ashi points. These are distributed on their related meridian pathways and are closely linked with the meridians. So acupoints should not be regarded as separate superficial points, but as special sites which are connected with each other, and through which the internal tissues and organs are related (Li 1999). Using acupuncture to restore and maintain the internal balance of body is accomplished by acupoint prescription and acupuncture manipulation.
The earliest written record of overweight and obesity in China is The Suwen (The Book of Plain Questions). TCM believes that overweight and obesity are significantly related to phlegm and dampness, stomach heat, poor spleen functioning, Qi deficiency and Blood stasis. TCM does not directly reduce excess weight but holds to a holistic concept by dealing with the underlying body changes which might have brought about the excess weight and fatness. The general principles of practicing acupuncture treatment are worked out under the guidance of the theories of TCM. According to TCM's understanding of overweight and obesity, the underlying principles for weight loss treatment are eliminating Phlegm, drying Damp, reinforcing Spleen and replenishing Qi. Strengthening the function of the Spleen and Stomach to carry out their transformation and transportation properly is the therapeutic principle that TCM adopts in treating overweight and obesity. Once the body's balance is restored, the metabolism will process food properly and excess Phlegm and Dampness will be resolved. Excess weight should no longer be a problem.
Why it is important to do this review
Due to the high prevalence of obesity worldwide and increasing popularity of acupuncture, this review aims to assess the effects and safety of acupuncture for overweight or obese people. Acupuncture appears to be effective, safe and cost‐effective for overweight or obese patients, but scientific evidence of its effectiveness and safety is still lacking.
In 2003, Lacey et al evaluated descriptive and controlled trials of acupuncture for enhancing weight loss (Lacey 2003). This publication provided a brief overview of the methods and mechanisms of acupuncture, a summary of descriptive and controlled studies of acupuncture in the treatment of obesity and an agenda for future research. Pittler et al aimed to assess the evidence from RCTs and systematic reviews of complementary therapies for reducing body weight (Pittler 2005). The evidence related to acupuncture and acupressure (one systematic review and three RCTs) were also included and reviewed. They found that the evidence for the effectiveness of acupuncture or acupressure for reducing body weight was not convincing.
Currently, there are seven systematic reviews or meta‐analyses of the evidence on the effects of acupuncture for overweight or obese people (Cho 2009; Liao 2014; Lin 2009; Liu Y 2011; Sui 2012; Yu 2010; Zhang 2013):
The aim of the first systematic review by Cho et al was to assess the acupuncture effects on body weight reduction and to evaluate adverse events of this therapy (Cho 2009). It has been suggested that acupuncture is an effective and a relatively safe treatment for obesity. However, the level of evidence was not fully convincing because of the poor methodological quality of trial reviews. The aim of the second systematic review was to systemically analyse the clinical effect of catgut embedding therapy for simple obesity (Liao 2014). This review suggested that clinical effectiveness of catgut embedding therapy is superior to other therapies in the treatment of simple obesity. The aim of the third systematic review was to evaluate the effects of acupuncture for treating obesity and to analyse the current situation of clinical studies (Lin 2009). This review concluded that besides reasonable diet and exercise, acupuncture was safe and effective for treating obesity. It may be more effective than pharmacological treatment. However, due to the limited quantity of literature and the low quality of some publications, higher quality and a larger scale of RCTs are needed. The purpose of Liu Y 2011 and Zhang 2013 was to evaluate the effects of catgut embedding therapy for simple obesity. Results suggested that catgut embedding therapy may be an effective and safe treatment for simple obesity. However, the quality of evidence was low and conclusions were not fully convincing. Sui 2012 examined the effectiveness, safety, rationale and incidence of relapse of weight gain using TCM (including acupuncture) to treat obesity. It suggested that Chinese herbal medicine and acupuncture were more effective than placebo or lifestyle modification in reducing body weight. They had a similar effectiveness to the Western anti‐obesity drugs but with fewer reported adverse effects. However, these conclusions were limited by small sample size and low quality of methodologies. The aim of Yu 2010 was to investigate the effects of acupuncture in treating obesity. Results of this study suggested that acupuncture may have certain advantages over routine medical treatment. As the quality of some studies was low, definite conclusions could not be drawn.
In summary, the previous systematic reviews have some limitations: firstly, search strategies have not been documented clearly and most of the search strategies were not up‐to‐date, therefore it is possible that relevant studies were overlooked and recent trials were not included. Secondly, the methodological quality of reviews did not appear to be rigorously controlled by a methodology panel and editorial team. Moreover, these publications can not be updated easily and reviewers can not change or adapt searches, methods, outcomes, conclusions and so on.
Objectives
To assess the effects of acupuncture for overweight or obese people.
Methods
Criteria for considering studies for this review
Types of studies
We included randomised controlled clinical trials (RCTs).
Types of participants
Male and female patients of any age or ethnic origin who were overweight or obese were eligible. The diagnosis of overweight and obese should preferably be consistent with the WHO definition. However, studies that used other generally accepted standards were also included.
Diagnostic criteria
The WHO defines overweight in adult Europeans as a body mass index (BMI) equal to or more than 25 (kg/m²), and obesity as a BMI equal to or more than 30; in Asians, overweight is defined as a BMI equal to or more than 23 and obesity as a BMI equal to or more than 25.
Diagnostic criteria will be potentially subjected to a sensitivity analysis.
Types of interventions
We planned to investigate the following comparisons of intervention versus control/comparator.
Intervention
Acupuncture
Acupuncture involves the act of needle insertion, although there are many other non‐invasive techniques for acupuncture point stimulation. Points may be selected according to traditional medical systems, symptoms, point selection based on the scientific relationships of point function and point prescription.
Comparator
No intervention
Placebo/sham acupuncture
Pharmacological treatments
Other non‐acupuncture interventions
Concomitant interventions had to be the same in the intervention and comparator groups to establish fair comparisons.
Exclusion criteria
Methods of stimulating acupoints which are quite different from traditional acupuncture, such as laser acupuncture and surface electrodes, will be excluded.
Trials that only compare different forms of acupuncture or different acupoints will be excluded.
Types of outcome measures
Primary outcomes
Weight loss (kg)
Morbidity
Adverse events
Secondary outcomes
Change in anthropometric measures other than weight loss (kg)
Physical activity
Health‐related quality of life
Socioeconomic effects
Blood pressure
Lipid levels
Glycaemic control
Method and timing of outcome measurement
Weight loss: measured as weight (kg) and measured at baseline and after treatment.
Change in anthropometric measures other than weight loss: measured as body mass index (BMI), lean body mass, body fat percentage and measured at baseline and after treatment.
Morbidity (all‐cause and obesity‐related): defined as coronary heart disease, diabetes and measured at baseline and after treatment.
Adverse events: such as local pain, inflammation, occasional infection and measured at baseline and after treatment.
Glycaemic control: glycosylated haemoglobin A1c (HbA1c) and measured at baseline and after treatment.
Lipid levels: as analysed by total cholesterol, LDL‐ and HDL‐cholesterol, triglycerides and measured at baseline and after treatment.
Blood pressure: systolic and diastolic blood pressure and measured at baseline and after treatment.
Physical activity: evaluated by a validated instrument such as International Physical Activity Questionnaire and measured at baseline and after treatment.
Health‐related quality of life: evaluated by a validated instrument such as WHOQoL‐BREF and measured at baseline and after treatment.
Socioeconomic effects: defined as hospital stay, costs of medicines and measured at baseline and after treatment.
Summary of findings
We present a 'Summary of findings' table reporting the following outcomes listed according to priority.
Weight loss (kg)
Morbidity
Adverse events
Anthropometric measures
Health‐related quality of life
Socioeconomic effects
Glycaemic control
Search methods for identification of studies
Electronic searches
We searched the following sources from inception of each database to the specified date and placed no restrictions on the language of publication.
-
Cochrane Library
Cochrane Database of Systematic Reviews (CDSR) (2014, issue 4).
Cochrane Central Register of Controlled Trials (CENTRAL) (2014, issue 4).
Database of Abstracts of Reviews of Effects (DARE).
Health Technology Assessment (HTA) reports.
MEDLINE (until April 2014)
EMBASE (until April 2014)
AcuTrials (http://acutrials.ocom.edu, until 10 September 2014)
ClinicalTrials.gov (until 10 September 2014)
ICTRP Search Portal (http://apps.who.int/trialsearch/) (until 18 August 2014))
AMED (until July 2010)
CBM (Chinese Biomedical Medicine Database) (until August 2014)
CNKI (China National Knowledge Infrastructure) (until August 2014)
VIP (VIP Database for Chinese Technical Periodicals) (until August 2014)
Digital Journal of Wanfang Data (until August 2014).
For details on search strategies see Appendix 1. After supplying the final review draft for editorial approval, the Cochrane Metabolic and Endocrine Disorders (CMED) Group performed a complete update search on all databases available at the editorial office and send the results to the review authors. Should we identified new studies for inclusion we evaluated these, incorporate the findings in our review and resubmitted for publication in The Cochrane Library (Beller 2013). The AMED database has not been searched since July 2010 because it is no longer available to the CMED.
Hand‐searched journals include Chinese Acupuncture & Moxibustion (until August 2014), Acupuncture Research (until August 2014), Journal of Clinical Acupuncture and Moxibustion (until August 2014), Shanghai Journal of Acupuncture and Moxibustion (until August 2014) and Journal of Traditional Chinese Medicine (until August 2014).
Searching other resources
Search in the reference lists has been conducted to identify other potentially eligible trials or ancillary publications that have included trials, (systematic) reviews, meta‐analyses and health technology assessment reports, to identify other potentially eligible trials or ancillary publications.
Data collection and analysis
Selection of studies
Two review authors (LY, LQ) independently scanned the abstract or title, or both, of every record retrieved, to determine which studies should be assessed further. We investigated the full text articles of all potentially relevant articles. We resolved any disagreements with this assessment through discussion and a decision was achieved based on consensus. If resolution of a disagreement was not possible, we categorised the study as a 'study awaiting classification' and contacted the study authors for clarification. We present an adapted PRISMA (Preferred Reporting Items for Systematic Reviews and Meta‐Analyses) flow diagram to showing the process of study selection (Figure 1) (Liberati 2009).
Data extraction and management
For studies that fulfilled inclusion criteria, two review authors (LY, LQ) independently exstracted key participant and intervention characteristics. We reported data on effectiveness outcomes and adverse events using standard data extraction form supplied by the CMED Group. We resolved any disagreements by discussion or, if required, by consultation with a third review author (SMY) (for details see Table 7; Appendix 2; Appendix 3; Appendix 4; Appendix 5; Appendix 6; Appendix 7; Appendix 8; Appendix 9; Appendix 10; Appendix 11). We reported interventions according to STRICTA (STRICTA 2010).
Table 1.
Overview of study populations
| Intervention(s) and comparator(s) | Sample sizea | Screened/eligible [N] | Randomised [N] | Safety [N] | ITT [N] | Analysed [N] | Finishing study [N] | Randomised finishing study [%] | Follow‐up timeb | |
| (1) Chen 2009 | I1: electro‐acupuncture | ‐ | 60 | 20 | ‐ | ‐ | 20 | 20 | 100 | 3 wks |
| I2: acupuncture | 20 | ‐ | ‐ | 20 | 20 | 100 | ||||
| C: no intervention | 20 | ‐ | ‐ | 20 | 20 | 100 | ||||
| total: | 60 | ‐ | ‐ | 60 | 60 | 100 | 3 wks | |||
| (2) Chen 2013 | I: catgut embedding therapy | ‐ | 60 | 30 | ‐ | ‐ | 30 | 30 | 100 | 8 wks |
| C: lifestyle control | 30 | ‐ | ‐ | 30 | 30 | 100 | ||||
| total: | 60 | ‐ | ‐ | 60 | 60 | 100 | 8 wks | |||
| (3) Dang 2012 | I1: electro‐acupuncture + lifestyle control | ‐ | 90 | 30 | 30 | ‐ | 30 | 30 | 100 | 10 wks |
| I2: computerized intermediate‐frequency therapy + electro‐acupuncture + lifestyle | 30 | 30 | ‐ | 30 | 30 | 100 | ||||
| C: lifestyle control | 30 | 30 | ‐ | 30 | 30 | 100 | ||||
| total: | 90 | ‐ | ‐ | 90 | 90 | 100 | 10 wks | |||
| (4) Ding 2013 | I: acupuncture + lifestyle control | ‐ | 202 | 102 | ‐ | ‐ | 102 | 102 | 100 | 1 year |
| C: lifestyle control | 100 | ‐ | ‐ | 100 | 100 | 100 | ||||
| total: | 202 | ‐ | ‐ | 202 | 202 | 100 | 1 year | |||
| (5) Duan 2013 | I: acupuncture + lifestyle control | ‐ | 90 | 45 | 45 | 45 | 45 | 45 | 100 | 13 wks |
| C: foot holographic scraping therapy + lifestyle control | 45 | 45 | 45 | 45 | 45 | 100 | ||||
| total: | 90 | 90 | 90 | 90 | 90 | 100 | 13 wks | |||
| (6) Feng 2014 | I: catgut embedding therapy + lifestyle control | ‐ | 96 | 72 | ‐ | 68 | 68 | 68 | 94 | 4 wks |
| C: lifestyle control | 24 | ‐ | 22 | 22 | 22 | 92 | ||||
| total: | 96 | ‐ | 90 | 90 | 90 | 94 | 4 wks | |||
| (7) Gucel 2012 | I: acupuncture | ‐ | 40 | 20 | ‐ | 20 | 20 | 20 | 100 | 5 wks |
| C: sham acupuncture | 20 | ‐ | 20 | 20 | 20 | 100 | ||||
| total: | 40 | ‐ | 40 | 40 | 40 | 100 | 5 wks | |||
| (8) Guo 2011 | I1: catgut embedding therapy+ Chinese herbal medicine + lifestyle control | ‐ | 90 | 30 | 30 | ‐ | 30 | 30 | 100 | 6 wks |
| I2: catgut embedding therapy + lifestyle control | 30 | 30 | ‐ | 30 | 30 | 100 | ||||
| C: Chinese herbal medicine + lifestyle control | 30 | 30 | ‐ | 30 | 30 | 100 | ||||
| total: | 90 | 90 | ‐ | 90 | 90 | 100 | 6 wks | |||
| (9)He 2012 | I: acupuncture | ‐ | 58 | 30 | ‐ | ‐ | 30 | 30 | 100 | 5 wks |
| C: flash‐fire cupping therapy | 28 | ‐ | ‐ | 28 | 28 | 100 | ||||
| total: | 58 | ‐ | ‐ | 58 | 58 | 100 | 5 wks | |||
| (10) Hsu 2009 | I: auricular acupuncture | ‐ | 60 | 30 | 30 | 23 | 23 | 23 | 77 | 6 wks |
| C: sham auricular acupuncture | 30 | 30 | 22 | 22 | 22 | 73 | ||||
| total: | 60 | 60 | 45 | 45 | 45 | 75 | 6 wks | |||
| (11) Hsu 2005a | I: electro‐acupuncture | 70 | 54 | 27 | 27 | 24 | 24 | 24 | 89 | 13 wks |
| C: sit‐up exercise | 27 | 27 | 22 | 22 | 22 | 81 | ||||
| total: | 54 | 54 | 46 | 46 | 46 | 85 | 13 wks | |||
| (12) Hsu 2005b | I: electro‐acupuncture | ‐ | 72 | 24 | 24 | 22 | 22 | 22 | 92 | 6 wks |
| C1: sit‐up exercise | 24 | 24 | 20 | 20 | 20 | 83 | ||||
| C2: no intervention | 24 | 24 | 21 | 21 | 21 | 88 | ||||
| total: | 72 | 72 | 63 | 63 | 63 | 88 | 6 wks | |||
| (13) Lai 2010 | I: acupuncture | ‐ | 86 | 43 | ‐ | ‐ | 43 | 43 | 100 | 24 wks |
| C: western medicine | 43 | ‐ | ‐ | 43 | 43 | 100 | ||||
| total: | 86 | ‐ | ‐ | 86 | 86 | 100 | 24 wks | |||
| (14) Li 2009 | I: catgut embedding therapy | ‐ | 74 | 36 | ‐ | ‐ | 36 | 36 | 100 | 8 wks |
| C: western medicine | 38 | ‐ | ‐ | 38 | 38 | 100 | ||||
| total: | 74 | ‐ | ‐ | 74 | 74 | 100 | 8 wks | |||
| (15) Li 2014 | I1: acupuncture | ‐ | 153 | 49 | 49 | ‐ | 49 | 49 | 100 | 24 wks |
| I2: acupuncture + western medicine | 53 | 53 | ‐ | 53 | 53 | 100 | ||||
| C: sham acupuncture + western medicine | 51 | 51 | ‐ | 51 | 51 | 100 | ||||
| total: | 153 | 153 | ‐ | 153 | 153 | 100 | 24 wks | |||
| (16)Li L 2006 | I1: electro‐acupuncture + lifestyle control | ‐ | 90 | 30 | ‐ | 26 | 26 | 26 | 87 | 100 days |
| I2: electro‐auricular acupuncture + auricular acupressure + lifestyle control | 30 | ‐ | 29 | 29 | 29 | 97 | ||||
| C: lifestyle control | 30 | ‐ | 30 | 30 | 30 | 100 | ||||
| total: | 90 | ‐ | 85 | 85 | 85 | 94 | 100 days | |||
| (17) Lien 2012 | I1: auricular acupuncture | ‐ | 90 | 30 | 30 | 24 | 24 | 24 | 80 | 4 wks |
| I2: auricular acupressure | 30 | 30 | 24 | 24 | 24 | 80 | ||||
| C: sham auricular acupuncture | 30 | 30 | 23 | 23 | 23 | 77 | ||||
| total: | 90 | 90 | 71 | 71 | 71 | 79 | 4 wks | |||
| (18) Liu 2010 | I1: catgut embedding therapy | ‐ | 67 | 22 | 21 | 21 | 21 | 21 | 95 | 24 wks |
| I2: catgut embedding therapy + Chinese herbal medicine | 23 | 18 | 18 | 18 | 18 | 78 | ||||
| C: Chinese herbal medicine | 22 | 20 | 20 | 20 | 20 | 91 | ||||
| total: | 67 | 59 | 59 | 59 | 59 | 88 | 24 wks | |||
| (19) Liu 2011 | I: electro‐acupuncture | ‐ | 60 | 30 | 30 | ‐ | 30 | 30 | 100 | 8 wks |
| C: low‐frequency electric stimulation therapy | 30 | 30 | ‐ | 30 | 30 | 100 | ||||
| total: | 60 | 60 | ‐ | 60 | 60 | 100 | 8 wks | |||
| (20) Lu 2014 | I: catgut embedding therapy + western medicine | ‐ | 32 | 20 | ‐ | ‐ | 20 | 20 | 100 | 12 wks |
| C: western medicine | 12 | ‐ | ‐ | 12 | 12 | 100 | ||||
| total: | 32 | ‐ | ‐ | 32 | 32 | 100 | 12 wks | |||
| (21) Luo 2006 | I1: electro‐acupuncture | ‐ | 60 | 20 | 20 | ‐ | 20 | 20 | 100 | 3 courses (days unclear) |
| I2: acupuncture | 20 | 20 | ‐ | 20 | 20 | 100 | ||||
| C: no intervention | 20 | 20 | ‐ | 20 | 20 | 100 | ||||
| total: | 60 | 60 | ‐ | 60 | 60 | 100 | 3 courses (days unclear) | |||
| (22) Mi 2005 | I: acupuncture | ‐ | 120 | 80 | ‐ | ‐ | 80 | 80 | 100 | 12 wks |
| C: lifestyle control | 40 | ‐ | ‐ | 40 | 40 | 100 | ||||
| total: | 120 | ‐ | ‐ | 120 | 120 | 100 | 12 wks | |||
| (23) Pan 2010 | I: acupuncture + lifestyle control | ‐ | 74 | 48 | ‐ | ‐ | 48 | 48 | 100 | 5 wks |
| C: sham acupuncture + lifestyle control | 26 | ‐ | ‐ | 26 | 26 | 100 | ||||
| total: | 74 | ‐ | ‐ | 74 | 74 | 100 | 5 wks | |||
| (24) Rerksuppaphol 2011 | I: electro‐acupuncture | ‐ | 45 | 22 | 22 | 22 | 22 | 22 | 100 | 8 wks |
| C: transcutaneous electrical acupoint stimulation | 23 | 23 | 23 | 23 | 23 | 100 | ||||
| total: | 45 | 45 | 45 | 45 | 45 | 100 | 8 wks | |||
| (25) Schukro 2014 | I: electro‐auricular acupuncture | ‐ | 56 | 28 | 28 | ‐ | 22 | 22 | 79 | 10 wks |
| C: sham auricular acupuncture | 28 | 28 | ‐ | 23 | 23 | 82 | ||||
| total: | 56 | 56 | ‐ | 45 | 45 | 80 | 10 wks | |||
| (26) Shan 2008 | I: acupuncture + lifestyle control | 112 | 72 | ‐ | ‐ | 72 | 72 | 100 | 4 wks | |
| C: lifestyle control | 40 | ‐ | ‐ | 40 | 40 | 100 | ||||
| total: | 112 | ‐ | ‐ | 112 | 112 | 100 | 4 wks | |||
| (27) Shu 2011 | I1: electro‐acupuncture + lifestyle control | ‐ | 45 | 15 | ‐ | ‐ | 15 | 15 | 100 | 6 wks |
| I2: auricular acupressure + lifestyle control | 15 | ‐ | ‐ | 15 | 15 | 100 | ||||
| C: moxibustion + lifestyle control | 15 | ‐ | ‐ | 15 | 15 | 100 | ||||
| total: | 45 | ‐ | ‐ | 45 | 45 | 100 | 6 wks | |||
| (28) Su 2013 | I: acupuncture + Chinese herbal medicine + lifestyle control | ‐ | 80 | 40 | ‐ | ‐ | 40 | 40 | 100 | 12 wks |
| C: Chinese herbal medicine + lifestyle control | 40 | ‐ | ‐ | 40 | 40 | 100 | ||||
| total: | 80 | ‐ | ‐ | 80 | 80 | 100 | 12 wks | |||
| (29) Tao 2009 | I: catgut embedding therapy + Chinese herbal medicine | ‐ | 42 | 22 | ‐ | ‐ | 22 | 22 | 100 | 12 wks |
| C: Chinese herbal medicine | 20 | ‐ | ‐ | 20 | 20 | 100 | ||||
| total: | 42 | ‐ | ‐ | 42 | 42 | 100 | 12 wks | |||
| (30) Tao 2010 | I1: catgut embedding therapy + Chinese herbal medicine | ‐ | 61 | 22 | ‐ | ‐ | 18 | 18 | 82 | 12 wks |
| I2: catgut embedding therapy | 20 | ‐ | ‐ | 19 | 19 | 95 | ||||
| C: Chinese herbal medicine | 19 | ‐ | ‐ | 17 | 17 | 89 | ||||
| total: | 61 | ‐ | ‐ | 54 | 54 | 88 | 12 wks | |||
| (31) Tong 2011 | I: acupuncture + lifestyle control | ‐ | 118 | 76 | ‐ | ‐ | 76 | 76 | 100 | 5 wks |
| C: acupuncture + lifestyle control | 42 | ‐ | ‐ | 42 | 42 | 100 | ||||
| total: | 118 | ‐ | ‐ | 118 | 118 | 100 | 5 wks | |||
| (32) Wang 2014 | I: acupuncture + lifestyle control | ‐ | 100 | 50 | ‐ | ‐ | 50 | 50 | 100 | 24 wks |
| C: Chinese herbal medicine + lifestyle control | 50 | ‐ | ‐ | 50 | 50 | 100 | ||||
| total: | 100 | ‐ | ‐ | 100 | 100 | 100 | 24 wks | |||
| (33) Wang X 2006 | I1: electro‐acupuncture | ‐ | 60 | 20 | ‐ | ‐ | 20 | 20 | 100 | 6 wks |
| I2: electro‐acupuncture + Chinese herbal medicine | 20 | ‐ | ‐ | 20 | 20 | 100 | ||||
| C: Chinese herbal medicine | 20 | ‐ | ‐ | 20 | 20 | 100 | ||||
| total: | 60 | ‐ | ‐ | 60 | 60 | 100 | 6 wks | |||
| (34) Wu 2009 | I: catgut embedding therapy + lifestyle control | ‐ | 60 | 30 | ‐ | ‐ | 30 | 30 | 100 | 12 wks |
| C: western medicine + lifestyle control | 30 | ‐ | ‐ | 30 | 30 | 100 | ||||
| total: | 60 | ‐ | ‐ | 60 | 60 | 100 | 12 wks | |||
| (35) Xing 2009 | I: acupuncture + lifestyle control | ‐ | 67 | 33 | ‐ | 31 | 31 | 31 | 94 | 51 days |
| C: lifestyle control | 34 | ‐ | 30 | 30 | 30 | 88 | ||||
| total: | 67 | ‐ | 61 | 61 | 61 | 91 | 51 days | |||
| (36) Xiong 2011 | I: acupuncture | ‐ | 54 | 18 | ‐ | ‐ | 18 | 18 | 100 | 8 wks |
| C1: needle‐knife | 18 | ‐ | ‐ | 18 | 18 | 100 | ||||
| C2: western medicine | 18 | ‐ | ‐ | 18 | 18 | 100 | ||||
| total: | 54 | ‐ | ‐ | 54 | 54 | 100 | 8 wks | |||
| (37) Xu 2008 | I: catgut embedding therapy + lifestyle control | ‐ | 60 | 30 | ‐ | ‐ | 30 | 30 | 100 | 8 wks |
| C: Chinese herbal medicine + lifestyle control | 30 | ‐ | ‐ | 30 | 30 | 100 | ||||
| total: | 60 | ‐ | ‐ | 60 | 60 | 100 | 9 wks | |||
| (38) Xu 2011 | I: acupuncture | ‐ | 150 | 100 | ‐ | ‐ | 100 | 100 | 100 | |
| C: western medicine | 50 | ‐ | ‐ | 50 | 50 | 100 | ||||
| total: | 150 | ‐ | ‐ | 150 | 150 | 100 | 9 wks | |||
| (39) Yan 2011 | I: acupuncture + lifestyle control | ‐ | 120 | 60 | ‐ | 57 | 57 | 57 | 95 | 6 wks |
| C: bian‐stone + lifestyle control | 60 | ‐ | 57 | 57 | 57 | 95 | ||||
| total: | 120 | ‐ | 114 | 114 | 114 | 95 | 6 wks | |||
| (40) Ye 2010 | I: electro‐acupuncture + lifestyle control | ‐ | 96 | 48 | ‐ | ‐ | 48 | 48 | 100 | 12 wks |
| C: lifestyle control | 48 | ‐ | ‐ | 48 | 48 | 100 | ||||
| total: | 96 | ‐ | ‐ | 96 | 96 | 100 | 12 wks | |||
| (41) Yin 2006 | I: acupuncture | ‐ | 108 | 50 | 50 | ‐ | 50 | 50 | 100 | 12 wks |
| C: acupoint plaster application | 58 | 58 | ‐ | 58 | 58 | 100 | ||||
| total: | 108 | 108 | ‐ | 108 | 108 | 100 | 12 wks | |||
| (42) Zhang 2005 | I: acupuncture | ‐ | 60 | 30 | ‐ | ‐ | 30 | 30 | 4 wks | |
| C: magnet plastering therapy | 30 | ‐ | ‐ | 30 | 30 | |||||
| total: | 60 | ‐ | ‐ | 60 | 60 | 4 wks | ||||
| (43) Zhang 2011 | I1: electro‐acupuncture + lifestyle control | ‐ | 78 | 26 | ‐ | ‐ | 26 | 26 | 100 | 8 wks |
| I2: electro‐acupuncture + computerized intermediate‐frequency + lifestyle control | 26 | ‐ | ‐ | 26 | 26 | 100 | ||||
| C: lifestyle control | 26 | ‐ | ‐ | 26 | 26 | 100 | ||||
| total: | 78 | ‐ | ‐ | 78 | 78 | 100 | 8 wks | |||
| (44) Zhang 2012 | I: electro‐acupuncture | ‐ | 30 | 15 | 15 | ‐ | 15 | 15 | 100 | 4 wks |
| C: sham acupuncture | 15 | 15 | ‐ | 15 | 15 | 100 | ||||
| total: | 30 | 30 | ‐ | 30 | 30 | 100 | 4 wks | |||
| (45) Zhang Y 2007 | I: electro‐acupuncture + lifestyle control | ‐ | 64 | 32 | ‐ | ‐ | 32 | 32 | 100 | 8 wks |
| C: lifestyle control | 32 | ‐ | ‐ | 32 | 32 | 100 | ||||
| total: | 64 | ‐ | ‐ | 64 | 64 | 100 | 8 wks | |||
| (46) Zhao 2010 | I: electro‐acupuncture + lifestyle control | ‐ | 72 | 35 | ‐ | ‐ | 30 | 30 | 86 | 8 wks |
| C: lifestyle control | 37 | ‐ | ‐ | 30 | 30 | 81 | ||||
| total: | 72 | ‐ | ‐ | 60 | 60 | 83 | 8 wks | |||
| (47) Zhao 2011 | I: electro‐acupuncture + transcutaneous electrical acupoint stimulation | ‐ | 70 | 35 | ‐ | ‐ | 35 | 35 | 100 | 4 wks |
| C: sham acupuncture + transcutaneous electrical acupoint stimulation | 35 | ‐ | ‐ | 35 | 35 | 100 | ||||
| total: | 70 | ‐ | ‐ | 70 | 70 | 100 | 4 wks | |||
| (48) Zhu 2007 | I1: acupuncture+ auricular acupuncture + lifestyle control | ‐ | 120 | 42 | ‐ | ‐ | 42 | 42 | 100 | 12 wks |
| I2: acupuncture+ auricular acupuncture | 40 | ‐ | ‐ | 40 | 40 | 100 | ||||
| C: lifestyle control | 38 | ‐ | ‐ | 38 | 38 | 100 | ||||
| total: | 120 | ‐ | ‐ | 120 | 120 | 100 | 12 wks | |||
| Grand total | All interventions | 61 | 2176 | 2116 | ||||||
| All comparators | 50 | 1630 | 1578 | |||||||
| All interventions and comparators | 101 | 3806 | 3694 | |||||||
aAccording to power calculation in study publication or report
bDuration of intervention and/or follow‐up under randomised conditions until end of study
"‐" denotes not reported
C: comparator; I: intervention; ITT: intention‐to‐treat; N/A: not applicable; PCOS: polycystic ovarian syndrome; wks: weeks
We provided information about potentially relevant ongoing studies including trial identifier in the 'Characteristics of ongoing studies' table and in Appendix 5 'Matrix of study endpoints (publications and trial documents)'. We also tried to find the protocol of each included study, either in databases of ongoing trials, in publications of study designs, or both, and specify data in Appendix 5.
We emailed all authors of included studies to enquire whether they were willing to answer questions regarding their trials. Appendix 12 shows the results of this survey. Thereafter, we sought relevant missing information on the trial from the study authors of the article, if required.
Dealing with duplicate and companion publications
In the event of duplicate publications, companion documents or multiple reports of a primary study, we maximised the yield of information by collating all available data across all known publications and thus providing the most complete data set. In case of doubt, we have given priority to the publication reporting the longest follow‐up associated with our primary or secondary outcomes.
Assessment of risk of bias in included studies
One review author (LY) assessed the risk of bias of each included study, and another review author (LJ) has checked. We resolved disagreements by consensus, or by consultation with a third review author (SMY). In cases of disagreement, we consulted the rest of the group and make a judgement based on consensus.
We used the cochrane risk of bias tool (Higgins 2011a; Higgins 2011b) and assessed the following criteria.
Random sequence generation (selection bias).
Allocation concealment (selection bias).
Blinding of participants and personnel (performance bias).
Blinding of outcome assessment (detection bias).
Incomplete outcome data (attrition bias).
Selective reporting (reporting bias).
Other potential sources of bias.
We judged the above 'Risk of bias criteria' as 'low risk', 'high risk' or 'unclear risk' and individual bias items have been evaluated as described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011a). We present a risk of bias graph and a risk of bias summary. The impact of individual bias domains on study results at the endpoint and study levels have also been assessed. In case of high risk of selection bias all endpoints investigated in the associated study has been marked as 'high risk'.
For performance bias (blinding of participants and personnel) and detection bias (blinding of outcome assessors) we evaluated the risk of bias separately for each outcome (Hróbjartsson 2013). We noted whether the outcomes were measured subjectively or objectively , for example if body weight was measured by participants or study personnel.
We considered the implications of missing outcome data from individual participants such as high drop‐out rates (e.g. above 15%) or disparate attrition rates (e.g. difference of 10% or more between study arms).
We assessed outcome reporting bias by integrating the results of Appendix 5 ('Matrix of study endpoints (publications and trial documents)', 'Examination of outcome reporting bias' (Appendix 6), and section 'Outcomes (outcomes reported in abstract of publication)' of the 'Characteristics of included studies' (Kirkham 2010). This analysis formed the basis for the judgment of selective reporting (reporting bias).
We defined the following endpoints as subjective outcomes.
Adverse events.
Health‐related quality of life.
Physical activity, depending on measurement (personnel or participant).
We defined the following endpoints as objective outcomes.
Morbidity.
Lipid levels.
Glycaemic control.
Socioeconomic effects.
Weight loss, depending on measurement (personnel or participant).
Blood pressure, depending on measurement (personnel or participant).
Change in anthropometric measures other than weight loss.
Measures of treatment effect
The dichotomous data were expressed as odds ratios (ORs) or risk ratios (RRs) with 95% confidence intervals (CIs). Continuous data were expressed as mean differences (MDs) with 95% CIs and time‐to‐event data were expressed as hazard ratios (HRs) with 95% CIs.
Unit of analysis issues
We took into account the level at which randomisation occurred, such as cross‐over trials, cluster‐randomised trials and multiple observations for the same outcome.
Dealing with missing data
Íf possible, we obtained relevant missing data from authors, and evaluated important numerical data such as screened, randomly assigned participants as well as intention‐to‐treat (ITT), and as‐treated and per‐protocol (PP) populations. We investigated attrition rates, (e.g. drop‐outs, losses to follow‐up, withdrawals), and critically appraised issues concerning missing data and imputation methods (e.g. last observation carried forward (LOCF)).
Assessment of heterogeneity
In the event of substantial clinical, methodological or statistical heterogeneity, we planned not to report results as the pooled effect estimate in a meta‐analysis.
We identified heterogeneity by visual inspection of the forest plots and by using a standard Chi² test with a significance level of α = 0.1. In view of the low power of this test, we also considered the I² statistic, which quantifies inconsistency across studies to assessed the impact of heterogeneity on the meta‐analysis (Higgins 2002; Higgins 2003); where an I² statistic of 75% or more indicates a considerable level of heterogeneity (Higgins 2011a).
Assessment of reporting biases
If 10 studies or more were included for a given outcome, the funnel plots will be used to assess small study effects. Due to several explanations for funnel plot asymmetry the results will interpreted carefully (Sterne 2011).
Data synthesis
Unless there is good evidence for homogeneous effects across studies we will primarily summarise low‐risk of bias data by means of a random‐effects model (Wood 2008). Random‐effects meta‐analyses were interested in consideration of the whole distribution of effects, ideally by presenting a prediction interval (Higgins 2009). A prediction interval specifies a predicted range for the true treatment effect in an individual study (Riley 2011). In addition, the statistical analyses were performed according to the statistical guidelines referenced in the latest version of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011a).
Subgroup analysis and investigation of heterogeneity
We expected the following characteristics to introduce clinical heterogeneity, and planned to carry out the following subgroup analysis with investigation of interactions:
Types of participants.
Type and duration of treatment.
Type of control intervention.
Type and time of outcome measurement.
Degree of overweight or obesity.
Age (depending on data).
Gender.
Sensitivity analysis
We planned to perform sensitivity analyses to explore the influence of the following factors (when applicable) on effect sizes by restricting the analysis to:
Published studies.
Taking into account risk of bias, as specified in the 'Assessment of risk of bias in included studies' section.
Very long or large studies to establish the extent to which they dominate the results.
Studies using the following filters: diagnostic criteria, imputation, language of publication, source of funding (industry versus other), or country.
We also tested the robustness of results by repeating the analysis using different measures of effect size (RR, OR etc) and different statistical models (fixed‐effect and random‐effects models).
Acknowledgements
The review authors thank Gudrun Paletta for her help with the protocol and the review. We thank Karla Bergerhoff and Maria‐Inti Metzendorf for designing the search strategies and undertaking the searches. We are grateful to Robin Fritts, an American teacher of Shanghai University of Traditional Chinese Medicine, for proofreading our review.
Appendices
Appendix 1. Search strategies
| Cochrane Library |
| #1 MeSH descriptor Obesity explode all trees #2 MeSH descriptor Weight Gain explode all trees #3 MeSH descriptor Weight Loss explode all trees #4 MeSH descriptor Body Mass Index explode all trees #5 (overweight in All Text or (over in All Text and weight in All Text) ) #6 (adipos* in All Text or (fat in All Text and overload in All Text and syndrom* in All Text) #7 (overeat* in All Text or (over in All Text and eat* in All Text) ) #8 (overfeed* in All Text or (over in All Text and feed* in All Text) ) #9 (weight in All Text and (cycl* in All Text or reduc* in All Text or los* in All Text or maint* in All Text or (decreas*or in All Text and watch* in All Text) or control* in All Text) #10 (weight in All Text and (gain in All Text or chang* in All Text) ) #11 (body in All Text and mass in All Text and ind* in All Text) #12 MeSH descriptor Skinfold thickness explode all trees #13 MeSH descriptor Waist‐Hip Ratio explode all trees #14 MeSH descriptor Abdominal fat explode all trees #15 MeSH descriptor Overweight explode all trees #16 (adipos* in All Text or obes* in All Text) #17 (waist‐hip in All Text and ratio* in All Text) #18 ( (skinfold in All Text and thickness* in All Text) or (abdominal in All Text and fat* in All Text) #19 (#1 or #2 or #3 or #4 or #5 or #6 or #7 or #8 or #9 or #10 or #11 or #12 or #13 or #14 or #15 or #16 or #17 or #18) #20 MeSH descriptor Acupuncture explode all trees #21 MeSH descriptor Acupuncture therapy explode all trees #22 MeSH descriptor Acupressure explode all trees #23 (acupuncture in All Text or acupressure in All Text or acupoint in All Text) #24 MeSH descriptor Electroacupuncture explode all trees #25 (electro‐acupuncture in All Text or electroacupuncture in All Text) #26 (#20 or #21 or #22 or #23 or #24 or #25) #27 (#19 and #26) |
| MEDLINE (Ovid SP) |
| 1. exp Acupuncture/ 2. exp Acupuncture Therapy/ 3. exp Acupressure/ 4. (acupuncture or acupressure or acupoint).tw,ot. 5. exp Electroacupuncture/ 6. (electro‐acupuncture or electroacupuncture).tw,ot. 7. or/1‐6 8. exp Obesity/ 9. exp weight gain/ or exp weight loss/ 10. exp body mass index/ or exp skinfold thickness/ or exp waist‐hip ratio/ 11. exp Abdominal Fat/ 12. exp Overweight/ 13. (overweight$ or over weight$).tw,ot. 14. fat overload syndrom$.tw,ot. 15. (overeat$ or over eat$).tw,ot. 16. (overfeed$ or over feed$).tw,ot. 17. (adipos$ or obes$).tw,ot. 18. (weight adj3 (cyc$ or reduc$ or los$ or maint$ or decreas$ or watch$ or control$ or gain$ or chang$)).tw,ot. 19. (body mass ind$ or waist‐hip ratio$).tw,ot. 20. skinfold thickness$.tw,ot. 21. abdominal fat$.tw,ot. 22. or/8‐21 23. 7 and 22 24. randomized controlled trial.pt. 25. controlled clinical trial.pt. 26. randomi?ed.ab. 27. placebo.ab. 28. drug therapy.fs. 29. randomly.ab. 30. trial.ab. 31. groups.ab. 32. or/24‐31 33. Meta‐analysis.pt. 34. exp Technology Assessment, Biomedical/ 35. exp Meta‐analysis/ 36. exp Meta‐analysis as topic/ 37. hta.tw,ot. 38. (health technology adj6 assessment$).tw,ot. 39. (meta analy$ or metaanaly$ or meta?analy$).tw,ot. 40. ( (review$ or search$) adj10 (literature$ or medical database$ or medline or pubmed or embase or cochrane or cinhal or psychinfo or psychlit or healthstar or biosis or current content$ or systemat$)).tw,ot. 41. or/33‐40 42. (comment or editorial or historical‐article).pt. 43. 41 not 42 44. 32 or 43 45. 23 and 44 46. (animals not (animals and humans)).sh. 47. 45 not 46 |
| EMBASE (Ovid SP) |
| 1. exp acupuncture/ 2. exp acupressure/ 3. exp electroacupuncture/ 4. (acupuncture or acupressure or acupoint).tw,ot. 5. (electro‐acupuncture or electroacupuncture).tw,ot. 6. or/1‐5 7. exp Obesity/ 8. exp weight change/ or exp weight control/ or exp weight gain/ or exp weight reduction/ 9. exp body mass/ or exp waist circumference/ or exp waist hip ratio/ 10. (obes$ or overweight or over weight).ab,ti. 11. (overeat or over eat or overfeed or over feed or fat overload syndrom$).ab,ti. 12. (weight adj6 (cyc$ or reduc$ or los$ or maint$ or decreas$ or watch$ or control or chang$ or gain)).ab,ti. 13. (body mass ind$ or waist hip ratio or waist circumferenc$).ab,ti. 14. adipos$.ab,ti. 15. exp skinfold thickness/ 16. (abdominal fat or skinfold thickness).ab,ti. 17. exp skinfold thickness/ 18. exp abdominal fat/ 19. or/7‐18 20. 6 and 19 21. exp Randomized Controlled Trial/ 22. exp Controlled Clinical Trial/ 23. exp Clinical Trial/ 24. exp Comparative Study/ 25. exp Drug comparison/ 26. exp Randomization/ 27. exp Crossover procedure/ 28. exp Double blind procedure/ 29. exp Single blind procedure/ 30. exp Placebo/ 31. exp Prospective Study/ 32. ( (clinical or control$ or comparativ$ or placebo$ or prospectiv$ or randomi?ed) adj3 (trial$ or stud$)).ab,ti. 33. (random$ adj6 (allocat$ or assign$ or basis or order$)).ab,ti. 34. ( (singl$ or doubl$ or trebl$ or tripl$) adj6 (blind$ or mask$)).ab,ti. 35. (cross over or crossover).ab,ti. 36. or/21‐35 37. exp meta analysis/ 38. (metaanaly$ or meta analy$ or meta?analy$).ab,ti,ot. 39. ( (review$ or search$) adj10 (literature$ or medical database$ or medline or pubmed or embase or cochrane or cinhal or psychinfo or psychlit or healthstar or biosis or current content$ or systematic$)).ab,ti,ot. 40. exp Literature/ 41. exp Biomedical Technology Assessment/ 42. hta.tw,ot. 43. (health technology adj6 assessment$).tw,ot. 44. or/37‐43 45. (comment or editorial or historical‐article).pt. 46. 44 not 45 47. 36 or 46 48. 20 and 47 |
| AcuTrials |
|
Fast search (each line run separately): obesity = 26 obese = 8 overweight = 5 = 27 unique results |
| ClinicalTrials.gov |
|
Fast search obesity | acupuncture overweight | acupuncture |
| ICTRP Search Portal |
|
Fast search obesity or overweight acupuncture |
| AMED (Ovid SP) |
| 1 exp Acupuncture/ 2 exp Acupuncture therapy/ 3 exp Acupressure/ 4 exp Electroacupuncture/ 5 exp Acupoints/ 6 (acupuncture or acupressure or acupoint*).tw. 7 (electro‐acupuncture or electroacupuncture).tw. 8 or/1‐7 9 exp Obesity/ 10 exp Weight loss/ 11 exp body mass index/ 12 skinfold thickness.mp. 13 waist‐hip‐ratio.mp. 14 abdominal fat.mp. 15 overweight.mp. 16 (overeat or over eat).tw. 17 (adipos* or obes*).tw. 18 (weight adj (cyc* or reduc* or los* or maint* or decreas* or watch* or control* or gain* or chang*)).tw. 19 or/9‐18 20 8 and 19 31 (animals not (human and animal)).sh. 33 20 not 31 |
| CBM (Chinese Biomedical Medicine Database) |
| 1. MeSH: fei pang zheng/all trees/XL/ZL/ZX 2. MeSH: fei pang/all trees 3. #2 OR #1 4. MeSH: zhen ci liao fa/all trees 5. MeSH: zhen jiu liao fa/all trees 6. MeSH: xue wei liao fa/all trees 7. MeSH: xue wei, er zhen, Ear/all trees 8. #7 OR #6 OR #5 OR #4 9. #8 AND #2 10. #9 OR #1 11. sui ji dui zhao shi yan 12. lin chuang dui zhao shi yan 13. xi tong ping jia 14. xi tong zong su 15. meta fen xi 16. hui cui fen xi 17. sui ji fen pei 18. shuang mang fa/all trees 19. dan mang fa/all trees 20. #19 OR #18 OR #17 OR #16 OR #15 OR #14 OR #13 OR #12 OR #11 21. shuang mang 22. dan mang 23. san mang 24. mang fa 25. an wei ji 26. sui ji 27. yan jiu she ji 28. #27 OR #26 OR #25 OR #24 OR #23 OR #22 OR #21 29. lin chuang yan jiu 30. lin chuang liao xiao 31. lin chuang xiao guo 32. lin chuang shi yan 33. lin chuang ping jia 34. lin chuang guan cha 35. #34 OR #33 OR #32 OR #31 OR #30 OR #29 36. #36 OR #28 37. ping jia yan jiu/all trees 38. sui fang yan jiu/all trees 39. qian zhan xing yan jiu/all trees 40. #39 OR #38 OR #37 41. Title: dui zhao 42. Title: dui bi 43. Title: bi jiao 44. Title: zi yuan 45. #44 OR #43 OR #42 OR #41 46. Abstract: dui zhao 47. Abstract: dui bi 48. Abstract: bi jiao 49. Abstract: zi yuan 50. #49 OR #48 OR #47 OR #46 51. Key word: dui zhao 52. Key word: dui bi 53. Key word: bi jiao 54. Key word: zi yuan 55. #54 OR #53 OR #52 OR #51 56. #55 OR #50 OR #45 OR #40 57. #56 OR #36 OR #20 58. ((#57) AND (#8) AND (#3)) AND (ren lei[Feature word]) |
| CNKI (China National Knowledge Infrastructure) |
| 1. Topic: fei pang zheng or fei pang 2. Title: fei pang zheng or fei pang 3. key word: fei pang zheng or fei pang 4. #3 or #2 or #1 5. topic: zhen jiu or zhen ci 6. Title: zhen jiu or zhen ci 7. key word: zhen jiu or zhen ci 8. #7 or #6 or #5 9. #8 and #4 |
| VIP (VIP Database for Chinese Technical Periodicals) |
| 1. Title/Keyword = zhen jiu or Any field = zhen jiu or Abstract = zhen jiu 2. Title/Keyword = fei pang 3. 2 and 1 |
| Digital Journal of Wanfang Data |
| 1. Title: zhenjiu 2. Keyword: zhenjiu 3. 2 or 1 4. Title: fei pang 5. Keyword: fei pang 6. abstract: fei pang 7. 6 or 5 or 4 8. Title: chao zhong 9. Keyword: chao zhong 10. abstract: chao zhong 10. 10 or 9 or 8 11. 10 and 7 and 3 |
Appendix 2. Description of interventions
| Intervention(s) [route, frequency, total dose/day] | Adequatea intervention [Yes / No] | Comparator(s) [route, frequency, total dose/day] | Adequatea comparator [Yes / No] | |
| Chen 2009 | I1: electro‐acupuncture | Y | No intervention | Y |
| I2: acupuncture | ||||
| Chen 2013 | Catgut embedding therapy | Y | Lifestyle control | Y |
| Dang 2012 | I1: electro‐acupuncture + lifestyle control | Y | Lifestyle control | Y |
| I2: computerized intermediate‐frequency therapy + electro‐acupuncture + lifestyle control | ||||
| Ding 2013 | Acupuncture + lifestyle control | Y | Lifestyle control | Y |
| Duan 2013 | Acupuncture + lifestyle controlC | Y | Foot holographic scraping therapy + lifestyle control | Y |
| Feng 2014 | Catgut embedding therapy + lifestyle control | Y | Lifestyle control | Y |
| Gucel 2012 | Acupuncture | Y | Sham acupuncture | Y |
| Guo 2011 | I1: catgut embedding therapy + Chinese herbal medicine + lifestyle control | Y | Chinese herbal medicine + lifestyle control | Y |
| I2: catgut embedding therapy + lifestyle control | ||||
| He 2012 | Acupuncture | Y | Flash‐fire cupping therapy | Y |
| Hsu 2009 | Auricular acupuncture | Y | Sham auricular acupuncture | Y |
| Hsu 2005a | Electro‐acupunctureI | Y | Sit‐up exercise | Y |
| Hsu 2005b | Electro‐acupuncture | Y | C1: sit‐up exercise | Y |
| C2: no intervention | ||||
| Lai 2010 | Acupuncture | Y | Western medicine | Y |
| Li 2009 | Catgut embedding therapy | Y | Western medicine | Y |
| Li 2014 | I1: acupuncture + western medicine | Y | Sham acupuncture + western medicine | Y |
| I2: acupuncture | Y | |||
| Li L 2006 | I1: electro‐acupuncture + lifestyle control | Y | Lifestyle control | Y |
| I2: electro‐auricular acupuncture + auricular acupressure + lifestyle control | N | |||
| Lien 2012 | I1: auricular acupuncture | Y | Sham auricular acupuncture | Y |
| I2: auricular acupressure | N | |||
| Liu 2010 | I1: catgut embedding therapy | Y | Chinese herbal medicine | Y |
| I2: catgut embedding therapy + Chinese herbal medicine | Y | |||
| Liu 2011 | Electro‐acupuncture | Y | Low‐frequency electric stimulation therapy | Y |
| Lu 2014 | Catgut embedding therapy + western medicine | Y | Western medicine | Y |
| Luo 2006 | I1: electro‐acupuncture | Y | No intervention | Y |
| I2: acupuncture | ||||
| Mi 2005 | Acupuncture | Y | Lifestyle control | Y |
| Pan 2010 | Acupuncture + lifestyle control | Y | Sham acupuncture + lifestyle control | Y |
| Rerksuppaphol 2011 | Electro‐acupuncture | Y | Transcutaneous electrical acupoint stimulation | Y |
| Schukro 2014 | Electro‐auricular acupuncture | Y | Sham auricular acupuncture | Y |
| Shan 2008 | Acupuncture + lifestyle control | Y | Lifestyle control | Y |
| Shu 2011 | I1: electro‐acupuncture + lifestyle control | Y | Moxibustion + lifestyle control | Y |
| I2: auricular acupressure + lifestyle control | N | |||
| Su 2013 | Acupuncture + Chinese herbal medicine + lifestyle control | Y | Chinese herbal medicine + lifestyle control | Y |
| Tao 2009 | Catgut embedding therapy + Chinese herbal medicine | Y | Chinese herbal medicine | Y |
| Tao 2010 | I1: catgut embedding therapy + Chinese herbal medicine | Y | Chinese herbal medicine | Y |
| I2: catgut embedding therapy | ||||
| Tong 2011 | Acupuncture + lifestyle control | Y | Sham acupuncture + lifestyle control | Y |
| Wang 2014 | Acupuncture + lifestyle control | Y | Chinese herbal medicine + lifestyle control | Y |
| Wang X 2006 | I1: electro‐acupuncture | Y | Chinese herbal medicine | Y |
| I2: electro‐acupuncture + Chinese herbal medicine | ||||
| Wu 2009 | Catgut embedding therapy + lifestyle control | Y | Western medicine + lifestyle control | Y |
| Xing 2009 | Acupuncture + lifestyle control | Y | Lifestyle control | Y |
| Xiong 2011 | Acupuncture | Y | C1: needle‐knife | Y |
| C2: western medicine | ||||
| Xu 2008 | Catgut embedding therapy + lifestyle control | Y | Chinese herbal medicine + lifestyle control | Y |
| Xu 2011 | Acupuncture | Y | Western medicine | Y |
| Yan 2011 | Acupuncture + lifestyle control | Y | Bian‐stone + lifestyle control | Y |
| Ye 2010 | Electro‐acupuncture + lifestyle control | Y | Lifestyle control | Y |
| Yin 2006 | Acupuncture | Y | Acupoint plaster application | Y |
| Zhang 2005 | Acupuncture | Y | Magnet plastering therapy | Y |
| Zhang 2011 | I1: electro‐acupuncture + lifestyle control | Y | Lifestyle control | Y |
| I2: electro‐acupuncture + computerized intermediate‐frequency + lifestyle control | ||||
| Zhang 2012 | Electro‐acupuncture | Y | Sham acupuncture | Y |
| Zhang Y 2007 | Electro‐acupuncture + lifestyle control | Y | Lifestyle control | Y |
| Zhao 2010 | Electro‐acupuncture + lifestyle control | Y | Lifestyle control | Y |
| Zhao 2011 | Electro‐acupuncture + transcutaneous electrical acupoint stimulation | Y | Sham acupuncture + transcutaneous electrical acupoint stimulation | Y |
| Zhu 2007 | I1: acupuncture+ auricular acupuncture + lifestyle control | Y | Lifestyle control | Y |
| I2: acupuncture+ auricular acupuncture | Y | |||
| "‐" denotes not reported aThe term 'adequate' refers to sufficient use of the intervention/comparator with regard to dose, dose escalation, dosing scheme, provision for contraindications and other features necessary to establish a fair contrast between intervention and comparator C: comparator; I: intervention; N: no; Y: yes | ||||
Appendix 3. Baseline characteristics (I)
| Intervention(s) and comparator(s) | Duration of intervention (duration of follow‐up) | Description of participants | Study period [year to year] | Country | Setting | Ethnic groups [%] | Duration of disease [mean/range years (SD), or as reported] | |
| Chen 2009 | I1: electro‐acupuncture | 3 wks (‐) | Adults with simple obesity | ‐ | China | Hospital outpatient clinic | Chinese: 100 | 2‐28 |
| I2: acupuncture | ||||||||
| C: no intervention | ||||||||
| Chen 2013 | I: catgut embedding therapy | 8 wks (‐) | Adults with simple obesity | 2012.7‐2012.12 | China | Hospital outpatient clinic | Chinese: 100 | 60 (4) |
| C: lifestyle control | 60 (4) | |||||||
| Dang 2012 | I1: electro‐acupuncture + lifestyle control | 10 wks (‐) | Adults with simple obesity ‐ syndrome differentiation of TCM diagnosed as damp impediment due to stomach heat | 2010.6‐2011.12 | China | Hospital outpatient clinic | Chinese: 100 | 4 (4) |
| I2: computerized intermediate‐frequency therapy + electro‐acupuncture + lifestyle control | 5 (3) | |||||||
| C: lifestyle control | 6 (2) | |||||||
| Ding 2013 | I: acupuncture + lifestyle control | 5 wks (1 year) | Obese patients with type 2 diabetes mellitus | 2010.1‐2012.1 | China | Hospital inpatient and outpatient clinic | Chinese: 100 | ‐ |
| C: lifestyle control | ‐ | |||||||
| Duan 2013 | I: acupuncture + lifestyle control | 4 wks | Adults with simple obesity | 2011.5‐2013.1 | China | University | Chinese: 100 | ≤3 yrs 47% ≤10 yrs 36% >10 yrs 18% |
| C: foot holographic scraping therapy + lifestyle control | 5 wks | Adults with simple obesity | University | ≤3 yrs 42% ≤10 yrs 45% >10 yrs 13% | ||||
| Feng 2014 | I: catgut embedding therapy + lifestyle control | 4 wks (‐) | Adults with simple obesity | 2012.5‐2013.8 | China | Hospital outpatient clinic | Chinese: 100 | 9 (3) |
| C: lifestyle control | 8 (4) | |||||||
| Gucel 2012 | I: acupuncture | 5 wks (‐) | Female obese adults | 2009.1‐2010.1 | Turkey | Hospital outpatient clinic | ‐ ‐ |
‐ |
| C: sham acupuncture | ‐ | |||||||
| Guo 2011 | I1: catgut embedding therapy + Chinese herbal medicine + lifestyle control | 6 wks (‐) | Adults with simple obesity | 2010.1‐2011.3 | China | outpatient clinic | ‐ | <5 yrs 40% 5‐10 yrs 40% >10 yrs 20% |
| I2: catgut embedding therapy + lifestyle control | <5 yrs 43% 5‐10 yrs 43% >10 yrs 13% | |||||||
| C: Chinese herbal medicine + lifestyle control | <5 yrs 50% 5‐10 yrs 33% >10 yrs 17% |
|||||||
| He 2012 | I: acupuncture | 5 wks (‐) | Adults with simple obesity | 2010.7‐2012.3 | China | University outpatient clinic | Chinese: 100 | 2‐5 yrs |
| C: flash‐fire cupping therapy | ||||||||
| Hsu 2009 | I: auricular acupuncture | 6 wks (‐) | Obese women | 2006.1‐2006.12 | China | Hospital outpatient clinic | ‐ | ‐ |
| C: sham auricular acupuncture | ‐ | ‐ | ||||||
| Hsu 2005a | I: electro‐acupuncture | 13 wks (‐) | Obese women | 2002.1‐2002.12 | China | Hospital outpatient clinic | ‐ | ‐ |
| C: sit‐up exercise | ‐ | ‐ | ||||||
| Hsu 2005b | I: electro‐acupuncture | 6 wks (‐) | Obese women | 2002.7‐2003.6 | China | Hospital outpatient clinic | ‐ | ‐ |
| C1: sit‐up exercise | ‐ | ‐ | ||||||
| C2: no intervention | ‐ | ‐ | ||||||
| Lai 2010 | I: acupuncture | 24 wks (‐) | Obesity‐type PCOS patients | 2006.1‐2009.5 | China | Hospital outpatient clinic | Chinese: 100 | 6 (3) |
| C: western medicine | 4 (2) | |||||||
| Li 2009 | I: catgut embedding therapy | 8 wks (‐) | Hypertriglyceridemia patients associated with obesity | 2007.4‐2007.6 | China | ‐ | Chinese: 100 | 3 |
| C: western medicine | 2008.4‐2008.6 | 3 | ||||||
| Li 2014 | I1: acupuncture | 24 wks (‐) | Obesity‐type PCOS patients | 2010.9‐2011.9 | China | Hospital outpatient clinic | Chinese: 100 | 4 |
| I2: acupuncture + western medicine | 4 | |||||||
| C: sham acupuncture + western medicine | 3 | |||||||
| Li L 2006 | I1: electro‐acupuncture + lifestyle control | 100 days (‐) | Teenager simple obesity | 2003.10‐2005.4 | China | Hospital outpatient clinic | Chinese: 100 | ‐ |
| I2: electro‐auricular acupuncture + auricular acupressure + lifestyle control | ‐ | |||||||
| C: lifestyle control | ‐ | |||||||
| Lien 2012 | I1: auricular acupuncture | 4 wks (‐) | Obese women | 2009.8‐2010.3 | China | Hospital outpatient clinic | ‐ | ‐ |
| I2: auricular acupressure | ‐ | |||||||
| C: sham auricular acupuncture | ‐ | |||||||
| Liu 2010 | I1: catgut embedding therapy | 12 wks (12 wks) | Obesity‐type PCOS patients | 2007‐2008 | China | Hospital outpatient clinic | Chinese: 100 | 5 (1) |
| I2: catgut embedding therapy + Chinese herbal medicine | 5 (2) | |||||||
| C: Chinese herbal medicine | 5 (1) | |||||||
| Liu 2011 | I: electro‐acupuncture | 8 wks (‐) | Patients with simple obesity | ‐ | China | University outpatient clinic | Chinese: 100 | 1‐5 |
| C: low‐frequency electric stimulation therapy | 1‐5 | |||||||
| Lu 2014 | I: catgut embedding therapy + western medicine | 12 wks (‐) | Obesity‐type PCOS patients | ‐ | China | Hospital outpatient clinic | Chinese: 100 | 5 (5) |
| C: western medicine | 5 (4) | |||||||
| Luo 2006 | I1: electro‐acupuncture | 3 courses (‐) | Patients with simple obesity | ‐ | China | ‐ | Chinese: 100 | ‐ |
| I2: acupuncture | ‐ | |||||||
| C: no intervention | ‐ | |||||||
| Mi 2005 | I: acupuncture | 12 wks (12 wks) | Patients with simple obesity | ‐ | China | Hospital outpatient clinic | Chinese: 100 | 7 |
| C: lifestyle control | 7 | |||||||
| Pan 2010 | I: acupuncture + lifestyle control | 5 wks (‐) | Patients with simple obesity | 2008.7‐2009.10 | China | Hospital outpatient clinic | Chinese: 100 | 11 (8) |
| C: sham acupuncture + lifestyle control | 11 (8) | |||||||
| Rerksuppaphol 2011 | I: electro‐acupuncture | 8 wks (‐) | Overweight or obese women | 2010.3‐2010.7 | Thailand | Hospital outpatient clinic | ‐ | ‐ |
| C: transcutaneous electrical acupoint stimulation | ‐ | |||||||
| Schukro 2014 | I: electro‐auricular acupuncture | 6 wks (4 wks) | Healthy, obese women | ‐ | Austria | University | ‐ | ‐ |
| C: sham auricular acupuncture | ‐ | |||||||
| Shan 2008 | I: acupuncture + lifestyle control | 4 wks (‐) | Patients with simple obesity | ‐ | China | ‐ | Chinese: 100 | 0.5‐16 |
| C: lifestyle control | ||||||||
| Shu 2011 | I1: electro‐acupuncture + lifestyle control | 6 wks (‐) | Women with simple obesity | ‐ | China | ‐ | Chinese: 100 | ‐ |
| I2: auricular acupressure + lifestyle control | ‐ | |||||||
| C: moxibustion + lifestyle control | ‐ | |||||||
| Su 2013 | I: acupuncture + Chinese herbal medicine + lifestyle control | 12 wks (‐) | Obesity‐type PCOS patients | 2011.1‐2012.6 | China | Hospital outpatient clinic | Chinese: 100 | 6 (2) |
| C: Chinese herbal medicine + lifestyle control | 5 (3) | |||||||
| Tao 2009 | I: catgut embedding therapy + Chinese herbal medicine | 12 wks (‐) | Obesity‐type PCOS patients | 2006.1‐2007.1 | China | Hospital outpatient clinic | Chinese: 100 | 5 (2) |
| C: Chinese herbal medicine | 5 (2) | |||||||
| Tao 2010 | I1: catgut embedding therapy + Chinese herbal medicine | 12 wks (‐) | Obesity‐type PCOS patients | 2007.2‐2008.2 | China | Hospital outpatient clinic | Chinese: 100 | ‐ |
| I2: catgut embedding therapy | ‐ | |||||||
| C: Chinese herbal medicine | ‐ | |||||||
| Tong 2011 | I: acupuncture + lifestyle control | 5 wks (‐) | Patients with simple obesity | 2008.7‐2010.4 | China | Hospital outpatient clinic | Chinese: 100 | 11 (7) |
| C: sham acupuncture + lifestyle control | 11 (8) | |||||||
| Wang 2014 | I: acupuncture + lifestyle control | 12 wks (12 wks) | Patients with simple obesity | ‐ | China | Hospital inpatient and outpatient clinic | Chinese: 100 | 16 (35) |
| C: Chinese herbal medicine + lifestyle control | 19 (42) | |||||||
| Wang X 2006 | I1: electro‐acupuncture | 6 wks (‐) | Patients with simple obesity | ‐ | China | Hospital outpatient clinic | Chinese: 100 | ‐ |
| I2: electro‐acupuncture + Chinese herbal medicine | ‐ | |||||||
| C: Chinese herbal medicine | ‐ | |||||||
| Wu 2009 | I: catgut embedding therapy + lifestyle control | 4 wks (8 wks) | Patients with simple obesity | 2008.8‐2009.5 | China | Hospital outpatient clinic | Chinese: 100 | 8 |
| C: western medicine + lifestyle control | ||||||||
| Xing 2009 | I: acupuncture + lifestyle control | 51 days (‐) | Patients with simple obesity | ‐ | China | Hospital outpatient clinic | Chinese: 100 | ‐ |
| C: lifestyle control | ‐ | |||||||
| Xiong 2011 | I: acupuncture | 8 wks (‐) | Patients with simple obesity | ‐ | China | Hospital outpatient clinic | Chinese: 100 | ‐ |
| C1: needle‐knife | ‐ | |||||||
| C2: western medicine | ‐ | |||||||
| Xu 2008 | I: catgut embedding therapy + lifestyle control | 8 wks (‐) | Patients with simple obesity | 2007.2‐2008.2 | China | outpatient clinic | Chinese: 100 | 8 |
| C: Chinese herbal medicine + lifestyle control | ||||||||
| Xu 2011 | I: acupuncture | 9 wks (‐) | diabetes and obese | 2008.10‐2010.10 | China | Hospital outpatient clinic | Chinese: 100 | 4 (0.1) |
| C: western medicine | 4 (0.2) | |||||||
| Yan 2011 | I: acupuncture + lifestyle control | 6 wks (‐) | Patients with simple obesity | ‐ | China | Hospital outpatient clinic | Chinese: 100 | ‐ |
| C: bian‐stone + lifestyle control | ‐ | |||||||
| Ye 2010 | I: electro‐acupuncture + lifestyle control | 12 wks (‐) | Patients with simple obesity | ‐ | China | Hospital outpatient clinic | Chinese: 100 | 1‐10 |
| C: lifestyle control | ||||||||
| Yin 2006 | I: acupuncture | 12 wks (‐) | Patients with simple obesity | ‐ | China | Hospital inpatient and outpatient clinic | Chinese: 100 | 36 (6) |
| C: acupoint plaster application | 37 (10) | |||||||
| Zhang 2005 | I: acupuncture | 4 wks (‐) | Patients with simple obesity | 2004.12‐2005.3 | China | ‐ | Chinese: 100 | ‐ |
| C: magnet plastering therapy | ‐ | |||||||
| Zhang 2011 | I1: electro‐acupuncture + lifestyle control | 8 wks (‐) | Patients with simple obesity | 2010.2‐2010.10 | China | Hospital outpatient clinic | Chinese: 100 | 4 (4) |
| I2: electro‐acupuncture + computerized intermediate‐frequency + lifestyle control | 6 (3) | |||||||
| C: lifestyle control | 6 (3) | |||||||
| Zhang 2012 | I: electro‐acupuncture | 4 wks (‐) | Patients with simple obesity | ‐ | China | ‐ | Chinese: 100 | ‐ |
| C: sham acupuncture | ‐ | |||||||
| Zhang Y 2007 | I: electro‐acupuncture + lifestyle control | 8 wks (‐) | Patients with simple obesity | ‐ | China | Hospital outpatient clinic | Chinese: 100 | ‐ |
| C: lifestyle control | ‐ | |||||||
| Zhao 2010 | I: electro‐acupuncture + lifestyle control | 8 wks (‐) | Patients with simple obesity | 2008.9‐2009.12 | China | Hospital outpatient clinic | Chinese: 100 | ‐ |
| C: lifestyle control | ‐ | |||||||
| Zhao 2011 | I: electro‐acupuncture + transcutaneous electrical acupoint stimulation | 4 wks (‐) | Patients with simple obesity | ‐ | China | Hospital outpatient clinic | Chinese: 100 | ‐ |
| C: sham acupuncture + transcutaneous electrical acupoint stimulation | ‐ | |||||||
| Zhu 2007 | I1: acupuncture+ auricular acupuncture + lifestyle control | 12 wks (‐) | Patients with simple obesity | ‐ | China | Hospital outpatient clinic | Chinese: 100 | ‐ |
| I2: acupuncture+ auricular acupuncture | ‐ | |||||||
| C: lifestyle control | ‐ | |||||||
| "‐" denotes not reported C: comparator; I: intervention; SD: standard deviation; PCOS: polycystic ovarian syndrome; TCM: Traditional Chinese Medicine; wks: weeks | ||||||||
Appendix 4. Baseline characteristics (II)
| Intervention(s) and comparator(s) | Sex [female %] | Age [mean/range years (SD), or as reported] | HbA1c [%] | BMI [mean kg/m² (SD)] | Comedications/Cointerventions | Comorbidities | |
| Chen 2009 | I1: electro‐acupuncture | ‐ | ‐ | ‐ | ‐ | none | none |
| I2: acupuncture | ‐ | ‐ | ‐ | ‐ | none | none | |
| C: no intervention | ‐ | ‐ | ‐ | ‐ | none | none | |
| all: | 63 | 22‐58 | ‐ | ‐ | none | none | |
| Chen 2013 | I: catgut embedding therapy | 70 | 29 (13) | ‐ | ‐ | none | none |
| C: lifestyle control | 50 | 28 (13) | ‐ | ‐ | none | none | |
| all: | 60 | ‐ | ‐ | ‐ | none | none | |
| Dang 2012 | I1: electro‐acupuncture + lifestyle control | ‐ | 32 (8) | ‐ | 28 (2) | none | none |
| I2: computerized intermediate‐frequency therapy + electro‐acupuncture + lifestyle control | ‐ | 30 (10) | ‐ | 27 (2) | none | none | |
| C: lifestyle control | ‐ | 31 (10) | ‐ | 28 (3) | none | none | |
| all: | 69 | ‐ | ‐ | ‐ | none | none | |
| Ding 2013 | I: acupuncture + lifestyle control | 53 | 52 (8) | 8 (2) | 27 (3) | Glycaemic control (not specified) | Type 2 diabetes |
| C: lifestyle control | 53 | 53 (9) | 7 (2) | 27 (3) | Glycaemic control (not specified) | Type 2 diabetes | |
| all: | 53 | ‐ | ‐ | ‐ | Glycaemic control (not specified) | Type 2 diabetes | |
| Duan 2013 | I: acupuncture + lifestyle control | 69 | 33 (8) | ‐ | 28(4) | none | none |
| C: foot holographic scraping therapy + lifestyle control | 71 | 34 (7) | ‐ | 29(4) | none | none | |
| all: | 70 | ‐ | ‐ | ‐ | none | none | |
| Feng 2014 | I: catgut embedding therapy + lifestyle control | 71 | 31 (11) | ‐ | 29 (2) | none | none |
| C: lifestyle control | 68 | 31 (8) | ‐ | 29 (2) | none | none | |
| all: | 70 | ‐ | ‐ | ‐ | none | none | |
| Gucel 2012 | I: acupuncture | 100 | 37 (8) | ‐ | 33 (5) | none | none |
| C: sham acupuncture | 100 | 35 (6) | ‐ | 34 (5) | none | none | |
| all: | 100 | ‐ | ‐ | ‐ | none | none | |
| Guo 2011 | I1: catgut embedding therapy + Chinese herbal medicine + lifestyle control | 63 | <30 yrs 20% 30‐55 yrs 50% 56‐65 yrs 30% | ‐ | 27 (2) | none | none |
| I2: catgut embedding therapy + lifestyle control | 67 | <30 yrs 13% 30‐55 yrs 53% 56‐65 yrs 33% | ‐ | 27 (3) | none | none | |
| C: Chinese herbal medicine + lifestyle control | 60 | <30 yrs 17% 30‐55 yrs 57% 56‐65 yrs 27% | ‐ | 27 (3) | none | none | |
| all: | 63 | ‐ | ‐ | ‐ | none | none | |
| He 2012 | I: acupuncture | ‐ | ‐ | ‐ | ‐ | none | none |
| C: flash‐fire cupping therapy | ‐ | ‐ | ‐ | ‐ | none | none | |
| all: | 53 | 31 (6) | ‐ | ‐ | none | none | |
| Hsu 2009 | I: auricular acupuncture | 100 | 40 (11) | ‐ | 32 (4) | none | none |
| C: sham auricular acupuncture | 100 | 39 (14) | ‐ | 31 (4) | none | none | |
| all: | 100 | 40 (12) | ‐ | 31 (4) | none | none | |
| Hsu 2005a | I: electro‐acupuncture | 100 | 42 (11) | ‐ | 34 (3) | none | none |
| C: sit‐up exercise | 100 | 41 (10) | ‐ | 33 (4) | none | none | |
| all: | 100 | ‐ | ‐ | ‐ | none | none | |
| Hsu 2005b | I: electro‐acupuncture | 100 | 40 (12) | ‐ | 34 (3) | none | none |
| C1: sit‐up exercise | 100 | 41 (10) | ‐ | 34 (3) | none | none | |
| C2: no intervention | 100 | 41 (10) | ‐ | 34 (3) | none | none | |
| all: | 100 | ‐ | ‐ | ‐ | none | none | |
| Lai 2010 | I: acupuncture | 43 | 27 (3) | ‐ | 29 (4) | Progesterone | PCOS |
| C: western medicine | 43 | 25 (5) | ‐ | 29 (4) | Progesterone | PCOS | |
| all: | 86 | ‐ | ‐ | ‐ | Progesterone | PCOS | |
| Li 2009 | I: catgut embedding therapy | 36 | 37 | ‐ | ‐ | none | Hypertriglyceridemia |
| C: western medicine | 38 | 36 | ‐ | ‐ | none | Hypertriglyceridemia | |
| all: | 74 | ‐ | ‐ | ‐ | none | Hypertriglyceridemia | |
| Li 2014 | I1: acupuncture | 100 | 26 (2) | ‐ | 29 (3) | none | PCOS |
| I2: acupuncture + western medicine | 100 | 27 (3) | ‐ | 29 (3) | none | PCOS | |
| C: sham acupuncture + western medicine | 100 | 25 (2) | ‐ | 29 (2) | none | PCOS | |
| all: | 100 | ‐ | ‐ | ‐ | none | PCOS | |
| Li L 2006 | I1: electro‐acupuncture + lifestyle control | 73 | 16 (2) | ‐ | 29 (4) | none | none |
| I2: electro‐auricular acupuncture + auricular acupressure + lifestyle control | 69 | 15 (2) | ‐ | 29 (4) | none | none | |
| C: lifestyle control | 73 | 16 (2) | ‐ | 29 (4) | none | none | |
| all: | 72 | ‐ | ‐ | ‐ | none | none | |
| Lien 2012 | I1: auricular acupuncture | 100 | 39 (12) | ‐ | 30 (2) | none | none |
| I2: auricular acupressure | 100 | 42 (12) | ‐ | 30 (2) | none | none | |
| C: sham auricular acupuncture | 100 | 41 (10) | ‐ | 31 (4) | none | none | |
| all: | 100 | ‐ | ‐ | ‐ | none | none | |
| Liu 2010 | I1: catgut embedding therapy | 100 | 27 (4) | ‐ | 27 (2) | none | PCOS |
| I2: catgut embedding therapy + Chinese herbal medicine | 100 | 28 (4) | ‐ | 27 (2) | none | PCOS | |
| C: Chinese herbal medicine | 100 | 28 (3) | ‐ | 28 (2) | none | PCOS | |
| all: | 100 | ‐ | ‐ | ‐ | none | PCOS | |
| Liu 2011 | I: electro‐acupuncture | 77 | 33 (5) | ‐ | 32 (4) | none | none |
| C: low‐frequency electric stimulation therapy | 77 | 30 (7) | ‐ | 30 (4) | none | none | |
| all: | 77 | ‐ | ‐ | ‐ | none | none | |
| Lu 2014 | I: catgut embedding therapy + western medicine | 100 | 27 (4) | ‐ | 29 (1) | none | PCOS |
| C: western medicine | 100 | 25 (4) | ‐ | 29 (2) | none | PCOS | |
| all: | 100 | ‐ | ‐ | ‐ | none | PCOS | |
| Luo 2006 | I1: electro‐acupuncture | ‐ | ‐ | ‐ | 30 (5) | none | none |
| I2: acupuncture | ‐ | ‐ | ‐ | 30 (5) | none | none | |
| C: no intervention | ‐ | ‐ | ‐ | 30 (5) | none | none | |
| all: | ‐ | 21‐48 | ‐ | ‐ | none | none | |
| Mi 2005 | I: acupuncture | ‐ | ‐ | ‐ | ‐ | none | none |
| C: lifestyle control | ‐ | ‐ | ‐ | ‐ | none | none | |
| all: | 91 | 38.4 | ‐ | ‐ | none | none | |
| Pan 2010 | I: acupuncture + lifestyle control | 79 | 36 (10) | ‐ | 30 (3) | none | none |
| C: sham acupuncture + lifestyle control | 77 | 36 (9) | ‐ | 31 (3) | none | none | |
| all: | 78 | ‐ | ‐ | ‐ | none | none | |
| Rerksuppaphol 2011 | I: electro‐acupuncture | 22 | 33 (6) | ‐ | 30 (4) | none | none |
| C: transcutaneous electrical acupoint stimulation | 23 | 34 (7) | ‐ | 28 (3) | none | none | |
| all: | 45 | ‐ | ‐ | ‐ | none | none | |
| Schukro 2014 | I: electro‐auricular acupuncture | 28 | 54 | ‐ | 34 | none | none |
| C: sham auricular acupuncture | 28 | 50 | ‐ | 34 | none | none | |
| all: | 56 | ‐ | ‐ | ‐ | none | none | |
| Shan 2008 | I: acupuncture + lifestyle control | 96 | 19‐60 | ‐ | ‐ | none | none |
| C: lifestyle control | 95 | 20‐58 | ‐ | ‐ | none | none | |
| all: | ‐ | ‐ | ‐ | none | none | ||
| Shu 2011 | I1: electro‐acupuncture + lifestyle control | 100 | ‐ | ‐ | 28 (3) | none | none |
| I2: auricular acupressure + lifestyle control | 100 | ‐ | ‐ | 27 (3) | none | none | |
| C: moxibustion + lifestyle control | 100 | ‐ | ‐ | 28 (3) | none | none | |
| all: | 100 | 20‐26 | ‐ | ‐ | none | none | |
| Su 2013 | I: acupuncture + Chinese herbal medicine + lifestyle control | 100 | 26 (5) | ‐ | 29 (3) | none | PCOS |
| C: Chinese herbal medicine + lifestyle control | 100 | 28 (5) | ‐ | 29 (4) | none | PCOS | |
| all: | 100 | ‐ | ‐ | ‐ | none | PCOS | |
| Tao 2009 | I: catgut embedding therapy + Chinese herbal medicine | 100 | 24 (5) | ‐ | 28 (2) | none | PCOS |
| C: Chinese herbal medicine | 100 | 25 (4) | ‐ | 27 (2) | none | PCOS | |
| all: | 100 | ‐ | ‐ | ‐ | none | PCOS | |
| Tao 2010 | I1: catgut embedding therapy + Chinese herbal medicine | 100 | ‐ | ‐ | 27 (2) | none | PCOS |
| I2: catgut embedding therapy | 100 | ‐ | ‐ | 27 (2) | none | PCOS | |
| C: Chinese herbal medicine | 100 | ‐ | ‐ | 28 (2) | none | PCOS | |
| all: | 100 | ‐ | ‐ | none | PCOS | ||
| Tong 2011 | I: acupuncture + lifestyle control | 76 | 35 (9) | ‐ | 30 (3) | none | none |
| C: sham acupuncture + lifestyle control | 71 | 35 (9) | ‐ | 31 (3) | none | none | |
| all: | 75 | ‐ | ‐ | ‐ | none | none | |
| Wang 2014 | I: acupuncture + lifestyle control | 80 | 36 (8) | ‐ | 28 (1) | none | none |
| C: Chinese herbal medicine + lifestyle control | 70 | 37 (8) | ‐ | 28 (1) | none | none | |
| all: | 75 | ‐ | ‐ | ‐ | none | none | |
| Wang X 2006 | I1: electro‐acupuncture | ‐ | ‐ | ‐ | 27 | none | none |
| I2: electro‐acupuncture + Chinese herbal medicine | ‐ | ‐ | ‐ | 28 | none | none | |
| C: Chinese herbal medicine | ‐ | 37 | ‐ | 28 | none | none | |
| all: | 92 | 20‐29 yrs 30% 30‐39 yrs 30% 40‐49 yrs 22% 50‐59 yrs 18% | ‐ | ‐ | none | none | |
| Wu 2009 | I: catgut embedding therapy + lifestyle control | 60 | ‐ | ‐ | 27 (2) | none | none |
| C: western medicine + lifestyle control | 53 | ‐ | ‐ | 24 (2) | none | none | |
| all: | 57 | 32 | ‐ | ‐ | none | none | |
| Xing 2009 | I: acupuncture + lifestyle control | 87 | 28 (7) | ‐ | 28 (2) | none | none |
| C: lifestyle control | 90 | 28 (7) | ‐ | 28 (1) | none | none | |
| all: | 89 | ‐ | ‐ | ‐ | none | none | |
| Xiong 2011 | I: acupuncture | ‐ | ‐ | ‐ | ‐ | none | none |
| C1: needle‐knife | ‐ | ‐ | ‐ | ‐ | none | none | |
| C2: western medicine | ‐ | ‐ | ‐ | ‐ | none | none | |
| all: | ‐ | ‐ | ‐ | ‐ | none | none | |
| Xu 2008 | I: catgut embedding therapy + lifestyle control | 83 | 36 (14) | ‐ | 28 (1) | none | none |
| C: Chinese herbal medicine + lifestyle control | 67 | 36 (12) | ‐ | 28 (1) | none | none | |
| all: | 75 | ‐ | ‐ | ‐ | none | none | |
| Xu 2011 | I: acupuncture | 76 | 42 (12) | ‐ | 33 (4) | none | Type 2 diabetes |
| C: western medicine | 74 | 43 (13) | ‐ | 32 (4) | none | Type 2 diabetes | |
| all: | 75 | ‐ | ‐ | ‐ | none | Type 2 diabetes | |
| Yan 2011 | I: acupuncture + lifestyle control | 60 | 18‐60 | ‐ | ‐ | none | none |
| C: bian‐stone + lifestyle control | 63 | 19‐58 | ‐ | ‐ | none | none | |
| all: | 61 | ‐ | ‐ | ‐ | none | none | |
| Ye 2010 | I: electro‐acupuncture + lifestyle control | 58 | <20 yrs 17% 21‐40 yrs 63% >41 yrs 21% | ‐ | ‐ | none | none |
| C: lifestyle control | 56 | <20 yrs 15% 21‐40 yrs 58% >41 yrs 27% | ‐ | ‐ | none | none | |
| all: | 57 | ‐ | ‐ | ‐ | none | none | |
| Yin 2006 | I: acupuncture | 50 | 37 (11) | ‐ | 26 (7) | none | none |
| C: acupoint plaster application | 58 | 38 (11) | ‐ | 26 (6) | none | none | |
| all: | 108 | ‐ | ‐ | none | none | ||
| Zhang 2005 | I: acupuncture | 87 | ‐ | ‐ | 28 (3) | none | none |
| C: magnet plastering therapy | 90 | ‐ | ‐ | 27 (3) | none | none | |
| all: | 88 | ‐ | ‐ | ‐ | none | none | |
| Zhang 2011 | I1: electro‐acupuncture + lifestyle control | ‐ | 35 (10) | ‐ | 28 (2) | none | none |
| I2: electro‐acupuncture + computerized intermediate‐frequency + lifestyle control | ‐ | 28 (12) | ‐ | 27 (2) | none | none | |
| C: lifestyle control | ‐ | 30 (9) | ‐ | 28 (3) | none | none | |
| all: | 77 | ‐ | ‐ | ‐ | none | none | |
| Zhang 2012 | I: electro‐acupuncture | ‐ | ‐ | ‐ | 28 (4) | none | none |
| C: sham acupuncture | ‐ | ‐ | ‐ | 27 (6) | none | none | |
| all: | 50 | 34 (6) | ‐ | ‐ | none | none | |
| Zhang Y 2007 | I: electro‐acupuncture + lifestyle control | 63 | 33 (4) | ‐ | ‐ | none | none |
| C: lifestyle control | 69 | 33 (4) | ‐ | ‐ | none | none | |
| all: | 66 | ‐ | ‐ | ‐ | none | none | |
| Zhao 2010 | I: electro‐acupuncture + lifestyle control | 84 | 29 (9) | ‐ | 29 (4) | none | none |
| C: lifestyle control | 80 | 30 (10) | ‐ | 28 (4) | none | none | |
| all: | 82 | ‐ | ‐ | ‐ | none | none | |
| Zhao 2011 | I: electro‐acupuncture + transcutaneous electrical acupoint stimulation | ‐ | ‐ | ‐ | 29 (3) | none | none |
| C: sham acupuncture + transcutaneous electrical acupoint stimulation | ‐ | ‐ | ‐ | 28 (2) | none | none | |
| all: | 97 | 29 | ‐ | ‐ | none | none | |
| Zhu 2007 | I1: acupuncture+ auricular acupuncture + lifestyle control | 86 | 38 (6) | ‐ | ‐ | none | none |
| I2: acupuncture+ auricular acupuncture | 90 | 37 (6) | ‐ | ‐ | none | none | |
| C: lifestyle control | 89 | 37 (6) | ‐ | ‐ | none | none | |
| all: | 88 | ‐ | ‐ | ‐ | none | none | |
| "‐" denotes not reported BMI: body mass index; C: comparator; HbA1c: glycosylated haemoglobin A1c; I: intervention; SD: standard deviation; PCOS: polycystic ovarian syndrome | |||||||
Appendix 5. Matrix of study endpoints (publications and trial documents)
|
Endpoints quoted in trial document (s) (e.g. ClinicalTrials.gov ID: NCT... FDA/EMA document manufacturer's website published design paper)a |
Time points of measurement in trial document (s) [e.g. mo/yr/wk] | Endpoints quoted in publication (s)b | Time points of measurement in publication (s) [e.g. mo/yr/wk] | |
| Chen 2009 | N/T | N/A |
Primary outcome measure (s): ‐ |
‐ |
| N/T | N/A |
Secondary outcome measure (s): FINS |
3 wks | |
| N/T | N/A |
Other outcome measure (s): (1) effective rate (2) leptin |
3 wks | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Chen 2013 | N/T | N/A |
Primary outcome measure (s): ‐ |
‐ |
| N/T | N/A |
Secondary outcome measure (s): ‐ |
‐ | |
| N/T | N/A |
Other outcome measure (s): effective rate |
8 wks | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Dang 2012 | N/T | N/A |
Primary outcome measure (s): (1) body weight (2) adverse effect |
10 wks |
| N/T | N/A |
Secondary outcome measure (s): (1) BMI (2) body fat percentage |
10 wks | |
| N/T | N/A |
Other outcome measure (s): effective rate |
10 wks | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Ding 2013 | N/T | N/A |
Primary outcome measure (s): ‐ |
‐ |
| N/T | N/A |
Secondary outcome measure (s): (1) BMI (2) FPG (3) 2hPG (4) HbA1C (5) Homa‐IR |
1 yr | |
| N/T | N/A |
Other outcome measure (s): (1) leptin (2) adiponectin |
1 yr | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Duan 2013 | N/T | N/A |
Primary outcome measure (s): (1) body weight (2) adverse effect |
I: 4 wks C: 5 wks |
| N/T | N/A |
Secondary outcome measure (s): (1) BMI (2) WC (3) HC |
I: 4 wks C: 5 wks | |
| N/T | N/A |
Other outcome measure (s): effective rate |
‐ | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Feng 2014 | N/T | N/A |
Primary outcome measure (s): body weight |
4 wks |
| N/T | N/A |
Secondary outcome measure (s): (1) BMI (2) WC (3) HC (4) WHR |
4 wks | |
| N/T | N/A |
Other outcome measure (s): effective rate |
4 wks | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Gucel 2012 | N/T | N/A |
Primary outcome measure (s): body weight |
5 wks |
| N/T | N/A |
Secondary outcome measure (s): (1) BMI (2) FINS |
5 wks | |
| N/T | N/A |
Other outcome measure (s): (1) leptin (2) ghrelin (3) cholecystokinin |
5 wks | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Guo 2011 | N/T | N/A |
Primary outcome measure (s): (1) body weight (2) adverse effect |
6 wks |
| N/T | N/A |
Secondary outcome measure (s): (1) BMI (2) WC (3) HC (4) TC (5) TG (6) HDL‐C (7) LDL‐C (8) FBG |
6 wks | |
| N/T | N/A |
Other outcome measure (s): effective rate |
6 wks | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| He 2012 | N/T | N/A |
Primary outcome measure (s): ‐ |
5 wks |
| N/T | N/A |
Secondary outcome measure (s): ‐ |
‐ | |
| N/T | N/A |
Other outcome measure (s): effective rate |
5 wks | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Hsu 2009 | N/T | N/A |
Primary outcome measure (s): (1) body weight (2) adverse effect |
6 wks |
| N/T | N/A |
Secondary outcome measure (s): (1) BMI (2) WC (3) HC (4) TC (5) TG (6) HDL‐C (7) LDL‐C (8) FPG (9) Homa‐IR |
6 wks | |
| N/T | N/A |
Other outcome measure (s): (1) leptin (2) adiponectin (3) ghrelin |
6 wks | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Hsu 2005a | N/T | N/A |
Primary outcome measure (s): (1) body weight (2) adverse effect |
6 wks; 13 wks |
| N/T | N/A |
Secondary outcome measure (s): (1) BMI (2) WC |
6 wks; 13 wks | |
| N/T | N/A |
Other outcome measure (s): ‐ |
‐ | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Hsu 2005b | N/T | N/A |
Primary outcome measure (s): (1) body weight (2) adverse effect |
6 wks |
| N/T | N/A |
Secondary outcome measure (s): (1) BMI (2) WC (3) HC (4) WHR (5) TC (6) TG (7) FBG |
6 wks | |
| N/T | N/A |
Other outcome measure (s): ‐ |
‐ | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Lai 2010 | N/T | N/A |
Primary outcome measure (s): adverse effect |
24 wks |
| N/T | N/A |
Secondary outcome measure (s): (1) BMI (2) WHR (3) body fat percentage (4) TC (5) TG (6) HDL‐C (7) LDL‐C (8) FBG (9) 2hPG (10) FINS (11) 2hINS (12) Homa‐IR |
24 wks | |
| N/T | N/A |
Other outcome measure (s): (1) FSH (2) LH (3) T |
24 wks | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Li 2009 | N/T | N/A |
Primary outcome measure (s): body weight |
8 wks |
| N/T | N/A |
Secondary outcome measure (s): (1) TC (2) TG (3) HDL‐C (4) LDL‐C (5) Lpa |
8 wks | |
| N/T | N/A |
Other outcome measure (s): ‐ |
‐ | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Li 2014 | N/T | N/A |
Primary outcome measure (s): adverse effect |
24 wks |
| N/T | N/A |
Secondary outcome measure (s): (1) BMI (2) WHR (3) TC (4) TG (5) HDL‐C (6) LDL‐C (7) FPG (8) FINS (9) Homa‐IR |
24 wks | |
| N/T | N/A |
Other outcome measure (s): (1) FSH (2) LH (3) LH/FSH (4) T |
24 wks | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Li L 2006 | N/T | N/A |
Primary outcome measure (s): body weight |
70 days; 100 days |
| N/T | N/A |
Secondary outcome measure (s): (1) BMI (2) TC (3) TG (4) HDL‐C (5) LDL‐C |
70 days; 100 days | |
| N/T | N/A |
Other outcome measure (s): effective rate |
70 days; 100 days | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Lien 2012 | N/T | N/A |
Primary outcome measure (s): (1) body weight (2) adverse effect |
4 wks |
| N/T | N/A |
Secondary outcome measure (s): (1) BMI (2) WC (3) HC (4) WHR (5) QOL (6) TC (7) TG (8) HDL‐C (9) LDL‐C (10) FINS (11) Homa‐IR |
4 wks | |
| N/T | N/A |
Other outcome measure (s): (1) leptin (2) adiponectin (3) ghrelin |
4 wks | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Liu 2010 | N/T | N/A |
Primary outcome measure (s): ‐ |
‐ |
| N/T | N/A |
Secondary outcome measure (s): BMI |
24 wks | |
| N/T | N/A |
Other outcome measure (s): (1) T (2) SHBG (3) A2 |
24 wks | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Liu 2011 | N/T | N/A |
Primary outcome measure (s): (1) body weight (2) adverse effect |
8 wks |
| N/T | N/A |
Secondary outcome measure (s): (1) BMI (2) WC (3) HC (4) WHR |
8 wks | |
| N/T | N/A |
Other outcome measure (s): (1) effective rate (2) accompanied symptoms |
8 wks | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Lu 2014 | N/T | N/A |
Primary outcome measure (s): ‐ |
‐ |
| N/T | N/A |
Secondary outcome measure (s): (1) BMI (2) WHR (3) body fat percentage |
12 wks | |
| N/T | N/A |
Other outcome measure (s): (1) FSH (2) LH (3) E2 (4) T |
12 wks | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Luo 2006 | N/T | N/A |
Primary outcome measure (s): (1) adverse effect |
3 courses (days unclear) |
| N/T | N/A |
Secondary outcome measure (s): (1) BMI (2) WHR (3) TC (4) TG (5) HDL‐C (6) LDL‐C |
3 courses (days unclear) | |
| N/T | N/A |
Other outcome measure (s): (1) effective rate (2) leptin (3) adiponectin |
3 courses (days unclear) | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Mi 2005 | N/T | N/A |
Primary outcome measure (s): ‐ |
‐ |
| N/T | N/A |
Secondary outcome measure (s): ‐ |
‐ | |
| N/T | N/A |
Other outcome measure (s): effective rate |
12 wks | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Pan 2010 | N/T | N/A |
Primary outcome measure (s): ‐ |
‐ |
| N/T | N/A |
Secondary outcome measure (s): BMI |
12 wks | |
| N/T | N/A |
Other outcome measure (s): (1) visual analogue scale (2) gastric fluid survival rate |
12 wks | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Rerksuppaphol 2011 | N/T | N/A |
Primary outcome measure (s): (1) body weight (2) adverse effect |
2 wks; 4 wks; 6 wks; 8 wks |
| N/T | N/A |
Secondary outcome measure (s): (1) BMI (2) WC (3) HC (4) WHR |
2 wks; 4 wks; 6 wks; 8 wks | |
| N/T | N/A |
Other outcome measure (s): ‐ |
‐ | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Schukro 2014 | N/T | N/A |
Primary outcome measure (s): (1) body weight (2) adverse effect |
6 wks; 10 wks |
| N/T | N/A |
Secondary outcome measure (s): (1) BMI (2) body fat percentage |
6 wks; 10 wks | |
| N/T | N/A |
Other outcome measure (s): ‐ |
‐ | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Shan 2008 | N/T | N/A |
Primary outcome measure (s): ‐ |
‐ |
| N/T | N/A |
Secondary outcome measure (s): ‐ |
‐ | |
| N/T | N/A |
Other outcome measure (s): effective rate |
6 wks; 10 wks | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Shu 2011 | N/T | N/A |
Primary outcome measure (s): body weight |
3 wks; 6 wks |
| N/T | N/A |
Secondary outcome measure (s): (1) BMI (2) WC (3) HC (4) body fat percentage (5) TC (6) TG |
3 wks; 6 wks | |
| N/T | N/A |
Other outcome measure (s): effective rate |
‐ | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Su 2013 | N/T | N/A |
Primary outcome measure (s): ‐ |
‐ |
| N/T | N/A |
Secondary outcome measure (s): (1) BMI (2) FPG (3) FINS (4) Homa‐IR |
12 wks | |
| N/T | N/A |
Other outcome measure (s): (1) FSH (2) LH (3) LH/FSH (4) T |
12 wks | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Tao 2009 | N/T | N/A |
Primary outcome measure (s): ‐ |
‐ |
| N/T | N/A |
Secondary outcome measure (s): (1) BMI (2) FPG (3) FINS (4) Homa‐IR |
12 wks | |
| N/T | N/A |
Other outcome measure (s): (1) leptin (2) TNF‐α |
12 wks | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Tao 2010 | N/T | N/A |
Primary outcome measure (s): ‐ |
‐ |
| N/T | N/A |
Secondary outcome measure (s): (1) BMI (2) WC (3) TC (4) TG (5) HDL‐C (6) LDL‐C (7) FPG (8) FINS (9) Homa‐IR |
12 wks | |
| N/T | N/A |
Other outcome measure (s): ‐ |
‐ | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Tong 2011 | N/T | N/A |
Primary outcome measure (s): ‐ |
‐ |
| N/T | N/A |
Secondary outcome measure (s): (1) BMI (2) TC (3) TG (4) glucose |
5 wks | |
| N/T | N/A |
Other outcome measure (s): (1) visual analogue scale (2) uric acid |
5 wks | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Wang 2014 | N/T | N/A |
Primary outcome measure (s): ‐ |
‐ |
| N/T | N/A |
Secondary outcome measure (s): (1) BMI (2) body fat percentage |
‐ | |
| N/T | N/A |
Other outcome measure (s): effective rate |
12 wks | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Wang X 2006 | N/T | N/A |
Primary outcome measure (s): body weight |
6 wks |
| N/T | N/A |
Secondary outcome measure (s): (1) BMI (2) WC (3) HC (4) BC (5) body fat percentage (6) TC (7) TG (8) HDL‐C |
6 wks | |
| N/T | N/A |
Other outcome measure (s): (1) glucose (2) T4 |
6 wks | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Wu 2009 | N/T | N/A |
Primary outcome measure (s): (1) body weight (2) adverse effect |
4 wks |
| N/T | N/A |
Secondary outcome measure (s): (1) BMI (2) WHR (3) TC (4) TG (5) HDL‐C (6) LDL‐C (7) FPG (8) FINS (9) Homa‐IR |
4 wks | |
| N/T | N/A |
Other outcome measure (s): effective rate |
4 wks | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Xing 2009 | N/T | N/A |
Primary outcome measure (s): body weight |
51 days |
| N/T | N/A |
Secondary outcome measure (s): (1) BMI (2) WHR (3) TC (4) TG (5) HDL‐C (6) LDL‐C |
51 days | |
| N/T | N/A |
Other outcome measure (s): (1) effective rate (2) leptin |
51 days | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Xiong 2011 | N/T | N/A |
Primary outcome measure (s): ‐ |
‐ |
| N/T | N/A |
Secondary outcome measure (s): FINS |
8 wks | |
| N/T | N/A |
Other outcome measure (s): (1) effective rate (2) leptin |
8 wks | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Xu 2008 | N/T | N/A |
Primary outcome measure (s): body weight |
8 wks |
| N/T | N/A |
Secondary outcome measure (s): (1) BMI (2) WC (3) HC (4) body fat percentage |
8 wks | |
| N/T | N/A |
Other outcome measure (s): ‐ |
‐ | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Xu 2011 | N/T | N/A |
Primary outcome measure (s): ‐ |
‐ |
| N/T | N/A |
Secondary outcome measure (s): (1) BMI (2) FPG (3) FINS |
9 wks | |
| N/T | N/A |
Other outcome measure (s): (1) Leptin (2) Adiponectin |
9 wks | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Yan 2011 | N/T | N/A |
Primary outcome measure (s): ‐ |
‐ |
| N/T | N/A |
Secondary outcome measure (s): WC |
6 wks | |
| N/T | N/A |
Other outcome measure (s): effective rate |
6 wks | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Ye 2010 | N/T | N/A |
Primary outcome measure (s): ‐ |
‐ |
| N/T | N/A |
Secondary outcome measure (s): ‐ |
‐ | |
| N/T | N/A |
Other outcome measure (s): effective rate |
12 wks | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Yin 2006 | N/T | N/A |
Primary outcome measure (s): (1) body weight (2) adverse effect |
12 wks |
| N/T | N/A |
Secondary outcome measure (s): (1) BMI (2) WC (3) HC (4) WHR (5) TC (6) TG (7) LDL‐C (8) glucose |
12 wks | |
| N/T | N/A |
Other outcome measure (s): effective rate |
‐ | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Zhang 2005 | N/T | N/A |
Primary outcome measure (s): (1) body weight (2) BMI |
4 wks |
| N/T | N/A |
Secondary outcome measure (s): (1) BMI (2) WC (3) HC (4) WHR (5) body fat percentage (6) TC (7) TG (8) HDL‐C (9) LDL‐C (10) glucose |
4 wks | |
| N/T | N/A |
Other outcome measure (s): (1) leptin (2) NPY |
4 wks | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Zhang 2011 | N/T | N/A |
Primary outcome measure (s): body weight |
8 wks |
| N/T | N/A |
Secondary outcome measure (s): (1) BMI (2) body fat percentage |
8 wks | |
| N/T | N/A |
Other outcome measure (s): effective rate |
8 wks | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Zhang 2012 | N/T | N/A |
Primary outcome measure (s): (1) BMI (2) adverse effect |
4 wks |
| N/T | N/A |
Secondary outcome measure (s): (1) WHR (2) body fat percentage |
4 wks | |
| N/T | N/A |
Other outcome measure (s): ‐ |
‐ | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Zhang Y 2007 | N/T | N/A |
Primary outcome measure (s): ‐ |
‐ |
| N/T | N/A |
Secondary outcome measure (s): ‐ |
‐ | |
| N/T | N/A |
Other outcome measure (s): (1) effective rate (2) patient satisfaction |
8 wks | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Zhao 2010 | N/T | N/A |
Primary outcome measure (s): body weight |
8 wks |
| N/T | N/A |
Secondary outcome measure (s): (1) BMI (2) WC (3) FBG (4) 2hPG (5) FINS (6) 2hFINS |
8 wks | |
| N/T | N/A |
Other outcome measure (s): effective rate |
8 wks | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Zhao 2011 | N/T | N/A |
(Primary outcome measure (s): body weight |
4 wks |
| N/T | N/A |
Secondary outcome measure (s): BMI |
‐ | |
| N/T | N/A |
Other outcome measure (s): effective rate |
4 wks | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| Zhu 2007 | N/T | N/A |
Primary outcome measure (s): ‐ |
12 wks |
| N/T | N/A |
Secondary outcome measure (s): (1) BMI (2) AC |
12 wks | |
| N/T | N/A |
Other outcome measure (s): effective rate |
12 wks | |
| N/T | N/A |
Reported subgroups: ‐ |
‐ | |
| "‐" denotes not reported aTrial document (s) refers to all available information from published design papers and sources other than regular publications (e.g. FDA/EMA documents, manufacturer's websites, trial registers) bPublication (s) refers to all published trial information (primary reference, duplicate publications, companion documents or multiple reports of a primary study) EMA: European Medicines Agency; FDA: Food and Drug Administration (US); mo: month (s); N/A: not applicable; N/T: no trial document available; yr: year (s); wk: week (s) 2hPG: 2‐hour plasma glucose; BMI: body mass index; FPG: fasting plasma glucose; FINS: fasting insulin; HbA1c: glycosylated haemoglobin A1c; HC: hip circumference; HDL‐C: high‐density lipoprotein cholesterol; Homa‐IR: homeostasis model assessment of insulin resistance; LDL‐C: low‐density lipoprotein cholesterol; TC: total cholesterol; TG: triglyceride; QOL: quality of life; WC: waist circumference; WHR: waist hip ratio | ||||
Appendix 6. Examination of outcome reporting bias according to ORBIT classification
| Outcome | High risk of bias (category A)a | High risk of bias (category D)b | High risk of bias (category E)c | High risk of bias (category G)d | |
| Ding 2013 | BMI, FPG, 2hPG, HbA1c, Homa‐IR, leptin and adiponectin | x | |||
| Hsu 2005a | body weight, BMI, adverse effect and WC | x | |||
| Liu 2010 | BMI, T, SHBG and A2 | x | |||
| Shu 2011 | body weight, BMI, effective rate, WC, HC, TC, TG and body fat percentage | x | |||
| Su 2013 | BMI, FPG, FINS and Homa‐IR, FSH, LH, LH/FSH and T | x | |||
| Wang 2014 | BMI, effective rate and body fat percentage | x | |||
| Wu 2009 | Body weight, BMI, effective rate, adverse effect, WHR, TC, TG, HDL‐C, LDL‐C, FPG, FINS and Homa‐IR | x | |||
| Zhang 2011 | Body weight, BMI, effective rate and body fat percentage | x | |||
| Zhao 2011 | Body weight, BMI and effective rate | x | |||
|
aClear that outcome was measured and analysed; trial report states that outcome was analysed but only reports that result was not significant (Classification 'A', table 2, Kirkham 2010) bClear that outcome was measured and analysed; trial report states that outcome was analysed but no results reported ( Classification 'D', table 2, Kirkham 2010) cClear that outcome was measured; clear that outcome was measured but not necessarily analysed; judgement says likely to have been analysed but not reported because of non‐significant results (Classification 'E', table 2, Kirkham 2010) dUnclear whether the outcome was measured; not mentioned but clinical judgement says likely to have been measured and analysed but not reported on the basis of non‐significant results (Classification 'G', table 2, Kirkham 2010) 2hPG: 2‐hour plasma glucose; A2: androstenedione; BMI: body mass index; FPG: fasting plasma glucose; FINS: fasting insulin; FSH: follicle stimulating hormone; HbA1c: glycosylated haemoglobin A1c; HDL‐C: high‐density lipoprotein cholesterol; Homa‐IR: homeostasis model assessment of insulin resistance; LDL‐C: low‐density lipoprotein cholesterol; LH: luteinizing hormone; SHBG: sex hormone binding globulin; T: testoserone; TC: total cholesterol; TG: triglyceride; WHR: waist hip ratio | |||||
Appendix 7. Definition of endpoint measurement (I)
| Weight lossa | Anthropometric measures other than weight lossa | Morbidity | Health‐related quality of life | Physical activitya | Socioeconomic effects | Severe / serious adverse events | |
| Chen 2009 | N/D | N/I | N/I | N/I | N/I | N/I | N/I |
| Chen 2013 | N/D | N/I | N/I | N/I | N/I | N/I | N/I |
| Dang 2012 | "BMI, body weight and F% were measured by Omron Fat Loss Monitor HBF‐351. Before taking a measurement personal data must be entered. Stand with both feet slightly apart. Place both hands on the monitor by holding the grip electrodes. Hold the electrodes with both hands. The monitor automatically starts the measurement." | "BMI, body weight and F% were measured by Omron Fat Loss Monitor HBF‐351.Before taking a measurement personal data must be entered. Stand with both feet slightly apart. Place both hands on the monitor by holding the grip electrodes. Hold the electrodes with both hands. The monitor automatically starts the measurement." | N/I | N/I | N/I | N/I | No |
| Ding 2013 | BMI = body weight/height (kg/m2). | "One person was responsible for measuring height, body weight, WC, HC." | N/I | N/I | N/I | N/I | N/I |
| Duan 2013 | "Body weight was measured by the same weighing scale. Participants were measured without shoes or heavy outer clothing and measured to the nearest 10 g." | "Height was measured by the same weighing scale. Participants were measured without shoes or heavy outer clothing and measured to the nearest 10 g." "WC and HC was measured by a tape measure after breathing out normally. The waist was measured around the bare abdomen. The hip was measured at its widest portion of the buttocks." |
N/I | N/I | N/I | N/I | No |
| Feng 2014 | N/D | "The hip was measured around the midpoint between 12th rib and anterior superior spine. WHR = WC/HC" | N/I | N/I | N/I | N/I | N/I |
| Gucel 2012 | N/D | N/I | N/I | N/I | N/I | N/I | N/I |
| Guo 2011 | N/D | "Participants were measured without shoes or heavy outer clothing and measured to the nearest 10 g." "WC and HC was measured by a tape measure after breathing out normally. The waist was measured around the 12th rib. The hip was measured at its widest portion of the buttocks." |
N/I | N/I | N/I | N/I | No |
| He 2012 | N/D | N/I | N/I | N/I | N/I | N/I | N/I |
| Hsu 2009 | "The anthropometric measures are described in our previous studies." | "The anthropometric measures are described in our previous studies." | N/I | N/I | N/I | N/I | No |
| Hsu 2005a | "All measurements were carried out after an overnight fast using standardized methods and were performed in the beginning, 6, 8 and 13 weeks later. Height was measured with a wall‐mounted stadiometer to the nearest 0.1 cm, weight was measured on a calibrated balance beam scale to the nearest 0.1 kg, and BMI was calculated (BMI = body weight (BW)/height (kg/m2))." | "WC was measured mid‐way between the lateral lower rib margin and the iliac crest, hip circumference (HC) was measured at the levels of the major trochanters through the pubic symphysis, with the scale to the nearest 0.1 cm, and WC/HC ratio (WHR) was calculated (WHR = WC/HC). All subjects were measured in the undergarments with a hospital gown on. " | N/I | N/I | N/I | N/I | N/I |
| Hsu 2005b | "The participants were measured in their undergarments and a hospital gown. Height was measured with a wallmounted stadiometer to the nearest 0.1 cm. Weight was measured on a calibrated balance beam scale to the nearest 0.1 kg, and BMI was calculated as body weight (BW)/height (kg/m2)). " | "WC was measured midway between the lateral lower rib margin and the iliac crest. Hip circumference (HC) was measured at the levels of the major trochanters through the pubic symphysis, with the scale to the nearest 0.1 cm. The ratio of WC/HC was calculated as waist/hip ratio (WHR)." | N/I | N/I | N/I | N/I | No |
| Lai 2010 | "BMI = body weight/height (kg/m2)." | N/D | N/I | N/I | N/I | N/I | N/I |
| Li 2009 | "Body weight was measured in the same conditions, e.g., time, clothing, measuring instrument, etc. One physician was responsible for measuring." | N/I | N/I | N/I | N/I | N/I | N/I |
| Li 2014 | "BMI = body weight/height (kg/m2)." | "Physician was responsible for recording medical history. The waist was measured around the 12th rib. The hip was measured at its widest portion of the buttocks." | N/I | N/I | N/I | N/I | No |
| Li L 2006 | Does not say how body weight was measured. | N/I | N/I | N/I | N/I | N/I | N/I |
| Lien 2012 | "All measurements were made after 8–9 hour of fasting using a standardized method, as detailed in our previous research, at the beginning and the end of the study. Parameters of physical parameters were measured once a week to identify any changes." | "Parameters of physical parameters were measured once a week to identify any changes." | N/I | "To measure the quality of life among our subjects, we used the self‐administered questionnaire of WHOQoL‐BREF, Taiwan version, which was well validated with consistency coefficients ranging from 0.70 to 0.77. The WHOQoL‐BREF questionnaire evaluated quality of life in physical, psychological, social and environmental domains, with scores ranging from 0 to 100. Subjects were asked to complete the questionnaire before the start and at the end of the study." | N/I | N/I | No |
| Liu 2010 | Does not say how body weight was measured. | N/I | N/I | N/I | N/I | N/I | N/I |
| Liu 2011 | "All measurements were measured with a standard method. Body weight and BMI were measured in the same conditions, e.g., time, clothing, measuring instrument, etc. BMI = body weight/height (kg/m2)" | "The waist was measured around the 12th rib. The hip was measured at its widest portion of the buttocks." | N/I | N/I | N/I | N/I | N/I |
| Lu 2014 | N/D | N/D | N/I | N/I | N/I | N/I | N/I |
| Luo 2006 | N/D | N/D | N/I | N/I | N/I | N/I | N/I |
| Mi 2005 | N/D | N/I | N/I | N/I | N/I | N/I | N/I |
| Pan 2010 | "The participants were measured on an empty stomach or after defecation. BMI = body weight/height (kg/m2)." | N/I | N/I | N/I | N/I | N/I | N/I |
| Rerksuppaphol 2011 | "Weight was measured to the nearest 0.1 kg using an electronic scale (Tanita®, BF‐680W, Tokyo, Japan)." "The body mass index was calculated as the ratio of weight/ (height) 2 [kg/m2]" "All measurements were carried out by trained staff." |
"Height, waist and hip circumferences were measured by tape to the nearest 0.1 cm." "Waist circumference was measured at the midpoint between the lower costal margin and the top of the iliac crest while the subject was in a standing position. Hip circumference was measured in the standing position at the maximum circumference over the buttocks." "All measurements were carried out by trained staff." |
N/I | N/I | N/I | N/I | "Any adverse events during the treatment were recorded." |
| Schukro 2014 | N/D | N/I | N/I | N/I | N/I | N/I | N/I |
| Shan 2008 | N/D | N/I | N/I | N/I | N/I | N/I | N/I |
| Shu 2011 | "Body weight was measured at 10 am. BMI = body weight/height (kg/m2)." | "Waist circumference was measured at the midpoint between the lower costal margin and the top of the iliac crest while the subject was in a standing position. Hip circumference was measured in the standing position at the maximum circumference over the buttocks. WHR = WC/HC." | N/I | N/I | N/I | N/I | N/I |
| Su 2013 | "BMI = body weight/height (kg/m2)." | N/I | N/I | N/I | N/I | N/I | N/I |
| Tao 2009 | N/D | N/I | N/I | N/I | N/I | N/I | N/I |
| Tao 2010 | N/D | N/D | N/I | N/I | N/I | N/I | N/I |
| Tong 2011 | N/D | N/I | N/I | N/I | N/I | N/I | N/I |
| Wang 2014 | N/D | N/I | N/I | N/I | N/I | N/I | N/I |
| Wang X 2006 | "All measurements were measured with a standard method. Body weight and BMI were measured in the same conditions, e.g., time, clothing, measuring instrument, etc." | "All measurements were measured with a standard method. Body weight and BMI were measured in the same conditions, e.g., time, clothing, measuring instrument, etc." | N/I | N/I | N/I | N/I | N/I |
| Wu 2009 | "Body weight was measured with a standard method. Body weight and BMI were measured in the same conditions, e.g., time, clothing, measuring instrument, etc. BMI = body weight/height (kg/m2)." | "Waist circumference should be measured at the midpoint between the lower margin of the least palpable rib and the top of the iliac crest, using a stretch resistant tape that provides a constant 100 g tension. Hip circumference should be measured around the widest portion of the buttocks, with the tape parallel to the floor. WHR = WC/HC." | N/I | N/I | N/I | N/I | N/I |
| Xing 2009 | "Body weight was measured with a standard method. Body weight and BMI were measured in the same conditions, e.g., time, clothing, measuring instrument, etc. BMI = body weight/height (kg/m2)." | "Waist circumference should be measured at the midpoint between the lower margin of the least palpable rib and the top of the iliac crest, using a stretch resistant tape that provides a constant 100 g tension. Hip circumference should be measured around the widest portion of the buttocks, with the tape parallel to the floor. WHR = WC/HC." | N/I | N/I | N/I | N/I | N/I |
| Xiong 2011 | N/D | N/I | N/I | N/I | N/I | N/I | N/I |
| Xu 2008 | "Body weight was measured with a standard method. Body weight and BMI were measured in the same conditions, e.g., time, clothing, measuring instrument, etc. BMI = body weight/height (kg/m2)." | "Waist circumference was measured at the midpoint between the lower costal margin and the top of the iliac crest while the subject was in a standing position. Hip circumference was measured around the widest portion of the buttocks, with the tape parallel to the floor. " | N/I | N/I | N/I | N/I | N/I |
| Xu 2011 | N/D | N/I | N/I | N/I | N/I | N/I | N/I |
| Yan 2011 | N/D | N/D | N/I | N/I | N/I | N/I | N/I |
| Ye 2010 | N/D | N/I | N/I | N/I | N/I | N/I | N/I |
| Yin 2006 | "Body weight was measured with a standard method. Body weight and BMI were measured in the same conditions, e.g., time, clothing, measuring instrument, etc." | "Waist circumference was measured at the midpoint between the lower costal margin and the top of the iliac crest while the subject was in a standing position. Hip circumference was measured around the widest portion of the buttocks, with the tape parallel to the floor. " | N/I | N/I | N/I | N/I | N/I |
| Zhang 2005 | "Body weight was measured with a standard method. Body weight and BMI were measured in the same conditions, e.g., time, clothing, measuring instrument, etc. BMI = body weight/height (kg/m2)." | "Waist circumference was measured at the midpoint between the lower costal margin and the top of the iliac crest while the subject was in a standing position. Hip circumference was measured around the widest portion of the buttocks, with the tape parallel to the floor. WHR = WC/HC." | N/I | N/I | N/I | N/I | N/I |
| Zhang 2011 | "BMI, body weight and F% were measured by Omron Fat Loss Monitor HBF‐351.Before taking a measurement personal data must be entered. Stand with both feet slightly apart. Place both hands on the monitor by holding the grip electrodes. Hold the electrodes with both hands. The monitor automatically starts the measurement." | "BMI, body weight and F% were measured by Omron Fat Loss Monitor HBF‐351.Before taking a measurement personal data must be entered. Stand with both feet slightly apart. Place both hands on the monitor by holding the grip electrodes. Hold the electrodes with both hands. The monitor automatically starts the measurement." | N/I | N/I | N/I | N/I | N/I |
| Zhang 2012 | "Body weight was measured with a standard method. Body weight and BMI were measured in the same conditions, e.g., time, clothing, measuring instrument, etc." | "Waist circumference was measured at the midpoint between the lower costal margin and the top of the iliac crest while the subject was in a standing position. Hip circumference was measured around the widest portion of the buttocks, with the tape parallel to the floor. F% were measured by Fat Loss Monitor HBF‐351." | N/I | N/I | N/I | N/I | N/I |
| Zhang Y 2007 | N/D | N/I | N/I | N/I | N/I | N/I | N/I |
| Zhao 2010 | N/D | N/D | N/I | N/I | N/I | N/I | N/I |
| Zhao 2011 | N/D | N/I | N/I | N/I | N/I | N/I | N/I |
| Zhu 2007 | "Participants were measured without shoes or heavy outer clothing." | "Abdominal circumference was measured at the midpoint between the midaxillary line costal margin and the top of the iliac crest while the subject was in a standing position. " | N/I | N/I | N/I | N/I | N/I |
| N/D: not defined; N/I: not investigated BMI: body mass index; F%: body fat percentage; WC: waist circumference; HC: hip circumference; WHR: waist hip ratio | |||||||
Appendix 8. Definition of endpoint measurement (II)
| Blood pressurea | Lipid levels | Glycaemic control | |
| Chen 2009 | N/I | N/I | "Insulin was measured according to instruction of test kits." |
| Chen 2013 | N/I | N/I | N/I |
| Dang 2012 | N/I | N/I | N/I |
| Ding 2013 | N/I | N/I | "FPG were measured by the glucose oxidase ‐peroxidase method (Siemens ADVIA 2400 Chemistry System ). HbA1C were measured by Automated Glycohemoglobin Analyzer (Bio‐Rad Laboratories, Inc). 2hPG were measured by radioimmunoassay kit (3V, Shangdong). Homa‐IR = (FPG × Fins) / 22.5." |
| Duan 2013 | N/I | N/I | N/I |
| Feng 2014 | N/I | N/I | N/I |
| Gucel 2012 | N/I | N/I | "Serum insulin was measured by ELISA. Biosource Insulin Elisa Kit (Biosource Europe S.A., Rue du Bosquet, Louvain‐La‐Neuve, Belgium.) was used." |
| Guo 2011 | N/I | "Morning fasting venous bloods were drawn at the beginning of first session and after completion of all sessions." | "Morning fasting venous bloods were drawn at the beginning of first session and after completion of all sessions." |
| He 2012 | N/I | N/I | N/I |
| Hsu 2009 | N/I | N/D | "Homeostasis model assessment for insulin resistance (HOMA‐IR) [fasting glucose (mmol=L)fasting insulin (UI=L)=22.5] was used as the insulin resistance measurement. All measurements were made at 8–9 am after an overnight fast using standardized methods." |
| Hsu 2005a | N/I | N/I | N/I |
| Hsu 2005b | N/I | N/D | N/D |
| Lai 2010 | N/I | "Insulin, FBG, TC, TG, HDL‐C and LDL‐C were recorded with a standard method between 7.00 and 8.00 am, after the participants had abstained from food since the previous evening." | "Insulin, FBG, TC, TG, HDL‐C and LDL‐C were recorded with a standard method between 7.00 and 8.00 am, after the participants had abstained from food since the previous evening. Homa‐IR = (FBG × Fins) / 22.5. " |
| Li 2009 | N/I | "Participants were measured at designated hospitals." | N/I |
| Li 2014 | N/I | "Insulin, FBG, TC, TG, HDL‐C and LDL‐C were recorded with a standard method between 7.00 and 8.00 am, after the participants had abstained from food since the previous evening." | "Insulin, FBG, TC, TG, HDL‐C and LDL‐C were recorded with a standard method between 7.00 and 8.00 am, after the participants had abstained from food since the previous evening." |
| Li L 2006 | N/I | "The morning fasting venous blood of all subjects were obtained for measuring TC, TG, HDL‐C and LDL‐C." | N/I |
| Lien 2012 | N/I | "The outcomes were evaluated as percentage reduction in four aspects. They were physical parameters (body weight, BMI and waist circumference), biochemical characteristics from whole blood (including fasting blood sugar, triglyceride, total cholesterol levels), obesity‐related hormone peptides and quality of life scores on the WHOQoL‐BREF scale. All measurements were made after 8–9 h of fasting using a standardized method, as detailed in our previous research, at the beginning and the end of the study." | "Obesity‐related hormone peptides including leptin, insulin, ghrelin and adiponectin were measured after 8‐ to 9‐h fasting in the morning at baseline and after 4 weeks of treatment." "BioSource INS‐IRMA Kits (BioSource Europe S.A., Nivelles, Belgium) were employed to determine the level of insulin in serum as reported by Starr et al. . Sampling would be repeated if a difference exceeding 10% CV was found between duplicate results of the sample. Following the approach of Matthews et al., we used the homeostasis model assessment for insulin resistance (HOMA‐IR) for measuring insulin resistance of our subjects at baseline and after treatment." |
| Liu 2010 | N/I | N/I | N/I |
| Liu 2011 | N/I | N/I | N/I |
| Lu 2014 | N/I | N/I | N/I |
| Luo 2006 | N/I | "The morning fasting venous blood of all subjects were obtained at 8–9 AM." | N/I |
| Mi 2005 | N/I | N/I | N/I |
| Pan 2010 | N/I | N/I | N/I |
| Rerksuppaphol 2011 | N/I | N/I | N/I |
| Schukro 2014 | N/I | N/I | N/I |
| Shan 2008 | N/I | N/I | N/I |
| Shu 2011 | N/I | "TC and TG were measured at 8.00 am, after the participants had abstained from food since the previous evening." | N/I |
| Su 2013 | N/I | N/I | "FPG was measured by the glucose oxidase ‐peroxidase method. Insulin was measured with radioimmunoassay. Homa‐IR = (Fins × FPG) / 22.5." |
| Tao 2009 | N/I | N/I | N/D |
| Tao 2010 | N/I | "The morning fasting venous blood of all subjects were obtained for measuring TC, TG, HDL‐C and LDL‐C." | "FPG and insulin were measured in the morning and after receiving oral glucose." |
| Tong 2011 | N/I | N/D | N/D |
| Wang 2014 | N/I | N/I | N/I |
| Wang X 2006 | N/I | "TC, TG and HDL‐C were measured by Hitachi 717 Chemistry Analyzer." | "Glucose was measured by Hitachi 717 Chemistry Analyzer." |
| Wu 2009 | N/I | "TC, TG, HDL‐C and LDL‐C were measured by Chemistry Analyzer." | "FPG was measured by the glucose oxidase ‐peroxidase method. Insulin was measured with radioimmunoassay. Homa‐IR = (Fins × FPG) / 22.5." |
| Xing 2009 | N/I | TG was measured by Glycerol Phosphate Oxidase‐Peroxidase method. TC was measured by cholesterol esterase, cholesterol oxidase and peroxidase method. HDL‐C was measured by Polyethylene glycol method. | N/I |
| Xiong 2011 | N/I | N/I | "Insulin was measured by ELISA. Biosource Insulin Elisa Kit (Jiamay Bio‐tech Co., LTD) was used." |
| Xu 2008 | N/I | N/I | N/I |
| Xu 2011 | N/I | N/I | N/D |
| Yan 2011 | N/I | N/I | N/I |
| Ye 2010 | N/I | N/I | N/I |
| Yin 2006 | N/I | N/D | N/D |
| Zhang 2005 | N/I | "The morning fasting venous blood of all subjects were obtained for measuring TC, TG, HDL‐C LDL‐C and glucose by biochemical laboratory." | "The morning fasting venous blood of all subjects were obtained for measuring TC, TG, HDL‐C LDL‐C and glucose by biochemical laboratory." |
| Zhang 2011 | N/I | N/I | N/I |
| Zhang 2012 | N/I | N/I | N/I |
| Zhang Y 2007 | N/I | N/I | N/I |
| Zhao 2010 | N/I | N/I | N/D |
| Zhao 2011 | N/I | N/I | N/I |
| Zhu 2007 | N/I | N/I | N/I |
| N/D: not defined; N/I: not investigated FPG: fasting plasma glucose; TC: total cholesterol; TG: triglyceride; FINS: fasting insulin; HbA1c: glycosylated haemoglobin A1c; HDL‐C: high‐density lipoprotein cholesterol; Homa‐IR: homeostasis model assessment of insulin resistance; LDL‐C: low‐density lipoprotein cholesterol | |||
Appendix 9. Adverse events (I)
| Intervention(s) and comparator(s) | Participants included in analysis [N] | Deaths [N] | Deaths [%] | All adverse events [N] | All adverse events [%] | Severe/serious adverse events [N] | Severe/serious adverse events [%] | |
| Chen 2009 | I1: electro‐acupuncture | 20 | 0 | 0 | ‐ | ‐ | ‐ | ‐ |
| I2: acupuncture | 20 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| C: no intervention | 20 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| Chen 2013 | I: catgut embedding therapy | 30 | 0 | 0 | ‐ | ‐ | ‐ | ‐ |
| C: lifestyle control | 30 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| Dang 2012 | I: electro‐acupuncture + lifestyle control | 30 | 0 | 0 | 0 | 0 | 0 | 0 |
| I2: computerized intermediate‐frequency therapy + electro‐acupuncture + lifestyle control | 30 | 0 | 0 | 0 | 0 | 0 | 0 | |
| C: lifestyle control | 30 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Ding 2013 | I: acupuncture + lifestyle control | 102 | 0 | 0 | ‐ | ‐ | ‐ | ‐ |
| C: lifestyle control | 100 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| Duan 2013 | I: acupuncture + lifestyle control | 45 | 0 | 0 | 0 | 0 | 0 | 0 |
| C: foot holographic scraping therapy + lifestyle control | 45 | 0 | 0 | 1 | 2 | 0 | 0 | |
| Feng 2014 | I: catgut embedding therapy + lifestyle control | 68 | 0 | 0 | ‐ | ‐ | ‐ | ‐ |
| C: lifestyle control | 22 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| Gucel 2012 | I: acupuncture | 20 | 0 | 0 | ‐ | ‐ | ‐ | ‐ |
| C: sham acupuncture | 20 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| Guo 2011 | I1: catgut embedding therapy + Chinese herbal medicine + lifestyle control | 30 | 0 | 0 | 0 | 0 | 0 | 0 |
| I2: catgut embedding therapy + lifestyle control | 30 | 0 | 0 | 0 | 0 | 0 | 0 | |
| C: Chinese herbal medicine + lifestyle control | 30 | 0 | 0 | 0 | 0 | 0 | 0 | |
| He 2012 | I: acupuncture | 30 | 0 | 0 | ‐ | ‐ | ‐ | ‐ |
| C: flash‐fire cupping therapy | 28 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| Hsu 2009 | I: auricular acupuncture | 23 | 0 | 0 | 8 | 35 | 0 | 0 |
| C: sham auricular acupuncture | 22 | 0 | 0 | 2 | 9 | 0 | 0 | |
| Hsu 2005a | I: electro‐acupuncture | 24 | 0 | 0 | 3 | 13 | 0 | 0 |
| C: sit‐up exercise | 22 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Hsu 2005b | I: electro‐acupuncture | 22 | 0 | 0 | 4 | 18 | 0 | 0 |
| C1: sit‐up exercise | 20 | 0 | 0 | 0 | 0 | 0 | 0 | |
| C2: no intervention | 21 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Lai 2010 | I: acupuncture | 43 | 0 | 0 | 0 | 0 | 0 | 0 |
| C: western medicine | 43 | 0 | 0 | 21 | 49 | 0 | 0 | |
| Li 2009 | I: catgut embedding therapy | 36 | 0 | 0 | ‐ | ‐ | ‐ | ‐ |
| C: western medicine | 38 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| Li 2014 | I1: acupuncture | 49 | 0 | 0 | 0 | 0 | 0 | 0 |
| I2: acupuncture + western medicine | 53 | 0 | 0 | 0 | 0 | 0 | 0 | |
| C: sham acupuncture + western medicine | 51 | 0 | 0 | 22 | 43 | 0 | 0 | |
| Li L 2006 | I1: electro‐acupuncture + lifestyle control | 26 | 0 | 0 | ‐ | ‐ | ‐ | ‐ |
| I2: electro‐auricular acupuncture + auricular acupressure + lifestyle control | 29 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| C: lifestyle control | 30 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| Lien 2012 | I1: auricular acupuncture | 24 | 0 | 0 | 0 | 0 | 0 | 0 |
| I2: auricular acupressure | 24 | 0 | 0 | 0 | 0 | 0 | 0 | |
| C: sham auricular acupuncture | 23 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Liu 2010 | I1: catgut embedding therapy | 21 | 0 | 0 | ‐ | ‐ | ‐ | ‐ |
| I2: catgut embedding therapy + Chinese herbal medicine | 18 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| C: Chinese herbal medicine | 20 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| Liu 2011 | I: electro‐acupuncture | 30 | 0 | 0 | 1 | 3 | 0 | 0 |
| C: low‐frequency electric stimulation therapy | 30 | 0 | 0 | 2 | 6 | 0 | 0 | |
| Lu 2014 | I: catgut embedding therapy + western medicine | 20 | 0 | 0 | ‐ | ‐ | ‐ | ‐ |
| C: western medicine | 12 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| Luo 2006 | I1: electro‐acupuncture | 20 | 0 | 0 | 0 | 0 | 0 | 0 |
| I2: acupuncture | 20 | 0 | 0 | 0 | 0 | 0 | 0 | |
| C: no intervention | 20 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Mi 2005 | I: acupuncture | 80 | 0 | 0 | ‐ | ‐ | ‐ | ‐ |
| C: lifestyle control | 40 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| Pan 2010 | I: acupuncture + lifestyle control | 48 | 0 | 0 | ‐ | ‐ | ‐ | ‐ |
| C: sham acupuncture + lifestyle control | 26 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| Rerksuppaphol 2011 | I: electro‐acupuncture | 22 | 0 | 0 | 0 | 0 | 0 | 0 |
| C: transcutaneous electrical acupoint stimulation | 23 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Schukro 2014 | I: electro‐auricular acupuncture | 22 | 0 | 0 | 0 | 0 | 0 | 0 |
| C: sham auricular acupuncture | 23 | 0 | 0 | 8 | 35 | 0 | 0 | |
| Shan 2008 | I: acupuncture + lifestyle control | 72 | 0 | 0 | ‐ | ‐ | ‐ | ‐ |
| C: lifestyle control | 40 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| Shu 2011 | I1: electro‐acupuncture + lifestyle control | 15 | 0 | 0 | ‐ | ‐ | ‐ | ‐ |
| I2: auricular acupressure + lifestyle control | 15 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| C: moxibustion + lifestyle control | 15 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| Su 2013 | I: acupuncture + Chinese herbal medicine + lifestyle control | 40 | 0 | 0 | ‐ | ‐ | ‐ | ‐ |
| C: Chinese herbal medicine + lifestyle control | 40 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| Tao 2009 | I: catgut embedding therapy + Chinese herbal medicine | 19 | 0 | 0 | ‐ | ‐ | ‐ | ‐ |
| C: Chinese herbal medicine | 19 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| Tao 2010 | I1: catgut embedding therapy + Chinese herbal medicine | 18 | 0 | 0 | ‐ | ‐ | ‐ | ‐ |
| I2: catgut embedding therapy | 19 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| C: Chinese herbal medicine | 17 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| Tong 2011 | I: acupuncture + lifestyle control | 76 | 0 | 0 | ‐ | ‐ | ‐ | ‐ |
| C: sham acupuncture + lifestyle control | 42 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| Wang 2014 | I: acupuncture + lifestyle control | 50 | 0 | 0 | ‐ | ‐ | ‐ | ‐ |
| C: Chinese herbal medicine + lifestyle control | 50 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| Wang X 2006 | I1: electro‐acupuncture | 20 | 0 | 0 | ‐ | ‐ | ‐ | ‐ |
| I2: electro‐acupuncture + Chinese herbal medicine | 20 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| C: Chinese herbal medicine | 20 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| Wu 2009 | I: catgut embedding therapy + lifestyle control | 30 | 0 | 0 | 3 | 10 | ‐ | ‐ |
| C: western medicine + lifestyle control | 30 | 0 | 0 | >25 | >83 | ‐ | ‐ | |
| Xing 2009 | I: acupuncture + lifestyle control | 31 | 0 | 0 | ‐ | ‐ | ‐ | ‐ |
| C: lifestyle control | 30 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| Xiong 2011 | I: acupuncture | 18 | 0 | 0 | ‐ | ‐ | ‐ | ‐ |
| C1: needle‐knife | 18 | ‐ | ‐ | ‐ | ‐ | |||
| C2: western medicine | 18 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| Xu 2008 | I: catgut embedding therapy + lifestyle control | 30 | 0 | 0 | ‐ | ‐ | ‐ | ‐ |
| C: Chinese herbal medicine + lifestyle control | 30 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| Xu 2011 | I: acupuncture | 100 | 0 | 0 | ‐ | ‐ | ‐ | ‐ |
| C: western medicine | 50 | ‐ | ‐ | ‐ | ‐ | |||
| Yan 2011 | I: acupuncture + lifestyle control | 57 | 0 | 0 | ‐ | ‐ | ‐ | ‐ |
| C: bian‐stone + lifestyle control | 57 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| Ye 2010 | I: electro‐acupuncture + lifestyle control | 48 | 0 | 0 | ‐ | ‐ | ‐ | ‐ |
| C: lifestyle control | 48 | ‐ | ‐ | ‐ | ‐ | |||
| Yin 2006 | I: acupuncture | 50 | 0 | 0 | 0 | 0 | 0 | 0 |
| C: acupoint plaster application | 58 | 0 | 0 | 1 | 2 | 0 | 0 | |
| Zhang 2005 | I: acupuncture | 30 | 0 | 0 | ‐ | ‐ | ‐ | ‐ |
| C: magnet plastering therapy | 30 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| Zhang 2011 | I1: electro‐acupuncture + lifestyle control | 26 | 0 | 0 | ‐ | ‐ | ‐ | ‐ |
| I2: electro‐acupuncture + computerized intermediate‐frequency + lifestyle control | 26 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| C: lifestyle control | 26 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| Zhang 2012 | I: electro‐acupuncture | 15 | 0 | 0 | 1 | 7 | 0 | 0 |
| C: sham acupuncture | 15 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Zhang Y 2007 | I: electro‐acupuncture + lifestyle control | 32 | 0 | 0 | ‐ | ‐ | ‐ | ‐ |
| C: lifestyle control | 32 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| Zhao 2010 | I: electro‐acupuncture + lifestyle control | 30 | 0 | 0 | ‐ | ‐ | ‐ | ‐ |
| C: lifestyle control | 30 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| Zhao 2011 | I: electro‐acupuncture + transcutaneous electrical acupoint stimulation | 35 | 0 | 0 | ‐ | ‐ | ‐ | ‐ |
| C: sham acupuncture + transcutaneous electrical acupoint stimulation | 35 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| Zhu 2007 | I1: acupuncture+ auricular acupuncture + lifestyle control | 42 | 0 | 0 | ‐ | ‐ | ‐ | ‐ |
| I2: acupuncture+ auricular acupuncture | 40 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| C: lifestyle control | 38 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | |
| "‐" denotes not reported C: comparator; I: intervention | ||||||||
Appendix 10. Adverse events (II)
| Intervention(s) and comparator(s) | Participants included in analysis [N] | Discontinued study due to adverse events [N] | Discontinued study due to adverse events [%] | Hospitalisation [N] | Hospitalisation [%] | Outpatient treatment [N] | Outpatient treatment [%] | |
| Chen 2009 | I1: electro‐acupuncture | 20 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| I2: acupuncture | 20 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | |
| C: no intervention | 20 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Chen 2013 | I: catgut embedding therapy | 30 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| C: lifestyle control | 30 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Dang 2012 | I: electro‐acupuncture + lifestyle control | 30 | 0 | 0 | 0 | 0 | 0 | 0 |
| I2: computerized intermediate‐frequency therapy + electro‐acupuncture + lifestyle control | 30 | 0 | 0 | 0 | 0 | 0 | 0 | |
| C: lifestyle control | 30 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Ding 2013 | I: acupuncture + lifestyle control | 102 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| C: lifestyle control | 100 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Duan 2013 | I: acupuncture + lifestyle control | 45 | 0 | 0 | 0 | 0 | 0 | 0 |
| C: foot holographic scraping therapy + lifestyle control | 45 | 0 | 0 | 0 | 0 | 1 | 2 | |
| Feng 2014 | I: catgut embedding therapy + lifestyle control | 68 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| C: lifestyle control | 22 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Gucel 2012 | I: acupuncture | 20 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| C: sham acupuncture | 20 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Guo 2011 | I1: catgut embedding therapy + Chinese herbal medicine + lifestyle control | 30 | 0 | 0 | 0 | 0 | 0 | 0 |
| I2: catgut embedding therapy + lifestyle control | 30 | 0 | 0 | 0 | 0 | 0 | 0 | |
| C: Chinese herbal medicine + lifestyle control | 30 | 0 | 0 | 0 | 0 | 0 | 0 | |
| He 2012 | I: acupuncture | 30 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| C: flash‐fire cupping therapy | 28 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Hsu 2009 | I: auricular acupuncture | 23 | 0 | 0 | 0 | 0 | 8 | 35 |
| C: sham auricular acupuncture | 22 | 0 | 0 | 0 | 0 | 2 | 9 | |
| Hsu 2005a | I: electro‐acupuncture | 24 | 0 | 0 | 0 | 0 | 3 | 13 |
| C: sit‐up exercise | 22 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Hsu 2005b | I: electro‐acupuncture | 22 | 0 | 0 | 0 | 0 | 4 | 18 |
| C1: sit‐up exercise | 20 | 0 | 0 | 0 | 0 | 0 | 0 | |
| C2: no intervention | 21 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Lai 2010 | I: acupuncture | 43 | 0 | 0 | 0 | 0 | 0 | 0 |
| C: western medicine | 43 | 0 | 0 | 0 | 0 | 21 | 49 | |
| Li 2009 | I: catgut embedding therapy | 36 | ‐ | ‐ | ‐ | ‐ | ‐ | |
| C: western medicine | 38 | ‐ | ‐ | ‐ | ‐ | ‐ | ||
| Li 2014 | I1: acupuncture | 49 | 0 | 0 | 0 | 0 | 0 | 0 |
| I2: acupuncture + western medicine | 53 | 0 | 0 | 0 | 0 | 0 | 0 | |
| C: sham acupuncture + western medicine | 51 | 0 | 0 | 0 | 0 | 22 | 43 | |
| Li L 2006 | I1: electro‐acupuncture + lifestyle control | 26 | 0 | 0 | 0 | 0 | 0 | 0 |
| I2: electro‐auricular acupuncture + auricular acupressure + lifestyle control | 29 | 0 | 0 | 0 | 0 | 0 | 0 | |
| C: lifestyle control | 30 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Lien 2012 | I1: auricular acupuncture | 24 | 0 | 0 | 0 | 0 | 0 | 0 |
| I2: auricular acupressure | 24 | 0 | 0 | 0 | 0 | 0 | 0 | |
| C: sham auricular acupuncture | 23 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Liu 2010 | I1: catgut embedding therapy | 21 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| I2: catgut embedding therapy + Chinese herbal medicine | 18 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | |
| C: Chinese herbal medicine | 20 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Liu 2011 | I: electro‐acupuncture | 30 | 0 | 0 | 0 | 0 | 1 | 3 |
| C: low‐frequency electric stimulation therapy | 30 | 0 | 0 | 0 | 0 | 2 | 6 | |
| Lu 2014 | I: catgut embedding therapy + western medicine | 20 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| C: western medicine | 12 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Luo 2006 | I1: electro‐acupuncture | 20 | 0 | 0 | 0 | 0 | 0 | 0 |
| I2: acupuncture | 20 | 0 | 0 | 0 | 0 | 0 | 0 | |
| C: no intervention | 20 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Mi 2005 | I: acupuncture | 80 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| C: lifestyle control | 40 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Pan 2010 | I: acupuncture + lifestyle control | 48 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| C: sham acupuncture + lifestyle control | 26 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Rerksuppaphol 2011 | I: electro‐acupuncture | 22 | 0 | 0 | 0 | 0 | 0 | 0 |
| C: transcutaneous electrical acupoint stimulation | 23 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Schukro 2014 | I: electro‐auricular acupuncture | ‐ | 0 | 0 | 0 | 0 | 0 | 0 |
| C: sham auricular acupuncture | ‐ | 0 | 0 | 0 | 0 | 0 | 0 | |
| Shan 2008 | I: acupuncture + lifestyle control | 72 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| C: lifestyle control | 40 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Shu 2011 | I1: electro‐acupuncture + lifestyle control | 15 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| I2: auricular acupressure + lifestyle control | 15 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | |
| C: moxibustion + lifestyle control | 15 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Su 2013 | I: acupuncture + Chinese herbal medicine + lifestyle control | 40 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| C: Chinese herbal medicine + lifestyle control | 40 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Tao 2009 | I: catgut embedding therapy + Chinese herbal medicine | 19 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| C: Chinese herbal medicine | 19 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Tao 2010 | I1: catgut embedding therapy + Chinese herbal medicine | 18 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| I2: catgut embedding therapy | 19 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | |
| C: Chinese herbal medicine | 17 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Tong 2011 | I: acupuncture + lifestyle control | 76 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| C: sham acupuncture + lifestyle control | 42 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Wang 2014 | I: acupuncture + lifestyle control | 50 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| C: Chinese herbal medicine + lifestyle control | 50 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Wang X 2006 | I1: electro‐acupuncture | 20 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| I2: electro‐acupuncture + Chinese herbal medicine | 20 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | |
| C: Chinese herbal medicine | 20 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Wu 2009 | I: catgut embedding therapy + lifestyle control | 30 | 0 | 0 | 0 | 0 | 3 | 10 |
| C: western medicine + lifestyle control | 30 | 0 | 0 | 0 | 0 | >25 | >83 | |
| Xing 2009 | I: acupuncture + lifestyle control | 31 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| C: lifestyle control | 30 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Xiong 2011 | I: acupuncture | 18 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| C1: needle‐knife | 18 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | |
| C2: western medicine | 18 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Xu 2008 | I: catgut embedding therapy + lifestyle control | 30 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| C: Chinese herbal medicine + lifestyle control | 30 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Xu 2011 | I: acupuncture | 100 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| C: western medicine | 50 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Yan 2011 | I: acupuncture + lifestyle control | 57 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| C: bian‐stone + lifestyle control | 57 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Ye 2010 | I: electro‐acupuncture + lifestyle control | 48 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| C: lifestyle control | 48 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Yin 2006 | I: acupuncture | 50 | 0 | 0 | 0 | 0 | 0 | 0 |
| C: acupoint plaster application | 58 | 0 | 0 | 0 | 0 | 1 | 2 | |
| Zhang 2005 | I: acupuncture | 30 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| C: magnet plastering therapy | 30 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Zhang 2011 | I1: electro‐acupuncture + lifestyle control | 26 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| I2: electro‐acupuncture + computerized intermediate‐frequency + lifestyle control | 26 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | |
| C: lifestyle control | 26 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Zhang 2012 | I: electro‐acupuncture | 15 | 0 | 0 | 0 | 0 | 1 | 7 |
| C: sham acupuncture | 15 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Zhang Y 2007 | I: electro‐acupuncture + lifestyle control | 32 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| C: lifestyle control | 32 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Zhao 2010 | I: electro‐acupuncture + lifestyle control | 30 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| C: lifestyle control | 30 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Zhao 2011 | I: electro‐acupuncture + transcutaneous electrical acupoint stimulation | 35 | ||||||
| C: sham acupuncture + transcutaneous electrical acupoint stimulation | 35 | |||||||
| Zhu 2007 | I1: acupuncture+ auricular acupuncture + lifestyle control | 42 | ||||||
| I2: acupuncture+ auricular acupuncture | 40 | |||||||
| C: lifestyle control | 38 | |||||||
| "‐" denotes not reported C: comparator; I: intervention | ||||||||
Appendix 11. Adverse events (III)
| Intervention(s) and comparator(s) | Participants included in analysis [N] | Specific adverse events [description] | Specific adverse events [N participants] | Specific adverse events [% participants] | |
| Chen 2009 | I1: electro‐acupuncture | 20 | ‐ | ‐ | ‐ |
| I2: acupuncture | 20 | ‐ | ‐ | ‐ | |
| C: no intervention | 20 | ‐ | ‐ | ‐ | |
| Chen 2013 | I: catgut embedding therapy | 30 | ‐ | ‐ | ‐ |
| C: lifestyle control | 30 | ‐ | ‐ | ‐ | |
| Dang 2012 | I: electro‐acupuncture + lifestyle control | 30 | No adverse effect | 0 | 0 |
| I2: computerized intermediate‐frequency therapy + electro‐acupuncture + lifestyle control | 30 | No adverse effect | 0 | 0 | |
| C: lifestyle control | 30 | No adverse effect | 0 | 0 | |
| Ding 2013 | I: acupuncture + lifestyle control | 102 | ‐ | ‐ | ‐ |
| C: lifestyle control | 100 | ‐ | ‐ | ‐ | |
| Duan 2013 | I: acupuncture + lifestyle control | 45 | Dizziness | 0 | 0 |
| C: foot holographic scraping therapy + lifestyle control | 45 | No adverse effect | 1 | 2 | |
| Feng 2014 | I: catgut embedding therapy + lifestyle control | 68 | ‐ | ‐ | ‐ |
| C: lifestyle control | 22 | ‐ | ‐ | ‐ | |
| Gucel 2012 | I: acupuncture | 20 | ‐ | ‐ | ‐ |
| C: sham acupuncture | 20 | ‐ | ‐ | ‐ | |
| Guo 2011 | I1: catgut embedding therapy + Chinese herbal medicine + lifestyle control | 30 | No adverse effect | 0 | 0 |
| I2: catgut embedding therapy + lifestyle control | 30 | No adverse effect | 0 | 0 | |
| C: Chinese herbal medicine + lifestyle control | 30 | No adverse effect | 0 | 0 | |
| He 2012 | I: acupuncture | 30 | ‐ | ‐ | ‐ |
| C: flash‐fire cupping therapy | 28 | ‐ | ‐ | ‐ | |
| Hsu 2009 | I: auricular acupuncture | 23 | Minor inflammation and mild tenderness | 8 | 35 |
| C: sham auricular acupuncture | 22 | Mild tenderness | 2 | 9 | |
| Hsu 2005a | I: electro‐acupuncture | 24 | Mild ecchymosis and abdominal discomfort | 3 | 13 |
| C: sit‐up exercise | 22 | No adverse effect | 0 | 0 | |
| Hsu 2005b | I: electro‐acupuncture | 22 | Mild ecchymosis and abdominal discomfort | 4 | 18 |
| C1: sit‐up exercise | 20 | No adverse effect | 0 | 0 | |
| C2: no intervention | 21 | No adverse effect | 0 | 0 | |
| Lai 2010 | I: acupuncture | 43 | No adverse effect | 0 | 0 |
| C: western medicine | 43 | Nausea, vomiting, diarrhea, dizziness and inappetence | 21 | 49 | |
| Li 2009 | I: catgut embedding therapy | 36 | ‐ | ‐ | ‐ |
| C: western medicine | 38 | ‐ | ‐ | ‐ | |
| Li 2014 | I1: acupuncture | 49 | No adverse effect | 0 | 0 |
| I2: acupuncture + western medicine | 53 | No adverse effect | 0 | 0 | |
| C: sham acupuncture + western medicine | 51 | Nausea, vomiting, diarrhea, dizziness and inappetence | 22 | 43 | |
| Li L 2006 | I1: electro‐acupuncture + lifestyle control | 26 | ‐ | ‐ | ‐ |
| I2: electro‐auricular acupuncture + auricular acupressure + lifestyle control | 29 | ‐ | ‐ | ‐ | |
| C: lifestyle control | 30 | ‐ | ‐ | ‐ | |
| Lien 2012 | I1: auricular acupuncture | 24 | No adverse effect | 0 | 0 |
| I2: auricular acupressure | 24 | No adverse effect | 0 | 0 | |
| C: sham auricular acupuncture | 23 | No adverse effect | 0 | 0 | |
| Liu 2010 | I1: catgut embedding therapy | 21 | ‐ | ‐ | ‐ |
| I2: catgut embedding therapy + Chinese herbal medicine | 18 | ‐ | ‐ | ‐ | |
| C: Chinese herbal medicine | 20 | ‐ | ‐ | ‐ | |
| Liu 2011 | I: electro‐acupuncture | 30 | Fainting during acupuncture | 1 | 3 |
| C: low‐frequency electric stimulation therapy | 30 | Fainting during acupuncture | 2 | 6 | |
| Lu 2014 | I: catgut embedding therapy + western medicine | 20 | ‐ | ‐ | ‐ |
| C: western medicine | 12 | ‐ | ‐ | ‐ | |
| Luo 2006 | I1: electro‐acupuncture | 20 | No adverse effect | 0 | 0 |
| I2: acupuncture | 20 | No adverse effect | 0 | 0 | |
| C: no intervention | 20 | No adverse effect | 0 | 0 | |
| Mi 2005 | I: acupuncture | 80 | ‐ | ‐ | ‐ |
| C: lifestyle control | 40 | ‐ | ‐ | ‐ | |
| Pan 2010 | I: acupuncture + lifestyle control | 48 | ‐ | ‐ | ‐ |
| C: sham acupuncture + lifestyle control | 26 | ‐ | ‐ | ‐ | |
| Rerksuppaphol 2011 | I: electro‐acupuncture | 22 | No adverse effect | 0 | 0 |
| C: transcutaneous electrical acupoint stimulation | 23 | No adverse effect | 0 | 0 | |
| Schukro 2014 | I: electro‐auricular acupuncture | 22 | No adverse effect | 0 | 0 |
| C: sham auricular acupuncture | 23 | Irritation | 8 | 35 | |
| Shan 2008 | I: acupuncture + lifestyle control | 72 | ‐ | ‐ | ‐ |
| C: lifestyle control | 40 | ‐ | ‐ | ‐ | |
| Shu 2011 | I1: electro‐acupuncture + lifestyle control | 15 | ‐ | ‐ | ‐ |
| I2: auricular acupressure + lifestyle control | 15 | ‐ | ‐ | ‐ | |
| C: moxibustion + lifestyle control | 15 | ‐ | ‐ | ‐ | |
| Su 2013 | I: acupuncture + Chinese herbal medicine + lifestyle control | 40 | ‐ | ‐ | ‐ |
| C: Chinese herbal medicine + lifestyle control | 40 | ‐ | ‐ | ‐ | |
| Tao 2009 | I: catgut embedding therapy + Chinese herbal medicine | 19 | ‐ | ‐ | ‐ |
| C: Chinese herbal medicine | 19 | ‐ | ‐ | ‐ | |
| Tao 2010 | I1: catgut embedding therapy + Chinese herbal medicine | 18 | ‐ | ‐ | ‐ |
| I2: catgut embedding therapy | 19 | ‐ | ‐ | ‐ | |
| C: Chinese herbal medicine | 17 | ‐ | ‐ | ‐ | |
| Tong 2011 | I: acupuncture + lifestyle control | 76 | ‐ | ‐ | ‐ |
| C: sham acupuncture + lifestyle control | 42 | ‐ | ‐ | ‐ | |
| Wang 2014 | I: acupuncture + lifestyle control | 50 | ‐ | ‐ | ‐ |
| C: Chinese herbal medicine + lifestyle control | 50 | ‐ | ‐ | ‐ | |
| Wang X 2006 | I1: electro‐acupuncture | 20 | ‐ | ‐ | ‐ |
| I2: electro‐acupuncture + Chinese herbal medicine | 20 | ‐ | ‐ | ‐ | |
| C: Chinese herbal medicine | 20 | ‐ | ‐ | ‐ | |
| Wu 2009 | I: catgut embedding therapy + lifestyle control | 30 | Inflammation and swelling | 3 | 10 |
| C: western medicine + lifestyle control | 30 | Diarrhea, dizziness, week, drowsiness and reduction of blood pressure |
>25 | >83 | |
| Xing 2009 | I: acupuncture + lifestyle control | 31 | ‐ | ‐ | ‐ |
| C: lifestyle control | 30 | ‐ | ‐ | ‐ | |
| Xiong 2011 | I: acupuncture | 18 | ‐ | ‐ | ‐ |
| C1: needle‐knife | 18 | ‐ | ‐ | ‐ | |
| C2: western medicine | 18 | ‐ | ‐ | ‐ | |
| Xu 2008 | I: catgut embedding therapy + lifestyle control | 30 | ‐ | ‐ | ‐ |
| C: Chinese herbal medicine + lifestyle control | 30 | ‐ | ‐ | ‐ | |
| Xu 2011 | I: acupuncture | 100 | ‐ | ‐ | ‐ |
| C: western medicine | 50 | ‐ | ‐ | ‐ | |
| Yan 2011 | I: acupuncture + lifestyle control | 57 | ‐ | ‐ | ‐ |
| C: bian‐stone + lifestyle control | 57 | ‐ | ‐ | ‐ | |
| Ye 2010 | I: electro‐acupuncture + lifestyle control | 48 | ‐ | ‐ | ‐ |
| C: lifestyle control | 48 | ‐ | ‐ | ‐ | |
| Yin 2006 | I: acupuncture | 50 | No adverse effect | 0 | 0 |
| C: acupoint plaster application | 58 | Skin allergy | 1 | 2 | |
| Zhang 2005 | I: acupuncture | 30 | ‐ | ‐ | ‐ |
| C: magnet plastering therapy | 30 | ‐ | ‐ | ‐ | |
| Zhang 2011 | I1: electro‐acupuncture + lifestyle control | 26 | ‐ | ‐ | ‐ |
| I2: electro‐acupuncture + computerized intermediate‐frequency + lifestyle control | 26 | ‐ | ‐ | ‐ | |
| C: lifestyle control | 26 | ‐ | ‐ | ‐ | |
| Zhang 2012 | I: electro‐acupuncture | 15 | Bleeding | 1 | 7 |
| C: sham acupuncture | 15 | No adverse effect | 0 | 0 | |
| Zhang Y 2007 | I: electro‐acupuncture + lifestyle control | 32 | ‐ | ‐ | ‐ |
| C: lifestyle control | 32 | ‐ | ‐ | ‐ | |
| Zhao 2010 | I: electro‐acupuncture + lifestyle control | 30 | ‐ | ‐ | ‐ |
| C: lifestyle control | 30 | ‐ | ‐ | ‐ | |
| Zhao 2011 | I: electro‐acupuncture + transcutaneous electrical acupoint stimulation | 35 | ‐ | ‐ | ‐ |
| C: sham acupuncture + transcutaneous electrical acupoint stimulation | 35 | ‐ | ‐ | ‐ | |
| Zhu 2007 | I1: acupuncture+ auricular acupuncture + lifestyle control | 42 | ‐ | ‐ | ‐ |
| I2: acupuncture+ auricular acupuncture | 40 | ‐ | ‐ | ‐ | |
| C: lifestyle control | 38 | ‐ | ‐ | ‐ | |
| "‐" denotes not reported C: comparator; I: intervention | |||||
Appendix 12. Survey of authors providing information on trials
| Study author contacted [DD/MM/YY] | Study author replied [DD/MM/YY] | Study author asked for additional information [short summary] | Study author provided data [short summary] | |
| Chen 2009 | Have no contact information | Have no contact information | Have no contact information | Have no contact information |
| Chen 2013 | Have no contact information | Have no contact information | Have no contact information | Have no contact information |
| Dang 2012 | Have no contact information | Have no contact information | Have no contact information | Have no contact information |
| Ding 2013 | 28/09/2014 | 28/09/2014 | no | details of the study design |
| Duan 2013 | Have no contact information | Have no contact information | Have no contact information | Have no contact information |
| Feng 2014 | 28/09/2014 | 02/10/2014 | no | details of the study design |
| Gucel 2012 | 02/10/2014 | 07/10/2014 | no | details of the study design |
| Guo 2011 | Have no contact information | Have no contact information | Have no contact information | Have no contact information |
| He 2012 | 28/09/2014 | no reply | no reply | no reply |
| Hsu 2009 | 02/10/2014 | no reply | no reply | no reply |
| Hsu 2005a | 02/10/2014 | no reply | no reply | no reply |
| Hsu 2005b | 02/10/2014 | no reply | no reply | no reply |
| Lai 2010 | 28/09/2014 | no reply | no reply | no reply |
| Li 2009 | Have no contact information | Have no contact information | Have no contact information | Have no contact information |
| Li 2014 | 28/09/2014 | no reply | no reply | no reply |
| Li L 2006 | 28/09/2014 | 09/10/2014 | no | details of the study design |
| Lien 2012 | 02/10/2014 | no reply | no reply | no reply |
| Liu 2010 | Have no contact information | Have no contact information | Have no contact information | Have no contact information |
| Liu 2011 | Have no contact information | Have no contact information | Have no contact information | Have no contact information |
| Lu 2014 | 28/09/2014 | 06/10/2014 | no | details of the study design |
| Luo 2006 | Have no contact information | Have no contact information | Have no contact information | Have no contact information |
| Mi 2005 | 28/09/2014 | no reply | Have no contact information | Have no contact information |
| Pan 2010 | Have no contact information | Have no contact information | Have no contact information | Have no contact information |
| Rerksuppaphol 2011 | 02/10/2014 | no reply | no reply | no reply |
| Schukro 2014 | 02/10/2014 | no reply | no reply | no reply |
| Shan 2008 | Have no contact information | Have no contact information | Have no contact information | Have no contact information |
| Shu 2011 | Have no contact information | Have no contact information | Have no contact information | Have no contact information |
| Su 2013 | Have no contact information | Have no contact information | Have no contact information | Have no contact information |
| Tao 2009 | Have no contact information | Have no contact information | Have no contact information | Have no contact information |
| Tao 2010 | 28/09/2014 | no reply | no reply | no reply |
| Tong 2011 | 28/09/2014 | no reply | no reply | no reply |
| Wang 2014 | Have no contact information | Have no contact information | Have no contact information | Have no contact information |
| Wang X 2006 | Have no contact information | Have no contact information | Have no contact information | Have no contact information |
| Wu 2009 | Have no contact information | Have no contact information | Have no contact information | Have no contact information |
| Xing 2009 | Have no contact information | Have no contact information | Have no contact information | Have no contact information |
| Xiong 2011 | Have no contact information | Have no contact information | Have no contact information | Have no contact information |
| Xu 2008 | Have no contact information | Have no contact information | Have no contact information | Have no contact information |
| Xu 2011 | Have no contact information | Have no contact information | Have no contact information | Have no contact information |
| Yan 2011 | Have no contact information | Have no contact information | Have no contact information | Have no contact information |
| Ye 2010 | Have no contact information | Have no contact information | Have no contact information | Have no contact information |
| Yin 2006 | Have no contact information | Have no contact information | Have no contact information | Have no contact information |
| Zhang 2005 | Have no contact information | Have no contact information | Have no contact information | Have no contact information |
| Zhang 2011 | Have no contact information | Have no contact information | Have no contact information | Have no contact information |
| Zhang 2012 | Have no contact information | Have no contact information | Have no contact information | Have no contact information |
| Zhang Y 2007 | Have no contact information | Have no contact information | Have no contact information | Have no contact information |
| Zhao 2010 | Have no contact information | Have no contact information | Have no contact information | Have no contact information |
| Zhao 2011 | Have no contact information | Have no contact information | Have no contact information | Have no contact information |
| Zhu 2007 | 28/09/2014 | no reply | no reply | no reply |
| N/A: not applicable | ||||
Appendix 13. STRICTA 2010 items of information for clinical trials of acupuncture (I)
| Acupuncture rationale | Details of needling | |||||||||
| 1a | 1b | 1c | 2a | 2b | 2c | 2d | 2e | 2f | 2g | |
| Chen 2009 | Traditional Chinese Medicine | Ancient TCM literature | Ten main fixed acupoints and two optional points | ‐ | The fixed points were Zhongwan (CV12), Guanyuan (CV4), Taichong (LR3), Sanyinjiao (SP6), Neiting (ST44), Daheng (SP15), Tianshu (ST25), Shuidao (ST28), Zhigou (SJ6), Zusanli (ST36) The optional points were Shangjuxu (ST37) and Fujie (SP14) for damp impediment due to Stomach Heat; Fenglong (ST40) and Yinlingquan (SP9) for damp impediment due to Spleen deficiency; Taixi (KI3) and Qihai (CV6) for liver qi stagnation; Pishu (BL20) and Shenshu (BL23) for Yang deficiency in Spleen and Kidney |
0.8‐1.2 cun | De qi | Manual and electrical stimulation: manual rotating needle with uniform reinforcing‐reducing method; electrical stimulation: dilatational wave | 40 min | Acupuncture: ‐; electrical stimulator: D860 |
| Chen 2013 | Catgut embedding therapy | Theory of TCM | Four main fixed acupoints and one to three optional points | ‐ | Four main fixed acupoints and one to three optional points The fixed points were Zhongwan (CV12), Zhangmen (LR13) and Fenglong (ST40) The fixed points were Tianshu (ST25), Dachangshu (BL25), Shangjuxu (ST37); Ciliao (BL32) for menstrual disorder; Zusanli (ST36) for constipation; Ashixue for fat places |
‐ | De qi | Manual stimulation: ‐ | ‐ | Catgut: chromic catgut 1‐1.5 cun |
| Dang 2012 | Traditional Chinese Medicine | Theory of TCM and literature sources | Fourteen main fixed acupoints | ‐ | The fixed points were Zhigou (SJ6), Quchi (LI11), Zhongwan (CV12), Qihai (CV6), Shuifen (CV9), Tianshu (ST25), Shuidao (ST28), Daheng (SP15), Yinlingquan (SP9), Zusanli (ST36), Fenglong (ST40), Neiting (ST44) and Shangjuxu (ST37) | ‐ | De qi | Manual stimulation: manual rotating needle with uniform reinforcing‐reducing method; electrical stimulation: continuous wave, 2‐15Hz | 30 min | Acupuncture: HUAN QIU stainless steel, Φ0.35 × 75mm (3 cun); electrical stimulator: G6805 |
| Ding 2013 | Traditional Chinese Medicine | ‐ | Eight main fixed acupoints and three to four optional points | ‐ | The fixed points were Yishu (EX‐B4), Chengjiang (CV24), Feishu (), Pishu (BL20), Weishu (BL21), Shenshu (BL23), Zusanli (ST36) and Sanyinjiao (SP6) The optional points were Tianshu (ST25), Neiting (ST44), Hegu (LI14) for excess heat in stomach and intestine; Fenglong (ST40), Yinlingquan (SP9) Zhongwan (CV12) and Qihai (CV6) for predominant dampness due to spleen deficiency; Taichong (LR3), Quanquan (LR8), Jiaxi (GB43) and Qimen (LR14) for liver qi stagnation; Guanyuan (CV4), Zhigou (SJ6), Zhaohai (KI6) and Taixi (KI3) for qi deficiency in kidney |
‐ | De qi | Manual stimulation: manipulation every 10 min | 30 min | Acupuncture: #29 or #30 sterile acupuncture |
| Duan 2013 | Traditional Chinese Medicine | ‐ | Five main fixed acupoints and four optional points | ‐ | The fixed points were Zhongwan (CV12), Qihai (CV6), Huaroumen (ST24), Daheng (SP15), Liangqiu (ST34) The optional points were Fenglong (ST40), Neiting (ST44), Hegu (LI14), Quchi (LI11) for excess heat in Stomach and Large intestine; Zusanli (ST36), Sanyinjiao (SP6), Gongsun (SP4), Yinlingquan (SP9) for predominant Dampness due to Spleen deficiency; Danzhong (CV17), Qimen (LR14), Yanglingquan (SP9), Taichong (LR3) for Liver qi stagnation; Guanyuan (CV4), Zusanli (ST36), Sanyinjiao (SP6), Zhaohai (KI6) for yang deficiency in spleen and kidney; Sanyinjiao (SP6), Zusanli (ST36), Neiguan (PC6), Taixi (KI3) for yin deficiency generating interior Heat |
0.5‐1 cun | ‐ | Manual stimulation: manual rotating needle with uniform reinforcing‐reducing method | 30 min | Acupuncture: HUANQIU sterile acupuncture (0.25 x 25mm, 0.25 x 40mm) |
| Feng 2014 | Traditional Chinese Medicine | Ancient TCM literature and theory of TCM | Four groups of points | ‐ | (1)Guilai (ST29), Shuidao (ST28), Daju (ST27) and Wailing (ST26) (2)Daheng (SP15), Qixue (KI13), Siman (KI14) and Zhongzhu (KI15) (3)Dachangshu (BL25), Xiaochangshu (BL27), Pangguangshu (BL28) and Zhishi (BL52) (4)Yaoshu (GV2), Mingmen (GV4), Zhibian (BL52) and Weicang (BL50) |
‐ | De qi | Manual stimulation: ‐ | ‐ | Catgut:chromic catgut (Shanghai Pudong Jinhuan Medical Products Co., LTD) |
| Gucel 2012 | Traditional Chinese Medicine | Literature sources | Five main fixed acupoints | The fixed points were Hegu (LI14), Shenmen (HT7), Zusanli (ST36), Neiting (ST44) and Sanyinjiao (SP6) | 5‐10 mm | De qi | Manual stimulation: ‐ | 20 min | Acupuncture: disposable stainless steel needles (25 mm long, 0.25 mm in diameter, Kingli, Lianghong Rd | |
| Guo 2011 | Catgut embedding therapy | Ancient TCM literature | Four main fixed acupoints and two to three optional points | ‐ | The fixed points were Pishu (BL20), Zhangmen (LR13), Yinlingquan (SP9) and Zusanli (ST36) The optional points were Liangmen (ST21), Xiawan (CV10) and Daheng (SP15) for fat above the belly button; Guanyuan (CV4), Daju (ST27), Guilai (ST29) for fat below the belly button; Tianshu (ST25) and Daheng (SP15) for abdominal obesity; Daimai (GB26) and Shenshu (BL23) for fat waist; Huantiao (GB30) and Chengfu (BL36) for fleshy hips |
Muscular layer (depths unknown) | De qi | Manual stimulation: ‐ | ‐ | Catgut: chromic catgut 2cm |
| He 2012 | Traditional Chinese Medicine | ‐ | Two groups of points were alternately used | ‐ | (1)Zhongwan (CV12), Liangmen (ST21), Xiawan (CV10), Tianshu (ST25), Shuifen (CV9), Huaroumen (ST24), Guanyuan (CV4), Qihai (CV6), Fuai (SP16), Fujie (SP14) and Ashixue (2)Geshu (BL17), Pishu (BL20), Weishu (BL21) and Ashixue |
The depth of needle insertion varied with thickness of the subcutaneous fatty tissues | ‐ | Manual stimulation: manual rotating needle with lifting and thrusting; manipulation every 10 min | 30 min | ‐ |
| Hsu 2005a | Traditional Chinese Medicine | Theory of TCM, clinical experience and consensus method | Nine main fixed acupoints | ‐ | The fixed points were Qihai (CV6), Shuifen (CV9), Shuidao (ST28), Suidao (ST28), Siman (KI14), Siman (KI14), Zusanli (ST26), Fenglong (ST40), Sanyinjiao (SP6) | Approximately 2.5cm | De qi | Manual stimulation: manual rotating needle (in the lower legs); electrical stimulation: dilatational wave, 42 Hz, 390 ms square pulse, and at a maximal tolerable intensity, 500Ω (12–23 V) (a strong, but not painful sensation to the patient) | 40 min | Acupuncture: stainless‐steel acupuncture needles (3.8cm long), electrical stimulator: GWO‐JIH, MODEL‐05, Taiwan |
| Hsu 2005b | Traditional Chinese Medicine | Theory of TCM and clinical experience | Eight main fixed acupoints | ‐ | Qihai (CV6), Shuifen (CV9), Shuidao (ST28), Suidao (ST28), Siman (KI14), Zusanli (ST26), Fenglong (ST40), Sanginjao (SP6) | Approximately 2.5 cm | De qi | Manual stimulation: manual rotating needle (in the lower legs); electrical stimulation: dilatational wave, 42 Hz, 390 ms square pulse, and at a maximal tolerable intensity, 500Ω (12–23 V) (a strong, but not painful sensation to the patient) | 40 min | Acupuncture: stainless‐steel acupuncture needles (3.8cm long); electrical stimulator: GWO‐JIH, MODEL‐05, Taiwan |
| Hsu 2009a | Auricular acupuncture | Theory of TCM and clinical experience | Four main fixed acupoints | ‐ | Hunger point (Jidian), shenmen point (TF4), stomach point (CO4), and endocrine point Needles (CO18) | ‐ | ‐ | Manual stimulation: ‐ | Three days | Auricular acupuncture: special stainless steel auricular acupuncture needles (36‐gauge 0.5‐inch) were made into a thumbtack form with a 0.2‐cm needle point and a 1.0‐cm annular‐shaped needle handle |
| Lai 2010 | Traditional Chinese Medicine | Theory of TCM | Five main fixed acupoints | ‐ | Zhongwan (CV12), Xiawan (CV10), Qihai (CV6), Guanyuan (CV4) and Liangmen (ST21) | ‐ | ‐ | Manual stimulation: manual without any manipulation | 30 min | Acupuncture: 0.25 mm × 40 mm |
| Li 2009 | Catgut embedding therapy | ‐ | Eight main fixed acupoints | ‐ | Zusanli (ST36), Fenglong (ST40), Zhongwan (CV12), Liangmen (ST21), Tianshu (ST25), Quchi (LI11), Fujie (SP14), Shangjuxu (ST37) | ‐ | De qi | Manual stimulation: Zusanli (ST36), Fenglong (ST40), Liangmen (ST21), Tianshu (ST25), Quchi (LI11), Fujie (SP14) and Shangjuxu (ST37) reducing by manual lifting and thrusting needle; Zhongwan (CV12) by manual lifting and thrusting needle with uniform reinforcing‐reducing method | ‐ | Catgut: chromic catgut 1cm |
| Li 2014 | Traditional Chinese Medicine | Ancient TCM literature | Seven main fixed acupoints | ‐ | Zhongji (CV3), Guanyuan (CV4), Zigong, Sanyinjiao (SP6), Fuliu (KI17), Zusanli (ST36) and Qixue (KI13) | 4‐5 mm | De qi | Manual stimulation: manipulation every 10 min | 30 min | ‐ |
| Li L 2006 | Traditional Chinese Medicine | Ancient TCM literature | Thirteen main fixed acupoints | Sanyinjiao (SP6), Tianshu (ST25), Zusanli (ST36), Quchi (LI11), Fenglong (ST40), Neiting (ST44), Zhongwan (CV12), Pishu (BL20), Shenshu (BL23), Qihai (CV6), Yinlingquan (SP9), Shangjuxu (ST37), Taichong (LR3) | ‐ | De qi | Manual stimulation: manual manipulating the needle with uniform reinforcing‐reducing method | 10 min | Acupuncture: Hwato stainless steel, Φ0.32 × 0.65mm; auricular acupuncture: Hwato stainless steel, Φ0.32 × 25mm; electrical stimulator: G6805‐Ⅱ | |
| Lien 2012 | Auricular acupuncture | Theory of TCM and clinical experience | Four main fixed acupoints | ‐ | Shenmen (TF4), Wei (CO4), hunger point (Jidian) and Neifenmi (CO18) | ‐ | ‐ | Manual stimulation: ‐ | Two days | Auricular acupuncture: standardized stainless auricular acupuncture needles with a 0.2 cm tip and a 1.0 cm annular‐shaped body |
| Liu 2010 | Catgut embedding therapy | ‐ | One group of points | ‐ | (1)Ganshu (BL18), Zhongji (CV3), Geshu (BL17), Zusanli (ST36), Sanyinjiao (SP6), Daimai (GB26), Guanyuan (CV4); (2)Shenshu (BL23), Pishu (BL20), Tianshu (ST25), Shuifen (CV9), Yinlingquan (SP9), Fenglong (ST40), Luancao | ‐ | ‐ | Manual stimulation: ‐ | Two days | Catgut: #3‐0 catgut 0.7 cm |
| Liu 2011 | Traditional Chinese Medicine | Ancient TCM literature and literature sources | Ten main fixed acupoints and two optional points | ‐ | The fixed points were Shuifen (CV9), Guanyuan (CV4), Tianshu (ST25), Shuidao (ST28), Zhongwan (CV12), Daheng (SP15), Daimai (GB26), Zusanli (ST36), Fenglong (ST40) and Sanyinjiao (SP6) The optional points were Yinlingquan (SP9) and Xuehai (SP10) for predominant dampness due to spleen deficiency; Neiting (ST44) and Quchi (LI11) for excess heat in stomach and intestine; Yinlingquan (SP9) and Taichong (LR3) for liver qi stagnation; Shenshu (BL23) and Mingmen (GV4) for yang deficiency in spleen and kidney; Sanyinjiao (SP6) and Taixi (KI3) for internal heat due to yin deficiency |
‐ | ‐ | Manual stimulation: ‐; electrical stimulation: continuous wave, 3 mA, 7 Hz | 30 min | Acupuncture: HUANQIU stainless steel, Φ0.3 × 0.4mm; electrical stimulator: ‐ |
| Lu 2014 | Catgut embedding therapy | ‐ | Two groups of points | ‐ | (1)Ganshu (BL18), Pishu (BL20) ,Shenshu (BL23), Yanglingquan (GB34), Sanyinjiao (SP6) and Fenglong (ST40); (2)Zhongwan (CV12), Xiawan (CV10), Tianshu (ST25), Guilai (ST29), Guanyuan (CV4), Zigong and Yinlingquan (SP9) |
‐ | ‐ | Manual stimulation: ‐ | ‐ | ‐ |
| Luo 2006 | Traditional Chinese Medicine | Theory of TCM | Twenty four main fixed acupoints | Liangqiu (ST34), Xuehai (SP10), Zusanli (ST36), Fenglong (ST40), Quchi (LI11), Neiguan (PC6), Zhigou (SJ6), Waiguan (SJ5), Yinlingquan (SP9), Sanyinjiao (SP6), Taixi (KI3),Taichong (LR3), Shangjuxu (ST37), Xiajuxu (ST39), Gongsun (SP4), Neiting (ST44), Shuifen (CV9), Zhongwan (CV12), Fujie (SP14), Daimai (GB26), Tianshu (ST25), Wailing (ST26), Daju (ST27), Shuidao (ST28) | ‐ | De qi | Manual stimulation: ‐; electrical stimulation with dilatational wave | 40 min | Acupuncture: Hwato stainless steel, Φ0.35 × 50mm, 0.35x40mm, 0.35x25mm; electrical stimulator: G6805‐B | |
| Mi 2005 | Traditional Chinese Medicine | Theory of TCM | Eighteen main fixed acupoints and six to seven optional points | ‐ | The fixed points were Zusanli (ST36), Sanyinjiao (SP6), Neiting (ST44), Liangqiu (ST34), Shangjuxu (ST37), Xiajuxu (ST39), Tianshu (ST25), Daheng (SP15), Zhongwan (CV12), Pishu (BL20), Weishu (BL21), Zhangmen (LR13), Neiguan (PC6), Qihai (CV6), Fenglong (ST40), Guanyuan (CV4), Zhigou (SJ6), Taixi (KI3) The optional points were Dachangshu (BL25), Xiaochangshu (BL27), Erjian (LI2), Shangwan (CV13), Xiawan (CV10), Zhiyang (GV10) for excess heat in stomach and intestine; Yinlingquan (SP9), Shuifen (CV9), Shuidao (ST28), Taibai (SP3), Fujie (SP14), Taiyang (EX‐HN5), Baihui (GV20) for predominant dampness due to spleen deficiency; Taichong (LR3), Xingjian (LR2), Qimen (LR14), Ligou (LR5), Ququan (LR8) for liver qi stagnation |
‐ | ‐ | Manual stimulation: manipulating needle with uniform reinforcing‐reducing method every 10 min | 35 min | Acupuncture: Φ 0.30 mm needles |
| Pan 2010 | Traditional Chinese Medicine | Theory of TCM and clinical experience | Thirteen main fixed acupoints | ‐ | The fixed points were Tianshu (ST25), Daheng (SP15), Zhongwan (CV12), Xiawan (CV10), Shimen (CV5), Zhongji (CV3), Liangqiu (ST34), Zusanli (ST36), Yinlingquan (SP9) and points at the upper left, lower left, upper right and lower right of umbilicus | ‐ | ‐ | Manual stimulation: manipulating needle with uniform reinforcing‐reducing method | 30 min | Acupuncture: Korea acupuncture (DONGBANG ACUPUNCTURE) |
| Rerksuppaphol 2011 | Traditional Chinese Medicine | Literature sources | Seven main fixed acupoints | ‐ | Guanyuan (CV4), Qihai (CV6), Xiawan (CV10), Zhongwan (CV12), Tianshu (ST25), Shuidao (ST28), Daheng (SP15) | ‐ | ‐ | Manual stimulation: ‐; electrical stimulation: continuous wave, 0.2 ms pulses, 40Hz | 30 min | Acupuncture: disposable needles (0.25 x 25mm); electrical stimulator: HM Stim2 fit (Wuxi Jiajian Medical Instrument Co Ltd, Wuxi, China) |
| Schukro 2014 | Traditional Chinese Medicine | Literature sources | Four main fixed acupoints | ‐ | Wei (CO4), hunger point (Jidian) and Dachang (CO7) Points were applied on only one ear in each treatment |
‐ | ‐ | Manual stimulation: ‐ | Four days | electro‐acupuncture device: P‐Stim® electro‐acupuncture device (Biegler GmbH. Allhangstrasse 18a, 3001 Mauerbach, Austria); acupuncture: sterile, single use permanent needles (titanium, 27 gauge, length 3 mm) |
| Shan 2008 | Traditional Chinese Medicine | Theory of TCM | Fifteen main fixed acupoints and two to three optional points | ‐ | The fixed points were Xiawan (CV10), Daheng (SP15), Qihai (CV6), Tianshu (ST25), Zusanli (ST36), Fenglong (ST40), Taichong (LR3), Jianfeixue (midpoint between CV 8 and anterior superior iliac spine), Pishu (BL20), Weishu (BL21), Dachangshu (BL25), Shenshu (BL23), Huantiao (GB30) Ashixue for fat places The optional points were Shangjuxu (ST37) and Zhigou (SJ6) for constipation; Baihui (GV20),Quchi (LI11) and Ganshu (BL18) for hypertension and fatty liver; Guanyuan (CV4), Zhongji (CV3) and Sanyinjiao (SP6) for irregular menstruation; Sanyinjiao (SP6) and Yishu (EX‐B3) for DM; Neiguan (PC6) and Xinshu (BL15) for coronary heart disease; Ashixue for fat places |
‐ | ‐ | Manual stimulation: ‐ | 25‐30 min | Acupuncture: Φ0.30 × 0.60mm |
| Shu 2011 | Traditional Chinese Medicine | Theory of TCM and literature sources | Nine main fixed acupoints | ‐ | Tianshu (ST25), Shuifen (CV9), Guanyuan (CV4), Zhongwan (CV12), Zusanli (ST36), Shousanli (LI11), Huaroumen (ST24), Sanyinjiao (SP6), Fenglong (ST40) | ‐ | De qi | Manual stimulation: manual rotating needle with lifting and thrusting manipulation; electrical stimulation: different wave | 28 min | Acupuncture: sterile acupuncture needle (KANG SHENG); electrical stimulator: G6805‐Ⅱ |
| Su 2013 | Traditional Chinese Medicine | Theory of TCM and literature sources | Six main fixed acupoints | ‐ | Guanyuan (CV4), Sanyinjiao (SP6), Daimai (GB26), Shenshu (BL23), Xuehai (SP10) and Zigong (EX‐CA1) | ‐ | ‐ | ‐ | ‐ | ‐ |
| Tao 2009 | Catgut embedding therapy | Theory of TCM and literature sources | Two groups of points | ‐ | (1)Ganshu (BL18), Zhongji (CV3), Geshu (BL17), Zusanli (ST36), Sanyinjiao (SP6), Daimai (GB26), Guanyuan (CV4); (2)Shenshu (BL23), Pishu (BL20), Tianshu (ST25), Shuifen (CV9), Yinlingquan (SP9), Fenglong (ST40), Luancao Points were applied only one group in each treatment | ‐ | ‐ | Manual stimulation: ‐ | ‐ | Catgut embedding: # 0‐3 catgut 0.7cm |
| Tao 2010 | Catgut embedding therapy | Theory of TCM | Two groups of points | ‐ | (1)Ganshu (BL18), Zhongji (CV3), Geshu (BL17), Zusanli (ST36), Sanyinjiao (SP6), Daimai (GB26), Guanyuan (CV4); (2)Shenshu (BL23), Pishu (BL20), Tianshu (ST25), Shuifen (CV9), Yinlingquan (SP9), Fenglong (ST40), Luancao Points were applied only one group in each treatment |
‐ | ‐ | Manual stimulation: ‐ | ‐ | Catgut embedding: catgut 0.7 cm |
| Tong 2011 | Traditional Chinese Medicine | Theory of TCM | Thirteen main fixed acupoints | ‐ | Tianshu (ST25), Daheng (SP15), Zhongwan (CV12), Xiawan (CV10), Shimen (CV5), Zhongji (CV3), Liangqiu (ST34), Zusanli (ST36), Yinlingquan (SP9) and points at the upper left, lower left, upper right and lower right of umbilicus | ‐ | De qi | Manual stimulation: manual rotating needle with lifting and thrusting manipulation, manipulating needle every 15 min | 30 min | Acupuncture: Korea acupuncture (DONGBANG ACUPUNCTURE) |
| Wang 2014 | Traditional Chinese Medicine | Clinical experience | Nine main fixed acupoints | ‐ | Zhongwan (CV12), Tianshu (ST25), Daheng (SP15), Quchi (LI11), Zhigou (SJ6), Neiting (ST44), Fenglong (ST40), Shangjuxu (ST37) and Yinlingquan (SP9) | 1.5‐2.5 cm | De qi | Manual stimulation: manual rotating needle with lifting and thrusting manipulation with a frequency between 20‐30 times/min | 30 min | Acupuncture: sterile acupuncture needle (0.25 × 40 mm) |
| Wang X 2006 | Traditional Chinese Medicine | ‐ | Seventeen main fixed acupoints | ‐ | Tianshu (ST25), Daheng (SP15), Zhongwan (CV12), Guanyuan (CV4), Shuifen (CV9), Siman(KI14), Qihai (CV6), Daimai (GB26), Wushu (GB27), Weidao (GB28), Fenglong (ST40), Shangjuxu (ST37), Zusanli (ST36), Sanyinjiao (SP6), Yinlingquan (SP9), Quchi (LI11), Zhigou (SJ6) | The depth of needle insertion varied with thickness of the subcutaneous fatty tissues at the site of the acupuncture points | De qi | Manual stimulation: manual rotating needle at lower legs; electrical stimulation with dilatational wave | 40 min | Acupuncture: (abdominal) gauge 30# with length 2mm and (lower limb) gauge 32# with length 1.5mm |
| Wu 2009 | Catgut embedding therapy | Ancient TCM literature | Eight main fixed acupoints and three to four optional points | ‐ | The fixed points were Zhongwan (CV12), Shuifen (CV9), Qihai (CV6), Guanyuan (CV4), Tianshu (ST25), Daheng (SP15), Zusanli (ST36), Yinlingquan (SP9) The optional points were Quchi (LI11), Shangjuxu (ST37), Xiajuxu (ST39), Neiting (ST44) for excess heat in stomach and spleen; Sanyinjiao (SP6), Taichong (LR3), Ququan (LR8) for Qi stagnation and blood stasis; Pishu (BL20), Fenglong (ST40), Shuidao (ST28) for phlegm dampness due to spleen deficiency; Pishu (BL20), Shenshu (BL23), Sanyinjiao (SP6), Taixi (KI3) for yang deficiency in spleen and kidney; Ashixue for fat places |
‐ | De qi | Manual stimulation: ‐ | ‐ | Catgut embedding: #2 catgut 1‐1.5cm |
| Xing 2009 | Traditional Chinese Medicine | ‐ | Nine main fixed acupoints | ‐ | Zhongwan (CV12), Tianshu (ST25), Guanyuan (CV4), Zusanli (ST36), Fenglong (ST40), Sanyinjiao (SP6), Pishu (BL20), Weishu (BL21) Ashixue for fat places |
‐ | De qi | Manual stimulation: manipulating needle 2 min; electrical stimulation: dilatational wave | 30 min | Acupuncture: Hwato stainless steel, gauge 30# with length 25mm, 40mm and 50mm; electrical stimulator: G6805‐2A |
| Xiong 2011 | Traditional Chinese Medicine | Theory of TCM and literature sources | Four groups of points | ‐ | (1)Tianshu (ST25), Daheng (SP15), Fenglong (ST40), Huaroumen (ST24) (2)Zhongwan (CV12), Shuidao (ST28), Liangqiu (ST34), Wailing (ST26) (3)Ashixue, Shuifen (CV9), Sanyinjiao (SP6), Liangmen (ST21) (4)Daimai (GB26), Daju (ST27), Fengshi (GB31), Shangjuxu (ST37) |
The depth of needle insertion varied with thickness of the subcutaneous fatty tissues | De qi | Manual stimulation: manual rotating needle with lifting and thrusting manipulation every 10 min | 40 min | Acupuncture: disposable needles (0.30 × 40mm, 0.30 × 75mm) |
| Xu 2008 | Catgut embedding therapy | Ancient TCM literature | Two main fixed acupoints | ‐ | Zusanli (ST36), Neiting (ST44) | Zusanli (ST36): 1.8cm; Neiting (ST44): 0.8cm | De qi | Zusanli (ST36): manual rotating needle with uniform reinforcing‐reducing method; Neiting (ST44): manual rotating needle with reducing method | ‐ | Catgut embedding: catgut 0.5, 1.5cm |
| Xu 2011 | Traditional Chinese Medicine | Theory of TCM | Fifteen main fixed acupoints | ‐ | Jianyu (LI15), Binao (LI14), Quchi (LI11),Pianli (LI16), Hegu (LI4), Biguan (ST31), Futu (ST32), Zusanli (ST36), Shangjuxu (ST37), Fenglong (ST40), Liangmen (ST21), Taiyi (ST23), Tianshu (ST25), Daju (ST27), Guilai (ST29) | ‐ | ‐ | Manual stimulation: cannot manipulate needle with lifting and thrusting method in the abdominal | 30 min | Acupuncture: stainless steel, 2cun |
| Yan 2011 | Traditional Chinese Medicine | ‐ | Eight main fixed acupoints | ‐ | Zhongwan (CV12), Daheng (SP15), Daimai (GB26), Qihai (CV6), Guanyuan (CV4), Zusanli (ST36), Fenglong (ST40), Yinlingquan (SP9) | ‐ | De qi | Manual stimulation: ‐ | 30 min | Acupuncture: 0.30 × 40mm |
| Ye 2010 | Traditional Chinese Medicine | Theory of TCM and literature sources | Five main fixed acupoints and two to three optional points | ‐ | Tianshu (ST25), Guanyuan (CV4), Sanyinjiao (SP6), Fenglong (ST40), Zusanli (ST36) The optional points were Quchi (LI11), Shangjuxu (ST37), Neiting (ST44) for excess heat in stomach and intestine; Yinlingquan (SP9), Qihai (CV6), Pishu (BL20) for predominant dampness due to spleen deficiency; Mingmen (GV4), Pishu (BL20), Shenshu (BL23) for yang deficiency in spleen and kidney |
‐ | De qi | Manual stimulation: manual rotating needle with lifting and thrusting manipulation, 2‐3 time in one treatment, 2‐3min/time; electrical stimulation: dilatational wave, 50/100 Hz | 30 min | Acupuncture: Φ0.30mm with length 40‐70mm; electrical stimulator: G6805‐Ⅱ |
| Yin 2006 | Traditional Chinese Medicine | Theory of TCM and clinical experience | Three main fixed acupoints and five to eight optional points | ‐ | Zhongji (CV3), Guanyuan (CV4), Qihai (CV6) The optional points were Shuifen (CV9), Sanyinjiao (SP6), Yinlingquan (SP9), Taibai (SP3), Pishu (BL20), Weishu (BL21), Zusanli (ST36), Baihui (GV20) for predominant dampness due to spleen deficiency; Quchi (LI11), Neiting (ST44), Weishu (BL21), Zusanli (ST36), Tianshu (ST25), Zhongwan (CV12), Gongsun (SP4) for predominant dampness due to stomach heat; Taichong (LR3), Xingjian (LR2), Qimen (LR14), Danzhong (CV17), Ganshu (BL18), Zhigou (SJ6) for liver qi stagnation; Pishu (BL20), Shenshu (BL23), Sanyinjiao (SP6), Taixi (KI3), Zusanli (ST36), Mingmen (GV4), Yinlingquan (SP9), Baihui (GV20) for yang deficiency in spleen and kidney |
1‐1.2cun (abdominal) | ‐ | Manual stimulation: manipulating needle with uniform reinforcing‐reducing method | 30 min | Acupuncture: stainless steel, #30 with length1cun and 1.5cun |
| Zhang 2005 | Traditional Chinese Medicine | Theory of TCM | Eight main fixed acupoints and three to four optional points | ‐ | Zhongwan (CV12), Shuifen (CV9), Qihai (CV6), Guanyuan (CV4), Tianshu (ST25), Daheng (SP15), Zusanli (ST36) and Yinlingquan (SP9) The optional points were Quchi (LI11), Shangjuxu (ST37), Xiajuxu (ST39) and Neiting (ST44) for excess heat in stomach and intestine; Sanyinjiao (SP6), Taichong (LR3) and Ququan (LR8) for liver qi stagnation; Pishu (BL20), Fenglong (ST40) and Shuidao (ST28) for predominant dampness due to spleen deficiency; Pishu (BL20), Shenshu (BL23), Sanyinjiao (SP6) and Taixi (KI3) for yang deficiency in spleen and kidney |
‐ | ‐ | Manual stimulation: ‐ | 30 min | Acupuncture: stainless‐steel acupuncture needles #30 (1.5‐2 cun) (Rui Qier) |
| Zhang 2011 | Traditional Chinese Medicine | Theory of TCM and literature sources | Nine main fixed acupoints and three optional points | Zhongwan (CV12), Shuifen (CV9), Qihai (CV6), Tianshu (ST25), Daimai (GB26), Daheng (SP15), Zhigou (SJ6), Zusanli (ST36), Fenglong (ST40), Yinlingquan (SP9) The optional points were Pishu (BL20), Taibai (SP3), Shuidao (ST28) for predominant dampness due to spleen deficiency; Quchi (LI11), Shangjuxu (ST37), Neiting (ST44) for predominant dampness due to stomach heat; Taichong (LR3), Qimen (LR14), Xuehai (SP10) for liver qi stagnation; Shenshu (BL23), Pishu (BL20), Taixi (KI3) for yang deficiency in spleen and kidney; Taixi (KI3), Sanyinjiao (SP6), Fuliu (KI7) for internal heat due to yin deficiency; Ashixue for fat places |
Approximately ≤ 2.5cun | De qi | Manual stimulation: manipulating needle with uniform reinforcing‐reducing method; electrical stimulation: continuous wave, 2‐15 Hz, at a maximal tolerable intensity | 30 min | Acupuncture: stainless‐steel acupuncture needles 0.35 × 75 mm (3 cun) (HUAN QIU); electrical stimulator: G6805 (Shanghai Medical Instrument High‐tech Co.) | |
| Zhang 2012 | Traditional Chinese Medicine | Theory of TCM | Four main fixed acupoints | ‐ | Tianshu (ST25), Sanyinjiao (SP6), Zhongwan (CV12), Zusanli (ST36) | ‐ | De qi | Manual stimulation: manual rotating needle; electrical stimulation: dilatational wave, 50 Hz and at a maximal tolerable intensity | 30 min | Acupuncture: ‐; electrical stimulator: Han's acupoint nerve stimulator (HANS) |
| Zhang Y 2007 | Traditional Chinese Medicine | Theory of TCM | Eleven main fixed acupoints and nine optional points | ‐ | Zhongwan (CV12), Guanyuan (CV4), Tianshu (ST25), Shuifen (CV9), Yinjiao (CV7), Huangshu (KI16), Zusanli (ST36), Xuehai (SP10), Xinshu (BL15), Geshu (BL17), Pishu (BL20) The optional points were Quchi (LI11), Binao (LI14), Fengshi (GB31), Liangqiu (ST34), Tianzong (SI11), Weiguanxia Shu (EX‐B3), Danshu (BL19), Dachangshu (BL25), Fenglong (ST40); Ashixue for fat places |
Zhongwan (CV12), Guanyuan (CV4) and Tianshu (ST25): 25 to 50 mm; Shuifen (CV9), Yinjiao (CV7), Huangshu (KI16): 15 to 20 mm | De qi | Manual stimulation: manipulating needle with uniform reinforcing‐reducing method; electrical stimulation: continuous wave with low frequency | 20 min | Acupuncture (abdomen): stainless steel, gauge #32 with length 25 ‐ 75 mm; electrical stimulator:KWD‐808Ⅰ |
| Zhao 2010 | Traditional Chinese Medicine | Ancient TCM literature and literature sources | Fourteen main fixed acupoints | ‐ | Tianshu (ST25), Huaroumen (ST24), Wailing (ST26), Futu (ST32), Zusanli (ST36), Shangjuxu (ST37), Xiajuxu (ST39), Neiting (ST44), Sanyinjiao (SP6), Daheng (SP15), Fujie (SP14), Zhongwan (CV12), Xiawan (CV10), Guanyuan (CV4) Tianshu (ST25), Daheng (SP15), Fujie (SP14), Zusanli (ST36), Shangjuxu (ST37), Xiajuxu (ST39) were connected to an electrical stimulator |
‐ | De qi | Manual stimulation:manipulating needle with uniform reinforcing‐reducing method; electrical stimulation: continuous wave, 2 Hz | 30 min | Acupuncture: gauge #30 with length 1.5‐2cun; electrical stimulator: G6805‐Ⅱ |
| Zhao 2011 | Traditional Chinese Medicine | Ancient TCM literature and literature sources | Eight main fixed acupoints | ‐ | Tianshu (ST25), Huaroumen (ST24), Wailing (ST26), Daju (ST27), Sanyinjiao (SP6), Yinlingquan (SP9), Yinlingquan (SP9), Fenglong (ST40), Zusanli (ST36) | ‐ | De qi | Manual stimulation: manipulating needle with uniform reinforcing‐reducing method; electrical stimulation: continuous wave | 30 min | Acupuncture: Φ0.25× 50mm (Shunhe, Jiangsu province); electrical stimulator: G6805 |
| Zhu 2007 | Traditional Chinese Medicine | ‐ | Acupuncture: thirteen main fixed acupoints; auricular acupuncture: eight main fixed acupoints |
‐ | Acupuncture: Tianshu (ST25), Fujie (SP14), Fushe (SP12),Daju (ST27), Shuidao (ST28), Huaroumen (ST24), Quchi (LI11), Hegu (LI4), Zusanli (ST36), Yinlingquan (SP9), Qihai (CV6), Guanyuan (CV4), Zhongwan (CV12); Ashixue for fat places auricular acupuncture: Jidian, Kou (CO1), Wei (CO4), Dachang (CO7), Zhichang (HX2), Sanjiao (CO17), Pi (CO13), Neifenmi (CO18) |
‐ | ‐ | Manual stimulation: manual rotating needle every 10 min | Acupuncture: 30 min; auricular acupuncture: ‐ | Acupuncture: stainless steel, Φ0.30× 40 mm |
| "‐" denotes not reported STRICTA (standards for reporting interventions in clinical trials of acupuncture) criteria (MacPherson 2010): 1a: style of acupuncture (e.g. Traditional Chinese Medicine, Japanese, Korean, Western medical, Five Element, ear acupuncture, etc) 1b: reasoning for treatment provided, based on historical context, literature sources, and/or consensus methods, with references where appropriate 1c: extent to which treatment was varied 2a: number of needle insertions per subject per session (mean and range where relevant) 2b: names (or location if no standard name) of points used (uni/bilateral) 2c: depth of insertion, based on a specified unit of measurement, or on a particular tissue level 2d: response sought (e.g. de qi or muscle twitch response) 2e: needle stimulation (e.g. manual, electrical) 2f: needle retention time 2g: needle type (diameter, length, and manufacturer or material) | ||||||||||
Appendix 14. STRICTA 2010 items of information for clinical trials of acupuncture (II)
| Treatment regimen | Other components of treatment | Practitioner background | Control or comparator interventions | ||||
| 3a | 3b | 4a | 4b | 5 | 6a | 6b | |
| Chen 2009 | 21 sessions | Seven sessions/course | No other intervention administered to the acupuncture group | ‐ | ‐ | ‐ | No intervention: maintain their former diet during the study period |
| Chen 2013 | Four sessions | One session/month | Lifestyle control | ‐ | ‐ | ‐ | Lifestyle control (1) Total course: eight weeks |
| Dang 2012 | 21 sessions | One session/day (in the first three days); three sessions/week (in the following days) | Lifestyle control | ‐ | ‐ | ‐ | Computerized intermediate‐frequency therapy (1) Dose of the Intervention: 20 min/session (2) Number of treatment sessions: 10 sessions (3) Frequency of treatment: one session/day (in the first three days); Three sessions/week (in the following days) (4) Total course: 10 weeks lifestyle control (1) Total course: 10 weeks |
| Ding 2013 | 30 sessions | One session/day | Lifestyle control | ‐ | ‐ | ‐ | Lifestyle control Total course: five weeks |
| Duan 2013 | 40 sessions | One session every three days | Lifestyle control | Patients were recruited from college students of Chengdu University of TCM and volunteers of Beijing between May 2011 and January 2013 | ‐ | Foot holographic scraping therapy based on theory of TCM | Foot holographic scraping therapy (1) Number of treatment sessions: 40 sessions (2) Frequency of treatment: one session every four days (3) Total course: five weeks |
| Feng 2014 | Four sessions | One session/week | Lifestyle control | Ninety six participants were from affiliated hospital of Chengdu University of TCM | ‐ | ‐ | Lifestyle control (1) Total course: four weeks |
| Gucel 2012 | Ten sessions | Two sessions/week | No other intervention administered to the acupuncture group | The study took place at Gazi University acupuncture outpatient clinic between 29 January 2009 and 7 January 2010 | Both treatments were performed by a certified acupuncturist | ‐ | sham acupuncture (1) Number of treatment sessions: ten sessions (2) Frequency of treatment: two sessions/week (3) Total course: five weeks |
| Guo 2011 | Six sessions | One session/week | Lifestyle control; Chinese herbal medicine | All participants were outpatient of Kangqiao TCM clinic, Taiwan | ‐ | Participants in this study belong to damp impediment due to spleen deficiency According to theory of TCM, Shenling Baizhu San is for the type of syndrome |
Chinese herbal medicine: (Formula)Shenling Baizhu San (1) Dose of the Intervention: 6‐9 g (2) Number of treatment sessions: 42 sessions (3) Frequency of treatment: one session/day (4) Total course: six weeks |
| He 2012 | 20 sessions | One session every two day | No other intervention administered to the acupuncture group | ‐ | ‐ | According to theory of TCM, flash‐fire cupping therapy can regulate qi and liquid in body, thus phlegm was eliminated | Flash‐fire cupping therapy (1) Number of treatment sessions: 20 sessions (2) Frequency of treatment: one session every two day (3) Total course: five weeks |
| Hsu 2005a | 12 sessions | Two sessions/week | No other intervention administered to the acupuncture group | The trial was conducted from January 2002 through December 2002 in the Taipei Hospital, Taiwan | All Chinese‐medicine doctors participating in this study have received a training course beforehand to ensure same‐quality procedures given | ‐ | Sit‐up exercise (1) Dose of the Intervention: not stated (2) Number of treatment sessions: 420 sessions (3) Frequency of treatment: 10 sessions/day (4) Total course: 13 weeks |
| Hsu 2005b | 12 sessions | Two sessions/week | No other intervention administered to the acupuncture group | The trial was conducted from July 2002 through June 2003 in Taipei Hospital, Taiwan | All Chinese‐medicine doctors participating in this study have received a training course beforehand to ensure same‐quality procedures given | ‐ | Sit‐up exercise (1) Dose of the Intervention: not stated (2) Number of treatment sessions: 420 sessions (3) Frequency of treatment: 10 sessions/day (4) Total course: six weeks no intervention (1) Total course: six weeks |
| Hsu 2009a | 12 sessions | Two sessions/week | No other intervention administered to the acupuncture group | The trial was conducted from January through December 2006 in Taipei Hospital, Taiwan | The treatment was given by the same Chinese medicine doctor, who had undergone a training course beforehand to ensure equal quality | ‐ | Sham auricular acupuncture (1) Dose of the Intervention: not stated (2) Number of treatment sessions: 12 sessions (3) Frequency of treatment: two sessions/week (4) Total course: six weeks |
| Lai 2010 | 48 sessions | Two sessions/week | Progesterone injection, 20 mg/day, one sessions/day In the first week of the study, patients received 250mg three times daily; thereafter, the metformin dose was 500mg three times daily |
Patients were recruited from outpatient department of gynecology between January 2006 and May 2009 | ‐ | Metformin has been widely used in the treatment of PCOS | Western medicine: Metformin (1) Dose of the Intervention: one week of 250 mg/time follow by 500 mg/time (2) Number of treatment sessions: 2160 sessions (3) Frequency of treatment: three sessions/day (4) Total course: 24 weeks |
| Li 2009 | eight sessions | One session/week | No other intervention administered to the acupuncture group | ‐ | ‐ | ‐ | Western medicine: Fenofibrate (1) Dose of the Intervention: 250 mg/time (2) Number of treatment sessions: 28 sessions (3) Frequency of treatment: one session/day (4) Total course: eight weeks |
| Li 2014 | 120 sessions | One session/day | No other intervention administered to the acupuncture group | Patients with PCOS were recruited from Guangdong Women and Children Hospital between September 2010 and September 2011 | ‐ | ‐ | Western medicine: metformin (1) Dose of the Intervention: one tablet/session (2) Number of treatment sessions: 72 sessions (3) Frequency of treatment: three sessions/day (4) Total course: 24 weeks |
| Li L 2006 | Six sessions | One session/day | No other intervention administered to the acupuncture group | ‐ | ‐ | ‐ | Lifestyle control (1) Total course: 100 days |
| Lien 2012 | 12 sessions | Three sessions/week | No other intervention administered to the acupuncture group | This study was a randomized, controlled trial conducted from August 2009 to March 2010 in Taipei City Hospital, Taiwan | ‐ | ‐ | Sham auricular acupuncture: auricular acupuncture needles with the tips removed (1) Number of treatment sessions: 12 sessions (2) Frequency of treatment: three sessions/week (3) Total course: four weeks |
| Liu 2010 | 12 sessions | One sessions/week | No other intervention administered to the acupuncture group | Patients with PCOS were recruited from department of gynecology, the first affiliated hospital, Guangzhou University of TCM and outpatient department of acupuncture, Guangdong second traditional Chinese medicine hospital | ‐ | ‐ | Chinese herbal medicine: (Formula) Cang Fu Daotan Tang: Cangzhu 10 g, Xiangfu 10 g, Fabanxia 10 g, Chenpi 6 g, Shichangpu 10 g, Fuling 30 g, Huangqi 30 g, Zaojiaoci 10 g, Yinyanghuo 15 g, Danggui 10 g, Danshen 15 g, Huanshanyao 20 g (1) Dose of the Intervention: one session/day (2) Number of treatment sessions: 62 sessions (3) Frequency of treatment: one sessions/day (4) Total course: 12 weeks |
| Liu 2011 | 30 sessions | One session every two day | No other intervention administered to the acupuncture group | Patients were recruited from department of acupuncture, the first affiliated hospital, Guangzhou University of TCM | ‐ | ‐ | Low‐frequency electric stimulation therapy (1) Dose of the Intervention: low‐frequency (2) Number of treatment sessions: 30 sessions (3) Frequency of treatment: one session every two day (4) Total course: eight weeks |
| Lu 2014 | nine sessions | One session/week | No other intervention administered to the acupuncture group | Patients with PCOS were recruited from department of gynecology, and outpatient department of acupuncture | ‐ | ‐ | Western medicine: Diane‐35 (1) Dose of the Intervention: one tablet/session (2) Number of treatment sessions: 63 sessions (3) Frequency of treatment: one session/day (4) Total course: 12 weeks |
| Luo 2006 | 27 sessions | ‐ | No other intervention administered to the acupuncture group | ‐ | ‐ | ‐ | No intervention (1) Total course: three courses (days unclear) |
| Mi 2005 | 12 sessions | One session every two day | No other intervention administered to the acupuncture group | ‐ | ‐ | ‐ | Lifestyle control (1) Total course: 12 weeks |
| Pan 2010 | 12 sessions | One session every two day | No other intervention administered to the acupuncture group | ‐ | ‐ | ‐ | Sham acupuncture (1) Number of treatment sessions: 12 sessions (2) Frequency of treatment: one session every two day (3) Total course: five weeks |
| Rerksuppaphol 2011 | 16 sessions | Two sessions/week | No other intervention administered to the acupuncture group | A prospective randomized open‐label study was conducted in overweight or obese women by the Acupuncture Clinic, Srinakharinwirot University Hospital, during the period March to July 2010 | A licensed acupuncturist with a minimum of 3 years experience | ‐ | Transcutaneous electrical acupoint stimulation (1) Dose of the Intervention: 0.2 ms pulses, at 40 Hz in the constant mode within the subject's tolerance level (2) Number of treatment sessions: 16 sessions (3) Frequency of treatment: two sessions/week (4) Total course: eight weeks |
| Schukro 2014 | 24 sessions | Four sessions/week | No other intervention administered to the acupuncture group | This prospective randomized placebo‐controlled clinical trial was conducted at the Department of Special Anesthesia and Pain Management at the Medical University of Vienna (AKH Vienna) | ‐ | ‐ | Sham auricular acupuncture (1) Dose of the Intervention: P‐Stim® dummy with constant current (2 mA) pulses of 1 Hz every 3s (3 h of stimulation followed by a pause of 3h to avoid development of tolerance); the dummy‐device had no power supply and had been grinded to leave only metal plates (2) Number of treatment sessions: 24 sessions (3) Frequency of treatment: four sessions/week (4) Total course: six weeks |
| Shan 2008 | One session/day | Four weeks | No other intervention administered to the acupuncture group | ‐ | ‐ | ‐ | Lifestyle control (1)Total course: four weeks |
| Shu 2011 | One session every two day | Six weeks | No other intervention administered to the acupuncture group | ‐ | ‐ | ‐ | moxibustion (1) Dose of the Intervention: five zhu/acupoint (2) Number of treatment sessions: 90 sessions (3) Frequency of treatment: one session every two day (4) Total course: six weeks |
| Su 2013 | 12 sessions | One session every two day | No other intervention administered to the acupuncture group | Patients were recruited from department of gynecology, Shi Jia Zhuang traditional Chinese medicine hospital | ‐ | ‐ | Chinese herbal medicine: (Formula) Shudi 12 g, Tusizi 12 g, Gouqi 12 g, Roucongrong 10 g, Danggui 10 g, Chenpi 10 g, Chaihu 10 g, Fuling 10 g, Shichangpu 10 g, Lulutong 12 g, Jixueteng 20 g, Jineijing 10 g (1) Dose of the Intervention: one session/day (2) Number of treatment sessions: 90 sessions (3) Frequency of treatment: one session/day (4) Total course: 12 weeks |
| Tao 2009 | 12 sessions | One session/week | No other intervention administered to the acupuncture group | Patients with PCOS were recruited from department of gynecology and department of acupuncture, the first affiliated hospital, Guangzhou University of TCM | ‐ | According to theory of TCM, phlegm and dampness are identified as etiologic factor; Clinical experience have suggested a positive effect of Cang Fu Daotan Tang in obesity‐type PCOS patients |
Chinese herbal medicine: (Formula)Cang Fu Daotan Tang: Cangzhu 10 g, Xiangfu 10 g, Fabanxia 10 g, Chenpi 6 g, Shichangpu 10 g, Yunfuling 30 g, Huangqi 30 g, Zaojiaoci 10 g, Xianlingpi 15 g, Danggui 10 g, Danshen 15 g, Huanshanyao 20 g (1) Dose of the Intervention: one session/day (2) Number of treatment sessions: 62 sessions (3) Frequency of treatment: one session/day (4) Total course: 12 weeks |
| Tao 2010 | 12 sessions | One session/week | No other intervention administered to the acupuncture group | Patients with PCOS were recruited from department of gynecology, the first affiliated hospital, Guangzhou University of TCM and outpatient department of acupuncture, Guangdong second traditional Chinese medicine hospital | ‐ | Clinical experience have suggested a positive effect of Cang Fu Daotan Tang in obesity‐type PCOS patients | Chinese herbal medicine: (Formula)Cang Fu Daotan Tang: Cangzhu 10 g, Xiangfu 10 g, Fabanxia 10 g, Chenpi 6 g, Shichangpu 10 g, Fuling 30 g, Huangqi 30 g, Zaojiaoci 10 g, Yinyanghuo 15 g, Danggui 10 g, Danshen 15 g, Huanshanyao 20 g (1) Dose of the Intervention: one session/day (2) Number of treatment sessions: 62 sessions (3) Frequency of treatment: one session/day (4) Total course: 12 weeks |
| Tong 2011 | 12 sessions | One session every two day | No other intervention administered to the acupuncture group | Patients with PCOS were recruited from department of endocrinology, the first clinical hospital of Guangzhou Medical University | Practitioners participating in this study should be senior acupuncturist | ‐ | Sham acupuncture (1) Number of treatment sessions: 12 sessions (2) Frequency of treatment: one session every two day (3) Total course: five weeks |
| Wang 2014 | 90 sessions | One sessions/day | No other intervention administered to the acupuncture group | ‐ | ‐ | ‐ | Chinese herbal medicine: (Formula): Juemingzi 10 g, Shanzha 15 g, Laifuzi 10 g, Heye 15 g (1) Dose of the Intervention: (2) Number of treatment sessions: 126 sessions (3) Frequency of treatment: two sessions/day (4) Total course: 12 weeks |
| Wang X 2006 | 12 sessions | Two sessions/week | No other intervention administered to the acupuncture group | ‐ | ‐ | ‐ | Chinese herbal medicine: (Formula) Lian Zhicheng Experienced Prescription: Taizishen 15 g, Beihuangqi 15 g, Fulingpi 30 g, Sugeng 12 g, Zhuling 12 g, Zexie 12 g, Maidong 12 g, Chishao 12 g, Danshen 12 g (1) Dose of the Intervention: (2) Number of treatment sessions: 126 sessions (3) Frequency of treatment: three sessions/day (4) Total course: six weeks |
| Wu 2009 | Four sessions | One session/week | No other intervention administered to the acupuncture group | ‐ | ‐ | ‐ | Western medicine: Xenical (ROCHE, Shanghai, China) (1) Dose of the Intervention: 120 g/time (2) Number of treatment sessions: 90 sessions (3) Frequency of treatment: three sessions/day (4) Total course: four weeks |
| Xing 2009 | 45 sessions | One session/day | No other intervention administered to the acupuncture group | ‐ | ‐ | ‐ | Lifestyle control (1) Total course: 51 days |
| Xiong 2011 | 40 sessions | One sessions/day | No other intervention administered to the acupuncture group | ‐ | ‐ | Clinical experience have showed that needle‐knife has shorter treatment time and better compliance | needle‐knife (1) Dose of the Intervention: not stated (2) Number of treatment sessions: 40 sessions (3) Frequency of treatment: one session every five day (4) Total course: eight weeks Western medicine: Sibutramine (1) Dose of the Intervention: 10 mg/day (2) Number of treatment sessions: 40 sessions (3) Frequency of treatment: one sessions/day (4) Total course: eight weeks |
| Xu 2008 | eight sessions | One sessions/week | No other intervention administered to the acupuncture group | ‐ | ‐ | ‐ | Chinese herbal medicine: No.1 Slimming capsule (Provided by He Qing Chinese medicine clinic, Taiwan, China) (1) Dose of the Intervention: nine g/day (2) Number of treatment sessions: 300 sessions (3) Frequency of treatment: five sessions/day (4) Total course: eight weeks |
| Xu 2011 | 90 sessions | One session/day | No other intervention administered to the acupuncture group | ‐ | ‐ | ‐ | Western medicine: Sibutramine (1) Dose of the Intervention: 10 mg/day (2) Number of treatment sessions: 90 sessions (3) Frequency of treatment: one session/day (4) Total course: nine weeks |
| Yan 2011 | 20 sessions | One session every two day | No other intervention administered to the acupuncture group | ‐ | ‐ | Bian‐stone had some special biological and physical effectc and can generate a high frequency ultrasonic pulse | bian‐stone (120mm × 60mm × 10mm. Provided by Beijing GengNaiGuang property testing technology research center) (1) Dose of the Intervention: 20‐30 min/session (2) Number of treatment sessions: 20 sessions (3) Frequency of treatment: one session every two day (4) Total course: six weeks |
| Ye 2010 | 45 sessions | One session every two day | No other intervention administered to the acupuncture group | ‐ | ‐ | Dietary restriction and physical exercise are conventional ways for managing weight | Lifestyle control (1) Total course: 12 weeks |
| Yin 2006 | 36 sessions | Three sessions/week | No other intervention administered to the acupuncture group | Patients were recruited from department of endocrinology, the first clinical hospital of Guangzhou Medical University | ‐ | Acupoint plaster application was widely used in clinic | Acupoint plaster application (The recipe contain Zhinanxing, Dahuang, Sanleng, Erzhu and Bingpian) (1) Dose of the Intervention: 1.5×1.5cm2 in size, 0.3cm in thickness (2) Number of treatment sessions: 90 sessions (3) Frequency of treatment: one session/day (4) Total course: 12 weeks |
| Zhang 2005 | 20 sessions | One sessions/day | No other intervention administered to the acupuncture group | ‐ | ‐ | ‐ | Magnet plastering therapy (1) Number of treatment sessions: 20 sessions (2) Frequency of treatment: one sessions/day (3) Total course: four weeks |
| Zhang 2011 | 20 sessions | Three days of one sessions/day follow by one treatment every other day within a month | No other intervention administered to the acupuncture group | Patients were recruited from department of acupuncture, Phoenix outpatient, Hubei provincial hospital of TCM | ‐ | ‐ | Computerized intermediate‐frequency (1) Total course: eight weeks lifestyle control (1) Total course: eight weeks |
| Zhang 2012 | 20 sessions | Five sessions/week | No other intervention administered to the acupuncture group | ‐ | Practitioners participating in this study were professionally trained acupuncturist and had at least three years working experience working experience | ‐ | Electrical stimulation was used 1‐1.5 cun lateral to Zusanli (ST36). (1) Number of treatment sessions: one sessions (2) Frequency of treatment: five days of one session (3) Total course: four weeks |
| Zhang Y 2007 | 20 sessions | Five sessions/week | No other intervention administered to the acupuncture group | ‐ | ‐ | ‐ | Lifestyle control (1) Total course: eight weeks |
| Zhao 2010 | 24 sessions | Four sessions/week in the first four weeks and two sessions/week in the following four weeks | No other intervention administered to the acupuncture group | ‐ | ‐ | Dietary restriction and physical exercise are conventional ways for managing weight | Lifestyle control (1) Total course: eight weeks |
| Zhao 2011 | 17 sessions | One session/week in the first week and session every two days in the following second to fourth week | No other intervention administered to the acupuncture group | ‐ | ‐ | It is more easier to blind participants with sham acupuncture | Sham acupuncture (1) Number of treatment sessions: 17 sessions (2) Frequency of treatment: one session/week in the first week and session every two days in the following second to fourth week (3) Total course: four weeks |
| Zhu 2007 | 37 sessions | Three sessions/week, 10 days of one sessions/day follow by one treatment every three day within three months | No other intervention administered to the acupuncture group | Patients were recruited from department of acupuncture, Chengndu integrated TCM & western medicine hospital | ‐ | ‐ | Lifestyle control (1) Total course: 12 weeks |
| "‐" denotes not reported STRICTA (standards for reporting interventions in clinical trials of acupuncture) criteria (MacPherson 2010): 3a: number of treatment sessions 3b: frequency and duration of treatment sessions 4a: details of other interventions administered to the acupuncture group (e.g. moxibustion, cupping, herbs, exercises, lifestyle advice) 4b: setting and context of treatment, including instructions to practitioners, and information and explanations to patients 5: description of participating acupuncturists (qualification or professional affiliation, years in acupuncture practice, other relevant experience) 6a: rationale for the control or comparator in the context of the research question, with sources that justify this choice 6b: precise description of the control or comparator. If sham acupuncture or any other type of acupuncture‐like control was used, details as for items 1 to 3 above PCOS: polycystic ovarian syndrome | |||||||
Appendix 15. Checklist to aid consistency and reproducibility of GRADE assessments (acupuncture vs sham acupuncture)
| (1) Weight loss (kg) | (2) Morbidity | (3) Adverse events | (4) Change in anthropometric measures other than weight loss: BMI | (5) Health‐related quality of life | (6) Scioeconomic effects | ||
| Trial limitations (risk of bias)a | Was random sequence generation used (i.e. no potential for selection bias)? | Yes | ‐ | Yes | Yes | ‐ | ‐ |
| Was allocation concealment used (i.e. no potential for selection bias)? | Yes | ‐ | Yes | Yes | ‐ | ‐ | |
| Was there blinding of participants and personnel (i.e. no potential for performance bias) or outcome not likely to be influenced by lack of blinding? | Yes | ‐ | Yes | Yes | ‐ | ‐ | |
| Was there blinding of outcome assessment (i.e. no potential for detection bias) or was outcome measurement not likely to be influenced by lack of blinding? | No (↓) | ‐ | Yes | Yes | ‐ | ‐ | |
| Was an objective outcome used? | Yes | ‐ | Yes | Yes | ‐ | ‐ | |
| Were more than 80% of participants enrolled in trials included in the analysis (i.e. no potential reporting bias)?e | Yes | ‐ | Unclear | Yes | ‐ | ‐ | |
| Were data reported consistently for the outcome of interest (i.e. no potential selective reporting)? | Yes | ‐ | Unclear | Yes | ‐ | ‐ | |
| No other biases reported (i.e. no potential of other bias)? | Yes | ‐ | Yes | Yes | ‐ | ‐ | |
| Did the trials end up as scheduled (i.e. not stopped early)? | Yes | ‐ | Yes | Yes | ‐ | ‐ | |
| Inconsistencyb | Point estimates did not vary widely? | N/A | ‐ | ‐ | Yes | ‐ | ‐ |
| To what extent did confidence intervals overlap (substantial: all confidence intervals overlap at least one of the included studies point estimate; some: confidence intervals overlap but not all overlap at least one point estimate; no: at least one outlier: where the confidence interval of some of the studies do not overlap with those of most included studies)? | N/A | ‐ | ‐ | Substantial | ‐ | ‐ | |
| Was the direction of effect consistent? | N/A | ‐ | ‐ | Yes | ‐ | ‐ | |
| What was the magnitude of statistical heterogeneity (as measured by I²) ‐ low (I²<40%), moderate (I² 40%‐60%), high I²>60%)? | N/A | ‐ | ‐ | Low | ‐ | ‐ | |
| Was the test for heterogeneity statistically significant (P < 0.1)? | N/A | ‐ | ‐ | Not statistically significant | ‐ | ‐ | |
| Indirectnessa | Were the populations in included studies applicable to the decision context? | Highly applicable | ‐ | Highly applicable | Highly applicable | ‐ | ‐ |
| Were the interventions in the included studies applicable to the decision context? | Highly applicable | ‐ | Highly applicable | Highly applicable | ‐ | ‐ | |
| Was the included outcome not a surrogate outcome? | Yes | ‐ | Yes | Yes | ‐ | ‐ | |
| Was the outcome timeframe sufficient? | Sufficient | ‐ | Sufficient | Sufficient | ‐ | ‐ | |
| Were the conclusions based on direct comparisons? | Yes | ‐ | Yes | Yes | ‐ | ‐ | |
| Imprecisionc | Was the confidence interval for the pooled estimate not consistent with benefit and harm? | N/A | ‐ | N/A | Yes | ‐ | ‐ |
| What is the magnitude of the median sample size (high: 300 participants, intermediate: 100‐300 participants, low: <100 participants)?e | Low (↓) | ‐ | Low (↓) | Low (↓) | ‐ | ‐ | |
| What was the magnitude of the number of included studies (large: >10 studies, moderate: 5‐10 studies, small: <5 studies)?e | Small (↓) | ‐ | Small (↓) | Small (↓) | ‐ | ‐ | |
| Was the outcome a common event (e.g. occurs more than 1/100)? | Yes | ‐ | Yes | Yes | ‐ | ‐ | |
| Publication biasd | Was a comprehensive search conducted? | Yes | ‐ | Yes | Yes | ‐ | ‐ |
| Was grey literature searched? | Yes | ‐ | Yes | Yes | ‐ | ‐ | |
| Were no restrictions applied to study selection on the basis of language? | Yes | ‐ | Yes | Yes | ‐ | ‐ | |
| There was no industry influence on studies included in the review? | Yes | ‐ | Yes | Yes | ‐ | ‐ | |
| There was no evidence of funnel plot asymmetry? | Unclear | ‐ | Unclear | Unclear | ‐ | ‐ | |
| There was no discrepancy in findings between published and unpublished trials? | Unclear | ‐ | Unclear | Unclear | ‐ | ‐ | |
|
aQuestions on risk of bias are answered in relation to the majority of the aggregated evidence in the meta‐analysis rather than to individual trials bQuestions on inconsistency are primarily based on visual assessment of forest plots and the statistical quantification of heterogeneity based on I² cWhen judging the width of the confidence interval it is recommended to use a clinical decision threshold to assess whether the imprecision is clinically meaningful dQuestions address comprehensiveness of the search strategy, industry influence, funnel plot asymmetry and discrepancies between published and unpublished trials eDepends on the context of the systematic review area (↓): key item for possible downgrading the quality of the evidence (GRADE) as shown in the footnotes of the 'Summary of finding' table(s); GRADE: Grading of Recommendations Assessment, Development and Evaluation; N/A: not applicable; "‐" denotes not reported |
|||||||
Appendix 16. Checklist to aid consistency and reproducibility of GRADE assessments (acupuncture vs Chinese herbal medicines)
| (1) Weight loss (kg) | (2) Morbidity | (3) Adverse events | (4) Change in anthropometric measures other than weight loss | (5) Health‐related quality of life | (6) Scioeconomic effects | ||
| Trial limitations (risk of bias)a | Was random sequence generation used (i.e. no potential for selection bias)? | Yes | ‐ | ‐ | Yes | ‐ | ‐ |
| Was allocation concealment used (i.e. no potential for selection bias)? | Yes | ‐ | ‐ | Yes | ‐ | ‐ | |
| Was there blinding of participants and personnel (i.e. no potential for performance bias) or outcome not likely to be influenced by lack of blinding? | Unclear | ‐ | ‐ | Unclear | ‐ | ‐ | |
| Was there blinding of outcome assessment (i.e. no potential for detection bias) or was outcome measurement not likely to be influenced by lack of blinding? | Unclear | ‐ | ‐ | Unclear | ‐ | ‐ | |
| Was an objective outcome used? | Yes | ‐ | ‐ | Yes | ‐ | ‐ | |
| Were more than 80% of participants enrolled in trials included in the analysis (i.e. no potential reporting bias)?e | Unclear | ‐ | ‐ | Unclear | ‐ | ‐ | |
| Were data reported consistently for the outcome of interest (i.e. no potential selective reporting)? | Yes | ‐ | ‐ | Yes | ‐ | ‐ | |
| No other biases reported (i.e. no potential of other bias)? | Yes | ‐ | ‐ | Yes | ‐ | ‐ | |
| Did the trials end up as scheduled (i.e. not stopped early)? | Yes | ‐ | ‐ | Yes | ‐ | ‐ | |
| Inconsistencyb | Point estimates did not vary widely? | N/A | ‐ | ‐ | N/A | ‐ | ‐ |
| To what extent did confidence intervals overlap (substantial: all confidence intervals overlap at least one of the included studies point estimate; some: confidence intervals overlap but not all overlap at least one point estimate; no: at least one outlier: where the confidence interval of some of the studies do not overlap with those of most included studies)? | N/A | ‐ | ‐ | N/A | ‐ | ‐ | |
| Was the direction of effect consistent? | N/A | ‐ | ‐ | N/A | ‐ | ‐ | |
| What was the magnitude of statistical heterogeneity (as measured by I²) ‐ low (I²<40%), moderate (I² 40%‐60%), high I²>60%)? | N/A | ‐ | ‐ | N/A | ‐ | ‐ | |
| Was the test for heterogeneity statistically significant (P < 0.1)? | N/A | ‐ | ‐ | N/A | ‐ | ‐ | |
| Indirectnessa | Were the populations in included studies applicable to the decision context? | Highly applicable | ‐ | ‐ | Highly applicable | ‐ | ‐ |
| Were the interventions in the included studies applicable to the decision context? | Highly applicable | ‐ | ‐ | Highly applicable | ‐ | ‐ | |
| Was the included outcome not a surrogate outcome? | Yes | ‐ | ‐ | Yes | ‐ | ‐ | |
| Was the outcome timeframe sufficient? | Sufficient | ‐ | ‐ | Sufficient | ‐ | ‐ | |
| Were the conclusions based on direct comparisons? | Yes | ‐ | ‐ | Yes | ‐ | ‐ | |
| Imprecisionc | Was the confidence interval for the pooled estimate not consistent with benefit and harm? | N/A | ‐ | ‐ | N/A | ‐ | ‐ |
| What is the magnitude of the median sample size (high: 300 participants, intermediate: 100‐300 participants, low: <100 participants)?e | Low (↓) | ‐ | ‐ | Low (↓) | ‐ | ‐ | |
| What was the magnitude of the number of included studies (large: >10 studies, moderate: 5‐10 studies, small: <5 studies)?e | Small (↓) | ‐ | ‐ | Small (↓) | ‐ | ‐ | |
| Was the outcome a common event (e.g. occurs more than 1/100)? | Yes | ‐ | ‐ | Yes | ‐ | ‐ | |
| Publication biasd | Was a comprehensive search conducted? | Yes | ‐ | ‐ | Yes | ‐ | ‐ |
| Was grey literature searched? | Yes | ‐ | ‐ | Yes | ‐ | ‐ | |
| Were no restrictions applied to study selection on the basis of language? | Yes | ‐ | ‐ | Yes | ‐ | ‐ | |
| There was no industry influence on studies included in the review? | Yes | ‐ | ‐ | Yes | ‐ | ‐ | |
| There was no evidence of funnel plot asymmetry? | Unclear | ‐ | ‐ | Unclear | ‐ | ‐ | |
| There was no discrepancy in findings between published and unpublished trials? | Unclear | ‐ | ‐ | Unclear | ‐ | ‐ | |
|
aQuestions on risk of bias are answered in relation to the majority of the aggregated evidence in the meta‐analysis rather than to individual trials bQuestions on inconsistency are primarily based on visual assessment of forest plots and the statistical quantification of heterogeneity based on I² cWhen judging the width of the confidence interval it is recommended to use a clinical decision threshold to assess whether the imprecision is clinically meaningful dQuestions address comprehensiveness of the search strategy, industry influence, funnel plot asymmetry and discrepancies between published and unpublished trials eDepends on the context of the systematic review area (↓): key item for possible downgrading the quality of the evidence (GRADE) as shown in the footnotes of the 'Summary of finding' table(s); GRADE: Grading of Recommendations Assessment, Development and Evaluation; N/A: not applicable; "‐" denotes not reported |
|||||||
Appendix 17. Checklist to aid consistency and reproducibility of GRADE assessments (acupuncture vs foot holographic scraping therapy)
| (1) Weight loss (kg) | (2) Morbidity | (3) Adverse events | (4) Change in anthropometric measures other than weight loss | (5) Health‐related quality of life | (6) Scioeconomic effects | ||
| Trial limitations (risk of bias)a | Was random sequence generation used (i.e. no potential for selection bias)? | Yes | ‐ | Yes | Yes | ‐ | ‐ |
| Was allocation concealment used (i.e. no potential for selection bias)? | Yes | ‐ | Yes | Yes | ‐ | ‐ | |
| Was there blinding of participants and personnel (i.e. no potential for performance bias) or outcome not likely to be influenced by lack of blinding? | Unclear | ‐ | Unclear | Unclear | ‐ | ‐ | |
| Was there blinding of outcome assessment (i.e. no potential for detection bias) or was outcome measurement not likely to be influenced by lack of blinding? | Unclear | ‐ | Unclear | Unclear | ‐ | ‐ | |
| Was an objective outcome used? | Yes | ‐ | Yes | Yes | ‐ | ‐ | |
| Were more than 80% of participants enrolled in trials included in the analysis (i.e. no potential reporting bias)?e | Yes | ‐ | Yes | Yes | ‐ | ‐ | |
| Were data reported consistently for the outcome of interest (i.e. no potential selective reporting)? | Unclear | ‐ | Unclear | Unclear | ‐ | ‐ | |
| No other biases reported (i.e. no potential of other bias)? | Yes | ‐ | Yes | Yes | ‐ | ‐ | |
| Did the trials end up as scheduled (i.e. not stopped early)? | Yes | ‐ | Yes | Yes | ‐ | ‐ | |
| Inconsistencyb | Point estimates did not vary widely? | N/A | ‐ | N/A | N/A | ‐ | ‐ |
| To what extent did confidence intervals overlap (substantial: all confidence intervals overlap at least one of the included studies point estimate; some: confidence intervals overlap but not all overlap at least one point estimate; no: at least one outlier: where the confidence interval of some of the studies do not overlap with those of most included studies)? | N/A | ‐ | N/A | N/A | ‐ | ‐ | |
| Was the direction of effect consistent? | N/A | ‐ | N/A | N/A | ‐ | ‐ | |
| What was the magnitude of statistical heterogeneity (as measured by I²) ‐ low (I²<40%), moderate (I² 40%‐60%), high I²>60%)? | N/A | ‐ | N/A | N/A | ‐ | ‐ | |
| Was the test for heterogeneity statistically significant (P < 0.1)? | N/A | ‐ | N/A | N/A | ‐ | ‐ | |
| Indirectnessa | Were the populations in included studies applicable to the decision context? | Highly applicable | ‐ | Highly applicable | Highly applicable | ‐ | ‐ |
| Were the interventions in the included studies applicable to the decision context? | Highly applicable | ‐ | Highly applicable | Highly applicable | ‐ | ‐ | |
| Was the included outcome not a surrogate outcome? | Yes | ‐ | Yes | Yes | ‐ | ‐ | |
| Was the outcome timeframe sufficient? | Sufficient | ‐ | Sufficient | Sufficient | ‐ | ‐ | |
| Were the conclusions based on direct comparisons? | Yes | ‐ | Yes | Yes | ‐ | ‐ | |
| Imprecisionc | Was the confidence interval for the pooled estimate not consistent with benefit and harm? | N/A | ‐ | N/A | N/A | ‐ | ‐ |
| What is the magnitude of the median sample size (high: 300 participants, intermediate: 100‐300 participants, low: <100 participants)?e | Low (↓) | ‐ | Low (↓) | Low (↓) | ‐ | ‐ | |
| What was the magnitude of the number of included studies (large: >10 studies, moderate: 5‐10 studies, small: <5 studies)?e | Small (↓) | ‐ | Small (↓) | Small (↓) | ‐ | ‐ | |
| Was the outcome a common event (e.g. occurs more than 1/100)? | Yes | ‐ | Yes | Yes | ‐ | ‐ | |
| Publication biasd | Was a comprehensive search conducted? | Yes | ‐ | Yes | Yes | ‐ | ‐ |
| Was grey literature searched? | Yes | ‐ | Yes | Yes | ‐ | ‐ | |
| Were no restrictions applied to study selection on the basis of language? | Yes | ‐ | Yes | Yes | ‐ | ‐ | |
| There was no industry influence on studies included in the review? | Yes | ‐ | Yes | Yes | ‐ | ‐ | |
| There was no evidence of funnel plot asymmetry? | Unclear | ‐ | Unclear | Unclear | ‐ | ‐ | |
| There was no discrepancy in findings between published and unpublished trials? | Unclear | ‐ | Unclear | Unclear | ‐ | ‐ | |
|
aQuestions on risk of bias are answered in relation to the majority of the aggregated evidence in the meta‐analysis rather than to individual trials bQuestions on inconsistency are primarily based on visual assessment of forest plots and the statistical quantification of heterogeneity based on I² cWhen judging the width of the confidence interval it is recommended to use a clinical decision threshold to assess whether the imprecision is clinically meaningful dQuestions address comprehensiveness of the search strategy, industry influence, funnel plot asymmetry and discrepancies between published and unpublished trials eDepends on the context of the systematic review area (↓): key item for possible downgrading the quality of the evidence (GRADE) as shown in the footnotes of the 'Summary of finding' table(s); GRADE: Grading of Recommendations Assessment, Development and Evaluation; N/A: not applicable; "‐" denotes not reported |
|||||||
What's new
Last assessed as up‐to‐date: 11 August 2014.
| Date | Event | Description |
|---|---|---|
| 24 July 2018 | Amended | This review was withdrawn by the Editorial Office of the Cochrane Metabolic and Endocrine Disorders Group because finishing the project within adequate deadlines could not be achieved.The review is considered low priority and therefore this review is currently not open for new authors. |
Contributions of authors
Jie Li (LJ): protocol draft, search strategy development, acquiring trial copies, data interpretation, review draft and update draft.
Ying Lu (LY): protocol draft, search strategy development, trial selection, data extraction, data interpretation, review draft and update draft.
Yu Mei Shi (SMY): protocol draft, acquiring trial copies, data analysis, data interpretation, review draft and update draft.
George Lenon (GL): protocol draft and review draft.
Li Qing (LQ): trial selection and data extraction.
Yin Shi (SY): protocol draft, acquiring trial copies and review draft.
Sources of support
Internal sources
Shanghai University of Traditional Chinese Medicine, China.
External sources
No sources of support supplied
Declarations of interest
LJ: none known.
LY: none known.
SMY: none known.
GL: none known.
LQ: none known.
SY: none known.
Notes
This review was withdrawn by the Editorial Office of the Cochrane Metabolic and Endocrine Disorders Group because finishing the project within adequate deadlines could not be achieved.The review is considered low priority and therefore this review is currently not open for new authors.
Withdrawn from publication for reasons stated in the review
References
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