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It has been over 20 years since the introduction of evidence-based medicine (EBM) into the research of traditional Chinese medicine (TCM). The development of evidence-based TCM research has profoundly influenced the process of clinical research and decision-making, impelling researchers to pay attention to raise evidence quality, accumulate data, and explore appropriate evaluation methods adaptive to TCM original theories and knowledge. In this paper, the authors aim to summarize and review the existing work and seek promising research interests in this field, expecting to inspire more thoughts leading to breakthroughs in the near future.

Background No treatment has convincingly been proven to be beneficial for microvascular obstruction (MVO) in patients with ST-elevation myocardial infarction (STEMI). Several studies have described the effects of Danhong Injection. However, evidence of a rigorously designed verification study is still lacking, and the intervention timing of Danhong Injection is uncertain. Methods The DIRECTION study is a multicenter, prospective, randomized, evaluator-blind study. A total of 336 patients with STEMI receiving percutaneous coronary intervention (PCI) will be randomly assigned to conventional treatment, the preoperative Danhong Injection, or the postoperative Danhong Injection. The primary outcome is rate of ST-segment resolution (STR) ≥ 70% at 90 min after PCI. The secondary outcomes are the degree of STR, Thrombolysis in Myocardial Infarction (TIMI) flow grade, TIMI myocardial perfusion grade, left ventricular ejection fraction, N-terminal prohormone brain natriuretic peptide, high-sensitivity C-reactive protein, and infarct size expressed as area under the curve for cardiac troponin I (cTnI) and for creatine kinase MB. The major adverse cardiovascular events and hospital readmission events will be recorded. Health quality will be assessed with the 12-item Short Form Health Survey. The safety outcomes include bleeding events, adverse events, and abnormal changes in routine blood tests. Psychological status and dietary patterns will be evaluated using Hamilton Depression Rating Scale and Food Frequency Questionnaire as the relevant indicators. Discussion This trial will evaluate the efficacy and safety of Danhong Injection, as well as its optimal timing of intervention to prevent MVO in patients with STEMI. Trial registration Chinese Clinical Trial Registry, ChiCTR1900021440. Registered on February 21, 2019.

Objectives. To review the evidence of acupuncture for acute and preventive treatment of migraine for further awareness of the effect of acupuncture for migraine. Design. An overview of systematic reviews and meta-analyses (SR/MAs) for randomized controlled trials. Material and Methods. We searched PubMed, Embase, the Cochrane Library, China Knowledge Resource Integrated Database, VIP Chinese Journal Full Text Database, WANFANG Data, and China Biology Medicine disc from their establishment to May 27, 2018. SR/MAs of randomized controlled trials comparing the effect of the acupuncture intervention with another treatment control in migraine patients were included. Results. 428 SRs were identified, and 15 of them were included. Only 4 SR/MAs were assessed by GRADE, which showed certainty of most evidence being low or very low. Assessed by AMSTAR-2, fourteen was critically low rating overall confidence in the results, and 1 was low rating overall confidence in the results. Evidence suggested that acupuncture has a significant advantage of pain improvement, efficacy, and safety relative to blank control, sham acupuncture, or drug treatment, but some of these results are contradictory. Conclusions. We found that acupuncture on treating migraine has the advantage for pain improvement and safety, but the quality of SR/MAs of acupuncture for migraine remains to be improved.

Considering the heavy burden of migraine, it is essential to update insufficient and/or outdated clinical evidence supporting electroacupuncture (EA) in migraine therapy. In this study, a literature search of seven medical databases was performed. After data extraction and quality evaluation, 13 randomized controlled trials, including 1559 patients, were assessed in this analysis. Results demonstrated that EA was superior to control treatment (Western medicine, sham-EA, blank control, acupuncture, and acupoint catgut embedding) according to the visual analog scale (VAS) score, frequency of headache attack (Western medicine, sham-EA, blank control), self-rating anxiety scale (SAS [blank control]), self-rating depression score (SDS [Western medicine and blank control]), and clinical efficiency (Western medicine and sham-EA) after treatment ([Formula: see text]). Results of network meta-analysis (for VAS, SAS, and SDS) demonstrated statistically significant differences in VAS scores for EA compared with sham-EA, acupuncture with sham-EA, acupoint catgut embedding with sham-EA, and acupoint catgut embedding with blank control. Rank probability analysis of VAS, SAS, and SDS scores all demonstrated that EA ranked first. Most studies were symmetrically distributed on both sides of the midline in funnel plots for VAS, SAS, and SDS, which indicated a low likelihood of small sample effects. Sensitivity analysis confirmed the stability of the studies included in this research. EA is one of several effective treatments for migraine pain symptoms, and, to some extent, anxiety and depression. Nevertheless, multi-center studies with large sample sizes and/or well-designed randomized controlled trials (RCTs) will be needed in the future.

Background. Non-ST segment elevation acute coronary syndrome has been one of the most serious diseases threatening human health. Long-term cardiac rehabilitation and secondary prevention is the essential method to control the recurrence and mortality of the disease. Traditional Chinese medicine has proved the efficiency on the treatment of non-ST segment elevation acute coronary syndrome, but there is a lack of appropriate methodological design to reflect the characteristics of individualized diagnosis and treatment of it. Therefore, this study used the evidenced-based Goal Attainment Scale to evaluate the clinical effectiveness of traditional Chinese medicine on the treatment of non-ST segment elevation acute coronary syndrome. Method. This is observational research with the prospective feature. A total of 200 patients will be recruited and observed in the three months by telephone or door visit, collecting the individualized intervention of traditional Chinese medicine and evaluating through the method of evidence-based Goal Attainment Scale. Participants will be included according to the inclusion and exclusion criteria. Any reasons for loss to follow-up and adverse events will be recorded strictly. Discussion. The evidence-based Goal Attainment Scale provides a personalized method of evaluation based on the Goal Attainment Scale and combined with evidence-based medicine, which can better reflect the characteristics and superiority of individualized and dynamic intervention for traditional Chinese medicine on the long-term prevention and treatment of non-ST segment elevation acute coronary syndrome than other methods of design. It is of great significance to explore and promote this method of design in the future.

Migraine is one of the most common chronic neurological disorders worldwide. Current clinical treatment mainly aims to relieve symptoms, and the outcome is primarily evaluated on subjective parameters with a lack of comprehensive and objective evaluation criteria. The development of a core outcome set (COS) may offer a solution to the problems with evaluating the outcome of treatments for migraine. A total of 57 outcome indicators were obtained from the systematic review and semi-constructed interviews. After the two-round Delphi survey and analytic hierarchy process were used to assess the weight of each outcome, 16 core outcomes of acupuncture treatment for migraine treatment were selected. The COS evaluates the degree of relief provided by acupuncture therapy in terms of pain level and symptoms and provides a comprehensive and multidimensional assessment of quality of life, sleep quality, and mental health from the perspective of pain and it presented here could guide the application and precise evaluation of treatment for migraine. Funding Statement: This research was funded by the National key R&D Program of China (No. 2018YFC1707604) and the National Natural Science Foundation of China (No. 81674150). Declaration of Interests: The authors declare that they have no competing interests. Ethics Approval Statement: Ethical approval was obtained from the ethics committee of Beijing university of Chinese medicine (Approval no. DZMEC-KY-2018-44).Written informed consent for publication of our research details was obtained from the patients.

Introduction. TCMI with the effect of Liqihuoxue and Yiqihuoxue has been applied as complementary therapies during the perioperative period of PCI for patients with ACS, while the recommended time points and plans of TCMI are still short of the support of evidence-based medicine. Methods. A systematic review and meta-analysis was conducted to evaluate the clinical efficacy and safety of TCMI on patients with ACS during the perioperative period of PCI. RCTs were searched based on standardized searching rules in seven medical databases from the inception up to August 2019. Two reviewers conducted the study selection, data extraction, and quality analysis independently. Data were analysed with the support of software RevMan and Stata. Results. A total of 68 articles with 6,043 patients were enrolled. The result of meta-analysis showed that the TCMI combined with western medicine was superior to the western medicine alone on clinical efficiency (before the PCI, before and after the PCI, or overall, P<0.05), the occurrence of MACE (myocardial infarction and stenocardia: before the PCI, before and after the PCI, or overall, P<0.05; arrhythmia: before and after the PCI, P<0.05), and the level of inflammatory factors (hs-CRP: before the PCI, before and after the PCI, or overall, P<0.05; IL-6: after the PCI, P<0.05). The TCMI with the effect of Liqihuoxue obtained more support compared with Yiqihuoxue based on the result of meta-analysis. Conclusions. TCMI with the effect of Liqihuoxue or Yiqihuoxue combined with western medicine generally showed the potential advantage on the treatment of ACS during the perioperative period of PCI. However, the optimal time point of intervention and recommended plan based on the effect still needs more clinical evidence. We consider that the research of precise and standardized application of TCMI will be a promising direction for TCM in the future.

Background Cardiomyocyte autophagy and apoptosis are crucial events underlying the development of cardiac abnormalities and dysfunction after myocardial infarction (MI). A better understanding of the cell signaling pathways involved in cardiac remodeling may support the development of new therapeutic strategies for the treatment of heart failure (HF) after MI. Methods A cardiac MI injury model was constructed by ligating the left anterior descending (LAD) coronary artery. Neonatal cardiomyocytes were isolated and cultured to investigate the mechanisms underlying the protective effects of nicorandil on MI-induced injury. Results Nicorandil reduced cardiac enzyme release, mitigated left ventricular enlargement and cardiac dysfunction after MI, as evaluated by echocardiography and hemodynamic measurements. According to the results of the western blot analysis and immunofluorescence staining, nicorandil enhanced autophagic flux and reduced apoptosis in cardiomyocytes subjected to hypoxic injury. Interestingly, nicorandil increased Mst1 and p-Mst1 levels in cardiomyocytes subjected to MI injury. Mst1 knockout abolished the protective effects of nicorandil on cardiac remodeling and dysfunction after MI. Mst1 knockout also abolished the beneficial effects of nicorandil on cardiac enzyme release and cardiomyocyte autophagy and apoptosis. Conclusions Nicorandil alleviates post-MI cardiac dysfunction and remodeling. The mechanisms were associated with enhancing autophagy and inhibiting apoptosis through Mst1 inhibition.

Objective Currently, there is still no effective strategy to diminish the infarct size (IS) in patients with ST-segment elevation myocardial infarction (STEMI). According to a previous animal study, nicorandil treatment is a promising pharmaceutical treatment to limit the infarct area. In this study, we aim to investigate the effects of continual nicorandil administration on the IS and the clinical outcomes in patients with STEMI who underwent primary percutaneous coronary intervention (pPCI). Methods One hundred seventeen patients with STEMI and undergoing pPCI were randomly divided into the sustained nicorandil group (5 mg, three times daily) or the control group (only single nicorandil before PCI). The primary endpoint was the IS, evaluated by single-photon emission computed tomography (SPECT) 3 months after pPCI. Results Eighty-five patients completed the IS assessment via SPECT, and 99 participants were available for follow-up after 6 months. Finally, there was a statistical difference in the IS between the nicorandil and control groups {13% [interquartile range (IQR), 8-17] versus 16% [IQR, 12-20.3], p=0.027}. Additionally, we observed that maintained nicorandil administration significantly improved the left ventricular ejection fraction at 3 months and enhanced the activity tolerance (physical limitation and angina stability) at 6 months after PCI. Conclusion Sustained nicorandil treatment reduced the IS and improved the clinical outcomes compared to the single nicorandil administration for patients with STEMI undergoing the pPCI procedure. Continuous cardioprotective therapy may be more beneficial for patients with STEMI.

Background The diabetic kidney disease (DKD) has become a seriously kidney disease that commonly caused by diabetes mellitus (DM). Oxidative stress response plays an essential role in the genesis and worsening of DKD and Coenzyme Q10 (CoQ10) has been reported the promising clinical effectiveness on DKD treatment. However, there is lack of relative evidence-based medical evidence currently. Objective The systematic review and meta-analysis was based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement, which conducted to evaluate the effectiveness of CoQ10 in combination with other western medicine for DKD therapy through the randomized controlled trials (RCTs) and experimental studies. Methods RCTs and experimental studies were searched based on standardized searching rules in 12 medical databases from the inception up to June 2018 and a total of 8 articles (4 RCTs and 4 experimental studies) were enrolled in the meta-analysis. Results The results revealed that CoQ10 combined with other western medicine show statistical differences in the laboratory parameters of fasting plasma glucose (FPG), Hemoglobin A1c (HbA1c), total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), triglyceride (TG), and malondialdehyde (MDA) amelioration after DKD therapy compared with control group. However, LDL-C and Urea level for RCTs and Urine output and Glucose for experimental studies on DKD was not superior to control group. Conclusion We need to make conclusion cautiously for the effectiveness of CoQ10 application on DKD therapy. More standard, multicenter, double-blind RCTs, and formal experimental studies of CoQ10 treatment for DKD were urgent to be conducted for more clinical evidence providing in the future. The underlying pharmacological mechanism of CoQ10 needs to be researched and revealed for its future application on DKD therapy.