Valerian for Sleep Disturbance in Healthy Older Adults

缬草治疗健康老年人的睡眠障碍

• 批准号: 6891701
• 负责人: CAROL A LANDIS
• 金额: $ 18.95万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-05-15 至 2008-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6891701
• 关键词: aging; alternative medicine; clinical research; dosage; electrocardiography; electroencephalography; electromyography; electrooculography; human old age (65+); human subject; medicinal plants; pharmacokinetics; plant extracts; polysomnography; psychobiology; sleep disorders

DESCRIPTION (provided by applicant): Sleep disturbances are very common in the elderly. As many as 40% of older adults complain about sleep problems, including inability to fall asleep quickly, frequent nocturnal awakenings, or early morning awakenings. Untreated sleep disturbances may increase the risk for depression and early mortality. Older adults frequently use prescription hypnotic and over-the-counter medications as sleep aids, despite observations these drugs further disrupt sleep patterns and have untoward side effects. Herbal medicines as dietary supplements are already quite popular and likely to be used by increasing numbers of adults in the next few decades. Alternative herbal medicines, such as valerian, which was in the top 20 best selling herbal products in the United States in 2001, have the potential to enhance sleep but their efficacy needs to be established in older adults. Valerian contains a variety of compounds including valerenic acid and its derivatives. The pharmacokinetic properties of the valerian constituents have not been reported and there is nothing known about the pharmacokinetic properties of valerian constituents in relation to objective sleep measures. A limited literature of small-sample placebo-controlled trials suggests that valerian may improve sleep and has a very low rate of side effects. The specific aims of this preliminary study are to determine the sleep enhancing effects of a recommended dose of valerian and to describe its pharmacokinetic properties in older adults with a complaint of sleep disturbance. We have developed an assay for valerenic acid and will describe the pharmacokinetics of valerian after a single dose and at steady state following two weeks of continuous treatment and relate the sleep enhancing effects as shown by polysomnography to valerian PK. Our working hypothesis is that valerian will enhance sleep after two weeks of daily nighttime dosing (chronic), but is not likely to enhance sleep after a single dose (acute). The design will be a single group, double-blind, placebo controlled cross-over trial in 20 relatively healthy older adult women and men, 55 to 80 years old. We expect the study outcomes will provide preliminary data in support of a large randomized clinical trial of valerian effects on subjective and objective sleep quality in older adults.

描述（由申请人提供）：睡眠障碍在老年人中非常常见。多达 40% 的老年人抱怨睡眠问题，包括无法快速入睡、夜间频繁醒来或清晨醒来。未经治疗的睡眠障碍可能会增加抑郁症和早期死亡的风险。老年人经常使用处方催眠药和非处方药作为睡眠辅助药物，尽管观察发现这些药物会进一步扰乱睡眠模式并产生不良副作用。草药作为膳食补充剂已经相当流行，并且可能在未来几十年内被越来越多的成年人使用。替代草药，例如缬草，2001 年跻身美国最畅销草药产品前 20 名，具有增强睡眠的潜力，但其功效需要在老年人中确定。缬草含有多种化合物，包括戊酸及其衍生物。缬草成分的药代动力学特性尚未被报道，并且对于缬草成分与客观睡眠测量相关的药代动力学特性也一无所知。有限的小样本安慰剂对照试验文献表明，缬草可以改善睡眠，并且副作用发生率非常低。这项初步研究的具体目的是确定推荐剂量的缬草的睡眠增强作用，并描述其在睡眠障碍的老年人中的药代动力学特性。我们开发了一种缬草酸测定方法，并将描述单剂量缬草和连续治疗两周后稳态的药代动力学，并将多导睡眠图显示的睡眠增强作用与缬草 PK 联系起来。我们的工作假设是，每天夜间服用缬草两周后（慢性）会增强睡眠，但单次服用后不太可能增强睡眠（急性）。该设计将是一项单组、双盲、安慰剂对照的交叉试验，受试者为 20 名年龄在 55 至 80 岁之间、相对健康的老年女性和男性。我们预计该研究结果将为一项大型随机临床试验提供初步数据，以支持缬草对老年人主观和客观睡眠质量的影响。