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Alert Number 163
Date: May 26, 2006
A short while ago we reported a slight hiccup in the EGCG: Green Tea extract clinical trial (“Project Alpha”) that we are sponsoring at the Mayo Clinic (MN). You can read the details by clicking on the link below - Latest on Green Tea.
In a nutshell, in January of 2006 the FDA temporarily halted accrual to all human studies of green tea extracts to allow review of newly available toxicity data in beagle dogs that had been fed lots of EGCG. There were reports of liver toxicity in some of the dogs, with the use of some over the counter green tea extracts. During this interruption, FDA required that green tea extract not be given even for patients already on clinical trials. This forced a temporary interruption of Project Alpha trial as well, much to the frustration of patients already in the trial.
After review of the new beagle dog data, the FDA announced in March 2006 the steps necessary to allow reopening of all human trials of green tea extracts, including our own Project Alpha at the Mayo Clinic. The changes required by the FDA were that the Polyphenon E (Trade name of the EGCG extract used in this clinical trial) be given to the patients along with a meal rather than in a fasting state, and dose adjustments made if patients experience evidence of liver irritation on blood tests. The investigators at Mayo Clinic have now incorporated these changes into the design of Project Alpha and the trial has re-opened as of May 2006.
This is exactly how things should be done - full evaluation of all available data, full disclosure of issues as they come up, reasonable and rational changes made to trial designs as they become necessary. If we knew all the answers ahead of time, there is hardly any point in doing clinical trials, is there? We can have dozens of anecdotal stories from patients after using over-the-counter EGCG extracts, or more official sounding reports from “neutraceutical” companies with their own axe to grind, but none of this is worth a hill of beans until and unless we have formal, well-documented clinical trial data from credible researchers. Does green tea EGCG work in controlling CLL, in at least a segment of the CLL patient population? Does it work without toxicity in these patients? What should the dosage be? What are reasonable expectations for patients using it?
Stay tuned: we are on our way to finding credible answers.
And take a bow. Your hard earned dollars made it possible for us to sponsor and fund this important clinical trial.
Be well,
Chaya
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