背景:经前综合症(PMS)是身体,育龄妇女的心理和社会症状,经前烦躁不安症(PMDD)是一种严重的综合征,以前称为黄体晚期焦虑障碍(LLPDD)。这两种综合征都会在月经前两周(黄体期)引起症状。选择性5-羟色胺再摄取抑制剂(SSRIs)越来越多地用作PMS和PMDD的治疗,在黄体期或连续给药。我们进行了系统审查,以评估SSRIs在PMS和PMDD管理中的积极作用和危害的证据。
目的:评估SSRIs治疗PMS和PMDD的益处和危害。
方法:我们搜索了Cochrane妇科和生育力(CGF)对照试验专业注册,中部,MEDLINE,Embase和PsycINFO用于2023年11月的随机对照试验(RCT)。我们检查了相关研究的参考清单,搜索试验登记册,并联系该领域的专家进行任何其他试验.这是上一次于2013年发布的评论的更新。
方法:我们考虑了前瞻性诊断为PMS的女性的研究,PMDD或LLPDD随机接受SSRIs或安慰剂。
方法:我们使用标准Cochrane方法。我们使用随机效应模型汇集数据。我们计算了经前症状评分的95%置信区间(CI)的标准化平均差(SMD),使用“治疗后”评分获取连续数据。我们计算了二分结果的95%CI的比值比(OR)。我们按给药类型(黄体期或连续)进行分层分析。我们计算了绝对风险和需要服用SSRIs以引起额外不良事件的女性人数(即治疗额外有害结果所需的人数(NNTH))。我们使用GRADE对主要发现的证据的总体确定性进行了评级。
结果:我们纳入了34项RCTs。这些研究比较了SSRIs(即氟西汀,帕罗西汀,舍曲林,艾司西酞普兰和西酞普兰)服用安慰剂。SSRIs可能会降低PMS和PMDD女性的总体自我评估的经前症状(SMD-0.57,95%CI-0.72至-0.42;I2=51%;12项研究,1742名参与者;中度确定性证据)。SSRI治疗在连续给药时可能比仅在黄体期给药时更有效(亚组差异P=0.03;黄体期组:SMD-0.39,95%CI-0.58至-0.21;6项研究,687名参与者;中度确定性证据;连续组:SMD-0.69,95%CI-0.88至-0.51;7项研究,1055名参与者;中等确定性证据)。与SSRIs相关的不良反应为恶心(OR3.30,95%CI2.58至4.21;I2=0%;18项研究,3664名妇女),失眠(OR1.99,95%CI1.51至2.63;I2=0%;18项研究,3722名妇女),性功能障碍或性欲下降(OR2.32,95%CI1.57至3.42;I2=0%;14项研究,2781名妇女),疲劳或镇静(OR1.52,95%CI1.05至2.20;I2=0%;10项研究,1230名妇女),头晕或眩晕(OR1.96,95%CI1.36至2.83;I2=0%;13项研究,2633名妇女),震颤(OR5.38,95%CI2.20至13.16;I2=0%;4项研究,1352名妇女),嗜睡和浓度降低(OR3.26,95%CI2.01至5.30;I2=0%;8项研究,2050年妇女),出汗(OR2.17,95%CI1.36至3.47;I2=0%;10项研究,2304名妇女),口干(OR2.70,95%CI1.75至4.17;I2=0%;11项研究,1753名妇女),虚弱或能量下降(OR3.28,95%CI2.16至4.98;I2=0%;7项研究,1704名妇女),腹泻(OR2.06,95%CI1.37至3.08;I2=0%;12项研究,2681名妇女),和便秘(OR2.39,95%CI1.09至5.26;I2=0%;7项研究,1022名妇女)。除嗜睡/浓度降低外,所有不良反应均有中等确定性证据,这是低确定性的证据。总的来说,证据的确定性是中等的。主要弱点是研究方法报告不佳。大多数结果的异质性较低或不存在,尽管在总体自我评估的经前症状分析中存在中等异质性。基于对应答率(纳入研究最多的结果)的荟萃分析,有可疑的发表偏倚。总的来说,68%的研究由制药公司资助。这强调了谨慎解释审查结果的重要性。
结论:SSRIs可能会减轻患有PMS和PMDD的女性的经前症状,并且与黄体期给药相比,连续服用可能更有效。SSRI治疗可能会增加不良事件的风险,最常见的是恶心,虚弱和嗜睡。
BACKGROUND: Premenstrual syndrome (PMS) is a combination of physical, psychological and social symptoms in women of reproductive age, and premenstrual dysphoric disorder (PMDD) is a severe type of the syndrome, previously known as late luteal phase dysphoric disorder (LLPDD). Both syndromes cause symptoms during the two weeks leading up to menstruation (the luteal phase). Selective serotonin reuptake inhibitors (SSRIs) are increasingly used as a treatment for PMS and PMDD, either administered in the luteal phase or continuously. We undertook a systematic review to assess the evidence of the positive effects and the harms of SSRIs in the management of PMS and PMDD.
OBJECTIVE: To evaluate the benefits and harms of SSRIs in treating women diagnosed with PMS and PMDD.
METHODS: We searched the Cochrane Gynaecology and Fertility (CGF) Specialised Register of Controlled Trials, CENTRAL, MEDLINE, Embase and PsycINFO for randomised controlled trials (RCTs) in November 2023. We checked reference lists of relevant studies, searched trial registers and contacted experts in the field for any additional trials. This is an update of a review last published in 2013.
METHODS: We considered studies in which women with a prospective diagnosis of PMS, PMDD or LLPDD were randomised to receive SSRIs or placebo.
METHODS: We used standard Cochrane methods. We pooled data using a random-effects model. We calculated standardised mean differences (SMDs) with 95% confidence intervals (CIs) for premenstrual symptom scores, using \'post-treatment\' scores for continuous data. We calculated odds ratios (ORs) with 95% CIs for dichotomous outcomes. We stratified analyses by type of administration (luteal phase or continuous). We calculated absolute risks and the number of women who would need to be taking SSRIs in order to cause one additional adverse event (i.e. the number needed to treat for an additional harmful outcome (NNTH)). We rated the overall certainty of the evidence for the main findings using GRADE.
RESULTS: We included 34 RCTs in the review. The studies compared SSRIs (i.e. fluoxetine, paroxetine, sertraline, escitalopram and citalopram) to placebo. SSRIs probably reduce overall self-rated premenstrual symptoms in women with PMS and PMDD (SMD -0.57, 95% CI -0.72 to -0.42; I2 = 51%; 12 studies, 1742 participants; moderate-certainty evidence). SSRI treatment was probably more effective when administered continuously than when administered only in the luteal phase (P = 0.03 for subgroup difference; luteal phase group: SMD -0.39, 95% CI -0.58 to -0.21; 6 studies, 687 participants; moderate-certainty evidence; continuous group: SMD -0.69, 95% CI -0.88 to -0.51; 7 studies, 1055 participants; moderate-certainty evidence). The adverse effects associated with SSRIs were nausea (OR 3.30, 95% CI 2.58 to 4.21; I2 = 0%; 18 studies, 3664 women), insomnia (OR 1.99, 95% CI 1.51 to 2.63; I2 = 0%; 18 studies, 3722 women), sexual dysfunction or decreased libido (OR 2.32, 95% CI 1.57 to 3.42; I2 = 0%; 14 studies, 2781 women), fatigue or sedation (OR 1.52, 95% CI 1.05 to 2.20; I2 = 0%; 10 studies, 1230 women), dizziness or vertigo (OR 1.96, 95% CI 1.36 to 2.83; I2 = 0%; 13 studies, 2633 women), tremor (OR 5.38, 95% CI 2.20 to 13.16; I2 = 0%; 4 studies, 1352 women), somnolence and decreased concentration (OR 3.26, 95% CI 2.01 to 5.30; I2 = 0%; 8 studies, 2050 women), sweating (OR 2.17, 95% CI 1.36 to 3.47; I2 = 0%; 10 studies, 2304 women), dry mouth (OR 2.70, 95% CI 1.75 to 4.17; I2 = 0%; 11 studies, 1753 women), asthenia or decreased energy (OR 3.28, 95% CI 2.16 to 4.98; I2 = 0%; 7 studies, 1704 women), diarrhoea (OR 2.06, 95% CI 1.37 to 3.08; I2 = 0%; 12 studies, 2681 women), and constipation (OR 2.39, 95% CI 1.09 to 5.26; I2 = 0%; 7 studies, 1022 women). There was moderate-certainty evidence for all adverse effects other than somnolence/decreased concentration, which was low-certainty evidence. Overall, the certainty of the evidence was moderate. The main weakness was poor reporting of study methodology. Heterogeneity was low or absent for most outcomes, although there was moderate heterogeneity in the analysis of overall self-rated premenstrual symptoms. Based on the meta-analysis of response rate (the outcome with the most included studies), there was suspected publication bias. In total, 68% of the included studies were funded by pharmaceutical companies. This stresses the importance of interpreting the review findings with caution.
CONCLUSIONS: SSRIs probably reduce premenstrual symptoms in women with PMS and PMDD and are probably more effective when taken continuously compared to luteal phase administration. SSRI treatment probably increases the risk of adverse events, with the most common being nausea, asthenia and somnolence.