基于正念的减压与艾司西酞普兰治疗成人焦虑症：一项随机临床试验
研究结果：在这项对 276 名患有焦虑症的成年人进行的随机临床试验中，基于正念减压的 8 周治疗并不劣于依他普仑。
研究意义：在这项研究中，基于正念的减压是一种耐受性良好的治疗选择，其效果与焦虑症患者的一线药物相当。
Abstract
Importance Anxiety disorders are common, highly distressing, and impairing conditions. Effective treatments exist, but many patients do not access or respond to them. Mindfulness-based interventions, such as mindfulness-based stress reduction (MBSR) are popular and can decrease anxiety, but it is unknown how they compare to standard first-line treatments.
Objective To determine whether MBSR is noninferior to escitalopram, a commonly used first-line psychopharmacological treatment for anxiety disorders.
Design, Setting, and Participants This randomized clinical trial (Treatments for Anxiety: Meditation and Escitalopram [TAME]) included a noninferiority design with a prespecified noninferiority margin. Patients were recruited between June 2018 and February 2020. The outcome assessments were performed by blinded clinical interviewer at baseline, week 8 end point, and follow-up visits at 12 and 24 weeks. Of 430 individuals assessed for inclusion, 276 adults with a diagnosed anxiety disorder from 3 urban academic medical centers in the US were recruited for the trial, and 208 completed the trial.
Interventions Participants were 1:1 randomized to 8 weeks of the weekly MBSR course or the antidepressant escitalopram, flexibly dosed from 10 to 20 mg.
Main Outcomes and Measures The primary outcome measure was anxiety levels as assessed with the Clinical Global Impression of Severity scale (CGI-S), with a predetermined noninferiority margin of −0.495 points.
Results The primary noninferiority sample consisted of 208 patients (102 in MBSR and 106 in escitalopram), with a mean (SD) age of 33 (13) years; 156 participants (75%) were female; 32 participants (15%) were African American, 41 (20%) were Asian, 18 (9%) were Hispanic/Latino, 122 (59%) were White, and 13 (6%) were of another race or ethnicity (including Native American or Alaska Native, more than one race, or other, consolidated owing to low numbers). Baseline mean (SD) CGI-S score was 4.44 (0.79) for the MBSR group and 4.51 (0.78) for the escitalopram group in the per-protocol sample and 4.49 (0.77) vs 4.54 (0.83), respectively, in the randomized sample. At end point, the mean (SD) CGI-S score was reduced by 1.35 (1.06) for MBSR and 1.43 (1.17) for escitalopram. The difference between groups was −0.07 (0.16; 95% CI, −0.38 to 0.23; P = .65), where the lower bound of the interval fell within the predefined noninferiority margin of −0.495, indicating noninferiority of MBSR compared with escitalopram. Secondary intent-to-treat analyses using imputed data also showed the noninferiority of MBSR compared with escitalopram based on the improvement in CGI-S score. Of patients who started treatment, 10 (8%) dropped out of the escitalopram group and none from the MBSR group due to adverse events. At least 1 study-related adverse event occurred for 110 participants randomized to escitalopram (78.6%) and 21 participants randomized to MBSR (15.4%).
Conclusions and Relevance The results from this randomized clinical trial comparing a standardized evidence-based mindfulness-based intervention with pharmacotherapy for the treatment of anxiety disorders found that MBSR was noninferior to escitalopram.
摘要
重要性 焦虑症是常见的、高度痛苦的和损害性的状况。存在有效的治疗方法，但许多患者无法获得或响应它们。基于正念的干预措施，例如基于正念的减压（MBSR）很受欢迎，可以减少焦虑，但尚不清楚它们与标准一线治疗的比较。
目的 确定 MBSR 是否不劣于艾司西酞普兰，艾司西酞普兰是一种常用的治疗焦虑症的一线精神药理学药物。
设计、设置和参与者 该随机临床试验（焦虑的治疗：冥想和依他普仑 [TAME]）包括具有预先指定的非劣效性边界的非劣效性设计。患者在 2018 年 6 月至 2020 年 2 月期间被招募。结果评估由盲法临床访谈员在基线、第 8 周终点以及第 12 周和第 24 周的随访中进行。在评估纳入的 430 人中，来自美国 3 个城市学术医疗中心的 276 名被诊断患有焦虑症的成年人被招募参加试验，其中 208 人完成了试验。
干预措施 参与者以 1:1 的比例随机分配到为期 8 周的每周 MBSR 课程或抗抑郁药依他普仑，剂量从 10 到 20 毫克不等。
主要结果和测量 主要结果测量是使用临床全球严重程度印象量表 (CGI-S) 评估的焦虑水平，预定的非劣效性边界为 -0.495 分。
结果 主要非劣效性样本包括 208 名患者（MBSR 102 人，依他普仑 106 人），平均 (SD) 年龄为 33 (13) 岁；156 名参与者 (75%) 是女性；32 名参与者 (15%) 为非裔美国人，41 名 (20%) 为亚洲人，18 名 (9%) 为西班牙裔/拉丁裔，122 名 (59%) 为白人，13 名 (6%) 为其他种族或民族（包括美洲原住民或阿拉斯加原住民，不止一个种族或其他种族，由于人数少而合并）。在符合方案样本中，MBSR 组的基线平均 (SD) CGI-S 评分为 4.44 (0.79)，依他普仑组为 4.51 (0.78)，在随机样本中分别为 4.49 (0.77) 和 4.54 (0.83) .在终点，MBSR 的平均 (SD) CGI-S 评分降低了 1.35 (1.06)，依他普仑降低了 1.43 (1.17)。组间差异为 -0.07（0.16；95% CI，-0.38 至 0.23；P = .65），区间的下限在 -0.495 的预定义非劣效性范围内，表明 MBSR 与依他普仑相比具有非劣效性。基于 CGI-S 评分的改善，使用估算数据进行的二次意向治疗分析也显示了 MBSR 与依他普仑相比的非劣效性。在开始治疗的患者中，有 10 名 (8%) 因不良事件而退出依他普仑组，而没有人退出 MBSR 组。随机分配到依他普仑组的 110 名参与者（78.6%）和随机分配到 MBSR 组的 21 名参与者（15.4%）至少发生了 1 次与研究相关的不良事件。
结论和相关性 这项随机临床试验比较标准化的循证正念干预与药物疗法治疗焦虑症的结果发现，MBSR 不劣于依他普仑。
近些年，用冥想的方法来缓解焦虑症状变得越来越流行，为焦虑症患者带来了很大的福音，正念的干预（MBI）正成为一种更可接受的治疗焦虑症的方式。
技术越来越多地被用于帮助练习正念。沉浸式虚拟现实增强的正念，可能被证明，对于传统正念目前被证明有价值的广泛临床干预特别有效。根据大多数研究，虚拟现实（VR） 技术可以保证提高放松自我效能，减少走神，并保留注意力资源。VR 展示了支持正念练习的潜在有利功能，尤其是身临其境和多感官的 VR。
https://link.springer.com/article/10.1007/s12671-021-01783-6
参考文献：
Elizabeth A. Hoge. et al. Mindfulness-Based Stress Reduction vs Escitalopram for the Treatment of Adults With Anxiety Disorders A Randomized Clinical Trial. JAMA Psychiatry. 2022.
Pasquale Arpaia. et al. A Narrative Review of Mindfulness-Based Interventions Using Virtual Reality. Mindfulness volume 13. pages556–571 (2022)
