Glanville Julie, King Sarah, Guarner Francisco, Hill Colin, Sanders Mary Ellen
York Health Economics Consortium LTD, York, UK.
University Hospital Vall d'Hebron, Ciberehd, Barcelona, Spain.
Nutr J. 2015 Feb 8;14:16. doi: 10.1186/s12937-015-0004-5.
This paper addresses the use of systematic review and meta-analysis to evaluate the strength of evidence for health benefits of probiotic foods, especially relating to health claim substantiation in the European Union. A systematic review is a protocol-driven, transparent and replicable approach, widely accepted in a number of scientific fields, and used by many policy-setting organizations to evaluate the strength of evidence to answer a focused research question. Many systematic reviews have been published on the broad category of probiotics for many different outcomes. Some of these reviews have been criticized for including poor quality studies, pooling heterogeneous study results, and not considering publication bias. Well-designed and -conducted systematic reviews should address such issues. Systematic reviews of probiotics have an additional challenge - rarely addressed in published reviews - in that there must be a scientifically sound basis for combining evidence on different strains, species or genera. The European Food Safety Authority (EFSA) is increasingly adopting the systematic review methodology. It remains to be seen how health claims supported by systematic reviews are evaluated within the EFSA approval process. The EFSA Panel on Dietetic Products, Nutrition and Allergies deems randomized trials to be the best approach to generating evidence about the effects of foods on health outcomes. They also acknowledge that systematic reviews (with or without meta-analyses) are the best approach to assess the totality of the evidence. It is reasonable to use these well-established methods to assess objectively the strength of evidence for a probiotic health claim. Use of the methods to combine results on more than a single strain or defined blend of strains will require a rationale that the different probiotics are substantively similar, either in identity or in their mode of action.
本文探讨了如何运用系统评价和荟萃分析来评估益生菌食品对健康有益的证据强度，特别是与欧盟健康声明的证实相关的内容。系统评价是一种由方案驱动、透明且可重复的方法，在多个科学领域被广泛接受，许多政策制定组织也用其来评估证据强度，以回答特定的研究问题。针对多种不同结果，已有许多关于益生菌大类的系统评价发表。其中一些评价因纳入质量不佳的研究、汇总异质性研究结果以及未考虑发表偏倚而受到批评。设计良好且实施得当的系统评价应解决此类问题。益生菌的系统评价还有一个已发表评价中很少涉及的额外挑战，即必须有科学合理的依据来合并不同菌株、菌种或菌属的证据。欧洲食品安全局（EFSA）越来越多地采用系统评价方法。在EFSA的批准过程中，如何评估由系统评价支持的健康声明还有待观察。EFSA的营养产品、营养和过敏专家组认为随机试验是获取有关食品对健康结果影响证据的最佳方法。他们也承认系统评价（无论是否进行荟萃分析）是评估全部证据的最佳方法。使用这些成熟的方法来客观评估益生菌健康声明的证据强度是合理的。要将单一菌株以上或特定菌株组合的结果合并起来使用这些方法，就需要一个理由，即不同的益生菌在特性或作用方式上本质上是相似的。
