Clinical Study On Traditional Chinese Medicine And Electro-Nape-Acupuncture Treatment Of Insomnia With The Type Of Heart-Spleen Deficiency

Objective:To investigate the clinical efficacy and mechanism of electro-nape-acupuncture and Traditional Chinese Medicine(TCM) on treating insomnia.Methods:Sixty subjects with insomnia conformed to the diagnostic criteria and inclusion criteria, were randomly and equally divided into two groups, using'table of random number'.The treatment group treated by electro-nape--acupuncture and TCM,while the sham group treated with Estazolam.In the treatment group, we operated bilateral Fengchi(GB20) and Gongxue by electric acupuncture apparatus with the sparse wave,2Hz for 30 minutes every morning.Meanwhile,250ml TCM was taken one hour before going to bed every night,6 days per week,2 weeks for a course of treatment, and healing efficacy was observed post 2 courses treatment.In the placebo group,2mg Estazolam was taken by each subject one hour before going to bed every night,2 weeks for a course of treatment, and 2 courses for the treatment. We evaluated the improvement of insomnia of every patient and the clinical efficacy according to the following items:(1) Self-rating anxiety scale (SAS);(2) The Pittsburgh Sleep Quality Index (PSQI),and also used "the guiding principle of clinical research on new drugs" by Ministry of Health of the People's Republic of China in 1993 as a clinical indicator criteria to determine the clinical efficacy of insomnia.Results:(1)There is a statistically significant difference of the overall response rate between the treatment group (96.7%) and control group (80%)(P<0.05).(2)As for the evaluation score of PSQI, there is a significant difference before and post treatment in the treatment group and sham group respectively (P<0.01).Also, there is a sound difference of sleep quality,sleep latency, sleep time, sleep efficiency, sleep disturbances and daytime function inter and between two groups(P<0.01).(3)When it comes to the SAS evaluation score, there is a significant difference before and post treatment in the treatment group and sham group respectively and also between two groups (P<0.01).Conclusions:(1)The clinical efficacy of treatment group is superior to that of sham group.(2)The improvement of the sleep quality, sleep latency, sleep time, sleep efficiency, sleep disturbances and daytime function is much better in the treatment group than that in the placebo group.(3)The enhancement of the anxiety level of Insomnia subjects is more effective in the treatment group than that in the sham group.