OT: Phytoestrogen Supplement May Increase Bone Mineral Density

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Phytoestrogen Supplement May Increase Bone Mineral Density

Menopause. 2003;10:522-525

http://www.medscape.com/viewarticle/465682?mpid=22301

Dec. 9, 2003 — DT56a, a dietary supplement described as a " novel

phyto-selective estrogen receptor modulator (SERM), " increases bone

mineral density (BMD) in postmenopausal women, according to the findings

of a new randomized trial.

Boris Kaplan, MD, from the Department of Obstetrics and Gynecology at

the Rabin Medical Center in Petah Tikva, Israel, and colleagues

evaluated DT56a, the active substance in a product called

Tofupill/Femarelle (Se-cure Pharmaceuticals, Yavne, Israel).

According to the researchers, DT56a is isolated from tofu, and the

product Tofupill/Femarelle " constitutes all the active phyto-estrogen

ingredients " found in tofu. In addition, " a unique enzymatic process of

isolation is employed to ensure that the whole isoflavone family, the

lignans, the coumestans, remain in their naturally intact form, " the

authors claim.

To evaluate the product's efficacy, Dr. Kaplan and colleagues randomized

98 healthy postmenopausal women to receive either 644 mg/day DT56a or

344 mg/day DT56a supplemented with calcium for 12 months.

The Israeli team assessed study participants with a comprehensive health

questionnaire, a physical examination, and laboratory and pelvic

sonograms every three months. BMD was assessed by dual-energy x-ray

absorptiometry of the lumbar spine and femoral neck before the study and

after 12 months.

BMD increased in the study group by 3.6% in the lumbar spine (P = .039)

and by 2.0% in the femoral neck (although this difference was not

significant [NS]). In contrast, in the low-dose group, BMD decreased in

the lumbar spine by 0.6% (NS) and by 0.6% in the femoral neck (NS).

Between the groups, the change in lumbar spine BMD was significantly

different (P = .037), the researchers report in the December issue of

Menopause.

In addition, " neither group showed a change in endometrial thickness and

sex hormone levels nor reported any side effects of treatment, " Dr.

Kaplan and colleagues note, suggesting that the product did not cause an

unwanted " estrogenic " effect.

" The study showed that daily treatment with two capsules of Femarelle

significantly elevated the BMD of postmenopausal women, " Dr. Kaplan told

Medscape. " Since reduction in the BMD is directly related to

osteoporotic fractures, Femarelle is an effective tool to fight

osteoporosis and fractures, " he said.

According to Dr. Kaplan, additional larger and multinational research

studies are planned to evaluate Tofupill/Femarelle.

The same researchers recently reported that Tofupill/Femarelle

selectively stimulates creatine kinase specific activity in skeletal

tissues of rats but not in the uterus, suggesting that DT56a " acts as a

SERM stimulating skeletal tissues without affecting the uterus. "

Tofupill/Femarelle is a supplement, and as such, does not require U.S.

Food and Drug Administration (FDA) approval based on clinical trials.

" It's nice to have any data about the effectiveness of an

over-the-counter remedy. Most of the time we do not, " Watts, MD,

the director of the University of Cincinnati Bone Health and

Osteoporosis Center in Ohio, told Medscape.

Dr. Watts pointed out that the study has some flaws. These limitations

include the lack of a control group, small sample size, and lack of

detail about how BMD was measured or the precision error for the Israeli

researchers' technique.

" These women had normal bone density. We don't know how this would work

in women with osteoporosis, " he added. " Most important, we don't know

anything about the safety of this agent. "

" There are good reasons why the FDA requires large-scale three-year

studies of drugs for osteoporosis, " Dr. Watts said, and he indicated

that he would need considerably more information before recommending

this supplement to a patient.