METHA-NeP: effectiveness and safety of methadone for neuropathic pain: a controlled randomized trial.

Autor:	Pentiado Júnior JAM; Pain Center, Department of Neurology, University of São Paulo, São Paulo, Brazil., Barbosa MM; Pain Center, Department of Neurology, University of São Paulo, São Paulo, Brazil., Kubota GT; Pain Center, Department of Neurology, University of São Paulo, São Paulo, Brazil., Martins PN; Faculty of Medicine, Federal University of Juiz de Fora, Juiz de Fora, Minas Gerais, Brazil., Moreira LI; Pain Center, Department of Neurology, University of São Paulo, São Paulo, Brazil., Fernandes AM; Pain Center, Department of Neurology, University of São Paulo, São Paulo, Brazil., da Silva VA; Pain Center, Department of Neurology, University of São Paulo, São Paulo, Brazil., Júnior JR; Pain Center, Department of Neurology, University of São Paulo, São Paulo, Brazil., Yeng LT; Pain Center, Department of Neurology, University of São Paulo, São Paulo, Brazil., Teixeira MJ; Pain Center, Department of Neurology, University of São Paulo, São Paulo, Brazil., Ciampi de Andrade D; Pain Center, Department of Neurology, University of São Paulo, São Paulo, Brazil.; Center for Neuroplasticity and Pain, Department of Health Sciences and Technology, Faculty of Medicine, Aalborg University, Aalborg, Denmark.
Jazyk:	angličtina
Zdroj:	Pain [Pain] 2024 Oct 22. Date of Electronic Publication: 2024 Oct 22.
DOI:	10.1097/j.pain.0000000000003413
Abstrakt:	Abstract: In this randomized, double-blind, parallel placebo-controlled clinical trial, we evaluated the efficacy of methadone as an add-on therapy for people with chronic neuropathic pain (NP). Eighty-six patients were randomly assigned to receive methadone or placebo for 8 weeks. The primary outcome was the proportion of participants achieving at least 30% pain relief from baseline using a 100-mm pain Visual Analogue Scale. Secondary outcomes included global impression of change, NP symptoms, sleep quality, quality of life, pain interference in daily activities, and mood. A larger number of responders were found in the methadone (68%), compared to the placebo (33%) arm; risk difference 33.6%; 95% confidence interval 13.0%-54.3%; P = 0.003; number needed to treat = 3.0. Methadone reduced pain intensity ( P < 0.001), burning ( P = 0.023), pressing ( P = 0.005), and paroxysmal dimensions ( P = 0.006) of NP. Methadone also improved sleep ( P < 0.001) and increased the patient's global impression of improvement ( P = 0.002). Methadone did not significantly impact quality of life, pain interference, or mood. Treatment-emergent adverse events occurred in all methadone- and in 73% of placebo-treated patients ( P < 0.001). No serious adverse events or deaths occurred. Discontinuation due to adverse events was reported in 2 participants in the methadone and none in the placebo arm. Methadone use as an add-on to an optimized treatment for NP with first- and/or second-line drugs provided superior analgesia, improved sleep, and enhanced global impression of change, without being associated with significant serious adverse effects that would raise safety concerns. (Copyright © 2024 International Association for the Study of Pain.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu