BACKGROUND: Evidence from diabetic animal models suggests that cilostazol, a cyclic AMP phosphodiesterase inhibitor used in the treatment of claudication, is efficacious in the treatment of peripheral neuropathy, although this is unproven in humans. The main aim of this study was to assess the effects of cilostazol on neuropathic symptomatology in diabetic patients with peripheral arterial disease (PAD). METHODS:Diabetic patients with PAD were prospectively recruited to a randomized double-blinded placebo-controlled trial. Baseline clinical data were recorded prior to trial commencement following medical optimization. Neurological assessment included the Toronto Clinical Neuropathy Scoring system (TCNS) and vibration perception thresholds (VPT) with a neurothesiometer at baseline, 6 weeks, and 24 weeks. RESULTS:Twenty-six patients were recruited from December 2004 to January 2006, which included 20 males. Baseline patient allocation to treatment arms was matched for age, sex, and medical comorbidities. There was no significant difference in neurological assessment between the treatment groups using the TCNS and VPT at 6 and 24 weeks. CONCLUSIONS: Despite extensive animal-based evidence that cilostazol attenuates neuropathic symptomatology, our results do not support this effect in human diabetic PAD patients.
RCT Entities:
BACKGROUND: Evidence from diabetic animal models suggests that cilostazol, a cyclic AMP phosphodiesterase inhibitor used in the treatment of claudication, is efficacious in the treatment of peripheral neuropathy, although this is unproven in humans. The main aim of this study was to assess the effects of cilostazol on neuropathic symptomatology in diabeticpatients with peripheral arterial disease (PAD). METHODS:Diabeticpatients with PAD were prospectively recruited to a randomized double-blinded placebo-controlled trial. Baseline clinical data were recorded prior to trial commencement following medical optimization. Neurological assessment included the Toronto Clinical Neuropathy Scoring system (TCNS) and vibration perception thresholds (VPT) with a neurothesiometer at baseline, 6 weeks, and 24 weeks. RESULTS: Twenty-six patients were recruited from December 2004 to January 2006, which included 20 males. Baseline patient allocation to treatment arms was matched for age, sex, and medical comorbidities. There was no significant difference in neurological assessment between the treatment groups using the TCNS and VPT at 6 and 24 weeks. CONCLUSIONS: Despite extensive animal-based evidence that cilostazol attenuates neuropathic symptomatology, our results do not support this effect in humandiabetic PADpatients.