针灸治疗慢性疲劳综合征文献质量评价

Evaluation of Literature Quality of Acupuncture in Treatment of Chronic Fatigue Syndrome

目的对针灸治疗慢性疲劳综合征的临床研究文献进行质量评价。方法检索1998-2008年针灸治疗慢性疲劳综合征的临床研究文献。按照临床流行病学和循证医学的原则和方法,对临床研究类型及方法学,一般情况,疾病诊断及纳入、排除标准,样本含量,疗效判定标准,随访,不良反应及安全性等进行评价。结果在78篇纳入文献中,国内研究76篇,且均发表于国内出版的中文期刊,仅有的2篇英文发表于国内出版的英文期刊;真正随机对照试验仅7篇,半随机对照试验及联系不到作者的随机对照试验21篇,非随机对照试验3篇,叙述性研究47篇;采用国际公认诊断标准的50篇,提及纳入、排除标准的22篇;采用中医疗效标准的26篇,用评分法进行疗效判定的研究有27篇;样本量100例以上的4篇,60～99例33篇;进行依从性评价的4篇;有退出、脱落病例记录及描述的3篇;记录随访情况的2篇;进行不良反应记录的11篇。结论针灸治疗慢性疲劳综合征的临床研究主要集中在国内,且研究质量和文献总体水平相对较低,这一领域迫切需要设计严谨的高质量随机对照研究,同时研究者应积极向国外期刊投稿。

Objective To assess the quality of literature of clinical studies on acupuncture in treatment of chronic fatigue syndrome. Methods The literatures between 1998--2008 were searched by means of electronic retrieval. Type and methodology, general condition, criteria for diagnosis and assessment of therapeutic effects, following-up and side effects etc. in clinical studies were evaluated according to principles and methods of clincial epidemiology and evidence-based medicine. Results Of the 78 literatures enrolled, 76 were studied in China and published in Chinese journal of China, only 2 were English literature and published in English journal of China. Only 7 were authentic randomized controlled trials （RCTs）, 21 quasi-randomized controlled trials and RCTs can＇t contact with authors, 3 non-randomized concurrent controlled trials and 47 narrative studies. 50 had clear international recognized diagnostic ctriteria. 22 mentioned enrolled or excluded criteria. 26 adopted TCM criteria for therapeutic effects, 27 evaluated therapeutic effects with grading. 4 the sample content above 100, 33 between 60 and 99, 4 mentioned compliance evaluation, 3 described retreat cases, 2 reported follow-up. 11 reported adverse reaction. Conclustion Clinical studies on acupuncture in treatment of chronic fatigue syndrome were mainly carried through in China, and the quality of study and literature is low comparatively. Therefore, high quality＇s RCTs with strict design are needed urgently in this area and the researchers should contribute to journals overseas.