Spironolactone versus placebo or in combination with steroids for hirsutism and/or acne

Background Hirsutism is the presence of excessive hair growth in women and is an important cosmetic condition often resulting in severe distress. The most common cause is by increased production of male sex hormones (androgens). It is also affected by increased sensitivity to androgens in the hair follicles, and secretory glands around hair follicles (sebaceous glands). Spironolactone is an antiandrogen and aldosterone antagonist used to treat hirsutism. Objectives The objective was to investigate the effectiveness of spironolactone and/or in combination with steroids (oral contraceptive pill included) in reducing excess hair growth and/or acne in women. Search strategy The Cochrane Menstrual Disorders and Subfertility Group (MDSG) trials register was searched (April 2008). The Cochrane MDSG register is based on regular searches of MEDLINE, EMBASE, CINAHL, PsycINFO and CENTRAL, handsearching of 20 relevant journals and conference proceedings, and searches of several key grey literature sources. In addition, all reference lists of relevant trials were searched and drug companies contacted for details of unpublished trials. Selection criteria All randomised controlled comparisons of spironolactone versus: placebo, steroids (oral contraceptive pill included), spironolactone of varying dosages, or spironolactone and steroids versus steroids alone when used to reduce hair growth and acne in women. Data collection and analysis Nine trials were included in the review, eight trials were excluded. Two other trials are awaiting assessment. Only one trial studied acne as an outcome, the remainder were concerned with hirsutism. Major outcome measures include the following: subjective observations, Ferriman and Gallwey hair scores, hormonal and biochemical parameters, side effects, sebum production measurement. Main results In the two trials that compared 100 mg of spironolactone with placebo significant differences were reported for subjective improvements in hair growth (OR 7.18, 95% CI 1.96 to 26.28), although not the Ferriman-Galwey score (WMD 7.20, 95% CI - 10.98 to - 3.42)). Data could not be otherwise pooled as only one trial reported an outcome. Authors' conclusions From the studies included in this review, there is some evidence to show that spironolactone is an effective treatment to decrease the degree of hirsutism but there was no evidence for effectiveness for the treatment of acne vulgaris. Studies in this area are scarce and small. Individual study data indicates some superiority of spironolactone over other drugs but results cannot be generalised.