Main findings
malodour, bacterial vaginosis
SIDE EFFECTS, RECURRENCES, RECURRENCE, BACTERIAL VAGINOSIS
In women with recurrent bacterial vaginosis, 70% had resolution of their symptoms two weeks after treatment with metronidazole compared to 47% for those receiving lactic acid gel. Recurrence of bacterial vaginosis within 6 months, in the sub-set of those who had initial resolution, was frequent and similar after both treatments. Side effects were more common following metronidazole compared to lactic acid gel. Treatment success over 6 months was poor in both groups with only 23% of those receiving metronidazole and 16% of those using lactic acid gel having symptom resolution with no subsequent recurrences following treatment, although these estimates are based on less than half of the original trial population.Our previously published qualitative study undertaken in a sub-set of 33 VITA trial participants [Rates of adherence to metronidazole in the treatment of bacterial vaginosis have been reported to be 50–68% [Entry into the VITA trial and assessment of treatment response were based on the presence or absence of self-reported bacterial vaginosis symptoms. An additional pre-planned analysis was performed on a sub-set of participants who had positive microscopic confirmation of bacterial vaginosis at baseline and further microscopy results available at Week 2. This showed a similar response rate to that seen in the primary analysis with microbiological resolution in 77% of participants receiving metronidazole versus 42% for lactic acid gel (compared to 70% and 47% respectively in those diagnosed with bacterial vaginosis based on symptoms). It is therefore possible that metronidazole has a greater effect on the vaginal microbiome (assessed on microscopy) than is suggested by our primary endpoint measure of symptom resolution. However, the clinical importance of microbiological resolution of bacterial vaginosis (compared to clinical symptom resolution) is uncertain because following a clinical response in either treatment group, no differences were detected in the frequency or timing of bacterial vaginosis recurrences over the next 6 months. Caution is, however, required in interpreting the limited data which were available over the full 6-month follow-up period since less than 40% of participants returned data for all three time-points.We chose resolution of bacterial vaginosis symptoms as the primary outcome to maximise the trial’s relevance to patients and to reflect clinical practice where, in many settings, microscopy is not available, and clinical diagnosis and management is based on history and examination. Also, microbiological evidence of bacterial vaginosis can be present without symptoms [From a patient perspective, the symptoms of discharge and malodour are the main cause of physical and emotional distress associated with bacterial vaginosis, and have an impact on self-esteem and relationships, and restrict sexual activity [Individuals with frequently recurrent bacterial vaginosis respond less well to treatment [