Clinical Trials in Acute Stroke: Is it ethical to randomise patients to the placebo group?.
The ethics of randomising a patient to the placebo group in acute stroke clinical trials has been called into question in one study as these patients may be deprived of routinely applied therapies. No other study has previously analysed this hypothesis. Objective: To compare the prognosis at day 90 of patients included in clinical trials of acute stroke and randomised to the placebo group with patients not included in any clinical trial. Material and Methods: 50 patients consecutively included in the placebo group (CLASS, ECASS-II, Trafermin, GAIN), and 50 patients not included in any clinical trial randomly selected from those sharing similar characteristics (age, sex, stroke severity and stroke subtype using the TOAST criteria) and hospitalised during the same period. Results: No differences were found in neurological attention delay, Canadian scale at admission, final infarct volume and length of hospital stay. The placebo group had a lower proportion of progressing stroke than the control group (14% vs. 25%). Infectious and cardiovascular complications were more frequent in the placebo group (12% vs. 6% and 15% vs. 8%, respectively). However, the placebo group displayed a more favourable outcome at day 90 (Figure). Conclusions: Inclusion in a placebo group in acute stroke clinical trials results in a significant benefit. This advantage may be explained by a more active intervention over progressing stroke, resulting from a higher rate of detection and control of the related factors.