Fragility of cardiovascular outcome trials (CVOTs) examining nutrition interventions among patients with diabetes mellitus: a systematic review of randomized controlled trials

Taouktsi, Niki; Papageorgiou, Stefanos T; Tousinas, Georgios; Papanikolopoulou, Stavroula; Grammatikopoulou, Maria G.; Giannakoulas, George; Goulis, Dimitrios G.

doi:10.1007/s42000-022-00396-5

Cited by 2 publications

(1 citation statement)

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“…A great number of scientists have expressed skepticism for the results of RCTs implementing nutrition interventions [ 2 , 55 , 56 , 57 ]. Concerns exist mainly over blinding and the placebo effect, as diet is difficult to blind and specific expectations are inevitably produced either as a placebo, or a nocebo effect.…”

Section: Discussionmentioning

confidence: 99%

A Meta-Epidemiological Study of Positive Results in Clinical Nutrition Research: The Good, the Bad and the Ugly of Statistically Significant Findings

et al. 2022

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Positive (statistically significant) findings are easily produced in nutrition research when specific aspects of the research design and analysis are not accounted for. To address this issue, recently, a pledge was made to reform nutrition research and improve scientific trust on the science, encompass research transparency and achieve reproducibility. The aim of the present meta-epidemiological study was to evaluate the statistical significance status of research items published in three academic journals, all with a focus on clinical nutrition science and assessing certain methodological/transparency issues. All research items were published between the years 2015 and 2019. Study design, primary and secondary findings, sample size and age group, funding sources, positivist findings, the existence of a published research protocol and the adjustment of nutrients/dietary indexes to the energy intake (EI) of participants, were extracted for each study. Out of 2127 studies in total, those with positive findings consisted of the majority, in all three journals. Most studies had a published research protocol, however, this was mainly due to the randomized controlled trials and not to the evidence-synthesis studies. No differences were found in the distribution of positive findings according to the existence/inexistence of a published research protocol. In the pooled sample of studies, positive findings differed according to study design and more significant findings were reported by researchers failing to report any funding source. The majority of items published in the three journals (65.9%) failed to account for the EI of participants. The present results indicate that there is still room for the improvement of nutrition research in terms of design, analyses and reporting.

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