• Pain · Oct 2024

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

    • Jorge Alberto Martins Pentiado Júnior, Marcell Maduro Barbosa, Gabriel Taricani Kubota, Pedro Nascimento Martins, Larissa Iulle Moreira, Ana Mércia Fernandes, da SilvaValquíria AparecidaVAPain Center, Department of Neurology, University of São Paulo, São Paulo, Brazil., JúniorJefferson RosiJRPain Center, Department of Neurology, University of São Paulo, São Paulo, Brazil., Lin Tchia Yeng, Manoel Jacobsen Teixeira, and Daniel Ciampi de Andrade.
    • Pain Center, Department of Neurology, University of São Paulo, São Paulo, Brazil.
    • Pain. 2024 Oct 22.

    AbstractIn 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.

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