| 1.Background:Generalized anxiety disorder is the clinical common disease, serious influence patient’s quality of life. At present western medicine mainly use the SSRI treatment and benzodiazepines, but side effects with these drugs, expensive, and poor adherence defect. And the clinical curative effect of TCM treatment of anxiety disorders, the less adverse reactions, no addiction, and get the favour of broad patients relapse, caused the wide attention of scholars both at home and abroad.This research through the mentor Mao Lijun chief physician summarizes the old 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 name old doctor of traditional Chinese medicine professor Zhou Shaohua excavated clinical experience in the therapy of phlegm heat in one type of generalized anxiety effectively and the commonly used Chinese medicine, differentiation of add and subtract WenDan Tang subtraction. This study applies the science of TCM clinical research methods to further validate the clinical curative effect, aims to provide Chinese medicine method of treatment of generalized anxiety, embodies the advantages of TCM treatment of generalized anxiety, provide reference for anti-anxiety new proprietary Chinese medicine research and development.2.Research:Objective:Through clinical research, to objectively evaluated the clinical effectiveness and safety of Wendan Tang Jiajian combined with paroxetine compared with intergrative Chinese and western medicine treatment in treating generalized anxiety disorder (phlegm heat disturbance C).Method:There were a total of90cases met the inclusion criteria.The cases were randomly divided into there groups:traditional Chinese medicine, western medicine group, and intergrative Chinese and western medicine. Traditional Chinese medicine group was given Wendan Tang Jiajian one dose daily, taking orally morning and evening;western medicine group was given paroxetine (20mg qd8am) orally; while intergrative Chinese and western medicine group was given Wendan Tang Jiajian one dose daily as well as paroxetine (20mg qd8am).The observation took4weeks. We measured HAMA.SAS,TCM syndrome score,TESS and contrast of the patients before the treatment,2weeks after the treatment and4weeks after the treatment. At the same time, we recorded any side events to evaluate the safety.Result:1.Among the total90cases,3cases were lost and1case was excluded. Data of89cases were finally entered for statistic analysis. 2. According to HAMA Analysis, among the total89cases,20cases were cured, and10cases were not effective, the cure rate was22.47%and the total effective rate was88.76%. In Traditional Chinese medicine group,6cases were cured,14cases were markedly effective,6cases were effective,4cases were not effective, and the cure rate was20.00%, the total effective rate was86.67%; in western medicine group3cases were cured,19cases were markedly effective,2cases were effective,5cases were not effective, and the cure rate was10.34%, the total effective rate was82.76%; in intergrative Chinese and western medicine group,11cases were cured,16cases were markedly effective,2cases were effective, and1case was not effective, the cure rate was36.67%with total effective rate96.67%. HAMA scores of three groups were significantly different before and after treatment (P<0.01), suggesting all three groups can effectively treat GAD. There was no statistical significant difference (P>0.05) among the three groups in total effective rate. The cure rate among the three groups in total effective rate. The cure rate of three groups was statistically different (P<0.05), the cure ratre of Chinese medicine group and western 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 no statistical difference (P>0.05), which indicating that intergrative Chinese and western medicine had higher than western medicine group. Somatic anxiety scores before and after treatment in three groups difference (P<0.05),showed statistic difference (P<0.05), there was no statistical difference between traditional Chinese medicine group and western medicine group in somatic anxiety points(P>0.05), somatic anxiety scores in intergrative Chinese and western medicine group and western medicine group were statistically different (P<0.05), the somatic anxiety scores in intergrative Chinese and western medicine and Chinese medicine group were statistically different (P<0.05), which indicating that intergrative Chinese and western medicine in improving somatic anxiety was superior to traditional Chinese medicine or western medicine alone.3.For TCM syndrome scores, in traditional Chinese medicine group,2cases were cured3cases had no effect, the cure rate was6.67%, total effective rate was90.00%; in intergraitve Chinese and western medicine group2cases were cured1case had no effect, the cure rate was6.67%, total effective rate was96.67%. The TCM syndrome scores of two groups before and after treatment was statistically difference. The effectiveness rate and cure rate of two groups had no statistical difference (P>0.05),suggesting Chinese medicine treatment and intergrative Chinese and western medicine group had no difference. The data showed that there was statistical significance (P<0.05) in the core TCM syndrome symptoms of fear and upset.irritability,palpitation,insomnia,much dream changecompared before and after treatment within groups,while the comparison between the two groups had no statistical difference (P>0.05).4.During the treatment, no adverse reactions were reported in Chinese medicine group, while9cases in western medicine group were found with adverse reactions, the adverse reaction rate was31.03%;2cases with adverse reactions were found in intergrative Chinese and western medicine group of,and the adverse reaction rate was6.67%.Incidence of adverse reactions 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 also found in intergrative Chinese and western medicine group and western medicine group, but there was no difference (P<0.05) was found between traditional Chinese medicine group and intergrative Chinese and western medicine group.Conclusion:1.Wendan Tang Jiajian can improve the clinical symptoms of phlegm type thermal perturbation in anxiety, and is effective in the treatment of phlegm type thermal perturbation in anxiety syndromes.2.Wendan Tang Jiajian combined with paroxetine is better than using paroxetine alone in the cure rate, and also superior in improving the phlegm heat in one type of GAD in patients with somatic anxiety compared to traditional Chinese medicine or western medicine group alone.3.Wendan Tang Jiajian has good safety in treating phlegm with internal heat type anxiety disorder, and is able to reduce the western medicine adverse reactionswith applied together with paroxetine... |
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