ArticlesRoutine oral nutritional supplementation for stroke patients in hospital (FOOD): a multicentre randomised controlled trial
Introduction
Undernutrition in hospital patients is a common and often unrecognised problem, especially in elderly people and those who remain in hospital for long periods.1 The frequency of undernutrition after stroke varies from 8% to 34%.2, 3 Nutritional status can worsen during admission, and undernutrition shortly after admission is associated with increased case fatality and poor functional status at 6 months, even after adjustment for other predictive factors.4 A systematic review of 20 small single-centre randomised controlled trials published between 1966 and 1999 suggested that oral protein energy supplementation in elderly patients reduces mortality by 39% (95% CI 18–55).5 However, only one of these trials6 exclusively recruited stroke patients and, since it reported outcomes for only 40 individuals, the estimates of treatment effect were very imprecise (odds reduction for death 75%, 95% CI –7 to 94). Perhaps because of the absence of reliable evidence, hospitals vary greatly in the use of oral supplements after stroke. The implications are that either many stroke patients are being denied effective treatment or that others are being unnecessarily overfed, wasting health-service resources. We aimed to establish whether routine oral protein energy supplementation of normal hospital diet would improve outcomes in stroke patients in hospital.
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Participants
The FOOD (feed or ordinary diet) trials consist of three randomised controlled trials, which share the same randomisation, data collection, and follow-up systems, allow co-enrolment, and aim to compare the outcomes of stroke patients in hospital. Dysphagic patients were enrolled into one or both of two trials: (1) early enteral tube feeding versus avoidance of tube feeding for at least 7 days; and (2) tube feeding via percutaneous endoscopic gastrostomy versus nasogastric tube. The results of
Results
Between Nov 1, 1996, and July 31, 2003, 125 hospitals in 15 countries enrolled 4023 patients (details at end of report). Data about compliance, in-hospital complications, and follow-up were obtained until March 31, 2004, when the database was closed. Patients were enrolled a median of 5 days (IQR 3–9) after stroke onset and a median of 5 days (2–8) after admission. The method of nutritional assessment was recorded on the discharge form only after the first 482 patients had been enrolled and was
Discussion
We have not shown a significant effect of routine oral nutritional supplements for a broad range of patients admitted to hospital with acute stroke. Our trial did not have sufficient power to exclude more modest differences overall (ie, we could not reliably detect a 2–3% difference in the absolute proportion with a primary outcome) or even larger and clinically important effects in subgroups, such as those who were judged to be undernourished at baseline. Although we stopped recruitment early,
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