中医药治疗更年期综合征随机对照试验文献的质量评价

目的:评价国内中医药治疗更年期综合征随机对照试验已发表文献的质量.方法:电子、手工检索获得发表的关于中医药治疗更年期综合征的随机对照试验或半随机对照试验或自称是随机对照试验无论是否采用盲法的文献,由两名研究者独立进行文献选择和资料提取工作,遵循循证医学的原则和文献系统性评价质量评价的原则,对文献质量进行分析评价.纳入试验的方法学质量采用Jadad评分标准与随机分配隐藏.结果:共51篇关于中医药治疗更年期综合征的随机对照试验满足纳入标准,2篇双盲试验被评为高质量试验,其余均为低质量.51篇文献中指出了具体随机方法的占7.9%,没有1篇提到分配隐匿;有明确诊断标准的占62.7%,明确疗效评价标准出处者占29.4%,明确指出组间有可比性的占56.9%,运用盲法的占7.8%,说明选择相应的统计学方法的依据或理由的占7.8%.结论:中医药治疗更年期综合征的随机对照研究中,高质量的随机对照试验较少,研究质量的总体水平亟待提高,应努力开展有资金资助的大样本、多中心、严格的前瞻性随机对照试验.

Evaluation the quality of Random control trials of traditional Chinese Medicine therapy for menopause

Objective:To evaluate the quality of pubilished Random control trials of traditional Chinese Medicine therapy for menopause in home.Methods:Electronic and manual retrieve RCTs or half RCTs or self-assumed RCTs of Traditional Chinese Medicine in treatment of Menopause.Two investigators select the trials independently.Evaluate the quality of trials according to the principle of EBM and systimetic review.Results:There were 51 randomized controlled trials with involved.2 trials were thought as high quality,and else trials,7.9% of 51 trials indicate the random method,none of the 51 trials refer to hiding the match;62.7%trials have diagnostic standard;29.4%trials have clearly therapeutic effect standard;56.9%trials indicate the groups are comparative;7.8%trials adapt blind method;7.8%trials clear the cause of statistical method.Conclusion:Among the RCTs of TCM therapy for menopause in China,the higher quality trials are very small,trials'quality as a whole are to be enhanced.It is supposed to carry out more sustentation funded,strictly controlled RCTs.