Margaret Polaneczky, MD's Open Salon Blog

HRT – Still No Place for Prevention

Tue, 29 May 2012 19:05:52 -0400

In a much needed and thoughtful analysis, the United States Preventive Service Task Force has summarized what we have learned about HRT since the Women’s Health Initiative was published in 2002. (See summary chart above.)

They have also issued draft recommendations on the use of HRT for prevention of disease -

The U.S. Preventive Services Task Force (USPSTF) recommends against the use of combined estrogen and progestin for the prevention of chronic conditions in postmenopausal women.

The USPSTF recommends against the use of estrogen for the prevention of chronic conditions in postmenopausal women who have had a hysterectomy.

I wholeheartedly agree.

The USPSTF Recommendations do not address the use of HRT for treatment of menopausal symptoms

That’s an important message for women who may want to consider using HRT for a year or two around menopause. In that setting, the heart disease risks are probably minimal for an otherwise healthy woman, while the breast cancer risks, while real, are quite small.

I tell my patients their breast cancer risk is about 1% higher for 20 years of HRT use, so HRT use for a few years conveys far less than even that risk. On balance, using HRT to get through the peri-menopause is not a terribly risky decision, and for women with severe symptoms, it is not an unreasonable choice.

Despite this reassurance, most of my patients with mild to moderate symptoms are choosing to forgo HRT and deal with their symptoms in other ways – exercise, reducing or eliminating alcohol, trying to lower stress. Those with more severe symptoms are still using hrt, but they are aiming for lower dosing and transdermal regimens, or considering non-hormonal alternatives such as SSRI’s instead.

It’s called informed choice. And when given that choice, these days, more women than not are choosing against using HRT.

And just in case you’re interested, here are my rules for prescribing HRT.

The USPSTF Recommendations do not address premature menopause

Most practitioners agree that women with early menopause benefit from HRT. The risks for osteoporosis in this group is quite high, and symptoms are often quite severe.

In my practice, almost all of these women choose to use HRT until they reach the usual age of menopause, at which they begin to think about it the same way the rest of my patients do and usually wean off over time.

The USPSTF Recommendations do not address vaginal estrogen use

The one symptoms of menopause that does not get better over time is vaginal dryness. Most women, unless they are very frequently sexually active, will need to use something to treat dryness.

One treatment option is low dose vaginal estrogen. Most practitioners feel comfortable prescribing vaginal estrogen, even in women at risk for blood clots and even in most women with breast cancer.

My patients, however, tend to want to avoid estrogen in any form and so they usually will try non-hormonal treatments first. I’d say that about half of these women eventually end up using vaginal estrogen.

Those who might disagree with the USPSTF

The window theory believers

The WHI naysayers will argue that no one has properly studied HRT the way in which it is most often used, and in which it is most likely to prevent heart disease – namely, starting at menopause and continuing indefinitely.

They hypothesize that there is a “window of opportunity” during which estrogen will protect against heart disease, and after which starting estrogen will worsen pre-existing heart disease.

Subgroups analysis of WHI findings suggest that they may be correct in this regard. In the WHI, women starting HRT shortly after menopause had a lower risk of cardiovascular disease than those starting 20 years or more later.

Unfortunately, even if HRT were cardio-protective, the risks of breast cancer (and stroke and blood clots) with combination HRT use cannot be ignored, and mitigate against prescribing hormones for reason of heart disease prevention.

The Gap Theory Believers

There are those who argue that the estrogen-only arm of the WHI actually showed less breast cancers, indicating a potential protective effect of estrogen on breast cancer. They theorize something called the “gap theory”, which states that estrogen, when started 10 years of more after menopause, actually acts to inhibit breast cell growth. They are supported in this by in vitro data.

Unfortunately, while the gap time theory may explain the findings of the WHI estrogen-only arm, it is irrelevant to clinical practice, since the way most women use HRT is to start it at menopause. (ie., there is no gap)

They are both right – and both wrong

If both the gap and window theories are correct (and I suspect they are), when considered together they actually support the findings of the WHI and the recommendations of the USPSTF. Starting estrogen at menopause may prevent heart disease, but it increases breast cancer risk. Waiting to start HRT may decrease breast cancer risks, but it increases the risks of clotting and stroke and dementia. Or, as my mother used to say, “You’re damned if you do and damned if you don’t.”

The benefits of HRT as they exist in practicality and theory come at a price. That price is high enough to recommend against their routine use of hormone replacement for the prevention of chronic disease.

If you have any issues with the USPSTF Recommendations on HRT -

You can submit a comment to the Task Force between now and June 26, 2012.

___________________________________________________________________________

Chart above from USPSTF Draft Recommendations on HRT

First Bread of the Season

Mon, 28 May 2012 14:05:56 -0400

We’ve only got one day to open up the cottage, having stopped along the way to taking my eldest daughter back to school for her summer research session.

There’s so much to be done. We really should clean out the gutters and scrub down the porch and the outdoor furniture.

The stone patio (and I use the word patio loosely) is overgrown; but the weeds are too pretty to pull right now, and gratefully, I let it be.

The herb garden needs weeding and replanting – only the thyme has survived.

But we’re only here for a day, so we just do the bare minimum while the girls sleep in. Mow the lawn, sweep the porch and put out the furniture, wipe down the refrigerator and the open kitchen shelves, sweep the kitchen and dispose of the two dead animals we found outside in the garbage can. (Somehow, it seems there are always dead animals…)

Then, before the day gets too far along, I head back into the kitchen to do what I love most when I am here – bake bread. We’ll serve it at lunch with egg salad made with thyme from the the garden, and sliced tomato and avocado. They’ll be plenty left to pack sandwiches for the road, and I’ll give the second loaf to my daughter to christen her new apartment at school.

Later this afternoon we’ll all head down to the lake for a cold but glorious first swim of the season. We feel so remarkable afterwards that I decide from here on in, we will shall call it “taking the waters”. The girls will sunbathe on the floating dock and Mr TBTAM and I catch up with the our neighbors and make plans for the rest of the summer. Tonight after dinner, we’ll have S’Mores on the back deck under a crescent moon, then play Boggle before an early bedtime. After all, we’ve got a long drive ahead of us tomorrow.

In a few weeks, we’ll be back again to properly settle in, but this christening has been exactly what the season needed.

Wheat Bread, No.1

This bread recipe comes from Mrs GH Leonard’s Cookbook, circa 1923, a little gem I picked up at last year’s antique fair. This is my first foray into the book, compiled by a woman who, according to the preface

…may properly be styled as one of those olden times wives and mothers who personally superintends and much of the time actually selects and prepares the food for her family.

this, of course, stands in contrast to myself, who

…may be properly styled as one of those modern times wives and mothers whose husband usually cooks weeknights and stocks the larder since he works near Fairway and sees a Saturday morning trip to Costco as sacred as completing a mignon, and who pretends she’s a good mother on weekends, when she cooks and posts recipes on her blog to create the impression that she is one of those olden times wives and mothers who… you get the point.

Mrs GH Leonard’s recipes read like recipes your grandmother might give you – rich with detail, but vague as to exact amounts and cooking times. The book also contains medicinal recipes and household cleaning formulas scattered amidst the foodstuffs – the “Antidotes for Poisons” chapter, for example, comes just before “Chafing Dish Recipes.”

I’m reprinting Mrs Leonard’s recipe exactly as written -

Take 3 pints of flour to 1 pint of wetting. The ‘wetting” may be either milk or water or half of each, but must be warmed. It mild is used, scald it and let it cool to a temperature of 75 degrees, or pour boiling water in the milk and let the milk and water cool to the same temperature. The flour should not be so cold as to cool the wetting below 75 degrees. Dissolve one cake compressed yeast in one cup warm water; add this yeast to the wetting; salt to taste; add 1/2 tbsp lard and 1 of sugar and mix with flour in a large bowl or pan in a stiff batter; place the batter on a moulding board and knead to a stiff dough; work in all the flour necessary at this kneading. Some breads require more flour than others. Grease a large bowl or pan, put in the dough, and set in a warm place to rise; also grease the top of the dough. When it has risen sufficiently, knead with as little flour as possible to keep from sticking, form into loaves and put into greased tins, pet it rise and bake. To test the oven, throw a little flour in the oven; if it browns quickly the oven is all right ; if the flour burns the oven is too hot. The fire must be hotter after the bread has been in 10 minutes. An ordinary sized loaf requires 45 minutes for baking. When taken from the oven, brush the loaf over with milk and place where it will cool quickly or near an open window.

I used 1 envelope instant yeast rather than compressed yeast. For “lard” I used olive oil, used 1.5 tbsp salt “to taste”, assumed “1 of sugar” meant 1 tbsp of sugar, and used about a cup of flour for the kneading. Following Mrs Leonard’s method for determining oven temp, I ended up with 400 degrees fahrenheit, which I raised to 425 degrees after 10 minutes of baking.

The bread was delicious – think homemade Wonder Bread, but a little more dense and without the squishiness, meaning that you can’t roll this bread up into a little ball and pop it in your mouth the way you can with Wonder Bread. Sorry. A very nice sandwich bread that should toast beautifully.

First Bread of the Season

Sat, 26 May 2012 15:05:17 -0400

We’ve only got one day to open up the cottage for the season, having stopped along the way to taking my eldest daughter back to school for her summer research session. There really is a lot to be done around here- the herb garden needs weeding and planting – only the thyme survived the winter.

The porch needs a good scrubbing, as does the porch furniture, there a more than a few cobwebs to be dealt with and the lawn is a mass of tiny wildflowers. which may please my eye, but stands like an eyesore against our neighbors more landscaped cottages. Not to mention all the projects we wanted to do last season but never got around to – getting a new stove, clearing the side yard (a mass of ferns and weeds), putting up new window treatments in Natalie’s room, getting a rug for my room…

But today is about spending time together as a family for the last time for two months, so we just do the bare minimum – mow the lawn, sweep the porch and put out the furniture, wipe down the refrigerator and the open kitchen shelves, sweep out the kitchen. We check in with our neighbors, one of whom lends us milk (Thanks, Shelly!) and the other who called the phone company this winter when our phone line got knocked down in a storm (Thanks Skip!).

And then – I head into the kitchen to do what I love most to do when I’m here – I bake bread.

This bread recipe comes from Mrs GH Leonard’s Cookbook, circa 1923.

Mrs CH Keonard may properly be styles as one of thos olden times wives and mothers who personally superintends and much of the time actually selects and prepares the food for her family.

That she does he work well is testified to by the fact that her family has been successful. Her husband, Mr CH Leonard, continuing after fifty years of exacting work to be the active head of one of the largest refrigerator manufacturing companies in the world.

These recipes were developed and assempbled through times of well asplentylm therefore they supply evey need of the average americn family.

Wives and mothers who want to be sure of servig good wholesome food, but who havent; the facilities of time to count calories, twill find this book an invaluable aid.

Osteoporosis Drugs – You Got to Know When to Fold Up …

Tue, 22 May 2012 16:05:18 -0400

If you are one of the millions of Americans taking a bisphosphonate drug for treatment of bone loss, you’ve most likely worried about what you’ve gotten yourself into. Earlier this month, the FDA took the highly unusual step of publishing the results of their investigation into reports of atypical fractures of the femur occurring in long term users of drugs like Fosamax (alendronate), Actonel (risedronate), Boniva (ibandronate) and Reclast (zoledronic acid).

Now we have yet another investigation confirming the association of these fractures with bisphosphonate use, and correlating the increasing risk with increasing duration of therapy.

When categorized by duration of treatment, compared with no treatment, the odds ratio for an atypical fracture vs. a classic fracture were 35.1 for less than two years of treatment, 46.9 for two to five years of treatment, 117.1 for five to nine years and 175.7 for more than nine years.

What’s Going On Here?

How do drugs that are supposed to prevent fractures cause new ones? That’s a good question. And the answer is complicated, so let’s see if I can simplify it.

Think of your bones as a road system that is constantly being remodeled depending on where the traffic is. There’s a large well-funded road crew constantly digging up the old road and replacing it with new road. They work in small sections scattered throughout the system, so as not to disrupt the road’s integrity. The members of the crew that digs up the old road are called the osteoclasts -

and the ones who fill in and re-pave it are called the osteoblasts.

Now suppose over time, for whatever reason – age, bad weather (underlying medical conditions), lack of road material (vitamin D deficiency, menopause) – you’ve dug up or lost more roads than you’ve replaced (Osteoporosis). So you start treatment with a bisphosphonate like Fosamax or Actonel or Boniva. These drugs work by cutting back on the digging crew, but keeping the paving and refilling going in the areas that have already been dug up, thus rapidly bringing miles and miles of untravelable road into good use. Not to mention it’s a nice strong road, becoming mineralized over time. (That’s your bone density increasing.)

The whole thing is working so well that you send almost the entire road crew on a prolonged vacation. (Suppression of bone turnover, which is how bisphosponates work) Now you’re left with a skeleton road crew (pun intended), which, for most folks is still enough to deal with the usual cracks and potholes that appear over time, and can keep the road (your bones) in good working condition. But in some of you (perhaps those who are genetically predisposed) the downsized crew just can’t keep up with the repair work. As time goes on, the structural integrity of your bones becomes weakened. And then one day, for no apparent reason, just during the course of usual activity, a small crack that the crew hasn’t yet repaired becomes a large crack – and you’ve just fractured your femur.

You don’t have to be on a bisphosphonate for these kind of atypical fractures to occur. Some folks just get them. But taking a bisphosponate increased the chances in predisposed individuals, and that chance increases the longer you take the drug, especially if your bone mass is in the osteopenic or normal range.

Exactly What are the Risks?

The chance that you’ll get one of these atypical spiral fractures while taking bisphosphonates is extremely low - one study estimates the incidence at about 32 per million users per year, compared with over 10 times that many fractures prevented in the same million users. So overall, the benefits of these drugs still far outweigh the risks.

However, drilling down into the fracture data reveals that we can do better than just accepting a rare risk in return for a common benefit.

Those who develop atypical fractures appear to be individuals whose bone mass in the femur is in the normal or osteopenic range, as opposed to those whose hips show osteoporosis. This happens to be the very same group that recent studies suggest may safely stop Fosamax after 5 years without losing the benefits of having been on the drug.

So, if continuing the drog for longer than 5 years adds little benefit but increases risks, even if those risks are rare, it becomes pretty darned obvious what we need to do. Stop the drug.

Which reminds me of that song from Kenny Rogers – “You got to know when to hold up / Know when to fold up / Know when to walk away /Know when to run… ” Not that treating osteoporosis is a gamble, but the Gambler’s advice rings eerily true for this class of drugs.

When to Fold up

New data suggest that as long as you are not in the osteoporotic range (T scores less than or equal to -2.5), you can stop taking your bone meds after 5 years. Continuing the drug past that time only brings added risk without any benefit.

When to Hold Up

If you’re at increased risk for fracture and have been taking your meds for less than 5 years, you may still be getting benefit without significant risk. Remember that these drugs decrease the risk of conventional osteoporotic fractures at over 10 times the rate that they increase the risk of atypical fractures, so don’t throw the baby out with the bathwater. But make sure you are getting adequate vitamin D, calcium and weight bearing exercise to maximize the benefits you’re getting while you’re still on these drugs. And discuss with your doctor whether its worth considering coming off the drug in the future if your bone mass improves into the osteopenic range.

If you’ve been on these drugs for 5 years or more, but your bone mass is still in the osteoporotic range, you also may still be getting benefit from continuing treatment. Ditto if you’re at high risk for vertebral fractures. You are not in the group at highest risk for atypical fractures, but are in the group at highest risk for the more common type of osteoporotic fractures. Talk to your doctor about the comparative risks of continuing vs stopping treatment. It may not be a straightforward decision, as we don’t have exactly clear guidance on when to stop in everyone. But at least have the conversation.

Should You Even Be in the Bisphosphonate Game?

Not everyone taking bisphosphonates needed to start them in the first place. Aggressive marketing and disease mongering by Big Pharma initially led to overuse of these drugs for treatment of osteopenia, a condition we now know does not necessarily need to be treated. With the help of the FRAX fracture risk calculator, we’re now able to determine which patients with osteopenia are at significant fracture risk and require treatment (very few, it turns out) and which ones can be adequately managed with lifestyle, calcium and vitamin D (most). Talk to your doctor about using FRAX before deciding if treatment is warranted.

Remember too that bisphosphonates are not the only drugs that treat osteoporosis. Other medications to consider include hormone replacement, Evista (raloxifene) and injectable terapeptide. Each of these drugs has its own set of risks and benefits, and some work better than others depending on your type and location of bone loss, so a reflex switch from bisphosphonates may not necessarily be the best option. As always, its best to talk with your doctor about what is right for you.

Bottom Line

The optimal duration of bisphosphonates for most individuals appears to be between 3-5 years. Beyond that point, unless osteoporosis at the hip or high spinal fracture risk exists, there appears to be added risk rather than additional benefit to prolonged use of these medications, and it may be time to consider stopping therapy.

__________________________________________________________

Resources

Ott, Susan. What is the Optimal Duration of Bisphosphonate Therapy? Cleveland Clinic Journal of Medicine September 2011 vol. 78 9 619-630. A must read for prescribers of bisphosphonate therapy.
Meier RH, Perneger TV, Stern R, Rizzoli R, Peter RE. Increasing occurrence of atypical femoral fractures associated with bisphosphonate use Arch Intern Med. Published online May 21, 2012. doi:10.1001/archinternmed.2012.1796.
Whitaker M, Guo J, Kehoe T, Benson, G, et al. Bisphosphonates for Osteoporosis — Where Do We Go from Here? New England Journal of Medicine. Published online May 9, 2012.
Black DM, Bauer DC, Schwartz AV, et al. Continuing Bisphosphonate Treatment for Osteoporosis — For Whom and for How Long? New England Journal of Medicine. Published online May 9, 2012. Doi: 10.1056/NEJMp1202623
Bridget M. Kuehn. Studies Probe Possible Link Between Bisphosphonates and Femoral Fractures JAMA. 2010;303(18):1795-1796. doi:10.1001/jama.2010.576

Inspiration – 93 year old yoga teacher

Thu, 17 May 2012 00:05:07 -0400