From the Guidelines
Bacterial vaginosis (BV) should be diagnosed based on clinical symptoms and treated with oral metronidazole 250 mg three times a day for 7 days, or alternative regimens such as metronidazole 2 g orally in a single dose or clindamycin 300 mg orally twice a day for 7 days, to reduce the risk of adverse pregnancy outcomes and relieve symptoms. The diagnosis of BV is typically based on the presence of thin, grayish-white vaginal discharge with a fishy odor, vaginal itching, and burning during urination, as well as an imbalance of bacteria in the vagina, specifically an overgrowth of anaerobic bacteria and a reduction in beneficial lactobacilli 1. Some key points to consider in the diagnosis and treatment of BV include:
- The normal acidic environment of the vagina (pH 3.8-4.5) is disrupted, allowing harmful bacteria to flourish 1
- Risk factors for BV include douching, multiple sexual partners, and new sexual partners 1
- BV can increase susceptibility to STIs and may cause complications during pregnancy, including preterm birth and postpartum endometritis 1
- Treatment should be tailored to the individual patient, with consideration given to the patient's symptoms, medical history, and pregnancy status 1
- Patients should be advised to avoid alcohol consumption with metronidazole due to potential disulfiram-like reactions, abstain from sexual intercourse or use condoms, and complete the full course of antibiotics even if symptoms resolve earlier 1. It is essential to note that while BV is not considered a sexually transmitted infection, it can have significant consequences for women's health, particularly during pregnancy, and therefore prompt diagnosis and treatment are crucial to reduce the risk of adverse outcomes.
From the FDA Drug Label
The single oral 2 g tinidazole dose was also assessed in four open-label trials in men... 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. 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. INDICATIONS AND USAGE Metronidazole vaginal gel is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis) NOTE: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a 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 clue cells on microscopic examination.
The diagnosis of bacterial vaginosis (BV) is based on:
- Amsel's criteria:
- Abnormal homogeneous vaginal discharge
- pH of greater than 4.5
- "Fishy" amine odor when mixed with a 10% KOH solution
- Contains ≥20% clue cells on microscopic examination
- Gram stain results:
- Markedly reduced or absent Lactobacillus morphology
- Predominance of Gardnerella morphotype
- Absent or few white blood cells
The treatment for BV includes:
- Tinidazole oral tablets: 2 g once daily for 2 days or 1 g once daily for 5 days 2
- Metronidazole vaginal gel 3
From the Research
Diagnosis and Treatment of Bacterial Vaginosis (BV)
The diagnosis and treatment of bacterial vaginosis (BV) involve several approaches, including:
- The use of 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) as the preferred treatment for nonpregnant women 4, 5
- 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 4
- For pregnant low-risk women with symptomatic disease, the main objective of the treatment is to relieve symptoms, and metronidazole (250 mg orally three times a day for 7 days) is recommended 4
- The treatment of BV during pregnancy should focus on the elimination of symptoms, as data on adverse pregnancy outcomes for women with BV remain insufficient to recommend treatment of asymptomatic patients 5
- For recurrent BV, an extended course of metronidazole treatment (500 mg twice daily for 10-14 days) is recommended; if ineffective, metronidazole vaginal gel 0.75% for 10 days, followed by two times per week for 3-6 months, is an alternate treatment regimen 6
Alternative Strategies
Alternative strategies for the treatment of BV include:
- The use of antimicrobial substances, such as other antimicrobials, antiseptics, and natural compounds 7
- The use of substances that aim to reestablish the physiologic vaginal environment, such as probiotics, prebiotics, and acidifying agents, while improving the local immunity response 7
- The development of formulation strategies and new dosage forms and drug delivery systems to improve treatment efficacy and overcome some limitations associated with conventional products 7
Recurrence and Resistance
Recurrence of BV is a common problem, with as many as 50% of women experiencing recurrence within 1 year of treatment for incident disease 6