A multicenter, randomized, investigator-blinded study of 5- and 10-day gatifloxacin versus 10-day amoxicillin/clavulanate in patients with acute bacterial sinusitis

Fluoroquinolones compared with -lactam antibiotics for the treatment of acute bacterial sinusitis: a meta-analysis of randomized controlled trials

“…Two additional trials eligible for inclusion were detected after a secondary search on the Scopus database, but no additional trials were identified in the Cochrane Central Register of Controlled Trials. A total of 11 trials [21][22][23][24][25][26][27][28][29][30][31] were included in the meta-analysis ( Figure 1). The 2 reviewers independently reached the same conclusions regarding studies to be included.…”

“…All but 1 of the randomized controlled trials included in the meta-analysis had 2 treatment arms; the exception compared short-course (5-day) gatifloxacin treatment with standard-duration (10-day) gatifloxacin treatment and with amoxicillin-clavulanate treatment. 24 We used the data for the standard-duration gatifloxacin treatment arm in this meta-analysis. In addition to the treatments being compared in these studies, adjunctive medications for symptomatic relief, mostly decongestants, antihistamines and analgesics, were permitted in 8 of the trials.…”

“…In addition to the treatments being compared in these studies, adjunctive medications for symptomatic relief, mostly decongestants, antihistamines and analgesics, were permitted in 8 of the trials. 22,[24][25][26][27][28][29][30] Two of these trials reported the percentage of patients using such medications: 76% in one study 28 and 83.5% in the other.…”

“…All of the trials involved outpatients with presumed acute bacterial sinusitis; 2 of the trials also enrolled patients with acute exacerbation of chronic sinusitis, but these patients represented less than 30% of the whole patient group. 23 the included studies 23,24,30 reported that a large number of the patients had a history of allergic rhinitis.…”

“…Adequate randomization procedures were reported in 6 of the 11 trials, 22,23,24,[28][29][30] allocation concealment was reported in 3 trials, 22,24,31 masking of the intervention was reported in 5 trials, 22,24,26,28,29 information on patient withdrawals from the trials was reported in 7 trials, 22,25-30 crossovers of patients between treatment arms were reported in 1 trial, 27 and violation of the inclusion criteria was reported in 4 trials. 26,28,29,31 In 10 of the 11 trials, the fluoroquinolone was the experimental treatment and the β-lactam antibiotic the comparator; in the other trial, the fluoroquinolone (levofloxacin) served as CMAJ • March 25, 2008 • 178 (7) 8 84 47 7…”