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A prospective, randomised and single blind clinical trial was designed to compare intravenous methylprednisolone pulse (IVGC) with oral methylprednisolone (OGC) monotherapy in terms of effectiveness and tolerability in Graves’ ophthalmopathy (GO). Fifty-two consecutive patients with untreated, moderately severe and active GO were randomly treated with either IVGC or OGC therapy for 12 weeks. IVGC therapy achieved a more rapid and significant improvement than OGC therapy according to clinical activity score (p < 0.01), proptosis (p < 0.038), lid width (p < 0.0001), extraocular muscle changes (p < 0.02), optic neuropathy. (p < 0.001), intraocular pressure (p < 0.04), visual acuity (p < 0.03), quality of life (p < 0.0001) and treatment response (p < 0.001). Diplopia was significantly improved in two groups but there was no difference between them (p < 0.6). Heavy smokers indicated alteration of ophthalmic signs with increased thyroid stimulating hormone (TSH)-receptor antibody during the therapy. In conclusion, IVGC therapy was more effective and better tolerated than OGC therapy in the management of GO. [ABSTRACT FROM AUTHOR]