| Objective:To observe the clinical efficacy and safety of modified Wendan Decoction in treating patients with phlegm-heat disturbance syndrome of generalized anxiety disorder.Methods:Patients admitted to the department of encephalopathy of the Third Affiliated Hospital of Beijing University of Traditional Chinese Medicine from March 2022 to October 2022 due to generalized anxiety disorder and conforming to the syndrome of phlegm-heat disturbance were randomly divided into the treatment group and the control group,with 36 cases in each group.The treatment group was given oral administration of modified Wendan Decoction,while the control group was given oral administration of Deanxit.Both group were treated for 4 weeks.Before treatment,2 weeks after treatment,4 weeks after treatment,Hamilton Anxiety Scale(HAMA),Traditional Chinese Medicine Syndrome Rating Scale(TCM),the World Health Organization Quality of Life-BREF(QOL-BREF)and Pittsburgh Sleep Quality Index(PSQI)were assessed,adverse reactions and adverse events were recorded during treatment,and safety evaluation was performed before and after treatment.The changes of scores of various scales and the occurrence of adverse reactions were observed before treatment,2 weeks after treatment and 4 weeks after treatment in the two groups.Moreover,the clinical efficacy and safety of the two groups were evaluated.Results:1 Evaluation of anxiety status:After 2 weeks and 4 weeks of treatment in both groups,there were significant differences in the scores of HAMA scales before and after treatment(P<0.05),suggesting that both modified Wendan Decoction and Deanxit can significantly improve GAD of phlegm and heat disturbance the scores of HAMA scale of patients;There was no significant difference in the scores of HAMA scale between the treatment group and the control group after 2 weeks of treatment(P>0.05),the HAMA score of the treatment group was lower than that of the control group after 4 weeks treatment(P<0.05),suggesting that modified Wendan Decoction has better efficacy than Deanxit with the prolongation of treatment time in improving HAMA scale scores.After 2 weeks and 4 weeks of treatment in both groups,except for some items(cognitive function,respiratory system symptom,genitourinary system symptom,behavior during interview),the other items were significantly different from those before treatment(P<0.05),suggesting that both modified Wendan Decoction and Deanxit can effectively reduce the patients partial factor score of HAMA scale;there was no significant difference in HAMA scale scores between the two groups after 2 weeks of treatment and 4 weeks of treatment(P>0.05).It is suggested that modified Wendan Decoction and Deanxit have the same effect in reducing the scores of HAMA.At the same time,the effect of modified Wendan Decoction is faster than that of Deanxit in reducing the scores of facters of HAMA scale.2 TCM syndrome evaluation:The scores of TCM syndromes 2 weeks after treatment and 4 weeks after treatment were significantly different from those before treatment(P<0.05),it is suggested that both modified Wendan Decoction and Deanxit can effectively reduce the score of TCM Syndrome Scale;The TCM syndrome scores of the treatment group were lower than those of the control group 2 weeks and 4 weeks after treatment,the difference was statistically significant(P<0.05),suggesting that modified Wendan Decoction was better than Deanxit in reducing TCM syndrome scores.After 2 weeks of treatment in treatment group,the differences of all items except fear and alert were statistically significant compared with those before treatment(P<0.05).After 4 weeks of treatment in treatment group,there were statistically significant differences in all items compared with those before treatment(P<0.05).It is suggested that modified Wendan Decoction has obvious improvement effect on all factors of TCM syndrome scale.After 2 weeks of treatment,the differences of entries of irritability,insomnia and dreaminess,dizziness,thorax and hypoxia in the control group were statistically significant(P<0.05),while the differences of other items were not statistically significant(P>0.05).After 4 weeks of treatment,except for tinnitus,nausea and nausea,tongue and pulse,the remaining items in the control group were compared with those before treatment,the differences were not statistically significant(P<0.05),suggesting that Deanxit has a significant improvement effect on the scores of some factors of TCM syndrome in patients.Compared with control group 2 weeks and 4 weeks after treatment,the scores of fear and alert,irritability,insomnia and dreaminess,dizziness and tinnitus in treatment group showed no significant differences(P>0.05).After 2 weeks and 4 weeks of treatment,the scores of thorax and hypochondriac distension,bitter mouth and dry throat,nausea,constipation,tongue and pulse in treatment group were lower than those in control group.The difference was statistically significant(P<0.05),suggesting that the therapeutic effect of modified Wendan Decoction and Deanxit in reducing the score of fear and alert,irritability,insomnia and dreaminess,dizziness and tinnitus in TCM syndrome scale is similar,and the therapeutic effect of modified Wendan Decoction in reducing the score of chest and pressure distension,bitter mouth and dry throat,numbness and vomiting,constipation,tongue and pulse in TCM syndrome scale is superior to that of Deanxit.3 Evaluation of quality of life:There were significant differences in QOL-BREF scale scores 2 weeks and 4 weeks after treatment in both groups compared with those before treatment(P<0.05),suggesting that modified Wendan Decoction and Deanxit could significantly improve QOL-BREF scale scores and improve quality of life of GAD patients.There was no significant difference in QOL-BREF scores between the two groups after 2 weeks and 4 weeks of treatment(P>0.05),suggesting that modified Wendan Decoction and Deanxit have similar efficacy in improving QOL-BREF scores.After 2 weeks of treatment,physiological scores in QOL-BREF scale of patients in both groups were higher than those before treatment,the differences were statistically significant(P<0.05),while there were no statistically significant differences in other items compared with those before treatment(P>0.05).After 4 weeks of treatment,the scores in physiological field and psychological field of QOL-BREF scale of patients in both groups were higher than those before treatment,the difference was statistically significant(P<0.05),while there were no statistically significant differences in other items compared with those before treatment(P>0.05).It is suggested that modified Wendan Decoction and Deanxit can significantly improve the physiological scores in the QOL-BREF scale of patients,and with the extension of treatment time,the two therapies can also significantly improve the psychological scores of patients.There were no significant differences in QOL-BREF scale scores between the two groups 2 weeks and 4 weeks after treatment(P>0.05),suggesting that modified Wendan Decoction and Deanxit have similar efficacy in improving QOL-BREF scale scores.4 Evaluation of sleep quality:After 2 weeks and 4 weeks of treatment,there were significant differences in PSQI scores in both groups compared with those before treatment(P<0.05),suggesting that modified Wendan Decoction and Deanxit could significantly reduce PSQI scale scores and improve sleep quality of GAD patients.There was no significant difference in PSQI scores between the two groups after 2 weeks and 4 weeks of treatment(P>0.05),suggesting that modified Wendan Decoction and Deanxit have similar efficacy in reducing PSQI scores.After 2 weeks and 4 weeks of treatment,the scores of all factors in the PSQI scale were lower than those before treatment,the difference was statistically significant(P<0.05),suggesting that modified Wendan Decoction and Deanxit could reduce the scores of all factors in the PSQI scale.There were no significant differences in PSQI scores between the two groups after 2 weeks and 4 weeks of treatment(P>0.05),suggesting that modified Wendan Decoction and Deanxit have similar efficacy in improving PSQI scores.5 Total effective rate:The total effective rate of the treatment group was 90.90%,and the control group was 61.76%,the difference was statistically significant(P<0.05),indicating that the overall curative effect of modified Wendan Decoction in the treatment of phlegm-heat internal interference type GAD was better than that of Deanxit.6 Safety evaluation:During the study,2 patients in the treatment group had diarrhea after taking the medicine,and the symptoms were relieved after adjusting the medication time.While 1 patient in the control group had dry mouth and aggravated constipation,and the patient dropped off after self-withdrawal of medicine,the symptoms were relieved by TCM differentiation.There were no adverse events during treatment in both groups.Safety index monitoring showed no obvious abnormalities in the two groups,indicating that there was no obvious toxic side effect in the current medication cycle of the two groups,indicating that modified Wendan Decoction has high safety in the treatment of phlegm-heat internal disturbance type GAD.Conclusion:Modified Wendan Decoction can effectively improve the anxiety symptoms,physical symptoms,sleep quality and quality of life of patients with generalized anxiety disorder with phlegm and heat disturbance,and it is safe. |
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