title: Activity of some physiological modulators in reducing the side effects of levothyroxine in patients suffering from primary hypothyroidism.
abstract: OBJECTIVE
  The use of L-T4 (levothyroxine) in the treatment of primary hypothyroidism causes oxidative stress (OS) and daily discomfort. It is believed that the use of physiological modulators (PMs) may make the treatment more tolerable.
  
  
  METHODS
  Thirty six patients of both sexes (15 M; 21 F) with hypothyroidism were enrolled (age 44-64 years), starting the treatment with LT-4 at the fixed dose of 75 µg/day. Subjects were randomly divided into three groups (A, B and C) of 12 subjects each in a double blind design. Group A was treated with a formula based on bioflavonoids; group B with a formula B based on oligomeric proanthocynidins (OPA); group C with placebo. Treatments continued for 30 days. Plasma levels of T3, T4, TSH, plasma hydroperoxides and hs-CRP, were determined before and after 30 days of treatment. During the treatment anxiety/agitation, sweating, palpitations, headache and daily discomfort were recorded through a daily questionnaire.
  
  
  RESULTS
  The same adequate hormone balancing was observed in all three groups (T4, T3, TSH). The hydroperoxide levels in the three groups (A, B and C) were similar at baseline (373 ± 36.1, 384 ± 39.1, 376 ± 24.0 U.CARR. respectively); after 30 days the values were significantly different (of 312 ± 21.0, 273 ± 24.3, and 409 ± 31.7 U.CARR respectively). The levels for hs-CRP at baseline were 3.8 ± 1.41, 3.4 ± 1.34, 3.6 ± 1.03, and 3.8 ± 1.31, 3.2 ± 0.99; and 4.4 ± 0.90 mg/L at 30 days respectively. Both markers were more consistently reduced by Formula B (anova p< 0.05). The incidence of side effects and the number of days of daily discomfort were significantly lower in the same group only (Anova P<0.05).
  
  
  CONCLUSIONS
  The use of a formula containing OPA with other PMs may limit the incidence of the side effects that occur during the initial phase of L-T4 treatment in hypothyroidism.
authors: Loyola University School of Medicine, Chicago, IL, USA. umbertocornelli@cornelliconsulting.it
authors: U
authors: U
authors: Cornelli
authors: G
authors: G
authors: Belcaro
authors: A
authors: A
authors: Ledda
authors: B
authors: B
authors: Feragalli
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005419:Flavonoids / Q000008:administration & dosage; D006801:Humans; D007037:Hypothyroidism / Q000097:blood / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D018384:Oxidative Stress / Q000187:drug effects; D010545:Peroxides / Q000097:blood; D044945:Proanthocyanidins / Q000008:administration & dosage; D013963:Thyroid Hormones / Q000097:blood; D013974:Thyroxine / Q000008:administration & dosage / Q000009:adverse effects*
chemical_list: D005419:Flavonoids; D010545:Peroxides; D044945:Proanthocyanidins; D013963:Thyroid Hormones; D013974:Thyroxine