The quality of randomized controlled trials of Chinese herbal medicine for multiple sclerosis is generally inadequate, with poor reporting around study design and verification of herbal ingredients.
Nine major databases were scoured from their inception up until September 2023, with studies that took the form of randomized controlled trials (RCTs) comparing Chinese herbal medicine with a placebo or other pharmacological interventions for multiple sclerosis being eligible for consideration. Quality was evaluated through the Consolidated Standards of Reporting Trials (CONSORT) and its derivative for Chinese herbal medicine formulas. Additionally, the risk of bias was evaluated through the use of the Cochrane Risk of Bias tool. The selection process of herbs was based on those that appeared the most frequently in successful trials.
In the discussion of results, it was found that only 33% of the CONSORT items and 21% of the CONSORT-CHM items had been correctly reported. Key elements including the official titles, the calculation of sample sizes, the unbiased distribution of participants into groups, the execution of randomized protocols and blinding descriptions, all fell below a 5% reporting rate. Insufficient information led to most studies being classified as 'unclear' in terms of bias risk. Despite this, no significant adverse effects were reported in the trials.
