Abstract
BackgroundBacterial vaginosis (BV) affects 30–50% of women at some time in their lives and is an embarrassing and distressing condition which can be associated with potentially serious comorbidities. Current antibiotic treatments such as metronidazole are effective but can result in side effects, and recurrence is common. This trial aims to investigate whether lactic acid gel is clinically effective and cost effective in the treatment of recurrent BV compared with metronidazole.MethodsVITA is an open-label, multicentre, parallel group randomised controlled trial for women with a clinical diagnosis of BV and at least one previous BV episode in the past 2 years. Participants will be randomised 1:1 to intravaginal lactic acid gel 5 ml once daily for 7 days or oral metronidazole tablets 400 mg twice daily for 7 days. All participants will be followed up for 6 months to assess health status and healthcare costs. A subgroup will be interviewed to further explore adherence, tolerability and acceptability of treatment. The estimated sample size is 1900 participants to detect a 6% absolute increase in response rate to 86% in those receiving lactic acid gel. The primary outcome is participant-reported resolution of BV at Week 2.DiscussionResults from this trial will help inform UK treatment guidelines for BV and may provide an alternative effective treatment for recurrent episodes of this condition which avoids repeated exposure to antibiotics.Trial registrationISRCTN, ISRCTN14161293. Registered on 8 September 2017.
Highlights
Bacterial vaginosis (BV) affects 30–50% of women at some time in their lives and is an embarrassing and distressing condition which can be associated with potentially serious comorbidities
The control group will receive a 7-day course of twice daily 400 mg oral metronidazole. This has been chosen as the comparator because it is recommended as first line therapy in the UK national BV treatment guideline [7], it is active against a wide range of the anaerobic bacteria associated with BV and it is commonly used in clinical practice supported by evidence from randomised controlled trials [18]
Power calculation/sample size calculation Assuming that 80% of participants receiving oral metronidazole achieve resolution of symptoms, 1710 participants are required for analysis to detect a 6% increase in response rate to 86% in participants receiving lactic acid gel at the 5% SL with 90% power
Summary
VITA is an open-label, multicentre, parallel group randomised controlled trial for women with a clinical diagnosis of BV and at least one previous BV episode in the past 2 years. Participants will be randomised 1:1 to intravaginal lactic acid gel 5 ml once daily for 7 days or oral metronidazole tablets 400 mg twice daily for 7 days. All participants will be followed up for 6 months to assess health status and healthcare costs. A subgroup will be interviewed to further explore adherence, tolerability and acceptability of treatment. The estimated sample size is 1900 participants to detect a 6% absolute increase in response rate to 86% in those receiving lactic acid gel. The primary outcome is participant-reported resolution of BV at Week 2
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