| Objective1.Through the randomized clinical trials,treating Parkinson’s disease patients with functional constipation by abdominal acupuncture,comparing with Maren soft capsules,to evaluate the clinical efficacy and safety of abdominal acupuncture in the treatment of Parkinson’s disease patients with functional constipation.2.Provide a repeatable quantitative treatment plan for abdominal acupuncture in the treatment of Parkinson’s disease patients with functional constipation,and form the clinical technical operation specification.MethodsSixty-eight Parkinson’s disease patients with mild to moderate functional constipation(TCM syndrome differentiation:Yin deficiency and intestinal dryness syndrome)who met the diagnostic criteria and inclusion criteria were selected from the Parkinson’s disease management center of Guangdong Province TCM Hospital.Based on the conventional treatment of traditional Chinese and western medicine,the subjects were randomly divided into the abdominal acupuncture group and the medicine control group with 34 cases for each.The abdominal acupuncture group were treated with abdominal acupuncture therapy,prescription:Yinqiguiyuan(Zhongwan RN4,Xiawan RN6,Qihai RN12,Guanyuan RN13),Tianshu ST25,Daheng SP15,30 minutes each time,every other day,3 times a week,continuous for 4 weeks,a total of 12 times of treatment for one course.The medicine control group were treated with Maren soft capsule,prescription:Maren soft capsule 0.6g-1.8g each time,once a day,continuous for 4 weeks,for one course.Before and after the treatment,the two groups of subjects need to fill in constipation symptoms scale,Chinese version Patient Assessment of Constipation Quality of life Scale(PAC-QOL)and part of the unified Parkinson’s Disease Rating Scale(UPDRS)Ⅲ to evaluate the clinical efficacy.The constipation symptom score is the main efficacy evaluation index,the PAC-QOL score and the UPDRSⅢ score are the secondary efficacy evaluation indicators.The follow-up was performed 4 weeks after the end of treatment,and the long-term efficacy of the two groups of subjects was evaluated using the constipation symptom score and the PAC-QOL score.At the end of the study,case data of all patients were collected and summarized,and SPSS 18.0 statistical software was used for statistical analysis.Results1.Comparison of baseline data between the two groups before treatmentIn the abdominal acupuncture group,there were 34 subjects,male to female ratio 15:19,mean age 65.29±7.79,course of disease 8.29±2.69,total score of constipation symptoms 9.35±2.20.In the medicine control group,there were 34 subjects,male and female ratio 18:16,mean age 65.62±8.09,course of disease 8.09±2.76,total score of constipation symptoms 9.20±2.07.There was no statistically significant difference in baseline data between the two groups(P>0.05).2.Main efficacy observation index:constipation symptom score2.1 constipation symptom score of the abdominal acupuncture groupAfter treatment,the total score of constipation symptoms and various scores(including defecation difficulty,fecal nature,frequency,defecation time,abdominal distension and falling down,not enough and feeling of distention and other accompanying symptoms)were statistically significant compared with those before treatment(P<0.05),and the total effective rate was 85.29%.In the one month follow-up,the total score of constipation symptoms and scores were statistically significant compared with those before treatment(P<0.05),and the long-term total effective rate was 82.36%.2.2 constipation symptom score of the medicine control groupAfter treatment,the total score of constipation symptoms and the scores of each item were statistically significant(P<0.05),and the total effective rate was 73.53%.In the one month follow-up,except for abdominal distension score,total constipation symptom score and other scores,the differences were statistically significant compared with those before treatment(P<0.05),and the long-term total effective rate was 55.88%.2.3 comparison of constipation symptom scores between the two groupsAfter treatment,the total score of constipation symptoms in the abdominal acupuncture group and the medicine control group was 4.00(2.00,5.00)and 5.00(2.00,7.25),respectively.There was no statistically significant difference in the total score of constipation symptoms between the two groups(P>0.05).In the one month follow-up,the total score of constipation symptoms in the abdominal acupuncture group and the medicine control group was 4.00(2.00,5.25)and 7.50(4.50,10.00),respectively,and the difference between the two groups was statistically significant(P<0.05).3.Secondary outcome:constipation patient quality of life scores(PAC-QOL score)and Parkinson’ s disease comprehensive assessment-part movement function score(UPDRS III score)3.1 PAC-QOL scoreIn the abdominal acupuncture group,the total scores of life quality after treatment and one month follow-up were 53.12±8.99 and 58.47±9.31,respectively,compared with 69.71±9.63 before treatment(P<0.05).In the medicine control group,the total scores of life quality after treatment and one month follow-up were 68.50(53.75,74.50)and 72.00(59.00,78.00),respectively,compared with 73.50(59.50,79.00)before treatment(P<0.05).3.2 comparison of PAC-QOL scores between the two groupsAfter treatment and one month follow-up,there were statistically significant differences in the total scores of quality of life between the two groups(P<0.05).3.3 UPDRS III scoreIn the abdominal acupuncture group,the UPDRS III score(31.44±5.62)after treatment compared with before treatment 36.00(32.00,39.25),the difference was statistically significant(P<0.05).In the medicine control group,the UPDRS III score(32.94+6.20)after treatment compared with before treatment(33.06+6.05),the difference was statistically significant(P<0.05).3.4 comparison of UPDRS III scores between the two groupsUPDRS III scores were compared between the two groups before and after treatment,and the difference was not statistically significant(P>0.05).Conclusion1.Abdominal acupuncture is effective in improving the symptoms of functional constipation in Parkinson’s disease.The short-term effect is similar to that of Maren Soft Capsule,and the long-term treatment is obviously better than that of Maren Soft Capsule.2.Abdominal acupuncture in the treatment of functional constipation of Parkinson’s disease has the advantages of safe operation,stable efficacy and no side effects compared with that of Maren soft capsule.3.Abdominal acupuncture treatment can effectively improve the quality of life of patients with functional constipation in Parkinson’s disease,and has a good long-term effect.4.Abdominal acupuncture is applied in the treatment of functional constipation in Parkinson’s disease,which has the advantages of stable and definite curative effect,safe operation,no side effects and stable long-term curative effect.Based on the quantifiable operation of abdominal acupuncture,standardized prescription and strong repeatability,it is suitable for grassroots application. |
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