Objective: Acute maxillary rhinosinusitis (AMRS) is a pathology in which the pain is often severe and requires appropriate treatment. Although the use of antibiotics is widely documented, the interest of short cycles of corticosteroids in the treatment of the functional manifestations of AMRS is based on professional experience. The aim of this study was to assess the efficacy and tolerance to prednisone administered for 3 days in addition to antibiotherapy in patients presenting with an AMRS.
Method: This was a double blind, randomised study in parallel groups and controlled versus a placebo, involving patients aged over 18, presenting with an AMRS confirmed by X-ray and endoscopy, having developed less than 5 days and complaining of spontaneous pain assessed as >or=50 millimetres on a visual analog scale (VAS). Together with cefpodoxime, the patients received either prednisone (0.8 to 1.2 mg/kg) for 3 days or a placebo. The primary efficacy endpoint was the mean of the differences versus the baseline value of pain (MPID - mean pain intensity difference) assessed on the VAS from Day 1 to Day 3. The secondary endpoints assessed were the mean of the differences in intensity of nasal obstruction, assessed in the same way as the MPID, the time lapse before the orally expressed relief of the pain (PRID - pain reflief intensity difference) and the administration of paracetamol during the first 3 days.
Results: 289 patients (placebo 147, prednisone 142) were assessable for analysis in intent-to-treat (ITT). The global spontaneous pain on inclusion, measured by a VAS was of 73.0 +/- 14.1 mm. The assessments made during the first 3 days of treatment showed a statistically significant difference in favour of the prednisone group regarding MPID: - 4.82 mm (CI 95% -9.25; -0.40) (p=0.03), nasal obstruction - 5.0 mm (CI 95% -9.1; -0.8) (p=0.02) and consumption of paracetamol (p=0.03). There was no difference between the two groups after the end of the antibiotherapy. The tolerance measured throughout the study was comparable between the two groups.
Conclusion: This study clearly showed the efficacy of a short course of oral prednisone (3 days), versus a placebo, in the treatment of the functional signs of acute maxillary rhinosinusitis with severe pain in adults in addition to an appropriate antibiotic treatment.