A total of 109 varieties of Chinese medicine injections have been approved by the State Food and Drug Administration of China, all of which have the potential to induce adverse drug reactions (ADRs). Major ADRs include systemic anaphylaxis, anaphylactic shock, acute intravascular hemolysis, hepatorenal damage, skin lesion, cardiac damage, respiratory system injury, and gastrointestinal disorders. Contributing factors of ADRs include healthcare workers’ inadequate attention to ADRs of Chinese medicine injections, complex ingredients, allergic uncertainties, and inappropriate drug use in children and the aged. To decrease ADRs resulting from Chinese medicine injections, it is essential to improve the selection of drug indications, delivery of proper dosage regimens, compliance with drug instructions, and selection of solvents for the drugs.
Traditional Chinese medicine equipment plays an indispensable role in the prevention, diagnosis, treatment and rehabilitation of traditional Chinese medicine from the needs of people's life and health, and provides technical support for the simple, convenient, cheap and effective clinical practice of traditional Chinese medicine. The traditional Chinese medicine equipment industry has the development advantages of large demand gap, strong policy support and emerging technology empowerment. At the same time, there are also bottlenecks such as lagging standardization construction, weak industrial foundation, insufficient characteristics of traditional Chinese medicine and immature evidence-based evaluation research. The coming of the era of digital intelligence has brought new opportunities for the development and reform of the traditional Chinese medicine equipment industry. This paper provides development ideas for the transformation of traditional Chinese medicine equipment from traditional to modern from the aspects of standardization construction, digital intelligence industry upgrading, improvement of evidence-based evaluation system and in-depth international exchanges and cooperation.
Objective The basic terms of the technical specifications for case-control studies in the field of traditional Chinese medicine (TCM) are formed by expert consensus methods, in order to develop detailed texts of the technical specifications. Methods According to the process of international guidelines, a total of 44 experts participated in the Delphi survey. Results The three rounds of questionnaire response rates were 73.3%, 86.4%, and 86.8%, respectively. The experts' authority coefficients were 0.82, 0.85, and 0.86, respectively; and the expert opinion coordination coefficients were 0.356, 0.349, and 0.422, respectively. Expert enthusiasm, authority, opinion centralization, and degree of coordination were relatively high. There were many opinions raised in the expert consensuses on how to measure TCM syndrome, TCM constitution, the time point of measurement and the selection of new cases. Conclusion The case-control studies in TCM field should pay more attention to the characteristics of TCM. The draft of technical specification involves the study design and reporting, which can improve the methodological and reporting quality of case-control studies.
Objective To evaluate the efficacy and safety of traditional Chinese medicine(TCM) paste in treating chronic obstructive pulmonary disease (COPD) in stable stage. Methods We electronically searched databases including PubMed, EMbase, The Cochrane Library (Issue 12, 2016), VIP, WanFang Data, CNKI and CBM to collect randomized controlled trials (RCTs) regarding TCM paste in combination with conventional Western therapy versus Western therapy alone in treating stable COPD from inception to December 2016. Two reviewers independently screened literature, extracted data and assessed the risk of bias of the included studies. The meta-analysis was conducted by RevMan 5.3 software. Results A total of 9 RCTs involving 605 Chinese patients were included. The results of meta-analysis showed that: when compared with conventional Western medicine alone, TCM paste combined with the conventional Western medicine significantly improved clinical effective rate (RR=1.20, 95% CI 1.10 to 1.31,P<0.000 1), decreased SGRQ score (MD=–4.53, 95% CI –5.41 to –3.65,P<0.000 01) and CAT score (MD=–2.45, 95% CI –3.38 to –1.51,P<0.000 01), increased FEV1% (MD=3.80, 95% CI 0.40 to 7.20,P=0.03), and reduced the frequency of acute exacerbation (P<0.05). No serious adverse reaction occurred in both groups. Conclusion The current evidence shows that combination of TCM paste and conventional Western medicine may improve clinical effective rate, quality of life, increase FEV1%, and reduce the frequency of acute exacerbation in patients with stable COPD. Due to the limited quality and quantity of included studies, the above results are needed to verify by more studies.
Master protocol with adaptive design is a new complex innovative trial design that combines an adaptive treatment strategy and master protocol. It is more flexible and adjustable. In the complex clinical trial environment, the dynamics emphasized in this design are consistent with the idea of traditional Chinese medicine (TCM) syndrome differentiation and treatment. In this study, we summarized its concept, characteristics and advantages, and we also discussed its application in TCM clinical research. We hope this paper can provide more thinking and suggestions for TCM clinical trials.
ObjectiveTo retrieve and summarize the clinical studies on traditional Chinese medicine for heart failure prevention and treatment and to observe the distribution of evidence in the field of heart failure by using the method of evidence map.MethodsPubMed, Web of Science, EMbase, CNKI, WanFang Data and VIP databases were searched from January 2000 to January 2020. Clinical studies, systematic reviews, guidelines, and clinical pathways related to traditional Chinese medicine for heart failure prevention and treatment were included, and the distribution characteristics of evidence were analyzed by using charts and text descriptions.ResultsA total of 8 580 papers were included, including 8 398 clinical studies (6 821 randomized controlled trials, 1 109 non-randomized controlled trials and 468 observational studies), 160 systematic reviews, and 22 guidelines, expert consensus and pathway studies. The number of clinical studies domestically and abroad showed an overall growth trend. The sample size was concentrated in 60- 100 cases. Coronary atherosclerotic heart disease was the most common comorbidity of heart failure. AMSTAR scores of systematic reviews were primarily 4 to 8. The results of high-quality randomized controlled trials and systematic reviews showed that traditional Chinese medicine combined with conventional Western medicine in the treatment of heart failure had certain advantages in improving heart function, quality of life and prognosis.ConclusionsHigh-quality clinical studies show that traditional Chinese medicine has certain advantages in the efficacy and safety of heart failure prevention and treatment; however, few studies have high methodological quality. In the future, multi-center, large sample size, and high methodological quality clinical studies are needed to further explore the efficacy and safety of traditional Chinese medicine therapy in the field of heart failure.
Chinese medicine (CM) has significant clinical effects in the treatment of tracheal-bronchitis. It is of important clinical significance to formulate guidelines for the diagnosis and treatment of tracheal-bronchitis based on the characteristics of TCM syndrome differentiation. The Respiratory Disease Branch of China Association of Chinese Medicine and Respiratory Disease Branch of China Medical Association of Minorities organized and established a multi-disciplinary background working group, based on the World Health Organization Handbook for Guideline Development and the Guideline Development Handbook for Diagnosis and Therapy of Integrative Medicine to develop this guideline. It was developed through technical links such as clinical problem investigation, evidence collection and evaluation, Delphi consultation, and expert consensus meetings. Based on the current best evidence, CM intervention costs and expert experience, 25 recommendations were established to standardize the etiology and pathogenesis of tracheal-bronchitis, syndrome differentiation and treatment, prevention, and care, etc., which can be used by physicians at different levels of medical institutions.
Background As part of the core outcome set (COS), the core traditional Chinese medicine (TCM) syndrome set can improve the consistency of syndrome efficacy evaluation outcomes in TCM clinical research. Previous studies proposed and empirically verified a method of developing core TCM syndrome sets based on complex syndromes under the disease-syndrome combination research model. However, this method is developed on the basis of syndrome types, which has the limitation that the finally included syndrome types are too single to adapt to the complexity of clinical syndromes. Therefore, it is urgent to optimize the existing development method to balance the complexity of clinical syndromes and methodological feasibility. Methods This study adopted qualitative research methods to obtain opinions from TCM clinicians and researchers on developing methods, efficacy evaluation criteria, and construction forms through expert steering committee meetings and semi-structured interviews. The sample size of semi-structured interviews was determined until data saturation was reached, and thematic analysis was used to analyze the transcription results. Results In the expert steering committee meeting, 60% (3/5) of the experts believed that developing in the form of syndrome elements was more operable; in the semi-structured interviews, 77.78% (7/9) of the experts supported developing in the form of syndrome elements, considering it convenient to use. Meanwhile, the research team added an expert semi-structured interview link in the development process, which complemented the cross-sectional survey used in previous studies to jointly improve the original list of TCM syndrome elements. Conclusion The method of developing core TCM syndrome sets based on syndrome elements formed in this study can consider clinical practice while improving the unity of TCM syndrome efficacy evaluation standards, which is helpful to promote the standardized development of TCM clinical research.
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 To explore whether the placebo-controlled trials in traditional Chinese medicine (TCM) were scientific and ethical. Method An electronic search concerned with placebo-controlled trials of TCM was performed at Chinese Journal Full-text Database, Chinese Scientific and Technological Periodical Database (VIP), Wanfang Database and Chinese Bio-medicine Database (CBM) from January 1979 to April 2008. In addition, we handsearched the trials in specialized journals of TCM. The trials were assessed regard with their scientificalness, ethic and traits of TCM of placebo-controlled trials. Results A total of 231 trials were included, occupying about 2.09% of all the randomized controlled trials (RCTs) of TCM; among which there were 79 (34.20%) with sequence generation, 10 (4.33%) with allocation concealment, 129 (55.84%) with blind methods; 106 (45.89%)with basic intervention, 13 (5.63%) with criteria of intervention quality control, 139 (60.17%) with preparation of placebo, 10 (10.33%) with aggravating scheme, 70 (30.30%) with syndrome type of TCM, 48 (20.78%) with the outcome measurement of TCM. There were 48 RCTs (20.78%) were not scientific. There were 221 RCTs without institutional review board and 187 RCTs without informed consent. Conclusion Placebo-controlled trials of TCM are not applied extensively, and some of them are not scientific. Most of than do not meet the ethical requirements.