title: Rupatadine improves quality of life in mastocytosis: a randomized, double-blind, placebo-controlled trial.
abstract: BACKGROUND
  Mastocytosis is frequently associated with mast cell-mediated symptoms which require relieving medication. While second generation antihistamines (sgAHs) are the first line therapeutic strategy to treat mast cell mediator-related symptoms, controlled clinical trials on how they improve quality of life have not been performed.
  
  
  METHODS
  This randomized, double-blind, placebo-controlled, cross-over trial assessed rupatadine 20 mg daily in the treatment of mastocytosis symptoms in 30 adult patients. Symptoms were assessed by a visual analogue scale (VAS) and symptom specific quality of life questionnaire (ItchyQoL).
  
  
  RESULTS
  The mean ItchyQoL total score and VAS symptom score were significantly improved in the rupatadine treatment phase compared with placebo. There were also significant reductions from placebo in the severity of itch, wheal and flare, flushing, tachycardia and headache but not gastrointestinal symptoms.
  
  
  CONCLUSIONS
  In this first comprehensive trial of a sgAH in mastocytosis, rupatadine 20 mg daily for 4 weeks significantly controlled symptoms and improved patients' quality of life.
authors.affiliation: Department of Dermatology and Allergy, Interdisciplinary Mastocytosis Center Charité, Charité - Universitätsmedizin Berlin, Berlin, Germany. frank.siebenhaar@charite.de
authors.forename: F
authors.initials: F
authors.lastname: Siebenhaar
authors.forename: A
authors.initials: A
authors.lastname: Förtsch
authors.forename: K
authors.initials: K
authors.lastname: Krause
authors.forename: K
authors.initials: K
authors.lastname: Weller
authors.forename: M
authors.initials: M
authors.lastname: Metz
authors.forename: M
authors.initials: M
authors.lastname: Magerl
authors.forename: P
authors.initials: P
authors.lastname: Martus
authors.forename: M K
authors.initials: MK
authors.lastname: Church
authors.forename: M
authors.initials: M
authors.lastname: Maurer
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D018592:Cross-Over Studies; D003533:Cyproheptadine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D034701:Mastocytosis, Cutaneous / Q000175:diagnosis* / Q000188:drug therapy* / Q000276:immunology; D008875:Middle Aged; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D011788:Quality of Life; D018570:Risk Assessment; D012720:Severity of Illness Index; D013030:Spain; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: C103639:rupatadine; D003533:Cyproheptadine
keywords: antihistamine; mastocytosis; platelet-activating factor; rupatadine; urticaria pigmentosa