O03.3 Intravaginal lactic acid gel versus oral metronidazole for treating women with recurrent bacterial vaginosis: the VITA randomised controlled trial

Background Bacterial vaginosis (BV) is a common, embarrassing and distressing condition, with serious comorbidities. The VITA trial assessed the effectiveness of intravaginal lactic acid gel versus oral metronidazole for treating recurrent BV. Methods Open-label, multicentre, parallel group, randomised controlled trial. Women aged ≥16 years with history of BV within the past 2 years and current symptoms were recruited at one GP practice and 19 sexual health centres in the UK. Participants were randomised to 5ml intravaginal lactic acid gel or oral 400mg twice daily metronidazole tablets, for 7 days. The primary outcome was participant reported resolution of BV symptoms by the end of Week 2, with subsequent follow up over 6 months. Semi-structured interviews explored tolerability and acceptability of the study treatments. Results 518 participants were randomised (259 to metronidazole, 259 to lactic acid gel). Primary outcome data were available for 204 (79%) participants allocated to metronidazole and 205 (79%) allocated to lactic acid gel. Resolution of BV at Week 2 occurred in 143 (70%) participants in the metronidazole arm versus 97 (47%) participants in the lactic acid gel arm (adjusted risk difference -23.2% (95% CI -32.3 to -14.0%). Symptom resolution with no subsequent recurrences over 6 months occurred in 23% of those who took metronidazole and 16% of those using lactic acid gel. Side effects were more common following metronidazole compared to lactic acid gel. Interviews revealed that many women preferred lactic acid gel despite perceiving antibiotics to be more effective. Conclusion Metronidazole is more effective than lactic acid gel in achieving short term resolution of BV symptoms but recurrence is common following both treatments. Lactic acid is associated with fewer reported side effects and is preferred by many women despite its lower efficacy. Funding UK National Institute for Health Research Health Technology Assessment. Trial Registration ISRCTN14161293