Misuse of randomization: a review of Chinese randomized trials of herbal medicines for chronic hepatitis B.
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.
Liu
Jianping
J
The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, H:S Rigshospitalet, Denmark.
Kjaergard
Lise Lotte
LL
Gluud
Christian
C
D003627:Data Interpretation, Statistical; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005069:Evaluation Studies as Topic; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D015201:Meta-Analysis as Topic; D008517:Phytotherapy; D011897:Random Allocation; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data; D012107:Research Design / Q000706:statistics & numerical data*; D016037:Single-Blind Method
D004365:Drugs, Chinese Herbal