Xiaomo Xiong
Gang Lv
Bin Jiang3*
Kevin Lu- 1Department of Clinical Pharmacy and Outcomes Sciences, University of South Carolina, Columbia, SC, United States
- 2Department of General Surgery, The First Medical Center of Chinese PLA General Hospital, Beijing, China
- 3Department of Administrative and Clinical Pharmacy, School of Pharmaceutical Sciences, Health Science Center, Peking University, Beijing, China
Editorial on the Research Topic
From randomized clinical trials to real-world data and big data sciences: Generating evidence-based medicine for value in western and herbal medicines
Evidence-based medicine (EBM) differs from traditional medical practices in that it places emphasis on the use of published evidence and rigorous evaluation (1). The main idea of EMB is that medical decisions should be based on objective research findings as much as possible (1, 2), and EBM is increasingly accepted in clinical practice and has a wide range of implementation (3). The goal of this Research Topic is to provide evidence-based medicine by assessing the effectiveness, safety, and economics of medicines that matter to patients, where we have collected a series of studies related to the topic. The collected studies under this topic cover a wide range of evidence-based studies related to clinical effectiveness, including comparative effectiveness research using real-world data, research related to the coronavirus disease of 2019 (COVID-19) pandemic, and systematic reviews and meta-analysis to summarize the best evidence-based medicine available in the literature. We expect that the research on this topic or the evidence they provide will act an informative role in clinical practice, to guide clinical treatment or formulate intervention measures.
Most clinical interventions that are marketed or approved have undergone a rigorous process of the gold standard of EBM, i.e., the randomized controlled trial (RCT), to measure clinical efficacy (4–7). However, in RCTs, the setting is rigorous, and the strict inclusion and exclusion criteria for patients may affect the external study of their findings (6, 8). Therefore, evidence derived from real-world studies or clinical effectiveness is warranted to guide day-to-day clinical practice (9). Meanwhile, many alternative treatments, such as herbal medicine and traditional medicine, are used in clinical practices, however, with a lack of evidence on efficacy from RCTs (10). As such, evidence of their clinical effectiveness is crucial. Therefore, being able to obtain more evidence about these studies is of great significance for informing practice.
Although EBM informing clinical practice and public health policy decision-making is well-documented in the literature, the role of EBM in some aspects of clinical effectiveness, such as clinical trial designs, medication use, quality of life, and the economic burden has received less attention. Several articles under this Research Topic may complement this point. First, for clinical trial designs, Iglesias-Lopez et al. conducted a systematic review, which found that most authorized advanced therapy medicinal products (ATMPs) are based on small, open-label, uncontrolled, and single-arm trials. The findings of this research suggest that in future studies, more methodologically sound randomized-controlled trials for ATMPs are needed. Meanwhile, a case study by Rui et al. found a relationship between short-term surrogate endpoint indicators and median progression-free survival (mPFS) and median overall survival (mOS) in clinical trials of malignant tumors. Second, for medication use, based on the hospital database with 3,422,710 outpatient and emergency visits and 26, 118, 436 inpatient hospitalizations from 2016 to 2019, Zhu et al. studied the trends and patterns of use of antibiotics in China, which might help inform clinical guidance in the future. Finally, in terms of quality of life and economic burden, Zou H. et al. systematically reviewed the economic burden and quality of life of patients with hepatocellular carcinoma (HCC) in Greater China, and found that HCC had a negative impact on the quality of life among the patients, mainly related to the aspects of physical, cognitive, and social functions. At the same time, this study revealed the impact of HCC on the economic burden of patients, which showed that HCC significantly increased patients' health-related costs (Zou H. et al.).
As the highest-level evidence in EBM that is able to integrate the results of multiple studies, meta-analysis can implement the generalization of RCTs and enhance the guidance of medical practice (11, 12). This Research Topic includes several systematic reviews and studies of meta-analysis that can help inform clinical practice. Specifically, these studies provide clinical evidence for several chronic conditions. Chen X. et al. systematically reviewed the clinical efficacy of conservative treatments on lumbar spinal stenosis, which found that limaprost might have better efficacy. In another review about the safety of fostamatinib among patients with rheumatoid arthritis, Chen Y. et al. found that compared to the placebo, fostamatinib was associated with a higher risk of malignant neoplasms at 52 weeks, with an odds ratio of 4.49 (95% CI 1.03–19.60). In a study with more than 1,000 patients with Peyronie's disease by Cao et al., the authors found that collagenase clostridium histolyticum has a significant effect on treating Peyronie's disease. In addition to chronic diseases, this topic has collected several studies on evidence generated in systematic reviews for patients with cancer. Based on five trials with more than 3,000 patients, Chen J. et al. found that cabazitaxel is effective in post-docetaxel settings but associated with a high risk of serious adverse events (SAEs). Using meta-analysis with 13 studies, Zou X. et al. found that a poorer socioeconomic status was associated with an increased risk of lung cancer in adulthood, with an OR of 1.25 (95% CI 1.10–1.43).
In the context of the pandemic, this Research Topic also collects a study about the evidence on the effectiveness of using oral anticoagulation for coronavirus disease 2019 (COVID-19). Specifically, Dai et al. conducted a systematic review and meta-analysis and found that chronic oral anticoagulation could not reduce mortality or intensive care unit (ICU) admission rate for patients with COVID-19. This Research Topic also contains a research protocol for a further clinical trial to assess the efficacy of integrative acupuncture and moxibustion treatment in patients with major depressive disorder (MDD; Zhang et al.).
We believe that the studies included in this Research Topic can serve as a clinical guide to a certain extent, especially as a supplement to randomized clinical trials. At the same time, we also believe that these studies can serve as a methodological inspiration for future research. Ultimately, we hope this Research Topic can support research on the value of health in evidence-based medicine.
Author contributions
KL, XX, GL, and BJ conceived the idea for the editorial and wrote the initial draft. All authors approved the final version of the editorial.
Acknowledgments
Thanks to the authors that submitted their articles to the Research Topic.
Conflict of interest
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
Publisher's note
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.
References
1. Guyatt G. Users' Guides to the Medical Literature: A Manual for Evidence-Based Clinical Practice. New York, NY: McGrawHill Education (2015).
2. Evidence-Based Medicine Working Group. Evidence-based medicine. A new approach to teaching the practice of medicine. JAMA. (1992) 268:2420–5. doi: 10.1001/jama.1992.03490170092032
3. Djulbegovic B, Guyatt GH. Progress in evidence-based medicine: a quarter century on. Lancet. (2017) 390:415–23. doi: 10.1016/S0140-6736(16)31592-6
4. Van Norman GA. Drugs, devices, and the FDA: part 1: an overview of approval processes for drugs. JACC Basic Transl Sci. (2016) 1:170–9. doi: 10.1016/j.jacbts.2016.03.002
5. Van Norman GA. Drugs, devices, and the FDA: part 2: an overview of approval processes: FDA approval of medical devices. JACC Basic Transl Sci. (2016) 1:277–87. doi: 10.1016/j.jacbts.2016.03.009
6. Bothwell LE, Greene JA, Podolsky SH, Jones DS. Assessing the Gold Standard–Lessons from the History of RCTs. N Engl J Med. (2016) 374:2175–81. doi: 10.1056/NEJMms1604593
7. Meldrum ML. A brief history of the randomized controlled trial. From oranges and lemons to the gold standard. Hematol Oncol Clin North Am. (2000) 14:745–60, vii. doi: 10.1016/s0889-8588(05)70309-9
8. Grossman J, Mackenzie FJ. The randomized controlled trial: gold standard, or merely standard?. Perspect Biol Med. (2005) 48:516–34. doi: 10.1353/pbm.2005.0092
9. Garrison LP Jr, Neumann PJ, Erickson P, Marshall D, Mullins CD. Using real-world data for coverage and payment decisions: the ISPOR Real-World Data Task Force report. Value Health. (2007) 10:326–35. doi: 10.1111/j.1524-4733.2007.00186.x
10. Fung FY, Linn YC. Developing traditional Chinese medicine in the era of evidence-based medicine: current evidences and challenges. Evid Based Complement Alternat Med. (2015) 2015:425037. doi: 10.1155/2015/425037
11. Leucht S, Chaimani A, Cipriani AS, Davis JM, Furukawa TA, Salanti G. Network meta-analyses should be the highest level of evidence in treatment guidelines. Eur Arch Psychiatry Clin Neurosci. (2016) 266:477–80. doi: 10.1007/s00406-016-0715-4
Keywords: real-world data, randomized controlled trial (RCT), evidence based medicine, value in health, herbal medicine, Traditional Chinese Medicine
Citation: Xiong X, Lv G, Jiang B and Lu K (2023) Editorial: From randomized clinical trials to real-world data and big data sciences: Generating evidence-based medicine for value in western and herbal medicines. Front. Public Health 11:1129399. doi: 10.3389/fpubh.2023.1129399
Received: 21 December 2022; Accepted: 17 January 2023;
Published: 13 February 2023.
Edited and reviewed by: Hai Fang, Peking University, China
Copyright © 2023 Xiong, Lv, Jiang and Lu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
*Correspondence: Kevin Lu, 
bHUzMiYjeDAwMDQwO2VtYWlsLnNjLmVkdQ==; Bin Jiang, YmluamlhbmcmI3gwMDA0MDtoc2MucGt1LmVkdS5jbg==
†These authors have contributed equally to this work