| ObjectiveTo analyze the efficacy and security of the Lingnan Traditional Tianjiu prescription No.2.MethodThe random controlled method was applied, and 180 patients conformed to the diagnostic criteria were allocated as a ratio of 1:1:1 into three groups: treatment group, control group 1 and control group 2.The treatment group applied Lingnan Traditional Tianjiu prescription No.2, control group 1 applied Lingnan Traditional Tianjiu prescription No.1, and the control group 2 applied placebo. All the acupoints were selected from the following two groups of acupoints alternately, and each acupoint was selected on both sides:Φ Fei shu (both), Xin shu (both), Ge shu (both), Dan shu (both) and Pi shu (both),Shen shu (both); (?) Po Hu (both), Shen tang (both), Hun men(both), Yang gang(both), Zhi shi(both), Shen dao(both), Ming men(both).Lingnan Traditional Tianjiu prescription No.2 consists of berberine, cinnamon, evodia, yellow mustard, provided by the Guangdong Provincial Hospital Pharmacy which made the powder into 80 mesh size uniformly mixed. Reconcile the ginger and the powder above into a cream powder (powder and ginger weight ratio of 3:4), and cut into about 1cm×1cm×1cm-sized drug cake, not at less than 25 degrees Celsius in the room the patient sitting, put the drug cake onto the ventilation tape (5cm×5cm) and affix it to the acupoint, tear off them by subjects themselvs after enough time.Lingnan Traditional Tianjiu prescription No.1 consists of mustard seed, asarum, euphorbia, fumaric et all, provided by the Guangdong Provincial Hospital Pharmacy which made the powder into 80 mesh size uniformly mixed. Then proceeded as the treatment group.Placebo (buckwheat flour mixed with chestnut shell pigment powder, red yeast rice powder and Lingnan Traditional Tianjiu prescription No.2 powder on a ratio of 6:3:1:1).The duration of each fixation was 1.5h. Treatments were provided twice a week for a total of 10 times in 5 weeks (1 treatment course) and the interval of every two therapies was no less than 48 hours.Efficacy evaluation:PHQ-9 scale and PSQI scale were adopted as the indexes of efficacy evaluation; adverse reactions and side effects occurred at any time during the study were recorded, and SPSS 19.0 statistical software was applied to build a database for statistical analysis.Result1.Baseline comparison:The differences of gender composition, age and course of disease in three groups were not statistically significant (P=0.091,0.089 and 0.199, respectively); Score of PHQ-9 scale, score of PSQI scale in patients of three groups were equivalent (P=0.888 and 0.516, respectively), indicating that the three groups were consistent at baseline level with comparability. Before treatment, there is no statistic significance among the three groups in gender, age, disease duration.2. PSQI scale score:Treatment group:Before treatment group, at the sixth treatment, at the end of the treatment, after a month of the treatment, PSQI Scale scores were:13.51± 3.66,11.33 ± 4.25,10.63 ± 4.33,10.57+4.56;by ITT analysis, after treatment, P=0.000,0.000,0.000, suggesting that the difference was statistically significant.Control group 1:Before treatment group, at the sixth treatment, at the end of the treatment, after a month of the treatment, PSQI Scale scores were:13.18±3.15,10.69± 3.94,10.22±4.30,9.98± 4.86; by ITT analysis, after treatment, P= 0.000,0.000,0.000, suggesting that the difference was statistically significant.Control group 2:Before treatment group, at the sixth treatment, at the end of the treatment, after a month of the treatment, PSQI Scale scores were:13.26±3.51,11.49± 4.44,10.46±4.90,10.85±4.91; by ITT analysis, after treatment,P= 0.000,0.000,0.000, suggesting that the difference was statistically significant.Through ANOVA analysis, AIS scale total scores of three groups among each time point were not significantly different, P=0.888,0.646,0.906,0.690.3.AIS scale score:Treatment group:Before treatment group, at the sixth treatment, at the end of the treatment, after a month of the treatment, PSQI Scale scores were:12.51±3.79,10.12±3.96,9.98±4.35,9.82±4.46; by ITT analysis, after treatment, P=0.000,0.000,0.000, suggesting that the difference was statistically significant.Control group 1:Before treatment group, at the sixth treatment, at the end of the treatment, after a month of the treatment, PSQI Scale scores were:12.91±3.92,9.78± 4.38,8.91±4.87,9.38±4.82; by ITT analysis, after treatment,P= 0.000,0.000,0.000, suggesting that the difference was statistically significant.Control group 2:Before treatment group, at the sixth treatment, at the end of the treatment, after a month of the treatment, PSQI Scale scores were:13.51±4.52,11.31± 5.43,10.31±5.56,11.00±6.12; by ITT analysis, after treatment,P= 0.000,0.000,0.000, suggesting that the difference was statistically significant.Through ANOVA analysis, AIS scale total scores of three groups among each time point were not significantly different, P=0.516,0.285,0.385,0.333.4. Effective rate comparisonThe total effective rate of treatment group was 84.5%, the control group 1 was 76.9%; control group 2 was 56.8%. Three simultaneous Kruscal-Wallis test for independent samples with a significant difference (P=0.039). Through lower a value pairwise comparison:the treatment group and the control efficacy of the two groups was significant difference (P=0.014) Comparative independent samples Mann-Whitney U test, there was no significant difference (P=0.717) between treatment group and control group 1 and no significant difference between the control group 1 and the control gourp 2 (P=0.056).According to the results of the effect of the cases which finished all the course, treatment group got the best and control group followed, placebo group was at the bottom. Through independent samples test, there was a significant difference (P=0.039<0.05) among the three groups. By independent samples test, there was a significant difference (P=0.014<0.017)5. SecurityThere were no serious adverse reactions during the treatment of each group.ConclusionThe twice formula of traditional Lingnan natural moxibustion, Tianjiu bulk and placebo are all effective. However, the twice formula of traditional Lingnan natural moxibustion is superior to placebo significantly. |
PDF Full Text Request