- 1. Editorial Board of Journal of Sichuan University (Medical Science Edition), Chengdu 610041, China2. West China School of Medicine, Sichuan University, Chengdu 610041, China3. Chinese Evidence-Based Medicine and Clinical Epidemiology Center, West China Hospital, Sichuan University, Chengdu 610041, China;
Objectives To explore the quality of the reporting of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) for chronic fatigue syndrome (CFS).
Methods We searched the Cochrane Central Register of Controlled Clinical Trials (CENTRAL) (The Cochrane Library, Issue 4, 2006), PubMed, EMbase, the Chinese Biomedical Database (CBMdisc), VIP Information, and China National Knowledge Infrastructure (CNKI) (from establishment to February 2007). We also checked the reference lists of included studies. The quality of the reporting of RCTs was assessed using the 22-item checklist of the CONSORT Statement and other self-established criteria.
Results Thirty-eight RCTs were included. The word “randomization” was not present in any of the trials, and only 17 reports used a structured abstract. All trials did not report the scientific background and the rational for the trial, the estimation of the necessary sample size, the methods of allocation concealment and blinding, participant flow chart, ITT analysis, and ancillary analyses. Some authors misunderstood the diagnostic criteria and inclusion criteria, some selected inappropriate control interventions, and some did not clearly describe their statistical methods or used incorrect methods. All 38 trials reported positive outcomes, few reported adverse effects. No report included a general interpretation of the new trial’s results in the context of current evidence in their discussion section, and none mentioned the limitations of the study, the clinical and research implications or the external validity of the trial findings.
Conclusion The overall reporting quality of RCTs of TCM for CFS is poor. Defects are found in each section of the reports. Researchers and journal editors should learn and use the principles and methods of evidence-based medicine—especially the use of a transparent prospective clinical trial register and the CONSORT Statement—to improve the design, conduct and report TCM trials.
Citation： SHEN Jin,TANG Xi,ZOU Kun. Quality Assessment of the Reporting of Randomized Controlled Trials of Traditional Chinese Medicine for Chronic Fatigue Syndrome. Chinese Journal of Evidence-Based Medicine, 2007, 07(5): 385-391. doi: Copy
Copyright ? the editorial department of Chinese Journal of Evidence-Based Medicine of West China Medical Publisher. All rights reserved
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- 1. Bu YF, Zhang XL, Shen AH. Observations on the curative effect of Huangqi injection in the treatment of 43 patients with Chronic Fatigue Syndrome. Modern Journal of Integrated Traditional Chinese and Western Medicine, 2002, 11(3): 224.
- 2. Kang FC, Luo XY. Observation for the effect of Yiqi Yangyin method in the treatment of 30 patients with Chronic Fatigue Syndrome. International Medicine and Health Guidance Newsreative Company, 2006, 12(22): 43-44.
- 3. Liang G. Clinical observation of variated Shengmai powder and Xuefuzhuyu decoction in the treatment of 63 patients with Chronic Fatigue Syndrome. LiShiZheng Medicine and Materia Medical Research, 2006, 17(5): 801-802.
- 4. Liu ZX. Clinical observe of medicine treatment on the Chronic Fatigue Syndrome. Hebei Medicine, 2004, 10(11): 1022-1024.
- 5. Ning TC, Li YP. Variated Sijunzi decoction in the treatment of 23 patients with Chronic Fatigue Syndrome. Research of Traditional Chinese Medicine, 2002, 18(4): 16-17.
- 6. Peng ZY. Shenmai injection in the treatment of patients with Chronic Fatigue Syndrome. Modern Integrated Traditional Chinese and Western Medicine Journal, 2000, 9(8): 684-685.
- 7. Shu YQ, Zhang GL. Variated Buzhong Yiqi decoction in the treatment of 40 patients with Chronic Fatigue Syndrome. Journal of Anhui Traditional Chinese Medicine College, 1997, 16(5): 11-12.
- 8. Sun LF, Hao L, Li L. Observations on the curative effect of Naoshenkang capsule in the treatment of 354 patients with Chronic Fatigue Syndrome. Hebei Journal of Traditional Chinese Medicine, 2005, 27(4): 261-262.
- 9. Wang N. Clinical analysis of Zhonghuichuanghuang liquid in the treatment of Chronic Fatigue Syndrome. Modern Journal of Integrated Traditional Chinese and Western Medicine, 2004, 13(1): 53-54.
- 10. Wang N, Dan YF. Clinical observation of Xianqi decoction in the treatment of Chronic Fatigue Syndrome. Practical Clinical Journal of Integrated Traditional Chinese and Western Medicine, 2006, 6(2): 31-37.
- 11. Wei LL. Clinical observation of Xiaocaihu decoction in the treatment of Chronic Fatigue Syndrome. Chinese Archives of Traditional Chinese Medicine, 2005, 23(7): 1315-1317.
- 12. Xiong FL, Xiao YP. Acupoints shot by using Huangqi injection in the treatment of 32 patients with Chronic Fatigue Syndrome. Guangxi Journal of Triditional Chinese Medicine, 2000, 23(6): 30-31.
- 13. Zhang SX, Zhou W. Buzhong Yiqi decoction in the treatment of 40 patients with Chronic Fatigue Syndrome. Chinese Journal of Primary Medicine and Pharmacology, 2004, 11(5): 608.
- 14. Zhang R, Li J, Chen J, et al. Clinical observation of Shenqi Fuyuan decoction in the treatment of patients with Chronic Fatigue Syndrome. Chinese Journal of Information on TCM, 2004, 11(2): 148.
- 15. Yang SH, Gao M, Yang XW, et al. Clinical Observation of the Treatment of Chronic Fatigue Syndrome by Using BuzhongYiqi Decoction in Combination with Xiaochaihu Decoction. Journal of Beijing University of Traditional Chinese Medicine, 2004, 27(2): 87-89.
- 16. Yao RM, Qiu MY. Clinical Observation of Chronic Fatigue Syndrome Treated by Chinese Medicine in Hong Kong. Shanghai Journal of Traditional Chinese Medicine, 2005, 39(6): 12-13.
- 17. Zhao DF, Duan HD, Zhao JW. Clinical Effect of Supplementing Qi and Nourishing Yin Method in 30 Patients with Chronic Fatigue Syndrome. Tianjin Journal of Traditional Chin Medicine, 2006, 23(2): 126-127.
- 18. E JS, Wen BL. Observations on the curative effect of acupuncture and massage in the treatment of Chronic Fatigue Syndrome. Study Journal of Traditional Chinese Medicine, 2005, 23(2): 349-364.
- 19. Feng SJ, Ma QJ, Meng Y, et al. Clinical study of feet massage in the intervention of Chronic Fatigue Syndrome. Shandong Journal of Traditional Chinese Medicine, 2005, 24(5): 288-290.
- 20. Gou CY, Tian FW, Li N. Clinical study of moxibustion following channels in the treatment of Chronic Fatigue Syndrome. Sichuan Journal of Traditional Chinese Medicine, 2004, 22(3): 87-8.
- 21. Gui SQ. Comparative observation for the effect of reflect method in the treatment of patients with Chronic Fatigue Syndrome. China Reflexolocy, 2003, (6): 9-10.
- 22. Guo FY, Xu L. Preliminary Study on Treatment of Chronic Fatigue Syndrome by Herbal Cake-separated Moxibustion on Five-zang Back-shu Points. Shanghai Journal of Acupuncture and Moxibustion, 2006, 25(10): 11-12.
- 23. Jiao YX, Li YT, Zhao Q. Tiaoshen Daoqi method in the treatment of 36 patients with Chronic Fatigue Syndrome. Journal of Clinical Acupuncture and Moxbustion, 2006, 22(12): 51-52.
- 24. Li YM, Liu HP, Feng SL, et al. Observation for the effect of electronic acupuncture with ear points in the treatment with 32 patients with Chronic Fatigue Syndrome. New Journal of Traditional Chinese Medicine, 2005, 37(1): 61-62.
- 25. Lu YJ, Wang WH. Acupuncture and cupping in the treatment of 25 patients with Chronic Fatigue Syndrome. Shandong Journal of Traditional Chinese Medicine, 2001, 20(5): 350-351.
- 26. Luo CG, Zhou ZB, Wen WQ, et al. Flip and dial following bladder channels in the treatment of 30 patients with Chronic Fatigue Syndrome. Chinese Manipulation & Qi Gong Therapy, 2006, 22(3): 4-6.
- 27. Ni KQ. Acupuncture and Traditional Chinese Medicine in the treatment of 35 patients with Chronic Fatigue Syndrome. Journal of Fujian College of Traditional Chinese Medicine, 2002, 12(4): 22-23.
- 28. Sun YZ, Li HL. Observations on the curative effect of channel-unblocking Back-Shu and FrontMu points prescription on Chronic Fatigue Syndrome. Shanghai Journal of Acupuncture and Moxibustion, 2006, 25(11): 3-4.
- 29. Tian HZ, Chen JL. Effect on immunologic function of Ai Jiu Qiangzhuang acupoint in the treatment of patients with Chronic Fatigue Syndrome. Shenzhen Journal of Integrated Traditional Chinese and Western Medicine, 2006, 16(4), 226-227.
- 30. Wang WH, Wu SJ, Lu YJ, et al. Clinical Analysis on Treatment of Chronic Fatigue Syndrome with Combination of Acupuncture of Cupping. Chinese Acupuncture & Moxibustion, 2001, 21(8): 481-482.
- 31. Wang CX, Song QZ. Observations on the curative effect of percussing and pricking dorsi-shu-acupoints with pyonex in the treatment of 34 patients with Chronic Fatigue Syndrome. Journal of Clinical Acupuncture and Moxibustion, 2005, 21(2): 52-53.
- 32. Liu YY, Sun ZR. Acupuncture and cupping in the treatment of 40 patients with Chronic Fatigue Syndrome. Journal of Clinical Acupuncture and Moxibustion, 2006, 22(7): 22-23.
- 33. Pan CQ, Tang ZG, Tan GB. Electronic acupuncture with acupoint shot in the treatment of 35 patients with Chronic Fatigue Syndrome. Hunan Journal of Traditional Chinese Medicine, 2005, 21(6): 22-24.
- 34. Xie L, Diao BS. A Clinical Study of 40 patients with Chronic Fatigue Syndrome by Combined Internal-External Therapy of TCM. Journal of Sichuan of Traditional Chinese Medicine, 2005, 23(9): 53-54.
- 35. Yuan SG, Zhao CW. Observations on the curative effect of traditional Chinese medicine in the treatment of Chronic Fatigue Syndrome. Chinese Journal of Information on TCM, 2006, 13(8): 57.
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