Reviewer’s report
Title: 
Intravaginal lactic acid gel versus oral metronidazole for treating women
with recurrent bacterial vaginosis: the VITA randomised controlled trial
Version: 
0 
Date: 
25 Sep 2022
Reviewer's report:
This was an open label, randomized trial of two interventions to treat bacterial
vaginosis, with a primary outcome of participant-reported resolution of
symptoms. The trial was stopped early by the DMC. 
The authors describe this as
a pragmatic trial, with a patient-relevant outcome. While the diagnostic criteria
and chosen outcome mirror clinical practice, it is also true that the common
clinical practice of diagnosing BV by symptoms is sub-optimal, as evidenced by
the fact that only 50% of participants had BV by laboratory criteria. 
The authors do a good job acknowledging the many limitations of the study
(non-blinded, non-standard diagnosis of BV, non-standard lactic acid product,
significant loss to follow up), and overall I think this is a valuable contribution to
the literature despite those limitations. 
However, there are some areas where clarification and improved clarity would
be helpful:
1. Because there was such a difference in treatment efficacy and such a
significant loss to follow up, presenting the analysis of recurrent symptoms only
among those who achieve initial resolution of symptoms so prominently may be
a bit misleading. Are there follow up data for ongoing symptoms in the people
who did not have initial resolution of symptoms? Were all of them re-treated?
How were persistent symptoms addressed? 
The Kaplan Meier curve in Figure S2 is valuable, but should be accompanied by
another panel with the curve including the whole study population. Additionally,
the population included (i.e. only those with symptom resolution) should be
more clearly stated in the title of the figure.
2. The exclusion criteria include use of antibiotics or vaginal products "recently"
- was there a specific time frame?
3. Table 1: There is only a variable about use of the contraceptive pill - was
anyone using other hormonal contraception such as injectable, implant or
hormone containing IUD? What about the copper IUD?
4. Figure 1: The footnotes are cut off and the formatting not ideal - this should be
remade so that it is visually easier to interpret and follow. 
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