针灸治疗胃轻瘫综合征临床随机对照试验质量评价

Quality Evaluation of Acupuncture for Treatment of Gastroparesis Syndrome on Clinical Randomized Control Study Literatures

目的:评价国内针灸治疗胃轻瘫综合征的临床随机对照试验的真实性和相关内容,为进一步提高研究者临床研究设计水平和质量提供理论依据。方法:全面广泛收集针灸治疗胃轻瘫综合征临床对照试验,按照临床流行病学和循证医学的原则,对1979-2008年发表的合格文献进行系统评价。结果:检索到符合纳入标准的临床对照试验文献20篇,有16篇(80%)报告了疾病诊断标准;有17篇文献(85%)有疗效判定标准;所有文献均未报告随访情况。纳入文献都使用针灸治疗为试验组措施,疗效的统计学分析基本都正确。文献中仅有1例采用单盲法,没有进行样本估算,没有病例退出和不良反应情况的描述,随机化方法均未详细描述。结论:针灸治疗胃轻瘫综合征的临床研究文献逐年增加,特别是近年来研究者更多采用了随机对照方法,但亦存在不足,有待提高。

Objective： To evaluate validity and effective on clinical randomized control study literatures of acupuncture for treatment of gastroparesis syndrome and provide theory evidence for enhancing clinical research designing level and quality.Methods： To carry out quality evaluation on clinical randomized control study literatures of acupuncture for treatment of gastroparesis syndrome from 1979 to 2008. Results：To retrieval twenty valid literatures that consistented with selected standard of clinical randomized control trial literatures. Of the 20 literatures enrolled, only 1 mentioned single- blinding, 16（80% ） had clear diagnostic criteria, 17（85% ） had clear criteria for therapeutic effects. None had reported follow-up and adverse reaction. Conclusion：The literatures of acupuncture for treatment of gastroparesis syndrome introduced randomly contrast method. But there was some deficient in the clinical design. The quality of the study need enhancement.