[Comparative study of the efficacy and tolerance of prednisolone versus niflumic acid in the treatment of acute sinusitis in adults]. [Treatment of functional signs of acute maxillary rhinosinusitis in adults. Efficacy and tolerance of administration of oral prednisone for 3 days]. Short-course, low-dose oral betamethasone as an adjunct in the treatment of acute infective sinusitis : a comparative study with placebo. Short therapy with amoxicillin-clavulanate and corticosteroids in acute sinusitis: results of a multicentre study in adults.
nan 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.
                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.
                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.
                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. To assess the effect of a short course of low-dose oral corticosteroid used as an adjunct to antimicrobials in patients with acute infective sinusitis.
                Double-blind, randomised, placebo-controlled study including 42 patients with a clinical diagnosis of acute infective sinusitis. The study was performed at three primary healthcare sites in South Africa during the period January-November 2003.
                Two equal groups received either betamethasone 1mg orally (n = 21; the treatment group) or placebo tablets (n = 21; the placebo group) once a day in the morning for five consecutive days. All patients received amoxicillin-clavulanic acid 625mg orally, three times daily for 5 days.
                Patients rated symptoms on a daily symptom score card for 5 days and were examined by the investigator at diagnosis (day 0) and on the second visit (day 6).
                Headache, facial pain, nasal congestion and dizziness improved significantly from baseline in the treatment group compared with the placebo group over 5 days of treatment (p = 0.028, p </= 0.047, p </= 0.04 and p </= 0.051, respectively). Percussion tenderness improved significantly (p = 0.049) and clearance of purulent secretions almost reached significance (p = 0.058) in the treatment group compared with the placebo group.
                This study suggests a benefit of oral corticosteroid added to antimicrobial treatment of acute sinusitis and documents the first successful use of a short course of low-dose oral corticosteroid in patients with acute infective sinusitis. Evolution of bacterial resistance shortens antibiotic treatment in ENT infections. The efficacy and tolerance of amoxicillin-clavulanate (ACA), with and without associated short steroid therapy, was evaluated in acute sinusitis of adults at a dosage of 1.5 g/d for 5 d vs. 10 d. This multicentre, randomized, double-blind, placebo-controlled study included 433 patients, 417 of whom were suitable for intent-to-treat (ITT) analysis. The therapeutic success rate in the ITT population, assessed according to strict clinical and radiological criteria, was respectively, 80% and 85% in the 5-d and 10-d treatment groups. Due to the statistical risks that were evidenced, the 2 durations of treatment could not be considered equivalent. The analysis of medical history shows that some risk factors (recurrence of sinusitis, previous surgical sinus drainage) seem to promote therapeutic failure and that 5-d treatment is inappropriate in these patients. The persistence of therapeutic success on day 30 was not influenced by the initial duration of treatment. The efficacy and good tolerance of ACA in acute sinusitis in adults were confirmed. Further studies will be needed to define the indications of short treatments better, which seem to be indicated in the absence of specific risk factors.
Current evidence suggests that oral corticosteroids as an adjunctive therapy to oral antibiotics are effective for short-term relief of symptoms in acute sinusitis. However, data are limited and there is a significant risk of bias. High quality trials assessing the efficacy of systemic corticosteroids both as an adjuvant and a monotherapy in primary care patients with acute sinusitis should be initiated.