Molecular authentication of commercial "Qian-hu" through the integration of nrDNA internal transcribed spacer 2 and nucleotide signature.

BACKGROUND: Peucedani Radix, also known as "Qian-hu" is a traditional Chinese medicine derived from Peucedanum praeruptorum Dunn. It is widely utilized for treating wind-heat colds and coughs accompanied by excessive phlegm. However, due to morphological similarities, limited resources, and heightened market demand, numerous substitutes and adulterants of Peucedani Radix have emerged within the herbal medicine market. Moreover, Peucedani Radix is typically dried and sliced for sale, rendering traditional identification methods challenging. MATERIALS AND METHODS: We initially examined and compared 104 commercial "Qian-hu" samples from various Chinese medicinal markets and 44 species representing genuine, adulterants or substitutes, utilizing the mini barcode ITS2 region to elucidate the botanical origins of the commercial "Qian-hu". The nucleotide signature specific to Peucedani Radix was subsequently developed by analyzing the polymorphic sites within the aligned ITS2 sequences. RESULTS: The results demonstrated a success rate of 100% and 93.3% for DNA extraction and PCR amplification, respectively. Forty-five samples were authentic "Qian-hu", while the remaining samples were all adulterants, originating from nine distinct species. Peucedani Radix, its substitutes, and adulterants were successfully identified based on the neighbor-joining tree. The 24-bp nucleotide signature (5'-ATTGTCGTACGAATCCTCGTCGTC-3') revealed distinct differences between Peucedani Radix and its common substitutes and adulterants. The newly designed specific primers (PR-F/PR-R) can amplify the nucleotide signature region from commercial samples and processed materials with severe DNA degradation. CONCLUSIONS: We advocate for the utilization of ITS2 and nucleotide signature for the rapid and precise identification of herbal medicines and their adulterants to regulate the Chinese herbal medicine industry.

Perspectives and Practice in Eastern and Western Medicine for Pain Management in Rehabilitation Training after Orthopedic Trauma Surgery: A Qualitative Study.

BACKGROUND: Despite the increasing emphasis on rehabilitation training after orthopedic surgery, little is known about the pain caused by the procedure itself. Clinical practice is driven by beliefs in pain management. AIMS: This study aimed to explore the perspective of pain management during rehabilitation training after orthopedic trauma in China and its influencing factors from different perspectives in traditional Chinese medicine and Western medicine, respectively. DESIGN: A phenomenological qualitative study involving semi-structured interviews. SETTINGS:   METHODS: A qualitative study was conducted with 16 medical workers working in the Rehabilitation Medicine Department in eastern China from July 2022-February 2023. A directed method to thematic analysis was used to code the transcribed data and identify themes. RESULTS: Four main themes emerged. (1) Inconsistent perspectives and practice: Chinese doctors majoring in Western medicine felt sympathy, helpless, and had a lack of knowledge and misconception about pain. Traditional Chinese medicine deemed that pain is a protective mechanism and attached importance to holism and unique means. (2) Consistent outcome: Insufficient pain management will have a series of negative consequences for patients' recovery, forming a vicious cycle. (3) Expectations: Though they are not optimistic about traditional analgesics, enhancement, cooperation and ideal analgesic methods still be expressed, and (4) Concept transformation: Conducting nitrous oxide is a process not only to promote analgesic technology but also to promote the awareness and concept of pain management. CONCLUSIONS: Our study emphasized that medical workers should be aware of the importance of pain management at the same time while treating the disability. The study provides insight into pain management experiences within different educational backgrounds. The findings enable professionals to recognize the importance of pain management and its influencing factors to provide feasible and effective pain management strategies.

[Methodological and reporting quality of randomized controlled trials on the treatment of benign prostatic hyperplasia with traditional Chinese medicine].

OBJECTIVE: To systematically evaluate the methodological quality and reporting quality of randomized controlled trials (RCT) on the treatment of BPH with traditional Chinese medicine (TCM), in order to provide some methodological reference for clinical practice and research. METHODS: We searched CNKI, VIP, Wanfang Data and PubMed for RCTs on the treatment of BPH with TCM published in China from January 2013 to November 2023. Two researchers screened the literature separately, and evaluated the methodological and reporting quality of the RCTs based on the Cochrane bias risk assessment tool and CONSORT TCM compound. RESULTS: Totally, 88 RCTs were included in this study. In terms of methodological quality, according to the Cochrane bias risk assessment tool, 27 biases in the process of randomization were identified as of low-risk and the other 61 of a certain risk. Among the allocation-related biases deviating from the established interventions, 76 were of low risk, 10 of a certain risk and 2 of high risk; among the compliance-related biases deviating from the established interventions, 76 were of low risk and 12 of a certain risk; among the biases due to missing outcome data, 86 were of low risk and 2 of a certain risk, while all the biases due to outcome measurement were of low risk; and among the biases from selective reporting, 65 were of low-risk, 2 of a certain risk and 21 of high-risk. In terms of reporting quality, according to the evaluation criteria of consort TCM compound, appropriate key words were used in 1 RCT (0.01%), the random assignment sequence method described in 27 (30.68%), the details of assignment limitation given in 5 (5.68%), assignment concealment mentioned in 3 (3.41%), the blind method and assignment concealment employed in 3 (3.41%), fall-offs recorded in 10 (11.36%), adverse events reported in 38 (43.18%), and limitations of the trials analyzed in 18 (20.45%). All the RCTs lacked complete intervention measures, subject flow chart, clinical trial registration and research schemes. CONCLUSION: At present, the methodological quality and reporting quality of RCTs on the treatment of BPH with TCM are generally low, with the main problems of incomplete experimental designs, lack of detailed description of randomized and blind methods, and insufficient TCM symptom evaluation of outcome indicators. Researchers should be cautious in adopting and applying the results reported, follow the CONSORT statement in design, registration, implement and reporting of the scheme, fully consider the clinical characteristics of TCM in the treatment of BPH, and reasonably design and report the evaluation indicators.

[Establishment and content validity assessment of evaluation index system for development value of traditional Chinese medicine preparations in medical institutions].

The development of traditional Chinese medicine(TCM) preparations as an incubator for new drugs in medical institutions has flourished, while an evaluation index system remains to be established for comprehensively assessing the development value of these prescriptions. This study established an item pool through literature research, employed the Delphi method to determine the content of evaluation indexes, and adopted the superiority chart to determine the weight of each index. Two-level evaluation index system for the development value of TCM preparations in medical institutions was established, which included 7 first-level items and 36 se-cond-level items, demonstrating scientific validity. The first-level items(weight) were inheritance(10.61%), effectiveness(23.22%), safety(22.71%), innovation(13.21%), economy(10.00%), suitability(8.57%), and accessibility(11.68%). The top three second-level items in terms of weight distribution were adverse reaction monitoring(6.73%), evidence of therapeutic effect(5.71%), and clinical response rate(4.75%). The bottom three second-level items were production advantages(0.86%), medicinal dosage(0.48%), and medicinal smell or taste(0.18%). The content validity of the established system was assessed, which revealed that the index system was reliable, with the overall and average content validity indexes of 0.47 and 0.90, respectively. Furthermore, the established evaluation index system was used to evaluate six TCM preparations in a city-level hospital of TCM in Sichuan Province, which demonstrated that the system had operability. The results indicate that the evaluation index system is scientific, reliable, and operable, providing a reference for developers to selectively develop TCM preparations in medical institutions. In practical application, the system can be adjusted regarding the index weights according to actual conditions.

[Application of process analysis technology in traditional Chinese medicine manufacturing industry].

In the traditional Chinese medicine(TCM) manufacturing industry, quality control determines the safety, effectiveness, and quality stability of the final product. The traditional quality control method generally carries out sampling off-line testing of drugs after the end of the batch production, which is incomprehensive, and it fails to find the problems in the production process in time. Process analysis technology(PAT) uses process testing, mathematical modeling, data analysis, and other technologies to collect, analyze, feedback, control, and continuously improve the critical quality attributes(CQA) in all aspects of the production of TCM preparations in real time. The application of PAT in the TCM manufacturing industry is one of the research hotspots in recent years, which has the advantages of real-time, systematic, non-destructive, green, and rapid detection for the production quality control of TCM preparations. It can effectively ensure the stability of the quality of TCM preparations, improve production efficiency, and play a key role in the study of the quantity and quality transfer law of TCM. Commonly used PAT includes near-infrared spectroscopy, Raman spectroscopy, online microwave, etc. In addition, the establishment of an online detection model by PAT is the key basic work to realize intelligent manufacturing in TCM production. Obtaining real-time online detection data through PAT and establishing a closed-loop control model on this basis are a key common technical difficulty in the industry. This paper adopted systematic literature analysis to summarize the relevant Chinese and foreign literature, policies and regulations, and production applications, and it introduced the development trend and practical application of PAT, so as to provide references for accelerating the application of PAT in the TCM manufacturing industry, the intelligent transformation and upgrading, and high-quality development of the TCM industry.

[Guideline for diagnosis and treatment of recurrent spontaneous abortion with integrated traditional Chinese and western medicine].

Recurrent spontaneous abortion is one of the most common pregnancy complications in obstetrics and gynecology. The normative diagnosis and treatment of recurrent spontaneous abortion has become an important problem to be solved urgently in the field of reproductive health. The integrated traditional Chinese and western medicine provides a safe and effective treatment method for recurrent spontaneous abortion, but there is no guideline for diagnosis and treatment of recurrent spontaneous abortion with integrated traditional Chinese and western medicine. The guideline is based on the requirements of World Health Organization(WHO) handbook for guideline development and follows the principles of evidence-based medicine. Through literature pre-search, expert interviews, clinical research, and conference consensus, 16 clinical problems are identified in this guideline. PICO principles are used for evidence retrieval, screening, and synthesis. The evidence quality is evaluated for the included evidence bodies. Recommendation opinions and consensus suggestions are formed through three rounds of the Delphi expert questionnaire survey. An expert meeting is held to finalize the draft. The opinions of experts in traditional Chinese medicine, western medicine, integrated traditional Chinese and western medicine, methodology and pharmacy are widely solicited. The guideline contains five parts: scope, term and definition, diagnosis, treatment, and diagnosis and treatment flow chart of integrated traditional Chinese and western medicine. There are corresponding recommendations and summaries of evidence for clinical problems related to the diagnosis and treatment of integrated traditional Chinese and western medicine. This guideline is guided by clinical problems, combining disease differentiation and syndrome differentiation and integrating pre-pregnancy regulation and treatment and post-pregnancy preservation, highlighting the therapeutic advantages of integrated traditional Chinese and western medicine, so as to further standardize the clinical diagnosis and treatment of recurrent spontaneous abortion and promote the diagnosis and treatment level of integrated traditional Chinese and western medicine for recurrent spontaneous abortion.

[Problems and thoughts in clinical safety evaluation of traditional Chinese medicine].

Amid the modernization and internationalization of traditional Chinese medicine(TCM), the safety of TCM has attracted much attention. At the moment, the government, scientific research teams, and pharmaceutical enterprises have made great efforts to explore methods and techniques for clinical safety evaluation of TCM. Although considerable achievements have been made, there are still many problems, such as the non-standard terms of adverse reactions of TCM, unclear evaluation indicators, unreasonable judgment methods, lack of evaluation models, out-of-date evaluation standards, and unsound reporting systems. Therefore, it is urgent to further deepen the research mode and method of clinical safety evaluation of TCM. Based on the current national requirements for the life-cycle management of drugs, this study focused on the problems in the five dimensions of clinical safety evaluation of TCM, including normative terms, evaluation modes, judgment methods, evaluation standards, and reporting systems, and proposed suggestions on the development of a life-cycle clinical safety evaluation method that conformed to the characteristics of TCM, hoping to provide a reference for future research.

Key factors influencing the TCM nomenclature in international standards.

Amid the globalization of traditional Chinese medicine (TCM), the English translation of related texts is in full swing. Several representative international organizations in fields regarding standardization and healthcare, one after another, have published a series of international standards for TCM nomenclature. With these efforts, the internationalization of TCM has been dramatically advanced. When selecting parallel texts for reference, translators need to be aware of key factors influencing the English translation of TCM terms in international standards, including the distinctive characteristics of this discipline and relevant influences of international standard makers. In this way, proper standards and reasonable English expression can be chosen for specific terms, thus stimulating the effective use of TCM nomenclature with consensus.

Status and prospect of international standardization of TCM diagnosis.

The present study aimed to review the current status and development of international standards in the domain of traditional Chinese medicine (TCM) diagnosis. Moreover, the roles and relevant work of different organizations in developing such standards were explored, and the difficulties and challenges encountered were analyzed. The study further elaborated on the approaches to establish a complete set of international standards on TCM diagnosis. It also provided a promising solution for the development of international standards on TCM diagnosis.

Features and development trends in international standardization of Chinese materia medica in ISO/TC 249.

Chinese materia medica (CMM) is indispensable component of Traditional Chinese Medicine (TCM) therapy. With the widespread of TCM around the world, the quality control and safe use of CMM become a major concern. This paper introduces the role of ISO standards for industrial development and current development status of CMM standards in ISO/TC 249. Through the comparison of similarities and differences between CMM standards in ISO/TC 249 and pharmacopoeias of main stakeholders, this paper suggests strengthening standard formulation in the following areas to provide more appropriate documents to facilitate the international trade and promote the industrial development of CMM: (1) Develop standards to fill the blanks among the whole industry chain of CMM; (2) Develop standards for new forms of CMM and services; (3) Develop specification and grade standards for CMM with large quantity and high value.

Development status and prospects of international standardization of medical devices of Traditional Chinese Medicine.

As Traditional Chinese Medicine (TCM) becomes widely used in many countries around the world, global demand for intelligent and modernized medical devices of TCM is increasing. Medical devices of TCM have played an important role in diagnosis and treatment of disease. Standardization on medical devices of TCM cannot only be beneficial to ensuring the life safety of patients, but also to enhancing the effectiveness of diagnosis and treatment. This paper includes (1) classification and trends in medical devices of TCM; (2) status review on international standardization of medical devices of TCM; (3) key technical factors in developing international standards for medical devices of TCM and (4) prospects for international standardization development of medical devices of TCM.

The RIGHT Extension Statement for Traditional Chinese Medicine: Development, Recommendations, and Explanation.

Nowadays, the number of traditional Chinese medicine (TCM) guidelines is constantly increasing, but its reporting quality remains unsatisfactory. One of the main reasons is that there is a lack of suitable reporting standard to guide it. In response to this long-standing problem, the Reporting Items for practice Guidelines in HealThcare (RIGHT) Working Group has invited a group of TCM clinical experts, methodologists and epidemiology, and developed the RIGHT Extension Statement for TCM (RIGHT-TCM) through a multi-staged development process, including systematic review, reporting quality evaluation and online Delphi expert consensus. The RIGHT-TCM extends two sections of the RIGHT Statement, includes basic information and recommendations section. Seven strong recommendation sub-items were added to RIGHT Statement and formed the final RIGHT-TCM. The group hopes that the RIGHT-TCM may assist TCM guideline developers in reporting guidelines, support journal editors and peer reviewers when considering TCM guideline reports, and help health care practitioners understand and implement a TCM guideline. This article will introduce its background, development, recommendations and explanation.

The importance of regulating the education and training of Traditional Chinese Medicine practitioners and a potential role for ISO/TC 249.

As Traditional Chinese Medicine (TCM) transcends its cultural boundaries and becomes widely used in many countries around the world, one of the major risks to the growing use of TCM internationally is the damage caused to its reputation and to community safety when TCM practitioners are not adequately trained. Ensuring the quality and competency of TCM practitioners is a fundamental requirement. This paper covers (1) the current level of regulation of education and training of TCM practitioners particularly in countries with well developed health systems; (2) the progress of self regulatory standards for education and training developed by international organizations and (3) the potential role of ISO/TC 249 in assisting these initiatives.

Analysis on the current quality standards of Chinese materia Medica used in COVID-19 prevention and treatment.

PURPOSE: Traditional Chinese medicine (TCM) has fully engaged and played an essential role in the prevention and treatment of Coronavirus Disease 2019 (COVID-19). This study compares relevant standards on high-frequent Chinese Materia Medicia (CMM) used in this pandemic aiming at reaching a global consensus and ensuring the use of Chinese medicines safely. METHODS: 141 representative Chinese formulas and Chinese Patent Medicines from the National Protocol and the most of Provincial Protocols for controlling COVID-19 in China have been collected to statistical analyze the composition and characteristics of CMM. Among them, the domestic and international standards of 47 varieties with the frequency usage over 10 times were selected to compare their quality requirements in the mainstream pharmacopoeias and international standards. RESULTS: The quality requirements of used CMM for fighting COVID-19 on the terms of overall quality control, marker compounds, and safety indicators showed different patterns in these mainstream pharmacopoeias and international standards. The uniformed and scientific quality standards of CMM were urgently needed to promote global acceptation and trade. CONCLUSIONS: These findings will provide evidence for building unified quality and safety standards that can adapt to the characteristics of CMM and promote international trade, and also will be stated that it is of the highest priority for ISO/TC 249 to formulate high-quality standards that consolidate international consensus to ensure quality and safety of the urgently needed CMM.

Use of a tolerance interval approach as a statistical quality control tool for traditional Chinese medicine.

Raw materials for traditional Chinese medicine (TCM) are often from different resources and its final product may also be made by different sites. Therefore, variabilities from different resources such as site-to-site or within site component-to-component may be expected. Consequently, test for consistency in raw materials, in-process materials, and/or final product has become an important issue in the quality control (QC) process in TCM development. In this paper, a statistical QC process for raw materials and/or the final product of TCM is proposed based on a two sided [Formula: see text]-content, [Formula: see text]-confidence tolerance interval. More specifically, we construct the tolerance interval for a random-effects model to assess the QC of TCM products from different regions and possibly different product batches. The products can be claimed to be consistency when the constructed tolerance interval is within the permitted range. Given the region and batch effects, sample sizes can also be calculated to ensure the desired measure of goodness. An example is presented to illustrate the proposed approach.

A review about industrialization of Chinese materia medica decoction pieces.

Chinese materia medica decoction pieces (CMMDPs), one of the three pillars of the Chinese materia medica industry, are a key link in the Chinese materia medica industrial chain. Industrialization is the only way for the modernization of CMMDPs. This review mainly summarizes the characteristics, history, current situation and prospect of CMMDPs industry, providing a new reference for promoting the flourishing development of the industrialization of CMMDPs and for serving massive health industry. The literature was collected from databases including Web of Science, PubMed, Elsevier and CNKI (Chinese). CMMDPs industry has the characteristics of regionalism, resource dependency, customer diversity and low industrial concentration. Deeply processed products include traditional Chinese medicine (TCM) formula granules, small-packed decoction pieces, ultrafine decoction pieces, puffed decoction pieces, compressed decoction pieces and instant decoction pieces. Integration of treatment and processing at the place of origin is emerging. However, there is still room for improvement, for example, the manufacturing technologies of CMMDPs industry need to be continually improved. The management of CMMDPs' normalized production also needs to be strengthened. The quality of CMMDPs should be strengthened supervision and it should establish the objective and feasible quality evaluation system for CMMDPs. At present, China has attached unprecedented importance to the development of TCM, and issued a number of supporting policies, sparing no effort to support its development.

[Academician Wang Qi's medication rules for oligoasthenozoospermia: An analysis based on the Traditional Chinese Medicine Inheritance Auxiliary Platform].

OBJECTIVE: To analyze the medication rules for oligoasthenozoospermia (OAZ) observed by Wang Qi, an academician, master of Traditional Chinese Medicine (TCM) and initiator of andrology in TCM. METHODS: We collected the outpatient cases of OAZ treated by Wang Qi and established a database of clinical medical records using the TCM Inheritance Auxiliary Platform. Employing the integrated rule-based system for analysis of the software, we modified the mutual information method, complex system entropy clustering analysis and other data mining methods, and summarized the medication rules Wang Qi followed in the treatment of OAZ. RESULTS: A total of 134 prescriptions made by Wang Qi for the treatment of OAZ were collected, involving 110 TCM drugs, which are mainly neutral and warm in nature and taste sweet and mostly act through the liver and kidney meridians. The core formula ingredients of the prescriptions included Morinda officinalis, Cuscuta chinensis, Lycium barbarum, Mulberry, Angelica sinensis, Astragalus mongholicus and Fish Maw, and most frequently Morinda officinalis, Cuscuta chinensis, Lycium barbarum and Mulberry. CONCLUSIONS: Wang Qi holds that kidney deficiency, dampness-heat, blood stasis and toxin are the main pathogenic factors for OAZ. The basic treatment of OAZ is to invigorate the kidney and replenish the essence, and meanwhile activate blood circulation, dissipate stasis and eliminate dampness-heat.

Application evaluation of clinical practice guidelines for traditional Chinese medicine: a clinical analysis based on the analytic hierarchy process.

BACKGROUND: Clinical Practice Guidelines (CPGs) play an important role in clinical practice, and they require appropriate evaluation, especially in application. This study explores the application evaluation method of CPGs for Traditional Chinese Medicines (TCM). It uses the Analytic Hierarchy Process (AHP) and clinical cases to evaluate the consistency between CPGs of TCM and clinical practice. METHODS: To evaluate the consistency between CPGs of TCM and clinical cases, a 3-level AHP construction was built. Weightings were calculated by collecting questionnaires according to AHP theory. To test the evaluation system, a retrospective study was performed. The study evaluated the China Association of Chinese Medicine's Guidelines for Diagnosis and Treatment of Common Internal Diseases in Chinese Medicine Diseases of Modern Medicine (CPGs of DTCID) (ZYYXH/T50-135-2008). A total of 150 cases were involved. The evaluation system was used to assess the consistency between CPGs of DTCID and clinical cases of angina pectoris. RESULTS: The results showed that the overall consistency between CPGs of DTCID and the 150 cases was 42.32 ± 6.94%, ranging from 35.21 to 63.37%. The overall consistency was not affected by age, gender, type of angina pectoris, condition of percutaneous coronary intervention (PCI), or angina classification as determined by the Canadian Cardiovascular Society. The consistencies of each index were as follows: Diagnosis of TCM, 100%; Diagnosis of Western medicine, 100%; Syndrome classification, 38.25 ± 4.40%; Syndrome key point, 34.17 ± 8.15%; TCM Decoction, 31.08 ± 23.64%; TCM particular treatment, 7.92 ± 19.13%; and Recuperation and prevention, 0. The most frequent syndromes were qi-deficiency, phlegm and blood stasis (n = 124) (82.7%). The overall consistency of qi-deficiency, turbid phlegm and blood stasis was lower than the overall consistency of the group without that syndrome. The difference was statistically significant (P < 0.05). 42 cases (28%) applied the TCM decoction recommended by CPGs of DTCID. Of these, Gualouxiebaibanxia decoction was applied in 34 cases. Wendan decoction, the most frequently used, was applied in 64 cases (42.7%). CONCLUSION: This study indicates that the AHP system can perform quantitative evaluation of consistency between TCM CPG and clinical practice. It also found the factors affecting the application of TCM CPGs and might indicate the need for revisions of CPGs.