title: Anatabine supplementation decreases thyroglobulin antibodies in patients with chronic lymphocytic autoimmune (Hashimoto's) thyroiditis: a randomized controlled clinical trial.
abstract: BACKGROUND
  Hashimoto's thyroiditis is less prevalent in tobacco smokers. Anatabine, an alkaloid found in Solanaceae plants including tobacco, has been reported to ameliorate a mouse model of Hashimoto's thyroiditis.
  
  
  OBJECTIVE
  The effects of anatabine in patients with Hashimoto's thyroiditis were studied.
  
  
  METHODS
  This was a double-blind, randomized, placebo-controlled multisite study. A total of 146 patients (70 treated with anatabine and 76 with placebo) completed the study. Approximately 50% of patients in each group were taking levothyroxine. Anatabine lozenges (9-24 mg/d) or placebo, each containing vitamins A and D3, were administered orally 3 times a day for 3 months.
  
  
  METHODS
  Serum thyroperoxidase antibody (TPOAb) and thyroglobulin antibody (TgAb) levels were assessed. Safety was assessed through adverse events, clinical laboratory evaluations, and vital sign measurements.
  
  
  RESULTS
  Anatabine-treated patients had a significant reduction in absolute serum TgAb levels from baseline by study end relative to those receiving placebo (P=.027); however, there were no significant changes or differences in treatment group means for TPOAb or TgAb levels. Mean±SD TgAb values decreased by 46.2±101.1 and 3.9±83.9 World Health Organization units for the anatabine and placebo groups, respectively. Significantly more patients had a >20% drop in TgAb levels in the anatabine than placebo group (P=.023). Overall, the anatabine supplement was safe and well tolerated, although significantly (P<.05) more patients in the anatabine group reported adverse events.
  
  
  CONCLUSIONS
  These results demonstrate an immunological effect of anatabine on TgAb levels. Further studies are warranted to determine the longer-term effects and possible actions of anatabine on the course of Hashimoto's thyroiditis.
authors.affiliation: Associated Endocrinologists, PC (L.R.S.), West Bloomfield, Michigan 48322; Texas Diabetes and Endocrinology (T.C.B.), Austin, Texas 78731; Endocrine Associates of Dallas (S.L.A.), Dallas, Texas 75231; Texas Diabetes and Endocrinology (K.O.), Round Rock, Texas 78681; North Texas Endocrine Center (J.D.L.), Dallas, Texas 75231; New Jersey Physicians, LLC (M.A.G.), Clifton, New Jersey 07012; Metabolic Research Institute, Inc (B.S.H.), West Palm Beach, Florida 33401; Diabetes and Endocrine Associates (R.H.B.), La Grange, Illinois 60525; Bay Area Endocrinology Associates, LLC (P.T.), Tampa, Florida 33614; and Rock Creek Pharmaceuticals, Inc (A.E.C., R.K.L., C.W.), Gloucester, Massachusetts 01930.
authors.forename: Lowell R
authors.initials: LR
authors.lastname: Schmeltz
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Blevins
authors.forename: Stephen L
authors.initials: SL
authors.lastname: Aronoff
authors.forename: Kerem
authors.initials: K
authors.lastname: Ozer
authors.forename: Jonathan D
authors.initials: JD
authors.lastname: Leffert
authors.forename: Marc A
authors.initials: MA
authors.lastname: Goldberg
authors.forename: Barry S
authors.initials: BS
authors.lastname: Horowitz
authors.forename: Richard H
authors.initials: RH
authors.lastname: Bertenshaw
authors.forename: Pedro
authors.initials: P
authors.lastname: Troya
authors.forename: Amy E
authors.initials: AE
authors.lastname: Cohen
authors.forename: Ryan K
authors.initials: RK
authors.lastname: Lanier
authors.forename: Curtis
authors.initials: C
authors.lastname: Wright
mesh_terms: D000470:Alkaloids / Q000627:therapeutic use*; D001323:Autoantibodies / Q000097:blood* / Q000187:drug effects*; D004311:Double-Blind Method; D015536:Down-Regulation / Q000187:drug effects; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D050031:Hashimoto Disease / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology; D006801:Humans; D007453:Iodide Peroxidase / Q000276:immunology; D008297:Male; D010919:Placebos; D011725:Pyridines / Q000627:therapeutic use*
chemical_list: D000470:Alkaloids; D001323:Autoantibodies; D010919:Placebos; D011725:Pyridines; C006606:anti-thyroglobulin; C012737:anatabine; D007453:Iodide Peroxidase