Wyeth Pharmaceuticals plans to release Lybrel, a contraceptive pill, and it is expected to be available in July. The idea that a woman can take a birth control pill for longer than a month and thereby reduce the number of menstrual periods has been marketed by other companies under Seasonale and Seasonique for a few years. These products are taken for about three months (rather than three weeks) and then the patient stops for a week to have a period. It is likely that Lybrel will be used the same way only for a year.

Many women may be concerned about not having a monthly, regular menstrual flow. Some feel it is not right or healthy or may cause illness. In reality, there is no evidence that a monthly menstrual flow is necessary for good health or a healthy reproductive life. This assumes, of course, that the absence of a period is not caused by some underlying problem. Gynecologists have, for decades, used the birth control pill in exactly this way to treat a variety of gynecologic conditions such as endometriosis, debilitating menstrual pain, or menstrual migraine. They have just used available oral contraceptives in a continuous manner rather than a cyclic manner.

Though we don't have long-term information on safety, it is likely that this new pill will be as safe as other oral contraceptives and have similar cardiovascular risks (especially in smokers).

The real question is whether this pill offers anything new to women. The doses of the estrogen and progesterone component are comparable to current pills and therefore offers no new safety benefits. It may be appropriate for some women with the above mentioned problems, however. Some women may like the idea of not having a period, but many are unsure it is a good idea.

However, continuous hormonal therapy like this does increase the risk of break-through bleeding. This is bleeding when you're not supposed to bleed. Break-through bleeding occurs in 2-5% of all oral contraceptive users. With this new pill, approximately 18% of women dropped out of the study because of unpredictable bleeding or spotting. This would be a drawback for many women. It will be up to women to decide for themselves if this new formulation offers any improvement in their current choices for contraception.

This is a very common question and concern! This is often (not always) a sign of hormonal transition. The female body produces three major hormones which regulate our cycles: estrogen, progesterone, and testosterone. During our peak reproductive years, these hormones work in balance with one another to produce (in most cases) cyclical and predictable menstrual cycles, with “normal” menstrual flow. During the “perimenopausal” years, or those transitional years leading up to menopause, the first change which occurs is typically a gradual drop in progesterone levels (with estrogen and testosterone levels remaining pretty constant). This has to do with the fact that during these later reproductive years, less of the egg follicles actually mature to the point of ovulation. Related to this, cycles become more irregular and heavy. With diminishing levels of progesterone, there is a relative excess of estrogen: More estrogen can cause our uterine lining (the endometrium) to become plumper than usual, leading to heavier flow with menses. This is a very common process that occurs in most women to some extent during the later reproductive years.

It is strongly advised that you seek consultation with your healthcare provider if you are experiencing significant changes in the pattern or flow of your menstrual cycles. In addition to hormonal changes, there are many other potential reasons for a woman to experience changes with menses in the perimenopausal years. An undiagnosed pregnancy, a thyroid condition, a blood disorder, an anatomical abnormality such as a uterine fibroid or endometrial polyp, or even uterine or cervical cancer are all examples of other possible causes for abnormal uterine bleeding. Based on your history and your clinical symptoms, your healthcare provider will help you to determine which types of evaluation and testing might be recommended in order to accurately determine the cause of your change in menstrual cycles.

Generally speaking, you are bleeding too much if you typically bleed for longer than one week, or if when you bleed you saturate a tampon or pad in less than one hour (in an ongoing way), OR if your bleeding interferes with your life either due to feeling depleted (some women will become anemic with heavy or frequent menses) or because of “flooding” which prevents you from being able to comfortably leave your home. When you are experiencing too much bleeding, there are many options in terms of treatment including, but not limited to, the use of NSAIDS, cauterization, hormones, surgery, and complementary therapies. Again, your healthcare provider can help you to determine which is the best method of treatment for you.

As for the interval between menses, we consider anything less than a 3-week interval (21 days from the start of one menses to the start of the next) to be abnormally short. If this type of pattern occurs in an ongoing way, it is advised that you seek care from a healthcare provider.

Concerning a long space between menstrual cycles (and not related to a pregnancy or any other underlying medical condition) we generally feel that an interval of 3 months between menses should prompt a call or visit to your provider. This has to do with the fact that during these perimenopausal years in which a woman still produces plentiful levels of estrogen, it is sometimes necessary to “induce” a menstrual bleed in order to be sure of effective shedding of the endometrium. If the uterine lining is not effectively shedding, it is possible, over time, for a condition to develop called hyperplasia. This means an overgrowth or thickening of the tissue, and which could become a precursor to the development of endometrial or uterine cancer. Your provider can help you decide how to most safely and effectively monitor your cycles, while minimizing risks and keeping you as satisfied and comfortable as possible along the way!

Please keep in mind that the above discussion is in no way meant to be inclusive of the many possible other factors which can affect and alter menstrual cycles. For further direction on this topic we highly recommend that you make an appointment with your healthcare provider to discuss any questions that you might have.

Continuous or extended contraception use is gaining popularity. “The pill” has typically been dispensed for birth control, however it has been found to help with other health risks such as decreasing incidence of cancer of the ovaries and uterus. It has also been helpful in reducing common menstrual complaints such as PMS, bloating, length and amount of bleeding, painful cramps, and ovarian cyst formation. We found that women with endometriosis or menstrual migraines (severe headaches that occur at the start of each period) could take the pill continuously for 3 months before stopping it to have a period. They were extremely happy to have their period 4 times each year.

This method of dosing has become extremely popular. In fact, 50% of women who take the pill this way have no medical problems and only do it for convenience. Scientific studies have been done over the past 15 years to test the safety and measure the satisfaction. There is one pill product that is now even packaged as three-tier rows of pills, taken daily, and the last week is a different color, for the period. Because “the pill” acts to stop ovulation, as when you are pregnant, it’s not necessary to have a period every 4 weeks.

We have found that the products “Nuva Ring” and the “Ortho Evra Patch” can be used in the same way. The Nuva Ring has a slow release of the hormones and lasts for 4 weeks. At the end of the 4 weeks the vaginal ring is removed and the new ring is inserted. This can be done for 3 months and at the end of the 3 months the ring is left out for a week to have her period. The patch lasts for 7 days. Used this way, the patch is changed for 12 weeks then left off for a week for a period. It is safe to use the pill, ring, or patch in this way, just as it is safe for a woman not to have a period when she is pregnant.

The studies show that bleeding rates for women on extended birth control are similar to rates of women taking it the typical 21 days on and 7 days off. As well, the contraceptive protection (pregnancy rates) were similar. If you have questions about this method of taking your pill, ring, or patch please talk with your provider. We want you to have access to new information and for you to have choices in your birth control method to fit your lifestyle.

In talking with women about the various aspects of their day-to-day lives, it is not uncommon to hear complaints about a lack of sleep. With this conversation comes talk about exhaustion, irritability, diminished concentration and memory. Sleep is essential in order to maintain physical and emotional well-being, but is frequently overlooked as one of the key elements in our quest for better health.

Women, in particular, are prone to sleep disorders for several reasons. Times of hormonal fluctuation (as in adolescence, pregnancy, menopause, or even the monthly cyclical changes) lead to a biological increase in the requirement for sleep. Ironically, hormonal changes are also often associated with an increase in sleep disturbances, making it all the more difficult to get the restorative sleep needed. Women experience frequent sleep interruptions with babies or children waking during the night, or in waiting for their teenager to get home at night. Women (or men) may have disturbances in sleep which relate to anxiety or depression, drug or alcohol use, sadness or grief, or an overly active mind – perhaps reflecting the over-extended lives we lead! Still, other causes of sleeplessness may include excessive caffeine intake, lack of exercise, smoking, an inconsistent sleep schedule (night shift workers), or even medical conditions such as sleep apnea or restless leg syndrome. Whatever the cause–while many of us will occasionally experience the irksome sleepless night, for some, sleeplessness will become a more chronic and troubling issue.

For those who unhappily experience chronic insomnia, a complete evaluation with a health care provider (and perhaps at a sleep disorders research lab) will be an important first step toward improving sleep. Sleep disorders that stem from a medical condition, depression or anxiety, or drug/alcohol use will necessitate help and treatment around that particular issue which is identified. For many, however, some or all of the following basic strategies may be useful in greatly improving one’s quantity and/or quality of sleep. This is frequently called “sleep hygiene”, and is considered the first line, and most successful form of treatment for most sleep disorders.

1. Get regular exercise. Exercise releases endorphins, a natural sleep aid. It is most beneficial to exercise late in the day, but not within 3 hours of sleep.
2. Avoid caffeine entirely, or limit use. Stop consumption within 6 hours of bedtime.
3. Avoid alcohol, or limit use. Alcohol affects quality of sleep by preventing the deep “delta” sleep which is so restorative and necessary to a “good night’s sleep”.
4. Avoid smoking. Nicotine is a stimulant.
5. Keep a regular sleep schedule, as much as is possible. Going to sleep and waking at consistent times leads to a consistent circadian rhythm, which helps the body to remember when to become drowsy and fall asleep, and when to wake up.
6. Eliminate or decrease fluid intake in the evening, in order to avoid waking during the night with a full bladder.
7. Complete the day’s activities prior to bedtime, allowing for pure relaxation time in the 2 hours prior to sleep. This should include making a list of the following day’s activities. Then, try reading, listening to music, or watching a non-stressful television program prior to bed.
8. Try a light, carbohydrate snack in the 2 hours prior to bedtime. Carbohydrate intake leads to the production of serotonin, a natural chemical which increases restorative sleep.

Allow for some time and consistent practice with these techniques before determining whether or not these strategies are useful for you. If after a few weeks of committed effort you do not start to notice improvement in the quality of your sleep, seek the advice of your health care provider.

Occasionally a person may require sleep medication in order to break a cycle of poor sleep. This type of treatment should only be initiated under the care of an experienced health care provider, and should ideally be implemented only for short-term use. Medications used to help induce sleep can be habit-forming, can lose their effectiveness over time, can cause a grogginess or “hangover” effect following use, and can cause”rebound” insomnia with discontinuation. Therefore, the decision to use sleep medication bears careful consideration. Please talk with your provider if you feel that this form of treatment is a necessary part of a plan to help you get the rest you need.

Remember – sleep begets sleep! Start by taking simple steps as illustrated to improve your sleep habits. You may soon notice vast improvements in both your quality of sleep and your overall sense of well-being and health.

Harbour Women’s Health has been providing on-site bone density tests for years, and in that time, determining bone density has become an integral part of the care regimen for peri- and post-menopausal women. If you are beginning to detect signs of menopause, the following questions and answers that we’ve collected from patients and our staff may help determine if it is time for you to schedule a bone density test with us.

How does it work? Is it an x-ray?

While there are various ways of measuring bone density, we have a GE Lunar machine that employs dual energy x-ray absorptiometry (DEXA) technology or an x-ray beam that splits into two. The x-rays pass through you, while you lie flat on a table, and are picked up by an arm extended over you called a receiver. The difference in the energy levels of the x-rays received is then used to compute bone mineralization, the most accurate approximation of bone density available.

How do I do it? Will it hurt? How long does it take? Will I be in a tube like this a CT scan?

There is no tube involved. The test is performed with you lying on a table so that the arm can extend over your whole body. Once you’re positioned on the table so that the machine can accurately measure locations in your spine and hips, the scan takes just a few seconds and is absolutely painless.

At what age should I have my first bone density test and how frequently after that?

Bone density is measured to try to estimate the risk of bone fracture and the potential need for treatment. There are no standardized guidelines as to who should be screened and how often but most of the national societies specializing in this area suggest that all women who would consider treatment for osteoporosis should have testing done. Because osteoporosis has no symptoms until a fracture occurs, testing is generally advised around the onset of menopause and at three to four year intervals thereafter. Testing is performed earlier if you are taking certain medications, have a family history of bone ailments or have been diagnosed with a bone condition that is being treated so that your response to treatment can be monitored.

If the results are abnormal, what will I have to do? Can bone density be improved?

There are several treatments available today, some of which slow the natural loss of bone that occurs with age, others that actively treat more advanced bone loss. Some treatments can increase bone density at any age and can substantially decrease the risk of bone fracture. As there are multiple factors to consider in this decision, such as personal risk factors, medications, family history and lifestyle, you should carefully explore your options with a care provider following an abnormal result.

Women in their forties often experience changes in the amount and/or frequency of their menstrual flow. This can affect lifestyle by causing fatigue and limiting activity. Some women must remain confined to home or at least within immediate proximity to a bathroom for days at a time. A woman’s mother or aunt may have had a hysterectomy for similar bleeding–raising concerns that surgery might also be in her future. We are often asked, “When do I get concerned?”

In general, menstrual cycles tend to shorten (i.e., menses get more frequent) as menopause approaches. This is a slow process occurring over the course of several years. They usually stay regular during this transition–every 23 or 24 days versus every 28-30 days previously. As the ovaries age and become less efficient, ovulation occurs less frequently. This is reflected in the menstrual cycle as a more pronounced irregularity; for example, cycles that will vary from 14-40 days or more in length. These patterns are generally hormonal and therefore benign.

Bleeding patterns that may signify a problem are those that tend to be prolonged and progressive. Prolonged meaning that the pattern persists over several months. Progressive meaning that every cycle seems to get worse, more and more heavy or perhaps longer and longer. A day or two of heavy bleeding is usually tolerable. Four or five is not. Changes such as this could signify a problem and should be discussed with your healthcare provider. The same is true for bleeding that lasts 10-12 days or more, even if light.

Your mother probably had a D&C performed to evaluate her bleeding. This approach is now considered outmoded. Nowadays a simple pelvic ultrasound usually suffices to make a diagnosis. It allows accurate identification of most pelvic pathology and allows a discussion of treatment options. And the key point here is that there are options. If you have menstrual symptoms that are worrisome, discuss them with your provider and get involved with the decisions about your care.

Black Cohosh is scientifically known as Actaea Recemosa, a North American herb that is a member of the buttercup family. It was originally used in North American Indian medicine for malaise, sore throat, rheumatism, malaria, kidney disorders, and gynecological disorders, as well as reduce hot flashes and other menopausal symptoms. No human studies have adequately evaluated the effect of Black Cohosh on the endometrium (the inside layer of the uterus) or vagina.

Black Cohosh contains biological components similar in structure to the human hormone estrogen. A number of studies have suggested that these plant hormones attach to the estrogen receptors in the body. This activity decreases the amount of luteinizing hormone which is associated with temperature fluctuations. Other studies have not been able to confirm this mechanism of action which leaves scientists questioning why Black Cohosh seems so effective.

Currently, it is sold as a dietary supplement; dietary supplements are regulated as foods and not drugs. Because dietary supplements are not always tested for consistency, the composition may vary.

Short term use of Black Cohosh, specifically for periods no longer than six months, was endorsed by the American College of Obstetrics and Gynecologists (ACOG) in 2001. This limited used is recommended because the herb reduces symptoms of menopause without any danger. ACOG suggests using the Black Cohosh at a dosage of one to two 20 mg pills twice daily. Black Cohosh can cause stomach upset and headaches.

Disclaimer: In accordance with FDA regulations, this information is not to be used for purposes of diagnosis or treatment. This information is not intended to be taken as a replacement for medical advice. It is strongly recommended that you talk to your provider-physician, nurse-midwife, nurse practitioner, or physician assistant – about any herbal therapy you are using or would like to use in order that he or she may best provide care for you. It is important that many prescription medications are not duplicated with herbal treatments.

Harbour Women’s Health has a commitment to providing you the option of combining traditional medicine with alternative approaches, many of which they provide. If you have any questions regarding Herbal Therapy in Women’s Healthcare please free to ask.

In this day and age, the internet is an amazing resource that we can all benefit from if used judiciously. However, there is a tendency when one has a medical concern to simply “google” a particular subject and end up with a variety of websites to investigate. There are countless websites to explore but the integrity and medical accuracy of each site varies. The following list includes links to resource we consider helpful and accurate.

At Harbour Women’s Health we advocate for women to learn as much as they can about their health and their bodies but do not want them to become overwhelmed or anxious with the information they discover. For this reason, we have previewed certain websites in an effort to strategically focus your searches on reliable websites.

Heart Health

A clearinghouse of information on women’s health. The site is run by United States Division of Health and Human Services and the Division of the National Women’s Health Information Center. Lots of good information on heart health as well as bacterial vaginosis, carpal tunnel syndrome, and breastfeeding.

A fine site sponsored by the popular weight loss business. Recipes and instruction on healthy weight loss.

Menopause

This website is sponsored by the Foundation for Better Health Care. The menopause patient education module is concise and has a great introduction to the topic.

Sponsored by Planned Parenthood, this site has a fair overall view of topics of concern to the perimenopausal and menopausal woman.

Sponsored by the National Sleep Foundation, they have a review of sleep issues, not only during menopause, but also at other challenging times in women’s lives. Constructive suggestions are offered for improving each night’s rest.

Osteoporosis

Sponsored by the National Osteoporosis Foundation, up-to-date information on prevention and continuing education seminars for professionals.

Sexually Transmitted Infections

Great resource for increasing your knowledge about any sexually transmitted infection, including herpes, hepatitis, and HPV. Run by American Social Health Association.

Sexual Health and Public HealthSexual Health and Public Health

The Alan Guttmacher institute is a well-known organization which has advanced studies regarding contraception and sexual health for men and women. They have an ambitious national and international agenda for women’s health. Great research site.

The Women’s Sexual Health Foundation supports a multidisciplinary approach to the treatment of sexual health issues and serves as an educational resource for public and healthcare professionals.

Infertility

Resolve is a national support organization for women and men struggling with infertility.

Breastfeeding

All of the above websites are excellent resources for women with any questions/concerns about breastfeeding.

Adolescent Health

Two excellent websites for adolescent women learning about their sexuality and sexually transmitted infections.

Happy Browsing.

Your bone is constantly active, balancing reabsorption of old bone and formation of new bone. Bone formation is greater than reabsorption up to age 30. After that, bone is broken down faster than it is reformed. Most of the time this does not cause any problems. After menopause, however, the decreasing amount of estrogen further slows bone formation. The result is bones that are thinner and weaker and more prone to fracture. It is most prominent in the spine, hip, and wrist.

What causes osteoporosis? A small percentage of patients have other diseases which increase their risk. However, many women have risk factors which might increase their individual risks. The greatest risk factors are: family history of osteoporosis, smoking, menopause, lack of exercise, low body weight, diet low in calcium (lifelong) and the use of certain medications.

Can I prevent it? Preventive measures can decrease the risk of osteoporosis. The two most effective measures are calcium and exercise. It should be mentioned that maximum bone density is achieved before age 30 and begins to decrease after that age. Exercise does not mean you have to join a gym. Any weight-bearing exercise such as walking will have a positive effect if it is done regularly.

Having a diet with adequate amounts of calcium and Vitamin D will slow bone loss. (Calcium is not very well absorbed unless Vitamin D is present.) A well-balanced diet is best, but the majority of women will probably not get enough calcium from diet alone. This is most true of women who do not include dairy products in their diets. An amount of calcium to strive for is approximately 1500mg. A cup of broccoli contains about 100mg of calcium whereas a cup of skim milk contains about 300mg. There are many supplements to choose from. It’s best to choose one with Vitamin D included, but there is no convincing evidence that any one type of calcium supplement is better than any others.

How is osteoporosis diagnosed? All women over 65 years of age and younger women with additional risk factors should have bone density testing. This is a painless and very easy test to have and you should discuss this with your practitioner.

Are medications needed? Medications can stop the bone loss and, in some instances, gradually increase bone density. However, the choice of medications should be based on your individual situation and bone density test. Medications have been shown to decrease the occurrence of fracture even when bone density has stayed the same. Medication does not eliminate the need for exercise and calcium.

Menopause is defined as the last menstrual cycle in a woman’s life, and marks the end of her reproductive years. Perimenopause is the term used to describe the time of transition between a woman’s reproductive years and menopause. This period of transition may be quite brief or may last as long as ten years. For many women, this transition begins in the forties and lasts through and sometimes beyond menopause. (The average age of menopause for American women is fifty-one.) A woman can theoretically conceive at any point up until the active time of menopause. Therefore, it is still necessary to use contraception throughout the perimenopause.

During this time, declining ovarian function is associated with changes in the production of estrogen, progesterone, and androgens (the hormones which regulate women’s menstrual cycles). These changes can lead to a variety of symptoms in women, including memory changes; menstrual irregularities (either more or less frequent, and with either a very heavy or light flow); hot flashes or night sweats; libido changes; insomnia; or mood fluctuations including symptoms of irritability, anxiety, or depression. Eventually, women might also experience signs of urinary or vaginal atrophy (meaning a loss of elasticity or thinning of the tissue) such as vaginal dryness, burning, discomfort with intercourse, and urinary frequency or discomfort. Some women experience none of these changes, while others struggle with many changes and symptoms during the perimenopausal period. For many women, this is also a busy and demanding time in life, whether related to a career, raising a family, or caring for aging parents. Women need and want to feel better, and many look for ways to more comfortably manage their perimenopausal symptoms.

There are a variety of approaches to the management of perimenopausal symptoms. Often, simple changes in a person’s diet, exercise routine, and lifestyle can make a positive difference. Women sometimes also find relief with the use of nutritional or herbal supplements. This may include the use of “phytoestrogens” which are plant-derived estrogens, such as black cohosh, Mexican wild yam, or soy products. Acupuncture is another modality which can be quite useful, particularly in treating the “vasomotor” symptoms, i.e., hot flashes or night sweats.

Some women opt for the use of hormonal supplementation during the perimenopause phase. This may mean the use of a low-dose oral contraceptive pill, or even the initiation of hormone replacement therapy (HRT). By supplementing a woman’s own physiologic production of hormones, women frequently feel relief from many of the symptoms related to hormonal fluctuations of perimenopause. However, HRT can be associated with health risks, so only after a discussion with a healthcare provider should HRT be initiated.

If you are interested in learning more about Perimenopause and Menopause, please join us for our monthly talks in our office during evening hours. Please call our office at 603-431-6011 to learn more about this special informational series.

For the last several years October has been recognized as Breast Cancer Awareness Month. As a major health problem—the second leading cause of cancer in women with over 200,000 cases diagnosed each year—this attention is warranted. Many women, however, experience fear out of proportion to their actual risk and often avoid routine screenings. We would like to put the risk of breast cancer into perspective and to emphasize the benefits of screening and the effectiveness of treatment.

As already noted, the incidence of breast cancer is second only to lung cancer in this country. As a treatable disease, however, it ranks as one of the most favorable. For example, as a reflection of treatment, 5-year survival rates are often examined. In regard to lung cancer, this number is 15%; for breast cancer, 86%. And for the last decade or more this percentage has been improving. The reasons for this are found both in mammogram screenings and in advances in treatment.

Mammography has repeatedly been shown to decrease the mortality rate in breast cancer. Compared to women who don’t have regular mammograms, those that do, decrease their risk of dying from the disease by 25-30%. Indeed, in a recent study out of Sweden published in the journal Cancer, researchers found a 45% risk reduction. The reason is that mammography can find breast cancers that are much smaller than what a person can suspect by touch alone; some people estimate they are found 1-2 years before they will be identified by a woman or her healthcare provider. Smaller cancers are more curable as they are more likely to be localized to the breast and not to have spread elsewhere in the body.

Another benefit of screening mammography is that it finds precancerous lesions, most commonly what is called ductal carcinoma in situ or DCIS. Identification and treatment of these lesions probably prevents many cases of breast cancer.

It is estimated that approximately 2/3 of the recent reduction of breast cancer mortality is attributed to better screening; the other 1/3 is felt to be due to improved treatment. This emphasizes the need for all women to have regular screening. We added a state-of-the-art GE mammography unit to our practice as soon as we moved to our facility here at Griffin Road three and a half years ago. Our goal was to improve ease of access for women, hoping that more women would have it performed if they could have it done at the same time as their annual exam. We provide a quiet, private area; experienced sensitive mammography technicians; and a commitment to maintaining an accredited facility.

If you or anyone you know needs a mammogram, and all women over the age of 40 are advised to have regular screening, then please call us today. It truly can save your life.

The week of July eighth saw headlines in all the news media advising women taking Prempro to stop immediately and consult their health care providers because of new evidence that this form of hormone replacement therapy (HRT) causes breast cancer. For the last several years there has been an ongoing debate in the medical literature as to whether HRT, in particular, estrogen therapy, increases a woman’s risk of developing breast cancer and, if so, to what degree. So why did this new evidence make the headlines and what are the researchers really saying?

Members of the research team running a study called the Women’s Health Initiative (WHI) released this information. The study began about five years ago and involves over 16,000 postmenopausal women. This is a randomized placebo-controlled drug study meaning the women were randomly assigned to receive either a form of hormone therapy or a placebo. Hormone therapy consisted of Prempro (an estrogen [Premarin] and a progesterone [Provera]) in women who had not undergone hysterectomy, and Premarin alone in those who had. The main goal of the study was to see if HRT decreased the risk of heart attacks and/or increased the risk of breast cancer. Other outcomes such as the risk of clotting and colon cancer were monitored as well.

Over the course of the study, the researchers periodically reviewed the data. At the beginning of the study they had set what they considered acceptable risk cut-off points for the adverse outcomes, that, if exceeded, would trigger termination of the study. For example, a slight increase in the risk of heart attacks had been noted earlier in the study, but at a level below the predetermined cut-off value, so the study continued. When the researchers looked at the results available as of April 2002, they noted an increase in the number of cases of breast cancer in the group taking Prempro that had not been previously seen. The number of cases in the treated group exceeded the limit so the decision was made to terminate the study. They claimed that the patients receiving the HRT had a 26% increased risk for developing breast cancer. News media reports covering this study included alarming quotes from various physicians such as “…long-term use of this therapy could be harmful…”;”…there is really no safe period…”; and “…this is a dangerous drug….” While the researchers were advising caution and asking women not to get alarmed, coverage of the study certainly had the opposite effect.

While this was clearly a well-designed, valuable study, several points need to be emphasized:

1. Other studies have looked at the same question (re: breast cancer risk) and have come to different conclusions. For example, another ongoing randomized study (HERS) that used the same drug could not demonstrate a statistically increased risk of breast cancer in the treated group over almost 7 years of follow up. The most recent update of this study was published in the same medical journal as the WHI study two weeks earlier (JAMA, 3 July 02) and it failed to make headlines.
2. The arm of the WHI study that involves 11,000 women taking Premarin alone is continuing, as there has been no increased risk of breast cancer noted in this group.
3. While the increased risk was quoted as 26%, this is misleading as this refers to what is called relative risk. The actual increased risk they noted was from 3.0 breast cancers per 1000 women in the placebo group to 3.8 in the Prempro group. According to the researchers, for an individual woman, this translates into an increased risk of approximately one-tenth of 1% per year of treatment.
4. There are several other forms of estrogen and progesterone used for HRT. None of these were evaluated in this study and the risk profile for these drugs could be quite different.
5. There remain well-established benefits of HRT including decreased risk for osteoporosis and bone fractures, decreased risk of colon cancer, and well-defined cognitive effects including possibly a lower risk of Alzheimer’s Disease. On the other hand, HRT seems less to be the fountain of youth it was once purported to be.

Harbour Women’s Health sponsored educational seminars three and four years ago addressing “Alternatives to Traditional Hormone Therapy.” We have never felt HRT was a cure all, but neither do we feel it has no place in the treatment of menopausal symptoms.

It has always been the policy of Harbour Women’s Health to discuss the use of HRT in the context of risks versus benefits. This is an individual decision that should be made with careful consideration of all the information available at the time. With the publication of the WHI results, this information has changed. However, it is our opinion that the issue remains complex, that the information will continue to evolve as more research is done, and that it is unlikely we have heard the last word on HRT.