Acupuncture for hip osteoarthritis

Abstract

Background

Hip osteoarthritis (OA) is a major cause of pain and functional limitation. Few hip OA treatments have been evaluated for safety and effectiveness. Acupuncture is a traditional Chinese medical therapy which aims to treat disease by inserting very thin needles at specific points on the body.

Objectives

To assess the benefits and harms of acupuncture in patients with hip OA.

Search methods

We searched Cochrane CENTRAL, MEDLINE, and Embase all through March 2018.

Selection criteria

We included randomized controlled trials (RCTs) that compared acupuncture with sham acupuncture, another active treatment, or no specific treatment; and RCTs that evaluated acupuncture as an addition to another treatment. Major outcomes were pain and function at the short term (i.e. < 3 months after randomization) and adverse events.

Data collection and analysis

We used standard methodological procedures expected by Cochrane.

Main results

Six RCTs with 413 participants were included. Four RCTs included only people with OA of the hip, and two included a mix of people with OA of the hip and knee. All RCTs included primarily older participants, with a mean age range from 61 to 67 years, and a mean duration of hip OA pain from two to eight years. Approximately two‐thirds of participants were women. Two RCTs compared acupuncture versus sham acupuncture; the other four RCTs were not blinded. All results were evaluated at short term (i.e. four to nine weeks after randomization).

In the two RCTs that compared acupuncture to sham acupuncture, the sham acupuncture control interventions were judged believable, but each sham acupuncture intervention was also judged to have a risk of weak acupuncture‐specific effects, due to placement of non‐penetrating needles at the correct acupuncture points in one RCT, and the use of penetrating needles not inserted at the correct points in the other RCT. For these two sham‐controlled RCTs, the risk of bias was low for all outcomes.

The combined analysis of two sham‐controlled RCTs gave moderate quality evidence of little or no effect in reduction in pain for acupuncture relative to sham acupuncture. Due to the small sample sizes in the studies, the confidence interval includes both the possibility of moderate benefit and the possibility of no effect of acupuncture (120 participants; Standardized Mean Difference (SMD) ‐0.13, (95% Confidence Interval (CI) ‐0.49 to 0.22); 2.1 points greater improvement with acupuncture compared to sham acupuncture on 100 point scale (i.e., absolute percent change ‐2.1% (95% CI ‐7.9% to 3.6%)); relative percent change ‐4.1% (95% CI ‐15.6% to 7.0%)). Estimates of effect were similar for function (120 participants; SMD ‐0.15, (95% CI ‐0.51 to 0.21)). No pooled estimate, representative of the two sham‐controlled RCTs, could be calculated or reported for the quality of life outcome.

The four other RCTs were unblinded comparative effectiveness RCTs, which compared (additional) acupuncture to four different active control treatments.

There was low quality evidence that addition of acupuncture to the routine primary care that RCT participants were receiving from their physicians was associated with statistically significant and clinically relevant benefits, compared to the routine primary physician care alone, in pain (1 RCT; 137 participants; mean percent difference ‐22.9% (95% CI ‐29.2% to ‐16.6%); relative percent difference ‐46.5% (95% CI ‐59.3% to ‐33.7%)) and function (mean percent difference ‐19.0% (95% CI ‐24.41 to ‐13.59); relative percent difference ‐38.6% (95% CI ‐49.6% to ‐27.6%)). There was no statistically significant difference for mental quality of life and acupuncture showed a small, significant benefit for physical quality of life.

The effects of acupuncture compared with either advice plus exercise or NSAIDs are uncertain.

We are also uncertain whether acupuncture plus patient education improves pain, function, and quality of life, when compared to patient education alone.

In general, the overall quality of the evidence for the four comparative effectiveness RCTs was low to very low, mainly due to the potential for biased reporting of patient‐assessed outcomes due to lack of blinding and sparse data.

Information on safety was reported in four RCTs. Two RCTs reported minor side effects of acupuncture, which were primarily minor bruising, bleeding, or pain at needle insertion sites. Four RCTs reported on adverse events, and none reported any serious adverse events attributed to acupuncture.

Authors' conclusions

Acupuncture probably has little or no effect in reducing pain or improving function relative to sham acupuncture in people with hip osteoarthritis. Due to the small sample size in the studies, the confidence intervals include both the possibility of moderate benefits and the possibility of no effect of acupuncture. One unblinded trial found that acupuncture as an addition to routine primary physician care was associated with benefits on pain and function. However, these reported benefits are likely due at least partially to RCT participants' greater expectations of benefit from acupuncture. Possible side effects associated with acupuncture treatment were minor.

Acupuncture for hip osteoarthritis

What is the aim of this review?

The aim of this Cochrane review was to find out if acupuncture improves pain and function in people with hip osteoarthritis. We collected and analyzed all relevant studies to answer this question and found 6 relevant studies with 413 people.

Key messages

In people with hip osteoarthritis, at close to 8 weeks:

‐ Acupuncture probably results in little or no difference in pain or function compared to sham acupuncture.

‐ Acupuncture plus routine primary physician care may improve pain and function compared to routine primary physician care alone.

‐ We are uncertain whether acupuncture improves pain and function compared to either advice plus exercise or NSAIDs.

‐ We are uncertain whether acupuncture plus patient education improves pain or function compared to patient education alone.

What was studied in the review?

Osteoarthritis (OA) is a disease of the joints, and the hip is the second most commonly affected joint. Some drug therapies commonly used for treating hip OA have a risk for side effects. Therefore, it is important to evaluate the effectiveness and safety of non‐drug therapies, including acupuncture. According to traditional acupuncture theory, stimulating the appropriate acupuncture points in the body by inserting very thin needles can reduce pain or improve function.

In clinical trials, sham acupuncture is intended to be a placebo for true acupuncture. In sham acupuncture, the patient believes he or she is receiving true acupuncture, but the needles either do not penetrate the skin or are not placed at the correct places on the body, or both. The purpose of the sham acupuncture control is to determine whether improvements from acupuncture are due to patient beliefs in acupuncture, rather than the specific biological effects of acupuncture. However, there is controversy about sham acupuncture. It is believed that some types of sham acupuncture may produce effects that are similar to the effects of true acupuncture.

What are the main results of the review?

After searching for all relevant trials published up to March 2018, we found 6 trials with 413 people. All trials included primarily older participants, with mean age range from 61‐67 years, and mean duration of hip OA pain from 2‐8 years. About two‐thirds of participants were women.

Two of the included trials compared acupuncture to sham acupuncture. These two sham‐controlled trials were small‐sized, but were well‐designed and of generally high methodological quality. The sham acupuncture control interventions were judged believable, but each sham acupuncture intervention was also judged to have a risk of weak acupuncture‐specific effects. This was due to placement of non‐penetrating needles at the correct acupuncture points in one trial, and use of penetrating needles not inserted at the correct points in the other. A meta‐analysis of these two trials gave moderate‐quality evidence of little or no effect in reduction in pain or improvement in function for true acupuncture relative to sham acupuncture. People who received true acupuncture had slight and non‐significant improvements on both pain and function outcomes (2 point greater improvement on a scale of 0‐100 for each), compared to those people who received sham acupuncture. Due to the small sample size in the studies the confidence intervals include both the possibility of moderate benefits and the possibility of no effect of acupuncture. A quality‐of‐life pooled outcome could not be estimated.

One unblinded trial gave low quality evidence that acupuncture as an addition to routine primary physician care is associated with benefits on pain, function, and physical component‐quality of life (but not mental component‐quality of life). However, these reports of benefits in trial participants who received the additional acupuncture are likely due at least partially to their a priori expectations of a benefit, or their preference to get randomized to acupuncture. Evidence from the 3 other unblinded trials was uncertain.

Possible side effects of acupuncture treatment included minor bruising and bleeding at the site of needle insertion, which were reported in 2 trials. Four trials reported on adverse events, and none reported any serious adverse events attributed to acupuncture. No trial reported on radiographic joint changes.

How up‐to‐date is this review?

We searched for studies that had been published up to 18 March 2018.

Summary of findings

Summary of findings for the main comparison.

Acupuncture versus sham acupuncture for hip osteoarthritis

Acupuncture versus sham acupuncture for hip osteoarthritis (changes from baseline analysis, short‐term follow‐up)
Patient or population: patients with hip osteoarthritis Settings: university physical medicine and rehabilitation department, Germany (Fink 2001), hospitals, UK (1 trial) (White 2012) Intervention: Acupuncture Comparison: Sham acupuncture
Outcomes	Illustrative comparative risks* (95% CI)		No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Sham acupuncture	Acupuncture
Pain (short‐term) WOMAC scale from: 0 to 100 (higher is worse pain). Follow‐up: 5 to 9 weeks	The mean change in pain in the control groups was ‐7.56 points	The mean change in pain in the acupuncture groups was 2.10 lower (7.91 lower to 3.55 higher)	105 (2 studies)	⊕⊕⊕⊝ Moderate a	SMD ‐0.13 (‐0.49 to 0.22) Absolute percent change: ‐2.1% (‐7.9% to 3.6%) (2.1 point lower on a 0 to 100 scale) Relative percent change: ‐4.1% (‐15.5% to 7.0%)
Function (short‐term) WOMAC scale from: 0 to 100 (higher is worse function). Follow‐up: 5 to 9 weeks	The mean change in function in the control groups was ‐3.1 points	The mean change in function in the acupuncture groups was 2.13 lower (7.26 lower to 2.99 higher)	105 (2 studies)	⊕⊕⊕⊝ Moderatea	SMD ‐0.15 (‐0.51 to 0.21) Absolute percent change: ‐2.1% (‐7.3% to 3.0%) (2.1 point lower on a 0 to 100 scale) Relative percent change: ‐3.8% (‐13.1% to 5.4%)
Quality of life	see comment	see comment	‐	See comment	No pooled estimate of effect, representative of the two sham‐controlled RCTs, could be calculated or reported for the quality of life outcome. Fink 2001 reported a significant benefit of acupuncture relative to sham acupuncture on the quality of life outcome ; however, White 2012 did not report extractable outcome data for the quality of life outcome, and only reported that the quality of life outcome improved in all groups, with no significant differences between groups. . Because no pooled estimate of effect could be calculated, no grade of evidence was assigned.
Number of patients experiencing adverse events	see comment	see comment	‐	see comment	Only one RCT (White 2012) included descriptions of adverse events, as follows: "three adverse events were recorded, none of which were related to treatment." White 2012 reported minor side effects of acupuncture ( which were primarily minor bruising, bleeding, or pain at needle insertion sites), and .
Withdrawals due to adverse events	see comment	see comment	‐	see comment	No trial reported withdrawals due to adverse events.
Serious adverse events	see comment	see comment	‐	see comment	No trial reported serious adverse events.
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio;
GRADE Working Group grades of evidence High‐quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate‐quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low‐quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low‐quality: We are very uncertain about the estimate.

^a Downgraded one level for serious imprecision of pooled results due to sparse data (total population size was less than 400) and confidence intervals included the possibility of difference.

Table 2

Summary of findings 2.

Acupuncture as an addition to the routine primary care that trial participants were receiving from their physicians versus routine primary physician care alone for hip osteoarthritis

Acupuncture as an addition to the routine primary care that trial participants were receiving from their physicians versus routine primary physician care alone for hip osteoarthritis (post‐treatment scores analysis, short‐term follow‐up)
Patient or population: Patients with hip osteoarthritis Settings: Germany Intervention: Acupuncture as an addition to routine primary physician care Comparison: Routine primary physician care alone
Outcomesa	Illustrative comparative risks* (95% CI)		No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Routine primary physician care alone	Acupuncture as an addition to routine primary physician care
Pain (short‐term) WOMAC scale from: 0 to 100 (higher is worse pain). Follow‐up: 13 weeks	The mean post‐treatment score in the control group was 49.2 points	The mean post‐treatment score in the acupuncture group was 22.9 points lower (29.2 lower to 16.6 lower)	137 (1 study)	⊕⊕⊝⊝ Lowa	mean percent difference: ‐22.9% (95% CI ‐29.2% to ‐16.6%) relative percent difference: ‐46.5% (95% CI ‐59.3% to ‐33.7%)
Function (short‐term) WOMAC scale from: 0 to 100 (higher is worse function). Follow‐up: 13 weeks	The mean post‐treatment score in the control group was 49.2 points	The mean post‐treatment score in the acupuncture group was 19.0 points lower (24.41 lower to 13.59 lower)	137 (1 study)	⊕⊕⊝⊝ Lowa	mean percent difference: ‐19.0% (95% CI ‐24.41 to ‐13.59) relative percent difference: ‐38.6% (95% CI ‐49.6% to ‐27.6%)
Quality of life (physical component) (short‐term) SF‐36 physical component scale from 0 to 100 (higher is better quality of life). Follow‐up: 13 weeks	The mean post‐treatment score in the control group was 30.8 points	The mean change in quality of life (physical component) in the acupuncture group was 6 points higher (8.64 higher to 3.36 higher)	137 (1 study)	⊕⊕⊝⊝ Lowa	mean percent difference: 6.0% (95% CI 8.64% to 3.36%) relative percent difference: 19.5% (95% CI 28.1% to 10.9%)
Quality of life (mental component) (short‐term) SF‐36 physical component scale from 0 to 100 (higher is better quality of life). Follow‐up: 13 weeks	The mean post‐treatment score in the control group was 49.7 points	The mean post‐treatment score in the acupuncture group was 1.5 points higher (4.27 higher to 1.27 lower)c	137 (1 study)	⊕⊕⊝⊝ Lowa	mean percent difference: 1.50% (95% CI 4.27% to ‐1.27%) relative percent difference: 3.0% (95% CI 8.6% to ‐2.6%
Number of patients experiencing adverse events	see comment	see comment	‐	see comment	Approximately 5% of participants reported side effects of acupuncture, which were primarily local bleeding, bruising, or pain at needle insertion site; no effects were life‐threatening.
Withdrawals due to adverse events	see comment	see comment	‐	see comment	not reported
Serious adverse events	see comment	see comment	‐	see comment	not reported
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk Ratio; SMD: Standardized Mean Difference
GRADE Working Group grades of evidence High‐quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate‐quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low‐quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low‐quality: We are very uncertain about the estimate.

^a Downgraded two levels: 1) one level for serious imprecision of results due to sparse data (total population size was less than 400); and 2) one level due to serious limitations in the design and implementation of available trials suggesting high likelihood of bias, including lack of blinding

Table 3

Summary of findings 3.

Acupuncture versus advice plus exercise for hip osteoarthritis

Acupuncture versus advice plus exercise for hip osteoarthritis (post treatment scores analysis, short‐term follow‐up)
Patient or population: patients with hip osteoarthritis Settings: UK Intervention: Acupuncture Comparison: Advice plus exercise
Outcomesa	Illustrative comparative risks* (95% CI)		No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Advice plus exercise	Acupuncture
Pain (short‐term) Follow‐up: 6 weeks	see comment	see comment	‐	see comment	not reported
Function (short‐term) Follow‐up: 6 weeks	see comment	see comment	‐	see comment	not reported
Symptom severity (modified WOMAC total) (range 0‐1,600, with lower scores indicating decrease in symptom severity)	mean post‐treatment score of advice and exercise group was 831 points	mean post‐treatment score in acupuncture group was 135 points lower	28 (1 study)	⊕⊝⊝⊝ Very lowa	Mean difference: ‐135 points [range 0‐1,600 points], 95% CI ‐315.13 to 45.13 points Absolute percent difference: ‐8.4% (95% CI ‐19.7 to 2.8%) Relative percent difference: ‐16.2% (95% CI ‐37.9% to 5.4%) Pain or function outcomes were not reported for this trial, and the only measure of treatment efficacy was a "slightly modified" version of the WOMAC osteoarthritis index which measured overall symptom severity, and included questions on pain, stiffness, function, and quality of life. We did not pre‐specify symptom severity as an outcome for our review, and we added this outcome post hoc to allow for inclusion of this trial's results.
Number of patients experiencing adverse events	see comment	see comment	‐	see comment	There were no self‐reported side effects potentially related to acupuncture.
Withdrawals due to adverse events	see comment	see comment	‐	see comment	not reported
Serious adverse events	see comment	see comment	‐	see comment	not reported
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk Ratio; SMD: Standardized Mean Difference
GRADE Working Group grades of evidence High‐quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate‐quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low‐quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low‐quality: We are very uncertain about the estimate.

^a Downgraded three levels: 1) two levels for very serious limitations in the design and implementation suggesting high likelihood of bias, including risk of biased reporting of patient‐reported outcomes due to lack of blinding, and risks of attrition, reporting and other biases; and 2) one level for serious imprecision of results due to sparse data (total population size was far less than 400) and confidence intervals including the possibility of difference.

Table 4

Summary of findings 4.

Acupuncture as an addition to patient education versus patient education alone for hip osteoarthritis

Acupuncture as an addition to patient education versus patient education alone for hip osteoarthritis (short‐term follow‐up)
Patient or population: Patients with hip osteoarthritis Settings: Sweden Intervention: Acupuncture as an addition to patient education Comparison: Patient education alone
Outcomes	Illustrative comparative risks* (95% CI)		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Routine primary physician care alone	Acupuncture as an addition to routine primary physician care
Pain (short‐term) VAS scale from: 0 to 100 (higher is worse pain). Follow‐up: 9 weeks	see comment	see comment	not estimable	25 (1 study)	see comment	Because no outcome data could be extracted for between‐group comparisons, no estimates of effect were available and no grade of evidence was assigned.
Function (short‐term) DRI scale from: 0 to 100 (higher is worse function). Follow‐up: 9 weeks	see comment	see comment	not estimable	25 (1 study)	see comment	Because no outcome data could be extracted for between‐group comparisons, no estimates of effect were available and no grade of evidence was assigned.
Quality of life (short‐term) GSI scale from 0 to 10 (higher is worse quality of life). Follow‐up: 9 weeks	see comment	see comment	not estimable	25 (1 study)	see comment	Because no outcome data could be extracted for between‐group comparisons, no estimates of effect were available and no grade of evidence was assigned.
Number of patients experiencing adverse events	see comment	see comment	not estimable	‐	see comment	not reported
Withdrawals due to adverse events	see comment	see comment	not estimable	‐	see comment	not reported
Serious adverse events	see comment	see comment	not estimable	‐	see comment	not reported
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk Ratio; SMD: Standardized Mean Difference
GRADE Working Group grades of evidence High‐quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate‐quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low‐quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low‐quality: We are very uncertain about the estimate.

Table 5

Summary of findings 5.

Acupuncture versus NSAIDs for hip osteoarthritis

Acupuncture versus NSAIDs for hip osteoarthritis (post‐treatment scores analysis, short‐term follow‐up)
Patient or population: patients with hip osteoarthritis Settings: China Intervention: Acupuncture Comparison: NSAIDs
Outcomesa	Illustrative comparative risks* (95% CI)		No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	NSAIDs	Acupuncture
Pain (short‐term) VAS scale from: 0 to 100 (higher is worse pain). Follow‐up: 4 weeks	The mean post‐treatment score in the NSAIDs group was 61.5 points	The mean post‐treatment score in the acupuncture group was 5.67points lower (10.11 lower to 1.23 lower)	60 (1 study)	⊕⊕⊝⊝ Very lowa	mean percent difference: ‐5.67% (95% CI ‐10.11% to ‐ 1.23%) relative percent difference: ‐9.2% (95% CI ‐16.4% to ‐2%)
Function (short‐term) Harris function score from: 0 to 47 (higher is better function).	The mean post‐treatment score in the NSAIDs group was 28.93 points	The mean post‐treatment score in the acupuncture group was 5.8 points higher (2.76 higher to 8.84 higher)	60 (1 study)	⊕⊕⊝⊝ Very lowa	mean percent difference: 12.34% (95% CI 5.87%‐18.81%) relative percent difference: 20.0% (95% CI 9.5%‐30.6%)‐
Quality of life	See comment	See comment	‐	See comment	Not reported
Number of patients experiencing adverse events	See comment	See comment	‐	See comment	Not reported
Withdrawals due to adverse events	See comment	See comment	‐	See comment	Not reported
Serious adverse events	See comment	See comment	‐	See comment	Not reported
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk Ratio; SMD: Standardized Mean Difference
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.

^a Downgraded three levels: 1) two levels for very serious limitations in the design and implementation suggesting high likelihood of bias, including risk of biased reporting of patient‐reported outcomes due to lack of blinding and potential for selection bias; and 2) one level for serious imprecision of results due to sparse data (total population size was far less than 400).

Background

Description of the condition

Osteoarthritis (OA) is the most common form of arthritis, and is the leading cause of disability among older adults (CDC 2001; Peat 2001). After the knee, the hip is the joint most commonly affected by OA (Felson 1998; Oliveria 1995).

When the joint loses cartilage due to age, injury, repetitive use, etc., the bone grows to try and repair the damage. Instead of making things better, however, the bone grows abnormally and makes things worse. For example, the bone can become misshapen and make the joint painful and unstable, and affect physical functioning or ability to use the hip.

The prevalence of hip OA among people aged 35 and older living in Western countries ranges from 3 to 11% (Zhang 2005), and nearly 200,000 total hip replacements are performed annually in the United States (Lane 2007).

Effective treatments for hip OA are needed to relieve pain, improve function, and reduce healthcare utilization. However, few treatments for hip OA have been evaluated with randomized controlled trials (RCTs). Recent guidelines for hip OA have recommended the use of a variety of non‐pharmacological (non‐drug) and pharmacological (drug) treatments for reducing pain and maintaining functional ability; however, the guidelines were largely based on expert opinion and indirect evidence from knee OA RCTs, and the guideline authors noted that RCT evidence specific for hip OA was "strikingly lacking" (Fernandes 2013; Zhang 2005). The guidelines (Fernandes 2013; Zhang 2005) did not include a recommendation regarding acupuncture.

Description of the intervention

According to the philosophy of traditional acupuncture, energy circulates in "meridians" (or pathways) located throughout the body. When something occurs to cause this meridian energy circulation to be blocked, pain or ill health will result. The way to restore energy, circulation, health, and balance is to stimulate the appropriate combination of the estimated 400 traditional meridian acupuncture points on the body (WHO 1991). According to acupuncture theory, one indication that acupuncture is exerting its analgesic effects is that a patient may experience a sensation of numbness or tingling, called 'de qi', at the needle insertion point.

In everyday practice, acupuncture treatment is often individualized, continually modified to take into account changes in the patient's condition, and combined with other treatments, such as herbal medicine and mind‐body exercises. In contrast, in RCTs of acupuncture, a prescribed formula of acupuncture points is generally evaluated as a sole treatment. While evaluating acupuncture as a sole, isolated treatment may not reflect everyday clinical practice, it does allow for the best estimation of the specific effects of acupuncture. Acupuncture is used by only about 1% (Quandt 2005) to 2% (Herman 2004) of people with arthritis. Even among people with OA who do use acupuncture, most do not use it specifically for treating their OA (Quandt 2005).

How the intervention might work

Laboratory evidence has documented a biological basis of acupuncture analgesia (the effect of minimizing the pain). For example, animal studies provide evidence that acupuncture may simply be a particular method of stimulating the nervous system to release a range of neurotransmitters (chemicals by which a nerve cell communicate with another nerve cell) ‐ particularly opioid peptides (biological molecules released in the brain to suppress pain) ‐ which are involved in the body's own pain‐suppressing mechanisms (Lewith 1984). Other research suggests that the noxious (harmful) stimulation of the acupuncture needles may act to suppress the nervous system pathways that are involved in the sensory and affective components of pain (Han 2003; Hui 2005). Because pain often limits a patient's activity, decreased pain may improve function. Also, basic science studies show that acupuncture suppresses inflammation (Li 2008); any decreases in inflammation may improve physical function. However, there is no widely agreed upon mechanism by which acupuncture sustains effects on a chronic pain condition, such as hip OA.

Why it is important to do this review

With the considerable risks and limited benefits of existing pharmacological treatments (Zhang 2010), there is a clear need for alternative safe and effective nonpharmacological treatments for hip OA. Incidence rates for major adverse events of acupuncture are often considered to be best estimated from large prospective surveys (Witt 2011). Four surveys of acupuncture safety among regulated, qualified practitioners, two conducted in Germany (Melchart 2004; Witt 2009) and two in the United Kingdom (MacPherson 2001; White 2001), confirmed that serious adverse events after acupuncture are uncommon. These surveys, covering more than 3 million acupuncture treatments all together, found that there were no deaths or permanent disabilities, and all those with adverse events fully recovered. Additionally, a large UK survey of patients who received acupuncture treatment supports the notion that serious adverse effects of acupuncture are very rare, while minor side effects such as pain, nausea, or bruising at the site of needling may be experienced by up to 30% of patients (Macpherson 2004; MacPherson 2005). Thus, it can be concluded that acupuncture has a very low rate of adverse events, when conducted among licensed, qualified practitioners in the West (White 2004). However, any medical intervention has the potential to cause harm, particularly when administered by untrained or unqualified practitioners, or in an unhygienic setting. Such potential risks are best estimated from systematic reviews of case reports. One such recent systematic review (Xu 2013) identified isolated case reports of bacterial infections resulting from acupuncture administered in unhygienic settings (skin contact with unsterilized equipment and dirty towels), as well as injuries resulting from the use of 'embedded' acupuncture needles. While there are several methodological problems with the evaluation of such case reports (Loke 2011), a review of case reports can nevertheless identify signals that might suggest the potential for adverse events of acupuncture, when administered in specific settings, or when using specific acupuncture styles. Thus, while acupuncture is a relatively safe treatment when administered by regulated qualified practitioners, it is not risk free if used in an unregulated setting or if administered by untrained or negligent practitioners. Additionally, some patients experience the minor side effects of bruising and bleeding at needle insertion points, and thus acupuncture should be used cautiously by patients on anticoagulant therapy, or by patients who have a bleeding disorder.

While systematic reviews have evaluated the effects of acupuncture for knee OA (Manheimer 2007; White 2007) and peripheral joint OA (Kwon 2006; Manheimer 2010), no systematic review has evaluated the benefits and harms of acupuncture for hip OA. It is important to conduct a systematic review and meta‐analysis of acupuncture for hip OA because the effects of acupuncture may vary according to the site of the OA, due to differences in anatomy, biomechanics, and the accessibility to acupuncture needles (Zhang 2005).

Objectives

To determine the benefits and potential adverse effects of needle acupuncture for OA of the hip, in comparison to sham acupuncture, other sham procedures, no (specific) treatment, and other active treatment, as well as the effects of acupuncture as an addition to another treatment.

Methods

Criteria for considering studies for this review

Types of studies

We included randomized controlled trials (RCTs) of four weeks or longer duration, published in any language, as either full articles or abstracts. Controlled clinical trials that were found to assign participants by alternation, rotation, or hospital record number were excluded (Lefebvre 2011).

We included only RCTs with at least four weeks of observation (including both treatment and follow‐up) because RCTs with a shorter duration were considered irrelevant for the question of whether acupuncture is helpful for people with a chronic disease like OA. In principle, a longer RCT duration would seem even more desirable; however, given the limited number of RCTs available, we considered a minimum duration of four weeks a reasonable compromise.

Types of participants

RCTs that included a mix of participants with either hip or knee OA, or both hip and knee OA, were included only if the results for the hip were reported separately from the results for the knee.

Types of interventions

We included RCTs evaluating traditional Chinese medicine (TCM) needle acupuncture. TCM acupuncture involves inserting needles into traditional meridian points, usually with the intention of influencing energy flow in the meridian. Needles may also be inserted at additional tender points and electrical stimulation of the needles may be used. We excluded RCTs of dry needling or trigger point therapy, a therapy which is based on principles of Western anatomy and physiology and rejects TCM concepts of energy and meridians, and which includes inserting needles only at unnamed tender or trigger points to stimulate nerves or muscles.

We included RCTs comparing acupuncture to any of the following control interventions: sham acupuncture, other sham procedures, no (specific) treatment, or an active non‐TCM treatment; and RCTs that evaluated needle acupuncture as an addition to another treatment. Because our objective was to evaluate the effects of TCM acupuncture compared to a sham treatment, no treatment, or a Western medicine control, we excluded RCTs in which one form of acupuncture was compared with another form of active acupuncture or a different type of TCM (e.g. Chinese herbal medicine). Adjuvant treatments, either Western or TCM, were allowed as long as they had been given to both the acupuncture and control groups.

Types of outcome measures

Major outcomes

The major outcomes for this review were pain and function at short‐term follow‐up (i.e. less than or equal to 3 months and closest to 8 weeks after randomizations) and, if available, long‐term follow‐up (i.e. more than 3 months and closest to 6 months after randomizations).

Minor outcomes

The minor outcomes were the following, at both short‐term and long‐term follow‐up:

• overall measure of symptom severity (e.g., WOMAC total) (post hoc outcome added to allow for inclusion of Haslam 2001, which only reported this outcome)

• health‐related quality of life;

• radiographic joint changes;

• number of participants experiencing adverse events;

• withdrawals due to adverse events;

• serious adverse events.

Search methods for identification of studies

To identify RCTs, we searched Cochrane CENTRAL, MEDLINE, and Embase all through March 2018 (for search strategies for each database, see Appendix 1).

All RCTs included in previous systematic reviews of acupuncture for OA (Ernst 1997; Ezzo 2001; Kwon 2006; Manheimer 2007; Manheimer 2010; White 2007) were also reconsidered for inclusion in this review. We scanned bibliographies of retrieved articles for further references. To identify details of RCTs that may be relevant for future updates of this review, we also searched the following four databases of ongoing RCTs.

• the National Research Register

(http://public.ukcrn.org.uk/search/).

• Clinical Trials

(http://www.clinicaltrials.gov/).

• the ISRCTN Register

(http://isrctn.org/).

• WHO ICTRP Search Portal

(http://apps.who.int/trialsearch/).

Data collection and analysis

Selection of studies

All records identified by searching were independently screened by at least one author. The full text of potentially relevant reports was obtained and independently reviewed by two authors (KC and EM for English language studies, or KC and MG for Chinese language studies) for eligibility. Disagreements between review authors were resolved by discussion. 

Recent research indicates that a large proportion of claimed Chinese‐language RCT publications are of studies that are not truly randomized (Wu 2009). The investigators of claimed Chinese language RCTs were therefore contacted and interviewed by telephone to determine whether they had used authentic randomizations, using interview questions adapted from the survey developed by Wu and colleagues to verify the authenticity of claimed randomized trials (Wu 2009). The same questions were asked of authors of English language RCTs that did not include details about randomizations methods in their published reports. We excluded one Chinese language RCT (Zheng 2004) for which the authors could not provide details of randomizations. There were no RCTs for which the authors' contact details could not be located, or for which the authors did not respond to interview requests.

Data extraction and management

All data were independently extracted by two authors (KC and EM for English language studies, or KC and MG for Chinese language studies), using a structured data extraction form. Consensus was generally achieved by discussion; if any disagreements persisted, a third author (LL) made the final decision on the extraction of the data item. We emailed the corresponding authors of all RCTs and requested that they review the information about their RCT that we had extracted into our Characteristics of Included Studies table, as well as review our 'risk of bias' assessments of their RCT. If data reported in RCT publications were incomplete or ambiguous, we also requested by email additional information or clarification from the corresponding authors.

When a given RCT reported more than one pain or function outcome measure, we selected which outcome measure to extract based on the Cochrane Musculoskeletal Group's hierarchy for pain and function outcome selection (Cochrane Musculoskeletal Group).

The method of selecting acupuncture points was categorized as individual, fixed formula, or flexible formula. For the individual style, the practitioner was free to choose any points. For the fixed formula, the same fixed points were used for all participants. For the flexible formula, a fixed formula was used and some additional points were chosen, according to the symptoms of the participant.

Assessment of risk of bias in included studies

For the risk of bias assessment, we assessed the following eight core Cochrane risk of bias criteria:

• Adequate sequence generation;

• Allocation concealment;

• Blinding of participants;

• Blinding of personnel (i.e. acupuncturists);

• Blinding of outcome assessment.

• Incomplete short‐term outcome data addressed (measurement point closest to eight weeks, and less than or equal to three months, after randomizations);

• Incomplete long‐term outcome data addressed (measurement point closest to six months, and more than three months, after randomizations);

• Selective outcome reporting.

We also assessed the following four additional risk of bias criteria:

• Groups similar at baseline regarding the most important prognostic indicators;

• Cointerventions avoided or similar between intervention groups;

• Compliance acceptable in all groups;

• Timing of the outcome assessment similar in all intervention groups.

For the one factorial RCT (i.e. White 2012), we assessed the following additional risk of bias item: "Are reports of the study free of suggestion of an important interaction between the effects of the different interventions?" (Higgins 2011 (Section 16.5.6))

For each RCT, we judged each criterion as 'low risk of bias', 'high risk of bias', or 'unclear' if there was either lack of information or uncertainty about potential for bias (Higgins 2011 (Chapter 8)).

For the 'Blinding of participants' 'risk of bias' criterion, we assigned sham‐controlled RCTs a judgment of 'unclear' unless the sham control was judged sufficiently credible to fully blind participants to the treatment being evaluated (Manheimer 2007; Manheimer 2010). Thus, for this blinding criterion, we assigned the 'low risk of bias' judgment only to sham‐controlled RCTs that either 1) evaluated the credibility of the true and sham acupuncture interventions at the testing time point closest to four weeks, and found the sham to be indistinguishable from the true acupuncture among RCT participants, or 2) used needle acupuncture as the sham and also informed participants that two different types of acupuncture were being compared (i.e. did not inform participants that a sham treatment was involved).

For determining whether the outcome assessor was blinded, we always considered the participant to be the outcome assessor for participant‐reported outcomes (i.e. VAS pain, WOMAC (the Western Ontario and McMaster Universities Arthritis Index), quality of life), even if the participant‐reported outcome data were collected by someone else.

For OA RCTs, investigators typically measure a number of outcomes at multiple time points using various outcome measurement instruments. For the selective outcome reporting item, we considered those RCTs to have a low risk of bias if they reported the results of the most relevant osteoarthritis outcomes measured (typically, a measure of pain and function) for the most relevant time points (end of treatment and, if done, follow‐up), and if these results made it unlikely that authors had picked them out because they were particularly favorable or unfavorable.

We used the GRADE approach to rate the overall quality of evidence for the major outcomes. RCTs start as high‐quality evidence, but may be downgraded due to: (1) limitations in design and implementation (risk of bias), (2) indirectness of evidence, (3) inconsistency (unexplained heterogeneity), (4) imprecision (sparse data), and (5) reporting bias (publication bias). The overall quality of evidence for each outcome was determined after considering each of these elements, and categorized as high‐quality (i.e. further research is very unlikely to change our confidence in the estimate of effect); moderate‐quality (i.e. further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate); low‐quality (i.e. further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate); or very low‐quality (i.e. we are very uncertain about the estimate) (Guyatt 2008; Schünemann 2011).

Acupuncture adequacy assessments

Two experienced clinical acupuncturists (LL, XS), who had also previously worked on RCTs and systematic reviews of acupuncture, independently assessed both the adequacy of the acupuncture intervention administered in the RCTs. Six aspects of the acupuncture intervention were assessed for adequacy: choice of acupuncture points; total number of sessions; treatment duration; treatment frequency; needling technique; and acupuncturist's experience (Manheimer 2010). The risk of the sham intervention having specific biological effects similar to true acupuncture was also assessed, using an open‐ended question. The acupuncturists assessed adequacy independently and were provided with only the part of the RCT publications that described the acupuncture and sham procedures (i.e. they were blinded to the identities and results of the RCTs). Consensus was achieved by discussion.

Measures of treatment effect

For all single trial comparisons, we presented results as mean differences (MD). For comparisons including > 1 RCT, we used mean differences if the RCTs assessed the same outcome and measured it using the same scale, and SMDs if the RCTs assessed the same outcome but measured it using different scales (e.g. WOMAC and VAS).

Unit of analysis issues

Studies with multiple treatment groups

In the White 2012 RCT, true acupuncture was compared to two different sham controls: 1) Streitberger sham acupuncture; and 2) sham TENS. We decided to focus on the sham acupuncture comparison because the Streitberger sham acupuncture intervention had previously been validated as believable (Streitberger 1998), and the Streitberger sham acupuncture was also a more believable sham control than sham TENS in this White 2012 RCT (i.e. a treatment credibility test was conducted and showed that there was no statistically significant difference between real acupuncture and Streitberger sham acupuncture (P = 0.35), but there was a statistically significant difference between real acupuncture and sham TENS (P = 0.01)).The results of the comparison of acupuncture versus sham TENS were similar (although slightly larger, for the pain outcome) to the results of the comparison of acupuncture versus sham acupuncture (i.e. SMD ‐0.34 (95% CI ‐0.97 to 0.28) vs. SMD ‐0.14 (95% CI ‐0.53 to 0.25) for pain). For these reasons, we therefore selected the sham acupuncture control and excluded the sham TENS control.

Dealing with missing data

In cases where participants were lost to follow‐up, and the RCT investigators conducted intention‐to‐treat (ITT) analyses using imputed values for the participants' missing data, we used these ITT results for our meta‐analyses in preference to the available case analyses, if the ITT method for imputing data was described, and if it was an appropriate method that appeared unlikely to bias the effect size calculation. If the method that the RCT investigators used for imputing missing data in their ITT analysis was not clearly described or not appropriate, we used the available case data instead (if available) for the primary analysis and the ITT data for a sensitivity analysis. If either only the ITT data or only the available case data were reported, then those available data were used. The potential impact of missing data was considered in interpreting the results of the review, taking into account the degree of missing RCT data across the treatment arms and its potential impact on the effect estimate of the individual trial and the pooled effect estimate.

When statistics such as standard deviations were not present in the RCT publication, we used the methods suggested in section 16.1.3 of the Cochrane Handbook (Higgins 2011 (Section 16.1.3.2)) to calculate the estimated values of these missing statistics.

Assessment of heterogeneity

Statistical heterogeneity was assessed using the I² statistic, with values > 50% indicating substantial heterogeneity.

Data synthesis

We pooled data using the random‐effects model because of the expected heterogeneity of the RCTs' acupuncture protocols and settings. Data from individual RCTs were pooled when the RCTs were sufficiently similar in terms of the following study characteristics:

1) Control group:

1. placebo or sham acupuncture;

2. other sham procedure (e.g. sham TENS);

3. no specific treatment;

4. other active treatment (RCTs using different active treatment comparators were analyzed separately);

5. other treatment alone (compared with acupuncture as an addition to the other treatment).

2) Outcome measures:

1. pain;

2. function;

3. overall measure of symptom severity (e.g., WOMAC total) (post hoc outcome);

4. health related quality of life;

5. radiographic joint changes;

6. number of participants experiencing adverse events;

7. withdrawals due to adverse events;

8. serious adverse events.

3) Timing of follow‐up:

1. short‐term follow‐up (i.e. less than or equal to three months and closest to eight weeks after randomizations);

2. long‐term follow‐up (i.e. more than three months and closest to six months after randomizations).

For the one RCT that used a waiting list control group (Witt 2006) to evaluate acupuncture as an addition to routine primary physician care, we excluded all outcome measurements after participants on the waiting list began acupuncture.

To allow for a more clinically relevant interpretation, we also evaluated whether the pooled effects of acupuncture met the threshold for minimal clinically important differences (MCIDs), defined as the smallest differences in scores that people with OA would perceive to be beneficial (Angst 2002). These MCIDs have been estimated to be SMDs of 0.39 for WOMAC pain and 0.37 for WOMAC function (Angst 2002).

To further aid clinical interpretation, we also converted the SMDs to the absolute and relative percent changes from baseline of acupuncture relative to the control group, using the approach recommended by the Cochrane Musculoskeletal Group (Santesso 2006; Ghogomu 2014). For these calculations, we first calculated the absolute change by multiplying the pooled standardized mean difference by the standard deviation of the control group of the trial that had a large weighting in the overall result in RevMan, and was most representative, in terms of the participant characteristics and the baseline mean and standard deviation of the control group. This absolute change was then divided by the baseline value of this trial's control group to calculate a relative percent change from baseline. For the meta‐analysis comparing acupuncture vs. sham acupuncture, we used White 2012 as the representative trial for these calculations.

If any studies within any category reported insufficient data for pooling even after asking authors for more details, we excluded such studies from the meta‐analyses and described their results narratively.

Sensitivity analysis

We calculated mean differences for single trials (Haslam 2001; Witt 2006) using both differences in changes and differences in post‐treatment scores; we considered the primary analysis that which did not require imputing SDs. For example, if SDs of changes needed to be imputed but SDs of post‐treatment scores were available without imputation, we considered comparison of post‐treatment scores as primary analysis, and comparison of changes from baseline as sensitivity analysis. For pooled analyses, we considered differences in changes from baseline to be primary analysis, and differences in post‐treatment scores to be sensitivity analysis.

Results

Description of studies

See: Characteristics of included studies; Characteristics of excluded studies; Characteristics of ongoing studies.

Results of the search

Figure 1 shows details of the search and selection process.

Figure 1.

Flow diagram.

Included studies

Six RCTs with a total of 413 participants were included (Fink 2001; Haslam 2001; Sheng 2010; Stener‐Victorin 2004; White 2012; Witt 2006; see 'Characteristics of included studies' table). For the White 2012 RCT, we requested and the author provided both post‐treatment outcome scores and change from baseline outcome scores, separately for the knee and hip participants. For the Witt 2006 RCT, the post‐treatment outcome scores were reported separately for the hip and knee. We also contacted corresponding authors of two other included RCTs (Sheng 2010; Stener‐Victorin 2004), and the authors provided relevant information about randomizations, allocation concealment, and dropouts.

Table 13 includes an overall description of RCT characteristics. All RCTs included primarily older participants, with a mean age range from 61 to 67 years, and a mean duration of hip OA pain from two to eight years. About two‐thirds of RCT participants were women.

Table 1.

Characteristics of randomized controlled trials of acupuncture for hip osteoarthritis

Study, Country	Populationa	Acupuncture treatmentb	Control treatment(s)	Outcome measures	Time point for outcome assessmentc
Fink 2001, Germany	62 participants with hip OA, mean age 62 yrs, mean duration of hip OA 5 yrs	fixed formula at 12 fixed points; 10 sessions over 3 wks	sham acupuncture: penetrating real needles inserted at non‐acupoints 5 cm away from true acupoints, and at same depth	pain: VAS; function: Lequesne; QoL: 'Everyday Life' (Bullinger 1993)	9 wks (6 wks after EoT)
Haslam 2001, UK	28 participants with hip OA, mean age 67 yrs, mean duration of hip OA 8 yrs	fixed formula at 16 fixed points; 6 sessions over 6 wks	advice plus exercise	modified WOMAC total	6 wks (EoT)
Sheng 2010, China	60 participants with hip OA, mean age 62 yrs, mean duration of hip OA 3 yrs	fixed formula EA at 4 fixed points; 8 sessions over 4 wks	NSAID (Diclofenac)	pain: VAS; function: Harris	4 wks (EoT)
Stener‐Victorin 2004, Sweden	38 participants with hip OA, mean age 67 yrs, mean duration not reported	flexible formula EA at 6 points; 10 sessions over 5 wks plus patient education	patient education aloned	pain: VAS; function: DRI; QoL: GSI	9 wks (4 wks after EoT)
White 2012, UK	88 participants with hip OA, mean age 67 yrs, mean duration not reported	flexible formula at mean of 6 points; 8 sessions over 4 wks	1) sham acupuncture: validated Streitberger sham needles placed at same points as real acupuncture; 2) sham TENS placed at same points as real acupuncture group	pain: VAS, WOMAC function: WOMAC; QoL: Nottingham Health (Jenkinson 1988)	5 wks (1 wk after EoT)
Witt 2006, Germany	137 participants with hip OA, mean age 61 yrs, mean duration 5 yrs	individualized formula; 15 sessions over 13 wks plus routine primary physician care	routine primary physician care alone	pain: WOMAC; function: WOMAC ; QoL: SF‐36 (mental and physical components)	13 wks (EoT)

acupoints, acupuncture points; DRI, disability rating index (Salen 1994); EA, electroacupuncture; EoT, end of treatment; GSI: Global self‐rating index (Salén 1995); Harris: Harris score (Harris 1969); Lequesne: Lequesne indices of severity in osteoarthritis for weight bearing joints (Lequesne 1991); NR, not reported; OA, osteoarthritis; QoL: quality of life; SF‐36: Short Form 36 (Ware 1992); TENS: transcutaneous electrical nerve stimulation; UK, United Kingdom; VAS, Visual Analogue Scale; wks, weeks; WOMAC, Western Ontario and McMaster Universities Arthritis Index (Bellamy 1988); yrs, years.

^a Number listed is the number of participants analyzed.

^b The method of selecting acupuncture points was categorized as follows: fixed formula = the same fixed points are used for all participants; flexible formula = fixed formula is used and some additional points chosen, according to the symptoms of the participant; or individualized formula = practitioner is free to choose any points.

^c The time point listed is the number of weeks after randomization.

^d The Stener‐Victorin 2004 RCT also included a 'hydrotherapy plus patient education' treatment arm, which was not relevant for any comparison in this review.

Characteristics of participants and details on outcome measures

For all RCTs, participants needed to be diagnosed with OA to be eligible. The included RCTs used different but valid and reliable instruments to measure pain (Bellamy 1988), function (Bellamy 1988; Harris 1969; Lequesne 1991; Salen 1994), and quality of life (Bullinger 1993; Jenkinson 1988; Salén 1995; Ware 1992) outcomes. No RCTs reported the radiographic joint change outcome.

Method of selecting acupuncture points and stimulating needles

Two RCTs (Stener‐Victorin 2004; White 2012) used a flexible formula for point selection, and three RCTs (Fink 2001; Haslam 2001; Sheng 2010) used a fixed formula. For the one remaining pragmatic RCT (Witt 2006), the point selection and needling techniques were entirely at the discretion of the treating physicians. Four RCTs (Fink 2001; Sheng 2010; Stener‐Victorin 2004; White 2012) reported that the acupuncturists sought to elicit the 'de qi' needling sensation. Two RCTs did not report on 'de qi': the pragmatic RCT (Witt 2006) and one other small RCT (Haslam 2001). Electrical stimulation of the needles was used in two RCTs (Sheng 2010; Stener‐Victorin 2004).

Funding source

Among the six included RCTs, one did not report the source of funding (Haslam 2001) and one was not funded (Sheng 2010); the other four were funded either by a pharmaceutical company (Fink 2001), government grant (Stener‐Victorin 2004), postdoctoral research award and complementary medical research trust (White 2012), or a social health insurance company (Witt 2006), respectively.

Excluded studies

The 'Characteristics of excluded studies' table lists the studies that we excluded as well as the reasons for exclusion.

Risk of bias in included studies

The use of a sham acupuncture control that adequately blinds RCT participants to treatment assignment is probably the most important 'risk of bias' criterion in acupuncture RCTs. For both sham‐controlled RCTs, the sham acupuncture interventions were judged likely to be indistinguishable from true acupuncture among the RCT participants. The sham acupuncture control used in the White 2012 RCT was the validated Streitberger placebo needles (Streitberger 1998) placed on the genuine acupuncture points among acupuncture‐naive participants. The sham acupuncture control used in the Fink 2001 RCT involved the same number of needles inserted to the same depth as the true acupuncture group; however, the needles in the sham acupuncture group were inserted at non‐genuine acupuncture points (at least 5 cm away from genuine acupuncture points). For both sham‐controlled RCTs, there were no statistically significant differences between the true acupuncture and sham acupuncture groups in the percentages of participants who believed their treatment had been real, which also suggests that blinding was successful.

In the RCTs comparing acupuncture head‐to‐head with another active treatment (Haslam 2001; Sheng 2010), or evaluating acupuncture as an addition to another active treatment received by all RCT participants (Stener‐Victorin 2004; Witt 2006), blinding of participants was not possible, and this likely represented the major risk of bias in these RCTs. Additionally, the Haslam 2001 RCT had risks of bias associated with several other domains such as incomplete outcome data and selective reporting, and Sheng 2010 had risk of selection bias. . All the other trials were assessed as free of attrition and reporting bias (see risk of bias tables in Characteristics of included studies and risk of bias graph, Figure 2).

Figure 2.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Assumptions used to derive the meta‐analysis study data

For four RCTs (Fink 2001; Haslam 2001; Sheng 2010; Witt 2006), there was incomplete reporting of SDs of change scores, and we needed to make assumptions to calculate these SDs for the changes from baseline analyses. We used the pre‐ and post‐treatment means and SDs for each group, and assumed a conservative within‐subject pretest‐post‐test correlation of 0.5, to calculate the SDs of change for each group. For the Witt 2006 RCT, the pretreatment means and SDs were not reported separately for the hip and knee participants. Therefore, in calculating the mean changes, we assumed the baseline means and SDs for participants with only hip OA were the same as those of all participants (i.e. OA of hip and knee participants), because the Witt 2006 publication reported that there were no significant baseline differences between participants with OA of the knee and participants with OA of the hip.

Assessments of acupuncture adequacy

All of the RCTs were judged adequate on 'choice of acupuncture points', 'treatment duration' and 'needling technique', except for Witt 2006, the pragmatic RCT for which the point selection and needling technique were entirely at the discretion of the treating physician/acupuncturist. All of the RCTs were judged adequate on 'total number of sessions' and 'treatment frequency', except for Haslam 2001 in which each participant received one session per week over six weeks, which the assessors judged to be potentially insufficient for treating hip OA. The 'training and experience' of the RCTs' treating acupuncturists were only reported in two RCT publications (Sheng 2010; White 2012); both described an adequate level of training and experience. The two sham acupuncture interventions used were each judged to have risks of weak acupuncture‐specific effects. This was due to the placement of non‐penetrating placebo needles on the genuine acupuncture points, for the sham intervention in the White 2012 RCT (White 2012; Foster 2007), and the use of the same number of needles inserted to the same depth as the true acupuncture group, but not inserted at the correct points, for the sham intervention in the Fink 2001 RCT (see Additional Tables: Table 14).

Table 2.

Acupuncture adequacy assessments of included studies^a

Study	Choice of acupuncture points	Total number of sessions	Treatment duration	Treatment frequency	Needling technique	Experience	Assessment of likelihood of physiological activity of sham control	Guess of study
Fink 2001	adequate	adequate	adequate	adequate	adequate	don't knowb	The insertion sham acupuncture used the same number of points and the same depths as the true acupuncture group and the sham needles were inserted 5 cm away from the 'real points'. This technique may have caused nonspecific endorphin release which has some effect on pain. And the sham points stimulated were also probably located at the twelve muscle region and twelve cutaneous region where qi and blood were distributed. Credibility of the blinding to treatment was assessed after the first treatment session.	don't know
Haslam 2001	adequate	inadequatec	adequate	inadequatec	adequate	don't knowd	no sham control	don't know
Sheng 2010	adequate	adequate	adequate	adequate	adequate	adequate	no sham control	don't know
Stener‐Victorin 2004	adequate	adequate	adequate	adequate	adequate	don't knowe	no sham control	don't know
White 2012	adequate	adequate	adequate	adequate	adequate	adequate	For the Streitberger needle group, the non‐insertion sham control seemed appropriate. The sham procedure may have created a mild physiological response, including an acupressure massage effect, because the sham devices were placed and left at the true acupuncture points. For the sham TENS group, it was not an appropriate sham control for acupuncture. The sham TENS may also have created a mild physiological effect, because the electrodes were fixed to the skin of the true acupuncture points. Credibility of the blinding to treatment was assessed at 4 weeks after randomization (end of treatment).	XS guessed it must be conducted in UK, but didn't know who the authors were.
Witt 2006	don't knowf	adequate	don't know	don't knowg	don't knowh	uncertaini	no sham control	don't know

^{qi: is an active principle forming part of any living thing in traditional Chinese culture and medicine.}

^{TENS: transcutaneous electrical nerve stimulation}

^a Two independent acupuncturists, LL and XS, assessed acupuncture as adequate in terms of the choice of acupuncture points, treatment duration and needling technique for all trials except for the Witt 2006 trial, a pragmatic trial for which the point selection and needling technique were entirely at the discretion of the treating physician.

^b No mention of the training of the physician who carried out the procedure. However, the paper stated that "[a]cupuncture was carried out by a physician with sound knowledge of traditional acupuncture techniques."

^c "Each participant received one session per week over a six‐week period." The number of sessions and the treatment frequency might not have been enough for the given condition of hip OA.

^d The treatments were performed 'by the author'. No information regarding the training background and practice experience of this author was provided.

^e The authors reported that "experienced physiotherapists" performed treatments but the acupuncture training and experience of these physiotherapists was not reported.

^f Acupuncture point selection was at the discretion of the physicians. No point selection was described.

^g 15 treatments within 3 months, but not known how frequent the treatments were given.

^h Not described. 140 hour training may not have been sufficient to have good needling techniques.

ⁱ Physician acupuncturists trained at least 140 hours. The training requirement was low.

Effects of interventions

See: Table 1; Table 2; Table 3; Table 4; Table 5

See: Table 1 Summary of findings for the principal comparison: Acupuncture versus sham acupuncture for hip OA; Table 2 Acupuncture as an addition to the routine primary care that trial participants were receiving from their physicians versus routine primary physician care alone for hip OA; Table 3 Acupuncture versus advice plus exercise for hip OA; Table 4 Acupuncture as an addition to patient education versus patient education alone for hip OA; and Table 5 Acupuncture versus NSAIDs for hip OA.

Of the six RCTs that met the selection criteria, all except one (Stener‐Victorin 2004) reported extractable outcome data.

Acupuncture versus sham acupuncture

The combined analysis of two sham‐controlled RCTs (White 2012; Fink 2001) gave moderate quality evidence of little or no effect in reduction in pain for acupuncture relative to sham acupuncture. Due to the small sample sizes in the studies, the confidence interval includes both the possibility of moderate benefit and the possibility of no effect of acupuncture (120 participants; SMD ‐0.13 (95% CI ‐0.49 to 0.22); 2.1 points greater improvement than sham acupuncture on 100 point scale (i.e. absolute percent change ‐2.1% (95% CI ‐7.9% to 3.6%)); relative percent change ‐4.1% (95% CI ‐15.6% to 7.0%)) (Figure 3; Analysis 1.1; Table 1). Estimates of effect were similar for function (120 participants; SMD ‐0.15 (95% CI ‐0.51 to 0.21)) (Figure 3; Analysis 1.1; Table 1).The GRADE analysis indicated that the evidence for these two outcomes was of moderate quality, and each was downgraded one level for serious imprecision of results due to sparse data (total population size was less than 400, for each outcome) (see Table 1). One of the two sham‐controlled RCTs (Fink 2001) found acupuncture was associated with short‐term improvements in quality of life (1 RCT; 62 participants; MD ‐8.00 (95% CI ‐14.97 to ‐1.03); absolute percent change ‐3.8% (95% CI ‐7.1% to ‐0.5%); relative percent change ‐5.0% (95% CI ‐9.3% to ‐0.6%)) (Analysis 1.2). However, the other sham‐controlled RCT (White 2012), which included a mix of participants with OA of the hip and OA of the knee, did not report numerical data on the quality of life outcome separately for hip and knee OA participants. The White 2012 trial only reported qualitatively that the quality of life score improved in both the true and sham acupuncture groups, with no significant differences between groups. Because there was no benefit of acupuncture relative to sham acupuncture on the quality of life outcome in the methodologically sound White 2012 trial, and also because combining the 'negative' White 2012 quality of life data with the 'positive' Fink 2001 quality of life data would be unlikely to result in a statistically significant pooled benefit, the 'positive' findings of the Fink 2001 trial quality of life outcome were not reported in our Abstract, Summary of Findings table, or Plain Language Summary (in order to avoid emphasizing a positive finding that was not representative of the included trials).

Figure 3.

Acupuncture versus sham acupuncture: Pain & Function (short‐term).

Analysis 1.1.

Comparison 1 Acupuncture vs. sham acupuncture (primary analysis, change from baseline at short‐term follow‐up), Outcome 1 Pain & function.

Analysis 1.2.

Comparison 1 Acupuncture vs. sham acupuncture (primary analysis, change from baseline at short‐term follow‐up), Outcome 2 Quality of life.

Acupuncture versus other active treatments

Acupuncture versus NSAIDs

In the head‐to‐head comparison of acupuncture with the nonsteroidal anti‐inflammatory drugs (NSAIDs) control (Sheng 2010), acupuncture was associated with statistically significant greater short‐term improvements than NSAIDs for pain (Analysis 4.1) and function (Analysis 4.2) in 1 trial with 60 participants. The GRADE analysis indicated that the evidence for both outcomes was of very low quality, and was downgraded three levels: 1) two levels for very serious limitations in the design and implementation suggesting high likelihood of bias, including risk of biased reporting of patient‐assessed outcomes due to lack of blinding and risk of selection bias; and 2) one level for serious imprecision of results due to sparse data (total population size included far fewer than 400) (see Table 5).

Analysis 4.1.

Comparison 4 Acupuncture vs. NSAIDs (primary analysis, post‐treatment scores without imputation at short‐term follow‐up), Outcome 1 Pain.

Analysis 4.2.

Comparison 4 Acupuncture vs. NSAIDs (primary analysis, post‐treatment scores without imputation at short‐term follow‐up), Outcome 2 Function.

Acupuncture versus advice plus exercise

In the head‐to‐head comparison of acupuncture with the 'advice plus exercise' control (Haslam 2001), there was no significant difference between groups in post‐treatment symptom severity scores, which was the only outcome reported, in 1 trial with 28 participants (Analysis 3.1). . The GRADE analysis indicated that the evidence for this outcome was of very low quality, and was downgraded three levels: 1) two levels for very serious limitations in the design and implementation suggesting high likelihood of bias, including risk of biased reporting of patient‐assessed outcomes due to lack of blinding, and risks of attrition, reporting and other biases; and 2) one level for serious imprecision of results due to sparse data (total population size included far fewer than 400) (see Table 3).

Analysis 3.1.

Comparison 3 Acupuncture vs. advice plus exercise (primary analysis, post‐treatment scores without imputation at short‐term follow‐up), Outcome 1 WOMAC total.

Acupuncture as an addition to another treatment versus the treatment alone

Acupuncture as an addition to the routine primary care that trial participants were receiving from their physicians versus routine primary physician care alone

One RCT (Witt 2006) reported low‐quality evidence that acupuncture plus routine primary physician care was associated with statistically significant and clinically relevant benefits compared to routine primary physician care alone, for the outcomes of pain (Analysis 2.1) and function (Analysis 2.2) (see Table 2). There was no statistically significant difference for mental quality of life (Analysis 2.3), and acupuncture showed a small benefit for physical quality of life (Analysis 2.4).The GRADE analysis indicated that the evidence for these four outcomes was low quality, and each outcome was downgraded two levels 1) one level for sparse data (total population size was less than 400 for each outcome) and 2) one level for risk of biased reporting of patient‐assessed outcomes, due to lack of blinding (see Table 2).

Analysis 2.1.

Comparison 2 Acupuncture as addition to routine primary physician care vs. routine primary physician care alone (primary analysis, post‐treatment scores without imputation at short‐term follow‐up), Outcome 1 Pain.

Analysis 2.2.

Comparison 2 Acupuncture as addition to routine primary physician care vs. routine primary physician care alone (primary analysis, post‐treatment scores without imputation at short‐term follow‐up), Outcome 2 Function.

Analysis 2.3.

Comparison 2 Acupuncture as addition to routine primary physician care vs. routine primary physician care alone (primary analysis, post‐treatment scores without imputation at short‐term follow‐up), Outcome 3 Quality of life (physical component).

Analysis 2.4.

Comparison 2 Acupuncture as addition to routine primary physician care vs. routine primary physician care alone (primary analysis, post‐treatment scores without imputation at short‐term follow‐up), Outcome 4 Quality of life (mental component).

Acupuncture as an addition to patient education versus patient education alone

Because the Stener‐Victorin 2004 publication reported only pre‐post changes for each intervention group based on median scores and interquartile ranges (rather than means and standard deviations), there were no extractable data from this RCT to allow for between‐group comparisons, and therefore we could not include this RCT in any meta‐analysis. In the Stener‐Victorin 2004 publication, the authors analyzed the data by comparing the baseline scores for each group with the post‐treatment scores (i.e. within‐group, rather than between‐group, analyses). In the analyses presented in the publication, the electro‐acupuncture (EA) plus patient education group showed large pre‐post improvements in the pain during day and pain during night outcomes, some improvements in the quality of life outcome, and no improvement in the function outcome, whereas the patient education alone group showed no or minimal improvements on any outcome.

Specifically, for the pain during day outcome, in the acupuncture plus patient education group, the pretest median score was 21/100 and the post‐test score was 4/100, which was a statistically significant pre‐post improvement in pain during the day; in the patient education alone group, the pretest median score was 28/100 and the post‐test score was 41.5/100, which was a non‐statistically significant pre‐post difference of pain during the day. For the pain during night outcome, in the acupuncture plus patient education group, the pretest median score was 27/100 and the post‐test score was 12/100, which was a non‐statistically significant pre‐post difference in pain during the night; in the patient education alone group, the pretest median score was 29/100 and the post‐test score was 41.5/100, which was a non‐statistically significant pre‐post difference of pain during the night. For the function outcome, in the acupuncture plus patient education group, the pretest median score was 36/100 and the post‐test score was 35/100, which indicated no improvement in function; in the patient education alone group, the pretest median score was 43/100 and the post‐test score was 45/100, which also indicated no improvement in function. For the quality of life outcome, in the acupuncture plus patient education group, the pretest median score was 2.5/10 and the post‐test score was 0.75/10, which was a statistically significant pre‐post improvement in quality of life; in the patient education alone group, the pretest median score for function was 3.75/10 and the post‐test score was 3/10, which was a non‐statistically significant difference in quality of life. Because no outcome data could be extracted for between‐group comparisons, no estimates of effect were available and no grade of evidence was assigned (see Table 4).

Other data not included in meta‐analyses

Three RCTs (Fink 2001; Haslam 2001; Stener‐Victorin 2004) each had outcome data collected during the follow‐up time relevant for our predefined long‐term time point analysis. However, because for each of these RCTs, the attrition rate was so high (almost 50% for at least one of the comparison groups), a post hoc decision was made to exclude these long‐term follow‐up data from our meta‐analyses.

Safety of acupuncture

Information on safety was reported in four RCTs (Fink 2001; Haslam 2001; White 2012; Witt 2006), but there was limited reporting and heterogeneous reporting methods. None reported any serious adverse events attributed to acupuncture. Two RCTs reported minor side effects of acupuncture, which were primarily minor bruising, bleeding, or pain at needle insertion sites (White 2012; Witt 2006). No RCTs reported on the outcome withdrawals due to adverse events (see Table 15).

Table 3.

Adverse events in the acupuncture and control groups^a

Study	Assessment Methods for Adverse Events/Side Effects	Minor Adverse Events per Group, n/n		Assessment Methods for Side Effects of Acupuncture	Adverse events/Side Effects of Acupuncture reportedb
		Acupuncture	Control
Fink 2001	Not reported	0	0	Not reported	Only mention of side effects or adverse events was in following sentence in Results section: "During the study course, no side effects occurred."
Haslam 2001	Not reported	0	0	Not reported	Only mention of side effects or adverse events was in following sentence in Discussion section: "Participants were compliant with treatment and there were no reported side effects."
Sheng 2010	NR	NR	NR	NR	NR
Stener‐Victorin 2004	NR	NR	NR	NR	NR
White 2012	Not reported	"Three adverse events were recorded, none of which were related to treatment." (Assume this is for all trial participants, but not explicitly stated.)		NR	"There were 28 cases of minor side effects (Table 7)" in all the three groups. 22 in the acupuncture group, 4 for the Streitberger needle group, 2 in the sham TENS group. The minor side effects that happened in the acupuncture group included bleeding or bruising at needle site (15), temporary increase in pain (5), tired post‐treatment (1), and became tearful post‐treatment (1).c
Witt 2006	"Side effects were recorded on participant and physician questionnaires after 3 months."	NR	NR		"Side effects. In 5.2% of the patients (n = 184), a total of 219 side effects were reported after the patients had acupuncture (66% minor local bleeding or hematoma, 5% pain at the site of needle insertion, 4% vegetative symptoms, and 25% other). No life‐threatening side effects were reported."

NR = not reported; RCT = randomized controlled trial.

^a Definitions of adverse events and side effects of acupuncture and methods of assessments varied among trials. Fink 2001 and Haslam 2001 both reported that no side effects occurred, so it was assumed that no adverse events (serious or otherwise) occurred in these two trials.

^b The frequency, severity, or duration of the minor side effects associated with the needling was not systematically reported in any RCT.

^c The numbers of side effects reported in White 2012 trial were for all participants with OA of hip and/or knee. The publication did not report the number of side effects for participants specifically with hip OA. It was also not clear whether the numbers reported in the publications (as included in the table above) were the numbers of side effects in each group or the numbers of participants in each group who had side effect(s).

Sensitivity analyses

For the acupuncture vs. sham acupuncture pooled analysis on the primary outcomes of pain and function, the SMDs comparing post‐treatment scores (Analysis 5.1) were consistent with the SMDs comparing changes from baseline scores (Analysis 1.1). For two single trial comparisons (Witt 2006; Haslam 2001), mean differences in changes from baseline scores using imputed SDs of change (Analyses 5 and 6 [data not shown, for review only]) were consistent with the mean differences in post‐treatment scores which did not require imputations (Analyses 2 and 3 [data not shown, for review only]).

Analysis 5.1.

Comparison 5 Acupuncture vs. sham acupuncture (sensitivity analysis, post‐treatment scores at short‐term follow‐up), Outcome 1 Pain & function.

Discussion

Summary of main results

We found moderate quality evidence of little or no effect in reduction in pain or improvement in function for acupuncture relative to sham acupuncture. Due to the small sample size in the studies, the confidence intervals include both the possibility of moderate benefits and the possibility of no effect of acupuncture. The sham acupuncture control interventions were judged believable, but each sham acupuncture intervention was also judged to have a risk of weak acupuncture‐specific effects. We found low‐quality evidence that the addition of acupuncture to routine primary physician care was associated with larger effects in the patient‐reported pain and/or function outcomes, compared to the routine primary physician care alone (Witt 2006). The effects of acupuncture compared with either advice plus exercise or NSAIDs are uncertain. We are also uncertain whether acupuncture plus patient education improves pain, function, and quality of life, when compared to patient education alone.

Overall completeness and applicability of evidence

Overall the evidence was limited, with only six RCTs of five different comparisons, with small sample sizes, and at high risk of bias, especially for the criteria of blinding of participants in four comparative effectiveness RCTs.

The participants included in the six included RCTs (from four different countries) were reasonably representative of hip OA patients, in respect of age and sex. These RCTs were mostly judged to have used a generally adequate acupuncture treatment protocol, which were similar to those used in clinical practice of TCM acupuncture. Most of the included RCTs reported the major outcomes of pain and function, but there was limited information on quality of life. Four of the included RCTs reported information related to adverse events. Only three RCTs reported outcomes at long‐term follow‐up, but the attrition rates were very high and evidence on the long‐term effects of treatment was therefore incomplete.

Quality of the evidence

The type of control used and whether or not it blinded patients to treatment assignment is the most likely explanation for the reported benefit of acupuncture as an addition to routine primary physician care (Witt 2006), but no significant differences in the comparison of acupuncture to sham acupuncture (Fink 2001; White 2012). In Witt 2006, RCT participants knew whether or not they were getting assigned to acupuncture as an addition to their routine care. If participants had pretreatment preferences for acupuncture, or expectations of improvements with acupuncture, this may have biased their responses to pain and function outcome questionnaires. Indeed, in Witt 2006, there was a pretreatment preference for acupuncture in a large proportion of participants, with about 31% of randomized participants reporting "previous successful acupuncture" as their "reason for participating in this study".

There are likely potent 'expectation effects' associated with acupuncture (Hrobjartsson 2001; Kaptchuk 2006; Kaptchuk 2008; Manheimer 2007; O'Connell 2009; Wechsler 2011), which might be explained by the novelty of acupuncture, its ritualistic associations, or its ancient history of use (Kaptchuk 2006; Kaptchuk 2008). In a recent meta‐analysis of the placebo effect in OA RCTs, the magnitude of the placebo effect was categorised according to 20 different interventions, and sham acupuncture showed the second largest placebo effect, only after sham intra‐articular hyaluronan (Zhang 2008). While RCT participants might have a priori preferences or expectations of benefit from acupuncture, participants would be unlikely to have strong a priori preferences or expectations of benefit from NSAIDs, for example, because NSAIDs are a standard treatment for OA, which most hip OA patients would have likely already tried, and would also likely have easy access to, even without participating in a trial.

One limitation of the sham‐controlled design is that the two sham acupuncture interventions used were each judged to have a risk of weak acupuncture‐specific effects, thereby potentially biasing the results of these two sham‐controlled RCTs to the null (Appleyard 2014). An additional limitation of the sham‐controlled RCT design, that has emerged through methodological research (Kaptchuk 2006; Wechsler 2011), is that the high placebo effects of sham acupuncture may preclude the detection of any small, true biological benefits of true acupuncture relative to sham acupuncture, when patient‐reported subjective outcome measures are used (e.g. pain, function) (Manheimer 2012).

Potential biases in the review process

It is unlikely that an important bias was introduced from the review methods used, which were state of the art, and which included comprehensive searching, dual and independent data extraction, and blinding of the acupuncture treatment adequacy assessors to the identities of the trials. However, some assumptions were made in calculating some effect estimates, and in determining if they were clinically important.

For Fink 2001, the SDs of change scores needed to be imputed for the changes from baseline analysis for the acupuncture vs. sham acupuncture comparison, and our pooled SMDs may be sensitive to the imputation method used. However, an analysis using post‐treatment scores which did not require imputing SDs gave similar pooled SMDs. In addition, the conversion of our pooled SMDs to absolute percent changes may also be sensitive to methods and assumptions, including our selection of White 2012 (instead of Fink 2001) as the more representative trial for which we used the control group SD to convert SMDs to absolute percent changes.

There were also assumptions made in determining whether the 95% CIs for the acupuncture vs. sham comparison included differences of any clinical importance. The lower 95% confidence limit of the SMDs exceeded our pre‐specified SMD thresholds for MCIDs, for pain and function. However, there are pitfalls in using MCID thresholds, including that Fink 2001 and White 2012 used different pain and function measures, which may yield different MCIDs, and that trial efficacy is impacted by various trial‐specific factors which can impact MCIDs, including population characteristics (e.g., baseline pain and function) (Katz 2015). In addition, the MCID value is impacted by the method used to determine it, and different research groups have estimated different MCIDs for hip OA. For example, Tubach 2005 estimated MCIDs for hip OA pain and function as absolute changes of 15.3 points and 7.9 points (on 100 point scale), respectively. These estimated MCIDs exceed the lower confidence limits for our absolute percent differences comparing acupuncture vs. sham acupuncture.

Agreements and disagreements with other studies or reviews

This is the first systematic review that has evaluated the effects of acupuncture specifically for hip OA. This review resulted from splitting our 2010 Cochrane review of acupuncture for peripheral joint OA into this current hip OA‐specific review and a knee OA‐specific review (ongoing). Our 2010 Cochrane review of acupuncture for peripheral joint OA did include four RCTs with hip OA participants (Fink 2001; Haslam 2001; Stener‐Victorin 2004; Witt 2006). However, we did not meta‐analyse these RCTs together in a hip‐specific analysis for that review, because there was heterogeneity of controls and outcome measures, and the outcomes were poorly reported or nonstandard. Since that 2010 review, a second sham‐controlled RCT (White 2012) has been published. The findings of this recent sham‐controlled RCT (White 2012) supported the findings of the earlier sham‐controlled RCT (Fink 2001), and provides additional evidence that acupuncture is not superior to sham acupuncture for hip OA.

Authors' conclusions

Because acupuncture has previously been documented to have a low risk of adverse effects, and because arthritis patients seem to be accepting of acupuncture (Rao 1999), there seem to be few drawbacks to hip OA patients electing to receive acupuncture, other than the additional costs incurred. While some private health insurance plans cover much of the costs of acupuncture, it is not typically covered by governmental health plans, with some exceptions (NICE 2009). Thus, the out‐of‐pocket costs of the acupuncture will vary depending on an individual's health plan. Given the potential disability caused by OA of the hip and the few available treatments, acupuncture may be considered one treatment option, particularly among patients who are not yet ready for a joint replacement or who are unable to tolerate oral NSAIDs. However, patients should be informed that acupuncture probably has little or no effect in reducing pain or improving function relative to sham acupuncture. . Because there are currently no registered ongoing RCTs, this evidence base is unlikely to substantially change in the near future.

While the sham acupuncture interventions used in the two sham‐controlled RCTs (Fink 2001; White 2012) were likely to be as believable to RCT participants as true acupuncture, these two sham interventions were also judged to have a risk of weak acupuncture‐specific effects, which may have resulted in the sham interventions decreasing pain through the same putative mechanism as that of the true acupuncture interventions. Therefore, the research recommendation for future sham‐controlled RCTs is to use a convincing sham acupuncture intervention that is as believable to RCT participants as true acupuncture, but that will not affect the outcome through the same mechanisms as that of the putative pathway of true acupuncture. Perhaps the best way to accomplish this is to use non‐penetrating, but demonstrably believable, sham needles that are placed far away from the true acupuncture points. In addition, such sham‐controlled RCTs should ideally be restricted to acupuncture‐naïve participants because such participants would be less likely to be able to differentiate between the needling from the true acupuncture versus the non‐penetrating sham acupuncture.

Because of the likely potent placebo effects of acupuncture, investigators conducting future RCTs that compare acupuncture with other active treatments might consider asking participants about their preferences and expectations, and studying the potential effects of pretreatment preferences on study outcomes. In addition, to minimize the recruitment of participants with a preference for acupuncture, advertisements to recruit participants should ideally not specify that acupuncture is one of the treatments being investigated.

Appendices

Appendix 1. Search strategies

CENTRAL (2014, Issue 4)	MEDLINE (OVID)	Embase (OVID)
(hip) AND (osteoarthritis OR pain OR arthritis OR arthralgia OR osteoarthrosis OR gonarthrosis) AND (acupunctur* OR electroacupuncture OR electro‐acupuncture OR acupoints OR "percutaneous electrical nerve stimulation" OR auriculoacupuncture) Search date: March 18, 2018 Results: 45	1 Acupuncture/ or acupuncture.mp. 2 acupuncture therapy.mp. or exp Acupuncture Therapy/ 3 auriculotherapy.mp. [mp=title, abstract, original title, name of substance word, subject heading word, protocol supplementary concept, rare disease supplementary concept, unique identifier] 4 electroacupuncture.mp. or Electroacupuncture/ 5 moxibustion.mp. or Moxibustion/ 6 oriental traditional medicine.mp. or Medicine, East Asian Traditional/ 7 chinese traditional medicine.mp. or Medicine, Chinese Traditional/ 8 1 or 2 or 3 or 4 or 5 or 6 or 7 9 arthritis.mp. [mp=title, abstract, original title, name of substance word, subject heading word, protocol supplementary concept, rare disease supplementary concept, unique identifier] 10 exp Osteoarthritis/ 11 Arthritis/ 12 osteoarthritis.mp. [mp=title, abstract, original title, name of substance word, subject heading word, protocol supplementary concept, rare disease supplementary concept, unique identifier] 13 Joint Diseases/ 14 Arthralgia/ 15 (joint pain or chronic joint symptoms or gonarthrosis or osteoarthrosis or astoarthrosis or degeneretive arthritis or joint diseases or arthralgia).mp. [mp=title, abstract, original title, name of substance word, subject heading word, protocol supplementary concept, rare disease supplementary concept, unique identifier] 16 hip osteoarthritis.mp. or Osteoarthritis, Hip/ 17 hip pain.mp. [mp=title, abstract, original title, name of substance word, subject heading word, protocol supplementary concept, rare disease supplementary concept, unique identifier] 18 9 or 10 or 11 or 12 or 13 or 14 or 15 or 16 or 17 19 clinical trial.pt. 20 randomized.ab. or randomized controlled trial.pt. or controlled clinical trial.pt. 21 placebo.ab. 22 exp Clinical Trial/ 23 randomly.ab. 24 trial.ti. 25 19 or 20 or 21 or 22 or 23 or 24 26 Animals/ 27 Humans/ 28 26 not (26 and 27) 29 25 not 28 30 8 and 18 and 29 31 limit 30 to yr="2007 ‐Current" Search date: March 18, 2018 Results: 336	1.'acupuncture'/exp OR acupuncture 2.'auriculotherapy'/exp OR auriculotherapy 3.'electroacupuncture'/exp OR electroacupuncture 4.'moxibustion'/exp OR moxibustion 5.east AND ('asian'/exp OR asian) AND traditional AND ('medicine'/exp OR medicine) 6.'chinese'/exp OR chinese AND traditional AND ('medicine'/exp OR medicine) 7.1 or 2 or 3 or 4 or 5 or 6 8.'arthritis'/exp OR arthritis 9.'osteoarthritis'/exp OR osteoarthritis 10.'joint diseases'/exp OR 'joint diseases' 11.'arthropathy'/exp OR arthropathy 12.'arthralgia'/exp OR arthralgia 13.'joint pain'/exp OR 'joint pain' OR 'chronic joint symptoms' OR 'gonarthrosis'/exp OR 'gonarthrosis' OR 'osteoarthrosis'/exp OR 'osteoarthrosis' OR 'astoarthrosis' OR 'degenerative arthritis'/exp OR 'degenerative arthritis' OR 'joint diseases'/exp OR 'joint diseases' OR 'arthralgia'/exp OR 'arthralgia' 14.'hip osteoarthritis'/exp OR 'hip osteoarthritis' 15.'hip pain'/exp OR 'hip pain' 16.8 or 9 or 10 or 11 or 12 or 13 or 14 or 15 17.'clinical trial'/exp OR 'clinical trial' 18.clinical trial: ti 19.random*:ab 20.'controlled clinical trial'/exp OR 'controlled clinical trial' OR 'controlled clinical trial':ti OR 'controlled clinical trial':ab 21.'randomized controlled trial' OR 'randomized controlled trial':ti OR 'randomized controlled trial':ab 22.placebo:ab 23.trial:ti 24.17 or 18 or 19 or 20 or 21 or 22 or 23 25.'animal'/exp OR animal 26.'human'/exp OR human 27.25 not (25 and 26) 28.24 not 27 29.7 and 16 and 28 30.29 (2007:py or 2008:py or 2009:py or 2010:py or 2011:py or 2012:py or 2013:py or 2014:py or 2015:py) Search date: March 18, 2018 Results: 1077

Data and analyses

Comparison 1.

Acupuncture vs. sham acupuncture (primary analysis, change from baseline at short‐term follow‐up)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain & function	2		Std. Mean Difference (IV, Random, 95% CI)	Subtotals only
1.1 Pain outcome	2	120	Std. Mean Difference (IV, Random, 95% CI)	‐0.13 [‐0.49, 0.22]
1.2 Function outcome	2	120	Std. Mean Difference (IV, Random, 95% CI)	‐0.15 [‐0.51, 0.21]
2 Quality of life	1	62	Mean Difference (IV, Random, 95% CI)	‐8.0 [‐14.97, ‐1.03]

Comparison 2.

Acupuncture as addition to routine primary physician care vs. routine primary physician care alone (primary analysis, post‐treatment scores without imputation at short‐term follow‐up)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain	1	137	Mean Difference (IV, Random, 95% CI)	‐22.9 [‐29.22, ‐16.58]
2 Function	1	137	Mean Difference (IV, Random, 95% CI)	‐19.00 [‐24.41, ‐13.59]
3 Quality of life (physical component)	1	137	Mean Difference (IV, Random, 95% CI)	‐4.00 [‐8.64, ‐3.36]
4 Quality of life (mental component)	1	137	Mean Difference (IV, Random, 95% CI)	‐1.5 [‐4.27, 1.27]

Comparison 3.

Acupuncture vs. advice plus exercise (primary analysis, post‐treatment scores without imputation at short‐term follow‐up)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 WOMAC total	1	28	Mean Difference (IV, Random, 95% CI)	‐135.0 [‐315.13, 45.13]

Comparison 4.

Acupuncture vs. NSAIDs (primary analysis, post‐treatment scores without imputation at short‐term follow‐up)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain	1	60	Mean Difference (IV, Random, 95% CI)	‐5.67 [‐10.11, ‐1.23]
2 Function	1	60	Mean Difference (IV, Random, 95% CI)	5.80 [2.76, 8.84]

Comparison 5.

Acupuncture vs. sham acupuncture (sensitivity analysis, post‐treatment scores at short‐term follow‐up)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain & function	2		Std. Mean Difference (IV, Random, 95% CI)	Subtotals only
1.1 Pain outcome	2	120	Std. Mean Difference (IV, Random, 95% CI)	0.02 [‐0.42, 0.45]
1.2 Function outcome	2	120	Std. Mean Difference (IV, Random, 95% CI)	‐0.07 [‐0.43, 0.28]
2 Quality of life	1	62	Mean Difference (IV, Random, 95% CI)	12.0 [5.52, 18.48]

Analysis 5.2.

Comparison 5 Acupuncture vs. sham acupuncture (sensitivity analysis, post‐treatment scores at short‐term follow‐up), Outcome 2 Quality of life.

Comparison 6.

Acupuncture as addition to routine primary physician care vs. routine primary physician care alone (sensitivity analysis, changes from baseline with imputed SDs of change at short‐term follow‐up)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain	1	137	Mean Difference (IV, Random, 95% CI)	‐23.4 [‐30.45, ‐16.35]
2 Function	1	137	Mean Difference (IV, Random, 95% CI)	‐18.6 [‐25.85, ‐11.35]
3 Quality of life (physical component)	1	137	Mean Difference (IV, Random, 95% CI)	‐4.00 [‐8.81, ‐3.19]
4 Quality of life (mental component)	1	137	Mean Difference (IV, Random, 95% CI)	‐0.60 [‐4.19, 2.99]

Analysis 6.1.

Comparison 6 Acupuncture as addition to routine primary physician care vs. routine primary physician care alone (sensitivity analysis, changes from baseline with imputed SDs of change at short‐term follow‐up), Outcome 1 Pain.

Analysis 6.2.

Comparison 6 Acupuncture as addition to routine primary physician care vs. routine primary physician care alone (sensitivity analysis, changes from baseline with imputed SDs of change at short‐term follow‐up), Outcome 2 Function.

Analysis 6.3.

Comparison 6 Acupuncture as addition to routine primary physician care vs. routine primary physician care alone (sensitivity analysis, changes from baseline with imputed SDs of change at short‐term follow‐up), Outcome 3 Quality of life (physical component).

Analysis 6.4.

Comparison 6 Acupuncture as addition to routine primary physician care vs. routine primary physician care alone (sensitivity analysis, changes from baseline with imputed SDs of change at short‐term follow‐up), Outcome 4 Quality of life (mental component).

Comparison 7.

Acupuncture vs. advice plus exercise (sensitivity analysis, change from baseline with imputed SDs of change at short‐term follow‐up)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 WOMAC total	1	28	Mean Difference (IV, Random, 95% CI)	‐151.0 [‐320.64, 18.64]

Analysis 7.1.

Comparison 7 Acupuncture vs. advice plus exercise (sensitivity analysis, change from baseline with imputed SDs of change at short‐term follow‐up), Outcome 1 WOMAC total.

What's new

Last assessed as up‐to‐date: 18 March 2018.

Date	Event	Description
8 May 2018	Amended	Reference corrected.

History

Review first published: Issue 5, 2018

Date	Event	Description
16 April 2018	New citation required and conclusions have changed	For this current hip osteoarthritis review, we included the 4 RCTs included in our 2010 peripheral joint osteoarthritis review (Fink 2001; Haslam 2001; Stener‐Victorin 2004; Witt 2006), and added 2 new trials published since then: 1) Sheng 2010, an unblinded Chinese trial that compared acupuncture to NSAIDs; and 2) White 2012, a methodologically sound sham‐controlled RCT. Also, in the 2010 review, we did not extract or report quality of life outcome data for hip OA patients, for the Witt 2006 trial. For both this current review and the 2010 review, we did not include in the meta‐analysis the Stener‐Victorin 2004 trial because this trial did not report any extractable outcome data. There were two other minor changes from the Methods used in the 2010 acupuncture for peripheral joint OA review. These changes are described in the section 'Differences between protocol and review'.
24 August 2016	New search has been performed	This review has resulted from the 'splitting' of our 2010 Cochrane review of 'Acupuncture for peripheral joint osteoarthritis' into 2 new reviews: 1) 'Acupuncture for hip osteoarthritis' (i.e., this current review); and 2) 'Acupuncture for chronic knee pain' .
11 November 2009	Amended	CMSG ID C104‐R

Differences between protocol and review

There were two minor changes from the Methods used in the 2010 acupuncture for peripheral joint OA review. These two changes, described below, were previously approved by the CMSG (in emails dated Nov 8 2010 and July 18 2012).

•  As part of our 'risk of bias' assessment in the 2010 review, we evaluated the credibility of the sham in the sham‐controlled trials. In the 2010 version of the review, we used the following criteria to evaluate credibility of the sham: "we assigned the 'Yes' score to sham‐controlled trials that either 1) evaluated the credibility of the sham and found the sham to be indistinguishable from true acupuncture, or 2) used needle acupuncture as the sham and also informed participants that two different types of acupuncture were being compared (i.e. did not inform participants that a sham treatment was involved)". Since completing the 2010 review, we further reviewed the Cochrane Reviewer's Handbook section 8.11.1 as well as the 2010 CONSORT statement and its corollary publication (i.e. Schulz 2010), both of which urge caution in taking notice of findings from participants' guesses as to which treatment they had been receiving, on the grounds that "Evidence of correct guesses exceeding 50% would seem to suggest that blinding may have been broken, but in fact can simply reflect the participants' experiences in the trial: a good outcome, or a marked side effect, will tend [to be] more often attributed to an active treatment, and a poor outcome to a placebo (Sackett 2007). It follows that we would expect to see some successful 'guessing' when there is a difference in efficacy or adverse effects, but none when the interventions have very similar effects, even when the blinding has been preserved" (Higgins 2011 (Chapter 8), section 8.11.1). Or, as Altman and colleagues described it in an earlier publication, "end of trial tests of blindness might be tests of hunches for adverse effects or efficacy" (Altman 2004). Because one might expect to see a difference in efficacy between acupuncture and sham, if such a difference exists, by 4 weeks after treatment has begun, any tests of participants' guesses of treatment received after that time point may not be interpretable. Therefore, for the update, we changed the criteria 1) above from "1) evaluated the credibility of the sham and found the sham to be indistinguishable from true acupuncture" to "1) evaluated the credibility of the sham at the testing time point closest to 4 weeks and found the sham to be indistinguishable from true acupuncture". That is, for the update, we specified a preferred time point for the test for participants' guesses as to treatment assignment, whereas we did not specify such a time point in the 2010 review.

• In the 2010 review, we included "only RCTs with at least six weeks of observation". In this hip OA review, we revised the criteria to specify inclusion of "only RCTs with at least four weeks of observation". The reason for this change from six to four weeks is that there are very few trials that have been conducted for hip osteoarthritis, and therefore we used somewhat less restrictive eligibility criteria in order to avoid excluding most trials.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Fink 2001

Methods	Design: parallel Blinding: successful blinding of participants. Physicians carrying out the clinical evaluations were also blinded. Attempt to confirm participant blinding for sham control?: Yes, credibility and expectation assessed using a 'modified Borkovec Expectancy Scale'. Participants rated credibility of acupuncture and sham as much the same. The authors noted that "[a]fter the first treatment session, a modified Credibility Scale showed no difference between the groups concerning the expectation, acceptance and credibility for the ongoing treatment. Therefore, coping and expectation should not influence treatment results". Dropouts/withdrawals: Out of 67 participants randomized (33 to acupuncture and 34 to sham), 65 were available at first follow‐up (33 in acupuncture group; 32 in sham group) and 62 were available at second follow‐up (32 in acupuncture group; 30 in sham group). Only 41/67 were available at the 6 months follow‐up (i.e. third follow‐up), of which only 17/34 were available at the third follow‐up for the acupuncture group. Because of the high dropouts at the third follow‐up time point, the RCT authors did not analyze the data from this time point in their statistical analysis. Similarly, because at the third follow‐up time point, 48% of the acupuncture group was unavailable for analysis, an ad hoc decision was made to exclude this third follow‐up time point data from this meta‐analysis. This trial did not earn the point for acceptability of dropout rate on the CBRG scale because of the high numbers of dropouts at the long‐term time point. However, our subgroup analyses used the short‐term time point, at which time this trial had low dropouts, and therefore this trial was classified as having met the 'acceptability of dropouts' criteria for our subgroup analyses. Duration: 3 weeks of acupuncture, participants followed up for 6 months Type of analysis reported: not explicitly stated but appears to be a per protocol analysis, since, for example, Table 5 indicated that participants who had a total hip replacement between follow‐up 2 and follow‐up 3 did not appear to be included in the follow‐up 3 analysis. Thus, it appears that only those participants who completed the trial and complied with their allocated treatments were included in the analysis.
Participants	Setting: a university department for physical medicine and rehabilitation, Hannover, Germany Mean age (±SD or range): ˜62 (9) years Men/women (n/n): 22/43 Recruitment method: through advertisements in a local newspaper Mean pain duration (SD) years: ˜5.2 (3.8) was mean 'duration of complaints' For bilateral OA diagnosis, which hip treated/evaluated?: not reported Diagnosis of hip OA required to be eligible? (if yes, describe how participants were verified to have OA): yes, hip arthritis with reduced range of motion and significant radiographic changes, 2° minimum as per Kellgren‐score on x‐ray of pelvis from the last year Radiologic evidence of knee OA required to be eligible? (if yes, describe requirement): yes (Kellgren 2° minimum) Minimum duration (and extent) of hip pain required to be eligible: complaints for at least 6 months and pain on most days of previous month Hospital inpatients? (Y/N; if Y list number inpatients): not reported (assumed none) Previous hip surgery? (Y/N; if Y list number with previous knee surgery): not reported Were people with a history of acupuncture treatment excluded?: not reported Other important inclusion criteria: none other than those described above Important exclusion criteria: "Exclusion criteria were mainly supposed to eliminate all factors influencing the symptoms of hip arthritis during the intervention, i.e. physical therapy or medical treatment".
Interventions	TEST GROUP INTERVENTION: acupuncture N allocated to acupuncture: 33 (32 analyzed) Style of acupuncture: Chinese Point selection: fixed formula Points stimulated: "Within the hip area, six pressure sensitive locations (‘Ah‐Shi’‐points) were used. In addition, the regional meridian points ‘GB‐30’, ‘GB‐31’, ‘BL‐37’ and the distal meridian points ‘ST‐40’ and ‘BL‐54’ were chosen, as well as the master point for tendons and muscles ‘GB‐34’." Total length of treatment period (weeks): 3 Number of sessions target (mean): 10 Times per week: assumed about 3 because 10 sessions total and duration was 3 weeks Number of points used: 12 Insertion depth: not reported (but needles were inserted deeper until subjects experienced Te chi) Was De qi reportedly sought?: yes Duration (mins): 20 Method of stimulation: manual manipulation (not reported when during the treatment session or how many times during the treatment session) CONTROL GROUP A (sham, if used): needle acupuncture "but the selected puncture sites were at least 5 cm away from the classical acupuncture points and their interconnecting lines (meridians) and also clear of painful pressure points (Ah‐Shi or trigger points)." N allocated to control group A: 34 (30 analyzed) Total length of treatment period: 3 weeks Number of sessions target (mean): 10 Times per week: about 3 (If relevant) Number of points used: same number as true acupuncture groups (If relevant) Insertion depth: same depth as true acupuncture group Was De qi sought?: no Duration (mins): same as true acupuncture group (If relevant) Method of stimulation: none
Outcomes	PAIN, FUNCTION, QUALITY OF LIFE, AND OVERALL INDEX OF SYMPTOM SEVERITY OUTCOMES EXTRACTED FROM PUBLICATIONS: MEASUREMENT TIME POINTS Pain: VAS scale: baseline (1 week before the beginning of treatment but assumedly after randomizations), 2 weeks after the end of treatment (i.e. ˜6 weeks after randomizations), 2 months after end of treatment (i.e. ˜3 months (or slightly less) after randomizations), and 6 months after end of treatment (i.e. ˜7 months after randomizations) Function: Lequesne: same time points as for pain measurement Quality of life: 'Everyday Life' questionnaire (Bullinger): same time points as for pain measurement (note: the QoL score at baseline reported in Table 3 were different with those reported in Fig 2, since we extracted post‐treatment QoL score in Fig 2, we also used the baseline QoL score in Fig 2) Radiographic joint changes: not reported Type of outcome data reported (i.e. post‐treatment/change from baseline/both): post‐treatment means and standard deviations only (data extracted from charts) Additional outcomes reported in the trial but not abstracted: 'overall assessment of participant satisfaction' measure Adverse effects: "During the study course, no side effects occurred."
Notes	Because the changes from baseline values were not reported, they were imputed for the changes from baseline analysis. The follow‐up times in the figures and the text were different in the publication. More specifically, the article stated “Clinical evaluation was performed by an independent observer not involved in the acupuncture, 1 week before the beginning of treatment (baseline) and 2 weeks (F1), 2 months (F2) and 6 months (F3) after the end of treatment.” While in Fig 1, 2, 3 & 4, the follow‐up times were 1 week (F1), 6 weeks (F2) and 6 months (F3) after the end of treatment. So specifically, the F1 and F2 follow‐up times were described to be at different time points in the text versus the figures. The choice of either F1 or F2 for the closest to 8 weeks short‐term analysis would depend on whether the description in the figure or the manuscript was correct. We assumed that the time point listed in the figure was correct, and therefore used the F2 time point for the primary short‐term meta‐analysis time point closest to 8 weeks and less than 3 months after randomizations (the F2 time point was chosen to be more conservative, as the effects were smaller at this time point and also because it was a longer follow‐up time than the F1 time point). A questionnaire was used to assess the expectation and credibility. However, the results data from this questionnaire were not reported in the Results section. Only in the Discussion section was the following reported: "After the first treatment session, a modified Credibility Scale19 showed no difference between the groups concerning the expectation, acceptance and credibility for the ongoing treatment. Therefore, coping and expectation should not influence treatment results." Based on this text in the Discussions section, for our risk of bias scoring, we assigned 1 point to this trial to indicate that this trial evaluated the credibility of the sham and found it to be indistinguishable from true acupuncture. However, there was some uncertainty because the credibility was only assessed after the first treatment, and the numerical results of this assessment were not reported. Source of support : "This study was supported in part by a grant from the PharmaMED Foundation Germany." PharmaMEd is the IDA subsidiary in Malta, and is a pharmaceuticals company.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“Written informed consent was obtained and patients were then randomly assigned to the treatment groups using computer generated random codes.”
Allocation concealment (selection bias)	Unclear risk	The method of concealment was not described. Although the Fink 2001 trial did not report information on allocation concealment, there were no significant differences between groups on primary outcomes and other parameters that may influence treatment results, suggesting that the RCT was free of selection bias.
Blinding of participants and personnel (performance bias) All outcomes ‐ participants	Low risk	“Needle acupuncture was also performed for the control group, but the selected puncture sites were at least 5 cm away from the classical acupuncture points and their interconnecting lines (meridians) and also clear of painful pressure points (Ah‐Shi or trigger points). ” “A modified Borkovec Expectancy Scale19 was used to assess credibility and expectation. The items in this questionnaire are listed in Table 4.” “After the first treatment session, a modified Credibility Scale showed no difference between the groups concerning the expectation, acceptance and credibility for the ongoing treatment. Therefore, coping and expectation should not influence treatment results.”
Blinding of participants and personnel (performance bias) All outcomes ‐ personnel	High risk	Acupuncturists could not be blinded. Other personnel were blinded. “The physician carrying out clinical evaluation of the study parameters was not informed about the acupuncture treatment, so he could not decide to which treatment group each patient belonged. ”
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Since the outcome assessments (VAS pain and Lequesne function) were made by the participants themselves using questionnaires, we considered the sham arm of this trial to have been both participant and outcomes assessor blinded.
Incomplete outcome data (attrition bias) Short term	Low risk	According to Table 5, out of 67 participants randomized (33 to acupuncture and 34 to sham), 32(33) in acupuncture group and 30(34) in sham group were available at second follow‐up (6 weeks after end of treatment). According to Table 5, only 41(67) were available at the 6 months follow‐up (i.e. third follow‐up) of which only 17(34) in acupuncture group and 24(33) in sham group were available at the third follow‐up. No ITT analysis was applied. However, there were a relatively small number of dropouts in both groups (i.e. 5/67), and the withdrawals were unlikely to be related to knowledge of treatment assignment or effects of the treatment, because the participants could not tell the difference between acupuncture and sham acupuncture. The degree of missing data would be unlikely to affect the estimate of the treatment effect.
Selective reporting (reporting bias)	Low risk	This trial reported outcomes for VAS pain score, Lequesne function score and 'Everyday' quality of life score at baseline, 1 and 6 weeks (short‐term time point for our review), and 6 months after end of treatment, as well as results for the other outcomes measured, as described in the Methods section. Adverse events during the trial were reported. “During the study course, no side effects occurred.”
Other bias	Unclear risk	1. The two treatment groups were comparable at baseline in terms of age, height, weight, BMI and baseline pain, hip function handicap, life quality and overall assessment. (low risk) 2. Cointerventions: not reported (unclear risk) 3. Compliance acceptable: Only the target number of treatment sessions, not the mean number of treatment sessions received by participants was reported. (unclear risk) 4. Timing of the outcome assessment similar?: Both groups were assessed for VAS pain and hip function handicap at baseline, 9 weeks, and 29 weeks. (low risk)

Haslam 2001

Methods	Design: parallel Blinding: none Attempt to confirm participant blinding for sham control?: NA Dropouts/withdrawals: All acupuncture participants available for post‐treatment assessment and 1 acupuncture participant dropped out later and was unavailable for the 8 week follow‐up assessment. In the advice plus exercise group, 4 participants were unavailable at the post‐treatment assessment, and an additional 3 participants dropped out between the post‐treatment assessment and the eight‐week follow‐up. Duration: 6 weeks of acupuncture, participants followed up for 8 additional weeks, for a total duration of 14 weeks Type of analysis reported: unclear ‐‐ assume available case. The 4 dropouts in the control group during the intervention period appear to have been excluded from the analysis, as suggested in Table 1.
Participants	Setting: physiotherapy department in a district general hospital, Princess Margaret hospital, Swindon, UK Mean age (±SD or Range): ˜67 years Men/women (n/n): 7/21 Recruitment method: participants were recruited from those on a waiting list for a total hip arthroplasty Mean pain duration (SD) years: ˜8 years For bilateral OA diagnosis, which hip treated/evaluated?: not reported Diagnosis of hip OA required to be eligible? (if yes, describe how participants were verified to have OA): yes, radiographic changes consistent with OA Radiologic evidence of hip OA required to be eligible? (if yes, describe requirement): yes Minimum duration (and extent) of hip pain required to be eligible: not reported Hospital inpatients? (Y/N; if Y list number inpatients): no Previous hip surgery? (Y/N; if Y list number with previous knee surgery): no Were people with a history of acupuncture treatment excluded?: not reported Other important inclusion criteria: none reported Important exclusion criteria: participants with rheumatoid arthritis, previous hip injection or surgery, intra‐articular steroid injection in last 3 months
Interventions	TEST GROUP INTERVENTION: acupuncture N allocated to acupuncture: 16 (16 analyzed) Style of acupuncture: Chinese Point selection: fixed formula Points stimulated: "GB29, GB30, GB34, GB43, ST44, LI4 bilaterally, and four 'ah shi' points around the great trochanter, in a north, south, east, west formation." Total length of treatment period (weeks): 6 Number of sessions target (mean): 6 Times per week: 1 Number of points used: 16 Insertion depth: not reported Was De qi reportedly sought?: not reported Duration (mins): 10 minutes for first session, and 25 minutes for subsequent sessions Method of stimulation: for first session, "Each needle was manually stimulated for approximately ten seconds half way through the treatment." For subsequent sessions, there was "manual stimulation of each needle, for approximately ten seconds, every five minutes." CONTROL GROUP A (sham, if used): advice plus exercise: N allocated to control group A: 16 (12 analyzed) Total length of treatment period: 6 weeks Number of sessions target (mean): 3 Times per week: once every 3 weeks (i.e. baseline session; 3 week post‐baseline session; 6 week post‐baseline session) (If relevant) Number of points used: NA (If relevant) Insertion depth: NA Was De qi sought?: NA Duration (mins): NA (If relevant) Method of stimulation: NA Any cointerventions in all groups?: none reported
Outcomes	Authors reported a modified version of the WOMAC questionnaire as the only outcome measure, and only reported WOMAC totals and not the WOMAC pain and function subscores. Their modified WOMAC questionnaire included 16 questions on pain, stiffness, function and quality of life, with each question measured on a 100 mm VAS scale, for a maximum possible score of 1,600 points. A lower modified WOMAC score was associated with better pain and function. hWe extracted the WOMAC total post‐treatment means and SDs from Table 2 and used these values for our primary analysis because no imputations were required, and found no significant differences. For their changes from baseline analysis, the authors reported a significant difference between the two groups (reported as p = 0.02 in Abstract, and p = 0.03 in Results text). Because our analysis on post‐treatment values was not significant, and the authors reported a significant benefit of acupuncture with their changes from baseline analysis, and because we would not expect differences in these two analysis methods given similar pretreatment means (ie, 870 for acupuncture group vs. 854 for advice and exercise group, on 1,600 point scale) we attempted a change from baseline analysis, using a within‐subject pretest‐posttest correlation of 0.5, and the differences were not statistically significant (mean difference ‐151 points [range 0‐1,600 points], 95% CI ‐320.64 to 18.64; p = 0.08]). ..
Notes	participants had severe OA considering they were on a waiting list for a total hip arthroplasty. Source of support: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“The patients were randomly allocated, using a random number table, to group A or B, with 16 in each group.”
Allocation concealment (selection bias)	Unclear risk	The method of concealment was not described.
Blinding of participants and personnel (performance bias) All outcomes ‐ participants	High risk	acupuncture vs. advice plus exercise, no sham control
Blinding of participants and personnel (performance bias) All outcomes ‐ personnel	High risk	acupuncture vs. advice plus exercise, no sham control
Blinding of outcome assessment (detection bias) All outcomes	High risk	acupuncture vs. advice plus exercise, no sham control The outcome assessments (WOMAC total) were made by the participants themselves, by completing questionnaires; because the participants knew which group they were in, they could not be blind for outcome assessment.
Incomplete outcome data (attrition bias) Short term	High risk	“Group A remained intact but in group B, four participants withdrew from the study during the intervention period. One participant was admitted for arthroplasty, another withdrew after the first session after having a fall at home, another withdrew after the first session due to difficulty in getting to the department because of poor mobility. The fourth participant attended the first session then did not attend the second and could not be re‐contacted. Three further participants dropped out of group B between the post‐treatment assessment and the eight‐week follow‐up. One reported having had an arthroplasty and the other two were not contactable. One participant dropped out of group A during this period to have a total hip replacement.” 1(/16) acupuncture participant was unavailable for the eight week follow‐up assessment. In the advice plus exercise group, 7(/16) participants were unavailable at the eight‐week follow‐up. ITT analysis was not applied. The dropout rate in the advice plus exercise group was 25% (4/16), and there was no dropout in the acupuncture group at 6 weeks (end of treatment). (high risk)
Selective reporting (reporting bias)	High risk	“A slightly modified version of the WOMAC (Western Ontario and McMaster Universities) osteoarthritis index was used as the outcome measure (Appendix 1)” at baseline, post‐treatment and 8 weeks follow‐up. From author: Their modified version had 16 questions rather than the full 24 questions. The major modification was that some of the function questions from the original WOMAC were dropped so that the questionnaire could be made shorter. Authors only reported WOMAC totals and not the WOMAC pain and function subscores. (unpublished information).
Other bias	High risk	1. The two treatment groups were comparable at baseline in terms of sex, age, and baseline modified WOMAC total score. (low risk) 2. Cointervention: not reported (unclear risk) 3. Compliance acceptable: Only the target number of treatment sessions, not the mean number of treatment sessions received by participants was reported. (unclear risk) 4. Timing of the outcome assessment similar?: Both groups were assessed for modified WOMAC total score at baseline, post‐treatment at 6 weeks and follow‐up at 14 weeks. (low risk)

Sheng 2010

Methods	Design: parallel Blinding: no, acupuncture vs. NSAID. Attempt to confirm participant blinding for sham control? no Drop‐outs/withdrawals: not reported in article. No dropout, according to the correspondence with the first author Sheng X on Jun 17, 2012. Duration: 4 weeks treatment and evaluated after treatment Type of analysis reported: not reported
Participants	Setting: Traumatology & Orthopedics out‐patient department in Shanghai Traditional Chinese Medicine Hospital from 2006 Oct to 2008 Dec. Mean age (±SD or range): mean 63.2 years, range 43 to 80 for EA group; mean 61.1 years, range 46 to 82 for NSAID group Men/women (n/n): 12/18 for EA group, 11/19 for NSAID group Recruitment method: Participants were recruit from Traumatology & Orthopedics out‐patient department Mean pain duration (SD) years: 30.9 (5.85) months for EA group, 32.0 (5.80) months for NSAID group For bilateral OA diagnosis, which hip treated/evaluated?: not reported Diagnosis of hip OA required to be eligible? (if yes, describe how participants were verified to have OA): yes, 1995 American College of Rheumatology criteria for diagnosis of hip OA Radiologic evidence of knee OA required to be eligible? (if yes, describe requirement): yes, radiographs were examined for joint space narrowing, and femoral or/and acetabular osteophytes; Kellgren‐Lawrence 0 or more Minimum duration (and extent) of knee pain required to be eligible: not reported Hospital inpatients? (Y/N; if Y list number inpatients): no Previous hip surgery? (Y/N; if Y list number with previous knee surgery): not reported Were people with a history of acupuncture treatment excluded?: not reported Other important inclusion criteria: age > 40 years old; participants who did not receive any treatments in previous month; participants who agreed to participate in this clinical research, signed the consent, and received treatment according to designed treatment procedure  Important exclusion criteria: “patients were excluded if they were complicated with severe primary diseases such as cardiovascular and psychological diseases; if they took medications (e.g. glucocorticoid) which may influence curative effects; if severe joint swelling and effusion were present; if they had complications influence the joints, such as bone tuberculosis, bone tumor, acute trauma of hip joint and infection, etc; if women during pregnancy or lactation; if participants who dropped out or lost to follow‐up during the trial.”
Interventions	TEST GROUP INTERVENTION: electroacupuncture N allocated to acupuncture: 30 (30 analyzed) Style of acupuncture: Chinese Point selection: fixed formula Points stimulated: Biguan (ST 31), Juliao (GB 29), Zuwuli (LR 10), Yinlian (LR 11) Total length of treatment period (weeks): 4 weeks Number of sessions target (mean): 8 Times per week: 2 Number of points used: 4 Insertion depth: 30 to 40 mm Was De qi reportedly sought?: yes Duration (mins): 45 mins Method of stimulation: electroacupucture, frequency: 2Hz/100Hz, current intensity: 8 mA. CONTROL GROUP A (sham, if used): NSAID (Diclofenac Sodium Sustained Release Tablets) N allocated to control group A: 30 (30 analyzed) Total length of treatment period: 4 weeks Number of sessions target (mean): 28 Times per week: 7 Times per day: 1 Dosage: 75 mg/time Any cointerventions in all groups? “Other treatments such as NSAIDs (e.g. acetaminophen, meloxicam, glucosamine Hydrochloride, etc.), glucocorticoid, thyrocalcitonin and physiotherapy were stopped 1 week before observation and during the observation.” Acupuncturists’ experience: The acupuncturist was an associate chief physician in Traumatology & Orthopedics department, and had more than 10 years of experience on acupuncture treatment.
Outcomes	PAIN, FUNCTION, QUALITY OF LIFE, AND OVERALL INDEX OF SYMPTOM SEVERITY OUTCOMES EXTRACTED FROM PUBLICATIONS: MEASUREMENT TIME POINTS Pain: VAS: baseline and post‐treatment (4 weeks) Function: Harris function score baseline and post‐treatment (4 weeks) Radiographic joint changes: not reported Overall symptom severity: Harris total score baseline and post‐treatment (4 weeks) Additional outcomes reported in the trial but not abstracted: Harris pain score, movement score, and total score Adverse effects: not reported
Notes	Comments: Source of support: no funding
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	(Translation of publication text is in quotes below, and information in brackets below was provided by the first author Sheng XP, in emails on Jun 17 & 18, 2012) “By using a random number table, the patients were assigned toelectroacupuncture group and medication group according to the date of admission, and 30 patients were assigned to each group.” Reason for identical numbers assigned to the two groups: [We assigned odd and even numbers to interventions A and B, respectively. After initial assignment of participants, if the number assigned to A was greater than the number assigned to B, we used the following procedure to ensure that an equal number of participants was assigned to each group. We used the subsequent number in the random number table (e.g. 55), divided that number by 30 to obtain a natural number and a remainder (e.g. 55/30 = 1 with a remainder of 25), and used the remainder to reassign a participant from the larger group to the smaller group (e.g. assigned the 25th participant in group A to group B).] The first author described a procedure involving nonrandom manipulation of assignments to balance sample sizes, which may have introduced selection bias.
Allocation concealment (selection bias)	Unclear risk	[Sequentially numbered, opaque, sealed envelopes] Judged at unclear risk because of the method of assignment (see above).
Blinding of participants and personnel (performance bias) All outcomes ‐ participants	High risk	acupuncture vs. NSAIDs
Blinding of participants and personnel (performance bias) All outcomes ‐ personnel	High risk	acupuncture vs. NSAIDs The care providers could not be blinded.
Blinding of outcome assessment (detection bias) All outcomes	High risk	acupuncture vs. NSAIDs [The outcome assessment (VAS pain, Harris pain, and Harris function) were made by the participants themselves using questionnaires with the assistance of a physician who did not know the assignment of the participants.] Because the participants knew which group they were in, they could not be blind for outcome assessment.
Incomplete outcome data (attrition bias) Short term	Low risk	[no dropout during the trial] ITT analysis was not reported, there were no drop‐outs, so it would not affect the estimate of the treatment effect in this trial.
Selective reporting (reporting bias)	Low risk	This trial reported outcomes for VAS pain score, Harris function and total score at baseline and the completion of the 4 week treatment period, as well as results for the other outcomes measured, as described in the Methods section.
Other bias	Unclear risk	1. The two treatment groups were comparable at baseline in terms of sex, age, and baseline VAS pain, Harris pain, function, movement and total scores. (low risk) 2. Cointervention: “Other treatment such as NSAIDs (e.g. Acetaminophen, Meloxicam, Glucosamine Hydrochloride, etc.), glucocorticoid, thyrocalcitonin and physiotherapy were stopped 1 week before observation and during the observation.” (low risk) 3. Compliance acceptable: Only the target number of treatment sessions, not the mean number of treatment sessions received by participants was reported. (unclear risk) 4. Timing of the outcome assessment similar?: Both groups were assessed for VAS pain, Harris pain, function, movement and total score at baseline and post‐treatment at 4 weeks. (low risk)

Stener‐Victorin 2004

Methods	Design: parallel Blinding: no blinding Attempt to confirm participant blinding for sham control?: NA Drop‐outs/withdrawals: At the end of treatment assessment (i.e. at end of 5 weeks of treatment) there were 13/15 available in the EA group; 13/15 in the hydrotherapy group; and 8/15 in the patient education group. For the short‐term follow‐up as defined for this review (i.e. 1 month after the end of treatment or ˜9 weeks after baseline), the numbers available for analysis were not provided in the paper. However, the authors provided these data as follows: EA = 13; Water = 13; Control = 12. At the six months end of treatment assessment (i.e. the long‐term follow‐up as defined for this review), there were 9/15 available in both the EA and hydrotherapy groups, and 7/15 available in the patient education group. Duration: 5 weeks of treatment with EA or hydrotherapy followed by an observation period of an additional 6 months Type of analysis reported: not explicitly stated but assumedly per protocol analysis
Participants	Setting: outpatient physiotherapy clinic, Molndal, Sweden Mean age (±SD or range): ˜67 years Men/women (n/n): 18/27 Recruitment method: recruited from patients on a waiting list for total hip arthroplasty Mean pain duration (SD) years: not reported For bilateral OA diagnosis, which hip treated/evaluated?: not reported Diagnosis of hip OA required to be eligible? (if yes, describe how participants were verified to have OA): yes. Diagnosis was based on radiographic changes consistent with hip OA and pain related to motion and/or pain on load or rest. Radiologic evidence of hip OA required to be eligible? (if yes, describe requirement): yes. It only stated that radiographic changes consistent with hip OA required to be eligible. Minimum duration (and extent) of hip pain required to be eligible: not reported Hospital inpatients? (Y/N; if Y list number inpatients): no Previous hip surgery? (Y/N; if Y list number with previous knee surgery): not reported Were people with a history of acupuncture treatment excluded? not reported (assume no, since no sham group) Other important inclusion criteria: none Important exclusion criteria: participants with other rheumatoid diseases
Interventions	TEST GROUP INTERVENTION: acupuncture plus patient education N allocated to acupuncture: 15 (13 analyzed at 1 month after last treatment) Style of acupuncture: Chinese Point selection: flexible formula Points stimulated: electroacupuncture locally at 4 of following points: BL 54, 36, GB 29, 30, 31, and ST 31. Distal points were always the same: GB34 and BL 60 ipsilateral. Total length of treatment period (weeks): 5 weeks Number of sessions target (mean): 10 Times per week: 2 Number of points used: 6 Insertion depth: 15 to 35 mm Was De qi reportedly sought?: yes Duration (mins): 30 Method of stimulation: Electrical stimulation at all points and needles were also rotated manually 4 times during each treatment to evoke needle sensation. CONTROL GROUP A (sham, if used): hydrotherapy plus patient education (hydrotherapy consisted of warming up, mobility and strengthening, and stretching exercises for area around the hip, in small groups of 1 to 3, in warm water) N allocated to control group A: 15 (13 analyzed at 1 month after last treatment) Total length of treatment period: 5 weeks Number of sessions target (mean): 10 Times per week: 2 (If relevant) Number of points used: NA (If relevant) Insertion depth: NA Was De qi sought?: NA Duration (mins): 30 (If relevant) Method of stimulation: NA CONTROL GROUP B: participant education alone about anatomy and physiology of hip, pain relief, and total hip arthroplasty. They were also given home exercise instructions. They were taught to train once per day with intensity below pain. N allocated to control group B: 15 (12 analyzed at 1 month after last treatment) Total length of treatment period: not reported Number of sessions target (mean): 2 Times per week: not clear Duration (minutes): 120 Any cointerventions in all groups?: all groups received the patient education cointervention
Outcomes	The pain outcome was pain intensity using the VAS scale and the function outcome was the disease‐related handicap as assessed by the DRI (Disability Rating Index). The quality of life outcome was the GSI (Global Self‐rating Index). The outcomes were reported as medians and interquartile ranges, rather than as means and SDs. Radiographic joint changes: not reported pain: VAS; Ache during day (median (interquartile range)); Ache during night (median (interquartile range)); function: DRI (median (interquartile range)) Quality of life: GSI (median (interquartile range))
Notes	This study reported median results rather than means, which is the primary reason that this trial did not contribute to effect size estimates. In addition, because of the high attrition rate at 6 months, a post hoc decision was made to not enter the 6 months follow‐up median data as 'Other data' in RevMan. The short‐term follow‐up median data (i.e. the data at 1 month after last treatment = 9 weeks after baseline) was also not entered as 'Other data' in RevMan because the numbers available for follow‐up were not reported at that time point. However, the authors provided these data as follows: EA = 13 (/15); Water = 13 (/15); Control = 12 (/15). Overall conclusions of RCT author: "The main outcome of the study was that EA and hydrotherapy, both in combination with patient education, offer clear advantages for patients with hip pain caused by osteoarthritis over patient education alone, as shown by reduced pain, increased function, and increased quality of life." Source of support: This study was "supported by Research and Development Unit, Vastra Goteborg, Sweden". Assumed it was supported by government grant.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	In response to an email request for further information about this, the author stated that the generation of the randomizations sequence was computerized, and that the process was administered by an independent person not responsible for determining the eligibility of the participants.
Allocation concealment (selection bias)	Low risk	“Participants were randomly allocated to EA in combination with patient education (n = 15) or hydrotherapy in combination with patient education (n = 15) as a control by using sealed, unlabeled envelopes.” In response to an email request for further information about this, the author stated that the envelopes were opaque and placed in a dark box and then selected by the trial participants, and that the process was administered by an independent person not responsible for determining the eligibility of the participants.
Blinding of participants and personnel (performance bias) All outcomes ‐ participants	High risk	EA plus patient education vs. hydrotherapy plus patient education vs. patient education alone, no sham control
Blinding of participants and personnel (performance bias) All outcomes ‐ personnel	High risk	EA plus patient education vs. hydrotherapy plus patient education vs. patient education alone, no sham control Care providers could not be blinded.
Blinding of outcome assessment (detection bias) All outcomes	High risk	EA plus patient education vs. hydrotherapy vs. patient education alone, no sham control The outcome assessments (VAS pain and DRI function) were made by the participants themselves, by completing questionnaires, because the participants knew which group they were in, they could not be blinded for outcome assessment.
Incomplete outcome data (attrition bias) Short term	Low risk	For the short‐term follow‐up as defined for this review (i.e. 1 month after the end of treatment or ˜9 weeks after baseline), the numbers available for analysis were not provided in the paper. However, the authors provided these data as follows: EA = 13 (/15); Water = 13 (/15); Control = 12 (/15). At the six months end of treatment assessment (i.e. the long‐term follow‐up as defined for this review), there were 9 (/15) available in both the EA and hydrotherapy groups, and 7 (/15) available in the patient education alone group. See Figure 1. No ITT analysis was applied. However, there were a relatively small number of dropouts in the three groups (i.e. 2/15, 2/15, 3/15) at the short‐term follow‐up.The degree of missing data would be unlikely to affect the estimate of the treatment effect.
Selective reporting (reporting bias)	Low risk	This trial reported outcomes for VAS pain, DRI function and GSI quality of life scores at baseline and immediately after the last treatment, as well as 1, 3 and 6 months after the last treatment, as described in the Material and Methods section.
Other bias	High risk	1. Baseline was not similar among groups (high risk). 2. Cointervention: not reported (unclear risk) 3. Compliance acceptable: Only the target number of treatment sessions, not the mean number of treatment sessions received by participants was reported. (unclear risk)  4. “The control group (patient education group) was assessed at the same point of time except from the time immediately after the last treatment.” Timings of assessment were not similar among groups. (high risk)

White 2012

Methods	Design: factorial Blinding: yes, participants and outcomes assessor blinding Attempt to confirm participant blinding for sham control?: yes, “Patients were asked at treatment completion, 'Do you think the treatment you had was real' and required to give a yes or no answer.” (page 457 section 2.6, Potential confounders). "A high percentage of patients believed that their treatment had been real; 96% (RA), 93% (SN), and 75% (mock electrical stimulation), which suggests that blinding was successful. These differences between treatments were significant (X2 = 15.486, P = .001).” (page 457 section 3.4, Blinding) Dropouts/withdrawals: 2 in acupuncture group, 6 in Streitberger needle, and 3 in mock electrical stimulation group (Fig. 1 & Table 4) dropped out during the 5 week trial. [For hip OA, there was only one dropout, which was from the Streitberger group.] Duration: 4 weeks treatment and 1 week of follow up, for a total duration of 5 weeks Type of analysis reported: Available case analysis, with intention‐to‐treat was used for participants who completed some pain outcome scores. “Missing data were dealt with by either taking a mean of the values on either side of the missing value or by carrying forward the last entry as appropriate.” (page 457 section 2.7, Sample size and analyses). “Eleven patients (4.9%) dropped out (Table 4); 3 completed some pain scores, and their data were carried forward per intention‐to‐treat analysis and included in the final analysis. Eight did not complete any outcomes and were excluded from analysis.” (page 457 section 3, Results) Stratification for treatment type within each joint: ["We did stratify for treatment type etc within each joint i.e. so for example within all the hips we had equal numbers of acupuncture, streitberger and mock electrical, we had equal numbers of consultation types. Within all the knees we had equal numbers of acupuncture, streitberger and mock electrical, we had equal numbers of consultation types." (2017 Sept 21 e‐mail to Eric Manheimer)]
Participants	Setting: Southampton General and Salisbury District Hospitals (UK) Mean age (±SD or range): 66.75 (8.29) years (page 457 section 3.1, Demographics and baseline measurements) Men/women (n/n): not reported specifically for hip OA; 94/127 for all participants, therefore this ratio was multiplied by the numbers of hip OA only participants to estimate number of male and female for hip OA (i.e. number of males with hip OA was 89 * 94/221 = 38; number of females with hip OA was 89 * 127/221 = 51). Recruitment method: Recruitment was via joint replacement waiting lists Mean pain duration (SD) years: not reported For bilateral OA diagnosis, which hip treated/evaluated?: not reported [The joint that the participant felt was the most painful of the two.] Diagnosis of knee OA required to be eligible? (if yes, describe how participants were verified to have OA): ; not reported [Yes, this was by Orthopaedic Consultant diagnosis, which would have included (without exception) X‐ray.] Radiologic evidence of knee OA required to be eligible? (if yes, describe requirement): not reported [Yes, this was by Orthopaedic Consultant diagnosis, which would have included (without exception) X‐ray.] Minimum duration (and extent) of hip pain required to be eligible: “A minimum mean weekly score of 30 of 100 was an inclusion requirement.” (page 456, section 2.4 and Table 1) Hospital inpatients? (Y/N; if Y list number inpatients): not reported Previous hip surgery? (Y/N; if Y list number with previous hip surgery): no [participants who had previous joint replacement surgery to the hip/knee were excluded but other types of surgery were not excluded] Were people with a history of acupuncture treatment excluded?: yes. “Outcome was not confounded by … previous acupuncture treatment.” Other important inclusion criteria: age 18 to 80 years, suffering chronic osteoarthritic pain from a single joint (hip or knee), awaiting joint replacement surgery, not on any current physical treatment (e.g. physiotherapy) (page 456, Table 1) Important exclusion criteria: pregnancy, serious comorbidity (including severe back pain), history of prolonged or current steroid use, awaiting hip/knee revision (i.e. current prosthesis), needle phobia, allergy to sticking plaster. (page 456, Table 1) How patients grouped for knee/hip subgroup: Eligibility criteria included "Suffering chronic osteoarthritic pain from a single joint (hip or knee)" and "Awaiting joint replacement surgery". They were grouped as hip or knee patients depending on which joint they were waiting to have replaced.
Interventions	TEST GROUP INTERVENTION: acupuncture N allocated to acupuncture: [30] (30 analyzed) Style of acupuncture: described as Western acupuncture approach, but traditional TCM acupoints were used Point selection: flexible formula Points stimulated: not reported [3 or 4 local points, selected from among the following 4: GB 30, GB 31, UB 34, ST 31; 1 or 2 distal points, selected from among the following 3: GB 34, GB 41, UB 60; Plus 1 or 2 ah shi points, if appropriate/evident] Total length of treatment period (weeks): 4 weeks Number of sessions target (mean): 8 Times per week: 2 Number of points used: 6 (reported as mean in the article, but stated as minimum in Peter White’s email) Insertion depth: “with deep needling”; [GB 30 (3 to 6cm), GB 31 (2 to 3cm), UB 34 (2 to 3cm), St 31 (2 to 3cm),GB 34 (2 to 3cm), GB 41 (1 to 2cm), UB60 (1 to 2cm)] Was De qi reportedly sought?: yes Duration (mins): 20 mins Method of stimulation: manual CONTROL GROUP A (sham, if used): Streitberger needle (“The format was exactly the same as those for real acupuncture (RA)”) N allocated to control group A: [29] (28 analyzed) Total length of treatment period: 4 weeks Number of sessions target (mean): 8 Times per week: 2 (If relevant) Number of points used: 6 (reported as mean in the article, but stated as minimum in Peter White’s email) (If relevant) Insertion depth: not applicable Was De qi sought?: not reported Duration (mins): 20 (If relevant) Method of stimulation: manual CONTROL GROUP B (sham, if used): mock electrical stimulation N allocated to control group B: [30] (30 analyzed) Total length of treatment period: 4 weeks Number of sessions target (mean): 8 Times per week: 2 (If relevant) Number of points used: 6 (reported as mean in the article, but stated as minimum in Peter White’s email) (If relevant) Insertion depth: not applicable Was De qi sought?: not applicable Duration (mins): 20 (If relevant) Method of stimulation: mock electrical stimulation was provided to acupoints via electrodes fixed to the surface of the participants' skin. Any cointerventions in all groups? Empathic or non‐empathic consultation (“Patients were first randomised to treatment type and consultation type, and then to specific practitioners.”) Participants were permitted to continue taking analgesia tablets. Acupuncturists’ experience: “Three qualified, experienced (range 3 to 10 years) practitioners were available and funded to provide treatments (physiotherapist, nurse, and licensed acupuncturist). They met frequently throughout the trial to ensure that treatments, including the acupoints used, and consultation types were as comparable and equivalent as possible.”
Outcomes	PAIN, FUNCTION, QUALITY OF LIFE, AND OVERALL INDEX OF SYMPTOM SEVERITY OUTCOMES EXTRACTED FROM PUBLICATIONS: MEASUREMENT TIME POINTS WOMAC pain, function, stiffness were not reported in publication, but information provided by Peter White, the trial’s principal investigator. [For the White 2012 RCT, Peter White provided both post‐treatment outcome scores and change from baseline outcome scores of WOMAC pain, function and stiffness, separately for the knee and hip participants.] Additional outcomes reported in the trial but not extracted: NA Nottingham Health Profile scores (quality of life) were not reported in the publication. The author only stated that "All scores for ... Nottingham Health Profile improved in all groups, with no significant differences between treatment or consultation types." Radiographic joint changes: not reported. Adverse effects: “Three adverse events were recorded, none of which were related to treatment. There were 28 cases of minor side effects (Table 7).” (page 458, section 3.4, Blinding)
Notes	Participants had severe OA, considering they were awaiting joint replacement surgery (for either hip or knee joint). Peter White provided following outcome data specific to patients with hip joint OA used for meta‐analysis (2012 June 20 e‐mail from Peter White to EM): WOMAC scores (range 0‐100 [PW confirmed to EM (2017 Sept 21 e‐mail) that range of WOMAC scales was 0‐100]): pre and post treatment, (sd) Pretreatment; Acupuncture; Streitberger Pain: 57.67 (17.63); 50.86 (15.63) Function: 57.95 (19.46); 55.49 (17.70) Post‐treatment; Acupuncture; Streitberger Pain: 48.83 (23.91); 43.50 (19.00) Function: 52.24 (22.63); 51.44 (17.80) WOMAC change in scores from pre to post treatment, (sd) NB a positive value here represents a fall in WOMAC score of that magnitude from Pre to post i.e. pre scores –post scores WOMAC changes; Acupuncture; Streitberger Pain: 8.84 (14.83); 7.56 (16.15) Function: 4.77 (12.03); 3.10 (14.23) Hip joint patients randomized to acupuncture vs. Streitberger: 30 vs. 29 Hip joint patients analyzed comparing acupuncture vs. Streitberger: 30 vs. 28 Source of support: "P.W. and this study were funded by a Department of Health Postdoctoral Research Award. C.S. was also funded by the same award. G.L.’s post is partially funded by the Rufford Maurice Laing Foundation. The Southampton Complementary Medicine Research Trust contributed funding for this trial. The funders played no role in study design, interpretation, or writing of this paper. All authors have no conflicts of interest to declare and no financial interests related to this study."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	(Information in square brackets below was provided by the first author White P’s email to Eric Manheimer on Jun 20, 2012) “After informed consent and 1‐week baseline pain recording, a 2‐stage randomisation occurred via an independent third party using a computer‐generated list. Patients were first randomised to treatment type and consultation type, and then to specific practitioners.” (page 456, section 2.1, Randomisation)
Allocation concealment (selection bias)	Low risk	“After informed consent and 1‐week baseline pain recording, a 2‐stage randomisation occurred via an independent third party using a computer‐generated list. Patients were first randomised to treatment type and consultation type, and then to specific practitioners.” (page 456, section 2.1, Randomisation) Comment: It seemed to be central randomizations, so the allocation concealment should be assured.
Blinding of participants and personnel (performance bias) All outcomes ‐ participants	Low risk	Sham 1 ‐ Streitberger needle: "The format was exactly the same as those for real acupuncture (RA), but using Streitberger needle (SN) nonpenetrating needles instead of RA needles. These work rather like a stage dagger, have been validated, and patients cannot distinguish them from RA needles." Sham 2 ‐ Mock electrical stimulation: "An electroacupuncture stimulator was used (NOMA Ltd., Southampton, UK) to provide mock transcutaneous electrical stimulation to acupoints via electrodes fixed to the surface of the patient’s skin. The cables were disconnected inside the output plug. All aspects of the intervention were exactly the same as with RA and SN, including time of treatment and checking on patients at regular intervals. This control has previously been well validated." “A high percentage of patients believed that their treatment had been real; 96% (RA), 93% (SN), and 75% (mock electrical stimulation), which suggests that blinding was successful. These differences between treatments were significant (X2 = 15.486, P = .001).” (page 457, section 3.4, Blinding) [For hip OA participants, the percentage of participants who believed that their treatment had been real were 93.3% (RA), 85.7% (SN), and 65.5% (mock electrical stimulation).] A statistical test was conducted and showed that there were no significant difference between RA and SN (P = 0.35), but a significant difference between RA and MES (P = 0.01). The percentage of participants who believed that their treatment had been real was similar between real acupuncture and Streitberger needle, but significantly different between real acupuncture and mock electrical stimulation, which suggested that the blinding between RA and SN was successful, but unclear between RA and SN.
Blinding of participants and personnel (performance bias) All outcomes ‐ personnel	High risk	Acupuncturists could not be blinded.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Since the outcome assessments (WOMAC pain, function and total) were made by the participants themselves using questionnaires, we considered the sham acupuncture arm of this trial to have been both participant and outcomes assessor blinded.
Incomplete outcome data (attrition bias) Short term	Low risk	For hip OA, there was only 1 dropout in the Streitberger needle group, so the degree of 'missingness' would be unlikely to affect the estimate of the treatment effect in this trial. [For hip OA, numbers included in final analysis of the major outcome (pain) were 30/30, 28/29 and 30/30 for WOMAC.]
Selective reporting (reporting bias)	Low risk	[For each of the three treatment groups, WOMAC pain, function and stiffness post‐treatment means and standard deviations, as well as mean changes and standard deviations of changes from baseline, were provided by Peter White.] The result of quality of life (Nottingham Health Profile) score was not reported in the publication but the publication state that "All scores for Western Ontario and McMaster University Osteoarthritis Index and Nottingham Health Profile improved in all groups, with no significant differences between treatment or consultation types.” (page 457, section 3.3, Secondary outcomes) Adverse events and side effects during trial were reported. (page 458, section 3.4, Blinding and Table 7)
Other bias	Low risk	1. The three treatment groups were comparable at baseline in terms of baseline pain VAS, and WOMAC pain, function and stiffness scores, for hip and knee OA separately. There were no comparisons in terms of demographic characteristics reported. (low risk) 2.    Cointervention: empathic or non‐empathic consultation (“Patients were first randomised to treatment type and consultation type, and then to specific practitioners.”) Participants were permitted to continue taking analgesia tablet. (low risk) 3.    Compliance acceptable: Only the target number of treatment sessions, not the mean number of treatment sessions, received by participants was reported. [The mean number (SD) of treatment sessions received by participants with knee OA were 7.67 (0.82) for RA, 7.78 (0.76) for SN and 7.60 (1.11) for MES.] (low risk) 4.    Timing of the outcome assessment similar?: All three groups were assessed for the outcomes at the same time points. (low risk) 5.    Free of interaction?: “ANCOVA at week 5 showed no significant effect on immediate post‐treatment pain of the factors practitioner, treatment, and consultation type, and their first‐order interactions with all of the possible baseline confounders as covariates (age, sex, joint, previous knowledge of acupuncture, credibility, CARE score, and HCAMQ scores).” (low risk)

Witt 2006

Methods	Design: parallel Blinding: no Attempt to confirm participant blinding for sham control?: NA Drop‐outs/withdrawals: "After 3 months, data were available on 93.2% of the participants (308 in the randomized acupuncture group, 289 in the control group...)." Duration: up to 15 sessions of acupuncture over a 3 month period, and additional follow‐up for 6 months after baseline. Type of analysis reported: Available cases analysis was the main analysis, with additional intention‐to‐treat as sensitivity analyis. Stratification for treatment type within each joint: Assume no (not reported in detailed description of randomization procedure)
Participants	Setting: outpatient clinics in Germany Mean age (±SD or range): ˜61(10) years for all participants randomized Men/women (n/n): 135/207 for all participants randomized, not reported for hip separately Recruitment method: participants selected from a group of experienced primary care practitioners participating in a large research initiative on acupuncture Mean pain duration (SD) years: 5.4 (7) for all participants (with knee and/or hip OA) randomized For bilateral OA diagnosis, which hip treated/evaluated?: Hip defined at baseline as most painful was evaluated throughout the study. Diagnosis of hip OA required to be eligible? (if yes, describe how participants were verified to have OA): yes, clinical diagnosis of OA‐associated pain in the hip with disease duration of > 6 months Radiologic evidence of knee OA required to be eligible? (if yes, describe requirement): yes, radiologic evidence of OA (osteophyte formation) Minimum duration (and extent) of knee pain required to be eligible: at least 15 days with pain in the preceding 30 days Hospital inpatients? (Y/N; if Y list number inpatients): no Previous hip surgery? (Y/N; if Y list number with previous knee surgery): not reported Were people with a history of acupuncture treatment excluded?: no. about 31% of participants listed "previous successful acupuncture" as their reason for participating in this study Other important inclusion criteria: written informed consent Important exclusion criteria: Hip pain due to inflammation or malignancy was a criterion for exclusion. How patients grouped for knee/hip subgroup: "OA of the knee was present in 57.1% of the patients, OA of the hip in 14.5%, and OA of both the knee and the hip in 28.4% (Table 1)...For subgroup analyses, patients were grouped according to the most painful joint (as reported at baseline and assessed throughout the study period);.."
Interventions	TEST GROUP INTERVENTION: acupuncture plus routine primary physician care N allocated to acupuncture: 87 (page 3488, Table 1; estimated 87 * 84.0% = 73 with data complete at 3 months) Style of acupuncture: Because the specifics of acupuncture treatment were left to the discretion of the physician, acupuncture treatment regimens varied among participants in the study. Point selection: individualized (determined by treating physician) Points stimulated: Number of needles and acupuncture points were chosen at the physician's discretion Total length of treatment period (weeks): 13 Number of sessions target (mean (SD)): target: up to 15; mean: ˜11 (2.5) Times per week: not specifically reported, but assumedly at physician's discretion Number of points used: at physician's discretion Insertion depth: not specifically reported, but assumedly at physician's discretion Was De qi reportedly sought?: not specifically reported, but assumedly at physician's discretion Duration (mins): 30 Method of stimulation: Only manual stimulation was allowed (administered at physician's discretion). CONTROL GROUP A: waiting list (routine primary physician care alone) N allocated to control group B: 82 (page 3488, Table 1; estimated 82 * 78.6% = 64 with data complete at 3 months) Total length of treatment period: NA (13 week waiting list) Number of sessions target (mean): NA Times per week: NA Duration (minutes): NA Any cointerventions in all groups?: Participants were permitted to receive any additional conventional treatments as needed.
Outcomes	PAIN, FUNCTION, QUALITY OF LIFE, AND OVERALL INDEX OF SYMPTOM SEVERITY OUTCOMES EXTRACTED FROM PUBLICATIONS: MEASUREMENT TIME POINTS Pain (WOMAC Pain): baseline, after 13 week treatment period, and at follow‐up 26 weeks after baseline Function (WOMAC function): baseline, after 13 week treatment period, and at follow‐up 26 weeks after baseline Quality of life: SF‐36 physical and mental component scales: baseline, after 13 week treatment period, and at follow‐up 26 weeks after baseline (Table 2 reported the post‐treatment means and SEMs at 3 months for each group and restricted to the hip OA participant. Table 3 and Table 4 reported the mean and SD of percentage changes from baseline at 3 months and 6 months, respectively, which could not be transformed into means and SDs of change from baseline.) Radiographic joint changes: not reported Type of outcome data reported (i.e. post‐treatment/change from baseline/both): post‐treatment means and standard deviations for each group as well as post‐treatment differences between groups Additional outcomes reported in the trial but not abstracted: percent reduction in the WOMAC index and SF‐36 (Table 3) Adverse effects: No life‐threatening side effects were reported. Only side effects resulting from acupuncture were reported, for the acupuncture participants only; data specific to the knee OA participants could not be obtained from authors. For knee plus hip OA participants: in 5.2% (n = 184), a total of 219 side effects were reported after the participants had acupuncture (66% minor local bleeding or hematoma, 5% pain at the site of needle insertion, 4% vegetative symptoms, and 25% other).
Notes	Comments: It is important to confirm that cointerventions were indeed either avoided in the trial design or similar between the index and control groups. For example, could the acupuncturists also offer herbs? If they could, the cointervention score for the CBRG scale item would need to be changed. For the participants for whom the site of OA was only the hip, the publicationreported only post‐treatment scores (in Table 2), but not changes from baseline. The outcomes were reported as means and SDs of percentage changes from baseline (Table 3), but these could not be transformed into means and SDs of change from baseline, which is why we needed to impute changes from baseline. To impute the changes from baseline, we assumed the baseline means and SDs for participants with only hip OA were the same as those of all participants, "because there were no significant baseline differences between patients with OA of the knee and patients with OA of the hip". The changes were calculated using the pre‐ and post‐means and SDs, and assuming a within‐subject pretest–post‐test correlation of 0.5. Because the post‐treatment values required no imputations, we considered these to be the primary analysis. For the hip OA participants, the number available at the 3‐month time point was not reported, only the numbers with hip OA randomized (87 for acupuncture group and 82 for control group, see Table 1 in article) and the numbers with WOMAC data complete at 3 months for all participants. Eighty‐four per cent (300/357) of acupuncture participants and 78.6% (279/355) of all control participants had WOMAC data complete at 3 months. Therefore, these percentages were multiplied by the numbers of hip OA‐only participants randomized to estimate number of hip OA participants with data complete at 3 months (i.e. 87 * 84.0% = 73 for acupuncture group; 82 * 78.6% = 64 for control group). Source of support: "Supported by the following statutory health insurance funds in Germany: Techniker Krankenkasse,..."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“For randomizations we used blocks of 10, and the random list was generated with SAS software.”
Allocation concealment (selection bias)	Low risk	“Those who met the inclusion criteria, provided informed consent, and signed an agreement for randomizations were randomized using a central telephone randomizations procedure.”
Blinding of participants and personnel (performance bias) All outcomes ‐ participants	High risk	acupuncture vs. waiting list. No sham control group.
Blinding of participants and personnel (performance bias) All outcomes ‐ personnel	High risk	acupuncture vs. waiting list. No sham control group. Care providers could not be blinded.
Blinding of outcome assessment (detection bias) All outcomes	High risk	The outcome assessments (WOMAC pain, function and total) were made by the participants themselves, by completing questionnaires; because the participants knew which group they were in, they could not be blind for outcome assessment.
Incomplete outcome data (attrition bias) Short term	Low risk	This was not reported specifically for participants with hip OA. "After 3 months, data were available on 93.2% of the participants (308 (/357) in the randomized acupuncture group, 289 (/355) in the control group...)" for all participants (see Figure 1). ITT: "Confirmatory testing of the primary and secondary outcome measures (using SPSS 11.5) was based on the intent‐to‐treat population, using the maximum available data set. Sensitivity analyses for the primary outcome measure were performed either by replacing missing data according to the last observation carried forward principle or by using various hot deck methods or regression‐based multiple imputation." "After 3 months, data were available on 93.2% of the patients (308 (/357) in the randomized acupuncture group, 289 (/355) in the control group...)" After 3 months, WOMAC data were complete for 300 (/357) in the acupuncture group, 279 (/355) in the control group (see Figure 1).
Selective reporting (reporting bias)	Low risk	This trial reported outcomes for WOMAC pain and function and quality of life SF‐36 scores at baseline and after 3 and 6 months. as well as results for the other outcomes (e.g., side effects) measured, as described in the Methods section.
Other bias	Unclear risk	1. The two treatment groups were comparable at baseline in terms of WOMAC scores. (low risk) 2. Cointervention was not reported. (unclear risk) 3. Compliance acceptable: "Patients in the acupuncture groups received a mean ± SD of 10.7 ± 3.9 acupuncture sessions (randomized acupuncture group 10.8 ± 2.1,...)." (low risk) 4. Timing of the outcome assessment similar?: Both groups were assessed for modified WOMAC total score at baseline, 13 weeks and 26 weeks. (low risk)

acetabular: Of the acetabulum, which is a concave (hollow) surface of the pelvis, where the thigh bone meets with the pelvis, forming the hip joint.

acupoints: acupuncture points on the body

BMI: body mass index

De qi: The sense of numbness or tingling at the needle insertion point when a patient is receiving acupuncture, which indicates that the acupuncture is exerting its effects.

DRI: disability rating index

EA: electroacupuncture

EoT: end of treatment

femoral: of the thigh bone

Hz: Hertz, is the unit of frequency.

GSI: global self‐rating index

mA: Milliampere, is the unit of electric current.

MES: mock electrical stimulation

NA: not available

NSAID: nonsteroidal anti‐inflammatory drug

OA: osteoarthritis

osteophytes: commonly referred to as bone spurs, are bony projections that form along joint margins.

QoL: quality of life

RA: real acupuncture

SD: standard deviation

SEM: standard error of the mean

SF‐36: The Short Form (36) Health Survey, is a 36‐item, patient‐reported survey of patient health.

SMD: standard mean difference

SN: Streitberger needle, a placebo acupuncture needle, which does not penetrate the skin, developed by Streitberger K (Streitberger 1998).

transcutaneous: through the surface of the skin

VAS: visual analogue scale

WOMAC: The Western Ontario and McMaster Universities Arthritis Index, is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints.

Characteristics of excluded studies [ordered by study ID]

Study	Reason for exclusion
Allam 2013	OA in a variety of joints except for hip joint
Ashraf 2014	OA of knee
Bao 2013	OA of knee
Berman 1999	OA of knee
Berman 2004	OA of knee
Cai 2013	OA of knee
Chao 2014	Immediate and delayed acupuncture were compared, which does not meet our inclusion criteria for type of interventions.
Chen LX 2013	OA of knee
Chen R 2013	OA of knee
Chen R 2015	OA of knee
Cheng 2013	OA of knee
Cheng 2014	OA of knee
Christensen 1992	OA of knee
Coan 1982	cervical OA
Dai 2014	OA of knee
Foster 2007	OA of knee
Gao 2013	OA of knee
Gaw 1975	OA in a variety of joints, including spine and results for the participants with OA of the peripheral joints were not reported separately from the results of the participants with OA of the spine.
Hinman 2014	OA of knee
Horng 2013	OA of knee
Itoh 2008	OA of knee
Itoh 2008a	OA of knee
Ju Z 2015	OA of knee
Jubb 2008	OA of knee
Junnila 1982	Not explicitly randomized
Kim T 2014	OA of knee
Li 2013	Hand OA
Li J 2015	OA of knee
Liang 2013	OA of knee
Liu K 2013	OA of knee
Liu YS 2013	OA of knee
Loy 1983	Cervical spondylosis
Lundeberg 1991	Cervical OA
McIndoe 1995	Trigger points acupuncture, not traditional Chinese acupuncture, were used.
Molsberger 1994	OA of knee
Petrie 1983	Cervical OA
Petrie 1986	Cervical OA
Plaster 2014	OA of knee
Qin 2013	OA of knee
Qiu 2013	OA of knee
Sangdee 2002	OA of knee
Scharf 2006	OA of knee
Shen 2003	Participant assignment used in this trial was based on odd and even patient admission numbers, which indicates that this was a quasi‐randomized trial.
Takeda 1994	OA of knee
Thomas 1991	Cervical OA
Tukmachi 2004	OA of knee
Vas 2004	OA of knee
Wang B 2016	OA of knee
Wei 2013	OA of knee
Weiner 2013	OA of knee
Williamson 2007	OA of knee
Witt 2005	OA of knee
Xie 2014	OA of knee
Xu L 2013	OA of knee
Yin 2014	OA of knee
Yu 2013	OA of knee
Zhao 2014	OA of knee
Zheng 2004	Randomization was claimed, however neither of the two authors could provide clear information about the randomizations method.
Zherebkin 1998	Not explicitly randomized; included both hip and knee joint participants.

^{OA: osteoarthritis}

^{Spondylosis: is the degeneration of the spinal column from any cause.}

Contributions of authors

Eric Manheimer and Ke Cheng determined inclusion eligibility of trials and extracted data/assessed risk of bias of all included trials. Eric Manheimer developed the data extraction form, and obtained unpublished outcome data specific to patients with only hip OA for White 2012, and unpublished information about methods and results for White 2012 and Stener‐Victorin 2004. Ke Cheng and Menghu Guo screened and extracted data for the Chinese language studies. Ke Cheng conducted interviews with Chinese authors of claimed randomized trials to determine authenticity of randomization procedures used, and obtained unpublished information about randomization procedure for Sheng 2010. Eric Manheimer managed and organized the data in RevMan and designed and conducted the analyses with help from Ke Cheng. Eric Manheimer wrote the manuscript. Ke Cheng contributed to data entry, data checks, data analysis, and preparation of tables and figures. Lixing Lao and Xueyong Shen rated the adequacy of the acupuncture treatments. All authors provided comments, and endorsed the final version of the manuscript.

Sources of support

Internal sources

• No sources of support supplied

External sources

• National Basic Research Program, National Natural Science Foundation, Shanghai Key Laboratory of acupuncture mechanism and acupoint function, China.

  Xueyong Shen and Ke Cheng were funded by the National Basic Research Program of China (2015CB554505), National Natural Science Foundation of China (81320108028) and Shanghai Key Laboratory of acupuncture mechanism and acupoint function (14DZ2260500).

• Budget research project and Xinglin Young Talent Program of Shanghai University of Traditional Chinese Medicine, China.

  Ke Cheng was funded by the budget research project (2016YSN19) and Xinglin Young Talent Program of Shanghai University of Traditional Chinese Medicine.

• National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health, USA.

  Brian Berman, Lixing Lao, Eric Manhaimer, and Susan Wieland were partially funded by Grant Number R24 AT001293.

Declarations of interest

No review authors have any affiliations or financial involvement (e.g. employment, consultancies, honoraria, stock options, expert testimony, grants or patents received or pending, or royalties) that conflict with material presented in this review.

Edited (no change to conclusions)