Gastro-oesophageal reflux disease (GORD) is a common, benign condition. It can be treated by changing eating habits or drugs. Many alternative therapies are also on offer, for instance, acupuncture. But does it work? Let’s find out.
The objective of this meta-analysis was to explore the effectiveness of acupuncture for the treatment of gastro-oesophageal reflux disease (GORD). Four English and four Chinese databases were searched through June 2016. Randomised controlled trials investigating the effectiveness of manual acupuncture or electroacupuncture (MA/EA) for GORD versus or as an adjunct to Western medicine (WM) were selected.
A total of 12 trials involving 1235 patients were included. The results demonstrated that patients receiving MA/EA combined with WM had a superior global symptom improvement compared with those receiving WM alone with no significant heterogeneity. Recurrence rates of those receiving MA/EA alone were lower than those receiving WM with low heterogeneity, while global symptom improvement (six studies) and symptom scores (three studies) were similar. Descriptive analyses suggested that acupuncture also improves quality of life in patients with GORD.
The authors concluded that this meta-analysis suggests that acupuncture is an effective and safe treatment for GORD. However, due to the small sample size and poor methodological quality of the included trials, further studies are required to validate our conclusions.
I am glad the authors used the verb ‘suggest’ in their conclusions. In fact, even this cautious terminology is too strong, in my view. Here are 9 reasons why:
- The hypothesis that acupuncture is effective for GORD lacks plausibility.
- All the studies were of poor or very poor methodological quality.
- All but one were from China, and we know that all acupuncture trials from this country are positive, thus casting serious doubt on their validity.
- Six trials had the infamous ‘A+B versus B’ design which never generates a negative result.
- There was evidence of publication bias, i. e. negative trials had disappeared and were thus not included in the meta-analysis.
- None of the trials made an attempt to control for placebo effects by using a sham-control procedure.
- None used patient-blinding.
- The safety of a therapy cannot be assessed on the basis of 12 trials
- Seven studies failed to report adverse effects, thus violating research ethics.
Considering these facts, I think that a different conclusion would have been more appropriate: this meta-analysis provides no good evidence for the assumption that acupuncture is an effective and safe treatment for GORD.
The purpose of the study was to compare utilization of conventional psychotropic drugs among patients seeking care for anxiety and depression disorders (ADDs) from general practitioners (GPs) who
- strictly prescribe conventional medicines (GP-CM),
- regularly prescribe homeopathy in a mixed practice (GP-Mx),
- or are certified homeopathic GPs (GP-Ho).
The investigation was an epidemiological cohort study of general practice in France, which included GPs and their patients consulting for ADDs (scoring 9 or more in the Hospital Anxiety and Depression Scale, HADS). Information on all medication utilization was obtained by a standardised telephone interview at inclusion, 1, 3 and 12 months.
Of 1562 eligible patients consulting for ADDs, 710 (45.5 %) agreed to participate. Adjusted multivariate analyses showed that GP-Ho and GP-Mx patients were less likely to use psychotropic drugs over 12 months, compared to GP-CM patients. The rate of clinical improvement (HADS <9) was marginally superior for the GP-Ho group as compared to the GP-CM group, but not for the GP-Mx group.
The authors concluded that patients with ADD, who chose to consult GPs prescribing homeopathy reported less use of psychotropic drugs, and were marginally more likely to experience clinical improvement, than patients managed with conventional care. Results may reflect differences in physicians’ management and patients’ preferences as well as statistical regression to the mean.
Aren’t we glad they added the last sentence to their conclusion!!!
Without it, one might have thought that the observed differences were due to the homeopathic remedies. In fact, the finding amounts to a self-fulfilling prophecy: Homeopaths tend to be against prescribing conventional drugs. This means that patients consulting homeopaths are bound to use less drugs than patients who consult conventional doctors. In that sense, the study was like monitoring whether consumers who go to the butchers buy more meat than those shopping in a shop for vegetarians.
The only result that requires a more serious consideration is that homeopathically treated patients experienced more clinical improvement than those treated conventionally. But even this difference is not hard to explain: firstly, the difference was merely marginal; secondly, patients with ADD are bound to respond particularly well to the empathetic and long therapeutic encounter most homeopaths offer. In other words, the difference had nothing to do with the alleged effectiveness of the homeopathic remedies.
Insomnia is a ‘gold standard’ indication for alternative therapies of all types. In fact, it is difficult to find a single of these treatments that are not being touted for this indication. Consequently, it has become a nice little earner for alternative therapists (hence ‘gold standard’).
But how good is the evidence suggesting that any alternative therapy is effective for insomnia?
Whenever I have discussed this issue on my blog, the conclusion was that the evidence is less than convincing or even negative. Similarly, whenever I conducted proper systematic reviews in this area, the evidence turned out to be weak or negative. Here are four of the conclusions we drew at the time:
- The evidence for acupuncture as a treatment of insomnia is plagued by important limitations, e.g. the poor quality of most primary studies and some systematic reviews. Those that are sensitive to such limitations, fail to arrive at a positive verdict about the effectiveness of acupuncture.
- We conclude that, because of the paucity and of the poor quality of the data, the evidence for the effectiveness of auricular acupuncture for the symptomatic treatment of insomnia is limited. Further, rigorously designed trials are warranted to confirm these results.
- The evidence for valerian as a treatment for insomnia is inconclusive.
- Evidence from RCTs does not show homeopathy to be an effective treatment for insomnia and sleep-related disorders. (FACT, 2011, 16:195-99)
“But this ERNST fellow cannot be trusted, he is not objective!”, I hear some of my detractors shout.
But is he really?
Would an independent, high-level panel of experts arrive at more positive conclusions?
Let’s find out!
This European guideline for the diagnosis and treatment of insomnia recently provided recommendations for the management of adult patients with insomnia. The guideline is based on a systematic review of relevant meta-analyses published till June 2016. The GRADE (Grading of Recommendations Assessment, Development and Evaluation) system was used to grade the evidence and guide recommendations.
The findings and recommendations are as follows:
- Cognitive behavioural therapy for insomnia is recommended as the first-line treatment for chronic insomnia in adults of any age (strong recommendation, high-quality evidence).
- A pharmacological intervention can be offered if cognitive behavioural therapy for insomnia is not sufficiently effective or not available. Benzodiazepines, benzodiazepine receptor agonists and some antidepressants are effective in the short-term treatment of insomnia (≤4 weeks; weak recommendation, moderate-quality evidence). Antihistamines, antipsychotics, melatonin and phytotherapeutics are not recommended for insomnia treatment (strong to weak recommendations, low- to very-low-quality evidence).
- Light therapy and exercise need to be further evaluated to judge their usefulness in the treatment of insomnia (weak recommendation, low-quality evidence).
- Complementary and alternative treatments (e.g. homeopathy, acupuncture) are not recommended for insomnia treatment (weak recommendation, very-low-quality evidence).
I think, I can rest my case.
The goal of this study was to assess clinical outcomes observed among adult patients who received acupuncture treatments at a United States Air Force medical center.
This retrospective chart review was performed at the Nellis Family Medicine Residency in the Mike O’Callaghan Military Medical Center at Nellis Air Force Base in Las Vegas, NV. The charts were from 172 consecutive patients who had at least 4 acupuncture treatments within 1 year. These patients were suffering from a wide range of symptoms, including pain, anxiety and sleep problems. The main outcome measures were prescriptions for opioid medications, muscle relaxants, benzodiazepines, and nonsteroidal anti-inflammatory drugs (NSAIDS) in the 60 days prior to the first acupuncture session and in the corresponding 60 days 1 year later; and Measure Yourself Medical Outcome Profile (MYMOP2) values for symptoms, ability to perform activities, and quality of life.
The most common 10 acupuncture treatments in descending order were: (1) the Auricular Trauma Protocol; (2) Battlefield Auricular Acupuncture; (3) Chinese scalp acupuncture, using the upper one-fifth of the sensory area and the Foot Motor Sensory Area; (4) the Koffman Cocktail; (5) lumbar percutaneous electrical nerve stimulation (PENS); (6) various auricular functional points; (7) Chinese scalp acupuncture, using the frontal triangle pattern; (8) cervical PENS; (9) the Great American Malady treatment; and (10) tendinomuscular meridian treatment with surface release.
The results show that opioid prescriptions decreased by 45%, muscle relaxants by 34%, NSAIDs by 42%, and benzodiazepines by 14%. MYMOP2 values decreased 3.50–3.11 (P < 0.002) for question 1, 4.18–3.46 (P < 0.00001) for question 3, and 2.73–2.43 (P < 0.006) for question 4.
The authors concluded that in this military patient population, the number of opioid prescriptions decreased and patients reported improved symptom control, ability to function, and sense of well-being after receiving courses of acupuncture by their primary care physicians.
The phraseology used by the authors is intriguing; they imply that the clinical outcomes were the result of the acupuncture treatment without actually stating it. This is perhaps most obvious in the title of the paper: Reduction in Pain Medication Prescriptions and Self-Reported Outcomes Associated with Acupuncture in a Military Patient Population. Association is not causation! But the implication of a cause effect relationship is clearly there. Once we realise who is behind this research we understand why: This study was funded by the ACUS Foundation as part of a Cooperative Research and Development Agreement with the 99th Medical Group, at Nellis Air Force Base.
The mission of Acus Foundation is to educate military physicians in the science and art of medical acupuncture, and to facilitate its integration into conventional military care… we are the most experienced team of physician teachers and practitioners of acupuncture in the United States. If they are so experienced, they surely also know that there are many explanations for the observed outcomes which are totally unrelated to acupuncture, e. g.:
- the natural history of the conditions that were being treated;
- the conventional therapies the soldiers received;
- the regression to the mean;
- social desirability;
- placebo effects.
In fact the results could even indicate that acupuncture caused a delay of clinical improvement; without a control group, we cannot know either way. All we can safely assume from this study is that it is yet another example of promotion masquerading as research.
This new RCT by researchers from the National Institute of Complementary Medicine in Sydney, Australia was aimed at ‘examining the effect of changing treatment timing and the use of manual, electro acupuncture on the symptoms of primary dysmenorrhea’. It had four arms:
- low frequency manual acupuncture (LF-MA),
- high frequency manual acupuncture (HF-MA),
- low frequency electro acupuncture (LF-EA)
- and high frequency electro acupuncture (HF-EA).
A total of 74 women were given 12 treatments over three menstrual cycles, either once per week (LF groups) or three times in the week prior to menses (HF groups). All groups received a treatment in the first 48 hours of menses. The primary outcome was the reduction in peak menstrual pain at 12 months from trial entry.
During the treatment period and 9 month follow-up all groups showed statistically significant reductions in peak and average menstrual pain compared to baseline. However, there were no differences between groups. Health related quality of life increased significantly in 6 domains in groups having high frequency of treatment compared to two domains in low frequency groups. Manual acupuncture groups required less analgesic medication than electro-acupuncture groups. HF-MA was most effective in reducing secondary menstrual symptoms compared to both–EA groups.
The authors concluded that acupuncture treatment reduced menstrual pain intensity and duration after three months of treatment and this was sustained for up to one year after trial entry. The effect of changing mode of stimulation or frequency of treatment on menstrual pain was not significant. This may be due to a lack of power. The role of acupuncture stimulation on menstrual pain needs to be investigated in appropriately powered randomised controlled trials.
If I were not used to reading rubbish research of alternative medicine in general and acupuncture in particular, this RCT would amaze me – not so much because of its design, execution, or write-up, but primarily because of its conclusion (why, oh why, I ask myself, did PLOS ONE publish this paper?). They are, I think, utterly barmy.
Let me explain:
- “acupuncture treatment reduced menstrual pain intensity” – oh no, it didn’t; at least this is not what the study proves; the fact that pain was perceived as less could be due to a host of factors, for instance regression towards the mean, or social desirability; as there was no proper control group, nobody can tell;
- the lack of difference between treatments “may be due to a lack of power”. Yes, but more likely it is due to the fact that all versions of a placebo therapy generate similar outcomes.
- “acupuncture stimulation on menstrual pain needs to be investigated in appropriately powered randomised controlled trials”. Why? Because the authors have a quasi-religious belief in acupuncture? And if they have, why did they not design their study ‘appropriately’?
The best conclusion I can suggest for this daft trial is this: IN THIS STUDY, THE PRIMARY ENDPOINT SHOWED NO DIFFERENCE BETWEEN THE 4 TREATMENT GROUPS. THE RESULTS ARE THEREFORE FULLY COMPATIBLE WITH THE NOTION THAT ACUPUNCTURE IS A PLACEBO THERAPY.
Something along these lines would, in my view, have been honest and scientific. Sadly, in acupuncture research, we very rarely get such honest science and the ‘National Institute of Complementary Medicine in Sydney, Australia’ has no track record of being the laudable exception to this rule.
I have repeatedly cautioned about the often poor quality of research into alternative medicine. This seems particularly necessary with studies of acupuncture, and especially true for such research carried out in China. I have also frequently noted that certain ‘CAM journals’ are notoriously prone to publishing rubbish. So, what can we expect from a paper that:
- is on alternative medicine,
- focusses on acupuncture,
- is authored by Chinese researchers,
- was published in the Journal of Alternative and Complementary Medicine (JACM)?
The answer is PROBABLY NOT A LOT!
As if for confirming my prediction, The JACM just published this systematic review. It reports pairwise and network meta-analyses to determine the effectiveness of acupuncture and acupuncture-related techniques for the treatment of psoriasis. A total of 13 RCTs were included. The methodological quality of these studies was ‘not rigorous’ according to the authors – in fact, it was lousy. Acupoint stimulation seemed to be more effective than non-acupoint stimulation. The short-term treatment effect was superior to the long-term effect (as one would expect with placebo). Network meta-analysis suggested that acupressure or acupoint catgut embedding generate superior effects compared to medications. It was noted that acupressure was the most effective treatment of all the acupuncture-like therapies.
The authors concluded that acupuncture-related techniques could be considered as an alternative or adjuvant therapy for psoriasis in short term, especially of acupressure and acupoint catgut embedding. This study recommends further well-designed, methodologically rigorous, and more head-to-head randomized trials to explore the effects of acupuncture-related techniques for treating psoriasis.
And what is wrong with that?
- The review is of very poor quality.
- The primary studies are even worse.
- The English language is defective to the point of being not understandable.
- The conclusions are misleading.
Correct conclusions should read something like this: Due to the paucity and the poor quality of the clinical trials, this review could not determine whether acupuncture and similar therapies are effective for psoriasis.
And then there is, of course, the question about plausibility. How plausible is the assumption that acupuncture might affect a genetic autoimmune disease like psoriasis. The answer, I think, is that the assumption is highly unlikely.
In the above review, most of the 13 primary RCTs were from China. One of the few studies not conducted in China is this one:
56 patients suffering from long-standing plaque psoriasis were randomized to receive either active treatment (electrostimulation by needles placed intramuscularly, plus ear-acupuncture) or placebo (sham, ‘minimal acupuncture‘) twice weekly for 10 weeks. The severity of the skin lesions was scored (PASI) before, during, and 3 months after therapy. After 10 weeks of treatment the PASI mean value had decreased from 9.6 to 8.3 in the ‘active’ group and from 9.2 to 6.9 in the placebo group (p < 0.05 for both groups). These effects are less than the usual placebo effect of about 30%. There were no statistically significant differences between the outcomes in the two groups during or 3 months after therapy. The patient’s own opinion about the results showed no preference for ‘active’ therapy. It was also clear from the answers that the blinded nature of the study had not been discovered by the patients. In conclusion, classical acupuncture is not superior to sham (placebo) ‘minimal acupuncture‘ in the treatment of psoriasis.
Somehow, I trust these conclusions more than the ones from the review!
And somehow, I get very tired of journal editors failing to do their job of rejecting papers that evidently are embarrassing, unethical rubbish.
Since more than 20 years, I have been writing about the risks of alternative therapies. One of my first papers on this issue was published in 1995 and focussed on acupuncture. Here is its abstract:
My reason for banging on about the potential harms (direct and indirect risks) of alternative medicine is fairly obvious: I want to alert healthcare professionals and consumers to the fact that these treatments may not be as harmless as they are usually advertised to be. Yet, I have often be called an alarmist fear-monger. In my view, nothing could be further from the truth.
Thinking about fear-mongering, I began to ask myself whether those who regularly accuse me are the ones guilty of the deed. Are alternative practitioners fear-mongers? Surely not all of them, but some clearly are. Here are a few of the strategies they use for their fear-mongering.
Perhaps the most obvious way to instil fear into people is to tell them that they are affected by a disease or condition they do not have. Many alternative practitioners do exactly that!
- A chiropractor might tell you that you have a subluxation in your spine.
- A naturopath would inform you that your body is full of toxins.
- An acupuncturist will tell you that your life energy is blocked.
- A homeopath might warn you that your vital force is too low.
These diagnoses have one thing in common: they do not exist. They are figments of the therapist’s imagination. And they have another thing in common: the abnormalities need to be corrected, and – surprise, surprise – the very therapy that the practitioner specialises in happens to be just the ticket for that purpose.
- The chiropractor will tell you that a simple spinal adjustment will solve the problem.
- The naturopath will inform you that a bit of detox will eliminate the toxins.
- The acupuncturist will tell you that his needles will de-block your chi.
- The homeopath will persuade you that he can find the exact remedy to revive your vital force.
And there we have the third thing these diagnoses have in common: they are all treatable, will all result in a nice bill, and will all improve the cash-flow of the therapist.
But often, it is not even necessary for an alternative therapist to completely invent a diagnosis. Patients usually consult an alternative practitioner with some sort of symptom – frequently with what one might call a medical triviality that does not need any treatment at all but can be dealt with differently, for instance, by issuing some life-style advice or just simple re-assurance that nothing major is amiss. But for the fear-monger, this is not enough. He feels the need to administer his therapy, and for that purpose he needs to medicalize trivialities :
- A low mood thus becomes a clinical depression.
- A sore back is turned into a nasty lumbago.
- A tummy upset morphs into a dangerous gastritis.
- Abdominal unrest is diagnosed to be a leaky gut syndrome.
- A food aversion turns into a food intolerance, etc., etc.
The common denominator is again the fact that fear is instilled into the patient. And again, a useless therapy is administered, if at all possible in the form of a lengthy series of treatments. This, of course, generates significant benefit – not therapeutic, but financial!
DEMONIZING CONVENTIONAL MEDICINE
But there is always the risk that the patient is wiser than expected. She might be so scared learning of her condition that she decides to see her doctor. That would mean a loss of income which has to be avoided! The trick to achieve this is usually not difficult: conventional healthcare professionals must be demonized.
- They are not treating the root cause of the problem.
- They are in the pocket of BIG PHARMA.
- They prescribe medicines with terrible side-effects.
- They have no idea about holism.
- They never have enough time to listen, etc., etc.
I know, some of these criticisms are not entirely incorrect (for instance, many conventional medicines do have serious side-effects but, as I try to point out ad nauseam, we need to consider their risk/benefit balance). But that is hardly the point here; the point is to scare the patient off conventional medicine. Only a person who is convinced that the ‘medical mafia’ is out to get her, will prove to be a loyal customer of all things alternative.
And a loyal customer is someone who comes not just once or twice but regularly, ideally from cradle to grave. The way to achieve this ultimate stimulus of the practitioners cash flow is to convince the patient that she needs regular treatments, even when she feels perfectly alright. The magic word here is PREVENTION! The masters here are the chiropractors, I guess; they promote what they call ‘maintenance care’, i.e. the regular treatment of healthy individuals to keep their spines subluxation-free. It goes without saying that maintenance care is a money-making scam.
The strategy requires two little lies, but that’s forgivable considering the good cause, boosting the income of the practitioner:
- Conventional doctors don’t do prevention.
- The alternative treatment is an effective preventative.
The first statement can be shown to be an obvious lie. All we know about effective disease prevention today comes from conventional medicine and science; nothing originates from the realm of alternative medicine. Remarkably, the most efficacious preventative measure of all times, immunisation, is frequently defamed and neglected by alternative practitioners.
The second statement is a necessary lie; how else would a patient agree to pay regularly for the practitioner’s services? I am not aware of any alternative therapy that can effectively prevent any disease.
- Some alternative practitioners regularly instil fear into consumers.
- Several strategies are being used for this purpose.
- They have the aim of maximising the therapists’ income.
- Fear-mongering is unethical and despicable.
- Pointing out that a certain therapy might fail to generate more good than harm is not fear-mongering.
Olivia Newton-John is postponing her June U.S. and Canadian concert tour dates, as the back pain that initially caused her to postpone the first half of her concert tour, has been diagnosed as bone metastases form her earlier breast cancer. She now intends to complete a short course of photon radiation therapy along with alternative therapies for improving her quality of life. “I decided on my direction of therapies after consultation with my doctors and natural therapists and the medical team at my Olivia Newton-John Cancer Wellness and Research Centre in Melbourne”, Newton-John said. The actress had been diagnosed with breast cancer in 1992. At that time, she underwent chemotherapy after initially trying alternative treatments like acupuncture and homeopathy.
Olivia Newton-John’s daughter Chloe Lattanzi has said her mum would use cannabis oil to aid in her fight against cancer, while long-time friend John Farnham has thrown his support behind the singer. Lattanzi owns a legal marijuana farm in Oregon and said that her mum would also use other natural healing remedies plus modern medicine in addition to cannabis oil to help her battle the deadly disease for the second time.
The Olivia Newton-John Cancer Wellness & Research Centre is a treatment centre of Austin Health, an Australian public hospital. They say that “anyone with a referral from their doctor can be treated here, regardless of the stage of their treatment or insurance status. At the ONJ Centre your care is built around your individual needs. This includes your physical, psychological and emotional health. Every patient is surrounded by a multidisciplinary team of cancer specialists, allied health and wellbeing therapists. Your dedicated treatment team work together to guide you through your optimal treatment pathway. Learn more about the cancer treatments we deliver at the ONJ Centre, how we support you through your care, and find answers to commonly asked questions.”
Their therapies include acupuncture and several other alternatives used for palliation, but the site seems refreshingly free of false claims and quackery. On their website, they say that “palliative care assists patients who have a life limiting illness to be as symptom free as possible. We work with you to meet your emotional, spiritual and practical needs in a holistic way. Our support is also extended to your family and carers.”
Altogether, this seems like a fairly reasonable approach. Olivia might have learnt a lesson the hard way when her initial breast cancer did not respond to homeopathy. Let’s hope she does get her metastases under control with cutting edge cancer care and is able to keep her spirits up with the additional help of a little complementary medicine.
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.”