Tag Archives: buried results

Yet another buried Valkee study: Placebo-controlled, completed, and silenced.

After Valkee’s public bust in 2012, humiliated with the flim-flam award just before christmas, the company was under immense pressure to come forward with placebo-controlled research. That winter saw a negative sham-controlled study, testing effects on blood pressure and heart rate. It failed and was buried. According to Valkee, a placebo-controlled anxiety study was ongoing, but unknown to the public.

In Seasonal Affective Disorder, there had been an inconclusive pilot trial, a halted one, and a negative placebo-controlled study. I.e. in the main indication, there was only proof that the device does not work. Valkee kept on selling the earlight, while it had been scientifically demonstrated to be ineffective. So another trial was set up, the third placebo-controlled study in SAD. As with its predecessors, the results would never see the light of the day.

sad3
The power was as low as in the previous two SAD placebo trials: 30 persons per treatment group. 60 participants were recruited to receive earlight or “placebo treatment” at home.

It is fully unclear how the placebo could have been given unidentified. If there was dim “placebo light” – then the setting would have been a copy of their previous failure, where placebo light scored better than earlight. Or, if there was no light, then it would be an obvious fraud as it was in the Oulun kärpät ice hockey study.

Therefore, the study quality seems not better than in the failed trials. No additional statistical power, no advanced methods. Why would someone waste time and money to conduct such a trial? Just to show “we are doing research”? Or to fake results planfully?

The results of the blood pressure trial were at best neutral and shown to maybe a few congress visitors. The results of this SAD trial were buried completely. There is no way to guess what the outcome was, as long as the data is hidden from the public. It’s not a good sign when the very existence of a study is silenced.

Until proven otherwise, there are now 3 unsuccessful placebo-controlled earlight studies in Seasonal Affective Disorder: The first, with 60 participants – halted. The second – failed. The third, again with 60 persons – buried. And sales go on.

#valkeeleaks 4

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.

Valkee’s vanishing patients

From September 2010, the english pages of valkee.com, as well as a number of reseller sites, fanfared revolutionary results. 9 of 10 patients were cured from severe depression with a 4-week earlight treatment. 25 individuals participated in the trial.valkeecom-25092010-25patients

In 2012, things have changed: It’s still 9 of 10, but the trial had 13 patients. What happened to the rest – that’s more than a scholarly question. If you can modify this number just like that, then the result is not reliable.

The thesis of A. Abou-Elseoud, about a set of fMRI trials, says:

elseoud-thesis-twopatientwaves

A number of patients was recruited into the pilot study in winter 2008/2009. This is obviously the same trial which was later published in Medical Hypotheses. The dates fit exactly, also the descriptions of the screening procedures and the entry criteria.

Abou-Elseoud tells more in an article about the fMRI findings, out of the thesis.

elseoud-humanbrainmapping-2014

There are slight, but clear differences between the wave I (pilot study) patients and the details in Valkee’s publication. Age, HAMD score, number of depressive episodes, all different. But it is the same patient set, with other characteristics identical.

timonen-medhyp-2012

The same study has variable numerical values, and most important, a volatile number of participants.

The claim that earlight somehow cured 9 of 10 patients in a trial is absolutely not credible, because even this low-class evidence for Valkee’s effects seems to be fabricated.

Buried Study: Valkee’s earlight does not enhance cognitive performance

[Updated 4.1.2014, see below]

Valkee tells to potential victims the public that the earlight device heals Seasonal Affective Disorder (SAD), alleviates jet-lag and resets the internal clock, enhances cognitive performance, and betters motoric reaction. The SAD and circadian rythm claims have been defeated in placebo-controlled trials, as earlightswindle.com evidenced before. But what about the supposed positive effects on healthy people?

Valkee did clinical trials that remained unknown so far, because it’s not mandatory to officially register studies on healthy people beforehand. The company accomplished amongst others a preliminary trial, described as follows in an addendum to a patent application:

cognitiveperformance-11-personsThe enhancement in performance test time for 11 persons exposed to Valkee’s earlight was moderate and of some heterogenity.

cognitiveperformance-11-persons-result

Valkee undertook a controlled study similar to (or part of) the failed SAD studyThree groups á 30 persons with 3 different light intensities ~1, 4 and 9 lumen. Treatment was to be applied over 4 weeks for 12min/day on weekdays.

cognitiveperformance-90-persons

The result was the same as in the SAD trial: No difference between the groups.

cognitiveperformance-90-persons-result

Valkee had done some dose-finding tests before, identifying the 1 lumen intensity as placebo (same source). It is likely, that this 90 persons study was also designed and run as a placebo-controlled trial.

light-intensity

In any case, it showed that it is irrelevant what to put in one’s ears, as long as you put something there at all. Valkee knew from this point, that earlight itself has no effect on a healthy person’s performance – but also that a trial would seemingly show an effect, if the test would not be properly controlled.

The company did then such a test with healthy students, with the “control group” getting no treatment at all, not even sham treatment (in biomedical research a so-called waiting list control). The result was as foreseen, and subsequently used for marketing.

performancestudy

The former and methodically better study results were buried. That’s the way Valkee does research, signed with “University of Oulu”. Finnish tax payers’ money at work.

/-ed.

Update 4.1.2014: It may not have been a separate study, but conducted in connection with, or as a part of, the RCT in Seasonal Affective Disorder. This would mean Valkee calls persons with severe depression “generally healthy”, and silenced completely these outcomes when the RCT was registered. This would also mean that a placebo-controlled trial showed that the device does not better cognitive performance.

Time for the Truth: The full text of Valkee’s buried SAD article

None of Valkee’s studies has been published in a peer-reviewed journal. However, the company often claims that they are submitting articles to journals – but that it takes usually around 3 years until an earlight paper appears in obscure sources.

One of the unpublished articles, which has been, according to Valkee, under review somewhere, is Valkee’s 2011 placebo-controlled study in Seasonal Affective Disorder. The company told repeatedly to have “published” this thing – instead, a forged abstract without details was listed in a congress supplement.

Here is exclusively a full-text version of the buried article. With all outcome details, but w/o abstract & references.

Note that the authors claim that there has been no placebo group. The study registration tells clearly that Valkee’s pseudoscientists are lying. The placebo was erased and declared as active treatment after the study had failed.

clintrialsforge

Nobody runs an expensive controlled study, if it’s not absolutely clear what the placebo does. The sham treatment was chosen accordingly to Valkee’s previous dose-finding studies, which indicated the following (source are the investigators):

light-intensity

Such a faked study can not be published in a medical journal, any editor will note the fraud. On the other hand, the authors may have been lucky to have avoided publication: An economically motivated research fraud of this dimension could easily be a career-stopper. An article wouldn’t have gone unnoticed, as the abstract did.

/-ed.

Valkee resorts to lies, gives up on science upon Swiss study

The first-ever peer-reviewed scientific article about Valkee was published some 3 weeks ago. It was the first placebo-controlled study on Valkee reaching the public, and it was done by independent, well-known researchers. Therefore, it’s not surprising that the result was negative. Valkee’s scam device is useless.

Valkee had time enough to answer to this piece threatening their scheme. Here is what their chairman Timo Ahopelto had to say:

ahopelto-twitterAs usual for Valkee’s leaders, Ahopelto does not give any proof for those claims. Just tell some random lies, who cares? On Facebook a more common-sense statement:

valkee-facebook-re-1

At this point, the swiss study was not “about to be published”, it was already published 6 days ago. But why not try to mislead those who cannot use PubMed? Valkee’s own earlight research never even came close to a scientific publication – i.e. it never passed independent peer-review.

All those snippets link to a blog entry by Melanie Rüger, PhD, in Valkee’s pop-science blog Shine. It’s reproduced here, because their statements are often volatile.

valkee-blogshine-reWhat Valkee is trying to sell tell on all channels: The Swiss had investigated something which is not related to the earlight’s function. The device does not influence Melatonin, because it’s not needed. All are looking on the Melatonin, but they’re all wrong. If they’d be experts, they’d know that Valkee had already told this – so nothing new here.

The reality, however, is somewhat different from Valkee’s tales.

Salivary melatonin is measured in such studies, because it is the direct marker of the internal clock’s state. That’s a basic thing with references ad libitum. Here, here, here, …

If something works on the internal clock, then it can be checked through salivary melatonin levels. Such studies are usually conducted at the evening or at night, to allow for best signal detection. The melatonin secretion rises in the evening, peaks around 03.00 – 04.00, then falls. It is very low during the day, making it difficult to find changes then. Light suppresses this melatonin level rise, and bright light applied in the evening makes alert. This was shown in the study for the active control condition, standard ocular bright light over 12 minutes. It clearly reduced sleepiness, although normal therapeutic exposition would be 30min or longer.

Valkee’s earlight performed on melatonin secretion like the sham condition, an ear lamp with no light output, it had zero effect. In other words: Valkee’s device does nothing on the internal clock. That’s why the swiss researchers’ conclusion is fully correct:

bromundt-2013-conclusion

Politely they add that longer-term effects were not studied. But how could chronic use have any effect, if there’s not even a short-term reaction to the light?

This has grave consequences for Valkee. All known treatments for jet-lag are interfering with the body’s internal clock. Phase-shifting, clock-setting effects are needed to work against such symptoms and circadian sleep disorders in general. If something is supposed to work on the internal clock, then it has to work on the internal clock. And Valkee’s device doesn’t.

Even if the company would be right with some of their marketing-driven speculations about alternative pathways – the output of the internal clock still says it is not affected by earlight. All embellished talk about feel-good monoamines is pointless, it misses the central question. A smoke screen.

But also the alternative path for promoting alertness is not for Valkee:

brainstem

This result smashes in any case Valkee’s marketing speech of a “portable substitute for sunlight”. Light through the ears definitely has not the beneficial effects of real sunlight on the brain. Their earlight device has nothing to do with true bright light therapy, which works on the internal clock. Valkee’s use of bright light studies for marketing is absolutely inappropriate, at the very least.

Valkee has every reason to silence the public discussion about these facts.

placebo

The company tells further it had foreseen these results already in a 2012 IFMAD congress presentation. They link to a PDF (page 18) with poster titles and author names, but no information on what the research (?) allegedly showed and how it was done. Not only that there’s no scientific publication. Not even the abstract can be found through database searches, and the content is inaccessible. It is virtually non-existing, in terms of science. To compare such a fictive thing to a real journal article is bad misinformation.

catintelligent

Furthermore, the effect of bright light therapy on Seasonal Affective Disorder (SAD) is thought to be related to the internal clock. The swiss results are excellently in line with the findings from clinical trials demonstrating that earlight works, at best, like a placebo in SAD.

Earlight lacks an alerting effect which was demonstrated for bright light, and the study showed that it also has no effect on motoric reaction and attention. The short ocular exposure in the control group did have neither. It is not marketed as improving sport performance in healthy people.

To make it short: Valkee is useless. And that is proven by clinical trials.

There is no reason, whatever, to suspect that it could work.
Are there any doubts, what Ms Rüger is being paid for by Valkee?

/-ed.

Update 28.12.2013: Valkee is reading this blog carefully. They’ve put now online the poster which allegedly told that Valkee’s earlight is working through some alternative pathway, not melatonin.

Here it is.

Instead, the poster says only, that earlight does not suppress melatonin (=does not influence the internal clock). Valkee had known for at least a year, that their marketing claims about effects on circadian rhythms are baseless.

Valkee is telling us, that “Light elicits its effects through different mechanisms than melatonin alone” without knowing a single bit what these mechanisms are. Because it does not work, it works! Because it has to work! We are telling you that it does!!

It is absolutely clear to me, why they hid this poster from the public. Incredible./-ed.

Note 7.2.2014:
On the IFMAD website, the 2012 and 2013 poster abstracts are available now.

UPDATE 18.7.2014:
Noted that the article PDF is better linked here than in the previous post.

Full-text PDF of the Bromundt study.

What are the side effects of Valkee’s earlight?

According to Valkee’s accounts, side effects of the earlight include:

  • headache
  • migraine
  • insomnia
  • nausea
  • vomiting
  • dizziness
  • earache
  • abnormal sensation in the maxillary region
  • tinnitus
  • tiredness
  • irregular heartbeat
  • irritability
  • lightheadedness
  • orthostatic hypotension.

In their negative, unpublished placebo-controlled study, >28% of the users experienced unwanted effects. These are only the spontaneously reported events – an under-reporting inherent to industry-sponsored clinical trials. The real numbers are therefore unknown, but likely to be much higher.