Introducion Acupotomy is an innovative combination of acupuncture with surgical treatment that is widely used for pain-related conditions. There has been an increasing number of randomized controlled trials (RCTs) in acupotomy, their design and reporting quality remain inconsistent. Additionally, these RCTs have not been systematically evaluated in accordance with the Consolidated Standards for Reporting of Trials (CONSORT) framework. Methods A systematic search was performed in China National Knowledge Infrastructure (CNKI) and PubMed until January 2024 to identify eligible acupotomy RCTs using keywords related to “Acupotomy” and “RCT.” Each study was assessed based on the 2010 CONSORT guidelines. Descriptive statistics, nonparametric tests, and regression analyses were conducted to compare the quality scores and examine potential influencing factors. Results We included 141 studies; among them, 93 and 48 RCTs were from the CNKI and PubMed, respectively. The mean quality scores of CNKI- and PubMed-indexed RCTs were 42.5 (median, 42; range, 24-74) and 53.4 (median, 49; range, 33-82). Further, the mean scores of each item and proportion of studies with excellent scores were higher in PubMed-indexed studies than in CNKI-indexed studies (2.1, 41.1% vs. 1.7, 32.3%). Among the 25 items, PubMed-indexed RCTs had higher scores in 23 (92%) items, with 13 items showing significant differences. Regarding the impacting factors, the number of authors, sample size, and funding were correlated with nine, four, and nine items, respectively. There were no significant differences among hospitals at different levels. The municipal gross domestic product per capita positively affected the total score. Conclusions The quality of RCTs on acupotomy has improved over two decades. Domestic articles covered a broader regional scope, while international trials demonstrated better adherence to the CONSORT guidelines. These findings highlight the need to improve awareness regarding trial design, ensure adherence to reporting standards, and support research teams through training and funding.
Introduction Palliative care for cancer patients has gained increasing recognition for its significance by improving patient quality of end of life care. However, unmet needs persist due to the limitations of conventional medical interventions and therapeutic approaches. Complementary and alternative medicine (CAM) interventions have potential applications in palliative care. This study aimed to investigate research trends and identify evidence gaps in this field through a bibliometric analysis of published research on the Web of Science (WoS). Methods The WoS database was comprehensively searched up to October 2025 for publications related to CAM used in palliative care. The extracted bibliographic information included basic study details and a citation analysis to identify the most influential publications. Additionally, thematic evolution analysis was conducted to structurally understand the research evolution. Co-word networks were constructed using author keywords from the included publications and were clustered based on density (development degree) and centrality (relevance degree). Results A total of 588 publications from 217 sources between 1995 and 2026 were included in the analysis. The annual growth rate of publications was estimated to be 9.67%. The United States of America, China, and United Kingdom emerged as the most productive countries in terms of publication output. Studies of music therapy, aromatherapy & massage, and acupuncture played key roles in integrative palliative care research, while digital health and telemedicine emerged as new areas of focus. Nevertheless, significant limitations in the evidence for these interventions, such as small sample sizes and methodological weaknesses in clinical trials, remain substantial barriers to establishing robust evidence. Conclusion This study highlights the continuous growth in research on CAM interventions in palliative care. Future studies are essential to establish the clinical evidence for individual interventions and future emerging and under-evaluated approaches in this field.
Introduction Due to the high rates of mortality and morbidity, chronic kidney disease (CKD) has become a significant public health concern. Evidence shows that Chinese patent medicine Bailing capsules may help protect kidney function by reducing proteinuria and having potential antioxidative and antiinflammatory effects. In this study, we aimed to investigate the real-world effectiveness and cost of Bailing capsules in the treatment of patients with CKD stage 3. Methods A retrospective study was conducted using data from patients newly diagnosed with CKD stage 3 who visited secondary and tertiary hospitals covered by the Tianjin Healthcare and Medical Big Data Platform in China between 2016 and 2021. Incidence rates and incidence densities were analyzed. Cox regression survival analysis was performed to estimate the hazard ratios of disease progression. Data on patient costs were extracted from electronic medical records, including outpatient, emergency, and hospitalization expenses. Results A total of 3370 patients were included, with 1337 retained after propensity score matching. The incidence rates for progression from CKD stage 3 to first dialysis and to CKD stage 5 were significantly lower in the exposed group than in the control group (11.79% vs. 18.44%, P = 0.01; 19.39% vs. 27.56%, P = 0.007, respectively). The corresponding incidence density ratios were 0.54 (0.52-0.55) and 0.57 (0.56-0.59), respectively. Cox regression analysis revealed a significantly lower risk of disease progression in the exposed group. The average annual cost was CNY 16 685 (USD 2336) for the exposed group and CNY 29 819 (USD 4175) for the control group. Conclusion Bailing capsules were associated with lower medical costs and slower disease progression, indicating their possible role as adjunct therapy. The results also reveal current gaps in evidence quality, emphasizing the need for well-designed prospective studies to confirm effectiveness, minimize confounding, and inform future clinical and policy decision-making.
Introduction Exercise supports the physical, mental, and social development of children and adolescents. Although Tai Chi is a well-documented mind-body exercise with established benefits in adults, its effects in younger populations remain unclear. This systematic review examined the physical, psychological, and safety outcomes of Tai Chi in children and adolescents and explored its potential underlying mechanisms. Methods Electronic searches of randomized controlled trials involving Tai Chi in children and adolescents were conducted from database inception to October 15, 2024, across major English- and Chinese-language databases, including PubMed, Cochrane Library, Embase, Web of Science, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP), SinoMed, and Wanfang. Two reviewers independently performed the study selection and data extraction. Risk of bias was assessed using the Risk of Bias 2 (RoB 2) tool. Results Fifteen trials involving 1004 participants aged 8‒18 years, both healthy and with chronic conditions were included. Yang-style Tai Chi was the most frequently used intervention, and control groups received either no Tai Chi or alternative exercise programs. Several studies reported positive effects on balance, physical function, mobility, muscle strength, fall risk, kyphosis, stereotypical behavior, and self-concept, suggesting possible mechanisms of benefit. However, safety data were limited. The overall methodological quality was moderate: three studies (20%) had low risk of bias, six (40%) had some concerns, and six (40%) had high risk. Conclusion Tai Chi may improve balance, flexibility, motor skills, physical fitness, and psychological factors such as self-concept in children and adolescents. However, further high-quality research is required to confirm its effectiveness and safety in this population.
Introduction In China, improved new drugs with known active ingredients, optimized through a new dosage form, formulation process, or administration route, have attracted increasing attention due to relatively low research and development risks and accelerated regulatory pathways. However, their clinical evidence, regulatory performance, and economic characteristics remain unclear. Methods We retrospectively reviewed all improved new drugs (Class 2.2 improved new drugs) approved and marketed in China between January 2020 and September 2025 using data from the YAOZH and Center for Drug Evaluation databases. We evaluated the following characteristics of each product: therapeutic area, dosage-form transition, clinical evidence type (bioequivalence [BE] or non-BE), duration of regulatory review, expedited-pathway designation, and price. Additionally, we identified published clinical trials on products supported by non-BE evidence. Price premiums were calculated as defined daily dose cost differences relative to the earliest marketed formulation of the same active pharmaceutical ingredient and indication. Results Across 14 International Classification of Diseases 11th Revision categories, 71 products (70 chemicals and 1 traditional Chinese medicine) were approved. Overall, 53.5% were approved through BE evidence and 22.5% received priority review. The median review time was 551 days; priority reviews had significantly shorter timelines than standard reviews (374 vs. 582 days; P = 0.00027). Within the priority review cohort, non-BE approvals were non-significantly faster than BE approvals (P = 0.100). Among 30 products eligible for pricing analysis, the median price premium was 91.24% (interquartile range 46.35%-339.05%) relative to the earliest formulations. Conclusions Improved new drugs represent a pragmatic innovation route that balances development efficiency with regulatory accessibility. For standard reviews, non-BE evidence may facilitate faster approval; further, substantial price premiums were observed and may not consistently align with patient-centered values. Future studies should integrate usability, adherence, safety, real-world outcomes, and pharmacoeconomic evaluations in order to inform value-based reviews and reimbursements.
Introduction Diabetic foot infections impose a substantial economic burden globally, particularly in developing countries such as China. This study evaluated the cost-effectiveness of Fufang Huangbai fluid (FHF) compared with Suprasorb® A + Ag antimicrobial calcium alginate wound dressing (SAAAD) for treating grade 1-2 diabetic foot ulcers (DFUs) (graded according to the International Working Group on the Diabetic Foot/the Infectious Diseases Society of America [IWGDF/IDSA]). Methods A cost-effectiveness analysis was conducted using 2 weeks of randomized controlled trial data (n = 176) using Chinese healthcare system costs and service fees. Quality-adjusted life years (QALYs) served as the primary health outcome, and costs included drug expenses and dressing services. Both deterministic and probabilistic sensitivity analyses were performed. Results Compared with the SAAAD group, the FHF group saved CNY 300.64 and gained an incremental 0.0013 QALYs, making it a dominant approach with a net monetary benefit of CNY 325.86. Sensitivity analysis indicated that the unit price of SAAAD had the greatest impact on the results. At a willingness-to-pay threshold of CNY 20 000 per QALY, the probability of FHF being cost-effective was 70.65%. Conclusion FHF is economically advantageous compared with SAAAD for the treatment of DFUs of IWGDF/IDSA grade 1-2.
Establishing a Data Monitoring Committee (DMC) is crucial for safeguarding participant safety and ensuring data integrity in clinical research. Originating in the United States and subsequently adopted worldwide, the DMC concept has been progressively integrated into China’s clinical research system. Through a series of clinical studies and the introduction of regulations tailored to traditional Chinese medicine (TCM) research, the Chinese Medicine Data Monitoring Committee (CMDMC) framework has been progressively defined, encompassing its formation, operational mechanisms, responsibilities, and standard operating procedures. Nevertheless, as DMC development in China remains at an early stage, CMDMCs continue to face numerous pressing challenges. This article provides an in-depth analysis of the evolution of CMDMCs and the current issues surrounding their implementation within the context of TCM clinical research in China. Further advancement and optimization of CMDMCs will require coordinated efforts among sponsors, committee members, regulatory agencies, and other relevant stakeholders.