Objective To systematically review the intervention effects and safety of cardiovascular polypill for the relevant risk factors of coronary heart disease. Methods The randomized clinical trials (RCTs) on polypill in intervening coronary heart disease were searched in PubMed, CENTRAL, ICTRP, CBM, CNKI, WanFang and VIP from their inception to September 2012. Two reviewers independently screened the literature according to the inclusion and exclusion criteria, extracted the data, and assessed the methodological quality. Then the analysis was conducted. Results A total of 5 RCTs from overseas were included. The descriptive analysis showed that: a) as for blood pressure, polypill was obviously superior to placebo in reducing SBP and DBP with a significant difference, but it didn’t reveal difference compared to the hypotensive drugs used alone; b) as for serum lipid, polypill was obviously superior to placebo in reducing TC, TG and LDL-C with a significant difference, but there was no difference between polypill and standard drug treatment; c) as for glucose, polypill was obviously superior to placebo in reducing glucose with a significant difference; d) as for adverse reaction, such adverse events as cough, bleeding tendency or gastritis, liver and kidney dysfunction were reported in the included studies; e) as for drug compliance, polypill showed no differences compared with either standard treatment or placebo. Conclusion Polypill has intervention effects on the relevant factors of coronary heart disease, such as hypertension and serum lipid, etc. Due to quantity limitation of the included trials, the above conclusion still needs to be further proved by performing more large scale and high quality studies. For lack of adequate evidence, this review does not recommend polypill as a primary care for cardiovascular disease.
Objective The core indicator pool of ischemic stroke (IS) was constructed to provide a basis for the establishment of the core outcome set (COS), so as to improve the consistency of clinical research and evaluation results of traditional Chinese medicine (TCM) treatment for IS. Methods In this study, the mixed methods research (MMR) convergent parallel design was used to carry out qualitative research and quantitative research at the same time, and the two research results were integrated to reach a conclusion. Quantitative research comprehensively collected the multi-source efficacy evaluation indicators of TCM treatment of IS, and carried out descriptive statistical analysis based on frequency theory. Semi-structured interviews were used in the qualitative research, relevant interest groups were selected to understand the evaluation indicators of the IS efficacy of TCM treatment that they were concerned about, and NVivo software was used for in-depth analysis, coding, classification, and extraction of the efficacy indicators. Based on the principle of pillar integration, quantitative and qualitative research results were integrated to construct an element pool of evaluation indicators for the treatment of IS with traditional Chinese medicine. Results A total of 437 standard papers, 71 registered trial protocols, 100 real-world medical data cases and several guideline consensus policy documents were included in the quantitative study, and a total of 314 indicators in the acute phase of IS, 154 indicators in the recovery phase, and 104 indicators in the sequelae phase were extracted. In the qualitative research part, a total of 32 indicators in the acute stage of IS, 34 indicators in the recovery stage and 35 indicators in the sequelae stage were extracted through interviews. Through group discussion and the principle of pillar integration, an element pool of IS indicators was formed, including 279 IS indicators in the acute stage, 142 indicators in the recovery stage and 91 indicators in the sequelae stage. Conclusion Based on the MMR convergent parallel design, the element pool of the characteristic indicators of the therapeutic effect of IS in TCM is constructed to meet the needs, which provides the preliminary work basis for the construction of the core outcome set of IS in the next stage.