The Effect of Supraphysiologic Levels of Iodine on Patients with Cyclic Mastalgia

Abstract

A randomized, double-blind, placebo-controlled, multicenter clinical trial was conducted with 111 otherwise healthy euthyroid women with a history of breast pain. Patients had to document moderate or severe breast pain by recording a score > or =5 on a visual analog scale (VAS) of pain for > or =6 days per cycle and had to present with fibrosis involving at least 25% of both breast surfaces. Subjects could not be effectively treated with more conservative measures such as local heat or nonprescription analgesics. There was not a statistically significant difference in the dropout rate for patients on placebo (11.8%), 1.5 mg/day (31.3%), 3.0 mg/day (18.4%), or 6.0 mg/day (25%) of molecular iodine for 6 months. Physicians assessed breast pain, tenderness, and nodularity each cycle; patients assessed breast pain and tenderness with the Lewin breast pain scale at 3-month intervals and with a VAS at each cycle. A statistically significant improvement (p < 0.01) associated with dose was observed in the Lewin overall pain scale for all treated groups compared to placebo. Reductions in all three physician assessments were observed in patients after 5 months of therapy in the 3.0 mg/day (7/28; 25%) and 6.0 mg/day (15/27; 18.5%) treatment groups, but not the 1.5 mg/day or placebo group. Patients recorded statistically significant decreases in pain by month 3 in the 3.0 and 6.0 mg/day treatment groups, but not the 1.5 mg/day or placebo group; more than 50% of the 6.0 mg/day treatment group recorded a clinically significant reduction in overall pain. All doses were associated with an acceptable safety profile. No dose-related increase in any adverse event was observed.

Antineoplastic effect of iodine and iodide in dimethylbenz[a]anthracene-induced mammary tumors: association between lactoperoxidase and estrogen-adduct production

“…), but in normal subjects only with higher doses of iodine or iodide (O20 mg/day; Robison et al 1998, Burgui et al 2001. No damaging effects were reported in either the human or animal studies that used therapeutic I 2 concentrations (3-15 mg/day; Ghent et al 1993, Kessler 2004, Anguiano et al 2007). In this study, our results showed that the thyroid epithelium response was directly proportional to the iodide concentration: iodide or iodine concentrations of 0.05% or less did not modify the cytoarchitecture (epithelium/lumen ratio), but 0.1% KI or Lugol decreased this ratio with the tissue exhibiting thinner thyroid epithelium and increased luminal volume, which suggested a hypothyroid-like situation.…”

Antiproliferative/cytotoxic effects of molecular iodine, povidone-iodine and Lugol's solution in different human carcinoma cell lines

“…Similarly, clinical trials have revealed that I 2 has beneficial effects in fibrocystic breast disease (4) and in cyclic mastalgia (5), suggesting that iodine therapy may diminish breast disease, including breast cancer progression (6,7). Povidone-iodine (PVP-I) is widely used in clinical practice as an antiseptic agent following tumour surgery.…”

Signaling pathways involved in the antiproliferative effect of molecular iodine in normal and tumoral breast cells: evidence that 6-iodolactone mediates apoptotic effects

“…Several studies have shown the beneficial potential of molecular iodine (I 2 ) in mammary pathologies either in humans or in animals (Ghent et al 1993, Eskin et al 1995, Funahashi et al 1996, Kessler 2004, Garcia-Solis et al 2005. It has been suggested that in thyroid gland the apoptotic iodide (I K ) effect is mediated by the derivatives of arachidonic acid (AA) or eicosapentaenoic acid such as 6-iodolactone (6-IL) or a-iodohexadecanal respectively (Dugrillon et al 1994, Langer et al 2003.…”

“…The formation of these iodolipids requires, in addition to iodide uptake by specific transporters, its oxidation by thyroperoxidase (Shah et al 1986, Dohan et al 2003. In mammary gland, I 2 but not I K supplementation alleviates human mastalgia (Ghent et al 1993, Kessler 2004) and exerts a potent antineoplasic effect on pharmaco-induced mammary tumoral progression in rats (Funahashi et al 1996, Garcia-Solis et al 2005. The lack of an I K effect has been explained by the fact that lactoperoxidase, the enzyme that oxidizes I K and covalently binds it to the milk protein casein, is expressed in normal lactating but not in tumoral mammary gland (Shah et al 1986, Anguiano et al 2007.…”