1.Interpretation of Reporting Items for Practice Guidelines in Healthcare for Chinese Patent Medicines (RIGHT for CPM)
Liaoyao WANG ; Hejing PAN ; Le ZHANG ; Wenya WANG ; Xing LIAO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(1):211-218
The clinical practice guidelines for Chinese patent medicines (CPM) provide reference for the selection of national drug catalogs, the formulation of prescription collections in medical institutions, and the clinical use of CPM, constituting an important part of traditional Chinese medicine (TCM) guidelines. As a crucial part of Chinese drug supply guarantee system, CPM plays an important role in the treatment, prevention, and healthcare of many disease categories, whereas the application of CPM has problems of misuse and even abuse. To standardize the application of CPM, a research team at Zhejiang Chinese Medical University developed the Reporting Items for Practice Guidelines in Healthcare for Chinese Patent Medicines (RIGHT for CPM) based on the RIGHT checklist framework. The RIGHT for CPM checklist gathers key information from published CPM guidelines, existing TCM reporting checklists, and the RIGHT checklist and its extensions to form an initial pool of reporting items. Seventeen experts from different disciplines were invited to conduct two rounds of Delphi surveys, and the final checklist was reviewed and approved for publication by 18 leading experts in TCM research and guideline reporting from China and abroad. The RIGHT for CPM checklist adds 16 sub-items and revises 2 sub-items on the basis of the RIGHT checklist, highlighting the characteristics of CPM guideline reporting. It considers CPM selection and inclusion criteria, policy access, indications and symptoms, drug combination instructions, drug use in special populations, precautions, and recommendations of Western medical physicians, among others. This can further improve the quality and transparency of CPM guideline reporting, promote standardized reporting of CPM guidelines, and facilitate the rational clinical use of CPM. This article interprets the development process of the RIGHT for CPM checklist and the items that highlight the characteristics of CPM guidelines, with a view to promoting the application of the RIGHT for CPM checklist.
2.Clinical Evidence Profile of Eleven Expensive Chinese Patent Medicines: A Scoping Analysis
Yajing LI ; Miaomiao LI ; Le ZHANG ; Wenya WANG ; Hui ZHAO ; Xing LIAO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(2):227-238
ObjectiveThis study employed the scoping review method to systematically retrieve and analyze the basic information and clinical research evidence of expensive Chinese patent medicines (CPMs), aiming to provide a basis for future related research and clinical applications. MethodsEight Chinese and English databases were systematically searched for the clinical research evidence on expensive CPMs. ResultsEleven expensive CPMs (Angong Niuhuang Wan, Jufang Zhibao Wan, Suhexiang Wan, Pien Tze Huang, Niuhuang Qingxin Wan, Qinggong Shoutao Wan, Compound Realgar Natural Indigo Tablets, Xihuang Wan, Dingkun Wan, Babao Wan, and Guilingji Capsules) were selected. A total of 365 related studies were included in this review, comprising 331 clinical studies (of which 291 were randomized controlled trials), 30 systematic reviews and Meta-analyses, 3 expert consensus, and 1 rapid health technology assessment. Among the 11 CPMs, 2(Angong Niuhuang Wan and Jufang Zhibao Wan) had a daily price over 500 yuan. The famous and precious Chinese medicinal materials involved included Moschus (frequency of 7), Bovisc Alculus (7), and Borneol (5). The dosage forms included pills, capsules, oral liquid, tablets, and lozenges. The diseases treated by these CPMs mainly included malignant tumors, cerebrovascular diseases, gynecological diseases, and hepatobiliary system diseases. The sample sizes of the clinical studies were mainly concentrated within the range of 51-100 cases, and the main control form was CPM + basic Western medicine treatment vs. basic Western medicine treatment. The 331 clinical studies reported a total of 44 adverse events occurred, of which 36 were determined to be adverse reactions. ConclusionThe scarcity of raw materials leads to the high prices of expensive CPMs. The difficulty of conducting clinical research and the critical and severe cases treated lead to a lack of clinical research evidence with large sample sizes. The uneven distribution of existing studies, incomplete information on medicine package, and non-standard clinical research designs remain to be addressed in the future.
3.Exploring Academic Characteristics of Contemporary Experts and Schools in Traditional Chinese Medicine Gynecology in Treating Endometriosis Diseases Based on SrTO
Zhiran LI ; Xiaojun BU ; Xiaodan WANG ; Le ZHANG ; Ruixue LIU ; Jingyu REN ; Xing LIAO ; Weiwei SUN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(6):249-259
ObjectiveStarting from the etiology, pathogenesis, and treatment strategies of endometriosis and adenomyosis, to integrate and sort out the academic characteristics of contemporary renowned experts and schools in the field of traditional Chinese medicine gynecology. MethodsAccording to the systematic review of text and opinion (SrTO) process developed by the Joanna Briggs Institute (JBI) in Australia, this paper determined literature screening criteria by searching China National Knowledge Infrastructure (CNKI), VIP, Wanfang, and China Biomedical Literature Database. Information was extracted after literature screening, and quality evaluation was conducted using the JBI Narrative, Text, and Opinion Systematic Review Strict Evaluation Checklist. The JBI Narrative, Opinion, Text Evaluation, and Review Tool Summary Table was used for information synthesis, and data analysis and display were conducted in the form of text and charts. ResultsThe 146 articles related to 39 renowned experts and 19 articles related to 10 schools of thought were included. Research has found that contemporary experts and schools in traditional Chinese medicine gynecology consider blood stasis as the core pathogenesis in understanding the etiology and pathogenesis of two diseases and related infertility. Their viewpoints varied from multiple aspects such as clinical symptom characteristics, meridian circulation location, pathological product evolution, disease duration, emotional psychology, lifestyle habits, preference for food and drink, innate endowment, and acquired injury. In terms of treatment, it was advocated to divide the stage, treat according to different types, adapt to the times, integrate nature and humans, and combine multiple methods to treat comprehensively when necessary. It was also recommended to skillfully use insects, make good use of classic formulas and small prescriptions, pay attention to protecting the spleen and stomach and regulating emotions, and make good use of self-formulated empirical formulas for internal or external use. Besides, individualized long-term management of patients was also advocated. ConclusionThis study applies the SrTO process to systematically summarize the academic ideas of contemporary renowned experts and schools in traditional Chinese medicine gynecology regarding the causes, mechanisms, diagnosis, and treatments of endometriosis, providing a scientific and standardized reference for future theoretical exploration.
4.Comprehensive Evaluation of Acupuncture for Secondary Dysmenorrhea Based on Health Technology Assessment
Xue WU ; Zhiran LI ; Jing HU ; Xing LIAO ; Weiwei SUN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(9):165-174
ObjectiveTo carry out a health technology assessment (HTA) of acupuncture for secondary dysmenorrhea (SD) caused by adenomyosis and endometriosis, in order to provide a reference for relevant medical decision-making. MethodsFrom the perspective of the health system, the assessment covers seven areas, including the technical characteristics, safety, effectiveness, economics, ethical fairness, organizational adaptability, and impact on patients and society. The results are reported accordingly. ResultsThe operational specifications of acupuncture are standardized, and the conditions for its use are clearly defined. Acupuncture has a lower overall incidence of adverse events. The main adverse events are localized pain, subcutaneous bleeding, and dizziness, with most symptoms being mild, all of which have corresponding standard treatments. No reports on occupational or environmental safety were found, and the safety operation specifications are available for reference. Compared with conventional Western medicine, acupuncture demonstrates higher effectiveness. Acupuncture may improve the quality of life scores of patients, though no significant difference was observed. The cost of acupuncture is higher than that of conventional Western medicine, but its overall economic value is greater. The informed consent information is relatively comprehensive. Most patients are aware of the potential benefits and risks of acupuncture and voluntarily opt for it. The treatment process fully respects patient privacy and human rights. The clinical application of acupuncture follows the current acupuncture medical service model, with no special requirements for the level of medical institutions. Patient accessibility and affordability are suitable. Patient satisfaction is high. Most patients indicated they would choose acupuncture again for SD. The main barriers to choosing acupuncture are psychological factors (such as fear of acupuncture), cost, and transportation issues. Nearly 70% of patients receiving acupuncture treatment benefit from medical insurance reimbursement, with reimbursement rates generally above 50%, indicating strong social security support. ConclusionThe implementation of HTA for acupuncture in the treatment of SD, using the standards for traditional Chinese medicine (TCM), is feasible. The implementation steps are clear, the data sources for each evaluation domain are adequate, the analysis methods are practical, and the evaluation results are comprehensive. Experts recommend that the findings be used as a reference for relevant medical decision-making.
5.Application and Production of Systematic Review and Meta-Analyses of Preclinical Studies in the Field of Traditional Chinese Medicine
Wenya WANG ; Chengyang JING ; Lanjun SHI ; Bin MA ; Xing LIAO
Journal of Traditional Chinese Medicine 2025;66(13):1333-1339
Preclinical studies include pharmacology, toxicology, pharmacokinetics research of animal experiments and in vitro experiments, which are crucial steps in the pre-marketing drugs and medical products, and are essential for exploring the mechanisms of traditional Chinese Medicine (TCM) therapeutic mechanism and promoting clinical translation. Systematic reviews and meta-analyses of preclinical studies in the field of TCM can comprehensively integrate preclinical evidence, consolidate research findings, assess the quality and risk of bias of included studies, enhance the utilization of research results, reduce resource waste, and promote the iterative optimization of TCM research models and evaluation indicators. This article introduced the process and methodology of conducting systematic review and meta-analyses of preclinical studies in TCM from nine steps, defining the research question, forming a research team, writing and registering a study protocol, conducting a comprehensive search, screening literature, evaluating included studies, extracting data, synthesizing data (meta-analysis), and reporting systematic reviews. It aims to provide methodological references for conducting systematic reviews and meta-analyses of preclinical studies in TCM and to promote the establishment and improvement of the evidence system in the field of TCM.
6.Efficacy of implantable neuromuscular electrical stimulation system on stress urinary incontinence model in female rats
Bohong LONG ; Chen LI ; Han DENG ; Haoyu SUN ; Limin LIAO ; Xing LI
Journal of Modern Urology 2025;30(5):438-441
Objective: To investigate the efficacy of implantable neuromuscular electrical stimulation system on stress urinary incontinence (SUI) model in female rats. Methods: A total of 21 female infertile SD rats were randomly divided into the control,sham stimulation,and stimulation groups,with 7 rats in each group.All rats received vaginal dilation (VD) to simulate postpartum SUI.One week after VD,the control group was given normal feeding,stimulators were implanted in the pelvic floor muscles of the sham stimulation and stimulation groups.The sham stimulation group received normal feeding for 2 weeks,and the stimulation group received pelvic floor electrical stimulation (PFES) for 2 consecutive weeks.The leak point pressure (LPP) of each rat was measured with cystometry before VD (baseline value),1 week after VD,and 2 weeks after PFES. Results: In the control group and sham stimulation group,LPP increased after 2 weeks of treatment compared with that after 1 week of VD,but it still did not return to the baseline level (P<0.001).In the stimulation group,after 2 consecutive weeks of PFES,LPP increased significantly compared with that 1 week after VD,and returned to the baseline value (P>0.05).There was no significant difference in the LPP baseline values and levels after 1 week of VD among the 3 groups (P>0.05).The LPP in the stimulation group after 2 weeks of PFES was significantly higher than that in the sham stimulation group and stimulation group (P<0.001). Conclusion: The implantable neuromuscular electrical stimulation system is effective in short-term intervention of SUI in female rats,the further studies are needed to confirm the long-term efficacy and safety of the system,the optimal stimulation sites,optimal stimulation parameters,and potential mechanisms of action.
7.Current Situation of Health Technology Assessment in Traditional Chinese Medicine Hospitals
Simin XU ; Hui ZHAO ; Jing HU ; Zhaolan LIU ; Weiwei SUN ; Xing LIAO
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(4):190-197
ObjectiveThis study aims to understand the recognition of practitioners in traditional Chinese medicine (TCM) hospitals on hospital-based health technology assessment (HB-HTA), assessment needs, challenges, and suggestions, so as to provide references for the future work. MethodThe convenient sampling method was adopted to survey the relevant practitioners in TCM hospitals. The questionnaire included 39 questions in 4 dimensions and was distributed through the online platform Weijuanxing. ResultA total of 244 questionnaires were recovered, and the obtained data were analyzed in SPSS. The results showed that 137 practitioners were very familiar with HB-HTA and there was no significant difference in the recognition of practitioners in different occupations (F=0.251; P=0.778). The practitioners in Hong Kong, Macao, and Taiwan had lower recognition than those in other regions. In terms of the assessment needs, 127 practitioners believed that it was very necessary to carry out HB-HTA in TCM hospitals in the future. Chinese patent medicines/Chinese herbal medicine decoction pieces (5.91) and TCM appropriate technology (5.57) had higher assessment priority scores. The assessment needs were high for the effectiveness (235 practitioners) and safety (224 practitioners) of health technology. The lack of specialized organization and standardized evaluation process system and the shortage of talents were considered to be the major challenges for the future development in this field. ConclusionThe stakeholders carrying out the health technology assessment in TCM hospitals had certain awareness of HB-HTA. Most practitioners believed that it was necessary to carry out HB-HTA in TCM hospitals in the future, while the work might face challenges such as the lack of organizations and system and the shortage of talents, which requires policy support.
8.Comparison of clinical efficacy and stability of Toric implantable collamer lens implantation in different orientations
Yanfen LIAO ; Nian GUAN ; Zhengwei SHEN ; Xing HE ; Ying LIU
International Eye Science 2024;24(2):210-215
AIM: To compare the clinical efficacy, vault, and rotational stability of horizontal, oblique, and vertical implantation of Toric implantable collamer lens(TICL).METHODS: Retrospective cohort study. A total of 92 cases(120 eyes)who underwent TICL implantation from July 2018 to March 2022 and had regular follow-up for at least 1 a postoperatively(1 d, 1 wk, 1, 3, 6 mo, and 1 a)at Wuhan Bright Eye Hospital were collected. The patients were divided into three groups, with 34 cases(45 eyes)in horizontal implantation group, 25 cases(29 eyes)in oblique implantation group(29 cases), and 33 cases(46 eyes)in vertical implantation group. Uncorrected distance visual acuity(UDVA), corrected distance visual acuity(CDVA), diopters, vault, and rotation angle(deviation of the actual axis of TICL from the expected axis).RESULTS: All surgeries were uneventful, and there were no complications such as infection, secondary glaucoma, or cataract opacity. Safety and efficacy of the surgery: the CDVA of the three groups of patients was better than or equal to the preoperative CDVA at 1 a postoperatively, and there was no statistically significant differences in postoperative UDVA and CDVA of the three groups(P>0.05). The safety index at 1a postoperatively was 1.34±0.21, 1.34±0.17, and 1.31±0.18 for the horizontal, oblique, and vertical groups, respectively. The efficacy index was 1.26±0.21, 1.33±0.18, and 1.27±0.16 for the three groups, respectively, both with no statistically significant differences(P>0.05). Vault: there was a significant difference in postoperative vault among the three groups(P=0.003), with the vertical group having the lowest vault, followed by the horizontal group and the oblique group. The vaults at different follow-up time points within each group showed significant differences(P<0.001), and all decreased over time. Residual astigmatism: there was no significant difference in residual astigmatism among the three groups(P=0.130), but there were differences at different follow-up time points within each group(P<0.001). Rotation angle: no significant differences in rotation angle were observed among the three groups(P=0.135), but there were differences at different follow-up time points within each group(P<0.001).CONCLUSION: The implantation of TICL in different orientations has good safety and efficacy, the postoperative rotational stability is good, and the appropriate angle can be selected to implant TICL according to the clinical situation.
9.Meta-analysis of Distribution Frequency of Traditional Chinese Medicine Syndrome in Primary Osteoporosis
Hailong WU ; Tianying CHANG ; Yan LU ; Zongjian LUO ; Xiangyang LENG ; Xing LIAO
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(5):111-117
ObjectiveTo systematically evaluate the distribution of traditional Chinese medicine(TCM) syndromes of primary osteoporosis(POP) in China by using evidence-based medicine methods, and to understand the distribution law of the syndromes. MethodChina National Knowledge Infrastructure(CNKI), VIP Chinese Science and Technology Journal Database(VIP), WanFang Data Knowledge Service Platform(WanFang) and China Biology Medicine(CBM) were searched to obtain representative literature, and each database was searched from the 1994 World Health Organization defined diagnostic criteria for osteoporosis until May 1, 2023. Two researchers independently screened literature according to the criteria, extracted data, and cross-checked them. Meta analysis was conducted using R4.1.3, and subgroup analysis was performed. ResultA total of 56 Chinese papers were included, involving 14 415 patients. After standardized classification of syndromes, 11 articles were excluded, and Meta analysis results of the ultimately included 45 Chinese articles showed that the distribution frequencies of liver-kidney Yin deficiency syndrome, spleen-kidney Yang deficiency syndrome and kidney deficiency and blood stasis syndrome in 12 723 patients were 27%[95% confidence interval(CI) 0.24-0.31], 32%(95% CI 0.29-0.36), 36%(95% CI 0.30-0.42). Subgroup analysis showed that there was a statistically significant difference in the distribution of the three TCM syndromes in the north and south(P<0.05). In addition, the incidence of TCM syndrome fractures in different types of POP was 15%(95% CI 0.09-0.24) for liver-kidney Yin deficiency syndrome, 20%(95% CI 0.12-0.30) for spleen-kidney Yang deficiency syndrome, and 31%(95% CI 0.25-0.39) for kidney deficiency and blood stasis syndrome. ConclusionThe distribution of syndromes in POP patients is mainly kidney deficiency, accompanied by liver and spleen dysfunction. Liver-kidney Yin deficiency syndrome, spleen-kidney Yang deficiency syndrome and kidney deficiency and blood stasis syndrome are all the main syndromes of POP and osteoporotic fractures, and kidney deficiency and blood stasis syndrome is most closely related to the development of osteoporotic fractures. The reference standards for syndrome determination among the included studies are inconsistent, and in the future, it is necessary to focus on their determination standards to obtain consensus research results, at the same time, conduct large-scale syndrome research to obtain representative research results, providing a basis for clinical practice and research.
10.Construction and Interpretation of Clinical Comprehensive Evaluation Index System for Chinese Patent Medicine Based on EVIDEM Framework
Zeqi DAI ; Chengyang JING ; Xue WU ; Le ZHANG ; Xing LIAO
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(6):134-143
ObjectiveTo establish the clinical comprehensive evaluation index system for Chinese patent medicine(CPM) based on Evidence and Value:Impact on DEcisionMaking(EVIDEM) framework, so as to promote the scientific, systematic and standardized implementation of clinical comprehensive evaluation of CPM. MethodThe clinical comprehensive evaluation index system was determined through literature review, semi-structured interview and Delphi method, and the weights of each index were clarified by analytic hierarchy process(AHP). ResultThe recovery rates of both rounds of expert consultation were 100%, and the authority coefficient of experts was 0.90 and 0.905, respectively. Kendall's coordination coefficients(W) of the second- and third-level indicators in the first-round consultation were 0.320 and 0.283(P<0.001), and in the second round were 0.411 and 0.351, respectively(P<0.001). The finally constructed clinical comprehensive evaluation index system for CPM included 6 first-level indicators, 13 second-level indicators and 28 third-level indicators. Among the first-level indicators, the weights of effectiveness, safety, economy, innovation, suitability and accessibility were 37.34%, 32.68%, 11.85%, 5.87%, 5.79% and 6.47%, respectively. ConclusionThis study has constructed a universal clinical comprehensive evaluation index system for CPM, and the domain and criteria are introduced and interpreted in detail, which can provide reference and information for carrying out the clinical comprehensive evaluation of CPM, but it needs to be refined and improved in combination with the clinical practice of CPM for specialized diseases.

Result Analysis
Print
Save
E-mail