Kinesiology tape KT is fashionable, it seems. Gullible consumers proudly wear it as decorative ornaments to attract attention and show how very cool they are.
Am I too cynical?
But does KT really do anything more?
A new trial might tell us.
The aim of this study was to investigate whether adding kinesiology tape (KT) to spinal manipulation (SM) can provide any extra effect in athletes with chronic non-specific low back pain (CNLBP).
Forty-two athletes (21males, 21females) with CNLBP were randomized into two groups of SM (n = 21) and SM plus KT (n = 21). Pain intensity, functional disability level and trunk flexor-extensor muscles endurance were assessed by Numerical Rating Scale (NRS), Oswestry pain and disability index (ODI), McQuade test, and unsupported trunk holding test, respectively. The tests were done before and immediately, one day, one week, and one month after the interventions and compared between the two groups.
After treatments, pain intensity and disability level decreased and endurance of trunk flexor-extensor muscles increased significantly in both groups. Repeated measures analysis, however, showed that there was no significant difference between the groups in any of the evaluations.
The authors, physiotherapists from Iran, concluded that the findings of the present study showed that adding KT to SM does not appear to have a significant extra effect on pain, disability and muscle endurance in athletes with CNLBP. However, more studies are needed to examine the therapeutic effects of KT in treating these patients.
Regular readers of my blog will be able to predict what I have to say about this study design: A+B versus B is not a meaningful test of anything. I used to claim that it cannot possibly produce a negative result – and yet, here it seems to have done exactly that!
The way I see it, there are two possibilities to explain this:
- the KT has a mildly negative effect on CNLBP; thus the expected positive placebo-effect was neutralised to result in a null-effect overall;
- the study was under-powered such that the true inter-group difference could not manifest itself.
I think the second possibility is more likely, but it does really not matter at all. Because the only lesson we can learn from this trial is this: inadequate study designs will hardly ever generate anything worthwhile.
And this is, I think, a lesson that would be valuable for many researchers.
Comparing spinal manipulation with and without Kinesio Taping® in the treatment of chronic low back pain.
Can I tempt you to run a little (hopefully instructive) thought-experiment with you? It is quite simple: I will tell you about the design of a clinical trial, and you will tell me what the likely outcome of this study would be.
Are you game?
Here we go:
Imagine we conduct a trial of acupuncture for persistent pain (any type of pain really). We want to find out whether acupuncture is more than a placebo when it comes to pain-control. Of course, we want our trial to look as rigorous as possible. So, we design it as a randomised, sham-controlled, partially-blinded study. To be really ‘cutting edge’, our study will not have two but three parallel groups:
1. Standard needle acupuncture administered according to a protocol recommended by a team of expert acupuncturists.
2. Minimally invasive sham-acupuncture employing shallow needle insertion using short needles at non-acupuncture points. Patients in groups 1 and 2 are blinded, i. e. they are not supposed to know whether they receive the sham or real acupuncture.
3. No treatment at all.
We apply the treatments for a sufficiently long time, say 12 weeks. Before we start, after 6 and 12 weeks, we measure our patients’ pain with a validated method. We use sound statistical methods to compare the outcomes between the three groups.
WHAT DO YOU THINK THE RESULT WOULD BE?
You are not sure?
Well, let me give you some hints:
Group 3 is not going to do very well; not only do they receive no therapy at all, but they are also disappointed to have ended up in this group as they joined the study in the hope to get acupuncture. Therefore, they will (claim to) feel a lot of pain.
Group 2 will be pleased to receive some treatment. However, during the course of the 6 weeks, they will get more and more suspicious. As they were told during the process of obtaining informed consent that the trial entails treating some patients with a sham/placebo, they are bound to ask themselves whether they ended up in this group. They will see the short needles and the shallow needling, and a percentage of patients from this group will doubtlessly suspect that they are getting the sham treatment. The doubters will not show a powerful placebo response. Therefore, the average pain scores in this group will decrease – but only a little.
Group 1 will also be pleased to receive some treatment. As the therapists cannot be blinded, they will do their best to meet the high expectations of their patients. Consequently, they will benefit fully from the placebo effect of the intervention and the pain score of this group will decrease significantly.
So, now we can surely predict the most likely result of this trial without even conducting it. Assuming that acupuncture is a placebo-therapy, as many people do, we now see that group 3 will suffer the most pain. In comparison, groups 1 and 2 will show better outcomes.
Of course, the main question is, how do groups 1 and 2 compare to each other? After all, we designed our sham-controlled trial in order to answer exactly this issue: is acupuncture more than a placebo? As pointed out above, some patients in group 2 would have become suspicious and therefore would not have experienced the full placebo-response. This means that, provided the sample sizes are sufficiently large, there should be a significant difference between these two groups favouring real acupuncture over sham. In other words, our trial will conclude that acupuncture is better than placebo, even if acupuncture is a placebo.
THANK YOU FOR DOING THIS THOUGHT EXPERIMENT WITH ME.
Now I can tell you that it has a very real basis. The leading medical journal, JAMA, just published such a study and, to make matters worse, the trial was even sponsored by one of the most prestigious funding agencies: the NIH.
Here is the abstract:
Musculoskeletal symptoms are the most common adverse effects of aromatase inhibitors and often result in therapy discontinuation. Small studies suggest that acupuncture may decrease aromatase inhibitor-related joint symptoms.
To determine the effect of acupuncture in reducing aromatase inhibitor-related joint pain.
Design, Setting, and Patients:
Randomized clinical trial conducted at 11 academic centers and clinical sites in the United States from March 2012 to February 2017 (final date of follow-up, September 5, 2017). Eligible patients were postmenopausal women with early-stage breast cancer who were taking an aromatase inhibitor and scored at least 3 on the Brief Pain Inventory Worst Pain (BPI-WP) item (score range, 0-10; higher scores indicate greater pain).
Patients were randomized 2:1:1 to the true acupuncture (n = 110), sham acupuncture (n = 59), or waitlist control (n = 57) group. True acupuncture and sham acupuncture protocols consisted of 12 acupuncture sessions over 6 weeks (2 sessions per week), followed by 1 session per week for 6 weeks. The waitlist control group did not receive any intervention. All participants were offered 10 acupuncture sessions to be used between weeks 24 and 52.
Main Outcomes and Measures:
The primary end point was the 6-week BPI-WP score. Mean 6-week BPI-WP scores were compared by study group using linear regression, adjusted for baseline pain and stratification factors (clinically meaningful difference specified as 2 points).
Among 226 randomized patients (mean [SD] age, 60.7 [8.6] years; 88% white; mean [SD] baseline BPI-WP score, 6.6 [1.5]), 206 (91.1%) completed the trial. From baseline to 6 weeks, the mean observed BPI-WP score decreased by 2.05 points (reduced pain) in the true acupuncture group, by 1.07 points in the sham acupuncture group, and by 0.99 points in the waitlist control group. The adjusted difference for true acupuncture vs sham acupuncture was 0.92 points (95% CI, 0.20-1.65; P = .01) and for true acupuncture vs waitlist control was 0.96 points (95% CI, 0.24-1.67; P = .01). Patients in the true acupuncture group experienced more grade 1 bruising compared with patients in the sham acupuncture group (47% vs 25%; P = .01).
Conclusions and Relevance:
Among postmenopausal women with early-stage breast cancer and aromatase inhibitor-related arthralgias, true acupuncture compared with sham acupuncture or with waitlist control resulted in a statistically significant reduction in joint pain at 6 weeks, although the observed improvement was of uncertain clinical importance.
Do you see how easy it is to deceive (almost) everyone with a trial that looks rigorous to (almost) everyone?
My lesson from all this is as follows: whether consciously or unconsciously, SCAM-researchers often build into their trials more or less well-hidden little loopholes that ensure they generate a positive outcome. Thus even a placebo can appear to be effective. They are true masters of producing false-positive findings which later become part of a meta-analysis which is, of course, equally false-positive. It is a great shame, in my view, that even top journals (in the above case JAMA) and prestigious funders (in the above case the NIH) cannot (or want not to?) see behind this type of trickery.
Why do most alternative practitioners show such dogged determination not to change their view of the efficacy of their therapy, even if good evidence shows that it is a placebo? This is the question that I have been pondering for some time. I have seen many doctors change their mind about this or that treatment in the light of new evidence. In fact, I have not seen one who has not done so at some stage. Yet I have never seen an alternative therapist change his/her mind about his/her alternative therapy. Why is that?
You might say that the answers are obvious:
- because they have heavily invested in their therapy, both emotionally and financially;
- because their therapy has ‘stood the test of time’;
- because they believe what they were taught;
- because they are deluded, not very bright, etc.;
- because they need to earn a living.
All of these reasons may apply. But do they really tell the whole story? While contemplating about this question, I thought of something that had previously not been entirely clear to me: they simply KNOW that the evidence MUST be wrong.
Let me try to explain.
Consider an acupuncturist (I could have chosen almost any other type of alternative practitioner) who has many years of experience. He has grown to be a well-respected expert in the world of acupuncture. He sits on various committees and has advised important institutions. He knows the literature and has treated thousands of patients.
This experience has taught him one thing for sure: his patients do benefit from his treatment. He has seen it happening too many times; it cannot be a coincidence. Acupuncture works, no question about it.
And this is also what the studies tell him. Even the most sceptical scientist cannot deny the fact that patients do get better after acupuncture. So, what is the problem?
The problem is that sceptics say that this is due to a placebo effect, and many studies seem to confirm this to be true. Yet, our acupuncturist completely dismisses the placebo explanation.
- Because he has heavily invested in their therapy? Perhaps.
- Because acupuncture has ‘stood the test of time’? Perhaps.
- Because he believes what he has been taught? Perhaps.
- Because he is deluded, not very bright, etc.? Perhaps.
- Because he needs to earn a living? Perhaps.
But there is something else.
He has only ever treated his patients with acupuncture. He has therefore no experience of real medicine, or other therapeutic options. He has no perspective. Therefore, he does not know that patients often get better, even if they receive an ineffective treatment, even if they receive no treatment, and even if they receive a harmful treatment. Every improvement he notes in his patients, he relates to his acupuncture. Our acupuncturist never had the opportunity to learn to doubt cause and effect in his clinical routine. He never had to question the benefits of acupuncture. He never had to select from a pool of therapies the optimal one, because he only ever used acupuncture.
It is this lack of experience that never led him to think critically about acupuncture. He is in a similar situation as physicians were 200 years ago; they only (mainly) had blood-letting, and because some patients improved with it, they had no reason to doubt it. He only ever saw his successes (not that all his patients improved, but those who did not, did not return). He simply KNOWS that acupuncture works, because his own, very limited experience never forced him to consider anything else. And because he KNOWS, the evidence that does not agree with his knowledge MUST be wrong.
I am of course exaggerating and simplifying in order to make a point. And please don’t get me wrong.
I am not saying that doctors cannot be stubborn. And I am not saying that all alternative practitioners have such limited experience and are unable to change their mind in the light of new evidence. However, I am trying to say that many alternative practitioners have a limited perspective and therefore find it impossible to be critical about their own practice.
If I am right, there would be an easy (and entirely alternative) cure to remedy this situation. We should sent our acupuncturist to a homeopath (or any other alternative practitioner whose practice he assumes to be entirely bogus) and ask him to watch what kind of therapeutic success the homeopath is generating. The acupuncturist would soon see that it is very similar to his own. He would then have the choice to agree that highly diluted homeopathic remedies are effective in curing illness, or that the homeopath relies on the same phenomenon as his own practice: placebo.
Sadly, this is not going to happen, is it?
THE CONVERSATION recently carried an article shamelessly promoting osteopathy. It seems to originate from the University of Swansea, UK, and is full of bizarre notions. Here is an excerpt:
To find out more about how osteopathy could potentially affect mental health, at our university health and well-being academy, we have recently conducted one of the first studies on the psychological impact of OMT – with positive results.
For the last five years, therapists at the academy have been using OMT to treat members of the public who suffer from a variety of musculoskeletal disorders which have led to chronic pain. To find out more about the mental health impacts of the treatment, we looked at three points in time – before OMT treatment, after the first week of treatment, and after the second week of treatment – and asked patients how they felt using mental health questionnaires.
This data has shown that OMT is effective for reducing anxiety and psychological distress, as well as improving patient self-care. But it may not be suitable for all mental illnesses associated with chronic pain. For instance, we found that OMT was less effective for depression and fear avoidance.
All is not lost, though. Our results also suggested that the positive psychological effects of OMT could be further optimised by combining it with therapy approaches like acceptance and commitment therapy (ACT). Some research indicates that psychological problems such as anxiety and depression are associated with inflexibility, and lead to experiential avoidance. ACT has a positive effect at reducing experiential avoidance, so may be useful with reducing the fear avoidance and depression (which OMT did not significantly reduce).
Other researchers have also suggested that this combined approach may be useful for some subgroups receiving OMT where they may accept this treatment. And, further backing this idea up, there has already been at least one pilot clinical trial and a feasibility study which have used ACT and OMT with some success.
Looking to build on our positive results, we have now begun to develop our ACT treatment in the academy, to be combined with the osteopathic therapy already on offer. Though there will be a different range of options, one of these ACT therapies is psychoeducational in nature. It does not require an active therapist to work with the patient, and can be delivered through internet instruction videos and homework exercises, for example.
Looking to the future, this kind of low cost, broad healthcare could not only save the health service money if rolled out nationwide but would also mean that patients only have to undergo one treatment.
END OF QUOTE
So, they recruited a few patients who had come to receive osteopathic treatments (a self-selected population full of expectation and in favour of osteopathy), let them fill a few questionnaires and found some positive changes. From that, they conclude that OMT (osteopathic manipulative therapy) is effective. Not only that, they advocate that OMT is rolled out nationwide to save NHS funds.
Vis a vis so much nonsense, I am (almost) speechless!
As this comes not from some commercial enterprise but from a UK university, the nonsense is intolerable, I find.
Do I even need to point out what is wrong with it?
Not really, it’s too obvious.
But, just in case some readers struggle to find the fatal flaws of this ‘study’, let me mention just the most obvious one. There was no control group! That means the observed outcome could be due to many factors that are totally unrelated to OMT – such as placebo-effect, regression towards the mean, natural history of the condition, concomitant treatments, etc. In turn, this also means that the nationwide rolling out of their approach would most likely be a costly mistake.
The general adoption of OMT would of course please osteopaths a lot; it could even reduce anxiety – but only that of the osteopaths and their bank-managers, I am afraid.
Amongst all the implausible treatments to be found under the umbrella of ‘alternative medicine’, Reiki might be one of the worst, i. e. least plausible and outright bizarre (see for instance here, here and here). But this has never stopped enthusiasts from playing scientists and conducting some more pseudo-science.
This new study examined the immediate symptom relief from a single reiki or massage session in a hospitalized population at a rural academic medical centre. It was designed as a retrospective analysis of prospectively collected data on demographic, clinical, process, and quality of life for hospitalized patients receiving massage therapy or reiki. Hospitalized patients requesting or referred to the healing arts team received either a massage or reiki session and completed pre- and post-therapy symptom questionnaires. Differences between pre- and post-sessions in pain, nausea, fatigue, anxiety, depression, and overall well-being were recorded using an 11-point Likert scale.
Patients reported symptom relief with both reiki and massage therapy. Reiki improved fatigue and anxiety more than massage. Pain, nausea, depression, and well being changes were not different between reiki and massage encounters. Immediate symptom relief was similar for cancer and non-cancer patients for both reiki and massage therapy and did not vary based on age, gender, length of session, and baseline symptoms.
The authors concluded that reiki and massage clinically provide similar improvements in pain, nausea, fatigue, anxiety, depression, and overall well-being while reiki improved fatigue and anxiety more than massage therapy in a heterogeneous hospitalized patient population. Controlled trials should be considered to validate the data.
Don’t I just adore this little addendum to the conclusions, “controlled trials should be considered to validate the data” ?
The thing is, there is nothing to validate here!
The outcomes are not due to the specific effects of Reiki or massage; they are almost certainly caused by:
- the extra attention,
- the expectation of patients,
- the verbal or non-verbal suggestions of the therapists,
- the regression towards the mean,
- the natural history of the condition,
- the concomitant therapies administered in parallel,
- the placebo effect,
- social desirability.
Such pseudo-research only can only serve one purpose: to mislead (some of) us into thinking that treatments such as Reiki might work.
What journal would be so utterly devoid of critical analysis to publish such unethical nonsense?
Ahh … it’s our old friend the Journal of Alternative and Complementary Medicine
Say no more!
The media have (rightly) paid much attention to the three Lancet-articles on low back pain (LBP) which were published this week. LBP is such a common condition that its prevalence alone renders it an important subject for us all. One of the three papers covers the treatment and prevention of LBP. Specifically, it lists various therapies according to their effectiveness for both acute and persistent LBP. The authors of the article base their judgements mainly on published guidelines from Denmark, UK and the US; as these guidelines differ, they attempt a synthesis of the three.
Several alternative therapist organisations and individuals have consequently jumped on the LBP bandwagon and seem to feel encouraged by the attention given to the Lancet-papers to promote their treatments. Others have claimed that my often critical verdicts of alternative therapies for LBP are out of line with this evidence and asked ‘who should we believe the international team of experts writing in one of the best medical journals, or Edzard Ernst writing on his blog?’ They are trying to create a division where none exists,
The thing is that I am broadly in agreement with the evidence presented in Lancet-paper! But I also know that things are a bit more complex.
Below, I have copied the non-pharmacological, non-operative treatments listed in the Lancet-paper together with the authors’ verdicts regarding their effectiveness for both acute and persistent LBP. I find no glaring contradictions with what I regard as the best current evidence and with my posts on the subject. But I feel compelled to point out that the Lancet-paper merely lists the effectiveness of several therapeutic options, and that the value of a treatment is not only determined by its effectiveness. Crucial further elements are a therapy’s cost and its risks, the latter of which also determines the most important criterion: the risk/benefit balance. In my version of the Lancet table, I have therefore added these three variables for non-pharmacological and non-surgical options:
|EFFECTIVENESS ACUTE LBP||EFFECTIVENESS PERSISTENT LBP||RISKS||COSTS||RISK/BENEFIT BALANCE|
|Advice to stay active||+, routine||+, routine||None||Low||Positive|
|Education||+, routine||+, routine||None||Low||Positive|
|Superficial heat||+/-||Ie||Very minor||Low to medium||Positive (aLBP)|
|Exercise||Limited||+/-, routine||Very minor||Low||Positive (pLBP)|
|CBT||Limited||+/-, routine||None||Low to medium||Positive (pLBP)|
|Rehab||Ie||+/-||Minor||Medium to high||Questionable|
Routine = consider for routine use
+/- = second line or adjunctive treatment
Ie = insufficient evidence
Limited = limited use in selected patients
vfbmae = very frequent, minor adverse effects
sae = serious adverse effects, including deaths, are on record
aLBP = acute low back pain
The reason why my stance, as expressed on this blog and elsewhere, is often critical about certain alternative therapies is thus obvious and transparent. For none of them (except for massage) is the risk/benefit balance positive. And for spinal manipulation, it even turns out to be negative. It goes almost without saying that responsible advice must be to avoid treatments for which the benefits do not demonstrably outweigh the risks.
I imagine that chiropractors, osteopaths and acupuncturists will strongly disagree with my interpretation of the evidence (they might even feel that their cash-flow is endangered) – and I am looking forward to the discussions around their objections.
The plethora of dodgy meta-analyses in alternative medicine has been the subject of a recent post – so this one is a mere update of a regular lament.
This new meta-analysis was to evaluate evidence for the effectiveness of acupuncture in the treatment of lumbar disc herniation (LDH). (Call me pedantic, but I prefer meta-analyses that evaluate the evidence FOR AND AGAINST a therapy.) Electronic databases were searched to identify RCTs of acupuncture for LDH, and 30 RCTs involving 3503 participants were included; 29 were published in Chinese and one in English, and all trialists were Chinese.
The results showed that acupuncture had a higher total effective rate than lumbar traction, ibuprofen, diclofenac sodium and meloxicam. Acupuncture was also superior to lumbar traction and diclofenac sodium in terms of pain measured with visual analogue scales (VAS). The total effective rate in 5 trials was greater for acupuncture than for mannitol plus dexamethasone and mecobalamin, ibuprofen plus fugui gutong capsule, loxoprofen, mannitol plus dexamethasone and huoxue zhitong decoction, respectively. Two trials showed a superior effect of acupuncture in VAS scores compared with ibuprofen or mannitol plus dexamethasone, respectively.
The authors from the College of Traditional Chinese Medicine, Jinan University, Guangzhou, Guangdong, China, concluded that acupuncture showed a more favourable effect in the treatment of LDH than lumbar traction, ibuprofen, diclofenac sodium, meloxicam, mannitol plus dexamethasone and mecobalamin, fugui gutong capsule plus ibuprofen, mannitol plus dexamethasone, loxoprofen and huoxue zhitong decoction. However, further rigorously designed, large-scale RCTs are needed to confirm these findings.
Why do I call this meta-analysis ‘dodgy’? I have several reasons, 10 to be exact:
- There is no plausible mechanism by which acupuncture might cure LDH.
- The types of acupuncture used in these trials was far from uniform and included manual acupuncture (MA) in 13 studies, electro-acupuncture (EA) in 10 studies, and warm needle acupuncture (WNA) in 7 studies. Arguably, these are different interventions that cannot be lumped together.
- The trials were mostly of very poor quality, as depicted in the table above. For instance, 18 studies failed to mention the methods used for randomisation. I have previously shown that some Chinese studies use the terms ‘randomisation’ and ‘RCT’ even in the absence of a control group.
- None of the trials made any attempt to control for placebo effects.
- None of the trials were conducted against sham acupuncture.
- Only 10 studies 10 trials reported dropouts or withdrawals.
- Only two trials reported adverse reactions.
- None of these shortcomings were critically discussed in the paper.
- Despite their affiliation, the authors state that they have no conflicts of interest.
- All trials were conducted in China, and, on this blog, we have discussed repeatedly that acupuncture trials from China never report negative results.
And why do I find the journal ‘dodgy’?
Because any journal that publishes such a paper is likely to be sub-standard. In the case of ‘Acupuncture in Medicine’, the official journal of the British Medical Acupuncture Society, I see such appalling articles published far too frequently to believe that the present paper is just a regrettable, one-off mistake. What makes this issue particularly embarrassing is, of course, the fact that the journal belongs to the BMJ group.
… but we never really thought that science publishing was about anything other than money, did we?
The pro arguments essentially are the well-rehearsed points acupuncture-fans like to advance:
- Some guidelines do recommend acupuncture.
- Sham acupuncture is not a valid comparator.
- The largest meta-analysis shows a small effect.
- Acupuncture is not implausible.
- It improves quality of life.
Cummings concludes as follows: In summary, the pragmatic view sees acupuncture as a relatively safe and moderately effective intervention for a wide range of common chronic pain conditions. It has a plausible set of neurophysiological mechanisms supported by basic science.12 For those patients who choose it and who respond well, it considerably improves health related quality of life, and it has much lower long term risk for them than non-steroidal anti-inflammatory drugs. It may be especially useful for chronic musculoskeletal pain and osteoarthritis in elderly patients, who are at particularly high risk from adverse drug reactions.
Our arguments are also not new; essentially, we stress that:
- The effects of acupuncture are too small to be clinically relevant.
- They are probably not even caused by acupuncture, but the result of residual bias.
- Pragmatic trials are of little value in defining efficacy.
- Acupuncture is not free of risks.
- Regular acupuncture treatments are expensive.
- There is no generally accepted, plausible mechanism.
We concluded that after decades of research and hundreds of acupuncture pain trials, including thousands of patients, we still have no clear mechanism of action, insufficient evidence for clinically worthwhile benefit, and possible harms. Therefore, doctors should not recommend acupuncture for pain.
Neither Asbjorn nor I have any conflicts of interests to declare.
Dr Cummings, by contrast, states that he is the salaried medical director of the British Medical Acupuncture Society, which is a membership organisation and charity established to stimulate and promote the use and scientific understanding of acupuncture as part of the practice of medicine for the public benefit. He is an associate editor for Acupuncture in Medicine, published by BMJ. He has a modest private income from lecturing outside the UK, royalties from textbooks, and a partnership teaching veterinary surgeons in Western veterinary acupuncture. He has participated in a NICE guideline development group as an expert adviser discussing acupuncture. He has used Western medical acupuncture in clinical practice following a chance observation as a medical officer in the Royal Air Force in 1989.
My question to you is this: WHICH OF THE TWO POSITION IS THE MORE REASONABLE ONE?
Please, do let us know by posting a comment here, or directly at the BMJ article (better), or both (best).
Lock 10 bright people into a room and tell them they will not be let out until they come up with the silliest idea in healthcare. It is not unlikely, I think, that they might come up with the concept of visceral osteopathy.
In case you wonder what visceral osteopathy (or visceral manipulation) is, one ‘expert’ explains it neatly: Visceral Osteopathy is an expansion of the general principles of osteopathy which includes a special understanding of the organs, blood vessels and nerves of the body (the viscera). Visceral Osteopathy relieves imbalances and restrictions in the interconnections between the motions of all the organs and structures of the body. Jean-Piere Barral RPT, DO built on the principles of Andrew Taylor Still DO and William Garner Sutherland DO, to create this method of detailed assessment and highly specific manipulation. Those who wish to practice Visceral Osteopathy train intensively through a series of post-graduate studies. The ability to address the specific visceral causes of somatic dysfunction allows the practitioner to address such conditions as gastroesophageal reflux disease (GERD), irritable bowel (IBS), and even infertility caused by mechanical restriction.
But, as I have pointed out many times before, the fact that a treatment is based on erroneous assumptions does not necessarily mean that it does not work. What we need to decide is evidence. And here we are lucky; a recent paper provides just that.
The purpose of this systematic review was to identify and critically appraise the scientific literature concerning the reliability of diagnosis and the clinical efficacy of techniques used in visceral osteopathy.
Only inter-rater reliability studies including at least two raters or the intra-rater reliability studies including at least two assessments by the same rater were included. For efficacy studies, only randomized-controlled-trials (RCT) or crossover studies on unhealthy subjects (any condition, duration and outcome) were included. Risk of bias was determined using a modified version of the quality appraisal tool for studies of diagnostic reliability (QAREL) in reliability studies. For the efficacy studies, the Cochrane risk of bias tool was used to assess their methodological design. Two authors performed data extraction and analysis.
Extensive searches located 8 reliability studies and 6 efficacy trials that could be included in this review. The analysis of reliability studies showed that the diagnostic techniques used in visceral osteopathy are unreliable. Regarding efficacy studies, the least biased study showed no significant difference for the main outcome. The main risks of bias found in the included studies were due to the absence of blinding of the examiners, an unsuitable statistical method or an absence of primary study outcome.
The authors (who by the way declared no conflicts of interest) concluded that the results of the systematic review lead us to conclude that well-conducted and sound evidence on the reliability and the efficacy of techniques in visceral osteopathy is absent.
It is hard not to appreciate the scientific rigor of this review or to agree with the conclusions drawn by the French authors.
But what consequences should we draw from all this?
The authors of this paper state that more and better research is needed. Somehow, I doubt this. Visceral osteopathy is not plausible and the best evidence available to date does not show it works. In my view, this means that we should declare it an obsolete aberration of medical history.
To this, the proponents of visceral osteopathy will probably say that they have tons of experience and have witnessed wonderful cures etc. This I do not doubt; however, the things they saw were not due to the effects of visceral osteopathy, they were due to chance, placebo, regression towards the mean, the natural history of the diseases treated etc., etc. And sometimes, experience is nothing more that the ability to repeat a mistake over and over again.
- If it looks like a placebo,
- if it behaves like a placebo,
- if it tests like a placebo,
IT MOST LIKELY IS A PLACEBO!!!
And what is wrong with a placebo, if it helps patients?
GIVE ME A BREAK!
WE HAVE ALREADY DISCUSSED THIS AD NAUSEAM. JUST READ SOME OF THE PREVIOUS POSTS ON THIS SUBJECT.
Some doctors use homeopathy, and for proponents of homeopathy this has always been a strong argument for its effectiveness. They claim that someone who has studied medicine would not employ a therapy that does not work. I have long felt that this view is erroneous.
This article goes some way in finding out who is right. It was aimed at describing the use of homeopathy by physicians working in outpatient care, factors associated with prescribing homeopathy, and the therapeutic intentions and attitudes involved.
All physicians working in outpatient care in the Swiss Canton of Zurich in the year 2015 (n = 4072) were approached. Outcomes of the survey were:
- association of prescribing homeopathy with medical specialties;
- intentions behind prescriptions;
- level of agreement with specific attitudes;
- views towards homeopathy including explanatory models,
- rating of homeopathy’s evidence base,
- the endorsement of indications,
- reimbursement of homeopathic treatment by statutory health insurance providers.
The participation rate was 38%, mean age 54 years, 61% male, and 40% specialised in general internal medicine. Homeopathy was prescribed at least once a year by 23% of the respondents. Medical specialisations associated with prescribing homeopathy were: no medical specialisation (OR 3.9; 95% CI 1.7-9.0), specialisation in paediatrics (OR 3.8 95% CI 1.8-8.0) and gynaecology/obstetrics (OR 3.1 95% CI 1.5-6.7).
Among prescribers, only 50% clearly intended to induce specific homeopathic effects, only 27% strongly adhered to homeopathic prescription doctrines, and only 23% thought there was scientific evidence to prove homeopathy’s effectiveness. Seeing homeopathy as a way to induce placebo effects had the strongest endorsement among prescribers and non-prescribers of homeopathy (63% and 74% endorsement respectively). Reimbursement of homeopathic remedies by statutory health insurance was rejected by 61% of all respondents
The authors concluded that medical specialties use homeopathy with significantly varying frequency and only half of the prescribers clearly intend to achieve specific effects. Moreover, the majority of prescribers acknowledge that effectiveness is unproven and give little importance to traditional principles behind homeopathy. Medical specialties and associated patient demands but also physicians’ openness towards placebo interventions may play a role in homeopathy prescriptions. Education should therefore address not only the evidence base of homeopathy, but also ethical dilemmas with placebo interventions.
These data suggest than many doctors use homeopathy as a placebo. And this is what I had always suspected. Certainly I did often employ it in this way when I still worked as a clinician. The logic of doing so is quite simple: there are many patients where, after running all necessary tests, you conclude that there is nothing wrong with them. You try your best to get the message across but it is not accepted by the patient who clearly wants to have a prescription for something. In the end, due to time pressure etc., you give up and prescribe a homeopathic remedy hoping that the placebo effect, regression towards the mean and the natural history of the condition will do the trick.
And often they do!
I do know that this is hardly good medicine and arguably even not entirely ethical, but it is the reality. If I found myself in the same situation again, I am not sure that I would not do something similar.