Valerian-hops combination and diphenhydramine for treating insomnia: A randomized placebo-controlled clinical trial
Valerian-hops combination and diphenhydramine for treating insomnia: A randomized placebo-controlled clinical trial
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DOI：
10.1093/sleep/28.11.1465
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发表时间：
2005-11-01
期刊：
影响因子：
5.6
通讯作者：
Wooten, V
中科院分区：
文献类型：
--
作者：
Morin, CM;Koetter, U;Wooten, V
背景：失眠是一种常见的健康问题，与日间功能障碍、生活质量下降和医疗费用增加有关。虽然它往往是自我治疗与草药和膳食补充剂或非处方睡眠aids，仍然有很少的证据，这些products.Objective的有效性和安全性的valerian-hops组合和苯海拉明治疗轻度失眠。设计和设置：在美国9个睡眠障碍中心进行的多中心、随机、安慰剂对照、平行组研究。（110名女性，74名男性;平均年龄44.3岁）。干预措施：（1）每晚两片标准化的缬草根提取物（187-mg天然提取物; 5-8：1，甲醇45%m/m）和啤酒花（41.9-mg天然提取物; 7-10：1，甲醇45%m/m）组合28天（n = 59），（2）安慰剂28天（n = 65），或（3）2片苯海拉明（25 mg）14天，随后安慰剂14天（n = 60）。通过每日日记和多导睡眠描记术测量睡眠参数，患者和医生的临床结局评级，以及生活质量measures.Results：主观睡眠参数的适度改善与缬草-啤酒花组合和苯海拉明，但与安慰剂的组比较很少达到统计学意义。在14天治疗结束时，相对于安慰剂和苯海拉明，缬草根产生了略大但不显著的睡眠潜伏期减少，并且在28天治疗结束时比安慰剂产生了更大的减少。在治疗的前14天，苯海拉明使睡眠效率显著增加，总睡眠时间有增加的趋势。通过多导睡眠图测量的任何睡眠连续性变量没有显著的组间差异。此外，任何治疗均未改变睡眠阶段3-4和快速眼动睡眠。在14天的治疗结束时，相对于安慰剂组，缬沙坦和苯海拉明组的患者对失眠严重程度的评价较低。在28天结束时，相对于安慰剂组，缬草-啤酒花组的生活质量（身体成分）显著改善。有没有显着的残留影响，没有严重的不良事件，无论是缬草或苯海拉明，并没有反弹失眠后continuous.Conclusions：研究结果显示，相对于安慰剂的缬草啤酒花组合和苯海拉明适度的催眠效果。缬草-啤酒花组合改善睡眠与改善生活质量有关。这两种治疗似乎都是安全的，并且在本研究期间停药后不会产生反弹性失眠。总的来说，这些研究结果表明，缬草-啤酒花组合和苯海拉明可能是治疗轻度失眠的有效药物。
Context: Insomnia is a prevalent health complaint associated with daytime impairments, reduced quality of life, and increased health-care costs. Although it is often self-treated with herbal and dietary supplements or with over-the-counter sleep aids, there is still little evidence on the efficacy and safety of those products.Objective: To evaluate the efficacy and safety of a valerian-hops combination and diphenhydramine for the treatment of mild insomnia.Design and Setting: Multicenter, randomized, placebo-controlled, parallel-group study conducted in 9 sleep disorders centers throughout the United States.Patients: A total of 184 adults (110 women, 74 men; mean age of 44.3 years) with mild insomnia.Interventions: (1) Two nightly tablets of standardized extracts of a valerian (187-mg native extracts; 5-8:1, methanol 45% m/m) and hops (41.9-mg native extracts; 7-10:1, methanol 45% m/m) combination for 28 days (n = 59), (2) placebo for 28 days (n = 65), or (3) 2 tablets of diphenhydramine (25 mg) for 14 days followed by placebo for 14 days (n = 60).Outcome Measures: Sleep parameters measured by daily diaries and polysomnography, clinical outcome ratings from patients and physicians, and quality of life measures.Results: Modest improvements of subjective sleep parameters were obtained with both the valerian-hops combination and diphenhydramine, but few group comparisons with placebo reached statistical significance. Valerian produced slightly greater, though nonsignificant, reductions of sleep latency relative to placebo and diphenhydramine at the end of 14 days of treatment and greater reductions than placebo at the end of 28 days of treatment. Diphenhydramine produced significantly greater increases in sleep efficiency and a trend for increased total sleep time relative to placebo during the first 14 days of treatment. There was no significant group difference on any of the sleep continuity variables measured by polysomnography. In addition, there was no alteration of sleep stages 3-4 and rapid eye movement sleep with any of the treatments. Patients in the valerian and diphenhydramine groups rated their insomnia severity lower relative to placebo at the end of 14 days of treatment. Quality of life (Physical component) was significantly more improved in the valerian-hops group relative to the placebo group at the end of 28 days. There were no significant residual effects and no serious adverse events with either valerian or diphenhydramine and no rebound insomnia following their discontinuation.Conclusions: The findings show a modest hypnotic effect for a valerian-hops combination and diphenhydramine relative to placebo. Sleep improvements with a valerian-hops combination are associated with improved quality of life. Both treatments appear safe and did not produce rebound insomnia upon discontinuation during this study. Overall, these findings indicate that a valerian-hops combination and diphenhydramine might be useful adjuncts in the treatment of mild insomnia.