New Horizons...........Living Well, Feeling Great

What to Expect in Menopause

Women want to know what to expect as they enter the menopausal years.  They have generally heard about hot flashes and night sweats, as well as vaginal dryness.  Many women also report that they experience the following symptoms:

Bouts of rapid heartbeat (palpitations).........irritability..........mood swings, sudden tears...........trouble sleeping..........loss of their sex drive.........painful intercourse..........fatigue..........anxiety, feeling ill at ease............difficulty concentrating, mental confusion..........disturbing memory lapses..........itchy dry skin.............aching joints, muscles, and tendons........... headaches.........gastrointestinal distress, indigestion, flatulence, gas pains, nausea

Questions addressed on this page include the following: 

 

  • When will I reach menopause?
  • Why do I have trouble sleeping?
  • How can I lose this weight?
  • Aren't there medications that help you lose weight?
  • When is surgery indicated for obesity?
  • What is a hot flash?
  • Why is sex painful since I stopped getting periods?
  • I don't seem to have any sex drive. Is that because of menopause?
  • I feel depressed. Is that related to menopause?
  • What is the latest update on hormone replacement therapy?
  • What type of hormones should I take? How are they given?
  • What about bioidentical hormones?
  • Do I have to wait until I've stopped getting periods to begin hormone replacement?
  • Is there an age when it is too late to start hormone replacement?
  • Should I avoid hormones because they cause cancer?
  • What side effects will I get from hormone replacement?
  • Are there women who can't take hormones?
  • What else can I take for my symptoms other than hormones?
  • What are those new drugs that are supposed to replace estrogen and are they safer?

                             

When will I reach menopause?

As 40 rolls by, thoughts turn to menopause. There is an assumption that menopause is just around the corner. Half of the women asking are looking forward to menopause and “getting rid of that darn period.” The other half is dreading its arrival. The average age of menopause is 52. The majority of women will completely cease menstruation between ages 48 and 55. However, it is not rare for a woman to stop menstruating as early as 40, or to persist into her late 50’s. There does appear to be a correlation with the age of your mother’s menopause. If you begin to skip periods and start to develop hot flashes or night sweats, menopause is approaching. At this point you are considered peri-menopausal. Menopause is the complete cessation of periods for one year.

 Why do I have trouble sleeping?

 Sleep problems are common in perimenopausal and postmenopausal women. You may have trouble falling asleep or wake up long before your usual time. When the sleep disturbances are related to hot flashes and night sweats, then clearly hormonal changes are the culprit. It also appears that perimenopausal women may not get enough rapid eye movement (REM) sleep. Without REM sleep, you will not feel rested and when normal sleep rhythms are interrupted, your mood and ability to function the next day may be affected. Sleep disturbances can also affect your ability to concentrate. Sleep changes can also simply be a part of growing older or be related to other medical conditions and therefore are not always the result of hormonal changes.

If you are having trouble falling asleep or staying asleep at night try the following suggestions:

 • Maintain a regular sleep schedule. Try to go to bed and wake up at the same time every day, including weekends.

 • Avoid caffeine, remembering that caffeine is found in coffee, tea, chocolate, and cola drinks. Caffeine can stay in your bloodstream for up to six hours so it should be limited to the morning and early afternoon.

 • Avoid alcohol. This seems counterintuitive since alcohol often relaxes us and makes us sleepy. Unfortunately, alcohol affects normal sleep patterns, and therefore may cause you to wake up during the night.

 • Eat regular meals and avoid late meals and snacks.

 • Exercise regularly, but not in the 2 to 3 hours before bedtime.

 • Incorporate regular stress reducing activities into your life such as prayer, meditation, exercise, and yoga.

 • Consider seeing a sleep specialist. A doctor who specializes in this area can help you decide whether additional studies (such as evaluation in a sleep lab), lifestyle changes, or medications would be helpful.

How Can I lose This Weight? 

How do I get rid of this midline bulge that I didn't seem to have before menopause? I seem to be gaining weight since menopause and it all seems to be settling in my midsection. How could I have gained another 5 pounds? I haven't been eating any differently. This isn't fair!

 
It is unclear whether the hormonal changes of menopause may make you more likely to gain weight around your abdomen rather than your hips and thighs. Certainly hormonal changes alone don't necessarily cause the weight gain seen around menopause. Weight gain in midlife occurs irrespective of the timing of menopause and hormone replacement therapy is not associated with weight gain or weight loss in well-controlled randomized studies. In midlife we tend to be less active in our everyday life and exercise less than we did earlier. In addition, muscle mass naturally decreases with age. If you don't do anything to replace this muscle, your body will burn fewer calories. If you continue to eat as usual, you will gain weight. Whether your weight gain is linked to menopause itself, or aging and lifestyle, is less important than understanding that it can be prevented with proper exercise, diet, and lifestyle modifications.

 
Currently, more Americans are overweight than normal weight. What is overweight? As a rule, a woman who is 5 feet tall should weigh 100 pounds. You can then add 5 pounds for every inch above 5 feet, plus or minus 10 percent. If you’re not sure, your doctor can refer to a chart that indicates a normal range of weight. If you are more than 20 % overweight, he may even use that hideous term, obese. Weight gain occurs when you consume more energy (as food) than you burn. Weight problems can result from certain medical conditions (such as hypothyroidism), or medications. However, heredity, eating habits, and lifestyle usually dictate your weight.
Tackling your weight problem is a difficult endeavor. There are no shortcuts, no instant cure for the problem. The most sensible approach is a gradual change to a, healthy diet and increased exercise. Fad diets that severely restrict calories are not the answer. When these diets are discontinued, weight rebounds, often shooting higher than before (now that’s depressing). Modest reduction in calories (300-500) is reasonable and usually occurs when changing to a lower-carb diet rich in fruits and vegetables. Excess carbohydrates and unhealthy fat, especially saturated fats and trans fats should be severely reduced. Help can also be obtained by consulting a nutritionist (check with your local hospital). Your change in habits should consider the following:
• Avoid alcohol -- “empty calories” with no nutritional value.
• Eliminate sweets (soda, candy, cake, cookies, pie, etc.).
• When eating a carbohydrate product such as bread, pasta, or rice, switch to a whole-grain product and limit your quantities.
• Don't try to eliminate fat altogether from your diet. To remain healthy, approximately 30% of our diet should come from the consumption of healthy fat. In addition, fat is more satiating, so you are less likely to eat between meals. Most of your fat consumption should come from monounsaturated or polyunsaturated fat (fish or plant-based oils such as olive oil). Saturated fat should be limited (animal fat such as red meat and full-fat dairy products). Trans fat products should be eliminated altogether. Trans fat usually occurs in processed foods like margarine, commercial baked goods, and fast food.
• Never eat “fast food”!
• Cook your own food. This allows you to use healthy ingredients, enables you to see exactly what you are putting into the recipe, allows for better portion control, and tends to make you eat slower since you want to appreciate the work you put into your meal.
• Eat slowly. When you eat slowly, your brain can catch up to your stomach in realizing that you are getting full. You can also trick your brain into thinking that it needs less by eating something bulky such as a salad before your meal or drinking a glass of water before your meal. You can also eat a small portion of something high in protein and fat, such as a handful of nuts, 20 or 30 min. before your meal.
• Incorporate a source of protein in each meal.
• Drink plenty of water -- up to 6 glasses of water every day (unless you must restrict fluids for other health reasons).
• Avoid second helpings.
• Use a salad plate to reduce your portion sizes (in place of the dinner plate).
• If hungry between meals, choose a healthy snack (fruit) over an unhealthy snack (ice cream, potato chips).
• Eat at regular intervals throughout the day. Eating next to nothing for breakfast and lunch and then inhaling everything in sight at the end of the day is not healthy and you won't burn up many of those calories while you're sleeping.
• Don’t associate eating with other activities (reading, watching television, etc.).
• Try not to eat for the wrong reasons (boredom, stress, depression).
• Eat out less often -- when you do eat out, be selective in your choices.

Adding a regular exercise routine to your daily regimen is essential for continued health. Not only does exercise burn up calories, but it improves your general conditioning, health, strength, and mobility. However, don't be fooled into thinking that exercise gives you a license to eat whatever you want. Most people overestimate the amount of calories burned during exercise. Exercise is employed as an adjunct to proper eating. It is not in place of proper eating. Exercise does not have to be tedious and boring. Choose an activity that you enjoy such as tennis, golf, swimming, or dancing. Even 30 minutes of brisk walking every day will make a difference. For a more disciplined approach, look into your local YMCA or fitness center. Incorporate strength training (weights or resistance machines) into your exercise schedule. This will help maintain your muscle mass, which in turn helps you burn calories more efficiently. Also consider adding yoga or Pilates. Both of these help maintain strength and flexibility and will help with conditioning the core part of your body (midsection) which is often problematic in menopause. Of course let’s not ignore all of those excuses we have for not exercising:

“I don’t have the time to exercise.” Do you have time to read or watch television? If so, you have the time to exercise. Both of these can be done while exercising. Buy a treadmill or exercise bike and put it in front of the television (makes it harder to ignore).
“I’m too tired to exercise. By the end of the day, I’m exhausted!” It seems paradoxical, but exercise is more likely to energize you than cause fatigue.
“I have arthritis (or bursitis, or tendinitis -- insert your own “itis”) so I can’t exercise.” Nice try, but I’m not buying it. There is usually some form of exercise that can be adapted to suit your medical condition. In the case of arthritis, you will probably do well in a swimming pool (pool aerobics are great), which takes the weight off your joints.
We are talking about a serious commitment. You have to dedicate yourself to changing years of poor eating habits. In some cases, we’re talking about a major overhaul in lifestyle. However, if you have the resolve to make this commitment, you will not only lose the pounds, but keep them off. 



Aren’t there medications that help you lose weight? 

Medications can help you lose weight, especially when coupled with a diet and exercise regimen. However, the additional weight loss is often modest (10 pounds), tends to level off after six months, and rebounds when the medications are discontinued. You must change to a healthier diet and exercise to maintain weight loss over the long run. Prescription medications are only indicated in severely obese patients with a BMI of 30 or above (or 27 and above if there are additional obesity related conditions such as diabetes).

 
The first class of medications that can be used for weight loss are appetite-suppressant medications, which promote weight loss by decreasing appetite or increasing the feeling of being full. Medications in this class include phentermine, phendimetrazine, and diethylpropion, and lorcaserin (Belviq), a newcomer approved by the FDA in June of 2012. There are a myriad of side effects that may appear with the use of appetite-suppressant medications. Most of the side effects are mild and usually improve with continued use. They cannot be used in people with certain medical conditions and serious (even fatal) outcomes have been reported. It is important that these medications be prescribed only by physicians with a thorough understanding of their potential adverse effects. Medications in this class should generally be used for several weeks, or several months at most. They are not intended for long-term use.
A second class of medications approved for weight loss are lipase inhibitors, or fat blockers. Xenical (orlistat) was approved for weight loss and is now available over-the-counter as Alli. Lipase inhibitors work by blocking 30% of dietary fat absorption. Side effects include abdominal cramping, passing gas, leakage of oily stool, increased number of bowel movements, and the inability to control bowel movements. The side effects may be worsened by eating foods that are high in fat and therefore patients should combine the medication with a low-fat diet. They reduce the absorption of some vitamins, so patients taking Xenical or Alli should take a multivitamin at least two hours before or after taking the medication.

 
There are additional medications normally used to treat other conditions but used off-label, in other words, without FDA approval for weight loss, including buproprion (antidepressant), topiramate and zonisamide (anti-seizure), and metformin (diabetes). Once again, they should only be used in situations where their benefit clearly outweighs the risk. No medication prescribed for weight loss should be used in a patient who is mildly or moderately overweight.

 
When is surgery indicated for obesity?


Surgery is a rather drastic approach to weight control. However, it can be a life saver for those who fail all other methods. Roughly 1 in 25 Americans is morbidly obese. Bariatric surgery, which includes gastric banding and gastric bypass techniques, is indicated for anyone with a BMI of 40 or above (roughly 100 pounds overweight for men and 80 pounds for women) or for someone with a BMI of 35 or above if they have obesity associated conditions such as hypertension, Type 2 diabetes, heart disease, sleep apnea, and high cholesterol. In these situations, the risk of getting sick or dying from obesity related conditions outweighs the risk and potential complications of surgery. Improved surgical techniques and the availability of laparoscopic surgery have greatly improved outcomes from bariatric surgery. In the vast majority of cases surgery successfully helps men and women dramatically reduce their weight, improving the quality of their life tremendously. Of course, surgery should still be combined with dietary changes and exercise in order to optimize benefits. Most bariatric (obesity) surgery programs hold periodic information sessions that can be invaluable in helping you decide whether this is an option that is right for you.


What is a hot flash?

You want the windows open. He wants them shut. What the heck is going on here? You may be experiencing hot flashes. Hot flashes, also referred to as hot flushes, are sudden, warm, flush feelings throughout the head, neck, and chest area. They may be quite dramatic. Often they appear with sweating, particularly at night. They may also be accompanied by insomnia, dizziness, or palpitations. A generalized sense of warmth, or intolerance to heat is not considered a hot flash. Hot flashes are directly related to a reduction in estrogen production. They are usually most prominent after menstruation has ceased completely, but may begin while you are still intermittently getting periods.

Why is sex painful since I stopped getting periods?

You’ve stopped getting periods. Terrific! Now you don’t have to worry about getting pregnant. This should put a shot of adrenaline into the ol’ sex life. But wait, something isn’t right. Intercourse is painful. You have vaginal dryness and burning. What’s happening? You probably have vaginal atrophy.

Estrogen sustains the lining of the vagina, referred to as the vaginal mucosa. Without estrogen, the mucosa thins and losses its normal elasticity. The normal moisture of the vagina is reduced causing dryness and irritation. Over time (months to years), the caliper of the vagina diminishes. All of these factors lead to painful intercourse. The vagina may even burn or itch without sexual activity. This is called atrophic vaginitis. The lining of the bladder also atrophies in menopause. This may cause symptoms of urinary burning or urgency.

Atrophic vaginitis is corrected with estrogen replacement. Within several months of beginning estrogen replacement, the vagina will regain its normal elasticity and lubrication. Even very small amounts of estrogen cream administered vaginally once or twice weekly can reverse atrophic changes. Nonhormonal moisturizing products (Gyne-moistren, Replens, Hyalo GYN) are also available to help those with vaginal dryness. They are particularly useful for women who have absolute contraindications to estrogen replacement (see below). Products are also available that enhance lubrication during intercourse such as Lubrin, Vagisil Intimate Moisturizer, Astroglide, and 1000 different KY productsl (OK that may be an exaggeration). Experiment to see which one you prefer. All of these nonhormonal preparations are available over-the-counter in the feminine hygiene section of your pharmacy or supermarket. Longer lasting silicone based lubricants are also available such as Millenium ID or Pjur silicone although you might have to purchase it online.

Another new option for vaginal dryness is Osphema, a once daily medication taken orally, which on the surface sounds ideal, certainly less messy than using vaginal products. However, keep in mind that Osphema is circulating throughout your entire body and binding to estrogen receptors elsewhere. While it appears to be rather safe in the initial studies, we do not have long term data on its use.

I don’t seem to have any sex drive. Is that because of menopause?

“I used to have a great sex drive. Now I’d just as soon see him go out with his buddies. What’s wrong? How can I get my sex drive back?”

Decreased libido, or sex drive, is frequently seen in menopause. You may also experience diminished sensitivity to sexual stimulation of the nipples and clitoris. Decreased arousability can then reduce your capacity for orgasm. This may be secondary to a decrease in ovarian hormone production. Estrogen replacement may help this problem, although sex drive in women correlates more with androgen production. Androgens, such as testosterone, are thought of as “male hormones”. However, the ovaries and adrenal glands of women make small amounts of androgens. If decreased libido is a significant problem for you in menopause, your doctor can begin estrogen replacement.
Estrogen, given orally, transdermally, or vaginally, may indirectly improve sex drive by improving vaginal lubrication and comfort, thereby making sex more enjoyable. If this does not correct the problem, a small amount of testosterone can be added to the hormone replacement. Although substantial evidence suggests that testosterone therapy improves sexual well-being in postmenopausal women with loss of sex drive, there is currently no FDA approved testosterone replacement therapy for women in the US (although this is likely to change, so ask your doctor). There is one product, Estratest, that combines estrogen and testosterone for hormone replacement. However, oral testosterone products are not generally recommended for women since they may adversely affect lipid levels (like cholesterol) or induce insulin resistance (like diabetes). Until there is an improved transdermal product, pharmacists can compound a testosterone cream or ointment under the direction of your gynecologist. 

The potential risks of testosterone replacement include a small chance of masculine icing side effects such as increased facial hair, male pattern baldness, acne, deepening of voice, and clitoral enlargement. Don't let us give you the wrong impression. It is very uncommon to see any of these effects from the doses of testosterone used to increase libido. There is no evidence from current studies that transdermal testosterone therapy, in formulations designed for women, adversely affect lipid levels, carbohydrate metabolism, blood pressure, or blood coagulation. Testosterone treatment may increase bone density and lean body mass (muscle) while reducing body fat in postmenopausal women. Whether testosterone therapy raises breast cancer risk is a concern that is unanswered. Although there is no evidence to date that transdermal testosterone therapy increases the risk of breast cancer in postmenopausal women, well-designed studies have not been of sufficient size or duration to permit a clear conclusion.

So what is all the fuss about the “Pink Pill” we had been hearing about on shows such as ABC’s Nightline. The pill in question is Flibanserin ( brand name Addyi), and no it is not the female Viagra. Viagra, Cialis, and Levitra all treat erectile dysfunction. Flibanserin stimulates chemicals, referred to as neurotransmitters, in the brain which are responsible for generating positive emotions, pleasure, and areas that control female sexual desire and sexual arousal. It was initially designed as an anti-depressant but was found to have benefits in improving sexual desire. This is not a magic pill that will instantly jumpstart your sex drive, but it can be useful in helping some women. In my review of five studies involving thousands of women, all of the studies demonstrate a statistically significant improvement in satisfying sexual encounters, overall improvement in sexual desire, and reduced distress associated with low sexual desire when compared to placebo (women taking a pill without the medication). The improvement over placebo is modest with a 10% to 20% greater response than placebo. Women on the placebo tablet were often found to have a 30% improvement in their sexual function, while those on Flibanserin tended to have a 45 to 50% improvement. Approximately 15% of women will have side effects from Flibanserin with the most common being somnolence, dizziness, nausea, and headache. While these are not pleasant if experienced, they are also not dangerous and will cease with discontinuation of the medication. Occasionally women will have a significant drop in their blood pressure with fainting and this is accentuated with alcohol so women on Flibanserin should not consume any alcohol.


Decreased libido often arises from factors unrelated to hormone production.
Medical conditions such as depression, iron deficiency, and hypothyroidism should be excluded. Medications, particularly antidepressants and antipsychotics, should be reviewed for their possible impact on sex drive.

 Menopause is a time of transition. You may have children leaving the house, a change in the location of your work (from the house to the workplace or vice versa), a new career, or a partner undergoing his own changes. All of these can lead to stress and changes in your relationship which can impact your sex drive. Make sure that you make time for each other, both in the house as well as getting away together. Tried to embrace some new, fresh adventures or hobbies that can help build, or rebuild, intimacy. Ultimately, sex is more about intimacy than lust. If you sense that the intimacy between you has been lost, work on it. If you don't know how, seek the help of a therapist. 



I feel depressed. Is that related to menopause?

Menopause is not associated with depression in the majority of women. However, decline in the production of ovarian hormones may induce mood disturbances in some women. In menopause, women may present with depressed mood, fatigue, irritability, anxiety, and sleep disturbances. It is not known whether these are directly attributable to the decrease in estrogen. Some of them may be secondary to the physical symptoms of menopause (hot flashes, night sweats, insomnia). There is no doubt that there are hormone receptors in the brain. Animal studies indicate that changes in hormone levels alter the activity of neurotransmitters (chemicals in the brain). This alteration could induce depression or other mood disturbances in susceptible women. Women at high risk for depression during menopause include those with a past history of depression (or severe premenstrual mood disorder) and those with a family history of depression.

Menopause occurs during mid-life, a time of transition. Women who have previously invested time and energy into raising children must redefine their role and explore other avenues for fulfillment. Mid-life is often accompanied by other stresses. You may have to care for infirm parents. Health problems may develop in you or your spouse. Friends may be lost through illness or relocation. Coping with these and other mid-life challenges may be difficult and lead to mood disturbances.

Your personal perspective on menopause and the views of our society influence your ability to confront menopause. For some women, the thought of losing their reproductive capacity is upsetting. It diminishes their sense of femininity and impacts on their self esteem. It certainly doesn’t help that North American society is youth oriented. Negative stereotyping of aging women promotes an “over-the-hill” mentality. It is interesting that women usually have an easier transition through menopause in cultures that place value on advancing age (increased privileges and stature).

You don’t have to know whether your mood changes are directly attributable to declining ovarian function. Presuming you don’t have any contraindications (ask your doctor)and you are aware of the risks and benefits of hormones, your doctor can begin estrogen replacement. It certainly appears that the administration of estrogen enhances mood in many women during menopause. Lack of general energy, and a diminished sense of well-being may also result from testosterone deficiency. Adding testosterone to the hormone replacement regimen may benefit mood more than estrogen alone. If you magically turn into a new person, the mood changes were probably related to the decrease in your hormones.

Another approach, particularly if mood changes are severe, is evaluation by a psychologist or psychiatrist. Given the fact that there are other risks associated with hormone replacement therapy, it is not unreasonable to consider use of an antidepressant preferentially over hormone replacement.

As you approach menopause, consider all the positives. The departure of your children creates more time for you to explore new activities and hobbies. It may give you the opportunity to reenter the work force or devote more time to your current job. Perhaps you can finally travel to those places that were inaccessible while the children were at home. You and your husband may have the chance to spend more time alone, thereby strengthening your relationship. Your sex life may flourish now that you are freed from concerns about unplanned pregnancy. There is no substitute for experience. You have acquired wisdom and insight throughout your life that enable you to tackle challenges that weren’t approachable in your youth.


What is the latest update on hormone replacement therapy?

Prior to the year 2000, it was standard for gynecologist to recommend hormone replacement therapy for all postmenopausal women. "Observational" studies, that is to say those studies following women over many years, found that hormone replacement therapy (HRT) helped protect against heart disease. Since heart disease kills more women than all other diseases, it was natural to think that HRT was beneficial. However, several "randomized clinical trials", studies that are felt to be more scientific in their design, were published and seemed to indicate that there was no cardioprotective benefit to hormone replacement therapy. The most noteworthy of these studies, The Women's Health Initiative (WHI), was published in 2002.

The WHI study found that there was an excess risk for heart attacks, strokes, breast cancers, and blood clots (in the leg or lung). They did find that there were fewer hip fractures and fewer cases of colon cancer, but the overall risk of hormone replacement therapy outweighed those benefits. It is important to realize that the excess risks found were fairly low:
• 7 additional cardiac events per 10,000 women per year of use
• 8 additional strokes per 10,000 women per year of use
• 8 additional cases of breast cancer per 10,000 women per year of use
• 18 additional cases of blood clots per 10,000 women per year of use
The WHI only looked at a particular hormone replacement therapy which combined Premarin (conjugated estrogens) and Provera (a synthetic progesterone). A second arm of the study looked at women who were using Premarin alone (women who have had a hysterectomy do not require progesterone). The women taking Premarin alone did not have a higher risk of breast cancer or heart disease. However, they still had an excess risk for strokes and blood clots. Following the WHI, physicians began to recommend hormone use only for short periods of time in women with severe menopausal symptoms. Women already taking HRT were encouraged to stop their hormone replacement.

More recently, scientists have asked, "How could there be so many discrepancies between the findings of prior observational studies and the newer randomized clinical trials?" The answer may be in the timing of hormone replacement therapy. Observational studies tended to follow women who started hormones close to their menopause and continued them for long periods of time. The randomized clinical trials tended to enroll women farther from their menopause and followed them for a smaller number of years. Analysts have looked more closely at the WHI and have found that the risks are very different for women in their 50’s than women in their 60’s and 70’s. Women in their 50s from the WHI study were not found to have an excess risk of cardiac events, and in fact, appear to have a cardioprotective benefit (and overall lower mortality rate). Likewise, the excess risk for stroke is not seen until the sixth decade. Looking at breast cancer risk, there is still a small excess risk for breast cancer for women using combination HRT (both estrogen and progesterone), but not in the women taking estrogen alone for a relatively short number of years. While there was still a small excess risk for blood clots for women in their 50’s, more recent studies suggest that this risk may be eliminated, or significantly reduced, by using non-oral preparations of estrogen (such as an estrogen patch or gel).

The other major benefits of estrogen relate to “quality of life” issues. Hot flashes, night sweats, and vaginal dryness are most effectively eradicated through estrogen replacement. The increase in facial hair often seen with menopause is decreased with estrogen replacement. Genital prolapse (see chapter 15) is also less likely. Symptoms that may improve with hormone replacement include insomnia, palpitations, mood disturbances (see above), decreased sex drive, and urinary frequency. These symptoms are not always related to menopause. However, when they are caused by menopause, estrogen replacement is beneficial. "Quality of life" issues are not addressed as medical benefits when studies evaluate hormone replacement but your doctor should certainly take them into consideration when helping you decide whether hormone replacement therapy is right for you

So what reasonable conclusions can be derived about the risks and rewards of using hormones in menopause? The latest analysis would suggest that while there is still a small risk for increasing breast cancer and blood clots with combination HRT, there may be a cardioprotective benefit in this age group that outweighs those risks. While it would still not be recommended to use HRT in women without menopausal symptoms, many gynecologists now feel more comfortable using HRT in women in their 50’s who are symptomatic. Reanalysis of the WHI data would still suggest that we should not institute HRT in women in their 60’s or 70’s. There will be some women in that age group who have sufficiently severe menopausal symptoms to recommend continuing HRT, but that should be the exception, not the rule.

The excess risk of blood clots may be reduced, or eliminated by using estrogen patches (or other estrogens absorbed through the skin) instead of pills, and the adverse consequences of adding Provera, or another synthetic progesterone, to HRT (needed to protect the uterus) may be reduced by using natural progesterone (brand name Prometrium). Randomized clinical trials are necessary to evaluate these premises.

 

What type of hormones should I take? How are they given?

The premenopausal ovary produces estrogen, progesterone, and a small amount of androgens such as testosterone. Almost all the benefits of hormonal replacement derive from estrogen. Therefore, estrogen is the foundation of any hormone replacement regimen. However, unopposed estrogen (without progesterone) increases the risk of endometrial cancer (see below). Women who have not undergone hysterectomy must also take progesterone to balance the effects of estrogen on the endometrium. Women with decreased sex drive, fatigue, or a diminished sense of well-being may benefit from the addition of testosterone although each of these symptoms are often unrelated to sex hormones. Most physicians do not routinely add testosterone to their hormone replacement regimen.

 Hormones are given in many formats. Pills, patches, implants (under the skin), injections, creams, suppositories, vaginal rings, and intrauterine devices have all been used. Oral administration (tablets or capsules) and skin patches are the two most common modalities for estrogen replacement in the USA. Estrogen tablets are usually taken daily. The patch is changed once or twice weekly. Patients with gastrointestinal distress from estrogen tablets may do better with the patch. There are certain theoretical benefits in using the patch in women with gallbladder disease, headaches, high blood pressure, hypertriglyceridemia (high triglycerides), or diabetes. There's also some evidence to suggest that women using transdermal estrogen (patches, creams, gels) have less risk for venous blood clots, a well-known risk with oral estrogens. Women who get skin reactions from the patch may do better with tablets. Women using estrogen primarily for vaginal symptoms may benefit most from vaginal creams or tablets, or the vaginal estrogen ring.

 Not all estrogens are the same. Traditionally, the most common estrogen used in replacement regimens has been Premarin, which is actually a composite of many estrogens derived from the urine of pregnant horses. Decades of experience with Premarin provided physicians with confidence in its use. Most of the studies that evaluate the effects of estrogen on women have looked at Premarin. Other physicians prefer to use estrogens similar to those found naturally in women. These are either synthesized or obtained from plant sources. Each physician tends to have his preference and there is no good evidence to support the superiority of one brand over another. Most hormonal regimens provide you with estrogen continuously. Some physicians have you stop the estrogen for 5-7 days each month although there is no evidence to suggest that this is necessary.

There is more variation in how physicians give progesterone. If you had a hysterectomy, there is usually no need for progesterone. Remember, the progesterone is only given to decrease the risk of endometrial cancer. In certain situations, such as hormone replacement after hysterectomy for endometriosis, progesterone may also be given. There are two basic regimens for giving progesterone. The cyclic regimen provides you with progesterone for 10-14 days periodically (every 1-3 months depending on the dose of estrogen). You will typically get a menstrual period after the progesterone is stopped each month (No, you can’t get pregnant). However, many women aren’t thrilled with the prospect of resuming menses. For that reason, many physicians have switched to a continuous regimen. In the continuous regimen you receive a smaller amount of progesterone every day. Up to 40% of women will have erratic bleeding initially on this regimen. By the end of one year, 80% of women will no longer have any bleeding. The most common progesterone prescribed is medroxyprogesterone acetate(Provera, Cycrin). However, others may be used with similar protection of the endometrium. Natural progesterone (Prometrium) may also be given, particularly when women experience side effects from the synthetic progestins.

 What about Bioidentical hormones?

Periodically, you will see the promotion of a concept referred to as "bioidentical hormones". The name is actually a bit of a misnomer. The hormones which are identical to those produced by your ovary before menopause are estradiol and progesterone. Both of these are available in FDA approved formulations. When people refer to bioidentical hormones, they are usually referring to an estrogen product that is a combination of two or three estrogens, dominated by estriol, a weaker estrogen that is produced in large quantities during pregnancy. Proponents of estriol suggest that it does not increase breast cancer risk, in contrast to the more potent estradiol, and even go as far as suggesting that it may protect against breast cancer. While there is some intriguing science behind this theory, we do not have randomized, prospective clinical studies to support this contention. At this time, there is no FDA approved estriol product. Hormone replacement regimens that include estriol must be compounded by a pharmacist. While this may be reasonable, there is at least the potential for more variability in the product you are receiving and you will pay "out-of-pocket" for your hormone replacement. Insurance companies do not generally cover products that are not approved by the FDA. The American College of Obstetrics and Gynecology and the North American Menopause Society do not support the use of compounded estrogen preparations at this time.

Bioidentical, natural progesterone is available as Prometrium (now available as generic progesterone capsules), which is FDA approved. There is some evidence that natural progesterone may be a better progesterone for use in hormone replacement therapy. Some of the beneficial things we see estrogen do for the heart such as improving cholesterol and dilating coronary vessels is offset when one adds the synthetic progesterone, Provera. This does not happen when natural progesterone is added. In the laboratory, breast cell proliferation seems to be induced by synthetic progestins, but not natural progesterone. However, once again, we do not have randomized, prospective studies that demonstrate the superiority of natural progesterone over synthetic progestins in hormone replacement therapy regimens. Prometrium is compounded in peanut oil so it is contraindicated in patients with a peanut allergy.

You will also see natural progesterone cream promoted as an alternative to standard hormone replacement therapy. The best designed scientific studies have shown little or no benefit of progesterone cream over placebo in the resolution of menopausal symptoms. The transdermal absorption of progesterone, and the amount of actual progesterone in creams, varies tremendously. If you would like to use a progesterone cream alone, there is little or no risk in doing so, but it is not recommended to use progesterone cream for the purpose of protecting the endometrium in women who are taking estrogen replacement.

 Do I have to wait until I stop getting periods to begin hormone replacement?

 You are still getting fairly regular periods, but have noticed progressively worsening hot flashes, and night sweats. Perhaps your mood swings are “off the chart”. You’re wondering if this could be menopause, but your doctor says, “No, because you are still getting periods.” To be fair, you both are correct. By definition, you are still producing premenopausal levels of estrogen. You will no longer menstruate when the estrogen level falls into the menopausal range. However, if you are producing estrogen with greater variability, you can still experience menopausal symptomatology. If the symptoms are severe, there is no reason why you can’t begin hormonal supplementation as long as it’s balanced with both estrogen and progesterone. Some physicians will provide you with hormonal supplementation in similar fashion to postmenopausal, cyclic hormone replacement regimens. Others will recommend low dose oral contraceptives if you do not have any contraindications to their use. Low dose oral contraceptives are a particularly good choice if you also have either heavy or irregular periods.

 Is there an age when it is too late to start hormone replacement?

 The ideal time to start hormone replacement is immediately after menopause. The most recent evidence would suggest that hormones begun shortly after menopause pose little or no additional adverse risk for strokes or heart attacks. This does not seem to be the case in later decades. Data from the Women's Health Initiative study suggests an excess cardiovascular risk in older women (beginning in the sixth decade for stroke, and the seventh decade for heart attacks). Current recommendations promote the use of hormone replacement therapy only for the indication of menopausal symptoms, and only for the shortest amount of time necessary. The emergence of new menopausal symptoms in the sixth and seventh decades of life (symptoms that were not there at the time of menopause) is extremely rare and unlikely to be related to sex hormone deficiency. Hot flashes or night sweats that develop for the first time late in life are more likely related to other medical conditions such as thyroid disease or instability of the autonomic nervous system.

Should I avoid hormones because they cause cancer?

 The Women's Health Initiative Study found a small excess risk for breast cancer in women using Prempro, a combination of conjugated estrogens (Premarin) and a synthetic progesterone (Provera). In 100 women, this would result in 1 to 2 additional breast cancers developing over a period of 20 years of hormone use. Obviously this risk is less if hormones are used for a limited time, and has very little impact if hormones are only used for 2 to 3 years during the menopausal transition. Interestingly, the Women's Health Initiative did not find an excess breast cancer risk in women using estrogen (Premarin) alone, and in fact found a lower risk for breast cancer in that group. This would suggest that the synthetic progesterone (Provera), was a greater culprit in causing breast cancer compared to the estrogen (Premarin). Other studies would suggest that long-term use of estrogen alone (10 to 15 years or more) probably does increase the risk of breast cancer, although not nearly as much as combination hormone replacement therapy (replacement therapy with estrogen and progesterone together). There is a suggestion that natural progesterone may not have the same adverse impact on breast cancer risk as synthetic progestins, but this is yet to be proven. Women who still have their uterus, must add progesterone to their hormone replacement regimen. Otherwise there is an excess risk for endometrial cancer, cancer of the inside lining of the uterus. Adding progesterone eliminates that excess risk when given appropriately.

Use of hormone replacement in menopause is always a balance between the severity of symptoms versus potential excess risks. Because the excess cancer risk is relatively small, you may be a good candidate for hormone replacement therapy if your symptoms are severe enough to adversely impact your ability to function at work or in the home, or if your symptoms are adversely impacting your relationships with other people. Because the risk increases with time, it makes sense to periodically reduce your dose of hormone replacement therapy, and eliminate its use when symptoms become more tolerable.

What side effects will I get from hormone replacement?

 The two most common complaints I receive from women beginning hormone replacement are bleeding and breast tenderness. Intermittent bleeding is not unusual when hormone replacement therapy is first begun and tends to disappear over time. If it persists beyond the first year, further investigation would be appropriate to rule out other pathology. Breast tenderness is another common complaint. It is most likely to be a problem if you had severe, premenstrual breast tenderness before menopause. The tenderness usually disappears after menopause, only to return when hormone replacement is started. Breast enlargement may also occur. Breast tenderness from hormone replacement sometimes improves over time. Decreasing caffeine and taking supplemental vitamin E (400-800 units per day), evening primrose oil ( 3-4 gms daily), or DIM (Diindolylmethane 100-300 mg. daily0 may help. If severe, adding a small amount of testosterone to the hormone regimen may reduce the breast tenderness.

Gastrointestinal distress including nausea, cramping, and bloating may be experienced as a side effect of hormone replacement. These tend to dissipate over time. The symptoms may also be reduced by changing to a different brand of estrogen or a different method of administration (transdermal versus the oral route), and also by reducing the dose.

Less common side effects include, headaches, mood disturbance, skin changes (particularly a spotty darkening of the skin when exposed to the sun), and fluid retention. You are also more likely to develop gallbladder disease on oral hormone replacement therapy.

 “What about weight gain? Aren’t those hormones going to make me gain weight?” You may gain weight, but it probably won’t be caused by the hormone replacement. Many women will gain weight at this time in their life whether or not they use hormone replacement. As your activity level decreases and your metabolic rate slows, your weight increases. You must either eat less (reduce fatty foods) or exercise more to keep your weight stable.

Most women tolerate hormone replacement with little or no side effects. You are far more likely to experience beneficial effects (decreased hot flashes and night sweats, prevention of vaginal dryness, less frequent urination, improved sleep, better mood) than detrimental effects. The possibility of getting a side effect should not prevent you from considering hormone replacement. If you develop a side effect that cannot be managed, you can always discontinue the therapy.

 Are there women who can’t take hormones?

 Some women are not candidates for hormone replacement therapy. Traditionally, women with a history of breast or endometrial cancer cannot use hormone replacement. The risk of recurrence may be increased if estrogen is given under these circumstances. More recently, physicians have begun to consider hormone replacement if the cancer was very early (your risk of recurrence is low) and /or you have been free of disease for a long time (usually considered to be at least 5-10 years). This is very controversial and the vast majority of physicians will not prescribe hormone replacement if you have had either of these cancers.

Historically, deep vein thrombosis (DVT) has been a contraindication to hormone replacement. DVT is the formation of blood clots in the large veins of your legs. We’re talking about the deep veins in your legs, not the superficial veins that are readily visible. Blood clots in the deep veins can travel to your lungs (pulmonary embolism), which is potentially life-threatening. Estrogen has effects on various factors responsible for regulating blood clotting. There are large case cohort studies which suggest that transdermal estrogen does not increase the risk of DVT in the same way that oral estrogens do. However, most physicians will not prescribe any type of hormone replacement therapy for a woman who has had a DVT or is predisposed to developing blood clots. If there is reason to suspect that you may be at an increased risk for DVT (usually based upon family history), further testing can be performed.

Women have an increased risk of gallbladder disease with oral hormone replacement. If you currently have gallbladder disease or assymptomatic gall stones, hormone replacement may not be in your best interest. This disadvantage must be weighed against the benefits that the hormones will provide your quality of life. Keep in mind that you can live perfectly fine without your gallbladder. If you are miserable from your menopausal symptoms, hormone replacement should still be considered. In this situation, however, I would recommend a transdermal estrogen preparation (patch, cream, or gel), which is much less likely to alter gallbladder function.

Diabetes (high blood sugar) and hypertension (high blood pressure) are two diseases that were previously considered“relative contraindications” to hormone replacement. Neither of these are currently considered to be contraindications. Estrogen replacement does not significantly alter these conditions.

 Active liver disease (hepatitis) may also contraindicate the use of hormones. Estrogen is metabolized (eliminated from your system) by your liver so it must be used with caution when there is liver dysfunction.

 What else can I take for my symptoms other than hormones?

 What can you do if you or your physician decides that hormone replacement is not an option but you have menopausal symptoms? Vaginal moisture can be somewhat restored with the use of over-the-counter products (Replens, Gyne-moistrin, and lubricants) and there are several types of nonhormonal prescription medicines which have been used to reduce vasomotor symptoms (hot flashes and night sweats).

The most commonly used alternatives to hormone replacement therapy are products that normally would be used for depression, SSRI’s and SNRI’s. One of the better studied of these medications, and the one that I tend to prefer, is venlafaxine (Effexor). Other SSRIs can be helpful, including fluoxetine (Prozac, Sarafem), paroxetine (Paxil, Brisdelle), citalopram (Celexa) and sertraline (Zoloft). Clonidine (Catapres) is usually used for treating high blood pressure.However, it has also been used as a treatment for hot flashes and night sweats. It is administered either orally or as a patch (changed weekly). Gabapentin (Neurontin), a drug more typically utilized for seizures or nerve pain syndromes, is a more recent addition to the list of medications used for menopausal symptoms. It is important to understand that none of these medications are without risk or potential side effects so their use must be discussed with your physician prior to their consideration.

We’re often asked about the use of "natural" products for the treatment of hot flashes. All of the products listed below have advocates within the complementary and alternative medical (CAM) community. As you will see, many of these have had mixed results when subjected to scientific scrutiny:

 

·         Phytoestrogens: Numerous plants have estrogen-like substances called phytoestrogens (the most common being isoflavones). Advocates of phytoestrogens propose that these are safer because they are far less potent than prescribed estrogens. Foods high in phytoestrogens include soybeans and soybean products such as soy milk and tofu. Phytoestrogens are also derived from some vegetables and berries as well as grains, seeds, and sprouts. Well-designed scientific studies in humans are rare, and those that do exist are conflicting in their conclusions. Women who want to consume phytoestrogens should do so through food products rather than supplements, and should aim for 100 mg of isoflavones per day or 25 g of soy protein (http://www.hss.edu/files/Soy_Phytoestrogens.pdf ).

                   ·         Red Clover: Red Clover is a member of the legume family and contains at least four estrogenic isoflavones. These have been extracted into a product called Promensil.  Most studies have not found Promensil to be significantly better than placebo in relieving hot flashes.

  •                    Black Cohosh : Black cohosh is perhaps the most commonly found ingredient in over-the-counter products promoted for menopause (Estroven,Remifemin). There have been many studies looking at black cohosh. Many of these studies have design weaknesses and more research is needed. Although definitive evidence of significant benefit is lacking, black cohosh does appear to be safe and may have efficacy in the treatment of menopausal symptoms in some women. It should be administered initially at 20 to 40 mg twice daily. It may take 4 to 8 weeks to feel an effect. Adverse effects are rare and include G.I. upset, headache, and dizziness. In laboratory studies, black cohosh appears to suppress rather than stimulate breast cells and appears to have an inhibitory effect on the estrogen receptors of breast cancer cells. However, there is no long term study looking at the safety of black cohosh beyond 12 months in patients with or without breast cancer.

·         Ginseng: There is no evidence to support the use of ginseng for the treatment of hot flashes and night sweats. However, one well-designed study looking at panax ginseng showed significant improvement in symptoms of depression and sense of well-being. Panax ginseng should not be taken with stimulants because it may cause headache, breast pain, diarrhea, or bleeding. The recommended dosage is 100 mg of a standardized extract twice daily for three out of four weeks.

·         Dong quai:  Dong quai has a long history of traditional use in menopause and menstrual disorders in Asia. However, there is no evidence to support the use of dong quai as a single agent in the treatment of menopausal symptoms. Its use in combination with other herbs, as it has been traditionally used in Asia, has not been well studied.

·         Kava:  Evidence has shown that 100-200 mg three times per day (standardized to 30% of kavalactones) decreases anxiety, irritability, and insomnia associated with menopause. Kava is often combined with other components such as black cohosh and valerian, for the management of menopausal symptoms. Kava has the potential for significant, albeit rare, side effects. Cases of hepatotoxicity (liver toxicity) so severe as to require liver transplant have been reported. Other adverse effects include dermatitis and a movement disorder similar to Parkinson’s disease. Because of these adverse effects, it has been removed from many European markets. We don't recommend using it but if you do, be aware of the risks and avoid taking it in conjunction with other anxiety-reducing agents, alcohol, or acetaminophen, and have liver function tests performed periodically.

·         St. John's wort: St. John's wort has been used primarily as an antidepressant. It is used in Germany for menopausal mood swings. St. John's wort appears to be beneficial in mild to moderate depression with 60% improvement in mood, energy, and sleep with a dose of 300 mg three times per day. It is not effective in reducing hot flashes and night sweats. St. John's wort should only be started after consulting with a physician since it has multiple drug interactions.

·         Chasteberry: Chasteberry has a long history for use in the treatment of menopausal symptoms although its efficacy in menopause has not yet been demonstrated through well-designed studies.

·         Ginkgo: Ginkgo biloba is often promoted for the improvement of libido in menopausal patients. In studies, Muira Puama plus ginkgo had a significant effect in 65% of patients studied, but further trials are needed. Adverse effects include G.I. upset and headache. Ginkgo has drug interactions and has anticoagulant effects so it should only be taken after consulting your physician.

·         Vitamin E: Vitamin E has been recommended for the treatment of hot flashes dating back to the 1940s. However, more recent studies investigating vitamin E at 200-600 IU's have failed to show an effect. Higher doses (1200 IU) may be effective but vitamin E is an anticoagulant and doses this high cannot be recommended. Vitamin E is still commonly recommended in the CAM community.  If you would like to try it, do not exceed 800 IU and do not use it in conjunction with anticoagulant medications.

·         Hesperidin: Hesperidin is extracted from citrus fruit and is purported to improve vascular integrity. One study that combined 900 mg. of hesperiden, 300 mg. of hesperiden methyl chalcone, and 1,200 mg. of vitamin C was found to be effective in reducing or eliminating hot flashes. The most common side effects are GI upset and headache. The long term safety of hesperiden has not been evaluated.

·         Evening Primrose Oil: One study found a reduction in night sweats but no reduction in daytime hot flashes.  More studies are needed.

Progesterone creams are also available over-the-counter today, some with micronized progesterone (which is natural progesterone, derived from plant precursors), and others with only wild yam extracts. Manufactures may claim that these wild yam precursors have progesterone-like effects, which is misleading. There is no pathway by which the human body can convert wild yam precursors to progesterone (although this can be done in the laboratory). Micronized progesterone is absorbed across the skin, but you need a lot of cream to achieve progesterone levels comparable to those found during a normal menstrual cycle. Using progesterone cream alone poses no significant risks. However, using progesterone cream as a substitute for prescribed progesterone in a hormone replacement regimen can be dangerous. These products may not adequately balance the effects of estrogen on the endometrium.

 Various changes in your lifestyle may help you cope with hot flashes. Some women notice worsening of their menopausal symptoms under stressful circumstances. Exercise, yoga, and meditation are several things that you can try when you are under stress to help decrease the frequency of your symptoms. These also help to increase your general sense of well-being. You can also be taught progressive relaxation techniques. Relaxation techniques can be found at the National Center for Complementary and Alternative Medicine through the National Institute of Health (http://nccam.nih.gov/health/stress/relaxation.htm). Studies on acupuncture and menopausal symptoms are mixed. Acupuncture is safe so it is reasonable to pursue this path if you choose to do so. Alcohol, caffeine, and hot or spicy foods will also increase vasomotor symptoms. It makes sense for you to avoid these. Wear breathable clothing like cotton and dress in layers so you can add and subtract layers as needed. Do the same with bedding. In place of a comforter, use several ight blankets. That will give you more flexibility.

What are those new drugs that are supposed to replace estrogen, and are they safer?

 Imagine a drug that has all the benefits of estrogen but none of the risks. It protects your bones, reduces your risk of heart disease, and douses those hot flashes without any effects on your breasts or uterus. OK, the dream’s over; no such drug exists. However, scientists are evaluating phytoestrogens (see above) and other compounds that aspire to meet those lofty goals. Some of these compounds, called SERMs (selective estrogen receptor modulators), mimic estrogen in some areas of the body while blocking it in others.

Raloxifene (Evista) was the first SERM to gain approval from the FDA for menopausal women. It prevents osteoporosis and bone fractures, has no adverse impact on your uterus, and reduces your risk of breast cancer. Overall it does not appear to cause excess risk for your heart, although there may be a smallexcess risk for stroke. Like oral estrogen, it causes an excess risk for DVT. More importantly, it does not treat vasomotor menopausal symptoms. In fact, it increases the frequency, although not the severity, of hot flashes. It is therefore not indicated for the treatment of menopausal symptoms. It is a reasonable drug to be considered in women for the prevention of osteoporosis, particularly those who are at excess risk (see the question on osteoporosis). More SERMs are in development and there is certainly a possibility for one to contain most of the benefits of estrogen without most of the risks.

DuaVee is a new product that combines conjugated estrogens (similar to Premarin) with a SERM bazedoxifene. It is an option for treating hot flashes and preventing osteoporosis in postmenopausal women who still have their uterus. Duavee did not significantly raise the risk of breast cancer, endometrial cancer, or blood clots in its original studies, but it contains estrogen so these risks remain a possibility and the same women who should not use estrogen replacement should not use DUaVee. Similarly, side effects seen with the use of estrogen may also be seen with DuaVee and it has not been studied in women who have had breast cancer.

Brisdelle is a low dose of an anti-depressant paroxetine (same as Paxil). While it may decrease hot flashes similarly to other SSRI anti-depressants, it is only available as a brand name drug and will be much more expensive than simply using a generic SSRI. 

Tibolone is a drug that is commonly used in menopausal women outside of the USA. It is approved in 90 countries for the treatment of menopausal symptoms and 45 countries for the prevention of osteoporosis. It has not been approved by the FDA in the US, although it may be in the future. Metabolites of tibolone have estrogenic,progestational, and androgenic properties. Tibolone decreases hot flashes and night sweats, treats vaginal dryness, and increases libido. It also prevents osteoporosis and bone fractures. The data on breast cancer is mixed. Observational studies have tended to show an increase in breast cancer. On the other hand, a well-designed study looking at older women (60 to 85) showed a substantial decrease in breast cancer. The cardiovascular data on tibolone is a bit murkier. It decreases total cholesterol and triglycerides, which should potentially be a benefit but it also reduces good cholesterol (HDL cholesterol). Overall, it does not appear to significantly increase the risk for deep vein thrombosis (blood clots) or myocardial infarction (heart attacks). However, tibolone increases the risk for stroke. If it eventually gets approved in the US, tibolone would seem to be a reasonable choice for treating menopausal symptoms in relatively young women (those in their 50s) who do not have additional risk factors for stroke such as high blood pressure, smoking, and diabetes.

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