| 1.BackgroundIn recent years, as the pressure of life and work increases, people’s thought burden is heavier, the physical and mental health is threatened. Generalized anxiety disorder incidence increased year by year, has become a clinical common disease, serious impact on the patient’s quality of life, caused the wide attention of scholars both at china and abroad. Modern medicine major intervention, use drugs but there existing drugs for dependencies and defects such as slow onset of action, side effect, patients with poor compliance, so clinical effect is not ideal.This research through the mentor Mao Lijun chief physician summarizes the famous experienced doctor of traditional Chinese medicine Zhou Shaohua director’s clinical experience in the treatment of generalized anxiety disorder, and summary in the11th five-year plan task in data mining methods famous experienced doctor of traditional Chinese medicine professor Zhou Shaohua excavated clinical experience in the therapy of Heart yin deficiency in one type of generalized anxiety effectively and the commonly used Chinese medicine, differentiation of add and subtract Tianwang Buxin decoction.This study further verify the clinical curative effect of TCM by the science research methods, aims to provide Chinese medicine method of treatment of generalized anxiety disorder, embodies the advantages of TCM treatment of generalized anxiety disorder, provide reference for the research and development of anti-anxiety new TCM Patent Prescription.2. Research:Objective:Through clinical research, to objectively evaluated the clinical effectiveness and safety of Add and subtract Tianwang Buxin decoction combined with paroxetine compared with integrative Chinese and western medicine treatment in treating generalized anxiety disorder (Heart yin deficiency).Method:There were a total of108cases met the inclusion criteria from Xiyuan hospital. The cases were randomly divided into three groups:traditional Chinese medicine group, western medicine group, and integrative Chinese and western medicine group. Traditional Chinese medicine group was given one dose daily, taking orally in morning and evening; western medicine group was given paroxetine (20mg qd8am) orally; while integrative Chinese and western medicine group was given add and subtract Tianwang Buxin decoction one dose daily as well as paroxetine (20mg qd8am). The observation for8weeks. We measured and contrast HAMA,SAS,PSQI,TCM symptoms scores and TESS of the patients before the treatment,4weeks after the treatment and8weeks after the treatment. At the same time, we recorded any side events to evaluate the safety.Result:1. Among the total108cases,1cases were lost and1case was excluded. Data of107cases were finally entered for statistic analysis. Among them,36cases for Chinese medicine group,36for cases western medicine group,35cases for Chinese and western medicine group.2. According to HAMA Analysis, In Traditional Chinese medicine group,6cases were cured,17cases were markedly effective,8cases were effective,5cases were not effective, and the cure rate was16.67%, the total effective rate was86.11%; in western medicine group5cases were cured,19cases were markedly effective,6cases were effective,6cases were not effective, and the cure rate wasl3.89%, the total effective rate was83.33%; in intergrative Chinese and western medicinegroup,14cases were cured,15cases were markedly effective,3cases were effective, and3case was not effective, the cure rate was40.00%with total effective rate91.43%. HAMA scores of three groups were significantly· different before and after treatment (P<0.05),suggesting all three groups can effectively treat GAD. There was no statistical significantdifference (P>0.05) among the three groups in total effective rate. The cure rate of three groups was statistically different(P<0.05), the cure ratrc of Chinese medicine group and western group medicine showed no statistical difference (P>0.05), the cure rate was statistically different between intergrative Chinese and western medicine group and western medicine group (P<0.05), the cure rate of Chinese medicine group and intergrative Chinese and western medicine group had statistical difference (P<0.05), which indicating that intergrative Chinese had higher cure rate than Chinese medicine group and western medicine group.3. For TCM syndrome scores, in traditional Chinese medicine group,5cases were cured7cases had no effect, the cure rate was13.89%, total effective rate was80.56%; in western medicine group,4cases were cured8cases had no effect, the cure rate was11.11%, total effective rate was77.78%;in intergraitve Chinese and western medicine group8cases were cured,4case had no effect, the cure rate was22.86%, total effective rate was88.57%. The TCM syndrome scores of three groups before and after treatment were statistically difference. The effectiveness rate and cure rate of there groups had no statistical difference (P>0.05),suggesting Chinese medicine treatment, western medicine treatment and intergrative Chinese and western medicine group had no difference in treatment of TCM syndrome. The data showed that there was statistical significance (P<0.05) in the core TCM syndrome symptoms of upset and irritability change compared before and after treatment within groups while the comparison among there groups had no statistical difference(P>0.05).And there was statistical significance in insomnia, while the comparison between intergrative Chinese and western medicine group and western medicine group(P<0.05), also between intergrative Chinese and western medicine group and Chinese medicine group, there was no statistical significance between Chinese medicine group and western medicine group had statistical difference(P>0.05).4. During the treatment, there are15cases totally, the adversereaction rate was14.02%.no adverse reactions were reported in Chinese medicine group,while11cases in western medicine group were found with adverse reactions, the adversereaction rate was30.56%;4cases with adverse reactions were found in intergrative Chineseand western medicine group, and the adverse reaction rate was11.43%. Incidence of adversereactions among three groups had statistics difference (P<0.05), when compared between two groups, there was statistical difference (P<0.05) between Chinese medicine group and western medicine group, and statistical difference (P<0.05) was found between intergrative Chinese and western medicine group-and western medicine group, and statistical difference (P<0.05)was also found between traditional Chinese medicine group and intergrative Chinese and western medicine group.Conclusion:1. Add and subtract Tianwang Buxin decoction can improve the clinical symptoms of Heart yin deficiency in one type of GAD, and is effective in the treatment of Heart yin deficiency type in GAD.2. Add and subtract Tianwang Buxin decoction combined with paroxetine is better than using paroxetine alone in the cure rate, and also superior in improving insomnia of the Heart yin deficiency in one type of GAD in patients with compared to traditional Chinese medicine or western medicine group alone.3. Add and subtract Tianwang Buxin decoction has good safety in treating Heart yin deficiency in one type of GAD, and is able to reduce the western medicine adverse reactions with applied together with paroxetine. |
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