Quality assessment of randomized controlled trials of Iranian traditional medicine: An eight-year study

Abstract

IntroductionIranian traditional medicine (ITM) has a long history that dates back to a thousand years ago. In recent years, quantity of scientific productions in this field have significantly grown, but there are no reviews of randomized controlled trials (RCT) conducted in this field and their quality has not been assessed. In this review, we evaluated the quality of RCTs in ITM between 2010 and 2017. MethodsA systematic online search was done in national and international databases between 2010 and 2017. Inclusion criteria were: RCTs investigating some aspect/s of ITM. Nnon-randomized trial designs, animal experiments, reviews and meta-analyses, conference abstracts, short communications, editorials, letters and case reports or case series were excluded. Quality assessment of each RCT was conducted using the Consolidated Standards of Reporting Trials (CONSORT) checklist and Cochrane risk of bias tool. ResultsFrom 9568 records initially retrieved, only 151 RCTs remained eligible and were included in the study. The number of RCTs increased during 2010–2017, with a mean annual growth rate of 63 %. Based on the Cochrane Collaboration’s tool, most studies (51 %) were at moderate risk of bias. The mean (SD) CONSORT score for all items was 1.25(0.46, ranging from 0 to 2). Mean scores were low for some key items related to methodology. ConclusionDespite the significant increase in the number of RCTs conducted between 2010 and 2017 and some improvements in the quality of reporting, no improvement was observed in the trial methodology. Shortcomings in the methodology of trials can be overcome by further adherence to CONSORT statement.