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Journal of Traditional Chinese Medicine logoLink to Journal of Traditional Chinese Medicine
. 2023 Jun 8;43(4):780–786. doi: 10.19852/j.cnki.jtcm.20230608.002

Effect of catgut embedding at acupoints versus non-acupoints in abdominal obesity: a randomized clinical trial

Xinghe ZHANG 1, Qifu LI 1, Rong YI 2, Chonghui XING 3, Yuhao JIN 1, Jiangqiong MENG 1, Jialei FENG 4, Siwen ZHAO 1, Fanrong LIANG 5,✉, Taipin GUO 1,✉
PMCID: PMC10320439  PMID: 37454263

Abstract

OBJECTIVE

To explore the difference of catgut embedding effect between acupoints and non-acupoints in patients with abdominal obesity (AO).

METHODS

In this multicenter, double-blind, randomized controlled trial, all subjects were randomly assigned into the acupoint catgut embedding (ACE) group and control group (catgut embedding at non-acupoints). With a 12-week actual intervention period and a 4-week period of follow-up. Waist circumference (WC), body weight, body mass index (BMI), hip circumference (HC) and appetite were applied and assessed at baseline and after 6, 12 and 16 weeks.

RESULTS

After the total intervention phase (12 weeks), the WC, body weight, BMI, HC and visual analogue scale scores of appetite, decreased significantly in the two groups as compared to the baseline (P < 0.001). Meanwhile, after the 4-week follow-up, the indicators still decreased significantly in the ACE group (P < 0.001). At 12 and 16 weeks, catgut embedding at acupoints showed significantly advantages to non-acupoints in WC and appetite (P < 0.05). No serious adverse events were observed in ACE group and control group.

CONCLUSIONS

Catgut embedding at acupoints and non-acupoints are all effective and safe for AO. ACE can effectively treat AO as expected and deliver lasting results.

Keywords: acupoint catgut embedding, non-acupoints, obesity, abdominal, waist circumference, randomized controlled trial

1. INTRODUCTION

Obesity has become a global health issue regardless of race, region and age. According to a WHO report, there are more than 1.9 billion adults (39%) overweight worldwide, and of which at least 650 million adults (13%) are obese.1 The prevalence of obesity is about 20% or more in USA, Middle East and North Africa, Caribbean, Polynesia and Micronesia.2 Although the increase of obese adults has leveled off in several high-income countries, but the incidence was dramatically on the rise in most low- and middle-income countries, particularly in urban regions.3,⇓-5 As a major type of obesity, the abdominal obesity (AO) rate in adults is about 29.1% and the prevalence increased rapidly in China.6,⇓-8

Studies showed that obesity is associated with many diseases, including cardiovascular diseases,1,9 diabetes,1,9,10 subfertility,11,12 musculoskeletal disorders,1 non-alcoholic fatty liver disease, 13 Alzheimer’s disease, 14 cancer1,9 and disability-adjustment life-years.15 Especially, AO more easily lead to diabetes, hypertension, dyslipidemia, atherosclerosis, and colorectal cancer.16,⇓,⇓,⇓-20 In addition to the health problem, obesity may cause a social obstacle such as people's pursuit of beauty and wage level, yet which also generate a large economic burden. 15,21,22

Acupoint catgut embedding (ACE) is a special acupuncture therapy based on the theory of Traditional Chinese Medicine (TCM). Whether there is difference between acupoints and non-acupoints in curative effect, has always been a bone of contention in acupuncture research.23 Studies indicated that catgut embedding at acupoints is effective for AO.24,25 Nevertheless, there is no credible evidence that non-acupoint catgut embedding owns the same effect. In this multicenter, randomized, double-blind, controlled study, we examined the efficacy and safety of catgut embedding at acupoints and non-acupoints in participants with AO. We expect that ACE would relieve the AO related indicators, and the effect would be better than non-acupoints catgut embedding.

2. MATERIALS AND METHODS

2.1. Study design

This study was undertaken between July 2018 and March 2020. Every participant received a 12-week intervention period and a 4-week follow-up. Primary and secondary outcomes were measured at baseline, and 6, 12, 18 weeks after the intervention. Possible adverse events were carefully monitored from 1 to 16 weeks. The flow chart was showed in Figure 1.

Figure 1. Flowchart of the screening, enrollment, randomization, and follow-up.

Figure 1

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ACE: acupoint catgut embedding; ITT: intention-to-treat.

This trial was registered in Chinese Clinical Trial Registry (ChiCTR1800016947), and approved by the Hospital Ethics Committee of The Sports Trauma Specialist Hospital of Yunnan Province (2018CK-001). All participants were fully informed and signed written informed consent forms.

2.2. Participant

We recruited participants from the outpatient department in 4 clinical centers: Second Affiliated Hospital of Yunnan University of Chinese Medicine, Sports Trauma Specialist Hospital of Yunnan Province, Kunming Hospital of Traditional Chinese Medicine and Shengai Hospital of Traditional Chinese Medicine.

According to the diagnostic criteria of AO by Chinese Medical Association, waist circumference (WC) is used to diagnose AO. In this study, the main inclusion criteria was WC ≥ 90 cm in males and ≥ 85 cm in females. The measurement method of WC: the participant in the standing position, and the circumference of the body was measured at the horizontal position of the lower costal edge of the midaxillary line and the midpoint of the iliac crest line.26 The second inclusion criteria included body mass index (BMI) ≥ 24 kg/m2, aged between 18 and 60, simple overweight or obesity.27

The exclusion criteria were: WC < 90 cm in males and < 85 cm in females, BMI < 24 kg/m2; secondary obesity caused by endocrine disease or medication; pregnancy, lactation and childbirth within the past 6 months; coronary heart disease, chronic obstructive pulmonary disease, liver cirrhosis, nephritis and other serious organ diseases; hypertension without effectively controlled; participants with severe mental and neurological diseases; allergic to alcohol or catgut; received other weight loss treatment within past 3 months.

2.3. Randomization and blinding

The randomization sequence was computer generated by the Clinical Research Center of Yunnan University of Chinese Medicine. Stratified randomization was performed for 4 clinical centers. Opaque envelopes with random number were managed by the independent coordinator. Participants, inspector and analyst were blinded to group allocation. After the assistant lays the drapes, the acupuncturist performed the manipulations. Therefore, the acupuncturists were also blinded to the group allocation.

2.4. Interventions

Participants received catgut embedding treatment every 2 weeks for a total of 6 sessions. All catgut embedding manipulations were performed by the acupuncturist with national medical qualifications. The acupoints of ACE group were Pishu (BL20), Weishu (BL21), Dachangshu (BL25), Zhongwan (CV12), Tianshu (ST25) and Zhangmen (LR13). The control group chose non-acupoints besides the acupoints, which were labeled NA1, NA2, NA3, NA4, NA5 and NA6. The location of these points and the operation of catgut embedding were showed in Table 1.

Table 1.

Location of the points and the details operation of catgut embedding

Acupoints Location Operation
Pishu (BL20) In the upper back region, at the same level of inferior border of the 11th thoracic spine (T11), 1.5 cun lateral to the posterior median line Slightly oblique needling in the medial direction of the spine to the depth of 0.5-1 cun
Weishu (BL21) In the upper back region, at the same level of inferior border of the 12th thoracic spine (T12), 1.5 cun lateral to the posterior median line
Dachangshu (BL25) In the lumbar region, at the same level thoracic spine 4th lumbar spine (L4), 1.5 cun lateral to the posterior median line
Zhongwan (CV12) On the upper abdomen, 4 cun superior to the navel, on the anterior median line Pinch and lift the skin slightly with the thumb and index finger. Needling at 90 degrees to the depth of 1-1.5 cun
Tianshu (ST25) On the left and right abdomen, 2 cun lateral to the navel
Zhangmen (LR13) On the lateral abdomen, inferior to the free extremity of the 11th rib Pinch and lift the skin slightly with the thumb and index finger. Needling at 15 degrees to the depth of 1 cun
NA1 2 cun outward from the Pishu (BL20) Pinch and lift the skin slightly with the thumb and index finger. Needling at 45 degrees downward to a depth of 0.5-1 cun
NA2 2 cun outward from the Weishu (BL21)
NA3 2 cun outward from the Dachangshu (BL25)
NA4 1.5 cun to the left of the Zhongwan (CV12) Pinch and lift the skin slightly with the thumb and index finger. Needling at 90 degrees to a depth of 1-1.5 cun
NA5 1 cun outward from the Tianshu (ST25)
NA6 2 cun forward from the Zhangmen (LR13) Pinch and lift the skin slightly with the thumb and index finger. Needling at 15 degrees to the depth of 1 cun
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The assistant marked the position of acupoints/non-acupoints, conventionally disinfected skin of the operation area, and layed the sterile drapes. Took a sterile medical catgut with a length of 1-2 cm (the length depends on the location of the acupoint), placed it on the front end of the trocar, then connected the needle core, lifted the partial skin with the thumb and forefinger of one hand, pierced the needle with the other hand. When the piercing reached the desired depth, the acupuncturist implanted the catgut in the subcutaneous tissue or muscle layer. After the needle removed, pressed the needle hole with a dry cotton ball for half a minute to stop bleeding, and then pasted a bandage to protect the needle hole. Participants were recommended not to bathe 24 h and keep the embedding place dry.

The thread-embedded needle used in this study was 8# disposable needle (Jiangxi Glance Medical Equipment Co., Ltd. Production, Nanchang, China), and the medical catgut was an absorbable collagen line with the specification of 2-0, 2 cm length (Jiangxi Longteng Biotechnology Co. Ltd., Nanchang, China).

Diet and physical activity were not restricted during treatment and follow-up, all participants were asked to continue their diet and lifestyle.

2.5. Outcome measures

Outcome measurements were performed at baseline, 6 and 12 weeks in the intervention period, and 16 weeks in follow-up phase. No eating or drinking for 2 h before the indicators test. The primary outcome indicator was waist WC. The secondary outcomes indicators were body weight, BMI, hip circumference (HC) and visual analogue scale (VAS) of appetite.

The body weight was in kilograms (kg) and accurate to 10 g. Body height in meters (m) and accurate to 1 cm. BMI was calculated by height and weight. At the end of the normal exhalation, measured round the abdomen and hip in the horizontal direction and without pressing skin. Circumference in centimeters (cm) and accurate to 1 mm. Assessed appetite by VAS as reported in the article.28 No appetite and minimal intake (0 score). Slight appetite and small amount of intake (1-3 score). Moderate appetite and moderate intake (4-6 score). Strong appetite and large intake (7-10 score).

Possible adverse event was monitored and recorded as needed from 1 to 16 weeks.

2.6. Sample size calculation and statistical analysis

According to the previous study,29 we anticipated that the decrease of the mean BMI would be 1.14 kg/m2 in ACE group and 0.9 kg/m2 in control group, considering a standard deviation (SD) of 0.31 kg/m2. With a significance level of 5% and power of 95%, at least 84 sample participants would be required, as calculated by German G*Power software3.1.30 With an estimated loss-to-follow-up rate of 10%, the total sample would be 92, and 46 participants in each group.

All data were analyzed by SPSS (vers 19.0, IBM Corp., Armonk, NY, USA) and GraphPad Prism (vers 7.0, GraphPad Software, San Diego, CA, USA). The clinical outcomes described and baseline characteristics were based on the intention-to-treat (ITT) population, which included participants who have received once treatment. Continuous variables were presented as the mean and SD. While the nonnormally distributed variables were presented as the median and interquartile range (IQR). Categorical variables were described as numbers and percentages. As the missing data were all in follow-up, expectation maximization and last observation carried forward method were not suitable. Therefore, when the missing data were involved, they were disposed by listwise deletion. The significance level used for the statistical analysis with 2-tailed testing was 5%.

Normality of continuous variables was determined by Shapiro-Wilk test, Kolmogorov-Smirnov test, Skewness and Kurtosis. Homogeneity of continuous variables was determined by F test, Brown-Forsythe and Bartlett's test. Independent-Sample t-test or nonparametric test (Mann-Whitney test) was used when compared between groups. One-way analysis of variance (ANOVA) or nonparametric (Friedman) test was used to compare the repeated measurements (≥ 3) within the group. Paired t-test or nonparametric test (Wilcoxon test) was performed to compare the two repeated measurements within the group. For the categorical data, the χ2 test was performed to evaluate the significance of the difference.

3. RESULTS

3.1. Participants and baseline characteristics

Approximately 500 potential people were invited and 186 participants aged between 18 and 65 had entered the baseline period. After initial screening, 137 of 186 participants were submitted to the randomized process. However, a total of 123 participants (60 in the ACE group and 63 in the control group) were included in the ITT population (Figure 1). Table 2 showed the statistical analysis of selected-participants' characteristics at baseline. The statistical analysis also yields comparable statistics across the 2 groups. During all intervention phases, 137 participants (100%) completed 6 treatments and 3 tests. Noted that three participants (2.19%) were unwilling to undergo follow-up (1 in the ACE group and 2 in the control group). During the follow-up test, 2 participants in ACE group had an emergency and failed to complete the measure. A WC data was not obtained for one participant, a appetite data was not obtained for another participant. Meanwhile, the recruiters mistakenly included 14 participants (10.22%) who were abdominal pre-obesity (WC 85-90 cm in males and 80-85 cm in females). As a result, totally 118 participants (86.13%) completed all treatments and assessments.

Table 2.

Baseline characteristics of 123 participants included in the ITT analysis

Baseline characteristic All participants (n = 123) ACE group (n = 60) Control group (n = 63)
Women [n (%)] 101 (82) 47 (78) 54 (86)
Age [years] 36.28 (9.60) 36.43 (10.30) 36.13 (8.96)
WC [cm] 94.00 (9.70) 94.00 (9.82) 94.00 (9.70)
Body weight [kg] 73.47 (11.60) 74.81 (13.08) 70.78 (12.60)
BMI [kg/m2] 27.94 (3.45) 27.93 (3.31) 28.01 (3.75)
HC [cm] 103.10 (8.50) 103.05 (5.88) 103.50 (10.00)
Appetite (VAS) 6.90 (1.41) 6.78 (1.26) 7.02 (1.54)
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Notes: the data without cases which been incorrectly included. ACE group received acupoint catgut embedding, control group received non-acupoints catgut embedding. BMI: body mass index; HC: hip circumference; IQR: interquartile range; ITT: intention-to-treat; SD: standard deviation; VAS: visual analogue scale; WC: waist circumference. Age, appetite presented as mean (SD). Waist circumference, body weight, body mass index, hip circumference were presented as median (IQR).

3.2. Primary outcome

Results indicated that the WC decreased significantly within ACE group in 0-12 weeks (P < 0.001) and follow-up (P < 0.001). The change in WC also differed significantly within control group in 0-12 weeks (P < 0.001) and follow-up (P < 0.001). Furthermore, at 12 weeks and 16 weeks, the WC of ACE group was statistically different from control group (P < 0.05) (Figure 2).

Figure 2. Waist circumference during the treatment and follow-up.

Figure 2

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Data were presented as median (IQR). ACE group received acupoint catgut embedding, control group received non-acupoints catgut embedding. ACE: acupoint catgut embedding; IQR: interquartile range. During the treatment from 0 to 12 week, the differences within ACE group (n = 60) and control group (n = 63) were significant (aP < 0.001). At 12 weeks, the difference between ACE group and control group was significant (bP < 0.05). During the follow-up from 12 to 16 week, the differences within ACE group and control group were significant (cP < 0.001). At 16 weeks, the difference between ACE group (n = 58) and control group (n = 61) was significant (dP < 0.05). Friedman test (treatment) and Wilcoxon test (follow-up) within group, Mann-Whitney test between two groups.

3.3. Secondary outcomes

The body weight, BMI, HC and appetite decreased significantly within ACE group in 0-12 weeks (P < 0.001) and follow-up (P < 0.001). While in control group, appetite decreased significantly in 0-12 weeks (P < 0.001) and follow-up (P < 0.001). HC decreased significantly in 0-12 weeks (P < 0.001) and follow-up (P < 0.01). However, in terms of body weight and BMI, despite the change differing significantly in 0-12 weeks (P < 0.001) and follow-up (P < 0.001), there was a marked rebound after 4 weeks follow-up. Participants whose body weight and BMI rebounded in control group (11/61, 18.03%) were more than that of ACE group (4/59, 6.78%), although the difference was not significant (P = 0.062). When compared the two groups, only the VAS score of appetite showed statistically difference at 12 (P < 0.01) and 16 weeks (P < 0.001) (Figure 3).

Figure 3. Secondary outcomes during the treatment and follow-up.

Figure 3

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A: body weight; B: BMI; C: hip circumference; D: VAS of appetite. Data were presented as median (IQR) in A-C, presented as mean (SD) in D. ACE group received acupoint catgut embedding, control group received non-acupoints catgut embedding. BMI: body mass index; HC: hip circumference; IQR: interquartile range; VAS: visual analogue scale. During the treatment from 0 to 12 week, body weight, BMI, HC and appetite decreased significantly within ACE group (n = 60) and control group (n = 63), aP < 0.001. During the follow-up from 12 to 16 week, the differences within the groups were also significant (bP < 0.001, cP < 0.01). For appetite, at 12 weeks, the differences between ACE group and control group were significant (dP < 0.01). At 16 weeks, the differences between ACE group (n = 58) and control group (n = 61) were significant (eP < 0.001). For body weight, BMI and HC, Friedman test (treatment) and Wilcoxon test (follow-up) within group, Mann-Whitney test between two groups. For appetite, One-way analysis of variance (treatment) and Paired t-test (follow-up) within the group. Independent-Sample t-test between two groups.

3.4. Adverse events

No serious adverse events were observed in totally 137 participants. The incidence of adverse cases (hematoma and induration) did not differ between the two groups (ACE group, n = 7, 11.67%; control group, n = 9, 14.28%; P = 0.666). The hematoma at the operative site was treated by hot compress. No treatment was given for the induration at the site of the operation. Both hematoma and induration subsided within two days.

4. DISCUSSION

The effective treatments for obesity mainly include pharmacotherapy, diet, physical activity, behavioral intervention and bariatric surgery.31,⇓,⇓-34 However, pharmacotherapy is usually associates with side effects, including abdominal pain, insomnia, headache, dysgeusia and insomnia.32 On the other hand, diet and physical activity are difficult to stick,33 as well as the effect of behavior intervention for obesity is typically limited.33 What’s more, bariatric surgery increases the risk of fractures.34 ACE is the most widely used alternative therapy for AO in China with many successful trials.24,25 However, whether non-acupoint catgut embedding function the same is still uncertain.

ACE is a special acupuncture therapy which based on traditional needling instrument and method, has been used for the treatment of clinical diseases since the mid-1960s.35 The acupoints are continuously stimulated by embedding catgut into the acupoints. The single treatment of ACE is less than 30 min, but it is effective for 2 weeks. The time-saving advantage is well suited to the fast-paced modern society when compared with other treatments. ACE has been widely used in the treatment of obesity.25 The decreases in several indicators (i.e., WC, body weight, BMI, HC and appetite) not only contribute to individual good health, but also helps obese people in reshaping their bodies, boosting self-confidence, enhancing their job competitiveness and increasing salary level.22,36

Although BMI is the most commonly used outcome of obesity research, it mainly reflects the total body fat but not abdominal fat alone. WC could directly reflect abdominal fat and is an important indicator of AO measurement. Therefore, we set WC as the primary outcome indicator and other related indicators as secondary in this study. According to the classification adopted by the Chinese Medical Association in 2019, we set the inclusion criteria as WC ≥ 90 cm in males and ≥ 85 cm in females,26 not the other criteria (WC ≥ 102 cm in males and WC ≥ 88 cm in females; WC ≥ 94 cm in males and WC ≥ 80 cm in females).6,37,38

In this trial, we set non-acupoint catgut embedding as the control and many interesting results were observed. Results showed that whatever during or post treatment, catgut embedding at acupoints was effective for AO. After 12 weeks intervention period and 4 weeks follow-up, the decrease of WC and appetite were more remarkable in ACE group when compared with the control, but showed no superiority in body weight, BMI and HC. After the 4-week follow-up period, the decreases in most indicators were still remarkable in the ACE group. While during the treatment, catgut embedding at non-acupoints was also effective for AO. However, during the follow-up, the value of body weight and BMI inconceivably rebounded in many participants.

This study verified the difference of acupoint specificity in curative effect again. The difference may be the result of the combined effect, which local and targeted regulation of the acupoint and non-acupoint.39 The anatomical structures of acupoint and non-acupoint are different in muscle fascia, blood vessels, nerves, lymph and other tissues. In the state of disease, there are differences in the sensitization of electricity, temperature and algesia between acupoint and non-acupoint. After the acupuncture, the Qi effect, degranulation of mast cells, adenosine release, the regulation of brain network and target organ are also different.40,⇓,⇓,⇓-44 These may be the reasons for the clinical differences between ACE and non-acupoint catgut embedding.

This trial has several limitations. These include the applicability of our results to AO patients in other ages, such as children and old folks. In addition, a short follow-up period may be another limitations of this study. Dietary and exercise limititions are more in line with scientific norms, it is easier to produce therapeutic effects. However, in order to better meet the demands of obese patients, we did not restrict participants' diet and lifestyle. Therefore, the interesting results make more sence.

In conclusion, catgut embedding at acupoints or non-acupoints can both effectively and safely treat AO during the treatment period, but ACE is more effective in reducing WC and appetite. Acupoints Catgut embedding could deliver lasting results.

Contributor Information

Fanrong LIANG, Email: acuresearch@126.com.

Taipin GUO, Email: gtphncs@126.com.

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