The effect of oral prostaglandin analogue on painful diabetic neuropathy: a
double-blind, randomized, controlled trial.
Author(s): Shin S(1), Kim KJ, Chang HJ, Lee BW, Yang WI, Cha BS, Choi D.
Affiliation(s): Author information:
(1)Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University
College of Medicine, Seoul, Korea.
Publication date & source: 2013, Diabetes Obes Metab. , 15(2):185-8
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.
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