| ObjectiveTo evaluate the therapeutic effects and safty of the No.4 formula of crude herb moxibustion in south of the five ridges (No.4FCHMSFR) on improving the symptoms of mild-to-moderate depression, Comparing with the placebo.Methods60 cases consistent with the standard were recruited and ramdonly divided into 2 groups:the treatment group (40 cases) and the control group (20 cases). Both of the groups were the same acupoints’selections (two groups of alternating):(1)BL13、BL17、BL19、DU、DU12、RN6、RN12、ST24; (2) BL42. BL44、BL18、BL47、BL22、RN1、ST25., No.4FCHMSFR was used for the treatment group while the placebo was used for the control group under the same operating scheme:The two kinds of drugs were respectively made into a cube-sharp(1*1*1cm) drug blocks for the test before, and then the operator sticks the drug blocks on the selected acupoints for 1 hour. During the period, if the patients feel any discomfort, they can remove the drugs and record the treating time and the adverse reactions in the CRF.For both groups, the course of treatment provided twice a week are for 5 weeks, totally 10 times for each case.Hamilton Depresson seale(HAMD))and Burns depressive conditions checking table (BDC) would be expoited as the evaluation index on the assessment time spot of "treatment started", "treatment finished", "1 month follow-up after treatment" between and within two groups. At the same time,the adverse reactions should be recorded. All the data above would be collected and input to build a database for statistical analysis with the aid of spss software 18.0. According to the data types, different test will be choice to analyze:Chi-square test for the enumeration data, Rank-sum test or t-test for the description of the measurement data. " α=0.05" is the level of significance test.Results1.Design 60 of case:shed off 3 of the control group case(5%),pick 0 of case, valid 57of case.2. Baseline level comparison:the differences of two groups among ages, courses of depression, courses of previous treatment, HAMD and BDC scores before treatments are no significance. It showed that the cases in two groups were comparable.3. Hamilton Depresson scale (HAMD):①For the treatment group:On the assessment time spot of "treatment finished", "1 month follow-up after treatment", the HAMD reductions were (8.20±6.086), (8.68±6.240). When the above two reductions respectively compared with the score on "treatment started", the t value was-8.522,-8.792 while the p value was 0.000,0.000, which showed that the differences were remarkable statistically significant. ②For the control group:On the assessment time spot of "treatment finished" " 1 month follow-up after treatment", the HAMD reductions were (3.12±5.231), (3.82±4.838). When the above two reductions respectively compared with the score on treatment started", the t value was-2.457,-3.259 while the p value was 0.026,0.005, which showed that there were significant statistical differences. ③Comparison between two groups:In comparison of the HAMD reductions on the three different assessment time spots between the two groups, it got the result that the t value was 3.001,3.001 and the p value was 0.004,0.004. There was a significantly statistics difference between them and it meant the treatment group was better in lowering the HAMD score.4. Burns depressive conditions checking table (BDC): ①For the treatment group:On the assessment time spot of " treatment finished", " 1 month follow-up after treatment",the BDC reductions were (11.93±13.411), (14.25±13.148). When the above two reductions respectively compared with the score on "treatment started", the t value was-5.624,-6.855, while the p score was 0.000,0.000, which showed that there were remarkable statistically significant differences.②For the control group:On the assessment time spot of "treatment finished", "1 month follow-up after treatment", the BDC reductions were(2.65±6.575), (2.82±6.297).When the above two reductions respectively compared with the score on "treatment started", the t value was-1.660,-1.849 while the p score was 0.116,0.083, which showed that there were no significant statistical differences.③ Comparison between two groups:In comparison of the BDC reductions on the three different assessment time spots between the two groups, it got the result that the t value was 2.707,3.408 and the p value was 0.009,0.001. There were significantly statistics differences5. Efficacious rate:there are 40 cases in the treatment group, including 26 efficacious cases (HAMD score lowering rate≥25%) and 14 invalid cases (HAMD score lowering rate<25%).The efficacious rate was 65%. There are 17 cases in the control group,including 5 efficacious cases and 12 invalid cases. The efficacious rate was 29.41%. In comparison of the efficacious rate between this two groups, it got the result that the Z value was -2.291 and the p value was 0.024, which meant that the difference was statistically significant.6. There were 4 adverse reaction cases during the treatment, including 3 in the treatment group and 1 in the control group. All of the 4 cases apparred light allergic skin reactions, however, none of them were got shed off.ConclusionThe No.4 formula of crude herb moxibustion in south of the five ridges could lower the HAMD and BDC score of the cases with mild-to-moderate depression. Its efficacious rate is better than the placebo and the treatment is safe. |
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