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  • N-of-1 randomized trials to assess the efficacy of gabapentin for chronic neuropathic pain

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    Author(s)
    Yelland, Michael J
    Poulos, Christopher J
    Pillans, Peter I
    Bashford, Guy M
    Nikles, Catherine Jane
    Sturtevant, Joanna M
    Vine, Norma
    Del Mar, Christopher B
    Schluter, Philip J
    Tan, Meng
    Chan, Jonathan
    Mackenzie, Fraser
    Brown, Robyn
    Griffith University Author(s)
    Yelland, Michael
    Chan, Jonathan H.
    Year published
    2009
    Metadata
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    Abstract
    Objective. The objective of this study was to compare the efficacy of gabapentin with placebo for neuropathic pain at the individual and population levels. Design. This study used an n-of-1 trial methodology with three double-blind, randomized, crossover comparisons of gabapentin with placebo. Setting. This study was carried out at specialist outpatient clinics at two Australian hospitals. Patients. The patients are adults with chronic neuropathic pain. Interventions. Following a dose-finding period, participants underwent three comparisons of 2-week periods on gabapentin (600-1,800 mg per day) and placebo. The dose-finding ...
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    Objective. The objective of this study was to compare the efficacy of gabapentin with placebo for neuropathic pain at the individual and population levels. Design. This study used an n-of-1 trial methodology with three double-blind, randomized, crossover comparisons of gabapentin with placebo. Setting. This study was carried out at specialist outpatient clinics at two Australian hospitals. Patients. The patients are adults with chronic neuropathic pain. Interventions. Following a dose-finding period, participants underwent three comparisons of 2-week periods on gabapentin (600-1,800 mg per day) and placebo. The dose-finding period was commenced by 112 patients, of whom 39 had no response so they did not enroll, leaving 73 trial participants. Of these, 48 completed and 7 partially completed their trials, and 18 withdrew. Outcome Measures. The five outcome measures were the visual analog scale (0-10) of pain, sleep interference and functional limitation; frequency of adverse events and medication preference. The aggregate response was determined by weighting the response to each measure equally. Results. Of the 55 participants who completed at least one cycle, the aggregate response to gabapentin was better than placebo in 16 (29%), of whom 15 continued gabapentin posttrial. No difference was shown in 38 (69%), and 1 (2%) showed a better response to placebo. Fifteen of these 39 continued gabapentin posttrial. Meta-analysis of the mean scores showed lower mean (standard deviation) scores for gabapentin by 0.8 (0.2) for pain, 0.6 (0.2) for sleep interference, and 0.6 (0.2) for functional limitation.
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    Journal Title
    Pain Medicine
    Volume
    10
    Issue
    4
    DOI
    https://doi.org/10.1111/j.1526-4637.2009.00615.x
    Copyright Statement
    © 2009 The American Academy of Pain Medicine. Published by Blackwell Publishing. This is the pre-peer reviewed version of the following article: N-of-1 randomized trials to assess the efficacy of gabapentin for chronic neuropathic pain, Pain Medicine Volume 10, Issue 4, 2009, 754-761, which has been published in final form at 10.1111/j.1526-4637.2009.00615.x.
    Subject
    Clinical sciences
    Pharmacology and pharmaceutical sciences
    Publication URI
    http://hdl.handle.net/10072/30570
    Collection
    • Journal articles

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