| Part 1 Evaluation of the Guidelines on its Clinical ApplicabilityObjective Through the clinical observation by finishing patients with diarrhea treatment program, and efficacy,economic evaluation, comparison with Guidelines for Diagnosis and Treatment of Common Internal Diseases in Chinese Medicine Symptoms in Chinese Medicine, to evaluate the guidelines on the clinical applicability.Methods 63 outpatient or inpatient with diarrhea Collected from February 2014 to June 2014 in gastroenterology dept. of Teaching Hospital of Chengdu University of Traditional Chinese medicine (T.C.M).Collecting clinical data to get its diagnosis, differentiation of syndromes,principle-method-recipe-medicines,the efficacy and economic evaluation, the related data was input Excel for statistical classification, comprehensive analysis, summarized in diarrhea treatment law and contrast the applicability of the treatment guidelines.Results1.63 patients with diarrhea including 57 outpatients (90.48%) and 6 inpatients (9.52%),the male to female ratio was about 1.42:1.The age distribution were from 30 to 44 years of age accounted for 38.1%, from 45 to 59 years of age accounted for 23.81%.2. Comparing with the Guidelines, coincidence rate of Chinese disease diagnosis was 49.21%(31 cases), probability of relative coincidence was 44.44%(28 cases), and coincidence rate of Western diagnostic was 12.7%(8 cases), probability of relative coincidence was 71.43%(45 cases), and coincidence rate of differentiation of syndromes was 12.7%(8 cases), probability of relative coincidence was 84.13%(53 cases).There was no one meeting the evaluation.3. Comparing with the Guidelines, coincidence rate of the rules of treatment was 11.11%(7 cases),probability of relative coincidence was 80.95%(51 cases).and coincidence rate of prescription was 11.11%(7 cases),probability of relative coincidence was 79.37%(50 cases),and coincidence rate of medicinal composition was 4.76%(3 cases),probability of relative coincidence was 76.19%(48 cases).coincidence rate of the rules of other treatment methods was 15.87%(10 cases),probability of relative coincidence was 60.32%(38 cases),and coincidence rate of maintain and prevention was 65.08%(41 cases),probability of relative coincidence was 15.87%(10 cases).There was no one meeting the evaluation.4. The treatment time distribution:The shortest duration of treatment was 3 days, the longest 37 days, and average 7.49 days. The duration of treatment≤ 7 days accounted for the largest proportion (85.71%, 54cases),the second was from 8 days to 14 days(12.7%,8cases).5. The clinical efficacy distributed as follows:16 cases (25.39%) were cured; the obvious effect was 43 cases (68.25%); the effectiveness was 4 cases (6.35%), ineffectiveness was 0 cases. The rate of cured and effective was 93.64%, and the total effective rate was 100%.6. This clinic security program distributed as follows:of well 31 cases (49.21%), good in 27 cases (42.86%).To evaluate the economy:well 17 cases (26.98%), good in 45 cases (71.43%). There were no poor cases.Conclusions By observing the treatment process and treatment evaluation of clinical cases, the Guidelines were suitable for clinical application. The rate of coincidence and probability of relative coincidence were more than 70%. And we recommended the Guidelines to pay attention to the flexibility on differentiation and complexity on the pattern of syndrome both, choose recipes on treatment comprehensively to reflect dynamic differentiation.Part 2 The Meta-analysisObjective Using evidence-based medicine, we did a Meta-analysis to assess the effectiveness and safety of Chinese medicine in the treatment of diarrhea.Methods According to the search strategy, we searched Pubmed,Cochrane library, China national knowledge infrastructure (CNKI),VIP Chinese Science and Technology Academic Journal database (VIP) and Wan fang dissertations database from inception to December 31,2014.According to the inclusion and exclusion criteria to select qualified researchs,two reviewers independently extracted data. The quality of include randomized controlled trials (RCTs) was evaluated according to the Cochrane Handbook 5.1.0 and RevMan5.3 was used for meta-analysis and gotten bias analysis by Stata 12.0.Results1. We collected 21 titles on Chinese medicine for diarrhea (2479 diarrhea patients),19 in Chinese and 2 in English. The methodological quality was medium.2. Results of Meta-analysis showed that there was a statistical difference between the TCM treatment group and control group on rate of cured and effective, total effective rate, the effective rate on Chinese medical, microscopic pathology with relative risk(RR) 1.89,95% confidence interval(CI)1.69 to 2.13 and P< 0.0001,RR1.29[95%CI 1.18 to 1.41]P<0.0001,RR1.40[95%CI 1.10 to 1.78]P=0.006 and RR1.43 [95%CI 1.19 to 1.71] P=0.0001.And no statistical difference was detected between the two groups on the changes of endoscopic features with RR1.11[95%CI 0.92 to 1.35]P= 0.28.There was a statistical difference between the TCM treatment group and control group on Chinese medical syndromes cores, delaying the recrudescent duration in symptoms with weight mean difference (WMD)-1.09[95%CI-3.55 to-0.46]P=0.01 and WMD5.30[95%CI 1.99 to 9.61]P=0.02.There was no statistical difference between two groups on the activity index with WMD-0.66[95%CI-1.55 to 0.23]P=0.15.3.14 RCTs done the safety evaluation, and 8 of those have no adverse effects and 6 have adverse effects. There was no significant difference between the TCM and control group on adverse events with RR0.49[95%CI 0.13 to 1,95]P= 0.31.4. The sensitivity analysis showed results of Meta-analysis about rate of cured and effective, total effective rate, changes of endoscopic featuresis, microscopic pathology, activity index, delaying the recrudescent duration in symptoms and safety evaluation were believable, and results of Meta-analysis about the effective rate on Chinese medical and Chinese medical svndromes cores were in doubt.5. The bias analysis showed us that the Begg’s test and Egger’s test showed there was publication bias.Conclusions The TCM treatment group was superior to control group on rate of cured and effective, total effective rate, the effective rate on Chinese medical, microscopic pathology, Chinese medical syndromes cores and delaying the recrudescent duration in symptoms. There was no significant difference between the TCM, control group on the changes of endoscopic features and safety evaluation. But the quality of included trials was medium, and there was publication bias about the trials, so we need to do more high quality clinical research to further explore the curative effect and safety of the treatment of diarrhea with TCM. |
PDF Full Text Request