Elsevier

The Lancet

Volume 365, Issue 9461, 26 February–4 March 2005, Pages 755-763
The Lancet

Articles
Routine oral nutritional supplementation for stroke patients in hospital (FOOD): a multicentre randomised controlled trial

https://doi.org/10.1016/S0140-6736(05)17982-3Get rights and content

Summary

Background

Undernutrition is common in hospital patients with stroke, can develop or worsen in hospital, and is associated with poor outcomes. We aimed to establish whether routine oral nutritional supplements improve outcome after stroke.

Methods

The FOOD trials are a family of three pragmatic, multicentre, randomised controlled trials. We measured the outcomes of stroke patients who could swallow and who were randomly allocated normal hospital diet or normal hospital diet plus oral nutritional supplements until hospital discharge. The primary outcome was death or poor outcome (modified Rankin scale [MRS] grade 3–5), 6 months after enrolment, measured unaware of treatment allocation. Analysis was by intention to treat.

Findings

Between Nov 1, 1996, and July 31, 2003, 4023 patients were enrolled by 125 hospitals in 15 countries. Only 314 (8%) patients were judged to be undernourished at baseline. Vital status and MRS at the end of the trial were known for 4012 and 4004 patients, respectively. Supplemented diet was associated with an absolute reduction in risk of death of 0·7% (95% CI –1·4 to 2·7) and an increased risk of death or poor outcome of 0·7% (–2·3 to 3·8).

Interpretation

We could not confirm the anticipated 4% absolute benefit for death or poor outcome from routine oral nutritional supplements for mainly well nourished stroke patients in hospital. Our results would be compatible with a 1% or 2% absolute benefit or harm from oral supplements. These results do not support a policy of routine oral supplementation after stroke.

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.

Section snippets

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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