Liu Jianping, Kjaergard Lise Lotte, Gluud Christian
The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, H:S Rigshospitalet, Denmark.
Am J Chin Med. 2002;30(1):173-6. doi: 10.1142/S0192415X0200017X.
The quality of randomization of Chinese randomized trials on herbal medicines for hepatitis B was assessed. Search strategy and inclusion criteria were based on the published protocol. One hundred and seventy-six randomized clinical trials (RCTs) involving 20,452 patients with chronic hepatitis B virus (HBV) infection were identified that tested Chinese medicinal herbs. They were published in 49 Chinese journals. Only 10% (18/176) of the studies reported the method by which they randomized patients. Only two reported allocation concealment and were considered as adequate. Twenty percent (30/150) of the studies were imbalanced at the 0.05 level of probability for the two treatments and 13.3% (20/150) imbalanced at the 0.01 level in the randomization. It is suggested that there may exist misunderstanding of the concept and the misuse of randomization based on the review.
对中国关于治疗乙型肝炎的草药随机试验的随机化质量进行了评估。检索策略和纳入标准基于已发表的方案。共识别出176项涉及20452例慢性乙型肝炎病毒（HBV）感染患者的随机临床试验（RCT），这些试验对中药进行了测试。它们发表在49种中文期刊上。只有10%（18/176）的研究报告了随机分配患者的方法。只有两项报告了分配隐藏情况，且被认为是充分的。20%（30/150）的研究在两种治疗的概率水平为0.05时不均衡，13.3%（20/150）在随机化的概率水平为0.01时不均衡。基于该综述表明，可能存在对随机化概念的误解和随机化的误用。
