Vaginal clindamycin and oral metronidazole for bacterial vaginosis: a randomized trial.
OBJECTIVE
To compare the efficacy and safety of clindamycin vaginal ovules with oral metronidazole for treatment of bacterial vaginosis.


METHODS
Women with bacterial vaginosis received either 100-mg ovules of clindamycin (intravaginally for 3 consecutive days) plus placebo capsules (orally twice daily for 7 days) or metronidazole 500 mg (two 250-mg capsules orally twice daily for 7 days) plus placebo ovules (intravaginally for 3 consecutive days). The sample was determined prospectively to provide a probability of.84 of correctly concluding that the rate of success for clindamycin is not more than 15% less than the expected 75% success rate for metronidazole. Clinical outcome was determined on the basis of vaginal fluid amine odor and clue cells.


RESULTS
Of the 399 patients enrolled, 233 could be evaluated for efficacy. Of those, 77 (68.1%) of 113 patients were cured with clindamycin, compared with 80 (66. 7%) of 120 who were cured with metronidazole (95% confidence interval -10.6%, 13.4%; P =.810). Treatment-related adverse events were reported more frequently in the metronidazole treatment group. Systemic symptoms, such as nausea and taste perversion, accounted for most of the difference between groups.


CONCLUSIONS
A 3-day regimen of clindamycin, given as intravaginal ovules, was as effective as and better tolerated than a 7-day regimen of oral metronidazole 500 mg, given twice daily, for treatment of bacterial vaginosis.
Paavonen
J
J
Department of Obstetrics and Gynecology, University of Helsinki, Helsinki, Finland. jpaavone@cc.helsinki.fi
Mangioni
C
C
Martin
M A
MA
Wajszczuk
C P
CP
D000282:Administration, Intravaginal; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002981:Clindamycin / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005060:Europe; D005260:Female; D006801:Humans; D008795:Metronidazole / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D016585:Vaginosis, Bacterial / Q000188:drug therapy*
D000900:Anti-Bacterial Agents; D000890:Anti-Infective Agents; D008795:Metronidazole; D002981:Clindamycin