INTRAVENOUS DEXAMETHASONE PULSE THERAPY IN DIFFUSE SYSTEMIC-SCLEROSIS- A RANDOMIZED PLACEBO-CONTROLLED STUDY

Thirty-five patients with diffuse systemic sclerosis were studied in a randomized, placebo-controlled, double-blind study. Seventeen patient s received intravenous dexamethasone ''pulse'' therapy, while 18 patie nts received placebo. Each ''pulse'' consisted of 100 mg dexamethasone in 250 ml 5% dextrose infused intravenously over 1 h. Pulse therapy w as repeated every month for 6 months. Assessment of disease status wit h various parameters was done at entry and at completion of trial, i.e . after 6 months. Significant improvement in skin involvement was seen in the study group, with the total skin score (TSS) decreasing from 2 8.5 +/- 12.2 to 25.8 +/- 12.8, while in the control group, TSS increas ed from 30.6 +/- 13.2 to 34.7 +/- 10. Similarly, significant improveme nt was noted in the flexion index. Other parametres that included exte nsion index, maximum oral opening, range of movement of joints, functi onal disability score, Raynaud's phenomenon (frequency and duration), ESR, proteinuria, chest X-ray, ECG, lung function tests, barium swallo w and antinuclear antibody were unchanged. Adverse effects of therapy were limited to an increased incidence of minor chest infections. It i s concluded that intravenous pulse dexamethasone may be useful in the treatment of diffuse systemic sclerosis.