Michael Heinrich1, Giovanni Appendino2, Thomas Efferth3, Robert Fürst4, Angelo A Izzo5, Oliver Kayser6, John M Pezzuto7, Alvaro Viljoen8. 1. Pharmacognosy and Phytotherapy, UCL School of Pharmacy, 29 - 39 Brunswick Sq., London, WC1N 1AX, UK. Electronic address: m.heinrich@ucl.ac.uk. 2. Dipartimento di Scienze del Farmaco, Largo Donegani 2, 28100, Novara, Italy. Electronic address: giovanni.appendino@uniupo.it. 3. Department of Pharmaceutical Biology, Institute of Pharmacy and Biochemistry, Johannes Gutenberg University, Staudinger Weg 5, 55128, Mainz, Germany. Electronic address: efferth@uni-mainz.de. 4. Institute of Pharmaceutical Biology, Faculty of Biochemistry, Chemistry and Pharmacy, Goethe University Frankfurt, Max-von-Laue-Str. 9, 60438, Frankfurt, Germany. Electronic address: fuerst@em.uni-frankfurt.de. 5. Department of Pharmacy, School of Medicine and Surgery, University of Naples Federico II, Via D Montesano 49, Naples, Italy. Electronic address: aaizzo@unina.it. 6. Technical Biochemistry, TU Dortmund University, Emil-Figge-Strasse 66, 44227, Dortmund, Germany. Electronic address: oliver.kayser@tu-dortmund.de. 7. Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Long Island University, 75 DeKalb Avenue, Brooklyn, NY, USA. Electronic address: John.Pezzuto@liu.edu. 8. Department of Pharmaceutical Sciences, Faculty of Science, Tshwane University of Technology, Private Bag X680, Pretoria, 0001, South Africa; SAMRC Herbal Drugs Research Unit, Faculty of Science, Tshwane University of Technology, Private Bag X680, Pretoria, 0001, South Africa. Electronic address: ViljoenAM@tut.ac.za.
Abstract
BACKGROUND: The pharmacology, toxicology and pharmacokinetics of bioactive preparations derived from natural sources has become a flourishing field of research. However, researching complex extracts and natural products faces numerous challenges. More broadly in recent years the critique of pharmacological research, and specifically its design, the methods used and reporting has intensified. AIMS: This consensus document provides a perspective on what constitutes best practice in pharmacological research on bioactive preparations derived from natural sources, providing a perspective of what the leading specialist journals in the field consider as the core characteristics of good research. APPROACH ('METHODS'): The editors-in-chief of seven journals developed this best practice statement in an iterative process. A first draft of the guidelines (prepared by MH) was then discussed and amended by the other editors. OUTCOMES: Core to this contribution is a table which provides detailed advice including simple points like a use of appropriate controls and the full taxonomic validity of the material under investigation (see also below), to the relevance of the model for the question being researched (e.g., can specific in silico or in vitro models really address the species anti-inflammatory activity?). Therefore, obviously, researchers must pay detailed attention to reporting and discussing such studies. This information must be discussed critically (as much as it is possible based on the published papers) in terms of their scientific quality and validity. While these points are obvious, as editors, we are aware that they are often not properly implemented. CONCLUSION: We call for an approach which incorporates a careful design, meticulous execution and a detailed reporting of studies focusing on the pharmacology/bioactivity of bioactive preparations. Clearly testable research questions must be developed and investigated experimentally. As the founder of pharmacology Claude Bernard put it already in 1865: '…. either the experimenter's hypothesis will be disproved or it will be proved by experiment. When experiment disproves its preconceived ideas, the experimenter must discard or modify it.'
BACKGROUND: The pharmacology, toxicology and pharmacokinetics of bioactive preparations derived from natural sources has become a flourishing field of research. However, researching complex extracts and natural products faces numerous challenges. More broadly in recent years the critique of pharmacological research, and specifically its design, the methods used and reporting has intensified. AIMS: This consensus document provides a perspective on what constitutes best practice in pharmacological research on bioactive preparations derived from natural sources, providing a perspective of what the leading specialist journals in the field consider as the core characteristics of good research. APPROACH ('METHODS'): The editors-in-chief of seven journals developed this best practice statement in an iterative process. A first draft of the guidelines (prepared by MH) was then discussed and amended by the other editors. OUTCOMES: Core to this contribution is a table which provides detailed advice including simple points like a use of appropriate controls and the full taxonomic validity of the material under investigation (see also below), to the relevance of the model for the question being researched (e.g., can specific in silico or in vitro models really address the species anti-inflammatory activity?). Therefore, obviously, researchers must pay detailed attention to reporting and discussing such studies. This information must be discussed critically (as much as it is possible based on the published papers) in terms of their scientific quality and validity. While these points are obvious, as editors, we are aware that they are often not properly implemented. CONCLUSION: We call for an approach which incorporates a careful design, meticulous execution and a detailed reporting of studies focusing on the pharmacology/bioactivity of bioactive preparations. Clearly testable research questions must be developed and investigated experimentally. As the founder of pharmacology Claude Bernard put it already in 1865: '…. either the experimenter's hypothesis will be disproved or it will be proved by experiment. When experiment disproves its preconceived ideas, the experimenter must discard or modify it.'
Authors: Angelo A Izzo; Mauro Teixeira; Steve P H Alexander; Giuseppe Cirino; James R Docherty; Christopher H George; Paul A Insel; Yong Ji; David A Kendall; Reynold A Panattieri; Christopher G Sobey; S Clare Stanford; Barbara Stefanska; Gary Stephens; Amrita Ahluwalia Journal: Br J Pharmacol Date: 2020-04-16 Impact factor: 8.739
Authors: Dâmaris Silveira; Jose Maria Prieto-Garcia; Fabio Boylan; Omar Estrada; Yris Maria Fonseca-Bazzo; Claudia Masrouah Jamal; Pérola Oliveira Magalhães; Edson Oliveira Pereira; Michal Tomczyk; Michael Heinrich Journal: Front Pharmacol Date: 2020-09-23 Impact factor: 5.810