MD, PhD, FMedSci, FSB, FRCP, FRCPEd

study design

1 2 3 7

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.

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.”

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.

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.

‘What Doctors Don’t Tell You’ (WDDTY) have been shown to be strangely economical with the truth many times before (for instance here, here and here). Now they have published an article entitled ‘Ombudsman investigates ‘flawed’ homeopathic study that claimed it doesn’t work’ It attacks in no uncertain terms the ‘NHMRC Statement on Homeopathy and NHMRC Information Paper – Evidence on the effectiveness of homeopathy for treating health conditions’ which I believe to be a sound evaluation of homeopathy and therefore have mentioned repeatedly on this blog. Here is what WDDTY stated:

START OF QUOTE

A major and influential review of homeopathy concluded that the controversial therapy doesn’t work—but it was so riddled with error and bad science that it’s sparked an official ombudsman investigation.

The world’s media announced that homeopathy was a scam after the Australia government’s National Health and Medical Research Council (NHMRC) published its findings in 2015 that “there are no health conditions for which there is reliable evidence that homeopathy is effective.”

But now the Commonwealth Ombudsman is investigating the review’s procedures after receiving reports of inaccuracies, mishandling of evidence and conflicts of interest.

The review has been triggered by the Australian Homeopathic Association (AHA), supported by the Homeopathic Research Institute (HRI), which began questioning the review’s processes after several solid studies that demonstrated homeopathy’s benefits had been overlooked.

The NHMRC review team set arbitrary parameters that only studies that involved more than 150 people—and which met standards that even drug trials rarely achieve—would be considered. Those requirements reduced the number of qualifying studies to just five—from an initial pool of more than 1,800 trials—and none of these showed that homeopathy was effective.

One of the NHMRC’s own reviewers produced a mysterious first report that has never been published, and hasn’t been released despite Freedom of Information requests.

And the AHA has discovered that Prof Peter Brooks, chair of the NHMRC committee that carried out the homeopathy review, never declared that he was a member of the anti-homeopathy lobby group, Friends of Science in Medicine.

There are solid studies that demonstrate homeopathy is effective against childhood diarrhea, sinusitis and hay fever—but they all involve fewer than 150 people, said HRI chief executive Rachel Roberts. “The public has a right to know that there are high quality studies showing homeopathy works for some medical conditions—information that was lost only due to NHMRC’s mishandling of the evidence.”

The homeopaths aren’t alone in challenging the NHMRC review: Australia’s independent Cochrane Centre said its conclusions are not an accurate reflection of the evidence, and a second expert also said he felt “uncertain of the definitive nature of the report’s conclusions.”

END OF QUOTE

As it happens, I am in contact with the lead author of this report, Paul Glasziou, not least because he very kindly wrote the foreword for my book HOMEOPATHY, THE UNDILUTED FACTS. So, we corresponded and discussed the latest WDDTY diatribe. Thus I am now in a position to put a few things straight (I hope Paul does not mind).

ISSUE 1. – The NHMRC review team set arbitrary parameters that only studies involving more than 150 people—and which met standards that even drug trials rarely achieve—would be considered.

The truth is that report focused on systematic reviews of trials, not individual trials. The 57 included systematic reviews found 176 individual trials which covered 61 conditions: an average of about 3 trials per condition. But some conditions only had 1 trial, and one small trial would, of course, not be considered a reasonable basis for reliable conclusions. GRADE – the international standard for assessing evidence – downgrades reviews for “imprecision” – the GRADE Handbook suggests “whenever there are sample sizes that are less than 400, review authors and guideline developers should certainly consider rating down for imprecision.” Hence the criterion of 150 which the Australians decided to use is considerably more lenient than the current GRADE guideline.

ISSUE 2 – Those requirements reduced the number of qualifying studies to just five—from an initial pool of more than 1,800 trials—and none of these showed that homeopathy was effective.

This is simply not correct. The report found 57 systematic reviews that contained 176 individual trials, not 5. These 176 trials, which covered 61 conditions, formed the body of evidence for the NHMRC report’s conclusions.

ISSUE 3 – There are solid studies that demonstrate homeopathy is effective against childhood diarrhoea, sinusitis and hay fever—but they all involve fewer than 150 people, said HRI chief executive Rachel Roberts.

The NHMRC report focused on systematic reviews that covered all trials for individual conditions. Given the conventional p-value of 0.05, one would expect 1 in 20 single trials to be “false positives”. So with 176 trials, we expect about 9 “false positive” trials. But using systematic reviews that combine all trials for individual conditions, reduces this risk of false positives. Most national evidence review bodies require more than 1 trial, e.g, the FDA requires 2 positive trials, whereas many others require a systematic review which has at least 2 trials. Replication of findings is obviously a cornerstone of science.

ISSUE 4 The homeopaths aren’t alone in challenging the NHMRC review: Australia’s independent Cochrane Centre said its conclusions are not an accurate reflection of the evidence, and a second expert also said he felt “uncertain of the definitive nature of the report’s conclusions.”

The truth is that the Cochrane Centre, which provided an independent check during the processes of the NHMRC review, concluded that “Overall, the conclusions arising from the review appear justified based on the evidence presented.”

I REST MY CASE.

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.

Yes, homeopaths are incredibly fond of the notion that homeopathy has been proven to work in numerous population studies of outbreaks of infectious diseases. The argument is bound to come up in any discussion with a ‘well-informed’ homeopathy fan. Therefore, it might be worth addressing it once and for all.

This website offers a fairly good summary of what homeopaths consider to be convincing evidence. It also provides links to the original articles which is valuable for all who want to study them in full detail. I will therefore present the crucial passage here unchanged.

START OF QUOTE

By the end of year 2014, there have been 19 papers published on Epidemiological studies on 7 epidemic diseases (scarlet fever, typhus fever, Cholera, Dengue, meningococcal, influenza and Leptospirosis) in 11 peer-reviewed (beyond year 1893) journals in evidence of Homeopathy including 2 Randomised Controlled Trials.

1. Samuel Hahnemann, “The Cure and prevention of scarlet fever”, Zeitschrift für Praktischen Medizin (Journal of Practical Medicine), 1801, Republished in Lesser Writings. B.Jain Publishing, New Delhi

Preventive use of homeopathy was first applied in 1799 during an epidemic of scarlet fever in Königslütter, Germany, when Dr. Hahnemann prescribed a single dose of Belladonna, as the remedy of the genus epidemicus to susceptible children in the town with more than 95% success rate. In this paper, he also specified how the Belladonna has to be potentised to 1/24,000,000 dilution. His recommended dose of Belladonna was 0.0416 nanograms to be repeated every 72 hrs. This is the first recorded nano dose of medicine used in treatment of any disease [6]. It was another 125 years before Gladys Henry and George Frederick developed a vaccine for scarlet fever in 1924.

2. Samuel Hahnemann, “Scarlet fever and Purpura miliaris, two different diseases”, Zeitschrift für Praktischen Medizin, vol. 24, part. 1, 1806

3. Samuel Hahnemann, “Observations on scarlet fever”, Allgemeine Reichanzeiger (General Reich Gazette), No. 160, Germany, 1808

4. Samuel Hahnemann, “Reply to a question about the prophylactic for scarlet fever”, Zeitschrift für Praktischen Medizin, vol. 27, part. 4, p. 152-156, 1808

5. Samuel Hahnemann, “Treatment of typhus & fever at present prevailing”, Allgemeine Reichanzeiger, No. 6, Jan. 1814.

6. Hufeland, Prophylactic powers of Belladonna against Scarlet Fever , The Lancet, 1829
The proper use of belladonna has, in most cases, prevented infection. Numerous observations have shown that, by the general use of belladonna, epidemics of scarlet fever have actually been arrested. In those few instances where the use of belladonna was insufficient to prevent infection, the disease has been invariably slight. The Prussian (German Empire) Government ordered the use of the prophylactic during all scarlet fever epidemics

7. Samuel Hahnemann, “Cure and prevention of Asiatic cholera”, Archiv für die homöopathische Heilkunst (Archives for the Homoeopathic Healing Art), Vol. 11, part 1, 1831.
Cuprum 30c once every week as preventive medicine

8. Samuel Hahnemann, “On the contagiousness of cholera”. British Homoeopathic Journal, Vol. 7, 1849

9. Samuel Hahnemann, “Appeal to Thinking Philanthropists Respecting the Mode of Propagation of the Asiatic Cholera”, 20 pages, 1831. Republished in British Homoeopathic Journal, Oct 1849.

He said, “On board ships – in those confined spaces, filled with mouldy watery vapours, the cholera-miasm finds a favourable element for its multiplication, and grows into an enormously increased brood of those excessively minute, invisible, living creatures, so inimical to human life, of which the contagious matter of the cholera most probably consists millions of those miasmatic animated beings, which, at first developed on the broad marshy banks or the tepid Ganges– on board these ships, I say, this concentrated aggravated miasm kills several of the crew …” [7].
It was another 59 years (1890) before Koch saw these organisms, and later on orthodox medicine gave them the name ‘germs’

10. Charles Woodhull Eaton, The Facts about Variolinum, Transactions of the American Institute of Homoeopathy, 1907
2806 patients were treated prophylactically with Variolinum 30 (a nosode) for prevention of smallpox in Iowa. Of the 547 patients definitely exposed, only 14 developed the disease. Efficacy rate of 97.5%

11. Taylor Smith A, Poliomyelitis and prophylaxis British Homoeopathic Journal, 1950
In 1950 during an epidemic of poliomyelitis, Dr Taylor Smith of Johannesburg, South Africa protected 82 people with homoeopathic Lathyrus sativus. Of the 82 so immunised, 12 came into direct contact with disease. None were infected.

12. Oscillococcinum 200c in the treatment of influenza during epidemic in France from 1984-1987, British Journal of Clinical Pharmacology (1989)
A DBRPCT, Oscillococcinum 200c taken twice daily for 5 days significantly increased the rate of cure within two days (n=487, 237 treated and 241 on placebo), absence of symptoms at 48 hours, relative risk estimate significantly favour homeopathy (p=0.048), no pain and no fever (p=0.048), recovery rate (headache, stiffness, articular pain, shivering reduction) at 48 hours better in homeopathy group (p=0.032)

13. Bernard Leary, Cholera 1854 Update, British Homoeopathic Journal, 1994
Sir William Wilde, the well-known allopathic doctor of Dublin, which in his work entitled “Austria and its Institutions”, wrote: “Upon comparing the report of the treatment of Cholera in the Homeopathic hospital testified to by two allopathic medical inspectors appointed by Government with that of the treatment of the same disease in the other hospitals of Vienna during the same period the epidemic of 1836, it appeared that while two-thirds of the cases treated by Dr. Fleischmann the physician of the Homeopathic hospital, recovered, two-thirds of those treated by the ordinary methods in the other hospitals died.”

14. Meningococcinum – its protective effect against meningococcal disease, Homeopathy Links, 2001 (2001)
A total of 65,826 people between the ages of 0–20 were immunised homeopathically to protect against meningococcal disease while 23,532 were not. Over a year period, 4 out of 65,826 protected homeopathically developed meningococcal infection. 20 out of 23,532 not protected developed meningococcal infection. Based on the infection rate in the unprotected group, 58 cases of infection could have been expected in the homeopathically protected group. Instead, there were only four cases of meningococcal infection. Statistical analysis showed that homeopathic immunisation offered 95% protection in the first six months and 91% protection over the year against meningococcal disease. [8]

15. Contribution of homeopathy to the control of an outbreak of dengue epidemic in Macaé, Rio de Janeiro, Brazil in 2007-8 , International Journal of High Dilution Research, 2008
In a campaign ‘Homeopathy campaign against dengue’ by Brazilian Govt, “156,000 doses of homeopathic remedy were freely distributed in April and May 2007 to asymptomatic patients and 129 doses to symptomatic patients treated in outpatient clinics, according to the notion of genus epidemicus . The remedy used was a homeopathic complex against dengue containing Phosphorus 30c, Crotalus horridus 30c and Eupatorium perfoliatum 30c. The incidence of the disease in the first three months of 2008 fell 93% by comparison to the corresponding period in 2007, whereas in the rest of the State of Rio de Janeiro there was an increase of 128%.”

16. Marino R. Eupatorium perfoliatum 30c for the Dengue Epidemics in Brazil in 2007. International Journal of High Dilution Research, 2008
In May 2001, prophylactic use of Eupatorium perfoliatum 30c single dose was given during a dengue outbreak to 40% of residents in the most highly affected neighbourhood which resulted in significant decrease in dengue incidence by 81.5% (p<0.0001) when compared with those neighbourhoods that did not receive homeopathic prophylaxis.

17. Bracho et. al. Application of 200C potency of bacteria for Leptospirosis epidemic control in Cuba 2007-8 (2010)
Conducted by the Finlay Institute, a vaccines producer in Cuba gave 2.308562 million (70% of the target population above the age of 1 year) people in Cuba given two doses (1 dose=5 drops) of 200C potency of a nosode prepared from Leptospirosis bacteria, each (7-9 days apart), for protection against Leptospirosis (fever+jaundice+ inflammation in kidney+enlargement of spleen) with 84% decrease in disease incidence and only 10 reported cases. Dramatic decrease in morbidity within two weeks and zero morbidity of hospitalised patients, non-treated (8.8 millions) area saw an increase in number of cases from 309 cases in 2007 to 376 in 2008 representing a 21% increase. The cost of homeopathic immunization =1/15th of conventional vaccine.

18. Effect of individualized homoeopathic treatment in influenza like illness, Indian Journal of Research in Homeopathy (2013)
A multicenter, single blind, randomized, placebo controlled study to evaluate the effect of homoeopathic medicines in the treatment of Influenza like illness and to compare the efficacy of LM (50 millisimal) potency vis-à-vis centesimal (C) potency. In LM group (n=152), C group (n=147) or placebo (n=148) group. The study revealed the significant effect of individualized homoeopathic treatment in the patients suffering from ILI with no marked difference between LM and Centesimal groups. The medicines which were commonly prescribed were: Arsenic album, Bryonia alba, Rhus tox., Belladonna, Nux vomica, Sepia, Phosphorus, Gelsemium, Sulphur, Natrum mur. and Aconitum napellus. [9]

19. Reevaluation of the Effectiveness of Homoeoprophylaxis Against Leptospirosis in Cuba in 2007-8, Journal of Evidence-based Complementary & Alternative Medicine (2014)
The results support the previous conclusions that homoeoprophylaxis can be used to effectively immunize people against targeted infectious diseases such as leptospirosis.

References
[1] Iman Navab, Lives saved by Homeopathy in Epidemics and Pandemics, https://drnancymalik.wordpress.com/2013/01/23/epidemics-and-pandemics/

[2] Reshu Agarwal, Natural History of Disease and Homeopathy at different levels of Intervention, http://www.homeorizon.com/homeopathic-articles/homeopathic-philosophy/disease-history

[3] Homoeopathy- Science of Gentle Healing, Deptt. of AYUSH, Ministry of Health & Family Welfare, Govt, of India, 2013, http://www.ccrhindia.org/Dossier/content/page22.html

[4] Conversation with David Little, http://hpathy.com/homeopathy-papers/conversations-with-david-little/

[5] Nancy Malik, Principles of Homeopathy Explained, 2015, https://drnancymalik.wordpress.com/article/homeopathy-explained/

[6] Nancy Malik, Recent Advances in Nanoparticle Research in Homeopathy, Homeopathy 4 Everyone, Vol.12, Issue 6, 18 June 2015, http://hpathy.com/scientific-research/recent-advances-in-nanoparticle-research-in-homeopathy/

[7] Samuel Hahnemann, “Appeal to Thinking Philanthropists Respecting the Mode of Propagation of the Asiatic Cholera”, 20 pages, 1831, Translated by R E Dudgeon, M.D. in The Lesser Writings of Samuel Hahnemann, 1851, B Jain Publishers, reproduced edition, 2002, p. 758

[8] Fran Sheffield, Homeoprophylaxis: Human Records, Studies and Trials, 2014, http://homeopathyplus.com/Homeoprophylaxis-Human-Records-Studies-Trials.pdf

[9] Homoeopathy in Flu-like Illness- Factsheet, Central Council for Research in Homoeopathy, Deptt. of AYUSH, Ministry of Health & Family Welfare, Govt, of India, 2015, http://ccrhindia.org/pdf/swineflu.pdf

END OF QUOTE

Whenever I read articles of this nature, I get a little embarrassed. It seems obvious to me that the authors of such reviews have done some ‘research’ and believe strongly in the correctness in what they write. It embarrasses me to see how such people, full of good will, can be so naïve, ignorant and wrong. They clearly fail to understand several crucial issues. To me. this seems like someone such as me lecturing others about car mechanics, quantum physics or kite flying. I have no idea about these subjects, and therefore it would be idiotic to lecture others about them. But homeopaths tend to be different! And this is when my embarrassment quickly turns into anger: articles like the above spread nonsense and misguide people about important issues. THEY ARE DANGEROUS! There is little room for embarrassment and plenty of room for criticism. So, let’s criticise the notions advanced above.

In my recent book, I briefly touched upon epidemics in relation to homeopathy:

Epidemics are outbreaks of disease occurring at the same time in one geographical area and affecting large number of people. In homeopathy, epidemics are important because, in its early days, they seemed to provide evidence for the notion that homeopathy is effective. The results of homeopathic treatment seemed often better than those obtained by conventional means. Today we know that this was not necessarily due to the effects of homeopathy per se, but might have been a false impression caused by bias and confounding.

This tells us the main reason why the much-treasured epidemiological evidence of homeopaths is far from compelling. The review above does not mention these caveats at all. But it is lousy also for a whole host of other reasons, for instance:

  • The text contains several errors (which I find too petty to correct here).
  • The list of studies is the result of cherry-picking the evidence.
  • It confuses what epidemiological studies are; RCTs are certainly not epidemiological studies, for instance.
  • It also omits some of the most important epidemiological studies suggesting homeopathy works.
  • It cites texts that are clearly not epidemiological studies.
  • Several studies are on prevention of illness rather than on treatment.
  • Some studies do not even employ homeopathy at all.

In the typical epidemiological case/control study, one large group of patients [A] is retrospectively compared to another group [B]. By large, I mean with a sample size of thousands of patients. In our case, group A has been treated homeopathically, while group B received the treatments available at the time. It is true that several of such reports seemed to suggest that homeopathy works. But this does by no means prove anything; the result might have been due to a range of circumstances, for instance:

  • group A might have been less ill than group B,
  • group A might have been richer and therefore better nourished,
  • group A might have benefitted from better hygiene in the homeopathic hospital,
  • group A might have received better care, e. g. hydration,
  • group B might have received treatments that made the situation not better but worse.

Because these are RETROSPECTIVE studies, there is no way to account for these and many other factors that might have influenced the outcome. This means that epidemiological studies of this nature can generate interesting results which, in turn, need testing in properly controlled studies where these confounding factors are adequately controlled for. Without such tests, they are next to worthless for recommendations regarding clinical practice.

As it happens, the above author also included two RCT in the review (these are NOT epidemiological studies, as I already mentioned). Let’s have a quick look at them.

The first RCT is flawed for a range of reasons and has been criticised many times before. Even its authors state that “the result cannot be explained given our present state of knowledge, but it calls for further rigorously designed clinical studies.” More importantly, the current Cochrane review of Oscillococcinum, the remedy used in this study, concluded: “There is insufficient good evidence to enable robust conclusions to be made about Oscillococcinum® in the prevention or treatment of influenza and influenza-like illness.”

The second RCT is equally flawed; for instance, its results could be due to the concomitant use of paracetamol, and it seems as though the study was not double blind. The findings of this RCT have so far not been confirmed by an independent replication.

What puzzles me most with these regularly voiced notions about the ‘epidemiological evidence’ for homeopathy is not the deplorable ineptitude of those who promote them, but it is this: do homeopaths really believe that conventional medics and scientists would ignore such evidence, if it were sound or even just encouraging? This assumes that all healthcare professionals (except homeopaths) are corrupt and cynical enough not to follow up leads with the potential to change medicine for ever. It assumes that we would supress knowledge that could save the lives of millions for the sole reason that we are against homeopathy or bribed by ‘BIG PHARMA’.

Surely, this shows more clearly than anything else how deluded homeopaths really are!!!

 

Acupuncture is often recommended as a treatment for shoulder pain, but its effectiveness is far from proven. A new study has just been published; but does it change this uncertainty?

A total of 227 patients with subacromial pain syndrome were recruited to this RCT. The patients were allocated to three groups who received either A) group exercise, B) group exercise plus acupuncture or C) group exercise plus electro-acupuncture. The primary outcome measure was the Oxford Shoulder Score. Follow-up was post treatment, and at 6 and 12 months. Data were analysed on intention-to-treat principles with imputation of missing values.

Treatment groups were similar at baseline. All treatment groups demonstrated improvements over time. Between-group estimates were, however, small and non-significant.

The authors concluded that neither acupuncture nor electro-acupuncture were found to be more beneficial than exercise alone in the treatment of subacromial pain syndrome. 

Well, that was to be expected!… I hear the rationalists amongst us exclaim.

Actually, I am not so sure.

One could easily have expected that the acupuncture groups (B and C) show a significant advantage over group A.

Why?

Because acupuncture is a ‘theatrical placebo’, a ritual that impresses patients and thus impacts on results, particularly on subjective outcomes like pain. If the results had shown a benefit for acupuncture + exercise (groups B and C) versus exercise alone (group A), what would we have made of it? Acupuncture fans would surely have claimed that it is evidence confirming acupuncture’s effectiveness. Sceptics, on the other hand, would have rightly insisted that it demonstrates nothing of the sort – it merely confirms that placebo effects can affect clinical outcomes such as pain.

As it turned out, however, this trial results happened to indicate that these placebo-effects can be so small that they fail to reach the level of statistical significance.

I think there is one noteworthy message here: RCTs with such a design (no adequate control for placebo effects) can easily generate false-positive results (in this case, this did not happen, but it was nevertheless a possible outcome). Such studies are popular but utterly useless: they don’t advance our knowledge one single iota. If that is so, we should not waste our resources on them because, in the final analysis, this is not ethical. In other words, we must stop funding research that has little or no chance of advancing our knowledge.

If you want to scientifically investigate this question, it might be a good idea NOT to start with the following sentence: “Auricular acupuncture (AA) is effective in the treatment of preoperative anxiety”. Yet, this is exactly what the authors did in their recent publication.

The aim of this new study was to investigate whether AA can reduce exam anxiety as compared to placebo and no intervention. Forty-four medical students were randomized to receive AA, placebo, or no intervention in a crossover manner. Subsequently they completed three comparable oral anatomy exams with an interval of one month between the exams/interventions.

A licensed acupuncturist with more than five years of experience with this technique applied AA at the acupuncture points MA-IC1 (Lung), MA-TF1 (ear Shenmen), MA-SC (Kidney), MA-AT1 (Subcortex) and MA-TG (Adrenal gland) bilaterally. Indwelling fixed ‘New Pyonex’ needles embedded in a skin-coloured adhesive tape were used for AA. The participants were instructed by the acupuncturist to stimulate the auricular needles for 3–5 minutes, if they felt anxious. For the placebo procedure, ‘New Pyonex’ placebo needles were attached to five sites on the helix of the auricle bilaterally. ‘New Pyonex’ placebo needles have the same appearance as AA needles but consist of self-adhesive tape only. In order to avoid potential physiologic effects of acupressure, the participants were not instructed to stimulate the attached ‘New Pyonex’ placebo needles. AA and placebo needles were left in situ until the next day and were removed out of sight of the participants after the exam by the investigator, who was not involved in acupuncture procedure

Levels of anxiety were measured using a visual analogue scale before and after each intervention as well as before each exam. Additional measures included the State-Trait-Anxiety Inventory, duration of sleep at night, blood pressure, heart rate and the extent of participant blinding.

All included participants finished the study. Anxiety levels were reduced after AA and placebo intervention compared to baseline and the no intervention condition (p < 0.003). Moreover, AA was also better at reducing anxiety than placebo in the evening before the exam (p = 0.018). Participants were able to distinguish between AA and placebo intervention.

The authors concluded that both auricular acupuncture and placebo procedure were shown to be effective in reducing levels of exam anxiety in medical students. The superiority of verum AA over placebo AA and no intervention is considered to be due to stimulation of cranial nerves, but may have been increased in effect by insufficient participant blinding.

Here are just three of the major concerns I have about this study:

  • The trial design seems odd: a crossover study can only work well, if there is a stable baseline. This may not be the case with three consecutive exams; the anxiety experienced by students is bound to get less as time goes by. I think anyone who has passed a series of exams will confirm that there is a large degree of habituation.
  • It seems inadequate to employ just one acupuncturist; it means that the trial might end up testing not acupuncture per se but the skills of the therapist.
  • The placebo used for this study cannot possibly have fooled anyone into believing that it was real AA; volunteers were not even instructed to ‘stimulate’ the placebo devices. The difference to the ‘real thing’ must have been very clear to all involved. This means that the control for placebo-effects was woefully incomplete. In turn, this means that the observed outcomes are most likely due to residual bias.

In view of these concerns, allow me to re-phrase the authors’ conclusions:

THE RESULTS OF THIS POORLY-DESIGNED STUDY ARE DIFFICULT TO INTERPRET. MOST LIKELY THEY SHOW THAT ACUPUNCTURE IS NOT EFFECTIVE BUT MERELY WORKS THROUGH A PLACEBO-RESPONSE.

1 2 3 7
Recent Comments

Note that comments can be edited for up to five minutes after they are first submitted.


Click here for a comprehensive list of recent comments.

Categories