EFFECT OF PERCUTANEOUS ETHANOL INJECTION THERAPY VERSUS SUPPRESSIVE DOSES OF L-THYROXINE ON BENIGN SOLITARY SOLID COLD THYROID-NODULES - A RANDOMIZED TRIAL
Fn. Bennedbaek et al., EFFECT OF PERCUTANEOUS ETHANOL INJECTION THERAPY VERSUS SUPPRESSIVE DOSES OF L-THYROXINE ON BENIGN SOLITARY SOLID COLD THYROID-NODULES - A RANDOMIZED TRIAL, The Journal of clinical endocrinology and metabolism, 83(3), 1998, pp. 830-835
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.