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. Hirsutism is most often caused by increased production of male sex hormones also known as androgens. It is also affected by increased sensitivity to androgens in the hair follicles, and the secretory glands around the hair follicles, called sebaceous glands. Spironolactone is an antiandrogen and aldosterone antagonist used to treat hirsutism.

OBJECTIVES: The objective of this review 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: We searched the Cochrane Menstrual Disorders and Subfertility Group trials register (searched 12 June 2003). The Cochrane Menstrual Disorders and Subfertility Group register is based on regular searches of MEDLINE, EMBASE, CINAHL, PsycINFO and CENTRAL, the 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 In addition, all reference lists of relevant trials were searched and drug companies contacted for details of unpublished trials.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: Seven trials were included in the review, eight trials were excluded. Two other trials are awaiting assessment. All included trials were small (no more than 41 participants) randomised and controlled. Only one trial studied acne as an outcome, the remainder were concerned with hirsutism. Two trials investigated spironolactone versus placebo; one trial was a dosage studies of spironolactone; one trial compared spironolactone with spironolactone in combination with dexamethasone; one trial used topical spironolactone for the treatment of acne, one trial compared three treatments; spironolactone, finasteride, cyproterone acetate. Major outcome measures include the following: subjective observations, Ferriman and Gallwey hair scores, hormonal and biochemical parameters, side effects, sebum production measurement.

MAIN RESULTS: All sample populations were small and confidence intervals were wide. 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), Ferriman-Galwey score (WMD 7.20, 95% CI -10.98 to -3.42)). The remaining comparisons were not statistically significant. There were statistically significant improvements in Ferriman-Galwey scores 12 months after the end of treatment in those women who received 100mg/day spironolactone compared to 12.5 mg/day cyproterone acetate (first 10 days of cycle) (WMD -1.18, 95% CI -2.1 to -0.26) and 5mg/day finasteride (WMD -2.34, 95% CI -3.23 to -1.45).

REVIEWER'S CONCLUSIONS: Six months treatment with 100 mg/day spironolactone compared with placebo was associated with a statistically significant subjective improvement in hair growth and a decrease in Ferriman-Galwey scores. Spironolactone 100mg/day is superior to finasteride 5 mg/day and low dose cyproterone acetate 12.5 mg/day (first 10 days of cycle) up to 12 months after the end of treatment. The effectiveness of treatment for acne vulgaris cannot be determined due to the small sample populations involved in the trials. Its value in clinical practice is difficult to assess from currently available research.