Repeat treatment with capsaicin 8% patch (179mg capsaicin cutaneous patch): Effects on pain, quality of life, and patient satisfaction in painful diabetic peripheral neuropathy: an open-label, randomized controlled clinical trial
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Abstract
Objective: To determine long-term safety and effectiveness of repeat treatments with a high concentration capsaicin patch.
Methods: In this 52-week, open-label, randomized controlled study, patients with painful diabetic peripheral neuropathy (PDPN) received either capsaicin patch: (30- or 60-min; 1–7 treatments to the feet) plus SOC or SOC alone. Effectiveness was assessed, by changes from baseline to end of study (EoS), in average and severity of pain, pain interference with daily function (Brief Pain Inventory-Diabetic Neuropathy version), responder rates, Patient Global Impression of Change (PGIC), and EuroQol 5-dimension (EQ-5D) questionnaire.
Results: 468 patients were randomized (n=156 and n=157, 30 and 60-min respectively; SOC alone, n=155). Safety data have been reported previously. Changes in average pain from baseline to EoS (mean percentage (SD)) were: 30-min, −37.5% (32.9); 60-min, −40.8% (39.7); SOC alone, −13.9% (74.6). The difference between groups increased progressively from −17.7% and −18.6% at Month 1 for 30- and 60-min., respectively, to −21.9% and −24% at Month 12.
More 30% responders occurred in the capsaicin groups (30-min, 67.3%; 60-min, 67.5%) and more felt: very much or much improved” (30-min, 24.2%; 60-min, 24.5%), compared with SOC alone (40.6% and 9.5% respectively). A greater mean improvement in EQ-5D utility index and EQ-5D visual analog scale score, from baseline to Month 12, was observed with the 30-min (0.12) and 60-min (0.15) versus SOC alone (0.07) and mean (SD), 30–min (10.4 [18.5]) and 60-min (11.2 [21.4]) versus SOC alone (5.5 [18.1]) respectively.
Conclusion: Capsaicin 8% patch showed differential effectiveness over SOC alone, further increasing with repeat treatments.