Lopez Laureen M, Kaptein Ad A, Helmerhorst Frans M
Behavioral and Biomedical Research, Family Health International, P.O. Box 13950, Research Triangle Park, North Carolina 27709, USA.
Cochrane Database Syst Rev. 2009 Apr 15(2):CD006586. doi: 10.1002/14651858.CD006586.pub3.
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.
To review all randomized controlled trials comparing combined oral contraceptives containing drospirenone versus a placebo or another COC for effect on premenstrual symptoms.
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.
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.
Two review authors independently abstracted data and assessed study quality.
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 mug 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.
经前综合征（PMS）是一个常见问题。经前烦躁障碍（PMDD）是PMS的一种严重形式。含有孕激素和雌激素的复方口服避孕药（COC）已被研究其缓解经前症状的能力。一种含有屈螺酮和低剂量雌激素的COC已被批准用于治疗选择COC进行避孕的女性的PMDD。
回顾所有比较含屈螺酮的复方口服避孕药与安慰剂或其他COC对经前症状影响的随机对照试验。
我们在计算机化数据库MEDLINE、POPLINE、CENTRAL、EMBASE、LILACS、PsycINFO和CINAHL中搜索关于屈螺酮和经前综合征的研究。我们还检查了相关文章的参考文献列表，并写信给知名研究者以寻找其他试验。
我们纳入了任何语言的随机对照试验，这些试验比较含屈螺酮的COC与安慰剂或其他COC对经前症状的影响。主要结局是经前症状（情感和身体方面）的前瞻性记录。检查了与使用COC相关的不良事件。
两位综述作者独立提取数据并评估研究质量。
我们纳入了5项试验，共1600名女性。两项针对PMDD女性的安慰剂对照试验显示，使用屈螺酮（加乙炔雌二醇（EE）20μg）三个月后经前症状比使用安慰剂时减轻（加权均数差 -7.83；95%可信区间 -10.91至 -4.75）。屈螺酮组在生产力受损（加权均数差 -0.42；95%可信区间 -0.64至 -0.20）、社交活动（加权均数差 -0.39；95%可信区间 -0.62至 -0.15）和人际关系（加权均数差 -0.38；95%可信区间 -0.61至 -0.51）方面的改善更大。使用COC更常见的副作用是恶心、经间期出血和乳房疼痛。将含更多雌激素的屈螺酮与另一种COC比较时，对较轻症状的影响较小。一项为期六个月的研究显示屈螺酮组症状较少，而一项为期两年的试验发现两组相似。
屈螺酮加EE 20μg可能有助于治疗PMDD女性的经前症状。安慰剂也有很大效果。我们不知道COC在三个周期后是否有效，对症状较轻的女性是否有效，或者是否比其他COC更好。需要开展更大规模、更长时间、更高质量的试验来解决这些问题。试验应遵循CONSORT报告指南。
