title: The effect of oral prostaglandin analogue on painful diabetic neuropathy: a double-blind, randomized, controlled trial.
abstract: 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 ± 6 years) with DPN but without evidence of peripheral artery disease were randomized to receive either BPS (40 µg, tid) or placebo for 8 weeks. The primary end point was the improvement of the total symptom score (TSS), temperature rebound (TR) and nadir to peak (NP) above baseline. After 8 weeks 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.
authors.affiliation: Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: S
authors.initials: S
authors.lastname: Shin
authors.forename: K J
authors.initials: KJ
authors.lastname: Kim
authors.forename: H-J
authors.initials: HJ
authors.lastname: Chang
authors.forename: B-W
authors.initials: BW
authors.lastname: Lee
authors.forename: W-I
authors.initials: WI
authors.lastname: Yang
authors.forename: B-S
authors.initials: BS
authors.lastname: Cha
authors.forename: D
authors.initials: D
authors.lastname: Choi
mesh_terms: D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000188:drug therapy*; D003929:Diabetic Neuropathies / Q000188:drug therapy*; D004311:Double-Blind Method; D011464:Epoprostenol / Q000031:analogs & derivatives* / Q000494:pharmacology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000494:pharmacology*
chemical_list: D014665:Vasodilator Agents; C048081:beraprost; D011464:Epoprostenol