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

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. Since 1978, many studies have been conducted to determine its effectiveness.

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.

All publications of randomised controlled trials of spironolactone versus placebo and/or in combination with steroids (oral contraceptive pill included) were identified. Search strategy was developed by the Menstrual Disorder Group. All accessible electronic databases were searched. In addition, all reference lists of relevant trials were searched and drug companies contacted for details of unpublished trials.

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.

Six trials were included in the review, seven trials were excluded. Two other trials are awaiting assessment. All included trials were small (no more than 40 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; the remaining trial used topical spironolactone for the treatment of acne. Major outcome measures include the following: - subjective observations - Ferriman and Gallwey hair scores - hormonal and biochemical parameters - side effects - sebum production measurement

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, 26.28), Ferriman-Galwey score (WMD 7.20, 95%CI -10.98, -3.42)). The remaining comparisons were not statistically significant.

Six months treatment with 100 mg spironolactone compared with placebo was associated with a statistically significant subjective improvement in hair growth and a decrease in Ferriman-Galwey scores. 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.