The concept of real-world studies (RWS) has emerged in recent years and differs from randomized controlled trials (RCTs) in design and implementation. The importance of real-world data (RWD) and real-world evidence (RWE) in the context of medical and health decision-making is rising. This is relevant for the many and diverse medical traditions globally. RWS can bring new ideas and methodologies for clinical efficacy and safety evaluation of different specific preparations used in a Traditional Medicine (TM) and allow a high-quality assessment of the evidence for specific uses of such preparations. TM, including Traditional Chinese medicine (TCM), Traditional European Medicine (TEM) or Traditional Indian Medicines (TIM) as well as interventions using herbal medicines or natural products such as dietary fibre are all examples of practices which can benefit from RWS.
For example, TCM is a unique form of medical practice based on a complex philosophy as well as on real-world clinical experience and evidence. RWE is essential for understanding the evidence one can derive from the outcomes of medical practice. It is of particular interest for understanding TCM diagnosis and treatment. In addition, there is potential for real-world traditional medical therapies based on other cultural and philosophical principles (natural products or herbal medicines). Currently, RWS is mostly utilized for evaluation the clinical efficacy of Traditional medicine (TM) treatments, including post-marketing re-evaluation of new medications or traditional classical prescriptions, as well as TM-related mechanistic research.
In case of TCM diseases relevant for an TWS analysis include mostly cerebral infarction, coronary heart disease, and non-small cell lung cancer, and the primary therapy strategy is Chinese herbal injections. RWS in natural product development focuses on patient rehabilitation and disease prevention. Retrospective cohort studies, case-control studies, registries, and HIS data mining-based research are among the study types. A recent study analysing the multi-pharmacological potential therapeutics of TM using complex population data highlights the potential of real-world TM studies in pharmacological studies of TM, such as for products based on danshen (Salvia miltiorrhiza Bunge [Lamiaceae]) for angina pectoris, which interacts with multiple targets. However, there is still a large body of real-world data to be mined, and the focus of this topic is the use of network analyses to demonstrate the clinical efficacy of Chinese medicine and its research of mechanisms based on these data.
We would like to build a forum on this topic to discuss how to evaluate the role of TM in the clinical context using real-world data or by conducting real-world studies. This comprises evaluation of the (clinical) efficacy and safety of TM treatments (TCM, TEM, TIM, herbal medicines, natural products, etc.), safety evaluation, or research on new findings on TM diagnostics (related to the use of herbal medicines), phytotherapy, or outcome-oriented research in clinical settings.
We want to attract manuscripts including review articles and original research work on real-world research using specific TM treatments and welcome manuscripts covering:
• The evaluation of the clinical effectiveness and safety based on real-world TM data.
•Clinical and mechanism research of TM intervention in subhealth based on real-world data.
• Research on clinical aspects and the pharmacological mechanism of TM intervention focusing on specific diseases based on real-world data.
• Exploring real-world data for potential patterns of TM including Chinese herbal medicines (crude and special extracts).
• Pharmacological evidence of herbal medicines (crude and special extracts), proprietary herbal medicines, and natural products, combined with real-world clinical data.
• Translational biomedical informatics for TM diagnosis and treatments.
All manuscripts must comply with our guidelines - the four pillars of best practice in ethnopharmacology (see www.frontiersin.org/files/pdf/4_pillars_FULL_TEXT.pdf) and the ConPhyMP statement: Front. Pharmacol. 13:953205. https://doi.org/10.3389/fphar.2022.953205). It is essential that the studies focus on specific, pharmacognstically well-defined preparations and these preparations must be characterised chemically if experimental studies are included. Purely in silico analyses of specific preparations using network analysis or docking studies are only considered if a detailed body of novel experimental pharmacological data are included.
The concept of real-world studies (RWS) has emerged in recent years and differs from randomized controlled trials (RCTs) in design and implementation. The importance of real-world data (RWD) and real-world evidence (RWE) in the context of medical and health decision-making is rising. This is relevant for the many and diverse medical traditions globally. RWS can bring new ideas and methodologies for clinical efficacy and safety evaluation of different specific preparations used in a Traditional Medicine (TM) and allow a high-quality assessment of the evidence for specific uses of such preparations. TM, including Traditional Chinese medicine (TCM), Traditional European Medicine (TEM) or Traditional Indian Medicines (TIM) as well as interventions using herbal medicines or natural products such as dietary fibre are all examples of practices which can benefit from RWS.
For example, TCM is a unique form of medical practice based on a complex philosophy as well as on real-world clinical experience and evidence. RWE is essential for understanding the evidence one can derive from the outcomes of medical practice. It is of particular interest for understanding TCM diagnosis and treatment. In addition, there is potential for real-world traditional medical therapies based on other cultural and philosophical principles (natural products or herbal medicines). Currently, RWS is mostly utilized for evaluation the clinical efficacy of Traditional medicine (TM) treatments, including post-marketing re-evaluation of new medications or traditional classical prescriptions, as well as TM-related mechanistic research.
In case of TCM diseases relevant for an TWS analysis include mostly cerebral infarction, coronary heart disease, and non-small cell lung cancer, and the primary therapy strategy is Chinese herbal injections. RWS in natural product development focuses on patient rehabilitation and disease prevention. Retrospective cohort studies, case-control studies, registries, and HIS data mining-based research are among the study types. A recent study analysing the multi-pharmacological potential therapeutics of TM using complex population data highlights the potential of real-world TM studies in pharmacological studies of TM, such as for products based on danshen (Salvia miltiorrhiza Bunge [Lamiaceae]) for angina pectoris, which interacts with multiple targets. However, there is still a large body of real-world data to be mined, and the focus of this topic is the use of network analyses to demonstrate the clinical efficacy of Chinese medicine and its research of mechanisms based on these data.
We would like to build a forum on this topic to discuss how to evaluate the role of TM in the clinical context using real-world data or by conducting real-world studies. This comprises evaluation of the (clinical) efficacy and safety of TM treatments (TCM, TEM, TIM, herbal medicines, natural products, etc.), safety evaluation, or research on new findings on TM diagnostics (related to the use of herbal medicines), phytotherapy, or outcome-oriented research in clinical settings.
We want to attract manuscripts including review articles and original research work on real-world research using specific TM treatments and welcome manuscripts covering:
• The evaluation of the clinical effectiveness and safety based on real-world TM data.
•Clinical and mechanism research of TM intervention in subhealth based on real-world data.
• Research on clinical aspects and the pharmacological mechanism of TM intervention focusing on specific diseases based on real-world data.
• Exploring real-world data for potential patterns of TM including Chinese herbal medicines (crude and special extracts).
• Pharmacological evidence of herbal medicines (crude and special extracts), proprietary herbal medicines, and natural products, combined with real-world clinical data.
• Translational biomedical informatics for TM diagnosis and treatments.
All manuscripts must comply with our guidelines - the four pillars of best practice in ethnopharmacology (see www.frontiersin.org/files/pdf/4_pillars_FULL_TEXT.pdf) and the ConPhyMP statement: Front. Pharmacol. 13:953205. https://doi.org/10.3389/fphar.2022.953205). It is essential that the studies focus on specific, pharmacognstically well-defined preparations and these preparations must be characterised chemically if experimental studies are included. Purely in silico analyses of specific preparations using network analysis or docking studies are only considered if a detailed body of novel experimental pharmacological data are included.
