Rupatadine improves quality of life in mastocytosis: a randomized, double-blind, placebo-controlled trial.

[cutaneous mastocytosis]

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 .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 ).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 .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 .