Intervention Review

Hormone replacement therapy for preventing cardiovascular disease in post-menopausal women

  1. Rafael Gabriel Sanchez1,*,
  2. Luis Maria Sanchez Gomez2,
  3. Loreto Carmona3,
  4. Marta Roqué i Figuls4,
  5. Xavier Bonfill Cosp5

Editorial Group: Cochrane Heart Group

Published Online: 21 JAN 2009

Assessed as up-to-date: 31 JAN 2005

DOI: 10.1002/14651858.CD002229.pub2

Database Title

Additional Information

How to Cite

Gabriel Sanchez R, Sanchez Gomez LM, Carmona L, Roqué i Figuls M, Bonfill Cosp X. Hormone replacement therapy for preventing cardiovascular disease in post-menopausal women. Cochrane Database of Systematic Reviews 2005, Issue 2. Art. No.: CD002229. DOI: 10.1002/14651858.CD002229.pub2.

Author Information

  1. 1

    Hospital Universitario de la Princesa, Unidad de Investigacion, Madrid, Spain

  2. 2

    Servico Galego de Salude, Agencia Evaluacion Tecnologias Sanitarias de Galicia, A Coruna, Spain

  3. 3

    Rheumatology Organization, Madrid, Spain

  4. 4

    Hospital de la Santa Creu i Sant Pau, Centro Cochrane Iberoamericano. CIBER Epidemiología y Salud Pública (CIBERESP), Spain. , Barcelona, Catalunya, Spain

  5. 5

    Hospital de la Santa Creu i Sant Pau, CIBER Epidemiología y Salud Pública (CIBERESP), Spain. Centro Cochrane Iberoamericano, Barcelona, Catalonia, Spain

*Rafael Gabriel Sanchez, Unidad de Investigacion, Hospital Universitario de la Princesa, Diego De Leon 62, Planta 9, Madrid, 28006, Spain. rgabriel.hulp@salud.madrid.org . rgsanchez@hup.es.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 21 JAN 2009

SEARCH

ARTICLE TOOLS

View Full Article (HTML) Summary (59K)Standard (247K)Full (481K)
 

Abstract

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

Background

There is apparently compelling evidence, from observational studies, that hormone replacement therapy (HRT) may have benefits in reducing cardiovascular events in post-menopausal women. However, these observational data are subject to biases and confounding and require support from formally designed randomised controlled trials of the effects of HRT on cardiovascular disease risk.

Objectives

To assess the effects of HRT for the primary and secondary prevention of cardiovascular diseases in post-menopausal women.

Search methods

We searched MEDLINE (1998 to December 2002)), EMBASE (1998 to December 2002), the Cochrane Controlled Trials Register (CCTR) (Issue 4 2002), the National Research Register (1998 to present), Clinical Trials.gov (1998 to present), and the database of Spanish Clinical Trials (1998 to present) and reference lists of articles.

Selection criteria

Randomised controlled trials comparing HRT with controls (placebo or no treatment) with a minimum follow up of 6 months for treating or preventing cardiovascular disease in postmenopausal women with or without cardiovascular disease.

Data collection and analysis

Three independent reviewers extracted information from the articles, solving discrepancies by consensus. All outcomes studied were dichotomous. Risk ratios and 95% confidence intervals (CI) were calculated for each study and plotted. Random effects meta-analysis was used in efficacy outcomes (cardiovascular events) and fixed-effects meta-analysis in variables regarding side effects (deep venous thrombosis).

Main results

No protective effect of HRT was seen for any of the cardiovascular outcomes assessed: all cause mortality, cardiovascular death, non-fatal MI, venous thromboemboli or stroke. Higher risks of venous thromboembolic events (Relative risk (RR) 2.15, 95% CI 1.61 to 2.86), pulmonary embolus (RR 2.15, 95% CI 1.41 to 3.28), and stroke (RR 1.44, 95% CI 1.10 to 1.89) was found in those randomised to HRT compared with placebo. No substantial heterogeneity (p <0.1) was detected in any of the outcomes studied.

Authors' conclusions

At present, a recommendation for initiating HRT for the reason of preventing cardiovascular events in post-menopausal women (with or without cardiovascular disease) should not be made. Women with other risk factors for venous thromboembolic events should be discouraged from using HRT if the sole goal is to prevent cardiovascular events.

 

Plain language summary

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

Hormone therapy has no heart-protective benefit to healthy postmenopausal women or to those with heart disease.

The authors analysed the data from the 10 clinical trials - two involved healthy women and eight involved women with heart disease. Altogether the trials included about 24,000 women who had been randomly assigned to take either hormones or placebos (dummy pill) every day for approximately five years. The authors found no evidence that hormone therapy provides heart-related benefits to postmenopausal women with or without heart disease. Rather, women taking hormones had a higher incidence of non-fatal heart attacks, stroke, and blood clots in the leg and lung than the women taking placebos.

 

摘要

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

背景

於停經後婦女使用荷爾蒙補充療法預防心血管疾病之探討

目前經由觀察性研究針對荷爾蒙補充療法對於停經後婦女已有明顯證據顯示出可以有效降低心血管事件的危險。然而這些研究存在主觀認知偏差及混淆, 仍待隨機對照試驗來支持荷爾蒙治療對於心血管風險性的影響

目標

評估荷爾蒙補充療法在停經後婦女針對心血管疾病其初級預防及次級預防之效果。

搜尋策略

我們搜尋以下資料庫之資料為佐證: MEDLINE (1998 至 December 2002)), EMBASE (1998 至 December 2002), the Cochrane Controlled Trials Register (CCTR) (2002年第4期), National Research Register (1998 至今), Clinical Trials.gov (1998至今), the database of Spanish Clinical Trials (1998至今)及其他在參考文獻上的著作.

選擇標準

隨機對照試驗關於荷爾蒙補充療法與對照組(安慰劑或無治療)於停經後婦女身上(已有或未具心血管疾病)預防心血管疾病之效果, 此試驗需至少追蹤試驗對象六個月以上。

資料收集與分析

三個獨立運作之檢閱人從這些文章中萃取資訊, 藉由達成共識來消除分歧。所有研討的結果皆二分化。每個研究的risk ratios及95%信賴區間(CI) 皆被計算出及作圖。 關於療效(心血管疾病相關事件)之結果以隨機效應的統合分析處理, 併發症(深層靜脈栓塞)相關之變數以固定效應的統合分析處理。

主要結論

於以下各項結果皆無顯現荷爾蒙補充療法於保護心血管上具有效果,其包括: 總死亡率, 心血管死亡率,非致命性心肌梗塞,靜脈栓塞或腦中風。在以下事件上則顯示荷爾蒙補充療法具較高之危險性,其包括: 靜脈栓塞 (相對風險 2.15, 95% 信賴區間 1.61 to 2.86), 肺栓塞 (相對風險.15, 95% 信賴區間 1.41 to 3.28), 及腦中風 (相對風險 1.44, 95% 信賴區間 1.10 to 1.89). 所有的研究結果分析均未顯現出統計學上的異質性(p < 0.1)

作者結論

至今仍不應該推薦在停經後婦女(無論有無心血管疾病)使用荷爾蒙補充療法以預防心血管疾病。於具有靜脈栓塞危險因子之女性身上如以預防心血管疾病為單一目標, 荷爾蒙療法不應被允許使用。

翻譯人

本摘要由臺北榮民總醫院楊勝翔翻譯。

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

總結

荷爾蒙療法無論在健康或具心血管疾病之停經女性身上皆無保護心臟之效益. 作者們分析了十篇臨床研究, 其中兩篇以健康女性為對象, 另外八篇以具心臟疾病之女性為對象。這些研究總括了24000位女性,其被隨機分配於服藥組(荷爾蒙)及對照組(服用安慰劑), 這些女性每天服藥持續近五年。作者們未發現荷爾蒙療法於停經後婦女身上(無論有無心血管疾病)可提供關於保護心臟之效益。更甚者, 服用荷爾蒙之女性相較於未服用者在非致命性心臟病, 腦中風及腿部血栓上具有較高之發生率。

View Full Article (HTML) Summary (59K)Standard (247K)Full (481K)