OBJECTIVE: To compare the efficacy and safety of 0.75% metronidazole vagina
l gel with oral metronidazole for the treatment of bacterial vaginosis (BV)
.
STUDY DESIGN: Non-pregnant women with BV were enrolled in a multi-center, r
andomized investigator-blind treatment trial. Patients were randomly assign
ed to either 0.75% metronidazole vaginal gel (5 g twice daily for five days
) or oral metronidazole (500 mg twice daily for seven days). Follow-up visi
ts occured approximately two and five weeks after initiation of therapy
RESULTS: BV was clinically eliminated at the first follow-up visit in 83.7%
(36/43 95% Cl 72.3%-95%) of the intravaginal group and 85.1% (40/47, 95% C
l 74.6-95.6%) of the oral group. At the final visit, BV was eliminated in 7
0.7% (29/41, 95% Cl 56.3-85.1%) of the intravaginal group and 71.1% (32/45,
95% Cl 57.4-84.8%) of the oral group. Significantly more patients in the o
ral treatment group (51.8%) reported gastrointestinal complaints as compare
d to the intravaginal treatment group (32.7%, P=.04).
CONCLUSION: The efficacy of 0.75% metronidazole vaginal gel twice daily for
five days in treating BV was similar to that of standard oral metronidazol
e treatment and was associated with fewer gastrointestinal complaints.