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From:
Ameda LC <[log in to unmask]>
Reply To:
Lactation Information and Discussion <[log in to unmask]>
Date:
Thu, 2 Sep 2004 10:53:07 -0500
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Nikki and all,
It is true that the Blair study showed no decrease in pain or increase in
healing in mothers using Soothies or Lansinoh and that the results were
comparable to the mothers who used no product.  The Dodd and Chalmers
study looked at a different product--a water-based hydrogel rather than a
glycerin-based hydrogel.  And mothers *did* report greater reduction in
pain as compared with the group using Lansinoh and used the hydrogel for a
signficantly shorter time than the mothers using Lansinoh.

The Dodd and Chalmers study was missing a "no product" group, even though
one was included in the original study design.  When the study was brought
before the two institutions' Internal Review Board, they decided that a
"no product" group was unethical.  They explained that if a product exists
that decreases women's pain during breastfeeding, it would be unethical to
withhold it and risk premature weaning.

To clarify, the Dodd and Chalmers study is not a "Hollister study," as it
took place before Hollister purchased this product for distribution.

Also to clarify, the women I described as being "gun-shy" were not those
in the study.  These were the mothers I saw in my practice, who even after
a 2-hour home visit, unlimited phone follow-up, and the option of seeing
me again, tended to use the products longer than truly "necessary," just
to be on the safe side.

Once a mother experiences moderate to severe nipple pain, I think that's a
natural reaction. And frankly, I didn't see anything wrong with that if it
keeps them breastfeeding.  Especially when the product is consistent with
"first do no harm."

The Dodd and Chalmers study followed women by phone for up to 72 days to
determine if any mothers developed infections (yeast or bacterial) as a
result of using these products.  None of the mothers using the water-based
hydrogel developed infections (even those in Alabama!) compared with 8 in
the Lansinoh group.  The infections in the Lansinoh group reflected an
average incidence of infection and was not assumed to be caused by
Lansinoh.

I share your sadness, Nikki, that women do not breastfeed exclusively and
that pacifier use contributes to breastfeeding problems.  I agree with you
that products are no substitute for good breastfeeding education.  (The
Duffy 1997 study we discussed in previous LN posts found that one class
CAN have a significant effect on nipple trauma AND breastfeeding
duration.)  In my experience hydrogels can be a helpful addition to good
education and help.

Ros Escott, an Australian LC I greately admire, suggests we consider using
a three-pronged approach to nipple treatment:  1) Remedy the underlying
cause of the nipple damage, 2) Offer symptomatic relief, and 3) Assist in
the restoration of skin integrity.  Hydrogels can help with both 2) and
3).  Research on water compresses is far more mixed.  (I'd be glad to
share references.)

I agree that mothers should receive all the education and services they
need to succeed at breastfeeding.  I know from first-hand experience
during my 10 years in private practice how many mothers "fall through the
cracks" after they leave the hospital.  Improvement is desperately needed
in this area.

Nancy Mohrbacher, IBCLC
Lactation Education Specialist, Hollister, Inc.
Distributor of the Ameda ComfortGels researched in the Dodd and Chalmers
study



    Another study that studied hydrogel and lanolin was the Blair study,
published last year in Breastfeeding Review Vol11(2) 2003 ("The
relationship
between positioning, the breastfeeding dynamic, the latching process, and
pain in
breastfeeding mothers with sore nipples"); the same authors (Blair,
Cadwell,
Turner-Maffei et al) also published "Pain Reduction and Treatment of Sore
Nipples in Nursing Mothers" in J Perinatal Ed 13(1) 2004, 29-35.
    Mothers in this study found hydrogel to be more soothing to nipple
soreness than lanolin cream and shells, although the difference wasn't
significant.
However, a key part of the Blair study was that there was a third group
that
used no product at all, and received only assessment, education and
corrective
interventions. All groups received assessment, education and corrective
intervention. All were exclusively breastfeeding.
    The results of this study showed that all groups had  reduction in
nipple
soreness and improvement in nipple healing. There was no significant
difference between the groups, meaning that products made no more
difference in
resolution of soreness and improvement in healing than only improving
latch and
positioning.
    If mothers are not educated and supported in learning about correct
positioning, wouldn't it be natural for them to assume that it is the
product that
makes the difference? Wouldn't that explain them purchasing product for a
month after delivery? Wouldn't that explain them being "gun-shy" about
breastfeeding without product?
    What the Hollister study does show is that a one-hour prenatal
breastfeeding class is insufficient to prevent nipple soreness, no matter
who teaches it.
    I am saddened that the assumption in the Hollister study is that
mothers
can't receive "extensive breastfeeding education" once their baby is born.
The
authors of that study ask, "Although certainly ideal, is extensive patient
education truly realistic in today's health care setting?" (p.492)
    Do we accept that good education in other situations in hospitals,
such
as with dressing changes and ostomies is not realistic and provide
alternatives
to good care? This is a rationale behind overuse of nipple shields.
    Mothers in the Blair study all had nipple soreness to begin with;
mothers
in the Hollister study were enrolled because they were breastfeeding and
assumed to become sore.
    It is also sad to accept that mothers don't breastfeed exclusively and
that they use pacifiers routinely. While we know those things are true, I
believe that all of us here are working to make a difference in both those
conditions. Is the answer is for mothers to buy product, and be ignorant
of all the
factors that promote nipple soreness?
    A company that manufactures the product and profits from it, is not
free
of influencing the results of a study about that product. This is the
reason
for disclosure.
    At the same time, it is valuable to see that hydrogel pads now have
support from two studies showing that mothers find them more soothing than
other
methods, although neither study considered what Ziemer reported. Ziemer
found
that mothers were soothed with cool, wet compresses.



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