Abdel-Aleem H, d'Arcangues C, Vogelsong K, Gülmezoglu A M
Faculty of Medicine, Obstetrics and Gynecology, Assiut University Hospital, Assiut, EGYPT.
Cochrane Database Syst Rev. 2007 Apr 18(2):CD003449. doi: 10.1002/14651858.CD003449.pub2.
Despite their high effectiveness, progestin-only contraceptives are considered less than ideal by the many women who experience disruption of their normal vaginal bleeding pattern when using these methods. Current treatments to control these bleeding irregularities are not sufficiently effective.
We evaluated preventive and therapeutic interventions of bleeding irregularities associated with the use of progestin-only contraceptives.
Literature was identified through database searches, reference lists, organisations and individuals, covering the period until December 2006.
Trials with random or alternate allocation, testing interventions for the prevention or treatment of bleeding irregularities associated with the use of progestin-only contraceptives were eligible.
Results are expressed as relative risks (RR) with 95 % confidence interval (CI) for categorical data and as weighted mean difference (WMD) with 95 % CI for continuous data. When we encountered heterogeneity (visual or statistical) we used the random-effects model (quantitative) or did not produce a summary estimate (qualitative).
19 Randomised controlled trials including 2290 participants were included. Over 60% of these trials had low to moderate risk of bias. Estrogen treatments reduced the number of days of an ongoing bleeding episode in DMPA users and had a positive therapeutic effect in Norplant users. However, treatment frequently led to discontinuation due to gastrointestinal upset. Combinations of oral ethinyl estradiol and levonorgestrel taken by Norplant users experiencing bleeding irregularities, improved bleeding patterns but method discontinuation rates remained the same. Norplant users administered the anti-progestin mifepristone therapeutically reported fewer days of bleeding than those given placebo. Prophylactic oral mifepristone used monthly by new Norplant users reduced bleeding, when compared to placebo.Ibuprofen was reported to decrease the length of bleeding episodes over a year, but the data were not presented in a suitable format for our analysis. Mefenamic acid reduced continued irregular bleeding during treatment in Norplant users, but not among DMPA users. Vitamin E and aspirin had no effect on bleeding patterns in a large trial of women using Norplant. Norplant users receiving tamoxifen had less unacceptable bleeding after treatment and were more likely to continue using Norplant than those receiving placebo.
AUTHORS' CONCLUSIONS: Some women may benefit from the interventions described, particularly with cessation of an ongoing bleeding episode. Several regimens offer promise in regulating bleeding, but findings need to be reproduced in larger scale trials. Intermittent treatment with an agent may help some women to continue the use of a progestin-only contraceptive. The results of this review do not support routine clinical use of any of the regimens included in the trials, particularly for long-term effect.
尽管单纯孕激素避孕药效果显著,但许多使用这些方法的女性认为其并不理想,因为她们的正常阴道出血模式会受到干扰。目前控制这些出血异常的治疗方法效果并不充分。
我们评估了与使用单纯孕激素避孕药相关的出血异常的预防和治疗干预措施。
通过数据库检索、参考文献列表、组织和个人确定文献,涵盖截至2006年12月的时间段。
符合条件的试验需采用随机或交替分配方式,测试用于预防或治疗与使用单纯孕激素避孕药相关的出血异常的干预措施。
分类数据的结果以相对风险(RR)及95%置信区间(CI)表示,连续数据的结果以加权平均差(WMD)及95%CI表示。当遇到异质性(视觉或统计学)时,我们使用随机效应模型(定量)或不进行汇总估计(定性)。
纳入了19项随机对照试验,共2290名参与者。其中超过60%的试验存在低至中度偏倚风险。雌激素治疗减少了使用醋酸甲羟孕酮(DMPA)的女性持续出血发作的天数,对使用左炔诺孕酮皮下埋植剂(Norplant)的女性有积极的治疗效果。然而,治疗常因胃肠道不适导致停药。经历出血异常的Norplant使用者服用炔雌醇和左炔诺孕酮的组合,出血模式有所改善,但方法停用率保持不变。接受抗孕激素米非司酮治疗的Norplant使用者报告的出血天数少于服用安慰剂者。新的Norplant使用者每月预防性口服米非司酮与安慰剂相比减少了出血。据报道布洛芬可减少一年中出血发作的时长,但数据呈现格式不适合我们的分析。甲芬那酸减少了Norplant使用者治疗期间的持续不规则出血,但对DMPA使用者无效。在一项针对使用Norplant的女性的大型试验中,维生素E和阿司匹林对出血模式没有影响。接受他莫昔芬治疗的Norplant使用者治疗后不可接受的出血较少,且比接受安慰剂者更有可能继续使用Norplant。
一些女性可能会从所述干预措施中受益,尤其是在停止持续出血发作方面。几种方案在调节出血方面有前景,但研究结果需要在更大规模的试验中重现。间歇性使用一种药物治疗可能有助于一些女性继续使用单纯孕激素避孕药。本综述的结果不支持试验中任何一种方案的常规临床应用,尤其是长期效果方面。