Introduction: A few cases of serious side effects have been reported of Momordica charantia L. (MC). No comprehensive safety assessment has yet been performed based on human intake.This systematic review aims to evaluate the potential harm of Momordica charantia L. derived products using data from randomized controlled trials. Methods: Databases Cochrane Library, Pubmed and EMBASE were searched until December 2020. The PRISMA harms checklist was followed. Data extraction was on aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine, adverse effects (AE), reasons for drop out related to the intervention and interaction with other treatment. Two authors independently extracted data and bias was evaluated based on the latest version of the Cochrane risk of Bias Tool (RoB 2). Additional safety data were requested from Health Regulatory Agencies, Herbal Medicine Associations and manufacturers. Results: Seventeen trials met the inclusion criteria. The IRR was calculated for each study ranging from 0.30 (95% CI = 0.12 to 0.75) to 13.00 (95% CI = 0.73 to 230.76) of any adverse events. Conclusions: Under a daily dosage of 6g of MC-derived products no evidence was seen of harms in humans. In case reports that showed serious harm, MC was used in a liquid form. The safety of traditional MC-based supplements appears more guaranteed when produced under strict quality standards.

The authors have declared no competing interest.

https://pubmed.ncbi.nlm.nih.gov/

The project was financially supported by the EFRO project Kansen voor West Green Health Solutions (KVW00117) and the Dutch Ministry of Agriculture, Nature and Food Quality project code EU-TU-18007.

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