| Objective:Objective evaluation on the recent and long term effect of electro-acupuncture treatment for female severe chronic constipation, by the comparative study on electro-acupuncture and Prucalopride Succinate tablets.Methods:40 female patients met the inclusion criteria were recruited and randomly divided into electro-acupuncture group and drug groups, each group of 20 people.1. EA groupSelection of points of bilateral Tianshu, Fujie, Shangjuxu. By subtraction with the disease in patients with symptoms, if the patients is accompanied by defecation effort, or need help defecation practices associated with poor stool, etc, add the Zhongliao points; if accompanied by anxiety and depression, add the Baihui and Shenting points.Operation:skin disinfection. Tianshu and Fujie points ued 2 to 3-inch stainless steel needle. After break the skin quickly, deep puncture slowly until the patients feel severe twinge while the doctor feel a sense of conflict tip. And then continue into the needle 0.2 to 0.3 cm basis, if the doctor feel a sense of a breakthrough, retreat 0.2cm, not to mention plug twirling. The electrodes are connected on the nee dle handle at Tianshu and Fujie pints. On Shangjuxu, used 1.5-inch needle, a slight lift and thrust twisting three times until the patients feel soreness. Do technique once every 10 minutes, a total of three times. Baihui and Shenting, with 2-inch needle into the back obliquely subgaleal 1.5 inch, row needle techniques and frequency the same as Shangjuxu points. Zhongliao points in acupuncture, the patients need to take the lateral position, use 3-inch needle in the third sacral foramen on the outside of about 0.5-lcm at the needle, inwardly down about 30-45°angle obliquely thorn 50-60mm. EA use dilatational wave, frequencies of 15/50Hz. The current intensity of Tianshu and Fujie points was 0. lma-1. Oma, Zhongliao points was 0.5ma-2. Oma. During treatment, each time the needle for half an hour, for 8 consecutive weeks, of which the first two weeks treatment five times a week, after six weeks treatment three times a week, one treatment every other day, a total of 28 times, after the end of treatment were followed for 24 weeks.2. the drug groupDrug selection Prucalopride Succinate tablets, before breakfast the patients taking 2mg, take 8 weeks of treatment and continue to take 24 weeks of follow-up period.3. Evaluation Index and period①CSBMs:the mean of average weekly CSBMs in baseline, after 6 weeks of treatment (3-8 weeks) and follow-up period of 24 weeks (11-12 weeks,15-16 weeks,19-20 weeks,31-32 weeks);SBMs:the mean of average weekly SBMs in baseline, after 6 weeks of treatment and follow-up period of 24 weeks;③ Stool character score in Bristol:the mean of average weekly stool rating in baseline, after 6 weeks of treatment;④Defecation difficulty score:the mean of average weekly defecation difficulty rating in baseline, after 6 weeks of treatment and follow-up period of 24 weeks;⑤The PAC-QOL scale (total score and four dimensions):the mean score of before treatment and after treatment; ⑥Effective rate:the percentage of the average weekly the number of cases CSBMs≥3 times in after six weeks of treatment and follow-up period of 24 weeks; During the study, adverse events were recorded at any time for safety evaluation.4.Statistical MethodsData analyzed by SPSS18.0. Metering data described by the mean±standard deviation, comparison between groups using independent t-test or rank sum test, intra-group comparison using paired t-test or rank sum test, count data using chi-square test.Results:1. The baseline dataThe difference was not statistically significant (P> 0.05) between the two groups education, occupation, age, weight, course of disease, defecation before the treatment, PAC-QOL scale scores, etc, indicating they had a comparability.2. Defecation situation(1)CSBMs:EA group in baseline, after 6 weeks of treatment and follow-up period of 24 weeks of the average about CSBMs were 0.10±0.26,2.69±2.04, 1.94±1.62, the drug group were 0.13±0.28,2.31±2.01,1.96±1.54.Intra-group comparison:There are increased of CSBMs which after 6 weeks of treatment and follow-up period of 24 weeks compared with baseline of two group, and the rate of increase were statistically significant (P=0.000). In the follow-up period of 24 weeks compared with after 6 weeks of treatment, differences in drug group was not statistically significant (P=0.139), EA group difference was statistically significant (P=000).Comparison between groups:after 6 weeks of treatment between the two groups was not statistically significant (P=0.639), follow-up period of 24 weeks between the two groups showed no significant difference (P=0.849).(2) SBMs:EA group in baseline, after 6 weeks of treatment and follow-up period of 24 weeks of the average about SBMs were 1.63±0.40,5.06±1.32,4.27 ±0.80, the drug group were 1.65±0.41,2.31±2.01,4.39±0.86.Intra-group comparison:There are increased of SBMs which after 6 weeks of treatment and follow-up period of 24 weeks compared with baseline of two group, and the rate of increase were statistically significant (P=0.000). In the follow-up period of 24 weeks compared with after 6 weeks of treatment, differences in drug group was not statistically significant (P=0.184), EA group difference was statistically significant (P=003).Comparison between groups:after 6 weeks of treatment between the two groups was not statistically significant (P=0.377), follow-up period of 24 weeks between the two groups showed no significant difference (P=0.661).(3) Stool character score in Bristol:EA group in baseline, after 6 weeks of treatment of the average about the stool character scores were 2.33±0.52, 3.22±0.48, the drug group were 2.41±0.75,3.37±0.0.83.Intra-group comparison:There are increased of stool character scores which after 6 weeks of treatment with baseline of two group, and the rate of increase were statistically significant (P=0.000).Comparison between groups:after 6 weeks of treatment between the two groups was not statistically significant (P=0.502).(4) Defecation difficulty score:EA group in baseline, after 6 weeks of treatment and follow-up period of 24 weeks of the average about defecation difficulty scores were 1.30±0.34,0.62±0.32,0.79±0.48, the drug group were 1.22±0.50,0.47±0.49,0.48±0.49.Intra-group comparison:There are decreased of defecation difficulty scores which after 6 weeks of treatment and follow-up period of 24 weeks compared with baseline of two group, and the rate of decrease were statistically significant (P=0.000). In the follow-up period of 24 weeks compared with after 6 weeks of treatment, the degree of defecation difficulty scores have rebounded, but the differences of two group was not statistically significant, in which the EA group P=0.426, the drug group P=0.546.Comparison between groups:after 6 weeks of treatment between the two groups was not statistically significant (P=0.193), follow-up period of 24 weeks between the two groups showed no significant difference (P=0.058).3. The PAC-QOL scale(1)Total:EA group before and after treatment total score were 94.94± 17.50,39.68±10.69, the drug group were 97.10±22.03,69.47±17.11.Intra-group comparison:There are decreased of total scores which before and after treatment compared with baseline of two group, and the rate of decrease were statistically significant (P=0.000).Comparison between groups:After treatment, there was statistically significant between the two groups (P=0.000).(2) The score of physical discomfort:EA group before and after treatment scores of physical discomfort were 13.31±3.03,5.21±1.31, the drug group were 12.78±3.58,9.00±2.66.Intra-group comparison:There are decreased of scores bout physical discomfort which before and after treatment compared with baseline of two group, and the rate of decrease were statistically significant (P=0.000).Comparison between groups:After treatment, there was statistically significant between the two groups (P=0.000).(3)The score of psychosocial discomfort:EA group before and after treatment scores of psychosocial discomfort were 23.57±7.52,10.47±2.63, the drug group were 24.42±9.66,18.42±5.34.Intra-group comparison:There are decreased of scores bout psychosocial discomfort which before and after treatment compared with baseline of two group, and the rate of decrease were statistically significant, in which the EA group P=0.000, the drug group P=0.005.Comparison between groups:After treatment, there was statistically significant between the two groups (P=0.000).(4) The score of anxiety:EA group before and after treatment scores of anxiety were 36.00±8.01,14.68±4.55, the drug group were 38.57±9.75, 27.21±6.72.Intra-group comparison:There are decreased of score bout anxiety which before and after treatment compared with baseline of two group, and the rate of decrease were statistically significant (P=0.000).Comparison between groups:After treatment, there was statistically significant between the two groups (P=0.000).(5) Satisfaction:EA group before and after treatment satisfaction were 22.05±2.61,9.36±3.18, the drug group were 22.00±2.56,14.68±4.59.Intra-group comparison:There are decreased of score bout satisfaction which before and after treatment compared with baseline of two group, and the rate of decrease were statistically significant (P=0.000).Comparison between groups:After treatment, there was statistically significant between the two groups (P=0.000).4. Effective rateEA group’s effective rate in treatment period was 42.10%, in follow-up period was 36.84%; The drug group’s effective rate in treatment period was 31.57%, in follow-up period was 31.57%。Intra-group comparison:after 6 weeks of treatment between the two groups was not statistically significant (P=0.737), follow-up period of 24 weeks between the two groups showed no significant difference (P= P=1.000).Conclusion:1. Electro-acupuncture has the same efficacy as Prucalopride Succinate tablets in increase the number of CSBMs and SBMs, improve fecal character and reduce the degree of difficulty of defecation, and electro-acupuncture has a long-term effect, for 24 weeks.2. In improving the quality of life(include total, physical discomfort, psychosocial discomfort, anxiety and satisfaction), electro-acupuncture is better than the Prucalopride Succinate tablets. |
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