MD, PhD, FMedSci, FSB, FRCP, FRCPEd

pain

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This study tested chondroitin sulfate 800 mg/day (CS) pharmaceutical-grade in the management of symptomatic knee osteoarthritis. It was designed as a prospective, randomised, 6-month, 3-arm, double-blind, double-dummy, placebo and celecoxib (200 mg/day)-controlled trial.  The primary endpoints were changes in pain on a Visual Analogue Scale (VAS) and in the Lequesne Index (LI). Minimal-Clinically Important Improvement (MCII), Patient-Acceptable Symptoms State (PASS) were used as secondary endpoints.

A total of 604 patients, diagnosed according to American College of Rheumalogy (ACR) criteria, were recruited in five European countries and followed for 182 days. CS and celecoxib showed a greater significant reduction in pain and LI than placebo. In the intention-to-treat (ITT) population, pain reduction in VAS at day 182 in the CS group (−42.6 mm) and in celecoxib group (−39.5 mm) was significantly greater than the placebo group (−33.3 mm) (p=0.001 for CS and p=0.009 for celecoxib). No difference observed between CS and celecoxib. Similar trend for the LI, as reduction in this metric in the CS group (−4.7) and celecoxib group (−4.6) was significantly greater than the placebo group (−3.7) (p=0.023 for CS and p=0.015 for celecoxib). Again, no difference was observed between CS and celecoxib. Both secondary endpoints (MCII and PASS) at day 182 improved significantly in the CS and celecoxib groups. All treatments demonstrated excellent safety profiles.
The authors concluded that a 800 mg/day pharmaceutical-grade CS is superior to placebo and similar to celecoxib in reducing pain and improving function over 6 months in symptomatic knee osteoarthritis (OA) patients. This formulation of CS should be considered a first-line treatment in the medical management of knee OA.

In my view, this is a good study with clear and useful results: CS seems to be efficacious and safe. Another recent study confirmed the superiority of CS over celecoxib at reducing cartilage volume loss in knee OA patients.

The current Cochrane review does not yet account for the new data; it concluded cautiously positive: A review of randomized trials of mostly low quality reveals that chondroitin (alone or in combination with glucosamine) was better than placebo in improving pain in participants with osteoarthritis in short-term studies. The benefit was small to moderate with an 8 point greater improvement in pain (range 0 to 100) and a 2 point greater improvement in Lequesne’s index (range 0 to 24), both seeming clinically meaningful. These differences persisted in some sensitivity analyses and not others. Chondroitin had a lower risk of serious adverse events compared with control. More high-quality studies are needed to explore the role of chondroitin in the treatment of osteoarthritis. The combination of some efficacy and low risk associated with chondroitin may explain its popularity among patients as an over-the-counter supplement.

The call for more high quality trials was justified but has now been answered. In my view, CS can be considered an evidence-based option in the management of OA.

A recent post discussed a ‘STATE OF THE ART REVIEW’ from the BMJ. When I wrote it, I did not know that there was more to come. It seems that the BMJ is planning an entire series on the state of the art of BS! The new paper certainly looks like it:

Headaches, including primary headaches such as migraine and tension-type headache, are a common clinical problem. Complementary and integrative medicine (CIM), formerly known as complementary and alternative medicine (CAM), uses evidence informed modalities to assist in the health and healing of patients. CIM commonly includes the use of nutrition, movement practices, manual therapy, traditional Chinese medicine, and mind-body strategies. This review summarizes the literature on the use of CIM for primary headache and is based on five meta-analyses, seven systematic reviews, and 34 randomized controlled trials (RCTs). The overall quality of the evidence for CIM in headache management is generally low and occasionally moderate. Available evidence suggests that traditional Chinese medicine including acupuncture, massage, yoga, biofeedback, and meditation have a positive effect on migraine and tension headaches. Spinal manipulation, chiropractic care, some supplements and botanicals, diet alteration, and hydrotherapy may also be beneficial in migraine headache. CIM has not been studied or it is not effective for cluster headache. Further research is needed to determine the most effective role for CIM in patients with headache.

My BS-detector struggled with the following statements:

  • integrative medicine (CIM), formerly known as complementary and alternative medicine (CAM) – the fact that CIM is a nonsensical new term has been already mentioned in the previous post;
  • evidence informed modalities – another new term! evidence-BASED would be too much? because it would require using standards that do not apply to CIM? double standards promoted by the BMJ, what next?
  • CIM commonly includes the use of nutrition – yes, so does any healthcare or indeed life!
  • the overall quality of the evidence for CIM in headache management is generally low and occasionally moderate – in this case, no conclusions should be drawn from it (see below);
  • evidence suggests that traditional Chinese medicine including acupuncture, massage, yoga, biofeedback, and meditation have a positive effect on migraine and tension headaches – no, it doesn’t (see above)!
  • further research is needed to determine the most effective role for CIM in patients with headache – this sentence does not even make the slightest sense to me; have the reviewers of this article been asleep?

And this is just the abstract!

The full text provides enough BS to fertilise many acres of farmland!

Moreover, the article is badly researched, cherry-picked, poorly constructed, devoid of critical input, and poorly written. Is there anything good about it? You tell me – I did not find much!

My BS-detector finally broke when we came to the conclusions:

The use of CIM therapies has the potential to empower patients and help them take an active role in their care. Many CIM modalities, including mind-body therapies, are both self selected and self administered after an education period. This, coupled with patients’ increased desire to incorporate integrative medicine, should prompt healthcare providers to consider and discuss its inclusion in the overall management strategy. Low to moderate quality evidence exists for the effectiveness of some CIM therapies in the management of primary headache. The evidence for and use of CIM is continuously changing so healthcare professionals should direct their patients to reliable and updated resources, such as NCCIH.

WHAT IS HAPPENING TO THE BMJ?

IT USED TO BE A GOOD JOURNAL!

The new guidelines by the American College of Physicians entitled ‘Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians’ have already been the subject of the previous post. Today, I want to have a closer look at a small section of these guidelines which, I think, is crucial. It is entitled ‘HARMS OF NONPHARMACOLOGIC THERAPIES’. I have taken the liberty of copying it below:

“Evidence on adverse events from the included RCTs and systematic reviews was limited, and the quality of evidence for all available harms data is low. Harms were poorly reported (if they were reported at all) for most of the interventions.

Low-quality evidence showed no reported harms or serious adverse events associated with tai chi, psychological interventions, multidisciplinary rehabilitation, ultrasound, acupuncture, lumbar support, or traction (9,95,150,170–174). Low-quality evidence showed that when harms were reported for exercise, they were often related to muscle soreness and increased pain, and no serious harms were reported. All reported harms associated with yoga were mild to moderate (119). Low-quality evidence showed that none of the RCTs reported any serious adverse events with massage, although 2 RCTs reported soreness during or after massage therapy (175,176). Adverse events associated with spinal manipulation included muscle soreness or transient increases in pain (134). There were few adverse events reported and no clear differences between MCE and controls. Transcutaneous electrical nerve stimulation was associated with an increased risk for skin site reaction but not serious adverse events (177). Two RCTs (178,179) showed an increased risk for skin flushing with heat compared with no heat or placebo, and no serious adverse events were reported. There were no data on cold therapy. Evidence was insufficient to determine harms of electrical muscle stimulation, LLLT, percutaneous electrical nerve stimulation, interferential therapy, short-wave diathermy, and taping.”

The first thing that strikes me is the brevity of the section. Surely, guidelines of this nature must include a full discussion of the risks of the treatments in question!

The second thing that is noteworthy is the fact that the authors confirm the fact I have been banging on about for years: clinical trials of alternative therapies far too often fail to mention adverse effects.  I have often pointed out that the failure to report adverse effects in clinical trials is an unacceptable violation of medical ethics. By contrast, the guideline authors seem not to feel strongly about this omission.

The third thing that is noteworthy is that the guidelines evaluate the harms of the treatments purely on the basis of the adverse effects reported in the clinical trials and systematic reviews included in their efficacy assessments. This is nonsensical for at least two reasons:

  1. The guideline authors themselves are aware that the trials very often fail to mention adverse effects.
  2. For any assessment of harm, one has to go far beyond the evidence of clinical trials, because trials tend to be too small to pick up rare adverse effects, and because they are always conducted under optimally controlled conditions where adverse effects are less likely to occur than in real life.

Together, these features of the assessment of harms explain why the guideline authors arrive at conclusions which are oddly misguided; I would even feel that they resemble a white-wash. Here are two of the most overt misjudgements:

  • no harms associated with acupuncture,
  • only trivial harm associated with spinal manipulations.

The best evidence we have today shows that acupuncture leads to mild adverse effects in about 10% of all cases and is also associated with very severe complications (e.g. pneumothorax, cardiac tamponade, infections, deaths) in an unknown number of patients. More details can be found for instance here, here, here and here.

And the best evidence available shows that spinal manipulation leads to moderately severe adverse effects in ~50% of all cases. In addition, we know of hundreds of cases of very severe complications resulting in stroke, permanent neurological deficits or deaths. More details can be found for instance here, here, here and here.

In the introduction, I stated that this small section of the guidelines is crucial.

Why?

The reason is simple: any responsible therapeutic decision has to be based not just on the efficacy of the treatment in question but on its risk/benefit balance. The evidence shows that the risks of some alternative therapies can be considerable, a fact that is almost totally neglected in the guidelines. Therefore, the recommendations of the new guidelines by the American College of Physicians entitled ‘Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians’ are in several aspects not entirely correct and need to be reconsidered.

Concerned about the new ACP guidelines on ‘Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians’, Andrea MacGregor asked me to publish her ‘open letter’:

I am a student about to graduate and register as a massage therapist in Canada, and I am writing to express my concern with your recommendation of the use of acupuncture in your new guideline for low-back pain management.

Leading medical and health research experts from around the world, including many who are highly familiar with the use of complementary and alternative therapies, have contributed to a highly informed commentary (attached) assembled by the Friends of Science in Medicine association (Aus.), which supports a strong conclusion that acupuncture is not effective for any specific condition, and that the evidence for it being an effective intervention for low-back pain is not convincing. Another review of acupuncture by FSM concluding that there is a lack of evidence of a therapeutic effect has been endorsed by the Royal Australian and New Zealand College of Obstetricians and Gynaecologists. Respected American medical science writers also maintain that claims of acupuncture’s efficacy are not science-based (examples here and here).

Additionally, previous acupuncture recommendations are being reconsidered by prominent institutions in other parts of the world. The National Institute for Health and Care Excellence guideline for NHS patients in the United Kingdom now recommends against the use of acupuncture for low-back pain, following a high-quality review that critically examined the existing evidence regarding the use of acupuncture and found it to be no more effective than a placebo. The Toronto Hospital for Sick Children has also recently removed references on their website that suggested the efficacy of acupuncture in managing specific chronic pain conditions. The World Health Organization has done the same, no longer suggesting that acupuncture is effective for low-back pain and sciatica.

As someone about to enter a field that is frequently associated with, or considered a part of, complementary healthcare, I know how tempting it can be for us, as professionals and as researchers, to exaggerate claims of efficacy and pin some very high hopes on “new possibilities” in physical therapies.

I also know first-hand how misguided and overblown some of these claims and hopes can be. Many of my own peers and instructors are proponents of acupuncture, and it is common for Canadian massage therapists to become licensed acupuncturists (a similar connection between massage and acupuncture communities, of course, also exists in the United States). I have often seen my own mentors and comrades pushing for the use of acupuncture treatments for many chronic and serious conditions for which there is no basis of evidence at all of acupuncture’s efficacy, including systemic, neurological, and developmental conditions. When questioned, they will usually refer to authorities perceived as “legitimate”, including the American College of Physicians, to say that claims of acupuncture “working” are backed by experts— whether their claims are even pain-related or not.

We see a similar situation with advertisers and media using the guise of “expert-backed” legitimization to recommend acupuncture in misleading ways, often to vulnerable people who could be making better-informed and more effective treatment and management choices for their conditions. Many of these advertising and media entities specifically mention the American College of Physicians as lending credence to their claims, sometimes somewhat out of context.

As someone with a chronic neurological disorder, I find it troubling to see untrue or exaggerated claims of benefit for incurable or serious conditions when we could be focusing on more accurate ideas and having more honest, realistic discussions of our options. This is also important when it comes to deciding how to best allocate our limited health funding resources. Quite a lot of our insurance and out-of-pocket funds are spent on alternative therapies, and it’s important to see things going to use in a way that’s proportionate and appropriate to the evidence we have.

I hope that you will reconsider your recommendation of a practice that is simply not supported by the majority of the research evidence that exists to date. Patients with complex conditions, including low-back pain, deserve accurate and realistic information regarding their treatment options, especially from such trusted and reputable sources as the American College of Physicians. Thank you for your time and attention.

Sincerely,

Andrea MacGregor

Below are informed conclusions on acupuncture from 28 international experts from 10 countries, including Australia, Canada, Denmark, France, Greece, Italy, Netherlands, New Zealand, United Kingdom and United States of America.

These include:

– Sir Richard John Roberts, English biochemist and molecular biologist, 1993 Nobel Prize in Physiology or Medicine  – Prof Nikolai Bogduk AM, Emeritus Professor of Pain Medicine, University of Newcastle, Australia – Prof Timothy Caulfield,  LLM, FRSC, FCAHS, Canada Research Chair in Health Law & Policy, Trudeau Fellow & Professor, Faculty of Law and School of Public Health, Research Director, Health Law Institute, University of Alberta, Canada – Prof. Assimakis Kanellopoulos, PhD MSc.Prof. Applied Physiotherapy, TEI Lamia, Greece – Prof Lesley Campbell AM, MBBS, FRACP FRCP(UK), Senior Endocrinologist, Diabetes Services, St Vincent’s Hospital, Professor of Medicine, UNSW. Laboratory Co-Head, Clinical Diabetes, Appetite and Metabolism, Garvan Institute of Medical Research, SVH, NSW, Australia – Emeritus Prof Donald M. Marcus, MD, Professor of Medicine and Immunology, Emeritus, Baylor College of Medicine, Houston, United States of America (USA) – Dr Michael Vagg, MBBS(Hons) FAFRM(RACP) FFPMANZCA, Consultant in Rehabilitation and Pain Medicine, Barwon Health. Clinical Senior Lecturer, Deakin University School of Medicine. Fellow, Institute for Science in Medicine, Victoria, Australia – Prof Bernie Garrett, The University of British Columbia, School of Nursing, Vancouver, BC, Canada – A/Prof David H Gorski, MD PhD FACS, surgical oncologist, Barbara Ann Karmanos Cancer Institute, Team Leader, Breast Cancer Multidisciplinary Team, Co-Leader, Breast Cancer Biology Program, Co-Director, Alexander J Walt Comprehensive Breast Center, Chief, Section of Breast Surgery, A/Professor, Surgery, Wayne State University School of Medicine, , and Professor (Honorary) Hanoi Medical University, USA – Prof Carl Bartecchi, MD, MACP, Distinguished Professor of Clinical Medicine, University of Colorado School of Medicine, USA – Prof David Colquhoun, FRS, Dept of Pharmacology, UCL United Kingdom (UK) – Prof Edzard Ernst, MD PhD FMEdSci FSB FRCP FRCP(Edin), Complementary Medicine, Peninsula Medical School, UK – Prof Marcello Costa FAAS. Matthew Flinders Distinguished Professor and Professor of Neurophysiology (2012), Professor of Neurophysiology, Flinders University, Australia. – Emeritus Prof Alastair H MacLennan AO MB CHb MD FRCOG FRANZCOG. The Robinson Research Institute, The University of Adelaide, Australia – Prof John M Dwyer AO PhD FRACP FRCPI Doc Uni(Hon) ACU. Emeritus Professor of Medicine, University of New South Wales. Founder of the Australian Health Care Reform Alliance. Clinical consultant to the NSW Government’s Inter-Agency committee on Health Care Fraud, Australia – A/Prof Steven M Novella, clinical neurologist Yale University School of Medicine, Connecticut,  USA – Prof William M London, EdD, MPH, Department of Public Health, California State University, Los Angeles, USA – Dr Steven Barrett, MD, retired psychiatrist, author, co-founder of the National Council Against Health Fraud (NCAHF), USA – Prof. Steven L. Salzberg, Ph.D., Bloomberg Distinguished Professor of Biomedical Engineering, Computer Science, and Biostatistics, Johns Hopkins University School of Medicine, USA – Prof Christopher C French, Head of the Anomalistic Psychology Research Unit, Department of Psychology, Goldsmiths, University of London, UK – Dr Cees Renckens MD PhD, gynaecologist, past president of the Dutch Society against Quackery, Netherlands  – Dr Alain Braillon. MD PhD. Senior consultant. University hospital, France – Dr John McLennan, MBBS FRACP, Paediatrician, Vic – Prof Shaun Holt, BPharm(hons), MBChB(hons), Medical Researcher, Victoria University of Wellington, New Zealand – Dr Lloyd B Oppel, MD, MHSc, Canada – Professor Asbjørn Hróbjartsson, Centre for Evidence-Based Medicine, University of Southern Denmark & Odense University Hospital, Denmark – Prof Maurizio Pandolfi MD, Florence, former Professor of Clinical Ophthalmology, The University of Lund, Sweden, Italy – Professor Mark Baker, Centre for Clinical Practice Director, National Institute for Health and Care Excellence (NICE), UK

According to Sir Richard: “From everything I have read about acupuncture I have to conclude that the evidence for efficacy is just not there.  I can believe it has a very strong and effective placebo effect, but if it really worked as advertised why are the numbers of successful outcomes so small when compared to treatments such as drugs that really do work. As a scientist, who likes to see proper experiments carried out so that the results can be judged with a rational analysis, the experiments I have read about just don’t meet even a low bar of acceptability. I certainly do not believe it should be endorsed as an effective treatment by any professional scientific or medical body that values its reputation.”

According to Professor Bogduk: “Although studies have shown that acupuncture “works”, the definition of “works” is generous. Most studies show minimal to no effect greater than that of sham therapy. Needles do not need to be placed at specific points; so, learning about meridians is not required. Effectiveness is marginally greater in those patients who believe in acupuncture or expect it to work. However, no studies have shown that acupuncture stops pain, while also restoring normal function and removing the need for other health care.”

According to Professor Caulfield: “In popular culture, acupuncture is often portrayed as being effective for a range of conditions. It is held up as an alternative medicine success story. In fact, the relevant data are, at best, equivocal. The most rigorous studies, such as those that are well controlled and use sham comparators, have found that in most situations acupuncture is little better than placebo.  More importantly, the supernatural foundations of the practice – that illness can be attributed to an imbalance in a life force energy – has absolutely no scientific basis. Given this reality, public representations of acupuncture that present it as science-based and effective can be deeply misleading.  Policies are needed to counter this noise, including, inter alia, the more aggressive deployment of truth-in-advertising regulations, the enforcement of a conceptually consistent science-based informed consent standard, and the oversight of healthcare professionals by the relevant regulatory entities.”

According to Professor Kanellopoulos: “According to the systematic reviews in the field of acupuncture, the benefits of the method, if any, are nothing more than a temporary placebo effect. From a scientific point of view, acupuncture is based on a theory, which has nothing to do with modern physiology and medicine. From a researcher’s point of view, any presented acupuncture effectiveness is due to methodological errors, data manipulation, statistical artefacts and (purposely?) poorly designed clinical trials in general. Finally, regarding the patient, any symptom’s relief comes from despair and post hoc fallacy. After decades of research and over 3000 clinical trials, any continuation of practicing, advertising, and research in the field of acupuncture is a waste of resources and puts the patients at risk, raising ethical issues for both science and society.”

According to Professor Campbell: “Acupuncture holds great theatrical appeal through its dramatic and historical aspects, particularly to those who feel that conventional medicine has failed to offer pain relief or sufficient improvement in symptoms. However an extensive body of data now exists from rigorous approaches to testing the validity of its claims of benefit actually related to the placement of the needles and not to placebo effect. For example, most recently the beneficial effect achieved in relieving fatigue in Parkinsons Disease (and there was one) was identical in a randomised controlled trial to that of placebo.”

According to Professor Donald M. Marcus: “When trials of acupuncture for relief of pain of osteoarthritis of the knee or back pain include a sham acupuncture control, there is no clinically relevant difference in efficacy between the conventional and sham procedures. A number of sham procedures have been used, including toothpicks in a plastic guide tube in a study of back pain. It’s evident that relief of pain, and probably other complaints, by acupuncture is mediated by a placebo mechanism. Since there is no scientific evidence supporting its efficacy, medical insurance should not pay for acupuncture treatments. Moreover, it is unethical to deceive patients by providing a placebo treatment without disclosure.”

According to pain specialist Dr Vagg: “Due to the lack of a scientifically plausible mechanism, and the poor quality of the bulk of the research concerning acupuncture in its many and varied forms, no credible body of pain medicine researchers or clinicians has endorsed any type of acupuncture as a recommended treatment for any identifiable group of patients with persistent pain. Moreover, there is no reason to suppose that further research of high quality will change this conclusion, given that high-quality, randomized and double-blinded studies have uniformly shown that any form of acupuncture is indistinguishable from placebo, making further research unwarranted.”

According to Professor Garrett: “Current levels of evidence on acupuncture as a therapeutic intervention for any condition is very poor. Most studies reported  are of very poor quality and are not reliable. Unfortunately, there is a strong element of propaganda in the dissemination of support for acupuncture in China, as it is a part of the Traditional Chinese Medicine supported by the government there. As such, much research has been demonstrated to involve data fabrication and extreme levels of confirmation bias. There are also strong ethical concerns about research involving acupuncture in China for anesthesia or other conditions where there is no established clinical theoretical basis for its use, and far better established therapeutics are available. Overall the current state of evidence on acupuncture is that the effectiveness of acupuncture as a treatment of any health condition remains unproven, and the only good quality trials have identified it has no better outcomes than placebo. Therefore, any claims of efficacy made against specific medical conditions are deceptive.”

According to Professor Gorski: “Acupuncture seems to garner more belief because it seems more plausible. The reason is that, unlike many other alternative therapies, acupuncture actually involves a physical act, namely inserting needles into the skin. However, it is also the case that the more acupuncture has been studied, the more it has become clear that it is, as David Colquhoun and Steve Novella put it, nothing more than a theatrical placebo. Indeed, as acupuncture is more rigorously studied in randomized clinical trials with proper controls and proper blinding, the more its seeming effects disappear, so that it becomes indistinguishable from placebo. Nor is it without risk, either. Recommending acupuncture to treat any condition is, from an ethical and scientific view, indefensible.”

According to Professor Bartecchi: “Acupuncture has no medical value other than that of a placebo. Acupuncture as viewed by many of us in academic medicine is merely an elaborate, theatrical placebo, a pre-scientific superstition which lacks a plausible mechanism. It really fits the bill as an alternative medicine hoax.”

According to Professor Colquhoun: “After over 3000 trials, some of them very well designed, there is still argument about the effectiveness of acupuncture.  If that were the case for a new drug, it would long since have been abandoned. The literature suggests that acupuncture has only a small and variable placebo effect: too small to be of noticeable benefit to patients. Most of its apparent effects result from a statistical artefact, regression to the mean. The continued use of acupuncture probably arises from the lack of effective treatments for conditions like non-specific low back pain. That cannot be justified, Neither is it worth spending yet more money on further research. The research has been done and it failed to produce convincing evidence.”

According to Professor Ernst: “The current evidence on acupuncture is mixed. Many trials are less than rigorous and thus not reliable. Much of the research comes from China where data fabrication has been disclosed to be at epidemic levels; it would therefore be a mistake to rely on studies from China which almost invariably report positive results.  If we account for such caveats and critically review the literature, we arrive at the following conclusions: – Acupuncture is clearly not free of risks, some of which are serious;  – The effectiveness of acupuncture as a treatment of any condition remains unproven, and – The current research in this area is mostly pseudo-research aimed at promoting rather than testing acupuncture”.

According to Professor Costa: “Acupuncture as a part of Traditional Chinese Medicine is not based on science simply because, as for all pre-scientific medicines, whether Greco-Roman-European, Indian or any other, none are founded on any evidence. As a Neuroscientist, I teach medical and non medical students the very foundations of how the nervous system works and how sensory stimulation affects the brain. There simply is no evidence that twigging the skin with needles or, for that matter with toothpicks, does any more than create an expectation to feel better. This is the well-known placebo effect. Selling placebos under the disguise of medicine is totally unethical.”

According to Professor MacLennan: “Acupuncture is elaborate quackery and like many placebos sold by those without responsibility for or knowledge of the wide range of health disorders and disease it can be dangerous. Dangerous because acupuncture may delay correct diagnosis and therapy, dangerous because it may delay possible evidence-based therapies and allow progression of disorders present and dangerous because it sucks limited health resources from the community.   Acupuncturists derive their income from elaborate subterfuge, taking advantage of the gullible unwell who are desperate, uneducated and seek a magic cure. If there is a placebo effect it is usually temporary, and eventually disappointment from lack of long term effect may lead to secondary depression in the patient.    According to Professor Dwyer: “Modern understanding of human anatomy and the distribution and function of the components of the human nervous system make a nonsense of theories that suggest there are invisible meridians criss-crossing the body wherein there are trigger spots which, when stimulated, can produce an array of benefits remote from that site. Scientists however, while dismissing the prescientific explanations offered by traditional Chinese medicine, have sought other reasons why acupuncture might provide clinical benefits particularly the relief of pain. Numerous theories have been addressed by numerous studies with many being conducted using disciplined scientific methods. The conclusions leave us with no doubt that acupuncture provides the scenario for a superb theatrical placebo; no more.”

According to Dr Novella:  “Pain is a big problem. If you read about pain management centers, you might think it had been solved. It has not. And when no effective treatment exists for a medical problem, it leads to a tendency to clutch at straws. Research has shown that acupuncture is little more than such a straw. It is clear from meta-analyses that results of acupuncture trials are variable and inconsistent, even for single conditions. After thousands of trials of acupuncture and hundreds of systematic reviews, arguments continue unabated. In 2011, Pain published an editorial that summed up the present situation well.”

According to Professor London & Dr Barrett: “The optimistic article by Vickers et al did not consider an important point. Research studies may not reflect what takes place in most acupuncturist offices. Most acupuncturists are graduates of “oriental medical schools,” where they learn about 5element theory, “energy” flow through meridians, and other fanciful traditional Chinese medicine (TCM) concepts that do not correspond with scientific knowledge of anatomy, physiology, or pathology. Practitioners of TCM typically rely on inappropriate diagnostic procedures (pulse and tongue diagnosis) and prescribe herbal mixtures that have not been sufficiently studied. Diagnoses based on TCM such as “Qi stagnation,” “blood stagnation,” “kidney Qi deficiency,” and “yin deficiency” may not jeopardize patients who are treated in an academic setting, where they have received a medical diagnosed before entering the study. But what about people with conditions that TCM-trained acupuncturists are not qualified or inclined to diagnose? Real-world evaluations of acupuncture should also consider the cost of unnecessary treatment.”

According to Professor Salzberg: “Acupuncture is a pre-scientific practice that persists only because of relentless and often very clever marketing by its proponents. The claimed mechanisms by which acupuncture works are clearly and obviously false: modern physiology, neurology, cell biology, and other scientific disciplines explain how pain signals are transmitted in the body, and none of them support the supposed “qi” or energy fields flowing along “meridians,” as acupuncturists describe them. Hundreds of scientific studies have shown that acupuncture doesn’t work for any medical condition. Acupuncture proponents ignore the evidence and persist, primarily because they profit from their practices. There are also documented risks of complications from acupuncture, ranging from infections to punctured lungs. For these and other reasons, recommending acupuncture for any patient is simply unethical. Acupuncturists make profits by putting patients at risk.”

According to Professor French: “Acupuncture has been extensively evaluated with respect to its possible therapeutic effectiveness for a wide range of disorders. The overall conclusion from meta-analyses of such studies is that any beneficial effects reported are small in terms of effect size and probably best accounted for in terms of statistical artefacts and placebo effects, etc. In general, the higher the quality of the study, the less likely are any beneficial effects to be reported. In light of this, it would be unwise and unethical to recommend acupuncture as the treatment of choice for any condition.”

According to Dr Renckens: “In 1683 the Dutch physician Willem ten Rhijne published the first book in the western world in which the word ‘acupuncture’ was mentioned, which referred to – as the Dutch title of the book was – ‘The Chinese and Japanese way of curing all diseases and especially the podagra by burning moxa and stabbing the Golden Needle’. This exotic treatment did not gain any popularity in the Netherlands and was mainly ridiculed. This heavenly situation remained unchanged until Nixon’s trip to China (1972) and the ‘successful’ acupuncture-treatment of the journalist James Reston of the New York Times. His story in that influential newspaper caused worldwide interest in acupunctures possible benefits. Also in the Netherlands and as early as 1989 a series of systematic reviews on the efficacy of acupuncture in a number of diseases was published in the Huisarts & Wetenschap, a journal of GP’s in the Dutch language (Ter Riet et al. H&W,1989;32:308-312).Their final conclusion was: ‘the main achievement of Chinese acupuncture is to have discovered a number of spots on the human body into which needles can be safely inserted’. The huge amount of scientific research into acupuncture has since been unable to undermine this right conclusion.”
According to Dr Braillon: “No discrimination!  The US Federal Trade Commission announced that homeopathic drugs should “be held to the same truthin-advertising standards as other products claiming health benefits”; very soon, homeopathic products will include statements indicating: “There is no scientific evidence backing homeopathic health claims” and “Homeopathic claims are based only on theories from the 1700s that are not accepted by modern medical experts.”  In Australia, the Royal Australian College of General Practitioners formally recommended GPs to ban homeopathic products from their prescriptions and pharmacists to ban them from their shelves. The same should be required for acupuncture.”

According to Dr McLennon: “Despite claims for effectiveness, there have been very few studies of acupuncture on children that have confirmed significant benefits.  Conditions such as headache, abdominal pain, bed wetting and fibromyalgia and behaviour problems such as ADHD have been investigated. More trials with better structure have universally been recommended. A double blinded trial on the treatment of headaches with laser acupuncture illustrates the problems. The number of patients was quite small (21 in each arm), the diagnoses were reasonable medically but required rediagnosis to fit Traditional Chinese Medicine criteria and treatments were individualised based on these diagnoses. It was not made clear whether the patients were completely blinded i.e. unaware they received active treatment or placebo. Until blinding can be guaranteed, trials of acupuncture will remain inconclusive.”
According to Professor Holt: “Unlike some alternative therapies, acupuncture has been extensively studied for many medical conditions and a summary would be that the higher the quality of the study, the less likely it is that a benefit other than a placebo effect is found. Studies have shown conclusively that a key aspect of acupuncture, putting needles into energy lines for medical benefits, is not true, and the same effect is elicited wherever the needles are placed. Acupuncture is not a science-based practice, can cause side effects and is not recommended for any medical condition.”

According to Dr Oppel: “It is extremely concerning that there remains no plausible rationale for a mechanism of action of acupuncture.  It is noteworthy that different schools of acupuncture offer contradictory patterns of treatment. It should not go without notice that acupuncture has been so well-researched that there are hundreds , if not thousands, of clinical trials now available Unfortunately, although there is no compelling evidence of effectiveness for any of the myriad of conditions where  acupuncture is claimed to be of benefit, poor quality unreplicated trials continue to be put forward by proponents as proof of acupuncture’s effectiveness. Critical thinkers will also take note that while the large majority of acupuncture trials are positive, the vast majority of properly controlled trials are not.   We are in a situation now where we have excellent evidence that acupuncture is not effective.”

According to Professor Hróbjartsson: “While there have been many trials done with acupuncture, most of them are small pilot studies and large scale high quality trials are rare. Some studies have reported measurable effects, but the mechanism is not yet understood, the size of the effect is small and it is possible that a large part of the effect or all of the effect is placebo. It is obvious that you would see a physiological effect when you stick a needle into your body, the question is whether that has a measurable clinical effect. There is insufficient evidence to say that electro acupuncture is any more or any less effective.”

According to Professor Pandolfi: “With a rationale completely disconnected from the basic principles of science acupuncture cannot be considered as belonging to modern evidence–based medicine.”

According to Professor Baker: “Millions of people are affected every year by these often debilitating and distressing conditions. For most their symptoms improve in days or weeks. However for some, the pain can be distressing and persist for a long time. Regrettably there is a lack of convincing evidence of effectiveness for some widely used treatments. For example acupuncture is no longer recommended for managing low back pain with or without sciatica. This is because there is not enough evidence to show that it is more effective than sham treatment.”

You might think that the question asked in the title of this post is a bit impertinent. Let’s see whether you change your mind after reading on.

“Come along for a ten minute taster sessions and experience the Bowen Technique.
It is appropriate for a wide range of acute and chronic conditions, including back pain, sciatica, neck, shoulder and knee problems, arthritis, asthma, migraine, sports injuries and stress. Ten-minute taster sessions will be offered so that you can experience the therapy first hand. Many find their aches and pains melt away!” 

It is with these exact words that the Royal College of Nursing advertises a session on Bowen Technique to be held during their major conference on Saturday 13 – Wednesday 17 May 2017, Liverpool Arena and Convention Centre.

You may not have heard of the Bowen Technique, one of the more exotic types of alternative medicine. So, let me fill you in:

According to proponents, it is “a system of subtle and precise mobilizations called “Bowen moves” over muscles, tendons, nerves and fascia. The moves are performed using the thumbs and fingers applying only gentle, non invasive pressure. A treatment consists of a series of specific sequences of moves called procedures, with frequent pauses to allow time for the body to respond.”

Wikipedia explains: “recipients are generally fully clothed. Each session typically involves gentle rolling motions along the muscles, tendons, and fascia. The therapy’s distinctive features are the minimal nature of the physical intervention and pauses incorporated in the treatment. Proponents claim these pauses allow the body to “reset” itself. In 2015 the Australian Government’s Department of Health published the results of a review of alternative therapies that sought to determine if any were suitable for being covered by health insurance; Bowen Technique was one of 17 therapies evaluated for which no clear evidence of effectiveness was found.”

Medline lists just one single trial of Bowen Technique; it is not a clinical trial with patients but a study with healthy volunteers; here is its abstract:

The hamstring muscles are regularly implicated in recurrent injuries, movement dysfunction and low back pain. Links between limited flexibility and development of neuromusculoskeletal symptoms are frequently reported. The Bowen Technique is used to treat many conditions including lack of flexibility. The study set out to investigate the effect of the Bowen Technique on hamstring flexibility over time. An assessor-blind, prospective, randomised controlled trial was performed on 120 asymptomatic volunteers. Participants were randomly allocated into a control group or Bowen group. Three flexibility measurements occurred over one week, using an active knee extension test. The intervention group received a single Bowen treatment. A repeated measures univariate analysis of variance, across both groups for the three time periods, revealed significant within-subject and between-subject differences for the Bowen group. Continuing increases in flexibility levels were observed over one week. No significant change over time was noted for the control group.

So, whichever way we look at it, there is no evidence whatsoever that Bowen Technique is helpful for patients suffering from any condition. This clearly means that therapeutic claims made for it are bogus, and that the way the Royal College of Nursing advertised it is misleading to the point of being unethical. By definition, the promotion of bogus treatments is quackery. Ergo, the Royal College of Nursing is promoting quackery.

If that is so, there is of course another question that needs an answer: Why does the Royal College of Nursing promote quackery?

As I see it, there are several possibilities, for instance:

  • They see nothing wrong with the Bowen session.
  • They don’t know better.
  • They don’t adhere to EBM.
  • They don’t care.
  • They were asked to run the session by someone with influence.
  • They believe that nurses want this sort of thing.
  • They think it’s trendy.

I would be fascinated to hear from someone who knows the correct answer.

The BMJ has always been my favourite Medical journal. (Need any proof for this statement? A quick Medline search tells me that I have over 60 publications in the BMJ.) But occasionally, the BMJ also disappoints me a great deal.

One of the most significant disappointments was recently published under the heading of STATE OF THE ART REVIEW. A review that is ‘state of the art’ must fulfil certain criteria; foremost it should be informative, unbiased and correct. The paper I am discussing here has, I think, neither of these qualities. It is entitled ‘Management of chronic pain using complementary and integrative medicine’, and here is its abstract:

Complementary and integrative medicine (CIM) encompasses both Western-style medicine and complementary health approaches as a new combined approach to treat a variety of clinical conditions. Chronic pain is the leading indication for use of CIM, and about 33% of adults and 12% of children in the US have used it in this context. Although advances have been made in treatments for chronic pain, it remains inadequately controlled for many people. Adverse effects and complications of analgesic drugs, such as addiction, kidney failure, and gastrointestinal bleeding, also limit their use. CIM offers a multimodality treatment approach that can tackle the multidimensional nature of pain with fewer or no serious adverse effects. This review focuses on the use of CIM in three conditions with a high incidence of chronic pain: back pain, neck pain, and rheumatoid arthritis. It summarizes research on the mechanisms of action and clinical studies on the efficacy of commonly used CIM modalities such as acupuncture, mind-body system, dietary interventions and fasting, and herbal medicine and nutrients.

The full text of this article is such that I could take issue with almost every second statement in it. Obviously, this would be too long and too boring for this blog. So, to keep it crisp and entertaining, let me copy the (tongue in cheek) ‘letter to the editor’ some of us published in the BMJ as a response to the review:

“Alternative facts are fashionable in politics these days, so why not also in healthcare? The article by Chen and Michalsen on thebmj.com provides a handy set of five instructions for smuggling alternative facts into medicine.

1. Create your own terminology: the term ‘complementary and integrated medicine’ (CIM) is nonsensical. Integrated medicine (a hotly disputed field) already covers complementary and conventional medicine.

2. Pretend to be objective: Chen and Michalsen elaborate on the systematic searches they conducted. But they omit hundreds of sources which do not support their message, which cherry-picks only evidence for the efficacy of the treatments they promote.

3. Avoid negativity: they bypass any material that might challenge what they include. For instance, when discussing therapeutic risks, they omit the disturbing lack of post-marketing surveillance: the reason we lack information on adverse events. They even omit to mention the many fatalities caused by their ‘CIM’.

4. Create an impression of thoroughness: Chen and Michalsen cite a total of 225 references. This apparent scholarly attention to detail masks their misuse of many of they list. Reference 82, for example, is employed to back up the claim that “satisfaction was lowest among complementary medicine users with rheumatoid arthritis, vasculitis, or connective tissue diseases”. In fact, it shows nothing of the sort.

5. Back up your message with broad generalisations: Chen and Michalsen conclude that “Taken together, CIM has an increasing role in the management of chronic pain, but high quality research is needed”. The implication is that all the CIMs mentioned in their figure 1 are candidates for pain control – even discredited treatments such as homeopathy.

In our view, these authors render us a service: they demonstrate to the novice how alternative facts may be used in medicine.”

James May, Edzard Ernst, Nick Ross, on behalf of HealthWatch UK

END OF QUOTE

I am sure you have your own comments and opinions, and I encourage you to post them here or (better) submit them to the BMJ or (best) both.

This double-blind RCT aimed to test the efficacy of self-administered acupressure for pain and physical function in adults with knee osteoarthritis (KOA).

150 patients with symptomatic KOA participated and were randomized to

  1. verum acupressure,
  2. sham acupressure,
  3. or usual care.

Verum and sham, but not usual care, participants were taught to self-apply acupressure once daily, five days/week for eight weeks. Assessments were collected at baseline, 4 and 8 weeks. The numeric rating scale (NRS) for pain was administered during weekly phone calls. Outcomes included the WOMAC pain subscale (primary), the NRS and physical function measures (secondary). Linear mixed regression was conducted to test between group differences in mean changes from baseline for the outcomes at eight weeks.

Compared with usual care, both verum and sham participants experienced significant improvements in WOMAC pain, NRS pain and WOMAC function at 8 weeks. There were no significant differences between verum and sham acupressure groups in any of the outcomes.

The authors concluded that self-administered acupressure is superior to usual care in pain and physical function improvement for older people with KOA. The reason for the benefits is unclear and placebo effects may have played a role.

Another very odd conclusion!

The authors’ stated aim was to TEST THE EFFICACY OF ACUPRESSURE. To achieve this aim, they rightly compared it to a placebo (sham) intervention. This comparison did not show any differences between the two. Ergo, the only correct conclusion is that acupressure is a placebo.

I know, the authors (sort of) try to say this in their conclusions: placebo effects may have played a role. But surely, this is more than a little confusing. Placebo effects were quite evidently the sole cause of the observed outcomes. Is it ethical to confuse the public in this way, I wonder.

 

 

Shiatsu is one of those alternative therapies where there is almost no research. Therefore, every new study is of interest, and I was delighted to find this new trial.

Italian researchers tested the efficacy and safety of combining shiatsu and amitriptyline to treat refractory primary headaches in a single-blind, randomized, pilot study. Subjects with a diagnosis of primary headache and who experienced lack of response to ≥2 different prophylactic drugs were randomized in a 1:1:1 ratio to receive one of the following treatments:

  1. shiatsu plus amitriptyline,
  2. shiatsu alone,
  3. amitriptyline alone

The treatment period lasted 3 months and the primary endpoint was the proportion of patients experiencing ≥50%-reduction in headache days. Secondary endpoints were days with headache per month, visual analogue scale, and number of pain killers taken per month.

After randomization, 37 subjects were allocated to shiatsu plus amitriptyline (n = 11), shiatsu alone (n = 13), and amitriptyline alone (n = 13). Randomization ensured well-balanced demographic and clinical characteristics at baseline.

The results show that all the three groups improved in terms of headache frequency, visual analogue scale score, and number of pain killers and there was no between-group difference in the primary endpoint. Shiatsu (alone or in combination) was superior to amitriptyline in reducing the number of pain killers taken per month. Seven (19%) subjects reported adverse events, all attributable to amitriptyline, while no side effects were related with shiatsu treatment.

The authors concluded that shiatsu is a safe and potentially useful alternative approach for refractory headache. However, there is no evidence of an additive or synergistic effect of combining shiatsu and amitriptyline. These findings are only preliminary and should be interpreted cautiously due to the small sample size of the population included in our study.

Yes, I would advocate great caution indeed!

The results could easily be said to demonstrate that shiatsu is NOT effective. There is NO difference between the groups when looking at the primary endpoint. This plus the lack of a placebo-group renders the findings uninterpretable:

  • If we take the comparison 2 versus 3, this might indicate efficacy of shiatsu.
  • If we take the comparison 1 versus 3, it would indicate the opposite.
  • If we finally take the comparison 1 versus 2, it would suggest that the drug was ineffective.

So, we can take our pick!

Moreover, I do object to the authors’ conclusion that “shiatsu is a safe”. For such a statement, we would need sample sizes that are about two dimensions greater that those of this study.

So, what might be an acceptable conclusion from this trial? I see only one that is in accordance with the design and the results of this study:

 

POORLY DESIGNED RESEARCH CANNOT LEAD TO ANY CONCLUSIONS ABOUT THERAPEUTIC EFFICACY OR SAFETY. IT IS A WASTE OF RESOURCES AND A VIOLATION OF RESEARCH ETHICAL.

D D Palmer was born on March 7, 1845; so, why do chiros celebrate the ‘CHIROPRACTIC AWARENESS WEEK’ from 10 – 16 of April? Perhaps out of sympathy with the homeopaths (many US chiros also use homeopathy) who had their ‘big week’ during the same period? Please tell me, I want to know!

Anyway, the HAW almost ‘drowned’ the CAW – but only almost.

The British Chiropractic Association did its best to make sure we don’t forget the CAW. On their website, we find an article that alerts us to their newest bit of research. Here are some excerpts:

The consumer survey by the British Chiropractic Association (BCA) of more than 2,000 UK adults who currently suffer from back or neck pain, or have done so in the past, found that almost three in five (56%) people experienced pain after using some form of technological device. Despite this, only 27% of people surveyed had limited or stopped using their devices due to concerns for their back or neck health and posture. The research showed people were most likely to experience back or neck pain after using the following technological devices:

•    Laptop computer (35%)
•    Desktop computer (35%)
•    Smart phone (22%)
•    Tablet (20%)
•    Games console (17%)

The age group most likely to experience back or neck pain when using their smart phone were 16-24 year olds, while nearly half (45%) of young adults 25-34 year olds) admitted to experiencing back or neck pain after using a laptop. One in seven (14%) 16-24 year olds attributed their back or neck pain to virtual reality headsets.

As part of Chiropractic Awareness Week (10-16 April) the BCA is calling for technology companies to design devices with posture in mind, to help tech proof our back health. BCA chiropractor Rishi Loatey comments: “We all know how easy it is to remain glued to our smart phone or tablet, messaging friends or scrolling through social media. However, this addiction to technology could be causing changes to posture, which can lead to increased pressure on the muscles, joints and discs in the spine. Technology companies are now starting to issue older phone models which hark back to a time before smart phones enabled people to do everything from check emails and take pictures, to internet banking. Returning to a time of basic functionality, which may see people look to limit the time spent on their phone, can only be good news for our backs. Yet, in an age where people can now track their health and wellbeing using their phone, technology companies should also start looking at ways to make their devices posture friendly from the outset, encouraging us to take time away from our desks and breaks from our scrolling, gaming and messaging.”

END OF QUOTE

So, here we have it: another piece of compelling, cutting edge research by the BCA. They have made us giggle before but rarely have I laughed so heartily about a ‘professional’ organisation confusing so unprofessionally correlation with causation.

Considering the amount of highly public blunders they managed to inflict on the profession in recent years, I have come to the conclusion that the BCA is a cover organisation of BIG PHARMA with the aim of giving chiropractic a bad name!

 

Tui Na is a massage technique that is based on the Taoist principles of TCM. It involves a range of manipulations usually performed by an operator’s finger, hand, elbow, knee, or foot applied to muscle or soft tissue at specific parts of the body. According to one website of TCM-proponents “Tui Na makes use of various hand techniques in combination with acupuncture and other manipulation techniques. To enhance the healing process, the practitioner may recommend the use of Chinese herbs. Many of the techniques used in this massage resemble that of a western massage like gliding, kneading, vibration, tapping, friction, pulling, rolling, pressing and shaking. In Tui Na massage, the muscles and tendons are massaged with the help of hands, and an acupressure technique is applied to directly affect the flow of Qi at different acupressure points of the body, thus facilitating the healing process. It removes the blockages and keeps the energy moving through the meridians as well as the muscles. A typical session of Tui Na massage may vary from thirty minutes to an hour. The session timings may vary depending on the patient’s needs and condition. The best part of the therapy is that it relaxes as well as energizes the person. The main benefit of Tui Na massage is that it focuses on the specific problem, whether it is an acute or a chronic pain associated with the joints, muscles or a skeletal system. This technique is very beneficial in reducing the pain of neck, shoulders, hips, back, arms, highs, legs and ankle disorders. It is a very effective therapy for arthritis, pain, sciatica and muscle spasms. Other benefits of this massage therapy include alleviation of the stress related disorders like insomnia, constipation, headaches and other disorders related to digestive, respiratory and reproductive systems. The greatest advantage of Tui Na is that it focuses on maintaining overall balance with both physical and mental health. Any one who wants to avoid the side effects of drugs or a chemical based treatment can adopt this effective massage technique to alleviate their pain. Tui Na massage therapy is now becoming a more common therapy method due to its focus on specific problems rather than providing a general treatment.”

This clearly begs the question IS IT EFFECTIVE?

This systematic review assessed the evidence of Tui Na for cervical radiculopathy. Seven databases were searched. Randomised controlled trials (RCTs) incorporating Tui Na alone or Tui Na combined with conventional treatment were included. Five studies involving 448 patients were found. The pooled analysis from the 3 trials indicated that Tui Na alone showed a significant lowering immediate effects on pain score with moderate heterogeneity compared to cervical traction. The meta-analysis from 2 trials revealed significant immediate effects of Tui Na plus cervical traction in improving pain score with no heterogeneity compared to cervical traction alone. None of the RCTs mentioned adverse effects. There was very low quality or low quality evidence to support the results.

The authors concluded that “Tui Na alone or Tui Na plus cervical traction may be helpful to cervical radiculopathy patients, but supportive evidence seems generally weak. Future clinical studies with low risk of bias and adequate follow-up design are recommended.”

In my view, this is a misleading conclusion. A correct one would have been: THE CURRENT EVIDENCE IS INSUFFICIENT TO DRAW ANY CONCLUSIONS ABOUT THE EFFECTIVENESS OF TUI NA.

Why?

Here are some of the most obvious reasons:

Personally, I am getting very tired of conclusions stating ‘…XY MAY BE EFFECTIVE/HELPFUL/USEFUL/WORTH A TRY…’ It is obvious that the therapy in question MAY be effective, otherwise one would surely not conduct a systematic review. If a review fails to produce good evidence, it is the authors’ ethical, moral and scientific obligation to state this clearly. If they don’t, they simply misuse science for promotion and mislead the public. Strictly speaking, this amounts to scientific misconduct.

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