Nelson Heidi D, Vesco Kimberly K, Haney Elizabeth, Fu Rongwei, Nedrow Anne, Miller Jill, Nicolaidis Christina, Walker Miranda, Humphrey Linda
Oregon Evidence-based Practice Center, Department of Medical Informatics and Clinical Epidemiology, Oregon Health and Science University, Portland, OR 97239, USA.
JAMA. 2006 May 3;295(17):2057-71. doi: 10.1001/jama.295.17.2057.
Concern regarding the adverse effects of estrogen and other hormones for treating menopausal symptoms has led to demand for other options; however, the efficacy and adverse effects of nonhormonal therapies are unclear.
To assess the efficacy and adverse effects of nonhormonal therapies for menopausal hot flashes by reviewing published randomized controlled trials.
MEDLINE (1966-October 2005), PsycINFO (1974-October 2005), and the Cochrane Controlled Clinical Trials Register Database (1966-October 2005) were searched for relevant trials that provided data on treatment of menopausal hot flashes using 1 or more nonhormonal therapies.
All English-language, published, randomized, double-blind, placebo-controlled trials of oral nonhormonal therapies for treating hot flashes in menopausal women measuring and reporting hot flash frequency or severity outcomes.
Trials were identified, subjected to inclusion and exclusion criteria, and reviewed. Data on participants, interventions, and outcomes were extracted and trials were rated for quality based on established criteria. A meta-analysis was conducted for therapies with sufficient trials reporting hot flash frequency outcomes.
From 4249 abstracts, 43 trials met inclusion criteria, including 10 trials of antidepressants, 10 trials of clonidine, 6 trials of other prescribed medications, and 17 trials of isoflavone extracts. The number of daily hot flashes decreased compared with placebo in meta-analyses of 7 comparisons of selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) (mean difference, -1.13; 95% confidence interval [CI], -1.70 to -0.57), 4 trials of clonidine (-0.95; 95% CI, -1.44 to -0.47), and 2 trials of gabapentin (-2.05; 95% CI, -2.80 to -1.30). Frequency was not reduced in meta-analysis of trials of red clover isoflavone extracts and results were mixed for soy isoflavone extracts. Evidence of the efficacy of other therapies is limited due to the small number of trials and their deficiencies. Trials do not compare different therapies head-to-head and relative efficacy cannot be determined.
The SSRIs or SNRIs, clonidine, and gabapentin trials provide evidence for efficacy; however, effects are less than for estrogen, few trials have been published and most have methodological deficiencies, generalizability is limited, and adverse effects and cost may restrict use for many women. These therapies may be most useful for highly symptomatic women who cannot take estrogen but are not optimal choices for most women.
对雌激素及其他激素治疗更年期症状的不良反应的担忧引发了对其他治疗方案的需求；然而，非激素疗法的疗效和不良反应尚不清楚。
通过回顾已发表的随机对照试验，评估非激素疗法治疗更年期潮热的疗效和不良反应。
检索MEDLINE（1966年至2005年10月）、PsycINFO（1974年至2005年10月）以及Cochrane对照临床试验注册数据库（1966年至2005年10月），以查找使用一种或多种非激素疗法治疗更年期潮热并提供相关数据的试验。
所有已发表的、英文的、随机、双盲、安慰剂对照试验，这些试验采用口服非激素疗法治疗更年期女性潮热，并测量和报告潮热频率或严重程度结果。
识别试验，根据纳入和排除标准进行审查。提取有关参与者、干预措施和结果的数据，并根据既定标准对试验进行质量评级。对有足够试验报告潮热频率结果的疗法进行荟萃分析。
从4249篇摘要中，43项试验符合纳入标准，包括10项抗抑郁药试验、10项可乐定试验、6项其他处方药试验和17项异黄酮提取物试验。在对选择性5-羟色胺再摄取抑制剂（SSRI）或5-羟色胺去甲肾上腺素再摄取抑制剂（SNRI）的7项比较、4项可乐定试验以及2项加巴喷丁试验的荟萃分析中，与安慰剂相比，每日潮热次数减少。红三叶草异黄酮提取物试验的荟萃分析中潮热频率未降低，大豆异黄酮提取物试验结果不一。由于试验数量少及其缺陷，其他疗法疗效的证据有限。试验未进行不同疗法的直接比较，无法确定相对疗效。
SSRI或SNRI、可乐定和加巴喷丁试验提供了疗效证据；然而，其效果不如雌激素，已发表的试验较少且多数存在方法学缺陷，普遍性有限，不良反应和成本可能限制许多女性使用。这些疗法可能对不能服用雌激素但症状严重的女性最有用，但对大多数女性并非最佳选择。
