title: Nickel oral hyposensitization in patients with systemic nickel allergy syndrome.
abstract: BACKGROUND
  This is the first randomized, double-blind, placebo-controlled trial (EUDRACT No. 2009-013923-43) evaluating nickel oral hyposensitizing treatment (NiOHT) in patients with "systemic nickel allergy syndrome" (SNAS), characterized by Ni-allergic contact dermatitis and systemic reactions after eating Ni-rich food.
  
  
  METHODS
  Adults with positive Ni-patch test, who reported symptoms suggesting SNAS, which improved after Ni-poor diet, and were positive to Ni-oral challenge were eligible. Patients were randomly assigned to three treatments (1.5 μg, 0.3 μg, or 30 ng Ni/week) or placebo for a year, with progressive reintroduction of Ni-rich foods form the 5(th) month. Out of 141 patients randomized, 113 completed the trial. Endpoints were efficacy and tolerability of treatment.
  
  
  RESULTS
  During Ni-rich food re-introduction, the 1.5 μg Ni/week group had a mean VAS score significantly higher than placebo (p = 0.044), with significant improvement of gastrointestinal symptoms (p = 0.016;) and significantly fewer rescue medications. Cutaneous manifestations also improved but without reaching statistical significance. After the treatment, oral challenge with higher Ni doses than at baseline were needed to cause symptoms to flare-up in significantly more patients given 1.5 μg Ni/week than placebo (p = 0.05). Patients reported no side-effects.
  
  
  CONCLUSIONS
  NiOHT is effective in SNAS, in particular on gastrointestinal manifestations, with trend toward improvement of cutaneous symptoms.
authors.affiliation: Allergy and Immunotoxicology Unit, Ce.S.I., G. d'Annunzio University Foundation , Chieti , Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Di Gioacchino
authors.forename: Luisa
authors.initials: L
authors.lastname: Ricciardi
authors.forename: Ornella
authors.initials: O
authors.lastname: De Pità
authors.forename: Mauro
authors.initials: M
authors.lastname: Minelli
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Patella
authors.forename: Susanna
authors.initials: S
authors.lastname: Voltolini
authors.forename: Valerio
authors.initials: V
authors.lastname: Di Rienzo
authors.forename: Marina
authors.initials: M
authors.lastname: Braga
authors.forename: Enzo
authors.initials: E
authors.lastname: Ballone
authors.forename: Rocco
authors.initials: R
authors.lastname: Mangifesta
authors.forename: Domenico
authors.initials: D
authors.lastname: Schiavino
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D017449:Dermatitis, Allergic Contact / Q000276:immunology / Q000628:therapy*; D003888:Desensitization, Immunologic / Q000379:methods; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009532:Nickel / Q000009:adverse effects / Q000276:immunology*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D009532:Nickel