Vol X, Issue 4 Date of Publication: October 10, 2025
DOI: https://doi.org/10.20529/IJME.2025.073

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Off-label use of baclofen: A response to Kattula

Florian Naudet
Alain Braillon
Abstract:

The “discussion” on our commentary about baclofen use in India perpetuates misconceptions. We want to: a) highlight the flood of overlapping and conflicting meta-analyses that obscure rather than clarify baclofen’s effects; b) stress the importance of pivotal trials which support hypothetico-deductive reasoning and provide the basis for regulatory decisions. Such trials use only high-dose baclofen without proven benefit but serious safety concerns, including mortality. Practitioner enthusiasm, lived experience, or off-label consensus — whether in the global North or recycled in the global South — cannot replace rigorous trial evidence. We call for careful evaluation of pivotal evidence and robust research.


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©Indian Journal of Medical Ethics 2025: Open Access and Distributed under the Creative Commons license ( CC BY-NC-ND 4.0),
which permits only non-commercial and non-modified sharing in any medium, provided the original author(s) and source are credited.

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