Efficacy of High Dose Pulse Methylprednsiolone (Somidex) vs Oral Prednisolone for Treatment of Newly Diagnosed Idiopathic Thrombocytopenic Purpura in Rajavithi Hospital: Open Labelled Randomized Controlled Trial

Background: ITP is a disease which develops as a result of increased activity of the reticuloendothelial system (mainly the liver and spleen). The role of high-dose short- acting corticosteroids in the treatment of immune thrombocytopenic purpura in adults is controversial. We assessed the effectiveness of high-dose corticosteroids, compared with that of standard oral prednisolone therapy, for initial treatment of adults with immune thrombocytopenic purpura.

Methods: 52 patients were randomized to receive pulse methylprednisolone (1gm/day) for 3 days, or oral prednisolone 1 mg/kg/day for 84 days. Response was evaluated at D10/D14/D28 and at the end of treatment on D84. Degree of response was evaluated in term of platelet count number and duration of response.

Results: The mean initial platelet count was 28,031.58+ 23,663.61 per cubic millimeter. Of these 52 eligible patients, about two thirds had an initial response to pulse methylprednisolone. Seventeen of the 26 patients (65%) on oral prednisolone responded to steroids on D10, and this was identical to the number of initial response patients in the methylprednisolone arm. At the end of the 3rd month of therapy, 20/26 (76.9%) those with methylprednisolone were still in complete response (platelet count more than 100,000/uL) compared with 20/24 (83.3%) patients in the oral prednisolone arm. Although mean platelet count in oral prednisolone group were slightly significantly higher than those of methylprednisolone group on D10, D14, D28 and at the end of study after treatment, platelet count was in complete remission in both arms. Life threatening side effects were more in those with oral prednisolone arm (4 cases), as compared with high dose pulse methylprednisolone, which is no grade 3,4 side effects.

Conclusion: The high-dose pulse methylprednisolone is not more effective than standard-dose oral medication during the study period. It is worth considering high dose pulse methylprednisolone for newly diagnosed chronic ITP patients who seem to be unable to tolerate the long-term side effects of standard oral corticosteroids and need a short response time.