Evaluation Of Clinical Efficacy Of TCM - Based Therapy For Coronary Heart Disease With Angina Pectoris Based On Evidence - Based Medicine

Purpose:This study was to evaluate the efficacy and safety of traditional Chinese treatments including sticking application, acupuncture and moxibustion which treat coronary heart disease in the principle of evidence-based medicine. It aimed to provide basic evidence for clinical decision of traditional treatments of coronary heart disease by means of Meta analysis.More important, the current situation and existing problems of evidence-based medicine were analyzed in the aim of improving quality of traditional Chinese clinical research.Method:1. Three most widely used traditional treatments of coronary heart disease including sticking application, acupuncture and moxibustion were chosen as the breakthrough point.The relative inclusion criteria and exclusion criteria of the documents were systematically set.2. According to the relative methods and principles of evidence-based medicine,Cochrane system assessment method was applied. A systematic search of Pubmed, Embase,Cochrane Library, China Biology Medicine Literature Database(CBMdisk), China National Knowledge Internet(CNKI) database, Wanfang Database was performed up to January, 2014.The study followed up the relative literatures that may possibly be included in the references of the relative papers or summaries.3. The title, the relative literature abstract and the whole article were screened according to the preset inclusion and exclusion criteria to confirm the final clinical research. According to the predesigned forms, materials were abstracted from the original literatures, including general features, intervening methods, outcome indicators and other relative data.Meanwhile, the bias risk assessment tool provided by Cochrane Reviewer’s Handbook was applied to evaluate research quality, including sequence generation, allocation sequence concealment, blinding, incomplete outcome data, selective outcome reporting and other potential sources of bias.4. Meta analysis and systematic reviewBased on material extract table, Meta analysis was performed by means of RevMan5.2software. The study applied RR or OR, MD or SMD and 95%CI as curative effect analysis statistical magnitude. By means of heterogeneity analysis, if P<0.1 or I2>50%, there existed statistics heterogeneity, and we may find out the source of heterogeneity and make further subgroup analysis according to clinical isotropy. Fixed model was chosen for the Meta analysis in the case of non-statistics heterogeneity, contrarily random model.5. Problems of the clinical trials were analyzed, which were the foundation of evidence-based research of TCM. These problems included random method, blind method,contrast, homogeneity of clinical research, selection of samples, conclusion analysis, safety evaluation, long-term follow-up and features of TCM researches.Results:1. In the systematic review of curative effect and safety of sticking application treatment for angina patients, 16 studies involved 1335 patients met the inclusion criteria and were included in this meta-analysis. The results showed that compared with control group, routine western medication treatment along with sticking application therapy can obviously improve symptoms of angina and electrocardiogram, and reduce dosage of nitroglycerin. Furthermore the therapy can improve the life quality of patients and reduce blood fat, the content of CRP,CD40 L, and ET with no obvious side effect.2. In the systematic review of curative effect and safety of acupuncture treatment for angina patients, 11 studies involved 1232 patients met the inclusion criteria and were included in this meta-analysis. The results showed that compared with control group, routine western medication treatment along with acupuncture therapy can obviously improve symptoms and electrocardiogram, and reduce dosage of nitroglycerin. It can reduce the content of CRP,MDA, LPO, ET and increase SOD and NO content. Also the therapy can reduce the occurrence rate of cardiovascular event with no obvious side effect.3. In the systematic review of curative effect and safety of moxibustion treatment for angina patients, 13 studies involved 1318 patients met the inclusion criteria and were included in this meta-analysis. The results showed that compared with control group, the symptoms of angina and electrocardiogram of treatment group improved, and it was much better than the compared group on blood fat regulation.4. There are still some problems existing among TCM clinical trial researches, including undefined and unscientific random methods,less usage of blind method,lack of placebo for the control group,large difference between inclusion criteria of the same kind of research, as well as the exclusion criteria and intervening measures,insufficient samples, not making ITTdata and PP data analysis in the same time, lack of safety evaluations, rare design of long-term research in the clinical trial so that the forward clinical effect is unknown, neglect of theoretical frame of TCM.Conclusion:1. TCM treatment methods of sticking application, acupuncture and moxibustion treating coronary heart disease,combined with western medicine,have far better curative effects than routine western medication treatment. But restricted by the quality of the included literatures,the research conclusions are still to be tested and verified by randomized controlled trials of better quality.2. Many challenges are ahead of us while evidence-based medicine is introduced into TCM research. It is the only road for the TCM evidence-based researches that clinical researches of high quality and TCM clinical evaluation system conform to TCM theoretical system.