In 2009, we published a systematic review of studies testing acupuncture as a treatment of menopausal hot flushes. We searched the literature using 17 databases from inception to October 10, 2008, without language restrictions. We only included randomized clinical trials (RCTs) of acupuncture versus sham acupuncture. Their methodological quality was assessed using the modified Jadad score. In total, six RCTs could be included. Four RCTs compared the effects of acupuncture with penetrating sham acupuncture on non-acupuncture points. All of these trials failed to show specific effects on menopausal hot flush frequency, severity or index. One RCT found no effects of acupuncture on hot flush frequency and severity compared with penetrating sham acupuncture on acupuncture points that are not relevant for the treatment of hot flushes. The remaining RCT tested acupuncture against non-penetrating acupuncture on non-acupuncture points. Its results suggested favourable effects of acupuncture on menopausal hot flush severity. However, this study was too small to generate reliable findings. At the time, we concluded that sham-controlled RCTs fail to show specific effects of acupuncture for control of menopausal hot flushes. We also argued that more rigorous research is warranted.
It seems that such research has just become available.
The aim of a brand-new study – a stratified, blind (participants, outcome assessors, and investigators, but not treating acupuncturists were blinded to treatment allocation), parallel, randomized, sham-controlled trial with equal allocation – was to assess the efficacy of Chinese medicine acupuncture against sham acupuncture for menopausal hot flushes (HFs). It was funded by the Australian National Health and Medical Research Council.
Women older than 40 years were recruited; they had to be in the late menopausal transition or postmenopause with at least 7 moderate HFs daily, meeting criteria for Chinese medicine diagnosis of kidney yin deficiency. These patients received 10 treatments over 8 weeks of either standardized Chinese medicine needle acupuncture designed to treat ‘kidney yin deficiency’ or they got the same amount of non-insertive sham acupuncture. The primary outcome was HF score at the end of treatment. Secondary outcomes included quality of life, anxiety, depression, and adverse events. Participants were assessed at 4 weeks, the end of treatment, and then 3 and 6 months after the end of treatment. Intention-to-treat analysis was conducted with linear mixed-effects models.
In total, 327 women were randomly assigned to acupuncture (n = 163) or sham acupuncture (n = 164). At the end of treatment, 16% of participants in the acupuncture group and 13% in the sham group were lost to follow-up. Mean HF scores at the end of treatment period were 15.36 in the acupuncture group and 15.04 in the sham group. No serious adverse events were reported.
The authors concluded that Chinese medicine acupuncture was not superior to non-insertive sham acupuncture for women with moderately severe menopausal HFs.
The trial has several strengths: it includes a large sample size and the patients were adequately blinded to eliminate the effects of expectations. It was published in a top journal, and we can therefore assume that it was properly peer-reviewed. Combined with the evidence from our previous systematic review, this indicates that acupuncture has no effect beyond placebo.
In other words: ACUPUNCTURE IS NOTHING BUT A THEATRICAL PLACEBO.
One does not need to be a clairvoyant to predict that acupuncturists will now find what they perceive as a flaw in the new study and claim that its results were false-negative. Subsequently they will probably conduct their own trial which, because it is wide open to bias, will generate the finding they were hoping for.
This sequence of poor quality positive and high quality negative studies could go on ad infinitum.
This begs the question: how can such wasteful pseudo-research be stopped?
In theory, applications to ethics committees for research that is not aimed at answering open and important questions should get rejected. In practice, however, this is unlikely to happen. In my experience, the main reason preventing such actions is that, when it comes to alternative medicine, ethics committees tend to be too lenient (attempting to be ‘politically correct’), too uninterested (thinking that alternative medicine is not really a serious area of research) and too uninformed (failing to insist on a rigorous assessment of the already available evidence).
One of the most common claims of alternative practitioners is that they take a holistic approach to health care. And it is this claim which attracts many consumers. It also makes conventional medicine look bad, reductionist and inhuman, as it implies that mainstream medicine is non-holistic.
The claim can be easily disclosed to be a straw man, because all good medicine was, is and always will be holistic. Moreover, the claim amounts to a falsehood, because much of alternative medicine is everything but holistic. I will try to explain what I mean using the recent example of acupuncture for neck pain, but I could have used almost any other alternative treatment and any other human complaint/condition/disease:
- chiropractic for back pain;
- homeopathy for asthma;
- energy healing for depression;
- aromatherapy for jet lag;
- etc. etc.
The recent trial found that adding acupuncture to usual care yields a slightly better outcome than usual care alone. This is hardly a big deal; adding a good cup of tea and a compassionate chat to usual care might have done a similar thing. Acupuncturists, however, will say that their holistic approach is successful.
How holistic is acupuncture?
A ‘Western’ acupuncturist would normally ask what is wrong with the patient; in the case of neck pain, he would probably ask several further questions about the history of the condition, when the pain occurs, what aggravates it etc. Then he might conduct a physical examination of his patient. Eventually, he would get out his needles and start the treatment.
A ‘traditional’ acupuncturist would ask similar questions, feel the pulse, look at the tongue and make a diagnosis in terms of yin and yang imbalance. Eventually, he too would get out his needles and start the treatment.
Is that holistic?
Certainly not! If we look at alternative practitioners in general, we cannot fail to notice that they tend to be the very opposite of holistic. They usually attribute a patients illness to one single cause such as yin/yang imbalance (acupuncture), subluxation (chiropractic), impediment of the life force (homeopathy), etc.
Holistic means that the patient is understood as a whole person. Our neck pain patient might have physical problems such as muscular tension; the acupuncturists might well have realised this and placed their needles accordingly. But neck pain, like most other symptoms, can have many other dimensions:
- there could be stress;
- there could be an ergonomically disadvantageous work place;
- there could be a history of injury;
- there could be a malformation of the spine;
- there could be a tumour;
- there could be an inflammation;
- there could be many other specific diseases;
- there could be relationship problems, et. etc.
Of course, the acupuncturists will claim that, during an acupuncture session, they will pick up on all of these. However, in my experience, this is little more than wishful thinking. And even if they did pick up other dimensions of the patient’s complaint, what can they do about it? They can (and often do) give rather amateur advice. This may be meant most kindly but it is rarely optimal.
And what about conventional practitioners, aren’t they even worse?
True, there often is far too much room for improvement. But at least the concept of multifactorial conditions and treatments is deeply ingrained in everyone who has been to medical school. We learn that symptoms/complaints/conditions/diseases are almost invariably multifactorial; they have many causes and contributing factors which can interact in complex ways. Therefore, responsible physicians always consider to treat patients in multifactorial ways; in the case of our neck pain patient:
- the stress might need a relaxation programme,
- the work place might need the input of an occupational therapist;
- in case of an old injury, a physio might be needed;
- specific conditions might need to be seen by a range of medical specialists;
- muscular tension could be reduced by a massage therapist;
- relationship problems might require the help of a psychologist; etc. etc.
I am NOT saying that all of this is necessary in each and every case. But I am saying that, in conventional medicine, both the awareness and the possibility for a professional multidisciplinary approach is well established. You don’t believe me? Ask a physiotherapist or an occupational therapist who refers more patients to them, an acupuncturist or a GP!
Alternative practitioners claim to be holistic and some might even be aware of the complexity of their patients’ symptoms. But, at best, they have an amateur approach to this complexity by dabbling themselves in issuing more or less suited advice. They are not adequately trained to do this job, and they refer very rarely.
My conclusion: professional multidiscipinarity is an approach deeply engrained in conventional medicine (we don’t often call it holism, perhaps because many doctors associate this term with charlatans), and it beats the mostly amateurish pseudo-holism of alternative practitioners any time.
The aim of this study was to evaluate clinical effectiveness of Alexander Technique lessons or acupuncture versus usual care for persons with chronic, nonspecific neck pain.
Patients with neck pain lasting at least 3 months, a score of at least 28% on the Northwick Park Questionnaire (NPQ) for neck pain and associated disability, and no serious underlying pathology were randomised to receive 12 acupuncture sessions or 20 one-to-one Alexander lessons (both 600 minutes total) plus usual care versus usual care alone. The NPQ score at 0, 3, 6, and 12 months (primary end point) and Chronic Pain Self-Efficacy Scale score, quality of life, and adverse events (secondary outcomes) served as outcome measures. 517 patients were recruited. Their median duration of neck pain was 6 years. Mean attendance was 10 acupuncture sessions and 14 Alexander lessons. Between-group reductions in NPQ score at 12 months versus usual care were 3.92 percentage points for acupuncture (95% CI, 0.97 to 6.87 percentage points) (P = 0.009) and 3.79 percentage points for Alexander lessons (CI, 0.91 to 6.66 percentage points) (P = 0.010). The 12-month reductions in NPQ score from baseline were 32% for acupuncture and 31% for Alexander lessons. Participant self-efficacy improved for both interventions versus usual care at 6 months (P < 0.001) and was significantly associated (P < 0.001) with 12-month NPQ score reductions (acupuncture, 3.34 percentage points [CI, 2.31 to 4.38 percentage points]; Alexander lessons, 3.33 percentage points [CI, 2.22 to 4.44 percentage points]). No reported serious adverse events were considered probably or definitely related to either intervention.
The authors drew the following conclusions: acupuncture sessions and Alexander Technique lessons both led to significant reductions in neck pain and associated disability compared with usual care at 12 months. Enhanced self-efficacy may partially explain why longer-term benefits were sustained.
Where to begin? There is much to be criticised about this study!
For starters, the conclusions are factually wrong. They should read “acupuncture sessions plus usual care and Alexander Technique lessons plus usual care both led to significant reductions in neck pain and associated disability compared with usual care at 12 months. Enhanced self-efficacy may partially explain why longer-term benefits were sustained.
On this blog, we have repeatedly discussed the ‘A+B versus B’ study design and the fact that it cannot provide information about cause and effect because it fails to control for placebo effects and the extra attention, time and empathy (for instance here and here). I suspect that this is the reason why it is so very popular in alternative medicine. It can make ineffective therapies appear to be effective.
Another point is a more clinical concern. Neck pain is not a disease, it is a symptom. In medicine we should, whenever possible, try to treat the cause of the underlying condition and not the symptom. Acupuncture is at best a symptomatic treatment. Usual care is often not very effective because we normally fail to see the cause of neck pain. In my view, alternative treatments should either be tested against placebo or sham interventions or against optimal care.
What is optimal care for nonspecific neck pain? As its causes are often unclear and usually multifactorial, the optimal treatment needs to be multifactorial (one could also call it holistic) as well. The causes often range from poor ergometric conditions at work to muscular tension, stress, psychological problems etc. Thus optimal care would be a team work tailor-made for each patient possibly including physiotherapists, pain specialists, clinical psychologists, orthopaedic surgeons etc.
My points here are:
- neither acupuncture nor Alexander technique take account of this complexity,
- they claim to be holistic but, in fact, this turns out to be merely a good sales-slogan,
- usual care is usually no good,
- if pragmatic trials using the ‘A+B versus B’ design make any sense at all, they should employ not usual care but optimal care for the control group.
In the end, we are left with a study that looks fairly rigorous at first sight, but that really tells us next to nothing (except that dedicating 600 minutes to patients in pain is not without effect). I am truly surprised that a top journal like the Annals of Internal Medicine decided to publish it.
Today the GUARDIAN published an article promoting acupuncture on the NHS. The article is offensively misleading, I think, and therefore deserves a comment. I write these comments with a heavy heart, I should add, because the GUARDIAN is by far my favourite UK daily. In the following, I will cite key passages from the article in question and add my comments in bold.
Every woman needing pain relief while giving birth at University College London hospital (UCLH) is offered acupuncture, with around half of the hospital’s midwives specially trained to give the treatment. UCLH is far from typical in this respect, though: acupuncture is not standard throughout the UK and many health practitioners claim patients are often denied access to it through the NHS because of entrenched scepticism from sections of the medical establishment.
Entrenched scepticism? I would say that it could be perhaps be related to the evidence. The conclusions of the current Cochrane review on acupuncture for labour pain are cautious and do not seem strong enough to issue a general recommendation for general use in childbirth: “acupuncture and acupressure may have a role with reducing pain, increasing satisfaction with pain management and reduced use of pharmacological management. However, there is a need for further research.”
“There are conditions for which acupuncture works and others where it doesn’t. It is not a cure-all, and should be open to scrutiny. But the focus of my work is for acupuncture to become a standard part of midwifery training, and at the same time change perceptions among clinicians about its appropriate use for a whole range of other conditions.”
Open to scrutiny indeed! And if we scrutinise the evidence critically – rather than engaging in uncritical and arguably irresponsible promotion – we find that the evidence is not nearly as convincing as acupuncture fans try to make us believe.
The UK lags behind many other European countries in its support for acupuncture. Just 2,500 medical professionals here are qualified to practice it, compared with 45,000 in Germany. The National Institute for Clinical Excellence (Nice) recommends WMA specifically for the treatment of only two conditions – lower back pain (which costs the NHS £1bn a year) and headaches.
Yes, the UK also lags behind Germany in the use of leeches and other quackery. The ‘ad populum’ fallacy is certainly popular in alternative medicine – but surely, it is still a fallacy!
A growing body of healthcare practitioners believe it should be offered routinely for a variety of conditions, including pain in labour, cancer, musculoskeletal conditions and even irritable bowel syndrome (IBS).
Here we go, belief as a substitute for evidence and fallacies as a replacement of logical arguments. I had thought the GUARDIAN was better than this!
At a time of NHS cuts the use of needles at 8p per unit look attractive. In St Albans, where a group of nurse-led clinics have been using acupuncture since 2008 for patients with knee osteoarthritis, economics have been put under scrutiny. WMA was offered to 114 patients rather than a knee replacement costing £5,000, and 79% accepted. Two years later a third of them had not required a knee transplant, representing an annual saving of £100,000, as estimated by researchers to the St Albans local commissioning group.
This looks a bit like a ‘back of an envelope’ analysis. I would like to see this published in a reputable journal and see it scrutinised by a competent health economist.
So why is acupuncture not being used more widely? The difficulty of proving its efficacy is clearly one of the biggest stumbling blocks. An analysis of 29 studies of almost 18,000 patients found acupuncture effective in treating chronic pain compared with sham acupuncture.
This passage refers to an analysis by Vickers et al. It was severely and repeatedly criticised for being too optimistic and, more importantly, it is not nearly as positive as implied here. Its conclusions are in fact quite cautious: “acupuncture is effective for the treatment of chronic pain and is therefore a reasonable referral option. Significant differences between true and sham acupuncture indicate that acupuncture is more than a placebo. However, these differences are relatively modest, suggesting that factors in addition to the specific effects of needling are important contributors to the therapeutic effects of acupuncture.”
But even treatment proponents question whether a randomised controlled trial – the gold standard of medical research – works, given that faking treatment is nearly impossible.
What do you mean ‘even treatment proponents’? It is only proponents who question these sham needles! The reason: they frequently do not generate the results acupuncture fans had hoped for.
The article is clearly not the GUARDIAN’s finest hour. It lacks even a tinge of critical assessment. This is regrettable, I think, particularly as the truth about acupuncture is not that difficult to transmit to the public:
- Much of the research is of woefully poor quality.
- Its effectiveness is not proven beyond doubt for a single condition.
- Serious adverse effects have been reported.
- Because it requires substantial amounts of therapist time, it also is not cheap.
This study created a media storm when it was first published. Several articles in the lay press seemed to advertise it as though a true breakthrough had been made in the treatment of hypertension. I would not be surprised, if many patients consequently threw their anti-hypertensives over board and queued up at their local acupuncturist.
Good for business, no doubt – but would this be a wise decision?
The aim of this clinical trial was to examine effectiveness of electroacupuncture (EA) for reducing systolic blood pressure (SBP) and diastolic blood pressures (DBP) in hypertensive patients. Sixty-five hypertensive patients not receiving medication were assigned randomly to one of two acupuncture intervention. Patients were assessed with 24-hour ambulatory blood pressure monitoring. They were treated by 4 acupuncturists with 30-minutes of EA at PC 5-6+ST 36-37 or LI 6-7+GB 37-39 (control group) once weekly for 8 weeks. Primary outcomes measuring effectiveness of EA were peak and average SBP and DBP. Secondary outcomes examined underlying mechanisms of acupuncture with plasma norepinephrine, renin, and aldosterone before and after 8 weeks of treatment. Outcomes were obtained by blinded evaluators.
After 8 weeks, 33 patients treated with EA at PC 5-6+ST 36-37 had decreased peak and average SBP and DBP, compared with 32 patients treated with EA at LI 6-7+GB 37-39 control acupoints. Changes in blood pressures significantly differed between the two patient groups. In 14 patients, a long-lasting blood pressure–lowering acupuncture effect was observed for an additional 4 weeks of EA at PC 5-6+ST 36-37. After treatment, the plasma concentration of norepinephrine, which was initially elevated, was decreased by 41%; likewise, renin was decreased by 67% and aldosterone by 22%.
The authors concluded that EA at select acupoints reduces blood pressure. Sympathetic and renin-aldosterone systems were likely related to the long-lasting EA actions.
These results are baffling, to say the least; and they contradict a recent meta-analysis which did not find that acupuncture without antihypertensive medications significantly improves blood pressure in those hypertensive patients.
So, who is right and who is wrong here?
Or shall we just look for alternative explanations of the effects observed in the new study?
There could be dozens of reasons for these findings that are unrelated to the alleged effects of acupuncture. For instance, they could be due to life-style changes suggested to the experimental but not the control group, or they might be caused by some other undisclosed bias or confounding. At the very minimum, we should insist on an independent replication of this trial.
It would be silly, I think, to trust these results and now recommend acupuncture to the millions of hypertensive patients worldwide, particularly as dozens of safe, cheap and very effective treatments for hypertension do already exist.
On this blog, we have repeatedly discussed the risks of acupuncture. Contrary to what we often hear, there clearly is potential for harm. Acupuncture is, of course most popular in China where it has been used for thousands of years. Therefore the Chinese literature, which is not easy to access for non-Chinese speakers and therefore often disregarded by Western researchers, might hold treasures of valuable information on the subject. It follows that a thorough review of this information might be helpful. A recent paper by Chinese scientists has tackled this issue.
The objective of this review was to determine the frequency and severity of adverse complications and events in acupuncture treatment reported from 1980 to 2013 in China. All first-hand case reports of acupuncture-related complications and adverse events that could be identified in the scientific literature were reviewed and classified according to the type of complication and adverse event, circumstance of the event, and long-term patient outcome. The selected case reports were published between 1980 and 2013 in 3 databases. Relevant papers were collected and analyzed by 2 reviewers.
Over the 33 years, 182 incidents were identified in 133 relevant papers. Internal organ, tissue, or nerve injury is the main complications of acupuncture especially for pneumothorax and central nervous system injury. Adverse effects also included syncope, infections, hemorrhage, allergy, burn, aphonia, hysteria, cough, thirst, fever, somnolence, and broken needles.
The authors of this review concluded that qualifying training of acupuncturists should be systemized and the clinical acupuncture operations should be standardized in order to effectively prevent the occurrence of acupuncture accidents, enhance the influence of acupuncture, and further popularize acupuncture to the rest of the world.
This is a bizarrely disappointing article followed by a most strange conclusion. The authors totally fail to discuss the most important issue and they arrive at conclusions which, I think, make little sense.
The issue to discuss here is, of course, under-reporting. We know that under-reporting in the Western literature is already huge. For every complication reported there could easily be 10 or even 100 that go unreported. There is no monitoring system for adverse effects, and acupuncturists have no incentive to publish their mistakes. Accurate and realistic prevalence data are therefore anybody’s guess.
In China, under-reporting is likely to be one or two orders of magnitude bigger. I say this because close to zero % of all Chinese papers on acupuncture report negative findings. For China, TCM is a huge export business, and the interest in reporting adverse effects is close to zero.
Seen from this perspective, it seems at first glance laudable that the Chinese authors dared to address this thorny issue. In the text of the article, they even mention that the included complications resulted in a total of 25 fatalities! This seems courageous. But one only needs to read the full article to get a strong suspicion that the authors are either in denial about the real figures, or their paper is a deliberate attempt to ‘white-wash’ acupuncture from its potential to do harm.
In 2010, we published a very similar review of the Chinese literature (unsurprisingly, it was not cited by the authors of the new paper). At the time, we found almost 500 published cases of serious adverse events and stated that we suspect that underreporting of such events in the Chinese-language literature is much higher than in the English-language literature.
The truth is that nobody knows how frequent adverse events of acupuncture truly are in China – or most other countries, for that matter. I believe that, before we “further popularize acupuncture to the rest of the world”, it would be ethical and necessary to 1) state this fact openly and 2) do something about it.
When I come across a study with the aim to “examine the effectiveness of acupuncture to relieve symptoms commonly observed in patients in a hospice program” my hopes are high. When I then see that its authors are from the ‘New England School of Acupuncture’, the ‘All Care Hospice and the ‘Tufts University School of Medicine, Boston, my hopes for a good piece of science are even higher. So, let’s see what this new paper has to offer.
A total of 26 patients participated in this acupuncture ‘trial’, receiving a course of weekly treatments that ranged from 1 to 14 weeks. The average number of treatments was five. The Edmonton Symptom Assessment Scale (ESAS) was used to assess the severity of pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and dyspnoea. A two-tailed, paired t test was applied to the data to compare symptom scores pre- versus post-acupuncture treatment. Patients enrolled in All Care Hospice’s home care program were given the option to receive acupuncture to supplement usual care offered by the hospice team. Treatment was provided by licensed acupuncturists in the patient’s place of residence.
The results indicated that 7 out of 9 symptoms were significantly improved with acupuncture, the exceptions being drowsiness and appetite. Although the ESAS scale demonstrated a reduction in symptom severity post-treatment for both drowsiness and appetite, this reduction was not found to be significant.
At tis stage, I have lost most of my hopes for good science. This is not a ‘trial’ but a glorified case-series. There is no way that the stated aim can be pursued with this type of methodology. There is no reason whatsoever to assume that the observed outcome can be attributed to acupuncture; the additional attention given to these patients is but one of several factors that are quite sufficient to explain their symptomatic improvements.
This is yet another disappointment then from the plethora of ‘research’ into alternative medicine that, on closer inspection, turns out to be little more than thinly disguised promotion of quackery. These days, I can bear such disappointments quite well – after all, I had many years to get used to them. What I find more difficult to endure is the anger that overcomes me when I read the authors’ conclusion: Acupuncture was found to be effective for the reduction and relief of symptoms that commonly affect patient QOL. Acupuncture effectively reduced symptoms of pain, tiredness, nausea, depression, anxiety, and shortness of breath, and enhanced feelings of well-being. More research is required to assess the long-term benefits and symptom reduction of acupuncture in a palliative care setting.
This is not disappointing; in my view, this is scientific misconduct by
- the authors,
- the institutions employing the authors,
- the ethics committee that has passed the ‘research’,
- the sponsors of the ‘research’,
- the peer-reviewers of the paper,
- the journal and its editors responsible for publishing this paper.
The fact that this sort of thing happens virtually every day in the realm of alternative medicine does not render this case less scandalous, it merely makes it more upsetting.
The press officers of journals like to send out press-releases of articles which are deemed to be particularly good and important. Sadly, it is not often that articles on alternative medicine fulfil these criteria. I was therefore excited to receive this press-release which seemed encouraging, to say the least:
Medical evidence supports the potential for acupuncture to be significantly more effective in the treatment of dermatologic conditions such as dermatitis, pruritus, and urticaria than alternative treatment options, “placebo acupuncture,” or no treatment, according to a review of the medical literature published in The Journal of Alternative and Complementary Medicine, a peer-reviewed publication from Mary Ann Liebert, Inc., publishers…
The abstract was equally promising:
Objectives: Acupuncture is a form of Traditional Chinese Medicine that has been used to treat a broad range of medical conditions, including dermatologic disorders. This systematic review aims to synthesize the evidence on the use of acupuncture as a primary treatment modality for dermatologic conditions.
Methods: A systematic search of MEDLINE, EMBASE, and the Cochrane Central Register was performed. Studies were limited to clinical trials, controlled studies, case reports, comparative studies, and systematic reviews published in the English language. Studies involving moxibustion, electroacupuncture, or blood-letting were excluded.
Results: Twenty-four studies met inclusion criteria. Among these, 16 were randomized controlled trials, 6 were prospective observational studies, and 2 were case reports. Acupuncture was used to treat atopic dermatitis, urticaria, pruritus, acne, chloasma, neurodermatitis, dermatitis herpetiformis, hyperhidrosis, human papillomavirus wart, breast inflammation, and facial elasticity. In 17 of 24 studies, acupuncture showed statistically significant improvements in outcome measurements compared with placebo acupuncture, alternative treatment options, and no intervention.
Conclusions: Acupuncture improves outcome measures in the treatment of dermatitis, chloasma, pruritus, urticaria, hyperhidrosis, and facial elasticity. Future studies should ideally be double-blinded and standardize the control intervention.
One has to read the actual full text article to understand that the evidence presented here is dodgy to the extreme. In fact, one has to go into the tedious details of the methods section to find the reasons why: All searches were limited to clinical trials, controlled studies, case reports, comparative studies, and systematic reviews published in the English language.
There are many more weaknesses of this review, but the inclusion of uncontrolled studies and even anecdotes is, in my view, a virtual death sentence to its credibility. It means that no general conclusions about the effectiveness of acupuncture, such as the authors have decided to make, are possible.
Such overt exaggerations are sadly no rarities in the realm of alternative medicine. I think, this begs a number of serious questions:
- Does this cross the line between flawed research and scientific misconduct?
- Why did the reviewers not pick up these flaws?
- Why did the editor pass this article for publication?
- How can the publisher tolerate such dubious behaviour?
- Should this journal (which I have commented on before here and which is one with the highest impact factor of all the alt med journals) be de-listed from Medline?
I don’t think that we will get answers from the people responsible for this disgrace, but I would like to learn my readers’ opinions.
A paper entitled ‘Real world research: a complementary method to establish the effectiveness of acupuncture’ caught my attention recently. I find it quite remarkable and think it might stimulate some discussion on this blog. Here is its abstract:
Acupuncture has been widely used in the management of a variety of diseases for thousands of years, and many relevant randomized controlled trials have been published. In recent years, many randomized controlled trials have provided controversial or less-than-convincing evidence that supports the efficacy of acupuncture. The clinical effectiveness of acupuncture in Western countries remains controversial.
Acupuncture is a complex intervention involving needling components, specific non-needling components, and generic components. Common problems that have contributed to the equivocal findings in acupuncture randomized controlled trials were imperfections regarding acupuncture treatment and inappropriate placebo/sham controls. In addition, some inherent limitations were also present in the design and implementation of current acupuncture randomized controlled trials such as weak external validity. The current designs of randomized controlled trials of acupuncture need to be further developed. In contrast to examining efficacy and adverse reaction in a “sterilized” environment in a narrowly defined population, real world research assesses the effectiveness and safety of an intervention in a much wider population in real world practice. For this reason, real world research might be a feasible and meaningful method for acupuncture assessment. Randomized controlled trials are important in verifying the efficacy of acupuncture treatment, but the authors believe that real world research, if designed and conducted appropriately, can complement randomized controlled trials to establish the effectiveness of acupuncture. Furthermore, the integrative model that can incorporate randomized controlled trial and real world research which can complement each other and potentially provide more objective and persuasive evidence.
In the article itself, the authors list seven criteria for what they consider good research into acupuncture:
- Acupuncture should be regarded as complex and individualized treatment;
- The study aim (whether to assess the efficacy of acupuncture needling or the effectiveness of acupuncture treatment) should be clearly defined and differentiated;
- Pattern identification should be clearly specified, and non-needling components should also be considered;
- The treatment protocol should have some degree of flexibility to allow for individualization;
- The placebo or sham acupuncture should be appropriate: knowing “what to avoid” and “what to mimic” in placebos/shams;
- In addition to “hard evidence”, one should consider patient-reported outcomes, economic evaluations, patient preferences and the effect of expectancy;
- The use of qualitative research (e.g., interview) to explore some missing areas (e.g., experience of practitioners and patient-practitioner relationship) in acupuncture research.
Furthermore, the authors list the advantages of their RWR-concept:
- In RWR, interventions are tailored to the patients’ specific conditions, in contrast to standardized treatment. As a result, conclusions based on RWR consider all aspects of acupuncture that affect the effectiveness.
- At an operational level, patients’ choice of the treatment(s) decreases the difficulties in recruiting and retaining patients during the data collection period.
- The study sample in RWR is much more representative of the real world situation (similar to the section of the population that receives the treatment). The study, therefore, has higher external validity.
- RWR tends to have a larger sample size and longer follow-up period than RCT, and thus is more appropriate for assessing the safety of acupuncture.
The authors make much of their notion that acupuncture is a COMPLEX INTERVENTION; specifically they claim the following: Acupuncture treatment includes three aspects: needling, specific non-needling components drove by acupuncture theory, and generic components not unique to acupuncture treatment. In addition, acupuncture treatment should be performed on the basis of the patient condition and traditional Chinese medicine (TCM) theory.
There is so much BS here that it is hard to decide where to begin refuting. As the assumption of acupuncture or other alternative therapies being COMPLEX INTERVENTIONS (and therefore exempt from rigorous tests) is highly prevalent in this field, let me try to just briefly tackle this one.
The last time I saw a patient and prescribed a drug treatment I did all of the following:
- I greeted her, asked her to sit down and tried to make her feel relaxed.
- I first had a quick chat about something trivial.
- I then asked why she had come to see me.
- I started to take notes.
- I inquired about the exact nature and the history of her problem.
- I then asked her about her general medical history, family history and her life-style.
- I also asked about any psychological problems that might relate to her symptoms.
- I then conducted a physical examination.
- Subsequently we discussed what her diagnosis might be.
- I told her what my working diagnosis was.
- I ordered a few tests to either confirm or refute it and explained them to her.
- We decided that she should come back and see me in a few days when her tests had come back.
- In order to ease her symptoms in the meanwhile, I gave her a prescription for a drug.
- We discussed this treatment, how and when she should take it, adverse effects etc.
- We also discussed other therapeutic options, in case the prescribed treatment was in any way unsatisfactory.
- I reassured her by telling her that her condition did not seem to be serious and stressed that I was confident to be able to help her.
- She left my office.
The point I am trying to make is: prescribing an entirely straight forward drug treatment is also a COMPLEX INTERVENTION. In fact, I know of no treatment that is NOT complex.
Does that mean that drugs and all other interventions are exempt from being tested in rigorous RCTs? Should we allow drug companies to adopt the RWR too? Any old placebo would pass that test and could be made to look effective using RWR. In the example above, my compassion, care and reassurance would alleviate my patient’s symptoms, even if the prescription I gave her was complete rubbish.
So why should acupuncture (or any other alternative therapy) not be tested in proper RCTs? I fear, the reason is that RCTs might show that it is not as effective as its proponents had hoped. The conclusion about the RWR is thus embarrassingly simple: proponents of alternative medicine want double standards because single standards would risk to disclose the truth.
I just came across a website that promised to”cover 5 common misconceptions about alternative medicine that many people have”. As much of this blog is about this very issue, I was fascinated. Here are Dr Cohen’s 5 points in full:
5 Misconceptions about Alternative Medicine Today
1. Alternative Medicine Is Only an Alternative
In fact, many alternative practitioners are also medical doctors, chiropractors, or other trained medical professionals. Others work closely with MDs to coordinate care. Patients should always let all of their health care providers know about treatments that they receive from all the others.
2. Holistic Medicine Isn’t Mainstream
In fact, scientists and doctors do perform studies on all sorts of alternative therapies to determine their effectiveness. These therapies, like acupuncture and an improved diet, pass the test of science and then get integrated into standard medical practices.
3. Natural Doctors Don’t Use Conventional Medicine
No credible natural doctor will ever tell a patient to replace prescribed medication without consulting with his or her original doctor. In many cases, the MD and natural practitioner are the same person. If not, they will coordinate treatment to benefit the health of the patient.
4. Alternative Medicine Doesn’t Work
Actual licensed health providers won’t just suggest natural therapies on a whim. They will consider scientific studies and their own experience to suggest therapies that do work. Countless studies have, for example, confirmed that acupuncture is an effective treatment for many medical conditions. Also, the right dietary changes are known to help improve health and even minimize or cure some diseases. Numerous other alternative therapies have been proven effective using scientific studies.
5. Big Medical Institutions are Against Alternative Medicine
According to a recent survey, about half of big insurers pay for tested alternative therapies like acupuncture. Also, hospitals and doctors do recognize that lifestyle changes, some herbal remedies, and other kinds of alternative medicine may reduce side effects, allow patients to reduce prescription medicine, and even lower medical bills.
This is not to say that every insurer, doctor, or hospital will support a particular treatment. However, patients are beginning to take more control of their health care. If their own providers won’t suggest natural remedies, it might be a good idea to find one who does.
The Best Medicine Combines Conventional and Alternative Medicine
Everyone needs to find the right health care providers to enjoy the safest and most natural care possible. Good natural health providers will have a solid education in their field. Nobody should just abandon their medical treatment to pursue alternative cures. However, seeking alternative therapies may help many people reduce their reliance on harsh medications by following the advice of alternative providers and coordinating their care with all of their health care providers.
END OF COHEN’S TEXT
COMMENT BY MYSELF
Who the Dickens is Dr Cohen and what is his background? I asked myself after reading this. From his website, it seems that he is a chiropractor from North Carolina – not just any old chiro, but one of the best!!! – who also uses several other dubious therapies. He sums up his ‘philosophy’ as follows:
There is an energy or life force that created us (all 70 trillion cells that we are made of) from two cells (sperm and egg cells). This energy or innate intelligence continues to support you throughout life and allows you to grow, develop, heal, and express your every potential. This life force coordinates all cells, tissues, muscles and organs by sending specific, moment by moment communication via the nervous system. If the nervous system is over-stressed or interfered with in any way, then your life force messages will not be properly expressed.
Here he is on the cover of some magazine and here is also his ‘PAIN CLINIC’
Fascinating stuff, I am sure you agree.
As I do not want to risk a libel case, I will abstain from commenting on Dr Cohen and his methods or beliefs. Instead I will try to clear up a few misconceptions that are pertinent to him and the many other practitioners who are promoting pure BS via the Internet.
- Not everyone who uses the title ‘Dr’ is a doctor in the sense of having studied medicine.
- Chiropractors are not ‘trained medical professionals’.
- The concepts of ‘vitalism’, ‘life force’ etc. have been abandoned in real heath care a long time ago, and medicine has improved hugely because of this.
- Hardly any alternative therapy has ‘passed the test of science’.
- Therefore, it is very doubtful whether alternative practitioners actually will ‘consider scientific studies’.
- True, some trials did suggest that acupuncture is an effective treatment for many medical conditions; but their methodological quality is often far too low to draw firm conclusions and many other, often better studies have shown the contrary.
- Numerous other alternative therapies have been proven ineffective using scientific studies.
- Therefore it might be a good idea to find a health care provider who does not offer unproven treatments simply to make a fast buck.
- Seeking alternative therapies may harm many people.