| ObjectiveTo compare the difference of clinical curative effect between No.2 prescription of medicinal vesiculation in south of the Five Ridges and placebo in treating insomnia,so as to provide objective clinical reference of No.2 prescription of medicinal vesiculation in south of the Five Ridges for the treatment of insomnia.MethodsA multi-center randomized controlled trial was conducted.According to the proportion of 1:1:1,60 cases(180 cases in total)of insomnia patients who met the inclusion criteria were recruited from the Outpatient department of Guangdong Provincial Hospital of Chinese Medicine,Guangzhou Haizhu District Hospital of traditional Chinese Medicine,and Gaozhou Hospital of traditional Chinese Medicine,respectively.Furthermore,in accordance with the proportion of 1:1,included subjects in each center were randomly divided into the treatment group(30 cases)and the control group(30 cases).Eventually,there were 90 cases in the treatment group and 90 cases in the control group of the three research centers.Drug compositionIn the treatment group,patients received No.2 prescription of medicinal vesiculation in south of the Five Ridges.The prescription composited of drugs powder of medicinal vesiculation powder(semen brassicae,asarum,Euphorbia kansui,and Corydalis ambigua),Coptis chinensis and cinnamon,etc.,which were blended with ginger juice as ointment,with the weight ratio of powder and ginger juice at 3:4.The control group was given a placebo,which including buckwheat flour(coarseness determined with 18 mesh sieve),chestnut shell brown powder,monascus pigment powder and No.2 prescription of medicinal vesiculation in south of the Five Ridges(mixing in proportion of 6:3:1:1),which were then blended with diluted ginger juice as ointment,with the volume ratio of ginger juice and water at 1:10.Acupoint selection1.Feishu(bilateral),Xinshu(bilateral),Geshu(bilateral),Danshu(bilateral),Pishu(bilateral),and Shenshu(bilateral);2.Pohu(bilateral),Shentang(bilateral),Hunmen(bilateral),Yangkang(bilateral),Zhishi(bilateral),Shendao,and Mingmen.Acupoint selection in the treatment group was the same as that of the control group,and the above two sets of acupoints were used alternately.Acupoint positioning referred to the "Acupuncture and Moxibustion" listed in the national 11th-five planning textbooks for common higher education.ManipulationThe ointment was cut into blocks of 1cm×1cm×1cm in size with standardized mold for further usage.In the indoor environment of no less than 25?,included patient were informed to keep their sitting position to expose the acupoint for location.One piece of drug block was clamped by tweezers and applied in each acupoint,which was then fixed with a breathable rubber cloth with a diameter of 5cm.The application was lasted for 1h each time,and patients were reminded to get rid of on time.Course of treatmentThe treatment was performed 2 times a week with the interval time of 48-72 h for continuous treatment of 5 weeks.The course of treatment was 10 times.Evaluation of time points and indicatorsThe patients were evaluated before the treatment,at the end of the treatment and 1 month later during the follow-up.The Pittsburgh Sleep Quality Index(PSQI)and Athens Insomnia Scale(AIS)were used to observe intra-group and inter-group differences of curative effect at different time points.Meanwhile,adverse reactions and events were recorded whenever necessary in the course of the study Statistical analysisSPSS22.0 statistical analysis software was utilized to carry out statistical processing and analysis of the data.Suitable method of statistical analysis was determined according to the nature of clinical trial data(measurement and categorical data).Chi-square test or Fisher's exact test was used for categorical data.The measurement data were tested by test of normality and homogeneity test of variance firstly.For those who met the requirements,the mean was compared by t test and self-comparison adopted the paired t test.For those who did not meet the requirements,the mean was compared by was compared with Wilcoxon rank sum test,and Wilcoxon was used for self-comparison.The measurement date with skewed distribution employed Kruskal-Wallis non-parametric test.The difference of curative effect between the two groups was analyzed by covariance analysis and Meta analysis was used to analyze the difference of multi-center curative effect.The test level used for analysis was ?=0.05,namely,the difference was statistically significant when P<0.05.Results 1.Baseline characteristicsThere was no significant difference in baseline characteristics of age(P =0.594),course of disease(P=0.663),gender(P =0.545),educational level(P=0.667),PSQI score(P=0.099),and AIS score(P=0.174)between the two groups before treatment,indicating comparability between groups.2.PSQI scale scoring(1)Intra-group comparisonThere was a difference in the treatment group before treatment and at the end of the treatment(P<0.01),and the difference was also significant before treatment and 1 month later during the follow-up(P<0.01).Furthermore,obvious differences were detected in the control group before treatment when compared to that at the end of the treatment,as well as 1 month later during the follow-up(all P<0.01).(2)Inter-group comparisonThere was a difference between the treatment group and the control group at the end of the treatment(P<0.01),and the difference was significant.However,there was no difference between the treatment group and the control group 1 month later during the follow-up(P<0.01).The results showed that PSQI evaluation was significantly improved in the treatment group and the control group at the end of the treatment and 1 month later during the follow-up than that before the treatment.As for the improvement of PSQI score,the treatment group was better than that of the control group at the end of treatment,but the two groups showed no difference 1 month later during the follow-up.3.AIS scale scoring(1)Intra-group comparisonIn the treatment group,there were statistical differences in AIS score before treatment than that at the end of treatment and 1 month later during the follow-up(all P<0.01).Meanwhile,in the control group,statistical difference was also found before treatment when compared to that at the end of treatment and 1 month later during the follow-up(all P<0.01).(2)Inter-group comparisonThere was a difference between the treatment group and the control group at the end of the treatment and 1 month later during the follow-up(P<0.01),and the differences were all significant.The results showed that AIS evaluation was significantly improved in the treatment group and the control group at the end of the treatment and 1 month later during the follow-up than that before the treatment.As for the improvement of AIS score,the treatment group was better than that of the control group at the end of treatment and 1 month later during the follow-up.4.Effective rateAt the end of the treatment,the total effective rate was 74.7% and 19.5% in the treatment group and the control group,respectively,with significant statistical difference(P<0.01),suggesting that the curative effect of the treatment group was superior to that of the control group.Furthermore,the total effective rate was 39.8% and 10.4% in the treatment group and the control group 1 month later during the follow-up,respectively,and the difference was statistically significant(P<0.01),indicating better curative effect in the treatment group than that in the control group.5.Expulsion rateA total of 180 cases were recruited in this study,with 90 cases in each group.Seven cases were lost in the treatment group,and 13 cases in the control group.The total expulsion rate was 11.11%.6.SafetyIn the course of treatment,3 cases of local skin pruritus and 3 cases of colds appeared in the treatment group.Additionally,1 case of local skin pruritus were found in the control group.No serious adverse reaction occurred in other subjects during the treatment.ConclusionNo.2 prescription of medicinal vesiculation in south of the Five Ridges has a definite effect on insomnia,and it is better than placebo in improving PSQI,AIS score and curative effect.It is worthy of further study and clinical application. |
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