From the Guidelines
Bacterial vaginosis (BV) is a common vaginal infection caused by an imbalance of bacteria in the vagina, where healthy lactobacilli decrease and harmful bacteria overgrow, and the most recent guidelines recommend treatment with antibiotics such as metronidazole or clindamycin to relieve symptoms and prevent complications 1.
Symptoms and Diagnosis
Symptoms of BV include thin, grayish-white discharge with a fishy odor, vaginal itching, and burning during urination, though some women have no symptoms. The diagnosis of BV is typically made based on the presence of symptoms and the results of a physical examination and laboratory tests.
Treatment
Treatment of BV typically involves antibiotics such as metronidazole (500mg orally twice daily for 7 days or 0.75% gel intravaginally once daily for 5 days) or clindamycin (300mg orally twice daily for 7 days or 2% cream intravaginally at bedtime for 7 days) 1. During treatment, it is recommended to avoid alcohol with metronidazole, complete the full course of antibiotics even if symptoms improve, and abstain from sex or use condoms.
Prevention and Recurrence
BV can recur, so maintaining vaginal health is important by:
- Avoiding douching
- Using unscented soaps
- Wearing cotton underwear
- Wiping front to back after using the toilet BV is not considered a sexually transmitted infection but is more common in sexually active women. If left untreated, BV can increase the risk of getting STIs and cause complications during pregnancy, including preterm birth.
Special Considerations
Pregnant women with BV are at increased risk for adverse pregnancy outcomes, including premature rupture of the membranes, preterm labor, and preterm birth. The established benefit of therapy for BV in pregnant women is to relieve vaginal symptoms and signs of infection, and additional potential benefits of therapy include reducing the risk for infectious complications associated with BV during pregnancy and reducing the risk for other infections 1. High-risk pregnant women who have asymptomatic BV may be evaluated for treatment.
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. A clinical diagnosis of bacterial vaginosis was based on Amsel's criteria and defined by the presence of an abnormal homogeneous vaginal discharge that (a) has a pH of greater than 4. 5, (b) emits a "fishy" amine odor when mixed with a 10% KOH solution, and (c) contains ≥20% clue cells on microscopic examination. Clinical cure required a return to normal vaginal discharge and resolution of all Amsel's criteria A microbiologic diagnosis of bacterial vaginosis was based on Gram stain of the vaginal smear demonstrating (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells, with quantification of these bacterial morphotypes to determine the Nugent score, where a score ≥4 was required for study inclusion and a score of 0 to 3 considered a microbiologic cure. Therapeutic cure was a composite endpoint, consisting of both a clinical cure and microbiologic cure 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.
- Bacterial Vaginosis Treatment: Tinidazole is indicated for the treatment of bacterial vaginosis in adult women 2.
- Key Points:
- 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.
- Therapeutic cure rates reported were based on resolution of 4 out of 4 Amsel's criteria and a Nugent score of <4.
- The cure rates for tinidazole were 97.5% for the 2-day regimen and 36.8% difference from placebo for therapeutic cure 2.
From the Research
Bacterial Vaginosis Treatment Options
- 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) 3, 4.
- For pregnant high-risk women, the recommended treatment is metronidazole (250 mg orally three times a day for 7 days) to prevent adverse outcomes of pregnancy and relieve symptoms 3.
- For pregnant low-risk women with symptomatic disease, the main objective of treatment is to relieve symptoms, and metronidazole (250 mg orally three times a day for 7 days) is recommended 3.
- Clindamycin may be a safe and effective alternative to metronidazole for treating women with bacterial vaginosis, with a study showing no significant difference in failure rates between the two treatments 5.
- A randomized trial comparing clindamycin vaginal ovules with oral metronidazole found that the two treatments had similar efficacy, but clindamycin was better tolerated 6.
Comparison of Treatment Options
- A study comparing oral metronidazole, metronidazole vaginal gel, and clindamycin vaginal cream found that the three treatments had similar cure rates, but patients treated with intravaginal products reported being more satisfied with the treatment 7.
- The same study found that posttreatment vulvovaginal candidiasis was experienced by a similar percentage of patients treated with oral metronidazole and clindamycin vaginal cream, but was more common in patients treated with metronidazole vaginal gel 7.