Clinical Observation Of QingReHaTanAnShen Decoction In Treating Primary Insomnia (Type Of Phlegm-Heat Attacking The Heart Inside Traditional Chinese Medical)

Objective:This subject studies to observe the clinical hypnotic effects, traditional chinese medical symptom efficacy and influence in sleeping quality of the QingReHaTanAnShen Decoction in treating primary insomnia (type of Phlegm-Heat Attacking the Heart inside TCM)Method:1. Clinical date:The all65clinical study cases are from outpatients who were treated in Hubei Provincial Hospital of TCM from October2012to October2013. All patients were met inclusion and exclusion criteria. Randomly assigned to two groups, control group and treatment group. In research5cases were got rid,60cases completed the study in final, and both of two groups had30cases. Two groups had no significant difference in age, sex, duration, degree of insomnia, Pittsburgh sleep quality index (PSQI) and scores of traditional Chinese medical symptom (P>0.05). The two groups were comparable.2. Treatment Method:Both2groups were treated by Sleep Health Education and Psychological behavior guide. The patient of control group took Estazolam Tablets orally by intermittent treatment which 3-5a week and lmg-2mg once. The treatment group took foundation treatment and QingReHaTanAnShen Decoction. The QingReHaTanAnShen Decoction supplied by Hubei Provincial Hospital of traditional Chinese medicine dispensary. QingReHaTanAnShen Decoction were constituted by Rhizoma Pinellinae Praeparata15g, pericarpium citri reticulatae lOg, immature bitter orange15g, caulis bambusae in taeniam lOg, Poria cocosl5g, honey-fried licorice root6g, Coptis chinensis3g, semen zizyphi spinosae20g, semen boitae lOg, nacre mother of pearl30g, dragon tooth lOg. QingReHaTanAnShen Decoction bolied by patients or hospital. Follow the traditional boiling method. One dose each day, boiled to200ml, each time take100m1.2weeks as a course of treatment, both groups take2course of treatment. During the observation, patients were not allowed to take drugs which may have the same efficacy or affect the observation.3. Efficacy observation:Estimating the continuing sleeping time, clinical effect, TCM symptom efficacy and medication safely of two groups who suffer from primary insomnia (type of Phlegm-Heat Attacking the Heart inside TCM) after the end of2course of treatment.4. Safety inspection program:Before treating, both patients should have inspect blood analysis, urine analysis, stool+OB, liver and kidney function, ECG, After treating reexamine all the above projects. During the treatment, recorded and dealt with adverse reactions instantly.5. Statistical method:The data is analyzed by SPSS17.0. Categorical data examined by Chi-square test. Measurement data (described by±S) examined by t-test and Rank sum test. Ranked data examined by Rank sum test. Repeated measurement data examined by Chi-square test. The bilateral P<0.05had significant differences, both P<0.01as there are very significant differences.Results:1. Comparing falling asleep time:After treating, two groups can significantly cut down falling asleep time (P<0.05). A week ago after treating, the treating groups average sleep time required (22.43±5.25)min, the control group required (33.37±5.04)min. There is very significantly difference between two groups. So, the treating group are better than the control group in the effect of improving time to falling asleep.2. Comparing Continuing sleeping time:After treatment, both controlled group and treatment group had improved significantly in continuing sleeping time (P<0.01). The treatment group average continuing sleeping time were (5.70±1.15)h; The controlled group average continuing sleeping time were (4.73±1.20) h. According to the statistical tests, the difference was very significantly different (P<0.01).3. Clinical efficacy:The treatment group had30patients, clinical cure in9cases (30%), markedly in12cases (40.00%), effective in7cases (23.33%), invalid in2cases (6.67), and the total efficiency is93.33%. The control group had30patients, clinical cure7in cases (23.33%), markedly in10cases (33.33%), effective in8cases (26.67%), invalid in5cases (16.66%) and the total efficiency is83.34%. Both treatment group and control group can improve PSQI and quality of sleeping. The total efficiency of the treatment group were higher than the control group. And according to the statistical tests, the difference was very significantly different (P<0.01).4. TCM symptoms efficacy:After treating, the treatment group had30patients, clinical cure in9cases (30%), markedly in14cases (46.67%), effective in6cases (20%), invalid in1cases (3.33%), and the total efficiency is96.69%. The control group had30patients, clinical cure6in cases (20%), markedly in12cases (40%), effective in6cases (20%), invalid in6cases (20%) and the total efficiency is80%. Both two group TCM symptoms scores have significantly different (P<0.05) compared with the scores before treating. The total efficiency of treatment group were higher than the control group, and according to the statistical tests, the difference was significantly different (P<0.01).5. Safety inspection:both two group had none of adverse reactions. The QingReHuaTanAnShen Decoction are safety.Conelusion:According to the clinical observation, QingReHaTanAnShen Decoction united with Estazolam can significantly improve patients who suffer from primary insomnia (type of Phlegm-Heat Attacking the Heart inside TCM) continuing sleeping time, quality of sleeping, TCM symptoms, shortening the time of falling sleep, medication safely and adverse reactions were rare and mild.