What is Ovarian Hormone Therapy?

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This site was archived on December 31, 2002 (Why? click HERE)
It is not maintained and cannot be relied upon for up to date medical information.
Despite this, there is much useful information which is not time sensitive

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OVARIAN HORMONE THERAPY

General - risks, definition

Long term considerations

Extract from http://www.fda.gov/bbs/topics/NEWS/2003/NEW00863.html

FDA NEWS
FOR IMMEDIATE RELEASE PO3-01 January 8, 2003
Media Inquiries: 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Approves New Labels for Estrogen and Estrogen with Progestin Therapies for Postmenopausal Women Following Review of Women's Health Initiative Data

The Food and Drug Administration (FDA) today is advising women and health care professionals about important new safety changes to labeling of all estrogen and estrogen with progestin products for use by postmenopausal women. These changes reflect FDA's analysis of data from the Women's Health Initiative study (WHI), a landmark study sponsored by the National Institutes of Health that raised concern about risks of using these products.
FDA's labeling revisions are part of a series of actions to provide risk management information to women and advice to health care providers who prescribe these estrogen and estrogen with progestin-containing drug products for postmenopausal women. FDA will also be issuing updated guidances for manufacturers of estrogen and estrogen with progestin products regarding labeling of those products and development of new products for use in postmenopausal women. FDA's new labeling changes include a new boxed warning that reflects new risk information and changes to the approved indications to emphasize individualized decisions that appropriately balance the benefits and the potential risks of these products.

For the full article see the URL above

News Flash July 9, 2002
The report about the early stopping of the estrogen/progestin arm of the long-awaited "definitive" Womens Health Initiative trial
Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women included:

.......the evidence for breast cancer harm, along with evidence for some increase in C[oronary] H[eart[ D[isease], stroke, and P[ulmonary] E[mbolism], outweighed the evidence of benefit for fractures and possible benefit for colon cancer over the average 5.2-year follow-up period.

While the study did not look at perimenopausal use or formulations of hormones other than conjugated estrogens with medroxyprogesterone acete, bear in mind that such use has NOT been proved to be safe - just not (yet?)proved to be harmful.

What is it? Defining the term
NHRT
phytoestrogens The term ovarian hormone therapy is not used much other than in Canadian medical literature but it is useful because it encompasses all varieties and overcomes the considerable confusion and sloppiness in the use of the terms ERT and HRT. It also excludes consideration of non-ovarian hormones such as melatonin, and avoids the contentious term "replacement".

As a general rule of thumb, estrogen alone is only used by women who have had a hysterectomy, whereas "intact" women who still have a uterus must have a progestin added to combat the greatly increased risk of estrogen-induced endometrial cancer. Where a progestin is not used, any bleeding must be investigated with an endometrial biposy. In her book, Dr Susan Love states that on average each woman following this method must submit to 3 such biopsies. Even without bleeding, prudence dictates an annual routine biopsy.

The term HRT or hormone replacement therapy may be used to mean estrogen+progestin or it may mean estrogen only since estrogen is a hormone... Similarly ERT may be used in situations (particularly studies) when progestin is in fact added, but the speaker's interest focusses on the estrogen component. This is particularly unfortunate since the addition of a progestin not only messes up the studies, but often messes up the woman too - a fact which is conveniently omitted more often than not.

Note: Since this was originally written, considerably greater care is being taken to differentiate between the two terms, and newer studies frequently have two treatment arms - one with, one without progestin - but caution is still in order when trying to interpret what exactly is being referred to, especially with earlier material.

Alt.support.menopause (ASM) at one time (circa 1997) tried to make a comprehensive list of possible OHT and the varieties of situations a woman might find herself in. The by no means exhaustive list follows:

Surgical menopause (no ovaries and no uterus)

Horse urine conjugated estrogen only
Plant based conjugated estrogen only
Estradiol only, oral
Estradiol only, transdermal (patch)
Estrogen (usually estradiol) gel

Natural menopause (with ovaries and uterus)

Conjugated horse urine estrogen and MPA - cyclical
Conjugated horse urine estrogen and MPA - continuous

Conjugated horse urine estrogen and MPA - quarterly
Conjugated horse urine estrogen and quarterly plant based progesterone

Conjugated horse urine and plant based progesterone - cyclical (monthly)
Conjugated horse urine estrogen and plant based progesterone - continuous

Conjugated plant based estrogen and MPA - cyclical (monthly)
Conjugated plant based estrogen and MPA - continuous
Conjugated plant based estrogen and quarterly MPA

Conjugated plant based estrogen and plant based progesterone - cyclical (monthly)
Conjugated plant based estrogen and plant based progesterone - continuous
Conjugated plant based estrogen and quarterly plant based progesterone

Transdermal estradiol with MPA - cyclical (monthly)
Transdermal estradiol with MPA - continuous
Transdermal estradiol with quarterly MPA

Transdermal estradiol with plant based progesterone - cyclical (monthly)
Transdermal estradiol with plant based progesterone - continuous
Transdermal estradiol with quarterly plant based progesterone

Oral plant based estradiol with MPA - cyclical (monthly)
Oral plant based estradiol with MPA - continuous
Oral plant based estradiol with quarterly MPA
"Low dose" oral plant based estradiol

Note: the best known brand of MPA (medroxyprogesterone acetate) is Provera and is the most frequently prescribed type of progestin in North America. Other formulations such as norethindrone acetate are more likely to be used in Europe.

Since this list was made, other varieties of HRT have sprung up, including those which are a repackaging of synthetic hormonal drugs used as oral contraceptives, typically at a lower dosage level. They tend to be introduced in Europe and only later cross the Atlantic.

Other combinations of "HRT" today can also contain testosterone. This is more likely after surgical menopause.

So as Joan said at the time:

Attention to all: the word "hormones" or HRT is a meaningless term. These possibilities are NOT interchangeable. When you hear these terms, demand to know which ones, which combinations, which dosages.

In other words, ascertain:

surgical status

without uterus? - then no need for progestin.
without ovaries? - then greater need for hormones. Only in this case is the term "replacement" accurate.

type of estrogen?
continuous or cyclical?
route of administration (pill, patch, sublingual, cream)?

then repeat for progestin, and for testosterone..

And then there's "NHRT" ie. Natural Hormone Replacement Therapy. Many of its proponents like to claim it is radically different from "HRT" which they reserve for "traditional" (their term) use of primarily Wyeth/Ayerst products i.e. Premarin, Prempro, etc. While it is true that the majority of research has been done using Premarin and Provera, it is illogical to lay equal claim to all the benefits which have been, rightly or wrongly, ascribed to P. and P. while at the same time DISclaiming all the risks which are increasingly being reported. While they *may* be right, there is certainly no evidence that they are.

To further complicate matters, people sometimes use the term "natural hormones" when the more accurate term would be phytoestrogens. For example, while the "natural" estrogen estradiol is synthesised in the lab from soy, soy taken as a food does not supply estradiol but much weaker phytoestrogens.

Increasingly, raloxifene (Evista) is being suggested as a substitute for OHT but the term "designer estrogen" is a misnomer. It is only approved for use in postmenopausal women and is totally inappropriate for perimenopausal women. It does not treat "menopausal" symptoms. Neither does it do many of the things which are claimed for it - it is very much over-hyped.
(2001 This overstatement is now less prevalent after adverse publicity and an FDA warning)

To Welcome
OVARIAN HORMONE THERAPY