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昆达里尼瑜伽冥想与放松反应冥想治疗成人强迫症的随机临床试验

Kundalini Yoga Meditation Versus the Relaxation Response Meditation for Treating Adults With Obsessive-Compulsive Disorder: A Randomized Clinical Trial.

作者信息

Shannahoff-Khalsa David, Fernandes Rodrigo Yacubian, Pereira Carlos A de B, March John S, Leckman James F, Golshan Shahrokh, Vieira Mário S R, Polanczyk Guilherme V, Miguel Euripedes C, Shavitt Roseli G

机构信息

BioCircuits Institute, University of California, San Diego, La Jolla, CA, United States.

Center for Integrative Medicine, University of California, San Diego, La Jolla, CA, United States.

出版信息

Front Psychiatry. 2019 Nov 11;10:793. doi: 10.3389/fpsyt.2019.00793. eCollection 2019.

Abstract

Obsessive-compulsive disorder (OCD) is often a life-long disorder with high psychosocial impairment. Serotonin reuptake inhibitors (SRIs) are the only FDA approved drugs, and approximately 50% of patients are non-responders when using a criterion of 25% to 35% improvement with the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). About 30% are non-responders to combined first-line therapies (SRIs and exposure and response prevention). Previous research (one open, one randomized clinical trial) has demonstrated that Kundalini Yoga (KY) meditation can lead to an improvement in symptoms of obsessive-compulsive severity. We expand here with a larger trial. This trial compared two parallel run groups [KY vs. Relaxation Response meditation (RR)]. Patients were randomly allocated based on gender and Y-BOCS scores. They were told two different (unnamed) types of meditation would be compared, and informed if one showed greater benefits, the groups would merge for 12 months using the more effective intervention. Raters were blind in Phase One (0-4.5 months) to patient assignments, but not in Phase Two. Primary outcome variable, clinician-administered Y-BOCS. Secondary scales: Dimensional Yale-Brown Obsessive Compulsive Scale (clinician-administered), Profile of Mood Scales, Beck Anxiety Inventory, Beck Depression Inventory, Clinical Global Impression, Short Form 36 Health Survey. Phase One: Baseline Y-BOCS scores: KY mean = 26.46 (SD 5.124; N = 24), RR mean = 26.79 (SD = 4.578; N = 24). An intent-to-treat analysis with the last observation carried forward for dropouts showed statistically greater improvement with KY compared to RR on the Y-BOCS, and statistically greater improvement on five of six secondary measures. For completers, the Y-BOCS showed 40.4% improvement for KY (N = 16), 17.9% for RR (N = 11); 31.3% in KY were judged to be in remission compared to 9.1% in RR. KY completers showed greater improvement on five of six secondary measures. At the end of Phase Two (12 months), patients, drawn from the initial groups, who elected to receive KY continued to show improvement in their Y-BOCS scores. KY shows promise as an add-on option for OCD patients unresponsive to first line therapies. Future studies will establish KY's relative efficacy compared to Exposure and Response Prevention and/or medications, and the most effective treatment schedule. www.ClinicalTrials.gov, identifier NCT01833442.

摘要

强迫症(OCD)通常是一种会造成严重心理社会功能损害的终身性疾病。血清素再摄取抑制剂(SRIs)是唯一获得美国食品药品监督管理局(FDA)批准的药物,然而,以耶鲁-布朗强迫症量表(Y-BOCS)评分改善25%至35%为标准时,约50%的患者对此类药物无反应。约30%的患者对一线联合治疗(SRIs与暴露反应阻止法)也无反应。先前的研究(一项开放性研究和一项随机临床试验)表明,昆达里尼瑜伽(KY)冥想可以改善强迫症的严重症状。我们在此通过一项更大规模的试验进行拓展。 本试验比较了两个平行组[KY组与放松反应冥想(RR)组]。患者根据性别和Y-BOCS评分被随机分配。他们被告知将比较两种不同(未命名)的冥想方式,并被告知如果其中一种显示出更大益处,两组将在12个月内采用更有效的干预措施合并。在第一阶段(0至4.5个月),评估者对患者分组情况不知情,但在第二阶段并非如此。 主要结局变量为临床医生评定的Y-BOCS。次要量表包括:维度耶鲁-布朗强迫症量表(由临床医生评定)、情绪量表简表、贝克焦虑量表、贝克抑郁量表、临床总体印象量表、健康调查简表36项。 第一阶段:Y-BOCS基线评分:KY组均值 = 26.46(标准差5.124;N = 24),RR组均值 = 26.79(标准差 = 4.578;N = 24)。对失访者采用末次观察值结转的意向性分析显示,在Y-BOCS上,KY组相比RR组有统计学上更显著的改善,并且在六项次要指标中的五项上有统计学上更显著的改善。对于完成试验者,KY组Y-BOCS评分改善了40.4%(N = 16),RR组改善了17.9%(N = 11);KY组31.3%的患者被判定为缓解,而RR组为9.1%。KY组的完成试验者在六项次要指标中的五项上有更大改善。在第二阶段(12个月)结束时,从最初分组中选择接受KY治疗的患者,其Y-BOCS评分持续改善。 KY显示出有望作为对一线治疗无反应的强迫症患者的附加治疗选择。未来的研究将确定KY与暴露反应阻止法和/或药物治疗相比的相对疗效,以及最有效的治疗方案。 美国国立医学图书馆临床试验注册网站,标识符NCT01833442。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fa51/6859828/ab85de657c52/fpsyt-10-00793-g001.jpg

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