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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.

Migraine headaches are one of the most common causes of pain and can vary from a minimal impact on activities of daily living to even incapacitating. Numerous over the counter and prescription drugs exist for acute migraine headaches but problems abound with poor satisfaction in many cases and varied side effects in others. In addition, some migraine sufferers have very frequent chronic and recurrent attacks, necessitating the frequent use of some of these acute intervention drugs and thus again, side effects can become an issue. An effective herbal intervention for acute pain relief would be a welcome addition to the list of options.

This double-blind randomized controlled clinical trial compared the efficacy of Ginger root and powderginger to sumatriptan, a standard conventional prescription treatment, in the treatment of common migraine. Study subjects were randomly delivered either one ginger capsule of 250 mg upon onset of headache or 50 mg of sumatriptan. Questionnaires were completed for each headache attack, recording time of headache onset, severity, timing of drug taking and response self-assessments at 30, 60, 90 and 120 minutes and 24 hours. Any adverse effects were also recorded. The overall study duration was one month.

One hundred sufferers of common migraine headaches, from a Hospital in Iran were the study subjects. The average age of participants was 35.1 in the sumatriptan group and 33.9 in the ginger group. Women comprised 68% of the sumatriptan group vs. 74% of the ginger group. The average duration of a migraine diagnosis was similar in both groups at approximately 7 years. The average number of headache attacks in the sumatriptan groups were 5.8 and 4.9 in the ginger treated group. Inclusion criteria for the study included a confirmed diagnosis of migraine without aura by a neurologist, 18 years and older, high school diploma or higher and a frequency of 2 to 10 headaches/month.

Both sumatriptan and ginger powder decreased the mean severity of common migraine attacks within 2 hours of use. No significant difference existed between the two treatments. Before taking the medication, 22% of the sumatriptan group and 20% of the ginger group had severe headaches. The mean headache severity at 2 hours after sumatriptan or ginger use demonstrated similar effectiveness for both groups. There was 4.7 unit reduction in the headache severity in the sumatriptan group and a 4.6 reduction in the ginger group. Favorable relief was achieved in 70% of the sumatriptan treated headache individuals and 64% of the ginger treated patients at 2 hours following intake. Both the sumatriptan and ginger significantly provided pain relief and no significant differences were achieved.

There were more side effects from sumatriptan using including dizziness, sedation, vertigo and heartburn. The only clinical adverse effect of ginger was dyspepsia.

Commentary: Ginger products have a long tradition of use for joint pain, nausea and vomiting, motion sickness, lipid lowering and a broad range of anti-inflammatory implications. For migraines, a previous study in 2005 demonstrated that ginger completely alleviated migraine headache in 48% of individuals and partially in 34% of individuals within 2 hours. Another study demonstrated that the ginger treated group had a higher pain relief rate at 65% for ginger versus 36% for the placebo.

I am quite impressed that the current study reveals both sumatriptan at 50 mg and ginger powder at 250 mg decreased the mean severity of a common migraine attack and within 2 hours of use. Pain relief and patient satisfaction did not show any significant difference, although side effects due to ginger were far less than those with sumatriptan.

In my experience, the natural medicine strategies for reducing the frequency and severity and duration of migraines are quite effective and include basic lifestyle and nutritional plans, but more robustly involve a multi-factorial approach using riboflavin, ginger, feverfew, 5-HTP, butterbur, magnesium, CoQ10, and sometimes cyclic estrogen patches in women with menstrual migraines. I have never felt very optimistic about acute intervention with these supplements or others in reducing the severity of an acute migraine. I am encouraged by this study, that acute use of ginger capsules for acute migraines may provide pain reduction, with an overall 44% palliation in all headache attacks within 2 hours.

Reference

Maghbooli M, Golipour F, Esfandabadi A, Yousefi M. Comparison between the efficacy of ginger and sumatriptan in the ablative treatment of the common migraine. Phytotherapy Res 2014;28:412-415.

Current study: Xi S, Liske E, Wang S, et al. Effect of isopropanolic Cimicifuga racemosa extract on uterine fibroids in comparison with tibolone among patients of a recent randomized, double blind, parallel-controlled study in Chinese women with menopausal symptoms.

Black-Cohosh-C-racemosa

An original menopause study, published in 2007[1] enrolled 244 Chinese women aged 40-60 years with menopause symptoms who were treated with either black cohosh extract, 40 mg/day (n=122) or tibolone 2.5 mg/day (n=122) for 3 months. The current study investigated the subset of women from that study (n=62) who had at least one uterine fibroid at the onset of the study, and compared the effect of black cohosh extract (n=34) on fibroid size compared with tibolone (n=28), using transvaginal ultrasound.

The patients were treated for 12 weeks with iCR (isopropanolic Cimicifuga Racemosa) or tibolone. Study visits were at entry, 4 weeks and 12 weeks. Clinical variables including the Kupperman Index (KI), vital signs, body weight, co-existing diseases, adverse events and co-existing medications were recorded. In addition to blood samples for follicle stimulating hormone (FSH), estrogen, standard hematology and biochemistry and urine samples, transvaginal ultrasound was also performed before onset of study and at the end of treatment.

In the black cohosh group, the median volume of the largest individual fibroid decreased from 1787 mm3 at visit one to 1086 mm3 after 12 weeks. The mean diameter of the largest fibroid per patient significantly decreased during the treatment with a decrease of the total myoma volume of – 30.3% on average observed in 24 of the women in the black cohosh group (70.1%) during the 12 weeks. In the tibolone group, the median volume of the largest individual fibroid changed from 1063 mm to 1096 mm after 12 weeks, actually slightly larger. No statistically significant difference was found for the mean diameter of the individual largest fibroid as well, from baseline to 12 weeks. There was a decrease in the myoma volume in 10 of the women in the tibolone group (35.7%), but on average, it increased by +4.7% in the tibolone group.

In summary, the key results were that the percentage of volume change in the black cohosh extract group (-30.3% decrease) was significantly superior to the tibolone group, a 4.7% increase and the percentage of mean diameter change in the herbal group was significantly superior to tibolone as well. Lastly, the superior response rate of black cohosh 70.1% vs. tibolone 35.7% was important.

Other questions about the effect of black cohosh on hormone sensitive tissues might be considered here as well. A 12 month study showed that after 12 months of treatment with black cohosh extract, no increase in the risk of malignant change of the breast or endometrium was observed.[2] In another study, black cohosh extract did not increase the risk of tumor recurrent in patients with early endometrial cancer after 24 months of treatment for menopausal symptoms and after surgery.[3] In another study, 6 months of treatment with black cohosh daily did not cause change in the mammographic density and breast cell proliferation.[4] And yet another found that isopropanolic black cohosh extract did not increase the risk of breast cancer recurrence. [5]

To my knowledge, the current clinical study analysis is the first of its kind evaluating the effect of iCR on uterine fibroids. I will add this to my eager approach to helping perimenopausal women in particular, decrease their fibroid growth. We now have two recent botanical studies of import for uterine fibroids, this one, and the green tea extract study I wrote in an earlier blog posting. [6]

References


[1] W. Bai, H.-H. Henneicke-von Zepelin, S. Wang, et al. Efficacy and tolerability of a medicinal product containing an isopropanolic Cimicifuga racemosa, aka black cohosh (iCR) extract was in Chinese women from five hospitals in China, with menopausal symptoms: a randomized, double blind, parallel-controlled study versus tibolone. Maturitas 2007;58(1):31-41)

[2] Geller S, Shulman L, van Breemen R, et al. Safety and efficacy of black cohosh and red clover for the management of vasomotor symptoms: a randomized controlled trial. Menopause 2009;16(6):1156-1166.

[3] Li W, Sun N, Chen X, et al. Cimicifuga racemosa for the treatment of menopausal symptoms in patients with eaerly endometrial cancer after operation. Academic Journal of Second Military Medical University 2012;33(5):562-564.

[4] Hirschberg A, Edlund M, Svane G, et al. An isopropanolic extract of black cohosh does not increase mammographic breast density or breast cell proliferation in postmenopausal women. Menopause 2007;14(1):89-96.

[5] Henneicke-von Zepelin H, Meden H, Kostev K, et al. Isopropanolic black cohosh extract and recurrence-free survival after breast cancer. International J of Clinical Pharmacology and Therapeutics 2007;45(3):143-154.

[6] Roshdy E, Rajaratnam V, Maitra S, et al. Treatment of symptomatic uterine fibroids with green tea extract: a pilot randomized controlled clinical study. Int J Womens Health. 2013;5:477-486.

 

Photo credit: http://chestofbooks.com/flora-plants/flowers/Wild/Black-Cohosh-Bugbane-Black-Snakeroot-Cimicifuga-Racemosa-Crowfoot-Family.html#.U6tOFLFhsTA

Nearly 50% of women who undergo screening mammography are classified as having either heterogeneously dense or extremely dense breast tissue. Dense breast tissue is defined as a greater amount of fibrous or glandular tissue than fatty tissue in the breasts. Women with dense breast tissue have a modestly elevated risk for breast cancer and the sensitivity of screening mammography is reduced. One 2007 report states a four to five fold increased likelihood of developing breast cancer in women with dense breast versus women with low breast density. [i] Due to this data, and some assertive women’s health scientists and activists, certain states now require that women found to have dense breast tissue on screening mammography be provided a letter informing them of these findings and are then encouraged to follow up with their primary care provider to discuss risk and screening guidelines. While this is dictated by at least 11 state jurisdictions, and more to come, most physicians have yet to urge patients to get further testing. Even the American College of Obstetrics and Gynecologists (ACOG) is currently not offering guidelines to physicians, for further testing when the mammogram detects heterogeneously dense or extremely dense (grade 3 and 4 density respectively).

In a recent evidence based review, ACOG noted that “the assessment of breast breast scandensity is subjective and affected by the perspective of individual radiologists.”[ii] Their statement also indicates that “use of supplemental imaging such as ultrasound, magnetic resonance imaging (MRI), tomosynthesis, or thermography has not been associated with meaningful benefits for women found at screening to dense breasts.” They support further research on the topics but as of this writing, ACOG does not recommend use of alternative tests for dense breast detected on screening mammography

Commentary

As a practicing clinician providing healthcare for women these last 30 years, I am currently recommending a more proactive approach and not waiting for guidelines from ACOG. I advise my patients to have additional imaging if they have heterogeneously dense or extremely dense breasts. If they have no other risk factors for breast cancer, I am likely to just recommend a screening breast ultrasound. If they also have other risk factors for breast cancer (ex/ first degree relative with breast cancer, obesity, an intake of greater than 7 alcohol drinks per week, history of estrogen/progestin for greater than 4 years), then I may consider an MRI, in consultation with the radiologist and a breast surgeon.

References


[i] Boyd, N.F., et al. (2007). Mammographic breast density and the risk and detection of breast cancer. N Engl J Med. 356(3):227-36.

[ii] Committee on Gynecologic Practice. Committee Opinion No. 593: Management of women with dense breasts diagnosed by mammography.  Obstet Gynecol 2014 Apr; 123:910

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