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Gabapentin for the treatment of postherpetic neuralgia: a randomized controlled trial.

Abstract

CONTEXT

Postherpetic neuralgia (PHN) is a syndrome of often intractable neuropathic pain following herpes zoster (shingles) that eludes effective treatment in many patients.

OBJECTIVE

To determine the efficacy and safety of the anticonvulsant drug gabapentin in reducing PHN pain.

DESIGN

Multicenter, randomized, double-blind, placebo-controlled, parallel design, 8-week trial conducted from August 1996 through July 1997.

SETTING

Sixteen US outpatient clinical centers.

PARTICIPANTS

A total of 229 subjects were randomized.

INTERVENTION

A 4-week titration period to a maximum dosage of 3600 mg/d of gabapentin or matching placebo. Treatment was maintained for another 4 weeks at the maximum tolerated dose. Concomitant tricyclic antidepressants and/or narcotics were continued if therapy was stabilized prior to study entry and remained constant throughout the study.

MAIN OUTCOME MEASURES

The primary efficacy measure was change in the average daily pain score based on an 11-point Likert scale (0, no pain; 10, worst possible pain) from baseline week to the final week of therapy. Secondary measures included average daily sleep scores, Short-Form McGill Pain Questionnaire (SF-MPQ), Subject Global Impression of Change and investigator-rated Clinical Global Impression of Change, Short Form-36 (SF-36) Quality of Life Questionnaire, and Profile of Mood States (POMS). Safety measures included the frequency and severity of adverse events.

RESULTS

One hundred thirteen patients received gabapentin, and 89 (78.8%) completed the study; 116 received placebo, and 95 (81.9%) completed the study. By intent-to-treat analysis, subjects receiving gabapentin had a statistically significant reduction in average daily pain score from 6.3 to 4.2 points compared with a change from 6.5 to 6.0 points in subjects randomized to receive placebo (P<.001). Secondary measures of pain as well as changes in pain and sleep interference showed improvement with gabapentin (P<.001). Many measures within the SF-36 and POMS also significantly favored gabapentin (P< or =.01). Somnolence, dizziness, ataxia, peripheral edema, and infection were all more frequent in the gabapentin group, but withdrawals were comparable in the 2 groups (15 [13.3%] in the gabapentin group vs 11 [9.5%] in the placebo group).

CONCLUSIONS

Gabapentin is effective in the treatment of pain and sleep interference associated with PHN. Mood and quality of life also improve with gabapentin therapy.

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  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    UCSF Pain Clinical Research Center, University of California, San Francisco 94115, USA.

    , , ,

    Source

    JAMA 280:21 1998 Dec 02 pg 1837-42

    MeSH

    Acetates
    Adult
    Aged
    Aged, 80 and over
    Amines
    Analgesics
    Anticonvulsants
    Cyclohexanecarboxylic Acids
    Double-Blind Method
    Female
    Gabapentin
    Herpes Zoster
    Humans
    Male
    Middle Aged
    Neuralgia
    Pain Measurement
    Quality of Life
    gamma-Aminobutyric Acid

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    9846778

    Citation

    Rowbotham, M, et al. "Gabapentin for the Treatment of Postherpetic Neuralgia: a Randomized Controlled Trial." JAMA, vol. 280, no. 21, 1998, pp. 1837-42.
    Rowbotham M, Harden N, Stacey B, et al. Gabapentin for the treatment of postherpetic neuralgia: a randomized controlled trial. JAMA. 1998;280(21):1837-42.
    Rowbotham, M., Harden, N., Stacey, B., Bernstein, P., & Magnus-Miller, L. (1998). Gabapentin for the treatment of postherpetic neuralgia: a randomized controlled trial. JAMA, 280(21), pp. 1837-42.
    Rowbotham M, et al. Gabapentin for the Treatment of Postherpetic Neuralgia: a Randomized Controlled Trial. JAMA. 1998 Dec 2;280(21):1837-42. PubMed PMID: 9846778.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Gabapentin for the treatment of postherpetic neuralgia: a randomized controlled trial. AU - Rowbotham,M, AU - Harden,N, AU - Stacey,B, AU - Bernstein,P, AU - Magnus-Miller,L, PY - 1998/12/10/pubmed PY - 2001/8/14/medline PY - 1998/12/10/entrez SP - 1837 EP - 42 JF - JAMA JO - JAMA VL - 280 IS - 21 N2 - CONTEXT: Postherpetic neuralgia (PHN) is a syndrome of often intractable neuropathic pain following herpes zoster (shingles) that eludes effective treatment in many patients. OBJECTIVE: To determine the efficacy and safety of the anticonvulsant drug gabapentin in reducing PHN pain. DESIGN: Multicenter, randomized, double-blind, placebo-controlled, parallel design, 8-week trial conducted from August 1996 through July 1997. SETTING: Sixteen US outpatient clinical centers. PARTICIPANTS: A total of 229 subjects were randomized. INTERVENTION: A 4-week titration period to a maximum dosage of 3600 mg/d of gabapentin or matching placebo. Treatment was maintained for another 4 weeks at the maximum tolerated dose. Concomitant tricyclic antidepressants and/or narcotics were continued if therapy was stabilized prior to study entry and remained constant throughout the study. MAIN OUTCOME MEASURES: The primary efficacy measure was change in the average daily pain score based on an 11-point Likert scale (0, no pain; 10, worst possible pain) from baseline week to the final week of therapy. Secondary measures included average daily sleep scores, Short-Form McGill Pain Questionnaire (SF-MPQ), Subject Global Impression of Change and investigator-rated Clinical Global Impression of Change, Short Form-36 (SF-36) Quality of Life Questionnaire, and Profile of Mood States (POMS). Safety measures included the frequency and severity of adverse events. RESULTS: One hundred thirteen patients received gabapentin, and 89 (78.8%) completed the study; 116 received placebo, and 95 (81.9%) completed the study. By intent-to-treat analysis, subjects receiving gabapentin had a statistically significant reduction in average daily pain score from 6.3 to 4.2 points compared with a change from 6.5 to 6.0 points in subjects randomized to receive placebo (P<.001). Secondary measures of pain as well as changes in pain and sleep interference showed improvement with gabapentin (P<.001). Many measures within the SF-36 and POMS also significantly favored gabapentin (P< or =.01). Somnolence, dizziness, ataxia, peripheral edema, and infection were all more frequent in the gabapentin group, but withdrawals were comparable in the 2 groups (15 [13.3%] in the gabapentin group vs 11 [9.5%] in the placebo group). CONCLUSIONS: Gabapentin is effective in the treatment of pain and sleep interference associated with PHN. Mood and quality of life also improve with gabapentin therapy. SN - 0098-7484 UR - https://www.unboundmedicine.com/medline/citation/9846778/Gabapentin_for_the_treatment_of_postherpetic_neuralgia:_a_randomized_controlled_trial_ L2 - https://jamanetwork.com/journals/jama/fullarticle/vol/280/pg/1837 DB - PRIME DP - Unbound Medicine ER -