Improving the relevance and quality of clinical trials in traditional Chinese medicine

See related article, pages 1973–1979. The lack of effective and widely applicable pharmacological treatments for ischemic stroke patients may explain a growing interest in traditional medicines, for which extensive observational and anecdotal experience has accumulated over the past thousand years. The World Health Organization (WHO) defines traditional medicine as “health practices, approaches, knowledge and beliefs incorporating plant, animal and mineral based medicines, spiritual therapies, manual techniques and exercises, applied singularly or in combination to treat, diagnose and prevent illnesses or maintain well-being”.1 Unlike Western medicine, which focuses on disease, traditional medicine takes the approach that the body provides external clues to an internal imbalance that can be addressed by interventions such as herbs and acupuncture (holistic treatment approach).2 According to a 2003 WHO report,1 traditional medicine is very popular in all developing countries, and its use is rapidly increasing in industrialized countries. For example, traditional herbal preparations account for 30% to 50% of the total medicinal consumption in China. In Europe, North America and other industrialized regions, over 50% of the population have used traditional medicine at least once. The global market for herbal medicines currently stands at over US $60 billion annually and is growing steadily.1 In recent years, several reviews have been published on the effect and potential benefits of traditional Eastern medicine in stroke.3–7 It has been suggested that some herbal medicines, or their products, may improve microcirculation in the brain,4,8 protect against ischemic reperfusion injury,8,9 possess neuroprotective properties3,4 and inhibit apoptosis,10 thus justifying their use in ischemic stroke patients. However, unlike industrially manufactured pharmacological drugs used in Western medicine, the active (potent) components of herbal medicines often have not been specified and measured precisely, although there have been recent attempts to regulate dosages and use of …

Improving research on the efficacy, effectiveness, and harms of traditional chinese medicine.

Methodological quality assessment of clinical trials in traditional Chinese medicine: the principles of evidence-based medicine

Factors influencing the quality of clinical trials on traditional Chinese medicine—Qualitative interviews with trial auditors, clinicians and academic researchers

Objective This study aimed to assess the clinical efficacy and safety of the treatment of refractory nephrotic syndrome with integrated traditional Chinese and western medicine. Methods The study was a prospective, randomized, double-blind, 2∶1 basic-control, multi-center clinical trial, with 120 patients recruited from 7 hospitals in China. The test group was administered with traditional Chinese medicine (TCM) particles on the base of prednisone and cyclophosphamide treatment for 3 months, while the control group was administered with placebo using the same method. The 24-hour urinary protein, serum albumin, serum creatinine, TCM syndrome score and adverse reactions were monitored timely. SPSS 20.0 software was used for data analysis. Results At 3 months, the total effective rate was 89.39% and 63.64% for the test and the control, respectively, the difference of which was of statistical significance (χ2=7.824, P=0.005). The total effective rate of TCM syndromes was 93.94% and 72.73% for the test and the control, respectively, the difference of which was also of statistical significance (χ2=6.918, P=0.009). The incidence of Cushing′s syndrome, digestive tract reactions, and infections in the test group were lower than in the control group, the difference of which was of statistical significance (χ2=7.666, P=0.006; χ2=5.088, P=0.024; χ2=5.227, P=0.022). Conclusion Treatment with integrated traditional Chinese and western medicine effectively improved the clinical efficacy of refractory nephrotic syndrome, improved the clinical symptoms, and reduced the side effects of immunosuppressive agents. Key words: Treatment with integrated traditional Chinese and western medicine; Refractory nephrotic syndrom; Clinical trial

Expert symposium on severe acute hepatitis of unknown cause in children, a paradigm of exchanges and sharing between Chinese and Western medicine professionals.

Clinical practice guidelines for the diagnosis and treatment of atopic dermatitis with integrative traditional Chinese and Western medicine.

: In China, allergic rhinitis patients are looking not only for western therapy in Chinese traditional medicine but also for treatment in Western and Chinese mixed medicine. Several studies have compared traditional Chinese medicine, Western and Western combined. Such three forms of treatment were not analyzed simultaneously. Aim: The research examines the differences between populations and medical applications of allergic rhinitis patients who received all three treatments to determine the use of different drugs. Methods: The inventory for patients diagnosed with allergic rhinitis (International Disease Classification). The Chi-square test and Tukey test were performed for the region of interest to check the disparity between these three treatments (a significant difference still exists). Results: The interview rate for women with allergic rhinitis is higher than for men regardless of whether it is treatment with traditional Chinese medicine, Western or combined traditional Chinese and Western medicine. Persons 0-19 years of age was first in the proportion of allergic rhinitis diagnosis and care. Traditional Chinese medicine includes medical measures with maximum hours per person, the daily cost per hour of medicines and minimum overall hourly expenditure. Western medicine, by comparison, costs the lowest daily drug per hour, and the highest total drug costs per hour per person. Between traditional Chinese and western medicine, the total cost per capita of integrated traditional Chinese and Western Medicine as well as drug costs per capita and the total cost per capita. Conclusion: Although only 6.82% of allergic rhinitis patients opt for combined traditional Chinese medicines and western medicine, their rate of receipt is higher each year. Moreover, mixed medications are used more frequently compared to single-component medicines

To analyze the outcome indicators of randomized controlled trial(RCT) of traditional Chinese medicine(TCM) in the treatment of non-severe community-acquired pneumonia(NSCAP), and to provide a basis for the design of NSCAP clinical trials and the construction of core outcome set. CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, and Web of Science were systematically searched from establishment to August 31, 2023. Two reviewers independently screened the literature, extracted data, and evaluated the risk of bias in the included studies. Qualitative analysis was used to describe the outcome indicators of the included studies. A total of 42 903 articles were preliminarily obtained, and 47 articles were finally included(4 articles in English and 43 articles in Chinese core). Seventy-nine outcome indicators were extracted, with 434 times. They were mainly divided into 9 categories: physical and chemical indicators(23 kinds, 96 times) [including inflammatory indicators(16 kinds, 78 times), arterial blood gas analysis(4 kinds, 8 times), and immune indicators(3 kinds, 10 times)], symptoms and signs(7 kinds, 86 times), clinical efficacy time(15 kinds, 83 times), clinical efficacy rate(12 kinds, 69 times), safety events(3 kinds, 50 times), TCM syndrome efficacy(4 kinds, 26 times), rating scales(13 kinds, 22 times), economic indicators(1 kind, 1 time), and other indicators(1 kind, 1 time). Numerous issues with the selection of outcome indicators of RCT in TCM treatment of NSCAP existed. These issues primarily showed up as unclear distinctions between primary and secondary outcome indicators, non-standard end point selection and TCM syndrome efficacy indicator evaluation criteria, and insufficiently used quality of life scales and health economics indicators. It is suggested to refer to the establishment method of the international core outcome set, improve the standardized TCM clinical efficacy evaluation system for NSCAP under the doctor-patient co-construction mode, and improve the quality of clinical trial.

Discussion on definition of "traditional Chinese medicine and western medicine integration" and "integrated traditional Chinese and western medicine"

Data of clinical trial projects involved by clinical trial institutions certified by the State Food and Drug Administration from 2002 to November 2012 were collected to summarize adverse reactions in project summary/statistical reports, analyze the rate of adverse reactions of clinical trials of new traditional Chinese medicines and relevant influencing factors, and increase the awareness of the safety of new traditional Chinese medicines. A total of 73 050 cases in 209 projects of 14 specialties were collected, including 49 689 cases in the new traditional Chinese medicine group and 271 adverse reaction cases, with an incidence rate of adverse reactions at 0.55%. The adverse reaction rate in 3 months < middle long course ≤ 6 months was the highest (1.04%), whereas that in short course ≤ half a month was the lowest (0.48%). The adverse reaction was closely related with the route of administration, 1.28% for topical > 0.63% for injection > 0.50% for oral. In the administration of only the test drug, the adverse reaction rate of patches was the highest (2.68%), whereas that of aerosols and suppositories was lowest (0). In the combined administration of the test drug and the simulation agent, the adverse reaction rate of external test patch + capsule was the highest (3.38%), whereas that of capsule + oral liquid, pills + granules, tablets + oral liquid, tablets + pills, tablet + capsule was the lowest (0). In the administration of only the test drug, the adverse reaction rate was 0.47%; In the combined administration with simulation agent (drug volume increase), the adverse reaction rate was 0.74%. Different doses caused adverse reaction different rates; The adverse reaction rate of drugs with whole-course dose between 1 100-1 200 g was the highest (3.36%), that for whole-course doses of 500-600, 900-1 000, 1 400-1 500, 1 600-1 700, 1 800-1 900 g was the lowest (0). In conclusion, the adverse reaction rate of new traditional Chinese medicines was still up to 0.55%, with the adverse reaction rate between 0.47% and 0.72% over the 11 years, without significant difference in each year. The adverse reaction rate was closely related to course of treatment, approach of administration, dosage form and medication dosage, with no significant correlation with medication dosage during the course of treatment. The adverse reaction rate increased with the rise in trial duration and drug volume. In the administration of only the test drug, the adverse reaction rates of external formulations and injections were higher than that of oral dosage forms. It is suggested to give more attention to the adverse reactions of drugs with long course of treatment and large volumes, injections and external patches in clinical trials of new traditional Chinese medicines.

Considerations about treatment programs of elderly patients with hypertension

Traditional Chinese patent medicine (TCPM) is widely used for essential hypertension (EH) in China. However, there is no critically appraised evidence, such as systematic reviews or meta-analyses, regarding the potential benefits and disadvantages of TCPM to justify their clinical use and recommendation. The aim of this review was to systematically evaluate and meta-analyze the effects of TCPM for EH.Seven databases, the Cochrane Library, PubMed, EMBASE, the China National Knowledge Infrastructure, the Chinese Scientific Journal Database, the Chinese Biomedical Literature Database, and the Wanfang Database, were searched from their inception to August 2014 for relevant studies that compared one TCPM plus antihypertensive drugs versus antihypertensive drugs alone. The methodological quality of the included trials was assessed using the Cochrane risk-of-bias tool. The primary outcome measures were mortality or progression to severe complications and adverse events. The secondary outcome measures were blood pressure (BP) and quality of life (QOL).Seventy-three trials, which included 8138 patients, on 17 TCPMs were included. In general, the methodological quality was low. Two trials evaluated the effects of TCPMs on mortality and the progression to severe complications after treatment, and no significant difference was identified compared with antihypertensive drugs alone. No severe adverse events were reported. Thirteen TCPMs used in complementary therapy significantly decreased systolic BP by 3.94 to 13.50 mmHg and diastolic BP by 2.28 to 11.25 mmHg. QOL was significantly improved by TCPM plus antihypertensive drugs compared with antihypertensive drugs alone.This systematic review provided the first classification of clinical evidence for the effectiveness of TCPM for EH. The usage of TCPMs for EH was supported by evidence of class level III. As a result of the methodological drawbacks of the included studies, more rigorously designed randomized controlled trials that focus on mortality and cardiovascular events during long-term follow-up are warranted before TCPM can be recommended for hypertensive patients. Two TCPMs, Song ling xue mai kang capsules and Yang xue qing nao granules, should be prioritized for further research.

Study on the therapeutic effect of combined traditional Chinese and western medicine on gouty arthritis

Ovarian cancer (OC) has the highest mortality rate among gynecologic malignant tumors and is clinically difficult to cure. Traditional Chinese medicine (TCM) has shown unique advantages in the treatment of OC. However, there is currently a lack of normative guidance documents for the treatment of OC with integrated traditional Chinese and western medicine. The guidelines are the first comprehensive approach to diagnosing and treating OC by integrating TCM with western medicine. Adhering to evidence-based principles, the guidelines draw on the most recent advancements in OC treatment from both domestic and international researches. The guidelines formulate a variety of therapeutic methods, including oral Chinese herbal medicine, acupuncture, and external treatments, providing a treatment strategy for the combined use of TCM and western medicine in OC. Furthermore, the guidelines establish a diagnostic and treatment pathway for the holistic management of OC with TCM throughout the disease’s progression. The guidelines were officially published in the China Association of Chinese Medicine in January 2023, which provided a scientific basis for the formulation of clinical diagnosis and treatment strategies and promoted integration with international academic standards. This paper interpreted the features of the guidelines and the 7 PICO issues (Population, Intervention, Comparison, Outcome) in the whole TCM management of OC, aiming to help TCM and western medicine practitioners better understand and apply the guidelines, and provide better medical services for patients with OC.