Gabapentin for the Symptomatic Treatment of Painful Neuropathy in Patients With Diabetes Mellitus: A Randomized Controlled Trial

• Published in: JAMA : the journal of the American Medical Association 1998-12, Vol.280 (21), p.1831-1836
• Main Authors: Backonja, Miroslav, Beydoun, Ahmad, Edwards, Keith R, Schwartz, Sherwyn L, Fonseca, Vivian, Hes, Marykay, LaMoreaux, Linda, Garofalo, Elizabeth, for the Gabapentin Diabetic Neuropathy Study Group
• Format: Article
• Language: English
• Subjects: Acetates - therapeutic use; Amines; Analgesics; Analgesics - therapeutic use; Anticonvulsants - therapeutic use; Biological and medical sciences; Cyclohexanecarboxylic Acids; Diabetes; Diabetic Neuropathies - complications; Diabetic Neuropathies - drug therapy; Double-Blind Method; Drug therapy; Female; Gabapentin; gamma-Aminobutyric Acid; Humans; Male; Medical sciences; Middle Aged; Neuropharmacology; Pain; Pain - drug therapy; Pain - etiology; Pain Measurement; peripheral neuropathy; Pharmacology. Drug treatments; Quality of Life
• ISSN: 0098-7484; 1538-3598
• DOI: 10.1001/jama.280.21.1831

CONTEXT.— Pain is the most disturbing symptom of diabetic peripheral neuropathy. As many as 45% of patients with diabetes mellitus develop peripheral neuropathies. OBJECTIVE.— To evaluate the effect of gabapentin monotherapy on pain associated with diabetic peripheral neuropathy. DESIGN.— Randomized, double-blind, placebo-controlled, 8-week trial conducted between July 1996 and March 1997. SETTING.— Outpatient clinics at 20 sites. PATIENTS.— The 165 patients enrolled had a 1- to 5-year history of pain attributed to diabetic neuropathy and a minimum 40-mm pain score on the Short-Form McGill Pain Questionnaire visual analogue scale. INTERVENTION.— Gabapentin (titrated from 900 to 3600 mg/d or maximum tolerated dosage) or placebo. MAIN OUTCOME MEASURES.— The primary efficacy measure was daily pain severity as measured on an 11-point Likert scale (0, no pain; 10, worst possible pain). Secondary measures included sleep interference scores, the Short-Form McGill Pain Questionnaire scores, Patient Global Impression of Change and Clinical Global Impression of Change, the Short Form–36 Quality of Life Questionnaire scores, and the Profile of Mood States results. RESULTS.— Eighty-four patients received gabapentin and 70 (83%) completed the study; 81 received placebo and 65 (80%) completed the study. By intent-to-treat analysis, gabapentin-treated patients' mean daily pain score at the study end point (baseline, 6.4; end point, 3.9; n = 82) was significantly lower (P