The Clinical Curative Effect Of Anshen Fang For The Adults With Primary Insomnia And Its Impacts On HAMA Score

BackgroundInsomnia is a subjective experience, and its patients always complain that the quality or quantity of sleep can not meet the normal physiological needs. It derives from being failed to fall asleep or maintain sleep in the vast majority of cases. Insomnia usually releases negative effect on the social function during the day and make itself the most common sleep disorder diseases. According to a survey by the W.H.O., about 27% of people have suffered from the sleep disorder all over the world, and 17% of them are the severe one. In addition, approximately 1/3 of the Americans have suffered from insomnia. And this number is 21% in Japan,19% in French,17.8% in Canada,11.9% in Finland. Insomnia is also the shared independent risk factors for the coronary heart disease(CHD) and the symptomatic diabetes. It usually contributes to emotional disorder, especially anxiety, depression, tension, irritability, etc. What’s worse, the mood disorders also aggravate insomnia.ObjectiveTo study the clinical curative effect of Anshen Fang for the adults with primary insomnia and its impacts on liver&kidney function and HAMA score.MethodsSelect 251 in-hospital and out-hospital patients of Southern Medical University affiliated Nanfang Hospital, who suffered from the primary insomnia during Nov 2012-Oct 2013. The diagnostic criteria is according to Chinese classification and diagnostic criteria for mental disorder Ⅲ by psychiatric branch of Chinese medical association. And the counterpart of the traditional Chinese medicine is in line with internal medicine of TCM by Shanghai Science and Technology Press.Inclusion criteria:①meet the criterion of Chinese classification and diagnostic criteria for mental disorder Ⅲ;②aged 18-65;③signed the informed consent.Exclusion criteria:①non-primary insomnia patients:caused by drugs, environment, psychogenic disorder and somatic symptom; ②combined severe diseases of other systems that may interfere the consequence;③sufferer with feedback disorders:psychiatric patients, someone with communication obstacle on language and writing, unwilling to cooperate with the investigation;④exposured to the antipsychotics, antidepressants or other CNS(central nervous system) drugs before clinical screening within one week;⑤had a history of drugs or alcohol dependence or abuse in one year; ⑥pregnant women or the going to be ones, breast-feeding women.Fall-off, elimination and full termination criteria:1. Fall-off criteria:the eligibles that fail to complete the clinical protocol:poor compliance patients, someone that automatically quit or lost to follow-up. The reasons of fall-off cases should be explained.2. Elimination criteria:the reasons of elimination cases should be explained, and these cases won’t be performed the statistical analyses. The cases are as follows:① misdiagnosed cases or these of mistaken inclusion;②the one didn’t take experimental drugs after the enrollment; ③the adverse events or the unwelcome reactions are too grievous to continue the study;④other drugs that would improve sleep had been taken after the enrollment, and it would lead to the outcome influenced; ⑤the patients can’t stick with their medications; ⑥the one didn’t evaluate the safety or curative effect even once;⑦other behaviors that broke the experimental program seriously.3. Full termination criteria:①the design of clinical protocols failed significantly; ②serious safety problems been discovered during the process;③the curative effect of the drugs were too poor to be essential for study.The questionnaire is designed in accordance with sleep disorder scale. All the research objects are taken history retrospectively, and the survey results are recorded and put in order. The patients are divided in treatment group and control group randomly. The patients in treatment group are administered with Anshen Fang by Professor Chen Baotian, while the counterparts in control group take the traditional Chinese herbal decoctions on the basic of syndrome differentiation classification. The patients with the syndrome of liver depression forming fire one take Longdan Xiegan Tang, the one with heart-spleen deficiency have Guipi Tang, the one with the syndrome of fire excess from Yin deficiency take Huanglian Ejiao Tang, the one with the syndrome of interior disturbance attacked by phlegm-heat take Wendan Tang and the one with the syndrome of heart-gallbladder qi deficiency take Anshen Dingzhi Wan.The ingredients of Anshen Fang are as follows:Scutellaria baicalensis 10g, Cassia twig 10g, Polygala tenuifolia 10g, Codonopsis pilosula 10g, Rhizome pinelliea preparatum 10g, Lliquorice 10g, Radix paeoniae alba 15g, Spina date seed 15g, Cortex albiziae 20g, Radix bupleuri 24g, Concha ostreae(be decocted first) 30g, Ossa draconis(be decocted first) 30g, Wine of multiflower knotweed 70g, Jujube 7 rockets.The one with the syndrome of liver depression forming fire one take Longdan Xiegan Tang, the ingredients are:Felwort 10g, Gardenia jasminoides 10g, Scutellaria baicalensis 10g, Tetrapanax papyriferus 10g, Rhizoma alismatis 10g, Semen plantaginis 10g, Radix bupleuri 10g, Angelica sinensis 10g, Rehmannia glutinosa libosch 10g, Radix glycyrrhizae preparata 10g.The patients with the syndrome of heart-spleen deficiency have Guipi Tang, the ingredients are:Rhizoma atractylodis macrocephalae 10g, Codonopsis pilosula 10g, Astragalus membranaceus 10g, Angelica sinensis 10g, Poria cocos 10g, Poly gala tenuifolia 10g, Spina date seed 10g, Arillus longan 10g, Radix aucklandiae 10g, Radix glycyrrhizae preparata 10g.The one with the syndrome of fire excess from Yin deficiency take Huanglian Ejiao Tang, the ingredients are:Coptis chinensis 20g, Scutellaria baicalensis 20g, Radix paeoniae alba 20g, Colla corii asini (melting by heat) 20g, egg yolk 2 rockets.The one with the syndrome of interior disturbance attacked by phlegm-heat take Wendan Tang and the ingredients are:Rhizoma pinellinae praeparata 10g, Caulis bambusae in taeniam 20g, Immature bitter orange 20g, Pericarpium citri reticulatae 20g, Poria cocos 20g, Radix glycyrrhizae preparata 10g.The one with the syndrome of heart-gallbladder qi deficiency take Anshen Dingzhi Wan, the ingredients are:Poly gala tenuifolia 10g, Rhizoma acori graminei 10g, Poria with hostwood 10g, Poria cocos 10g, Codonopsis pilosula 10g, Concha ostreae(be decocted first) 30g, Ossa draconis(be decocted first) 30g, Cinnabar (take it after mixing it with water) 2g.All the herbs of treatment group and control group are from Nanfang Hospital dispensary and decocted with water for 1h every time, twice a day. And then mix the every dose of 150ml together. Take 100ml in the morning and the other 100ml in the afternoon for 3 months.Other drugs and decoctions that could help sleep are forbidden, as well as the linked treatments. Keep an emotional balance and surroundings quiet. Light diet is advocated, and you’d better to avoid excitant food and drinks before sleep, such as coffer, strong tea and so on. Taking some exercise is necessary. The obligatory medicine for other diseases isn’t forbidden, but the name, dosage, usage count and specific time are required in detail to summarize, analyze and report.Observation indexes are as follows:①physical examination:body temperature, pulse, heart rate, blood pressure and respiratory;②compliance indexes:take the medicine regularly or not, the herbs are decocted correctly or not, take other medicine that help sleep or not, receive other prophylaxis or not.③efficacy criteria: record frequency, lasting time, degree and accompanying symptoms of the insomniac 4 times during the process (before taking medicine, one month later, two month later and three month later). Cure:insomnia seldomly happen. Markedly effective:the degree and frequency of insomnia have significantly reduced by more than 2/3. Effective:the degree and frequency of insomnia have reduced by more than 1/3. Ineffective:insomnia doesn’t ease, on the contrary, it gets exacerbate.All the relevant data adopts SPSS17.0 software for the statistical analysis, measurement data uses t test, count data to calculate its constitution, and the constituent ratio uses chi-square test. With P<0.05 was considered statistically significant. ResultsThe study has gathered 269 cases of primary insomnia patients during Nov 2012-Oct 2013.11 cases in treatment group have dropped out. Among them,2 cases are non-compliant patients while the other 9 cases have failed to keep on their medicine.7 cases in control group have dropped out. Among them,3 cases are non-compliant patients while the other 4 cases have failed to keep on their medicine. Thus,251 patients have completed the 3-month courses of treatment. There are no significant differences between the two groups in gender distribution, marital status, occupation, age distribution and degree of insomnia.1. The treatment group and the control group compared to the situation in generalThere are 120 cases in the treatment group,43 cases of male,77 cases of female. 81 cases of the married,21 cases of the unmarried,10 cases of the divorced and 8 cases of others.56 cases of workers,25 cases of peasants,14 cases of cadres,9 cases of teachers,5 cases of the retired,4 cases of students and 7 cases of others.64 cases of mild insomnia,35 cases of moderate insomnia and 21 cases of severe insomnia. 33 cases of liver depression forming fire,33 cases of heart-spleen deficiency,27 cases of fire excess from Yin deficiency,19 cases of interior disturbance attacked by phlegm-heat and 8 cases of heart-gallbladder qi deficiency. There are 131 cases in the treatment group,51 cases of male,80 cases of female.95 cases of the married, 18 cases of the unmarried,11 cases of the divorced and 7 cases of others.58 cases of workers,27 cases of peasants,12 cases of cadres,10 cases of teachers,8 cases of the retired,7 cases of students and 9 cases of others.There are 65 cases of mild insomnia, 45 cases of moderate insomnia and 21 cases of severe insomnia.40 cases of liver depression forming fire,31 cases of heart-spleen deficiency,26 cases of fire excess from Yin deficiency,21 cases of interior disturbance attacked by phlegm-heat and 13 cases of heart-gallbladder qi deficiency. The differences beween the two groups on gender, age distribution and insomnia degree are not statistically significant.2. The compare of clinical curative effect between the two groupsThe patients in the treatment group are administered with Anshen Fang, and they aren’t classified by the syndrome differentiation classification. The total effective rate of this group is 91.67%, and it’s significantly higher than 79.39% in the control group. The difference is statistically significant(x2=14.968, P=0.002), hinting the clinical curative effect of Anshen Fang is better than what of traditional syndrome differentiation classification.3. The compare of liver and kidney functions between the two groups before and after the treatmentThe liver and kidney functions of the patients in the two groups are compared 3 months later, and P>0.05 in both groups. It reminds that Anshen Fang and the other decoctions have unconspicuous negative impacts on the liver and kidney functions.4. The compare of HAMA in the two groups before and after the treatmentThe score of HAMA has significantly decreased in both treatment group and control group, and the treatment group has more noteworthy decline.ConclusionThe study reveals that Anshen Fang by Professor Chen Baotian gets better effect than the decoctions formulated by syndrome differentiation classification. It not only has an obvious effect in patients with primary insomnia, but also significantly fewer patients with anxiety symptoms. Moreover, it hints that anxiety symptoms improvement may be related to the improvement of sleep quality. Both groups have no obvious impact on the liver and kidney functions, and there are no occurrence of complications in all the cases during the process. All above prove Anshen Fang safe in the 3 months.