EFFECT OF PERCUTANEOUS ETHANOL INJECTION THERAPY VERSUS SUPPRESSIVE DOSES OF L-THYROXINE ON BENIGN SOLITARY SOLID COLD THYROID-NODULES - A RANDOMIZED TRIAL

The results of studies using suppressive doses of L-T-4 on benign soli tary solid cold thyroid nodules have been conflicting. Recently, intra nodular injection of absolute ethanol has been proposed as an effectiv e treatment, but has been evaluated only in uncontrolled studies. Our objective was to evaluate the effect of two alternative medical treatm ent modalities, percutaneous ethanol injection therapy and L-T-4, on t he benign solitary solid cold thyroid nodule. In a prospective randomi zed clinical trial, 50 euthyroid patients with a single solid colloid thyroid nodule causing local discomfort were assigned to a single intr anodular injection of sterile 98% ethanol (n = 25) or suppressive dose s of L-T-4 (n = 25). We aimed at an ethanol dose of 20-50% of the pret reatment nodular volume. The initial daily dose of L-T-4 was 1.5 mu g/ kg BW and was adjusted monthly during the first 6 months to reduce ser um TSH to subnormal levels (<0.40 mU/L). Thyroid nodule volume and tot al thyroid volume were assessed by ultrasound, and thyroid function wa s determined by routine assays before and during follow-up. Symptom sc ores before and at 12 months were evaluated by a questionnaire rating pressure symptoms and cosmetic symptoms. The median ethanol dose given was 21% [95% confidence interval (CI), 18;25] of the pretreatment nod ule volume. In this group, the median reduction in nodule volume was 4 7% (CI, 33;57; P < 0.0001) compared to 9% (CI, -7;22; P = 0.09) in the L-T-4 group. The difference between the two treatment regimens was st atistically significant (P < 0.0001). The median reduction in perinodu lar thyroid volume was 20% (CI, 11;31; P = 0.03) in the L-T-4 group, w hereas no change was seen in the ethanol group (-2.5%; CI, -18;11; P = 0.9). Fourteen of 25 (56%) patients treated with ethanol injection an d 8 of 25 (32%) treated with L-T-4 had complete relief of symptoms at 12 months of follow-up (P = 0.09). No major side-effects were seen in either group. Percutaneous ethanol injection therapy administered as a single small dose results in a satisfactory clinical response in simi lar to 50% of patients by halving the nodule volume. The thyroid nodul e-reducing effect of L-T-4 suppressive therapy is insignificant, but a subjective satisfactory clinical response is seen in a subgroup of pa tients, probably explained by the concomitant reduction of perinodular thyroid volume.