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A Randomized Controlled Trial

Michael Rowbotham, MD; Norman Harden, MD; Brett Stacey, MD; Paula Bernstein, MS; Leslie Magnus-Miller, MD; for the Gabapentin Postherpetic Neuralgia Study Group

JAMA. 1998;280:1837-1842.

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.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.

From the UCSF Pain Clinical Research Center, University of California, San Francisco (Dr Rowbotham); Department of Physical Medicine and Rehabilitation, Rehabilitation Institute of Chicago, Chicago, Ill (Dr Harden); Department of Anesthesiology, Oregon Health Sciences University, Portland (Dr Stacey); and Departments of Biometrics (Ms Bernstein) and Medical Research (Dr Magnus-Miller), Parke-Davis, Morris Plains, NJ.

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