About this Research Topic
Frontiers in Pharmacology is pleased to present this Research Topic on 'Clinical Phytopharmacology', covering all aspects of clinical research on complex mixtures derived from plants and fungi. Although some plant-derived drugs have been well-recognised such as Artemisinin, herbal medicines and specifically herbal medical products remain controversial. Often there is little trust by the public and medical doctors (esp. those trained in biomedicine). A considerable body of research has focused on some specific medical traditions and in recent years most importantly Traditional Chinese Medicine (TCM). Common problems encountered with such studies dramatically limit their validity and thus usefulness. In particular, we want to highlight the following clinical problems and find solutions on how to overcome them:
(i) Limited sample size in a study.
(ii) Relatively short duration.
(iii) Poor and incomplete description of the medication investigated.
(iv) Poor reporting of, for example, blinding and the incomplete reporting of outcomes.
(v) Poor designing of clinical trial, e.g. inappropriate randomization concealment, lack of placebo control, inappropriate blinding etc.
(vi) Manufacturing process and quality control of herbs not usually well documented.
(vii) Use of non-validated outcome parameters.
(viii) challenges of linking traditional uses with clinical tools accepted globally.
(ix) Lack of information regarding the combination with Western medicine and potential interaction among herbs for multi-herbal preparations.
The approach to tackle these problems is to provide convincing clinical evidence in a study. So with this research topic we want to raise the bar for the design and reporting of clinical studies. Therefore, the main goal of this research topic is to collect high-quality investigations assessing such phytomedicines. Studies need to follow the Cochrane "Best Practice and Guidance" to report their studies and we require that the authors follow the ConPhyMP guidelines as it relates to the reporting of the preparation investigated (see https://www.frontiersin.org/articles/10.3389/fphar.2022.953205/full). This must include a detailed description of the botanical drugs, their processing, and clinical use, as well as a fingerprint as required in the statement (normally for a preparation using botanical drugs monographed in a pharmacopoeia). This ensures that the approach is reproducible and contributes to an understanding of the potential efficacy and safety of these preparations.
Herbal preparations to be covered include single and multi-herbal preparations. We encourage authors to submit Original Research, Review, Opinion, and Perspective articles related to the themes of this topic: The themes of this Research Topic include, but are not limited to, the following:
- Real world evidence of clinical Phytopharmacology.
- Cost-effectiveness of Phytomedicine.
- The effect of combination of Phytomedicine and Western medicine.
- Early phase of clinical trials in specific phytomedical preparations
- Phase IV trial or Post-market surveillance of phytomedical products.
- The safety of Phytomedicine.
- The impact of Phytomedicine on public health system.
Systematic reviews and Meta-analysis target to specific herbal drugs or formulas are also welcomed, but are limited to topics that are not been discussed.
All the manuscripts submitted to the collection will need to fully comply with the Four Pillars of Best Practice in Ethnopharmacology (you can freely download the full version here).). For clinical studies a detailed description of the study material is of particular importance. Therefore, We also expect that the MS follow the standards established in the ConPhyMP statement Front. Pharmacol. 13:953205.
Importantly, please ascertain that the ethnopharmacological context is clearly described and that the material investigated is characterized in detail .
(i) Limited sample size in a study.
(ii) Relatively short duration.
(iii) Poor and incomplete description of the medication investigated.
(iv) Poor reporting of, for example, blinding and the incomplete reporting of outcomes.
(v) Poor designing of clinical trial, e.g. inappropriate randomization concealment, lack of placebo control, inappropriate blinding etc.
(vi) Manufacturing process and quality control of herbs not usually well documented.
(vii) Use of non-validated outcome parameters.
(viii) challenges of linking traditional uses with clinical tools accepted globally.
(ix) Lack of information regarding the combination with Western medicine and potential interaction among herbs for multi-herbal preparations.
The approach to tackle these problems is to provide convincing clinical evidence in a study. So with this research topic we want to raise the bar for the design and reporting of clinical studies. Therefore, the main goal of this research topic is to collect high-quality investigations assessing such phytomedicines. Studies need to follow the Cochrane "Best Practice and Guidance" to report their studies and we require that the authors follow the ConPhyMP guidelines as it relates to the reporting of the preparation investigated (see https://www.frontiersin.org/articles/10.3389/fphar.2022.953205/full). This must include a detailed description of the botanical drugs, their processing, and clinical use, as well as a fingerprint as required in the statement (normally for a preparation using botanical drugs monographed in a pharmacopoeia). This ensures that the approach is reproducible and contributes to an understanding of the potential efficacy and safety of these preparations.
Herbal preparations to be covered include single and multi-herbal preparations. We encourage authors to submit Original Research, Review, Opinion, and Perspective articles related to the themes of this topic: The themes of this Research Topic include, but are not limited to, the following:
- Real world evidence of clinical Phytopharmacology.
- Cost-effectiveness of Phytomedicine.
- The effect of combination of Phytomedicine and Western medicine.
- Early phase of clinical trials in specific phytomedical preparations
- Phase IV trial or Post-market surveillance of phytomedical products.
- The safety of Phytomedicine.
- The impact of Phytomedicine on public health system.
Systematic reviews and Meta-analysis target to specific herbal drugs or formulas are also welcomed, but are limited to topics that are not been discussed.
All the manuscripts submitted to the collection will need to fully comply with the Four Pillars of Best Practice in Ethnopharmacology (you can freely download the full version here).). For clinical studies a detailed description of the study material is of particular importance. Therefore, We also expect that the MS follow the standards established in the ConPhyMP statement Front. Pharmacol. 13:953205.
Importantly, please ascertain that the ethnopharmacological context is clearly described and that the material investigated is characterized in detail .
Keywords: clinical trial, meta-analysis, systematic review, Cochrane, ConPhyMP, Phytopharmacology, clinical studies, pharmacology, ethnopharmacology, healthcare, real world evidence
Important Note: All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.
