Oral Spironolactone for Acne Vulgaris in Adult Females: A Hybrid Systematic Review

• Published in: American journal of clinical dermatology 2017-04, Vol.18 (2), p.169-191
• Main Authors: Layton, Alison M., Eady, E. Anne, Whitehouse, Heather, Del Rosso, James Q., Fedorowicz, Zbys, van Zuuren, Esther J.
• Format: Article
• Language: English
• Subjects: Acne; Acne Vulgaris - blood; Acne Vulgaris - drug therapy; Administration, Oral; Adult; Androgens; Androgens - blood; Androgens - metabolism; Anti-Bacterial Agents - therapeutic use; Antibiotics; Birth control; Clinical medicine; Clinical trials; Contraceptives, Oral, Combined - therapeutic use; Dermatology; Diuretics; Drug dosages; Evidence-based medicine; Female; Humans; Hyperandrogenism - blood; Hyperandrogenism - complications; Medicine; Medicine & Public Health; Mineralocorticoid Receptor Antagonists - administration & dosage; Mineralocorticoid Receptor Antagonists - adverse effects; Mineralocorticoid Receptor Antagonists - therapeutic use; Pharmacology/Toxicology; Pharmacotherapy; Potassium; Quality; Randomized Controlled Trials as Topic; Sebaceous Glands - drug effects; Spironolactone - administration & dosage; Spironolactone - adverse effects; Spironolactone - therapeutic use; Systematic Review; Treatment Failure; Womens health
• ISSN: 1175-0561; 1179-1888; 1179-1888
• DOI: 10.1007/s40257-016-0245-x

Background The management of acne in adult females is problematic, with many having a history of treatment failure and some having a predisposition to androgen excess. Alternatives to oral antibiotics and combined oral contraceptives (COCs) are required. Objective Our aim was to conduct a hybrid systematic review of the evidence for benefits and potential harms of oral spironolactone in the management of acne in adult females. Methods The review was conducted according to a previously published protocol. Three reviewers independently selected relevant studies from the search results, extracted data, assessed the risk of bias, and rated the quality of the evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Results Ten randomized controlled trials (RCTs) and 21 case series were retrieved. All trials were assessed as being at a ‘high risk’ of bias, and the quality of evidence was rated as low or very low for all outcomes. Apart from one crossover trial that demonstrated statistical superiority of a 200 mg daily dose versus inflamed lesions compared with placebo, data from the remaining trials were unhelpful in establishing the degree of efficacy of lower doses versus active comparators or placebo. Menstrual side effects were significantly more common with the 200 mg dose; frequency could be significantly reduced by concomitant use of a COC. Pooling of results for serum potassium supported the recent recommendation that routine monitoring is not required in this patient population. Conclusion This systematic review of RCTs and case series identified evidence of limited quality to underpin the expert endorsement of spironolactone at the doses typically used (≤100 mg/day) in everyday clinical practice.