Complementary medicine for fatigue and cortisol variability in breast cancer survivors

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Jain and colleagues1 observed sufficient encouragement in their null results from a modest sized clinical trial with breast cancer survivors to call for further studies of biofield healing and, specifically, therapeutic touch (TT). Their article describes TT as affecting “energy fields that purportedly surround and penetrate the human body for the purposes of healing,” and—in the case of their trial—reducing fatigue. It also indicates that TT can affect the immune system. The only evidence cited consists of anecdotal patient reports and a loose analogy to the process of chelating to remove heavy metals from the body.

TT was selected for study not on the basis of any proof of concept or biologic plausibility, because it has no scientific basis. Rather, the article states that TT was nominated by 1 of the authors, a Reverend Rosalyn L. Bruyere affiliated with Healing Light Center Church. Other sources indicate that Rev. Bruyere's credentials are a background in Egyptian temple symbology, sacred geometry, shamanic practices, pre-Buddhist Tibetan Bon-Po Ways, and Native American medicine traditions. It is not obvious what control is obtained in the comparison with the mock treatment condition; but, apparently, the lack of intention to heal by the mock treatment condition providers would render their touch ineffective.

The registered primary outcomes of the trial were self-reported fatigue, depressive symptoms, and quality of life. No significant differences were obtained between TT and the mock treatment, whereas both conditions were superior to waitlist control. Essentially, the authors examined 3 primary outcomes, with secondary analyses of 5 subscales of the fatigue measure, and a secondary outcome, cortisol, with all pairwise differences explored between the TT, mock treatment, and waitlist control conditions. With any control for multiple comparisons, the modest difference between TT and mock treatment in cortisol is no longer significant.

Patients were not recruited to the trial on the basis of their interest in having their cortisol changed but, rather, based on reductions in their cancer-related fatigue that were not obtained. There is no known therapeutic benefit to changed cortisol slopes. To justify cortisol as a secondary outcome, the authors selectively cite findings that flatter cortisol slopes are modestly related to metastatic disease and predict mortality in breast cancer patients. These limited correlational data alone do nothing to establish that cortisol is a suitable surrogate endpoint.

The modest size trial with 30 patients in the active treatment arm, 30 patients in the mock treatment control condition, and 20 patients on the waitlist control arm, despite Jain and colleagues' assertion, is underpowered to detect meaningful changes in the designated primary outcomes. Nonetheless, if Jain and colleagues are unwilling to concede that it is a null trial with such results, we have to wonder why they bothered to conduct the trial. We believe that publication of this TT trial encourages more pseudoscientific studies of energy fields or auras and gives the wrong message to clinicians and patients.

James C. Coyne PhD*, Christoffer Johansen MD, PhD, DSc (Med)†, David Gorski MD‡, * Abramson Cancer Center, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, † Institute for Cancer Epidemiology, Copenhagen, Denmark, ‡ Karmanos Cancer Center, Detroit, Michigan.

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