基于本地食材的补充剂是治疗 6 至 59 月龄儿童中度急性营养不良的玉米-大豆混合物的替代方法：在埃塞俄比亚南部沃莱塔的一项随机对照非劣效性试验。

A local-ingredients-based supplement is an alternative to corn-soy blends plus for treating moderate acute malnutrition among children aged 6 to 59 months: A randomized controlled non-inferiority trial in Wolaita, Southern Ethiopia.

机构信息

School of Public and Environmental Health, Hawassa University, Awassa, Ethiopia.

Centre for International Health, University of Bergen, Bergen, Norway.

出版信息

PLoS One. 2021 Oct 28;16(10):e0258715. doi: 10.1371/journal.pone.0258715. eCollection 2021.

BACKGROUND

Globally, moderate acute malnutrition (MAM) affects approximately 5% of children below five years of age. MAM is a persistent public health problem in Ethiopia. The current approach in Ethiopia for managing MAM is a supplementary feeding program; however, this is only provided to chronically food-insecure areas. The objective of the study was to compare a local-ingredients-based supplement (LIBS) with the standard corn-soy blend plus (CSB+) in treating MAM among children aged 6 to 59 months to test the hypothesis that the recovery rate achieved with LIBS will not be more than 7% worse than that achieved with CSB+.

METHODS AND FINDINGS

We used an individual randomized controlled non-inferiority trial design with two arms, involving 324 children with MAM aged 6 to 59 months in Wolaita, Southern Ethiopia. One hundred and sixty-two children were randomly assigned to each of the two arms. In the first arm, 125.2 g of LIBS with 8 ml of refined deodorized and cholesterol-free sunflower oil/day was provided. In the second arm, 150 g of CSB+ with 16 ml of refined deodorized and cholesterol-free sunflower oil/day was provided. Each child was provided with a daily ration of either LIBS or CSB+ for 12 weeks. Both intention-to-treat (ITT) and per-protocol (PP) analyses were done. ITT and PP analyses showed non-inferiority of LIBS compared with CSB+ for recovery rate [ITT risk difference = 4.9% (95% CI: -4.70, 14.50); PP risk difference = 3.7% (95% CI: -5.91, 13.31)]; average weight gain [ITT risk difference = 0.10 g (95% CI: -0.33 g, 0.53 g); PP risk difference = 0.04 g (95% CI: -0.38 g, 0.47 g)]; and recovery time [ITT risk difference = -2.64 days (95% CI: -8.40 days, 3.13 days); PP difference -2.17 days (95% CI: -7.97 days, 3.64 days]. Non-inferiority in MUAC gain and length/height gain was also observed in the LIBS group compared with the CSB+ group.

CONCLUSIONS

LIBS can be used as an alternative to the standard CSB+ for the treatment of MAM. Thus, the potential of scaling up the use of LIBS should be promoted.

TRIAL REGISTRATION

Pan-African Clinical Trial Registration number: PACTR201809662822990.

背景

在全球范围内，中度急性营养不良（MAM）影响了约 5%的五岁以下儿童。MAM 是埃塞俄比亚持续存在的公共卫生问题。埃塞俄比亚目前管理 MAM 的方法是补充喂养方案；然而，这仅提供给长期食物无保障的地区。本研究的目的是比较基于当地原料的补充剂（LIBS）与标准玉米-大豆混合补充剂（CSB+）在治疗 6 至 59 个月大的 MAM 儿童方面的效果，以检验以下假设：LIBS 的恢复率不会比 CSB+差 7%以上。

方法和发现

我们使用了个体随机对照非劣效性试验设计，有两个手臂，涉及沃莱塔，埃塞俄比亚南部的 324 名 6 至 59 个月大的 MAM 儿童。162 名儿童被随机分配到两个手臂。在第一只手臂中，每天提供 125.2 克 LIBS 和 8 毫升精制脱臭无胆固醇葵花籽油。在第二只手臂中，每天提供 150 克 CSB+和 16 毫升精制脱臭无胆固醇葵花籽油。每个孩子每天都要服用 LIBS 或 CSB+中的一种，持续 12 周。均进行了意向治疗（ITT）和符合方案（PP）分析。ITT 和 PP 分析表明，LIBS 与 CSB+相比，恢复率无差异[ITT 风险差异=4.9%（95%CI：-4.70，14.50）；PP 风险差异=3.7%（95%CI：-5.91，13.31）]；平均体重增加[ITT 风险差异=0.10 克（95%CI：-0.33 克，0.53 克）；PP 风险差异=0.04 克（95%CI：-0.38 克，0.47 克）]；以及恢复时间[ITT 风险差异=-2.64 天（95%CI：-8.40 天，3.13 天）；PP 差异=-2.17 天（95%CI：-7.97 天，3.64 天）]。LIBS 组在 MUAC 增加和长度/身高增加方面也表现出与 CSB+组的非劣效性。