Abstract

Objectives: The study aimed to investigate the effect on survival after 6 months of treatment involving individual dietary advice and oral nutritional supplements in older malnourished adults after discharge from hospital.

Methods: This multicentre randomised controlled trial included 671 patients aged 65 years who were malnourished or at risk of malnutrition when admitted to hospital between 2010 and 2014, and followed up after 8.2 years (median 4.1 years). Patients were randomised to receive dietary advice or oral nutritional supplements, separate or in combination, or routine care. The intervention started at discharge from the hospital and continued for 6 months, with survival being the main outcome measure.

Results: During the follow-up period 398 (59.3%) participants died. At follow-up, the survival rates were 36.9% for dietary advice, 42.4% for oral nutritional supplements, 40.2% for dietary advice combined with oral nutritional supplements, and 43.3% for the control group (log-rank test p = 0.762). After stratifying the participants according to nutritional status, survival still did not differ significantly between the treatment arms (log-rank test p = 0.480 and p = 0.298 for the 506 participants at risk of malnutrition and the 165 malnourished participants, respectively).

Conclusions: Oral nutritional supplements with or without dietary advice, or dietary advice alone, do not improve the survival of malnourished older adults. These results do not support the routine use of supplements in older malnourished adults, provided that survival is the aim of the treatment.

Trial registration: ClinicalTrials.gov with ID: NCT01057914

摘要

目的：该研究旨在研究出院后营养不良的老年成年人接受个体饮食建议和口服营养补充剂治疗6个月后对存活的影响。

方法：这项多中心随机对照试验包括671名65岁的患者，这些患者在2010年至2014年期间入院时营养不良或有营养不良的风险，并在8.2年（中位数4.1年）后进行了随访。患者被随机接受饮食建议或口服营养补充剂，分别或组合使用，或常规护理。干预措施从出院开始，持续了6个月，生存率是主要的结局指标。

结果：在随访期内，有398人（59.3％）参与者死亡。随访时，饮食建议的生存率为36.9％，口服营养补充剂的生存率为42.4％，饮食建议和口服营养补充剂的生存率为40.2％，对照组为43.3％（对数秩检验p  = 0.762）。根据营养状况对参与者进行分层后，各治疗组之间的生存率仍然没有显着差异（对 有营养不良风险的506名参与者和165名营养不良的参与者分别进行log-rank检验p  = 0.480和p = 0.298）。

结论：有或没有饮食建议的口服营养补品，或仅饮食建议的营养补充品都不能改善营养不良的老年人的存活率。这些结果不支持在营养不良的老年人中常规使用补充剂，前提是生存是治疗的目标。

试验注册： ClinicalTrials.gov，ID：NCT01057914