Auricular acupressure as assistant in primary insomnia management: a randomized single-blind controlled clinical trial / 针灸推拿医学（英文版）

ABSTRACT

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 inclusion criteria were enrolled in a randomized controlled 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 P＜0.001).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 P＜0.001),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).Conclusion:Dexzopiclone plus auricular acupressure is effective and safe for patients with primary insomnia both in short and long terms,and it is more effective than monotherapy of dexzopiclone.