Evans Malkanthi, Lewis Erin D, Antony Joseph M, Crowley David C, Guthrie Najla, Blumberg Jeffrey B
KGK Science Inc., London, ON, Canada.
Friedman School of Nutrition Science and Policy, Tufts University, Boston, MA, United States.
Front Nutr. 2022 Sep 23;9:958753. doi: 10.3389/fnut.2022.958753. eCollection 2022.
Despite sophisticated study designs and measurement tools, we have yet to create an innovative space for diet and dietary supplements in the health care system. The path is challenging due to current hierarchies of scientific evidence and regulatory affairs. The role of the randomized, double-blind, placebo-controlled clinical trial (RCT) as a research approach functions well to characterize the benefits and risks of drugs but lacks the sensitivity to capture the efficacy and safety of nutraceuticals. While some facets of RCTs can be relevant and useful when applied to nutraceuticals, other aspects are limiting and potentially misleading when taken in their entirety. A differentiation between guidelines for evidence-based medicine and the evidence required for nutrition spotlight the need to reconceptualize constituents of the RCT and their applicability with relevance to health promotion. This perspective identifies the limitations of the traditional RCT to capture the complexities of nutraceuticals and proposes the N-of-1 as Level 1 evidence better suited for the proof of efficacy of nutraceuticals.
尽管有精密的研究设计和测量工具，但我们仍未在医疗保健系统中为饮食和膳食补充剂创造出一个创新空间。由于当前科学证据和监管事务的层级关系，这条路充满挑战。随机、双盲、安慰剂对照临床试验（RCT）作为一种研究方法，在描述药物的益处和风险方面发挥着很好的作用，但缺乏捕捉营养保健品功效和安全性的敏感性。虽然RCT的某些方面应用于营养保健品时可能相关且有用，但从整体来看，其他方面则具有局限性且可能产生误导。循证医学指南与营养所需证据之间的差异凸显了重新审视RCT的组成部分及其与健康促进相关性的适用性的必要性。这一观点指出了传统RCT在捕捉营养保健品复杂性方面的局限性，并提出将单病例试验作为更适合证明营养保健品功效的一级证据。
