| Objective: Observe the clinical efficacy and safety of Zhuang medicine umbilical ring acupuncture combined with Zhuang medicine Tiaoqi decoction on insomnia with deficiency of both heart and spleen,in order to provide simple,convenient and experimental methods and ideas for the clinical treatment of insomnia.Methods: Sixty patients meeting the diagnostic criteria were selected and divided into a treatment group and a control group using a random number table method,each with 30 cases.The treatment group was treated with Zhuang medicine umbilical ring needle combined with Zhuang medicine Tiaoqi decoction,and the control group was taken orally Treatment with Estazolam Tablets.Both groups were treated for 4 weeks.The changes of Pittsburgh Sleep Quality Index(PSQI)and TCM Syndrome Score Scale before and after treatment were observed in the two groups,and the evaluation was made with reference to "Guiding Principles for Clinical Research of New Chinese Medicines" and PSQI score reduction Clinical efficacy,the adverse reactions during the treatment of the two groups were observed,and their safety was evaluated.Four weeks after the treatment,the patients who were effective in the two groups were followed up to evaluate the recurrence rate.Results: 1.Comparing the two groups after treatment and before treatment,the PSQI scores and TCM syndrome scores were significantly reduced,and the difference was statistically significant(P<0.05);2.After treatment,the PSQI scale was compared between the treatment group and the control group.The scores decreased by the same amount,and the difference between the two groups was not statistically significant(P>0.05);3.After treatment,the treatment group and the control group showed that the score of TCM syndrome decreased better than that of the control group,and the difference between the two groups was statistically significant(P<0.05)4.After 4 weeks of treatment,the effective rate of TCM symptoms in the treatment group was 100%,and that of the control group was 90.0%.There was no statistically significant difference between the two groups(P>0.05);5.The total effective rate of the treatment group after 4 weeks of treatment The total effective rate in the control group was 90.0%,and the total effective rate in the control group was 83.33%.There was no statistically significant difference between the two groups(P>0.05);6.Safety: During the treatment period,there were 2 cases of adverse reactions in the treatment group and 9cases in the control group.No serious adverse reactions and complications occurred in the two groups.The safety level was level 2.The incidence of adverse reactions in the treatment group and the control group were 6.67%and 30.0%,respectively.The difference between the two groups was statistically significant(P<0.05);7.Recurrence rate: 4 weeks after the end of treatment,the two groups of patients who were effective in the treatment had a total of 5 relapses in the treatment group and 12 in the control group.The recurrence rates of the treatment group and the control group were 18.52%and 48.0%,respectively.The contrast difference was statistically significant(P<0.05).Conclusion: Zhuang medicine umbilical ring acupuncture combined with Zhuang medicine Tiaoqi decoction has a good therapeutic effect on patients with heart and spleen deficiency type insomnia.It is equivalent to western medicine in terms of decreasing the patient’s PSQI score,the curative effect of traditional Chinese medicine,and the total effective rate.The symptom score decline was significantly better than the western medicine group,and it was better than the control group in terms of safety and reducing the recurrence rate. |