Patients with Graves orbitopathy benefitted from supplementation with selenium, but not from pentoxifylline, in a controlled trial.

Graves' disease is an autoimmune disorder directed at the thyroid gland, and about half of those who have it will have ophthalmic disease (thyroid eye disease, Graves' ophthalmopathy, Graves' orbitopathy). Although mild disease can improve spontaneously, therapy is justifiable as in many patients it does not. A number of therapeutic options exist, including corticosteroids and local treatment depending on severity, however some evidence suggests that both selenium and pentoxifylline might be beneficial. The activity of both was assessed further in this double-blind placebo-controlled study. Participants were patients with mild Graves' orbitopathy of up to 18 months duration. They were randomised to pentoxifylline 600mg, selenium 100microgm, or placebo, all given twice daily, with the selenium and placebo matching the pentoxifylline in appearance. Treatment duration was 6 months with a further 6 month evaluation period after stopping: evaluations were at 3, 6, and 12 months. The primary outcomes were overall ophthalmic assessment by an assessor unaware of the treatment assignments, and a Graves' orbitopathy–specific quality-of-life questionnaire, completed by the patient.

Of 204 potentially eligible patients, 159 were randomised to treatment (remainder declined to participate): 52 to placebo, 55 to selenium, and 52 to pentoxifylline. There were 7 who withdrew within the first month (2, 1, and 4 respectively) and thus could not be included: withdrawals in the pentoxifylline group were due to adverse effects.

At six months, those in the selenium group had an improved quality of life (P<0.001) and less eye involvement (P=0.01), as compared with placebo; they also had slowed progression of orbitopathy (P=0.01. Clinical Activity Score decreased in all groups, but the change was significantly greater in the selenium-treated patients. Changes in the selenium group persisted at the 12-month evaluation and remained significantly better than placebo.

Selenium and placebo were well tolerated with no reported adverse events, however patients receiving pentoxifylline reported gastro-intestinal adverse effects and skin rashes.

The authors conclude that in patients with Graves' eye disease, selenium supplementation had clinical and subjective benefits that persisted after withdrawal. Pentoxifylline caused only minor and transient improvements, and was associated with more adverse effects.