| ObjectiveIn this randomized controlled clinical trial, we try to evaluate the clinical effect and safety of drug-separated moxibustion at the navel for insomnia with deficiency syndrome.MethodPatients with insomnia who met diagnostic criteria of Traditional Chinese Medicine and Western Medicine from TaiWan outpatient department were recruited as research objects. They were randomly divided into two groups. One group (test group) was treated with drug-separated moxibustion at the navel and the other one (control group) was treated with drugs. The effect of Drugs for improving sleep quality, Traditional Chinese Medicine syndrome, index of PSQI and quality of life was observed.Results206 patients were recruited initially in this trial. All cases had involved in safety evaluation, yet 204 cases joined in effect evaluation. Baseline information including demography characteristic(age, gender, weight, stature), case source, vital signs (temperature, heart rate,respiratory rate, blood pressure), allergic history of drugs, accompanying diseases, insomnia severity, was analyzed by t test or chi-square test, and the result showed no significance statistically (P>0.05), indicating baseline information of the two groups was equivalent and comparable.After a course of treatment, a number of indicators observed in the test group had shown more advantages than the control group, specifically on the following aspects:The test and control group all made good effect in improving sleep quality. The test group had 42.16% of patients improved in the grade of their sleep quality while the control group had 27.45%.The difference was statistically significant (P<0.05).On the Effective of TCM syndrome aspect, the total score of the syndrome were 22.118±7.493 in test group and 22.912±8.089 in control group before treatment and decreased to 13.392±7.163 and 16.225±8.236 respectively after treatment. The differences were 8.725±5.697 and 6.686±7.842. The variation rate of TCM syndrome scores were 40.17% and 25.48%. Comparing the two groups in total score after treatment, difference and the change rate before and after treatment, there were significant differences (P<0.05).The therapeutic effect of TCM syndrome were 71.59% in test group and 44.12% in control group, showing statistically significant difference between the two groups (P<0.05);scoring single symptom including insomnia, palpitations, morbid forgetfulness and abdominal distension, the grades decreased than that of pre-treatment. Comparing the two groups of the improved grade at all single symptoms and disappearance rate, the differences were statistically significant (P<0.05).PSQI total scores were 11.899±5.594 in test group and 12.245±5.175 in control group before treatment and decreased to 10.941±4.626 and 12.916±6.248 respectively after treatment.The differences were 0.895±3.42 and-0.67±4.05. The variation rate on PSQI total score were 40.17% and 25.48% before and after treatment. Comparing the total score after treatment, difference and the variation rate between the two groups before and after treatment, there were significant differences (P<0.05).The effectiveness of TCM syndromes were 2.266% in test group and-9.727% in control group, showing statistically significant difference between the two groups (P<0.05).The effective rate of TCM syndromes were 77.45% and 43.14%, meaning there was statistically significant difference in the two groups (P<0.05).In the Quality of life, comparing the SF-36 scale scores in the two groups before and after treatment, there was no significant change. In test group, the SF-36 scale scores were 34.034±13.402 before treatment and 33.646±14.203 after treatment:in control group, they were 31.276±12.038 and 30.434±13.63, indicating that the differences were not statistically significant (P> 0.05). In this study, we found 39 adverse events of 33 cases, but no severe adverse events. Test group had 22 adverse events of 18 cases, and 3 drug-related events of 3 cases. The control group had 15 adverse events of 15 cases, and 3 drug-related events of 3 cases, among whom all had mild diarrhea. In this trial,no serious adverse event was found.. In addition to these laboratory abnormalities treated as adverse events statistics, blood test, urine test, liver, renal function, ECG and other tests of other study subjects in the two groups showed no abnormal changes related to the test drug. ConclusionDrug-separated moxibustion at the navel for treatment of insomnia is a therapy with more security.fewer toxic and side effect than the oral drugs. That Patients received this treatment have no pain and good adaptability.It's a simply and convenient method, with the advantages of saving medical material, so It can be applied in clinical.
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