[Effectiveness and tolerance of fenspiride treatment in chronic sinusitis. Results of the Polish multicenter study].

Abstract

During this randomized, double blind study versus placebo efficacy of 3 month treatment of patients with chronic sinusitis was assessed. Main efficacy criterion was defined as the change in computed tomography of paranasal sinuses, measured in V. Lund scale. In fenspiride group, overall score changed from 8.54 to 7.57 points (0.97 points i.e. 11.4% decrease, p=0.008), while in placebo group no statistically significant change was observed (change from 9.25 to 9.27 points--0.02 points i.e. 0.2% increase). Percentage of patients who experienced worsening (defined as at least 1 point increase between the beginning and the end of the study) in the placebo group was twice as big as in the fenspiride group (35.4% and 15.2% respectively; p=0.025). Clinical symptoms of chronic sinusitis--sneezing, itchy nose and purulent character of sputum--were decreasing in the fenspiride group significantly more than in the placebo group. Data from previous studies demonstrated beneficial effect of fenspiride treatment of patients with chronic sinusitis. During this study fenspiride treatment was proved to be relatively effective in terms of computed tomography results, and well tolerated during three month therapy.