CLINICAL TRIAL
JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
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Nutritional support and quality of life in stable chronic obstructive pulmonary disease (COPD) patients.

RATIONALE: Nutritional depletion is a common problem in chronic obstructive pulmonary disease (COPD) patients. It is caused, to a large extent, by an imbalance between low-energy intake and high-energy requirements. This problem adversely affects morbidity and mortality. However, the use of nutritional supplements to reach their energy necessities requires optimisation between positive and adverse effects on outcome before being used systematically as part of their comprehensive care.

PURPOSE: The aim of our study was to investigate the effects of oral nutritional repletion on quality of life in stable COPD patients.

METHODS: Prospective, randomised and multi-centre study. Stable COPD patients with a body mass index 22, a fat-free mass index 16, and/or a recent involuntary weight loss (5% during last month, or 10% during the last 3 months) were studied. Exclusion criteria were to present signs of an airway infection, to have a cardiovascular, neurological, or endocrine disease, to be treated with oral steroids, immunosuppressors or oxygen therapy at home, and to receive nutritional supplements. During 12 weeks, patients were encouraged to ingest a total daily defined energy intake. Randomly, in patients from group A the total daily energy load was Resting Energy Expenditure (REE)x1.7, and those from group B, REE x1.3. Total daily energy intake was achieved with regular food plus, if necessary, oral nutritional supplement rich in proteins (with 50% of whey protein), with predominance of carbohydrates over fat, and enriched in antioxidants. Primary end-point variable was quality of life. Secondary end-point outcomes included body weight, body composition, lung function, handgrip strength, and compliance with the energy intake previously planned. Data were treated with a SAS System. Student's test, Wilcoxon's rank sum test, and Mann-Whitney's test were used.

RESULTS: At baseline both groups of patients were comparable. All patients needed oral nutritional supplements to achieve total daily defined energy intake. After 12 weeks of follow-up, patients in both groups significantly increased energy intake. Patients in group A increased body weight (P=0.001), triceps skin fold thickness (P=0.009) and body fat mass (P=0.02), and decreased body fat-free mass index (P=0.02). In this group a marked increase in airflow limitation was observed. A tendency to increase body weight and handgrip strength, and to decrease airflow limitation was observed in patients from group B. Furthermore, patients in the later group showed a significant improvement in the feeling of control over the disease (P=0.007) and a tendency to better the other criteria in a quality of life scale.

CONCLUSIONS: According to our results, total daily energy intake of REE x 1.3 is preferable to REE x 1.7 in mild stable COPD patients. The administration of oral nutritional supplements, rich in proteins (with 50% of whey protein), with predominance of carbohydrates over fat, and enriched in antioxidants, to achieve total daily defined energy intake in patients in group B was followed by a significant improvement of one criteria (mastery) among many others in a quality of life scale.

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