Wong Chooi L, Farquhar Cindy, Roberts Helen, Proctor Michelle
O & G, FMHS, Auckland, New Zealand.
Cochrane Database Syst Rev. 2009 Oct 7;2009(4):CD002120. doi: 10.1002/14651858.CD002120.pub3.
Dysmenorrhoea (painful menstrual cramps) is common. Combined OCPs are recommended in the management of primary dysmenorrhoea.
To determine the effectiveness and safety of combined oral contraceptive pills for the management of primary dysmenorrhoea.
We conducted electronic searches for randomised controlled trials (RCTs) in the Cochrane Menstrual Disorders and Subfertility Group Register of controlled trials CENTRAL, CCTR, MEDLINE, EMBASE, and CINAHL (first conducted in 2001, updated on 5 November 2008).
RCTs comparing all combined OCPs with other combined OCPs, placebo, no management, or management with nonsteroidal anti-inflammatories (NSAIDs) were considered.
Twenty three studies were identified and ten were included. Six compared the combined OCP with placebo and four compared different dosages of combined OCP.
One study of low dose oestrogen and four studies of medium dose oestrogen combined OCPs compared with placebo, for a combined total of 497 women, reported pain improvement. For the outcome of pain relief across the different OCPs the pooled OR suggested benefit with OCPs compared to placebo (7 RCTs: Peto OR 2.01 [95% CI 1.32, 3.08]).The Chi-squared test for heterogeneity showed there is significant heterogeneity with an I(2) statistic of 64% and a significant chi-square test (14.06, df=5, p=0.02). A sensitivity analysis removing the studies with inadequate allocation concealment suggested significant benefit of treatment with the pooled OR of 2.99 (95% CI 1.76, 5.07) and heterogeneity no longer statistically significant and I(2) statistic of 0%.Three studies reported adverse effects (Davis 2005; Hendrix 2002; GPRG 1968) The adverse effects were nausea, headaches and weight gain. Two studies reported if women experienced any side effect and no evidence of an effect was found (3 RCTs: OR = 1.45 (95% 0.71, 2.94). There was no evidence of statistical heterogeneity.There were no studies identified that compared combined OCP versus non steroidal anti-inflammatory drugsThere was no evidence of a difference for the pooled studies for 3rd generation pro gestagens (OR = 1.11 (95% CI 0.79 - 1.57)). For the 2nd generation versus 3rd generation the OR was 0.44 (95% CI 0.23-0.84) suggesting benefit of the 3rd generation OCP but this was for a single study (Winkler 2003).
AUTHORS' CONCLUSIONS: There is limited evidence for pain improvement with the use of the OCP (both low and medium dose oestrogen) in women with dysmenorrhoea. There is no evidence of a difference between different OCP preparations.
痛经(经期疼痛性痉挛)很常见。复方口服避孕药(OCP)被推荐用于原发性痛经的治疗。
确定复方口服避孕药治疗原发性痛经的有效性和安全性。
我们在Cochrane月经紊乱与生育力低下研究组对照试验注册库CENTRAL、CCTR、MEDLINE、EMBASE和CINAHL中进行了电子检索(首次检索于2001年,2008年11月5日更新)。
纳入比较所有复方OCP与其他复方OCP、安慰剂、不治疗或使用非甾体抗炎药(NSAIDs)治疗的随机对照试验(RCT)。
共识别出23项研究,纳入了10项。6项研究比较了复方OCP与安慰剂,4项研究比较了不同剂量的复方OCP。
一项低剂量雌激素和四项中剂量雌激素复方OCP与安慰剂比较的研究,共纳入497名女性,报告疼痛有改善。对于不同OCP的疼痛缓解结果,汇总的比值比表明与安慰剂相比OCP有益(7项RCT:Peto比值比2.01 [95%置信区间1.32, 3.08])。异质性卡方检验显示存在显著异质性,I²统计量为64%,卡方检验显著(14.06,自由度=5,p = 0.02)。一项敏感性分析排除了分配隐藏不充分的研究,结果显示治疗有显著益处,汇总比值比为2.99(95%置信区间1.76, 5.07),异质性不再具有统计学意义,I²统计量为0%。三项研究报告了不良反应(Davis 2005;Hendrix 2002;GPRG 1968)。不良反应为恶心、头痛和体重增加。两项研究报告了女性是否经历任何副作用,未发现有影响的证据(3项RCT:比值比 = 1.45 [95% 0.71, 2.94])。没有统计学异质性的证据。未发现比较复方OCP与非甾体抗炎药的研究。对于汇总研究,第三代孕激素没有差异的证据(比值比 = 1.11 [95%置信区间0.79 - 1.57])。第二代与第三代相比,比值比为0.44(95%置信区间0.23 - 0.84),表明第三代OCP有益,但这仅基于一项研究(Winkler 2003)。
使用OCP(低剂量和中剂量雌激素)改善痛经女性疼痛的证据有限。不同OCP制剂之间没有差异的证据。