New Guidelines for Hormone Replacement Therapy

In 2002, we learnt that in post-menopausal women, hormone replacement therapy (HRT) with estrogen was doing more harm than good. The study, Women’s Health Initiative trial, involved 16,608 post-menopausal women, aged 50 to 79. Because of these findings, the study was discontinued early.

The harmful effects of estrogen therapy were: 41 percent increase in stroke, 29 percent increase in heart attacks, doubling of rates of blood clots in the legs and lungs, 26 percent increase in breast cancer and 22 percent increase in total cardiovascular disease.

But the report also said HRT has benefits: 37 percent reduction in cases of colorectal cancer, 33 percent reduction in hip fractures, no difference in total death rate from all causes and controls hot flashes.

Women have been taking estrogen to relieve post-menopausal symptoms for many years. In 1940s, pharmaceutical companies started producing estrogen from pregnant mare’s urine called Premarin. Twenty years later, the drug was being recommended for women who showed evidence of estrogen lack. Practically, all women over the age of 50. But things changed after 2002. According media reports, the highly publicized research led to a sharp drop in HRT prescriptions, to about five million prescriptions last year from 12 million in 2002.

The new guidelines from the Society of Obstetricians and Gynaecologists of Canada say hormone replacement therapy is safe and effective when used immediately at the onset of menopause and for a relatively short time. That means it would be safe to use HRT in women in their 50s to relieve their hot flashes, night sweats and vaginal dryness. And they should discontinue using HRT within five years.

The new guidelines were announced after a committee of experts re-examined the data from the previous study and came to the conclusion that the age at which women begin taking HRT, the dose and the duration all have an influence on risk. The guidelines do not endorse the use of complementary therapies as there is little or no evidence that herbal products sold for the treatment of menopausal symptoms have any benefit.

Women are advised to take control of their lives. Many problems (mood swings, insomnia, osteoporosis and difficulty concentrating) can be alleviated with lifestyle changes – weight control, healthy eating, exercise, no smoking, stress relief and meditation.

So, what should women do now? Why do experts change their minds about such things? First they create a panic then it takes them seven years to come back and say you are ok to take it within certain limitations.

I guess that is the nature of medical science. There is so much we know and again there is so much we do not know. Physicians find this as frustrating as the general public. Some women are going to be quite upset, may be even angry and frustrated, that they were deprived of HRT when they needed it. But it is never too late to sit down with your doctor and discuss your symptoms and indication for HRT.

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Quitting HRT

Couple of weeks ago, we published a column on hormone replacement therapy (HRT). The column reported on Women’s Health Initiative (WHI) trial. The trial was suddenly stopped because it was found that HRT (estrogen and progestin) in post-menopausal women was responsible for:

-41 percent increase in stroke
-29 percent increase in heart attacks
-doubling of rates of blood clots in the legs and lungs
-26 percent increase in breast cancer
-22 percent increase in total cardiovascular disease.

But, it also said that HRT has benefits:

-37 percent reduction in cases of colorectal cancer
-33 percent reduction in hip fractures
-no difference in total death rate from all causes
-controls hot flashes

After reading that column, a lady wrote:

“I have been on HRT for around eight to 10 years, and after reading your column in the paper, I totally stopped using the HRT.”

This lady was scared that now she is off HRT she will get “emotional problems” and she had started to get hot flashes. She was worried because she could not get to see her doctor for three weeks!

My advice in the column was simple – DO NOT STOP TAKING HRT WITHOUT DISCUSSING FIRST WITH YOUR FAMILY PHYSICIAN OR GYNECOLOGIST. If one is on HRT for 10 years then waiting three weeks to see a doctor is not going to make anything worse.

I was also told by Dr. Robert Woolf that women who need HRT should look into natural hormone replacement therapy. Woolf is a family physician in Medicine Hat who also practices alternative or complementary medicine. The natural hormones are derived from plants.

What is the safety and efficacy of the natural hormones over a long period of time? NEWSEEK reports that the National Institutes of Health is now supporting a trial to test two herbs for post-menopausal symptoms. So far, researchers have found no side effects, but they will continue to monitor women for changes in the breast, uterus and bones. Results will be keenly awaited.

What should post-menopausal women do now?

Last week, the Canadian Society of Obstetricians and Gynecologists (SOGC) released guidelines for HRT use in response to WHI trial. Here are the main points:

-If you have been on HRT for more than five years then talk to your physician whether you should continue
-Do not be overly concerned if you have been on HRT for more than five years – danger to an individual woman is small
-If you need to be on HRT then take the lowest possible dose for the shortest possible time – probably not longer than four years
-97.5 per cent of women, out of 8000 in the WHI study, had no adverse outcomes
-If you have been off HRT for five years then the risk of cancer drops to zero
-These guidelines apply to women who are on combination therapy of estrogen and progestin.

If you are on HRT then there is no need to panic. Discuss your options with your family doctor or gynecologist. There is more than one way to stay healthy and happy.

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Risks of HRT

A month ago, it was announced that hormone replacement therapy (HRT) is causing more harm than good.

The Canadian Medical Association Journal (CMAJ) reports that the Women’s Health Initiative trial involving 16,608 women aged 50 to 79, was stopped because preliminary results showed statistically significant increases in coronary artery disease, invasive breast cancer, stroke and pulmonary embolism (clot in the lungs) in women treated with estrogen plus progestin (Prempro).

According to a report in the NEWSWEEK, last year U.S. pharmacists filled some 45 million prescriptions for Premarin and an additional 22 million for Prempro. There are more than 13 million American women on HRT.

Menopause is a natural event. But the event is very troublesome to the woman who is going through the menopause and also to the husband who has to show understanding and patience to help his wife get through these difficult years.

About 60 years ago, researchers discovered that a substance from pigs’ ovaries can put off old age and relieve menopausal symptoms.

In 1940s, pharmaceutical companies started producing estrogen from pregnant mare’s urine called Premarin. Twenty years later, the drug was being recommended for women who showed evidence of estrogen lack. Practically, all women over the age of 50.

HRT has several benefits. It was prescribed to menopausal women to relieve hot flashes, prevent heart disease and osteoporosis. There were other reasons such as improvement in quality of life.

But the risks and benefits of long-term postmenopausal HRT with estrogen alone or combined with progestin have long been a source of controversy.

This has now changed. The evidence is clear that women taking combination of estrogen and progestin have increased risk of breast cancer, heart disease, stroke and blood clots in the lungs. Potentially life threatening.

There were some benefits like reduction of hip fractures, decrease in the rates of osteoporosis and colon and rectal cancers. It also alleviates hot flashes after menopause.

What happens now?

HRT should not be used for preventative measures in healthy postmenopausal women without severe symptoms. It causes more harm than good. Other methods of prevention should be undertaken to prevent chronic illnesses.

Preventive measures for heart disease are: quit smoking, exercise, control blood pressure, control high cholesterol level, and eat a healthy diet (remember ELMOSS?).

Osteoporosis can be prevented by: exercise (starting early in life), calcium and vitamin D and in high risk women use bisphophonates.

Finally, this brief article does not cover all aspects of HRT. If you are on HRT and haven’t spoken with your family physician or gynecologist in the last one month then you better find out whether you should still be on HRT. A visit to your doctor may save your life.

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Estrogen Therapy

“One of the most complex and difficult health care decisions that women face is whether to use postmenopausal hormone-replacement therapy”, says an article in the New England Journal of Medicine (NEJM).

Couple of weeks ago we discussed hormone-replacement therapy (testosterone) for aging men. Benefits and risks of testosterone therapy in men are still being debated. And there aren’t millions of men on testosterone yet.

But hormone replacement therapy (HRT) – estrogen – for women has been prescribed for many years. On an average, women live 30 years after menopause. Currently, approximately 38 percent of postmenopausal women use HRT although there is dearth of conclusive evidence regarding the benefits and risks of this therapy.

What are the definite benefits of postmenopausal HRT in women?

About 50 to 80 percent of women suffer from menopausal related symptoms like: hot flashes, night sweats, vaginal dryness, insomnia, mood swings, and depression. There is strong evidence that estrogen therapy is highly effective. For genital and urinary symptoms, vaginal estrogen is as effective as oral or skin patch estrogen.

HRT reduces age-related bone loss (osteoporosis) and reduces the fracture of the spine by 50 percent and the risk of hip fracture by 30 percent. Increased physical activity and adequate intake of calcium and vitamin D may also help reduce the risk of osteoporosis-related fractures.

What are the definite risks of HRT?

Cancer of the uterus (endometrial cancer) and blood clot in the legs and lungs (venous thromboembolism) are definite risks related to HRT.

Besides these there are two probable areas where there is increased risk of HRT. These are breast cancer and gall bladder disease. There is no appreciable increase in the risk of breast cancer if the postmenopausal estrogen therapy is given for less than five years. In contrast, the risk of breast cancer was increased by 35 percent in women who used estrogen for five years or more. Combination therapy – estrogen and progesterone – is worse than estrogen therapy alone when it comes to breast cancer risk, says the NEJM article.

What are the areas of uncertainty?

Coronary artery disease
Colon and rectal cancer
Alzheimer’s disease
Ovarian cancer

What is the best approach to starting HRT for a postmenopausal woman?

Two most valid reasons for starting HRT are menopausal symptoms and prevention and treatment of osteoporosis. Patients with intact uterus should be warned that they might get vaginal bleeding if on estrogens therapy alone. They should be on combination therapy (estrogen-progesterone).

Short-term use (less than five years) is appropriate for relieving menopausal symptoms. But longer-term use (five years or more) of HRT is problematic due to increase risk of breast cancer. Some women with osteoporosis will require long-term therapy.

Your family physician or gynaecologist will carefully weigh the risks and benefits before prescribing HRT.

The central principle is that menopause does not always need to be treated with medication, says the NEJM article. Life style changes, such as quitting smoking, increasing physical activity, and maintaining a healthy diet, may be useful in controlling symptoms and preventing chronic disease.

Further research on this subject continues. Results of one large-scale study are expected to come out in 2005 and another one in 2012. Until then, postmenopausal women and their clinicians will have to make the best possible judgement regarding the use of HRT.

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