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: 5Date:26 November 2007
Reviewer: Marika Mikelsaar
Reviewer's report:
General
This is an important study confirming that with repeated administration of
lactobacilli the relapse rate of bacterial vaginosis (BV) can be reduced after
successful initial clindamycin therapy.
The study is well organised, the sample size is appropriate, the methods and
results are reliable and interesting yet there are some important issues still
needing correction before publication.
I fully agree with prof. Gregor Reid in some points that need to be corrected.
However, by my understanding these revisions are easy and quick to perform.
1) Lactobacilli as adjuvant. Really, the term "adjuvant" indicates a supportive
material/substance that is usually added as a component to the active
compound/substance or administered at the same time with the main active
compound.
For instance - in polysaccharide pneumococcal vaccines the extra added
proteinaceous compounds serve as adjuvant.
It seems that the authors mention the use of lactobacilli as "adjunct to
clindamycin therapy". It can be defined also as "supplementation of clindamycin
therapy by lactobacilli".
2)The concern of Prof. Reid about the rationale for repeated therapy is true and
still not clear in the last version of the paper. It seems that the AIM of the study
has to be rephrased by authors for increased clarity showing the repeated
supplementation with lactobacilli during 3 months after initial therapy.
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Major Compulsory Revisions (that the author must respond to before a decision
on publication can be reached)
1)The title of the paper is inappropriate ( see comment 1 for "adjuvant")
2)The possible new version for AIM:
"The primary objective of this study was to investigate if supplementary
lactobacilli treatment could improve the initial cure rate after vaginal clindamycin
therapy, and secondly, if lactobacilli as repeated adjunct treatment during 3
menstrual cycles could lengthen the time to relapse after initial cure.
3)In methods section the 3 times for 10 days administration of lactobacilli has not
clearly shown though it has been stated in Abstract.
4)Conclusion - the more precise statement is necessary according to the
rephrased AIM.
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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)
The English language revision is necessary.
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Discretionary Revisions (which the author can choose to ignore)
All the other concerns of Reviewer 2 have been sufficiently answered by authors
and can be considered as scientifically well disputable.
What next?: Accept after minor essential revisions
Level of interest: An article of importance in its field
Quality of written English: Needs some language corrections before being
published
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I declare that I have no competing interests'
M. Mikelsaar