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J Acupunct Res > Volume 34(2); 2017 > Article
Kim, Ryoo, Jeong, Kim, Baek, Lee, Yoon, Goo, Kim, Park, Seo, Baek, Nam, and Kim: A Systematic Review of Acupuncture for Chronic Fatigue Syndrome

Abstract

Objectives

To evaluate and summarize the efficacy and safety of acupuncture treatment (AT) in chronic fatigue syndrome (CFS).

Methods

Fifteen databases (Pubmed, Cochrane, EMBASE, AMED, CINAHL, CNKI, Wanfang, and eight Korean databases) were searched up to September 2016. Only trials in which acupuncture was the sole treatment were included. Fatigue was used as the primary outcome measure, while the quality of life, pain, mood disorders, and adverse events were used as secondary outcome measures. We adopted three classifications: AT vs Sham AT, AT vs Wait-list, AT vs Western medication. The Cochrane risk of bias tool was used to assess the methodological quality.

Results

A total of 11 randomized controlled trials involving 869 participants were identified. In comparison with Sham AT, AT significantly alleviated fatigue and pain, but no conclusions about the quality of life and mood disorders could be drawn. In the Wait-list group and Western medication groups, patients with CFS might feel less fatigued following acupuncture treatment, but the evidence was insufficient due to lack of study. Nine of 11 RCTs (81.8%) reported adverse events and there were two cases of mild subcutaneous hemorrhage, but no serious adverse cases.

Conclusion

This review found evidence that patients with CFS may generally benefit from alleviation of symptoms by acupuncture treatment, and there is no evidence of worsening symptoms or causing of serious adverse events. A positive effect on fatigue and pain was observed, but no conclusion for improving quality of life and mood disorders.

Abstract

목적

만성피로증후군(CFS) 환자에 대한 침치료의 효과와 안전성을 평가하고자 하였다.

방법

2016년 9월까지 15개의 DB(Pubmed, Cochrane, EMBASE, AMED, CINAHL, CNKI, Wanfang 및 8개 국내 DB)를 통해 검색을 실시하였으며, 침치료가 주된 치료로 사용된 연구만을 대상으로 하였다. 피로 증상을 일차적 평가지표로 하였으며, 삶의 질, 통증, 기분 장애, 부작용 여부 등을 이차적 평가지표로 설정하였다. 침치료군 vs Sham 침치료군, 침치료군 vs 대기군, 침치료군 vs 양약치료군 3가지 그룹으로 분류하여 분석을 시행하였으며, Cochrane risk of bias 기준을 통해 문헌의 질을 평가하였다.

결과

최종적으로 11개의 RCT에서 869명의 환자가 연구에 포함되었다. 침치료군이 Sham 침치료군에 비해 피로 및 통증 증상을 더 유의하게 완화시켰으며, 삶의 질 및 기분 장애 증상에서는 통계적으로 유의하지 않았다. 대기군 및 양약치료군과의 비교에서도 침치료군에서 유의한 피로 완화 효과를 보였으나, 포함된 연구 수가 부족하여 근거가 불분명하였다. 최종적으로 선정된 11개의 문헌 중 9개 문헌(81.8%)에서 부작용 여부를 보고하였으며, 2명의 가벼운 피하출혈 사례 외 중대한 부작용은 보고되지 않았다.

결론

본 연구에서는 CFS 환자의 증상을 완화시키는 데 침치료가 효과적일 수 있다는 근거를 확인하였으며, 침치료가 증상을 악화시키거나 심각한 부작용을 야기한 사례는 없었다. 특히 피로 및 통증 항목에서 긍정적인 효과를 보였으며, 삶의 질과 기분 장애 항목에서는 효과의 근거가 불분명하였다.

I. Introduction

Chronic fatigue syndrome (CFS) results in an unexplained fatigue that lasts for more than 6 months and is accompanied by various symptoms such as memory and concentration losses, postexercise fatigue, sleep disorder, depression, and anxiety. Diagnostic criteria such as those of the Centers for Disease Control and Prevention (CDC; 1988)1), CDC (1994)2), Australian criteria3), and British criteria4) have been officially used. Among these, Fukuda’s CDC (1994) criteria were the most widely used. According to Wessely’s study where the literature related to CFS in several countries was reviewed, the prevalence of chronic fatigue was 7–21%, and the prevalence of patients who met the criteria for CFS was 0.5–2%5). In a prospective study of patients who visited a primary medical clinic, 1.2–2.6% of them were diagnosed with CFS; in particular, the patients who met the CDC (1994) criteria were 2.6%6). In general, the prevalence rate of CFS is reported to be 1–2%.
The cause and mechanism of CFS are so far unclear, and to date there is no officially recognized treatment. In Cochrane-Reviews, several systematic reviews on exercise therapy7), cognitive behavior therapy8), and herbal medicine treatment9) have been reported. Furthermore, oriental medicine treatment10) and complementary and alternative medicine (CAM) therapies have also been reported11). However, no studies on acupuncture and CFS have been reported since the systematic review in China in 200912), in which studies published until 2008 only in domestic databases were searched and methodological limitations in analyzing the effect of acupuncture treatment (AT) were noted.
Therefore, the purpose of the present review was to assess the efficacy and safety of AT by systematically summarizing data from randomized controlled trials (RCTs) of acupuncture in patients with CFS.

II. Methods

1. Search methods

We searched the following 15 databases up to September 2016 without language and publication type restrictions: PubMed, the Cochrane Library 2016 (Issue 9), Excerpta Medica Database (EM-BASE), Alternative Medicine (AMED), the Cumulative Index to Nursing & Allied Health Literature (CINAHL), two Chinese databases (China National Knowledge Infrastructure (CNKI) and Wanfang), and eight Korean databases (KoreaMed, KMBASE, NDSL, KISTI, KISS, RISS, Oasis, and Korean traditional knowledge portal). Additionally, relevant references from previous systematic reviews were also searched.
The following keywords were used for the search and were adjusted for each database: (“chronic fatigue syndrome” OR “myalgic encephalomyelitis” OR “myalgic encephalitis”) AND (“acupuncture” OR “electroacupuncture” OR “pharmaco-acupuncture” OR “acupressure” OR “acupoints” OR “acupoint injection” OR “dry needle” OR “needling”). The details are described in Appendix 1.

2. Study selection

1) Types of studies

We included all relevant RCTs and quasi-RCTs of any type of AT regardless of the study design, published language, number of participants, and blinding. Observational, uncontrolled, case- control, case series and laboratory studies were excluded.

2) Types of patients

Patients who were diagnosed by any defined diagnosis criteria of CFS such as CDC, Australian and British criteria were included regardless of sex, age, race, disease course, and severity.

3) Types of interventions

(1) Experimental interventions

All types of AT were included including electroacupuncture, scalp acupuncture, laser acupuncture, auricular acupuncture, acupressure, acupoint injection, and pharmaco-acupuncture. We only included trials in which acupuncture was the sole treatment. Studies with the following treatment were excluded: (1) AT combined with other complementary and alternative medicine (CAM) (e.g., [acupuncture + herbs] vs control); (2) two or more different types of AT in the experimental group (e.g., [electroacupuncture + Auricular acupuncture] vs control); and (3) uncontrolled interventions (e.g., using different acupoints in the same group according to the diagnostic pattern).

(2) Control interventions

Sham acupuncture (e.g., non-acupoints stimulation or placebo needle), Wait-list, and Western medications (e.g., steroids and vitamins) were included as control interventions. Studies that compared AT with other CAM treatments were excluded.

4) Types of outcome measures

We extracted the data of each measured outcome at the end of the treatment. The outcomes were divided into primary and secondary outcomes.

(1) Primary outcome

Fatigue measured by validated scales such as the Chalder fatigue scale (FS) and Fatigue Severity Scale (FSS) was applied as the primary outcome.

(2) Secondary outcomes

Studies using at least one of the following clinical outcome variables were included, while those only reporting laboratory outcomes were excluded. (1) Quality of life was measured by validated scales such as the Short Form-12 (SF-12), SF-20, SF-36, Somatic and Psychological Health Report (SPHERE), and World Health Organization Quality of Life-BREF (WHOQOL- BREF). (2) Pain was measured by validated scales such as the Visual Analogue Scale (VAS) and Numerical Rating Scale (NRS). (3) Mood disorders were measured by validated scales such as the Beck Depression Index (BDI), Self-rating Anxiety Scale (SAS), and Self-rating Depression Scale (SDS). (4) Effective rates were measured by calculating the change in each score such as [(score before treatment − score after treatment) / score before treatment] × 100. (5) Adverse events were measured using any reporting system such as serious adverse reactions (SARs).

5) Data extraction and quality assessment

Two independent reviewers participated in the process of literature search, selection, and data extraction. The literature was first searched through the titles and abstracts, and subsequently selected and included in this review by considering the full texts. Furthermore, the sample size, demographic characteristics, diagnostic criteria, treatment details, outcome measures, results, adverse events, and additional information about AT such as acupoints, meridians, retaining time, and De-Qi were also extracted. We resolved any disagreements between the two reviewers first through discussion and, when necessary, by seeking the opinion of a third reviewer.
The methodological quality was evaluated independently by two reviewers using the Cochrane risk of bias tool; if needed, a third reviewer was involved. The tool included seven criteria: (1) random sequence generation, (2) allocation concealment, (3) blinding of participants and personnel, (4) blinding of outcome assessment, (5) incomplete outcome data, (6) selective outcome reporting, and (7) other potential biases (i.e., the baseline imbalance).

3. Data synthesis

To create a Summary of Findings table, we used the GRADEpro software (Grade Working Group) and data synthesis was performed by Review Manager (RevMan) Version 5.3.0 for Windows (Copenhagen, The Nordic Cochrane Center).
For the dichotomous data, we presented the effect size as the relative risk (RR) with 95% confidence interval (CI). For the continuous data, we calculated the weighted mean difference (WMD) when the same scale was used, while standardized mean difference (SMD) was calculated if different scales were used.
Meta-analysis was performed only when a quantitative synthesis was possible. We used the chi-square test and the Higgins I2 test to assess the heterogeneity. Heterogeneity was considered at a p < 0.1. The fixed effect model was used unless there was evidence of heterogeneity. Subgroup analysis was performed according to different types of AT in the case of I2 > 50%. In addition, the funnel plot analysis was used to confirm publication bias, but failed due to the small number of studies.

III. Results

1. Study selection and description

A total of 1,277 studies were screened and 869 participants of 11 RCTs were finally included in this review. Fig. 1 illustrates the flow diagram of the selection process.
Among the 11 studies, nine were conducted in China1315,1823), one was in Hong Kong16), and one was in Korea17). The number of participants included in each study ranged between 17 and 157, with a mean age of 38.0 years and a men-to-women ratio of 1:1.5. The CDC criteria were used for diagnosis in all studies; one study used the 1988 CDC criteria13), while the other 10 studies used the 1994 CDC criteria (Fukuda criteria). Moreover, the FS was the most commonly used primary out-come13,15,16,1921), while FSS was used in four studies17,18,22,23). As secondary outcomes, SF-36 was used in four studies14,18,22,23), SPHERE in four14,18,22,23), WHOQOL-BREF in two20,21), and various scales were used in each study (Table 1).

2. Interventions

1) Classification

The study design was classified into three categories based on the intervention in the control group. Among the 11 RCTs, nine studies1416,1823) were compared with Sham acupuncture, while the other two studies were compared to the Wait-list group17) and Western medication group13).

2) General characteristics of acupuncture treatment (Appendix 2)

(1) Types of acupuncture treatment

Among the 12 groups of the 11 selected studies, simple AT was used in nine groups1321), electroacupuncture was used in two22,23), and moxa-heated needling was used in one15).

(2) Acupoints and meridians

A total of 21 acupoints were used. The most used acupoint was ST36, which was applied in eight studies1416,18,2023), followed by BL23 in seven studies13,14,17,18,2123), BL1813,14,17,18,21) and GV20 in five studies1417,21), BL1513,17,19), BL2017,19,21), CV413,15,21), CV613,15,21), CV1713,15,21), and SP615,16,21) in three studies, CV1213,21), HT714,18), LI415,21), LR315,21), KI320,21) in two studies, and BL1117), BL1317), BL1713), BL2213), BL4319), and GB2017) in one study.
The Bladder meridian was the most used meridian (nine acupoints in eight studies13,14,1719,2123)), followed by Conception extra meridian (four acupoints in three studies13,15,21)), Stomach meridian (one acupoint in eight studies1416,18,2023)), Governor extra meridian (one acupoint in five studies1417,21)), Spleen meridian (one acupoint in three studies15,16,21)), Large Intestine meridian15,21), Gall Bladder meridian17) (one acupoint in one study), and Liver meridian15,21), Heart meridian14,18), and Kidney meridian20,21) (one acupoint in two studies).

(3) Treatment methods

In seven of the 11 RCTs1316,18,20,21), the retaining time of AT was 30 minutes, while it was 20 minutes in the remaining four studies17,19,22,23).
De-Qi was performed in eight studies1416,1822), while one study17) did not perform it, and the remaining two studies13,23) did not describe it.

3. Risk of bias

The quality of the literature was evaluated by using the Cochrane risk of bias tool (Fig. 2 and 3). All the selected studies used randomization methods, but only eight RCTs1418,20,21,23) presented a detailed methodological description, while the remaining three13,19,22) did not. Three RCTs17,21,23) adequately performed the allocation concealment, which was not described in the remaining studies1316,1820,22). Because of the nature of the AT, the practitioners cannot be blinded during the treatment. Therefore, all the included studies had a high risk of performance bias. The blinding of the evaluator was reported in six RCTs14,1719,21,23), while four RCTs13,15,20,22) did not, and one16) implemented it inadequately. Six RCTs1719,2123) fully reported the reasons for dropouts and withdrawals, while two RCTs16,20) involving dropouts did not describe the reasons, and the remaining three RCTs1315) did not involve any dropouts. Only one study17) had a protocol that was followed adequately. Out of the 11 RCTs, there were no baseline differences in 10 trials, while the remaining study15) did not present the baseline data, and had thus a high risk of potential bias.

4. Summary of the main results

The efficacy of AT was analyzed in the following three categories: Acupuncture vs Sham acupuncture, Acupuncture vs Wait-list, and Acupuncture vs Western medicine treatment (Table 2, 3, and 4).

1) Acupuncture vs Sham acupuncture

(1) Fatigue

Both the FS and FSS were used as outcome variables. Three RCTs16,20,21) using the FS in the same study design were included in the meta-analysis and showed a significant fatigue reduction effect compared with the Sham acupuncture group (Fig. 4; n = 216; WMD, −1.63; 95% CI, −2.55 to −0.72; p = 0.0005; I2 = 0%). Moreover, two RCTs18,22) of different interventions, which applied the FSS, were quantitatively synthesized and showed a significant effect in the AT group (Fig. 5; n = 132, WMD, −9.54; 95% CI, −17.20 to −1.89; p = 0.01; I2 = 77%). Wang et al23) also reported a significant reduction in the FSS in the AT group (p < 0.0001), but FSS was not scored as continuous data but presented only as effective rates; thus, it was excluded from the quantitative synthesis.

(2) Quality of life

SPHERE, SF-12, SF-20, SF-36, WHOQOL-BREF, and General Health Questionnaire-12 items (GHQ-12) were used. Three RCTs14,18,22) of the same study design using SPHERE were synthesized and showed a significant effect compared with the Sham group (Fig. 6; n = 149; WMD, −5.27; 95% CI, − 8.63 to −1.92; p = 0.002; I2 = 61%). As defined earlier, subgroup analysis by intervention was performed to analyze the cause of heterogeneity.
Among five RCTs using SF-1216), SF-2019), and SF-3614,18,22), two studies19,22) reported a significant improvement compared with the control group (SMD 1.22; IV, Random; 95% CI, 0.82 to 1.61/SMD 1.84; IV, Random; 95% CI, 1.23 to 2.45). However, there were no significant differences between the two groups in the remaining three studies14,16,18). In one14) of the studies, the effect of improving the quality of life was higher in the Sham acupuncture group, although not statistically significant. Meta+-analysis was not performed due to the unexplained high heterogeneity (I2 = 89%). Wang et al23) was excluded from the quantitative synthesis because of insufficient data.
Three RCTs using WHOQOL-BREF20,21) and GHQ- 1216) were quantitatively synthesized and indicated no significant difference between the two groups (Fig. 7; n = 216; SMD 0.21; 95% CI, −0.06 to 0.48; p = 0.12; I2 = 8%).

(3) Pain

Two RCTs21,22) using the VAS were included in the meta-analysis. There was a significant pain relief effect compared with the Sham group (Fig. 8; n = 124; WMD, −11.81; 95% CI, −16.99 to −6.63; p < 0.00001; I2 = 36%).

(4) Mood disorder

One RCT21) reported about depression and anxiety using the SDS and SAS. Depression and anxiety symptoms in the AT group decreased more than in controls, but there was no significant difference between the two groups (n = 64; SDS: MD, −2.40; IV; Fixed; 95% CI, −6.79 to 1.99; p = 0.28/SAS: MD, −0.44; IV; Fixed; 95% CI, −3.92 to 3.04; p = 0.80).

2) Acupuncture vs Wait-list

(1) Fatigue

Among the 11 selected studies, one RCT17) was compared with the Wait-list group and FSS was used as outcome variable. The AT group showed more significant fatigue reduction (n = 24; MD, − 1.50; IV; Fixed; 95% CI, −2.25 to −0.75; p < 0.0001).

(2) Quality of life and pain

The quality of life and pain were not reported in comparing AT to the Wait-list group.

(3) Mood disorder

The Stress Response Inventory (SRI), BDI, and Insomnia Severity Index (ISI) were used as outcome variables to analyze the stress response, depression, and insomnia. The symptoms were significantly alleviated according to the scores in all three variables in the AT group compared with the Wait-list group (one study; n = 24; SRI: MD, − 27.00; IV; Fixed; 95% CI, −38.17 to −15.83; p < 0.00001/BDI: MD, −12.17; IV; Fixed; 95% CI, −19.09 to −5.25; p = 0.0006; ISI: MD, −7.42; IV; Fixed; 95% CI, −11.36 to −3.48; p = 0.0002).

3) Acupuncture vs Western medicine treatment

(1) Fatigue

In one RCT13), AT was compared with Western medication treatment and FS was used as outcome variable. There was a significant fatigue reduction effect compared with the Western medicine group (n = 157; MD, −2.83; IV; Fixed; 95% CI, −3.18 to −2.48; p < 0.00001).

(2) Quality of life, pain, and mood disorder

The quality of life, pain, and mood disorder were not reported in comparing AT to the Western medication group.

4) Safety

Nine (81.8%) out of the 11 RCTs13,1521,23) reported adverse events (Table 1). Among these nine studies, there were only two cases of mild subcutaneous hemorrhage in Zhang et al.18), but the group to which these cases belonged to was not reported. No other adverse events were reported in the remaining eight studies13,1517,1921,23).

IV. Discussion

The CFS is a group of symptoms accompanied by severe fatigue, cognitive decline, pain, and insom- nia2). There are no definite diagnosis methods and the causes of CFS remain unclear. Therefore, various treatments are currently used to alleviate the fatigue and improve the quality of life17,24).
In recent studies comparing individuals with CFS to healthy controls, the involvement of the central nervous system, neuro-hormone control system, chronic immune activity, and psycho-social factors has been reported 24). Based on this, a variety of therapies such as exercise7), behavioral therapy8), and CAM912) have been studied.
In particular, several studies2529) have shown that AT is also effective in relieving fatigue. In the reactive oxygen mechanism, AT increases superoxide dismutase (SOD) and glutathione peroxidase (GSH-PX), and decreases malonaldehyde (MDA)25,26). Furthermore, AT increases the lactate dehydrogenase (LDH), decreases creatine kinase (CK)27), enhances the muscle function by participating in Ca2+-ATPase activity in skeletal muscle cells28), and activates the neuro-endocrine- immune system by controlling the hypothalamus- pituitary-adrenal axis and the immune system29).
Although studies about the mechanism of acupuncture in reducing fatigue exist, there is no systematic review of acupuncture since 2009. In addition, there were several limitations in the previous review12) Therefore, we attempted to systematically summarize the efficacy and safety of AT.
A total of 1,277 studies were selected by searching 15 domestic and overseas databases. Finally, 11 RCTs with 869 patients with CFS were included and analyzed.
First, nine RCTs1416,1823) compared between AT and Sham acupuncture and demonstrated a statistically significant effect of AT in relieving fatigue and pain, but not in improving the quality of life and mood (Table 2). The evidence was unclear in the analysis of quality of life possibly due to the lack of consistency in the reported results, wide range of confidence intervals, small sample size, and the small number of studies that evaluated mood disorders such as depression and anxiety (i.e., one study21)).
Second, one RCT17) compared between AT and patients in the Wait-list group and showed a significant effect of AT in alleviating fatigue and mood disorders including stress response, depression, and insomnia; the results were not conclusive due to the low number of studies (Table 3).
Finally, one RCT13) compared between AT and Western medication and also showed a significant fatigue reducing effect of AT. This evidence was also inconclusive due to the low number of studies (Table 4).
Nine (81.8%) of the 11 RCTs13,1521,23) reported adverse events, but there were no serious adverse cases except for two18) with mild subcutaneous hemorrhage.
The previous systematic review12) of AT in CFS also reported a significant effect of AT in alleviating the symptoms, but the search period was limited to the period between 1998 and 2008. Furthermore, the search was conducted in databases based in China except for core overseas databases such as Pubmed, Cochrane, and EMBASE. In addition, there was the limitation of including studies that compared AT with other CAM therapies, but not with Sham or Wait-list groups; thus, the conclusion in that review was limited. Therefore, we modified the search strategy in order to analyze clearly the efficacy of AT in CFS. We added the databases mentioned above that are related to the field and retrieved all RCTs until 2016. In addition, the selection criteria was strictly limited to assess the effect of AT alone, while we used the Cochrane risk of bias tool instead of the Jadad score for a detailed assessment of the quality of the literatures.
Nevertheless, our present review has several limitations. First, the number of studies included in the final analysis was relatively small due to the exclusion of various studies while strictly applying the selection criteria. Many studies that compared acupuncture with CAM therapy and those of combined therapy were excluded in the secondary selection process. As a result, a quantitative analysis was impossible for certain outcome variables due to insufficient number of studies. Moreover, the funnel plot analysis was not performed for the same reason. Second, the risk of bias of the included studies was generally unclear. The risk of performance bias was particularly high because of the nature of AT whereby the practitioner cannot be blinded for the treatment. Third, several of the selected studies that did not mention the details of the random sequence generation, allocation concealment, and blinding of the evaluator. Therefore, the quality of the literature was not properly evaluated. Fourth, there was a risk of potential reporting bias because only one study15) presented a study protocol. Fifth, nine of the 11 selected studies1315,1823) were conducted in China; thus there was a possibility of potential bias in publishing. Finally, there was a variety of symptoms in patients with CFS, which were evaluated as different outcome variables for each study. As a result, the number of participants included in the quantitative synthesis of each variable was insufficient and there was also a heterogeneity problem arising when different outcome measures were synthesized together. Furthermore, there was a possibility that heterogeneity occurred according to the methodological quality because no comparisons were performed between strictly conducted and non-strictly conducted studies.
In future systematic reviews, more well- designed RCTs should be included in the final selection. Hence, the study design of each RCT including intervention and control group settings, random sequence generation, allocation concealment, blinding of patients and evaluators, and preprotocol study registration should be made appropriately. In addition, in order to obtain a more clear evidence from the meta-analysis, larger studies should be included and unexplained heterogeneity should be minimized in the quantitative synthesis by additional subgroup analysis according to the study design. Moreover, future studies should standardize the outcome variables for the same symptom to reduce the heterogeneity.

V. Conclusion

This review established evidence that AT in patients with CFS may be beneficial in alleviating the symptoms, and showed that there are no indications of symptom deterioration or serious adverse events. A positive effect on fatigue and pain was also observed, but no conclusion regarding improvement in the quality of life and mood disorders could be drawn.

Fig. 1
Flow Diagram of Selection Process (CAM: complementary and alternative medicine)
acup-34-2-93f1.tif
Fig. 2
Risk of Bias Graph
acup-34-2-93f2.tif
Fig. 3
Risk of Bias Summary
acup-34-2-93f3.tif
Fig. 4
Forest Plot: AT vs Sham AT (FS)
acup-34-2-93f4.tif
Fig. 5
Forest Plot: AT vs Sham AT (FSS)
acup-34-2-93f5.tif
Fig. 6
Forest Plot: AT vs Sham AT (SPHERE)
acup-34-2-93f6.tif
Fig. 7
Forest Plot: AT vs Sham AT (QOL)
acup-34-2-93f7.tif
Fig. 8
Forest Plot: AT vs Sham AT (VAS)
acup-34-2-93f8.tif
Table 1
Summary of Included Studies
Author (year) Diagnosis Sample size Sex (M/F) Mean age Treatment period AT Sessions Intervention group (regime) Control group (regime) Main outcomes Intergroup differences Adverse events
Hou13) (2016) CDC (1988) 157
74/83
36.0
30 days
21
(A) AT (n = 89)
(30 min, once daily, 7 times as a course, for three courses, with 3 days interval in between)
(B) Western medicine (n = 68)(br)(Floxetine Hydrochloride cap. 20 mg/d for 30 days + Vit B6 20 mg/d for 3 weeks) 1) FS 1) p < 0.05 no
Tang14) (2015) CDC (1994) 17
(n.r.)
34.9
4 wk
16
(A) AT (n = 8)
(30 min, 5 times weekly for 2 weeks + 3 times weekly for 2 weeks)
(B) Sham AT (n = 9)
(30 min, nonacupoint, Streitberger placebo needle, 5 times weekly for 2 weeks + 3 times weekly for 2 weeks)
1) CIS
2) SPHERE
3) SF-36
1) p > 0.05
2) p > 0.05 2)
p > 0.05
(n.r.)
Lu15) (2014) CDC (1994) 133
60/73
34.4
20 days
20
(A) AT (n = 47) (30 min, once daily)
(B) moxa-heated AT (n = 44)
(moxa-heated AT 20 min + AT 30 min, once daily)
(C) Sham AT (n = 42)
(30 min, nonacupoint, once every day)
1) FS 1) [AvsC]
p < 0.05
[BvsC]
p < 0.01
no
Ng16) (2013) CDC (1994) 99
31/68
40.9
4 wk
8
(A) AT (n = 50)
(30 min, 2 times weekly)
(B) Sham AT (n = 49)
(30 min, acupoint, Streitberger placebo needle, 2 times weekly)
1) FS
2) SF-12
3) GHQ-12
1) [p]
p < 0.05
[m]
p < 0.01
2) [p]
p < 0.05
[m]
p = 0.452
3) p = 0.766
no
Kim17)
(2012)
CDC (1994) 24
9/15
43.7
4 wk
12
(A) AT (n = 12)
(20 min, 3 times weekly)
(B) no treatment (n = 12) 1) FSS
2) SRI
3) BDI
4) ISI
5) PGA
1) p<0.001
2) p<0.005
3) p = 0.0001
4) p < 0.005
5) p < 0.05
no
Zhang18) (2012) CDC (1994) 72
30/42
34.0
4 wk
13
(A) AT (n = 47)
(30 min, 5 times for 1 week, 3 times for the subsequent 2 weeks, 2 times for the last week)
(B) Sham AT (n=25)
(30 min, acupoint, Streitberger placebo needle, 5 times for one week, 3 times for next 2 weeks, 2 times for last one week)
1) FSS
2) SPHERE
3) SF-36
1) p < 0.05
2) p < 0.05
3) p = 0.099
subcutaneous hematoma 2*
Zhang19) (2011) CDC (1994) 119
56/64
43.3
4 wk
20
(A) AT (n = 59)
(20 min, once daily except weekend)
(B) Sham AT (n = 60)
(20 min, nonacupoint, once daily except weekend)
1) FS
2) SF-20
1) p < 0.01
2) p < 0.05
no
Chan20) (2010) CDC (1994) 53
23/30
38.7
2 wk
6
(A) AT (n = 27)
(30 min, 3 times weekly)
(B) Sham AT (n = 26)
(30 min, acupoint, Streitberger placebo needle, 3 times weekly)
1) WHOQOL
2) FS
3) Effective rate
1) p < 0.01
2) p < 0.01
3) p < 0.01
no
Wang21) (2009) CDC (1994) 64
26/38
37.3
(n.r.)
14
(A) AT (n = 32)
(30 min, 3 times weekly, 7 times as a course, for 2 courses, with 3-7 days interval in between)
(B) Sham AT (n = 32)
(30 min, nonacupoint, 3 times weekly, 7 times as a course, for 2 courses, with 3-7 days interval in between)
1) WHOQOL
2) FS
3) VAS
4) SDS
5) SAS
1) 2) 3) 4) 5)
Not stated
no
Zhu22 (2008) CDC (1994) 60
16/44
38.1
12 d
10
(A) EA (n = 30)
(20 min, once daily, 5 times as a course, for 2 courses, with 2 days interval in between)
(B) Sham EA (n = 30)
(20 min, nonacupoint, once daily, 5 times as a course, for 2 courses, with 2 days interval in between)
1) FSS
2) SPHERE
3) SF-36
4) VAS
1) p < 0.01
2) p < 0.01
3) p < 0.01
4) p < 0.01
(n.r.)
Wang23) (2007) CDC (1994) 71
18/53
36.5
10 d
10
(A) EA (n = 36)
(20 min, once daily)
(B) Sham EA (n = 35)
(20 min, nonacupoint, once daily)
1) FSS
2) SPHERE
3) SF-36
1) p < 0.0001
2) p < 0.05
3) p < 0.05
no

* Not stated about the group.

CDC: Centers for Disease Control and Prevention, AT: acupuncture, FS: Chalder fatigue scale, CIS: checklist for individual strength, SPHERE: somatic and psychological health report, SF: short form, GHQ: general health questionnaire, FSS: fatigue severity scale, SRI: stress response inventory, BDI: Beck depression inventory, ISI: insomnia severity index, PGA: patient global assessment, VAS: visual analogue scale, SDS: self-rating depression scale, SAS: self-rating anxiety scale, EA: electro-acupuncture.

Table 2
Summary of Findings: AT versus Sham AT
Outcomes Illustrative comparative risks* (95% CI) Relative effect (95%CI) Number of Participants (studies) Quality of the evidence (GRADE) Comments
Assumed risk
Sham AT
Corresponding risk
AT
FS
(Fatigue)
The mean FS in the control groups was 12.16 points The mean FS in the intervention groups was 1.63 lower (2.55 to 0.72 lower) 216
(3 studies)
⊕⊕⊕⊖
moderatea,b
Lower score indicates less fatigue
FSS
(Fatigue)
The mean FSS in the control groups was 39.72 points The mean FSS in the intervention groups was 9.54 lower (17.2 to 1.89 lower) 132
(2 studies)
⊕⊕⊕⊖
moderatec,d
Lower score indicates less fatigue
SPHERE
(Quality of life)
The mean SPHERE in the control groups was 6.64 points The mean SPHERE in the intervention groups was 5.27 lower (8.63 to 1.92 lower) 149
(3 studies)
⊕⊕⊕⊖
moderatec,e
Lower score indicates improved general health
SF- 12,20,36
(Quality of life)
The SF score in the intervention groups was on average 0.65 SDs(0.04 lower to 1.34 higher) higher than in the control groups 367
(5 studies)
⊕⊖⊖⊖
very lowf,g,h
As a rule of thumb, 0.2 SD represents a small difference, 0.5 a moderate, and 0.8 a large
QOL
(Quality of life)
The QOL score in the intervention groups was on average 0.21 SDs(0.06 lower to 0.48 higher) higher than in the control groups 216
(3 studies)
⊕⊕⊖⊖
lowa,h
As a rule of thumb, 0.2 SD represents a small difference, 0.5 a moderate, and 0.8 a large
VAS
(Pain)
The mean VAS in the control groups was 69.92 points The mean VAS in the intervention groups was 11.81 lower (16.99 to 6.63 lower) 124
(2 studies)
⊕⊕⊕⊖
moderatec
Lower score indicates improved pain
SDS
(Mood disorders)
The mean SDS in the control groups was 36.34 points The mean SDS in the intervention groups was 2.4 lower (6.79 lower to 1.99 higher) 64
(1 study)
⊕⊖⊖⊖
very lowc,i
Lower score indicates fewer depressive symptoms
SAS
(Mood disorders)
The mean SAS in the control groups was 33.22 points The mean SAS in the intervention groups was 0.44 lower (3.92 lower to 3.04 higher) 64
(1 study)
⊕⊖⊖⊖
very lowc,i
Lower score indicates fewer anxiety

* 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).

WHOQOL-BREF and GHQ-12

AT: acupuncture therapy, CI: Confidence interval, SD: standard deviation, FS: Chalder Fatigue Scale, FSS: Fatigue Severity Scale, SPHERE: Somatic and Psychological Health Report, SF: Short Form, VAS: Visual Analogue Scale, SDS: Self-rating Depression Scale, SAS: Self-rating Anxiety Scale, GHQ-12: General Health Questionnaire-12.

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 Two studies have a high risk of incomplete outcome data and one study has a high risk of detection bias.

b The 95% CIs of two studies are wide, but all studies relatively have a consistency of MD and there is no heterogeneity (I2=0%).

c There is no high risk of bias, but several domains are unclear.

d Although there is a heterogeneity, two studies have same effect for alleviating fatigue.

e The I2 score is large and heterogeneity is significant, but the heterogeneity is explained by subgroup analysis and all studies have a consistency of MD.

f One study has a high risk of detection bias and incomplete outcome data bias, and other studies are unclear in several domains.

g Unexplained heterogeneity (I2=90.5%) and there is no consistency of SMD.

h The CIs encompass benefit and harm.

i Only one study included and total sample size is relatively small. In addition, the CIs are wide and encompass benefit and harm.

Table 3
Summary of Findings: AT versus Wait-list
Outcomes Illustrative comparative risks (95% CI) Relative effect (95%CI) Number of Participants (studies) Quality of the evidence (GRADE) Comments
Assumed risk
Wait-list
Corresponding risk
AT
FSS (Fatigue) The mean FSS in the control groups was 5.41 points The mean FSS in the intervention groups was 1.5 lower (2.25 to 0.75 lower) 24 (1 study) ⊕⊕⊖⊖
lowa,b
Lower score indicates less fatigue
SRI (Mood disorders) The mean SRI in the control groups was 61.5 points The mean SRI in the intervention groups was 27 lower (38.17 to 15.83 lower) 24 (1 study) ⊕⊕⊖⊖
lowa,b
Lower score indicates lower stress- response
BDI (Mood disorders) The mean BDI in the control groups was 16.42 points The mean BDI in the intervention groups was 12.17 lower (19.09 to 5.25 lower) 24 (1 study) ⊕⊕⊖⊖
lowa,b
Lower score indicates fewer depressive symptoms
ISI (Mood disorders) The mean ISI in the control groups was 15.67 points The mean ISI in the intervention groups was 7.42 lower (11.36 to 3.48 lower) 24 (1 study) ⊕⊕⊖⊖
lowa,b
Lower score indicates lower severity of insomnia

SRI: Stress Response Inventory; BDI: Beck Depression Index; ISI: Insomnia Severity Index.

a This trial have a high risk of performance bias due to unblinded patients.

b The evidence was downgraded due to small number of participants of meta-analysis.

Table 4
Summary of Findings: AT versus Western Medication
Outcomes Illustrative comparative risks (95% CI) Relative effect (95%CI) Number of Participants (studies) Quality of the evidence (GRADE) Comments
Assumed risk
Western medication
Corresponding risk
AT
FS
(Fatigue)
The mean FS in the control groups was 7.31 points The mean FS in the intervention groups was 2.83 lower (3.18 to 2.48 lower) 157
(1 study)
⊕⊕⊕⊖
moderatea
Lower score indicates less fatigue

a Downgraded because of unblinded patients and unclear risk of bias in several domains.

VI. References

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3. Lloyd AR, Hickie I, Boughton CR, Spence O, Wakefield D. Prevalence of chronic fatigue syndrome in an Australian population. Med J Aust. 1990;153:522–8.
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4. E Sharpe M, Archard LC, Banatvala JE, et al. A report—chronic fatigue syndrome: guidelines for research. J R Soc Med. 1991;84:118–21.
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5. Wessely S. The epidemiology of chronic fatigue syndrome. Epidemiol Rev. 1995;17(1):139–51.
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7. Larun L, Brurberg KG, Odgaard-Jensen J, Price JR. Exercise therapy for chronic fatigue syndrome. Cochrane Database Syst Rev. 2016;12:CD003200.
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8. Price JR, Mitchell E, Tidy E, Hunot V. Cognitive behaviour therapy for chronic fatigue syndrome in adults. Cochrane Database Syst Rev. 2008;3:CD001027.
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9. Denise A, Wu TX, Yang XZ, Tai SS, Sunita V. Traditional Chinese medicinal herbs for the treatment of idiopathic chronic fatigue and chronic fatigue syndrome. Cochrane Database Syst Rev. 2009;4:CD006348.
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11. Terje A, Lee MS, Choi TY, Cao HJ, Liu JP. Complementary and alternative medicine for patients with chronic fatigue syndrome: A systematic review. BMC Complement Altern Med. 2011;11:87.
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12. Wang JJ, Song YJ, Wu ZC, et al. A Meta-Analysis on Randomized Controlled Trials of Acupuncture Treatment of Chronic Fatigue Syndrome. Zhen Ci Yan Jiu. 2009;34(6):421–8.
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13. Hou XY, Jia GP, Tian LY, Gao F, Liu XW. The study on the mechanism of the front and rear points acupuncture method for chronic fatigue syndrome patient (前后配穴法对慢性疲劳综合征患者 的作用机制研究). Hebei Medical J. 2016;38(10):1560–2. PMID: 10.3969/j.issn.1002-7386.2016.10.037.

14. Tang LW. A Multimodel MRI Study of Central Mechanism in Acupuncture for Cognitive Function of CFS [dissertation]. Chengdu: Chengdu Univ, 2015. Chinese.

15. Lu C, Yang XJ, Hu J. Randomized controlled clinical trials of acupuncture and moxibustion treatment of chronic fatigue syndrome patients. Zhen Ci Yan Jiu. 2014;39(4):313–7.
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16. Ng SM, Yiu YM. Acupuncture for Chronic Fatigue Syndrome: A Randomized, Sham-controlled Trial With Single-blinded Design. Altern Ther Health Med. 2013;19(4):21–6.

17. Kim JE, Kang KW, Kim AR, et al. Acupuncture for chronic fatigue syndrome and idiopathic chronic fatigue: a pilot randomized controlled trial. The Acupunct. 2012;29(5):109–18.
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18. Zhang RF. A Randomized Controlled Study on Treating Chronic Fatigue Syndrome by Acupuncturing Acupoints on Meridians [dissertation]. Chengdu: Chengdu Univ, 2012. Chinese.

19. Zhang W, Liu ZS, Xu HR, Liu YS. Observation on therapeutic effect of acupuncture of Back-shu acupoints for chronic fatigue syndrome patients. Zhen Ci Yan Jiu. 2011;36(6):437–48.
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20. Chan CW. Mechanism and clinical observation on acupuncture in chronic fatigue syndrome [dissertation]. Guangzhou: Guangzhou Univ, 2010. Chinese.

21. Wang JJ. The Clinical Effect Study of Acupuncture on Quality of Life of Patients with Chronic Fatigue Syndrome [dissertation]. Beijing: China Academy of Chinese Medical Sciences, 2009. Chinese.

22. Zhu YH, Liang FR, Cheng CS, Wu X, Wang HW, Bao KY. A randomized controlled trial of electroacupuncture for chronic fatigue syndrome. SH J TCM. 2008;42(10):48–50.
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23. Wang HW. The Clinical Effect Study of Electric Acupuncture to Treat Chronic Fatigue Syndrome [dissertation]. Chengdu: Chengdu Univ, 2007. Chinese.

24. Jung SP, Lee KM. Chronic Fatigue Syndrome. Yeungnam Univ J Med. 2007;24(1):1–10.
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25. Liu CZ, Lei B. Effect of acupuncture intervention on learning-memory ability and cerebral superoxide dismutase activity and malonaldehyde concentration in chronic fatigue syndrome rats. Zhen Ci Yan Jiu. 2013;38(6):478–81.
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26. Liu CZ, Lei B. Effect of acupuncture on serum malonaldehyde content, superoxide dismutase and glutathione peroxidase activity in chronic fatigue syndrome rats. Zhen Ci Yan Jiu. 2012;37(1):38–40, 58.

27. Gu YH, Ren JN, Wu YC, Li SD, Shi SS. Influence of acupuncture on the motor ability in training-induced fatigue mice. Zhen Ci Yan Jiu. 2010;35(5):359–62.
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28. Gao M, Yang HY, Le K, Liu TY, Gu XJ. Effects of manual acupuncture and electroacupuncture on Ca2+ content and Ca2+-ATPase Activity in sarcoplasmic reticulum of skeletal muscle cells in rats during acute swimming exercise. Zhen Ci Yan Jiu. 2008;33(1):13–6.
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29. Chen YS, Lu J, Su-Chao LM, Wu QZ, Tu Y, Agula . Effects of electro-warmed needle of inner-Mongolian medicine on serum TNF-alpha, ACTH and corticosterone contents in fatigue rats. Zhen Ci Yan Jiu. 2008;33(4):258–61.
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Appendices

Appendix 1. Search Strategy

A. Pubmed (16-09-08)
 #1 “fatigue syndrome, chronic”[mh] (n=4766)
 #2 “myalgic encephalomyelitis” (n=579)
 #3 “myalgic encephalitis” (n=30)
 #4 #1 OR #2 OR #3 (n=5010)
 #5 acup* OR “acupuncture”[mh] OR “acupuncture therapy”[mh] (n=26324)
 #6 electroacup* OR electro-acup* OR “electroacupuncture”[mh] (n=4344)
 #7 “auricular acup*” OR “ear acup*” OR “acupuncture, ear”[mh] (n=1160)
 #8 “acupuncture points”[mh] (n=5094)
 #9 “scalp acup*” (n=277)
 #10 pharmacoacup* OR pharmaco-acup* (n=3)
 #11 “laser acup*” (n=806)
 #12 “acupoint injection” (n=125)
 #13 “dry needle” OR “dry needling” OR needling (n=2085)
 #14 #5 OR #6 OR #7 OR #8 OR #9 OR #10 OR #11 OR #12 OR #13 (n=27158)
 #15 #4 AND #16 (n=50)
B. Cochrance Library (16-09-08)
 #1 chronic fatigue syndrome (n=1616)
 #2 myalgic encephalomyelitis (n=33)
 #3 myalgic encephalitis (n=7)
 #4 #1 or #2 or #3 (n=1616)
 #5 acup* (n=11237)
 #6 electroacup* or electro-acup* (n=1534)
 #7 “auricular acup*” or “ear acup*” (n=456)
 #8 “scalp acup*” (n=213)
 #9 pharmacoacup* or pharmaco-acup* (n=2)
 #10 “laser acup*” (n=240)
 #11 “acupoint injection” (n=304)
 #12 needling or “dry needl*” (n=1135)
 #13 #5 or #6 or #7 or #8 or #9 or #10 or #11 or #12 (n=11632)
 #14 #4 and #13 (n=153)
C. EMBASE (16-09-19)
 #1 ‘chronic fatigue syndrome’ (n=8877)
 #2 ‘myalgic encephalomyelitis’ OR ‘myalgic encephalitis’ (n=694)
 #3 #1 OR #2 (n=9004)
 #4 acup* (n=42262)
 #5 electroacup* OR ‘electro-acup*’ (n=6119)
 #6 ‘auricular acup*’ OR ‘ear acup*’ (n=847)
 #7 ‘scalp acup*’ (n=283)
 #8 pharmacoacup* OR ‘pharmaco-acup*’ (n=8)
 #9 ‘laser acup*’ (n=399)
 #10 ‘acupoint injection’ (n=156)
 #11 needling OR “dry needl*” (n=2803)
 #12 #4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10 OR #11 (n=44088)
 #13 #3 AND #12 (n=136)
D. CINAHL (EBSCO host) (16-09-08)
 S1 TX chronic fatigue syndrome (n=3663)
 S2 TX myalgic encephalomyelitis (n=449)
 S3 TX myalgic encephalitis (n=42)
 S4 or/1-3 (n=3752)
 S5 TX acup* (n=23621)
 S6 TX electroacup* or electro-acup* (n=1915)
 S7 TX “auricular acup*” or “ear acup*” (n=698)
 S8 TX “scalp acup*” (n=114)
 S9 TX pharmacoacup* or pharmaco-acup* (n=5)
 S10 TX “laser acup*” (n=288)
 S11 TX “acupoint injection” (n=37)
 S12 TX needling or “dry needl*” (n=1902)
 S13 or/5-12 (n=24321)
 S14 S4 and S13 (n=248)
E. AMED (EBSCO host) (16-09-08)
 S1 TX chronic fatigue syndrome (n=1396)
 S2 TX myalgic encephalomyelitis (n=99)
 S3 TX myalgic encephalitis (n=5)
 S4 or/S1-3 (n=1433)
 S5 TX acup* (n=10195)
 S6 TX electroacup* or electro-acup* (n=997)
 S7 TX “auricular acup*” or “ear acup*” (n=486)
 S8 TX “scalp acup*” (n=112)
 S9 TX pharmacoacup* or pharmaco-acup* (n=0)
 S10 TX “laser acup*” (n=76)
 S11 TX “acupoint injection” (n=19)
 S12 TX needling or “dry needl*” (n=804)
 S13 or/S5-12 (n=10398)
 S14 S4 and S13 (n=24)
F. CNKI (16-09-09)
 1 SU=(‘chronic fatigue syndrome’+‘myalgic encephalomyelitis’+‘myalgic encephalitis’+‘慢性疲劳综合征’) (n=3070)
 2 SU=(‘acupuncture’+‘electroacupuncture’+‘electro-acupuncture’+‘auricular acupuncture’+‘ear acupuncture’+‘scalp acupuncture’+‘pharmacoacupuncture’+‘pharmaco-acup-uncture’+‘laser acupuncture’+‘acupoint injection’+‘needling’+‘dry needle’+‘针’+‘针法’+‘针刺’+‘刺法’+‘电针’+‘电针疗法’+‘电针刺’+‘穴位注射疗’+‘针药治疗’+‘穴位注射’+‘光針’+‘耳針’+‘頭針’) (n=256285)
 3 1 and 2 (n=386)
G. Wanfang (16-09-09)
 1 标题: “chronic fatigue syndrome” or 标题: “myalgic encephalomyelitis” or 标题: “myalgic encephalitis” or 标题: “慢性疲劳综合征” (=937)
 2 标题: “acupuncture” or 标题: “electroacupuncture” or 标题: “electro-acupuncture” or 标题: “pharmacoacupuncture” or 标题: “pharmaco-acupuncture” or 标题: “auricular acupuncture” or 标题: “ear acupuncture” or 标题: “scalp acupuncture” or 标题: “laser acupuncture” or 标题: “acupoint injection” or 标题: “needling” or 标题: “dry needle” or 标题: “针” or 标题: “针法” or 标题: “刺法” or 标题: “针刺” or 标题: “电针” or 标题: “电针疗法” or 标题: “电针刺” or 标题: “穴位注射疗” or 标题: “针药治疗” or 标题: “穴位注射” or 标题: “光針” or 标题: “耳針” or 标题: “頭針” (n=124158)
 3 1 and 2 (n=277)

Appendix 2. General characteristics of acupuncture treatment

Study Intervention Acupoints De-Qi Retaining time
Hou 2016 AT BL15, BL17, BL18, BL22, BL23, CV4, CV6, CV12, CV17 (n.r.) 30min
Tang 2015 AT BL18, BL23, ST36, HT7, GV20 O 30min
Lu 2014 (A) AT (A) GV20, CV17, CV6, CV4, ST36, LI4, LR3, SP6 (A) O (AT) 30min
(B) Moxa-AT & AT (B) (Moxa-AT) GV20, CV6, CV4, ST36 (B) X (Moxa-AT) 20min
(AT) CV17, LI4, LR3, SP6
Ng 2013 AT GV20, ST36, SP6 O 30min
Kim 2012 AT GV20, GB20, BL11, BL13, BL15, BL18, BL20, BL23 X 20min
Zhang 2012 AT BL18, BL23, ST36, HT7 O 30min
Zhang 2011 AT BL15, BL20, BL43 O 20min
Chan 2010 AT ST36, KI3 O 30min
Wang 2009 AT GV20, CV17, CV12, CV6, CV4, LI4, ST36, SP6, LR3, KI3, BL18, BL20, BL23 O 30min
Zhu 2008 EA ST36, BL23 O 20min
Wang 2007 EA ST36, BL23 (n.r.) 20min

AT: Acupuncture treatment, Moxa-AT: Moxa-heated needling, EA: Electro-acupuncture



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