Article type
Year
Abstract
Background: As one of the registered specialized master journals in Cochrane Hepato-Biliary Group, "Chinese Journal of Integrated Traditional and Western Medicine on Liver Diseases" is an important Chinese journal in which clinical trials in fields of liver diseases are published. Chronic liver diseases are the major causes of mortality and morbidity in China. Therefore, it is necessary for systematic search and evaluation to be conducted to understand current status of the clinical trials and work out issues related to the condition in China. Objectives: To find out randomized controlled trials (RCTs) from the clinical trials published in "Chinese Journal of Integrated Traditional and Western Medicine on Liver Diseases" chronologically and to make preliminary evaluation on the baseline data.
Methods: Page by page handsearching was used in identifying RCTs amongst clinical trials from start publication (1991) to Dec., 1999 of the journal, which amounted to 9 volumes and 38 issues. The definitions of RCT and controlled clinical trial (CCT) were strictly based on "The Cochrane Collaboration Handbook (1998)".
Results: One hundred and forty one RCTs were identified from 286 clinical trials, with a percentage of 49.3, among which, four were double-blinded and two used placebo control as comparison. The percentage of RCTs in clinical trials was varied by every three-year period, i.e. 31.7%(13/41) in 1991~1993, 37.8% (31/82) in 1994~1996, and 63.4%(97/153) with three double blind in 1997~1999. Trials that showed explicit inclusion criteria accounted for 35.5%, while having exclusion criteria did 12.8%. Method of randomization allocation was stated only in 6.4%(9/141), without any trials mentioning allocation concealment. The published RCTs included 14,118 cases in studies, with average sample size of 45.8 43(ranging from 11 to 647 cases) in treatment group and 42.8 38 (from 6~360) in control group. The major diseases studied in 141 RCTs included 57 for chronic viral hepatitis, 17 for liver cirrhosis, 12 for severe hepatitis, 12 for chronic liver diseases, eight for acute viral hepatitis, and other untyped liver diseases. There was no multi-center, double-blind placebo controlled trial published during the nine years.
Conclusions: Though the numbers of RCT in publication increased, with its small sample size, inadequate randomization and other design's problems, the quality of RCTs needs to be improved. More RCTs and double blind method should be used in design of clinical trial. Recommendations: * Collecting and evaluating RCTs in Chinese medical literature; * Establishing Chinese RCT and systematic review database in all areas of health care; * Promoting popularization of Evidence-based Medicine; * Increasing nationwide and worldwide academic exchanges. E-mail of correspondence: tmmude@public.cta.cq.cn Fax: (86) 23 65316682
Methods: Page by page handsearching was used in identifying RCTs amongst clinical trials from start publication (1991) to Dec., 1999 of the journal, which amounted to 9 volumes and 38 issues. The definitions of RCT and controlled clinical trial (CCT) were strictly based on "The Cochrane Collaboration Handbook (1998)".
Results: One hundred and forty one RCTs were identified from 286 clinical trials, with a percentage of 49.3, among which, four were double-blinded and two used placebo control as comparison. The percentage of RCTs in clinical trials was varied by every three-year period, i.e. 31.7%(13/41) in 1991~1993, 37.8% (31/82) in 1994~1996, and 63.4%(97/153) with three double blind in 1997~1999. Trials that showed explicit inclusion criteria accounted for 35.5%, while having exclusion criteria did 12.8%. Method of randomization allocation was stated only in 6.4%(9/141), without any trials mentioning allocation concealment. The published RCTs included 14,118 cases in studies, with average sample size of 45.8 43(ranging from 11 to 647 cases) in treatment group and 42.8 38 (from 6~360) in control group. The major diseases studied in 141 RCTs included 57 for chronic viral hepatitis, 17 for liver cirrhosis, 12 for severe hepatitis, 12 for chronic liver diseases, eight for acute viral hepatitis, and other untyped liver diseases. There was no multi-center, double-blind placebo controlled trial published during the nine years.
Conclusions: Though the numbers of RCT in publication increased, with its small sample size, inadequate randomization and other design's problems, the quality of RCTs needs to be improved. More RCTs and double blind method should be used in design of clinical trial. Recommendations: * Collecting and evaluating RCTs in Chinese medical literature; * Establishing Chinese RCT and systematic review database in all areas of health care; * Promoting popularization of Evidence-based Medicine; * Increasing nationwide and worldwide academic exchanges. E-mail of correspondence: tmmude@public.cta.cq.cn Fax: (86) 23 65316682