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Papers of the Week

Papers: 12 Oct 2019 - 18 Oct 2019

Human Studies, Pharmacology/Drug Development

2020 Apr

Basic Clin Pharmacol Toxicol



A data science approach to the selection of most informative readouts of the human intradermal capsaicin pain model to assess pregabalin effects.


Lötsch J, Walter C, Zunftmeister M, Zinn S, Wolters M, Ferreiros N, Rossmanith T, Oertel BG, Geisslinger G
Basic Clin Pharmacol Toxicol. 2020 Apr; 126(4):318-331.
PMID: 31608551.


Persistent and in particular neuropathic pain is a major health care problem with still insufficient pharmacological treatment options. This triggered research activities aimed at finding analgesics with a novel mechanism of action. Results of these efforts will need to pass through the phases of drug development, in which experimental human pain models are established components often implemented as chemical hyperalgesia induced by capsaicin. We aimed at ranking the various readouts of the human capsaicin-based pain model with respect to the most relevant information about the effects of a potential reference analgesic. In a placebo-controlled, randomised cross-over study, seven different pain-related readouts were acquired in 16 healthy subjects before and after oral administration of 300 mg pregabalin. The sizes of the effect on pain induced by intradermal injection of capsaicin were quantified by calculating Cohen's d. While in four of the seven pain-related parameters, pregabalin provided a small effect judged by values of Cohen's d exceeding 0.2, an item-categorization technique implemented as computed ABC analysis identified the pain intensities in the area of secondary hyperalgesia and of allodynia as the most suitable parameters to quantify the analgesic effects of pregabalin. Results of this study provide further support for the ability of the intradermal capsaicin pain model to show analgesic effects of pregabalin. Results can serve as a basis for the designs of studies where the inclusion of this particular pain model and pregabalin is planned.