A Hospital Based Randomized Clinical Assessment of the Effect of Pregabalin in Patients with Neuropathic Pain

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Abstract (English)

Abstract Aim: To evaluate the efficacy of pregabalin in the treatment of painful diabetic neuropathy.  Materials and Methods: The present study was conducted in the Department of General Medicine, Jannayak Karpoori Thakur Medical College and Hospital Madhepura,, Bihar, India for 10months, and twenty patients were recruited with diabetes and painful distal symmetrical sensorimotor polyneuropathy for 1 to 5 years were potentially eligible to enter into the study. Results: Efficacy results indicate that pregabalin 600 mg/day significantly decreased mean pain score to 4.3 (vs 5.6 for placebo, P _ .0002) and increased the proportion of patients who had a >50% decrease from baseline pain (39% vs 15% for placebo, P _ .002). Pregabalin also significantly reduced sleep interference, past week and present pain intensity, sensory and affective pain scores, and bodily pain and decreased by >50% the number of patients describing their pain as gnawing, sickening, fearful, and punishing–cruel. More patients receiving pregabalin 600 mg/day than placebo showed improvement, as rated on the Clinical and Patient Global Impression of Change scales, 73% vs 45% and 85% vs 47%, respectively. Pregabalin 150 mg/day was essentially no different from placebo. Dizziness was the most common side effect. Conclusion: These study results show pregabalin 600 mg/day to be safe and effective in reducing the pain and other associated symptoms of painful diabetic neuropathy.