Quality of reporting of randomized controlled trials of herbal medicines conducted in metabolic disorders in Middle East countries: A systematic review.

Send to Complement Ther Med. 2018 Jun;38:61-66. doi: 10.1016/j.ctim.2018.04.004. Epub 2018 Apr 11. Tabatabaei-Malazy O1, Shadman Z2, Ejtahed HS3, Atlasi R4, Abdollahi M5, Larijani B6. Author information Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran; Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: tabatabaeiml@sina.tums.ac.ir. 2 Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran; Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: zhaleh_shadman@yahoo.com. 3 Obesity and Eating Habits Research Center, Endocrinology and Metabolism Molecular -Cellular Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: haniejtahed@yahoo.com. 4 Evidence based Practice Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran; Department of Medical Library & Information Science, School of Allied Medical Sciences, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: rashaatlasi@gmail.com. 5 Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran; Toxicology and Diseases Group, Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, Tehran, Iran; Department of Toxicology and Pharmacology, Faculty of Pharmacy, and Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: Mohammad.Abdollahi@UToronto.Ca. 6 Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: emrc@tums.ac.ir. Abstract INTRODUCTION: Based on WHO recommendation for considering herbal medicine as an inexpensive appropriate method to treat metabolic disorders, conducting randomized controlled trials (RCTs) is increasing worldwide. Since poor quality RCTs can lead to wrong conclusion, we assessed the quality of reporting of herbal medicines' RCTs conducted in Middle East in a systematic review study. MATERIALS & METHODS: All herbal medicines' RCTs in metabolic disorders (diabetes mellitus, metabolic syndrome, hyperlipidemia, obesity and osteoporosis) conducted in Middle East countries and published before January 2017 were included. To obtain all related studies PubMed, Scopus, Web of Science, Cochran library, and Embase web databases were searched. Exclusion criteria were animal studies, non-herbal medicines' RCTs, RCTs conducted in Type 1 diabetes, in children or pregnant women. We used Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist for reporting study selection processes as well as Consolidated Standards of Reporting Trials (CONSORT) statement for assessment of quality of reporting. RESULTS: Out of 5319 identified studies, 215 RCTs were included. The proportion of published RCTs in the topic increased significantly over the time (P < 0.001). The total mean ± SD score for 37 items of CONSORT checklist was 21.15 ± 4.27. Most of RCTs (60%) were not reported randomization in the title. Some important items were incompletely reported including trial registration (42.3%), sample size estimation (38.1%), randomization method (35.3%), generation of allocation (27.9%), and concealment of allocation (13.5%). CONCLUSIONS: Our findings indicate that the quality of reporting of herbal medicines' RCTs in metabolic disorders has improved over time in Middle East, but remains suboptimal. Copyright © 2018 Elsevier Ltd. All rights reserved. KEYWORDS: CONSORT statement; Herbal medicine; Metabolic disorders; Randomized controlled trial; Systematic review PMID: 29857881 DOI: 10.1016/j.ctim.2018.04.004 [Indexed for MEDLINE]