A randomized controlled trial of 5-day regimen of azithromycin and a 10-day regimen of co-amoxiclav for treatment of acute sinusitis

Background: Acute sinusitis constitutes a significant portion of health service utilization globally both in- and outpatient as well as emergency department visits, with 83% resulting in a prescription for an antibiotic. This study compared the efficacy of a 5-day regimen of azithromycin (a macrolid antibiotic) with a 10-day regimen of coamoxiclav (combination of an aminopenicillin with a betalactamase inhibitor) for the treatment of acute sinusitis. Patients and methods: A total of 76 subjects with acute sinusitis were randomly assigned in two groups, azithromycin (n=40) and co-amoxiclav (n=36). One group received azithromycin, 500mg in the first day and 250mg for 4 days and the other group received co-amoxiclav 625mg, 3 times a day for 10 days. Patients were visited 4 times during the study (baseline, phone call, end of treatment, end of study) and regression/progression of their symptoms and their response to the treatment was evaluated. Results: There was no significant difference between the two groupsʹ demographic and clinical presentations. Duration of regression of the symptoms in the azithromycin group was significantly shorter than the co-amoxiclav group (7.6 days versus 10.6, p=0.03). Clinical success rate at end of the study was 80% for azithromycin and 66.7% for co-amoxiclav (p=0.025). Clinical success rates among females in both groups seemed to be higher than males, but this difference was not statistically significant (p=0.13). Conclusion: Results revealed that azithromycin regimen is more efficient, has less side effects, and required shorter treatment period. Patients were able to tolerate the medications better with a higher compliance and less economic cost than co-amoxiclav regimen.