Auricular acupressure as assistant in primary insomnia management: a randomized single-blind controlled clinical trial

耳穴按压辅助治疗原发性失眠的随机单盲临床对照试验

Objective: To observe the efficacy and safety of dexzopiclone plus auricular acupressure in intervening primary insomnia. Methods: A total of 72 participants who met the in clusi on criteria were en rolled in a ran domized con trolled trial, with 36 cases allocated to a treatment group and 36 cases allocated to a control group. Both groups were given dexzopiclone as the routine treatment. Patients in the treatment group were given auricular acupressure with Wang Bu Liu Xing (Semen Vaccariae) seeds at the auricular acupoints related to sleep and emotion based on meridian theory, whereas for patients in the control group, the medical plasters with Wang Bu Liu Xing (Semen Vaccariae) seeds were only gently stuck to acupoints unrelated to sleep without stimulation. Patients in both groups were required to visit the hospital once a week for replacing the seeds and plasters. The course of intervention lasted for 8 weeks and the patients were followed up for another 4 weeks. Pittsburgh sleep quality index (PSQI) and Karolinska sleep diary (KSD) were used to evaluate the outcomes. Meanwhile, adverse effects were monitored and recorded. Results: In the enrolled 72 cases, 4 patients (one in the treatment group and three in the control group) reported thirst and a bitter taste, and one case in the control group reported nausea and vomiting. At last, 3 cases in the control group dropped out for adverse reactions, and 69 cases completed the clinical trial. After 8 weeks of treatment, the global scores of PSQI in both treatment and control groups decreased significantly compared with the baseline (both PvO.001). Furthermore, the global score of PSQI in the treatment group was lower than that in the control group (P<0.01). The global scores of PSQI in both groups at the follow-up were significantly different from the baseline (both PvO.001), but insignificantly different compared with the post-treatment results (both P>0.05). According to KSD, both treatment protocols could prolong the total sleep time, shorten sleep-onset latency, improve sleep efficacy and sleep quality significantly, and the changes in the treatment group were more significant. The total effective rate was 88.9% in the treatment group, higher than 81.8% in the control group, though the difference was statistically insignificant (P>0.05). Con elusion: Dexzopicl one plus auricular acupressure is effective and safe for pati ents with primary in somnia both in short and long terms, and it is more effective tha n mono therapy of dexzopicl one.

目的:观察右佐匹克隆联合耳穴按压干预原发性失眠症的有效性及安全性。方法:将符合入组标准的72例受试者随机分为两组,治疗组36例,对照组各36例。两组均接受右佐匹克隆作为基础治疗。治疗组在此基础上根据经络理论选用与睡眠、情绪相关的耳穴以王不留行籽按压,对照组则只在与睡眠无关的耳穴上轻轻贴上王不留行籽,不予以按压。所有患者被要求1周来院更换1次耳贴。治疗共持续8周,随访4周。采用匹兹堡睡眠质量指数(PSQI)和卡罗林斯卡睡眠日志(KSD)评价临床疗效,同时观察并记录不良反应。结果:招募的72例受试者中,4例(治疗组1例,对照组3例)报告口干、口苦,1例(对照组)报告恶心呕吐。最终,对照组3例因不良反应退出临床试验,共69例完成临床研究。经8周治疗,对照组与治疗组PSQI评分均明显下降,治疗前后评分均具有统计学差异(均P<0.001),且治疗组PSQI总分下降较对照组更明显(P<0.01)o随访时与治疗前相比,两组PSQI总分均有统计学差异(均P<0.001),但与治疗刚结束时相比,差异均无统计学意义(均P>0.05)。根据KSD,提示两种治疗方案均能显著延长睡眠总时间,缩短睡眠潜伏期和提高睡眠质量及睡眠效率,且治疗组效果更显著。治疗组总有效率88.9%,高于对照组的81.8%,但组间差异无统计学意义(P>0.05)。结论:耳穴按压联合右佐匹克隆是治疗原发性失眠的有效、安全方法,近期、远期疗效佳'且疗效优于单独应用右佐匹克隆。