Effectiveness of high dose dexamethasone in the treatment of acute stroke.

A prospective double-blind placebo-controlled, randomised clinical trial was carried out to determine the effectiveness of short-course of high dose dexamethasone therapy on mortality and neurological recovery in stroke patients. During a sixteen month period of study, 230 patients with clinical diagnosis of stroke were seen. Of these, 40 were eligible for the study (27 were presumed to have had haemorrhagic stroke; and 13 were presumed to have had cerebral infarction). The commonest cause of exclusion was presentation after 24 hours of the ictus. Patients were sequentially paired and randomised into high dose dexamethasone and placebo groups in a double-blind fashion. There were twenty patients in either group. Of the 27 patients with haemorrhagic stroke, 15 were in the dexamethasone group and 12 in the placebo group. Of the 13 patients with cerebral infarction, 5 were in the dexamethasone group and 8 in the placebo group. Each patient received 100 mg of dexamethasone stat, and 16 mg every 6 hours for a period of 48 hours or equivalent volumes of placebo. Assessment of each patient was done using a neurological score. Sequential analysis by Armitage was employed, using survival at 1 month as the primary criterion of effectiveness. Survivors were followed-up for 6 months. At the end of one month, 16 patients (80%) had died in the dexamethasone group and 17 (85%) in the placebo group. The average day of death was six days in the dexamethasone group and 15 days in the placebo group, but this was not statistically significant. Of the seven survivors at one month, four were in the dexamethasone group and 3 in the placebo group. Five of them had cerebral infarction and two had haemorrhagic stroke. The two in the haemorrhagic subgroup who survived the first month died at the 2nd and 4th month respectively. At the end of six months, only the five patients with cerebral infarction were alive. Of these, 2 in the dexamethasone group were back at work while the third was chair-bound. The 2 survivors in the placebo group were chair and bed bound respectively. In conclusion, this study failed to demonstrate any benefit of a short-course of high dose steroid in improving the mortality of stroke patients and its use should be discouraged. However, possible benefit in the morbidity of survivors in the patients with cerebral infarction requires further studies.