125 Amoxicillin In Patients With Suspected Rhinosinusitis: A Double-Blind Placebo Controlled Trial

Author(s): 
DE SUTTER An, Department of General Practice, University of Ghent, Belgium, DE MEYERE Marc, PEERSMAN Wim, DE MAESENEER Jan. E-mail: An.Desutter@rug.ac.be
Text: 
Context: Most trials on the effectiveness of antibiotic therapy in rhinosinusitis included patients on basis of the results of technical investigations such as CT-scan and conventional radiology. General practitioners however generally make the diagnosis rhinosinusitis relying on clinical symptoms only. In this trial we included patients with clinically suspected rhinosinusitis in order to investigate a population more identifiable in daily practice.
Objective:
To compare the effectiveness of amoxicillin with placebo in patients with rhinosinusitis-like complaints.
Design: Randomised, double blind, placebo-controlled trial.
Setting: Fifty general practices in Belgium.
Patients: 415 patients, 12 years or older, with at least purulent rhinorroea.
Intervention:
After randomisation, 207 received 500 mg amoxicillin t.i.d during 10 days and 209 received identical capsules containing placebo. All patients received symptomatic treatment.
Outcome score:
Comparison between treatment groups of prevalence of 31 clinical signs and symptoms after 10 days of treatment.
Results: At day 10, fewer patients in the antibiotic group complained of purulent rhinorroea (31.4% with antibiotics and 43.7% with placebo; p = 0.025. NNT = 8). None of the other signs or symptoms, including fever, pain, fatigue, sleep disturbance, reduced energy or concentration, were significantly less prevalent in the treatment group in comparison with placebo.
Conclusion:
Although there is some effect, antibiotic treatment was not able to influence the more troublesome symptoms such as pain or feeling ill. Therefore we conclude that, for patients consulting their general practitioners with suspicion of uncomplicated rhinosinusitis, antibiotics are not indicated.
Literature: 
125 AMOXICILLIN IN PATIENTS WITH SUSPECTED RHINOSINUSITIS: A DOUBLE-BLIND PLACEBO CONTROLLED TRIAL