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Product Review: Supplements for Menopausal Symptoms (Soy and Red Clover Isoflavones, Black Cohosh, and Progesterone Cream) |
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How Products Were Selected:
Products selected represent those commonly sold and/or available nationally in the U.S. or Canada. ConsumerLab.com purchased products on the open market through retail stores, on-line retailers, catalogues, or multi-level marketing companies. Products were not accepted directly from manufacturers.
Testing Methods:
Soy, red clover and combination products were tested for their total isoflavone content (specifically glycosidic and aglycone forms of the isoflavones). All products were analyzed using a HPLC (High Performance Liquid Chromatography) assay in an independent laboratory. The extraction and HPLC method was designed to specifically test for the presence and amount of various glycosidic and aglycone forms of the isoflavones found in soy and red clover. Products not passing this initial assay were tested in a second independent laboratory utilizing a similar HPLC assay.
Progesterone cream products were tested for their progesterone content and for potential contamination with other steroids. Products were analyzed by GC/MS/MS for progesterone content and for undeclared steroidal ingredients. Products not passing this initial assay for progesterone were tested in a second independent laboratory using a method from USP 28, NF 23.
Products containing Black Cohosh were evaluated for triterpene glycoside content (using 23-epi-26-deoxyactein as a standard) by HPLC-ELSD according to the INA method (113.001) and a published, modified USP method.
Disintegration of non-chewable and non-time release formulations was analyzed utilizing USP (United States Pharmacopeia) <2040> recommendations entitled "Disintegration and Dissolution of Nutritional Supplements."
All testing was conducted in independent laboratories to which the identities of the products were not disclosed.
Passing Score: *
To achieve a "Pass" in the testing, a product had to meet applicable criteria:
Soy and Red Clover Isoflavones
Meet 100% of label claim for total isoflavone content and, if declared, for specific glycosidic or aglycone isoflavones. Total isoflavones is calculated as the sum of the glycosidic and aglycone forms.
Black Cohosh
- Meet 100% of label claim for total triterpene glycosides, and not more than 150% of the claim
- Contain a minimum of 1 mg of total triterpene glycosides per daily recommended dose. An "extract" product must also contain a minimum of 2.5% triterpene glycosides. (Reference: German Commission E Expanded Monographs recommends 40 mg of extract standardized to 2.5% triterpene glycosides per day).
Progesterone Creams
- Meet 100% of label claim for progesterone, and not more than 125% of the claim.
- Not contain unlisted steroidal compounds that, in total, exceed 1% of the total progesterone found in the product (% wt/wt).
All Products
- Meet recommended USP parameters for disintegration for vitamin supplements (excluding chewable and time-release products).
- Meet all FDA labeling requirements.
For a product to fail, confirmation of a failing result was required on at least one of the criteria through repeat testing in a second independent laboratory.
* Passing scores allow for specific margins of technical error associated with each analysis. ConsumerLab.com reserves the right to disqualify a product at any time from passing its testing if it considers such product to present a safety risk or to provide misleading or inaccurate information in its labeling.
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