Randomised, double blind, placebo controlled trial of penicillin V in the treatment of acute maxillary sinusitis in adults in general practice

Abstract

Objective - To compare the effectiveness of penicillin V with placebo in the treatment of adult patients with acute maxillary sinusitis in general practice. Design - Randomised, double blind, placebo controlled trial. Setting - 26 Danish general practices. Patients - 133 adult patients with a clinical diagnosis of acute maxillary sinusitis based on maxillary pain and raised values of either C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR). Main outcome measures - Pain score and illness score as well as measurement of CRP and ESR values after initiation of treatment. Results - Penicillin V led to a better recovery than did placebo. The difference was statistically significant 3 days after the initiation of treatment with regard to pain reduction, whereas no significant difference was found with regard to the reduction in the sense of illness. At the end of the study, significantly more patients in the penicillin group were completely free of pain compared to the placebo group. This difference was only found in patients with an initial pain score of more than three. The cure rate was 71% in the penicillin group and 37% in the placebo group. Significantly more patients achieved normal CRP values when treated with penicillin (88%) as opposed to placebo (75%). Conclusion - Penicillin V is more effective than placebo in the treatment of acute maxillary sinusitis in adults in general practice, but only in patients with pronounced pain.