Hi.  I'm Nancy Mohrbacher, and this is my first post to Lactnet,
although I've been receiving and reading it for many years.  I am
co-author of The Breastfeeding Answer book.  (Thanks to all of you whose

posts helped inspire some of the changes in the new edition!)  Since
January of this year I've been employed as an LC in the Education
Department at Hollister, maker of the Ameda breast pumps and distributor
of the Ameda ComfortGels (previously Kendall Maternimates) and Lansinoh.

I'm writing to respond to Sue Huml's recent post about the Dodd and
Chalmers JOGNN study on Maternimates (Sue is a dear and old friend of
mine.) .  I had the pleasure of getting to know one of this study's
authors, Kate Chalmers, and contacted her for her response to some of
Sue's comments.  Kate gave me permission to post her comments and to
clarify aspects of the study that were in question.

As background, prior to taking my current position, I was in private
practice for 10 years in the Chicago area and saw hundreds of mothers a
year. My own experience with hydrogels (which I had been recommending
since 1997) was universally positive.

About 99% of the women I saw reported that their pain was instantly
diminished when they applied a hydrogel (more so than when they used
Lansinoh, which I also recommend).  With the hydrogels in place, they
could wear their bras and regular clothes with little to no discomfort.
Of course I was  clear with the mothers that the hydrogels would not
"cure" sore nipples by themselves.  But they were a wonderful boon as we
worked to correct the cause of the trauma.

Because they cut the pain, mothers were more willing to put the baby to
breast as their nipples healed.  In my experience, when a mother is not
highly motived to breastfeed or has a low pain threshhold, having to
deal with pain may be enough to convince her to quit breastfeeding, even
when she knows the problem is fixable.

Of course, the central issue that has caused many of us to question the
use of these products is whether they contribute to a higher rate of
infection, as the 1998 Brent study indicated.  However, the Brent study
was cut short, which compromised its statistical significance.  Also, it
did not clearly describe the hygiene used, making it difficult to gauge
whether the Elasto-gel hydrogel (a precursor of Soothies, with identical

composition) was a contributing factor or whether less-than-optimal
hygiene could have also contributed to the higher rate of infection in
the hydrogel group.  In the years I recommended hydrogels, I did not
notice more infections among the mothers who used these products.  So I
was anxious to see what other studies would find.

Regarding the issues Sue raised about the Dodd and Chalmers study, Kate
Chalmers (one of the authors) writes:

"In the northeast, especially in Boston, it was common practice at the
time of this study for ALL mothers to be discharged with a tube of
Lansinoh from the hospital. This did have impact on the design of the
study and that was why Victoria and I chose to use all mothers, not just
those with sore nipples - many nurses were under that impression that
lanolin "prevents" sore nipples.

"Regarding the Brent study, the sample size was much smaller not
reaching statistical power and was halted due to infections in the
hydrogel group. These were women more at risk for infections since they
already had nipple trauma, and we were trying to improve the
generalizability of the study results, thus including a wider audience.

"We chose primips since we needed to have some entry criteria and this
is the easiest way to standardize the subjects.  We also chose only
vaginal deliveries. I stand by the study design as compared to the
literature search and the design of available studies at the time this
project was undertaken. Since these women had no prior breastfeeding
experience, that eliminated a major bias.

"I think we were very clear that the infection rate was no higher than
expected in the general breastfeeding
population.

"Of interest, and seems to be lost in Susan's response is the fact the
women tended to continue to use the lanolin much longer, weeks longer.

"I would also like to make it clear that although the study was 'funded'
by Tyco, this was in the way of supplies. The researchers were
compeletely independent in their decisions regarding study design,
implementation and analysis.  No information from the study results has
been excluded from the
article and the researchers in no way want to imply preference of one
item over the other.

In clinical practice, both researchers currently support a three tier
approach to sore nipple management which includes education, positioning
and latch assessment along with liberal use of expressed breast milk as
first line, purified lanolin for complaints of soreness next and
hyrdogel dressings for actual breakdown.  This is supported in the wound
literature in regards to the effect of temperature in wound healing."

I also asked Kate to clarify some of Sue's other points, which she was
happy to do.

1)  The women in the study were only provided with enough Lansinoh and
hydrogels for a short period, so as not to influence the duration of
use. (Giving unlimited free samples would encourage longer use.)  After
the initial 3-day sample of Lansinoh was used, the mothers had to go to
the store to buy more if they wanted to continue using it. Same with the
hydrogel group.

2) Kate and Victoria debated about whether or not to bring in more
researchers to allow for a "blinded" data collection period.  However,
reliability decreases as more people become involved, and the questions
asked to both groups were identical.  So they chose to limit the number
of interviewers in an effort to increase study reliability.

3) The mothers were randomized to the two treatment groups by picking a
blank envelope, which contained a piece of paper with the assigned
treatment (Lansinoh or Maternimates) written on it.

4) Although a woman didn't have to have sore nipples to join the study,
a majority did.  Hospital nurses referred mothers to the study when they
reported nipple soreness during their hospital stay.

5) All mothers in the study had a one-hour basic assessment covering
latch and had the choice to participate in the study or not.

6) All the women were exclusively breastfeeding upon enrollment and said
that they planned to continue.  At each interview, they were asked if
they were still breastfeeding and when was their most recent
breastfeeding. Since the study continu ed for 72 days, some women did
stop (for common reasons, such as
returning to work), but the majority were still mostly breastfeeding at
the end.

7) Regarding the "funding" of the study, as Kate said, Tyco simply
provided products.  Two separate internal review boards (IRBs) at the
two hospitals where the study took place reviewed the study design to be
sure it was completely objective. Both IRBs approved it.  Kate noted
that it is very difficult to get
approval for any studies that include pregnant women or children.

Kate also mentioned that the reason the authors comments are, as Sue put
it, "lost at the end of the study" is that in a study, author comments
are traditionally confined to the "discussion" or "conclusion" section
at the end. It is not appropriate for an author to begin a study with
their opinions.  Even less so to include
them in the "methods" and "results" section of a study, which are closer
to the beginning. Although authors' comments are at the end, as someone
who reads a lot of studies, I can tell you that most study readers begin
by "cutting to the chase" and reading the discussion or conclusion
section first, so they can determine whether the authors' opinions are
borne out by the study itself.

I believe that this study gives us enough information to consider this
product an evidence-based intervention for sore nipples.  I hope this
helps clarify, and I apologize for my long-windedness. Anyone with more
questions or comments can feel free to write to me
personally.

Nancy Mohrbacher, IBCLC
Chicago suburbs, Illinois USA
where we are enjoying crisp autumn weather, my favorite time of year!

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