Giacomo Visioli, Maria Pia Pirraglia, Alessandro Lambiase, Magda Gharbiya
{"title":"Misleading Citations and Publication Bias in COVID-19 in Ophthalmology","authors":"Giacomo Visioli, Maria Pia Pirraglia, Alessandro Lambiase, Magda Gharbiya","doi":"10.1111/jebm.12664","DOIUrl":"10.1111/jebm.12664","url":null,"abstract":"<p>Misrepresentation of scientific findings can lead to an overestimation of a medical issue, a phenomenon exacerbated when the scientific community is eager for information on a novel pathogen. The COVID-19 pandemic has led to an unprecedented growth in research output, including numerous studies on potential ocular manifestations [<span>1</span>]. The identification of conjunctivitis as an early symptom of COVID-19 naturally prompted questions about whether SARS-CoV-2 could affect other ocular structures [<span>2</span>]. Initial reports suggesting retinal involvement generated significant interest and debate within the medical community. While such inquiries were legitimate, it is important to approach them with scientific rigor to avoid drawing unwarranted conclusions.</p><p>Four years ago, we conducted a study on retinal findings in 46 patients with severe COVID-19 pneumonia. Our conclusion was unequivocal: we found no retinal alterations attributable to SARS-CoV-2 infection [<span>3</span>]. Instead, the observed changes were likely due to systemic conditions such as hypertension or diabetes. Surprisingly, an analysis of the past 2 years' citations revealed that 41.7% misrepresented our article, citing it to claim we supported COVID-19-related retinal findings, despite us stating the opposite. These distortions occurred across journals regardless of their prestige, as detailed in Table 1.</p><p>This case study underscores a critical issue in scientific interpretation: the assumption that simultaneous occurrence indicates causation [<span>4</span>]. Observing retinal abnormalities in patients with COVID-19 does not necessarily mean that SARS-CoV-2 is the etiological or predisposing factor. Especially during a pandemic, when a significant portion of the global population is infected, coincidental occurrences are statistically more likely.</p><p>One method to establish a causal relationship is to demonstrate an increased incidence of a condition that correlates specifically with the infection [<span>5, 6</span>]. However, after 4 years of extensive research, no definitive evidence has emerged to support an increased incidence of retinal pathology directly linked to SARS-CoV-2 [<span>7</span>]. Findings such as retinal thrombosis or cotton wool spots are more plausibly explained by systemic conditions or comorbidities common in severely ill patients rather than a direct pathogenic role of the virus [<span>8</span>].</p><p>Furthermore, it remains unclear whether the ocular findings reported in COVID-19 patients represent a problem of significant medical relevance. In many cases, these retinal changes are minor, asymptomatic, and do not necessitate specific treatment. Overstating such findings can misdirect scientific focus and may lead to unnecessary alarm among patients. Moreover, there were some highly cited early reports during the pandemic that claimed to identify retinal abnormalities in COVID-19 patients, but subsequent scrutiny revealed t","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 4","pages":"703-704"},"PeriodicalIF":3.6,"publicationDate":"2024-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11684496/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142828803","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Yaxuan Ren, Xufei Luo, Ye Wang, Haodong Li, Hairong Zhang, Zeming Li, Honghao Lai, Xuanlin Li, Long Ge, Janne ESTILL, Lu Zhang, Shu Yang, Yaolong Chen, Chengping Wen, Zhaoxiang Bian, ADVANCED Working Group
{"title":"Large Language Models in Traditional Chinese Medicine: A Scoping Review","authors":"Yaxuan Ren, Xufei Luo, Ye Wang, Haodong Li, Hairong Zhang, Zeming Li, Honghao Lai, Xuanlin Li, Long Ge, Janne ESTILL, Lu Zhang, Shu Yang, Yaolong Chen, Chengping Wen, Zhaoxiang Bian, ADVANCED Working Group","doi":"10.1111/jebm.12658","DOIUrl":"10.1111/jebm.12658","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>The application of large language models (LLMs) in medicine has received increasing attention, showing significant potential in teaching, research, and clinical practice, especially in knowledge extraction, management, and understanding. However, the use of LLMs in Traditional Chinese Medicine (TCM) has not been thoroughly studied. This study aims to provide a comprehensive overview of the status and challenges of LLM applications in TCM.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>A systematic search of five electronic databases and Google Scholar was conducted between November 2022 and April 2024, using the Arksey and O'Malley five-stage framework to identify relevant studies. Data from eligible studies were comprehensively extracted and organized to describe LLM applications in TCM and assess their performance accuracy.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>A total of 29 studies were identified: 24 peer-reviewed articles, 1 review, and 4 preprints. Two core application areas were found: the extraction, management, and understanding of TCM knowledge, and assisted diagnosis and treatment. LLMs developed specifically for TCM achieved 70% accuracy in the TCM Practitioner Exam, while general-purpose Chinese LLMs achieved 60% accuracy. Common international LLMs did not pass the exam. Models like EpidemicCHAT and MedChatZH, trained on customized TCM corpora, outperformed general LLMs in TCM consultation.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Despite their potential, LLMs in TCM face challenges such as data quality and security issues, the specificity and complexity of TCM data, and the nonquantitative nature of TCM diagnosis and treatment. Future efforts should focus on interdisciplinary talent cultivation, enhanced data standardization and protection, and exploring LLM potential in multimodal interaction and intelligent diagnosis and treatment.</p>\u0000 </section>\u0000 </div>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"18 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2024-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142801123","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The Acceptability and Effects of Internet-Based Cognitive Behavioral Therapy on Depressive Symptoms and Remission in 13- to 17-Year-Old Adolescents: A Systematic Review and Meta-Analysis","authors":"Pei Liu, Mingjing Situ, Xiaoxia Duan, Huan Sun, Meiwen Wang, Yujie Tao, Tingting Luo, Sixun Li, Zhuo Wang, Yi Huang","doi":"10.1111/jebm.12657","DOIUrl":"10.1111/jebm.12657","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>This study aimed to evaluate the acceptability and effects of internet-based cognitive behavioral therapy (iCBT) or CBT-oriented interventions compared with control groups on depressive symptoms, remission of depression, and quality of life (QOL) in adolescents.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We searched English and Chinese databases for randomized controlled trials up to October 10, 2024 that investigated the effects of iCBT compared with controls in adolescents exhibiting elevated depressive symptoms or diagnosed with depression. Standardized mean differences (SMDs), relative risks (RRs), and 95% confidence intervals were applied to evaluate the pooled effects of outcomes.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>A total of 19 RCTs involving 3574 cases were included in this study. We found small effects on depressive symptoms severity at different time points (posttest: SMD = –0.49 [–0.66, –0.33]; 3-month follow-up [FU3]: SMD = –0.21 [–0.30, –0.11]; FU6: SMD = –0.18 [–0.35, –0.02]; FU12: SMD = –0.38 [–0.56, –0.20]). We also found a significant effect in depression remission rate at the posttest (RR = 1.74 [1.36, 2.21]) and a significant effect in QOL at the posttest (SMD = 0.30 [0.07, 0.54]). However, the result regarding acceptability was nonsignificant (RR = 1.22 [0.76, 1.97]). No significant publication bias was found in these results.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>iCBT or internet-based CBT-oriented interventions can effectively reduce depressive symptom severity and improve depression remission rate and QOL in depressed adolescents. These results are preliminary and require further validation through future systematic reviews.</p>\u0000 </section>\u0000 </div>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 4","pages":"740-757"},"PeriodicalIF":3.6,"publicationDate":"2024-11-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142710477","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Xiaohui Pan, Hongbo He, Yuqian Bao, Yan Bi, Luyuan Chen, Xiaoping Chen, Hui Fang, Wenhuan Feng, Ling Gao, Lixin Guo, Yifang Guo, Yaling Han, Qi Hua, Nanfang Li, Quanmin Li, Yan Li, Yong Li, Xialian Li, Jing Liu, Huijuan Ma, Jianjun Mu, Kailei Nong, Huiqian Shang, Yunfeng Shen, Zhongwei Shi, Fang Sun, Ningling Sun, Jun Tao, Jiguang Wang, Xinling Wang, Jing Wu, Xinhua Xiao, Liangdi Xie, Jing Xu, Jing Xu, Hongying Ye, Dongni Yu, Hong Yuan, Huijie Zhang, Jian Zhang, Lili Zhang, Yuqing Zhang, Jiaqiang Zhou, Xinli Zhou, Dalong Zhu, Tiehong Zhu, Sheyu Li, Zhiming Zhu, Diabetes and Obesity Research Group of Chinese Diabetes Society (CDS) and Chinese Hypertension League (CHL)
{"title":"Chinese expert consensus on the management of hypertension in adults with type 2 diabetes","authors":"Xiaohui Pan, Hongbo He, Yuqian Bao, Yan Bi, Luyuan Chen, Xiaoping Chen, Hui Fang, Wenhuan Feng, Ling Gao, Lixin Guo, Yifang Guo, Yaling Han, Qi Hua, Nanfang Li, Quanmin Li, Yan Li, Yong Li, Xialian Li, Jing Liu, Huijuan Ma, Jianjun Mu, Kailei Nong, Huiqian Shang, Yunfeng Shen, Zhongwei Shi, Fang Sun, Ningling Sun, Jun Tao, Jiguang Wang, Xinling Wang, Jing Wu, Xinhua Xiao, Liangdi Xie, Jing Xu, Jing Xu, Hongying Ye, Dongni Yu, Hong Yuan, Huijie Zhang, Jian Zhang, Lili Zhang, Yuqing Zhang, Jiaqiang Zhou, Xinli Zhou, Dalong Zhu, Tiehong Zhu, Sheyu Li, Zhiming Zhu, Diabetes and Obesity Research Group of Chinese Diabetes Society (CDS) and Chinese Hypertension League (CHL)","doi":"10.1111/jebm.12655","DOIUrl":"10.1111/jebm.12655","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <p>Both hypertension and type 2 diabetes are attributable to premature death, cardiovascular and kidney diseases with largely overlapping population. Followed the GRADE approach, this expert consensus aimed to reduce the cardiovascular and kidney death and disability due to hypertension and minimize the treatment burden in adults with type 2 diabetes. Through online survey and discussion, a multidisciplinary team comprehensively prioritized seven key guideline questions. Informed by the evidence synthesis and online discussion, the team developed 12 recommendations under the GRADE Evidence-to-decision (EtD) framework. The recommendations covered the screening of hypertension in adults diagnosed with type 2 diabetes but not hypertension and the monitoring, lifestyle interventions, and medications in those diagnosed with type 2 diabetes and hypertension.</p>\u0000 </section>\u0000 </div>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 4","pages":"851-864"},"PeriodicalIF":3.6,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142621992","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Xuan Zhang, Lin Zhang, Juan Wang, Lihan Hu, Xuanqi Zhang, Nana Wang, Hanzhi Tan, Chung Wah Cheng, Ji Li, Fei Han, Ping Wang, Aiping Lyu, Zhaoxiang Bian
{"title":"Outcomes reporting in clinical trials of Chinese herbal medicine on ulcerative colitis: A systematic review","authors":"Xuan Zhang, Lin Zhang, Juan Wang, Lihan Hu, Xuanqi Zhang, Nana Wang, Hanzhi Tan, Chung Wah Cheng, Ji Li, Fei Han, Ping Wang, Aiping Lyu, Zhaoxiang Bian","doi":"10.1111/jebm.12649","DOIUrl":"10.1111/jebm.12649","url":null,"abstract":"<p>Ulcerative colitis (UC) is a prevalent type of inflammatory bowel disease (IBD) characterized by inflammation and ulceration in the rectum and colon.<span><sup>1</sup></span> The optimal therapeutic effect of current treatment strategies for UC may be unattainable; even surgery may be followed by ongoing morbidity. Pharmacological therapies, mainly including aminosalicylates, steroids, immunosuppressants, etc., are used to control the acute onset of UC, heal the mucosa, and prevent complications.<span><sup>2</sup></span> In clinical practice, some patients, however, may experience a gradual loss of response to the therapy while others may show intolerance to the adverse effects of drugs.<span><sup>3</sup></span> Consequently, an increasing number of UC patients (21%–60%) prefer to seek additional help from Chinese herbal medicine (CHM). While numerous clinical studies have demonstrated the efficacy of CHM therapies in relieving symptoms, enhancing the therapeutic effects of chemical drugs, and reducing side effects and recurrence rates in UC patients, recommending CHM interventions for UC treatment remains cautious due to significant issues related to the choice and reporting of outcome measures.<span><sup>4-7</sup></span> The lack of agreed-upon and standardized evaluation criteria, such as tongue and pulses in Chinese medicine (CM), contributes to considerable variation in outcome measurement and reporting among studies, making comparisons challenging.<span><sup>8</sup></span> Therefore, we aim to summarize existing endpoint definitions and measurement tools, and inspect the efficacy and safety outcomes reported in randomized controlled trials (RCTs) of CHM in adults with UC. Given that some UC patients in China receive integrative Chinese and Western Medicine (ICWM) therapy over CHM or Western Medicine (WM) alone, the development of a core outcome set (COS) for CHM studies of UC is crucial. Such a COS would help reduce outcome heterogeneity, enhance study quality, and contribute to generating robust evidence for innovative UC therapies, ultimately fostering international recognition in the field.</p><p>This study included RCTs that investigated CHM, including single herbs, formulas, or both as interventions to treat UC. Accordingly, RCTs published in English or Chinese from January 1, 2011 to December 31, 2022 were limited to adults with UC diagnosis based on clear diagnostic criteria or references, but without limitations in control groups or outcomes. A systematic search was conducted in six databases: All EBM Reviews (Ovid), Allied and Complementary Medicine (Ovid), Embase and Ovid MEDLINE(R) (Ovid), CNKI, VIP, and Wanfang. Detailed inclusion and exclusion criteria and search strategy are presented in Supplementary File 1. Two reviewers were independently involved in reviewing the titles and abstracts, full text of the selected studies based on the criteria. Any disagreements between the reviewers were resolved through discussion or cons","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 4","pages":"691-695"},"PeriodicalIF":3.6,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11684495/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142522085","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Technical specification for developing a clinical practice guideline for the integration of traditional Chinese medicine and Western medicine","authors":"Jianxin Wang, Rui Sun, Fengwen Yang, Jianping Liu, Jiajie Yu, Yuanyuan Sun, Xuemin Gao, Boli Zhang, Junhua Zhang, Jinzhou Tian","doi":"10.1111/jebm.12654","DOIUrl":"10.1111/jebm.12654","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <p>Developing a clinical practice guideline (CPG) for integrating traditional Chinese medicine (TCM) and Western medicine (WM) requires the accurate identification, collation, and integration of all available evidence on TCM and WM in a comprehensive, meaningful, and resource-efficient manner. This entails framing appropriate clinical questions, retrieving and synthesizing evidence from multiple resources, and providing concise and complete recommendations for specific diseases. However, some existing CPGs for integrating TCM and WM lack deep and organic integration. As the effective preparation of a CPG for integrating TCM and WM typically involves a complex set of principles, methodology, and steps, we believe that a cohesive, step-by-step guide on how to prepare a CPG for integrating TCM and WM is essential. To facilitate the design and development of a robust CPG, we present a clear and concise methodology, outlining relevant principles and procedures, supported by references for guidance. This technical specification aims to simplify the methodology for preparing a CPG for integrating TCM and WM; provide healthcare professionals and researchers with methodologically sound tools; and enhance the quality of CPGs for integrating TCM and WM. This technical specification may help elucidate this complex process, facilitate evaluation of the quality of published CPGs for integrating TCM and WM, and improve the understanding and application of recommendations for the combined and integrated use of TCM and WM in a new system.</p>\u0000 </section>\u0000 </div>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 4","pages":"865-873"},"PeriodicalIF":3.6,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11684505/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142467550","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sujata Purja, Minji Kim, Yomna Elghanam, Hae Jung Shim, Eunyoung Kim
{"title":"Efficacy and safety of vancomycin compared with those of alternative treatments for methicillin-resistant Staphylococcus aureus infections: An umbrella review","authors":"Sujata Purja, Minji Kim, Yomna Elghanam, Hae Jung Shim, Eunyoung Kim","doi":"10.1111/jebm.12644","DOIUrl":"10.1111/jebm.12644","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>To summarize the evidence on the efficacy and safety of vancomycin compared with those of alternative treatments in adult patients with methicillin-resistant <i>Staphylococcus aureus</i> (MRSA) infection.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>PubMed, Embase, and Web of Science were searched up to December 15, 2023, for systematic reviews and meta-analyses comparing vancomycin with alternative MRSA treatments. Primary outcomes included clinical cure and microbiological eradication rates. Organ-specific safety outcomes were assessed. Summary estimates were recalculated using a random-effects model. Evidence was graded using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) tool. This study was registered in PROSPERO (CRD42022340359).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>This umbrella review included 19 studies and 71 meta-analyses (46 efficacy and 25 safety) comparing vancomycin with 10 alternative treatments across different MRSA infection types and populations. GRADE assessment showed that 29.58% of the meta-analyses were of high quality. Linezolid and daptomycin showed higher efficacy in MRSA-induced skin and soft tissue infections and pneumonia (moderate evidence quality) and bacteremia (very low evidence quality), respectively, compared with that of vancomycin. Cephalosporins had a higher risk of nausea, whereas linezolid had a higher risk of nausea, diarrhea, and thrombocytopenia than that of vancomycin. Vancomycin posed a higher risk of rash, pruritus, red man syndrome, and nephrotoxicity than that of alternatives.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>The quality of evidence supporting the higher efficacy of alternative treatment over vancomycin for MRSA infection was not high. Given varying safety profiles and advancements in therapeutic monitoring, careful consideration of patient-specific factors and pharmacokinetics is crucial when selecting treatment alternatives to vancomycin.</p>\u0000 </section>\u0000 </div>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 4","pages":"729-739"},"PeriodicalIF":3.6,"publicationDate":"2024-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11684502/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142348227","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Clinical practice guidelines addressing Chinese patent medicine interventions: A systematic survey of 113 guidelines and 993 recommendations","authors":"Jianxin Wang, Rui Sun, Xuemin Gao, Rui Gao","doi":"10.1111/jebm.12640","DOIUrl":"10.1111/jebm.12640","url":null,"abstract":"<p>Chinese patent medicines (CPM) are widely used in China and are increasingly used in Western countries.<span><sup>1</sup></span> CPMs have gained social acceptance for fixed prescription, precise dosage, ease of use, and storage. Numerous CPM clinical trials have been conducted, with approximately 14,000 systematic reviews published in journals. Over 600 guidelines were published in the past two decades.<span><sup>2</sup></span> However, the clinical and methodological status, usefulness, and recommendations of CPMs remain understudied. This systematic review aimed to summarizes the clinical and methodological characteristics of CPM-related guidelines, critically assessing their methodological quality and usefulness.</p><p>China National Knowledge Infrastructure (CNKI), Wanfang Data, VIP, SinoMed, MEDLINE, EMBASE, and Guidelines International Network, the scientific, transparent, and applicable ranking (STAR) tools for clinical practice guidelines<span><sup>3</sup></span> and Practice Guideline Registration for Transparency (PREPARE) were searched. All of CPM-related guidelines published from January 2021 to December 2023 were included, no matter the type of guideline, which include CPM-specific guidelines (all recommendations solely focused on CPM interventions), TCM guidelines (encompassing recommendations on traditional Chinese herbal medicines, CPMs, acupuncture, and other TCM interventions), and integrated TCM and WM guidelines (offering recommendations on both conventional medicine and TCM interventions together).</p><p>A structured data extraction table was used to collect the data. Reviewers extracted three types of information from each guideline: (1) general information, including types of guidelines, target users, subjects, journal of the publication, sponsoring institutions, and diseases or conditions investigated; (2) CPM recommendation information, including the types of CPM recommended in the guidelines, strength and direction of the recommendation, and details of CPM interventions; and (3) usefulness information of CPM recommendations, for example, clinical questions, comparators, outcomes, and presentation of the recommendation. χ<sup>2</sup> was used to compare the variables across different types of guidelines when necessary and the significance level was set at 5% (<i>p</i> < 0.05).</p><p>A total of 113 guidelines with 933 recommendations for the use of CPMs were included. Only 4 (3.5%) guidelines were published in English and almost all guidelines (94.7%) focused on treatment. For the target users of the guidelines, more than half of the guidelines (56.6%) were formulated for TCM physicians and 46.5% for WM physicians. Only one guideline was enacted by primary physicians. 13.3% of the guidelines were investigator-initiated and the rest were sponsored by the China Association of TCM (31%), China Association of Traditional Medicine, China Association of Integrative Medicine and World Federation of Chinese Medicine Societi","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 3","pages":"474-476"},"PeriodicalIF":3.6,"publicationDate":"2024-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jebm.12640","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142348229","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ning Liang, Yujing Zhang, Xuefei Zhang, Lijiao Yan, Chen Zhao, Sihong Yang, Ziteng Hu, Zehui Ye, Qianzi Che, Bin Liu, Haili Zhang, Huizhen Li, Zhao Chen, Qi Zhang, Taixiang Wu, Yanping Wang, Nannan Shi, Luqi Huang
{"title":"International Traditional Medicine Clinical Trial Registry: A meaningful initiative and its future development","authors":"Ning Liang, Yujing Zhang, Xuefei Zhang, Lijiao Yan, Chen Zhao, Sihong Yang, Ziteng Hu, Zehui Ye, Qianzi Che, Bin Liu, Haili Zhang, Huizhen Li, Zhao Chen, Qi Zhang, Taixiang Wu, Yanping Wang, Nannan Shi, Luqi Huang","doi":"10.1111/jebm.12651","DOIUrl":"10.1111/jebm.12651","url":null,"abstract":"<p>Traditional medicine (TM) has become an indispensable resource worldwide and it makes great contributions to global health. Searching for “traditional medicine” and related items by setting filters for clinical trials and randomized controlled trials, returns almost 17,000 items in the PubMed database till 2024 April. Moreover, more than 22,000 TM clinical studies have been found in the WHO International Clinical Trial Registry Platform (ICTRP) when conducting a systematic search. Despite the growing interest and number of clinical studies in TM, issues concerning the quality of the evidence have emerged.<span><sup>1, 2</sup></span> Empirical studies have found that studies with positive results are more likely to be published, and outcomes with significant effect estimates are very likely to be fully reported.<span><sup>3</sup></span> Similar to conventional medicine, selective outcome reporting is widespread in TM, accounting for almost one-third of relative clinical studies when comparing between the registered outcomes and the reported ones in the publications.<span><sup>2</sup></span> Conclusions based on biased evidence due to selective reporting can be misleading. An alternative approach to solve this issue is the registration of the protocol before the conduct of the clinical study.</p><p>To register the key administrative and scientific information of clinical studies on an open-access platform before enrolling participants has been imperative from ethical, scientific, and even legal perspectives.<span><sup>4, 5</sup></span> Since 2005, the initiative by the WHO to develop ICTRP marks an important milestone in which region- or country-based registration platforms have been developed following unified standards, and ensuring that all registered trials receive a unique identification number for global searching.<span><sup>6</sup></span> Many efforts have been made to promote the transparency of the design and reporting the results of clinical studies; however, it seems that there is still a long way to go.<span><sup>7</sup></span> In a recent analysis of the registration of TM clinical studies, Zhang et al. have analyzed a total of 3339 Traditional Chinese Medicine studies registered in WHO ICTRP and found that 39% of the studies were retrospectively registered, and only 12.8% of studies shared resultant publications.<span><sup>8</sup></span> Compared to the 20 items required by WHO, none of the registered studies had a 100% reporting rate, and 11 items had a reporting rate lower than 65%. The fact that the registration quality of clinical studies in TM is not satisfactory is thought-provoking.</p><p>First, a unified portal for registering clinical studies in TM is necessary. Before 2023, people conducting TM clinical studies mainly registered the protocols by selecting one of the registries of WHO ICTRP or other publicly accessible registries such as ClinicalTrials.gov available in their regions or countries. Therefore, registered TM c","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 3","pages":"486-489"},"PeriodicalIF":3.6,"publicationDate":"2024-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jebm.12651","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142348232","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}