Guaiana Giuseppe, Barbui Corrado, Cipriani Andrea
Department of Psychiatry, University of Western Ontario, Regional Mental Health Care-Saint Thomas, 467 Sunset Drive, St Thomas, Ontario, Canada, N6P 3V9.
Cochrane Database Syst Rev. 2010 Dec 8(12):CD006815. doi: 10.1002/14651858.CD006815.pub2.
Generalised anxiety disorder (GAD) is a common chronic long-term psychiatric disorder, particularly frequent in primary care. There are several treatment options available, both non-pharmacological (i.e. cognitive behavioral therapy) and pharmacological. Among the pharmacological interventions, antidepressants, buspirone and benzodiazepines (BDZs) have been studied in GAD. Hydroxyzine is an anti-histamine medication which has been used in the treatment of anxiety.
The Cochrane Depression, Anxiety and Neurosis Group's controlled trial registers (CCDANCTR-Studies and CCDANCTR-References) were searched on 1 March 2010. The author team ran complementary searches on MEDLINE, CINAHL and PsycINFO and checked reference lists of included studies, previous systematic reviews and major textbooks of anxiety disorders. Personal communication with pharmaceutical companies and experts in the field was also undertaken.
Randomised controlled trials allocating patients with GAD to hydroxyzine versus placebo and/or any other anxiolytic agent.
Two authors independently extracted data. Information extracted included study characteristics, participant characteristics, intervention details and outcome measures in terms of efficacy (such as the number of patients who responded to treatment or remitted), acceptability (the number of patients who failed to complete the study) and tolerability (side effect profile).
The search yielded 39 studies. We included five studies in the review with a total of 884 participants. We excluded 31 studies and designated three as awaiting assessment. The data from the included studies provide some evidence that hydroxyzine is more effective than placebo for GAD (odds ratio (OR) 0.30, 95% CI 0.15 to 0.58) and that it is also acceptable/tolerable (OR 1.00, 95% CI 0.63 to 1.58) (OR 1.49, 95% CI 0.92 to 2.40). Compared to other anxiolytic agents (benzodiazepines and buspirone), hydroxyzine was equivalent in terms of efficacy, acceptability and tolerability (hydroxyzine vs chloridiazepoxide: OR 0.75, 95% CI 0.35 to 1.62; hydroxyzine vs buspirone efficacy OR 0.76, 95% CI 0.40 to 1.42). In terms of side effects, hydroxyzine was associated with a higher rate of sleepiness/drowsiness than the active comparators (OR 1.74, 95% CI 0.86 to 3.53). There was, however, a high risk of bias in the included studies.
AUTHORS' CONCLUSIONS: The included studies did not report on all the outcomes that were pre-specified in the protocol for this review. Even though more effective than placebo, due to the high risk of bias of the included studies, the small number of studies and the overall small sample size, it is not possible to recommend hydroxyzine as a reliable first-line treatment in GAD.
广泛性焦虑障碍（GAD）是一种常见的慢性长期精神疾病，在初级保健中尤为常见。有多种治疗选择，包括非药物治疗（如认知行为疗法）和药物治疗。在药物干预中，抗抑郁药、丁螺环酮和苯二氮䓬类药物（BDZs）已在GAD中进行了研究。羟嗪是一种抗组胺药物，已用于治疗焦虑症。
2010年3月1日检索了Cochrane抑郁、焦虑和神经症小组的对照试验注册库（CCDANCTR-研究和CCDANCTR-参考文献）。作者团队在MEDLINE、CINAHL和PsycINFO上进行了补充检索，并检查了纳入研究、先前的系统评价和焦虑症主要教科书的参考文献列表。还与制药公司和该领域的专家进行了个人交流。
将GAD患者随机分配至羟嗪组与安慰剂组和/或任何其他抗焦虑药组的随机对照试验。
两位作者独立提取数据。提取的信息包括研究特征、参与者特征、干预细节以及疗效（如对治疗有反应或缓解的患者数量）、可接受性（未完成研究的患者数量）和耐受性（副作用概况）方面的结局指标。
检索共得到39项研究。我们纳入了5项研究，共884名参与者。我们排除了31项研究，并将3项指定为待评估。纳入研究的数据提供了一些证据，表明羟嗪治疗GAD比安慰剂更有效（优势比（OR）0.30，95%置信区间0.15至0.58），并且也是可接受/耐受的（OR 1.00，95%置信区间0.63至1.58）（OR 1.49，95%置信区间0.92至2.40）。与其他抗焦虑药（苯二氮䓬类和丁螺环酮）相比，羟嗪在疗效、可接受性和耐受性方面相当（羟嗪与氯氮䓬：OR 0.75，95%置信区间0.35至1.62；羟嗪与丁螺环酮疗效OR 0.76，95%置信区间0.40至1.42）。在副作用方面，羟嗪与活性对照相比嗜睡/困倦发生率更高（OR 1.74，95%置信区间0.86至3.53）。然而，纳入研究存在较高的偏倚风险。
纳入研究未报告本综述方案中预先指定的所有结局。尽管比安慰剂更有效，但由于纳入研究的偏倚风险高、研究数量少且总体样本量小，因此无法推荐羟嗪作为GAD可靠的一线治疗药物。
