I’m not sure if you saw the headlines yesterday in light of news on the government shutdown but the healthwebz are buzzing about a study published in published in JAMA evaluating outcomes in the now infamous Women’s Health Initiative and the utilization of hormone replacement therapy (HRT) for menopausal symptoms. My only question is why do we keep beating this dead horse?
However, I would be remiss if I did not share the highlights of this latest analysis. So here’s what you need to know and honestly, it’s not very different than the stance of other organizations:
- The study or analysis, if you will, provides a detailed overview of the findings from both the original and extension trials of the WHI, looking at both combination and estrogen alone hormone therapy.
- Overall, the risks of combination therapy appear to have outweighed the benefits during the trial. During the extension period, the risk for heart disease remained elevated, a reduced risk for endometrial cancer was seen. Among women who had had hysterectomies before taking HRT, a more balanced risk/benefit equation was seen.
- With regard to breast cancer, the risks of taking combination therapy versus estrogen alone are not equal; more women have adverse effects from combination therapy.
- Proponents of HRT have long argued that age matters. The researchers involved in this analysis state that age influences the effects of hormone therapy ‘in some cases’ as does time since menopause onset, and that results appear to be better for younger versus older women, at least in terms of overall death rates due to all causes, deaths due to heart attack and deaths due to cancer.
- HRT appears to have a more harmful effect on coronary heart disease when used in older women; the effect on younger women is unclear. They say that further research is needed.
- Less clear is the link to breast cancer. While the researchers acknowledge that combined hormones may increase breast cancer incidence and cancer is diagnosed at a later stage, the risk might decline once HRT is stopped. They hypothesize that the progestin component is at play but say that more research is needed.
- While combined HRT may reduce endometrial cancer, it might also increase ovarian cancer risk, as may estrogen alone.
- Combined HRT has been shown to increase deaths from lung cancer, although neither combined or single hormone therapy appears to influence the total incidence of the cancer.
- With regard to diabetes, clot risk, gall bladder disease and dementia? A decrease in diabetes risk during treatment disappears overtime and the risk for clotting and gallbladder disease as well as dementia increase.
The researchers write that the overall findings do not support the use of either combination therapy or estrogen alone for chronic disease prevention, even in younger women. And they note that the risks of combination HRT outweigh the benefits, irrespective of a woman’s age.
Look, I don’t need to cover any additional findings or conclusions. Combination HRT is not all it’s cracked up to be. Speak to your doctor. Analyze your risks and determine if a fewer hot flashes or mood swings are worth it. Only you can decide. Me? I’m sticking with the devil I know and like: alternative strategies.
If you’ve been following this blog for any period of time, you know that I’ve consistently shared data that demonstrate the hormones, particularly combination hormone replacement therapy (HRT) can be dangerous, depending on age, time since menopause and other concomitant health issues. Yet, the medical community continues to beat the dead horse of trying to prove the hormone replacement in any form has a role in women’s health. And because I have promised to share the facts, regardless of whether or not I have questions about the motivation underlying their derivation, I am writing this post.
According to research appearing in the July 28 online issue of the American Journal of Public Health, estrogen actually prevents deaths among women who have had hysterectomies. By the way, that’s estrogen ALONE, not estrogen plus progestin, and that is a critical distinction.
Onto the findings. When researchers took another gander at the Women’s Health Initiative data, they sought to determine how the rate of excess mortality among women who took placebo versus those who took estrogen over the course of the landmark study actually translated into premature deaths that might have been preventable. And what they found is pretty shocking:
- The researchers looked at deaths in women who had undergone hysterectomy and still had an ovary intact compared with those who did not have any ovaries (note that sightly more than half — 54% — of women have both ovaries removed at the time of hysterectomy)
- They also examined the use of oral estrogen among the 50 to 59 year old set between the years 2001 and 2004, noting a decline by as much as 60% (largely the result of the the findings of the Women’s Health Initiative) and a relative decline by as much as 71% by the year 2009.
- In composite, they were able to calculate that between 2002 and 2011, a least 18,601 excess deaths occurred and as many as 91,61o excess deaths occurred among women who had had hysterectomies and chose not to use estrogen. This translates to an actual toll attributed to the decision of 40,292 to 48,835 deaths.
The researchers say that estrogen therapy alone reduces mortality mainly by reducing the number of heart disease-related deaths; notably early surgical menopause and complete removal of the ovaries boost the risk for coronary heart disease. Estrogen prevents the development of atherosclerosis and helps maintain normal blood flow.
It’s important to remember that these findings do not apply to women younger than age 50 or older than age 59. Moreover, they also fail to consider other reasons for the increase in heart disease among women as their estrogen declines, such as a surge in cholesterol. And, despite the improved odds against dying from heart disease, these data also ignore other health issues associated with estrogen alone, such as incontinence, hip fracture and of course, breast cancer among certain subsets of women. Hence, again, I am forced to ask the question why researchers continue to beat this horse to death when the deaths prevented may carry the cost of other issues?
I don’t believe that this is anything that will be resolved any time soon. And, as I have written previously we’re drowning in politics, medicine and industry. And it’s difficult to discern truth from fiction, data from data, risk from benefit. Ongoing analyses will eventually reveal what’s what. Meanwhile, read the library of HRT posts on Flashfree. Talk to your physician. Avoid hasty decisions. And consider alternatives. If the medical community can’t agree, perhaps it’s time to put down the gauntlet and wait out the firestorm.
The choice is yours’. Which side are you willing to err on?Read More
If you saw the headlines last week, you may be wondering what’s up with calcium supplementation. Afterall, don’t medical professionals advise the use of supplements to stave off bone loss associated with osteoporosis? And as a result, the Centers for Disease Control reports that over 50% of adults currently use calcium supplements and more than 60% of women over age 60.
It’s important to get away from the sensational headline and take a closer look at what the research shows and what you need to know.
Previous studies have suggested that there may be a link between use of calcium supplements (without vitamin D) and heart attack; in fact, as Reuters‘ reported last year, calcium supplements were shown to increase the risk of heart attack by as much as 31%, possibly as a result of plaque formation in blood vessels. However, is the risk the same if calcium is used alone versus if it is used in conjunction with vitamin D? In the Women’s Health Initiative study, the use of calcium and vitamin D did not appear to influence heart disease risk at all.
However, researchers decided to take another look at the data because they say that in this trial, more than half of participants were taking ‘personal calcium’ (i.e. not regulated or standardized to all trial participants) and almost half were also adding Vitamin D.
In this reanalysis, published just last week in the British Medical Journal, the researchers discounted the women who were characterized as personal users of calcium supplements and instead, limited their evaluation to a group of women who were not using personal calcium supplements at the study’s start and previously unpublished data from the trial. The findings? The use of calcium with or without vitamin D appeared to cause a 25% to 30% increase in the risk for heart attack and a 15% to 20% increased risk for stroke. However, the researchers say that even small increases in the incidence in heart disease may manifest substantially, especially in the elderly. They add that if you take a look at the risk-benefit ratio, it is unfavourable, meaning that taking calcium with or without vitamin D for five years would cause twice as many heart attacks or strokes than then numbers of fractures that would be prevented. Additionally, the data analysis suggests that dosing is not a factor, and that the total amount of calcium taken daily is less important than the abrupt changes in blood calcium levels immediately following supplementation.
Although this research answers a few questions about potential risks about calcium supplementation, it also leaves a key question unanswered: how does the addition of magnesium and vitamin K, which are often included in commercially-available calcium supplements, affect these findings? Data suggest that these minerals and vitamins are added to keep calcium in the bones where it belongs and out the arteries where it does not.
The best guideline, as always, is to visit a physician to assess your bone health and come up with a plan that works specifically for you. Although calcium supplementation appears to be risky, more data are needed before leading organizations start to change their tune about calcium and bone health. Meanwhile, stay ahead of the headlines and try to focus on increasing the amount of calcium-rich foods in your diet:
|Yogurt, plain, low fat, 8 ounces||415||42|
|Sardines, canned in oil, with bones, 3 ounces||324||32|
|Cheddar cheese, 1.5 ounces||306||31|
|Milk, nonfat, 8 ounces||302||30|
|Milk, reduced-fat (2% milk fat), 8 ounces||297||30|
|Milk, lactose-reduced, 8 ounces**||285–302||29–30|
|Milk, whole (3.25% milk fat), 8 ounces||291||29|
|Milk, buttermilk, 8 ounces||285||29|
|Mozzarella, part skim, 1.5 ounces||275||28|
|Yogurt, fruit, low fat, 8 ounces||245–384||25–38|
|Orange juice, calcium-fortified, 6 ounces||200–260||20–26|
|Tofu, firm, made with calcium sulfate, ½ cup***||204||20|
|Salmon, pink, canned, solids with bone, 3 ounces||181||18|
|Pudding, chocolate, instant, made with 2% milk, ½ cup||153||15|
|Cottage cheese, 1% milk fat, 1 cup unpacked||138||14|
|Tofu, soft, made with calcium sulfate, ½ cup***||138||14|
|Spinach, cooked, ½ cup||120||12|
|Ready-to-eat cereal, calcium-fortified, 1 cup||100–1,000||10–100|
|Instant breakfast drink, various flavors and brands, powder prepared with water, 8 ounces||105–250||10–25|
|Frozen yogurt, vanilla, soft serve, ½ cup||103||10|
|Turnip greens, boiled, ½ cup||99||10|
|Kale, cooked, 1 cup||94||9|
|Kale, raw, 1 cup||90||9|
|Ice cream, vanilla, ½ cup||85||8.5|
|Soy beverage, calcium-fortified, 8 ounces||80–500||8–50|
|Chinese cabbage, raw, 1 cup||74||7|
|Tortilla, corn, ready-to-bake/fry, 1 medium||42||4|
|Tortilla, flour, ready-to-bake/fry, one 6″ diameter||37||4|
|Sour cream, reduced fat, cultured, 2 tablespoons||32||3|
|Bread, white, 1 ounce||31||3|
|Broccoli, raw, ½ cup||21||2|
|Bread, whole-wheat, 1 slice||20||2|
|Cheese, cream, regular, 1 tablespoon||12||1|
* DV = Daily Value. DVs were developed by the U.S. Food and Drug Administration to help consumers compare the nutrient contents among products within the context of a total daily diet. The DV for calcium is 1,000 mg for adults and children aged 4 years and older. Foods providing 20% of more of the DV are considered to be high sources of a nutrient, but foods providing lower percentages of the DV also contribute to a healthful diet. The U.S. Department of Agriculture’s Nutrient Database Web site lists the nutrient content of many foods. It also provides a comprehensive list of foods containing calcium.
** Calcium content varies slightly by fat content; the more fat, the less calcium the food contains.
*** Calcium content is for tofu processed with a calcium salt. Tofu processed with other salts does not provide significant amounts of calcium.
Any regular reader of this blog knows that I am not a fan of hormone replacement therapy (HRT) nor the health risks associated with it. Nevertheless, although I espouse alternative strategies for dealing with menopause, I do feel that sharing news about HRT is important; accurate information leads to informed and shared decisionmaking.
So, do they (i.e. hormones) or don’t they (cause harm)? Undoubtedly, important variables come into play, including current age, how close to menopause hormones are started, current health status, whether or not a woman has had a hysterectomy, smoking history, etc. Also important is whether estrogen is used alone or in combination with progesterone. And yet despite these factors, many medical organizations continue to recommend that HRT be used for the shortest time period possible if at all.
Still, researchers continue to delve into data from the now infamous Women’s Health Initiative Study to tease out the bad, ugly and even the good.
This week, they are reporting on over 7,600 women who had taken estrogen alone for approximately 6 years, had had prior hysterectomies and were followed for an average of 10 years after the trial ended. If you recall, there has been some controversy as to whether or not estrogen alone is safer than combined HRT and actually lowers the risk for breast cancer in particular, which is why these data are particularly intriguing.
The researchers report that age at the time that hormone therapy (in this case, estrogen alone) is started is important. In fact, women who started estrogen therapy in their 50s, an increased risk for stroke and embolism, which appeared while taking estrogen, actually disappeared in the years that followed. Unfortunately, so did protection against hip fracture. Moreover, earlier reports of a decline in breast cancer risk were upheld despite body mass indices. However, the researchers say that this finding in particular, runs contrary to the preponderance of evidence from the majority of observational studies which show that estrogen use increases the risk of breast cancer, especially in lean women and after a long time period of use.
In an accompanying editorial, also in JAMA, the authors point out that more than 80% of women who took estrogen as directed only used it for an average of 3.5 years. Their point is that the results don’t directly address the “balance of risk and benefits associated with longer term estrogen use.” They also point to a larger review of data that show duration is an important factor when it comes to breast cancer risk, especially among lean women. Additionally, they say that tamoxifen, which actually antagonizes estrogen, has been shown to reduce breast cancer by 50%, which has led the International Agency for Research on Cancer to “conclude that unopposed estrogen therapy and combination HRT are carcinogenic.”
Are you confused yet?
Both set of researchers say that the decision to use estrogen or not is one that should be made between a woman and her doctor. Don’t forget: study findings continue to contradict. They add that while “there may still be a role for short-term use of unopposed estrogen for treating some women with menopausal symptoms, this role may be vanishing as existing and emerging data continue to be better understood in terms” of patients.
My thoughts? Err on the side of caution. Always.Read More
A study presented at the esteemed San Antonio Breast Cancer Symposium last week has fanned the flames about the benefits versus risks of hormone replacement for menopausal symptoms. In this study, which ironically was pulled from the site press release highlights after experts questioned its merit, researchers did a reanalysis of data from the Women’s Health Initiative trial, the infamous 2002 study that was halted after Preempro was shown to increase breast cancer risk. Their findings? That women who had participated in the estrogen only arm of the study, had had benign breast disease, had had hysterectomies and had family histories of no breast cancer actually had significant reductions in breast cancer incidence. What’s more, 75% of women who did not have benign breast disease at the study’s start also had a reduced risk of developing breast cancer.
So, this is good news, right?
Well, estrogen alone can only be used by women who have had hysterectomies; estrogen plus progestin is used in women with intact uteri in order to avoid uterine cancer. This means that only a subset of women with menopausal symptoms are eligible to use estrogen alone. Moreover, as a physician blogger points out, the findings run counter to most data that show that estrogen use is actually associated with an increased risk of breast cancer. He also notes that abstracts that are accepted as posters at major medical meetings often have flawed or spotty data; in fact, in my years as a medical writer, I’ve often run across abstracts that ultimately disagree with published works.
The bottom line here is that despite the news, using estrogen alone to treat menopausal symptoms might only be an option for a very small percentage of women and may still place them at risk for cancer. At the end of the day, prescribing hormone replacement therapy continues to challenge the Hippocratic Oath: first do no harm.Read More