From the Guidelines
Bacterial vaginosis (BV) should be treated with oral metronidazole or clindamycin in pregnant women to reduce the risk of premature rupture of the membranes, preterm labor, preterm birth, and postpartum endometritis, as recommended by the CDC guidelines 1, 2.
Treatment Options
The treatment options for BV include:
- Oral metronidazole 250 mg orally three times a day for 7 days
- Metronidazole 2 g orally in a single dose
- Clindamycin 300 mg orally twice a day for 7 days
- Metronidazole gel, 0.75%, one full applicator (5 g) intravaginally, twice a day for 5 days The goal of therapy for BV is to relieve vaginal symptoms and signs of infection, and all women who have symptomatic disease require treatment, regardless of pregnancy status 3.
Risk Factors and Complications
BV is associated with adverse pregnancy outcomes, including premature rupture of the membranes, preterm labor, preterm birth, and postpartum endometritis 2, 4. Risk factors for BV include douching, multiple sexual partners, and lack of condoms. To prevent recurrence, it is recommended to avoid douching, use condoms, and complete the full course of antibiotics.
Testing and Diagnosis
Testing for BV involves checking vaginal pH (typically >4.5 in BV) and microscopic examination of discharge for "clue cells" and reduced lactobacilli. All symptomatic pregnant women should be tested and treated for BV to reduce the risk of complications 1.
From the FDA Drug Label
A randomized, double-blind, placebo-controlled clinical trial in 235 non-pregnant women was conducted to evaluate the efficacy of tinidazole for the treatment of bacterial vaginosis. In patients with all four Amsel's criteria and with a baseline Nugent score ≥4, tinidazole oral tablets given as either 2 g once daily for 2 days or 1 g once daily for 5 days demonstrated superior efficacy over placebo tablets as measured by therapeutic cure, clinical cure, and a microbiologic cure. Table 2 Efficacy of Tinidazole in the Treatment of Bacterial Vaginosis in a Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Trial:
- Therapeutic Cure: 36.8% for 1g x 5 days, 27.4% for 2g x 2 days
- Clinical Cure: 51.3% for 1g x 5 days, 35.6% for 2g x 2 days
- Nugent Score Cure: 38.2% for 1g x 5 days, 27.4% for 2g x 2 days
Tinidazole is effective for the treatment of bacterial vaginosis. The therapeutic cure rates for tinidazole were 36.8% for the 1g x 5 days regimen and 27.4% for the 2g x 2 days regimen, as measured by resolution of all Amsel's criteria and a Nugent score of <4 5. Clinical cure rates were 51.3% for the 1g x 5 days regimen and 35.6% for the 2g x 2 days regimen. Nugent score cure rates were 38.2% for the 1g x 5 days regimen and 27.4% for the 2g x 2 days regimen.
- Key points: + Tinidazole is indicated for the treatment of bacterial vaginosis in adult women 6 + The efficacy of tinidazole was evaluated in a randomized, double-blind, placebo-controlled clinical trial 5 + Tinidazole demonstrated superior efficacy over placebo for the treatment of bacterial vaginosis 5
From the Research
Treatment Options for Bacterial Vaginosis
- The preferred treatment for bacterial vaginosis in nonpregnant women includes metronidazole (500 mg orally twice daily for 7 days), clindamycin vaginal cream (2%, once daily for 7 days), or metronidazole vaginal gel (0.75%, twice daily for 5 days) 7.
- For pregnant women, the treatment objective is to prevent adverse outcomes of pregnancy and relieve symptoms. Metronidazole (250 mg orally three times a day for 7 days) is recommended for both high-risk and low-risk pregnant women 7.
- Current FDA-approved treatments for bacterial vaginosis are antibiotics such as metronidazole and clindamycin, which provide a short-term cure but may not provide a consistent long-term cure 8.
Recurrence and Alternative Strategies
- Recurrence of bacterial vaginosis is common, with 50-80% of women experiencing a recurrence within a year of completing antibiotic treatment 8, 9.
- Recommended treatment for recurrent bacterial vaginosis includes an extended course of metronidazole treatment or metronidazole vaginal gel 9.
- Alternative strategies being explored for the treatment and prevention of bacterial vaginosis include probiotics, vaginal microbiome transplantation, pH modulation, and biofilm disruption 8, 10.
- Behavioral modifications such as smoking cessation, condom use, and hormonal contraception may also help prevent bacterial vaginosis 8.
Limitations of Current Treatments
- Current treatments for bacterial vaginosis have limitations, including high failure and recurrence rates, which may be associated with antibiotic resistance and the inability to eradicate polymicrobial biofilms 10.
- The development of new formulation strategies and drug delivery systems may improve treatment efficacy and overcome some limitations associated with conventional products 10.