Efficacy of Black Seed ( Nigella sativa ) and Lemon Balm ( Melissa officinalis ) on Non-Alcoholic Fatty Liver Disease: A Randomized Controlled Clinical Trial
Abstract
Background: There are several therapeutic strategies available from the viewpoint of Traditional Persian Medicine (TPM) to treat hepatic diseases. Objectives: This study aimed at assessing the efficacy and safety of Nigella sativa and Melissa officinalis in patients with Non-Alcoholic Fatty Liver Disease (NAFLD). Methods: From November 2014 to May 2016, in an open-label, simple-blocked, randomized controlled clinical trial, the researchers evaluated the efficacy of Nigella sativa and Melissa officinalis compared with Orlistat capsule on the grade of fatty liver and the serum levels of Aspartate Transaminase (AST) and Alanine Transaminase (ALT) in 50 patients with NAFLD in Iran. Results: Regarding within-group changes, a significant decrease was observed in the serum level of AST, ALT, body mass index, and grade of fatty liver in both groups after the intervention compared with baseline (P < 0.001). Repeated measures logistic regression analysis showed that there was a more significant reduction in the grade of fatty liver over the study period in the intervention group compared with the control group (0.58 ± 0.50 versus 1.51 ± 0.54, P < 0.001). Conclusion: Traditional Persian Medicine-based preparations of Nigella sativa and Melissa officinalis could reduce body weight and liver enzymes and improves the grade of fatty liver in Non-Alcoholic Fatty Liver Disease.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 50 participants or records.
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