The effect of oral prostaglandin analogue on painful diabetic neuropathy: A double-blind, randomized, controlled trial

This study was performed to assess the efficacy of beraprost sodium (BPS) in painful diabetic peripheral neuropathy (DPN) in type 2 diabetes mellitus (T2DM) patients. In this randomized clinical trial, 99 T2DM patients (41% male, age 60±6years) with DPN but without evidence of peripheral artery disease were randomized to receive either BPS (40 μg, tid) or placebo for 8weeks. The primary end point was the improvement of the total symptom score (TSS), temperature rebound (TR) and nadir to peak (NP) above baseline. After 8weeks treatment, the change of TSS in the BPS group showed a significant improvement compared to the placebo group (2.80±2.48 vs. 1.60±1.94 points, p=0.009). Furthermore, the number of patients who showed signs of improvement in TSS and the proportion of patients with 50% relief of symptom was also significantly greater in the BPS group than in the placebo group (83.7 vs. 62%, p=0.015, 36.2 vs. 14%, p=0.009, respectively). In conclusion, treatment with BPS significantly improved TSS over an 8-week period.