Background: Swallowing dysfunction after stroke is common, but there is little reliable evidence for how the disorder should be managed. This study compared standard low-intensity and high-intensity behavioural interventions with usual care for dysphagia.
Methods: 306 patients with clinical dysphagia admitted to hospital with acute stroke were randomly assigned to receive usual care (n=102), prescribed by the attending physician; standard low-intensity intervention (n=102), comprising swallowing compensation strategies and diet prescription three times weekly for up to a month; or standard high-intensity intervention and dietary prescription (n=102), at least daily for up to a month. The primary outcome measure was survival free of an abnormal diet at 6 months. Analysis was done by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00257764.
Findings: 60 patients died and three patients were lost to follow up before the 6-month analysis. Of patients randomly allocated usual care, 56% (57/102) survived at 6 months free of an abnormal diet compared with 67% (136/204) allocated standard swallowing therapy (relative risk 1.19, 95% CI 0.98-1.45). Standard swallowing therapy was associated with a non-significant trend toward a reduction in death (0.80, 0.5-1.3), institutionalisation (0.69, 0.4-1.1), and dependency (1.05, 0.8-1.3); a significant reduction in swallowing-related medical complications (0.73, 0.6-0.9), chest infection (0.56, 0.4-0.8), and death or institutionalisation (0.73, 0.55-0.97); and a significant rise in the proportion of patients regaining swallowing function (1.41, 1.03-1.94) by 6 months. Compared with usual care and low-intensity therapy, high-intensity therapy was associated with an increased proportion of patients who returned to a normal diet (p=0.04) and recovered swallowing (p=0.02) by 6 months.
Interpretation: These data show a consistent trend towards more favourable outcomes in dysphagic stroke patients who are assigned a standard programme of early behavioural swallowing intervention, including active therapeutic approaches and dietary modification.