| BackgroundChronic fatigue syndrome (CFS) is one of the prevalent disorders with an increasing incidence in clinic, which influence patients'life quality. There are kinds of acupuncture methods to deal with CFS, however, the effectiveness of acupuncture for CFS maintains unknown due to the lacking of high-quality research evidence. Moreover, the acupoint selection rules of acupuncture for CFS is still not clear, thus, cannot maximize the effectiveness of acupuncture.ObjectiveTo assess the clinical therapeutic effectiveness and security of acupuncture for CFS; Establishing the scoring and weighting scheme of CONSORT and STRICTAto assess the reporting quality of randomized controlled trials (RCT) of acupuncture for CFS; To analyze the acupoint selection rules of acupuncture for CFS by using data mining technology, providing optimized evidence for treatment and research.Methods1. Systematic review:Comprehensive retrieve large medical databases at home and abroad, conduct strict screening according to inclusive/exclusive criteria, use the bias risk assessment recommended by Cochrane Handbook 5.1 to assess the bias risk of the included literature, analyze the data statistically with an analysis software RevMan5.2, and evaluate the quality of the evidence with a software GRADE profiler 3.6.2. Assessment of the reporting quality of RCT: ?Based on 3 versions of CONSORT in 1996,2001,2010, and 2 versions of STRICTA in 2001,2010, developed the coring scheme and weighting scheme of each item.?Retrieved and screened literatures of acupuncture RCTs for CFS,2 researchers evaluated the reporting quality of included trials respectively. Then conducted statistical analysis by using Microsoft Excel 2007 and SPSS 21.0.3. Data mining:Combine subject headings and text words, retrieve Embase, Pubmed, Cochrane Library, CBM, CNKI, VIP, WangFang. Conduct strict screening according to inclusive/exclusive criteria. Set up the database of acupuncture prescription, input data. Use "acupuncture data mining system V1.0 (2009SR014647)" to analyze the acupoint regulation rules.Results1. Systematic review:9 RCTs were included, including 730 patients. Bias risk mainly existed in incomplete data and blinding method. Comparing acupuncture with placebo, there were significant difference in Chalder [WMD=-8.19,95% CI (-10.62,-5.76)], FSS [WMD=-4.96,95% CI (-11.83,1.91)], SF-36 [WMD= 10.78,95% CI (6.01,15.55)], SPHERE [WMD=-2.75,95% CI (-5.94,0.44)], VAS [WMD=-34.69,95% CI (-70.89,1.51)]. Comparing acupuncture with infusion, significant difference existed in Chalder [WMD=-1.93,95% CI (-2.75,-1.11)]. Comparing electro-acupuncture with placebo, significant difference existed in FSS [WMD=-12.87,95% CI (-15.86,-9.88)], SF-36 [WMD= 17.15,95% CI (15.54,18.76)], SPHERE [WMD=-6.94,95% CI (-8.67,-5.21)], VAS [WMD=-11.33,95% CI (-16.56,-6.10)]. The evidence quality of all outcomes remained moderate or low. There was no report of adverse event.2. Assessment of the reporting quality of RCT:34 articles were included, ?ccording to CONSORT:the average of total score was 133.68 out of 329. The average of each part score were 5.38 out of 19 in "Title and abstract",5.32 out of 19 in "Introduction",3.38 out of 157 in "Methods",3.69 out of 89 in "Results",5.67 out of 30 in "Discussion",0.29 out of 15 in "Other information".?according to STRICTA:the average of total score is 94.39 out of 166. The average of each part score were 5.25 out of 28 in "Acupuncture rationale",6.03 out of 70 in "Details of needling",9.12 out of 20 in "Treatment regimen",3.16 out of 18 in "Other components of treatment",0.15 out of 10 in "Practitioner background",5.88 out of 20 in "Control or comparator interventions", ?tratified analysis of CONSORT and STRICTA:The results showed there were no statistical significance when stratified factor were "whether the paper was published before 2010"and "whether the paper was included in Chinese core periodicals" (P> 0.05). The results showed there were statistical significance when stratified factor were "whether the paper was academic dissertation" and "whether the paper was funded" (P<0.05).3. Data mining:196 articles,218 acupuncture prescriptions were included.43 acupoints were used for 1377 times in total. The top 5 frequently-used acupoints were ST36 (136/62.4%), BL23 (92/42.2%), BL20 (86/39.4%), BL18 (84/38.5%), SP6 (78/35.8%). The most frequently-used 2 acupoints-combination was ST36?SP6 (29.4%),3 acupoints-combination ST36+SP6?DU20 (18.3%), and 4 acupoints-combination ST36+RN4+BL23?BL20 (12.8%).Conclusions1. Acupuncture may be effective and safe in improving CFS. However, due to the low quality of evidence and small number of RCTs, cautious attitude should be taken on this conclusion, and also need to be exploded by further trials with large sample and high quality.2. When reporting the RCT of acupuncture for CFS, following aspects should be paid attention to:randomization, allocation concealment, calculation of sample size, statistical methods, the adjustment of research plan, relevant research information, assistant methods, the background and qualifications of practitioner, operation details. Establishment of the scoring and weighting scheme of CONSORT and STRICTA makes the reporting quality assessment results of acupuncture clinical trials more informative and accurate, and provides more guidance for improving the design and reporting of acupuncture clinical trial.3. Acupoint selection of CFS is given priority to disease differentiation. Points of Foot-Yangming Meridian, Foot-Taiyang Meridian and Foot-Taiyin Meridian are most frequently used. The use of Tonifying points and Back-shu points is emphasized. "ST36 combines with acupoints on above meridian" is the fundamental acupoints combination. Cooperation of superficial-internal meridians, crossed meridians and local-nearby-distal acupoints show that we should tonify the root of body:spleen and kidney to treat CFS. |
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