What are hormones?

The Ovaries act as endocrine glands when they produce the oestrogens and progesterone that control a woman’s menstrual cycle and fertility.  They make some very important hormones and amongst these are three oestrogens, as well as progesterone.  These hormones then pass into the blood stream where they are transported to wherever they are needed in the body.

The Oestrogens

The ovaries produce the three oestrogens: Oestradiol, Oestrone and Oestriol.  These are secreted in different amounts and ratios to each other at different stages in a woman’s life.

Oestradiol is the strongest and is produced in large amounts by the ovaries during a woman’s reproductive years.

Oestriol is a gentle oestrogen produced in large quantities by the placenta during pregnancy and also in larger quantities after the menopause.

Oestrone is also produced in greater amounts after the menopause and it too is also a gentler oestrogen than oestradiol.

Sometimes the total amount of oestrogens produced after the menopause can be as high as before the menopause. This can then produce a situation of oestrogen dominance because ovulation has ceased and the amount of progesterone being produced has dropped considerably. This may need to be corrected with progesterone supplementation.

Progesterone.

Progesterone is produced throughout the monthly cycle, but the amount increases at ovulation as one of its important roles is to prepare the body for pregnancy. Progesterone is also very important in that it protects the body against the unwanted effects of the oestrogens. These include:

increase in stimulation of the lining of the uterus

stimulation of breast tissue

weight increase

fluid retention

mood swings

Hormone Treatment

There are times when the body’s hormones are out of balance and additional amounts may be given.  There are two types that are available:

1. Natural, or bio-identical, hormones which are molecularly identical to those made by the body.

2. Synthetic, or chemical, hormones and, although these have similar actions to our own body’s natural hormones, they also have additional and often unwanted and potential dangerous actions.  This is because their molecular structure is different from the body’s natural hormones;  that is to say that they are not identical to those made by the body.

Standard HRT

This is usually prescribed to contain oestradiol combined with a chemical progestogen (not progesterone as made by the ovary) in a standard dose.

The progestogen is put into the mixture for one reason only: to protect the uterus from over stimulation by the oestradiol. This over stimulation if not controlled can lead to cancer of the uterus.  The reason a chemical progestogen is used rather than the bio-identical progesterone is because natural progesterone cannot be patented, but the chemical form can.

Sadly, the artificial progestogen does not protect the body from any of the other unwanted effects of oestrogens either.  In addition it is now realised that these progestogens can in fact increase the risk of over stimulation of the breasts by oestrogen.

In recent surveys it has been found that women who take oestradiol combined with progestogens (normal HRT) have a slightly higher risk of breast cancer than women who only take oestradiol.

Oestradiol on its own is usually only prescribed to women who have had a hysterectomy.

Bio-Identical HRT

When bio-identical HRT is prescribed it is usual for a combination of the three naturally occurring oestrogens combined with progesterone to be used. This means that the body is receiving as near as possible the combination of hormones that the ovaries themselves produced. Also the progesterone protects the body against all the unwanted effects of oestrogens, not just the uterus. This means that the increased risk of breast cancer that exists when taking additional oestrogens should be considerably less than when taking traditional HRT.

The dosage of these oestrogens and progesterone is individually adjusted to the individual woman and based upon her response to them, not given as a standard dose.

The dosage can be adjusted by reference to a blood or saliva test but this is not as reliable a way as simply adjusting the dosage to the woman’s response to the hormones.

The reason for this is that the results of both blood tests and saliva testing of hormones will vary from day to day and the actual hormone blood level required by one woman will not be the same as another.

Sometimes instead of prescribing all three oestrogens the doctor may just prescribe the weak oestriol, or oestriol and oestrone combined with progesterone.

How Is It Given?

The three bio-identical oestrogens are given as a tablet (Hormonin) and Oestradiol can be prescribed as a vaginal cream or pessary or as a tablet (Ovestin).

The Progesterone can be prescribed as a transdermal cream (such as Wellsprings Serenity), a tablet (Uterogestan) or as suppositories (Cyclogest).

Further reading:

http://www.bio-hormone-health.com/2010/03/15/what-is-oestrogen-dominance/

http://www.bio-hormone-health.com/2012/08/10/progesterone-or-progestogen-why-they-are-not-the-same/

http://www.bio-hormone-health.com/2012/06/08/how-to-most-effectively-use-hormone-creams

Progesterone is an essential hormone released by the corpus luteum that stimulates the uterus to prepare for pregnancy, and provides optimum conditions in the body that are necessary for the furtherance of the pregnancy and the development of healthy babies.

For the study, Dr. Sonia S. Hassan and her team from the National Institutes of Health (NIH) assigned 458 pregnant women to either receive a once-daily dose of vaginal progesterone, or a once-daily dose of a placebo gel, during their second and third trimesters. While 16 percent of those in the placebo group gave birth before the 33rd week of pregnancy, only 8.9 percent in the progesterone group gave birth early.

Besides reducing the overall rate of preterm births, the progesterone also demonstrably reduced the rate of respiratory distress syndrome (RDS), a breathing disorder linked to early births. Not only did the women themselves experience less cases of RDS as a result of taking progesterone, but so did their children. Infants whose mothers did not receive progesterone during their pregnancies were nearly three times more likely to develop RDS than children from mothers who took the hormone.

Dr. Roberto Romero, chief of the Perinatology Research Branch of NIH, said “The study … offers hope to women, families and children. Worldwide, more than 12 million premature babies – 500,000 of them in this country – are born each year, and the results are often tragic. Our clinical study clearly shows that it is possible to identify women at risk and reduce the rate of preterm delivery by nearly half, simply by treating women who have a short cervix with a natural hormone – progesterone.”

Although this study was done using progesterone gel, progesterone cream is a highly effective and rapid delivery method, as well as being cost effective, and I would like to see another study done using it.

Progesterone is already effectively used to help women suffering from post partum depression (the Baby Blues) and it is good to see it also endorsed to support the beginning of the birth cycle as well.

The money invested can be considered a marker for the anticipated profits to be achieved via KV’s 300-strong sales force with direct access to American obstetrician/gynaecologists.  Why should we be uneasy about this?  Surely, with this level of investment, this must be a new wonder drug, offering hope to the estimated 500,000 women who experience premature births in the USA each year, suffering anxiety, grief or despair due to the complications, illness and even death that may overtake such babies?

Well, not exactly, because this drug was in fact originally marketed by another company under a different name in 1956 (!), before being voluntarily withdrawn from the market in 1999.  Doctors continued to use it ‘off label’ as it could be, and still is, made up by compounding pharmacies.  However, both the effectiveness and the safety of this hormone have been uncertain. The Cochrane review in 2006 concluded that ‘information regarding the potential harm of this therapy is limited’, with ‘maternal and infant outcomes being poorly reported’.  One study from the NIH (National Institutes of Health) has shown a reduction in risk of pre-term birth, with no apparent risk to the foetus, but several others actually showed a trend to increased risk of miscarriage and stillbirth.  In addition to this, a toxicology study in rhesus monkeys resulted in the deaths of all foetuses exposed to doses of the hormone between 1 and 10 times the human dose equivalent.

All this for a drug that was thought to have the very opposite effect!  And yet, in spite of serious uncertainty about its safety and even its effectiveness, it is again being granted a licence under a new name.

It gets worse. For many years compounding pharmacies have been able to produce this formula at a cost of $10-20 per dose (by weekly injection, over a minimum of 15-20 weeks in the second and third trimesters of pregnancy).  KV, justifying this against the cost of potential intensive care for a seriously premature baby, set the price of a single dose at $1500!  After the inevitable furore, and the fact that the FDA then announced that compounding pharmacies could continue to make up the same compound at their usual cost, KV relented, and reduced their price to just $690 per dose.  This is Alice in Wonderland stuff, but I would tentatively suggest that they are on a loser here.

What about the good news?

If we take this further, and look for the nearest equivalent to 17-OHPC in the human steroid hormone biosynthesis pathways, we find 17-Hydroxyprogesterone, similarly named (without the caproate) and similar in structure up to a point. Both molecules are made out of carbon, hydrogen and oxygen, but the natural form has 21 carbon, 30 hydrogen, and 3 oxygen atoms, while the synthetic form has 27 carbon, 40 hydrogen and 4 oxygen atoms per molecule. Regular readers of this site will know it takes only very small changes in molecular structure to bring about significant changes in properties and effects, – the synthetic medroxyprogesterone known as Provera, for instance, has 24 carbon, 34 hydrogen and 4 oxygen atoms in each molecule, a sort of halfway structure between the natural form and 17-OHPC.

Provera has been extensively assessed, in combination with Premarin (a mixture of equine estrogens), by the Women’s Health Initiative.  In this study, it was found that the apparent benefits of this form of HRT – reduced risk of hip fracture and endometrial cancer – was offset by an increased risk of coronary heart disease, breast cancer, strokes and pulmonary embolism. Very good reasons to be extremely cautious about taking any of these synthetic progestins.

What about the natural form in the human body, 17-hydroxyprogesterone, you may well ask?  Could this have potential ill-effects?  Probably not, as the body has had hundreds of thousands of years to iron out any glitches, but even if it does, in the biosynthesis pathway the natural 17-hydroxyprogesterone appears as an intermediate form in the conversion of progesterone (which as you know all of us on this site are much in favour of), to the stress hormone cortisol, both hormones of vital importance in our metabolism. As such, the 17-OHP molecule is not in existence for very long, so that any harmful potential will hardly come into play.

Now at last for the good news, and some welcome common sense.  A new study published in the journal ‘Ultrasound in Obstetrics and Gynaecology’ from Dr Sonia Hassan and her team at the National Institutes of Health assigned 458 pregnant women with a diagnosis of ’short cervix’ (a risk factor for premature delivery) to receive either a once-daily dose of vaginal bio-identical progesterone, or a daily dose of a placebo gel, during their second and third trimesters. 16% of the women in the placebo group had premature births before the 33rd week of pregnancy, while this figure was only 8.9% in the natural progesterone group, a reduction of nearly half.

Besides this, the infants in the progesterone group were three times less likely to develop RDS, Respiratory Distress Syndrome, a common and difficult complication in premature babies.

Dr Roberto Romero, head of the Perinatal Research Branch of the NIH  said “This study offers hope to women, families and children. Worldwide, more than 12 million premature babies are born each year, and the results are often tragic. Our clinical study clearly shows that it is possible to identify women at risk and reduce the rate of pre-term delivery by nearly half, simply by treating women who have a short cervix with a natural hormone, progesterone.”

As bio-identical progesterone can also relieve nausea in early pregnancy, reduce the risk of miscarriage before 16 weeks, and prevent the development of ‘baby blues’ or more serious depression after the birth, I am very much in favour of extending the use of progesterone to include all these indications.

In conclusion, you can have Makena from KV Pharmaceutical, with an uncertain pedigree and effects, for $690 per 1 week’s dose.

Or the same synthetic hormone from a compounding pharmacy, for $10-20 per dose.

Or  bio-identical natural progesterone which is safer, more effective, and costs approx $30 (£25) for a 4-6 week supply.

We live in a very strange world.

Women suffering with PMS may have a metabolic block that interferes with the body’s ability to make GLA, a natural chemical required for hormonal balance. This can be effectively corrected by supplementing with EPO which is rich in this natural ingredient.

The benefit of EPO in this area is not a new discovery by any means.

Another recent clinical trial from the University of Minnesota showed the effectiveness of EPO supplementation over six months in decreasing the severity of cyclical mastalgia (breast pain associated with the menstrual cycle). These results confirm other open trial results where Efamol Pure Evening Primrose Oil achieved improvements in breast tenderness, irritability, anxiety, depression, headache, fluid retention and tiredness. Efamol Pure Evening Primrose Oil is made from a unique variety of seed called Rigel that produces oil containing up to 33% more GLA than other evening primrose oils.

Stress reduction, a supporting diet and exercise are all factors in helping deal with severe PMS, but this natural supplement has certainly shown that it can be highly effective in helping to deal with these distressing monthly symptoms.

Researchers from the Boston Collaborative Drug Surveillance Program at Boston University School of Medicine looked at nearly 900 women on birth control since 2002. For women taking Yaz or Yasmin, the rate of blood clots was 30.8 per 100,000 person-years. For women talking levonorgestrel-based pills, the rate was only 12.5 per 100,000 person-years.

The researchers adjusted for obesity and other factors. They found that women younger than 30 who used Yaz or Yasmin appeared to have an even greater disparity in the rate of blood clots than if they took older birth control pills, with an incidence rate of 24.8 per 100,000 for the new pills compared to only 5.39 per 100,000 if they took levonorgestrel.

“These findings support more recent studies that suggest that drospirenone oral contraceptives are not as safe as levonorgestrel oral contraceptives with respect to venous thromboembolism and, in the absence of other considerations, should not be the first choice in oral contraception,” the study’s authors concluded.

The study comes out just days after other research published by the British Medical Journal examined the potential risk of gallbladder disease from Yaz and Yasmin, finding that women taking the newer pills may be 20% more likely to experience gallbladder disease than those taking levonorgestrel. However, those researchers determined that while the risk was statistically significant, it was not clinically significant.

Bayer faces about 7,000 Yaz and Yasmin lawsuits over the birth control pills. The complaints involve claims filed by women who suffered a stroke, pulmonary embolism, deep vein thrombosis, gallbladder disease or other potential side effects from Yaz and Yasmin birth control.

The federal Yaz litigation has been consolidated and centralized for pretrial proceedings as part of an MDL, or multi-district litigation, in the U.S. District Court for the Southern District of Illinois. There are also hundreds of cases filed at the state level in New Jersey and Pennsylvania.

The first Yaz trials are expected to begin early next year. A small group of cases, known as bellwether lawsuits, are being prepared for early trial dates to help parties to gauge the strengths and weaknesses of cases involved in the litigation. The outcome of the bellwether trials may facilitate a possible settlements for blood clots from Yaz and Yasmin.

Related Studies

Yaz and Yasmin Gallbladder Disease Risk Higher Than Other Pills: Study (4/21/2011)

Birth Control Pill Blood Clot Risk Higher Among Some Drugs: Study (8/14/2009)

According to a new study from the Case Western Reserve University School of Dental Medicine and the Cleveland Clinic it appears that brushing, flossing and two checkups a year may not be enough to prevent tooth loss in postmenopausal women. The researchers found that two groups of postmenopausal women – those taking bisphosphonates (for osteoporosis) and those with normal bones – had abnormally high levels of dental plaque, a film of bacteria, bacterial waste and food particles that sticks to teeth.

All of these women had carried out the standard advice on taking care of their teeth: brushing twice a day, flossing and having two dental checkups a year. In fact, in my experience, that is more than the average woman undertakes but it seems that even all of that was not sufficient to keep plaque in check.

Because plaque sticks to teeth, it sets in motion the conditions that cause gum disease. This in turn is a process that can erode the sockets that anchor teeth and lead to tooth loss.

There are some sensible precautions that you can take to avoid losing your teeth at or after the menopause. The first is never to finish a meal with any sweet or sugary substance without cleaning your teeth immediately afterwards. Another is that you actually increase your checkups to at least four a year and to make sure that they include deep periodontal cleaning to control plaque. Then you can happily smile your way through the menopause.

I would have thought that an inadequate nutrition intake was a risk at any age, but the lead investigator, Cynthia A. Thomson, PhD, RD, Associate Professor Nutritional Sciences at the University of Arizona, believes that menopausal and older women are particularly at risk. She also highlights the fact that taking multivitamin/mineral supplements to counteract this poor diet does not affect the rates of anaemia in this age group – helpful though they may be for general health and wellbeing.

The problem here is iron deficiency, which many women do suffer from – particularly during their reproductive years – and the symptoms are often just ‘lived with’. They include:

•Fatigue

•Weakness

•Fainting

•Breathlessness

•Heart palpitations (rapid or irregular beating)

•Dizziness

•Headache

•Ringing in the ears (tinnitus)

•Difficulty sleeping

•Difficulty concentrating

If you wonder if you are suffering then these are the most common signs:

•Pale complexion

•The normally red lining of the mouth and eyelids fades in color

•Rapid heartbeat (tachycardia)

•Abnormal menstruation (either absence of periods or increased bleeding)

Interestingly there have been few studies of anaemia and diet relating to women in the past 20 years, despite it being widespread from minor to major impact.

Using data from 72,833 women in the Observational Cohort of the Women’s Health Initiative the researchers found that deficiencies in more than a single nutrient were associated with a 21% greater risk of persistent anaemia while three deficiencies resulted in a 44% increase in risk. Women with anaemia also reported lower intakes of energy, protein, folate, vitamin B12, iron, vitamin C and red meat. In fact, inadequate intake of dietary iron, vitamin B12 and folate were each associated with approximately 10% to 20% elevated risk.

Postmenopausal women need to ensure an adequate intake of anaemia-associated nutrients including iron, vitamin B12 and folate. An anti-anaemia diet usually consists of an iron-rich diet along with iron supplements. Absorption of iron from food is influenced by multiple factors. One important factor being the form of the iron. Heme Iron, found in animal sources, is highly available for absorption. Non-heme iron on the other hand, found in vegetable sources, is less available.

A diet to avoid anaemia should include:

Good sources of heme iron that the body can easily absorb include: Oysters/Mussels/Shrimp/Sardines/Liver/Beef/Turkey

Good sources of non-heme iron include: Enriched breakfast cereals/cooked beans and lentils/pumpkin seeds/molasses/canned beans/baked potato with skin.

These foods enhance the absorption of iron:

Meat/fish/poultry/oranges & juice/cantaloupe/strawberries/grapefruit/broccoli/brussels sprouts/tomatoes & juice/potatoes/green & red peppers/white wine

These foods inhibit the absorption of iron:

Red wine/coffee/tea/spinach/chard/rhubarb/sweet potato/whole grains and bran/soy products

Injectable progesterone for preterm birth has been in the news lately, thanks to an outrageous move to corner the market and price gouge pregnant women. In true Big Pharma fashion, which puts profits above all else, KV Pharmaceutical applied to the FDA for “orphan drug” status for an injectable progesterone (Makena) used to prevent preterm birth. In spite of the fact that injectable progesterone has been available since the 1950s, the FDA approved KV’s application, which gives the company exclusive rights to market progesterone in this form, for this purpose. KV then promptly raised the price of injectable progesterone from $10 to $50 a dose to $1500 a dose.

As predictably predatory as this move is, there’s more than one way to get injectable progesterone, and for that matter, more than one way to deliver progesterone. First, Makena is not progesterone per se, it is hydroxyprogesterone caproate, or 17P, a naturally occurring metabolite of progesterone, so actual progesterone is not restricted other than by the fact that it would be an off-label use. Doctors can contact a compounding pharmacy, most of which can provide generic injectable hydroxyprogesterone caproate, or actual progesterone, available at a fraction of the price of Makena.

Vaginal progesterone is also used for prevention of preterm labor, particularly in Great Britain, and it’s just as effective as the injections, and much less expensive.

Although progesterone cream hasn’t been studied specifically for prevention of preterm labor and birth, it should be. It’s a highly effective and rapid delivery method, and extremely cost effective. Dr. John Lee maintained that the only caveat for using progesterone cream is that it should not contain any active ingredients besides progesterone, such as other hormones or herbs. It would also be wise to find the cleanest, or most chemical-free cream possible.

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Virginia Hopkins worked for many years with Dr John Lee on his books and articles. Since his death, she has set up Healthwatch whose mission is to educate women and men about the safe use of bioidentical (natural) hormones, and to share helpful, useful and commonsense information about health and nutrition based on solid scientific research. Virginia Hopkins Health Watch Newsletter can be found at her website www.virginiahopkinstestkits.com

The recommendation comes from an expert review published in the journal Lancet Oncology. It recommends all women with a greater than 4 per cent above average risk of developing breast cancer in the next ten years should be offered preventative drugs and closer monitoring. At present there are 44,000 new cases of breast cancer every year but this new initiative would equate to one in ten women being offered drug treatment and could double the number of women over 50 advised to take preventative action. In reality this means the drug Tamoxifen which is already linked to serious health risks.

Of course any women at serious risk needs to take every precaution, but this new trend of ‘preventive’ health care which has also seen women prescribed HRT as a ‘preventive’ for symptoms of menopause is not one I can endorse. This sounds perilously like the policy that has seen the widespread prescription of statins to people who may be at risk of heart problems, but are certainly at risk of the side effects of being on a continuous drug regime for a condition they may not have.

Women with higher than average odds of breast tumours already have access to regular checks and some are given drugs to cut their chances of contracting the disease and in extreme cases are offer both mastectomies and hysterectomies. But these are extreme cases, and Tamoxifen in trials has shown that it may reduce the risk of the most common kind of breast cancer by around a third in women of the highest vulnerability. These women know the price they will pay for having breast cancer and that treatment may be appropriate for them but to extend out to less vulnerable women a drug that has raised doubts in many is not a good idea in my view .

The known, serious side effects of tamoxifen are blood clots, strokes, uterine cancer and cataracts, and less serious side effects are similar to the symptoms of menopause such as hot flashes and vaginal discharge. Tamoxifen is licensed in the U.S. but is not widely used, mainly due to concern about potential side-effects, and an inability to predict cancer risk accurately.

A more natural approach includes using natural hormones such as progesterone which counteracts and balances estrogen’s potentially carcinogenic effect, going on an anti-cancer diet, having a healthy weight and taking more exercise. Dr Tony Coope, who works extensively with natural hormones in his practice, had this comment to make on the practice of taking these preventive drugs for cancer:

“There are several problems with this approach, part of a trend in medicine that I think is very counter-productive. Firstly, there is the focus on intervening at this level with drugs which have known and serious side effects, when there are bio-identical alternatives that perform this function more efficiently, at lower cost, and without harmful side effects.

Secondly, it distracts us from exploring the root cause of the problem, which is at the level of the unconscious, the storehouse of beliefs and attitudes that create our perception of the world we live in, and drive the mutations and expression of our genes.

As Dr Vincent Felitti of San Diego has commented, a person unfamiliar with fire would be initially tempted to treat the smoke, – the most visible aspect of the problem. Fortunately for us our fire departments have learned to distinguish cause and effect long ago; if they hadn’t, they would be using fans instead of water hoses.

Unfortunately in modern medicine it seems that we are still often investing in fans.”

I couldn’t agree more, and although it may have seemed prudent to our ancestors to have all their teeth removed to prevent any future toothache, I had thought we had moved on from this blunderbuss approach.

Their findings reveal that largazole, the key component from the coral reef, is an effective bone remedy with lots of potential. It is also an effective anti-cancer treatment, according to earlier research.

Components similar to largazole are already used in a variety of popular medications and bacteria containing such substances come from various trees, plants, soil and animals. However, the recent discovery of the substance in the coral reefs off Key Largo, Florida, offers added potential as scientists were able to identify key cell regeneration properties in this particular variety of the substance that were previously unknown.

“Largazole’s ability to reprogram cells can also be exploited for tissue regeneration, and we initially focused on potential bone-forming properties of largazole,” said Hendrik Luesch, associate Professor of Medicinal Chemistry at the University of Florida College of Pharmacy. He and assistant professor Jiyong Hong, from Duke University, performed extensive testing on largazole’s ability to regenerate bones and came up with some amazing findings.

It seems that largazole initiates the process of osteogenesis in the body, which is when the body begins not only to repair damaged bones but also to grow new bone tissue. And at the same time as it performs this function, largazole also prevents bones from breaking down and being reabsorbed back into the body. The implications of this dual effect are highly promising and this data clearly shows the great potential of largazole for improvement of the property of bone graft substitutes in bone defect reconstruction.

It would also seem to offer another possibility for treatment for women who suffer from bone fractures and thinning due to osteoporosis and other bone diseases. This research is at an early stage but it is definitely worth pursuing and my only question would be the environmentally ethical one as to whether coral reefs can sustain the level of research required. I presume that they are also going to be looking, as is usual, for a synthetic substitute for the natural substance.