Label Review

Estroven™

December 1998; Volume 1: 7

Label and Package Insert Information

Dietary supplement with natural estrogens, calcium, B-6 and E.

Estroven™ is not solely for use during menopause. Estrogen loss can begin in your 30s, and many women notice changes years before menopause begins. It is important to remember that Estroven™ is a natural, nutritional supplement, not a drug. We do not suggest it functions the same as prescription HRT. However, we do believe that the natural estrogens and balancing nutrients provide valuable benefits for women before, during, and after menopause.

Package Directions

Take one caplet daily before bedtime with food.

Estroven™ may be taken in addition to other nutritional supplements and prescription estrogen.

Because Estroven™ is a natural product, please take daily and allow 30-60 days for it to begin to work in harmony with your body’s natural processes.

(Estroven™ is a trademark of AmeriFit™)

Price: 30 capsules, $14.39

Analysis of Ingredients

Vitamin E, 30 IU: This safe supplemental dose of vitamin E meets RDA. However, the dose is lower than in standard supplements, which range from 100-800 IU.

Thiamin, 2 mg; Riboflavin, 2 mg; Niacin (niacinamide), 20 mg; Vitamin B6, 10 mg; Vitamin B12, 6 mcg; folate, 400 mcg: These are safe doses of B vitamins that meet RDA. The B vitamins (excluding folate) are in much lower doses than standard B-complex supplements, which typically contain 50 mg each of thiamin, riboflavin, niacin, and vitamin B6, and 100 mcg of vitamin B12.

Calcium (calcium carbonate), 150 mg: This is a small supplemental dose of calcium. Postmenopausal women should ingest 1500 mg calcium qd; premenopausal women should ingest at least 1000 mg qd.

Selenium (l-selenomethionine), 70 mg: This is a safe supplemental dose of selenium that meets RDA.

Boron (chelate), 1.5 mg: This is a safe supplemental dose of boron. RDA has not been established.

Purified isoflavones (from soy and pueraria), 50 mg: This is a small dose of isoflavones (a type of phytoestrogen). In trials of soy products for menopausal symptoms, daily doses of isoflavones have ranged from 76 mg to more than 300 mg. Genestein is the predominant isoflavone in soy; there are no trials of isoflavones from pueraria root (kudzu), which contains different isoflavones (daidzein and daidzin). Although this appears to be a small dose, there are no clinical trials of its effects on menopausal symptoms (see page 1).

Kava root standardized extract (30% kavalactones), 100 mg: This dose of kava is equivalent to 30 mg/d of kavalactones. There are two clinical trials of kava for menopausal symptoms; one tested a dose of 30 mg and one of 60 mg (see page 5). The usual dose of kavalactones for anxiety is higher, at 210 mg daily.

Black cohosh root, 40 mg: Black cohosh contains the phytoestrogen formononetin, a very different phytoestrogen than that found in soy products and other foods. For standardized dried extract, the daily dose is 8-40 mg; for dried root the usual daily dose is 900- 2000 mg. Long-term safety has not been established.

Conclusion and Recommendations

This typical dietary supplement contains a sprinkling of many ingredients in small amounts in combinations that have not been tested in clinical trials. The vitamins and minerals in this formula are present in safe amounts, and the B vitamins, E, and selenium are provided in amounts that meet the RDA. The formula also includes various plant estrogens (isoflavones, pueraria, and black cohosh) and an anxiolytic herb (kava). Although there is some evidence for the estrogenic effects of soy isoflavones, isoflavones are not interchangeable. If these are soy isoflavones, the dose is subtherapeutic. Pueraria is a Chinese herb used for fevers and diarrhea; there are no clinical trials on kudzu for menopausal symptoms.

The black cohosh dose is either a low dose of dried root or a high dose of dried extract. The phytoestrogens in black cohosh are very different than those found in soybeans, flaxseed, or other food plants. Black cohosh is a medicinal herb that is not traditionally used long-term. There are no data on long-term safety; black cohosh should not be taken for more than six months.

It is unlikely that this combination of ingredients in the amounts provided would have therapeutic effects. Theoretically, there could be a synergistic effect of phytoestrogens present in this formula, but there is no evidence provided in the label or package insert that any human or animal experiments have been performed on this combination. Daily use of this product cannot be recommended given the lack of long-term safety data on black cohosh.