Reviewer's report
Title:Human lactobacilli as adjuvant given to patients with bacterial vaginosis
reduce the recurrence rate after vaginal clindamycin therapy; a 6 month double
blind randomized placebo controlled study.
Version: 4Date:31 July 2007
Reviewer: Gregor Reid
Reviewer's report:
General
My original review is below, and my new comments are in bold.
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Major Compulsory Revisions (that the author must respond to before a decision
on publication can be reached)
I have a number of concerns about this paper.
1. The use of lactobacilli does not constitute an adjuvant. This term should not be
used.
THIS WAS NOT ADDRESSED
2. What was the rationale for repeated vaginal therapy for three months? This
does not constitute cure of BV.
THIS WAS NOT ADDRESSED. SIX MONTHS LATER WHY WOULD THERE BE
A DIFFERENCE DUE TO A THERAPY THAT DID NOT WORK AND WAS NOT
ABLE TO COLONIZE THE VAGINA?
3. BV can be caused by aerobic bacteria and Gram positive Atopobium. Please
update your knowledge of the condition.
4. Treatment of BV does not reduce the incidence of Preterm labour – not if you
look at all the literature.
THIS WAS NOT ADDRESSED, AND THERE IS A MISLEADING STATEMENT
ON PAGE 5.
5. This is not the first study on augmentation of antibiotics with probiotics to treat
BV. See Anukam et al. 2006. THEY DO NOT CITE THE PAPER
6. The paper by Anukam in late 2006 showed that lactobacilli could cure BV, so
the statement on page 5 is incorrect.
9. What is the sample size calculation and why were sexually transmitted
infections not ruled out given their high occurrence in BV subjects?
NO SAMPLE SIZE GIVEN
10. Was BV cured by the time lactobacilli was given? If so, you are using the
lactobacilli to prevent recurrence not treat BV.
THIS WAS NOT ADDRESSED.
11. As the lactobacilli used here did not work (see first month’s results – 64% v
74%), you should discuss this. Presumably the strains do not have the
appropriate properties to populate the vagina and interfere with the process of
BV.
THE FACT THAT THE THERAPY DID NOT WORK IS NOT ADDRESSED
12. Were subjects instructed how to take swabs? How was compliance checked?
NOT STATED. DID ANYONE TEACH THE SUBJECTS TO SELF-SWAB AND
HOW GOOD AT THIS WERE THEY?
13. Bacteria are not roughly recorded. They must be precisely enumerated.
14. Sentence for reference 17 is completely incomprehensible!
15. What is increased discharge?
16. No antibiotics should have been given. If subjects had UTI or other conditions
prior to entry, these should have been cured before inclusion of the patients into
the BV study.
17. Presumably the 18 candidiasis patients were not included in the BV analysis.
Why would resolution of candidiasis have any effect on malodour caused by
amine production by BV organisms?
18. Be careful how you report adverse events. How can whiplash ever be
perceived to be due to lactobacilli or placebo!! Who got UTI in which group at
what time of the study?
Additional comments:
THE STRAINS ARE CALLED 'PROBIOTIC', BUT IF THEY SHOW NO BENEFIT
TO HUMANS THEY ARE NOT PROBIOTIC.
ECOVAG IS NOT A DRUG - OR IS IT REGISTERED AS ONE?
PLEASE EXPLAIN THE HAY SCORE IN TERMS OF THE AMSEL CRITERIA.
READERS CAN'T FOLLOW THIS.
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Minor Essential Revisions (such as missing labels on figures, or the wrong use of
a term, which the author can be trusted to correct)
There are too many spelling and grammatical errors.
Use ‘microbiota’ instead of ‘flora’. Lactobacillus should be italicized. 'Motile'
bacteria, not 'mobile'. Women 'who', not women 'that'. The visit 'was' due, not
'should be' due. Metronidazole is misspelt on page 5.
What next?: Unable to decide on acceptance or rejection until the authors have
responded to the major compulsory revisions
Level of interest: An article of importance in its field
Quality of written English: Not suitable for publication unless extensively edited
Statistical review: Yes, but I do not feel adequately qualified to assess the
statistics.