{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T16:13:55Z","timestamp":1760112835196,"version":"build-2065373602"},"reference-count":0,"publisher":"Forum for Medical Ethics Society","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["IJME"],"abstract":"<jats:p>The \u201cdiscussion\u201d 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\u2019s 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 \u2014 whether in the global North or recycled in the global South \u2014 cannot replace rigorous trial evidence. We call for careful evaluation of pivotal evidence and robust research.<\/jats:p>","DOI":"10.20529\/ijme.2025.073","type":"journal-article","created":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T15:32:21Z","timestamp":1760110341000},"page":"315-318","source":"Crossref","is-referenced-by-count":0,"title":["Off-label use of baclofen: A response to Kattula"],"prefix":"10.20529","volume":"10","author":[{"given":"Florian","family":"Naudet","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alain","family":"Braillon","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"8506","published-online":{"date-parts":[[2025,10,10]]},"container-title":["Indian Journal of Medical Ethics"],"original-title":[],"link":[{"URL":"https:\/\/ijme.in\/wp-content\/uploads\/2025\/10\/Off-label-use_315.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T15:32:24Z","timestamp":1760110344000},"score":1,"resource":{"primary":{"URL":"https:\/\/ijme.in\/articles\/off-label-use-of-baclofen-a-response-to-kattula\/"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10,10]]},"references-count":0,"journal-issue":{"issue":"4","published-online":{"date-parts":[[2025,10,10]]}},"URL":"https:\/\/doi.org\/10.20529\/ijme.2025.073","relation":{},"ISSN":["0974-8466","0975-5691"],"issn-type":[{"value":"0974-8466","type":"print"},{"value":"0975-5691","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,10,10]]}}}