title: Prospective, non-interventional study on the tolerability and analgesic effectiveness over 12 weeks after a single application of capsaicin 8% cutaneous patch in 1044 patients with peripheral neuropathic pain: first results of the QUEPP study.
abstract: BACKGROUND
  Reversible defunctionalisation of nociceptors by the TRPV1 agonist capsaicin in high concentration is an emerging new concept for the treatment of peripheral neuropathic pain.
  
  
  OBJECTIVE
  The capsaicin 8% cutaneous patch with a long-lasting effect for up to 3 months after a single application is available in Germany by prescription since October 2010. The aim of this study was to monitor its usage and therapeutic performance in clinical practice.
  
  
  METHODS
  Patients had a single patch application with up to 4 patches and were followed up after 7-14 days, 4, 8, and 12 weeks. Average pain intensity (NPRS-11), pain attacks, neuropathy symptoms, sleep parameters, quality of life, working capacity and concomitant neuropathic pain medication were assessed during at least two visits.
  
  
  RESULTS
  A total of 509 females (48.8%; effectiveness population N = 1044) and 531 males (50.9%) were included; the mean age was 61.2 ± 14.4 (SD) years. Postherpetic neuralgia was the most frequent diagnosis (31.9%), followed by postsurgical neuralgia (22.8%), post-traumatic neuropathy (12.4%), polyneuropathy (14.3%), and mixed pain syndromes (16.6%). Thirty and 50% responder rates were 42.7% and 23.7%, respectively, with a mean relative reduction of pain intensity during weeks 1-12 of 24.7% (1.1 SEM) and significant improvements in pain attacks, sleep duration and sleep quality, while the consumption of opioids and antiepileptics decreased significantly. In 106 patients (10.0%; safety population n = 1063) 146 adverse drug reactions (ADRs) were reported, mainly application site reactions (erythema, pain). A total of 27 serious ADRs were documented in 17 patients (1.6%).
  
  
  CONCLUSIONS
  Analgesic treatment of peripheral neuropathic pain with the capsaicin 8% cutaneous patch is safe and effective.
  
  
  CONCLUSIONS
  The study did not include a control group; therefore, a comparison of the results with that of therapeutic alternatives is not justified.
authors.affiliation: Department of Neurology, University Hospital Erlangen, Erlangen, Germany. christian.maihoefner@uk-erlangen.de
authors.forename: C
authors.initials: C
authors.lastname: Maihofner
authors.forename: M-L
authors.initials: ML
authors.lastname: Heskamp
mesh_terms: D000279:Administration, Cutaneous; D000700:Analgesics / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D002211:Capsaicin / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009437:Neuralgia / Q000188:drug therapy*; D059408:Pain Management; D010523:Peripheral Nervous System Diseases / Q000188:drug therapy*; D057968:Transdermal Patch; D016896:Treatment Outcome
chemical_list: D000700:Analgesics; D002211:Capsaicin