Efficacy and safety of Spironolactone in treating patients with acne vulgaris: a systematic review and meta-analysis of 1,086 patients.

Acne vulgaris affects 9% of the global population, particularly women, affecting their quality of life. Topical treatments are preferred for mild acne, while systemic management is necessary for moderate and severe cases. Spironolactone, an androgen receptor inhibitor, may be effective for severe acne, although no concrete evidence exists. A comprehensive literature search was conducted on five databases up until July 25th, 2024, to evaluate the effectiveness or safety of Spironolactone for acne vulgaris. A meta-analysis using R software was conducted to assess the total number of lesions, acne severity score, adverse events, mean count of comedones, papules, and pustules, and acne severity. Search process identified 14 studies (n = 1,086). Meta-analysis found that Spironolactone 5% was more effective than placebo in reducing total lesion count and acne severity index (ASI) (MD - 6.85, 95% CI [-10.94; -2.76], P < 0.01) and (MD - 6.33, 95% CI [- 8.89; -3.76], P < 0.01) respectively. The 100 mg group showed a significant improvement in ASI compared to the topical group. A meta-analysis of randomized controlled trials found no significant difference in comedones and pustules count over 6-8 weeks, while single-arm studies showed significant improvement after 8 weeks. Meta-analysis found that spironolactone 5% significantly reduced total lesion count and acne severity index after eight weeks, while also reducing comedones and papules. The safety profile is excellent. The limited number of eligible studies and evidence from single-arm studies indicates the need for more randomized controlled trials.