Off-label use of baclofen: A response to Kattula.

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.