Zhang Leixiao, Tang Yu, Hui Ruting, Zheng Hui, Deng Yanli, Shi Yunzhou, Xiao Xianjun, Zheng Qianhua, Zhou Siyuan, Yu Siyi, Cao Wei, Liu Yin, Hu Youping, Li Ying
Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine , Chengdu, China.
Department of Traditional Chinese Medicine Rehabilitation, Chongqing Emergency Medical Center , Chongqing, China.
Psychol Health Med. 2020 Dec;25(10):1201-1215. doi: 10.1080/13548506.2020.1738015. Epub 2020 Mar 13.
The purpose of this study was to observe and compare the clinical efficacy of active acupuncture and placebo acupuncture in the treatment of insomnia and mood disorders. 96 patients with insomnia in Chengdu were randomly divided into two groups (1:1). The active acupuncture group (AA group n = 48) received the tube of Park sham device with deep needle insertion. The placebo acupuncture group (PA group n = 48) received the tube of Park sham device with a retractable needle shaft and a blunt tip. The same acupuncture points and treatment cycles were used in both groups. The overall score for the Pittsburgh Sleep Quality Index (PSQI) is the primary outcome. Secondary outcomes recorded sleep rate, self-reported depression scale (SDS), self-assessment anxiety scale (SAS), the 'six component' scores of PSQI, and scale scores. Eventually, 90 patients completed the study. After 2 weeks of treatment, the total score of PSQI in the AA group was 4.6 ± 2.4 and in the PA group was 12.9 ± 1.8 ( = 3.91, < .1). The SAS, SDS score in the AA group were 39.9 ± 5.6/39.9 ± 5.9 and in the PA group were 59.7 ± 6.1/61.2 ± 4.4 ( = 3.38/4.9, < .1). The sleep rate were 93.8% and 25.0% ( < .1). During the 1 month follow-up period, the PSQI total score in the AA group (5.2 ± 1.9) was superior to the PA group (13.1 ± 1.8) ( = 4.27, < .1). The SAS, SDS score in the AA group were 40.4 ± 5.1/42.7 ± 6.6 and in the PA group were 63.7 ± 6.6/63.5 ± 4.8 ( = 3.95/3.60, < .1). Throughout the study period, the 'six component' scores of PSQI in the AA group was superior to the PA group (each < .1). Except for tingling and cooling, other acupuncture sensations were significant differences (each < .1). Compared to the placebo acupuncture, active acupuncture can significantly improve insomnia, and clinical efficacy is maintained for at least 6 weeks.
本研究旨在观察和比较主动针刺与安慰剂针刺治疗失眠及情绪障碍的临床疗效。将成都的96例失眠患者随机分为两组（1:1）。主动针刺组（AA组，n = 48）采用Park假装置套管进行深刺。安慰剂针刺组（PA组，n = 48）采用带有可伸缩针轴和钝尖的Park假装置套管。两组采用相同的穴位和治疗周期。匹兹堡睡眠质量指数（PSQI）的总分是主要观察指标。次要观察指标记录睡眠率、自评抑郁量表（SDS）、自评焦虑量表（SAS）、PSQI的“六个成分”得分以及量表得分。最终，90例患者完成了研究。治疗2周后，AA组PSQI总分是4.6±2.4，PA组是12.9±1.8（t = 3.91，P <.01）。AA组的SAS、SDS得分分别为39.9±5.6/39.9±5.9，PA组分别为59.7±6.1/61.2±4.4（t = 3.38/4.9，P <.01）。睡眠率分别为93.8%和25.0%（P <.01）。在1个月的随访期内，AA组的PSQI总分（5.2±1.9）优于PA组（13.1±1.8）（t = 4.27，P <.01）。AA组的SAS、SDS得分分别为40.4±5.1/42.7±6.6，PA组分别为63.7±6.6/63.5±4.8（t = 3.95/3.60，P <.01）。在整个研究期间，AA组PSQI的“六个成分”得分均优于PA组（均P <.01）。除了刺痛和发凉外，其他针刺感觉有显著差异（均P <.01）。与安慰剂针刺相比，主动针刺可显著改善失眠，且临床疗效至少维持6周。
