Open AccessA double‐blind randomized controlled trial of ketotifen versus placebo in early diffuse scleroderma
Author(s) -
Gruber Barry L.,
Kaufman Lee D.
Publication year - 1991
Publication title -
arthritis & rheumatism
Language(s) - English
Resource type - Journals
eISSN - 1529-0131
pISSN - 0004-3591
DOI - 10.1002/art.1780340315
Subject(s) - ketotifen , medicine , scleroderma (fungus) , placebo , mast cell , double blind , drug , randomized controlled trial , clinical trial , gastroenterology , dermatology , asthma , immunology , pathology , pharmacology , alternative medicine , inoculation
To determine the efficacy of the mast cell‐stabilizing drug ketotifen in scleroderma, we conducted a 6‐month, randomized, prospective, double‐blind, placebo‐controlled trial in 24 patients. No significant improvement in the clinical paramenters, pulmonary function, global assessments, and mast cell releasability was noted. Pruritus tended to improve in the group taking the active drug. Six months of treatment with ketotifen (6 mg/day), therefore, produced no apparent benefit in patients with early scleroderma. We were unable to address the role of mast cells in scleroderma since mast cell suppression was not achieved.