| Objectives:1. To conduct systematic review on previous literatures, so as to look for an evidence-based support on the treatment of constipation with moxibustion.2. To conduct clinical randomized controlled studies on the treatment of chronic functional constipation, and to compare the treatment results of the Treatment Group (treated with Lingnan Chuantong Tianjiu Formula No.5), Control Group 1 (treated with Prucalopride) and Control Group 2 (treated with Tianjiu Powder); to value the curative effects of Lingnan Traditional Tianjiu Formula No.5 on the treatment of chronic functional constipation, and to widen the spectrum of Tianjiu-treated illnesses.Research Contents and Methods:3. Literature evaluationTo undergo quality assessment of those randomized controlled trials and meta-analysis on the treatment of constipation with moxibustion prior March 2015; to evaluate objectively the clinical efficacy of treatment of constipation with moxibustion; to explore any current research problem and speculate the progress of future research. The database being applied for data searching including PubMed, Chinese Biomedical Literature Database, Chinese Academic Journal, VIP network and Wanfang Data Resource System.By applying NoteExpress 3.0.2 to maintain a database management system, then through the reading the text title, abstract and full text to scrutinize related randomized controlled literatures for conducting systematic evaluation and meta-analysis.2. Clinical Research90 chronic functional constipation patients whose situation were met with the criteria of research were selected in accordance with their registration sequence numbers to randomly be divided into different groups by using of SPSS13.0, i.e. Treatment Group (treated with Lingnan Traditional Tianjiu Formula No.5), Control Group 1 (treated with Prucalopride) and Control Group 2 (treated with Tianjiu Powder), there were 30 patients in each group.Treatment Group:Using Lingnan Traditional Tianjiu Formula No.5 to undergo Tanjiu application. To select two groups of acupoints alternately, First Group:Tian Shu (double), Fu Jie (double), Fe Shu (double), Da Chang Shu (double), Ges Hu (double), Shang Ju Xu (double); Second Group:Da Heng (double), Hua Rou Men (double), the Da Ju (double), Hun Men (double), Gan Shu (double), shen Shu (double). To perform treatment twice a week, every two days, in total there were 10 times of treatment in a 5-week duration.Control Group 1:Administering of Prucalopride Succinate Tablets (Italy Janssen SPA) orally 2mg every morning before breakfast, once daily for 5 weeks continuously;Control Group 2:Applying Tianjiu Power (manufactured by Guangdong Provincial Hospital) to perform Tianjiu application which the acupoints and schedule were identical to the Treatment Group.Subjected patients were interviewed respectively during the baseline period, the 4th-5th week of treatment period and the 3rd-4th week of interviewing period. They were also requested to fill in the "Diary Bowel Movement Card" with details liked difficulties with defecation, wholly self-depend defecation, Bristol stool scale, etc., in order to evaluate the result of various treatments given to the subjected patients.Also during the pre-treatment period, post-treatment period and the randomly -interview period, the subjects should fill in the patient Assessment of Constipation Quality of Life questions (PAC-QOL), in order to understand the impact and changes of life quality of the subjected patients. By collecting the data and being analyzed with SPSS18.0 for the results.Results:1. Literature System EvaluationIn accordance with the searching strategy and data collection methods, 311 pieces of literatures were found, Among them,261 literatures were excluded by applying Noteexpress; After reading all the full texts, another 37 literatures were excluded, Finally, there were only 13 literature were screened and met the criteria. There were all together 1,088 patients and all literatures were published in Chinese language. The total efficiency of 13 trials were included, the heterogeneity test among various research (P<0.00001, 12=24%), by adopting the fixed effect model and subgroup analyzes, the results between the Treatment Group and Control Groups were of statistically significant difference [OR=7.01,95% CI (4.76,10.23)] i.e. the result of the Treatment Group was better than the Control Groups.Symptoms scores were included in two trials, there are five different symptoms in this part, the heterogeneity test among various research are very high.By adopting the fixed effect model.With the Meta analyzes, result of the Treatment Group was better than the Control Group.2. Clinical Research(1) Baseline dataBefore receiving treatment, the general information liked age, occupation, gender, illness duration, and treatment history, etc. were tendered for the chi-square test on analysis of variance, comparison between their differences was not statistically significant (P>0.05); the difference between comparison of self-controlled defecation, their PAC-QOL Score,SCBM, difficulty of defecation of the patients one week before receiving treatment was not statistically significant (P>0.05);(2) The proportion of subjected patients with SCBMs= 3 timesAfter five weeks of treatment, the proportion of subjected patients with SCBMs≥3 times, SCBMs≥3 times:82.76%in the Treatment Group,57.14% in the Control Group 1, and 30% in the Control Group 2, the chi-square test x2 =10.5628, P=0.005<0.05, it was indicated that the proportion of patients of Treatment Group with SCBMs ≥ 3 times was significantly higher than those of Control Group 1 & 2.(3) Stool Bristol ScoresThe Stool Bristol Score after treatments:There were 3.14 ± 1.57 in the Treatment Group; 3.25 ± 1.06 in the Control Group 1 and 2.51 ± 0.93 in Control Group 2. With statistical analysis, the difference of Stool Nature Score between all 3 groups were very small (x2=3.605, P-0.1648> 0.05), it was indicated that the improvement of the nature of stool, all subject patients of the Treatment Group and the two Control Groups were of effective result.(4) The Degree of Difficulty of DefecationComparison within Group:for the Treatment Group, the degree of difficulty of defecation before and after treatment was of statistically significant difference (P=0.0000), it was depicted that the Lingnan Traditional Tianjiu Formula No.5 could reduce the degree of difficulty of defecation of the patients; For Control Group 1, the degree of difficulty of defecation before and after treatment was of statistically significant difference (P=0.0001), it was shown that Prucalopride could significantly reduce the degree of difficulty of defecation of the subjected patients; For Control Group 2, the degree of difficulty of defecation before and after treatment, it had no statistically significant difference (P=0.0505), P value at critical line and was indicated that Tianjiu Power might not be possible to reduce the degree of difficulty of defecation of the patients.Comparison between Groups:to conduct analysis of variance on the degree of difficulty of defecation of three groups were of statistically significantly difference (F=6.62, P= 0.00<0.005), it was depicted that there were difference between the degree of difficulty of Defecation between 3 groups, The result of the Treatment Group and Control Group 1 and better than the Control Group(5) PAC-QOL scoresComparison within Group:the PAC-QOL of the Treatment Group was of statistically significantly different (P=0.0017<0.05), it was depicted that the Lingnan Traditional Tianjiu Formula No.5 could improve the quality of life of the patients; the PAC-QOL scores of Control Group 1 was of statistically significantly different (P= 0.0000<0.05), it was shown that Prucalopride could improve the quality of life of the patients; the PAC-QOL scores of Control Group 2 of the PAC-QOL score was not statistically significantly different (P=0.2649> 0.05), it was indicated that that Tianjiu Power could not effectively improve the quality of life of the patients.Comparison between Groups:to conduct analysis of variance among the three groups (F=7.93, P= 0.00<0.005) it was indicated that there were significant different between the PAC-QOL scores before and after treatment.(6) The Total EfficiencyThe total efficiency after treatment, it was 82.76% in Treatment Group, 64.29% in Control Group 1,36.70%, in Control Group 2. With statistical comparison(χ2=9.8268, P=0.007), the total efficiency of all three groups were of statistically significant difference, The result of the Treatment Group might be better than that of the Control Group 1 & Control Group 2.The total efficiency after 1 month without treatment:62.76% in the Treatment Group; 35.72% in Control Group 1; 16.67% in Control Group 2, the comparison among the three groups were differnce, the chi-square test group (χ2=10.0297, P=0.007<0.05), The Short-Term effect of the Treatment Group was better than that of the Control Group 1 & Control Group 2.(7) Evaluation on the acceptances of the patientsThere were 29 patients being treated in Treatment Group and there were 3 patients showing little difficulty in accepting treatment; 30 patients being treated in Control Group 2, and there were4patients showing little difficulty in accepting treatment. The acceptance of the patients of Treatment Group and Control Group 2 were compared (χ2=0.0123, P=0.548> 0.05), both groups of patients on the acceptance of Tianjiu showing no statistically significant difference..(8) Adverse Events, Loss, discontinue of treatmentDuring observation process, there were 2 adverse events. There was 1 patient from Treatment Group who forgot to peel off the medication, and both Ge Shu were blistering; also there was 1 patient had mild skin allergies. Due to incomplete data, there were 2 cases in Control Group 1 were loss; and there was 1 patient from the Treatment Group who regarded that the result was not satisfaction and terminated the treatment.Conclusion:1.With the Meta-analysis of the literature, it was considered that for the treatment of constipation, either moxibustion or moxibustion with other therapeuticremedies were better than that of western medicine Group.2. This clinical study and research also showing that the Lingnan Traditional Tianjiu Formula No.5 could effectively improve chronic and symptoms and quality of life in patients with chronic functional illness.3. The clinical trials and research indicated that the Lingnan Traditional Tianjiu Formula No.5 could improve the nature of stool of the patients effectively; we look forward to having a much large scale studies and more advance methodological qualitative randomized clinical research to verify that the Lingnan Chuantong Tianjiu Formula No.5 could influence the nature of the stool. |
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