My very first Lactnet post was on this study and at the risk of getting
mega-flamed again, I'd like to comment.  I know one of the study's authors
and have the "inside scoop" on it.  I'd be glad to answer any questions if
you e-mail me privately.

The researchers were motivated to study this product because it had been
used in their institutions and they received positive feedback from
mothers. Neither researcher is affiliated with a commercial company.  And
although the study was "funded by Tyco," Tyco provided products and helped
defray some costs (like phone calls).  They had no influence on the study
itself.  The LCs did this research to give our field some real evidence on
which to base our recommendations.  (A randomized controlled clinical
trial is one of the best ways to do this!)

Regarding the "sore nipples are normal" idea, I know from the research and
discussions with colleagues that our field seems to be moving away from
the thinking that all nipple pain is a sign there is something wrong.  Not
long ago Jane Heinig, editor of JHL, wrote that perhaps we do mothers a
disservice by promoting this idea and suggested there may be hormonal
forces at work that are a factor in the pervasive nipple pain that is
reported in the research.  She did a study in Davis CA (breastfeeding
utopia) where moderate to severe pain (not just mild pain!) was reported
in 49% of mothers on day 3 and 36% pf mothers on day 7. These were all
mothers who had lots of LC one-on-one follow-up.

LCs in areas of the world where breastfeeding is the norm report similar
observations.  (See the quote at the bottom of p. 40 in the 2nd edition of
The Breastfeeding Atlas.)

When I sold my private practice, the LC who carried on after me said that
she was glad to be carrying hydrogels because they were soothing and
comforting to mothers and kept them breastfeeding while they were learning
to adjust their technique.  (I began using them in 1997, when the Cable
article in JHL appeared.)

Should we begrudge mothers products that they find comforting?  (The
mothers using these hydrogels were unanimous that they were comforting.)
In the 2005 (!) edition of her book, Jan Riordan and chapter co-author
Linda Smith write (p. 225) "Given the low cost of such products, it seems
insensitve to discourage the[ir]...use unless some harm has resulted."  In
this study, mothers did report less pain when they used the hydrogels and
they used them for a much shorter time than the Lansinoh (a mean of 33
days vs. 44 days with the Lansinoh).  I found in my practice that many
mothers used these products longer than they really needed to because they
were gunshy after experiencing pain.

It is true that not all the mothers were exclusively breastfeeding through
the duration of this study (although they all were at the beginning) and
pacifier use is not considered.  But I think this reflects the norm in our
culture.  So, it seems appropriate to me that these were the mothers
testing this product.

Nancy Mohrbacher, IBCLC
Lactation Education Specialist, Hollister, Inc.
Hollister is current distributor of this hydrogel, now the Ameda
ComfortGel


    JOGGN 2003; Vol 12(4):486-494 is an article "Comparing the Use of
Hydrogel Dressings to Lanolin Ointment With Lactating Mothers" that was
sent to me as
a promotion for an Ameda product.
    106 primalacta (first time breastfeeders) mothers were recruited
within
24 hours of delivery; they "had breastfed at least once" in that time.
Mothers
who had prior breastfeeding experience were excluded from the study. We
don't
know how many mothers dropped out or why. The length of the study time was
12
days, with follow-up by telephone to 72 days. While participants had
received
a one-hour class with an IBCLC, and "each infant was assess for proper
latch-on, sucking ability, and anatomical anomalies", we have no idea how
many times
infants were feeding, if they were using pacifiers, or if they were
feeding on
schedule or on cue. We don't know if they were exclusively breastfeeding
either. The control group used topical lanolin ointment; the experimental
group
used the hydrogel pads.
    "By day 72, both groups reported similar pain levels....." So the
product
doesn't cure anything, does it?
    I encourage folks to read this paper critically; obviously, I didn't
like
it. Apparently it is being used to market a product that mothers in this
study were using for over a month! There was no assessment of reasons for
nipple
pain; instead there is an assumption that nipple pain is inevitable, and
this
new product can be used for a long time to deal with the pain.
    The paper says "Demand is rising for evidence-based practice,
providing
patient care guided by scientific results." Seems to me that this concept
is
being perverted for commerical ends, at least in this paper.
    What do you all think?



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