Knapp Peter, Campbell Burton C Alexia, Holmes John, Murray Jenni, Gillespie David, Lightbody C Elizabeth, Watkins Caroline L, Chun Ho-Yan Y, Lewis Sharon R
Department of Health Sciences, University of York, York, UK, YO10 5DD.
Adelphi Values, Bollington, Cheshire, UK.
Cochrane Database Syst Rev. 2017 May 23;5(5):CD008860. doi: 10.1002/14651858.CD008860.pub3.
Approximately 20% of stroke patients experience clinically significant levels of anxiety at some point after stroke. Physicians can treat these patients with antidepressants or other anxiety-reducing drugs, or both, or they can provide psychological therapy. This review looks at available evidence for these interventions. This is an update of the review first published in October 2011.
The primary objective was to assess the effectiveness of pharmaceutical, psychological, complementary, or alternative therapeutic interventions in treating stroke patients with anxiety disorders or symptoms. The secondary objective was to identify whether any of these interventions for anxiety had an effect on quality of life, disability, depression, social participation, caregiver burden, or risk of death.
We searched the trials register of the Cochrane Stroke Group (January 2017). We also searched the Cochrane Central Register of Controlled Trials (CENTRAL; the Cochrane Library; 2017, Issue 1: searched January 2017); MEDLINE (1966 to January 2017) in Ovid; Embase (1980 to January 2017) in Ovid; the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1937 to January 2017) in EBSCO; and PsycINFO (1800 to January 2017) in Ovid. We conducted backward citation searches of reviews identified through database searches and forward citation searches of included studies. We contacted researchers known to be involved in related trials, and we searched clinical trials registers for ongoing studies.
We included randomised trials including participants with a diagnosis of both stroke and anxiety for which treatment was intended to reduce anxiety. Two review authors independently screened and selected titles and abstracts for inclusion.
Two review authors independently extracted data and assessed risk of bias. We performed a narrative review. We planned to do a meta-analysis but were unable to do so as included studies were not sufficiently comparable.
We included three trials (four interventions) involving 196 participants with stroke and co-morbid anxiety. One trial (described as a 'pilot study') randomised 21 community-dwelling stroke survivors to four-week use of a relaxation CD or to wait list control. This trial assessed anxiety using the Hospital Anxiety and Depression Scale and reported a reduction in anxiety at three months among participants who had used the relaxation CD (mean (standard deviation (SD) 6.9 (± 4.9) and 11.0 (± 3.9)), Cohen's d = 0.926, P value = 0.001; 19 participants analysed).The second trial randomised 81 participants with co-morbid anxiety and depression to paroxetine, paroxetine plus psychotherapy, or standard care. Mean levels of anxiety severity scores based on the Hamilton Anxiety Scale (HAM-A) at follow-up were 5.4 (SD ± 1.7), 3.8 (SD ± 1.8), and 12.8 (SD ± 1.9), respectively (P value < 0.01).The third trial randomised 94 stroke patients, also with co-morbid anxiety and depression, to receive buspirone hydrochloride or standard care. At follow-up, the mean levels of anxiety based on the HAM-A were 6.5 (SD ± 3.1) and 12.6 (SD ± 3.4) in the two groups, respectively, which represents a significant difference (P value < 0.01). Half of the participants receiving paroxetine experienced adverse events that included nausea, vomiting, or dizziness; however, only 14% of those receiving buspirone experienced nausea or palpitations. Trial authors provided no information about the duration of symptoms associated with adverse events. The trial of relaxation therapy reported no adverse events.The quality of the evidence was very low. Each study included a small number of participants, particularly the study of relaxation therapy. Studies of pharmacological agents presented details too limited to allow judgement of selection, performance, and detection bias and lack of placebo treatment in control groups. Although the study of relaxation therapy had allocated participants to treatment using an adequate method of randomisation, study recruitment methods might have introduced bias, and drop-outs in the intervention group may have influenced results.
AUTHORS' CONCLUSIONS: Evidence is insufficient to guide the treatment of anxiety after stroke. Further well-conducted randomised controlled trials (using placebo or attention controls) are required to assess pharmacological agents and psychological therapies.
约20%的中风患者在中风后的某个阶段会出现临床上显著的焦虑症状。医生可以用抗抑郁药或其他减轻焦虑的药物治疗这些患者,或者两者并用,也可以提供心理治疗。本综述着眼于这些干预措施的现有证据。这是对2011年10月首次发表的综述的更新。
主要目的是评估药物、心理、补充或替代治疗干预措施在治疗患有焦虑症或焦虑症状的中风患者中的有效性。次要目的是确定这些焦虑干预措施是否对生活质量、残疾、抑郁、社会参与、照顾者负担或死亡风险有影响。
我们检索了Cochrane中风小组的试验注册库(2017年1月)。我们还检索了Cochrane对照试验中心注册库(CENTRAL;Cochrane图书馆;2017年第1期:检索于2017年1月);Ovid平台上的MEDLINE(1966年至2017年1月);Ovid平台上的Embase(1980年至2017年1月);EBSCO平台上的护理及相关健康文献累积索引(CINAHL;1937年至2017年1月);以及Ovid平台上的PsycINFO(1800年至2017年1月)。我们对通过数据库检索确定的综述进行了反向引文检索,并对纳入研究进行了正向引文检索。我们联系了已知参与相关试验的研究人员,并在临床试验注册库中搜索正在进行的研究。
我们纳入了随机试验,这些试验的参与者同时被诊断为中风和焦虑症,且治疗旨在减轻焦虑。两位综述作者独立筛选并选择纳入的标题和摘要。
两位综述作者独立提取数据并评估偏倚风险。我们进行了叙述性综述。我们计划进行荟萃分析,但由于纳入的研究缺乏充分的可比性而未能进行。
我们纳入了三项试验(四项干预措施),涉及196名患有中风和共病焦虑症的参与者。一项试验(描述为“试点研究”)将21名社区中风幸存者随机分为两组,一组使用放松CD四周,另一组作为候补对照。该试验使用医院焦虑抑郁量表评估焦虑,并报告使用放松CD的参与者在三个月时焦虑有所减轻(均值(标准差(SD))分别为6.9(±4.9)和11.0(±3.9),Cohen's d = 0.926,P值 = 0.001;分析了19名参与者)。第二项试验将81名患有共病焦虑和抑郁的参与者随机分为三组,分别接受帕罗西汀、帕罗西汀加心理治疗或标准护理。随访时基于汉密尔顿焦虑量表(HAM - A)的焦虑严重程度评分均值分别为5.4(SD ±1.7)、3.8(SD ±1.8)和12.8(SD ±1.9)(P值 < 0.01)。第三项试验将94名同样患有共病焦虑和抑郁的中风患者随机分为两组,分别接受盐酸丁螺环酮或标准护理。随访时,两组基于HAM - A的焦虑均值分别为6.5(SD ±3.1)和12.6(SD ±3.4),差异具有统计学意义(P值 < 0.01)。接受帕罗西汀治疗的参与者中有一半经历了不良事件,包括恶心、呕吐或头晕;然而,接受丁螺环酮治疗的参与者中只有14%经历了恶心或心悸。试验作者未提供与不良事件相关症状持续时间的信息。放松疗法试验未报告不良事件。证据质量非常低。每项研究纳入的参与者数量较少,尤其是放松疗法的研究。药物治疗研究提供的细节过于有限,无法判断选择、实施和检测偏倚以及对照组缺乏安慰剂治疗的情况。尽管放松疗法研究使用了适当的随机化方法分配参与者,但研究招募方法可能引入了偏倚,干预组的退出情况可能影响了结果。
证据不足以指导中风后焦虑症的治疗。需要进一步开展设计良好的随机对照试验(使用安慰剂或注意力对照)来评估药物治疗和心理治疗。