Pharyngeal stimulation after stroke: more evidence is needed

The trial was stopped early before it had reached its prespecified maximum sample size—a factor that has previously been associated with overestimation of treatment effects.7 The independent data safety monitoring board advised stopping early for effectiveness; such advice is warranted when a trial has provided incontrovertible evidence that it would be unsafe to continue because the control group, or similar future patients, might be denied a very effective treatment if the trial continued. Shortly after the measurement of the primary outcome 24–72 h after randomisation, non-responders and patients who had been allocated to sham treatment received the active stimulation, apparently with very good effects, but without a comparator control group. Because of this design, no information is available about the effect of the treatment on the timing of feeding tube removal, resumption of oral intake, and other important clinical outcomes. While these results do not support the introduction of the device into routine management of patients with post-stroke dysphagia, or even that of the small subset of patients with stroke who are intubated, the data are encouraging enough to support larger multicentre randomised controlled trials to help identify which, if any, subgroups of patients with stroke derive clinically important benefits from this treatment.