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Biotech / Medical : Paracelsian Inc (PRLN)

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To: Jonathan Schonsheck who wrote (4293)1/10/2000 10:17:00 AM
From: Jonathan Schonsheck  Read Replies (1) of 4342
 
The Boston Globe does a test of St. John's Wort: BioFIT!

Here's the start of the main article; there's more, and two other articles.

St. John's wort: less than meets the eye

Globe analysis shows popular herbal antidepressant varies widely in content, quality

By Judy Foreman, Globe Staff, 1/10/2000

e thought it would be easy.

After all, we had just two seemingly simple questions: Does St. John's wort, the popular herbal antidepressant on which Americans spend $250 million a year, work - at least on rat brain cells in a test tube? And do the product labels accurately reflect what's inside the tablets?

The path toward answers proved tortuous indeed.

We hired two companies, Paracelsian, Inc., of Ithaca, N.Y., and PhytoChem Technologies, Inc., of Chelmsford, Mass., to independently test seven St. John's wort products we purchased and repackaged into bottles coded by number. The companies didn't know it at the time, but we also sent each one an eighth product, a placebo or inert drug, supplied to us by the Massachusetts College of Pharmacy.

We found that there was considerable chemical and biological variation among the products tested.

We'll give you the bottom line next - but read on, because the caveats are important.

On the basis of the PhytoChem analysis, only one product, Nature's Resource, lived up to the standard claim on product labels that the products contain 0.3 percent of hypericin, a substance once thought to be the active ingredient in St. John's wort. (Now, some scientists think a compound called hyperforin may be the active ingredient, but the industry continues to standardize products to 0.3 percent of hypericin.)

Four other products, Natrol, natureMade, Herbalife, and YourLife, were lower in hypericin, containing 0.28 percent, 0.27 percent, 0.25 percent, and 0.25 percent, respectively - less than their labels claimed.

With prescription drugs, the US Food and Drug Administration allows products to contain slightly less (10 percent above) than the contents stated on the label.

With dietary supplements, the FDA insists that they contain at least 100 percent of what's declared on the label, but because the agency does not require supplements to meet the same stringent requirements for safety and efficacy that it does for drugs, it does not specify what tests should be used to measure herbal ingredients or which labs should do them.

Although many of the products we tested fell short of their labeling numbers using the PhytoChem test, they might have passed with other testing methods in other labs.

One product, Quanterra, contained almost no hypericin, but its label makes no claim that it does.

According to the Paracelsian biological assays, only two products, Quanterra and NatureMade, passed the company's 'BioFIT' test for their ability to block the reuptake of both serotonin and dopamine, two neurotransmitters involved in depression.

(Abnormalities in the reuptake, or absorption, of serotonin and other neurotransmitters are believed to be a major cause of depression; many prescription antidepressants work by blocking the reuptake of serotonin into brain cells, thus leaving more in the synapse, or gap, between cells.)
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