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首页> 外文期刊>Journal of women’s health >Minimum trial duration to reasonably assess long-term efficacy of nonhormonal hot flash therapies.
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Minimum trial duration to reasonably assess long-term efficacy of nonhormonal hot flash therapies.

机译：最短试验持续时间，以合理评估非激素性潮热疗法的长期疗效。

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BACKGROUND: Because hot flashes usually persist for years after menopause, a clinically meaningful hot flash therapy needs to have long-term efficacy; however, it is unclear for how long a therapy needs to be compared with a placebo before long-term efficacy can be reasonably deduced. The Food and Drug Administration (FDA) requires a 12-week treatment period for industry-initiated hot flash trials, whereas most academic-initiated trials have ranged from 4 to 12 weeks. We have focused on reviewing nonhormonal hot flash trials to identify inadequate trial durations as a guide toward deducing adequate trial duration to reasonably assess for long-term efficacy. METHODS: An electronic database search of MEDLINE, Web of Science, and PsycINFO was performed from 1966 to May 2009 to identify target studies showing a nonhormonal hot flash therapy to be effective at early time points only to become ineffective at later time points (i.e., showing short-term but not long-term efficacy) in a randomized controlled trial (RCT). The longest early time point of efficacy from the target studies plus 1 additional week would be considered the minimum treatment duration necessary to assess for long-term efficacy. RESULTS: Of 2518 citations, 54 RCTs met our inclusion criteria, from which 3 target studies were identified. These 3 target studies evaluated Bellergal Retard (Sandoz, East Hanover, NJ), soy, and venlafaxine and showed times of 2, 6, and 7 weeks, respectively, when the nonhormonal compound last demonstrated efficacy before subsequently losing efficacy in a single RCT. CONCLUSIONS: This analysis supports a hot flash RCT duration of at least 8 weeks to reasonably assess a nonhormonal compound's long-term efficacy.
机译：背景：由于潮热通常在绝经后持续数年，因此临床上有意义的潮热疗法需要长期有效。然而，尚不清楚在合理地得出长期疗效之前，需要与安慰剂比较一种疗法的时间。美国食品药品监督管理局（FDA）对于行业启动的热潮试验要求12周的治疗期，而大多数学术启动的试验则为4至12周。我们专注于审查非激素性热潮红试验，以确定不足的试验持续时间，以此作为推导合理评估长期疗效的适当试验持续时间的指南。方法：从1966年到2009年5月，对MEDLINE，Web of Science和PsycINFO进行了电子数据库搜索，以鉴定目标研究，该研究显示非激素性热潮红疗法在早期时间点有效，而在较晚时间点无效（即，显示短期但非长期疗效）。来自目标研究的最长的早期疗效时间点加上另外的1周时间将被视为评估长期疗效所需的最短治疗时间。结果：在2518篇文献中，有54篇RCT符合我们的纳入标准，从中确定了3篇目标研究。这3个目标研究评估了Bellergal Retard（Sandoz，East Hanover，NJ），大豆和文拉法辛，分别显示了2周，6周和7周的时间，即非激素化合物在单项RCT中失去疗效之前最后一次证明了疗效。结论：该分析支持至少8周的热RCT持续时间，以合理评估非激素化合物的长期疗效。

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