MD, PhD, FMedSci, FSB, FRCP, FRCPEd

clinical trial

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.

Regular readers of this blog will have noticed: when homeopathy-fans run out of arguments, they tend to conduct an ‘ad hominem’ attack. They like to do this in several different ways, but one of the most popular version is to shout with indignation: YOU ARE NOT QUALIFIED!!!

The aim of this claim is to brand the opponent as someone who does not know enough about homeopathy to make valid comments about it. As this sort of thing comes up regularly, it is high time to ask: WHO ACTUALLY IS AN EXPERT IN HOMEOPATHY?

This seems to be an easy question to answer, but – come to think of it – it is more complex that one first imagines. Someone could be an expert in homeopathy in more than one way; for instance, one could be an expert:

  • in the history of homeopathy,
  • in the manufacture of homeopathics,
  • in the regulation of homeopathy,
  • in the clinical use of homeopathy in human patients,
  • in the clinical use of homeopathy in animals,
  • in the use of homeopathy in plants (no, I am not joking!),
  • in basic research of homeopathy,
  • in clinical research of homeopathy.

This blog is almost entirely devoted to clinical research; therefore, we should, for the purpose of this post, narrow down the above question to: WHO IS AN EXPERT IN CLINICAL RESEARCH OF HOMEOPATHY?

I had always assumed to be such an expert – until I was accused of being a swindler and pretender, that is. I have no formal qualifications for practising homeopathy (and never claimed otherwise), and this fact has prompted many homeopathy-fans to claim that I am not qualified to comment on the value of homeopathy. Do they have a point?

Rational thinkers have often pointed out that one does not need such qualifications for practicing homeopathy. In many countries, anyone can be a homeopath, regardless of background. In all the countries I know, one certainly can practise homeopathy, if one is qualified as a doctor. Crucially, do you really need to know how to practice homeopathy for conducting a clinical trial or a systematic review of homeopathy? Homeopaths seem to think so. I fear, however, that they are wrong: you don’t need to be a surgeon, psychiatrist or rheumatologist to organise a trial or conduct a review of these subjects!

Anyway, my research of homeopathy is not valid, homeopaths say, because I lack the formal qualifications to call myself a homeopath. Let me remind them that I have:

  1. been trained by leading homeopaths,
  2. practised homeopathy for quite some time,
  3. headed a team of scientists conducting research into homeopathy,
  4. conducted several clinical trials of homeopathy,
  5. published several systematic reviews of homeopathy,
  6. no conflicts of interest in regards to homeopathy.

However, this does not impress homeopath, I am afraid. They say that my findings and conclusions about their pet therapy cannot be trusted. In their eyes, I am not a competent expert in clinical research of homeopathy. They see me as a fraud and as an impostor. They prefer the real experts of clinical research of homeopathy such as:

  • Robert Mathie
  • Jos Kleinjen
  • Klaus Linde

These three researchers who are fully accepted by homeopaths; not just accepted, loved and admired! They all have published systematic reviews. Intriguingly, their conclusion all contradict my results in one specific aspect: THEY ARE POSITIVE.

I do not doubt their expertise for a minute, yet have always found this most amusing, even hilarious.

Why?

Because none of these experts (I know all three personally) is a qualified homeopath, none of them has any training in the practice of homeopathy, none of them has ever practised homeopathy on human patients, none of them has even worked for any length of time as a clinician.

What can we conclude from these insights?

We could, of course, descend to the same level as homeopaths tend to do and conclude that homeopathy-fans are biased, barmy, bonkers, stupid, silly, irrational, deluded, etc. However, I prefer to draw a different and probably more accurate conclusion: according to homeopathy-fans, an expert in clinical research of homeopathy is someone who has published articles that are favourable to their trade. Anyone who fails to do likewise is by definition not competent to issue a reliable verdict about it.

As the data suggesting that homeopathy is effective for improving health is – to put it mildly – less than convincing, a frantic search is currently on amongst homeopaths and their followers to identify a specific condition for which the evidence is stronger than for all conditions pooled into one big analysis. If they could show that it works for just one disease, they could celebrate this finding and henceforth use it for refuting doubters stating that highly diluted homeopathic remedies are pure placebos. One such condition is allergic rhinitis; there have been several trials suggesting that homeopathy might be effective for it, and therefore it is only logical that homeopathy-promoters want to summarise these data in order to silence sceptics once and for all.

A new paper ought to be seen in this vein. It is systematic review by the Mathie group with the stated aim “to evaluate the efficacy and effectiveness of homeopathic intervention in the treatment of seasonal or perennial allergic rhinitis (AR).”

Randomized controlled trials evaluating all forms of homeopathic treatment for AR were included in a systematic review (SR) of studies published up to and including December 2015. Two authors independently screened potential studies, extracted data, and assessed risk of bias. Primary outcomes included symptom improvement and total quality-of-life score. Treatment effect size was quantified as mean difference (continuous data), or by risk ratio (RR) and odds ratio (dichotomous data), with 95% confidence intervals (CI). Meta-analysis was performed after assessing heterogeneity and risk of bias.

Eleven studies were eligible for SR. All trials were placebo-controlled except one. Six trials used the treatment approach known as isopathy, but they were unsuitable for meta-analysis due to problems of heterogeneity and data extraction. The overall standard of methods and reporting was poor: 8/11 trials were assessed as “high risk of bias”; only one trial, on isopathy for seasonal AR, possessed reliable evidence. Three trials of variable quality (all using Galphimia glauca for seasonal AR) were included in the meta-analysis: nasal symptom relief at 2 and 4 weeks (RR = 1.48 [95% CI 1.24-1.77] and 1.27 [95% CI 1.10-1.46], respectively) favoured homeopathy compared with placebo; ocular symptom relief at 2 and 4 weeks also favoured homeopathy (RR = 1.55 [95% CI 1.33-1.80] and 1.37 [95% CI 1.21-1.56], respectively). The single trial with reliable evidence had a small positive treatment effect without statistical significance. A homeopathic and a conventional nasal spray produced equivalent improvements in nasal and ocular symptoms.

The authors concluded that the low or uncertain overall quality of the evidence warrants caution in drawing firm conclusions about intervention effects. Use of either Galphimia glauca or a homeopathic nasal spray may have small beneficial effects on the nasal and ocular symptoms of AR. The efficacy of isopathic treatment of AR is unclear.

Extracts of Galphimia glauca (GG) have been used traditionally in South America for the treatment of allergic conditions, with some reports suggesting effectiveness. A 1997 meta-analysis of 11 clinical trials (most of them of very poor quality) of homeopathic GG suggested this therapy to be effective in the treatment of AR. In 2011, I published a review (FACT 2011, 16 200-203) focussed exclusively on the remarkable set of RCTs of homeopathic Galphimia glauca (GG). My conclusions were as follows: three of the four currently available placebo-controlled RCTs of homeopathic GG suggest this therapy is an effective symptomatic treatment for hay fever. There are, however, important caveats. Most essentially, independent replication would be required before GG can be considered for the routine treatment of hay fever. Since then, no new studies have emerged.

I am citing this for two main reasons:

  • There is nothing homeopathic about the principle of using GG for allergic conditions; according to homeopathic theory GG extracts would need to cause allergies for GG to have potential as a homeopathic allergy remedy. Arguably, the GG trials should therefore have been excluded from this meta-analysis for not following the homeopathic principal of ‘like cures like’.
  • All the RCTs of GG were done by the same German research group. There is not a single independent replication of their findings!

Seen from this perspective, the conclusion by Mathie et al, that the use of either Galphimia glauca … may have small beneficial effects on the nasal and ocular symptoms of AR, seems more than a little over-optimistic.

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.

On this blog, we have had (mostly unproductive) discussions with homeopath so often that sometimes they sound like a broken disk. I don’t want to add to this kerfuffle; what I hope to do today is to summarise  a certain line of argument which, from the homeopaths’ point of view, seems entirely logical. I do this in the form of a fictitious conversation between a scientist (S) and a classical homeopath (H). My aim is to make the reader understand homeopaths better so that, future debates might be better informed.

HERE WE GO:

S: I have studied the evidence from studies of homeopathy in some detail, and I have to tell you, it fails to show that homeopathy works.

H: This is not true! We have plenty of evidence to prove that patients get better after seeing a homeopath.

S: Yes, but this is not because of the remedy; it is due to non-specific effect like the empathetic consultation with a homeopath. If one controls for these factors in adequately designed trials, the result usually is negative.

I will re-phrase my claim: the evidence fails to show that highly diluted homeopathic remedies are more effective than placebos.

H: I disagree, there are positive studies as well.

S: Let’s not cherry pick. We must always consider the totality of the reliable evidence. We now have a meta-analysis published by homeopaths that demonstrates the ineffectiveness of homeopathy quite clearly.

H: This is because homeopathy was not used correctly in the primary trials. Homeopathy must be individualised for each unique patient; no two cases are alike! Remember: homeopathy is based on the principle that like cures like!!!

S: Are you saying that all other forms of using homeopathy are wrong?

H: They are certainly not adhering to what Hahnemann told us to do; therefore you cannot take their ineffectiveness as proof that homeopathy does not work.

S: This means that much, if not most of homeopathy as it is used today is to be condemned as fake.

H: I would not go that far, but it is definitely not the real thing; it does not obey the law of similars.

S: Let’s leave this to one side for the moment. If you insist on individualised homeopathy, I must tell you that this approach can also be tested in clinical trials.

H: I know; and there is a meta-analysis which proves that it is effective.

S: Not quite; it concluded that medicines prescribed in individualised homeopathy may have small, specific treatment effects. Findings are consistent with sub-group data available in a previous ‘global’ systematic review. The low or unclear overall quality of the evidence prompts caution in interpreting the findings. New high-quality RCT research is necessary to enable more decisive interpretation.

If you call this a proof of efficacy, I would have to disagree with you. The effect was tiny and at least two of the best studies relevant to the subject were left out. If anything, this paper is yet another proof that homeopathy is useless!

H: You simply don’t understand homeopathy enough to say that. I tried to tell you that the remedy must be carefully chosen to fit each unique patient. This is a very difficult task, and sometimes it is not successful – mainly because the homeopaths employed in clinical trials are not skilled enough to find it. This means that, in these studies, we will always have a certain failure rate which, in turn, is responsible for the small average effect size.

S: But these studies are always conducted by experienced homeopaths, and only the very best, most experienced homeopaths were chosen to cooperate in them. Your argument that the trials are negative because of the ineffectiveness of the homeopaths – rather than the ineffectiveness of homeopathy – is therefore nonsense.

H: This is what you say because you don’t understand homeopathy!

S: No, it is what you say because you don’t understand science. How else would you prove that your hypothesis is correct?

H: Simple! Just look at individual cases from the primary studies within this meta-analysis . You will see that there are always patients who did improve. These cases are the proof we need. The method of the RCT is only good for defining average effects; this is not what we should be looking at, and it is certainly not what homeopaths are interested in.

S: Are you saying that the method of the RCT is wrong?

H: It is not always wrong. Some RCTs of homeopathy are positive and do very clearly prove that homeopathy works. These are obviously the studies where homeopathy has been applied correctly. We have to make a meta-analysis of such trials, and you will see that the result turns out to be positive.

S: So, you claim that all the positive studies have used the correct method, while all the negative ones have used homeopathy incorrectly.

H: If you insist to put it like that, yes.

S: I see, you define a trial to have used homeopathy correctly by its result. Essentially you accept science only if it generates the outcome you like.

H: Yes, that sounds odd to you – because you don’t understand enough of homeopathy.

S: No, what you seem to insist on is nothing short of double standards. Or would you accept a drug company claiming: some patients did feel better after taking our new drug, and this is proof that it works?

H: You see, not understanding homeopathy leads to serious errors.

S: I give up.

The question whether spinal manipulative therapy (SMT) is effective for acute low back pain is still discussed controversially. Chiropractors (they use SMT more regularly than other professionals) try everything to make us believe it does work, while the evidence is far less certain. Therefore, it is worth considering the best and most up-to-date data.

The  aim of this paper was to systematically review studies of the effectiveness and harms of SMT for acute (≤6 weeks) low back pain. The research question was straight forward: Is the use of SMT in the management of acute (≤6 weeks) low back pain associated with improvements in pain or function?

A through literature search was conducted to locate all relevant papers. Study quality was assessed using the Cochrane Back and Neck (CBN) Risk of Bias tool. The evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria. The main outcome measures were pain (measured by either the 100-mm visual analog scale, 11-point numeric rating scale, or other numeric pain scale), function (measured by the 24-point Roland Morris Disability Questionnaire or Oswestry Disability Index [range, 0-100]), or any harms measured within 6 weeks.

Of 26 eligible RCTs identified, 15 RCTs (1711 patients) provided moderate-quality evidence that SMT has a statistically significant association with improvements in pain (pooled mean improvement in the 100-mm visual analog pain scale, −9.95 [95% CI, −15.6 to −4.3]). Twelve RCTs (1381 patients) produced moderate-quality evidence that SMT has a statistically significant association with improvements in function (pooled mean effect size, −0.39 [95% CI, −0.71 to −0.07]). Heterogeneity was not explained by type of clinician performing SMT, type of manipulation, study quality, or whether SMT was given alone or as part of a package of therapies. No RCT reported any serious adverse event. Minor transient adverse events such as increased pain, muscle stiffness, and headache were reported 50% to 67% of the time in large case series of patients treated with SMT.

The authors concluded that among patients with acute low back pain, spinal manipulative therapy was associated with modest improvements in pain and function at up to 6 weeks, with transient minor musculoskeletal harms. However, heterogeneity in study results was large.

This meta-analysis has been celebrated by chiropractors around the world as a triumph for their hallmark therapy, SMT. But there have also been more cautionary voices – not least from the lead author of the paper. Patients undergoing spinal manipulation experienced a decline of 1 point in their pain rating, says Dr. Paul Shekelle, an internist with the West Los Angeles Veterans Affairs Medical Center and the Rand Corporation who headed the study. That’s about the same amount of pain relief as from NSAIDs, over-the-counter nonsteroidal anti-inflammatory medication, such as ibuprofen. The study also found spinal manipulation modestly improved function. On average, patients reported greater ease and comfort engaging in two day-to-day activities — such as finding they could walk more quickly, were having less difficulty turning over in bed or were sleeping more soundly.

It’s not clear exactly how spinal manipulation relieves back pain. But it may reposition the small joints in the spine in a way that causes less pain, according to Dr. Richard Deyo, an internist and professor of evidence-based medicine at the Oregon Health and Science University. Deyo wrote an editorial published along with the study. Another possibility, Deyo says, is that spinal manipulation may restore some material in the disk between the vertebrae, or it may simply relax muscles, which could be important. There may also be mind-body interaction that comes from the “laying of hands” or a trusting relationship between patients and their health care provider, he says.

Deyo notes that there are many possible treatments for lower back pain, including oral medicine, injected medicine, corsets, traction, surgery, acupuncture and massage therapy. But of about 200 treatment options, “no single treatment is clearly superior,” he says.

In another comment by Paul Ingraham the critical tone was much clearer: “Claiming it as a victory is one of the best examples I’ve ever seen of making lemonade out of science lemons! But I can understand the mistake, because the review itself does seem positive at first glance: the benefits of SMT are disingenuously summarized as “statistically significant” in the abstract, with no mention of clinical significance (effect size; see Statistical Significance Abuse). So the abstract sounds like good news to anyone but the most wary readers, while deep in the main text the same results are eventually conceded to be “clinically modest.” But even even that seems excessively generous: personally, I need at least a 2-point improvement in pain on a scale of 10 to consider it a “modest” improvement! This is not a clearly positive review: it shows weak evidence of minor efficacy, based on “significant unexplained heterogeneity” in the results. That is, the results were all over the place — but without any impressive benefits reported by any study — and the mixture can’t be explained by any obvious, measurable factor. This probably means there’s just a lot of noise in the data, too many things that are at least as influential as the treatment itself. Or — more optimistically — it could mean that SMT is “just” disappointingly mediocre on average, but might have more potent benefits in a minority of cases (that no one seems to be able to reliably identify). Far from being good news, this review continues a strong trend (eg Rubinstein 2012) of damning SMT with faint praise, and also adds evidence of backfiring to mix. Although fortunately “no RCT reported any serious adverse event,” it seems that minor harms were legion: “increased pain, muscle stiffness, and headache were reported 50% to 67% of the time in large case series of patients treated with SMT.” That’s a lot of undesirable outcomes. So the average patient has a roughly fifty-fifty chance of up to roughly maybe a 20% improvement… or feeling worse to some unknown degree! That does not sound like a good deal to me. It certainly doesn’t sound like good medicine.”

END OF QUOTE

As I have made clear in many previous posts, I do fully agree with these latter statements and would add just three points:

  1. We know that many of the SMT studies completely neglect reporting adverse effects. Therefore it is hardly surprising that no serious complications were on record. Yet, we know that they do occur with sad regularity.
  2. None of the studies controlled for placebo effects. It is therefore possible – I would say even likely – that a large chunk of the observed benefit is not due to SMT per se but to a placebo response.
  3. It seems more than questionable whether the benefits of SMT outweigh its risks.

The aim of this pragmatic study was “to investigate the effectiveness of acupuncture in addition to routine care in patients with allergic asthma compared to treatment with routine care alone.”

Patients with allergic asthma were included in a controlled trial and randomized to receive up to 15 acupuncture sessions over 3 months plus routine care, or to a control group receiving routine care alone. Patients who did not consent to randomization received acupuncture treatment for the first 3 months and were followed as a cohort. All trial patients were allowed to receive routine care in addition to study treatment. The primary endpoint was the asthma quality of life questionnaire (AQLQ, range: 1–7) at 3 months. Secondary endpoints included general health related to quality of life (Short-Form-36, SF-36, range 0–100). Outcome parameters were assessed at baseline and at 3 and 6 months.

A total of 1,445 patients were randomized and included in the analysis (184 patients randomized to acupuncture plus routine care and 173 to routine care alone, and 1,088 in the nonrandomized acupuncture plus routine care group). In the randomized part, acupuncture was associated with an improvement in the AQLQ score compared to the control group (difference acupuncture vs. control group 0.7 [95% confidence interval (CI) 0.5–1.0]) as well as in the physical component scale and the mental component scale of the SF-36 (physical: 2.5 [1.0–4.0]; mental 4.0 [2.1–6.0]) after 3 months. Treatment success was maintained throughout 6 months. Patients not consenting to randomization showed similar improvements as the randomized acupuncture group.

The authors concluded that in patients with allergic asthma, additional acupuncture treatment to routine care was associated with increased disease-specific and health-related quality of life compared to treatment with routine care alone.

We have been over this so many times (see for instance here, here and here) that I am almost a little embarrassed to explain it again: it is fairly easy to design an RCT such that it can only produce a positive result. The currently most popular way to achieve this aim in alternative medicine research is to do a ‘A+B versus B’ study, where A = the experimental treatment, and B = routine care. As A always amounts to more than nothing – in the above trial acupuncture would have placebo effects and the extra attention would also amount to something – A+B must always be more than B alone. The easiest way of thinking of this is to imagine that A and B are both finite amounts of money; everyone can understand that A+B must always be more than B!

Why then do acupuncture researchers not get the point? Are they that stupid? I happen to know some of the authors of the above paper personally, and I can assure you, they are not stupid!

So, why?

I am afraid there is only one reason I can think of: they know perfectly well that such an RCT can only produce a positive finding, and precisely that is their reason for conducting such a study. In other words, they are not using science to test a hypothesis, they deliberately abuse it to promote their pet therapy or hypothesis.

As I stated above, it is fairly easy to design an RCT such that it can only produce a positive result. Yet, it is arguably also unethical, perhaps even fraudulent, to do this. In my view, such RCTs amount to pseudoscience and scientific misconduct.

The recent meta-analysis by Mathie et al for non-individualised homeopathy (recently discussed here) identified just 3 RCTs that were rated as  ‘reliable evidence’. But just how rigorous are these ‘best’ studies? Let’s find out!

THE FIRST STUDY

The objective of the first trial was “to evaluate the efficacy of the non-hormonal treatment BRN-01 in reducing hot flashes in menopausal women.” Its design was that of a multicentre (35 centres in France), randomized, double-blind, placebo-controlled. One hundred and eight menopausal women, ≥50 years of age, were enrolled in the study. The eligibility criteria included menopause for <24 months and ≥5 hot flashes per day with a significant negative effect on the women’s professional and/or personal life. Treatment was either BRN-01 tablets, a registered homeopathic medicine [not registered in the UK] containing Actaea racemosa (4 centesimal dilutions [4CH]), Arnica montana (4CH), Glonoinum (4CH), Lachesis mutus (5CH), and Sanguinaria canadensis (4CH), or placebo tablets, prepared by Laboratoires Boiron according to European Pharmacopoeia standards [available OTC in France]. Oral treatment (2 to 4 tablets per day) was started on day 3 after study enrolment and was continued for 12 weeks. The main outcome measure was the hot flash score (HFS) compared before, during, and after treatment. Secondary outcome criteria were the quality of life (QoL) [measured using the Hot Flash Related Daily Interference Scale (HFRDIS)], severity of symptoms (measured using the Menopause Rating Scale), evolution of the mean dosage, and compliance. All adverse events (AEs) were recorded. One hundred and one women were included in the final analysis (intent-to-treat population: BRN-01, n = 50; placebo, n = 51). The global HFS over the 12 weeks, assessed as the area under the curve (AUC) adjusted for baseline values, was significantly lower in the BRN-01 group than in the placebo group (mean ± SD 88.2 ± 6.5 versus 107.2 ± 6.4; p = 0.0411). BRN-01 was well tolerated; the frequency of AEs was similar in the two treatment groups, and no serious AEs were attributable to BRN-01. The authors concluded that BRN-01 seemed to have a significant effect on the HFS, compared with placebo. According to the results of this clinical trial, BRN-01 may be considered a new therapeutic option with a safe profile for hot flashes in menopausal women who do not want or are not able to take hormone replacement therapy or other recognized treatments for this indication.

Laboratoires Boiron provided BRN-01, its matching placebo, and financial support for the study. Randomization and allocation were carried out centrally by Laboratoires Boiron. I would argue that the treatment time in this study was way too short for generating a therapeutic response. The evolution of the HFS in the two groups was assessed by analysis of the area under the curve (AUC) of the mean scores recorded weekly from each patient in each group over the duration of the study, including those at enrollment (before any treatment). I wonder whether this method was chosen only when the researchers noted that the HFS at the pre-defined time points did not yield a significant result or whether it was pre-determined (elsewhere in the methods section we are told that “The primary evaluation criterion was the effect of BRN-01 on the HFS, compared with placebo. The HFS was defined as the product of the daily frequency and intensity of all hot flashes experienced by the patient, graded by the women from 1 to 4 (1 = mild; 2 = moderate; 3 = strong; 4 = very strong). These data were recorded by the women on a self-administered questionnaire, assisted by a telephone call from a clinical research associate. Data were collected (i) during the first 2 days after enrolment and before any medication had been taken; (ii) then every Tuesday and Wednesday of each week until the 11th week of treatment, inclusive; and (iii) finally, every day of the 12th week of treatment.”). Two of the authors of this paper are employees of Boiron.

THE SECOND STUDY

The second trial was aimed at finding out “whether a well-known and frequently prescribed homeopathic preparation could mitigate post-operative pain.” It was a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of the homeopathic preparation Traumeel S® in minimizing post-operative pain and analgesic consumption following surgical correction of hallux valgus. Eighty consecutive patients were randomized to receive either Traumeel tablets or an indistinguishable placebo, and took primary and rescue oral analgesics as needed. Maximum numerical pain scores at rest and consumption of oral analgesics were recorded on day of surgery and for 13 days following surgery. Traumeel was not found superior to placebo in minimizing pain or analgesic consumption over the 14 days of the trial, however a transient reduction in the daily maximum post-operative pain score favoring the Traumeel arm was observed on the day of surgery, a finding supported by a treatment-time interaction test (p = 0.04). The authors concluded that Traumeel was not superior to placebo in minimizing pain or analgesic consumption over the 14 days of the trial. A transient reduction in the daily maximum post-operative pain score on the day of surgery is of questionable clinical importance.

Traumeel is a mixture of 6 ingredients, 4 of which are in the D2 potency. Thus it neither is administered as a homeopathic remedy (no ‘like cures like’) nor is it highly diluted. In fact, it is not homeopathy at all but belongs to a weird offspring of homeopathy called ‘homotoxicology’ [this is an explanation from my book: Homotoxicology is a method inspired by homeopathy which was developed by Hans Heinrich Reckeweg (1905 – 1985). He believed that all or most illness is caused by an overload of toxins in the body. The toxins originate, according to Reckeweg, both from the environment and from the malfunction of physiological processes within the body. His treatment consists mainly in applying homeopathic remedies which usually consist of combinations of single remedies, because health cannot be achieved without ridding the body of toxins. The largest manufacturer and promoter of remedies used in homotoxicology is the German firm Heel.] The HEEL Company (Baden-Baden, Germany) provided funding for the performance and monitoring of this project, supplied the study medication and placebo, and prepared the randomization list. The positive outcome mentioned in the authors’ conclusion refers to a secondary endpoint. I would argue that the authors should not have noted it there and should have made it clear that the trial generated a negative result.

THE THIRD STUDY

Finally, the third of the 3 ‘rigorous’ studies “evaluated the effectiveness of the homeopathic preparation Plumbum Metallicum  (PM) in reducing the blood lead levels of workers exposed to this metal.” The Brazilian researchers recruited 131 workers to this RCT who took PM in the CH15 potency or placebo for 35 days (10 drops twice daily). Thereafter, the percentage of workers whose lead level had fallen by at least 25% did not differ between the groups, both on intention to treat and per protocol analyses. The authors concluded that PM “had no effect in this study in terms of reducing serum lead in workers exposed to lead.”

This study lacks a power calculation, and arguably the period might have been too short to show an effect. The trial was published in the journal HOMEOPATHY which, some might argue, has not the most rigorous of peer-review procedures.

CONCLUDING REMARKS

The third study seems the most rigorous by far, in my view. The other two trials are seriously under-whelming in several respects, primarily because we cannot be sure how much influence the commercial interests of the sponsor had on their findings. I am sure others will spot weaknesses in all three trials that I failed to see.

Mathie et al partly disagree with my assessment when they write in their paper: “We report separately our model validity assessments of these trials, evaluating consequently their overall quality based on a GRADE-like principle of ‘downgrading’ [14]: two trials [23, 25] rated here as reliable evidence were downgraded to ‘low quality’ overall due to the inadequacy of their model validity; the remaining trial with reliable evidence [24] was judged to have adequate model validity. The latter study [24] thus comprises the sole RCT that can be designated ‘high quality’ overall by our approach, a stark finding that reveals further important aspects of the preponderantly low quality of the current body of evidence in non-individualised homeopathy.”

References 23, 24 and 25 are Padilha (the paper on Plumbum Metallicum), Colau (the RCT on menopausal women) and Singer (the Traumeel trial) respectively. This means that – as per Mathie’s assessment – just the Colau study remains as the sole trial with ‘reliable evidence’ for non-individualised homeopathy.

What Mathie et al seem to forget entirely is that none of the 3 RCTs is a trial of homeopathy as defined by treatment according to the ‘like cures like’ principle. The authors of the second study acknowledge this fact by stating: “Homeopathic purists may find fault in the administration of a standardized combination homeopathic formula to all patients, based upon clinical diagnosis – as opposed to the individualized manner dictated by standard homeopathic practice.”

So, which ever way we look upon this evidence, we cannot possibly deny that the evidence for non-individualised homeopathy is rubbish.

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