A blind parallel comparative study of the efficacy and safety of rovamycin versus augmentin in the treatment of acute otitis media.

Author(s): Mgbor NC, Umeh RE

Affiliation(s): Department of Otolaryngology, University of Nigeria Teaching Hospital, Enugu.

Publication date & source: 2002-04, West Afr J Med., 21(2):117-20.

Publication type: Clinical Trial; Randomized Controlled Trial

A single blind randontised controlled parallel clinical trial of Rovamycin was conducted in which (Rovamycin Rhone-Poulenc Rorer) was compared with Augmentin in patients with acute otitis media. Forty patients were randomised to treatment with either Rovamycin or Augmentin and the drugs were evaluated for efficacy and safety. The efficacy parameters used were fever clearance, symptom clearance and cure rate after 8 days of treatment Our study showed that fever regressed in 19 (95%) of the 20 patients in both groups; otalgia in 19 (95) patients for the Augmentin and 18 (90%) for Rovamycin after 8 days of application of the trial drugs in these parameters. There was also no significant difference between them in their safety and tolerability profiles. These results showed that Rovamycin is a useful addition to our armamentarium in the fight against bacterial otitis media. Operationally, Rovamycin has an advantage over Augmentin for the reason that is given only twice a day as against thrice-daily dosage f orAugmentin. Compliance and consequently effectiveness in practices should therefore be better for Rovamycin.