Effectiveness of spironolactone for women with acne vulgaris (SAFA) in England and Wales: pragmatic, multicentre, phase 3, double blind, randomised controlled trial
RCT (n=410) found spironolactone improved acne Acne-QoL symptom subscale score vs placebo at week 12 (primary endpoint - diff +1.27, 95%CI 0.07-2.46) and week 24 (secondary endpoint +3.45, 2.16-4.75). Adverse effects were more common with spironolactone (20% vs 12%, p=0.02).
Source:
British Medical Journal
SPS commentary:
The Acne-QoL contains 19 questions with seven response categories, each referring to the past week, reported in four domains (self-perception, role-social, role-emotional, and acne symptoms): each subscale has a range of 0-30, in which higher scores reflect improved quality of life.
A commentary notes dermatologists have prescribed spironolactone for acne over the last 20 years on the basis of case series and very small trials, and that the new evidence from this trial might now support GP prescribing of this treatment. Current acne guidelines recommend limiting oral antibiotics to 3-6 months and the new research shows that, for women with acne that persists despite topical treatment, prescribing oral spironolactone alongside topical treatment has the potential to significantly reduce long term oral antibiotic prescribing. Questions remain about starting dose, relative effectiveness in comparison with other treatments, and which subgroups benefit most from spironolactone. Some of these questions will be answered in ongoing trials and it is also hoped that further understanding of the mechanism of action of spironolactone may lead to new treatment options.