Newer antidepressants and gabapentin for hot flashes: a discussion of trial duration
Newer antidepressants and gabapentin for hot flashes: a discussion of trial duration
复制标题
治疗潮热的新型抗抑郁药和加巴喷丁：试验持续时间的讨论
DOI：
10.1097/gme.0b013e31819c46c7
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发表时间：
2009
期刊：
影响因子：
2.7
通讯作者：
J. Sloan
中科院分区：
文献类型：
--
作者：
C. Loprinzi;B. Diekmann;P. Novotny;V. Stearns;J. Sloan
目的：有关潮热试验理想持续时间的信息很少。在文献中，潮热试验持续时间通常为4 - 12周。本文致力于提供科学数据，以更好地确定需要多长时间进行潮热试验与新的中央代理。研究方法：个体受试者数据收集自所有已知的已发表的，截至2007年12月，关于使用新型抗抑郁药和加巴喷丁缓解潮热的随机、安慰剂对照、双盲临床试验。该项目包括研究时间超过4周的试验。对每项研究的潮热活动纵向数据单独进行特征分析，从而比较6 - 12个治疗周收集的数据与仅4个治疗周收集的数据。结果如下：确定了10项研究，其中5项符合本研究的合格标准，3项评估加巴喷丁，2项新的抗抑郁药。来自轮廓分析的平坦度测试没有提供任何证据表明潮热活动在第4周和长达12周的时间段之间增加或减少。结论：新抗抑郁药和加巴喷丁治疗4周后，热潮红评分的变化是明显的。现有数据表明，与安慰剂相比，潮热治疗疗效在长达12周的随访中保持稳定。
Objective: Information regarding the ideal length of hot flash trials is scarce. In the literature, hot flash trial durations have commonly varied from 4 to 12 weeks. This article is devoted to providing scientific data to better ascertain how long it is necessary to conduct hot flash trials with newer centrally acting agents. Methods: Individual participant data were collected from all known published, through December 2007, randomized, placebo-controlled, double-blinded clinical trials regarding the use of newer antidepressants and gabapentin for hot flash relief. Trials that studied periods longer than 4 weeks were included for this project. Profile analysis was applied to the hot flash activity longitudinal data for each study individually, allowing a comparison of data collected for 6 to 12 treatment weeks versus data collected for only 4 treatment weeks. Results: Ten studies were identified, five of them fulfilled the eligibility criteria for this investigation, three evaluating gabapentin, and two newer antidepressants. Flatness tests from a profile analysis did not provide any evidence that hot flash activity increased or decreased between week 4 and time periods up to 12 weeks. Conclusions: Changes in hot flash scores from newer antidepressants and gabapentin are apparent within 4 weeks of therapy. Available data indicate that hot flash treatment efficacy, compared with that of placebo, remains stable for up to 12 weeks of follow-up.