AIM: 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). CONCLUSION: 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.
RCT Entities:
AIM: 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). CONCLUSION: 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.