Buried Study: Earlight does not influence heartbeat and blood pressure

we will continue to present … at conferences [and] share information with anybody interested in their own well-being” – Pekka Somerto, Valkee CEO

The mainstay of Valkee’s marketing has been the production of pseudoscientific congress presentations in lieu of scientific journal articles. Their website has more than half a dozen such commercial posters, meant to deceive the lay reader about the efficacy and background of Valkee’s device.

However, a number of studies does not make it into Valkee’s ad circus, despite their leaders’ promise to “inform our customers” whenever “new results become available”. One of three buried studies known to earlightswindle.com was done to show an effect on the cardiovascular system. If earlight mysteriously “activates” the brain, what does it do with the heart and the blood pressure? You may guess it: Nothing.

The following abstract is from a poster drowned among hundreds of its kind on the EuroPRevent 2013 congress. Like all other earlight studies, this one is not published in a peer-reviewed journal.

Abstract: P534
Effects of transcranial bright light treatment on cardiovascular autonomic regulation

Authors: MP Tulppo1, AM Kiviniemi1, AJ Hautala1, J Karjalainen1, JJ Jaakkola2, TM Ikaheimo2, J Nissila3, H Jurvelin3, T Takala4, HV Huikuri5
1Verve Research, Department of Exercise and Medical Physiologic – Oulu – Finland
2Centre for Environmental and Respiratory Health Research, University of Oulu – Oulu – Finland
3Department of Biology, University of Oulu – Oulu – Finland
4Oulu Deaconess Institute – Oulu – Finland
5Institute of Clinical Medicine, University of Oulu – Oulu – Finland

Topic(s): Hypertension (Rehabilitation & Implementation)
Citation: European Journal of Preventive Cardiology ( April 2013 ) 20 ( Supplement 1 ), 96

Purpose: A recent study suggests that transcranial brain targeted light treatment via ear canals may have physiological effects on brain function studied by functional magnetic resonance imaging techniques in humans. We tested the hypothesis that an acute transcranial bright light treatment via ear canals may have effects on autonomic regulation in mild hypertensive subjects.
Methods: Hypertensive men without any medication participated in the study (n=19, age 61±3 years, systolic blood pressure 140-160 and/or diastolic blood pressure 90-100 mmHg during one week follow up at home). In a blinded study design, a twelve min dose of bright light treatment or sham treatment were administered in a random order on separate days by a transcranial bright light device via the ear canals (blue based LEDs). Blood pressure and ECG were measured during the treatments. Heart rate variability was analyzed in 5 min periods at baseline, at the end of treatment, immediately following and from 7 to 12 min after treatment. Standard deviation of R-R intervals (SDNN) and high (HF), low (LF) and very low (VLF) frequency powers of R-R intervals were calculated by standard spectral techniques. Analysis of variance for repeated measures with time x group interaction was performed for the measured variables.
Results: There was no time x group interaction in heart rate or blood pressure. SDNN and VLF power increased during the bright light treatment but not during the sham treatment (time x group interaction p=0.019 and p=0.040 for SDNN and VLF, respectively). VLF power was 6.7±0.7 vs. 6.6±0.6 ln ms2 (p=ns) at baseline for bright light treatment and sham, respectively. The corresponding VLF values for bright light and sham were 7.0±0.7 vs. 6.6±0.7 (p=0.034) at the end of treatment, 7.3±0.7 vs. 6.8±0.7 (p=0.013) immediately after treatment and 6.9±0.5 vs. 6.9±0.6 ln ms2 (p=ns) at the end of the recordings. LF or HF power did not differ between treatments (interaction p=0.33 for both).
Conclusion: The results of this blinded and sham controlled trial provide evidence that acute transcranial bright light treatment via ear canals have effects on cardiovascular autonomic regulation in hypertensive males documented by increasing long-term heart rate variability indices.

The only transient difference between placebo and Valkee treatment was found for a tertiary calculated value:  Very low frequency (VLF) oscillations are for instance dependent on the ambient temperature. The difference vanished quickly and was not seen at the end of the recordings, after approx. 10 minutes. The VLF measure is very questionable.

dubious-heart-study

SDNN is not valid for short-time recordings (same source). The authors have a background in physiology, they surely know that they are faking.

The important LF and HF values were unchanged, and heart rate and blood pressure did not change with earlight.

“In clinical trials … Valkee light exposure has been evidenced to have effects that also regular sunlight has: reduced stress and blood pressure, elevated mood … “– Timo Ahopelto

A dubious study for a dubious device – and Valkee spreads dubious information.

How many buried negative Valkee trials may be out there? One more will be featured on this blog soon.
On twitter: @earlightswindle #valkeeleaks – or simply #Valkee.

#valkeeleaks 3

Update 14.3.2014: This trial was announced by Valkee’s Timo Ahopelto shortly before their bust in 2012.  A good example of how Valkee’s trials and publications are announced by their marketing team and later vanish without any word. At the same source a second broken promise – also the Kärpät Ice Hockey trial remains still unpublished.

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