Tribulus terrestris is a medicinal herb purported to enhance reproductive function, particularly in instances of erectile dysfunction (ED). This study aims to assess the effectiveness and safety of administering Tribulus terrestris to patients with ED. We performed a systematic literature review in the Cochrane Library, Medline, Scopus, and Europe PMC databases utilizing particular keywords. The primary endpoint in this study is International Index of Erectile Function, that may be in abridged form (IIEF-5) or full form (IIEF-15). The outcomes of continuous variables were aggregated into the mean difference (MD) with corresponding 95% confidence intervals (95% CI) utilizing random-effects models. Eight studies were selected for inclusion. After the intervention with Tribulus terrestris, the IIEF-5 [MD 4.21, p < 0.00001] and IIEF-15 scores [MD 15.88, p = 0.0004] were markedly elevated compared to their pre-supplementation levels, as per our comprehensive analysis. Additionally, on both the IIEF-5 [MD 3.23 (95%CI 1.89, 4.58), p < 0.00001] and IIEF-15 [MD 14.44 (95%CI 5.75, 23.14), p = 0.001], Tribulus terrestris outperformed placebo. However, the two groups were not significantly different in terms of total testosterone levels. We observed no difference in the incidence of adverse events between Tribulus terrestris and placebo. Tribulus terrestris supplementation may offer benefits in improving erectile function among patients with ED with a relatively good safety profile.
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