Irwin Michael R, Olmstead Richard, Carrillo Carmen, Sadeghi Nina, Nicassio Perry, Ganz Patricia A, Bower Julienne E
All authors: University of California Los Angeles, Los Angeles, CA.
J Clin Oncol. 2017 Aug 10;35(23):2656-2665. doi: 10.1200/JCO.2016.71.0285. Epub 2017 May 10.
Purpose Cognitive behavioral therapy for insomnia (CBT-I) and Tai Chi Chih (TCC), a movement meditation, improve insomnia symptoms. Here, we evaluated whether TCC is noninferior to CBT-I for the treatment of insomnia in survivors of breast cancer. Patients and Methods This was a randomized, partially blinded, noninferiority trial that involved survivors of breast cancer with insomnia who were recruited from the Los Angeles community from April 2008 to July 2012. After a 2-month phase-in period with repeated baseline assessment, participants were randomly assigned to 3 months of CBT-I or TCC and evaluated at months 2, 3 (post-treatment), 6, and 15 (follow-up). Primary outcome was insomnia treatment response-that is, marked clinical improvement of symptoms by the Pittsburgh Sleep Quality Index-at 15 months. Secondary outcomes were clinician-assessed remission of insomnia; sleep quality; total sleep time, sleep onset latency, sleep efficiency, and awake after sleep onset, derived from sleep diaries; polysomnography; and symptoms of fatigue, sleepiness, and depression. Results Of 145 participants who were screened, 90 were randomly assigned (CBT-I: n = 45; TCC: n = 45). The proportion of participants who showed insomnia treatment response at 15 months was 43.7% and 46.7% in CBT-I and TCC, respectively. Tests of noninferiority showed that TCC was noninferior to CBT-I at 15 months ( P = .02) and at months 3 ( P = .02) and 6 ( P < .01). For secondary outcomes, insomnia remission was 46.2% and 37.9% in CBT-I and TCC, respectively. CBT-I and TCC groups showed robust improvements in sleep quality, sleep diary measures, and related symptoms (all P < .01), but not polysomnography, with similar improvements in both groups. Conclusion CBT-I and TCC produce clinically meaningful improvements in insomnia. TCC, a mindful movement meditation, was found to be statistically noninferior to CBT-I, the gold standard for behavioral treatment of insomnia.
目的 失眠的认知行为疗法（CBT-I）和太极（TCC，一种动中禅）可改善失眠症状。在此，我们评估了太极在治疗乳腺癌幸存者失眠方面是否不劣于失眠的认知行为疗法。
患者与方法 这是一项随机、部分设盲的非劣效性试验，纳入了2008年4月至2012年7月从洛杉矶社区招募的患有失眠的乳腺癌幸存者。在经过为期2个月的逐步纳入期并进行重复基线评估后，参与者被随机分配接受3个月的失眠认知行为疗法或太极训练，并在第2、3个月（治疗后）、6个月和15个月（随访）进行评估。主要结局是失眠治疗反应，即根据匹兹堡睡眠质量指数在15个月时症状有显著临床改善。次要结局包括临床医生评估的失眠缓解情况；睡眠质量；从睡眠日记得出的总睡眠时间、入睡潜伏期、睡眠效率和睡眠后觉醒时间；多导睡眠图；以及疲劳、嗜睡和抑郁症状。
结果 在145名接受筛查的参与者中，90名被随机分配（失眠认知行为疗法组：n = 45；太极组：n = 45）。在15个月时显示出失眠治疗反应的参与者比例在失眠认知行为疗法组和太极组中分别为43.7%和46.7%。非劣效性检验表明，太极在15个月时（P = 0.02）、3个月时（P = 0.02）和6个月时（P < 0.01）不劣于失眠认知行为疗法。对于次要结局，失眠缓解率在失眠认知行为疗法组和太极组中分别为46.2%和37.9%。失眠认知行为疗法组和太极组在睡眠质量、睡眠日记测量指标及相关症状方面均有显著改善（均P < 0.01），但多导睡眠图方面无改善，两组改善情况相似。
结论 失眠认知行为疗法和太极在临床上均能显著改善失眠。太极，一种正念动中禅，在统计学上被发现不劣于失眠认知行为疗法，后者是失眠行为治疗的金标准。
