“A COMPARATIVE STUDY OF EFFICACY AND SAFETY OF PREGABALIN WITH METHYLCOBALAMIN VERSUS DULOXETINE WITH METHYLCOBALAMIN IN DIABETIC PERIPHERAL NEUROPATHY PATIENTS WITH TYPE 2 DIABETES MELLITUS”

BACKGROUND: Diabetic peripheral neuropathy (DPN) is the most common microvascular complication in type I and type II diabetes mellitus, an average 30% of patients with clinical manifestation as a painful neuropathy. Symptomatic treatment with an anticonvulsant and SNRI (Serotonin Nor-Adrenaline Receptor reuptake inhibitor) like Pregabalin (PGB) and Duloxetine (DLX with Methylcobalamin (MCB)) improve neuropathic pain and sleep. METHODS: 90 DPN patients who have been screened using Michigan Neuropathy Score Instrument were randomized into two groups of 45 each to receive either Duloxetine(DLX) 20 mg (dose titration allowed up to 40 mg/day) with Methylcobalamin (MCB) 1500 mcg or Pregabalin (PGB)75 mg (dose titration allowed up to 150 mg/day) with MCB 1500 mcg tablet once daily in the night for 12 weeks. Efficacy was measured by reduction in Visual analog score (VAS) score and sleep interference (SIS) score at week 4, 8 and 12 from baseline. Safety was assessed by monitoring treatment emergent adverse effects. Data analysed by using repeated measure ANOVA, unpaired and paired‘t’ test for continuous data and chi-square test for categorical data. RESULTS: The mean VAS and SIS score after 12 weeks of treatment was 5.1±1.03 and 4.6±1.07 PGB + MCB in the group and 4.3±1.02 and 3.2±0.97 in DLX + MCB group. PGB + MCB and DLX + MCB both groups effectively reduced VAS and SIS score compared to baseline (p<0.0001) at the end of 12 weeks. A greater percentage of patients experienced improvement in sleep and pain in the DLX + MCB group (73%) compared to PGB + MCB (64%). No significant adverse effects were noted. CONCLUSION: DLX + MCB combination significantly reduced VAS and SIS score as compared to PGB + MCB with no significant adverse effects and thus can be favourable therapeutic option in patients who failed monotherapy with PGB OR DLX in DPN.