Intervention Review

Danazol for heavy menstrual bleeding

  1. Heather H Beaumont1,*,
  2. Cristina Augood2,
  3. Kirsten Duckitt3,
  4. Anne Lethaby4

Editorial Group: Cochrane Menstrual Disorders and Subfertility Group

Published Online: 18 JUL 2007

Assessed as up-to-date: 14 MAY 2007

DOI: 10.1002/14651858.CD001017.pub2


How to Cite

Beaumont HH, Augood C, Duckitt K, Lethaby A. Danazol for heavy menstrual bleeding. Cochrane Database of Systematic Reviews 2007, Issue 3. Art. No.: CD001017. DOI: 10.1002/14651858.CD001017.pub2.

Author Information

  1. 1

    not applicable, not applicable, Birmingham, England, UK

  2. 2

    London School of Hygiene and Tropical Medicine, Department of Epidemiology & Population Sciences,, London, UK

  3. 3

    Prince George Regional Hospital, Prince George, British Colombia, Canada

  4. 4

    School of Population Health,University of Auckland, Section of Epidemiology & Biostatistics, Auckland, New Zealand

*Heather H Beaumont, not applicable, not applicable, 59 Grosvenor Road, Harborne, Birmingham, England, B17 9AL, UK. heather_beaumont@hotmail.com.

Publication History

  1. Publication Status: Stable (no update expected for reasons given in 'What's new')
  2. Published Online: 18 JUL 2007

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Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要
  5. Laički sažetak

Background

Heavy menstrual bleeding (HMB) is an important cause of ill health in pre menopausal women. Medical therapy, with the avoidance of possibly unnecessary surgery is an attractive treatment option, but there is considerable variation in practice and uncertainty about the most effective therapy. Danazol is a synthetic steroid with anti-oestrogenic and anti progestogenic activity, and weak androgenic properties. Danazol suppresses oestrogen and progesterone receptors in the endometrium, leading to endometrial atrophy (thinning of the lining of the uterus) and reduced menstrual loss and to amenorrhoea in some women.

Objectives

To determine the effectiveness and tolerability of Danazol when used for heavy menstrual bleeding in women of reproductive years.

Search methods

We searched the Menstrual Disorders and Subfertility Group's Specialised Register (April 2007). We also searched the Cochrane Controlled Trials Register (Cochrane Library, Issue 2, 2007), MEDLINE (1966 to April 2007), EMBASE (1980 to April 2007, CINAHL (1982 to April 2007). Attempts were also made to identify trials from citation lists of included trials and relevant review articles.

Selection criteria

Randomised controlled trials of Danazol versus placebo, any other medical (non-surgical) therapy or Danazol in different dosages for heavy menstrual bleeding in women of reproductive age with regular HMB measured either subjectively or objectively. Trials that included women with post menopausal bleeding, intermenstrual bleeding and pathological causes of heavy menstrual bleeding were excluded.

Data collection and analysis

Nine RCTs, with 353 women, were identified that fulfilled the inclusion criteria. Quality assessment and data extraction were performed independently by two reviewers. The main outcomes were menstrual blood loss, the number of women experiencing adverse effects, weight gain, withdrawals due to adverse effects and dysmenorrhoea. If data could not be extracted in a form suitable for meta-analysis, they were presented in a descriptive format.

Main results

Most data were not in a form suitable for meta analysis, and the results are based on a small number of trials, all of which are under-powered. Danazol appears to be more effective than placebo, progestogens, NSAIDs and the OCP at reducing MBL, but confidence intervals were wide. Treatment with Danazol caused more adverse events than NSAIDs (OR 7.0; 95% CI 1.7 to 28.2) and progestogens (OR 4.05, 95% CI 1.6 to10.2). Danazol was shown to significantly lower the duration of menses when compared with NSAIDs (WMD -1.0; 95% CI -1.8 to -0.3) and a progesterone releasing IUD (WMD -6.0; 95% CI -7.3 to -4.8). There were no randomised trials comparing Danazol with tranexamic acid or the levonorgestrel-releasing intrauterine system.

Authors' conclusions

Danazol appears to be an effective treatment for heavy menstrual bleeding compared to other medical treatments. The use of Danazol may be limited by its side effect profile, its acceptability to women and the need for continuing treatment. The small number of trials, and the small sample sizes of the included trials limit the recommendations for clinical care. Further studies are unlikely in the future and this review will not be updated unless further studies are identified.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要
  5. Laički sažetak

Danazol is an effective treatment for the reduction of heavy menstrual bleeding, but the adverse effects may be unacceptable to women

Options to help avoid surgery can be important for many women who are having problems with heavy menstrual bleeding. One of the drug options is Danazol. Danazol suppresses the hormones that increase the endometrium (the lining of the uterus that is shed during menstruation). However, Danazol can also produce male characteristics and some menopause-like symptoms, as well as weight gain and acne. The review found that although Danazol is effective at reducing menstrual blood loss there are not enough trials to show whether this treatment is acceptable to women with heavy menstrual bleeding.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要
  5. Laički sažetak

背景

Danazol治療大量月經出血的效果

大量月經出血是造成停經前婦女罹病的重要成因之一。藥物治療因為可以避免掉非必要的手術,故成為較具吸引力的治療選擇,但這樣的選擇在實行面上仍具相當的差異且是否為最有效的治療仍存在不確定性。Danazo 是合成的類固醇,同時具有抗雌激素及抗黃體素的活性以及弱的雄性激素特性。其機轉在於抑制子宮內膜雌激素及黃體素的受體,造成子宮內膜萎縮(子宮襯壁變薄)以減少經血流失,在某些婦女則會出現無月經的情形。

目標

評估Danazol用於治療育齡婦女大量月經出血的效果及耐受性。

搜尋策略

我們搜尋了 Menstrual Disorders and Subfertility Group's Specialised Register(2007年4月)另外,我們也搜尋Cochrane Controlled Trials Register (Cochrane Library, Issue 2, 2007年)、MEDLINE(1966年到2007年4月)、EMBASE(1980年到2007年4月)、CINAHL(1982年到2007年4月)。也嘗試找出納入試驗中有引用的研究試驗清單及相關回顧性文章。

選擇標準

比較Danazol 與安慰劑、任何其他藥物治療(非手術的),或者不同劑量的Danazol用於嚴重大量月經出血的育齡婦女(主觀或客觀被評估有規則性大量月經出血: HMBHeavy menstrual bleeding)。 排除條件包括停經後的出血、月經間期的出血和病理性的大量月經出血的婦女的隨機對照試驗。

資料收集與分析

根據納入標準找到九篇隨機對照試驗研究共353位婦女。由兩位審查作者獨立執行研究品質的評估及資料萃取。 主要的結果在評估婦女經血的流失、婦女出現副作用次數、體重增加、因為副作用而停藥、及經痛。若這些萃取出來的資料無法用同一種格式進行統合分析,審查作者便會以描述性的格式呈現。

主要結論

大多數萃取出來的資料無法用同一種格式進行統合分析,作出來的結論是基於樣本數小的臨床試驗研究且證據力均弱。在減少經血流失(MBL: menstrual blood loss)這方面,Danazol的效果似乎比安慰組、黃體素、非類固醇類抗發炎藥物(Nonsteroidal antiinflammatory drugs, NSAIDs)、口服避孕藥(OCP ral contraceptive pill)較好,但信賴區間很大。副作用方面,Danazol治療組比非類固醇類抗發炎藥物(勝算比7.0,95% I 1.7 to 28.2)及黃體素(勝算比4.05,95% I 1.6 to 10.2]來得高。 Danazol明顯地縮短經期,當相較於非類固醇類抗發炎藥物時其加權均數差(WMD = weighted mean difference)為−1.0而95% CI −1.8 to −0.3;當相較於子宮內避孕器釋放黃體素時,同樣地,Danazol亦明顯地縮短經期(WM 為 −6.0;95% CI −7.3 to −4.8)。尚無隨機臨床試驗比較Danazo 與tranexamic acid 或子宮內給藥系統釋放levonorgestrel的相關研究。

作者結論

對於大量月經出血的患者Danazol相較於其他藥物似乎是較有效的治療。Danazol的使用常因其副作用、婦女患者的接受度以及需要長期持續治療而受到限制。由於研究的文獻少且納入的這些研究樣本數也小,導致其結論運用於臨床照護的建議有所受限。未來似乎不太有可能有進一步的相關研究,而本篇回顧性研究將不再進一步更新,除非有更新的研究報告出來。

翻譯人

本摘要由高雄醫學大學附設醫院許郁笙翻譯。

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

總結

Danazol能有效減少大量月經出血,但是其副作用有可能較難讓婦女接受。許多有大量月經出血的婦女能夠避免開刀是她們重要的想法,而Danazol是藥物治療的選項之一。Danazo 會抑制使子宮內膜增生(子宮的內襯,經期時會剝落)的賀爾蒙 。然而,Danazol可能也會產生男性特徵、一些停經後症狀、體重增加,及粉刺。本篇綜論發現,雖然Danazo 可以有效減少經血的流失,但仍無足夠的研究顯示對於大量月經出血的婦女而言,這樣的藥物選擇是否是可被接受的。

 

Laički sažetak

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要
  5. Laički sažetak

Danazol za obilno menstrualno krvarenje je učinkovit, ali ima nuspojave koje ženama možda nisu prihvatljive

Mnoge žene koje imaju problema s obilnim menstrualnim krvarenjem htjele bi izbjeći kirurški zahvat. Jedna od mogućnosti liječenja je danazol, lijek koji potiskuje hormone koji su odgovorni za zadebljanje endometrija (unutarnjeg sloja maternice koji se ljušti tijekom menstruacije). Međutim, danazol također uzrokuje pojavu muških osobina kao što su pojačana dlakavost i dubok glas, simptome nalik menopauzi, kao i povećanje tjelesne težine i akne. Cochrane sustavni pregled je zaključio da je danazol učinkovit u smanjenju količine menstrualnog krvarenja, međutim nije dovoljno istraženo je li ova terapija ženama prihvatljiva.

Bilješke prijevoda

Prevoditelj:: Croatian Branch of the Italian Cochrane Centre