ObjectiveTo evaluate the effect and safety of regulating spirit acupuncture technique in the treatment of menopausal women with generalized anxiety disorder(heart-kidney disharmony syndrome),and provide a possible therapy idea of Chinese mental disease.MethodRandomized,single-blind and parallel-controlled research methods were adopted.According to 1 to 1 ratio,qualified participants with generalized anxiety disorder and heart-kidney disharmony syndrome were included and randomly allocated into two groups: treatment group and control group.Participants in the treatment group were treated with regulating spirit acupuncture technique,while the control group received ordinary acupuncture.The main acupoints of treatment group were four spirit points,DU24,GB13,HT7,SP6,LI4 and LR3,while KI3 and GB39 were add associated for the heart-kidney disharmony syndrome.The acupoints of conventional acupuncture were RN4,BL18,BL23,SP6 and KI3,while BL15 and HT7 were add associated for the heart-kidney disharmony syndrome.Quickly insertion was used and lifting-thrusting and twirling reinforcement-reduce method was carried out at every 15 minutes interval.Retaining the needles for 30 min per time.Treatments in two groups were last for four weeks,three times a week.All participants were scored before,during and after the treatment with the Hamilton Anxiety Scale(HAMA)and Self-rating Anxiety Scale(SAS).Primary outcomes was the HAMA score reduction rate.Secondary outcomes included SAS scale scores and safety.All data were processed by software SPSS 21.0.All measurement data were firstly test for normality.T-test was for the fits one while rank sum test was for the no-fits one and rank data.Chi-square testwas chosen for counting data.Repeated measurement analysis of variance was for the total HAMA scale scores,psychiatric symptom scores,somatic symptom scores,and SAS scale scores.P﹤0.05 serves as a standard with statistical difference while P﹤0.01 serves as a statistically significant difference standard.Results1.Totally 66 participants were enrolled from November 2016 to January2018 in ward and outpatient clinics of the First Affiliated Hospital of Guangzhou University of Chinese Medicine.In the treatment group,1 case was removed,0 cases were excluded,and 32 cases were completed.In the control group,2 cases were removed,0 cases were excluded,31 cases were completed,and finally 63 cases were completed.The resulting data was analyzed with per protocol analysis.2.Baseline comparison: There were no statistical differences between the two groups at baseline,such as age,course of diseases,severity,HAMA scale scores,psychiatric symptom scores,somatic symptom scores,and SAS scale scores(P﹥0.05)and they were good to comparability.3.Efficacy comparison: At the end of the treatment,the treatment group recovered in 13 cases,markedly improved in 14 cases,3 cases were effective,2 cases were ineffective,with the total effective rate of 93.8%.The control group recovered in 2 cases,markedly improved in 15 cases,8 cases were effective,6 cases were ineffective,with the total effective rate of rate was 80.7%.The differences between two groups were statistically significant(P﹤0.01).4.HAMA scale scores comparison: After 2 weeks of treatment and after treatment,the scores of HAMA total score,psychiatric symptoms,and somatic symptoms were decreased in both groups.The treatment group had a greater decrease with statistically significant difference(P ﹤ 0.01).After the treatment,the treatment group decreased the score significantly in 6 aspects of anxiety,nervousness,insomnia,performance at the meeting,respiratory symptoms and autonomic nervous symptoms,with the statistically significant difference(P﹤0.05).There was no significant difference in the symptoms of fear,depression,cognitive function,muscular system,sensory system,cardiovascular system,gastrointestinal tract and genitourinary system(P﹥0.05).5.SAS scale scores comparison: After 2 weeks of treatment and after treatment,the scores of SAS scale were decreased in both groups.The treatment group had a greater decrease with statistically significant difference(P﹤0.01).6.Safety comparison: No obvious adverse reactions or serious adverse events occurred in both groups during the trial.Conclusions1.Both groups are effective in improving the objective anxiety index and subjective anxiety experience,and the treatment group works faster and more effectively.2.The treatment group has better efficacy in aspects of anxiety,nervousness,insomnia,performance at the meeting,respiratory symptoms and autonomic nervous symptoms than the control group.And two groups have similar efficacy in the symptoms of fear,depression,muscular system,sensory system,cardiovascular system,gastrointestinal tract and genitourinary system.3.The regulating spirit acupuncture technique achieves the remarkably effects in the treatment of menopausal women with generalized anxiety disorder(heart-kidney disharmony syndrome),which is favorable in safety and adverse reactions and worthy of promotion. |