Reduction of thyroid nodule volume by levothyroxine and iodine alone and in combination: a randomized, placebo-controlled trial.

Abstract

CONTEXT:

Nodular goiter is common worldwide, but there is still debate over the medical treatment.

OBJECTIVE:

The objective of the study was the measurement of the effect of a treatment with (nonsuppressive) T(4), iodine, or a combination of both compared with placebo on volume of thyroid nodules and thyroid.

DESIGN:

This was a multicenter, randomized, double-blind trial in patients with nodular goiter in Germany [LISA (Levothyroxin und Iodid in der Strumatherapie Als Mono-oder Kombinationstherapie) trial].

SETTING:

The study was conducted in outpatient clinics in university hospitals and regional hospitals and private practices.

PARTICIPANTS:

One thousand twenty-four consecutively screened and centrally randomized euthyroid patients aged 18-65 yr with one or more thyroid nodules (minimal diameter 10 mm) participated in the study.

INTERVENTION:

Intervention included placebo, iodine (I), T(4), or T(4)+I for 1 yr. T(4) doses were adapted for a TSH target range of 0.2-0.8 mU/liter.

OUTCOME MEASURES:

The primary end point was percent volume reduction of all nodules measured by ultrasound, and the main secondary end point was a change in goiter volume.

RESULTS:

Nodule volume reductions were -17.3% [95% confidence interval (CI) -24.8/-9.0%, P < 0.001] in the T(4)+I group, -7.3% (95% CI -15.0/+1.2%, P = 0.201) in the T(4) group, and -4.0% (95% CI -11.4/+4.2%, P = 0.328) in the I group as compared with placebo. In direct comparison, the T(4)+I therapy was significantly superior to T(4) (P = 0.018) or I (P = 0.003). Thyroid volume reductions were -7.9% (95% CI -11.8/-3.9%, P < 0.001), -5.2% (95% CI -8.7/-1.6%, P = 0.024) and -2.5% (95% CI -6.2/+1.4%, P = 0.207), respectively. The T(4)+I therapy was significantly superior to I (P = 0.034) but not to T(4) (P = 0.190).

CONCLUSION:

In a region with a sufficient iodine supply, a 1-yr therapy with a combination of I and T(4) with incomplete suppression of thyrotropin reduced thyroid nodule volume further than either component alone or placebo.

• Authors: M Grussendorf, C Reiners, R Paschke, K Wegscheider, LISA Investigators
• Journal: The Journal of clinical endocrinology and metabolism (J Clin Endocrinol Metab) Vol. 96 Issue 9 Pg. 2786-95 (Sep 2011) ISSN: 1945-7197 [Electronic] United States
• PMID: 21715542 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Iodine
• Thyroxine

Topics

• Adolescent
• Adult
• Aged
• Double-Blind Method
• Drug Therapy, Combination
• Female
• Germany
• Humans
• Iodine (therapeutic use)
• Male
• Middle Aged
• Prospective Studies
• Thyroid Nodule (diagnostic imaging, drug therapy)
• Thyroxine (therapeutic use)
• Treatment Outcome
• Ultrasonography