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Research update.

The Calcium and Cardiovascular Disease Risk Connection--Is It True?

Bolland M, Barber P, Doughty R, et al. Vascular events in healthy older women receiving calcium supplementation: Randomised controlled trial. BMJ. 2008;Feb 2; 336:262-266.

A study was conducted in which 1,471 post-menopausal women in New Zealand with a mean age of 74 were randomized to receive 1 gm of calcium citrate or placebo daily for five years. Either the women or their family members reported occurrences of sudden death, heart attacks, strokes, and transient ischemic attacks. A twofold increase in myocardial infarctions (Mls) was seen among women in the calcium group compared with the placebo group. When accumulating the total of heart attacks, strokes, or sudden deaths, the incidence was 1.47 times higher in the calcium group than in the placebo group as well. However, when the investigators incorporated national health database results for unreported cardiovascular events, the increase in the incidence in heart attacks was not statistically significant.

Commentary: It is interesting and important to point out that the Women's Health Initiative {Circulation. 2007;115:846) showed no statistically significant increase in cardiovascular events in postmenopausal women receiving calcium supplements, and another study showed (a non-significant) trend toward increased risk for ischemic heart disease (Arch Intern Med. 2006;166:869). These three studies all point to the fact that no definite statement or conclusion can be made regarding calcium and cardiovascular events. That said, I am concerned that the importance of calcium supplementation in postmenopausal women, especially younger postmenopausal women, is considerably overplayed. Most individuals do not estimate their dietary calcium sources. They use a pill to supplement, in addition to getting calcium from dietary sources, to meet a total of 1,200 mg-1,500 mg per day. But that total is incorrect. Women often take 1,000 mg to 1,500 mg per day, in addition to their dietary sources. A result of this misinterpretation of calcium guidelines might be excessive calcium and depletion of other nutrients such as copper, silicon, and magnesium, all of which have cardioprotective benefits. In addition, these total daily calcium guidelines turn out to be most important to young girls and postmenopausal women 65 and older. These are the times in life when lack of bone architecture/density growth (young girls) and bone loss (elderly women) are most crucial in the prevention of osteoporosis and risk for fractures. For women in their 30s, 40s, 50s, and early 60s, bones seem to do just fine with average dietary intake.

Pycnogenol and Perimenopause Symptoms

Yang H-M, Liao M-F, Zhu S-Y, Liao M-N, Rohdewald P. A randomised, double-blind, placebo-controlled trial on the effect of Pycnogenol on the climacteric syndrome in perimenopausal women. Acta Obstetricia et Gynecologica. 2007;86:978-985

In a double-blind study, Taiwanese perimenopausal women, aged 45-55, were given either placebo or 100 mg of Pycnogenol twice daily for six months. One hundred fifty-five women received the Pycnogenol, and 75 women were given a placebo. The Women's Health Questionnaire with 36 items was used to evaluate the climacteric symptoms at baseline and at one, three, and six months.

Blood pressure decreased similarly in both groups. HDL increased and LDL decreased significantly from baseline with Pycnogenol, but no significant differences were seen in HDL between the two groups. However, LDL was more significantly reduced in the Pycnogenol group. Perimenopause symptoms of depression, vasomotor symptoms, memory, anxiety, sexual function, and sleep ail improved significantly (P< 0.001) with Pycnogenol as soon as one month after starting the treatment, in both severity and frequency. Most symptoms also improved with placebo, but not significantly.

Commentary: I was surprised to see this study, as I have never thought to use Pycnogenol in the treatment of perimenopausal/menopausal symptoms. The most common symptoms of perimenopause/menopause that I see in my practice are hot flashes, sweating, heart palpitations, fatigue, depression, decreased sexual function, insomnia, and cognitive impairment. It's imperative to have as many natural medicine, non-hormonal options as possible, and making clinical decisions based on evidence based therapies is extremely helpful, enhancing our ability to help more women, more of the time. I'm pleased to be able to add Pycnogenol to my list of choices and will look forward to hopefully positive results.

Soy Isoflavone Supplementation Improves Menopause Symptoms Only in Equol Producers

Jou H-J, Wu S-S, Change F-W, Ling P-Y, Chue K, Wu W-H. Effect of intestinal production of equol on menopausal symptoms in women treated with soy isoflavones. Intl J Gynecology and Obstetrics. 2008.

This randomized, double-blind, placebo-controlled clinical trial with 96 menopausal women was conducted over six months. Sixty-six women were given 135 mg of soy isoflavones, and 30 women were given placebo. After one week, the women in the treatment group were tested and further divided into two subgroups, equol-producing (EP) and non equol-producing (non-EP), according to peak levels of equol in the urine. Women in both of these subgroups were then given 3 grams of soy germ extract powder twice a day, totaling 135 mg of isoflavones daily, for six months.

Menopause symptoms were evaluated using a modified Kupperman Index, measuring 17 items (hot flashes, excessive sweating, coldness of extremities, shortness of breath, numbness of extremities, paresthesia of extremities, insomnia, easy awakening, excitability, nervousness, melancholia, vertigo, weakness, arthralgia or myalgia, headaches, palpitations, and formication) and scoring them as none, mild, moderate, or severe.

Compared with the placebo group, symptoms of hot flashes and excessive sweating significantly reduced after three months, and weakness, palpitations, limb paresthesias, and total symptoms significantly decreased after six months (P< 0.05) but only in the equol producers. At three months, total scores had decreased by 66% in the EP group, 54% in the non-EP group, and 59% in the placebo group. At six months, symptom scores had decreased by 84% in the EP group, 58%in the non-EP group, and 66% for the placebo group.

Commentary: The research on soy's ability to relieve menopause symptoms has produced quite mixed results. Differences in study doses, different proportions of genistein and daidzein used in the study medication, and differences in the study population have been used to explain the discrepancies. Previous study populations may have a higher percentage of women who are equol producers, which has been previously suspected to be the determining factor in the effectiveness of soy isoflavones. However, the current study seems to be the first to demonstrate more clearly that a woman's ability to produce equol determines her response to soy isoflavone supplementation. Daidzein and genistein are the two most significant phytoestrogens in soy. Daidzein is converted to equol, a metabolite of daidzein, by bacterial flora in the gut. For clinicians, part of our task in treating menopausal women with soy may be to test for equol production prior to treatment and/or improve their gut flora so that they can more easily transform soy isoflavones to equol.

Saffron in the Treatment of PMS

Agha-Hosseini M, Kashani L, Aleyaseen A, et al. Crocus sativus L. (saffron) in the treatment of premenstrual syndrome: A double-blind, randomized, and placebo-controlled trial. BJOC. 2008;! 15:515-519.

The objective of this double-blind, placebo-controlled trail was to study whether saffron could be used to relieve premenstrual syndrome (PMS) symptoms. Fifty reproductively aged women with regular menstrual cycles and with PMS symptoms for at least the last six months were randomly assigned to receive 15 mg of saffron twice daily or placebo twice daily for four full menstrual cycles. The Daily Symptom Report and the Hamilton Depression Rating Scale were used to evaluate the response.

According to the Daily Symptom Report, 19 of the 25 women in the saffron group responded with at least a 50% reduction in severity of symptoms vs. only two of 25 in the placebo group (P< 0.0001). A significant difference between the saffron group and placebo group occurred between the third and four cycles and was statistically significant by the end of the study (P< 0.0001).

According to the Hamilton Depression Rating Scale, 15 of 25 women in the saffron group responded to treatment vs. only one of 25 in the placebo group. (P< 0.0001). Again, a significant difference was seen between cycles 3 and 4 with a statistically significant difference by the study's end (P< 0.0001).

Commentary: Improvements in the Total Premenstrual Daily Symptoms and the Hamilton Depression Rating Scale with saffron should give us definite motivation to try this simple treatment. Saffron has been previously shown to have an antidepressant effect in women with mild to moderate depression through a serotonergic mechanism, so it's not surprising that it would work in PMS. Research on PMS in the last several years has pointed strongly to the etiology being the dysregulation of the serotonergic system. This is why we have seen conventional medical practitioners focus on the use of selective serotonin reuptake inhibitors (SSRls) in treatment.

This is the first clinical trial I've seen in the use of saffron for the treatment of PMS. While only a small study and short follow-up, the positive results warrant further study and, in the meantime, the need to accumulate some clinical experience in our patient populations.

A New and Improved Approach to Determining Osteoporosis Fracture Risk

Measuring bone mineral density and the standard deviation below the bone density of a healthy young adult woman is considered to be the gold standard for determining osteoporosis treatment. However, it is really only one factor determining the risk she has for a fracture. Others are age, thinness, a personal history of fracture as a postmenopausal woman, and a family history of fracture as an adult in a first-degree family member.

The World Health Organization (WHO) has been working on a new paradigm to help determine risk for fracture and therefore help determine who needs to be treated and when. Analyzing data from nine worldwide population-based studies, the research team created a model that predicts ten-year risk for hip and other major fractures. This new model has been named FRAX [TM] and incorporates bone density, age, sex, body-mass index, weight, height, previous fracture, parent with hip fracture, current smoking use, rheumatoid arthritis, current glucocorticoid use, and alcohol use. To calculate your patient's risk for fracture, you can use the FRAX online calculator at

This approach to determining fracture risk and treatment is comprehensive and can serve as an important guide to alternative and conventional practitioners alike. This will likely result in fewer women needing to follow the premature advice of clinicians who recommend bisphosphonates. Fine-tuning the evaluation and assessment by using the FRAX model makes for more appropriate individualized prevention and treatment strategies and better identification of those who really will need conventional treatment.

by Tori Hudson, ND
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Title Annotation:Women's Health Update
Author:Hudson, Tori
Publication:Townsend Letter
Geographic Code:1USA
Date:Aug 1, 2008
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