AZITHROMYCIN VERSUS PLACEBO IN ACUTE INFECTIOUS RHINITIS WITH CLINICAL SYMPTOMS BUT WITHOUT RADIOLOGICAL SIGNS OF MAXILLARY SINUSITIS

In this double-blind, parallel-group, multicenter study, 169 patients with symptoms of maxillary sinusitis but without radiographically conf irmed empyema (pus) were randomly assigned to receive either 500 mg az ithromycin once daily for 3 days (87 patients) or placebo daily for 3 days (82 patients). Nasal secretion, maxillary tenderness and pain, na sal obstruction, general malaise, and hyposmia were assessed at the st art of the study and on days 4, 11, and 25 of treatment. After 11 days 58% of the patients in the azithromycin group were cured versus 31% i n the placebo group; after 25 days the cure rate was 79% versus 67%, r espectively. When both cure and improvement were considered, the corre sponding figures after day 25 were 90% and 88%, respectively. Adverse events, predominantly gastrointestinal, occurred in 24 (27%) of the az ithromycin-treated patients and in 15 (18%) of those treated with plac ebo, but the difference was not statistically significant. There was a difference in efficacy in favor of azithromycin in the treatment of r hinitis with symptoms of maxillary sinusitis but without radiological signs of empyema (pus). Antibiotics should only be used to alleviate s ymptoms in patients with moderate to severe symptoms, as the results a fter 25 days for both improvement and cure are equal. In the treatment of acute rhinitis with symptoms and signs of maxillary sinusitis but without empyema, treatment with azithromycin seems to result in a bett er cure rate after 10-12 days when compared with placebo.