Randomized trials published in some Chinese journals: how many are randomized?

Area of Science:

• Clinical Trials
• Medical Research Methodology
• Evidence-Based Medicine

Background:

• Increasing number of medical journals in China publishing research, including randomized controlled trials (RCTs).
• Concerns raised regarding the quality and authenticity of published RCTs, particularly those reporting positive results.
• Need to assess the adequacy of randomization methods in Chinese clinical trials.

Purpose of the Study:

• To investigate the adequacy of randomization in clinical trials published in China.
• To determine the proportion of published trials that meet acceptable standards for participant allocation.
• To identify factors influencing the authenticity of randomized controlled trials.

Main Methods:

• Searched China National Knowledge Infrastructure database for RCTs published between January 1994 and June 2005.
• Selected a subset of trials that appeared to use randomization.
• Interviewed original authors regarding randomization methods and quality control.

Main Results:

• From 37,313 articles, 3137 apparent RCTs were identified (1452 conventional medicine, 1685 traditional Chinese medicine).
• Only 207 studies (6.8%) adhered to accepted randomization methodology.
• Trials at university-affiliated hospitals and higher-level hospitals showed higher authenticity rates; all pre-market drug trials were authentic.

Conclusions:

• Most published RCTs in Chinese journals lack adequate randomization description and methodology.
• A significant number of 'RCTs' are not authentic due to a lack of understanding of rigorous trial design.
• Improved peer review and development of authenticity identification guidelines are urgently needed.