Selenium Effective for Mild Graves' Orbitopathy

May 19, 2011

By Gene Emery

NEW YORK (Reuters Health) May 18 - A twice-daily supplement of selenium helped symptoms and improved quality of life in European patients with mild Graves' orbitopathy, doctors report in the May 19 New England Journal of Medicine.

"Now we may want to say to patients, you may get improvement using selenium and you may also have a lower chance of worsening," said Dr. Claudio Marcocci of the University of Pisa in Italy, who led the study.

Also known as Graves' ophthalmopathy or thyroid eye disease, the condition affects 16 women and 3 men per 100,000 per year and mostly occurs in conjunction with the hyperthyroidism of Graves' disease. Roughly half of all Graves' patients develop the eye condition. In 3% to 5% it can be severe, with swelling and inflammation causing intense pain and corneal ulceration.

Even mild disease, which can improve by itself and is usually treated with artificial tears and ointments, can disrupt quality of life. So Dr. Marcocci and his colleagues tested selenium and the Sanofi Aventis drug Trental (pentoxifylline), which has anti-inflammatory and immunomodulatory properties.

In the randomized study, some volunteers got 100 mcg of selenium twice daily for six months, some received 600 mg twice a day of pentoxifylline, and some took placebo tablets. All had experienced eye problems for less than 18 months. The treatment lasted six months.

Six months after the end of therapy, "Graves' orbitopathy improved in 33 of 54 patients (61%) in the selenium group, 17 of 48 (35%) in the pentoxifylline group, and 18 of 50 patients (36%) in the placebo group; the disease worsened in 4 of 54 (7%) in the selenium group, 5 of 48 (10%) in the pentoxifylline group, and 13 of 50 patients (26%) in the placebo group," the authors reported.

They said the rate of worsening of Graves' orbitopathy was significantly lower in the selenium group than in the placebo group (P = 0.01).

"We could definitely see an improvement just by looking at some of the patients," Dr. Marcocci told Reuters Health in a telephone interview. "But this was not necessarily true in all cases."

None of the selenium patients had any drug-related side effects, but seven of the pentoxifylline patients had skin and gastrointestinal problems such as nausea, bloating and erythema. Four of the seven left the study during the first month because of such side effects.

The improvements in the selenium group were probably due to a reduction in the opening of the eyelid and ameliorating soft-tissue changes, the researchers said.

Dr. Marcocci says the findings may not apply in parts of the world where people are less likely to have selenium deficiency. "We gave selenium to patients living in moderate selenium-deficient areas, as in many European countries," he said.

The study was conducted by the European Group on Graves' Orbitopathy (EUGOGO).


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


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