Antibiotic treatment of sinusitis in general practice. A double-blind study comparing ofloxacin and erythromycin.

The present study compared ofloxacin and erythromycin in a double-blind study with parallel groups for clinical efficacy and the number and severity of adverse reactions in patients treated in general practice for acute or chronic sinusitis. All patients lived in medium-sized to large towns and rural districts in the northern and western parts of Sealand, Funen and eastern Jutland, Denmark. Three hundred and nineteen patients were enrolled in the study, of whom 280 were clinically evaluable. From this total number, 136 patients were treated with ofloxacin (31 males and 105 females) and 144 patients were treated with erythromycin (40 males and 104 females). Following administration of either ofloxacin 400 mg once daily or erythromycin 500 mg twice daily for 7-14 days, 94.9% of the ofloxacin-treated group and 94.4% of the erythromycin-treated group were cured of their infections. There was no difference in clinical efficacy. Complications occurred in 18 of 155 patients in the ofloxacin-treated group and 32 of 164 in the erythromycin-treated group (P < 0.05), corresponding to 27 and 45 symptoms respectively (P < 0.01). This difference in adverse reactions principally involved gastrointestinal symptoms, i.e. 19 in the ofloxacin-treated group and 41 in the erythromycin-treated group (P < 0.01). Present findings show that the two antibiotics are comparable as to clinical efficacy, but the frequency of adverse reactions is significantly higher in the erythromycin-treated group due to the greater incidence of gastrointestinal adverse reactions.

RCT Entities:   Population Interventions Outcomes