Meditation: a game-changing clinical trial?

"The medical community is really sceptical about meditation," Elizabeth Hoge claimed to Time magazine¹ in 2017. Hoge was an associate professor of psychiatry at Georgetown University (Washington, D.C.) and had just published the results of a study² on the MBSR meditation programme. Participants showed a change in biomarkers associated with stress.

Hoge then investigated the clinical effectiveness of the MBSR programme by comparing it to pharmacological first-line treatment for anxiety disorders in a randomised trial. The results were recently published in JAMA Psychiatry³. They are particularly expected in a context where the therapeutic effectiveness of meditation is difficult to evaluate.

Anxiety disorders: A public health challenge

In September of the same year, a task force (US Preventive Services Task Force)⁴ recommended that all US citizens aged 8 to 65 be systematically screened for anxiety disorders. According to the experts, 40% of women and over 25% of men in the US are affected by social anxiety, generalised anxiety or panic attacks at some point in their lives. On a global level, numerous reports indicate that rates of anxiety disorder have increased recently due to the pandemic, the political-economic environment and uncertainties related to climate change.

In 2017, about 15% of US Americans have meditated in some form⁵. It is no longer just a practice considered esoteric and reserved for the interested few. For Elizabeth Hoge, the advantage of the MBSR programme is that it is easy to implement: it can be offered on a large scale and outside the medical setting. The prerequisite, however, is that its effectiveness is proven.

Assessing the effects of meditation

The physiological effects of meditation have been studied for over twenty years. Researchers focus mainly on the alleged effects on brain plasticity, blood pressure, or even immunological or hormonal biomarkers. These studies use novel techniques, such as phosphorus spectroscopy measurements, which can be used to measure energy consumption in specific areas of the brain.⁶

Researchers looking at the effects of meditation on health encounter several biases. First of all, what form of meditation are we talking about? Since practices differ greatly, the physiological results of one cannot be extrapolated to the other.

Another hurdle is the level of practice. The effects observed in Buddhist monks with tens of thousands of hours of meditation are of course not transferable to casual practitioners.

However, the major limitation of most studies on meditation is the small sample size. These studies usually involve a few dozen participants. Nevertheless, the media likes to report on them when physiological effects are demonstrated. Recently, researchers regretted that some of the high-profile work could not be replicated. Their own study⁷ concluded that brain structures did not change after an MBSR programme, challenging old findings.

Finally, the sustainability of the meditation effects must also be questioned: Are the physiological changes observed after a session confirmed after a certain time? Are they dose-dependent? These are all essential questions if one expects therapeutic effects from meditation.

Overall, the results of the numerous research studies on the effects of meditation are heterogeneous, contrasting, sometimes contradictory and suffer from a lack of statistical power. In this context, the approach of evaluating the clinical effectiveness of a particular type of meditation compared to a pharmacological treatment is innovative. Elizabeth Hoge compared the effectiveness of a drug for the treatment of anxiety disorders (the antidepressant escitalopram - known under the brand Seroplex®) with the effectiveness of the MBSR programme.

This specific and standardised meditation programme, which is becoming increasingly popular, is aimed at newcomers. This makes it possible to obtain a large and homogeneous sample within the framework of a research study.

The Mindfulness Based Stress Reduction-Program

MBSR was developed in the 1970s by the American physician Jon Kabat-Zinn at the University of Massachusetts Medical Centre and aims to develop mindfulness, i.e. an awareness of the moment. The programme is strictly secular. "There is no need to believe in anything or to chant in any other language," clarifies Elizabeth Hoge.

The aim is to learn to focus attention on body sensations, typically sensations related to breathing. If attention drifts away in the form of thoughts, the participant simply returns their attention to their own sensations.

MBSR is therefore primarily a "training program". The sequence is unchanging. It consists of eight weekly courses of 2.5 hours each and a one-day retreat (quiet time) in the fifth to sixth week. The retreat is a day of quiet time for participants to express their feelings or any difficulties they may be experiencing. Like any training, MBSR requires discipline. Those who sign up for the programme commit to practising at home for 45 minutes a day for the eight weeks.

Bodyscan, Yoga, Meditation & Discipline

What happens in the eight sessions? In the first and second weeks, participants are introduced to Bodyscan. They lie for 45 minutes and are guided by the teacher or an audio recording, systematically focusing their attention on the sensations they feel in each part of the body from the feet to the head.

In the third and fourth weeks, participants alternate between practising the Bodyscan and a relaxed yoga sequence that is accessible to all. Meditation times are offered throughout the programme, gradually increasing in length. You don't have to sit in the lotus position, a cushion or low chair will do - and you don't have to bring your thumb and index finger together. The final course teaches the keys to integrating meditation into everyday life.

In addition to the "formal" practices (body scan, yoga, sitting meditation), the participant is also sensitised to the "informal" practice. The aim here is to become aware of what is happening in a particular moment, be it in an everyday action or in a relationship moment, e.g. in a conflict. Putting oneself "on pause" and observing what one feels helps to break through the automatisms that dictate our reactions.

An alternative treatment method?

The study led by Hoge included 210 patients with anxiety disorder recruited from three medical centres in the USA. The average age of the participants was 33 years. 75% of the participants were women - reflecting the demographics of anxiety disorders in the US.

Participants were randomised (1:1) to either complete the eight-week MBSR programme or receive treatment with escitalopram. Treatment was started at 10 mg per day and increased to 20 mg after one week. Anxiety scores were measured at the beginning of the study, after 8 weeks (i.e. at the end of the MBSR programme) and after 12 and 24 weeks. The scale used (Clinical Global Impression - Severity) ranges from 1 to 7, with the last number meaning maximum anxiety.

The average score at the beginning of the study was about 4.5 for the participants. It decreased to about 3 after two months and slightly decreased after three and six months in both groups. In the end, there was a statistically equivalent reduction in anxiety symptoms of about 20 % in both groups.

10 participants in the escitalopram group dropped out of the study due to side effects. The MBSR group remained complete. At least one adverse event related to the study occurred in 110 participants in the escitalopram group (78.6%) and 21 participants in the MBSR group (15.4%).

After the study was completed, one participant in the MBSR group summarised the programme's contribution: "Once you are aware of an anxiety reaction, you can decide for yourself how to deal with it. It's not a magic cure, but it's a kind of training that lasts a lifetime."

For Elizabeth Hoge, it would now be necessary to determine what kind of patients respond best to drug treatment, to MBSR or to a combination of both approaches. Other potential indications for the programme, such as the treatment of depression or insomnia, could also be evaluated.

Meditation: An issue of compliance

The effectiveness of MBSR depends above all on the regularity of the participants. In addition to the weekly courses, they commit to practising at home for 45 minutes every day, preferably in the morning - without exception.

One study has already shown that the average duration of these daily exercises is in fact no more than 30 minutes, with large differences from person to person. Danish researchers wanted to check this and used a smartphone app provided to 25 participants.⁸ The aim was to find out who used the audio recording that accompanied bodyscan, yoga and sitting meditation, how often and for how long.

Theoretically, participants were supposed to listen to one session every day, i.e. 6 per week. In fact, the observed median was 3. They also had difficulty establishing a routine. During the week, most of the exercises were done in the morning, as recommended. At the weekend, however, participants practised more often in the evening.

Here, too, one question remains open: Do participants have to commit to practising at the same time every day for MBSR to be effective? A parallel can be drawn here with drug treatment: Studies have already shown that weekend exercises are more likely to be forgotten and that a routine is associated with better compliance.

How Meditation Helps You Handle Stress Better (Times – 2017)
The effect of mindfulness meditation training on biological acute stress responses in generalized anxiety disorder. Elizabeth A. Hoge, Eric Bui, Sophie A. Palitz, Noah R. Schwarz, Maryann E. Owens, Jennifer M. Johnston, Mark H. Pollack, Naomi M. Simon, Psychiatry Research, Volume 262, 2018, Pages 328-332.
Hoge EA, Bui E, Mete M, Dutton MA, Baker AW, Simon NM.: Mindfulness-Based Stress Reduction vs Escitalopram for the Treatment of Adults With Anxiety Disorders: A Randomized Clinical Trial. JAMA Psychiatry. Published online November 09, 2022. doi:10.1001/jamapsychiatry.2022.367
US task force recommends screening children for anxiety and depression. BMJ 2022; 379 doi: https://doi.org/10.1136/bmj.o2490 (Published 18 October 2022)
Georgetown University Medical Center: Mindfulness-Based Stress Reduction is as Effective as an Antidepressant Drug for Treating Anxiety Disorders. Gizewski ER, Steiger R, Waibel M, Pereverzyev S, Sommer PJD, Siedentopf C, Grams AE, Lenhart L, Singewald N.
Short-term meditation training influences brain energy metabolism: A pilot study on 31 P MR spectroscopy. Brain Behav. 2021 Jan;11(1):e01914. doi: 10.1002/brb3.1914. Epub 2020 Dec 10. PMID: 33300668; PMCID: PMC7821578.
Tammi R. A. Kral, Cole Korponay, Matthew J. Hirshberg, Rachel Hoel, Lawrence Y. Tello, Robin I. Goldman, Melissa A. Rosenkranz, Antoine Lutz, Richard J. Davidson: Absence of structural brain changes from mindfulness-based stress reduction: Two combined randomized controlled trials. Science Advances, 20 May 2022, Vol 8, Issue 20, DOI: 10.1126/sciadv.abk3316
Parsons C, Madsen M, Jensen K, Kæseler S, Fjorback L, Piet J, Roepstorff A, Linehan C.: Smartphone Monitoring of Participants’ Engagement With Home Practice During Mindfulness-Based Stress Reduction: Observational Study. JMIR Ment Health 2020;7(1):e14467, DOI: 10.2196/14467