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What are your recommendations and how do they compare to current guidelines for hormone replacement therapy in women?
Our recommendations are the same as those of the The Society of Obstetricians and Gynaecologists of Canada, The American College of Obstetricians and Gynecologists, and the U.S. Food and Drug Administration (FDA). We all agree that the guiding principle of hormone replacement therapy is to use the lowest possible dose for the shortest period of time to ease symptoms.
How do you ensure the lowest possible dose?
Assessment – In our Body Chemistry Balancing test, we investigate hormone levels, as well as a multitude of biochemical and nutritional factors that influence the way
hormones work in a woman’s body. This assessment allows us to see
which hormones may be helpful, or to see if hormones are needed at
all. Often there are underlying biochemical issues that can affect
menopausal symptoms, such as low iron, adrenalthyroid function,
digestive problems, low magnesium and , or neurochemical imbalances. Once
these issues are identified, the body chemistry imbalance can be
corrected, and hormone therapy may not be required.
Route of Administration – Due to what is known as the “first
pass effect”, our liver selectively detoxifies anything we foolishly
put in our mouth that may have toxic properties. When hormones are
given orally, higher doses are needed in order to counteract this first
pass effect (1). When hormones are given through the skin, it bypasses
this step, and doses ten times less than what is given orally can be
used. Achieving the lowest dose is therefore easiest by giving
hormones through the skin.
Selection of Hormone – Human identical hormones, or
bio-identical hormones as they are more commonly called, have been
shown to be effective for a variety of menopausal symptoms. With
synthetic hormones, which look and act differently than human hormones,
years of work go into establishing toxicity profiles because something
foreign is being put in the body. Since the biochemistry of human
hormones and how they function in the body is well-known, toxicity
profiles don’t have to be re-established. The key to achieving the
lowest and safest dose with human identical hormones is to stay within
physiological ranges. When it comes to choosing which hormone to use,
progesterone in particular, has demonstrated effectiveness for
relieving several menopausal symptoms, including hot flashes, insomnia,
anxiety and mood issues (2-5).
What is the safest product for vaginal dryness?
There is no question that estrogens, used locally, are effective for
perimenopausal and menopausal women to relieve vaginal dryness, and
help with bladder control and other urinary tract issues. However,
concern should be raised when a product such as Premarin is used
topically or vaginally in equivalent doses to that used orally. This
results in unnecessarily high doses of estrogen in the body and does
not follow the guiding principle of using the lowest dose possible for
the shortest period of time to relieve symptoms.
Topical and vaginal estrogens have much higher bioavailability (up to
10x higher) than oral doses (6). Human estradiol has been shown to be
effective for vaginal dryness and bladder issues. However, controlled
studies have shown estriol to have very high rates of success when used
to treat vaginal dryness, urinary tract infections, vaginal irritation,
and bladder problems and improve overall vaginal health (7-14). As an
added advantage, estriol is a weaker estrogen than estradiol and
contributes less systemic estrogen activity. Estriol, when given
vaginally, has been reported to be safe for the endometrium (15-17) and
is not associated with an increased risk of breast cancer (18-19).
The base that the hormone is placed in is important. Our product
Nutriplens was designed to replicate natural vaginal secretions.
Primrose oil, which has been shown to help with skin dryness (20-22),
is used as the oily phase in Nutriplens. A good base of primrose oil
to help with dryness allows the use of less total estriol dosage and
therefore follows the guiding principle of providing hormones at low
doses to alleviate symptoms.
What are the benefits of compounding?
If we continue to follow the guiding principle of “lowest possible dose
for the shortest possible time to ease symptoms”, then compounding or
individualizing the dose is the safest and simplest way to achieve
these goals. As discussed in the example on vaginal dryness, we can
manipulate the base formula and the amount of hormone to the lowest
dose so that a woman gets symptom relief. We’ve learned the ‘one size
fits all’ approach of the past has created a lot of problems.
Compounding provides a very safe approach, if a woman does indeed need
hormones.
References
1. Sitruk-Ware, R. (2007) New hormonal therapies and regimens in the
postmenopause: routes of administration and timing of initiation.
Climacteric 10: 358-370.
2. Leonetti HB. et al. (1999) Transdermal progesterone cream for
vasomotor symptoms and postmenopausal bone loss. Obstet Gynecol
94(2):225-228.
3. Montplaisir J., et al. (2001) Sleep in menopause: Differential
effects of two forms of hormone replacement therapy. Menopause
8:6-10.
4. Cummings J., Brizedine, L. (2002) Comparison of physical and
emotional side effects of progesterone or medroxy progesterone in early
postmenopausal women. Menopause 9:253-263.
5. Fitzpatrick L., et al. (2000) Comparison of regimens containing
oral micronized progesterone or medroxyprogesterone acetate on quality
of life in postmenopausal women: a cross-sectional survey. J Womens
Health Gend Based Med 9:381-387.
6. Head, K.A. (1998) Estriol: Safety and Efficacy. Alt Med Rev 3(2): 101-113.
7. Barentsen R, et al. (1997) Continuous low dose estradiol released
from a vaginal ring versus estriol vaginal cream for urogenital
atrophy. Eur J Obstet Gynecol Reprod Biol 71:73-80.
8. Bottiglione F, et al. (1995) Transvaginal estriol administration in
postmenopausal women: A double-blind comparative study of two
different doses. Maturitas 22:227-232.
9. Casper F, Petri E. (1999) Local treatment of urogenital atrophy
with an estradiol-releasing vaginal ring: A comparative and a
placebo-controlled multicenter study. Vaginal Ring Study Group. Int
Urogynecol J Pelvic Floor Dysfunct 10:171-6.
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estriol on urogenital aging in postmenopausal women. Menopause.
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11. Dugal R, et al. (2000) Comparison of usefulness of estradiol
vaginal tablets and estriol vagitories for treatment of vaginal
atrophy. Acta Obstet Gynecol Scand 79:293-7.
12. Henriksson L, et al. (1994) A comparative multicenter study of the
effects of continuous low-dose estradiol released from a new vaginal
ring versus estriol vaginal pessaries in postmenopausal women with
symptoms and signs of urogenital atrophy. Am J Obstet Gynecol 171:
624-32.
13. Lose G, Englev E. (2000) Oestradiol-releasing vaginal ring versus
oestriol vaginal pessaries in the treatment of bothersome lower urinary
tract symptoms. BJOG 107:1029.
14. Raz R, Stamm WE. (1993) A controlled trial of intravaginal estriol
in postmenopausal women with recurrent urinary tract infections. N Engl
J Med 329:753.
15. Iosif, CS. (1992) Effects of protracted administration of estriol
on the lower genito urinary tract in postmenopausal women. Arch
Gynecol Obstet. 251(3): 115-20.
16. Weiderpass, E. et al. (1999) Low-potency oestrogen and risk of
endometrial cancer: a case-control study. Lancet. 353(9167):1824-8.
17. Vooijs GP, Geurts TB. (1995) Review of the endometrial safety
during intravaginal treatment with estriol. Eur J Obstet Gynecol
Reprod Biol. 62(1):101-6.
18. Rosenberg LU. et al. (2006) Menopausal hormone therapy and other
breast cancer risk factors in relation to the risk of different
histological subtypes of breast cancer: A case-control study. Breast
Cancer Res 8:R11.
19. Lyytinen H, et al. (2006) Breast cancer risk in postmenopausal
women using estrogen-only therapy. Obstet Gynecol 108:1354.
20. Yoshimoto-Furuie, K., et al. (1999) Effects of oral
supplementation with evening primrose oil for six weeks on plasma
essential fatty acids and uremic skin symptoms in hemodialysis
patients. Nephron 81(2):151-9.
21. Morse, P.F. et al. (1989) Meta-analysis of placebo-controlled
studies of the efficacy of Epogam in the treatment of atopic eczema.
Relationship between plasma essential fatty acid changes and clinical
response. Br J Dermatol. 121(1):75-90.
22. Schalin-Karrila, M., et al. (1987) Evening primrose oil in the
treatment of atopic eczema: effect on clinical status, plasma
phospholipid fatty acids and circulating blood prostaglandins. Br J
Dermatol. 117(1):11-9.
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