Reviewer's report
Title:Intravaginal practices and Lactobacilli colonization among women and risk
of sexually transmitted infections in Accra, Ghana
Version:1Date:1 February 2015
Reviewer: Abigail Norris Turner
Reviewer's report:
General comments
This paper has at least three significant flaws. First, the authors repeatedly
discuss how a given factor (in this case, IVP or the lack of lacto sp) “impacts” or
“affects” the “risk” of an outcome. These terms are inappropriate for a
cross-sectional analysis where one cannot determine if the factors of interest
occurred before, after or at the same time as the outcome under study. The
problem emerges as early as the title of the manuscript and occurs repeatedly in
every section. Second, the authors are not quite up to date on current
understanding of Lactobacilli sp. In short, not all lacto are created equal – some
species are associated with vaginal health, some with the transition from health
to disease or disease to health. Some produce H2O2 but some do not, and
therefore they do not impact vaginal pH. It does not appear that the authors
attempted to distinguish between lacto species in their characterization of which
bacteria were colonizing the vagina. Third, the authors present their findings
about IVP all in the context of vaginal pH – that IVP decrease presence of lacto
sp, which consequently increases vaginal pH, which consequently increases risk
of STIs. STI risk clearly relates to more factors than just vaginal pH; especially in
light of the point above that not all lacto sp produce lactic acid and therefore
modulate vaginal pH, the authors might consider framing their findings more
expansively than just focusing on IVP and vaginal pH.
Specific comments
Abstract
1. Line 25. The function of lactobacilli is not to maintain low vaginal pH. This is a
consequence of the existence of some lacto species in the vagina, but it is not
their “function.”
2. Line 26. Vaginal pH is one of many factors related to women’s susceptibility to
HIV and STIs. The mechanism through which BV increases HIV risk is not yet
fully understood. pH is one hypothesized mechanism, but it is far from confirmed
as the key to increased HIV susceptibility, as is suggested here.
3. Line 28. Risk cannot be assessed in a cross-sectional study.
4. Line 30. Please specify that this study was a single-site project.
5. Line 33. Typo – ‘be’ should be ‘by’
6. Line 26. Why is Douching capitalized? Was this practice clearly described to
participants? In our own work on this topic we found that “douching” as a term
was confusing to participants, and did not always refer to the same practice
typically connoted by that word in Western contexts.
7. Lines 37-40 – please use a consistent number of decimal places when
reporting results, either rounded to whole integer or to one decimal place. This is
true in abstract and results section of main text.
8. Line 39. “Clinical history of candidiasis” – when I read this I assumed you
mean a self-reported history of past candidiasis. Having read the full paper I now
think this refers to candidiasis detected at the study visit. Please clarify in the
abstract if you are referring with these percentages to past or current, prevalent
infections.
9. Line 45: please clarify what is meant by “uncontrolled engagement.” Do the
authors recommend instead “controlled engagement” and if so, what does that
look like?
10. Line 45-46: “…engagement of these practices over time represent a risk of
adverse health effects…” The conclusions of the abstract should follow directly
from the findings of the study being presented. This study did not examine the
effect of these practices over time, and thus it is inappropriate for the conclusion
section of the abstract to make this statement.
Background
11. Line 75: L acidophilus is not a primary vaginal commensal. L. iners, L
jensenii, L. crispatus and L. gasseri are the most frequently occurring vaginal
lactobacilli. Please update the background to more current information on this
topic.
12. Line 98: “… soaps, detergents and antiseptics … can cause chemical
imbalances that could lead to increase in the vaginal pH…” I am not aware of
studies which have actually measured vaginal pH before and after use of these
products. (Please cite them if they exist). It may be the case that these products
“cause chemical imbalances,” but if there is no published reference supporting
this claim, it should be made more clear that this idea is only speculative.
13. Line 102: “In light of the problems associated with sexually transmitted
infections…” Please provide more context for what problems the authors are
talking about. Or are you referring to the problems associated with IVP? In any
case, please be more specific about the problems being referenced (including
citations).
14. Line 106: Cannot assess possible effects of lacto sp on STI acquisition in a
cross-sectional study. Cannot assess “effects” or “acquisition” in a
cross-sectional study.
15. Line 106: As above, some lacto sp are beneficial to vaginal health and some
may not be. The simplification of calling all lacto sp “beneficial” is misleading.
Methods
16. Line 114: Cannot assess STI risk in a cross-sectional study.
17. Line 115: What were the inclusion criteria?
18. Line 118: If 141 enrolled, how many women were approached? What were
the reasons that approached women did not enroll?
19. Line 119: Description of the questionnaire suggests it was self-administered.
Please clarify. In addition, in the Discussion, please assess the potential bias
resulting from a self-administered survey – presumably women with low literacy
or numeracy were not able to provide the same quality of data as more educated
women. The sample is highly educated – is this because it was necessary to be
capable of self-administering a survey?
20. Line 123: “women on prescribed contraceptive usage were excluded.” What
specific methods are included in “prescribed contraceptive usage”? Given known
associations between contraception and lacto/BV, in the Discussion please
discuss the implications of this exclusion decision for the observed findings and
their generalizability to other populations.
21. Line 126: what are “yeast-like cells” and how does this differ from yeast?
22. Line 128: The current language suggests that microscopic observation of
STI/RTI pathogens was considered “evidence of indulging in” IVPs. This seems a
very great leap to make. Presence of STI pathogens is much more likely
evidence of having sex with someone with an STI, not evidence of “indulging”
(also a peculiar word choice) in IVPs.
23. The diagnostic approach used to detect STIs (microscopy) lacks sensitivity
for several of the outcomes, most importantly trich and gonorrhea. This limitation
should be noted in the Discussion.
24. Lines 135-146: Please provide peer-reviewed references for culture methods.
Results and Discussion
25. Line 164: in addition to describing who enrolled, please say more about who
did not enroll (see #18 above)
26. Who attends this specific KBTH clinic? Are these women referred by specific
providers? Are they unique in any way to be sent to this particular clinic? The
prevalence of RTIs and the education level of participants would seem to suggest
that this is not a generalizable sample. (See also #32 below).
27. Lines 175-178: please use a consistent number of decimal places when
reporting results, either rounded to whole integer or to one decimal place (see
also #7 above).
28. Line 186: The authors discuss syphilis, but neither blood collection methods
nor syphilis diagnostic methods are discussed.
29. Line 197: “The low level of lactobacilli detection and the high number of
confirmed cases of vaginal infections … thus implicates intravaginal practices as
indeed the harmful cause ….” This is simply not true. In a cross-sectional study,
the authors cannot make any claims of causality.
30. Line 209: A small point, but that women need education on “safe methods of
maintaining vaginal health” is not clear, rather, they may need education on
cessation of practices that may actively disrupt vaginal health. The authors’
current wording suggests that actions should be taken (which is not supported by
any evidence I am aware of) versus actions that should be avoided (which is
what current evidence – not in this paper, but in other research – does support).
31. Line 216: “… a considerable record of vaginal infections” – unclear what this
means. What threshold constitutes “a considerable record”? As above, the high
STI/RTI prevalence cannot be attributed to IVP, given limitations in the study
design. But even if the temporality of this association was supported by the study
design, the extremely high prevalence of RTIs is very unlikely to be due to IVP
only, which past research has shown to have fairly modest effects on vaginal
flora (in particular since the vast majority of participants in this study reported
using water only, or water plus soap, for IVP. In addition, given that all women in
the study engaged in IVP (see #35 below), the authors have no non-IVP
population to compare to. Thus they cannot claim that women doing IVP have
higher prevalence of STIs/RTIs than women not reporting IVP, since the latter
women are not included in this study.
Acknowledgements
32. Line 240: The authors thank someone for her role in sample collection in the
emergency room. Nowhere in the methods is it stated or suggested that women
were recruited from the emergency room. By referencing the Dept of Ob/gyn, the
authors imply that women were recruited from a setting other than the
emergency room. Please clarify in the Methods.
References
33. Ref 3 is Torok M, not Torok R
Table 2
34. Legend: refers to “intravaginal participants,” but surely the authors intend to
say “intravaginal practices”
35. The legend states that all women engaged in intravaginal practices. This is
not clear from Table 2. Please add a row to Table 2 showing the number and
percentage reporting no IVP (presumably it will be 0 and 0%, but this will clarify
for the reader; see #31 above). If participation in IVP was a requirement for study
eligibility, this should be made clear in the Methods.
36. Was any effort made to correlate specific IVP practices with RTI/STI? The
authors gathered information on a range of behaviors which could have different
effects – some quite abrasive (theoretically) and some quite mild. Yet there
appears to be no effort to look at the associations of these behaviors with any of
their STI/RTI outcomes.
Level of interest: An article of limited interest
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.