The new guidelines by the American College of Physicians entitled ‘Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians’ have already been the subject of the previous post. Today, I want to have a closer look at a small section of these guidelines which, I think, is crucial. It is entitled ‘HARMS OF NONPHARMACOLOGIC THERAPIES’. I have taken the liberty of copying it below:
“Evidence on adverse events from the included RCTs and systematic reviews was limited, and the quality of evidence for all available harms data is low. Harms were poorly reported (if they were reported at all) for most of the interventions.
Low-quality evidence showed no reported harms or serious adverse events associated with tai chi, psychological interventions, multidisciplinary rehabilitation, ultrasound, acupuncture, lumbar support, or traction (9,95,150,170–174). Low-quality evidence showed that when harms were reported for exercise, they were often related to muscle soreness and increased pain, and no serious harms were reported. All reported harms associated with yoga were mild to moderate (119). Low-quality evidence showed that none of the RCTs reported any serious adverse events with massage, although 2 RCTs reported soreness during or after massage therapy (175,176). Adverse events associated with spinal manipulation included muscle soreness or transient increases in pain (134). There were few adverse events reported and no clear differences between MCE and controls. Transcutaneous electrical nerve stimulation was associated with an increased risk for skin site reaction but not serious adverse events (177). Two RCTs (178,179) showed an increased risk for skin flushing with heat compared with no heat or placebo, and no serious adverse events were reported. There were no data on cold therapy. Evidence was insufficient to determine harms of electrical muscle stimulation, LLLT, percutaneous electrical nerve stimulation, interferential therapy, short-wave diathermy, and taping.”
The first thing that strikes me is the brevity of the section. Surely, guidelines of this nature must include a full discussion of the risks of the treatments in question!
The second thing that is noteworthy is the fact that the authors confirm the fact I have been banging on about for years: clinical trials of alternative therapies far too often fail to mention adverse effects. I have often pointed out that the failure to report adverse effects in clinical trials is an unacceptable violation of medical ethics. By contrast, the guideline authors seem not to feel strongly about this omission.
The third thing that is noteworthy is that the guidelines evaluate the harms of the treatments purely on the basis of the adverse effects reported in the clinical trials and systematic reviews included in their efficacy assessments. This is nonsensical for at least two reasons:
- The guideline authors themselves are aware that the trials very often fail to mention adverse effects.
- For any assessment of harm, one has to go far beyond the evidence of clinical trials, because trials tend to be too small to pick up rare adverse effects, and because they are always conducted under optimally controlled conditions where adverse effects are less likely to occur than in real life.
Together, these features of the assessment of harms explain why the guideline authors arrive at conclusions which are oddly misguided; I would even feel that they resemble a white-wash. Here are two of the most overt misjudgements:
- no harms associated with acupuncture,
- only trivial harm associated with spinal manipulations.
The best evidence we have today shows that acupuncture leads to mild adverse effects in about 10% of all cases and is also associated with very severe complications (e.g. pneumothorax, cardiac tamponade, infections, deaths) in an unknown number of patients. More details can be found for instance here, here, here and here.
And the best evidence available shows that spinal manipulation leads to moderately severe adverse effects in ~50% of all cases. In addition, we know of hundreds of cases of very severe complications resulting in stroke, permanent neurological deficits or deaths. More details can be found for instance here, here, here and here.
In the introduction, I stated that this small section of the guidelines is crucial.
The reason is simple: any responsible therapeutic decision has to be based not just on the efficacy of the treatment in question but on its risk/benefit balance. The evidence shows that the risks of some alternative therapies can be considerable, a fact that is almost totally neglected in the guidelines. Therefore, the recommendations of the new guidelines by the American College of Physicians entitled ‘Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians’ are in several aspects not entirely correct and need to be reconsidered.
Concerned about the new ACP guidelines on ‘Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians’, Andrea MacGregor asked me to publish her ‘open letter’:
I am a student about to graduate and register as a massage therapist in Canada, and I am writing to express my concern with your recommendation of the use of acupuncture in your new guideline for low-back pain management.
Leading medical and health research experts from around the world, including many who are highly familiar with the use of complementary and alternative therapies, have contributed to a highly informed commentary (attached) assembled by the Friends of Science in Medicine association (Aus.), which supports a strong conclusion that acupuncture is not effective for any specific condition, and that the evidence for it being an effective intervention for low-back pain is not convincing. Another review of acupuncture by FSM concluding that there is a lack of evidence of a therapeutic effect has been endorsed by the Royal Australian and New Zealand College of Obstetricians and Gynaecologists. Respected American medical science writers also maintain that claims of acupuncture’s efficacy are not science-based (examples here and here).
Additionally, previous acupuncture recommendations are being reconsidered by prominent institutions in other parts of the world. The National Institute for Health and Care Excellence guideline for NHS patients in the United Kingdom now recommends against the use of acupuncture for low-back pain, following a high-quality review that critically examined the existing evidence regarding the use of acupuncture and found it to be no more effective than a placebo. The Toronto Hospital for Sick Children has also recently removed references on their website that suggested the efficacy of acupuncture in managing specific chronic pain conditions. The World Health Organization has done the same, no longer suggesting that acupuncture is effective for low-back pain and sciatica.
As someone about to enter a field that is frequently associated with, or considered a part of, complementary healthcare, I know how tempting it can be for us, as professionals and as researchers, to exaggerate claims of efficacy and pin some very high hopes on “new possibilities” in physical therapies.
I also know first-hand how misguided and overblown some of these claims and hopes can be. Many of my own peers and instructors are proponents of acupuncture, and it is common for Canadian massage therapists to become licensed acupuncturists (a similar connection between massage and acupuncture communities, of course, also exists in the United States). I have often seen my own mentors and comrades pushing for the use of acupuncture treatments for many chronic and serious conditions for which there is no basis of evidence at all of acupuncture’s efficacy, including systemic, neurological, and developmental conditions. When questioned, they will usually refer to authorities perceived as “legitimate”, including the American College of Physicians, to say that claims of acupuncture “working” are backed by experts— whether their claims are even pain-related or not.
We see a similar situation with advertisers and media using the guise of “expert-backed” legitimization to recommend acupuncture in misleading ways, often to vulnerable people who could be making better-informed and more effective treatment and management choices for their conditions. Many of these advertising and media entities specifically mention the American College of Physicians as lending credence to their claims, sometimes somewhat out of context.
As someone with a chronic neurological disorder, I find it troubling to see untrue or exaggerated claims of benefit for incurable or serious conditions when we could be focusing on more accurate ideas and having more honest, realistic discussions of our options. This is also important when it comes to deciding how to best allocate our limited health funding resources. Quite a lot of our insurance and out-of-pocket funds are spent on alternative therapies, and it’s important to see things going to use in a way that’s proportionate and appropriate to the evidence we have.
I hope that you will reconsider your recommendation of a practice that is simply not supported by the majority of the research evidence that exists to date. Patients with complex conditions, including low-back pain, deserve accurate and realistic information regarding their treatment options, especially from such trusted and reputable sources as the American College of Physicians. Thank you for your time and attention.
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.
– 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.”
The BMJ has always been my favourite Medical journal. (Need any proof for this statement? A quick Medline search tells me that I have over 60 publications in the BMJ.) But occasionally, the BMJ also disappoints me a great deal.
One of the most significant disappointments was recently published under the heading of STATE OF THE ART REVIEW. A review that is ‘state of the art’ must fulfil certain criteria; foremost it should be informative, unbiased and correct. The paper I am discussing here has, I think, neither of these qualities. It is entitled ‘Management of chronic pain using complementary and integrative medicine’, and here is its abstract:
Complementary and integrative medicine (CIM) encompasses both Western-style medicine and complementary health approaches as a new combined approach to treat a variety of clinical conditions. Chronic pain is the leading indication for use of CIM, and about 33% of adults and 12% of children in the US have used it in this context. Although advances have been made in treatments for chronic pain, it remains inadequately controlled for many people. Adverse effects and complications of analgesic drugs, such as addiction, kidney failure, and gastrointestinal bleeding, also limit their use. CIM offers a multimodality treatment approach that can tackle the multidimensional nature of pain with fewer or no serious adverse effects. This review focuses on the use of CIM in three conditions with a high incidence of chronic pain: back pain, neck pain, and rheumatoid arthritis. It summarizes research on the mechanisms of action and clinical studies on the efficacy of commonly used CIM modalities such as acupuncture, mind-body system, dietary interventions and fasting, and herbal medicine and nutrients.
The full text of this article is such that I could take issue with almost every second statement in it. Obviously, this would be too long and too boring for this blog. So, to keep it crisp and entertaining, let me copy the (tongue in cheek) ‘letter to the editor’ some of us published in the BMJ as a response to the review:
“Alternative facts are fashionable in politics these days, so why not also in healthcare? The article by Chen and Michalsen on thebmj.com provides a handy set of five instructions for smuggling alternative facts into medicine.
1. Create your own terminology: the term ‘complementary and integrated medicine’ (CIM) is nonsensical. Integrated medicine (a hotly disputed field) already covers complementary and conventional medicine.
2. Pretend to be objective: Chen and Michalsen elaborate on the systematic searches they conducted. But they omit hundreds of sources which do not support their message, which cherry-picks only evidence for the efficacy of the treatments they promote.
3. Avoid negativity: they bypass any material that might challenge what they include. For instance, when discussing therapeutic risks, they omit the disturbing lack of post-marketing surveillance: the reason we lack information on adverse events. They even omit to mention the many fatalities caused by their ‘CIM’.
4. Create an impression of thoroughness: Chen and Michalsen cite a total of 225 references. This apparent scholarly attention to detail masks their misuse of many of they list. Reference 82, for example, is employed to back up the claim that “satisfaction was lowest among complementary medicine users with rheumatoid arthritis, vasculitis, or connective tissue diseases”. In fact, it shows nothing of the sort.
5. Back up your message with broad generalisations: Chen and Michalsen conclude that “Taken together, CIM has an increasing role in the management of chronic pain, but high quality research is needed”. The implication is that all the CIMs mentioned in their figure 1 are candidates for pain control – even discredited treatments such as homeopathy.
In our view, these authors render us a service: they demonstrate to the novice how alternative facts may be used in medicine.”
James May, Edzard Ernst, Nick Ross, on behalf of HealthWatch UK
END OF QUOTE
I am sure you have your own comments and opinions, and I encourage you to post them here or (better) submit them to the BMJ or (best) both.
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!
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.
Acupuncture is little more than a theatrical placebo! If we confront an acupuncture fan with this statement, he/she is bound to argue that there are some indications for which the evidence is soundly positive. One of these conditions, they would claim, is nausea and vomiting. But how strong are these data? A new study sheds some light on this question.
The objective of this RCT was to evaluate if consumption of antiemetics and eating capacity differed between patients receiving verum acupuncture, sham acupuncture, or standard care only during radiotherapy. Patients were randomized to verum (n = 100) or sham (n = 100) acupuncture (telescopic blunt sham needle) (12 sessions) and registered daily their consumption of antiemetics and eating capacity. A standard care group (n = 62) received standard care only.
The results show that more patients in the verum and the sham acupuncture group did not need any antiemetic medications, as compared to the standard care group after receiving 27 Gray dose of radiotherapy. More patients in the verum and the sham acupuncture group were capable of eating as usual, compared to the standard care group. Patients receiving acupuncture had lower consumption of antiemetics and better eating capacity than patients receiving standard antiemetic care, plausible by nonspecific effects of the extra care during acupuncture.
The authors concluded that patients receiving acupuncture had lower consumption of antiemetics and better eating capacity than patients receiving standard antiemetic care, plausible by nonspecific effects of the extra care during acupuncture.
I find these conclusions odd because they seem to state that acupuncture was more effective than standard care. Subsequently – almost as an afterthought – they mention that its effects are brought about by nonspecific effects. This is grossly misleading, in my view.
The study was designed as a comparison between real and sham acupuncture, and the standard care group was not a randomised comparison group. Therefore, the main result and conclusion has to focus on the comparison between verum and sham acupuncture. This comparison shows that the two did not produce different result. Therefore, the study shows that acupuncture was not effective.
A much more reasonable conclusion would have been: THIS STUDY FAILED TO FIND SIGNIFICANT EFFECTS OF ACUPUNCTURE BEYOND PLACEBO.
Drug and alcohol dependencies are notoriously difficult to treat effectively. Patients and their families are often desperate and willing to try anything. This seems like an ideal ground for acupuncturists who are, in my experience, experts in putting up smokescreens hiding the true value of their treatment.
The best way to determine the value of any intervention is probably conducting a systematic review of the evidence from rigorous clinical trials. Today we are in the fortunate position to have not just one of those articles; but do they really tell us the truth?
This brand-new systematic review investigated the effects of acupuncture on alcohol-related symptoms and behaviors in patients with this disorder. The PubMed database was searched until 23 August 2016, and reference lists from review studies were also reviewed. The inclusion criteria were the following: (1) being published in a peer-reviewed English-language journal, (2) use of randomized controlled trials (RCTs), (3) assessing the effects of acupuncture on psychological variables in individuals with a primary alcohol problem, and (4) reporting statistics that could be converted to effect sizes.
Seventeen studies were identified for a full-text inspection, and seven (243 patients) of these met our inclusion criteria. The outcomes assessed at the last post-treatment point and any available follow-up data were extracted from each of the studies. Five studies treated patients by inserting a needle into several acupoints in each ear. Two studies stimulated body points with or without ear stimulation. Four studies treated control patients with a placebo needle or under a completely different type of intervention, such as relaxation or transdermal stimulation, whereas the remaining studies inserted needles into nonspecific points. The patients were treated for 2 weeks to 3 months, and the treatment duration per session was 15–45 min. The results of the meta-analysis demonstrated that an acupuncture intervention had a stronger effect on reducing alcohol-related symptoms and behaviours than did the control intervention. A beneficial but weak effect of acupuncture treatment was also found in the follow-up data.
The authors concluded that although our analysis showed a significant difference between acupuncture and the control intervention in patients with alcohol use disorder, this meta-analysis is limited by the small number of studies included. Thus, a larger cohort study is required to provide a firm conclusion.
I am used to reading poor research papers, but this one is like a new dimension. Here are just the most obvious flaws:
- by searching just one database, the likelihood of missing studies is huge,
- by excluding non-English papers, the review automatically becomes non-systematic,
- the included studies differed vastly in many respects and can therefore not be pooled.
As it happens, a further meta-analysis has just been published. Here is its abstract:
Acupuncture has been widely used as a treatment for alcohol dependence. An updated and rigorously conducted systematic review is needed to establish the extent and quality of the evidence on the effectiveness of acupuncture as an intervention for reducing alcohol dependence. This review aimed to ascertain the effectiveness of acupuncture for reducing alcohol dependence as assessed by changes in either craving or withdrawal symptoms.
In this systematic review, a search strategy was designed to identify randomised controlled trials (RCTs) published in either the English or Chinese literature, with a priori eligibility criteria. The following English language databases were searched from inception until June 2015: AMED, Cochrane Library, EMBASE, MEDLINE, PsycINFO, and PubMed; and the following Chinese language databases were similarly searched: CNKI, Sino-med, VIP, and WanFang. Methodological quality of identified RCTs was assessed using the Jadad Scale and the Cochrane Risk of Bias tool.
Fifteen RCTs were included in this review, comprising 1378 participants. The majority of the RCTs were rated as having poor methodological rigour. A statistically significant effect was found in the two primary analyses: acupuncture reduced alcohol craving compared with all controls (SMD = −1.24, 95% CI = −1.96 to −0.51); and acupuncture reduced alcohol withdrawal symptoms compared with all controls (SMD = −0.50, 95% CI = −0.83 to −0.17). In secondary analyses: acupuncture reduced craving compared with sham acupuncture (SMD = −1.00, 95% CI = −1.79 to −0.21); acupuncture reduced craving compared with controls in RCTs conducted in Western countries (SMD = −1.15, 95% CI = −2.12 to −0.18); and acupuncture reduced craving compared with controls in RCTs with only male participants (SMD = −1.68, 95% CI = −2.62 to −0.75).
This study showed that acupuncture was potentially effective in reducing alcohol craving and withdrawal symptoms and could be considered as an additional treatment choice and/or referral option within national healthcare systems.
This Meta-analysis is only a little better than the first, I am afraid. What its conclusions do not sufficiently reflect, in my view, is the fact that the quality of the primary studies was mostly very poor – too poor to draw conclusions from (other than ‘acupuncture research is usually lousy’; see figure below). Therefore, I fail to see how the authors could draw the relatively firm and positive conclusions cited above. In my view, they should have stated something like this: DUE TO THE RISK OF BIAS IN MANY TRIALS, THE EFFECTIVENESS OF ACUPUNCTURE REMAINS UNPROVEN.
The authors of the first meta-analysis open the discussion by proudly declaring that “the present study is the first meta-analysis to examine the effect of acupuncture treatment on patients with alcohol use disorder and to provide data on the magnitude of this effect on alcohol-related clinical symptoms and behaviours.” They discretely overlook this meta-analysis from 2009 (and several others which even their rudimentary search would have identified):
Nineteen electronic databases, including English, Korean, Japanese, and Chinese databases, were systematically searched for RCTs of acupuncture for alcohol dependence up to June 2008 with no language restrictions. The methodological qualities of eligible studies were assessed using the criteria described in the Cochrane Handbook.
Eleven studies, which comprised a total of 1,110 individual cases, were systematically reviewed. Only 2 of 11 trials reported satisfactorily all quality criteria. Four trials comparing acupuncture treatment and sham treatments reported data for alcohol craving. Three studies reported that there were no significant differences. Among 4 trials comparing acupuncture and no acupuncture with conventional therapies, 3 reported significant reductions. No differences between acupuncture and sham treatments were found for completion rates (Risk Ratio = 1.07, 95% confidence interval, CI = 0.91 to 1.25) or acupuncture and no acupuncture (Risk Ratio = 1.15, 95% CI = 0.79 to 1.67). Only 3 RCTs reported acupuncture-related adverse events, which were mostly minimal.
The results of the included studies were equivocal, and the poor methodological quality and the limited number of the trials do not allow any conclusion about the efficacy of acupuncture for treatment of alcohol dependence. More research and well-designed, rigorous, and large clinical trials are necessary to address these issues.
One does not need to be an expert in interpreting meta-analyses, I think, to see that this paper is more rigorous than the new ones (which incidentally were published in the very dubious journals). And this is why I trust the conclusions of this last-named meta-analysis more than those of the new one: the efficacy of acupuncture remains unproven. And this means that we should not employ or promote it for routine care.
The aim of this paper was to systematically review effectiveness, safety, and robustness of evidence for complementary and alternative medicine in managing premature ejaculation (PE). Nine databases were searched through September 2015. Randomized controlled trials (RCTs) evaluating complementary and alternative medicine for PE were included. Studies were included if they reported on intravaginal ejaculatory latency time (IELT) and/or another validated PE measurement. Adverse effects were summarized.
Ten RCTs were included. Two assessed acupuncture, five assessed Chinese herbal medicine, one assessed Ayurvedic herbal medicine, and two assessed topical “severance secret” cream. Risk of bias was unclear in all studies because of unclear allocation concealment or blinding, and only five studies reported stopwatch-measured IELT. Acupuncture slightly increased IELT over placebo in one study (mean difference [MD] = 0.55 minute, P = .001). In another study, Ayurvedic herbal medicine slightly increased IELT over placebo (MD = 0.80 minute, P = .001). Topical severance secret cream increased IELT over placebo in two studies (MD = 8.60 minutes, P < .001), although inclusion criteria were broad (IELT < 3 minutes). Three studies comparing Chinese herbal medicine with selective serotonin reuptake inhibitors (SSRIs) favored SSRIs (MD = 1.01 minutes, P = .02). However, combination treatment with Chinese medicine plus SSRIs improved IELT over SSRIs alone (two studies; MD = 1.92 minutes, P < .00001) and over Chinese medicine alone (two studies; MD = 2.52 minutes, P < .00001). Adverse effects were not consistently assessed but where reported were generally mild.
The authors concluded that there is preliminary evidence for the effectiveness of acupuncture, Chinese herbal medicine, Ayurvedic herbal medicine, and topical severance secret cream in improving IELT and other outcomes. However, results are based on clinically heterogeneous studies of unclear quality. There are sparse data on adverse effects or potential for drug interactions. Further well-conducted randomized controlled trials would be valuable.
One has to be an optimist to agree that this constitutes ‘preliminary evidence for the effectiveness of acupuncture, Chinese herbal medicine, Ayurvedic herbal medicine, and topical severance secret cream in improving IELT and other outcomes.’ In the discussion section, the authors stress that “…all 10 studies were classed as having an overall unclear risk of bias because of unclear reporting of allocation concealment (all 10 studies) and unclear blinding of participants and personnel (five studies).” This hardly allows even a preliminary conclusion, in my view.
So, what DOES this review show? I think it demonstrates that
- alternative therapies are being touted and occasionally tested for even the most unlikely conditions,
- the quality of the studies is generally too poor to justify the research (particularly in an area as intrusive as PE),
- clinical trials often seem to be used not for finding answers but for promotion,
- in alternative medicine, trialists regularly violate research ethics by failing to report adverse effects.
George Lewith has died on 17 March, aged 67. He was one of the most productive researchers of alternative medicine in the UK; specifically he was interested in acupuncture. If you search this blog, you find several posts that mention him or are entirely dedicated to his work. Undeniably, my own views and research were often very much at odds with those of Lewith.
Wikipedia informs us that Lewith graduated from Trinity College, Cambridge in medicine and biochemistry. He then went on to Westminster Medical School to complete his clinical studies and began working clinically in 1974. In 1977 Lewith became a member of the Royal College of Physicians. Then, in 1980, he became a member of the Royal College of General Practitioners and, later in 1999, was elected a fellow of the Royal College of Physicians.
He was a Professor of Health Research in the Department of Primary Care at the University of Southampton and a director of the International Society for Complementary Medicine Research. Lewith has obtained a significant number of institutional peer reviewed fellowships at doctoral and post-doctoral level and has been principal investigator or collaborator in research grants totally over £5 million during the last decade.
Between 1980 and 2010, Lewith was a partner at the Centre for Complementary and Integrated Medicine, a private practice providing complementary treatments with clinics in London and Southampton.
A tribute by the British Acupuncture Council is poignant, in my view: “George was a friend not only to all of the acupuncture profession, be it traditional, medical or physiotherapist – he was a member of all three professional bodies – but to the whole of complementary medicine. As well as being a research leader he was also politically savvy, working tirelessly up front and behind the scenes to try to bring acupuncture and CAM further into the mainstream. Nobody did more.”
I find it poignant because it hints at the many differences I (and many others) had with Lewith during the last 25 years that I knew him. George was foremost a proponent of acupuncture. His 1985 book – the first of many – advocated treating many internal diseases with acupuncture!
George did not strike me as someone who had the ability or even the ambition to use science for finding the truth and for falsifying hypotheses; in my view, he employed it to confirm his almost evangelic belief. In the pursuit of this all-important aim he did indeed spend a lot of time and energy pulling strings, including on the political level. George was undoubtedly successful but the question has to be asked to what extent this was due to his tireless work ‘behind the scenes’.
In my view, George was a typical example of someone who first and foremost was an advocate and a researcher second. During my time in Exeter, I have met numerous co-workers who had the same problem. Almost without exception, I found that it is impossible to turn such a person into a decent scientist. The advocacy of alternative medicine always got in the way of objectivity and rationality, qualities that are, of course, essential for good science.
George’s very first publication on acupuncture was a ‘letter to the editor’ published in the BMJ. In it, he announced that he is planning to conduct a trial of acupuncture and stated that “acupuncture will be compared to an equally magical placebo”. Yes, George always had the ability to make me laugh; and this is why I will miss him.
One phenomenon that can be noted more frequently than any other in alternative medicine research is that studies arrive at wrong or misleading conclusions. This is more than a little disappointing, not least because it is the conclusion of a trial that is often picked up by health writers and others who in turn mislead the public. On this blog, we must have seen hundreds of examples of this irritating phenomenon. Here is yet another one. This study, a randomized, parallel, open-label exploratory trial, evaluated and compared the effects of systemic manual acupuncture, periauricular electroacupuncture and distal electroacupuncture for treating patients with tinnitus. It included patients who suffered from idiopathic tinnitus for more than two weeks were recruited. They were divided into three groups:
- systemic manual acupuncture group (MA),
- periauricular electroacupuncture group (PE),
- distal electroacupuncture group (DE).
Nine acupoints (TE 17, TE21, SI19, GB2, GB8, ST36, ST37, TE3 and TE9), two periauricular acupoints (TE17 and TE21), and four distal acupoints (TE3, TE9, ST36, and ST37) were selected. The treatment sessions were performed twice weekly for a total of 8 sessions over 4 weeks. Outcome measures were the tinnitus handicap inventory (THI) score and the loud and uncomfortable visual analogue scales (VAS). Demographic and clinical characteristics of all participants were compared between the groups upon admission using one-way analysis of variance (ANOVA). One-way ANOVA was used to evaluate the THI, VAS loud, and VAS uncomfortable scores. The least significant difference test was used as a post-hoc test. In total, 39 subjects were eligible for analysis. No differences in THI and VAS loudness scores were observed between groups. The VAS uncomfortable scores decreased significantly in MA and DE compared with those in PE. Within the group, all three treatments showed some effect on THI, VAS loudness scores and VAS uncomfortable scores after treatment except DE in THI. The authors concluded that there was no statistically significant difference between systemic manual acupuncture, periauricular electroacupuncture and distal electroacupuncture in tinnitus. However, all three treatments had some effect on tinnitus within the group before and after treatment. Systemic manual acupuncture and distal electroacupuncture have some effect on VAS. Neither of the three treatments tested in this study have been previously proven to work. Therefore, it is quite simply nonsensical to compare them. Comparative studies are indicated only with therapies that have a solid evidence-base. They are called ‘superiority trials’ and require a different statistical approach as well as much larger sample sizes. In other words, this study was an unethical waste of resources from the outset. With this in mind, there is only one conclusion that fits the data: there was no statistically significant difference between the three types of acupuncture. The data are therefore in keeping with the notion that all three are placebos. Alternatively one might conclude more clearly for those who are otherwise resistant to learning a lesson: POORLY DESIGNED CLINICAL TRIALS ARE UNETHICAL AND NEVER LEND THEMSELVES TO MEANINGFUL CONCLUSIONS.
A new study published in JAMA investigated the long-term effects of acupuncture compared with sham acupuncture and being placed in a waiting-list control group for migraine prophylaxis. The trial was a 24-week randomized clinical trial (4 weeks of treatment followed by 20 weeks of follow-up). Participants were randomly assigned to 1) true acupuncture, 2) sham acupuncture, or 3) a waiting-list control group. The trial was conducted from October 2012 to September 2014 in outpatient settings at three clinical sites in China. Participants 18 to 65 years old were enrolled with migraine without aura based on the criteria of the International Headache Society, with migraine occurring 2 to 8 times per month.
Participants in the true acupuncture and sham acupuncture groups received treatment 5 days per week for 4 weeks for a total of 20 sessions. Participants in the waiting-list group did not receive acupuncture but were informed that 20 sessions of acupuncture would be provided free of charge at the end of the trial. Participants used diaries to record migraine attacks. The primary outcome was the change in the frequency of migraine attacks from baseline to week 16. Secondary outcome measures included the migraine days, average headache severity, and medication intake every 4 weeks within 24 weeks.
A total of 249 participants 18 to 65 years old were enrolled, and 245 were included in the intention-to-treat analyses. Baseline characteristics were comparable across the 3 groups. The mean (SD) change in frequency of migraine attacks differed significantly among the 3 groups at 16 weeks after randomization; the mean (SD) frequency of attacks decreased in the true acupuncture group by 3.2 (2.1), in the sham acupuncture group by 2.1 (2.5), and the waiting-list group by 1.4 (2.5); a greater reduction was observed in the true acupuncture than in the sham acupuncture group (difference of 1.1 attacks; 95% CI, 0.4-1.9; P = .002) and in the true acupuncture vs waiting-list group (difference of 1.8 attacks; 95% CI, 1.1-2.5; P < .001). Sham acupuncture was not statistically different from the waiting-list group (difference of 0.7 attacks; 95% CI, −0.1 to 1.4; P = .07).
The authors concluded that among patients with migraine without aura, true acupuncture may be associated with long-term reduction in migraine recurrence compared with sham acupuncture or assigned to a waiting list.
Note the cautious phraseology: “… acupuncture may be associated with long-term reduction …”
The authors were, of course, well advised to be so atypically cautious:
- Comparisons to the waiting list group are meaningless for informing us about the specific effects of acupuncture, as they fail to control for placebo-effects.
- Comparisons between real and sham acupuncture must be taken with a sizable pinch of salt, as the study was not therapist-blind and the acupuncturists may easily have influenced their patients in various ways to report the desired result (the success of patient-blinding was not reported but would have gone some way to solving this problem).
- The effect size of the benefit is tiny and of doubtful clinical relevance.
My biggest concern, however, is the fact that the study originates from China, a country where virtually 100% of all acupuncture studies produce positive (or should that be ‘false-positive’?) findings and data fabrication has been reported to be rife. These facts do not inspire trustworthiness, in my view.
So, does acupuncture work for migraine? The current Cochrane review included 22 studies and its authors concluded that the available evidence suggests that adding acupuncture to symptomatic treatment of attacks reduces the frequency of headaches. Contrary to the previous findings, the updated evidence also suggests that there is an effect over sham, but this effect is small. The available trials also suggest that acupuncture may be at least similarly effective as treatment with prophylactic drugs. Acupuncture can be considered a treatment option for patients willing to undergo this treatment. As for other migraine treatments, long-term studies, more than one year in duration, are lacking.
So, maybe acupuncture is effective. Personally, I am not convinced and certainly do not think that the new JAMA study significantly strengthened the evidence.