To Compare the Efficacy of Pregabalin and Amitriptyline for Pain Relief in Patients with Diabetic Peripheral Neuropathy

BACKGROUND: Diabetic neuropathy affects more than 50% patients with diabetes mellitus of more than 25 years' duration. Up to 16.2% of diabetic patients have painful neuropathy which can profoundly undermine the quality of life. Both Pregabalin and Amitriptyline are commonly used to relieve symptoms of painful diabetic peripheral neuropathy (DPN).The objectives were to compare efficacy of Pregabalin and Amitriptyline in relieving pain associated with DPN and to compare their adverse effect profiles. METHODS: We conducted a non-blinded, randomized controlled trial at the Diabetic Clinic, Department of Medicine at Benazir Bhutto Hospital, Rawalpindi, Pakistan from January 2015 to August 2015 on a total of 320 patients who met the inclusion and exclusion criteria. 160 patients each were randomly allocated to either Pregabalin group or Amitriptyline group for up to 6 weeks. Likert Numeric Rating Scale (NRS) was used to assess the severity of pain at the start and six weeks later. Patient-reported adverse outcomes were recorded. Chi-square test was applied to compare the pain relief amongst the two groups. RESULTS: Of the 320 patients, 180 (56.3%) had pain relief (Likert NRS improvement > 50% from the baseline). Of the 160 patients assigned to Pregabalin group, 104 (65%) achieved good pain relief as compared to just 76 (47.5%) of the 160 patients assigned to Amitriptyline group (p-value= 0.002). CONCLUSION: Pregabalin is more effective and safer than Amitriptyline for control of symptoms of painful DPN