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The perception of dry mouth (known as xerostomia) affects up to 40% of adults in the U.S. and can have a significant effect on quality of life. Causes can include medications, diabetes, Sjogren syndrome and hormonal changes such as menopause. Previous animal and laboratory studies provided evidence that green tea polyphenols could be beneficial for xerostomia.

The current human study used a double-blind, placebo-controlled, randomized design comparing green tea to xylitol. The study involved 60 individuals (58 green tea powderwomen and 2 men) with the complaint of dry mouth and had Sjogren syndrome mediated salivary gland hypofunction, with 30 taking the placebo and 30 taking the green tea medicine. The green tea proprietary formula contained green tea catechins and other ingredients (amounts not given; but internet search reveals the following information: Xylitol, Sorbitol, Natural Flavors, Green Tea (Leaf), Acadia Gum, Jaborandi Extract (Leaf), Magnesium Stearate, Silicon Dioxide, Sucralose). The placebo contained 500 mg xylitol and other non-plant ingredients. Participants took 1 lozenge every 4 hours for a maximum of 6 lozenges per day, over an 8 week period. Quality of life assessments and saliva collection with volume determined were used to evaluate response.

After 8 weeks of therapy, the xylitol-containing placebo failed to affect saliva output while the green tea catechin containing formulated resulted in a statistically significant increase in saliva output with a 3.8 fold increase in unstimulated saliva output and a 2.1 fold increase in stimulated saliva output, compared with baseline. This occurred within 1 week. Both groups experienced a quality of life scored demonstrating significant improvement with no significant difference between groups.

Commentary: Most commercial products for xerostomia contain xylitol although it has not been known if xylitol does in fact play a role in saliva output. A xylitol chewing gum, a sorbitol containing lozenge and a xylitol containing spray previously showed no efficacy in stimulating saliva in patients with xerostomia. Other research using a maltose-containing lozenge found a potential benefit for xerostomia and another with a 1% malic acid spray did show a modest increase in salivary flow rates. It is not clear why there is a discrepancy between salivary output-increase in the treatment medication compared to placebo vs. the similar effects on subjective quality of life measures. A longer study with more participants would hope to clarify and produce greater results in the treatment group not only in objective measures of salivary output but also in subjective quality of life values.

Reference

De Rossi S, Thoppay J, Dickinson D, et al. A phase Ii clinical trial of a natural formulation containing tea catechins for xerostomia. Oral Surg Oral Med Oral Pathol Oral Radiol 2014;118:447-454.

black cohosh, freshThis randomized, double-blind, placebo-controlled clinical trial was conducted in Iran with a total of 84 postmenopausal women. Women were randomly assigned to one black cohosh tablet per day (n=42) or one placebo (n=42) per day for 8 weeks. The severity of vasomotor symptoms and number of hot flashes were recorded in the pre-treatment phase and 4 and 8 weeks after intervention. In Iran, black cohosh is supplied by Goldaru Pharmaceutical Company under the name of Cimifugol and each tablet contains 6.5 mg of dried extract of black cohosh root, equal to 0.12 to 0.18 mg of 27 deoxy ectoine.

Participants were postmenopausal women ages 45 to 60 years old were included in the study if no menses for 12 consecutive months, normal blood pressure, a minimum score of 2 for vasomotor symptom severity; no history of breast or cervical cancer, liver disease, abnormal postmenopausal bleeding, depression or hyperthyroidism and no psychiatric medications or hormones or herbs used for treating menopausal symptoms. In addition, no smoking and no alcohol use were also inclusion criteria.

The primary outcome was the effect of black cohosh or placebo on vasomotor symptoms severity, using the FDA and Green climacteric vasomotor scale for both hot flashes and night sweats. For daytime hot flashes, a score of 1 = mild, without sweating. A score of 2 = average sensation of heat with sweating but no interruption of daily task functions. A score of 3 = severe, extra intense sensation of heat and sweating with dysfunction and interruption of daily tasks. For night sweats, 1= mild and they do not wake the woman up and only wake up if they realize they are sweating; 2 = average, they wake up due to heat and sweating but no change of clothing or sheets is needed; 3= severe and they wake up due to heat and sweating and do need to change their cloths or get out of bed or open windows. A minimum Green vasomotor score is 1 and the maximum is 6. There was a considerable decline in vasomotor symptom severity and number of hot flashes after 4 weeks and 8 weeks in particular, compared with placebo.

Commentary: Vasomotor symptoms are seen in approximately 75% of perimenopausal and postmenopausal women and can last from 1-10 years and even more than 10 years for some women. Hot flashes can not only be very uncomfortable if moderate to severe, they can make many women anxious, self-conscious in their work environment and can significantly interfere with sleep resulting in fatigue, poor cognitive function and labile moods. Treating the vasomotor symptoms successfully can improve and potentially even alleviate all these issues. This is not the first study where I’ve run into these very low doses of extracts of an herb, and it is difficult comparing them to products in the U.S.

Reference

Shahnazi M, Nahaee J, Moammad-Alizadeh-Charandabi S, Bayatipayan S. Effects of black cohosh on vasomotor symptoms in postmenopausal women: A randomized clinical trial. J Caring Sciences 2013;2(2):105-113

Menstrual cramps are one of most common menstrual related problems that women face. Non-steroidal anti-inflammatory (NSAIDS) are the most common self-treatment that women use, but they don’t always work adequately or at all, and some women have side effects from them. I have written previous blogs on natural solutions for menstrual cramps, including ginger and valerian. This double-blind, randomized, placebo-controlled trial investigated the use of fenugreek seed powder during menses, in women with moderate to severe menstrual cramps.fenugreek seeds

Iranian women of similar age, body mass index (BMI) and pain level of menstrual cramps were enrolled in this study and given either ground fenugreek seed capsules at 900 mg three times per day or placebo for the first 3 days of menses and for two consecutive menstrual cycles. If the woman felt she needed pain medication, she was instructed to take this 1 hour or more after consumption of the study medicine/placebo.

Patients reported additional medications used for pain, pain severity, and any other menstruation symptoms. A visual analog scale (VAS) was used to assess pain during the first 3 days of menstruation in addition to the time of day the pain was most prominent. A score of 1-2 indicated mild pain, 3-7 was moderate, and 8-10 was severe.

A total of 106 patients were enrolled and 101 completed the study. There were 51 in the fenugreek group and 50 in the placebo group. At study entry, there were no significant differences in age, age of menstruation, menstrual pain, pain severity, or BMI. At the end of the study, the severity of pain significantly decreased in both groups after the second menstrual cycle as compared to baseline (fenugreek group=3.25 vs. 6.4, placebo group=5.96 vs. 6.14). After each cycle, pain severity in the fenugreek group was significantly less as compared to placebo (cycle 1=4.32 vs. 6.03, and cycle 2=3.25 vs. 5.96). The duration of pain was significantly decreased in the fenugreek group and the average use of pain medication in the fenugreek group significantly decreased by the end of the study compared to the placebo group.

Commentary: The results of this study point to a meaningful response of fenugreek seed powder compared to baseline at 900 mg three times daily the first 3 days of menses for women with moderate to severe menstrual cramps. The use of fenugreek was more effective than placebo in reducing severity of pain, duration of pain and a decrease in the use of pain medications. This approach to moderate to severe menstrual cramps is easy and safe to try as an alternative treatment for menstrual cramps.

Reference

Younesy S, Amiraliakbari S, Esmaeili S, Alavimajd H, Nouraei S. Effects of fenugreek seed on the severity and systemic symptoms of dysmenorrhea. J Reprod Infertil. January 2014;15(1):41-48.

The Effects of chaste tree berry (Vitex agnus castus) extract and magnesium on fracture healing in women with long bone fractures.

The purpose of this study was to investigate the effects of chaste tree with and without magnesium on the healing of long bone fractures in young women.

In this double-blind randomized placebo-controlled clinical trial, 64 women ages 20 to 45 y.o. with a traumatic (injury) long bone fracture (upper arm=humerus, bone fractureforearm= radius or ulna, upper leg=femur or lower leg=tibia), were enrolled. All of these patients were treated with surgery for their fracture. The patients were randomized to one of four groups: either the chaste tree (1 tablet containing 4 mg of a dried fruit extract), plus placebo, or the chaste tree extract plus magnesium oxide 250 mg/day or magnesium plus placebo or placebo plus placebo daily, for 8 weeks. A questionnaire was given at the beginning of the study that included age, fracture cause, any history of a previous fracture as well as anatomical location of that fracture. They were also categorized into 3 groups according to the amount of physical activity they usually did= light (household tasks, riding in a car, light activity while sitting), moderate (walking 3-5 km/h, light sport, occasional gardening or husbandry), or severe (rigorous sports, agriculture or husbandry).

Nutritional intake was evaluated by a food frequency questionnaire. Blood tests were taken including alkaline phosphatase, osteocalcin, and vascular endothelial factor (VEGF), plus standard X-ray, all at the beginning and after 8 weeks.

Sixty four patients entered the study and 51 completed it. The 14 patients were excluded due to not taking the supplements adequately or lack of returning for follow-up. The starting fracture rates were distributed in 52.9% in the tibia, 25.5% in the femur, 13.7% in the humerus and 7.8% in the radius and ulna. A total of 21.6% had a previous history of fractures.

Comparison of the average differences of alkaline phosphatase levels at the beginning and end of the treatment intervention was not statistically significant between the four groups. The only group in which there was any increase in alkaline phosphatase was in the chaste tree only group. There was a difference in the average value of osteocalcin between the groups. The increased osteocalcin level in the chaste tree and magnesium group was significant compared to the chaste tree alone or placebo alone. There were no significant differences in the average values of VEGF variation in the study groups although again, the chaste tree only group did have some increase. Most importantly, x-ray evidence of the percentage of callus formation at the site of the fracture (a sign of healing), was most significant in the chaste tree and magnesium group (80%), then the chaste tree 71.4%), magnesium alone (50.0%) and placebo (53.8%).

These results suggest that administration of chaste tree plus magnesium may promote fracture healing in premenopausal women with long bone fractures of the arm or leg.

Comments: This study is a new and innovative idea for the treatment of long bone fractures in young women, especially in the realm of using chaste tree for this purpose. It deserves pointing out that the group of women studied was not postmenopausal women let alone not postmenopausal women with low bone density or outright osteoporosis. It would be important not to extrapolate the results to those women, although I would find no harm in adding chaste tree and magnesium to enhance healing of fractures in those women.

In summary, the combination use of chaste tree and magnesium may synergistically improve fracture healing by increased osteocalcin and VEGF levels and callous formation, even for just 8 weeks.

Reference

Eftekhari M, Rostami Z, Emami M, Tabatabaee H. Effects of vitex agnus castus extract and magnesium supplementation, alone and in combination, on osteogenic and angiogenic factors and fracture healing in women with long bone fracture. J Res Med Sci. 2014;19(1):1-7

The most common perimenopause and menopause symptoms are vasomotor symptoms, aka hot flashes and/or night sweats. In addition to numerous perimenopause/menopause symptoms, postmenopausal women in particular, are at increased risk for cardiovascular disease, dyslipidemia, hypertension and type 2 diabetes. Plant compounds such as French maritime pine bark extract (Pycnogenol) are rich in proanthocyanidins and have been studied in 3 studies to alleviate menopause symptoms such as vasomotor symptoms. Because of grape seeds on white background macro closeupthese 3 studies, and an analysis showing that grape seeds are even richer in proanthocyanidins, researchers have conducted and published a study examining the effects of grape seed proanthocyanidin extract on menopause symptoms, body composition and cardiovascular markers.

A randomized, double-blind, placebo-controlled study was conducted in almost 100 premenopause, perimenopause and postmenopause middle-aged women between 40 and 60 y.o. The average age was 49-59 years with 40% to 48% premenopausal women, 52% to 60% perimenopausal, postmenopausal or were surgically menopausal. Women were randomized to receive grape seed extract tablets that contained either 100 mg per day or 200 mg/day of proanthocyanidins or placebo for a total of 8 weeks. Menopause symptoms were evaluated using the Menopausal Health-Related Quality of Life Questionnaire, the Hospital Anxiety and Depression Scale and the Athens Insomnia Scale before the start of treatment as well as after 4 weeks and 8 weeks of treatment.

Significant changes were observed in hot flashes, anxiety, insomnia, increased muscle mass and reduced blood pressure. The average physical symptom score for the nine items in the physical health domain of the Menopause Health Related Questionnaire significantly improved in the high dose grape seed extract group after 8 weeks, as did the mean score for hot flashes. The mean depression score did not improve in any of the groups but the anxiety subscale score improved in both the 100 mg and 200 mg group and was significantly better in the higher dose group than in the placebo. Mean body weight and fat mass did not change in any of the groups, but the mean lean mass and muscle mass increased significantly in both the 100 mg and 200 mg grape seed extract groups. Lastly, the mean systolic and diastolic blood pressure was significantly reduced in both the 100 mg and 200 mg groups and after as short as 4 weeks. The mean systolic and diastolic blood pressure decreased by about 5 mm Hg with both doses after 8 weeks.

Commentary: The menopause studies using pine bark demonstrated positive results in improving menopause symptoms at all three different doses studied in each of the studies, 60 mg, 100 mg and 200 mg. Similarly in the current study, the two doses of grape seed extract, 100 mg and 200 mg, both worked well for hot flashes, although the 200 mg dose was clearly better than the 100 mg dose in the anxiety subscale. This study appears to be the first report of proanthocyanidins affecting body composition, increasing muscle mass with both doses. The positive effect on blood pressure using proanthocyanidins, including those in grape seed extract is not a new finding. I have been using pine bark extract for vasomotor symptoms in perimenopause and menopause women for the past several years, with mixed results. I am intrigued by the current study and look forward to using grape seed extract in these two doses, as another non hormonal option, especially in women who need not only vasomotor symptom relief, but are struggling with overweight and pre-hypertension or stage I hypertension.

Reference

Terauchi M, Horiguchi N, Kajiyama A, et al. Effects of grape seed proanthocyanidin extract on menopausal symptoms, body composition, and cardiovascular parameters in middle-aged women: a randomized, double-blind, placebo-controlled pilot study. Menopause 2014;21(9):990-996.

Most practitioners of women’s health are familiar with the terms vulvovaginal atrophy and atrophic vaginitis. Many women with this condition, also are familiar with these terms. However, they can be quite inadequate and not precise enough for describing the actual physical changes that are occurring and the symptoms that result from these changes that occur with the vulva, vagina and/or lower urinary tract that is associated with lowering of the body’s natural production of estrogen. The term vulvovaginal atrophy describes what the postmenopausal vulva looks like but doesn’t describe the associated symptoms. The term atrophic vaginitis implies inflammation or even infection, even though neither of these is the primary aspect of atrophic changes of the vulva and/or vagina.

I know that I always feel quite impolite and sound somewhat rude or at least insensitive, when I use the term vulvovaginal atrophy or atrophic vulvovaginitis with my patients. I think it imparts an excessive aging image, when these changes are in fact within the realm of normal. Neither of the current terms properly addresses the changes in the lower urinary tract. Other previous urogenital terminology changes have been useful, in both men and women… examples include overactive bladder (in place of urge incontinence, and erectile dysfunction instead of impotence).

Recognizing these issues, the board of directors of the International Society for the Study of Women’s Sexual Health (ISSWSH) and the North American Menopause Society (NAMS) cosponsored a terminology consensus conference in May of 2013. Experts in the field were selected and the relevant scientific literature was reviewed. Participants were then separated into 3 groups to determine a more descriptive, comprehensive and accurate terminology for practitioners, patients and the media. Each of the 3 groups then proposed terms to the entire consensus group for discussion and assessment. Through this process, potentially acceptable terms were voted on. The final two choices were further discussed and then a consensus was met. The process and consensus results were presented at the 2 scientific meetings of ISSWSH (February 2014) and NAMS (October 2013). The boards of both organizations then approved the new term, genitourinary syndrome of menopause (GSM).

female anatomyGSM is now defined as a collection of symptoms and signs associated with a decrease in estrogen and other sex steroids involving the changes to the labia majora/minora, clitoris, vestibule/introitus, vagina, urethra and bladder. These physical signs may include anatomic changes (ex/ thinning of the vulvar and/or vaginal tissue, a thin and smaller labia majora, a narrowed introitus- vaginal opening). The physiological changes result in reduced vaginal blood flow, diminished lubrication, decreased elasticity of the vaginal wall, an increased vaginal pH and decreased vaginal flora with loss of lactobacilli. The syndrome can include, but is not exclusively limited to genital symptoms of dryness, burning and irritation, fissuring of vulvar tissue, and bleeding after sex; sexual symptoms of decreased lubrication, discomfort or pain with vulvovaginal touch/penetration, and impaired arousal/orgasm functions; and urinary symptoms of urgency, dysuria and recurrent urinary tract infections. Women with GSM can present with some or even all of the signs and symptoms which must be bothersome to indicate the diagnosis and without some other diagnosis that accounts for the symptoms.

A full description of the process, new terminology and comprehensive description is found in the paper cited in the citation for this column below.

Reference

Portman D, Gass M. and consensus panel. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women’s Sexual Health and The North American Menopause Society. : 1063-1068

breast cancer awarenessIn women’s health, nothing is quite as confusing and bustling with controversy as the role of screening mammography in low-risk women and its presumed reduction of mortality from breast cancer. Regular screening mammography is promoted as an early detection test, conducted in an attempt to diagnose breast cancer early, treat it early, and thus reduce mortality from breast cancer. The practice is based on the presumption that mammograms detect breast cancers that are smaller than those detected by physical breast exams, meaning they can be detected sooner on average than clinically palpable breast cancers. This “early detection” confers better prognosis than later detection of larger tumors. However, avoiding breast cancer–related deaths is not the only outcome to consider. Two other outcomes need attention as well: false alarms and over diagnosis. According to a recent review in JAMA Internal Medicine by Welch and Passow, “Among 1,000 US women aged 50 years who are screened annually for a decade, 0.3 to 3.2 will avoid a breast cancer death, 490 to 670 will have at least 1 false alarm, and 3 to 14 will be over diagnosed and be treated needlessly.”[i]

According to randomized trials conducted from the 1960s to the 1980s, screening mammography reduced breast cancer mortality.[ii] A significant insight into these studies is the plausibility that screening mammography was more effective in the past when breast cancer treatments were less effective. Researchers with this perspective point out, “If women with new breast lumps now present earlier for evaluation, the benefit of screening will be less. If clinically detected breast cancer has now improved, the benefit of screening will be less.”[iii] They also point out that these randomized trials occurred before 1990, and since then we no longer have randomized trials but observational studies in the United States.

There has been much debate about the benefit versus harm of mammography in the last few years, especially since the United States Preventive Services Task Force (USPSTF) guidelines were published in 2009.[iv] USPSTF guidelines differed from the major advisory groups on this subject (i.e., the American College of Obstetrics and Gynecology [ACOG], the American College of Radiology [ACR], the American Cancer Society [ACS], and the Susan G. Komen Foundation). I’ll discuss those differences in a moment.

The controversy swelled up recently with the publication of the Canadian National Breast Screening Study and its findings from 25 years of follow-up in a screening mammography trial.[v] It was initiated in 1980 and included almost 90,000 women ages 40–59. All the women received baseline mammograms. Women aged 40–49 were randomized to 5 annual mammograms plus annual breast exams or to usual care. Women in the 50–59 age group were randomized to 5 annual mammograms plus breast exams or to only annual breast exams. Over the next 25 years, approximately the same number of incidences of and deaths from breast cancer occurred in each group. In short, annual screening mammography in women aged 40–59 did not reduce mortality from breast cancer any better than physical exam or usual care (when access to adjuvant therapy for breast is free and available via the Canadian healthcare system). In addition 22% of screening detected cancers (106/484) represented over diagnosed breast tumors.

This Canadian study is not the only study that has cast doubt on the value of screening mammography. Other findings in the last few years have revealed similar findings. These include the Kalager et al study in Norway,[vi] the Mandelblatt et al study,[vii] and the Atelier et al study.[viii] In 2012, Bleyer and Welch published a large analysis of 3 decades of screening mammography and breast cancer incidence using Surveillance, Epidemiology and End Results (SEER) data to examine data from 1976 through 2008. They concluded that yes, there were substantial increases in the number or cases of early-stage breast cancers detected through screening mammography, but it only slightly reduced the rate at which women presented with advanced breast cancer – suggesting that there is substantial over diagnosis of approximately one third of the cases. They also concluded that, at best, screening had only a small effect on the rate of death from breast cancer.[ix] In a 2011 publication of Swedish data based on 3 decades of follow-up, major benefits of screening were observed, with a 31% lowered risk of breast cancer mortality in the screening group; however, the number of women needed to screen for 7 years to prevent 1 breast cancer death was 414.[x] Then in 2012, another Swedish study was published and looked at data from the Swedish Board of Health and Welfare from 1960 to 2009 to analyze the trends in breast cancer mortality in women 40 and older, by country. [xi] These researchers compared the actual mortality trends with the theoretical models. They expected that screening would be associated with a gradual reduction in mortality, especially because Swedish mammography trials and observational studies have suggested that mammography leads to a reduction in breast cancer mortality. However, what they found was that breast cancer mortality rates in Swedish women started to decrease in 1972, which was before the introduction of mammography, and that breast cancer mortality rates continued to decline at a similar rate to the rates prior to the institute of screening. In other words, the downward trends of breast cancer mortality in Sweden continued as if there were no screening at all. These findings are consistent with other studies that show limited or no effect of breast cancer screening on breast cancer mortality.

In his stunning NEJM editorial after the Kalager, et al Norwegian study, 6 Gilbert Welch concluded an even more alarming mathematical calculation, that it would take screening 2,500 women every year over a 10 year period to avoid 1 death from breast cancer.3 These studies collectively have contributed greatly to the ongoing debate over the risk and benefit of screening mammography.

Analyzing the Pros and Cons

I have found it extremely useful to read the critiques of the Canadian study. The first point of contention is that the Canadian study dates back to a time when women had more primitive mammograms. Between 1980 and 1984, the technology and equipment were limited and mammograms could only detect 30% of breast cancers. Mammography today is in the range of being able to detect 70% to 80% of breast cancers. You can see the problem. Yes, the Canadian study is a randomized controlled study, and over 25 years, but it’s generated by technology from 34 years ago. Another critique is that the study was not truly randomized in that nurses and doctors preferentially put the patient into the mammography arm when a breast lump/mass was detected.

Critics of any conclusion other than an endorsement of screening mammography starting at age 40 also point out that many of the editorials and analyses of benefits and risks are based on calculations and numerical predictions rather than actual studies. They [the American College of Obstetrics and Gynecologists (ACOG), the American Cancer Society (ACS), the American College of Radiologists (ACR) and the Susan Komen Foundation, and many clinicians and surgeons amidst those groups] insist we look at the actual studies, randomized and observational, that conclude that screening mammograms saves lives (i.e., early detection—and thus earlier treatment—leads to fewer deaths from breast cancer). Others point out that in fact there has not been a randomized trial in the United States on this subject for about 50 years, and again, the earlier randomized trials showing benefit also occurred when there were less effective treatments and less awareness of breast cancer and exams.

I won’t be surprised if you are confused, even with this attempt at reducing a vast amount of complicated and contradictory data into a hopefully simplified discussion.

The most important thing for patients and clinicians is to try to be aware of the controversies and different recommendations, despite every advisory group looking at the exact same data and numbers.

Here are the 2009 USPSTF recommendations:

  • No universal screening mammography for women ages 40–49 and urging an individualized, informed decision making process based on specific benefits and harms
  • Biennial screening mammography for women ages 50–69
  • Screening extended to women between 70 and 74
  • Insufficient evidence to assess the benefits and harms of screening mammography in women 75 and older
  • Insufficient evidence to assess the benefits and risks of clinical breast exams in women aged 40 years and older who undergo mammography, digital mammography, and MRI versus film mammography
  • Teaching self-examination is harmful and not recommended
  • These recommendations do not apply to women who are at excess risk for breast cancer due to known genetic mutations or histories of chest radiation

The key ACOG, ACS, ACR, and Komen Foundation guidelines for screening mammography in low-risk women are as follows:

· Screening mammograms starting at age 40 and annually thereafter

· Clinical breast exams yearly for ages 40 and older

· Clinical breast exams every 1–3 years for women 20–39 years of age

It is especially challenging to clinicians and to patients when these multiple organizations come out with conflicting studies, data, and recommendations. For those who recommend a reduced screening program, they argue that screening, in low risk women, does not improve the death rate from breast cancer, and that there are too many call back additional mammograms and then too many biopsies that are in fact normal. In addition, there are many cancers that would actually have never caused death and the timing of detection and treatment and survival does not matter whether you detect it early before a lump is detected or later after a lump is actually felt. Those who continue to advocate for regular screening assert that we cannot adequately predict who has a non-lethal vs. lethal breast cancer and they assert that no matter the false positives and extra procedures and cost, treating breast cancer as early as possible is the best way to improve survival. And if survival statistics are maybe modest at best, oncologists and surgeons in particular, assert that seeing women later in the process, with later stage breast cancers, may require more extensive surgical treatment and more extensive chemotherapy than would have been otherwise needed.

So, what’s A Woman and her Clinician to Do?

When speaking with patients, I let them know that there are 4 camps regarding screening mammography that differ greatly:

Camp 1 is the dominant school of thought held by organizations including ACOG, ACR, ACS, and Komen Foundation. They all recommend screening mammography yearly starting at age 40 and ending approximately mid-70s, although this is based on individual health and ability to withstand treatment regimens.

Camp 2 is held by the USPSTF, which is quite a bit different with screening mammography. This recommendation is not to start mammography screening in low-risk women until age 50, and then to do it every other year.

Camp 3 is a model common in many European countries: screening mammography every 3 years, some starting at age 40 and others at 50. There is no evidence that countries using this model have any higher rates of breast cancer mortality than countries that employ more frequent screening.

Camp 4. No screening at all in low-risk women, based on calculations from one of the leading U.S. researchers on analyzing screening mammography data. As mentioned earlier, his conclusions are that it would be necessary to screen 2,500 women every year for 10 years to avoid 1 death from breast cancer.3

I also point out a few caveats to my patients. The first is that the current scientific data do not explain whether avoiding screening mammograms (and their potential for earlier detection) will result in exposing women to more aggressive treatments and the ensuing impacts on quality of life and adverse effects. The second is that breast cancer diagnosed in younger women, ages 40–49, tends to be more aggressive. So screening mammography in this age group might in fact be more important than screening mammography after age 50 or so.

After sharing all the above information, I feel that my patients are reasonably well informed and can make their own decisions, with my support.

Final Comments

Some readers might conclude that they won’t recommend screening mammography at all or may instead choose to recommend breast thermography. Before going the route of thermography, I recommend the excellent article by Walker and Kaczor: Breast Thermography: History, Theory, and Use.[xii] The recent research pointing to more serious questions about the benefits vs. harm of screening mammography in low risk women has not caused me to stop recommending screening mammography or to suggest thermography. Instead it has caused me to have an increased awareness that the mortality benefit is possibly modest and that my recommendations and my patients’ decisions may in fact be a close call with trade-offs of modest benefit and modest harm. This highlights the need for us to make individual recommendations based on known risk factors including obesity, more than 7 alcohol drinks per week, a first-degree relative with breast cancer history, BRCA mutations, and the slight increased risk incurred after estrogen with progestin (and not necessarily progesterone and not estrogen only) use for 3–4 years in postmenopausal women. As a point of clarification though, I would typically recommend annual screening for these higher-risk women 40 and older.

I always try to present information and recommendations in a manner that provides my patients with quality and up to date information and encouragement to decide what they are comfortable with and what choice they want to make for themselves.

Note: A large part of this blog was originally written by Dr. Tori Hudson for the Natural Medicine Journal, an electronic publication for the natural medicine practitioner community.

References


[i] Welch G, Passow H. Quantifying the benefits and harms of screening mammography. JAMA Internal Medicine; online Dec 30, 2013.

[ii] Cochrane Database Syst Rev 2013;6:CD001877

[iii] Welch G. Screening Mammography- A long run for a short slide. NEJM 2010;Sept 23: 1276-1278

[iv] http://viajwatc.ch/dnqQj6).

[v] Miller A, et al. Twenty five year follow-up for breast cancer incidence and mortality of the Canadian National Breast Screening Study: randomised screening trial. BMJ 2014;Feb 11:348:g366

[vi] Kalager M, Zelen M, Langmark F, Adami H. Effect of screenign mammography on breast cancer mortality in Norway. NEJM 2010; 363: 1203-1210.

[vii] Mandelblatt J, Cronin K, Bailey S, et al. Effects of mammography screening under different screening schedules: model estimates of potential benefits and harms. Ann Intern Med 2009; 151:738-47.

[viii] Autier P, et al. Breast cancer mortality in neighboring European countries with different levels of screening but similar access to treatment: Trend analysis of WHO mortality database. BMJ 2011 July 28;343:d4411.

[ix] Bleyer A, Welch G. Effect of three decades of screening mammography on breast-cancer incidence. NEJM 2012;267(21):1998-2005.

[x] Tabar L, et al. Swedish Two-County Trial: Impact of mammographic screening on breast cancer mortality during 3 decades. Radiology 2011 Sep; 260:658.

[xi] P. Autier, A. Koechlin, M. Smans, L. Vatten, and M. Boniol. Mammography Screening and Breast Cancer Mortality in Sweden. J Natl Cancer Inst, 2012,July 17

[xii] http://naturalmedicinejournal.com/journal/2012-07/breast-thermography-history-theory-and-use

In early July, 2014, the American College of Physicians (ACP) issued guidelines challenging the need for a vaginal speculum and bimanual (internal) pelvic exam as an integral part of a routine well-woman office visit. The ACP reviewed the evidence and concluded that the routine pelvic examination is not useful in screening for malignancies other than cervical cancer, and can lead to unnecessary evaluation and surgery, while also often causing discomfort and embarrassment and may actually be a deterrent to some women seeking gynecological care. Their recommendations are summarized as follows:

  • Routine pelvic exam is not recommended in asymptomatic non-pregnant adult women
  • This recommendation does not apply to the timing and need for cervical cancer screening

The cervical cancer screening tests… pap smears, liquid based paps and/or human papilloma virus (HPV) testing should include a vaginal speculum exam while visualizing the cervix and collection of samples, but does not need to include bimanual examination

  • Screening for chlamydia and gonorrhea can be done with urine tests or vaginal swabs

Commentary:

As a Naturopathic Physician women’s health practitioner, I think these recommendations from the ACP are worrisome for women. Routine annual pelvic exams (yes still annually even when it is not the year to collect the pap smear), including visualizing the external genitalia, inserting the speculum and visualizing the cervix and vaginal walls, and a bimanual exam provide a wealth of important information even in women who do not have any symptoms. Many women have bacterial vaginosis or some other vaginal or cervical infection, severe vulvovaginal atrophy, cervical polyps, uterine fibroids, ovarian enlargement, vaginal wall growths, and/or vulvar skin disorders. Any of these can occur without symptoms and the only way we would know it is if the full exam was performed. The asymptomatic woman is indeed the woman who might benefit most from the routine annual pelvic exam. It has been hard enough to communicate to women Doctor checking woman blood pressurethe need for continued annual exams (which also include height, weight, blood pressure, temperature, pulse, breast exam, thyroid exam, heart/lung/abdominal exam and more) even when they don’t need a pap smear or HPV test that year. Too many women have ceased seeing their health care provider every year and only come every 3 years when the need a pap smear.

The ACP guidelines also differ from women’s health practitioners such as the American College of Obstetricians and Gynecologists. In 2012, they reaffirmed that the speculum and bimanual examination is a part of annual well-women visits in women 21 y.o. and older.

In addition, as a Naturopathic Physician, the annual visit is used to check in on nutrition, alcohol, nicotine, recreational and prescription drugs, stressors, exercise, sleep, dietary supplements, other health issues, changes in their health including weight gain or weight loss, and an eye towards prevention of diseases based on family history, aging, habits and select routine or specific testing.

With these ACP recommendations (which I will ignore), I am certain that we can predict that even less women will seek annual visits with their health care provider. I will encourage my patients to seek annual visits and be clear in communicating the value of each exam and each test if/when needed.

Reference

Bloomfield H, et al. Screening pelvic examinations in asymptomatic, average-risk adult women: An evidence report or a clinical practice guideline from the American College of Physicians. Ann Intern Med 2014 Jul 1;161:46

The purpose of this study was to determine whether a combination of valerian/lemon balm could improve sleep problems in menopausal women. A total of 100 postmenopausal women aged 50-60 years with sleep disorders were studied. Women were selected randomly after fulfilling the entrance criteria. The Pittsburgh Sleep Quality Index (PSQI) questionnaire was completed to assess the status of their sleep disorder in the month prior. The PSQI consists of 7 measurements : general description of individual sleep quality and patterns, delay in the onset of sleep, sleep duration and pattern as well as waking in the night, use of tranquilizers, daily performance problems due to lack of sleep. A score of 5 or greater constitutes a sleep disorder and the 100 women selected were those with a scoring. Women were randomly divided into two groups with 50 women in the herbal treatment group and 50 in the control group containing starch. The herbal group received two capsules containing 160 mg of valerian and 80 mg of lemon balm. Participants and investigators and the statistician were all blinded. The duration of the intervention was one month and then followed by another PSQI questionnaire.Woman lying in bed sleeping

One month following the use of the valerian/lemon balm supplement, 36% of the treatment group and 8% of the placebo group showed an improvement in the quality of their sleep. Sleep disorder scores decreased by 5 points which was statistically significant.

Commentary: Perimenopausal and menopausal women are faced with hormonal changes that can result in not only night time hot flashes that can disrupt sleep, but lengthening in the time it takes to fall asleep, frequent awakenings, waking and poor return to sleep, early morning waking and non-restorative sleep. Botanical options that can improve any or all aspects of sleep disruption are an important part of a comprehensive approach to treating this. However, addressing sleep disorders in this population usually also involves strategies that target the fundamental issue, which is hormonal changes and the impact on neurotransmitters, cortisol, stress adaptation and sleep cycle physiology.

In 2011, another study of valerian and insomnia was published on the impact of valerian for sleep quality in postmenopausal women who were experiencing insomnia.[i] The postmenopausal women studied were generally healthy women aged 50 to 60 years who were menopausal for at least 1 year, were not using hormone therapy and were experiencing insomnia. One group of women were given capsules containing 530 mg of concentrated valerian extract twice per day and the other group was given placebo twice per day, for 4 weeks. A statistically significant change was reported in the quality of the sleep in the valerian group when compared to the placebo group. The average scored on the sleep scale before valerian was 9.8 and after valerian it was 6.02. The placebo group had an initial average sleep scale score of 11.1 and after placebo, 9.4. Overall, 30% of the women taking valerian and 4% taking placebo reported an improvement in their sleep quality.

Although not all research on valerian and insomnia have resulted in positive results, the current study with the valerian in combination with the lemon balm in menopausal women, along with the 2011 valerian study in menopausal women, bring more focus to using valerian in menopausal women for sleep disorders.

References

Taavoni S, Nazem ekbatani N, Haghani H. Valerian/lemon balm use for sleep disorders during menopause. Comp Therapies in Clinical Practice 2013;19:193-196


[i] Taavoni S, Ekbatani N, Kashaniyan M, Haghani H. Effect of valerian on sleep quality in postmenopausal women: a randomized placebo-controlled clinical trial. Menopause 2011; 18(9): 951-955.

Introduction:

The relationship between the microbiota in the gut and the etiology (cause) of irritable bowel syndrome (IBS) is becoming increasingly clear. IBS is one of the Young casual girl woman is having stomach ache.most common gastrointestinal conditions, and more common in women. It is characterized by abdominal discomfort or pain and variable types of other symptoms including episodic diarrhea and/or constipation, bloating, and even non-gut symptoms such as backache, muscle pains, joint pains, anxiety and mood issues and fatigue. The use of probiotics has received much interest in that different probiotics species and strains can effect intestinal motility, visceral hypersensitivity, secretion of immune chemicals and increase anti-inflammatory populations. While clinical trials with probiotics for IBS still yields conflicting results, improved research designs and research quality are warranted. That said, two large meta-analyses of 2008 and 2009 concluded that probiotics may be of benefit in the treatment of IBS. For practitioners of alternative and integrative medicine in particular, probiotics are becoming one of the mainstays of treatment for IBS. The current study is supportive of that practice.

Study:

This recent randomized, double-blind, placebo-controlled trial of adult women and men with symptomatic IBS was undertaken for 12 weeks. A total of 152 patients completed the 12 week study with 100 in the probiotic group and 52 in the placebo group. The four species/strains of probiotic were Lactobacillus rhamnosus NCIMB 30174, L. plantarum NCIMB 30173, L. acidophilus NCIMB 30175 and Enterococcus faecium NCIMB 30176. The bacteria were in a water based suspension of barley extract with each 50mL dose containing 10 billion live organisms.

Results:

The primary outcome showed a highly significant result in favor of the probiotic. Improvements in individual symptoms of pain and bowel habits were noted, rather than in bloating or quality of life issues. The pain symptoms improved in severity from moderate/severe to mild/no symptoms, although the difference was not considered statistically significant. Four weeks after completing the 12 week treatment, the difference in the IBS symptom severity scores between the probiotic and placebo groups were no longer apparent.

Commentary: In the current study, 94% of the patients enrolled had at least moderate to severe symptoms of IBS… indicating that probiotics can help even these folks. The significant improvement in pain scores in the probiotics group is especially relevant given that pain is most often the single most important bothersome symptoms of IBS.

Multi-species/strain probiotics are one of the four pillars in my treatment strategies for IBS which includes a probiotic combination of 10 billion per day, plus enteric coated peppermint oil, a fiber supplement and lifestyle changes (diet and stress reduction). I typically have a first follow-up in 6-8, which most often results in good improvement, with great improvement by 12 weeks. Adjustments can be made accordingly, with some individuals needing fine tuning on the kind of fiber supplement that best suits them. If they also have reflux, I would avoid the enteric coated peppermint oil. I do not hesitate to continue the probiotic combination long term.

Reference

Sisson G, Ayis S, Sherwood R, Bjarnason I. Randomised clinical trial: a liquid multi-strain probiotic vs placebo in the irritable bowel syndrome- a 12 week double-blind study. Aliment Pharmacol Ther 2014; 40:51-62.

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