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 acu...
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.
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.
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문제 정의
Therefore, the purpose of the present review was to assess the efficacy and safety of AT by system-atically summarizing data from randomized controlled trials (RCTs) of acupuncture in patients with CFS.
제안 방법
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 study design was classified into three categories based on the intervention in the control group. Among the 11 RCTs, nine studies14-16,18-23) were compared with Sham acupuncture, while the other two studies were compared to the Wait-list group17) and Western medication group13).
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).
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.
대상 데이터
A total of 1,277 studies were screened and 869 participants of 11 RCTs were finally included in this review. Fig.
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.
A total of 21 acupoints were used. The most used acupoint was ST36, which was applied in eight studies14-16,18,20-23), followed by BL23 in seven studies13,14,17,18,21-23), BL1813,14,17,18,21) and GV20 in five studies14-17,21), 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.
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.
. 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).
이론/모형
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 RCTs14-18,20,21,23) presented a detailed methodological description, while the remaining three13,19,22) did not.
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 ap < 0.
성능/효과
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).
(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.
(4) Effective rates were measured by calculating the change in each score such as [(score before treatment – score after treatment) / score before treatment] × 100.
First, nine RCTs14-16,18-23) 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.
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).
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).
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%).
후속연구
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.
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