Systematic Evaluation Of Yixinshu Capsule In The Treatment Of Angina Pectoris

Background:The Angina Pectoris is a common clinical disease, which affects the pa-tient's quality of the life and brings about a serious burden to patient an-d their families as well as the whole society. Although there are many k-inds of medicines for the disease in the clinical treatment, the western me dicine treatment is the general choice in the clinical. AS we known, the t-raditional Chinese medicine treatment for chest bi-syndrome (Angina Pect-oris) has been using in the curing for thousands of years. Moreover, thi-s special way gradually highlights the advantages for treatment in recent decades, which has a variety of drugs for therapy. YixinShu capsule is ju-st one of them.Objective:The study is to collect the Randomized controlled trials which had used YixinShu capsule for angina pectoris.Besides these experiment papers had been published on domestic or foreign journals before March1st,2012. A-ccording to the methods of evidence-based Medicine, the study is evaluat-e YixinShu capsulehe efficacy and safety in the treatment of angina pect-orist. It also will provide the basic clinical therapy of angina pectoris for YixinShu capsule in the evidence-based medicine and offer the anther idea for doctors in treatment.Materials and Methods:Firstly, the study made the strict inclusion and exclusion criteria and ret-rieved the Chinese Academic Journal (CNKI), Pubmed, Wanfang Databas-e,VIP Chinese periodical database, Chinese Journal Full-text Database and Chinese Biomedical Literature database by NoteExpress2.0software for ra-ndomized controlled trials, which met the inclusion criteria. Then the qual-ity assessments of the original trials were made and data extractions wer-e picked up together. After selected, the Final trials were included. At the same time, the trials evidence rating were done by GRADE profile versio-n3.6quality evaluation software. The last step was to appraise YixinShu capsule efficacy of treatment for angina pectoris on Symptoms of angina, and ECG,TCM symptoms, blood lipids through Calculating effective num-ber of cases and the number of invalid cases. The statistical processing i -s used RevManS.1.21software from Cochrane Collaboration.It contained Counting data, calculating the odds ratio (OR), relative ris-k (RR), their95%confidence interval (CI), measurement data, calculating th-e weighted mean difference (WMD) or standardized mean difference (SM-D) and its95%confidence interval (CI).Results:The final inclusion has12randomized controlled trials. A total of1078cases were enrolled in the system. The methodological quality of final tri-als is regenerally low. The mainly reflected in the following Respects:the imperfect random allocation scheme, the unused allocation concealment, an-d the improper usage of blinding, and the not special reasons for withdra-wal and exit, the shortage offollow-up for patients with a certain time aft-er finished. Simultaneously the articles experimental evidence that include-d are very low.Meta-analysis results are as follow:1YixinShu capsule compared with western medicine alone in treatment of angina pectoris.1) Isosorbide MononitrateSymptoms of angina:OR0.83,95%Cl (0.41,1.67), P=0.60. Description of the experimental group (YixinShu capsule) with the control group co-mpared to (isosorbide mononitrate), does not have advantage, and there is no publication bias.ECG:OR=3.35,95%CI (0.63,17.88), P=0.16. Of the experimental grou-p (YixinShu capsule) with the control group (isosorbide mononitrate) com-pared to the ECG does not have the advantage and there is the publicati-on bias.2) Isosorbide dinitrateSymptoms of angina:OR=3.39,95%CI (0.80,14.41), P=0.10. The exp-erimental group (YixinShu capsule) and the control group (isosorbide dini-trate) have no advantage in symptoms of angina. And there is publicatio-n bias.ECG:OR=1.59,95%CI (0.88,2.96), P=0.13. The experimental group (Yi-xinShu capsule) and the control group (isosorbide dinitrate) do not hav-e the advantage on ECG and have not the existence of publication bias.Chinese medicine symptom improvement:the point of view of four sy- mptoms.Chest pain:OR=3.71,95%CI (1.75,7.86), P=0.00006, the experimental group (YixinShu capsule) and the control group (isosorbide dinitrate) have an advantage in changing the symptom of chest pain;Chest tightness:OR1.57,95%CI (0.85,2.88), P=0.15, the experimental group (YixinShu capsule) and the control group (isosorbide dinitrate) does not have an advantage in changing the chest tightness;Palpitations:OR2.04,95%CI (1.08,3.87), P=0.03, indicating that the experimental group (YixinShu capsule) with the control group (isosorbide dinitrate) exists an advantage in changing the symptoms of palpitation;Shortness of breath symptoms:OR=3.97,95%CI (1.95,8.06), P=0.000-1, indicating that the experimental group (YixinShu capsule) with the cont-rol group (isosorbide dinitrate) has the advantage to improve shortness of breath symptoms. And the publication bias exists.2YixinShu capsule and conventional western medicine treatment com-pared with conventional Western medicine treatment of angina pectoris.1) Symptoms of angina:The combined effect size OR=2.07,95%CI (1.13,3.78), P=0.02, the experimental group (YixinShu capsule and conv-entional western medicine treatment) and control group (conventional west-ern treatment medicines) in angina pectoris there are advantages. There is the existence of publication bias.2) ECG:The combined effect size OR=1.92,95%CI (1.44,2.55), P<0.00001, indicating the experimental group (Yixin capsule and convention-al western medicine treatment) and the control group (conventional wester-n medicine treatment) on the ECG advantage. There isthe existence of p-ublication bias.3) Lipids:TC:MD=0.18,95%CI (-0.11,0.47), P=0.22. Description does not exist the advantages of the experimental group (YixinShu capsule and conventi-onal western medicine treatment) and the control group (conventional W-estern medicine treatment) TC improvement in the efficacy considerable;TG:MD=0.51,95%CI (-0.51,1.53), p=0.33. Describes does not exist advantages of the experimental group (YixinShu capsule and conventional western medicine treatment) and control group (Western medicine conventi-onal treatment) and the improvement of efficacy in TG; LDL2C:MD=0.73,95%CI (-0.13,1.59), p=0.10. It dose not have thea-dvantage, the experimental group (YixinShu capsule and conventional wes-tern medicine treatment) improve in LDL2C, with the control group (con-ventional western medicine treatment) efficacy. It has the existence of pu-blication bias.3YixinShu capsule compared with other proprietary Chinese medicines.1) YixinShu capsule compared with Xuesaitong pieceSymptoms of angina:OR1.44,95%CI (0.67,3.08), P=0.35, indicating t-he experimental group (YixinShu capsule) compared the control group (X-uesaitong piece) does not have the advantage, there is no publication bia-s.ECG:The combined effect size OR=1.24,95%CI (0.69,2.21), P=0.47. It indicates the test group (YixinShu capsule) with the control group (Xue saitong film) on the ECG does not have the advantage, has not The exist ence of publication bias.2) YixinShu capsule compared with Danshen Dripping PillSymptoms of angina:OR1.19,95%CI (0.53,2.68), P=0.67, indicated t-he experimental group (YixinShu capsule) compared with the control grou-p (compound Danshen dripping pill) dose not have the advantage in chan-ging Symptoms of anginas, there is no publication bias.Chinese medicine symptom improvement:divided into five areas on t-he TCM symptoms:chest pain and palpitations, shortness of breath, fatig-ue, the dizziness.Chest pain and tightness:OR=1.19,95%CI (0.53,2.68), P=0.67, indic-ates that the experimental group (YixinShu capsule) compared with the c-ontrol group (isosorbide dinitrate) has an advantage in improving symptom-s of chest pain and tightness;Palpitations:OR=1.29,95%CI (0.59,2.84), P=0.53. The experimental g-roup (YixinShu capsule) compared with the control group (isosorbide dini-trate) does not have the advantage in im-proving the symptoms of palpita-tion,;Shortness of breath symptoms:OR5.66,95%CI2.59,12.38), P<0.0001. The experimental group (YixinShu capsule) compared with the control gro-up (isosorbi-de dinitrate) exists on the advantage to improve shortness of breath symptoms Fatigue:OR9.78,95%CI (4.33,22.09), P<0.00001, the experimental g-roup (YixinShu capsule) the control group (isosorbide dinitrate) has an ad-vantage in improving fatigue symptoms.Dizziness and Dizzy:OR3.82,95%CI (1.72,8.45), P=0.0010. The e-xperimental group (YixinShu capsule) compared with the control group (is-osorbide d-initrate) have an advantage in improving symptoms of dizzines ssand publication bias exists.Conclusion:From the main indicators of the efficiency, it can be concluded that Yi xinShu capsule do not have the advantage in changing symptoms of angin-a and ECG compared with isosorbide mononitrate and isosorbide dinitrate. But it has the advantage in changing chest pain, palpitations and shortness of breath symptoms compared with isosorbide dinitrate in Chinese medicin-e symptom improvement. The secondly, YixinShu capsule and convention-al western medicine takes the advantage on the view of symptoms of ang-ina and ECG compared with conventional western medicine treatment alo-ne. At the same time, the experimental group has the same considerable effect on the Lipid compared with the control group. The thirdly, the Yixi-nShu capsule dose not have the advantage on changing symptoms of ang ina and ECG compared with Xuesaitong piece. Compared with Danshen Dripping Pill, YixinShu capsule has the advantage in changing shortness o-f breath symptoms, fatigue and dizziness, dizzy.