Introduction:

Objectives:

To assess the quality of randomized controlled trials (RCTs) relevant to viral hepatitis published in Chinese medical journals to provide scientific basis for improvement

Methods:

Nine Chinese medical journals in the years of 1990 to 1998 were handsearched and 199 RCTs for viral hepatitis were identified from 542 issues of 77 volumes. The journals include Chin J Infect Dis, Chin J Hepatol, Chin J Internal Med, Chin J Digest, Chin J Experim & Clinical Virol, Chin J Clinical Hepatol, Chin J Integrated Trad & Western Med, Chin J Integrated Trad & Western Med on Liver Dis, J Trad Chin Med.

Results:

In the recent 9 years, the numbers of RCTs increased by each 3 years. Among the 199 trials, 59.8% were with explicit inclusion criteria for subject selection, 9.5% with exclusion criteria and 19.6% with pathological diagnosis by liver biopsy. Only 17 RCTs described the methods for random allocation and 3 trials had random concealment. Blindness and placebo control were used in 9 and 10 RCTs respectively. Average sample sizes of intervention group(s) and control group were 51.8+-52.2 cases (7 - 647) and 46.3+-39.9 cases (5 - 360) separately. Statistical management was mainly assessed on the basis of p value through y1 or t test. Clinical outcome. assessment was made by the normalization of biochemical indices, seroconversion of viral markers, elimination of symptoms and signs, but none of them used relative risk reduction(RRR), absolute risk reduction(ARR), number needed to treat(NNT) or intention-to-treat analysis to evaluate treatment effects. Fifteen trials accounted for compliance of patients, and of 45.7% trials, side effects or adverse drug reaction was observed, of 29.1%, follow-up did.

Results:

Discussion:

More and more RCT for viral hepatitis with small, mediate sample size were published in Chinese medical literatures. But, the quality of the RCTs is not high, as placebo control and blinding were less used, and adequate randomization and its concealment were not used correctly and rigorously. Actually, pseudo- and quasi-randomization have been applied as real one. Therefore, clinicians should be further trained on clinical epidemiology in order to improve the quality of clinical trial and nation-wide and world-wide trials with multi-center, large-scale and long-term collaboration should be made.