Valkee, the creator of the bright-light headset used to treat seasonal depression and mood disorders, has published the first results of its clinical and neurobiological research program. The clinical trial, published in Medical Hypothesis, studied therapeutic effects of bright light channeled into the human brain via the ear canal to test the sensitivity of the human brain to light. The trial has been conducted since 2007 and challenges the existing paradigm that light therapy is only effective when transmitted through the eyes.
People with suspicions of Valkee’s claimed benefits have long been asking for some proof from a peer reviewed study that acknowledges that the medical concept is sound. Unfortunately this paper will likely do little to remove those suspicions after taking a look at the colorful history of the journal, Medical Hypothesis.
The journal began in the 70’s as a forum for unconventional ideas, and for most of its life was the only journal published by Elsevier that did not send submitted papers to other researchers for review. In June 2010, Elsevier announced that “Submitted manuscripts will be reviewed by the Editor and external reviewers to ensure their scientific merit”, suggesting that peer review is now in place. According to Wikipedia, peer review was only put into place after two articles written by AIDS denialists had been accepted for publication.
One of the withdrawn articles, written by Peter Duesberg and David Rasnick, claimed that there is “yet no proof that HIV causes AIDS”. Another paper had attributed the article and misrepresented the results of medical research on antiretroviral drugs.
Still, the journal is now considered peer reviewed, and the University of Oulu is a respected research institution.
“There is no conclusive evidence that light therapy is only transmitted through the eyes,” comments Juuso Nissilä, Valkee’s co-founder and chief scientist. “On the contrary, in mammals, a significant amount of light penetrates the skull and reaches the brain. The brain has photoreceptive proteins such as encephalopsin, and physiological influences have been measured by extra ocular light exposure. Therefore, we challenged the existing paradigm by showing that the brain-targeted bright light therapy via the ear canal is an effective mechanism to relieve seasonal depression.”
The final patient series used in the study consisted of 13 physically healthy indoor workers suffering from SAD according to the DSM-IV-TR criteria, and during the trial received 8-12 minutes of 6.0-8.5 lumen bright light daily into both ear canals for four weeks using the Valkee headset. Severity of depressive symptoms was assessed using the 17-item Hamilton Depression Rating Scale (HAMD-17) and Beck Depression Inventory (BDI)-21. Furthermore, severity of anxiety symptoms was measured by the 14-item Hamilton Anxiety Rating Scale (HAMA).
The paper’s abstract concludes:
During the study period, 12 out of 13 (92.3%) patients achieved at least 50% reduction in their HAMA sum scores, and in 10 out of 13 patients (76.9%), the HAMA sum score was <7 (considered to be normal). In conclusion, it is hard to believe that our findings could be explained solely by placebo effect. Consequently, the basic assumptions underlying extraocular photoreception in humans deserve to be reconsidered. Given that a proper placebo treatment can be implemented via ear canals, further investigations with randomized placebo-controlled and/or dose-finding study designs regarding the extraocular transcranial bright light in the treatment of SAD are called for.
Timo Ahopelto of Valkee, “people in general think that publishing scientific papers is easy and straightforward if the trials are just done properly. Well, it is not. Ask any scientist about publishing of a new, revolutionary paradigm – like ours that is challenging the eye as the only route for bright light to work – and they will tell you it takes from three to four years. Now, after three years from completing this trial, we see the peer-reviewed publication in press, and the acceptance of the scientific community.”
I trust that the scientists at the University of Oulu have done legitimate work in this study. And that if Medical Hypothesis has legitimate peer reviewed standards today, then that’s all good and well. But I still question the reasoning behind publishing the paper in the same journal that less than four years ago published “Ejaculation as a potential treatment of nasal congestion in mature males” and “Revealed: The secrets of belly button fluff.”
Why associate with pseudoscience?