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Author’s reply to: Incorrect analyses were used in “Different enteral nutrition formulas have no effect on glucose homeostasis but on diet-induced thermogenesis in critically ill medical patients: a randomized controlled trial” and corrected analyses are requested

European Journal of Clinical Nutrition volume 73, pages 150–151 (2019)Cite this article

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In our study, we evaluated the effect of fat-based (group A) or glucose-based (group B) enteral nutrition formulas on various parameters of glucose homeostasis in critically ill patients; however, both formulas seem to influence glucose levels and insulin demand similarly. Furthermore, we found a significant increase of resting energy expenditure (REE) over time in patients receiving fat-based enteral nutrition but not in patients receiving glucose-based formulas [1]. Dickinson et al. criticized that our conclusion “diet-induced thermogenesis was substantially higher in critically ill patients receiving fat-based enteral nutrition” was drawn from informal comparison of the nominal significance of change in each within-group comparison rather than a significance test of the difference in changes between the two groups [2]. Thus, we conducted the suggested additional statistical analyses. We evaluated differences in REE between both groups over time in a mixed model including diet, time points, and interaction between diet and time points as fixed effect and a random intercept for each patient. Significance of each estimated co-efficient in the model was calculated with t-statistics. Overall significance of discriminating between diet A and B over both follow up time points was calculated with Wald F test. The overall test for interaction between diet and time points was not significant (p = 0.1644). The estimated difference of the REE change until day 3 between the two groups (B–A) was −13.70 (95%CI:−193.47,166.07/p = 0.8811) and the estimated difference of the REE change until day 7 between the two groups (B–A) was −196.977 (95%CI:−407.98,14.04/p = 0.0708). Despite not reaching overall significance, there was a strong trend for an overall difference between groups until day 7.

Our study was powered to detect differences of 20% in average glucose under different enteral nutrition formulas [3]. Therefore, it is likely that our sample size is too small to reach significance in this mixed model. Nonetheless, we are convinced that our conclusion concerning a secondary endpoint that diet-induced thermogenesis is higher in patients receiving fat-based enteral nutrition, can be drawn. We saw a substantial increase in REE only in patients fed with the fat-based formula (group A: baseline: 1556 (1227–1808) kcal/24 h vs. day 7: 1844 (1437–2018) kcal/24 h vs. group B: baseline 1563 (1306–1789) kcal/24 h vs. day 7: 1530 (1373–1871) kcal/24 h) and a strong trend (p = 0.07) of difference in change between groups over time in the mixed model. In addition, we would like to encourage to undertake further studies to validate our results in independent samples.

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References

  1. Wewalka M, Drolz A, Seeland B, Schneeweiss M, Schmid M, Schneeweiss B, et al. Different enteral nutrition formulas have no effect on glucose homeostasis but on diet-induced thermogenesis in critically ill medical patients: a randomized controlled trial. Eur J Clin Nutr. 2018;72:496–503. https://doi.org/10.1038/s41430-018-0111-4

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  2. Dickinson S, Brown A, Mehta T, Heymsfield S, Ebbeling C, Ludwig D et al. Incorrect analyses were used in “Different enteral nutrition formulas have no effect on glucose homeostasis but on diet-induced thermogenesis in critically ill medical patients: a randomized controlled trial” and corrected analyses are requested. Eur J Clin Nutr. 2018. in press.

  3. Tappy L, Schwarz JM, Schneiter P, Cayeux C, Revelly JP, Fagerquist CK, et al. Effects of isoenergetic glucose-based or lipid-based parenteral nutrition on glucose metabolism, de novo lipogenesis, and respiratory gas exchanges in critically ill patients. Crit Care Med. 1998;26:860–867.

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Funding

The study was supported by a scientific grant of Fresenius Kabi, Austria.

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Authors and Affiliations

  1. Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Intensive Care Unit, Waehringer Guertel 18-20, 1090, Vienna, Austria

    Marlene Wewalka & Christian Zauner

  2. Medical Universtiy of Vienna, Center for Medical Statistics, Informatics and Intelligent Systems, Spitalgasse 23, 1090, Vienna, Austria

    Eleonore Pablik

Authors
  1. Marlene Wewalka
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  2. Eleonore Pablik
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  3. Christian Zauner
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Correspondence to Marlene Wewalka.

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Wewalka, M., Pablik, E. & Zauner, C. Author’s reply to: Incorrect analyses were used in “Different enteral nutrition formulas have no effect on glucose homeostasis but on diet-induced thermogenesis in critically ill medical patients: a randomized controlled trial” and corrected analyses are requested. Eur J Clin Nutr 73, 150–151 (2019). https://doi.org/10.1038/s41430-018-0244-5

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