Objective: Nigella sativa (NS) has been widely used and investigated in several pediatric studies; however, its safety and efficacy in pediatrics are yet to be evaluated. This systematic review evaluates the clinical uses, safety, and efficacy of NS in pediatrics.
Methods: The search was conducted across 4 databases, including PubMed, Web of Science, Scopus, and Cochrane, up to September 6, 2023, and included clinical trials using NS in pediatrics. A methodological quality assessment was performed using the Cochrane risk of bias tool for randomized trials (Rob 2). A meta-analysis was conducted to evaluate safety. The systematic review follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.
Results: Two hundred sixty-five studies were screened for eligibility, including 125 papers from Scopus, 31 from PubMed, 37 from Cochrane, and 72 from the Web of Science. Sixty-eight duplicate papers were eliminated, and 185 studies were excluded. Three studies were added from snowballing. Fifteen clinical trial studies were included in this review. Limited studies have been conducted on NS in pediatrics. Based on the meta-analysis, no statistically significant side effects have occurred. Different doses and forms of NS were used, and most studies have reported improvements in the outcomes.
Conclusion: More high-quality studies are needed to establish the efficacy of using NS in different diseases, along with its effective dose and form. The studies in this review report no severe adverse effects and no statistically significant occurrence of side effects. However, further studies are needed to fully understand the safety of using NS in pediatrics.
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