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: 6756154
• 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 2006-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6756154
• 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很常见。多达40％的老年人抱怨睡眠问题，包括无法快速入睡，频繁的夜间觉醒或清晨觉醒。未经治疗的睡眠障碍可能会增加抑郁症和早期死亡率的风险。尽管观察到这些药物进一步破坏了睡眠模式并具有不良的副作用，但老年人经常将处方催眠和非处方药作为睡眠辅助药。草药作为饮食补充剂已经很受欢迎，并且在未来几十年中增加了成年人的数量。替代性草药（例如瓦莱里亚人）在2001年在美国排名前20名最畅销的草药产品，有可能增强睡眠，但需要在老年人中确定其功效。 Valerian含有多种化合物，包括丙烯酸及其衍生物。尚未报道瓦莱里亚成分的药代动力学特性，并且对瓦莱里亚成分的药代动力学特性尚无相对于客观睡眠测量。小样本的安慰剂对照试验的文献有限，表明缬草可能会改善睡眠，并且副作用率非常低。这项初步研究的具体目的是确定推荐剂量的Valerian剂量的睡眠增强作用，并描述其在老年人中的药代动力学特性，并抱怨睡眠障碍。我们已经开发了一种用于丙烯酸的测定法，并将在单剂量连续治疗后进行单剂量和稳态后描述valerian的药代动力学，并将睡眠增强的效果与valerian PK相关联。我们的工作假设是，瓦莱安（Valerian）每天两周的夜间给药（慢性）会增强睡眠，但在一次剂量（急性）后不可能增强睡眠。该设计将是一组单一的，双盲，安慰剂受控的跨试验，在20名相对健康的成年男女，55至80岁。我们预计，研究结果将提供初步数据，以支持大型随机临床试验对缬草对老年人主观和客观睡眠质量的影响。