| ObjectiveThis research adopts clinical epidemiological,clinical research methodological and mathematical statistical methods. This randomized controlled clinical trial intends to discuss the clinical curative effect and safety of insomnia treatment objectively with Acupuncture plus Chinese Herbal Medicine Therapy.MethodsResearch objects are patients who met the case selection criteria of insomnia and were treated from March 2010 to October 2010 in Xu Shifeng's Chinese Medicine Clinic in Taiwan. Randomized single-blind method is adopted to group patients at the rate of 1:1 into the Acupuncture plus Chinese Herbal Medicine Group and the Chinese Herbal Medicine Group.10 days make one period of treatment and observe one treatment period in total. Adopt Pittsburgh PSQI to evaluate and observe its clinical curative effect. Use EPIDATA 3.1 software to set up a database and analyze with SPSS 15.0. The measurement data is expressed by mean±tandard deviation (x±S) and the numeration data by constituent ratio (%). The interclass comparison of the measurement data is expressed by the t-test (t'test or rank sum test for heterogeneity of variance), the self AP comparison by pair t test or Wilcoxon pair rank sum test. The interclass comparison of classified data is expressed by theχ2 test and the interclass comparison of ranked data by Wilcoxon rank sum test. Statistical graphics were produced by software Graph Pad Prism 4.03.Results60 insomnia patients are observed in this research of type of heart-spleen deficiency in Chinese Medicine syndrome differentiation, including 30 in the Acupuncture plus Chinese Herbal Medicine Group:male 13, female 17, between 19 and 69 years old, average age of 38.6±12.5 years old, disease course of 2 months-18 years, average disease course of 6.2±3.6 years, the Pittsburg PSQI of 14.1±3.0; 30 cases in the Chinese Herbal Medicine Group:male 18, female 12, aged 21-68 years old, an average age of 37.1±10.0 years old, the disease course 1 month-16 years, the average disease course 4.9±2.8 years, the Pittsburg PSQI of 12.6±2.8.In comparing the baseline features of patients, there's no statistical significant difference in two groups'age, gender, disease course, Pittsburg PSQI index total score before treatment which indicates that the baseline data of two groups are comparable.After one treatment period, there's significant difference in the in-class comparison and self AP comparison of the curative effect of principal research indexes and PSQI factors. These indicate that Acupuncture plus Chinese Herbal Medicine Group and the Chinese Herbal Medicine Group can both improve patients'hours of sleep, sleep latency, daytime function, sleep quality, sleep efficiency and sleep disorder, etc. The interclass comparison shows that the Acupuncture plus Chinese Herbal Medicine Group is superior to the Chinese Herbal Medicine group in factors of hours of sleep, daytime function, sleep quality and sleep disorder, but they have similar curative effects in other factors.In clinical efficacy, among the 30 patients in the Acupuncture plus Chinese Herbal Medicine Group, full recovery:17 cases, excellence:9 cases, utility: 3 cases, inefficacy:1 case, the total effective rate:96.6%; among the 30 patients in the Chinese Herbal Medicine Group:full recovery:10 cases, excellence:7 cases, utility:7 cases, inefficacy:6 cases, the total effective rate:80.0%. Comparing two groups'clinical curative effect and the total effective shows statistically significant differences. And the Acupuncture plus Chinese Herbal Medicine Group is superior to the Chinese Herbal Medicine Group in total effective rate. Acupuncture plus Chinese Herbal Medicine can effectively improve the clinical symptoms of insomnia patients and it's better than the Control Group.Safety test indicated no abnormal changes occur to those with normal blood, urine, stool, liver and kidney function and electrocardiogram results which indicate that this therapy has clinical application security. With the above clinical research results taken into consideration, this thesis preliminary confirms that Acupuncture plus Chinese Herbal Medicine Therapy can improve the clinical efficacy of insomnia treatment and it's safe and reliable.ConclusionAcupuncture plus Chinese Herbal Medicine has obvious clinical curative effect in the treatment of insomnia of heart-spleen deficiency type. It can improve sleep quality, shorten the sleep latency, extend sleep time, enhance sleep efficiency, alleviate sleep disorders and improve the daytime function. It's superior to the Chinese Herbal Medicine Group in improving the sleep time, alleviating sleep disorders, enhancing sleep quality and daytime function. It has little side effect and it's safe, reliable, simple and effective. |
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