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A placebo-controlled trial of gabapentin for painful HIV-associated sensory neuropathies.

Abstract

BACKGROUND

Painful HIV-associated sensory neuropathies (HIV-SN) are a common complication of HIV infection. The pathogenesis is unknown and the treatment very limited. Gabapentin (GBP) is effective in painful diabetic neuropathy and postherpetic neuralgia and its effectiveness on painful HIV-SN has been reported anecdotally.

DESIGN

Multicenter, prospective, randomised, double-blind, placebo-controlled study.

METHODS

Patients were followed for a 1-week screening, a 4-week double-blind and a 2-week open treatment phase. GBP was initiated at 400 mg/d, titrated over 2 weeks to 1200 mg/d, and then either maintained at this level or-if not beneficial-titrated to 2400 mg/d. After 4 weeks the medication was unblinded and the patient had the choice to begin, to maintain or to increase GBP to 3600 mg/d. The primary outcome measure was an improvement in median pain on the Visual Analogue Scale (VAS) from the screening week compared to the 4(th) treatment week. A secondary efficacy measure was the median sleep score (VAS).

RESULTS

15 patients received GBP and 11 placebo. In each group one patient dropped out during the doubleblind phase. Median pain (GBP 5.1; placebo 4.7) and sleep score (GBP 4.5; placebo 5.6) did not differ between both groups at baseline. In the GBP-group there was a significant decrease of the pain to 2.85 (-44.1 %) as well as of the sleep VAS to 2.3 (-48.9 %). No significant decrease in the pain (median VAS=3.3, -29.8 %) as well as in the sleep score (median VAS=4.95, -11.6 %) was observed in the placebo-group. GBP was generally well tolerated. The most frequent side effect was somnolence reported in 80% of GBP-treated patients.

CONCLUSIONS

GBP was more effective than placebo in reducing pain and sleep interference in patients with HIV-SN.

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  • Authors+Show Affiliations

    ,

    Department of Neurology, Charité Campus Mitte, Schumannstr. 20/21, D-10117 Berlin, Germany. katrin.wetzel@charite.de

    , , , , , , ,

    Source

    Journal of neurology 251:10 2004 Oct pg 1260-6

    MeSH

    Adult
    Amines
    Analgesics
    Cyclohexanecarboxylic Acids
    Double-Blind Method
    Female
    Gabapentin
    HIV Seropositivity
    Humans
    Male
    Middle Aged
    Neuralgia
    Pain Measurement
    Peripheral Nervous System Diseases
    Sleep
    Time Factors
    Treatment Outcome
    gamma-Aminobutyric Acid

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    15503108

    Citation

    Hahn, K, et al. "A Placebo-controlled Trial of Gabapentin for Painful HIV-associated Sensory Neuropathies." Journal of Neurology, vol. 251, no. 10, 2004, pp. 1260-6.
    Hahn K, Arendt G, Braun JS, et al. A placebo-controlled trial of gabapentin for painful HIV-associated sensory neuropathies. J Neurol. 2004;251(10):1260-6.
    Hahn, K., Arendt, G., Braun, J. S., von Giesen, H. J., Husstedt, I. W., Maschke, M., ... Schielke, E. (2004). A placebo-controlled trial of gabapentin for painful HIV-associated sensory neuropathies. Journal of Neurology, 251(10), pp. 1260-6.
    Hahn K, et al. A Placebo-controlled Trial of Gabapentin for Painful HIV-associated Sensory Neuropathies. J Neurol. 2004;251(10):1260-6. PubMed PMID: 15503108.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - A placebo-controlled trial of gabapentin for painful HIV-associated sensory neuropathies. AU - Hahn,K, AU - Arendt,G, AU - Braun,J S, AU - von Giesen,H-J, AU - Husstedt,I W, AU - Maschke,M, AU - Straube,M E, AU - Schielke,E, AU - ,, PY - 2003/08/14/received PY - 2004/04/27/revised PY - 2004/05/03/accepted PY - 2004/10/27/pubmed PY - 2005/2/23/medline PY - 2004/10/27/entrez SP - 1260 EP - 6 JF - Journal of neurology JO - J. Neurol. VL - 251 IS - 10 N2 - BACKGROUND: Painful HIV-associated sensory neuropathies (HIV-SN) are a common complication of HIV infection. The pathogenesis is unknown and the treatment very limited. Gabapentin (GBP) is effective in painful diabetic neuropathy and postherpetic neuralgia and its effectiveness on painful HIV-SN has been reported anecdotally. DESIGN: Multicenter, prospective, randomised, double-blind, placebo-controlled study. METHODS: Patients were followed for a 1-week screening, a 4-week double-blind and a 2-week open treatment phase. GBP was initiated at 400 mg/d, titrated over 2 weeks to 1200 mg/d, and then either maintained at this level or-if not beneficial-titrated to 2400 mg/d. After 4 weeks the medication was unblinded and the patient had the choice to begin, to maintain or to increase GBP to 3600 mg/d. The primary outcome measure was an improvement in median pain on the Visual Analogue Scale (VAS) from the screening week compared to the 4(th) treatment week. A secondary efficacy measure was the median sleep score (VAS). RESULTS: 15 patients received GBP and 11 placebo. In each group one patient dropped out during the doubleblind phase. Median pain (GBP 5.1; placebo 4.7) and sleep score (GBP 4.5; placebo 5.6) did not differ between both groups at baseline. In the GBP-group there was a significant decrease of the pain to 2.85 (-44.1 %) as well as of the sleep VAS to 2.3 (-48.9 %). No significant decrease in the pain (median VAS=3.3, -29.8 %) as well as in the sleep score (median VAS=4.95, -11.6 %) was observed in the placebo-group. GBP was generally well tolerated. The most frequent side effect was somnolence reported in 80% of GBP-treated patients. CONCLUSIONS: GBP was more effective than placebo in reducing pain and sleep interference in patients with HIV-SN. SN - 0340-5354 UR - https://www.unboundmedicine.com/medline/citation/15503108/A_placebo_controlled_trial_of_gabapentin_for_painful_HIV_associated_sensory_neuropathies_ L2 - https://dx.doi.org/10.1007/s00415-004-0529-6 DB - PRIME DP - Unbound Medicine ER -