University at Buffalo , Buffalo, New York 14214, USA.
J Womens Health (Larchmt). 2010 Apr;19(4):699-702. doi: 10.1089/jwh.2009.1610.
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.
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.
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.
This analysis supports a hot flash RCT duration of at least 8 weeks to reasonably assess a nonhormonal compound's long-term efficacy.
由于热潮通常在绝经后持续多年，因此一种有临床意义的热潮治疗需要具有长期疗效；但是，尚不清楚与安慰剂相比，需要多长时间的治疗才能合理推断长期疗效。食品和药物管理局（FDA）要求行业发起的热潮试验的治疗期为 12 周，而大多数学术发起的试验则为 4 至 12 周。我们一直专注于审查非激素热潮试验，以确定试验持续时间不足，作为推断合理评估长期疗效所需的足够试验持续时间的指南。
从 1966 年至 2009 年 5 月，我们通过 MEDLINE、Web of Science 和 PsycINFO 进行了电子数据库搜索，以确定目标研究，这些研究表明，一种非激素热潮治疗方法在早期仅有效，但在随后的时间点无效（即仅显示短期而不是长期疗效）随机对照试验（RCT）。从目标研究中最早的有效时间点再加 1 周，将被视为评估长期疗效所需的最短治疗持续时间。
在 2518 条引文中，有 54 项 RCT 符合我们的纳入标准，其中有 3 项是目标研究。这 3 项目标研究评估了 Bellergal Retard（Sandoz，新泽西州东 Hanover）、大豆和文拉法辛，分别显示出 2、6 和 7 周的时间，在这些时间之后，非激素化合物在单次 RCT 中随后失去疗效之前，最后一次显示出疗效。
这项分析支持至少进行 8 周的热潮 RCT，以合理评估非激素化合物的长期疗效。
