小柴胡汤治疗慢性乙型肝炎的临床文献质量评价

目的：评价小柴胡汤治疗慢性乙型肝炎（HBV）的文献的质量，寻找目前中医药临床试验和文献报道中存在的问题。方法：检索了The Cochrane Library、The Cochrane Complementary Medicine Field、The trials registers of The Cochrane Hepato-Biliary Group、medline，医学中央杂志网（日语版）、ebm、cnki、维普、万方等，并手工检索《日本东洋医学杂志》、《中西医结合肝病杂志》、《中华传染病杂志》等期刊杂志，并在纳入文献及相关综述中查阅参考文献。其评价内容主要参照CONSORT FOR TCM（For Solicitation of Cxaranents）声明，并制作数据资料提取表。结果：共得到46篇文献，有1篇简单交待了随机分配序列的产生方法；统计学方法描述正确的15篇，只有9篇给出了具体的统计量，且有部分数据错误现象；描述中、西医诊断标准分别为3、42篇；中、西医疗效标准8、23篇；治疗组中24篇采用小柴胡汤和西药联合作为干预措施，3篇采用小柴胡汤原方；对照组以抗病毒药为对照的8篇；疗效指标采用生化学、血清学、病毒学、肝组织学的分别为43、33、23、9；交待疗程的有44篇，12个月以上的占2篇；提到随访的共8篇，12个月以上的占2篇。结论：小柴胡汤治疗慢性乙型肝炎的临床研究文献存在诸多问题，包括方法学部分和医学专业部分，仍有待于以后研究更多的努力和改进。

Quality Evaluation of Randomized Controlled Trials on Xiaochaihu Decoction for Chronic Hepatitis B

Objectives：To evaluate the quality of reporting of randomized controlled trials on xiaochaihu decoction for chronic hepatitis B （HBV）. Methods： We searched the Cochrane Library, the Cochrane Complementary Medicine Field, the trials registers of the Cochrane Hepato-Biliary Group, medline, PubMed, http：//www, jamas, gr. jp/, the Chinese Biomedical of Database （CBMdisc）, China National Knowledge Infrastructure （CNKI）, VIPInformation, and wanfang data, and also handsearched the Journal of Japan Oriental Medical Society, Chinese Journal of Integrated Traditional and Western Medicine on Liver Diseases and Chinese Journal of Infectious Diseases, etc. We also checked the reference lists of included studies and reviews. The quality of the reporting of RCTs was as- sessed mainly using the 22-item checklist of the CONSORT for TCM （For Solicitation of Comments）. Results：46 articles were included. No one present the word ＂randomization＂, and only 8 reports used a structured abstract. All trials did not report the scientific background and the rational for the trial,and only one described the random allocation sequence. Blind is hard to be carried out in the clinical rearch of TCM, especially the broth ;The patients in 42/46 trials were diagnustied by western medicine and the ones in 5/46 were diagnustied by Syndrome diagnostic criterion; it took accounts for 23/46 and 3/46 by western medicine and traditional Chinese medicine in the assessment of currative effects ;24/46 trials carried out the combination of xiaochaihu decoction and western medicine as intervention, as well as 3/46 trials carried out xiaochaihu decoction; 8/46 took the antiviral drugs as control; Statistical methods were correctly selected in 15/45 trials, some authors didn＇t give the exact data and used incorrect methods; the course of treatment longer than 12 months explored in 2/43 trials;The record of follow up longer than 12 months accounted for 2/8. Conclusion： It can be obersved the disadvandages both in statistical metho