ObjectiveTo systematically review the effect of compound Danshen dripping pills combined with Western medicine on inflammatory factors and cardiac function after percutaneous coronary intervention (PCI) in patients with acute myocardial infarction.MethodsDatabases including CNKI, WanFang Data, VIP, CBM, PubMed, Web of Science, EMbase and The Cochrane Library were searched for randomized controlled trials of compound Danshen dripping pills combined with Western medicine in the treatment of acute myocardial infarction after PCI. The retrieval time was from the establishment of the databases to June 11th, 2020. Two reviewers independently screened literature, extracted data and evaluated the risk bias of included studies. RevMan 5.3 software was used for meta-analysis.ResultsA total of 16 studies were included, involving 2 069 patients. The results of the meta-analysis showed that the combination of compound Danshen dripping pills could increase the left ventricular ejection fraction (MD =−4.74, 95%CI 4.07 to 5.42, P<0.01), decrease the B-type natriuretic peptide (SMD=−3.81, 95%CI −5.06 to −2.57, P<0.01), the level of interleukin-6 (SMD=−3.20, 95%CI −4.54 to −1.86, P<0.01) and level of tumor necrosis factor-a (SMD=−4.96, 95%CI −7.03 to −2.89, P<0.01).ConclusionsCurrent evidence suggests that the combination of compound Danshen dropping pills has potential benefits in inhibiting inflammation and improving cardiac function after PCI. Due to the limited quality and quantity of the included studies, more high-quality studies are required to verify the above conclusions.
The Core Outcome Measures in Effectiveness Trials (COMET) Working Group has published a series of research and reporting guidelines related to core outcome sets since it was established. This article introduces and interprets the Core Outcome Set-STAndardised Protocol Items: the COS-STAP Statement which is developed by the COMET and published in February 2019. It will then be compared with Core Outcome Set-STAndards for Reporting (COS-STAR) and Core Outcome Set-STAndards for Development (COS-STAD), which have been introduced to China. The significance of these guidelines for the development of core outcomes in the field of traditional Chinese medicine is discussed, so as tp draw researchers' attention to this area.
Since the concept of core outcome set (COS) was introduced into clinical trials of traditional Chinese medicine (TCM), researchers have paid much more attention to develop COS for specific diseases. Although researchers believe that the characteristics of TCM, such as syndromes, should be considered in the COS of TCM, it was insufficiently addressed. In addition, the naming of TCM syndromes has not been standardized, and the classification and diagnostic criteria for specific diseases have been inconsistent. Thus, it is difficult to include TCM syndromes in the COS. Different diseases may show similar TCM syndromes which makes research difficult. Based on previous studies, this paper provided methods of developing core TCM syndromes set according to the model of combination of disease and syndrome and the model of syndrome dominating disease to provide references for future researches.
Objective The objective of this research was to develop a core traditional Chinese medicine (TCM) syndromes set for non-valvular atrial fibrillation (NVAF). MethodsA dataset of TCM syndrome names via systematic review and medical records was developed, and common TCM syndromes classification for NVAF via cross-sectional study were identified. A questionnaire was then developed according to the results of cross-sectional study and the TCM syndrome names dataset. Two rounds of the Delphi survey were carried; clinicians, researchers of TCM/integrated medicine, and nurses were included in the Delphi survey. After a face to face consensus meeting, a core TCM syndromes set for NVAF was developed. ResultsThe core TCM syndromes set for NVAF included four core TCM syndromes, which involved qi stagnation and blood stasis syndrome (core symptoms/signs: palpitations, chest distress or pain, dark purple tongue, or tongue with ecchymosis or petechial, irregular pulse or uneven pulse), heart-kidney yang deficiency syndrome (core symptoms/signs: palpitation, chest distress, fatigue, weakness, chills, pale complexion, frequent urination, wheezing, edema on the face or both lower extremities, oliguria, slippery pulse or slender pulse or deep pulse), qi and yin deficiency (core symptoms/signs: palpitation, chest distress, fatigue, shortness of breath, fine pulse, spontaneous perspiration, night sweats, forgetfulness, lassitude, red tongue, little or no moss on the tongue, and fine pulse), heart and spleen deficiency (core symptoms/signs: palpitation, chest tightness, spontaneous perspiration, abdominal distension after eating, loose stools, pale tongue, weak pulse). ConclusionsThe core TCM syndromes set of NVAF may improve the consistency of TCM syndromes efficacy evaluation in clinical trials of NVAF.
Safeguarding patient’s safety is important in clinical research and practice. At present, there are many problems in the clinical safety evaluation of traditional Chinese medicine. For instance, combination of Chinese and western medicines provides difficulty for definite reflection of clinical safety of Chinese medicine, lack of reliability of reporting of symptomatic adverse events/reactions, as well as discrepancy in safety outcomes reporting in similar clinical studies. Based on the application of adverse events/reactions term sets and core outcomes sets in clinical trials of western medicine, it is proposed that the concept of core outcome sets should be introduced to the clinical safety evaluation of integrated Chinese and western medicines in order to improve the clinical safety evaluation.
The characteristics of traditional Chinese medicine (TCM) practice include treatment based on syndrome differentiation and holism, which determines it is difficult to reflect the individualized therapeutic evaluation and overall regulation of TCM through traditional randomized controlled trials, which is based on quantitative evaluation. The implementation of N-of-1 trials will provide opportunities for quantitative evaluation of individualized therapeutic evaluation of TCM. Using mixed methods research, such as exploratory sequence design, interpretive sequence design or convergent design can provide abundant data to individualized therapeutic evaluation of TCM in different aspects, which may reflect holism and humanities characteristics of TCM in individual level.