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.
One could define alternative medicine by the fact that it is used almost exclusively for conditions for which conventional medicine does not have an effective and reasonably safe cure. Once such a treatment has been found, few patients would look for an alternative.
Alzheimer’s disease (AD) is certainly one such condition. Despite intensive research, we are still far from being able to cure it. It is thus not really surprising that AD patients and their carers are bombarded with the promotion of all sorts of alternative treatments. They must feel bewildered by the choice and all too often they fall victim to irresponsible quacks.
Acupuncture is certainly an alternative therapy that is frequently claimed to help AD patients. One of the first websites that I came across, for instance, stated boldly: acupuncture improves memory and prevents degradation of brain tissue.
But is there good evidence to support such claims? To answer this question, we need a systematic review of the trial data. Fortunately, such a paper has just been published.
The objective of this review was to assess the effectiveness and safety of acupuncture for treating AD. Eight electronic databases were searched from their inception to June 2014. Randomized clinical trials (RCTs) with AD treated by acupuncture or by acupuncture combined with drugs were included. Two authors extracted data independently.
Ten RCTs with a total of 585 participants were included in a meta-analysis. The combined results of 6 trials showed that acupuncture was better than drugs at improving scores on the Mini Mental State Examination (MMSE) scale. Evidence from the pooled results of 3 trials showed that acupuncture plus donepezil was more effective than donepezil alone at improving the MMSE scale score. Only 2 trials reported the incidence of adverse reactions related to acupuncture. Seven patients had adverse reactions related to acupuncture during or after treatment; the reactions were described as tolerable and not severe.
The Chinese authors of this review concluded that acupuncture may be more effective than drugs and may enhance the effect of drugs for treating AD in terms of improving cognitive function. Acupuncture may also be more effective than drugs at improving AD patients’ ability to carry out their daily lives. Moreover, acupuncture is safe for treating people with AD.
Anyone reading this and having a friend or family member who is affected by AD will think that acupuncture is the solution and warmly recommend trying this highly promising option. I would, however, caution to remain realistic. Like so very many systematic reviews of acupuncture or other forms of TCM that are currently flooding the medical literature, this assessment of the evidence has to be taken with more than just a pinch of salt:
- As far as I can see, there is no biological plausibility or mechanism for the assumption that acupuncture can do anything for AD patients.
- The abstract fails to mention that the trials were of poor methodological quality and that such studies tend to generate false-positive findings.
- The trials had small sample sizes.
- They were mostly not blinded.
- They were mostly conducted in China, and we know that almost 100% of all acupuncture studies from that country draw positive conclusions.
- Only two trials reported about adverse effects which is, in my view, a sign of violation of research ethics.
As I already mentioned, we are currently being flooded with such dangerously misleading reviews of Chinese primary studies which are of such dubious quality that one could do probably nothing better than to ignore them completely.
Isn’t that a bit harsh? Perhaps, but I am seriously worried that such papers cause real harm:
- They might motivate some to try acupuncture and give up conventional treatments which can be helpful symptomatically.
- They might prompt some families to spend sizable amounts of money for no real benefit.
- They might initiate further research into this area, thus drawing money away from research into much more promising avenues.
IT IS HIGH TIME THAT RESEARCHERS START THINKING CRITICALLY, PEER-REVIEWERS DO THEIR JOB PROPERLY, AND JOURNAL EDITORS STOP PUBLISHING SUCH MISLEADING ARTICLES.
On 26/5/2015, I received the email reproduced below. I thought it was interesting, looked up its author (“Shawn is a philosopher and writer educated at York University in Toronto, and the author of two books. He’s also worked with Aboriginal youth in the Northwest Territories of Canada”) and decided to respond by writing a blog-post rather than by answering Alli directly.
Hello Dr. Ernst, this is Shawn Alli from Canada, a blogger and philosopher. I recently finished a critical article on James Randi’s legacy. It gets into everything from ideological science, manipulation, ESP, faith healing, acupuncture and homeopathy.
Let me know what you think about it:
It’s quite long so save it for a rainy day.
So far, the reply from skeptical organizations range from: “I couldn’t read further than the first few paragraphs because I disagree with the claims…” to one word replies: “Petty.”
It’s always nice to know how open-minded skeptical organizations are.
Hopefully you can add a bit more.
Yes, indeed, I can but try to add a bit more!
However, Alli’s actual article is far too long to analyse it here in full. I therefore selected just the bit that I feel most competent commenting on and which is closest to my heart. Below, I re-produce this section of Alli’s article in full. I add my comments at the end (in bold) by inserting numbered responses which refer to the numbers (in round brackets [the square ones refer to Alli’s references]) inserted throughout Alli’s text. Here we go:
Homeopathy & Acupuncture:
A significant part of Randi’s legacy is his war against homeopathy. This is where Randi shines even above mainstream scientists such as Dawkins or Tyson.
Most of his talks ridicule homeopathy as nonsense that doesn’t deserve the distinction of being called a treatment. This is due to the fact that the current scientific method is unable to account for the results of homeopathy (1). In reality, the current scientific method can’t account for the placebo effect as well (2).
But then again, that presents an internal problem as well. The homeopathic community is divided by those who believe it’s a placebo effect and those that believe it’s more than that, advocating the theory of water memory, which mainstream scientists ridicule and vilify (3).
I don’t know what camp is correct (4), but I do know that the homeopathic community shouldn’t follow the lead of mainstream scientists and downplay the placebo effect as, it’s just a placebo (5).
Remember, the placebo effect is downplayed because the current scientific method is unable to account for the phenomenon (3, 5). It’s a wondrous and real effect, regardless of the ridicule and vilification (6) that’s attached to it.
While homeopathy isn’t suitable as a treatment for severe or acute medical conditions, it’s an acceptable treatment for minor, moderate or chronic ones (7). Personally, I’ve never tried homeopathic treatments. But I would never tell individuals not to consider it. To each their own, as long as it’s within universal ethics (8).
A homeopathic community in Greece attempts to conduct an experiment demonstrating a biological effect using homeopathic medicine and win Randi’s million dollar challenge. George Vithoulkas and his team spend years creating the protocol of the study, only to be told by Randi to redo it from scratch.  (9) I recommend readers take a look at:
Randi’s war against homeopathy is an ideological one (10). He’ll never change his mind despite positive results in and out of the lab (11). This is the epitome of dogmatic ideological thinking (12).
The same is true for acupuncture (13). In his NECSS 2012 talk Randi says:
Harvard Medical School is now offering an advanced course for physicians in acupuncture, which has been tested endlessly for centuries and it does not work in any way. And believe me, I know what I’m talking about. 
Acupuncture is somewhat of a grey area for mainstream scientists and the current scientific method. One ideological theory states that acupuncture operates on principles of non-physical energy in the human body and relieving pressure on specific meridians. The current scientific method is unable to account for non-physical human energy and meridians.
A mainstream scientific theory of acupuncture is one of neurophysiology, whereby acupuncture works by affecting the release of neurotransmitters. I don’t know which theory is correct; but I do know that those who do try acupuncture usually feel better (14).
In regards to the peer-reviewed literature, I believe (15) that there’s a publication bias against acupuncture being seen as a viable treatment for minor, moderate or chronic conditions. A few peer-reviewed articles support the use of acupuncture for various conditions:
Eight sessions of weekly group acupuncture compared with group oral care education provide significantly better relief of symptoms in patients suffering from chronic radiation-induced xerostomia. 
It is concluded that this study showed highly positive effects on pain and function through the collaborative treatment of acupuncture and motion style in aLBP [acute lower back pain] patients. 
Given the limited efficacy of antidepressant treatment…the present study provides evidence in supporting the viewpoint that acupuncture is an effective and safe alternative treatment for depressive disorders, and could be considered an alternative option especially for patients with MDD [major depressive disorder] and PSD [post-stroke depression], although evidence for its effects in augmenting antidepressant agents remains controversial. 
In conclusion: We find that acupuncture significantly relieves hot flashes and sleep disturbances in women treated for breast cancer. The effect was seen in the therapy period and at least 12 weeks after acupuncture treatment ceased. The effect was not correlated with increased levels of plasma estradiol. The current study showed no side effects of acupuncture. These results indicate that acupuncture can be used as an effective treatment of menopausal discomfort. 
In conclusion, the present study demonstrates, in rats, that EA [electroacupuncture] significantly attenuates bone cancer induced hyperalgesia, which, at least in part, is mediated by EA suppression of IL-1…expression. 
In animal model of focal cerebral ischemia, BBA [Baihui (GV20)-based Scalp acupuncture] could improve IV [infarct volume] and NFS [neurological function score]. Although some factors such as study quality and possible publication bias may undermine the validity of positive findings, BBA may have potential neuroprotective role in experimental stroke. 
In conclusion, this randomized sham-controlled study suggests that electroacupuncture at acupoints including Zusanli, Sanyinjiao, Hegu, and Zhigou is more effective than no acupuncture and sham acupuncture in stimulating early return of bowel function and reducing postoperative analgesic requirements after laparoscopic colorectal surgery. Electroacupuncture is also more effective than no acupuncture in reducing the duration of hospital stay. 
In conclusion, we found acupuncture to be superior to both no acupuncture control and sham acupuncture for the treatment of chronic pain…Our results from individual patient data meta-analyses of nearly 18000 randomized patients in high-quality RCTs [randomized controlled trials] provide the most robust evidence to date that acupuncture is a reasonable referral option for patients with chronic pain. 
While Randi and many other mainstream scientists will argue (16) that the above claims are the result of ideological science and cherry picking, in reality, they’re the result of good science going up against dogmatic (17) and profit-driven (17) ideological (17) science.
Yes, the alternative medicine industry is now a billion dollar industry. But the global pharmaceutical medical industry is worth hundreds of trillions of dollars. And without its patients (who need to be in a constant state of ill health), it can’t survive (18).
Individuals who have minor, moderate, or chronic medical conditions don’t want to be part of the hostile debate between alternative medicine vs. pharmaceutical medical science (19). They just want to get better and move on with their life. The constant war that mainstream scientists wage against alternative medicine is only hurting the people they’re supposed to be helping (20).
Yes, the ideologies (21) are incompatible. Yes, there are no accepted scientific theories for such treatments. Yes, it defies what mainstream scientists currently “know” about the human body (22).
It would be impressive if a peace treaty can exist between both sides, where both don’t agree, but respect each other enough to put aside their pride and help patients to regain their health (23).
END OF ALLI’S TEXT
And here are my numbered comments:
(1) This is not how I understand Randi’s position. Randi makes a powerful point about the fact that the assumptions of homeopathy are not plausible, which is entirely correct – so much so that even some leading homeopaths admit that this is true.
(2) This is definitely not correct; the placebo effect has been studied in much detail, and we can certainly ‘account’ for it.
(3) In my 40 years of researching homeopathy and talking to homeopaths, I have not met any homeopaths who “believe it’s a placebo effect”.
(4) There is no ‘placebo camp’ amongst homeopaths; so this is not a basis for an argument; it’s a fallacy.
(5) They very definitely are mainstream scientists, like F Benedetti, who research the placebo effect and they certainly do not ‘downplay’ it. (What many people fail to understand is that, in placebo-controlled trials, one aims at controlling the placebo effect; to a research-naïve person, this may indeed LOOK LIKE downplaying it. But this impression is wrong and reflects merely a lack of understanding.)
(6) No serious scientist attaches ‘ridicule and vilification’ to it.
(7) Who says so? I know only homeopaths who hold this opinion; and it is not evidence-based.
(8) Ethics demand that patients require the best available treatment; homeopathy does not fall into this category.
(9) At one stage (more than 10 years ago), I was involved in the design of this test. My recollection of it is not in line with the report that is linked here.
(10) So far, we have seen no evidence for this statement.
(11) Which ones? No examples are provided.
(12) Yet another statement without evidence – potentially libellous.
(13) Conclusion before any evidence; sign for a closed mind?
(14) This outcome could be entirely unrelated to acupuncture, as anyone who has a minimum of health care knowledge should know.
(15) We are not concerned with beliefs, we concerned with facts here, aren’t we ?
(16) But did they argue this? Where is the evidence to support this statement?
(17) Non-evidence-based accusations.
(18) Classic fallacy.
(19) The debate is not between alt med and ‘pharmaceutical science’, it is between those who insist on treatments which demonstrably generate more good than harm, and those who want alt med regardless of any such considerations.
(20) Warning consumers of treatments which fail to fulfil the above criterion is, in my view, an ethical duty which can save much money and many lives.
(21) Yes, alt med is clearly ideology-driven; by contrast conventional medicine is not (if it were, Alli would have explained what ideology it is precisely). Conventional medicine changes all the time, sometimes even faster than we can cope with, and is mainly orientated on evidence which is not an ideology. Alt med hardly changes or progresses at all; for the most part, its ideology is that of a cult celebrating anti-science and obsolete traditions.
(22) Overt contradiction to what Alli just stated about acupuncture.
(23) To me, this seems rather nonsensical and a hindrance to progress.
In summary, I feel that Alli argues his corner very poorly. He makes statements without supporting evidence, issues lots of opinion without providing the facts (occasionally even hiding them), falls victim of logical fallacies, and demonstrates an embarrassing lack of knowledge and common sense. Most crucially, the text seems bar of any critical analysis; to me, it seems like a bonanza of unreason.
To save Alli the embarrassment of arguing that I am biased or don’t know what I am talking about, I’d like to declare the following: I am not paid by ‘Big Pharma’ or anyone else, I am not aware of having any other conflicts of interest, I have probably published more research on alt med (some of it with positive conclusions !!!) than anyone else on the planet, my research was funded mostly by organisations/donors who were in favour of alt med, and I have no reason whatsoever to defend Randi (I only met him personally once). My main motivation for responding to Alli’s invitation to comment on his bizarre article is that I have fun exposing ‘alt med nonsense’ and believe it is a task worth doing.
Twenty years ago, I published a short article in the British Journal of Rheumatology. Its title was ALTERNATIVE MEDICINE, THE BABY AND THE BATH WATER. Reading it again today – especially in the light of the recent debate (with over 700 comments) on acupuncture – indicates to me that very little has since changed in the discussions about alternative medicine (AM). Does that mean we are going around in circles? Here is the (slightly abbreviated) article from 1995 for you to judge for yourself:
“Proponents of alternative medicine (AM) criticize the attempt of conducting RCTs because they view this is in analogy to ‘throwing out the baby with the bath water’. The argument usually goes as follows: the growing popularity of AM shows that individuals like it and, in some way, they benefit through using it. Therefore it is best to let them have it regardless of its objective effectiveness. Attempts to prove or disprove effectiveness may even be counterproductive. Should RCTs prove that a given intervention is not superior to a placebo, one might stop using it. This, in turn, would be to the disadvantage of the patient who, previous to rigorous research, has unquestionably been helped by the very remedy. Similar criticism merely states that AM is ‘so different, so subjective, so sensitive that it cannot be investigated in the same way as mainstream medicine’. Others see reasons to change the scientific (‘reductionist’) research paradigm into a broad ‘philosophical’ approach. Yet others reject the RCTs because they think that ‘this method assumes that every person has the same problems and there are similar causative factors’.
The example of acupuncture as a (popular) treatment for osteoarthritis, demonstrates the validity of such arguments and counter-arguments. A search of the world literature identified only two RCTs on the subject. When acupuncture was tested against no treatment, the experimental group of osteoarthritis sufferers reported a 23% decrease of pain, while the controls suffered a 12% increase. On the basis of this result, it might seem highly unethical to withhold acupuncture from pain-stricken patients—’if a patient feels better for whatever reason and there are no toxic side effects, then the patient should have the right to get help’.
But what about the placebo effect? It is notoriously difficult to find a placebo indistinguishable to acupuncture which would allow patient-blinded studies. Needling non-acupuncture points may be as close as one can get to an acceptable placebo. When patients with osteoarthritis were randomized into receiving either ‘real acupuncture or this type of sham acupuncture both sub-groups showed the same pain relief.
These findings (similar results have been published for other AMs) are compatible only with two explanations. Firstly acupuncture might be a powerful placebo. If this were true, we need to establish how safe acupuncture is (clearly it is not without potential harm); if the risk/benefit ratio is favourable and no specific, effective form of therapy exists one might still consider employing this form as a ‘placebo therapy’ for easing the pain of osteoarthritis sufferers. One would also feel motivated to research this powerful placebo and identify its characteristics or modalities with the aim of using the knowledge thus generated to help future patients.
Secondly, it could be the needling, regardless of acupuncture points and philosophy, that decreases pain. If this were true, we could henceforward use needling for pain relief—no special training in or equipment for acupuncture would be required, and costs would therefore be markedly reduced. In addition, this knowledge would lead us to further our understanding of basic mechanisms of pain reduction which, one day, might evolve into more effective analgesia. In any case the published research data, confusing as they often are, do not call for a change of paradigm; they only require more RCTs to solve the unanswered problems.
Conducting rigorous research is therefore by no means likely to ‘throw out the baby with the bath water’. The concept that such research could harm the patient is wrong and anti-scientific. To follow its implications would mean neglecting the ‘baby in the bath water’ until it suffers serious damage. To conduct proper research means attending the ‘baby’ and making sure that it is safe and well.
If we listen to acupuncturists and their supporters, we might get the impression that acupuncture is totally devoid of risk. Readers of this blog will know that this is not quite true. A recent case report is a further reminder that acupuncture can cause serious complications; in extreme cases it can even kill.
A male patient in his late forties died right after an acupuncture treatment. A medico-legal autopsy disclosed severe haemorrhaging around the right vagus nerve in the neck. All other organs were normal, and laboratory findings revealed nothing significant. Thus, the authors of this case-report concluded that the man most probably died from severe vagal bradycardia and/or arrhythmia resulting from vagus nerve stimulation following acupuncture: To the best of our knowledge, this is the first report of a death due to vagus nerve injury after acupuncture.
In total, around 100 deaths have been reported after acupuncture in the medical literature. ‘This is a negligible small figure’ claim acupuncture fans. True, it is a small number, but it could just be the tip of a much larger ice-berg: there is no reporting system that could possibly pick up severe complications, and in the absence of such a scheme, nobody can name reliable incidence rates. And even if the numbers of severe complications and deaths are small – even a single fatality would seem one too many.
The deaths that are currently on record are mostly due to bilateral pneumothorax or cardiac tamponade. The present case of vagus nerve injury seems to be ‘a first’. Perhaps we should watch out for similar events?
IF WE DON’T LOOK, WE DON’T SEE.
The discussion whether acupuncture is more than a placebo is as long as it is heated. Crucially, it is also quite tedious, tiresome and unproductive, not least because no resolution seems to be in sight. Whenever researchers develop an apparently credible placebo and the results of clinical trials are not what acupuncturists had hoped for, the therapists claim that the placebo is, after all, not inert and the negative findings must be due to the fact that both placebo and real acupuncture are effective.
Laser acupuncture (acupoint stimulation not with needle-insertion but with laser light) offers a possible way out of this dilemma. It is relatively easy to make a placebo laser that looks convincing to all parties concerned but is a pure and inert placebo. Many trials have been conducted following this concept, and it is therefore highly relevant to ask what the totality of this evidence suggests.
A recent systematic review did just that; specifically, it aimed to evaluate the effects of laser acupuncture on pain and functional outcomes when it is used to treat musculoskeletal disorders.
Extensive literature searches were used to identify all RCTs employing laser acupuncture. A meta-analysis was performed by calculating the standardized mean differences and 95% confidence intervals, to evaluate the effect of laser acupuncture on pain and functional outcomes. Included studies were assessed in terms of their methodological quality and appropriateness of laser parameters.
Forty-nine RCTs met the inclusion criteria. Two-thirds (31/49) of these studies reported positive effects. All of them were rated as being of high methodological quality and all of them included sufficient details about the lasers used. Negative or inconclusive studies mostly failed to demonstrate these features. For all diagnostic subgroups, positive effects for both pain and functional outcomes were more consistently seen at long-term follow-up rather than immediately after treatment.
The authors concluded that moderate-quality evidence supports the effectiveness of laser acupuncture in managing musculoskeletal pain when applied in an appropriate treatment dosage; however, the positive effects are seen only at long-term follow-up and not immediately after the cessation of treatment.
Surprised? Well, I am!
This is a meta-analysis I always wanted to conduct and never came round to doing. Using the ‘trick’ of laser acupuncture, it is possible to fully blind patients, clinicians and data evaluators. This eliminates the most obvious sources of bias in such studies. Those who are convinced that acupuncture is a pure placebo would therefore expect a negative overall result.
But the result is quite clearly positive! How can this be? I can see three options:
- The meta-analysis could be biased and the result might therefore be false-positive. I looked hard but could not find any significant flaws.
- The primary studies might be wrong, fraudulent etc. I did not see any obvious signs for this to be so.
- Acupuncture might be more than a placebo after all. This notion might be unacceptable to sceptics.
I invite anyone who sufficiently understands clinical trial methodology to scrutinise the data closely and tell us which of the three possibilities is the correct one.
Moxibustion is an ancient variation of acupuncture using moxa made from dried mugwort (Artemisia argyi). It has long played an important role in the traditional heath care systems of China and other Asian countries. More recently, it has become popular also in the West. Practitioners use moxa sticks indirectly to warm acupuncture needles, or burn it close to the patient’s skin. Essentially, moxibustion is a treatment where acupuncture points are stimulated mainly or exclusively by the heat of burning moxa.
Because of moxibustion’s long history of usage and the fact that it is employed in many countries for a very wide range of conditions, some might argue that it has stood the ‘test of time’ and should be considered to be a well-established therapy. More critical thinkers would, however, point out that this is not an argument but a classical fallacy.
My team at Exeter regularly had research fellows from Korea and other Asian countries, and we managed to develop a truly productive cooperation. It enabled us to conduct systematic reviews including the Asian literature – and this is how we got involved in an unusual amount of research into moxibustion which, after all, is a fairly exotic alternative therapy. In 2010, we began a series of systematic reviews of moxibustion.
One of the first such articles included 9 RCTs testing the effectiveness of this treatment for stroke rehabilitation. Three RCTs reported favorable effects of moxibustion plus standard care on motor function versus standard care alone Three randomized clinical trials compared the effects of moxibustion on activities of daily living alone but failed to show favorable effects of moxibustion.
Also in 2010, our systematic review of RCTs of moxibustion as a treatment of ulcerative colitis (UC) concluded that current evidence is insufficient to show that moxibustion is an effective treatment of UC. Most of included trials had high risk of bias. More rigorous studies seem warranted.
Our (2010) systematic review od RCTs of moxibustion as a therapy in cancer care found that the evidence was limited to suggest moxibustion is an effective supportive cancer care in nausea and vomiting. However, all studies had a high risk of bias so effectively there was not enough evidence to draw any conclusion.
Our (2010) systematic review of RCTs of moxibustion for treating hypertension concluded that there was insufficient evidence to suggest that moxibustion is an effective treatment for hypertension.
Our (2010) systematic review of RCTs of moxibustion for constipation concluded as follows: Given that the methodological quality of all RCTs was poor, the results from the present review are insufficient to suggest that moxibustion is an effective treatment for constipation. More rigorous studies are warranted.
Our (2010) systematic review found few RCTs were available that test the effectiveness of moxibustion in the management of pain, and most of the existing trials had a high risk of bias. Therefore, more rigorous studies are required before the effectiveness of moxibustion for the treatment of pain can be determined.
Our (2011) systematic review of 14 RCTs of moxibustion for rheumatic conditions failed to provide conclusive evidence for the effectiveness of moxibustion compared with drug therapy in rheumatic conditions.
The, so far, last article in this series has only just been published. The purpose of this systematic review was to assess the efficacy of moxibustion as a treatment of chemotherapy-induced leukopenia. Twelve databases were searched from their inception through June 2014, without a language restriction. Randomized clinical trials (RCTs) were included, if moxibustion was used as the sole treatment or as a part of a combination therapy with conventional drugs for leukopenia induced by chemotherapy. Cochrane criteria were used to assess the risk of bias.
Six RCTs with a total of 681 patients met our inclusion criteria. All of the included RCTs were associated with a high risk of bias. The trials included patients with various types of cancer receiving ongoing chemotherapy or after chemotherapy. The results of two RCTs suggested the effectiveness of moxibustion combined with chemotherapy vs. chemotherapy alone. In four RCTs, moxibustion was more effective than conventional drug therapy. Six RCTs showed that moxibustion was more effective than various types of control interventions in increasing white blood cell counts.
Our conclusion: there is low level of evidence based on these six trials that demonstrates the superiority of moxibustion over drug therapies in the treatment of chemotherapy-induced leukopenia. However, the number of trials, the total sample size, and the methodological quality are too low to draw firm conclusions. Future RCTs appear to be warranted.
Was all this research for nothing?
I know many people who would think so. However, I disagree. If nothing else, these articles demonstrated several facts quite clearly:
- There is quite a bit of research even on the most exotic alternative therapy; sometimes one needs to look hard and include languages other than English.
- Studies from China and other Asian counties very rarely report negative results; this fact casts a dark shadow on the credibility of such data.
- The poor quality of trials in most areas of alternative medicine is lamentable and must be stimulus for researchers in this field to improve their act.
- Authors of systematic reviews must resist the temptation to draw positive conclusions based on flawed primary data.
- Moxibustion is a perfect example for demonstrating that the ‘test of time’ is no substitute for evidence.
- As for moxibustion, it cannot currently be considered an evidence-based treatment for any condition.
Acupuncture seems to be as popular as never before – many conventional pain clinics now employ acupuncturists, for instance. It is probably true to say that acupuncture is one of the best-known types of all alternative therapies. Yet, experts are still divided in their views about this treatment – some proclaim that acupuncture is the best thing since sliced bread, while others insist that it is no more than a theatrical placebo. Consumers, I imagine, are often left helpless in the middle of these debates. Here are 7 important bits of factual information that might help you make up your mind, in case you are tempted to try acupuncture.
- Acupuncture is ancient; some enthusiast thus claim that it has ‘stood the test of time’, i. e. that its long history proves its efficacy and safety beyond reasonable doubt and certainly more conclusively than any scientific test. Whenever you hear such arguments, remind yourself that the ‘argumentum ad traditionem’ is nothing but a classic fallacy. A long history of usage proves very little – think of how long blood letting was used, even though it killed millions.
- We often think of acupuncture as being one single treatment, but there are many different forms of this therapy. According to believers in acupuncture, acupuncture points can be stimulated not just by inserting needles (the most common way) but also with heat, electrical currents, ultrasound, pressure, etc. Then there is body acupuncture, ear acupuncture and even tongue acupuncture. Finally, some clinicians employ the traditional Chinese approach based on the assumption that two life forces are out of balance and need to be re-balanced, while so-called ‘Western’ acupuncturists adhere to the concepts of conventional medicine and claim that acupuncture works via scientifically explainable mechanisms that are unrelated to ancient Chinese philosophies.
- Traditional Chinese acupuncturists have not normally studied medicine and base their practice on the Taoist philosophy of the balance between yin and yang which has no basis in science. This explains why acupuncture is seen by traditional acupuncturists as a ‘cure all’ . In contrast, medical acupuncturists tend to cite neurophysiological explanations as to how acupuncture might work. However, it is important to note that, even though they may appear plausible, these explanations are currently just theories and constitute no proof for the validity of acupuncture as a medical intervention.
- The therapeutic claims made for acupuncture are legion. According to the traditional view, acupuncture is useful for virtually every condition affecting mankind; according to the more modern view, it is effective for a relatively small range of conditions only. On closer examination, the vast majority of these claims can be disclosed to be based on either no or very flimsy evidence. Once we examine the data from reliable clinical trials (today several thousand studies of acupuncture are available – see below), we realise that acupuncture is associated with a powerful placebo effect, and that it works better than a placebo only for very few (some say for no) conditions.
- The interpretation of the trial evidence is far from straight forward: most of the clinical trials of acupuncture originate from China, and several investigations have shown that very close to 100% of them are positive. This means that the results of these studies have to be taken with more than a small pinch of salt. In order to control for patient-expectations, clinical trials can be done with sham needles which do not penetrate the skin but collapse like miniature stage-daggers. This method does, however, not control for acupuncturists’ expectations; blinding of the therapists is difficult and therefore truly double (patient and therapist)-blind trials of acupuncture do hardly exist. This means that even the most rigorous studies of acupuncture are usually burdened with residual bias.
- Few acupuncturists warn their patients of possible adverse effects; this may be because the side-effects of acupuncture (they occur in about 10% of all patients) are mostly mild. However, it is important to know that very serious complications of acupuncture are on record as well: acupuncture needles can injure vital organs like the lungs or the heart, and they can introduce infections into the body, e. g. hepatitis. About 100 fatalities after acupuncture have been reported in the medical literature – a figure which, due to lack of a monitoring system, may disclose just the tip of an iceberg.
- Given that, for the vast majority of conditions, there is no good evidence that acupuncture works beyond a placebo response, and that acupuncture is associated with finite risks, it seems to follow that, in most situations, the risk/benefit balance for acupuncture fails to be convincingly positive.