Abstract

To assess the quality of Randomized Controlled Trials (RCTs) for variety of preparations made from Glycyrrhizin Acid (GA), an ingredient found in Chinese herb Glycyrrhiza that is widely used in the treatment of hepatitis in clinical practice in China. From electronic searches of PubMed, CNKI, TCMDS, CBMdisc and Chongqing VIP database, we identified 93 reported RCTs between 1991 and 2007 that GA was the subject of the trial. The quality of each trial was assessed using the number of Consolidated Standards for Reporting of Trials (CONSORT) checklist items included, the frequency of allocation concealment and a 5-point quality assessment instrument (Jadad scale). 72.22% (26/36) of the CONSORT checklist items was included in the RCTs. Only 3 (3.22%) of 93 RCTs reported allocation concealment by sealed envelopes. 59 (63.44%) trials described baseline demographic and clinical characteristics of each group, but only 7 (7.52%) reported statistical results of baseline data. Although 77 (82.79%) trials described the number of participants in each group included in each analysis, none of the trials adopted intention-to-treat analysis. Information regarding adverse events was reported in 36 (38.70%) of the RCTs. The quantity of RCTs increased from 1 in 1993 to 15 in 2007, but the average points assessed by CONSORT in each yeardidn’t elevate. At the same time, the overall quality of the trials was low as assessed by the Jadad scale. Although the quantity of RCTs related to GA mainly against hepatitis increased in recent years, the methodological quality of these reports was low. Therefore, the efficacy and safety of GA being used in clinical practice need to be further confirmed by carefully designed clinical research.

Key words: Traditional Chinese medicine, glycyrrhizin acid, randomized controlled trial, evaluation of quality.