OBJECTIVE: To compare the efficacy and safety of 0.75% metronidazole vaginal gel with oral metronidazole for the treatment of bacterial vaginosis (BV). STUDY DESIGN:Nonpregnant women with BV were enrolled in a multicenter, randomized, investigator-blind treatment trial. Patients were randomly assigned 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 visits occurred 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% CI 72.3-95.1%) of the intravaginal group and 85.1% (40/47, 95% CI 74.6-95.6%) of the oral group. At the final visit, BV was eliminated in 70.7% (29/41, 95% CI 56.3-85.1%) of the intravaginal group and 71.1% (32/45, 95% CI 57.4-84.8%) of the oral group. Significantly more patients in the oral treatment group (51.8%) reported gastrointestinal complaints as compared 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 metronidazole treatment and was associated with fewer gastrointestinal complaints.
RCT Entities:
OBJECTIVE: To compare the efficacy and safety of 0.75% metronidazole vaginal gel with oral metronidazole for the treatment of bacterial vaginosis (BV). STUDY DESIGN: Nonpregnant women with BV were enrolled in a multicenter, randomized, investigator-blind treatment trial. Patients were randomly assigned 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 visits occurred 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% CI 72.3-95.1%) of the intravaginal group and 85.1% (40/47, 95% CI 74.6-95.6%) of the oral group. At the final visit, BV was eliminated in 70.7% (29/41, 95% CI 56.3-85.1%) of the intravaginal group and 71.1% (32/45, 95% CI 57.4-84.8%) of the oral group. Significantly more patients in the oral treatment group (51.8%) reported gastrointestinal complaints as compared 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 metronidazole treatment and was associated with fewer gastrointestinal complaints.
Authors: Caroline Mitchell; Jennifer Balkus; Kathy Agnew; Richard Lawler; Jane Hitti Journal: J Womens Health (Larchmt) Date: 2009-11 Impact factor: 2.681
Authors: Jeanne M Marrazzo; Katherine K Thomas; Tina L Fiedler; Kathleen Ringwood; David N Fredricks Journal: Ann Intern Med Date: 2008-07-01 Impact factor: 25.391
Authors: Taha E Taha; Newton I Kumwenda; George Kafulafula; Bonus Makanani; Chiwawa Nkhoma; Shu Chen; Amy Tsui; Donald R Hoover Journal: PLoS Clin Trials Date: 2007-02-23
Authors: Muriel Aldunate; Daniela Srbinovski; Anna C Hearps; Catherine F Latham; Paul A Ramsland; Raffi Gugasyan; Richard A Cone; Gilda Tachedjian Journal: Front Physiol Date: 2015-06-02 Impact factor: 4.566