Tags

Type your tag names separated by a space and hit enter

N-of-1 randomized trials to assess the efficacy of gabapentin for chronic neuropathic pain.
Pain Med 2009 May-Jun; 10(4):754-61PM

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.

Authors+Show Affiliations

Griffith University, School of Medicine, Logan Campus, University Drive, Meadowbrook, Queensland 4131, Australia. m.yelland@griffith.edu.au

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19453961

Citation

Yelland, Michael J., et al. "N-of-1 Randomized Trials to Assess the Efficacy of Gabapentin for Chronic Neuropathic Pain." Pain Medicine (Malden, Mass.), vol. 10, no. 4, 2009, pp. 754-61.
Yelland MJ, Poulos CJ, Pillans PI, et al. N-of-1 randomized trials to assess the efficacy of gabapentin for chronic neuropathic pain. Pain Med. 2009;10(4):754-61.
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 (Malden, Mass.), 10(4), pp. 754-61. doi:10.1111/j.1526-4637.2009.00615.x.
Yelland MJ, et al. N-of-1 Randomized Trials to Assess the Efficacy of Gabapentin for Chronic Neuropathic Pain. Pain Med. 2009;10(4):754-61. PubMed PMID: 19453961.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR 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, Y1 - 2009/04/22/ PY - 2009/5/21/entrez PY - 2009/5/21/pubmed PY - 2009/11/17/medline SP - 754 EP - 61 JF - Pain medicine (Malden, Mass.) JO - Pain Med VL - 10 IS - 4 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. SN - 1526-4637 UR - https://www.unboundmedicine.com/medline/citation/19453961/N_of_1_randomized_trials_to_assess_the_efficacy_of_gabapentin_for_chronic_neuropathic_pain_ L2 - https://academic.oup.com/painmedicine/article-lookup/doi/10.1111/j.1526-4637.2009.00615.x DB - PRIME DP - Unbound Medicine ER -