Intravaginal metronidazole gel versus metronidazole plus nystatin ovules for bacterial vaginosis: a randomized controlled trial.
OBJECTIVE
We compared metronidazole 0.75% gel (containing 37.5 mg metronidazole per dose) with ovules containing metronidazole 500 mg and nystatin 100,000 U, for intravaginal treatment of bacterial vaginosis (BV).


METHODS
In a single-blinded trial, symptomatic women with BV by both Amsel and Nugent criteria were randomly assigned to gel or ovules, once nightly for 5 nights, and asked to return 3 times after treatment. Analyses were intent-to-treat.


RESULTS
Of 151 women with BV by both criteria at enrollment, 138 (91%) returned at least once. Product limit estimates for persistence or recurrence of BV at 14, 42, and 104 days were 20% (95% CI 10%-29%), 38% (95% CI 25%-48%), and 52% (95% CI 37%-63%) after gel treatment, and 4% (95% CI 0%-9%), 17% (95% CI 7%-26%), and 33% (95% CI 21%-46%) after ovule treatment ( P = .01). Among women without BV at first follow-up, subsequent intercourse without condoms independently predicted subsequent recurrence ( P </= .01).


CONCLUSIONS
Metronidazole/nystatin ovules were significantly more effective than metronidazole gel. Unprotected sex predicted recurrence after initial improvement.
Sanchez
Sixto
S
Hospital dos de Mayo, Lima, Peru.
Garcia
Patricia J
PJ
Thomas
Katherine K
KK
Catlin
Mary
M
Holmes
King K
KK
D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D002214:Capsules; D002626:Chemistry, Pharmaceutical; D016001:Confidence Intervals; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008795:Metronidazole / Q000008:administration & dosage*; D009761:Nystatin / Q000008:administration & dosage*; D010349:Patient Compliance; D011336:Probability; D012016:Reference Values; D018570:Risk Assessment; D012720:Severity of Illness Index; D016037:Single-Blind Method; D016896:Treatment Outcome; D014622:Vaginal Creams, Foams, and Jellies; D014626:Vaginal Smears; D016585:Vaginosis, Bacterial / Q000175:diagnosis* / Q000188:drug therapy*
D002214:Capsules; D014622:Vaginal Creams, Foams, and Jellies; D009761:Nystatin; D008795:Metronidazole