Women's Health Community

This product, being a "supplement" (as opposed to a medication) is not required to have FDA approval and thus is not required to undergo testing to determine either its safety or efficacy.

In other words, there is likely to be no data on it's effect upon the liver or other body organs.

A review of its ingredients seems that it made up mainly of nutrients; calcium, zinc, a few amino acids, vitamin E and magnesium.

Gail

Dear Godsgirl: ). I looked at the studies produced by Amberen (on their website)---there are not many published in scientific journals. This suggests caution when evaluating what the manufacturer claims. Here is the best I could find at the National Library of Medicine site:

Adv Gerontol. 2008;21(2):298-305.
A succinate-based composition reverses menopausal symptoms without sex hormone replacement therapy.

Maevsky EI, Peskov AB, Uchitel ML, Pogorelov AG, Saharova NY, Vihlyantseva EF, Bogdanova LA, Kondrashova MN.

Institute of Theoretical and Experimental Biophysics RAS, 3 Institutskaya ul., Pushchino, Moscow region 142290, Russia. eim1@rambler.ru
Abstract

Menopausal transition is often accompanied by a variety of adverse pathological symptoms, currently treated with hormone replacement therapy, which is associated with a number of health risks. This report investigated the role of a food supplement--a composition of energy-exchange metabolites, with succinate as the main component--for treating menopausal syndrome. We studied the impact of a 4-week succinate-based food composition (SBC) treatment on the estral cycle, and bone mass and calcium content of aging mice. The impact of SBC on hormone levels and on the progression of several neurovegetative and psycho-emotional symptoms was further investigated in a randomized, double-blind, placebo-controlled clinical study of early menopausal women. Data were collected from questionnaires, Kupperman index scores, Spielberger-Hanin tests, and blood analysis of hormone levels taken at baseline and throughout the 5-week study. A "rejuvenating" effect of SBC on menopausal animals was observed, expressed as restoration of the estral cycle and an increase in the weight and calcium content of bone tissue. Furthermore, in the randomized, placebo-controlled clinical study in menopausal women, SBC-based monotherapy significantly lowered most subjectively evaluated characteristics of menopausal syndrome and increased blood serum levels of estradiol fourfold. This monotherapy also alleviated symptoms of some neurovegetative and psycho-emotional disorders, such as hot flushes, headache, and anxiety. Succinate-based therapy alleviated many biochemical symptoms of menopause in aging mice and early menopausal women, as well as neurovegetative and psycho-emotional disorders in women. Succinate-based therapy appeared to be free of adverse side effects.

Godsgirl55, note that estradiol levels increased by four fold. Yet we are not told if that means from 5 picograms to 20 (still menopausal range) or from 20 to 80 (premenopausal range). The website is predominantly testimonials-- not a list of ingredients or data.

Bottom line, as georgiagail has noted, this product is not regulated by the FDA so in depth testing is not always done, or required. If you have a pre-existing liver condition you should consult with your MD. They may want to do baseline liver enzymes before and after Amberen treatment. After a month or more of use you will know if this product meets your needs--and if it impacts your liver.

Yours,
Jane