Intermittent Use of Intravaginal Antibiotic Gel for Bacterial Vaginosis
Author Information
Author(s): Taha Taha E, Kumwenda Newton I, Kafulafula George, Makanani Bonus, Nkhoma Chiwawa, Chen Shu, Tsui Amy, Hoover Donald R
Primary Institution: Johns Hopkins University
Hypothesis
Repeated (intermittent) presumptive treatment with an intravaginal antibiotic regimen would restore normal vaginal flora, enhance BV clearance, and decrease BV recurrence.
Conclusion
Intermittent microbicide treatment with intravaginal gels is an innovative approach that can reduce the frequency of vaginal infections such as BV.
Supporting Evidence
- At baseline, 842 HIV-uninfected and 844 HIV-infected women were enrolled.
- The prevalence of BV was consistently lower in treatment than placebo arms irrespective of HIV status.
- Intravaginal metronidazole treatment gel significantly increased BV clearance among both HIV-uninfected and -infected women.
- Safety: No serious adverse events were related to use of intravaginal gels.
Takeaway
This study tested a gel to help women with a common infection called bacterial vaginosis. It showed that using the gel can help reduce the infection, but it didn't work as well as hoped.
Methodology
A randomized, double-masked, placebo-controlled phase 3 trial was conducted with HIV-uninfected and -infected women receiving intravaginal metronidazole or placebo every three months for one year.
Potential Biases
The placebo gel may have had a microbicidal effect, complicating the interpretation of the metronidazole gel's efficacy.
Limitations
The absence of a 'no treatment' study arm limits the ability to assess the true efficacy of the metronidazole gel.
Participant Demographics
Participants included nonpregnant HIV-uninfected and -infected women recruited from postnatal and family planning clinics in Malawi.
Statistical Information
P-Value
p<0.001
Confidence Interval
95% CI 0.83–0.97 for HIV-uninfected women; 95% CI 0.89–1.01 for HIV-infected women
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
Want to read the original?
Access the complete publication on the publisher's website