An Internet-based randomized, placebo-controlled trial of kava and valerian for anxiety and insomnia
An Internet-based randomized, placebo-controlled trial of kava and valerian for anxiety and insomnia
复制标题
DOI：
10.1097/01.md.0000172299.72364.95
复制
发表时间：
2005-07-01
期刊：
影响因子：
1.6
通讯作者：
Cummings, SR
中科院分区：
文献类型：
--
作者：
Jacobs, BP;Bent, S;Cummings, SR
草本提取物Kava和Valerian分别是用于焦虑和失眠自我管理的主要膳食补充剂。支持它们对这些常见症状有效的证据有限。互联网用于研究的程度有限，但尚不清楚是否可以完全使用互联网技术进行随机对照试验。我们进行了一项随机、双盲、安慰剂对照试验，使用一种基于互联网的新设计，以确定卡瓦是否有效降低焦虑，安定是否有效改善睡眠质量。在为期8周的时间里，通过电子邮件招聘信件和网站上的横幅广告，从45个州招募了大量感兴趣的参与者(1551人)。参与者首先被要求阅读研究信息，完成所有在线知情同意过程，并接受电子身份验证。为了有资格参加这项研究，参与者被要求1)焦虑，在两次不同的情况下，状态-特质焦虑量表(STAI-State)的得分至少比平均数高0.5个标准差，以及2)失眠，定义为“在过去的两周内入睡或保持睡眠问题”。我们将391名符合条件的参与者随机分配到以下3组中的1组，并邮寄28天的补给：卡瓦加安定安慰剂(n=121)，安定加卡瓦安慰剂(n=135)，或双倍安慰剂(n=135)。主要结果是与安慰剂相比，焦虑(STAI-State问卷)和失眠(失眠严重指数[ISI])的基线发生了变化。接受安慰剂的参与者在STAI-State评分上的焦虑症状降低了14.4分，在ISI上的失眠症状降低了8.3分。接受Kava治疗的患者在STAI-State评分上也有类似的降低(与Kava相比，安慰剂组降低了2.7分；95%可信区间[CI]为-0.8至+6.2)。服用安定和安慰剂的患者在睡眠方面也有类似的改善(服用安慰剂的患者睡眠减少幅度比服用安定的患者多0.4个百分点；95%可信区间为-1.3至+2.1)。当限制到83%的参与者坚持研究化合物4周时，结果是相似的。卡瓦和安定都不能比安慰剂更好地缓解焦虑或失眠。这项试验证明了完全通过互联网进行随机、盲法试验的可行性。
The herbal extracts kava and valerian are the leading dietary supplements used in the self-management of anxiety and insomnia, respectively. There is limited evidence to Support their effectiveness for these common symptoms. The Internet has been used to a limited extent for research, but it is not known whether randomized controlled trials can be conducted entirely using Internet technology.We performed a randomized, double-blind, placebo-controlled trial using a novel Internet-based design to determine if kava is effective for reducing anxiety and if valerian is effective for improving sleep quality. E-mail recruitment letters and banner advertisements on websites were used to recruit a large pool of interested participants (1551) from 45 states over an 8-week period. Participants were first asked to read study information, complete all online informed consent process, and undergo electronic identity verification. In order to be eligible for the study, participants were required to have 1) anxiety as documented by scores of at least 0.5 standard deviations above the mean on the State-Trait Anxiety Inventory State subtest (STAI-State) on 2 separate occasions, and 2) insomnia, defined as a "problem getting to sleep or staying asleep over the past 2 weeks." We randomly assigned 391 eligible participants to 1 of the following 3 groups, and mailed 28 days' supply: kava with valerian placebo (n = 121), valerian with kava placebo (n = 135), or double placebo (n = 135). The primary outcome measures were changes from baseline in anxiety (STAI-State questionnaire) and insomnia (Insomnia Severity Index [ISI]) compared with placebo.Participants receiving placebo had a 14.4 point decrease in anxiety symptoms on the STAI-State score and an 8.3 point decrease in insomnia symptoms on the ISI. Those receiving kava had similar reductions in STAI-State score (2.7 point greater reduction in placebo compared with kava; 95% confidence interval [CI], -0.8 to +6.2). Those receiving valerian and placebo had similar improvements in sleep (0.4 point greater reduction in the placebo than the valerian group; 95% CI, -1.3 to +2.1). Results were similar when limited to the 83% of participants who adhered to study compounds for all 4 weeks.Neither kava nor valerian relieved anxiety or insomnia more than placebo. This trial demonstrates the feasibility of conducting randomized, blinded trials entirely via the Internet.