Effect of Exercise, Escitalopram, or Placebo on Anxiety in Patients With Coronary Heart Disease The Understanding the Benefits of Exercise and Escitalopram in Anxious Patients With Coronary Heart Disease (UNWIND) Randomized Clinical Trial
Effect of Exercise, Escitalopram, or Placebo on Anxiety in Patients With Coronary Heart Disease The Understanding the Benefits of Exercise and Escitalopram in Anxious Patients With Coronary Heart Disease (UNWIND) Randomized Clinical Trial
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DOI：
10.1001/jamapsychiatry.2021.2236
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发表时间：
2021-08-18
期刊：
影响因子：
25.8
通讯作者：
Sherwood, Andrew
中科院分区：
文献类型：
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作者：
Blumenthal, James A.;Smith, Patrick J.;Sherwood, Andrew
焦虑在冠心病（CHD）患者中很常见，并与较差的健康结果相关；然而，冠心病患者焦虑的有效治疗方法尚不确定。目的确定运动和艾司西酞普兰在减轻医院焦虑和抑郁-焦虑量表（HADS-A）测量的焦虑症状和改善冠心病风险生物标志物方面是否优于安慰剂。设计、环境和参与者本随机临床试验于2016年1月至2020年5月在美国一家三级护理教学医院进行，包括128名年龄大于40岁、久坐不动、目前未接受心理健康治疗的稳定型冠心病和诊断为焦虑症或HADS-A评分为8分或更高的门诊患者。干预措施：12周有氧运动，每周3次，强度为70% - 85%心率储备，艾司西酞普兰（每天20mg），或安慰剂药片等效。主要结局和测量主要结局为HADS-A评分。冠心病生物标志物包括心率变异性、压力反射敏感性、血流介导的舒张以及24小时尿儿茶酚胺。结果本研究纳入128名受试者。平均（SD）年龄为64.6（9.6）岁，37名参与者（29%）为女性。与随机分配到安慰剂组（-3.5;95% CI, -4.5至-2.4;P = 0.03）相比，随机分配到运动组和艾司西酞普兰组的参与者报告了更大的HADS-A降低（运动，-4.0;95% CI, -4.7至-3.2；艾司西酞普兰，-5.7;95% CI, -6.4至-5.0）；与随机分配到运动组的参与者相比，随机分配到艾司西酞普兰组的参与者报告的焦虑较少（-1.67;95% CI, -2.68至-0.66;P = 0.002）。24小时尿儿茶酚胺干预后组间差异显著（运动z评分= 0.05;95% CI, -0.2 ~ 0.3；艾司西酞普兰z评分= -0.24;95% CI, -0.4 ~ 0；安慰剂z评分= 0.36;95% CI, 0 ~ 0.7），运动组和艾司西酞普兰组较安慰剂组降低幅度更大（f1127 = 4.93; P = 0.01），艾司西酞普兰组较运动组降低幅度更大（f1127 = 4.37; P = 0.04）。所有组在冠心病生物标志物方面均取得了可比性但很小的变化，治疗组之间没有差异。结论及相关性艾司西酞普兰治疗冠心病患者焦虑是安全有效的。然而，运动对焦虑症状的有益影响并不一致。运动和艾司西酞普兰并没有改善冠心病风险的生物标志物，这应该促使进一步研究这些干预措施对焦虑和冠心病患者临床结果的影响。
IMPORTANCE Anxiety is common among patients with coronary heart disease (CHD) and is associated with worse health outcomes; however, effective treatment for anxiety in patients with CHD is uncertain.OBJECTIVE To determine whether exercise and escitalopram are better than placebo in reducing symptoms of anxiety as measured by the Hospital Anxiety and Depression-Anxiety Subscale (HADS-A) and in improving CHD risk biomarkers.DESIGN, SETTING, AND PARTICIPANTS This randomized clinical trial was conducted between January 2016 and May 2020 in a tertiary care teaching hospital in the US and included 128 outpatients with stable CHD and a diagnosed anxiety disorder or a HADS-A score of 8 or higher who were older than 40 years, sedentary, and not currently receiving mental health treatment. INTERVENTIONS Twelve weeks of aerobic exercise 3 times per week at an intensity of 70% to 85% heart rate reserve, escitalopram (up to 20mg per day), or placebo pill equivalent.MAIN OUTCOMES AND MEASURES The primary outcome was HADS-A score. CHD biomarkers included heart rate variability, baroreflex sensitivity, and flow-mediated dilation, along with 24-hour urinary catecholamines.RESULTS The study included 128 participants. The mean (SD) age was 64.6 (9.6) years, and 37 participants (29%) were women. Participants randomized to the exercise group and escitalopram group reported greater reductions in HADS-A (exercise, -4.0; 95% CI, -4.7 to -3.2; escitalopram, -5.7; 95% CI, -6.4 to -5.0) compared with those randomized to placebo (-3.5; 95% CI, -4.5 to -2.4; P =.03); participants randomized to escitalopram reported less anxiety compared with those randomized to exercise (-1.67; 95% CI, -2.68 to -0.66; P =.002). Significant postintervention group differences in 24-hour urinary catecholamines were found (exercise z score = 0.05; 95% CI, -0.2 to 0.3; escitalopram z score = -0.24; 95% CI, -0.4 to 0; placebo z score = 0.36; 95% CI, 0 to 0.7), with greater reductions in the exercise group and escitalopram group compared with the placebo group (F1,127 = 4.93; P =.01) and greater reductions in the escitalopram group compared with the exercise group (F1,127 = 4.37; P =.04). All groups achieved comparable but small changes in CHD biomarkers, with no differences between treatment groups.CONCLUSIONS AND RELEVANCE Treatment of anxiety with escitalopram was safe and effective for reducing anxiety in patients with CHD. However, the beneficial effects of exercise on anxiety symptoms were less consistent. Exercise and escitalopram did not improve CHD biomarkers of risk, which should prompt further investigation of these interventions on clinical outcomes in patients with anxiety and CHD.