Professor Anthony Pelosi just published an intriguing paper. Here is the abstract:
During the 1980s and 1990s, Hans J Eysenck conducted a programme of research into the causes, prevention and treatment of fatal diseases in collaboration with one of his protégés, Ronald Grossarth-Maticek. This led to what must be the most astonishing series of findings ever published in the peer-reviewed scientific literature with effect sizes that have never otherwise been encounterered in biomedical research. This article outlines just some of these reported findings and signposts readers to extremely serious scientific and ethical criticisms that were published almost three decades ago. Confidential internal documents that have become available as a result of litigation against tobacco companies provide additional insights into this work. It is suggested that this research programme has led to one of the worst scientific scandals of all time. A call is made for a long overdue formal inquiry.
The Guardian reported further details on this story sating that the work of one of the most famous and influential British psychologists of all time, Hans Eysenck, is under a cloud following an investigation by King’s College London, which has found 26 of his published papers “unsafe”.
It is argued that there is now suficient evidence to regard psychosocial variables, in
particular personality and stress, as important risk factors for cancer and coronary heart
disease (CHD), equal in importance to smoking, heredity, cholesterol level, blood pressure,
and other physical variables. Furthermore, it is now clear that both types of factors act
synergistically; that is, each by itself is relatively benign, but their effects multiply to produce
high levels of disease…
The claim (which Eysenck published many times over, for instance here) was picked up and promoted by many believers in SCAM. This might have been helped by Eysenck’s bizarre openness to all things paranormal. Today his belief of a link between personality/stress and cancer is deeply engrained in SCAM.
King’s College says the results and conclusions of the papers “were not considered scientifically rigorous” by its committee of inquiry. Prof Sir Robert Lechler, the provost at King’s, has contacted the editors of the 11 journals where the papers appeared, recommending they should be retracted.
Prof Anthony Pelosi, consultant psychiatrist at the Priory Hospital, Glasgow, whose own investigation prompted the inquiry by King’s, said their work “led to what must be the most astonishing series of findings ever published in the peer-reviewed scientific literature, with effect sizes that have never otherwise been encountered in biomedical research”.
Among more than 3,000 people in the studies, Eysenck and his colleague claimed people with a “cancer-prone” personality were 121 times more likely to die of the disease than those without. Cancer-prone personalities were described as generally passive in the face of stress from outside.
Eysenck and Grossarth-Maticek apparently even had a cure for cancer. In one study, they gave 600 “cancer-prone” individuals a leaflet on how to be more “autonomous” and take control of their destiny. It contained such advice as: “Your aim should always be to produce conditions which make it possible for you to lead a happy and contented life.” It appeared to deliver miracles. Over 13 years, the 600 people randomly assigned to bibliotherapy, as it was called, had all-cause mortality of 32%, compared with 82% of 600 people not fortunate enough to receive a leaflet.
“I honestly believe, having read it so carefully and tried to find alternative interpretations, that this is fraudulent work,” said Pelosi, who is concerned Eysenck’s ideas still have a following. “His acolytes always bragged he was the most cited psychologist of all time… In the social sciences citation index, he was number three. Number two was Freud. Number one was Karl Marx. He was hugely prolific, widely cited and very influential… Many fringe medical practitioners hold the same conviction.”
Four speakers have been announced for next year’s conference (25-26 April 2020) of the UK ‘Society of Homeopaths’ (SoH). It has the theme ‘All About Men’ (which is surprising considering the majority of homeopathy fans are women). The meeting will aim to provide a better understanding of men’s lives and illnesses in order for practitioners to help them seek homeopathic treatments with confidence.
One of the 4 speakers will be California-based chiropractor, homeopath and health coach Joel Kriesberg. The SoH’s announcement proudly states that “Joel Kreisberg is going to bring the very interesting tool, the Enneagram, which was originally devised by the famous philosopher, George Gurdjieff. This is the first time Joel has lectured in the UK and he is well respected and highly thought of by the likes of Karen Allen and Dana Ullman.”
(A note to the SoH: Gurdjieff did not devise the Enneagram, he popularised it; perhaps you want to correct this statement?)
But, what is the ENNEAGRAM?
According to Wikipedia, the Enneagram (from the Greek words ἐννέα [ennéa, meaning “nine”] and γράμμα [grámma, meaning something “written” or “drawn”]), is a model of the human psyche which is principally understood and taught as a typology of nine interconnected personality types. Although the origins and history of many of the ideas and theories associated with the Enneagram of Personality are a matter of dispute, contemporary Enneagram claims are principally derived from the teachings of Oscar Ichazo and Claudio Naranjo. Naranjo’s theories were partly influenced by some earlier teachings of George Gurdjieff. As a typology the Enneagram defines nine personality types (sometimes called “enneatypes”), which are represented by the points of a geometric figure called an enneagram, which indicate connections between the types. There are different schools of thought among Enneagram teachers, therefore their ideas are not always in agreement.
The Enneagram of Personality has been widely promoted in both business management and spirituality contexts through seminars, conferences, books, magazines, and DVDs. In business contexts it is generally used as a typology to gain insights into workplace interpersonal-dynamics; in spirituality it is more commonly presented as a path to higher states of being, essence, and enlightenment. Both contexts say it can aid in self-awareness, self-understanding and self-development.
In a nutshell, the Enneagram is an obsolete personality test that has never been properly validated and is today used mostly by quacks and other dubious characters and institutions. Yet, this is what Kriesberg has to say on his website about the use of the Enneagram in homeopathy:
The Enneagram’s application to homeopathy and health coaching makes a dramatic difference as it allows practitioner to identify the client’s learning style quickly. As we engage the Enneagram, we are able to provide specific developmental paths and activities based on their Enneagram style. Healing is faster, deeper, and has longer-lasting results.
To teach all this, Kriesberg is offering classes that are grounded in Tinus Smits’ method for studying universal healing with homeopathy, in which direct experience of the Enneagram types is enhanced by the use of homeopathic remedies.
Tinus Smits! … where have I heard this name before?
Ah yes, this is the homeopath who invented CEASE!
Smits became convinced that autism is caused by a child’s exposure to an accumulation of toxic substances and published several books about his theory. In his experience (as far as I can see, Smits never published a single scientific paper in the peer-reviewed literature) autism is caused by an accumulation of different toxins. About 70% is due to vaccines, 25% to toxic medication and other toxic substances, 5% to some diseases. According to the ‘like cures like’ principle of homeopathy, Smits claimed that autism must be cured by applying homeopathic doses of the substances which caused autism. Step by step all assumed causative factors (vaccines, regular medication, environmental toxic exposures, effects of illness, etc.) are detoxified with the homeopathically prepared substances that has been administered prior to the onset of autism. Smits and his followers believe that this procedure clears out the energetic field of the patient from the imprint of toxic substances or diseases.
I herewith congratulate the SoH on their forthcoming conference – an event that must not be missed! They have managed to pack an unprecedented amount of unethical nonsense into just one lecture!
Spinal manipulation is a treatment employed by several professions, including physiotherapists and osteopaths; for chiropractors, it is the hallmark therapy.
- They use it for (almost) every patient.
- They use it for (almost) every condition.
- They have developed most of the techniques.
- Spinal manipulation is the focus of their education and training.
- All textbooks of chiropractic focus on spinal manipulation.
- Chiropractors are responsible for most of the research on spinal manipulation.
- Chiropractors are responsible for most of the adverse effects of spinal manipulation.
Spinal manipulation has traditionally involved an element of targeting the technique to a level of the spine where the proposed movement dysfunction is sited. This study evaluated the effects of a targeted manipulative thrust versus a thrust applied generally to the lumbar region.
Sixty patients with low back pain were randomly allocated to two groups: one group received a targeted manipulative thrust (n=29) and the other a general manipulation thrust (GT) (n=31) to the lumbar spine. Thrust was either localised to a clinician-defined symptomatic spinal level or an equal force was applied through the whole lumbosacral region. The investigators measured pressure-pain thresholds (PPTs) using algometry and muscle activity (magnitude of stretch reflex) via surface electromyography. Numerical ratings of pain and Oswestry Disability Index scores were collected.
Repeated measures of analysis of covariance revealed no between-group differences in self-reported pain or PPT for any of the muscles studied. The authors concluded that a GT procedure—applied without any specific targeting—was as effective in reducing participants’ pain scores as targeted approaches.
The authors point out that their data are similar to findings from a study undertaken with a younger, military sample, showing no significant difference in pain response to a general versus specific rotation, manipulation technique. They furthermore discuss that, if ‘targeted’ manipulation proves to be no better than ‘general’ manipulation (when there has been further research, more studies), it would challenge the need for some current training courses that involve comprehensive manual skill training and teaching of specific techniques. If simple SM interventions could be delivered with less training, than the targeted approach currently requires, it would mean a greater proportion of the population who have back pain could access those general manipulation techniques.
Assuming that the GT used in this trial was equivalent to a placebo control, another interpretation of these results is that the effects of spinal manipulation are largely or even entirely due to a placebo response. If this were confirmed in further studies, it would be yet one more point to argue that spinal manipulation is not a treatment of choice for back pain or any other condition.
Once upon a time, arsenic has been used widely for medicinal and other purposes. Now that we know how toxic it is, few people would voluntarily take it – except of course fans of homeopathy. In homeopathy, arsenic is an important and popular remedy.
Here is what HOMEOPATHY PLUS tell us about its therapeutic potential:
Arsenic is a toxic chemical element, historically used as a poison. It is safe to use with infants through to the elderly when prepared in homeopathic potencies. Those who need Arsenicum are prone to hypochondriasis and are intolerant of untidiness and disorder. They are anxious, critical, and restless, and dislike being alone but may be irritable with company. Restlessness may be followed by exhaustion which is out of proportion to their illness. They fear illness and disease, death, and being alone. Discharges tend to be acrid and burning. Burning pains paradoxically feel better for heat (except the headache which is better for cold applications). Thirst is for sips of warm drinks but cold drinks worsen. Symptoms worsen between midnight and 2 AM.
Colds and Hayfever
- Red, puffy, burning eyes that feel better for hot compresses.
- Watery, nasal discharge that burns and reddens the nostrils and lip.
- Frequent sneezing with no relief.
- Worsened by cold air or cold drinks.
- Rapid, difficult breathing, with wheezing (asthma).
- Coughs or wheezing worse for lying down and better for sitting upright.
- Burning, throbbing pain.
- Worsened by heat and relieved by cold applications or cool air (though rest of body will be chilly and rugged up).
- Eczema with burning, itching, dry skin.
- Thirst for frequent small sips of water.
- Burning stomach pains eased by drinking milk.
- Offensive, burning, scalding diarrhoea.
- A key remedy for food poisoning or gastroenteritis.
- Hot head and cold body.
- Chilly and want to be rugged up.
- Restless and anxious – insomnia between midnight and 2 AM
- Dreams of robbers
- Chilly, anxious pets.
- Itchy, dry skin eruptions in chilly, anxious animals.
Where do I find it?
Arsenicum album (Ars.) is available from our online store as a single remedy and is also included in the following Complexes (combination remedies): Anxiety; Common Cold – Watery; Hay Fever; Insomnia; Mouth Ulcer; Panic Stop; Sinus Pain; Winter Defence.
While above self-limiting or acute complaints are suitable for home treatment, see your healthcare provider if symptoms worsen or fail to improve. Chronic or persistent complaints, which may or may not be mentioned above, require a different treatment and dosage protocol so are best managed by a qualified homeopath for good results.
For acute and self-limiting complaints, take one pill or five drops of the remedy every 30 minutes to 4 hours (30 minutes for intense symptoms, 4 hours for milder ones). Once an improvement is noticed, stop dosing and repeat the remedy only if symptoms return. If there is no improvement at all by three doses, choose a different remedy or seek professional guidance. Chronic symptoms or complaints require a course of professional treatment to manage the changes in potencies and remedies that will be required.
So, arsenic is safe to use with infants through to the elderly when prepared in homeopathic potencies!
True of false?
We recently discussed a case of homeopathic arsenic poisoning from India. Now a similar one has been reported from Switzerland. A Swiss doctor published a case report of chronic arsenic poisoning associated with the intake of a homeopathic remedy.
For about 4 years the patient had taken globules of a freely purchasable homeopathic remedy containing inorganic arsenic (iAs) diluted to D6 (average arsenic content per single globule: 0.85 ± 0.08 ng). She took the remedy because it was advertised for gastrointestinal confort. In the previous 7 months, she had taken 20 to 50 globules daily (average 30 ng arsenic daily).
She complained of nausea, stomach and abdominal cramps, diarrhoea and flatulence, headache, dizziness, anxiety, difficulty concentrating, insomnia, snoring, leg cramps and fatigue, loss of appetite, increased thirst and sweating, reduced diuresis, weight gain, paleness and coolness of both hands with a furry feeling of the hands, eczema of the hands, arms and legs, conjunctivitis and irregular menstruation.
The physical and laboratory examinations showed a body mass index of 30 kg/m2, acne vulgaris, bilateral spotted leukonychia, eczema of hands, arms and legs, non-pitting oedema of the legs, elevated plasma alkaline phosphatase activity, folate deficiency and severe vitamin D3 insufficiency. The arsenic concentration in her blood was <0.013 µmol/l, and arsenic was undetectable in her scalp hair. The total iAs concentration was 116 nmol/l in the morning urine and 47 nmol/l in the afternoon urine.
The urinary arsenic concentration decreased and the patient’s complaints improved upon interruption of the arsenic globules, vitamin D3, thiamine and folic acid supplementation, and symptomatic therapy.
The author concluded that an avoidable toxicant such as inorganic arsenic, for which no scientific safe dose threshold exists, should be avoided and not be found in over-the-counter medications.
The author rightly states that causality of this association cannot be proven. However, he also stresses that a causal link between chronic iAs exposure and the patient’s nonspecific systemic symptoms is nevertheless suggested by circumstantial evidence pointing to the disappearance of CAsI signs and symptoms after therapy including interruption of the exposure. In his (and my) view, this renders causality most likely.
A systematic review of the evidence for effectiveness and harms of specific spinal manipulation therapy (SMT) techniques for infants, children and adolescents has been published by Dutch researchers. I find it important to stress from the outset that the authors are not affiliated with chiropractic institutions and thus free from such conflicts of interest.
They searched electronic databases up to December 2017. Controlled studies, describing primary SMT treatment in infants (<1 year) and children/adolescents (1–18 years), were included to determine effectiveness. Controlled and observational studies and case reports were included to examine harms. One author screened titles and abstracts and two authors independently screened the full text of potentially eligible studies for inclusion. Two authors assessed risk of bias of included studies and quality of the body of evidence using the GRADE methodology. Data were described according to PRISMA guidelines and CONSORT and TIDieR checklists. If appropriate, random-effects meta-analysis was performed.
Of the 1,236 identified studies, 26 studies were eligible. In all but 3 studies, the therapists were chiropractors. Infants and children/adolescents were treated for various (non-)musculoskeletal indications, hypothesized to be related to spinal joint dysfunction. Studies examining the same population, indication and treatment comparison were scarce. Due to very low quality evidence, it is uncertain whether gentle, low-velocity mobilizations reduce complaints in infants with colic or torticollis, and whether high-velocity, low-amplitude manipulations reduce complaints in children/adolescents with autism, asthma, nocturnal enuresis, headache or idiopathic scoliosis. Five case reports described severe harms after HVLA manipulations in 4 infants and one child. Mild, transient harms were reported after gentle spinal mobilizations in infants and children, and could be interpreted as side effect of treatment.
The authors concluded that, based on GRADE methodology, we found the evidence was of very low quality; this prevented us from drawing conclusions about the effectiveness of specific SMT techniques in infants, children and adolescents. Outcomes in the included studies were mostly parent or patient-reported; studies did not report on intermediate outcomes to assess the effectiveness of SMT techniques in relation to the hypothesized spinal dysfunction. Severe harms were relatively scarce, poorly described and likely to be associated with underlying missed pathology. Gentle, low-velocity spinal mobilizations seem to be a safe treatment technique in infants, children and adolescents. We encourage future research to describe effectiveness and safety of specific SMT techniques instead of SMT as a general treatment approach.
We have often noted that, in chiropractic trials, harms are often not mentioned (a fact that constitutes a violation of research ethics). This was again confirmed in the present review; only 4 of the controlled clinical trials reported such information. This means harms cannot be evaluated by reviewing such studies. One important strength of this review is that the authors realised this problem and thus included other research papers for assessing the risks of SMT. Consequently, they found considerable potential for harm and stress that under-reporting remains a serious issue.
Another problem with SMT papers is their often very poor methodological quality. The authors of the new review make this point very clearly and call for more rigorous research. On this blog, I have repeatedly shown that research by chiropractors resembles more a promotional exercise than science. If this field wants to ever go anywhere, if needs to adopt rigorous science and forget about its determination to advance the business of chiropractors.
I feel it is important to point out that all of this has been known for at least one decade (even though it has never been documented so scholarly as in this new review). In fact, when in 2008, my friend and co-author Simon Singh, published that chiropractors ‘happily promote bogus treatments’ for children, he was sued for libel. Since then, I have been legally challenged twice by chiropractors for my continued critical stance on chiropractic. So, essentially nothing has changed; I certainly do not see the will of leading chiropractic bodies to bring their house in order.
May I therefore once again suggest that chiropractors (and other spinal manipulators) across the world, instead of aggressing their critics, finally get their act together. Until we have conclusive data showing that SMT does more good than harm to kids, the right thing to do is this: BEHAVE LIKE ETHICAL HEALTHCARE PROFESSIONALS: BE HONEST ABOUT THE EVIDENCE, STOP MISLEADING PARENTS AND STOP TREATING THEIR CHILDREN!
Controlled clinical trials are methods for testing whether a treatment works better than whatever the control group is treated with (placebo, a standard therapy, or nothing at all). In order to minimise bias, they ought to be randomised. This means that the allocation of patients to the experimental and the control group must not be by choice but by chance. In the simplest case, a coin might be thrown – heads would signal one, tails the other group.
In so-called alternative medicine (SCAM) where preferences and expectations tend to be powerful, randomisation is particularly important. Without randomisation, the preference of patients for one or the other group would have considerable influence on the result. An ineffective therapy might thus appear to be effective in a biased study. The randomised clinical trial (RCT) is therefore seen as a ‘gold standard’ test of effectiveness, and most researchers of SCAM have realised that they ought to produce such evidence, if they want to be taken seriously.
But, knowingly or not, they often fool the system. There are many ways to conduct RCTs that are only seemingly rigorous but, in fact, are mere tricks to make an ineffective SCAM look effective. On this blog, I have often mentioned the A+B versus B study design which can achieve exactly that. Today, I want to discuss another way in which SCAM researchers can fool us (and even themselves) with seemingly rigorous studies: the de-randomised clinical trial (dRCT).
The trick is to use random allocation to the two study groups as described above; this means the researcher can proudly and honestly present his study as an RCT with all the kudos these three letters seem to afford. And subsequent to this randomisation process, the SCAM researcher simply de-randomises the two groups.
To understand how this is done, we need first to be clear about the purpose of randomisation. If done well, it generates two groups of patients that are similar in all factors that might impact on the results of the study. Perhaps the most obvious factor is disease severity; one could easily use other methods to make sure that both groups of an RCT are equally severely ill. But there are many other factors which we cannot always quantify or even know about. By using randomisation, we make sure that there is an similar distribution of ALL of them in the two study groups, even those factors we are not even aware of.
De-randomisation is thus a process whereby the two previously similar groups are made to differ in terms of any factor that impacts on the results of the trial. In SCAM, this is often surprisingly simple.
Let’s use a concrete example. For our study of spiritual healing, the 5 healers had opted during the planning period of the study to treat both the experimental group and the control group. In the experimental group, they wanted to use their full healing power, while in the control group they would not employ it (switch it off, so to speak). It was clear to me that this was likely to lead to de-randomisation: the healers would have (inadvertently or deliberately) behaved differently towards the two groups of patients. Before and during the therapy, they would have raised the expectation of the verum group (via verbal and non-verbal communication), while sending out the opposite signals to the control group. Thus the two previously equal groups would have become unequal in terms of their expectation. And who can deny that expectation is a major determinant of the outcome? Or who can deny that experienced clinicians can manipulate their patients’ expectation?
For our healing study, we therefore chose a different design and did all we could to keep the two groups comparable. Its findings thus turned out to show that healing is not more effective than placebo (It was concluded that a specific effect of face-to-face or distant healing on chronic pain could not be demonstrated over eight treatment sessions in these patients.). Had we not taken these precautions, I am sure the results would have been very different.
In RCTs of some SCAMs, this de-randomisation is difficult to avoid. Think of acupuncture, for instance. Even when using sham needles that do not penetrate the skin, the therapist is aware of the group allocation. Hoping to prove that his beloved acupuncture can be proven to work, acupuncturists will almost automatically de-randomise their patients before and during the therapy in the way described above. This is, I think, the main reason why some of the acupuncture RCTs using non-penetrating sham devices or similar sham-acupuncture methods suggest that acupuncture is more than a placebo therapy. Similar arguments also apply to many other SCAMs, including for instance chiropractic.
There are several ways of minimising this de-randomisation phenomenon. But the only sure way to avoid this de-randomisation is to blind not just the patient but also the therapists (and to check whether both remained blind throughout the study). And that is often not possible or exceedingly difficult in trials of SCAM. Therefore, I suggest we should always keep de-randomisation in mind. Whenever we are confronted with an RCT that suggest a result that is less than plausible, de-randomisation might be a possible explanation.
Myelopathy is defined as any neurologic deficit related to the spinal cord. When due to trauma, it is known as (acute) spinal cord injury. When caused by inflammatory, it is known as myelitis. Disease that is vascular in nature is known as vascular myelopathy.
The symptoms of myelopathy include:
- Pain in the neck, arm, leg or lower back
- Muscle weakness
- Difficulty with fine motor skills, such as writing or buttoning a shirt
- Difficulty walking
- Loss of urinary or bowel control
- Issues with balance and coordination
The causes of myelopathy include:
- Tumours that put pressure on the spinal cord
- Bone spurs
- A dislocation fracture
- Autoimmune diseases like multiple sclerosis
- Congenital abnormality
- A traumatic injury
This review presents a series of cases with cervical spine injury and myelopathy following therapeutic manipulation of the neck, and examines their clinical course and neurological outcome.
Its authors conducted a search for patients who developed neurological symptoms due to cervical spinal cord injury following neck SMT in the database of a spinal unit in a tertiary hospital between the years 2008 and 2018. Patients with vertebral artery dissections were excluded. Patients were assessed for the clinical course and deterioration, type of manipulation used and subsequent management.
A total of four patients were identified, two men and two women, aged between 32 and 66 years. In three patients neurological deterioration appeared after chiropractic adjustment and in one patient after tuina therapy. The patients had experienced symptoms within one day to one week after neck manipulation. The four patients had signs of:
- central cord syndrome,
- spastic quadriparesis,
- spastic quadriparesis,
- radiculopathy and myelomalacia.
Three patients were managed with anterior cervical discectomy and fusion while one patient declined surgical treatment.
The authors note that their data cannot determine whether the spinal cord dysfunction was caused my the spinal manipulations or were pre-existing problems which were aggravated by the treatments. They recommend that assessment for subjective and objective evidence of cervical myelopathy should be performed prior to cervical manipulation, and suspected myelopathic patients should be sent for further workup by a specialist familiar with cervical myelopathy, such as a neurologist, a neurosurgeon or orthopaedic surgeon who specializes in spinal surgery. They also state that manipulation therapy remains an important and generally safe treatment modality for a variety of cervical complaints. Their review, the authors stress, does not intend to discard the role of spinal manipulation as a significant part in the management of patients with neck related symptoms, rather it is meant to draw attention to the need for careful clinical and imaging investigation before treatment. This recommendation might be medically justified, yet one could argue that it is less than practical.
This paper from Israel is interesting in that it discloses possible complications of cervical manipulation. It confirms that chiropractors are most frequently implicated and that – as in our survey – under-reporting is exactly 100% (none of the cases identified by the retrospective chart review had been previously reported).
In light of this, some of the affirmations of the authors are bizarre. In particular, I ask myself how they can claim that cervical manipulation is a ‘generally safe’ treatment. With under-reporting at such high levels, the only thing one can say with certainty is that serious complications do happen and nobody can be sure how frequently they occur.
An abstract from the recent ‘2nd OFFICIAL SIPS CONFERENCE ON PLACEBO STUDIES’ caught my attention. It is not available on-line; therefore let me reproduce it here in full:
The role of placebo effects in mindfulness-based analgesia 1. Jonathan Davies. University of Sydney, Sydney, NSW, Australia. 2. Louise Sharpe. University of Sydney, Sydney, NSW, Australia. 3. Melissa Day. University of Queensland, Brisbane, QLD, Australia. 4. Ben Colagiuri. University of Sydney, Sydney, NSW, Australia.
Background: Mindfulness meditation can reduce pain both in experimental and clinical settings, though it is not known to what extent mindfulness-specific vs placebo-like expectancy effects account for these changes. This study aimed to: 1. establish whether placebo effects contribute to mindfulness-mediated analgesia; and 2. identify putative cognitive mechanisms responsible for placebo- vs mindfulness-mediated analgesia. Methods: We compared the effects of focussed-attention mindfulness training (6 x 20 min), sham mindfulness, and a no-treatment in a double-blind RCT for experimental heat pain. Sham mindfulness instructions lacked the ‘active ingredients’ of the real training but were matched on all other contextual factors. Results: Both real and sham mindfulness training led to greater pain tolerance relative to no treatment, but there was no difference between the real and sham training. This was accompanied by increased expectancy, beliefs, and pain-related cognitive processes in the two mindfulness groups relative to no treatment, but again there were no differences between real and sham training on these outcomes. There were no effects on pain intensity, pleasantness or threshold. Conclusion: These findings suggest that mindfulness training – at least those involving focused-attention – may lead to improved pain tolerance via the placebo effect rather than any specific mindfulness-related mechanisms. Potential mediators of these effects will be discussed.
I find this study remarkable in two ways:
- It shows that, with a bit of fantasy, ingenuity and will, one can design and use sham procedures even in clinical trials of mind/body therapies.
- Its results suggest that, if one does control for placebo effects, these treatments may not prove to be more than a placebo therapy.
What implications might this have for clinical practice?
Mindfulness is currently hugely popular. It would not be surprising, if the news that it might rely purely on placebo effects would calm down the enthusiasm about this treatment. Many might ask, does it matter? As long as patients benefit, the mechanism of action seems irrelevant. This, of course, is an interesting debate which we have had on this blog many times before.
What do you think?
The journal NATURE has just published an excellent article by Andrew D. Oxman and an alliance of 24 leading scientists outlining the importance and key concepts of critical thinking in healthcare and beyond. The authors state that the Key Concepts for Informed Choices is not a checklist. It is a starting point. Although we have organized the ideas into three groups (claims, comparisons and choices), they can be used to develop learning resources that include any combination of these, presented in any order. We hope that the concepts will prove useful to people who help others to think critically about what evidence to trust and what to do, including those who teach critical thinking and those responsible for communicating research findings.
Here I take the liberty of citing a short excerpt from this paper:
Claims about effects should be supported by evidence from fair comparisons. Other claims are not necessarily wrong, but there is an insufficient basis for believing them.
Claims should not assume that interventions are safe, effective or certain.
- Interventions can cause harm as well as benefits.
- Large, dramatic effects are rare.
- We can rarely, if ever, be certain about the effects of interventions.
Seemingly logical assumptions are not a sufficient basis for claims.
- Beliefs alone about how interventions work are not reliable predictors of the presence or size of effects.
- An outcome may be associated with an intervention but not caused by it.
- More data are not necessarily better data.
- The results of one study considered in isolation can be misleading.
- Widely used interventions or those that have been used for decades are not necessarily beneficial or safe.
- Interventions that are new or technologically impressive might not be better than available alternatives.
- Increasing the amount of an intervention does not necessarily increase its benefits and might cause harm.
Trust in a source alone is not a sufficient basis for believing a claim.
- Competing interests can result in misleading claims.
- Personal experiences or anecdotes alone are an unreliable basis for most claims.
- Opinions of experts, authorities, celebrities or other respected individuals are not solely a reliable basis for claims.
- Peer review and publication by a journal do not guarantee that comparisons have been fair.
Studies should make fair comparisons, designed to minimize the risk of systematic errors (biases) and random errors (the play of chance).
Comparisons of interventions should be fair.
- Comparison groups and conditions should be as similar as possible.
- Indirect comparisons of interventions across different studies can be misleading.
- The people, groups or conditions being compared should be treated similarly, apart from the interventions being studied.
- Outcomes should be assessed in the same way in the groups or conditions being compared.
- Outcomes should be assessed using methods that have been shown to be reliable.
- It is important to assess outcomes in all (or nearly all) the people or subjects in a study.
- When random allocation is used, people’s or subjects’ outcomes should be counted in the group to which they were allocated.
Syntheses of studies should be reliable.
- Reviews of studies comparing interventions should use systematic methods.
- Failure to consider unpublished results of fair comparisons can bias estimates of effects.
- Comparisons of interventions might be sensitive to underlying assumptions.
Descriptions should reflect the size of effects and the risk of being misled by chance.
- Verbal descriptions of the size of effects alone can be misleading.
- Small studies might be misleading.
- Confidence intervals should be reported for estimates of effects.
- Deeming results to be ‘statistically significant’ or ‘non-significant’ can be misleading.
- Lack of evidence for a difference is not the same as evidence of no difference.
What to do depends on judgements about the problem, the relevance (applicability or transferability) of evidence available and the balance of expected benefits, harm and costs.
Problems, goals and options should be defined.
- The problem should be diagnosed or described correctly.
- The goals and options should be acceptable and feasible.
Available evidence should be relevant.
- Attention should focus on important, not surrogate, outcomes of interventions.
- There should not be important differences between the people in studies and those to whom the study results will be applied.
- The interventions compared should be similar to those of interest.
- The circumstances in which the interventions were compared should be similar to those of interest.
Expected pros should outweigh cons.
- Weigh the benefits and savings against the harm and costs of acting or not.
- Consider how these are valued, their certainty and how they are distributed.
- Important uncertainties about the effects of interventions should be reduced by further fair comparisons.
END OF QUOTE
I have nothing to add to this, except perhaps to point out how very relevant all of this, of course, is for SCAM and to warmly recommend you study the full text of this brilliant paper.
Japanese neurosurgeons reported the case of A 55-year-old man who presented with progressive pain and expanding swelling in his right neck. He had no history of trauma or infectious disease. The patient had undergone chiropractic manipulations once in a month and the last manipulation was done one day before the admission to hospital.
On examination by laryngeal endoscopy, a swelling was found on the posterior wall of the pharynx on the right side. The right piriform fossa was invisible. CT revealed hematoma in the posterior wall of the right oropharynx compressing the airway tract. Aneurysm-like enhanced lesion was also seen near the right common carotid artery. Ultrasound imaging revealed a fistula of approximately 1.2 mm at the posterior wall of the external carotid artery and inflow image of blood to the aneurysm of a diameter of approximately 12 mm. No dissection or stenosis of the artery was found. Jet inflow of blood into the aneurysm was confirmed by angiography. T1-weighted MR imaging revealed presence of hematoma on the posterior wall of the pharynx and the aneurysm was recognized by gadolinium-enhancement.
The neurosurgeons performed an emergency operation to remove the aneurysm while preserving the patency of the external carotid artery. The pin-hole fistula was sutured and the wall of the aneurysm was removed. Histopathological assessment of the tissue revealed a pseudoaneurysm (also called a false aneurism), a collection of blood that forms between the two outer layers of an artery.
The patient was discharged after 12 days without a neurological deficit. Progressively growing aneurysm of the external carotid artery is caused by various factors and early intervention is recommended. Although, currently, intravascular surgery is commonly indicated, direct surgery is also feasible and has advantages with regard to pathological diagnosis and complete repair of the parent artery.
The relationship between the pseudoaneurysm and the chiropractic manipulations seems unclear. The way I see it, there are the following three possibilities:
- The manipulations have causally contributed to the pseudo-aneurysm.
- They have exacerbated the condition and/or its symptoms.
- They are unrelated to the condition.
If someone is able to read the Japanese full text of this paper, please let us know what the neurosurgeons thought about this.