title: Capsaicin 8% Patch in Painful Diabetic Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Study.
abstract: This 12-week study evaluated the efficacy and safety of capsaicin 8% patch versus placebo patch in painful diabetic peripheral neuropathy (PDPN). Patients aged 18 years or older with PDPN were randomized (1:1) to one 30-minute treatment (capsaicin 8% patch or placebo patch) to painful areas of the feet. Overall, 369 patients were randomized (capsaicin 8% patch, n = 186; placebo patch, n = 183). Percentage reduction in average daily pain score from baseline to between weeks 2 through 8 (the primary end point) was statistically significant for capsaicin 8% patch versus placebo (-27.4% vs -20.9%; P = .025); improvements in pain were observed from week 2 onward. Versus placebo, patients treated with capsaicin 8% patch had a shorter median time to treatment response (19 vs 72 days) and modest improvements in sleep interference scores from baseline to between weeks 2 through 8 (P = .030) and weeks 2 through 12 (P = .020). Apart from application site reactions, treatment-emergent adverse events were similar between groups. No indications of deterioration in sensory perception of sharp, cold, warm, or vibration stimuli were observed. In patients with PDPN, capsaicin 8% patch treatment provided modest pain relief and sleep quality improvements versus a placebo patch, similar in magnitude to other treatments with known efficacy, but without systemic side effects or sensory deterioration.
  
  
  
  To our knowledge, this is the first study of the capsaicin 8% patch versus placebo in patients with PDPN to show that one 30-minute capsaicin treatment provides modest improvements in pain and sleep quality. Results confirm the clinical utility of the capsaicin 8% patch in the diabetic population.
authors.affiliation: Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: david.simpson@mssm.edu.
authors.forename: David M
authors.initials: DM
authors.lastname: Simpson
authors.affiliation: Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, New York.
authors.forename: Jessica
authors.initials: J
authors.lastname: Robinson-Papp
authors.affiliation: Diabetes Research Center, Tustin, California.
authors.forename: Joanna
authors.initials: J
authors.lastname: Van
authors.affiliation: Global Medical Science, Astellas Pharma Europe BV, Leiden, The Netherlands.
authors.forename: Malcolm
authors.initials: M
authors.lastname: Stoker
authors.affiliation: Global Medical Science, Astellas Pharma Europe BV, Leiden, The Netherlands.
authors.forename: Hélène
authors.initials: H
authors.lastname: Jacobs
authors.affiliation: Global Medical Science, Astellas Pharma Europe BV, Leiden, The Netherlands.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Snijder
authors.affiliation: Global Medical Science, Astellas Pharma Europe BV, Leiden, The Netherlands; Chiltern International, Leiden, The Netherlands.
authors.forename: Diederik S
authors.initials: DS
authors.lastname: Schregardus
authors.affiliation: Global Medical Science, Astellas Pharma Europe BV, Leiden, The Netherlands; INC Research, Camberley, United Kingdom.
authors.forename: Stephen K
authors.initials: SK
authors.lastname: Long
authors.affiliation: Helix Biomedics LLC, Boynton Beach, Florida.
authors.forename: Bruno
authors.initials: B
authors.lastname: Lambourg
authors.affiliation: Analgesic Solutions, Natick, Massachusetts; Department of Anesthesiology, Tufts University School of Medicine, Boston, Massachusetts.
authors.forename: Nathaniel
authors.initials: N
authors.lastname: Katz
mesh_terms: D001786:Blood Glucose / Q000378:metabolism; D002211:Capsaicin / Q000008:administration & dosage*; D003929:Diabetic Neuropathies / Q000150:complications / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D010147:Pain Measurement; D018689:Sensory System Agents / Q000008:administration & dosage*; D012893:Sleep Wake Disorders / Q000188:drug therapy / Q000209:etiology; D018709:Statistics, Nonparametric; D013997:Time Factors; D057968:Transdermal Patch
chemical_list: D001786:Blood Glucose; D018689:Sensory System Agents; D002211:Capsaicin
keywords: Brief Pain Inventory-Diabetic Neuropathy; Capsaicin 8% patch; NPRS average daily pain score; painful diabetic peripheral neuropathy; phase 3 study