|
| |
|
Natural Progesterone
There has been much interest in the
effects of natural progesterone cream after
observational data from the USA suggested it
could prevent bone-loss in post-menopausal
women and stimulate bone formation. We have
been concerned for some years that many
women are using these creams to prevent or
treat osteoporosis without good supporting
evidence that they are effective.
In this study, rubbing progesterone cream
into the skin at these doses was unable to
influence bone-loss significantly. Other
results from the study suggested a trend
that progesterone cream may be helpful in
improving hot flushes and sweats in some
women, compared to the placebo, although
this was not as effective as HRT.
This is now the second placebo-controlled
study to show that progesterone cream, used
as recommended by the standard instructions,
is not effective in preventing bone-loss in
post-menopausal women. It therefore should
not be considered a therapy for the
prevention or treatment of osteoporosis.
Research finds progesterone creams do not
halt bone loss
During the first year of the study at the
Southampton Osteoporosis Research Unit into
natural progesterone creams post-menopausal
women were picked at random to use either a
quarter of a teaspoon of the progesterone
cream twice a day (40 mg progesterone) or an
identical looking placebo cream. In the
second year the progesterone cream group
used half a teaspoon twice daily while the
placebo group started to use a quarter of a
teaspoon of the active cream twice a day.
This second group was also given a
comprehensive vitamin and mineral
supplement.
For comparison, there was also a separate
group of 14 women allocated to take hormone
replacement therapy (HRT) using a skin
patch, who underwent the same procedures as
the cream groups. All the women were
encouraged to eat healthy diets high in
dairy calcium, fruit and vegetables and to
follow the general lifestyle advice
recommended by the NOS.
At the end of the first year, DXA scans
of the lumbar spine showed that both groups
using the active and placebo creams showed a
similar loss in bone density, compared to
the women using the HRT patch who showed an
increase in their BMD.At the end of the
second year, bone loss in the lumbar spine
had continued in both the active cream
groups, compared to a further increase in
BMD for the women on HRT.
Measurements of bone-turnover markers
showed no change in the progesterone groups
compared to a suppression of turnover in the
HRT group, further confirming the BMD
findings. Other results from the study
suggest a trend that progesterone cream may
be helpful in improving hot flushes and
sweats in some women, compared to placebo,
although this trend was not as strong as
shown with HRT.
Source: National Osteoporosis Society
Online located at
http://www.nos.org.uk/researchupdate.asp |
|
Does
natural progesterone cream build bone?
One of progesterone cream's strongest
proponents, Dr. John Lee, claims that
progesterone cream actually reverses
osteoporosis. However, he has published only
one study in a medical journal. Although he
reports that the women who used progesterone
cream had increased bone density, he doesn't
indicate whether they were also taking
estrogen -- which has been proven to
increase bone density. In other words, it's
likely that the positive effect was due to
estrogen, not progesterone cream. A few
randomized studies have been conducted and
none have found that progesterone cream
increases bone density.7,8
The
nature of natural progesterone creams
The creams are formulated from a vehicle
-- a "base" of a fatty or oily substance --
and the active agent -- in this case,
micronized natural progesterone. Micronized
natural progesterone is extracted from
diascorea, a variety of wild yam, and as
such is considered a supplement rather than
a drug and therefore does not require FDA
approval. The creams are produced by
compounding pharmacies, which make their own
prescriptions rather than dispense products
manufactured by drug companies. As a result,
the creams aren't standardized, and there is
no guarantee of the amount of progesterone
in a cream. Nor is there much information
about a cream's effectiveness, because the
pharmacies aren't required to conduct
clinical trials to test the product.
source: Susan Love MD--The Website for
Women
Susan
Love MD-Frequently Asked Questions-Natural
progesterone cream
|
|
from
Medscape Ob/Gyn & Women's
Health
Question
Is there a role for natural
progesterone in osteoporosis
prevention?
Response from Ego Seeman,
MD, PhD
Professor, The University of
Melbourne, Melbourne,
Victoria, United Kingdom
No. The questions of why
treat, whom to treat,
and what drug to choose
are fundamental. Why
treat is
straightforward. The
purpose of treatment is
to prevent the morbidity
and mortality associated
with fractures. Whom and
when to treat is
complex, and I will not
deal with this here. The
final question is drug
choice, and this is the
subject of your
question. The answer is
easy if we stick to the
rules of evidence-based
medical research, which
provide clarity, but is
complex if we break
these rules. In terms of
osteoporosis prevention,
the rules are that drugs
must be shown to reduce
the risk of fracture in
properly designed,
executed, presented, and
interpreted clinical
trials. If this is not
done, the drug may well
be efficacious, but the
evidence is not there
one way or another, so
the decision of whether
to prescribe the drug
will be according to
feeling-based medicine
or opinion-based
medicine but not
evidence-based medicine.
What are the rules of
engagement? Inferences
at the end of papers are
always made by authors,
but the validity of the
inference cannot be
deduced unless the rules
are followed and the
data are presented
transparently.
The studies must be
double-blind and
placebo-controlled; they
must involve large
sample sizes and have
few drop-outs; the end
points should be numbers
of persons with
fracture, not numbers of
fractures. The primary
end points must be
predefined and analysis
carried out by intention
to treat, not post hoc
-- ie , the data are
examined until something
with statistical
significance (P <
.05) is squeezed out of
the data and presented
as if it was planned
before the study was
done. Finally, and
perhaps most important,
is reproducibility and
consistency; the studies
should be done by
different investigators
in different parts of
the world and the same
result observed. Not
following these rules
fosters confusion. Most
studies don't fulfill
all of these criteria,
but the best studies
follow most. The best
studies we have to date
are those of alendronate,
risedronate, raloxifene,
parathyroid hormone,
and, more recently,
strontium ranelate (the
latter results have been
presented but are
unpublished at this
time). The quality of
the data for other drugs
such as calcitonin,
etidronate, menopausal
hormone therapy, vitamin
D metabolites, and
calcium is not as
compelling so that
inferences are much more
difficult to make --
they are made to be
sure, but the rules of
engagement are
incompletely satisfied.
So, that's why the
answer to your question
is no. I have no idea
whether natural
progesterone reduces the
risk of fracture --
there are no studies to
answer this question.
So, should you use the
drug? In my opinion, a
resounding NO.
|
|
|
progesterone
cream fails to stop bone disease
A hormone cream used by women to
prevent the bone disease
osteoporosis has been shown to be
ineffective in tests. Researchers
carried out a year-long study into
natural progesterone cream, which
observational studies had previously
shown improved bone health after the
menopause.
Results of the study were
presented to the National
Osteoporosis Society (NOS) annual
conference in Bath, the leading UK
conference on the condition, where
bones crumble and fracture easily.
The lack of estrogen women suffer
after the menopause means they are
more at risk of losing bone density
and developing osteoporosis. Women have chosen the cream as a
natural alternative to hormone
replacement therapy (HRT). The
Osteoporosis Research Unit at
Southampton University carried out a
randomised trial to compare HRT, the
progesterone cream and a placebo
version. Only the group taking HRT saw
their bone density increase. Though
progesterone creams are not available
over the counter in the UK, women can
still buy them in European countries or
the US, or on the Internet.
Informed choice
Fifty-three healthy women aged
between 52 and 65 took part in the
study. Twenty-one were given a quarter
teaspoon of progesterone cream, and
twenty-one the same amount of a placebo
cream, to rub into their skin twice a
day. The remainder were given an HRT
patch. Bone density at the spine and
hip was measured, and blood and urine
levels checked to monitor the cream's
effects. Bone density in the HRT group
increased by about 5%, while women using
both the progesterone cream and the
placebo lost around 2.5%.
Professor Cyrus Cooper, director of
the osteoporosis service at Southampton
University told BBC News Online the
research had shown "unequivocally" that
the creams did not work.
He said: "These data suggest that
natural progesterone cream at these
doses do not prevent post-menopausal
bone loss and cannot be viewed as an
alternative to HRT for this purpose."
Professor Cooper added there was no
indication the creams did any harm, and
there were some indications they could
be beneficial in terms of reducing
severe menopausal symptoms such as hot
flushes and night sweats.
Alternative treatments
Jackie Parrington, a nurse manager
with the NOS, said: "The NOS helpline
nurses take numerous calls from women
interested in natural progesterone cream
and wanting to know if it is going to
protect their bones. "This research
will help women make a more informed
choice about the treatment."
Dr Val Godfrey of the Amarant Trust,
which offers women advice on the
menopause and HRT, told BBC News Online:
"I'm not at all surprised by these
results." She said previous work done
by the trust had also indicated the
creams failed to prevent a loss of bone
density.
Dr Godfrey said many women did not
want to take HRT, and went for the
creams as the 'natural' option, even
though doctors could prescribe other
non-hormonal treatments. "Hopefully,
these findings will encourage women to
ask questions a bit more," she said.
|
|
|
|
Young People Get Osteoporosis Too Organization
Copyright © 2001 All rights reserved.
Revised: 03/11/08.
|
|
