Open AccessThe Effect of Supraphysiologic Levels of Iodine on Patients with Cyclic Mastalgia
Author(s) -
Kessler Jack H.
Publication year - 2004
Publication title -
the breast journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.533
H-Index - 72
eISSN - 1524-4741
pISSN - 1075-122X
DOI - 10.1111/j.1075-122x.2004.21341.x
Subject(s) - medicine , placebo , breast pain , visual analogue scale , tenderness , breast cancer , euthyroid , randomized controlled trial , physical therapy , surgery , hormone , cancer , alternative medicine , pathology
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 ≥5 on a visual analog scale (VAS) of pain for ≥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.