title: Single-blind, multicenter, placebo controlled, parallel study to assess the safety and efficacy of intralesional interferon alpha-2B for minimally invasive treatment for Peyronie's disease.
abstract: OBJECTIVE
  We investigated the efficacy and safety of intralesional interferon alpha-2b for the treatment of Peyronie's disease.
  
  
  METHODS
  A total of 117 consecutive patients with a mean age of 55.1 years who had Peyronie's disease were enrolled in a single-blind, multicenter, placebo controlled, parallel study to determine the efficacy and safety of intralesional interferon alpha-2b therapy (Schering, Kenilworth, New Jersey), including 62 who received placebo and 55 who received interferon alpha-2b. Saline (10 ml) in controls and interferon alpha-2b (5 x 10(6) U) were administered biweekly for 12 weeks. Each patient was evaluated for penile curvature, plaque size and density, penile pain, erectile function and penile hemodynamics before and after study completion. Improvement in these parameters was statistically compared between the groups.
  
  
  RESULTS
  A total of 53 patients in the control arm and 50 in the interferon alpha-2b arm completed the study. Improvement in penile curvature, plaque size and density, and pain resolution was significantly greater in patients treated with interferon alpha-2b vs placebo. The increase in mean International Index of Erectile Function scores was not significantly different between the groups. Penile blood flow improvement was observed in interferon alpha-2b treated patients but not in those who received placebo. The decrease in the number of penile vascular pathologies was significantly higher in interferon alpha-2b cases. Side effects, mostly flu-like symptoms, which were frequently noted in patients on interferon alpha-2b, were mild to moderate in degree and of short duration.
  
  
  CONCLUSIONS
  This single-blind, multicenter, placebo controlled, parallel study demonstrates that intralesional interferon alpha-2b at a dose of 5 x 10(6) units biweekly for 12 weeks is effective and safe as minimally invasive therapy for Peyronie's disease.
authors.affiliation: Department of Urology, Tulane University School of Medicine, 1430 Tulane Avenue, New Orleans, LA 70112, USA. whellst@tulane.edu
authors.forename: Wayne J G
authors.initials: WJ
authors.lastname: Hellstrom
authors.forename: Muammer
authors.initials: M
authors.lastname: Kendirci
authors.forename: Richard
authors.initials: R
authors.lastname: Matern
authors.forename: Yolanda
authors.initials: Y
authors.lastname: Cockerham
authors.forename: Leann
authors.initials: L
authors.lastname: Myers
authors.forename: Suresh C
authors.initials: SC
authors.lastname: Sikka
authors.forename: Dennis
authors.initials: D
authors.lastname: Venable
authors.forename: Stanton
authors.initials: S
authors.lastname: Honig
authors.forename: Andrew
authors.initials: A
authors.lastname: McCullough
authors.forename: Lawrence S
authors.initials: LS
authors.lastname: Hakim
authors.forename: Ajay
authors.initials: A
authors.lastname: Nehra
authors.forename: Lance E
authors.initials: LE
authors.lastname: Templeton
authors.forename: Jon L
authors.initials: JL
authors.lastname: Pryor
mesh_terms: D000328:Adult; D000368:Aged; D006801:Humans; D015552:Injections, Intralesional; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D010146:Pain; D010410:Penile Erection; D010411:Penile Induration / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D010413:Penis / Q000098:blood supply / Q000473:pathology; D011994:Recombinant Proteins; D016037:Single-Blind Method; D012965:Sodium Chloride / Q000008:administration & dosage
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D012965:Sodium Chloride