Systematic evaluation of therapeutic effects of stem cell transplantation trials for heart diseases in China

Abstract

The evaluation of the efficacy and safety of a new medical intervention relies on clinical trials. Several clinical trials are available, which include randomized controlled trials (RCTs) and non-randomized controlled trials. RCT is considered to be the gold standard for the evaluation of drugs, vaccines, diagnostics, and procedures. The report of a RCT is required to contain sufficient details so that a reader can accurately evaluate the conclusion. 1 Unfortunately, many trial reports do not include some critical data and items, which makes the evaluation of conclusion difficult. 2-4 The CONSORT (consolidated standards of reporting trials) statement was first published by the CONSORT Group in 1996 in an effort to improve the quality of clinical trial reports. It was revised in 2001 and updated in 2010; the CONSORT statement provides authors and editors with a checklist for reporting trial design, data collection, results, analysis, and interpretation of RCTs. 5-7 Studies have shown that the quality of trial reporting can be improved when authors follow the CONSORT checklist. 8-11 Although the CONSORT statement is originally used as a guideline for reporting, it is also a useful tool to assess the quality of RCT reports 12 in addition to the Jadad score, which is a reliable tool to assess the methodological quality of a clinical trial. 13,14 Stem cells are a population of cells capable of differentiating into more specific cells. 15 Stem cell represents a potential treatment for various diseases, including lung, brain, liver, kidney, and heart diseases. Although meta-analyses have confirmed stem cell transplantation can improve cardiac function in patients suffering from myocardial infarction, there are conflicts between individual trials. 16-18 Recently, some pioneering trials of stem cells have been found to have unexplained discrepancies that cast doubt on their validity. 19 Nowbar found that there was a significant correlation between the number of discrepancies and the reported ejection