| ObjectiveObjectively evaluate the difference between the efficacy of acupuncture and non-acupoint shallow acupuncture on CP/CPPS by randomized controlled clinical study.Methods(1)Case source50 cases of CP/CPPS who met the inclusion criteria were enrolled in the acupuncture department of Guangdong Hospital of Traditional Chinese Medical.(2)Randomization,grouping and blindingThe patients were divided into acupuncture group and non-acupoint shallow acupuncture group by the simple randomization according to the proportion of 1:1,each group had 25 cases,blinding evaluators and data analysts.(3)TreatmentPatients in acupuncture group were acupunctured with BL23、BL33、BL35、SP6.After routine disinfection,the 0.3mm X 40mm needles were inserted at the BL23 and SP6 for 20 to 30mm,and the 0.3mm X 75mm needles were inserted at the BL33 and BL35 for 50 to 70mm.Needles were retained for 30 minutes.Patients in non-acupoint shallow acupuncture group were acupunctured with beside BL23、BL33、BL35 2cm,and the non-point of SP6 is located in the back of SP6 intersection,the middle point of spleen channel and kidney channel.The method of needles’ inserting was the same as that of acupuncture group,and the needles were inserted shallowly into the acupoints for only 2 or 3mm,retained for 30 minutes.(4)Treatments and follow-upThe case information collected by Excel 2010 was imported into SPSS 22.0 statistical software to establish the analysis database and complete the statistical analysis of the data.Treatments were for 8 weeks,three times a week for the first four weeks and the interval of each treatment was 1 day,and twice a week for the last four weeks and the interval of each treatment was 2 or 3 days.The follow-up period was 24 weeks.(5)Main outcome indicators and evaluation pointsNIH-CPSI scale was used as the main outcome indicators.HANDS scale,maximum urine flow rate and average urine flow rate were used as the secondary outcome indicators.During the study,adverse reactions and side effects were recorded.A total of 4 evaluation points were set,namely,before the treatment,after the treatment,12 weeks after the treatment,and 24 weeks after the treatment.(6)Statistical methodThe case information collected by Excel 2010 was imported into SPSS 22.0 statistical software to establish the analysis database and to complete the statistical analysis of the data.Kolmogorov-Smirnov method and Levene method are used for normal test and variance homogeneity test.Measurement data,which conforms to normal distribution,is expressed by mean and standard deviation.Single factor ANOVA of variance or independent sample t-test is used for inter group comparison,and the p-value corrected by Bonferroni method is used for the comparison between the two groups.The measurement data that does not conform to normal distribution is expressed by median and quartile.Kruskal-Wallis test or Mann-Whitney U test is used for comparison between groups,and the p-value corrected by Dunnett’s method is used for pairwise comparison.Composition ratio and frequency are used to describe the distribution law of dichotomous data,and chi-square test and exact Fisher test are used for comparison between groups.NIH-CPSI score,HADS score,mean urinary flow rate and maximum urinary flow rate are compared between the two groups at different time points using repeated measures analysis of variance-generalized linear model equation.It is statistically significant when P<0.05.Result46 patients were involved in this trial(6 were free study),among which 22 patients were in the acupuncture group and 24 were in the non-acupoint shallow acupuncture group.(1)Baseline comparison:Baseline information of the patients such as age,duration,daily sedentary time,addiction to smoking and drinking has no difference,hence the groups are comparable.(2)NIH-CPSIComparison within groups:NIH-CPSI after the treatments,12 weeks after the treatments and 24 weeks after the treatments was lower than that before the treatments both in two groups.P<0.05).Comparison among groups:NIH-CPSI after the treatments,12 weeks after the treatments and 24 weeks after the treatments was a significant difference between the two groups(P=0.006<0.01),and the median of NIH-CPSI in acupuncture group was lower than that of non-acupoint shallow acupuncture group at three time points after treatment.The results showed that NIH-CPSI after the treatments,12 weeks after the treatments and 24 weeks after the treatments both in two groups were lower than that before the treatments(P<0.05).The therapeutic effect of acupuncture group was better than that of non-acupoint shallow acupuncture group.(3)HANDSComparison within groups:After the treatments and 12 weeks after the treatments,HANDS of the patient from both groups was significantly decreased(P<0.05),but no obvious effect as time went on to 24 weeks after the treatments both in two groups P>0.05).Comparison among groups:There was no significant difference in HADS between the two groups after the treatments,12 weeks after the treatments and 24 weeks after the treatments.The results showed that after the treatments and 12 weeks after the treatments,HANDS of the patient from both groups was significantly decreased,but no obvious effect as time went on to 24 weeks after the treatments both in two groups.There was no difference between the treatment effect of two groups at three time points after treatment.(4)Average urine flow rateComparison within groups:The average urine flow rate was higher after the treatments(P<0.05)but as time went on to 12 weeks after the treatments,it was the same with that before the treatment both in two groups(P>0.05).Comparison among groups:There was no significant difference in the average urine flow rate between the two groups after treatments,12 weeks after treatment(P>0.05).The results showed that the average urine flow rate was higher after the treatments both in two groups(P<0.05),but as time went on to 12 weeks after the treatments,it was the same with that before the treatment(P>0.05).There was no difference between the treatment effect of two groups at two time points after treatment.(5)Maximum urine flow rateComparison within groups:The maximum urine flow rate was higher after the treatments(P<0.05)but as time went on to 12 weeks after the treatments,it was the same with that before the treatment both in two groups(P<0.05).Comparison among groups:There was no significant difference in the maximum urine flow rate between the two groups after treatments,12 weeks after treatments(P>0.05).The results showed that the maximum urine flow rate was higher after the treatments both in two groups(P<0.05),but as time went on to 12 weeks after the treatments,it was the same with that before the treatment(P>0.05).There was no difference between the treatment effect of two groups at two time points after treatment.(6)Curative effectAfter the treatments,the total effective rate of acupuncture group was 95.5%and that of non-acupoint shallow acupuncture group was 41.7%,and There was significant difference between the two groups(P<0.05).12 weeks after the treatments,the total effective rate of acupuncture group was 86.3%and that of non-acupoint shallow acupuncture group was 29.2%,and there was significant difference between the two groups(P<0.05).24 weeks after the treatments,the total effective rate of acupuncture group was 86.4%and that of non-acupoint shallow acupuncture group was 20.8%,and there was significant difference between the two groups(P<0.05).The data above showed that the total effective rate of acupuncture group was higher than that of non-acupoint shallow acupuncture group at three time points after treatment,and there were significant differences.(7)Safety comparisonNo adverse event happened during this study.ConclusionThe acupuncture and non-acupoint shallow acupuncture can decrease the NIH-CPSI and the HANDS,raise the average urine flow rate and the maximum urine flow rate,improve the clinical symptoms of the patients.Comparing with non-acupoint shallow acupuncture,the acupuncture can lower the NIH-CPSI more effectively,which can last for 24 weeks. |
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