Amitriptyline Vs Pregabalin in Painful Diabetic Neuropathy: A Randomised Placebo-Based Study

Aim: To compare the efficacy of amitriptyline, pregabalin and placebo in alleviating pain associated with diabetic peripheral neuropathy. Method: A total of 150 patients were randomly recruited for the study. Assessment for pain relief was carried out on an 11-point, Likert-like numeric rating scale [NRS]; 0= no pain” to 10=worst possible pain”) over a 7-day baseline period. Following a 1-week washout period without study medications, the participants were divided into 3 groups, each consisting of 70 patients, receiving either placebo, amitriptyline or pregabalin for a period of 6-week .The initial doses of pregabalin and amitriptyline were 75 mg twice daily and 10 mg at bedtime, respectively. Doses were titrated upward as necessary during weeks 1 and 3 of therapy The maximum doses of pregabalin and amitriptyline were 300 mg twice daily and 75 mg at bedtime, respectively. Responders were patients who experienced 50% or more reduction in the baseline pain score on NRS. Results: 210 patients were included in the study. 126(60%) were males and 84 (40%) were females. The age ranged from 22 to 76 years. 112(53.3%) had diabetes of <15 years duration, while the rest 98 (46.7%) had been suffering from DM for >15 years. 105 (50%) suffered from diabetic neuropathy for a duration <6 months, while the rest 50% had painful DN for a period exceeding 6 months. Significant improvement in pain of DPN was observed in patients receiving pregabalin (48.1%) and amitriptyline (41.4%) as compared to the ones getting placebo (10.5%) Conclusion: treating patients of DPN with pregabalin and amitriptyline results in better improvement in pain as compared to placebo. Out of the two drugs, pregabalin demonstrated greater response.