中药治疗癌痛临床文献41篇的分析

Quality of reporting in 41 randomized controlled clinical trials of Chinese medicine for cancer pain

目的:本文通过对41篇中药治疗癌痛的临床研究文献进行分析,讨论提高中医论文质量的重要性和必要性.方法:检索《中国生物医学文献数据库》(CBM),《中国生物医学期刊文献数据库》(Chinese Medical Current Contents,CMCC)和维普中文数据库以及PubMed和荷兰医学文摘数据库(Excerpta Medical Datebase,EMBASE)英文数据库在1986年至2006年中医药治疗癌痛的文献.根据the National Cancer Institute(NCI)"补充和替代医学领域中癌症临床研究循证医学的强度等级"筛选出属于随机对照临床研究的论文41篇,并以Gagnier et al的"中药治疗随机对照试验的报道质量"一文为参考,进行论文质量分析.结果:41篇论文中一些必要信息如随机方法,纳入和排除标准,研究结果测定,盲法应用,中药制剂的质量控制和评价.以及药物的不良反应等表述不足.结论:科研论文报告的信息量是影响论文质量的因素,也是阻碍中医药在癌痛治疗领域被广泛接受的原因之一.

AIM： To highlight the importance and necessity of quality assurance in clinical trial reporting by analyzing 41 papers on of Chinese medicine for cancer pain. METHODS： A search for clinical trial reports published from 1986 to 2006 on the effects, mechanisms, safety and application of Chinese herbal medicine in cancer pain management was conducted using the CBM, Chinese Medical Current Contents （CMCC） and Weipu （available since 1989） databases in Chinese, and PubMed and EMBASE in English. We evaluated the methodological quality of the articles, following the guidelines set forth in Levels of Evidence of Human Studies of Cancer in Complementary and Alternative Medicine by the National Can- cer Institute （NCI） and Quality of Reporting of Randomized Controlled Trials of Herbal Medi- cine Interventions by Gagnier et al. RESULTS： Some research information was insufficiently reported, including methods of randomization, inclusion and exclusion criteria, outcome measurements, blinding and concealment, quality control and quality assurance of herbal preparations, and adverse events. CONCLUSION： Two crucial elements of high quality scientific reporting are the provision of sufficient research information and the transparency of research methodology. Insufficient reporting may be one of the major reasons. Chinese medicine is not widely and globally used to treat cancer pain.