Rhodes Joshua R, Alldredge Cameron T, Elkins Gary R
Department of Psychology, Abilene Christian University, Abilene, TX, United States.
Department of Psychology and Neuroscience, Baylor University, Waco, TX, United States.
Front Psychiatry. 2023 Aug 4;14:1204163. doi: 10.3389/fpsyt.2023.1204163. eCollection 2023.
Vasomotor symptoms, or hot flashes, are among the most common complaints for menopausal and postmenopausal women. As an alternative to hormone replacement therapy, paroxetine mesylate became the only non-hormonal treatment approved by the U.S. Food and Drug Administration (FDA), despite limited evidence for its efficacy. More specifically, there is uncertainty around paroxetine's unique benefit and the magnitude of the placebo response in clinical trials of paroxetine.
Relevant databases were searched to identify randomized clinical trials examining the efficacy of paroxetine to treat hot flashes. The primary outcomes of interest were hot flash frequency and hot flash severity scores. Data was extracted from the published results, and risk of bias assessments were conducted.
Six randomized clinical trials that included a total of 1,486 women were coded and analyzed. The results demonstrated that 79% of the mean treatment response for hot flash frequency is accounted for by a placebo response, resulting in a mean true drug effect of 21% at most. Additionally, 68% of the mean treatment response for hot flash severity is accounted for by a placebo response, resulting in a maximum true drug effect of 32%.
The results herein call into question the actual efficacy of the only FDA approved, non-hormonal treatment for hot flashes by demonstrating that a placebo response accounts for the majority of treatment responses for reductions in both hot flash frequency and severity. The findings provide evidence to reevaluate the use of paroxetine to treat postmenopausal hot flashes and emphasize the importance of considering effective, alternative treatments for vasomotor symptoms.
血管舒缩症状，即潮热，是绝经和绝经后女性最常见的症状之一。作为激素替代疗法的替代方案，甲磺酸帕罗西汀成为美国食品药品监督管理局（FDA）批准的唯一非激素治疗药物，尽管其疗效证据有限。更具体地说，在帕罗西汀的临床试验中，其独特益处以及安慰剂反应的程度存在不确定性。
检索相关数据库，以确定研究帕罗西汀治疗潮热疗效的随机临床试验。感兴趣的主要结局是潮热频率和潮热严重程度评分。从已发表的结果中提取数据，并进行偏倚风险评估。
对总共纳入1486名女性的6项随机临床试验进行编码和分析。结果表明，潮热频率平均治疗反应的79%可归因于安慰剂反应，因此平均真实药物效应至多为21%。此外，潮热严重程度平均治疗反应的68%可归因于安慰剂反应，因此最大真实药物效应为32%。
本文结果对FDA批准的唯一非激素潮热治疗药物的实际疗效提出质疑，表明安慰剂反应在潮热频率和严重程度降低的治疗反应中占多数。这些发现为重新评估帕罗西汀治疗绝经后潮热的应用提供了证据，并强调了考虑血管舒缩症状有效替代治疗方法的重要性。
