Comparison of ofloxacin and metronidazole for the treatment of bacterial vaginosis.

The efficacy and safety of ofloxacin, 200 mg twice daily for 7 days, was compared with metronidazole, 400 mg twice daily for 7 days, for the treatment of bacterial vaginosis (BV). Diagnosis of BV was confirmed by at least 3 of the following 4 criteria: the presence of an abnormal vaginal discharge on examination, clue cells on microscopy of vaginal specimens, vaginal pH greater than 5.0 and a positive amine test. Vaginal specimens were examined for Mobiluncus spp, analysed for the succinate/lactate (S/L) ratio and cultured for Trichomonas vaginalis, Gardnerella vaginalis, Bacteroides spp. and Mycoplasma hominis. Patients were reviewed on completion of treatment (visit 2) and 14 days later (visit 3). The diagnosis of BV was accepted in 119 of 149 patients recruited, 60 of whom received treatment with ofloxacin and 59 received metronidazole. Sixty-two patients, 31 in each treatment group, completed the study. Diagnostic cure at visit 2 was significantly better in the metronidazole group with cure rates of 56% (metronidazole) vs 23% (ofloxacin) (P = 0.001); this was associated with higher eradication rates for G. vaginalis (100% vs 56%) and Bacteroides spp. (97% vs 49%). There were no significant differences between the two groups in clinical cure at either visit 2 or 3 or in diagnostic cure at visit 3. Both treatments were well tolerated. We conclude that metronidazole is likely to remain the first choice of treatment for BV but ofloxacin offers a safe and effective alternative.

RCT Entities:   Population Interventions Outcomes