I probably shouldn’t start this week’s article on tidbits with the subject of circumcision…but oh well, here goes… There was a small piece (I can’t help it!) about the advantage of circumcision that appeared this week in news@JAMA. A report was published about a study that compared 1754 men with prostate cancer to 1645 controls (men who did not have diagnosed prostate cancer). The men who were circumsized before they first had intercourse (I assume the circumcision occurred when they were newborns or infants and not just before they became sexually active!) had a 15% reduced risk of developing prostate cancer. I know this isn’t a strictly a women’s health issue but it does add one more argument to consider in a nonreligious debate for parents (and grandparents) when considering circumcision for a newborn.

The next tidbit was in last week’s news@JAMA. It contained updated warnings about the adverse affects of cholesterol lowering statins. Although there are now warnings of increased risks of developing diabetes, liver damage, memory problems and muscle pain and injury with statins, the FDA has stated that statins’ cardiovascular benefits still outweigh the risks. There have been some expert “naysayers” however, who state that most users take them to prevent strokes and heart attacks but only about 2 per 100 such individuals will actually benefit from this category of drugs. This is where you have to evaluate your lipid levels, family history and your cardiac status and risk with your physician. Statins can help save lives, but will it be yours?

Finally, a word about health costs… The same JAMA news site published a report by the Centers for Disease Control and Prevention. The agency estimates that about 1 in 3 individuals lives in a family with financial problems caused by health care costs, 1 in 5 have problems paying medical bills and 1 in 10 have families unable to pay any of their medical bills! (Since I am just reporting these numbers, which are most concerning, I won’t go into my personal opinions on the issues of health care affordability and insurance.)

I thought using the above initials might get most of you who don’t necessarily need emergency contraception (EC) to pay attention. OTC obviously stands for over-the-counter.

The April issue of the journal Obstetrics and Gynecology included an evaluation of proper use of an over-the counter single tablet emergency contraceptive called Plan B One-Step which was given to females aged 11-17 who requested emergency contraception at reproductive clinics. (I have to say that even I was appalled that 11 and 12 year olds were sexually active….but the authors pointed out that in actuality no 11- or 12 year olds were enrolled in the study, although statistics tell us that approximately 3% of teens initiate sexual activity before age 13.) The authors simply wanted to see if very young women would and could read the instructions and use the pill appropriately without interacting with providers.

A total of 345 females were enrolled in 5 cities, 279 were younger than 17.  This product was then given to participants who were eligible. They were then contacted 1,4, and 8 weeks later to assess use, pregnancy and adverse events.

As many of you know, the Plan B One-Step (one tablet of 1.5 mg levonorgestrel, a type of progestin that is in many birth control pills) has been granted approval by the FDA to be marketed as emergency contraception without a prescription for females aged 17 and older. It is restricted and can be given by prescription only for females aged 16 and younger. (And this decision created a huge political and gender based battle.) But despite the recommendations by major medical associations, physicians and women’s groups, the FDA insisted that additional data was needed demonstrating that females aged 17 and younger understood the “key concepts needed for safe and effective use for this product to be sold over-the-counter.”

This study pretty much answers this concern.  The participants had to agree and use the emergency contraceptive only after reading the information on the front and back panels without any assistance from the study staff or health care providers, as well as understand when and how to take it and the possible consequences. Parental consent was waived because minors can receive contraceptive services without parental consent in the states where the study was conducted. The study participants were considered appropriate (and understood that they were) if they responded yes to one of 4 questions that they were asked and they don’t want to get pregnant: Did they have sex but didn’t use a condom?  Did the condom break? Did they not use their birth control pills correctly? Did they have sex without any form of birth control?  And they were not eligible for the study if they thought they were pregnant or indeed were, they had unprotected sex more than 3 days before they requested the EC or they simply wanted to use EC every time instead of birth control.

Among the 298 participants who used this single pill, 274 (92.9%) used it correctly as labeled.  Selection and correct use was not associated with age. Fifty-seven participants (18.8%) used additional emergency contraception over the study period. (So repeat use was not common). Only seven (2.3%) who used Plan B One-Step became pregnant and there were no unusual adverse events.  The conclusions in the article were a sort of “see we told you so” to the FDA. “Restricting young females’ use of a single tablet emergency contraceptive by prescription only is not warranted, because females younger than 17 years can use it in a manner consistent with over-the-counter access.” I couldn’t have said it better myself!

That one in eight lifetime risk of breast cancer scares all of us. And there are many women whose odds of getting this malignancy may be even greater. Should those with an elevated risk be screened with more than “just” a yearly mammogram?

A study attempting to answer this query was published in the April 4 issue of JAMA. Between April 2004 and February 2006, 2809 women at 21 sites through out the US who had an elevated cancer risk and/or dense breasts underwent a series of 3 annual screens with mammogram and ultrasound. Each test was independently given and the radiologists were blinded to the result of the prior test. After 3 rounds of both, 612 of the women consented to also undergo breast MRI. (Not everyone wanted it…breast MRI requires intravenous dye and can be a lengthy, uncomfortable exam.)

The median age of the women was 55 with a range of 25 to 91 years. Approximately 29% of the women were younger than 50 and 23% were premenopausal. Nearly 54% had a personal history of previous breast cancer. High risk women were defined as having one or more of the following: a known mutation for BRCA1 and BRCA 2, a history of prior chest radiation, a significant family history of breast cancer, a lifetime risk of over 25 % of developing breast cancer, a previous biopsy that showed atypical ductal hyperplasia, atypical lobular hyperplasia, lobular carcinoma in situ or any atypical growth that increased risk for future cancer. And finally the study included women who had demonstrated in previous mammograms an increased density in more than 25% of their breasts. (When the breast tissue is very dense, meaning the glands are not separated by fatty tissue, the mammographic image looks white, it’s hard to see white on white…and it’s the white distortions and calcifications that allow the mammographer to suspect and diagnose cancer. Moreover, dense breast are more likely to develop a malignancy.)

A total of 110 participants were diagnosed with breast cancer during the 3-year study. Thirty three (30%) were detected by mammography alone; 32 (29%) by ultrasound alone; and 9 (8%) by MRI after both mammography and ultrasound failed to detect cancer. Eleven cancers (10%) were not detected by any imaging. (The patient or physician probably found “something” during physical exam of the breast.)

What does this data mean? The researchers summarized the study by stating that supplemental ultrasound can increase cancer detection with each annual screen done in conjunction with mammography. They calculated that ultrasound adds detection of 5.3 cancers per 1000 women in the first year; 3.7 per 1000 women the second and third years, and an average of 4.3 per 1000 for each of the 3 rounds of annual screening for women who were at risk. The addition of MRI screening further increased cancer detection with a yield of 14.7 per 1000 women vs. mammogram plus ultrasound. Another way of putting it (for cost -effective reasons that are so important to the practice of medicine today): the number of screens needed to detect 1 cancer in high risk women was 127 for mammogram, 234 for supplemental ultrasound and 68 for supplemental MRI (after negative mammography plus ultrasound screening results).

They went on to state “one of the major concerns (aside from the cost, especially that of MRI) is the harm of extra testing and biopsies for women who don’t have cancer. Five percent of biopsies were prompted in the women screened with additional ultrasound. Obviously not all of them showed cancer. (This becomes a philosophical issue….. will high risk women take the chance of having an unnecessary biopsy on what turns out to be a false positive finding when there is also an increased chance of detecting cancer and treating it? )

In conclusion, the authors state that “for high -risk women unable to undergo MRI and for intermediate -risk women with dense breasts, including those with a personal history of breast cancer, this study supports the use of ultrasound in addition to mammography.”

Bottom line: Most women who are high risk for breast cancer due to a previous cancer, a strong family history of breast cancer or previous abnormal biopsies are aware of their risk and seek appropriate screening. (Or at least their physicians should.) But if you have no known risks for breast cancer, make sure you ask your doctor if your mammogram was difficult to read and/or displayed significant density. If so, you could benefit from additional ultrasound imaging. Now if only all of the insurance companies agreed… Perhaps this study will help get them to pay!

Some of the worst hot flashes and night sweats can occur during the menopause transition…. between our mid- forties and early fifties. Aside from embarrassing perspiration, flushing, a desire to disrobe, as well as a loss of sleep, are women also losing their heart health?

The Study of Women’s Health Across the Nation examined that question and found that, unfortunately the answer was “to some degree, yes.” This study, published in the journal Obstetrics and Gynecology in April, 2012, followed 3,201 women aged 42-52 years for 8 years. They were interviewed once a year and asked to recall the frequency and severity of hot flashes and night sweats during the previous 2 weeks. The women also underwent a physical exam and blood tests were done to check their lipids. The latter included low-density lipoprotein (LDL), high-density lipoprotein (HDL), Apolipoprotein A-1, apolipoprotein B, lipoprotein (a),  and triglycerides.  Blood estrogen (estradiol) levels and follicle stimulation hormone (FSH) were also checked to see if they had become menopausal. (Estrogen levels plummet and FSH goes up in menopause.)  Remember, all of the lipids (think fats in the blood stream) with the exception of the “good lipid” HDL encourage plaque development in blood vessels and subsequent coronary heart disease and stroke.

The average age of the women at the onset of the study was 46.  One third of the women had hot flashes; these increased over the years (as they transitioned into menopause) and at the 7th visit, 54% had significant hot flashes and 38% had night sweats. The factors that were associated with a worsening lipid profile at baseline included older age, Hispanic race, smoking, low education, not drinking alcohol, being perimenopausal at a young age, obesity, low physical activity, low estrogen level, high FSH and high anxious or depressive symptoms. But even when they controlled for all these factors which were present at the onset of the study, hot flashes and night sweats, particularly when experienced frequently were associated with higher levels of the lipids over the 8 year study period,  most particularly in leaner women. These lipid markers are well known to be associated with elevated cardiovascular risk.

I know it seems weird that the changes in the lipids were more common in thin women with hot flashes rather than obese women who experienced this symptom. The authors hypothesized that the effect of weight and BMI on lipids or vasomotor symptoms may have overwhelmed the more modest associations seen in the study.

What does this mean for women going through a difficult menopausal transition and why the correlation with cardiovascular disease? No one is sure.

This study simply raises concerns: if you experience significant hot flashes and night sweats during the menopause transition, make sure your physician checks your lipid levels. If they are elevated, they may portend the development of cardiovascular problems.  You and your doctor should consider appropriate prevention and if necessary, treatment

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