28 May 2018

Are-parachutes-useful?-Evidence-Based-Medicine-and-a-plea-for-common-sense…

We are all making decisions every moment of the day. Some big. Some inconsequential.

So how do we decide what to do?

Current mainstream medicine loves describing itself as “Evidence Based”. The implication is that all decisions are made based upon “good scientific evidence”, with randomized trials being the “gold standard”.

But would you volunteer for a randomized controlled study into the efficacy of parachutes?

Maybe not; so this week, an exploration of what really does constitute “good scientific evidence” - and where does common sense fit in; but first



       Thought for the day

Simple can be harder than complex :
You have to work hard
To get your thinking clean
To make it simple.

But it is worth it in the end
Because once you get there,
You can move mountains.

                         Steve Jobs






To quote the authors of a landmark research paper published in the prestigious British Medical Journal (BMJ) way back in 2003, “As with many interventions intended to prevent ill health, the effectiveness of parachutes has not been subjected to rigorous evaluation by using randomised controlled trials.



Advocates of evidence based medicine have criticised the adoption of interventions evaluated by using only observational data. 

We think that everyone might benefit if the most radical protagonists of evidence based medicine organised and participated in a double blind, randomised, placebo controlled, crossover trial of the parachute.”




Simple really! We use the best available evidence for any decision we face.

In medicine, drugs are one type of intervention that often can be evaluated well using double blind, crossover trials.

But let us not even go into how often drug companies and researchers under all sorts of pressures (both external and internal) have been proven to falsify results.

The truth is that it is estimated around 75% of all recommendations made in common medical practice do not have high level scientific evidence to support them.

A good example is the treatment of early bowel cancer. Everyone accepts surgery is the best option; yet there has never been a randomized trial to confirm this - probably never will be; the fact remains this option is based entirely on clinical experience.

So it may be helpful to point out what the definition for “Evidence Based Medicine is. The commonly accepted definition first appeared in the BMJ, this time back in 1996 :

Evidence based medicine (EBM) is the conscientious, explicit, judicious and reasonable use of modern, best evidence in making decisions about the care of individual patients. EBM integrates clinical experience and patient values with the best available research information.

Key points? 
Not just “best available research”, but “clinical experience and patient values”. This is the definition. This is EMB. Clinical experience is important. And the patient and what is important to them needs to be taken into account. You need a good clinician!

The problem? 
Current medicine in my opinion has been railroaded by those who overly value scientific research.

My sense of it is that many current practitioners have lost confidence in their own abilities.

It seems that unless a test confirms something for them, they are unable to trust their own clinical acumen.

Rather than examining their patients, they send them off for tests - blood tests, XRays, CAT scans; and often it seems the more complex the tests the better.

And this reliance on investigations is certainly driving and being supported by big business in medicine. An MRI costs a lot more than palpating an abdomen.

And the lawyers have a lot to answer for as well. If challenged - as in sued - a doctor has a better chance of defending themselves these days if they can refer to the evidence of pathology and other tests rather then clinical examinations.

So what to do?

Firstly be aware that evidence has a hierarchy.
There is good evidence and bad evidence, or should we say evidence with greater or lesser weight. In science and medicine there is what actually is called “The Hierarchy of Evidence”. This describes the quality of evidence as follows…

1. Systematic reviews and meta-analyses of "Randomised Controlled Studies (RCTs) with definitive results".
2. RCTs with definitive results (confidence intervals that do not overlap the threshold clinically significant effect)
3. RCTs with non-definitive results (a point estimate that suggests a clinically significant effect but with confidence intervals overlapping the threshold for this effect)
4. Cohort studies
5. Case control studies
6. Cross sectional surveys
7. Case reports

No need to bother with the detail of the above unless you are really into it; where a read of Wiki on this matter may be useful (3).

Clearly when it comes to evaluating research evidence, this hierarchy has some use; the implication being that the higher up the hierarchy you go, the better the quality of evidence.

But be aware that even when the research evidence is good, it still needs to be personalised for you as an individual and there may be several if not many other factors to take into account as well as the scientific research.

An example?

It is summed up by what in the definition of EBM was described as “patient values”.



Finally, note how the hierarchy of evidence starts with case reports (reports in journals of individual or similar case histories with details of diagnosis, treatments and outcomes, but no systematic research)- which scientific types commonly describe as “anecdotes” and demean.

However, case reports often are the best evidence available - as in the only evidence available -  and as such they constitute the basis for correctly informed EBM.

An example?
For many years it could well be argued that the best way to treat cancer nutritionally was to follow the diet as recommended in You Can Conquer Cancer (4).

The reason for this assertion is that for many years there was no better evidence; the Foundation through the clinical experience of myself and all my colleagues had amassed more clinical experience with treating cancer with nutrition than anyone else in the country, so to be Evidence based, we had the best evidence!

How do you like that idea???

Anyway, what to do now? 
Now there is more formal research evidence for cancer nutrition, as well as so much bogus stuff floating around the net and in the press. How to make the best decision we can in any circumstances - medical or elsewhere???

So a push for common sense.

That is it.

That is where this post ends.

A push for common sense.

And more trust in, and support for doctors who do actually talk with their patients and do actually physically examine them.



And avoid any suggestion you take part in a RCT to do with parachutes.

REFERENCES 
1. Smith GCS and Pell JP : Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials. BMJ 2003; 327:1459

2. Sackett DL et al : Evidence based medicine: what it is and what it isn't. BMJ 1996;312:71

3. Greenhaigh T : How to read a paper. Getting your bearings (deciding what a paper is about)  1997  BMJ. 315 (7102): 243–6.

EDITOR’s NOTE This is a very useful paper if you are interested in reading original research papers and interpreting their qualities.

4. You Can Conquer Cancer : First published 1984, revised current edition 2015, Wilkinson Publishing, Melbourne. Also available as a spoken book - from my website...

RELATED BLOG
Just give me the facts


Ruth Gawler's 
next meditation retreat

Meditation - Pure and Simple

This particular retreat will be ideal for everyone seeking deep healing
Whether burnt out, dealing with physical or mental issues, this retreat provides a unique opportunity to be led and supported by a doctor well versed in Mind-Body Medicine who has a particular expertise with deep relaxation and healing 
Ruth will focus in this retreat upon the meditation techniques of Dr Ainslie Meares and Ian Gawler

Combine deep relaxation techniques and mindfulness meditation to release the stress we carry in our bodies in this busy and complex modern world. Ideal for healing, rejuvenation and opening our awareness.

Ruth’s teaching style is one of openness and authenticity, and there will be plenty of opportunity for questions and discussion. Techniques covered in this retreat will be accessible and engaging for both beginners and more experienced meditators. This retreat is well suited to all Health Professionals.

DATES                                    September - Monday 10th to Friday 14th 2018
VENUE                                   Yarra Valley Living Centre, Rayner Crt, Yarra Junction, Victoria
ENQUIRIES, BOOKINGS     The Gawler Foundation ClientServices@gawler.org
                                                 and 1300 651 211 - Call Mon-Fri 9-5pm



WEBSITE LINK CLICK HERE

14 May 2018

Challenging-new-mindfulness-and-meditation-research

Research has shown that we come back refreshed from a holiday but that on average those benefits disappear within 2 weeks! (Reference link).

So is mindfulness longer lasting? What about meditation and other mind training practices? People do seem happier when they do them, they seem to smile more and are nicer to be around. But what does current research say?

Time for an update; there are some real problems yet this may be a good post to share…, but first,


                 Thought for the day

The odd thing about pleasure
Is that instead of fully enjoying what is here,
Being able to be fully present with it,
We are busy looking for more.

We miss the true depth of pleasure 

By being intoxicated with the possibility of more.


                     Zen Roshi Nancy Mujo Baker


Spoiler alert! If you do read on through this post, it may well be challenging! 

The challenge is that while there is some great new research confirming mindfulness and meditation’s many benefits, there are major problems within the research itself. But first, let us start on the bright side with an update…

Recent meditation research findings in brief

1. Meditation eases stress reactions
A new and rigorously designed mindfulness study showed that hormonal and inflammatory reactions to stress were reduced after meditation training.

Hoge EA et al : The effect of mindfulness meditation training on biological acute stress responses in generalized anxiety disorder Psych Res, Vol 262 April 2018, Pages 328-332


2. Meditation improves quality of life for breast cancer survivors.
Meditation was associated with significant decreases in depression, anxiety, perceived stress, and an increase in quality of life, satisfaction with life, post-traumatic growth and quality of sleep.

Significantly, participants had a high attendance rate in the program, which speaks to the likelihood of the applicability of the meditation program on an outpatient basis.

Yun MR et al : The Effects of Mind Subtraction Meditation on Breast Cancer Survivors' Psychological and Spiritual Well-being and Sleep Quality: A Randomized Controlled Trial in South Korea. Cancer Nurs. 2017 Sep/Oct;40(5):377-385. doi: 10.1097/NCC.0000000000000443.


3. Mindfulness may improve cognitive functioning in the elderly
After reviewing the scientific literature, researchers wrote "There is preliminary evidence that meditation can improve cognitive function."


Investigation of 6 Mindfulness Based Interventions in older people based upon MBSR and MBCT suggested positive effects on memory, executive function and processing speed.

However, most reports had a high risk of bias and sample sizes were small.

The only study with low risk of bias, large sample size and active control group reported no significant findings.


The conclusion?

More research is needed, and while meditation and mindfulness may well be useful for the elderly, maybe it is wise to start practicing at an early age!

Berk L et al : Can mindfulness-based interventions influence cognitive functioning in older adults? A review and considerations for future research. Aging Ment Health. 2017 Nov;21(11):1113-1120. doi: 10.1080/13607863.2016.1247423. Epub 2016 Nov 9.

4. Meditation reduces cortisol
Cortisol is popularly known as the stress hormone. Mental states such as worry and rumination over past or future events may prolong cortisol release, which in turn may contribute to pre-disease pathways and adversely affect physical health.

Meditation training has been suggested to increase self-reported mindfulness, which has been linked to reductions in such states. This is the first study to investigate self-reported mindfulness and resting cortisol output.

The results? Good! Meditation did lower the amount of cortisol in the body. The outcome?  Less cortisol, less stress, more capacity for joy.

Jacobs TL et al: Self-reported mindfulness and cortisol during a Shamatha meditation retreat.
Health Psychol. 2013 Oct;32(10):1104-9. doi: 10.1037/a0031362. Epub 2013 Mar 25.

5. Mindfulness changes brain activity in just 8 weeks

In a landmark study (included here for its significance), Richard Davidson, Ph.D - seen here with HH the Dalai Lama- , and his colleagues at the University of Wisconsin, along with Jon Kabat-Zinn, put a group of stressed biotech employees through Kabat-Zinn's eight-week MBSR program.

They found that the employees who completed the program had more activity in the left prefrontal cortex—the happy, calm zone of the brain—than those who did not do the training.

This was the first study to demonstrate brain changes associated with a mindfulness-based practice.

Davidson RJ et al. Alterations in brain and immune function produced by mindfulness meditation.
Psychosom Med. 2003 Jul-Aug;65(4):564-70.

6. Mindfulness changes brain structure
As well as brain function, it seems mindfulness changes brain structure. In this study higher levels of mindfulness accomplished through practice were associated with decreased grey matter volume in the right amygdala, and decreased grey matter volume in the left caudate.

These are parts of the brain that control anxiety and fear. Less anxiety and fear translates to less stress. Again, less stress means more joy.

Taren AA et al: Dispositional Mindfulness Co-Varies with Smaller Amygdala and Caudate Volumes in Community Adults  PLoS ONE 8(5): e64574. 2013

7. Mindfulness and compassion change brain structure - but differently!
This study used functional MRI scans to investigated the brain changes associated with different types of mind trainings - in this case mindfulness, compassion practices and controls.

In the mindful attention group, the after-training brain scans showed a decrease in activation in the right amygdala in response to all images, supporting the hypothesis that meditation can improve emotional stability and response to stress.

In the compassion meditation group, right amygdala activity also decreased in response to positive or neutral images.

But among those who reported practicing compassion meditation most frequently outside of the training sessions, right amygdala activity tended to increase in response to negative images, all of which depicted some form of human suffering.

No significant changes were seen in the control group or in the left amygdala of any study participants.

We think these two forms of meditation cultivate different aspects of mind,” one of the researchers explains.

Since compassion meditation is designed to enhance compassionate feelings, it makes sense that it could increase amygdala response to seeing people suffer. 

Increased amygdala activation was also correlated with decreased depression scores in the compassion meditation group, which suggests that having more compassion towards others may also be beneficial for oneself. 

‘Overall, these results are consistent with the overarching hypothesis that meditation may result in enduring, beneficial changes in brain function, especially in the area of emotional processing.”

Desbordes G et al : Effects of mindful-attention and compassion meditation training on amygdala response to emotional stimuli in an ordinary, non-meditative state Front Hum Neurosci. 2012; 6: 292.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3485650/


BUT NOW FOR THE BIG QUESTION - and the challenge

Is it the mindfulness/meditation that is bringing about the changes?

Research shows Mindfulness benefits are similar to non-meditation based intervention

Jon Kabat-Zinn’s Mindfulness Based Stress reduction Program (MBSR) has become famous and is now widely used based upon the science supporting it; and the positive experiences reported by those who take it up. There is no doubt it is beneficial.

However, a major question needs addressing… Is it the mindfulness itself or other components of the MBSR program that bring about the positive benefits?

This is the first study comparing MBSR to an active control program that was designed to have no mindfulness component, while being structurally equivalent to MBSR and credible to both patients and providers.

The result? MBSR had a extra benefit in reducing pain, but otherwise the two interventions were just as beneficial!

In other words, this study poses the possibility that it may not be the mindfulness on its own but the whole program package that produces the many benefits!

Given these provocative findings the research authors state “although our results do not undermine the substantial evidence supporting the effectiveness of MBSR, they do suggest that the active ingredient of mindfulness in MBSR is no more effective than alternative active ingredients present in the control program for the measures we employed. This conclusion represents an important shift in how we interpret the vast majority of MBSR outcomes in the extant literature”.

This suggests that future studies investigating mindfulness as a specific ingredient in MBSR include control groups designed to address the questions being addressed, and use behavioral or other more objective measures of intervention-specific skill acquisition.

MacCoon DG et al. The Validation of an Active Control Intervention for Mindfulness Based Stress Reduction (MBSR). Behav Res Ther. 2012 Jan; 50(1): 3–12.


So if Mindfulness is beneficial, how does it stand up to thorough analysis?

Meta-analysis suggests limits to mindfulness benefits
Reviews the findings of 47 trials of the health effects of meditation programs on over 3,500 study participants. After carefully controlling for the placebo effect, the authors found that mindfulness meditation resulted in moderate improvements in anxiety, depression and pain. They also found no evidence or insufficient evidence of an improvement in several other measures of health or well-being, such as mood, substance use, eating habits, sleep, and weight.

At the same time, no evidence of harm from meditation was found.

Clearly there is wide variability in what are collectively described as “meditative practices” and equally clearly, the research published to date has very often overlooked this.

The collective research on mindfulness and meditation has been presented as if all techniques are the same - a bit like suggesting all antibiotics are the same - an obvious fallacy.

Clearly too, we will all know people who have made major beneficial changes in their lives associated with taking up a meditation type practice.


The authors go on to state
 “Many people use meditation to treat stress and stress-related conditions and to promote general health. Meditation training programs vary in several ways, including the type of mental activity promoted, the amount of training recommended, the use and qualifications of an instructor, and the degree of emphasis on religion or spirituality. Some meditative techniques are integrated into a broader approach that includes dietary and/or movement therapies (eg, ayurveda or yoga).

‘Meditative techniques are categorized as emphasizing mindfulness, concentration, and automatic self-transcendence. Popular techniques, such as transcendental meditation, emphasize the use of a mantra in such a way that it transcends one to an effortless state where focused attention is absent.

Other popular techniques, such as mindfulness-based stress reduction, emphasize training in present-focused awareness or mindfulness. Uncertainty remains about what these distinctions mean and the extent to which these distinctions actually influence psychosocial stress outcomes’.

So while this meta-analysis aimed to take these variations into account, it still suffers from major limitations in comparing techniques and amount of practice completed. This is like comparing treatments for pneumonia without stating which drugs are being compared and how much of each was taken. Obviously we are still in early days with meditation research - useful days, but early ones! Now we need more details.

Goyal M et al. Meditation Programs for Psychological Stress and Well-being A Systematic Review and Meta-analysis. JAMA Intern Med. 2014;174(3):357-368. doi:10.1001/jamainternmed.2013.13018


FUTURE DIRECTIONS FOR MEDITATION RESEARCH
The JAMA article that is cited above and forms the basis of this article was itself based on a more comprehensive report, one in a series of Comparative Effectiveness Reviews  (No. 124 : Meditation Programs for Psychological Stress and Well-Being) prepared for the Agency for Healthcare Research and Quality in the U.S. Department of Health and Human Services.)

This report makes good reading, part of the conclusion having great relevance to the therapeutic application of meditation and something we are bound to hear more of as meditation is used more widely for its healing potential.

And another thing… Maybe the studies need to be conducted over longer time frames…

From the above report
Historically, the general public has not conceptualized meditation as a quick fix toward anything. 

It is a skill or state one learns and practices over time to increase one’s awareness, and through this awareness gain insight and understanding into the various subtleties of one’s existence. 

Training the mind in awareness, non-judgmentalness, and the ability to become completely free of thoughts or other activity are daunting accomplishments. 


While some meditators may feel these tasks are easy, they likely overestimate their own skills due to a lack of awareness of the different degrees to which these tasks can be done or the ability to objectively measure their own progress. 


Since becoming an expert at simple skills such as swimming, reading, or writing (which can be objectively measured by others) takes a considerable amount of time, it follows that meditation would also take a long period of time to master. 

However, many of the studies included in this review were short term (e.g., 2.5 hours a week for 8 weeks), and the participants likely did not achieve a level of expertise needed to improve outcomes that depend on a mastery of mental and emotional processes. The short-term nature of the studies, combined with the lack of an adequate way to measure meditation competency, could have significantly contributed to results.

Lots to contemplate in all of this ……

CONCLUSION
The current research is interesting and certainly helps win acceptance for mindfulness and meditation. But we need to be clear. This arena for research is still in its infancy and what is needed now is more detailed investigation into the benefits of different techniques, how those techniques interact with the teachers and groups they are taught within, and how much difference the amount of time spent doing the practice makes to the outcome.

This progression in the quality of research is normal and reasonable, but it is time now for the quality to lift.

In the interim, trust your own experience
Meditation is not always easy. It takes time to learn, persevere, develop skills and receive the many benefits on offer. Trust your own experience. Mine tells me this is something worth doing every day. There is no need for external research to confirm that; my own inner experience is confirmation enough! And I know I need support to maintain the practice...


“Do yourself a favour… “

Ruth Gawler's 
next meditation retreat

Meditation - Pure and Simple


Experience 
. Being more at ease with yourself and your feelings
. The connectedness and clarity of mindfulness
. Profound relaxation into stillness.


Combine deep relaxation techniques and mindfulness meditation to release the stress we carry in our bodies in this busy and complex modern world. Ideal for healing, rejuvenation and opening our awareness.


Ruth’s teaching style is one of openness and authenticity, and there will be plenty of opportunity for questions and discussion. Techniques covered in this retreat will be accessible and engaging for both beginners and more experienced meditators. This retreat is well suited to all Health Professionals.

DATES                                    September - Monday 10th to Friday 14th 2018
VENUE                                   Yarra Valley Living Centre, Rayner Crt, Yarra Junction, Victoria
ENQUIRIES, BOOKINGS     The Gawler Foundation ClientServices@gawler.org
                                                 and 1300 651 211 - Call Mon-Fri 9-5pm
WEBSITE LINK CLICK HERE