interesting finding. Of course, you won’t find a large scale study for a medicinal that is regulated as a FOOD. Whatever the cost, if the side effect were insignificant, it would be a challenge to pharma, but the cost is not picked up by insurance.
read-
Fading Rainbow
A Reporter’s Last Story
by Robert E. Liss
Methuen, Inc. 1980
Leukemia – biography
ISBN: 0-416-00631-0
Reporter for Miami Herald, merit scholar graduate from Brandeis U., father of 3, develops Hairy Cell Leukemia, going out like a “failing rainbow”, tells the story of tests, hospitalizations, treatments, pain. Story completed by his wife – Bonnie Liss.
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interestingl that the authors looked at aromatase activity but feel they have fell on the issue with most studies I see on herbals. There have been many studies showing anti-tumor activity (cucurimin, green tea extracts etc) which have shown anti-tumor activity in isolated tumor cell lines as well as xenograft studies using the same tumor cell lines however not have made much success in human clinical trials. Years back a compound Oltipraz showed similar promising results and thought to be a great candidate for chemoprevention studies. The mechanism of action (MOA) was very intuitive for this (elevated GSH) however never seemed to make it in the clinic. I believe there are multiple reasons fro this. First, it is relatively easy to show anti-tumor effects in isolated cancer cell lines as well as in xenograft studies using those cell lines however you want to show complete log kill and Gomptzerian anti-tumor growth kinetics in the animal studies. In addition many of these studies fall short in determining the fraction of extracts, or isolated active compound responsible for the anti-tumor effect making it hard to determine potency and perform pharmacokinetic analyses. With little data on potency and kinetics, moving into human trials is difficult. In addition there still remains a void between our understanding why we still see high failure rates from preclinical to early phase I, II. Hopefully this will be tackled in the future studies.
The other problem with most natural product clinical trials is lot standardization. There needs to be a means by which you can standardize dose, potency, and pharmacokinetic profile and I don’t feel this has been done with the natural product market. Therefore it is very difficult to even start a clinical trial before you know this. Perhaps the authors could compare different lots of extracts with other traditionals head-to head in one study. May be more informative
Very good observations.