Evidence-based Clinical Chinese Medicine:What Has Changed Over the Past 20 Years

Chinese medicine has been used for centuries to treat a range of health conditions.This history has produced a wealth of classical literature,case studies and clinical research data detailing its use and effectiveness.However,high-quality and conclusive evidence that meets modern requirements for clinical decision support is lacking.This evidence gap limits the integration of Chinese medicine with contemporary medicine,which in turn limits global access and acceptance of Chinese medicine as a form of safe and effective health care.Over the past 20 years,researchers and organisations around the world,including the World Health Organization(WHO)and United Nations,have worked to support the integration of traditional medicines,such as Chinese medicine,with conventional medicines to improve global health care.This paper provides an overview of Chinese medicine studies published in the top four general medical journals(BMJ,JAMA,Lancet and New England Journal of Medicine)from February 2005 to February 2024 in the past 20 years to highlight the progress in the development of this evidence base.It also highlights key actions taken to promote evidence-based clinical Chinese medicine,including product and practitioner regulation,formalising education standards,and international collaborations.Research conducted at the China-Australia International Research Centre for Chinese Medicine demonstrates the benefits of such a collaboration.Through development of its unique and inclusive‘whole-evidence’approach,plus clinical studies and systematic reviews,the Centre has significantly contributed to the evidence base for clinical Chinese medicine.In addition,its high-impact papers and groundbreaking monographs have been cited in international conventional medicine guidelines.While progress has certainly been made during the past 20 years to build a stronger evidence base for clinical Chinese medicine,there is still a considerable gap that limits its integration with conventional medicine.Future funding and research are needed to continue this work and achieve to safe,effective and accessible traditional medicine as part of the WHO’s Universal Health Coverage strategy.

Improving the Selection Model of Essential Medicines in China by Evidence-based Thinking

Objective To sort out the problems in the selection model of essential medicines in China,and to put forward some suggestions to optimize the selection model to ensure the rationality of the medicines in the essential medicines list.Methods The domestic and foreign literature on the selection of essential medicines was reviewed.Then,the opinions on the selection methods and results of essential medicines from foreign literature were investigated to make a comparison with the selection of essential medicines in China.Finally,the general and special laws of the selection process of the essential medicines were explored.Results and Conclusion It is recommended that the selection model of essential medicines in China should be further optimized,and the evidence-based thinking and methods should be utilized to enhance the scientific nature of the selection process.

Application of evidence-based medicine methods in integrative oncology research

To present the advances of evidence-based medicine and clinical research methodology in integrative oncology,we conducted a literature review of real-world studies of traditional Chinese medicine(TCM)in cancer care and summarized the available evidence.Pragmatic randomized controlled trials(pRCTs)and clinical registry studies are becoming more popular as they could compensate for the limitations of RCTs.Many RCTs of TCM for cancer treatment as well as systematic reviews have been published.The most investigated therapies are based on acupuncture,Chinese herbal compounds,and Chinese patent medicines.Acupuncture has a significant advantage in relieving cancer-related symptoms.Published studies focus more on improving clinical symptoms and laboratory indicators.However,the patient's quality of life deserves more attention.

The artificial intelligence evidence-based medicine pyramid

Several studies exist in the literature regarding the exploitation of artificial intelligence in intensive care.However,an important gap between clinical research and daily clinical practice still exists that can only be bridged by robust validation studies carried out by multidisciplinary teams.

Evidence-based orthobiologic practice:Current evidence review and future directions

The field of orthopedic and regenerative medicine is rapidly evolving with the increasing utilization of orthobiologic.These biologically derived therapies,inc-luding platelet-rich plasma,mesenchymal stem cells,bone marrow aspirate con-centrate,stromal vascular fraction(SVF),and autologous chondrocyte implanta-tion,are gaining traction for their potential to enhance the body's natural healing processes.They offer a promising alternative to traditional surgical interventions for musculoskeletal injuries and degenerative conditions.Current evidence su-ggests significant benefits of orthobiologics in treating conditions like osteoarth-ritis,tendon injuries,and spinal disorders,yet inconsistencies in treatment pro-tocols and outcomes persist.The global market for orthobiologics is projected to grow substantially,driven by advancements in biologic therapies such as adipose-derived stem cells and SVF,and the demand for minimally invasive treatments.Despite their promise,regulatory and ethical challenges,as well as the need for high-quality,standardized research,remain significant obstacles.Future dire-ctions in the field include advancements in delivery systems,personalized medi-cine approaches,and the exploration of novel sources like induced pluripotent stem cells,aiming for more targeted and effective treatments.Collaborative efforts are crucial to overcoming these challenges and ensuring the safe and effective application of orthobiologics in clinical practice.

Clinical research report on traditional Chinese patent medicines and traditional Chinese classic famous prescriptions(2022)

Objective:The paper is to comprehensively summarize and analyze the basic situation and methodological quality of clinical randomized controlled trials(RCTs)of traditional Chinese patent medicines and traditional Chinese classic famous prescriptions published in 2022,to provide evidence and reasonable suggestions for the advancement of clinical research and the formulation of policies and guidelines.Methods:The Evidence Database System of clinical evidence-based evaluation of traditional Chinese medicine was searched,and data from China National Knowledge Infrastructure(CNKI),PubMed,and other databases were supplemented.The search duration was from January 1,2022,to December 31,2022.RCTs of traditional Chinese patent medicines and traditional Chinese classic famous prescriptions were included as the source of clinical evidence,and published information,sample size,intervention,control measures,treatment course,methodological quality,and key link report were analyzed and evaluated.Results:A total of 1,464 RCTs of traditional Chinese patent medicines were included,which comprised 667 types of traditional Chinese patent medicines;“traditional Chinese patent medicines+Western medicine vs.Western medicine”was the most widely used intervention and control setting,involving 417 RCTs(28.48%).A total of 245 RCTs of traditional Chinese classic famous prescriptions were included,comprising 55 types of traditional Chinese classic famous prescriptions.“Decoction+conventional treatment vs.conventional treatment”was the most widely used intervention and control setting,with 87 RCTs(35.51%).Published RCTs on traditional Chinese patent medicines and traditional Chinese classic famous prescriptions were limited by the study design and implementation.Most“allocation concealment”and“blinding of patients and personnel”were rated as medium to high risk.There are insufficient reports on key research links such as experimental registration and ethical approval.Conclusions:The number of RCTs on traditional Chinese patent medicines has decreased in 2022,but there has been a slight improvement in the research quality and impact.There are relatively few studies on traditional Chinese classic famous prescriptions.Measures must be taken to improve clinical trial design,implementation,and reporting.Methodological experts should be invited to provide professional technical guidance on the trial design.In the research implementation process,attention should be paid to quality control,particularly the standardization of the randomized execution.

Irritable bowel syndrome: Pathogenesis, diagnosis, treatment, and evidence-based medicine

Irritable bowel syndrome (IBS) is a chronic and debilitating functional gastrointestinal disorder that affects 9%-23% of the population across the world. The percentage of patients seeking health care related to IBS approaches 12% in primary care practices and is by far the largest subgroup seen in gastroenterology clinics. It has been well documented that these patients exhibit a poorer quality of life and utilize the health care system to a greater degree than patients without this diagnosis. The pathophysiology of IBS is not clear. Many theories have been put forward, but the exact cause of IBS is still uncertain. According to the updated ROME III criteria, IBS is a clinical diagnosis and presents as one of the three predominant subtypes: (1) IBS with constipation (IBS-C); (2) IBS with diarrhea (IBS-D); and (3) mixed IBS (IBS-M); former ROME definitions refer to IBS-M as alternating IBS (IBS-A). Across the IBS subtypes, the presentation of symptoms may vary among patients and change over time. Patients report the most distressing symptoms to be abdominal pain, straining, myalgias, urgency, bloating and feelings of serious illness. The complexity and diversity of IBS presentation makes treatment difficult. Although there are reviews and guidelines for treating IBS, they focus on the efficacy of medications for IBS symptoms using high-priority endpoints, leaving those of lower priority largely unreported. Therefore, the aim of this review is to provide a comprehensive evidence-based review of the diagnosis, pathogenesis and treatment to guide clinicians diagnosing and treating their patients.

Traditional Chinese Medicine as a Treatment for Rheumatoid Arthritis:From Empirical Practice to Evidence-Based Therapy

Rheumatoid arthritis(RA)is a common autoimmune condition with an elusive etiology.Conventional and biological disease-modifying drugs sometimes fail or produce only partial responses.Traditional Chinese medicine(TCM)has long been used in China as a treatment for RA and is achieving everincreasing acceptance worldwide.TCM treatments are traditionally guided by the theory of treatment based on TCM syndrome differentiation;however,they remain a matter of empirical practice relying on TCM theories and doctors’own experience,which places severe restrictions on worldwide TCM application.Nevertheless,TCM is a treasure trove for drug discovery,particularly as a treatment for complicated human conditions.The discoveries of artemisinin as a treatment for malaria and of TCM–arsenic trioxide(As2O3)combination therapy as a treatment for acute promyelocytic leukemia(APL)are excellent examples of the great value of TCM.Regarding RA treatments,many Chinese medicinal herbs and their formulas,extracts,ingredients,and even single compounds have been used in clinical applications.Several Chinese proprietary medicines(CPMs)derived from TCM formulas or herbal bioactive components,such as the controlled-release ZhengQingFengTongNing(ZQFTN)Tablets,Tripterygium Glycoside Tablets,and Total Glucosides of Peony(TGP)Capsules,have been included in the National Health Insurance Directory of China,and show comparable therapeutic efficacies to those of western chemical drugs with fewer side effects.As TCM research has advanced,particularly in the use of multidisciplinary technologies,the scientific foundations and characteristics of the use of TCM to treat RA have been revealed,and the quality of TCM treatments have been increasingly enhanced.However,TCM generally lacks sufficient clinical and laboratory data to be consistent with international standards for quality,safety,and efficacy in order to support its application worldwide.Therefore,intensive basic and clinical studies on TCM are required.In particular,investigations that use cutting-edge technologies in analytical chemistry,biology,and biomedical sciences,and the development of randomized clinical trials(RCTs)and personalized pragmatic randomized controlled trials(PPRCTs)are necessary.Researchers should also collaborate to advance TCM from empirical practice to evidence-based therapy,thus consistently promoting TCM development and globalization in a vital,beneficial,and contributable manner.

Problems faced by evidence-based medicine in evaluating lymphadenectomy for gastric cancer

Gastric cancer surgical management differs between Eastern Asia and Western countries. Extended lymphadenectomy (D2) is the standard of care in Japan and South Korea since decades, while the majority of United States patients receive at most a limited lymphadenectomy (D1). United States and Northern Europe are considered the scientific leaders in medicine and evidence-based procedures are the cornerstone of their clinical practice. However, surgeons in Eastern Asia are more experienced, as there are more new cases of gastric cancer in Japan (107898 in 2012) than in the entire European Union (81592), or in South Korea (31269) than in the entire United States (21155). For quite a long time evidence-based medicine (EBM) did not solve the question whether D2 improves long-term prognosis with respect to D1. Indeed, eastern surgeons were reluctant to perform D1 even in the frame of a clinical trial, as their patients had a very good prognosis after D2. Evidence-based surgical indications provided by Western trials were questioned, as surgical procedures could not be properly standardized. In the present study we analyzed indications about the optimal extension of lymphadenectomy in gastric cancer according to current scientific literature (2008-2012) and surgical guidelines. We searched PubMed for papers using the key words “lymphadenectomy or D1 or D2” AND “gastric cancer” from 2008 to 2012. Moreover, we reviewed national guidelines for gastric cancer management. The support to D2 lymphadenectomy increased progressively from 2008 to 2012: since 2010 papers supporting D2 have achieved a higher overall impact factor than the other papers. Till 2011, D2 was the procedure of choice according to experts’ opinion, while three meta-analyses found no survival advantage after D2 with respect to D1. In 2012-2013, however, two meta-analyses reported that D2 improves prognosis with respect to D1. D2 lymphadenectomy was proposed as the standard of care for advanced gastric cancer by Japanese National Guidelines since 1981 and was adopted as the standard procedure by the Italian Research Group for Gastric Cancer since the Nineties. D2 is now indicated as the standard of surgical treatment with curative intent by the German, British and ESMO-ESSO-ESTRO guidelines. At variance American NCCN guidelines recommend a D1+ or a modified D2 lymph node dissection. In conclusion, D2 lymphadenectomy, originally developed by Eastern surgeons, is now becoming the procedure of choice also in the West. In gastric cancer surgery EBM is lagging behind national guidelines, rather than preceding and orienting them. To eliminate this lag, EBM should value to a larger extent Eastern Asian literature and should evaluate not only the quality of the study design but also the quality of surgical procedures.

Optimization of evidence-based research in the prevention and treatment of coronary heart disease with traditional Chinese medicine:A comprehensive review

Coronary heart disease(CHD) has severely impacted the lives and health of patients for ages. Although the modern methods used for the prevention and treatment of CHD have been increasingly perfected,clinical problems remain that require solutions. In the prevention and treatment of CHD with traditional Chinese medicine(TCM), great therapeutic advantages have been demonstrated. However, the expression of its advantages relies on scientific evidence-based research and evaluation, which require further optimization and improvement. Therefore, this review aims to comprehensively emphasize our understanding of the current deficiencies in TCM evidence-based studies and the necessity of adopting scientific evidence-based optimization methods for use in research. In this process, evidence should be produced in a standard manner, and the advantages of TCM patterns should be accurately stated because these factors contribute to efficient transformation and proper verification of the obtained evidence.Additionally, focusing on patient-oriented medicine and doctor-patient relationships is also essential.These methods are of great significance to prove the clinical efficacy of TCM and promote its development.

Under the narrative medicine theory to establish the evidence-based medical record written by doctors and patients through integrated therapy of traditional Chinese and western on digestive system diseases

Objective:The aim of this article was to discuss the theory of doctor-patient co-operated evidence-based medical record and set up the preliminary frame of the doctor-patient co-operated evidence-based medical record following the concept of narrative evidence-based medicine.Methods:The information was searched from Pubmed,Embase,CBMdisc,CNKI.A preliminary agreement was reached by referring to the principles of narrative medicine and advises given by experts of digestive system and evidence-based medicine in both Traditional Chinese Medicine and Western Medicine.Result:This research is a useful attempt to discuss the establishment of doctor-patient co-operated evidence-based medical record guided by the direction of narrative evidence-based medicine.Reflection and outlook:Doctor-patient co-operated medical record can be a key factor of the curative effect evaluation methodology system of integrated therapy of Tradition Chinese Medicine and Western Medicine on spleen and stomach diseases.

Calling into Question the Efficacy of Evidence-Based Medicine: Is It Always the Best Approach? Is That Really the Placebo Effect?

The techniques of evidence-based medicine (EBM) are being frequently used recently. The generally accepted theory is that if a medicine is not absorbed by the body, it will have no effect. However, the author has noticed that even when substances, including medicines, are not absorbed by the body, they can have a marked effect. In some cases, just bringing the substance close to the body can have an effect;in such cases, the efficacy of EBM for estimating the therapeutic value of medicines may be debatable. Therefore, a more accurate evaluation method should be devised. The author proposes that another group be introduced into trials. This group would include subjects who were exposed to but did not have an opportunity to absorb the medicine being tested.

Evidence-Based Medicine Research on Prescriptions in Synopsis of the Golden Chamber in the Treatment of Pelvic Inflammatory Disease

Purpose: Based on the National Natural Science Foundation of China, we collect and sort out the literature published in approximately the last 30 years, which use prescriptions in Synopsis of the Golden Chamber to treat pelvic inflammatory disease (PID). This study provides theoretical basis for the treatment of PID;we recommend this achievement to colleagues. Method: Firstly, we searched and collected the literatures from last three decades in CNKI, Wanfang and VIP databases, which are about classical prescriptions treating endometriosis. Then, by screening all the literatures, we obtained the clinical research literatures and individual case reports. Finally, we went through the internal quality of the two categories of literatures to get the dominant prescriptions. Using a retrospective study of evidence-based medicine research, we comprehensively collect literature, standardize the disease spectrum, classify the evidence, and then evaluate the internal quality. Results: We refine 4 prescriptions which commonly are used in the treatment of PID;in other words, they are also the clinical symptoms of PID: Gui Zhi Fu Ling Wan symptom, which manifests blood stasis and cold-damp stagnancy;Dang Gui Shao Yao San symptom, which manifests disharmony of liver and spleen, qi-blood stasis and damp obstruction;Da Huang Mu Dan Tang symptom, which manifests the gathering toxic heat and qi-blood stasis;Yi Yi Fu Zi Bai Jiang San symptom, which manifests the internal toxic heat and qi-blood injury. Conclusion: This study is gospel for the patients with recurrent episodes of PID who can’t often use antibiotics. At the same time, it is also a green therapeutics which Chinese ancients dedicated to human medicine.

Management of upper gastrointestinal bleeding emergencies： evidence-based medicine and practical considerations

Acute upper gastrointestinal （GI） bleeding remains one of the most common encounters in emergency medicine. The increased use of non-steroid anti-inflammatory drugs by the general population and the increased prescription of anti-platelet agents and anti-coagulants after cardiovascular interventions and for prevention of cerebral vascular accidents may have aggravated the situation. Significant progress has been made in the past decade or so in the non-surgical management of acute upper GI bleeding emergencies. This article will review the current standard treatment of the most common upper GI bleeding emergencies in adults as supported by evidence- based medicine with practical considerations from the authors＇ own practice experience.

The concept of narrative evidence-based medicine and shared decision-making in traditional Chinese medical practice

For the explosive development of emerging diagnostic and therapeutic technologies brought by the advancement of precision medicine strategy, shared decision-making could improve the quality of clinical decision-making and promote the transformation of clinical research evidence in TCM. Paying attention to patients＇ narrative needs and strengthening medical humanistic concerns could improve clinical outcome and patient satisfaction. We described the origins and development of evidence-based medicine, narrative medicine and shared decision-making, and analyzed the existing problems in TCM clinical decision-making. Further, we put forward the model of shared decision-making between clinicians and patients under the guidance of narrative evidence-based medicine concepts and methods.

Evidence-based optimization of integrated traditional Chinese and Western medicine therapies for prevention and treatment of coronary heart disease： design and implementation

As a chronic disease that seriously endangers public health, the number of coronary heart disease （CHD） patients in China has increased in recent years. There is great potentiality to integrate traditional Chinese and Western medicine therapies to prevent and treat CHD in clinical practice. However, most of the current integrated therapies still lack sufficient high-quality evidence, and the key links in how to apply are unclear. It is urgent to optimize them through evidence-based research to further improve the effectiveness. Therefore, we propose strategies to conduct evidence-based optimization of integrated traditional Chinese and Western medicine therapies in prevention and treatment of progressive cardiovascular diseases. These are integrated clinical trial design, attention to the key links of taking effect, combination of clinical and basic research. Based on the strategies, we started the national key research and development project ＂Evidence-based optimization research of TCM therapies in prevention and treatment of CHD （angina pectoris - myocardial infarction - heart failure）＂, which is expected to be a new paradigm in the field.

Medical futility in the era of evidence-based medicine

One definition of futility is any treatment that merely preserves permanent unconsciousness or fails to end total dependence of a patient on intensive medical care However, no agreement has ever been reached on what the exact defmition of futility is, as it is not only based on temporary values but also evolves into different subtypes, making it harder to define. The difficulty in dealing with futility problem is how doctors evaluate the futile situation, which is further complicated by lack of standards for specific diseases and experience-based prognosis, leading to subjectivity in evaluation for futility.

Research in spinal surgery: Evaluation and practice of evidence-based medicine

Evidence-based medicine(EBM) is a common concept among medical practitioners, yet unique challenges arise when EBM is applied to spinal surgery. Due to the relative rarity of certain spinal disorders, and a lack of management equipoise, randomized controlled trials may be difficult to execute. Despite this, responsibility rests with spinal surgeons to design high quality studies in order to justify certain treatment modalities. The authors therefore review the tenets of implementing evidencebased research, through the lens of spinal disorders. The process of EBM begins with asking the correct question.An appropriate study is then designed based on the research question. Understanding study designs allows the spinal surgeon to assess the level of evidence provided.Validated outcome measurements allow clinicians to communicate the success of treatment strategies, and will increase the quality of a given study design. Importantly,one must recognize that the randomized controlled trial is not always the optimal study design for a given research question. Rather, prospective observational cohort studies may be more appropriate in certain circumstances, and would provide superior generalizability. Despite the challenges involved with EBM, it is the future of medicine. These issues surrounding EBM are important for spinal surgeons, as well as health policy makers and editorial boards, to have familiarity.

Thoughts on the Construction of Evidence-based Nursing Standard Plan for Dominant Diseases in Traditional Chinese Medicine

The evidence-based Traditional Chinese Medicine(TCM) nursing in standard plan is to be constructed by a combination of evidence-based thinking and expert consensus.(1) The symptoms of diseases with better curative effect in TCM and the nursing techniques of TCM based on scientific evidence can be preliminarily presented through bibliometric analysis.(2) Expert consultation letters can be developed based on bibliometric results, and symptoms of dominant diseases in TCM and TCM nursing techniques can be selected through those letters.(3) Based on the selected symptoms and TCM nursing techniques, the PICO can be determined, and then evidence search, evidence extraction, evidence analysis can be conducted and synthesized, and recommendations would be chosen.(4) The recommendation grade of each recommendation can be determined by applying the Delphi method and referring to GRADE.(5) The plan will be determined through discussions of experts. The construction of TCM nursing plan would make sure that TCM nursing is scientific, and internationalize TCM nursing.

Clinical effects of antidiabetic drugs on psoriasis:The perspective of evidence-based medicine

Psoriasis and diabetes shared common underlying pathophysiological mechanisms.Emerging data suggested that antidiabetic medications may improve the psoriasis severity in patients with diabetes mellitus.Several hypoglycemic agents including thiazolidinediones,glucagon-like peptide-1 receptor agonists,dipeptidyl peptidase-4 inhibitors,and biguanides have been reported to make a remarkable reduction in the Psoriasis Area and Severity Index score from baseline.This antipsoriatic effect could be mediated not only by the glucoselowering action of these agents but also via inhibition of keratinocyte over proliferation,increase expression of differentiation markers,suppression the immune inflammatory pathway,and blocking the calcium channels and mitogen-activated protein kinase signaling pathways.On the other hand,there was no significant increase in adverse reactions associated with the treatment of pioglitazone or metformin.However,previous studies often had the relatively short duration of the trials,and did not have enough power to assess recurrence of psoriasis.Potential bias in the study and missing data could undermine the reliability of the results.Therefore,the appropriately randomized controlled studies with large sample sizes and long-term durations in various psoriasis patients are warranted for further support.