| ObjectiveTo evaluate the clinical efficacy and safety of acupuncture treatment of regulating liver and spirit for nausea and vomiting(liver Qi invading stomach syndrome)caused by taking SSRIs antidepressants by comparing with domperidone.MethodsA prospective clinical trial design was used.51 subjects who met the inclusion criteria were randomly divided into experimental group(n=25)and control group(n=26).The experimental group was given the following treatment:Prescription of acupuncture treatment of regulating liver and spirit:Baihui,Yintang,Zhongwan,Neiguan,Siguan(Hegu,Taichong),Zusanli,Qimen(both pairs).Source of prescription:refer to the acupoint prescription of vomiting in Wenbin Fu’s acupuncture and moxibustion essence published by Science Press and edited by Professor Wenbin Fu in 2017.Acupuncture operation:fast needling with three fingers,first needling the four limbs points:Taichong 0.5-0.8 inch,Zusanli 1-1.5 inch,Hegu and Neiguan 0.5-1 inch;then needling the head points:Baihui 0.5-0.1 inch,Yintang lifting and kneading 0.3-0.5 inch;finally needling the chest and abdomen points:Zhongwan 1-1.5 inch,Qimen oblique or flat 0.5-0.8 inch,pay attention not to deep needling Thorn.Each acupoint twists to get Qi,and the needle is kept for 30 minutes.The needle is given once every 10 minutes,three times in total.With the method of guiding Qi,the patient is instructed to take deep nasal breathing,and finally the needle is given.Course of treatment:3 times a week,once every other day,3 times as a course of treatment,each patient received 2 courses(2 weeks),a total of 6 times of treatment.Control group was given the following treatment:Methods:Domperidone Tablets(domperidone,Xian Janssen Pharmaceutical Ltd.,H10910003)usage:oral administration,10 mg(1 tablet),3 times a day,15-30 minutes before meals,for 2 weeks.Evaluation time point and observation index:PHQ-9 self rating depression scale and TCM Syndrome Scale were recorded before treatment(baseline period)and 2 weeks after treatment;NCI-CTC grade of nausea and vomiting and Eisenberg adverse reaction scale(SERS)were observed and recorded before treatment(baseline period),1 week after treatment,2 weeks after treatment and 4 weeks after follow-up;adverse reactions and side effects in the study were also recorded effect.Statistical analysis:SPSS 23.0 software was used for statistical analysis.According to different sample data,t test,X2 test,rank sum test and repeated measurement ANOVA test were used for analysis.The difference was considered to be statistically significant when P<0.05.Results1.Case inclusion:51 effective cases were included in the initial stage of this experiment,including 25 cases in the experimental group and 26 cases in the control group.Because of various force majeure factors in the test,4 people fell off(2 people in the experimental group and 2 people in the control group),and the falling off rate was 7.8%;one person was eliminated(1 person in the control group),and the elimination rate was 2.0%.A total of 46 people completed the trial and were finally included in the statistical analysis,23 in the experimental group and 23 in the control group.2.Baseline data comparison:before treatment,there was no significant difference in age,course of disease,gender,marital status,education level,occupation and other general information between the two groups(P>0.05),and the samples of the two groups were comparable.3.Comparison of curative effect of TCM Syndrome:The total score comparison:the total effective rate of the experimental group was 95.65%,the total effective rate of the control group was 60.87%,and the total score of the two groups was statistically significant(P=0.001),indicating that acupuncture treatment of regulating liver and spirit on nausea and vomiting of liver Qi invading stomach is better than domperidone.Comparison of each score:compared with in the group,acupuncture treatment of regulating liver and spirit was effective in the treatment of nausea and vomiting,fullness of epigastric and hypochondriac region,sighing frequently,hiccup or belching,and food less and poor appetite(all P<0.05),while doperidone was ineffective in the treatment of sighing frequently(P=0.058),and the other four items were effective(all P<0.05).Compared with domperidone,acupuncture treatment of regulating liver and spirit was more effective in the treatment of nausea and vomiting.fullness of epigastric and hypochondriac region,sighing frequently,less food and poor appetite(all P<0.05),but there was no difference in the treatment of hiccup or belching(P=0.366).4.Comparison of results of PHQ-9 self rating Depression Scale:after acupuncture treatment,the depression symptoms of patients in the experimental group were improved(P=0.000),and there was no significant difference in the control group before and after treatment(P=0.523).The difference between the two groups was statistically significant(P=0.000),indicating that acupuncture treatment of regulating liver and spirit can improve the depression symptoms of patients,while domperidone can not.5.Comparison of curative effect on nausea and vomiting:There was significant difference in the degree of nausea after treatment at different observation time points(P=0.000),indicating that both acupuncture treatment of regulating liver and spirit and domperidone can effectively reduce the degree of nausea.There was significant difference between the two groups(P=0.032).After 2 weeks of treatment(P=0.003)and 4 weeks of follow-up(P=0.010),the degree of nausea reduced by acupuncture was higher than that by domperidone.After 2 weeks of treatment,the complete remission rate of nausea in the experimental group was 86.96%,and the total effective rate was 95.65%.The complete remission rate of nausea in the control group was 39.13%,and the total effective rate was 91.30%.There was a statistical difference between the two groups(P=0.002),indicating that the effect of acupuncture treatment of regulating liver and spirit on complete remission of nausea was better than that of domperidone.There was significant difference in the degree of vomiting after treatment at different observation time points(P=0.000),indicating that acupuncture treatment of regulating liver and spirit and domperidone can effectively reduce the degree of vomiting,and there was no significant difference between the two groups(P=0.644).After 2 weeks of treatment,the complete remission rate was 95.65%and the total effective rate was 100%in the experimental group,and 91.30%and 100%in the control group.There was no difference in the curative effect between the two groups(P=0.153).6.Comparison of antidepressant side effects scale(SERS)After 1 week,2 weeks and 4 weeks of treatment,the adverse reactions of the experimental group were decreased compared with those before treatment(all P<0.05),indicating that acupuncture treatment of regulating liver and spirit can reduce the occurrence of other adverse reactions caused by SSRIs;the adverse reactions of the control group after 2 weeks of treatment were increased compared with those before treatment and 1 week of treatment(all P<0.05),indicating that domperidone can increase the occurrence of other adverse reactions.ConclusionThe clinical efficacy of acupuncture in the treatment of liver Qi invading stomach type nausea and vomiting caused by SSRls antidepressants is objective and effective,and can effectively improve the depression symptoms and TCM syndromes(nausea and vomiting,fullness of epigastric and hypochondriac region,sighing frequently,hiccup or belching,and food less and poor appetite),and reduce the occurrence of adverse reactions. |
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