Placebo improvement in pharmacologic treatment of menopausal hot flashes: time course, duration, and predictors.
Placebo improvement in pharmacologic treatment of menopausal hot flashes: time course, duration, and predictors.
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DOI：
10.1097/psy.0000000000000143
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发表时间：
2015-02
影响因子：
3.3
通讯作者：
LaCroix AZ
中科院分区：
文献类型：
--
作者：
Freeman EW;Ensrud KE;Larson JC;Guthrie KA;Carpenter JS;Joffe H;Newton KM;Sternfeld B;LaCroix AZ
这项研究描述了安慰剂治疗绝经期潮热的时间进程、改善持续时间和临床预测因素。数据来自在MsFLASH网络中进行的两个试验，提供了一个联合安慰剂组(N=247)和一个联合积极治疗组(N=297)。受试者在治疗期间(0-8周)和随后的随访(9-11周)每天两次在日记中记录潮热频率。主要的结果变量是临床显著改善，定义为潮热频率较基线减少50%，并在研究中每周计算。对于显著改善和部分改善，使用标准临床定义先验地定义了亚组。参与者的临床和人口学特征被评估为改善的预测因素。服用安慰剂的患者每周都有显著的临床改善，其中33%在第8周有显著改善。在第4周和第8周均有改善的安慰剂应答者中，77%的患者在治疗结束后第11周仍有临床改善。在最终的多变量模型中，安慰剂显著改善的独立预测因素是非洲裔美国人(OR5.61，95%CI：2.41-13.07，p<；0.001)；当前吸烟者(OR2.3，95%CI：1.05-5.06，p=0.038)；筛查中潮热的严重程度(OR1.45，95%CI：1.00-2.10，p=0.047)。在整个治疗过程中，使用安慰剂的临床显著改善与使用活性药物改善的时间进程相似。在安慰剂组中，有相当数量的参与者在停止服用安慰剂药片后出现了临床上显著的反应。结果表明，非特异性效应是治疗的重要组成部分，需要进一步研究，以优化其在临床护理中的贡献。
This study characterized the time course, duration of improvement and clinical predictors of placebo response in treatment of menopausal hot flashes. Data were pooled from two trials conducted in the MsFLASH network, providing a combined placebo group (N=247) and a combined active treatment group (N=297). Participants recorded hot flash frequency in diaries twice daily during treatment (week 0-8) and subsequent follow-up (week 9-11). The primary outcome variable was clinically significant improvement, defined as >=50% decrease in hot flash frequency from baseline and calculated for each week in the study. Subgroups were defined a priori using standard clinical definitions for significant improvement and partial improvement. Clinical and demographic characteristics of the participants were evaluated as predictors of improvement. Clinically significant improvement with placebo accrued each treatment week, with 33% significantly improved at week 8. Of placebo responders who were improved at both weeks 4 and 8, 77% remained clinically improved at week 11 after treatment ended. Independent predictors of significant placebo improvement in the final multivariable model were African American race (OR 5.61, 95% CI: 2.41-13.07, p<0.001); current smokers (OR 2.30, 95% CI: 1.05-5.06, p=0.038); and hot flash severity in screening (OR 1.45, 95% CI: 1.00-2.10, p=0.047). Clinically significant improvement with placebo accrued throughout treatment with a time course similar to improvement with active drug. A meaningful number of participants in the placebo group sustained a clinically significant response after stopping placebo pills. The results suggest that non-specific effects are important components of treatment and warrant further studies to optimize their contributions in clinical care.