[Efficacy and tolerance of cefotiam hexetil in the super-infected chronic sinusitis. A randomized, double-blind study in comparison with cefixime].

Efficacy and safety of a new oral third generation Cephalosporin, Cefotiam Hexetil (CTM) 200 mg bid were compared with those of Cefixime (CX) 200 mg bid over 10 day duration of treatment. One hundred and twenty two ambulatory adults suffering from chronic sinusitis were randomized by ENT specialists in this multicentre prospective double blind, doubled dummy study. Sinusitis diagnosis evocated in front of fascial pain, purulent nasal discharge and/or obstruction was confirmed with sinus X-ray. Use of antibiotics or corticosteroids concomitantly or 15 days prior inclusion represented one of the major exclusion criterion. One hundred and seventy one patients were evaluated for efficacy analysis (62 and 59 respectively in CTM and CX groups). Regarding demographic data, clinical and radiological signs, the two populations were comparable at inclusion excepted for sex and weight (female: 73% in CTM group versus 47% in CX group). The overall clinical success rate at the end of treatment (cure+improvement) was not significantly different between the two groups (CTM: 82% versus CX: 80%). The incidence of adverse events was less frequent in the CTM group (14.5% versus 19%). In conclusion, CTM 200 mg bid is as efficacious and as well tolerated as CX 200 mg bid in the treatment of chronic sinusitis in adults.

RCT Entities:   Population Interventions Outcomes