Two meditation papers retracted for failures to report primary outcomes

A pair of psychology journals have retracted two related papers on the health benefits of a popular form of meditation after a reader pointed out that the authors failed to report the primary outcome of the study underpinning the articles.

The now-retracted articles describe the putatively salubrious effects of sahaj samadhi meditation, a form of meditation developed by Sri Sri Ravi Shankar and promoted by the Art of Living Foundation, which describes itself thusly: 

Operating in 156 countries, The Art of Living Foundation (AOLF) is a non-profit, educational and humanitarian organization founded in 1981 by the world-renowned humanitarian and spiritual teacher Sri Sri Ravi Shankar. All of AOLF’s programs are guided by Sri Sri’s philosophy: “Unless we have a stress-free mind and a violence-free society, we cannot achieve world peace.

The guru is worth a purported $200 million. And AOLF, too, has a financial interest, offering its meditation programs for a fee. 

In 2016, a group led by Canadian psychiatrist Akshya Vasudev, of Western University in London, Ontario, reported in the BJPsych Open, a Cambridge University Press title, that sahaj samadhi meditation could improve depression in elderly practitioners.  

The Canadian Broadcasting Company picked up on the findings: 

Vasudev studied two groups of elderly patients. The members in the first group received anti-depressants. The second group also received medication, but in addition, were offered meditation sessions. Vasudev says half of the meditators saw their symptoms disappear, while just nine per cent in the other group saw the same success.

AOLF trumpeted the results, too. The foundation issued a press release about a poster version of the findings that won an award at the 2017 annual meeting of the World Psychiatry Association. The statement notes that one of the authors of the study, Ronnie Newman — a co-author on both of the now-retracted articles — is a “research expert” at the foundation.

In 2019, Vasudev and his colleagues published a paper in the British Journal of Psychiatry (a sister title to the other journal) building on their 2016 article. This time, the authors claimed to find that the meditation practice improved not just depression but heart rate variability.  

The two papers, and the award-winning poster, caught the attention of a reader, who informed the journals that the studies as reported did not accurately reflect how the original research was registered on ClinicalTrials.gov. On that site, a trial with the title “Automatic Self Transcending Meditation (ASTM) Versus Heart Rate Variability (HRV) Biofeedback in Patients With Late Life Depression (LLD): a Longitudinal Pilot Feasibility Study,” lists the primary outcome as: 

Change in Heart Rate Variability (HRV) [ Time Frame: Week 0 and week 12 ]

The secondary outcome is: 

Change in depression severity [ Time Frame: week 0 and week 12 ]

But the abstract of the paper, titled “A training programme involving automatic self-transcending meditation in late-life depression: preliminary analysis of an ongoing randomised controlled trial,” says nothing about heart rate variability:

This study aimed to evaluate a category of meditation, automatic self-transcending meditation (ASTM), in alleviating symptoms of depression when augmenting treatment as usual (NCT02149810). The preliminary results of an ongoing single-blind randomised controlled trial comparing a training programme involving ASTM with a wait-list control indicate that a 12-week ASTM programme may lead to significantly greater reductions in depression and anxiety severity. As such, ASTM may be an effective adjunctive therapy in the treatment of late-life depression.

Here’s the retraction notice:

We, the Editors of BJPsych Open, have retracted the following article: Vasudev, A., Arena, A., Burhan, A. M., Ionson, E., Hirjee, H., Maldeniya, P., Wetmore, S. and Newman, R. I., BJPsych Open (2016), Cambridge University Press, 2(2), pp. 195–198. DOI: https://doi.org/10.1192/bjpo.bp.115.002394

The primary outcome measure listed in the trial protocol (NCT02149810) is change in heart rate variability. The primary outcome measure is not reported in this paper, the secondary outcome measure of depression severity is reported instead.

Additionally, the basis of this paper is a preliminary analysis of results. The preliminary analysis is not specified in the trial protocol.

That’s similar to the notice for the 2019 article, “Effects of Sahaj Samadhi meditation on heart rate variability and depressive symptoms in patients with late-life depression,” which reads: 

We, the Editors of BJPsych, have retracted the following article: Effects of Sahaj Samadhi meditation on heart rate variability and depressive symptoms in patients with late-life depression, Ionson, E., Limbachia, J., Rej, S., Puka, K., Newman, R. I., Wetmore, S., Burhan, A. M. and Vasudev, A, The British Journal of Psychiatry (2019), Cambridge University Press, 214(4), pp. 218–224. DOI: https://doi.org/10.1192/bjp.2018.265

A preliminary analysis of results from this study was previously published in BJPsych Open. The preliminary analysis is not specified in the trial protocol.

Preliminary analysis from the trial is also cited as prior evidence from the literature in the introduction (SSM may have a beneficial effect on depression symptoms as well as HRV12).

Additionally, the trial protocol (NCT02149810) states that the secondary outcome measures will be assessed at weeks 0, 4, 8, 12, and 24. However, assessments at week 24 were offered to the intervention arm and not the control arm.

Together, the papers have been cited 15 times, according to Clarivate Analytics’ Web of Science.

Vasudev, the author of Be YourSelf: Spiritual Awakening for Everyone — which he dedicated to Shankar — told us that his group acted properly: 

The Editors have chosen to retract the papers on technical issues, which did happen, but did it warrant retractions? Well, I cant answer that myself. It is for the reader to judge that. These retractions are sadly the editors’ decision, not the authors. There was no unethical issues committed, the more common reason for retractions.

We are, nevertheless in process of [submitting] our study findings on ClinicalTrials.gov so that the results remain in public domain. We are also in the process of updating our clinicaltrials.gov listing to show that we did plan a preliminary analysis and change in analysis plan for week 12 to 24, for which we had received prior approval from our IRB/REB, but we did fail to update our public domain listing of these changes.

Update, 1600 UTC, 6/18/21: We have removed the word “transcendental” from the headline and first sentence of this post. We received a request from Jason Sytsma, an attorney for Maharishi Foundation USA, to do so based on claims that “Transcendental Meditation” is a registered trademark that represents something other than what the papers referred to here are about.

We noted in responding to Sytsma that one of the papers refers twice to times to transcendental meditation (lowercase), including this passage: “So far as we are aware, there has also not been any previous published trial of any meditation technique belonging to the larger category of ASTM, to which SSM and transcendental meditation belong, in patients with LLD.” The other paper cites papers that include the phrase “transcendental meditation” in their titles.

In a letter, Sytsma wrote that

With regard to the meditation practice at issue, the Foundation possesses no knowledge of or control over the Art of Living SSM program referenced in the journal articles at issue. References or implications in those articles themselves and in your retraction [sic; this was of course not our retraction, but retractions by the journals] to the effect that the studied technique is TM , or is the same as or similar to, or even can be claimed to produce the same effects as the TM program have no basis in fact and are improper. This is not helped by the claim of Art of Living that SSM is a type of ASTM. While we see no evidence this is true, even if it were, that does not entitle those who make the self-serving claim that their practice belongs in that general category of ASTM to claim, as Art of Living does, that their technique produces the same effects as the TM technique. It certainly does not entitle them or yourselves to call that technique Transcendental Meditation.

Sytsma acknowledged that

While the Foundation and this Firm are constantly on the lookout for and forcefully pursue these and other infringements of its federally registered trademarks, sometimes wrongful uses escape the Foundation’s attention. Such is the case in the two articles you attached to your email.

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