Smyth Rosalind L, Rayner Oli
Institute of Child Health, UCL, 30 Guilford Street, London, UK, WC1N 1EH.
CF Trust, Bromley, Kent, UK, BR1 1BY.
Cochrane Database Syst Rev. 2017 May 4;5(5):CD000406. doi: 10.1002/14651858.CD000406.pub5.
Poor nutrition occurs frequently in people with cystic fibrosis and is associated with other adverse outcomes. Oral calorie supplements are used to increase total daily calorie intake and improve weight gain. However, they are expensive and there are concerns they may reduce the amount of food eaten and not improve overall energy intake. This is an update of a previously published review.
To establish whether in people with cystic fibrosis, oral calorie supplements: increase daily calorie intake; and improve overall nutritional intake, nutritional indices, lung function, survival and quality of life. To assess adverse effects associated with using these supplements.
We searched the Cochrane Cystic Fibrosis Trials Register comprising references from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. We contacted companies marketing oral calorie supplements.Last search: 18 October 2016.
Randomised or quasi-randomised controlled trials comparing use of oral calorie supplements for at least one month to increase calorie intake with no specific intervention or additional nutritional advice in people with cystic fibrosis.
We independently selected the included trials, assessed risk of bias and extracted data. We contacted the authors of included trials and obtained additional information for two trials.
We identified 21 trials and included three, reporting results from 131 participants lasting between three months and one year. Two trials compared supplements to additional nutritional advice and one to no intervention. Two of the included trials recruited only children. In one trial the risk of bias was low across all domains, in a second trial the risk of bias was largely unclear and in the third mainly low. Blinding of participants was unclear in two of the trials. Also, in one trial the clinical condition of groups appeared to be unevenly balanced at baseline and in another trial there were concerns surrounding allocation concealment. There were no significant differences between people receiving supplements or dietary advice alone for change in weight, height, body mass index, z score or other indices of nutrition or growth. Changes in weight (kg) at three, six and 12 months respectively were: mean difference (MD) 0.32 (95% confidence interval (CI) -0.09 to 0.72); MD 0.47 (95% CI -0.07 to 1.02 ); and MD 0.16 (-0.68 to 1.00). Total calorie intake was greater in people taking supplements at 12 months, MD 265.70 (95% CI 42.94 to 488.46). There were no significant differences between the groups for anthropometric measures of body composition, lung function, gastro-intestinal adverse effects or activity levels. Moderate quality evidence exists for the outcomes of changes in weight and height and low quality evidence exists for the outcomes of change in total calories, total fat and total protein intake as results are applicable only to children between the ages of 2 and 15 years and many post-treatment diet diaries were not returned. Evidence for the rate of adverse events in the treatment groups was extremely limited and judged to be of very low quality AUTHORS' CONCLUSIONS: Oral calorie supplements do not confer any additional benefit in the nutritional management of moderately malnourished children with cystic fibrosis over and above the use of dietary advice and monitoring alone. While nutritional supplements may be used, they should not be regarded as essential. Further randomised controlled trials are needed to establish the role of short-term oral protein energy supplements in people with cystic fibrosis and acute weight loss and also for the long-term nutritional management of adults with cystic fibrosis or advanced lung disease, or both.
营养不良在囊性纤维化患者中经常出现,并与其他不良后果相关。口服热量补充剂用于增加每日总热量摄入并促进体重增加。然而,它们价格昂贵,且有人担心它们可能会减少食物摄入量,而无法改善总体能量摄入。这是对先前发表的综述的更新。
确定在囊性纤维化患者中,口服热量补充剂是否:增加每日热量摄入;改善总体营养摄入、营养指标、肺功能、生存率和生活质量。评估使用这些补充剂相关的不良反应。
我们检索了Cochrane囊性纤维化试验注册库,其中包括来自全面电子数据库检索、相关期刊手工检索以及会议论文摘要集的参考文献。我们联系了销售口服热量补充剂的公司。上次检索时间:2016年10月18日。
随机或半随机对照试验,比较使用口服热量补充剂至少一个月以增加热量摄入与对囊性纤维化患者不进行特定干预或额外营养建议的情况。
我们独立选择纳入试验,评估偏倚风险并提取数据。我们联系了纳入试验的作者,并为两项试验获取了额外信息。
我们识别出21项试验,纳入了3项,报告了131名参与者为期三个月至一年的结果。两项试验将补充剂与额外营养建议进行比较,一项与不干预进行比较。纳入的两项试验仅招募了儿童。在一项试验中,所有领域的偏倚风险较低,在第二项试验中,偏倚风险大多不明确,在第三项试验中主要为低风险。两项试验中参与者的盲法情况不明确。此外,在一项试验中,各组的临床状况在基线时似乎不均衡,在另一项试验中,存在分配隐藏方面的问题。接受补充剂或单独饮食建议的人群在体重、身高、体重指数、z评分或其他营养或生长指标的变化方面没有显著差异。三个月、六个月和十二个月时体重(kg)的变化分别为:平均差(MD)0.32(95%置信区间(CI)-0.09至0.72);MD 0.47(95%CI -0.07至1.02);以及MD 0.16(-0.68至1.00)。服用补充剂的人群在十二个月时总热量摄入更高,MD 265.70(95%CI 42.94至488.46)。两组在身体成分的人体测量指标、肺功能、胃肠道不良反应或活动水平方面没有显著差异。体重和身高变化结果存在中等质量证据,总热量、总脂肪和总蛋白摄入量变化结果存在低质量证据,因为结果仅适用于2至15岁的儿童,且许多治疗后饮食日记未返回。治疗组不良事件发生率的证据极其有限,被判定为质量非常低。作者结论:在对中度营养不良的囊性纤维化儿童进行营养管理时,口服热量补充剂在单独使用饮食建议和监测之外没有带来任何额外益处。虽然可以使用营养补充剂,但不应将其视为必不可少。需要进一步的随机对照试验来确定短期口服蛋白质能量补充剂在囊性纤维化和急性体重减轻患者中的作用,以及在成年囊性纤维化患者或晚期肺部疾病患者或两者的长期营养管理中的作用。