A randomized, double-blind, placebo-controlled trial of oral Matricaria recutita (chamomile) extract therapy for generalized anxiety disorder.
A randomized, double-blind, placebo-controlled trial of oral Matricaria recutita (chamomile) extract therapy for generalized anxiety disorder.
复制标题
DOI：
10.1097/jcp.0b013e3181ac935c
复制
发表时间：
2009-08
影响因子：
2.9
通讯作者：
Shults J
中科院分区：
文献类型：
--
作者：
Amsterdam JD;Li Y;Soeller I;Rockwell K;Mao JJ;Shults J
我们进行了一项随机，双盲，安慰剂对照的疗效和耐受性试验母菊（洋甘菊）提取物治疗轻度至中度广泛性焦虑症（GAD）患者。我们假设洋甘菊在减轻GAD症状方面上级安慰剂，且耐受性相当。入选61例轻度至中度GAD门诊患者，其中57例随机接受双盲法洋甘菊提取物（n=28）或安慰剂（n=29）治疗8周。本研究的效力在于检测总汉密尔顿焦虑评分（HAM-A）评分随时间变化的统计学显著性和临床意义组间差异。次要结局包括Beck焦虑量表评分、心理健康评分、临床总体印象严重程度评分的变化，以及基线HAM-A评分降低≥50%的患者比例。我们观察到，与安慰剂治疗相比，洋甘菊治疗期间平均总HAM-A评分显著降低（p=0.047）。尽管该研究没有把握度来识别次要结局的小到中度差异，但我们观察到所有次要结局的积极变化与主要结局指标相同。每个治疗组中有1例患者因不良事件而停止治疗。两组发生0、1、2或≥3起不良事件的患者比例无显著差异（p=0.417）。这是甘菊提取物治疗广泛性焦虑症的第一个对照临床试验。结果表明，洋甘菊可能对轻度至中度广泛性焦虑症患者有适度的抗焦虑活性。未来的研究需要重复这些观察结果。
We conducted a randomized, double-blind, placebo-controlled efficacy and tolerability trial of Matricaria recutita (chamomile) extract therapy in patients with mild to moderate Generalized Anxiety Disorder (GAD). We hypothesized that chamomile would be superior to placebo in reducing GAD symptoms with a comparable tolerability profile. 61 outpatients with mild to moderate GAD were enrolled and 57 were randomized to either double blind chamomile extract (n=28) or placebo (n=29) therapy for 8 weeks. The study was powered to detect a statistically significant and clinically meaningful group difference in change over time in total Hamilton Anxiety Rating (HAM-A) scores. Secondary outcomes included change in the Beck Anxiety Inventory score, Psychological Well Being score, Clinical Global Impression Severity score, and the proportion of patients with ≥50% reduction in baseline HAM-A score. We observed a significantly greater reduction in mean total HAM-A score during chamomile versus placebo therapy (p=0.047). Although the study was not powered to identify small to moderate differences in secondary outcomes, we observed a positive change in all secondary outcomes in the same direction as the primary outcome measure. One patient in each treatment group discontinued therapy for adverse events. The proportion of patients experiencing 0, 1, 2, or ≥3 adverse events was not significantly different between groups (p=0.417). This is the first, controlled clinical trial of chamomile extract for GAD. The results suggest that chamomile may have modest anxiolytic activity in patients with mild to moderate GAD. Future studies are needed to replicate these observations.