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

 

Abstract

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 methods

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 In addition, all reference lists of relevant trials were searched and drug companies contacted for details of unpublished trials.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 (MD 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.

 

Plain language summary

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

The evidence suggests a lack of evidence to show whether spironolactone can reduce hirsutism and acne. Hirsutism in women (excessive hair growth) is most often caused by an increased production of male hormones. Spironolactone (`Aldactone' or `Spirotone') is an anti-androgen, which can be taken with or without the oral contraceptive pill to try and reduce hirsutism. 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 insufficient evidence for the management of acne vulgaris. It appears to be more effective than finasteride 5mg/day, metformin and low dose cyproterone acetate.

 

摘要

背景

Spironolactone或Spironolactone加上類固醇和安慰劑對多毛症和/或粉刺的治療比較

多毛症是婦女毛髮生長過度，是一個重要的美觀問題往往造成嚴重的困擾。多毛症是最常見的原因是男性荷爾蒙，也被稱為雄激素生產大量增加。也受到在毛囊、毛囊周圍的分泌腺體(稱為皮脂腺)，雄激素敏感性增加的影響。Spironolactone是一種抗雄激素(antiandrogen)和醛固酮拮抗劑(aldosterone antagonist)用於治療多毛症。

目標

這篇回顧論文的目的，在探討對於毛髮過度生長和/或粉刺(acne)的婦女，spironolactone和/或加上類固醇(口服避孕藥包括在內)的治療效果。

搜尋策略

我們檢索了在Cochrane註冊的月經失調和不孕組試驗(搜尋2003年6月12日)。該Cochrane月經失調和不孕組試驗記錄是根據定期查了MEDLINE，EMBASE，CINAHL，PsycINFO和CENTRAL，進行手查的20個有關期刊和會議錄，並搜尋了幾個關鍵的灰色文獻的來源。 此外，也搜尋所有的參考文獻的有關試驗和聯繫製藥公司詢問未發表的試驗的詳細資料。

選擇標準

所有隨機對照比較spironolactone與：安慰劑，類固醇(包含口服避孕藥)，不同劑量的spironolactone，或spironolactone和類固醇相較於單獨使用類固醇，以減少婦女的毛髮生長和粉刺。

資料收集與分析

7個試驗被列入回顧，8項試驗被排除在外。2個試驗在等待評估中。所有列入的試驗都是小的隨機對照試驗(不超過41人參加)。只有一個試驗以粉刺當成研究的結果，其餘的是有關多毛症。兩個試驗討論 spironolactone與安慰劑比較，一個試驗是spironolactone的劑量研究; 一個試驗是比較spironolactone和 spironolactone加上dexamethasone，一個試驗中使用外用spironolactone治療粉刺，一個試驗比較3種治療：spironolactone, finasteride, cyproterone acetate。主要結果包括測量以下：主觀意見，Ferriman and Gallwey頭髮分數，激素和生化指標，副作用，皮脂產生測量。

主要結論

所有樣本人數都很小，且寬的置信區間(confidence intervals)。在這兩個試驗中，比起100毫克spironolactone與安慰劑，在主觀改善毛髮生長(OR 7.18，95％ CI 1.96 – 26.28)和Ferriman  Galwey評分(WMD 7.20，95％ CI −10.98 – 3.42)有顯著性差異報告。其餘比較無統計學意義。在接受100mg/day spironolactone 治療12個月後結束治療的婦女，比起12.5毫克/天 yproterone acetate(第10天的週期)(WMD −1.18，95％CI為 −2.1到 0.26)和5mg/day finasteride(WM 2.34，95％CI為−3.23至−1.45)，在Ferriman  Galwey分數有統計學顯著改善。

作者結論

spironolactone治療6個月100毫克/天 與安慰劑相比，有顯著的主觀改善毛髮生長和減少Ferriman  Galwey分數。長達12個月後結束治療，Spironolactone 100mg/day優於finasteride5毫克/天和低劑量cyproterone acetate 12.5毫克/天(前10天週期)。Acne vulgaris治療的有效性不能確定，由於是小樣本數的試驗。 從現有的研究很難評估它在臨床應用的價值。

翻譯人

本摘要由高雄醫學大學附設醫院廖正宇翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

沒有足夠的證據顯示spironolacton可以減少多毛及粉刺。多毛症的婦女(過多的毛髮生長)可能會導致粉刺和脫髮。最常見的原因是產生過多雄性激素。Spironolactone(‘Aldactone’ 或 ‘Spirotone’)是一種抗雄激素，可單獨或與口服避孕藥合用，來試著減少多毛症。沒有足夠的數據來確定它是否有效，但大多數研究表明，使用後一些改善，這似乎是比 finasteride 5mg/day和低劑量cyproterone acetate更有效。