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Intervention Review
Oral contraceptives containing drospirenone for premenstrual syndrome
Editorial Group: Cochrane Menstrual Disorders and Subfertility Group
Published Online: 15 APR 2009
Assessed as up-to-date: 9 SEP 2007
DOI: 10.1002/14651858.CD006586.pub3
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Database Title
Additional Information
How to Cite
Lopez LM, Kaptein AA, Helmerhorst FM. Oral contraceptives containing drospirenone for premenstrual syndrome. Cochrane Database of Systematic Reviews 2009, Issue 2. Art. No.: CD006586. DOI: 10.1002/14651858.CD006586.pub3.
Publication History
- Publication Status: Edited (no change to conclusions)
- Published Online: 15 APR 2009
This is not the most recent version of the article.View current version (15 Feb 2012)
Abstract
Background
Premenstrual syndrome (PMS) is a common problem. Premenstrual dysphoric disorder (PMDD) is a severe form of PMS. Combined oral contraceptives (COCs), which have both progestin and estrogen, have been examined for their ability to relieve premenstrual symptoms. A COC containing drospirenone and low estrogen has been approved for treating PMDD in women who choose COCs for contraception.
Objectives
To review all randomized controlled trials comparing combined oral contraceptives containing drospirenone versus a placebo or another COC for effect on premenstrual symptoms.
Search methods
We searched the computerized databases MEDLINE, POPLINE, CENTRAL, EMBASE, LILACS, PsycINFO, and CINAHL for studies of drospirenone and premenstrual syndrome. We also examined references lists of relevant articles, and wrote to known investigators to find other trials.
Selection criteria
We included randomized controlled trials in any language that compared a COC containing drospirenone versus a placebo or another COC for effect on premenstrual symptoms. Primary outcome was the prospective recording of premenstrual symptoms (affective and physical). Adverse events related to COC use were examined.
Data collection and analysis
Two review authors independently abstracted data and assessed study quality.
Main results
We included five trials with a total of 1600 women. Two placebo-controlled trials of women with PMDD showed less severe premenstrual symptoms after three months with drospirenone (plus ethinyl estradiol (EE) 20g) than with the placebo (WMD -7.83; 95% CI -10.91 to -4.75). The drospirenone group had greater decreases in impairment of productivity (WMD -0.42; 95% CI -0.64 to -0.20), social activities (WMD -0.39; 95% CI -0.62 to -0.15), and relationships (WMD -0.38; 95% CI -0.61 to -0.51). Side effects more common with COC use were nausea, intermenstrual bleeding, and breast pain. Little effect was found on less severe symptoms when comparing drospirenone plus more estrogen to another COC. A six-month study showed fewer symptoms with drospirenone, while a two-year trial found the groups to be similar.
Authors' conclusions
Drospirenone plus EE 20 μg may help treat premenstrual symptoms in women with PMDD. The placebo also had a large effect. We do not know whether the COC works after three cycles, for women with less severe symptoms, or better than other COCs. Larger and longer trials of higher quality are needed to address these issues. Trials should follow CONSORT reporting guidelines.
Plain language summary
Birth control pills with drospirenone for treating premenstrual symptoms
Premenstrual syndrome (PMS) is a common problem. A severe form of PMS is called premenstrual dysphoric disorder (PMDD). Birth control pills with the hormones progestin and estrogen have been studied for treating such symptoms. A birth control pill with the progestin drospirenone may provide more benefits than other such pills. A drospirenone pill with low estrogen was approved for treating PMDD in women who want to use birth control pills.
We did a computer search for randomized controlled trials in any language that compared a birth control pill with drospirenone and estrogen to a placebo ('dummy') or another birth control pill for effect on premenstrual symptoms. We wrote to researchers to find other trials. We looked at whether the pills reduced symptoms and if side effects were reported. Women recorded their premenstrual symptoms over time.
We found five trials with a total of 1600 women. Two trials compared a sugar pill to a drospirenone pill. All the women had PMDD before the trial. After three months, fewer women on a drospirenone pill with low estrogen had severe premenstrual symptoms than the placebo group did. The drospirenone group had better productivity, social activities, and relationships. Women on the drospirenone pill had more nausea, bleeding between periods, and breast pain. These side effects are common with birth control pills. We found little information on treating less severe premenstrual symptoms. Two trials compared a drospirenone pill with more estrogen to another birth control pill. These women did not all have PMDD. In a six-month trial, fewer of the drospirenone group had premenstrual symptoms. In a two-year study, the groups were similar in symptoms and side effects.
A drospirenone pill with low estrogen seems to help premenstrual symptoms in women with PMDD. The placebo, or dummy pill, also had an effect on symptoms. We do not know if the birth control pill works longer than three cycles, in women with less severe symptoms, or better than other birth control pills. Longer and better studies with more women would help. Trials reports should explain more clearly how the study was carried out.
摘要
背景
含drospirenone口服避孕藥對月經前症候群(premenstrual syndrome)的治療效果
月經前症候群(PMS)是一個常見的問題。經前焦燥障礙(Premenstrual dysphoric disorder; PMDD)是一種月經前症候群(PMS) 的嚴重表現形式。含drospirenone的複方口服避孕藥(Combined oral contraceptives，COCs)，內含黃體激素與雌激素，減輕月經前症候群症狀的效能已被檢定。選擇含有drospirenone和低劑量雌激素的複方口服避孕藥，已被批准用於治療使用複方口服避孕藥避孕婦女的月經前焦燥障礙。
目標
評論所有的隨機對照試驗來比較含有drospirenone的複方口服避孕藥與安慰劑或其他複方口服避孕藥，對月經前症候群的效果。
搜尋策略
我們搜尋在MEDLINE、POPLINE、CENTRAL、EMBASE、LILACS、PsycINFO以及CINAHL等電腦資料庫中，有關drospirenone和月經前症候群的研究。我們還檢定參考文獻清單中的相關文獻，並寫信給已知的研究者，以找出其他的研究
選擇標準
我們收錄任何語言的隨機對照試驗，比較含有drospirenone的複方口服避孕藥與安慰劑或其他複方口服避孕藥對月經前症候群的效果。主要結果是事前記錄的月經前症候群(包括情感和身體症狀)，也檢定複方口服避孕藥相關的不良事件。
資料收集與分析
兩位作者獨立評論摘要的數據並評估研究的質量。
主要結論
我們共收錄五個試驗1600位婦女。二篇為安慰劑對照試驗治療經前焦燥障礙的婦女，顯示drospirenone(另加ethinyl estradiol (EE 0微克)治療3個月後，比安慰劑治療者月經前症狀較不嚴重(WMD −7.83; 95% CI −10.91至 −4.75)。drospirenone組有更佳的生育力(WMD −0.42; 95% CI −0.64至−0.20)，社交活動(WMD −0.39; 95% CI −0.62至−0.15)和社交關係(WMD −0.38; 95% CI −0.61至−0.51)。使用複方口服避孕藥較常見的副作用是使人噁心，經期間的出血和乳房疼痛。對較不嚴重的症狀， drospirenone加上較多的雌激素與其他複方口服避孕藥，效果差異不大。一個為期六個月的研究結果顯示，drospirenone治療有較少的症狀，而另一個為期兩年的試驗則發現兩組類似。
作者結論
Drospirenone 加上 EE 20 微克可能有助於治療經前焦燥障礙婦女的經前症狀。安慰劑效果也相當大。我們不知道對症狀較不嚴重的婦女，經過三個週期含Drospirenone複方口服避孕藥治療是否有效，或優於其他複方口服避孕藥 。要解決這些問題需要較大、較長和更高品質的試驗。這些臨床試驗並應遵循CONSORT報告準則。
翻譯人
本摘要由高雄醫學大學附設醫院蘇富敏翻譯。
此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。
總結
含drospirenone避孕藥治療月經前症候群，月經前症候群是一個常見的問題。月經前症候群的一個嚴重形式，是所謂的經前焦燥障礙。含黃體脂酮(progestin)與雌激素荷爾蒙的避孕藥已進行治療這種症狀的研究。含drospirenone黃體脂酮(progestin)的避孕藥比其他避孕藥可提供更多的好處。drospirenone與低劑量雌激素已被准許用於治療想要使用避孕藥的經前焦燥障礙婦女。我們使用電腦收尋任何語言的隨機對照試驗，比較含有drospirenone與雌激素的避孕藥與安慰劑或其他避孕藥對經前症狀的效果。我們寫信給研究人員以收尋其他的研究。我們期待避孕藥是否可減少症狀，及副作用是否被報告。婦女隨著時間記錄他們的經前症狀。我們共發現五篇論文1600婦女。其中兩篇試驗，比較糖丸安慰劑與含drospirenone避孕藥。所有婦女在試驗前都有經前焦燥障礙。 3個月試驗後，使用drospirenone與低劑量雌激素的婦女比安慰劑組較少有嚴重經前症狀。drospirenone組有較好的生育力，社交活動，和社會關係。drospirenone組婦女有較多噁心，經期間出血，乳房疼痛，這些都是避孕藥常見的副作用。對治療較不嚴重經前症狀的資料較少。有兩篇試驗比較drospirenone加較多劑量雌激素與其他種避孕藥的效果。這些婦女並不都有經前焦燥障礙。在為期六個月的試驗中，drospirenone組有較少的經前症狀。而另一個為期兩年的試驗則發現兩組的症狀和副作用類似。有經前焦燥障礙的婦女使用drospirenone加低劑量雌激素有助於改善經前症狀。安慰劑對經前症狀也有效果。我們不知道對症狀較不嚴重的婦女，避孕藥在3個週期後是否仍然有效，或優於其他避孕藥。較長和更好品質的研究與更多的婦女參與將有助於解決這些問題。試驗報告應更清楚解釋如何進行研究。