Institute of Complementary and Integrative Medicine, University of Bern, 3010 Bern, Bern, Switzerland; Institute of Integrative Medicine, Witten/Herdecke University, 58455 Witten, North Rhine-Westphalia, Germany; Homeopathy Research Institute, London SW7 4EF, United Kingdom.
Graduate Program on Environmental and Experimental Pathology, Paulista University, São Paulo 01504-000, São Paulo, Brazil.
J Integr Med. 2024 Sep;22(5):533-544. doi: 10.1016/j.joim.2024.06.005. Epub 2024 Jun 25.
Pharmacopoeias regulate the manufacture of potentised pharmaceutical preparations used in different branches of complementary and integrative medicine. The physicochemical properties and biological activity of these preparations are often investigated in preclinical research, yet no guidelines for experimental research currently exist in this area. The present PrePoP guidelines aim to provide recommendations to promote high-quality, statistically sound, and reproducible preclinical research on potentised preparations.
Input was gathered from researchers nominated by the relevant scientific societies using a simplified Delphi consensus approach covering the most relevant aspects of basic research methodology in the field including appropriate controls, sample preparation and handling, and statistics. After three rounds of feedback, a consensus was finally reached on the most important aspects and considerations for conducting high-quality research on potentised preparations.
We present a series of recommendations on a range of topics including experimental controls, system stability, blinding and randomisation, environmental influences, and procedures for the preparation of potentised samples and controls, and we address some specific challenges of this research field.
This expert consensus process resulted in a robust set of methodological guidelines for research on potentised preparations and provides a valuable framework that will inform and improve the quality of subsequent research in this emerging field.
Tournier AL, Bonamin LV, Buchheim-Schmidt S, Cartwright S, Dombrowsky C, Doesburg P, Holandino C, Kokornaczyk MO, van de Kraats EB, López-Carvallo JA, Nandy P, Mazón-Suástegui JM, Mirzajani F, Poitevin B, Scherr C, Thieves K, Würtenberger S, Baumgartner S. Scientific guidelines for preclinical research on potentised preparations manufactured according to current pharmacopoeias-the PrePoP guidelines. J Integr Med. 2024; 22(5): 533-544.
药典规范了用于补充和整合医学不同分支的强制药剂的制造。这些制剂的物理化学性质和生物活性通常在临床前研究中进行研究，但该领域目前没有实验研究的指南。本《PrePoP 指南》旨在提供建议，以促进高质量、统计学合理且可重复的强制剂临床前研究。
使用简化的 Delphi 共识方法从相关科学学会提名的研究人员那里收集意见，涵盖该领域基础研究方法学的最相关方面，包括适当的对照、样品制备和处理以及统计学。经过三轮反馈，最终就强制剂研究的高质量研究的最重要方面和考虑因素达成共识。
我们提出了一系列关于实验对照、系统稳定性、盲法和随机化、环境影响以及强制剂样品和对照制备程序的建议，并解决了该研究领域的一些具体挑战。
这一专家共识过程产生了一系列关于强制剂研究的方法学指南，为该新兴领域的后续研究提供了有价值的框架，将提高研究质量。
Tournier AL, Bonamin LV, Buchheim-Schmidt S, Cartwright S, Dombrowsky C, Doesburg P, Holandino C, Kokornaczyk MO, van de Kraats EB, López-Carvallo JA, Nandy P, Mazón-Suástegui JM, Mirzajani F, Poitevin B, Scherr C, Thieves K, Würtenberger S, Baumgartner S. 基于现行药典生产的强制剂临床前研究的科学指南——PrePoP 指南。综合医学杂志。2024; 22(5): 533-544.
