The Reporting Quality and Risk of Bias of Randomized Controlled Trials in Traditional Persian Medicine: A Systematic Review

Objective:: This study aimed to assess the quality of randomized controlled trials (RCTs) in the field of Traditional Persian Medicine (TPM) by utilizing specific checklists and the Cochrane Risk-of-Bias tools (RoB 1.0 and RoB 2.0). Methods:: RCTs in the field of TPM were analyzed in a systematic review between 2018 and 2022. Quality assessment was performed using CONSORT 2010, CONSORT extensions, RoB1.0 and RoB 2.0. Results:: Out of 1112 primary retrieval articles, 139 were eligible for quality assessment. The mean scores of multi-arm studies and trials of herbal medicine interventions, according to CONSORT extensions, were 1.47 ± 0.66 and 1.48 ± 0.61 out of 2. Based on RoB 2.0, two-thirds of the studies were assessed as "high risk" and "some concerns". The highest risk and most concerns were related to outcome measurement and randomization process, respectively. The lowest mean score was related to the methods section. Reports on drug and herbal interventions were insufficient, and the scores of key items, such as randomization implementation and allocation concealment, were less than one. Conclusion:: The reporting style of a considerable number of the TPM randomized controlled trials, especially in methodology, is a point of concern. The utilization and adherence to CONSORT extensions can be effective in improving the methodological quality of these studies and enhancing the credibility of the obtained results.