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Critique of Cutshall, Bergstrom, Kalish, “Evaluation of a functional medicine approach to treating f

Irresponsible use of hormones, poorly-structured research, and misrepresentation of functional medicine: critique of Cutshall, Bergstrom, Kalish’s “Evaluation of a functional medicine approach to treating fatigue, stress, and digestive issues in women” in Complement Ther Clin Pract. 2016 May

  • Reviewer: Alex Vasquez DC ND DO FACN

  • Citation: Cutshall SM, Bergstrom LR, Kalish DJ. Evaluation of a functional medicine approach to treating fatigue, stress, and digestive issues in women. Complement Ther Clin Pract. 2016 May;23:75-81

  • Date of review: June 10, 2016, minor formatting updates October 29, 2016

  • Update: This critique has been accepted for publication as Correspondence regarding Cutshall, Bergstrom, Kalish's "Evaluation of a functional medicine approach to treating fatigue, stress, and digestive issues in women" in Complement Ther Clin Pract 2016 DOI:

  • Summary of study from the authors’ abstract: The authors report a “28-week pilot study to assess the efficacy of a functional medicine approach to improving stress, energy, fatigue, digestive issues, and quality of life in middle-aged women. Findings showed significant improvements in many stress, fatigue, and quality-of-life measures. The treatment program increased mean salivary dehydroepiandrosterone levels and the cortisol-dehydroepiandrosterone ratio. Stool sample analyses suggested that these treatments reduced Helicobacter pylori infections. This study suggests that functional medicine may be an effective approach to managing stress and gastrointestinal symptoms.”

  • Interventions: The authors state that treatments were “personalized” but provide no data on how the treatment was allocated and selected, other than to divide patients into two groups “low cortisol” and “high cortisol” for the “adrenal protocols” which are poorly described other than administration of “DHEA drops” and “pregnenolone drops.” The authors fail to provide the dosages of either of these steroid hormones; such a failure to describe the dosage is scientifically irresponsible as it makes replication and validation of the study impossible, and it is also ethically irresponsible as it suggests to the public that such hormones could be taken in any undefined range with impunity. Nowhere in the report are the doses or product descriptions provided for either of these neurotropic steroid hormones. A common error in articles of this sort is the statement that treatments were "personalized" by which the authors justify their failure to disclose and describe how treatments were administered; however, because the treatments are personalized in the deployment of the study does not mean that the results have to be secretive in the reporting of the study.

  • Errors in this study’s design and report; negative findings:

  1. Inaccurate definitions of functional medicine: The authors define functional medicine as “The functional medicine model is focused on restoring optimal functioning of 3 body systems: hormonal, digestive, and detoxification.” This is an inaccurate definition and inappropriately limits an otherwise wide clinical approach; the definition of functional medicine provided by these authors is discordant with descriptions published by other groups such as the Institute for Functional Medicine[1] and International College of Human Nutrition and Functional Medicine.[2]