[A clinical trial of treatment of primary insomnia of patients with qi-stagnation constitution by shallow acupuncture combined with ear-acupoint pellet-pressing]

Objective: To investigate the clinical effect of shallow acupuncture combined with ear-acupoint pellet-pressing in the treatment of primary insomnia in patients with qi-stagnation constitution.

Methods: A total of 60 primary insomnia outpatients with qi-stagnation constitution were randomly divided into treatment group and control group, with 30 patients in each group. The patients in the control group were given oral Alprazolam tablets once a day, and those in the treatment group given shallow acupuncture of Yintang (EX-HN3), Shangen (inferior to EX-HN3), Anmian (EX-HN16) and bilateral Xingjian (LR2) and bilateral Taichong (LR3), once a day, and combined with pellet-pressing of ear acupoints "Shenmen""Sympathy""Subcortex""Heart" and "Liver" once every other day. Each course of treatment was 10 consecutive days, and both groups were treated for three courses. The sleep quality was assessed using Pittsburgh Sleep Quality Index (PSQI), the emotional status assessed using Self-rating Depression Scale (SDS), and the qi-stagnation state evaluated according to "the Criteria for Classification and Judgement of Constitution of Traditional Chinese Medicine (2009)". The therapeutic effect was evaluated according to "the Criteria for Diagnosis and Evaluation of Therapeutic Effect of Diseases of Traditional Chinese Medicine"．.

Results: Of the two 30 cases in the control and treatment groups, 2 (6.7%) and 6 (20.0%) were cured, 6 (20.0%) and 14 (46.7%) experienced marked improvement in their symptoms, 21 (70.0%) and 6 (20.0%) were effective, and 1 (3.3%) and 4 (13.3%) ineffective, with the effective rate being 86.7% and 96.7%, respectively. No significant difference was found between the two groups in the short-term effect (P>0.05). One month's follow-up showed that, of the two 30 cases in the control and treatment groups, 2 (6.7%) and 5 (16.7%) were cured, 4(13.3%) and 14 (46.6%) experienced marked improvement, 10 (33.3%) and 6 (20.0%) were effective, and 14(46.7%) and 5(16.7%) ineffective, with the effective rate being 53.3% and 83.3%, respectively. The long-term therapeutic effect of the treatment group was significantly superior to that of the control group (P<0.05). After the treatment, both PSQI and SDS scores in the two groups, and qi-stagnation score in the treatment group showed a significant reduction in comparison with their own pretreatment (P<0.05), and one-month's follow-up (not the short-term outcome) displayed that the PSQI, SDS and qi-stagnation scores of the treatment group were significantly lower than those of the control group (P<0.05)．.

Conclusion: Shallow acupuncture combined with ear-acupoint pellet-pressing can significantly improve sleep quality, depression symptoms, and pathological constitution in primary insomnia patients with qi-stagnation constitution, possessing a stable long-term clinical effect.