| Background:Generalized anxiety is a common type of anxiety disorder.The anxiety of the patient is persistent,but the object and content are often unfixed,and often involve many systemic autonomic nervous dysfunction symptoms involving digestion,respiration,urology and reproduction.The social function of the patients is seriously affected.There are five hydroxytryptamine reuptake inhibitors(SSRI),selective norepinephrine reabsorption inhibitor(SNRI)and benzene two nitrogen(BZD),but these drugs have different levels of side effects,the treatment compliance is poor,the drug is easy to relapse after withdrawal,followed by some drugs.There are many drawbacks in addiction and cardiotoxicity.With the development of traditional Chinese medicine and new technology of anti anxiety therapy,traditional medicine in China pays attention to the treatment based on syndrome differentiation and the whole treatment.Although the effect is not as fast as western medicine,there is no definite anti anxiety effect of Western medicine,but there is little adverse reaction and no addiction.Therefore,it is one of the directions of this study to imagine that the combined treatment with western medicine can strengthen the effect of anti anxiety and reduce the occurrence of adverse reactions.Repetitive transcranial magnetic stimulation(rTMS)is a new and effective physical therapy for neuropsychiatric disorders.However,there are few studies on the treatment of generalized anxiety(rTMS)in the treatment of generalized anxiety disorder(GAD),which has proved that rTMS is effective in the treatment of generalized anxiety(GAD)and has a quick onset time.It also received satisfactory results.Jieyu Anshen Decoction is an effective prescription for the treatment of liver depression fire type GAD.On the basis of Pa Rossi Dean's routine anti anxiety treatment,the combination of Jieyu Anshen Decoction and / or low frequency repetitive transcranial magnetic stimulation therapy is better than the single use of Pa Rossi Dean,and the side effects are less.In this study,the clinical research method of Chinese medicine was used to verify and compare the therapeutic effect of this study.It aims to enrich the treatment of traditional Chinese medicine in generalized anxiety and the promotion of new treatment methods.ObjectiveThis study compared Jieyu Anshen Decoction + Pa Rossi Dean(Chinese medicine group),low frequency repetitive transcranial magnetic stimulation + Pa Rossi Dean(transcranial magnetic group),low frequency repetitive transcranial magnetic stimulation + Jieyu Anshen Decoction + Pa Rossi Dean(joint group)and Pa Rossi Dean(control group),to treat liver depression fire type widespread anxiety,from Han Dynasty.The clinical efficacy of Milton Anxiety Scale(HAMA),self rating Anxiety Scale(SAS)and TCM syndrome score were analyzed.The adverse reaction was evaluated from the side of adverse reaction scale(TESS),and the effectiveness and safety of the above scheme were evaluated.Methods: In this study,160 cases of liver depression fire type GAD were randomly divided into four groups,40 cases in each group,40 cases in each group.The four groups were treated with Pa Rossi Dean,20 mg,9 points daily in the morning,once a day,single use of Pa Rossi Dean as the control group,and the remaining three groups were added to jiejiean on the basis of this.Shen Tang,low frequency repetitive transcranial magnetic stimulation(rTMS)and Jieyu Anshen Decoction(+rTMS)were used in this study.The Chinese medicine group was given Jieyu Anshen Tang for one day,and served for half an hour after breakfast.The rTMS group was selected for the latest optimization of the Department of geriatrics of Hubei Provincial Traditional Chinese Medical Hospital for the treatment of GAD: the interplexus frequency was 1HZ,the length of treatment was 19 min,and the location was DLPFC in the right side of the frontal lobes,once a day.The combined group adopted the combined scheme of the Chinese traditional Chinese medicine(+r TMS).The course of treatment was 10 days.Before treatment,the general baseline data,HAMA,SAS,TCM syndrome scores and safety indexes were recorded.Adverse reactions were recorded in the treatment process and symptomatic treatment was recorded.Meanwhile,treatment compliance supervision was strengthened,and the loss rate of clinical research was reduced as much as possible.At the same time,the adverse reactions in the treatment process were recorded in detail.After the treatment,the scores of HAMA,TESS,SAS and TCM syndrome were evaluated,and the statistical data were analyzed.After the course of treatment,the curative effect data were counted in the group before and after the control.The treatment effectiveness was evaluated,the related safety examination indexes were reviewed,and the adverse reactions during the clinical observation were recorded and divided.Analysis,evaluation of the safety of this clinical study.Results1.among the four groups,160 cases were included,2 of them fell off,1 cases were excluded,and 157 cases entered final clinical data.2.Observation of curative effect indexFrom the HAMA analysis,the scores of the four groups were significantly decreased after treatment(P < 0.05),suggesting that the four groups were effective.The comparison between the groups showed that the three groups were all superior to the control group.The effect of the combined group was the best,the second was the Chinese medicine group,the difference was statistically significant(P < 0.05).The total effective rate of the four groups of 157 patients was 70.7%,and the total effective rate was 32.5%.The effective rate of the Chinese medicine group was 77.5%,the effective rate was 27.5%,the effective rate of the transcranial magnetic group was 74.4%,the effective rate was 30.8%,the effective rate of the combined group was 89.5%,the effective rate was 63.2%,the control group was 42.5% and the effective rate was 10%.According to the statistical analysis,the effective rate of the combined group,the Chinese medicine group and the transcranial magnetic group were all better than the control group(P < 0.0083),but there was no statistical difference between the three groups(P > 0.0083).The significant efficiency of the rTMS group and the combined group was higher than that of the control group.The combination group was superior to the traditional Chinese medicine group and the transcranial magnetic group.The difference was statistically significant(P < 0.0083),but there was no significant difference between the traditional Chinese medicine group and the control group(P > 0.0083),and the Chinese medicine group was compared with the transcranial magnetic group.The difference was not statistically significant(P > 0.0083).From the point of mental anxiety score,the scores of the four groups were all lower than before(P < 0.05).The study did not make 22 comparisons in the group after treatment.From the point of somatic anxiety,the scores of the four groups were lower than those before the treatment(P < 0.05),and the combined group,the transcranial magnetic group and the traditional Chinese medicine group were all superior to the control group(P < 0.05).The combined group had the best effect,and there was no significant difference between the Chinese medicine group and the transcranial magnetic group(P > 0.05).In this study,only the Chinese medicine group and the joint group participated in the TCM syndrome integral comparison,a total of 78 patients,the total effective rate was 87.2%.Among them,the effective rate of Chinese medicine group was 37.5%,the effective rate was 85%,the effective rate of combined group was 60.5%,and the effective rate was 89.5%.There was no statistical difference between the two groups(P > 0.05),but it was found that the combination group was better than the traditional Chinese medicine group(P < 0.05).From the SAS scale,the scores of SAS in the four groups were significantly lower than before(P < 0.05)after treatment,and the four groups were effective.Further comparison showed that the combination group was superior to the Chinese medicine group and the transcranial magnetic group,and the three groups were better than the control group(P < 0.05).At the same time,the difference between Chinese medicine group and transcranial magnetic group was not statistically significant(P > 0.05).From the TESS scale analysis,157 patients completed the study during the clinical observation period,of which 24 cases had different degrees of adverse reactions.These include abdominal distension,dizziness,physical fatigue,scalp tingling,muscle tremors,loss of appetite,dry mouth and sweating.The incidence of adverse reactions in the traditional Chinese medicine group was 10%,the transcranial magnetic group was 15.4%,the combined group was 18.4%,the control group was 17.5%,the four groups had no statistically significant difference in the incidence of adverse reactions(P > 0.05).Further to the TESS score,the combined group,the traditional Chinese medicine group and the transcranial magnetic group were all lower than the control group,the differences were all statistically significant.The study significance(P < 0.05),the score of the three groups was lower than that of the other two groups(P < 0.05).There was no significant difference in the TESS score between the Chinese medicine group and the transcranial magnetic group(P > 0.05).No serious adverse reactions were found in the four groups,suggesting that the four groups had better safety.3.Safety indicators and follow-up results The safety indexes of the four groups before and after treatment were not obviously abnormal,and no obvious adverse reactions were found after follow-up.Conclusion:1.Jieyu Anshen Decoction and low frequency repetitive transcranial magnetic stimulation are effective in the treatment of generalized anxiety disorder of liver depression and fire type,and the combination of the two is the best.It can improve the symptoms of physical anxiety and mental anxiety at the same time,and reduce the degree of adverse reactions,so it has good therapeutic effect.2.During treatment and follow-up,no serious adverse reactions were found in each group,suggesting that the regimen of this study had good safety. |
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