Table 3.
Stratified analysis by iodine status: comparisons between outcome variables in MTF and Placebo groups during the study.
| Insufficient UIC (<100μg/L) | Adequate UIC (100–199 μg/L) | More than adequate + excessive UIC (≥ 200μg/L) | |||||||
|---|---|---|---|---|---|---|---|---|---|
| MTF (n = 1) | Placebo (n = 1) | P* | MTF (n = 4) | Placebo (n = 5) | P* | MTF (n = 5) | Placebo (n = 6) | P* | |
| EVALUATIONS BY PATIENTS THAT CONCLUDED THE STUDY BY IODINE STATUS | |||||||||
| ΔTSH (mUI/L) | – | – | NE | −0.06 (0.64) | +0.07(0.32) | 0.413 | −0.69 (0.41)a | +0.07(0.58) | 0.082 |
| ΔTV (cm3) Δ%TV |
– | – | NE | +0.61(7.2) +0.22(0.56) |
+2.8(8.46) +0.15(0.58) |
0,730 1.0 |
−1.4 (2.97) −0.11(0.2) |
+2.0 (8.9) +0.16(0.52) |
0.082 0.247 |
| Thyroid volume that growth# | – | – | NE | 50% | 60% | 0.76 | 0% | 50% | 0.120 |
| ΔHoma | – | – | NE | −0.30(1.43) | −0.10(1.55) | 0.730 | +0.2 (3.7) | 0.0 (1.2) | 0.792 |
| ΔBMI (kg/m2) | −0.25(1.6) | 0.00(2.35) | 0.556 | +0.2(1.8) | +0.05(1.7) | 0.662 | |||
| EVALUATIONS BY NODULES FROM PATIENTS THAT CONCLUDED THE STUDY | |||||||||
| MTF (n= 2) | Placebo (n= 3) | P* | MTF (n= 7) | Placebo (n= 7) | P* | MTF (n= 10) | Placebo (n= 10) | P* | |
| ΔBTN Volume (cm3) | +0.15 (–) | −0.006 (–) | 1.00 | +0.17(0.64) | +0.03(0.57) | 0.535 | −0.029 (0.28) | +0.10 (2.8) | 0.075 |
| Δ%BTN Volume | −0.062 (–) | −0.19 (–) | 0.80 | +0.06(0.58) | +0.01(0.62) | 0.805 | −0.03(0.32) | +0.24(0.5) | 0.075 |
| BTNs that growth # | 50% | 33.3% | 0.700 | 42.9% | 42.9% | 0.704 | 20% | 70% | 0.035 |
a
P = 0.043 (Wilcoxon test- paired analysis);
*
Mann-Whitney test between MTF and Placebo group; NE: not evaluated; UIC: Urinary iodine Concentration; MTF metformin; TSH, thyroid-stimulating hormone; TNV, thyroid nodule volume; TV, thyroid volume; BTNs, benign thyroid nodules; BMI, body mass index.
#
: growth of more than 10%. In paired analysis only p ≤ 0.10 are highlighted.