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

Michael J. Yelland, Christopher J. Poulos, Peter I. Pillans, Guy M. Bashford, Catherine Jane Nikles, Joanna M. Sturtevant, Norma Vine, Christopher B. Del Mar, Philip J. Schluter, Meng Tan, Jonathan Chan, Fraser Mackenzie, Robyn Brown

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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 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. Conclusions. The response rate and mean reduction in symptoms with gabapentin were small. Gabapentin prescribing posttrial was significantly influenced by the trial results.

Original languageEnglish
Pages (from-to)754-761
Number of pages8
JournalPain Medicine
Volume10
Issue number4
DOIs
Publication statusPublished - 2009

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Neuralgia
Chronic Pain
Placebos
Sleep
Outcome Assessment (Health Care)
gabapentin
Pain
Ambulatory Care Facilities
Visual Analog Scale
Meta-Analysis

Cite this

Yelland, M. J., Poulos, C. J., Pillans, P. I., Bashford, G. M., Nikles, C. J., Sturtevant, J. M., ... Brown, R. (2009). N-of-1 randomized trials to assess the efficacy of gabapentin for chronic neuropathic pain. Pain Medicine, 10(4), 754-761. https://doi.org/10.1111/j.1526-4637.2009.00615.x
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. / N-of-1 randomized trials to assess the efficacy of gabapentin for chronic neuropathic pain. In: Pain Medicine. 2009 ; Vol. 10, No. 4. pp. 754-761.
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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 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. Conclusions. The response rate and mean reduction in symptoms with gabapentin were small. Gabapentin prescribing posttrial was significantly influenced by the trial results.",
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Yelland, MJ, Poulos, CJ, Pillans, PI, Bashford, GM, Nikles, CJ, Sturtevant, JM, Vine, N, Del Mar, CB, Schluter, PJ, Tan, M, Chan, J, Mackenzie, F & Brown, R 2009, 'N-of-1 randomized trials to assess the efficacy of gabapentin for chronic neuropathic pain' Pain Medicine, vol. 10, no. 4, pp. 754-761. https://doi.org/10.1111/j.1526-4637.2009.00615.x

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

In: Pain Medicine, Vol. 10, No. 4, 2009, p. 754-761.

Research output: Contribution to journalArticleResearchpeer-review

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T1 - N-of-1 randomized trials to assess the efficacy of gabapentin for chronic neuropathic pain

AU - Yelland, Michael J.

AU - Poulos, Christopher J.

AU - Pillans, Peter I.

AU - Bashford, Guy M.

AU - Nikles, Catherine Jane

AU - Sturtevant, Joanna M.

AU - Vine, Norma

AU - Del Mar, Christopher B.

AU - Schluter, Philip J.

AU - Tan, Meng

AU - Chan, Jonathan

AU - Mackenzie, Fraser

AU - Brown, Robyn

PY - 2009

Y1 - 2009

N2 - 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. Conclusions. The response rate and mean reduction in symptoms with gabapentin were small. Gabapentin prescribing posttrial was significantly influenced by the trial results.

AB - 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. Conclusions. The response rate and mean reduction in symptoms with gabapentin were small. Gabapentin prescribing posttrial was significantly influenced by the trial results.

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Yelland MJ, Poulos CJ, Pillans PI, Bashford GM, Nikles CJ, Sturtevant JM et al. N-of-1 randomized trials to assess the efficacy of gabapentin for chronic neuropathic pain. Pain Medicine. 2009;10(4):754-761. https://doi.org/10.1111/j.1526-4637.2009.00615.x