Journal of Evidence‐Based Medicine最新文献

Objective: To develop an evidence-based patient version of guideline (PVG) for fibromyalgia, aiming to improve patients' understanding of disease symptoms and therapeutic options and to enhance their self-management abilities.

Methods: Following the World Health Organization Handbook for Guideline Development (2014), a multidisciplinary working group was established, including patient representatives, physicians, pharmacists, nurses, and methodologists. The process comprised (a) systematic retrieval of clinical practice guidelines and expert consensus statements to establish the evidence base; (b) integration of large language models (LLMs) with expert review to identify and refine key patient-centered concerns; (c) a three-round Delphi consensus guided by the Grading of Recommendations Assessment, Development and Evaluation approach to finalize clinical questions and formulate recommendations; and (d) evaluation of understandability using the Patient Education Materials Assessment Tool for Print Materials (PEMAT-P).

Results: The final PVG covers 13 clinical questions across seven domains, including disease awareness, diagnostic evaluation, pharmacological and non-pharmacological interventions, and long-term management. All recommendations were rated as strong. The guideline emphasizes the importance of pharmacological management, emotional regulation, and exercise in the comprehensive management of fibromyalgia. The PEMAT-P assessment showed an understandability score of 100%.

Conclusions: Developed collaboratively by a multidisciplinary team and patient representatives, this PVG is based on 13 evidence-based fibromyalgia guidelines. Combining LLMs with expert review enhanced question generation and readability. The PVG provides a practical and accessible tool to support early self-management in fibromyalgia.

Objective: Several studies suggested that the risk of cardiovascular disease (CVD) had increased before individuals developed hyperhomocysteinemia. This study aimed to investigate the dose-response relationship between circulating homocysteine (Hcy) levels and the risk of CVD.

Methods: Observational studies examining the relationship between circulating Hcy levels and CVD risks were included. Searches were conducted on English databases (PubMed, Embase, and Web of Science) and Chinese databases (CNKI, WanFang, VIP, and SinoMed) in May 2025. Combined relative risks (RRs) or odds ratios (ORs) were calculated using random-effects models. The dose-response relationship between circulating Hcy levels and CVD risks was assessed using restricted cubic spline analysis. The risk of bias was assessed using the Newcastle-Ottawa Scale for cohort and case-control studies, and the Agency for Healthcare Research and Quality criteria for cross-sectional studies. Publication bias was assessed using funnel plots and the trim-and-fill method.

Results: A total of 117 original studies (35 cohort studies, 60 case-control studies, and 22 cross-sectional studies) were included, involving 504,469 participants with 43,089 CVD cases. Elevated circulating Hcy levels were significantly associated with increased CVD risks in all study types (RRs/ORs: 1.61-2.14). A non-linear dose-response relationship was observed between circulating Hcy levels and CVD risks (all p < 0.001), with thresholds at 10.4 µmol/L for cohort studies, and 10.0 µmol/L for both case-control studies and cross-sectional studies.

Conclusions: In this meta-analysis, increased Hcy levels were linked to higher CVD risks. Circulating Hcy level >10 µmol/L may implement nutritional intervention in primary prevention of CVD.

Background and objective: Bailing Capsules (BLC) and Yong Chong Cao Capsules (YChCC) share similar medicinal components, but Yong Chong Cao benefit from more advanced cultivation and large-scale production. This study systematically compared their therapeutic effects in patients with mild-to-severe Chronic Obstructive Pulmonary Disease (COPD).

Patients and method: This study was designed as a multi-center, randomized, active-controlled trial. 240 COPD patients were randomized 1:1 to receive YChCC or BLC for 24 weeks, followed by a 24‑week follow‑up. The primary endpoints were number of acute exacerbations. Secondary outcomes included, time to first exacerbation, and exacerbation duration, forced expiratory volume in 1 s (FEV₁), FEV₁%, forced vital capacity (FVC), FVC%, FEV₁/FVC%, modified Medical Research Council dyspnea scale (mMRC), Chronic Obstructive Pulmonary Disease Assessment Test (CAT), and Chronic Obstructive Pulmonary Disease Clinical Questionnaire (CCQ).

Results: A total of 208 patients completed the trial (full analysis set, FAS), and 178 comprised the per‑protocol set (PPS). Compared with BLC, YChCC significantly reduced the number of acute exacerbations (FAS: p = 0.002; PPS: p = 0.003) and prolonged time to first exacerbation. No significant between‑group differences were observed in lung function parameters or mMRC, CAT, and CCQ scores.

Conclusion: YChCC represent a promising adjuvant therapy for patients with stable COPD, ranging from mild to severe. They significantly prolong the time to the first acute exacerbation and reduce the frequency of acute exacerbations, thereby offering potential benefits in managing COPD.

Trial registration: This trial has been registered at ClinicalTrials.gov under the registration number NCT03745261.

Trial registration number (if clinical trial): NCT0374526.

Aim: The quality of drug clinical trials is crucial for authorizing new drugs and fostering innovations in clinical practice. This study aimed to report the status, trends, and factors of the quality of drug clinical trials in China.

Methods: This mixed methods study assessed trial quality using quantitative data from public sources and qualitative data from focus groups and interviews with key stakeholders.

Results: The No Action Indicated findings issued by the Food and Drug Administration increased from 43% from 2009-2015 to 88% from 2016-2022, whereas the Official Action Indicated findings decreased from 9% to 0% (p = 0.001). The Center for Food and Drug Inspection revealed that 12% of new drug applications in 2015-2017 were suspected of data fabrication, compared to only 0.6% failed to pass the inspection in 2022 (p < 0.001). Number of drug trials published by Chinese institutions in top medical journals increased from 1.3% in 2009 to 4.9% in 2022 (p for trend <0.001). Moreover, the number of clinical trial guidelines increased from approximately 10/year from 2015-2019 to 50-60/year from 2020-2022, number of internationally accredited ethics committees increased from 4 in 2009 to 82 in 2022, and over 130,000 individuals received training on the International Council for Harmonization guidelines. Interviews with stakeholders revealed a consensus on quality improvement, attributed to seven key factors, and highlighted further recommendations to enhance clinical trial quality in China.

Conclusions: The quality of drug clinical trials in China has significantly improved over the past decade, yet there remains scope for further enhancement.