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Star Scientific and Rock Creek Pharmaceuticals Announce the Publication of a Peer-Reviewed Article about the ASAP Clinical Trial Showing Immune System Support in Hashimoto's Thyroiditis
Date:10/31/2013

the thyroid gland in cases of autoimmune thyroiditis.  The results showed that anatabine reduced the patients' immune reaction against their own thyroid gland.  Patients taking anatabine had a significantly greater reduction from baseline in serum thyroglobulin antibody levels compared to patients on placebo (p= 0.027).  Similarly, more patients in the anatabine group had a greater than 20% drop in thyroglobulin antibodies than patients on placebo (p=0.023).  Finally, the percentage of patients on anatabine with reductions in thyroglobulin antibodies of at least 25, 50, 75, or 100 WHO units was significantly greater than that of patients on placebo (all p < 0.05 at all cut-off levels). There were no significant changes or treatment group differences in serum thyroid function tests, thyroperoxidase antibody, inflammatory biomarkers, or ultrasonography measures.

Overall, as the study concludes, the anatabine supplement was safe and well tolerated, although it was associated with more minor adverse events on initial dose adjustment.  The most common MedDRA adverse events upon starting anatabine supplementation were mild dizziness (36%), nausea (8%), headaches (7%), and paresthesia (7%); most of the events were resolved with simple dose adjustment. Very few patients withdrew from the study due to adverse events (7 on anatabine and 1 on placebo). There were no significant abnormalities in clinical laboratory values attributed to anatabine, and no clinically significant effects of supplementation, either with anatabine or placebo, on vital sign measures.

Curtis Wright, MD, MPH, Medical Director of Rock Creek Pharmaceuticals, commented, "The concept for this clinical trial originated after receiving reports from individuals that the addition of anatabine, a Solanaceous alkaloid, to their diet improved their thyroid inflammatory disease.  The idea was supported by multiple recent epidemiological st
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SOURCE Star Scientific, Inc.
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