November 06, 2013
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ASAP trial: Anatabine decreased thyroid autoimmunity

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Supplementation with anatabine led to a statistically significant reduction in thyroid autoimmunity, according to researchers. With continued supplementation, patients’ overall autoimmune responses could also improve.

Data from the Anatabloc Supplementation Autoimmune Prevention (ASAP) clinical trial were published in the Journal of Clinical Endocrinology and Metabolism.

“This study’s results show a selective decrease in [thyroglobulin antibodies] but not [thyroperoxidase antibodies] in patients with Hashimoto’s thyroiditis after 12 weeks of anatabine supplementation. Anatabine is an alkaloid found in plants of the Solanaceae family, including tobacco, tomatoes, potatoes, peppers and eggplants,” study researcher Lowell R. Schmeltz, MD, of Associated Endocrinologists in West Bloomfield, Mich., and colleagues wrote. “Although dietary anatabine’s mechanism of action on thyroid autoimmunity remains to be elucidated, it may produce immunomodulatory effects through activation of alpha4beta2 or alpha7 cholinergic receptors like nicotine and other structurally related agonists.”

The double blind, randomized, placebo-controlled multisite study included 146 patients (70 assigned anatabine; 76 placebo). Lozenges of anatabine (Rock Creek Pharmaceuticals) 9 mg to 24 mg per day or placebo, each containing vitamins A and D3, were randomly assigned to patients by mouth three times per day for 3 months.

Patients assigned to anatabine demonstrated a significant reduction in absolute serum thyroglobulin antibodies (TgAb) levels from baseline to 3 months compared with those assigned placebo (P=.027).

Mean TgAb values decreased by 46.2 WHO units for those in the anatabine group compared with 3.9 WHO units for patients in the placebo group.

There was also a more than 20% decrease in TgAb in the anatabine group compared with the placebo group (P=.023), according to data.

The supplement was well tolerated and safe, according to researchers. The most common adverse events were mild dizziness (36%), nausea (8%), headaches (7%) and paresthesia (7%). However, dose adjustments resolved such events in most cases.

Long-term studies are warranted to confirm these results, researchers wrote.

Disclosure: This study was funded by Rock Creek Pharmaceuticals Inc. Three of the researchers report employment with Rock Creek Pharmaceuticals, and another researcher reports speaker fees on behalf of AbbVie Inc. Schmeltz reports no relevant financial disclosures.