Selenium beneficial in mild Graves' orbitopathy

N Engl J Med.2011;364(20):1920-1931.

Six months of treatment with selenium improved the course of disease and quality of life in patients with mild Graves' orbitopathy, according to a study.

Compared with placebo, patients with mild Graves' orbitopathy demonstrated significant improvement in self-reported quality of life measures (P < .001), less eye involvement (P = .001) and a slower progression of Graves' orbitopathy (P = .001) after receiving selenium treatment for 6 months.

The multicenter, randomized, double blind, placebo-controlled clinical trial compared twice-daily treatment with the antioxidant agent selenium (100 mcg), the anti-inflammatory agent pentoxifylline (600 mg) and placebo in 159 patients who had mild Graves' orbitopathy. Treatment lasted 6 months, and patients were followed for 6 months thereafter.

The clinical activity score decreased in all groups, with the greatest change in the selenium group. The clinical activity score consisted of seven items: swelling of the eyelids; spontaneous retrobulbar pain; conjunctival redness; eyelid redness; pain on attempted eye movements; chemosis; and swelling of the caruncle.

Sixty-one percent of patients in the selenium group experienced improvement in Graves' orbitopathy, primarily related to amelioration of soft-tissue changes and a decrease in eyelid aperture, compared with 35% of the pentoxifylline group and 36% of the placebo group. Graves' orbitopathy worsened in 7% of the selenium group, 10% of the pentoxifylline group and 26% of the placebo group.

"Thus, as compared with placebo, selenium was associated with an increased rate of improvement but also with a decreased rate of worsening," the researchers said. "Except for a transient benefit with respect to soft-tissue changes at 6 months, the outcomes with pentoxifylline did not differ significantly from those seen with placebo."

In addition, quality-of-life measures did not change significantly in the pentoxifylline or placebo groups.

Evaluation at 12 months confirmed the results observed at 6 months, according to the researchers. Two patients in the placebo group and one patient in the pentoxifylline group required immunosuppressive therapy for deterioration of Graves' orbitopathy.

The researchers observed no drug-related adverse events associated with selenium or placebo. However, skin and gastrointestinal disorders were reported with pentoxifylline.