acupuncture
On 25 and 26 May of this year I wrote two posts about an acupuncture trial that, in my view, was dodgy. To refresh your memory, here is the relevant part of the 2nd post:
This new study was designed as a randomized, sham-controlled trial of acupuncture for persistent allergic rhinitis in adults investigated possible modulation of mucosal immune responses. A total of 151 individuals were randomized into real and sham acupuncture groups (who received twice-weekly treatments for 8 weeks) and a no acupuncture group. Various cytokines, neurotrophins, proinflammatory neuropeptides, and immunoglobulins were measured in saliva or plasma from baseline to 4-week follow-up.
Statistically significant reduction in allergen specific IgE for house dust mite was seen only in the real acupuncture group. A mean (SE) statistically significant down-regulation was also seen in pro-inflammatory neuropeptide substance P (SP) 18 to 24 hours after the first treatment. No significant changes were seen in the other neuropeptides, neurotrophins, or cytokines tested. Nasal obstruction, nasal itch, sneezing, runny nose, eye itch, and unrefreshed sleep improved significantly in the real acupuncture group (post-nasal drip and sinus pain did not) and continued to improve up to 4-week follow-up.
The authors concluded that acupuncture modulated mucosal immune response in the upper airway in adults with persistent allergic rhinitis. This modulation appears to be associated with down-regulation of allergen specific IgE for house dust mite, which this study is the first to report. Improvements in nasal itch, eye itch, and sneezing after acupuncture are suggestive of down-regulation of transient receptor potential vanilloid 1.
…the trial itself raises a number of questions:
- Which was the primary outcome measure of this trial?
- What was the power of the study, and how was it calculated?
- For which outcome measures was the power calculated?
- How were the subjective endpoints quantified?
- Were validated instruments used for the subjective endpoints?
- What type of sham was used?
- Are the reported results the findings of comparisons between verum and sham, or verum and no acupuncture, or intra-group changes in the verum group?
- What other treatments did each group of patients receive?
- Does anyone really think that this trial shows that “acupuncture is a safe, effective and cost-effective treatment for allergic rhinitis”?
In the comments section, the author wrote: “after you have read the full text and answered most of your questions for yourself, it might then be a more appropriate time to engage in any meaningful discussion, if that is in fact your intent”, and I asked him to send me his paper. As he does not seem to have the intention to do so, I will answer the questions myself and encourage everyone to have a close look at the full paper [which I can supply on request].
- The myriad of lab tests were defined as primary outcome measures.
- Two sentences are offered, but they do not allow me to reconstruct how this was done.
- No details are provided.
- Most were quantified with a 3 point scale.
- Mostly not.
- Needle insertion at non-acupoints.
- The results are a mixture of inter- and intra-group differences.
- Patients were allowed to use conventional treatments and the frequency of this use was reported in patient diaries.
- I don’t think so.
So, here is my interpretation of this study:
- It lacked power for many outcome measures, certainly the clinical ones.
- There were hardly any differences between the real and the sham acupuncture group.
- Most of the relevant results were based on intra-group changes, rather than comparing sham with real acupuncture, a fact, which is obfuscated in the abstract.
- In a controlled trial fluctuations within one group must never be interpreted as caused by the treatment.
- There were dozens of tests for statistical significance, and there seems to be no correction for multiple testing.
- Thus the few significant results that emerged when comparing sham with real acupuncture might easily be false positives.
- Patient-blinding seems questionable.
- McDonald as the only therapist of the study might be suspected to have influenced his patients through verbal and non-verbal communications.
I am sure there are many more flaws, particularly in the stats, and I leave it to others to identify them. The ones I found are, however, already serious enough, in my view, to call for a withdrawal of this paper. Essentially, the authors seem to have presented a study with largely negative findings as a trial with positive results showing that acupuncture is an effective therapy for allergic rhinitis. Subsequently, McDonald went on social media to inflate his findings even more. One might easily ask: is this scientific misconduct or just poor science?
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This and the previous post created lots of discussion and comments. However, the question whether the study in question amounted to scientific misconduct was never satisfactorily resolved. Therefore, I decided to write to the editor of ‘Ann Allergy Asthma Immunol‘ where the trial had been published. He answered by saying I would need to file an official complaint for him to address the issue. On 13 June, I therefore sent him the following email:
Thank you for your letter of 3/6/2016 suggesting I make a formal complaint about the paper entitled ‘EFFECT OF ACUPUNCTURE ON HOUSE DUST MITE…’ [ Ann Allergy Asthma Immunol 2016] by McDonald et al. I herewith wish to file such a complaint.
The article in question reports an RCT of acupuncture for persistent allergic rhinitis. It followed a parallel group design with 3 groups receiving the following interventions:
1. Acupuncture
2. Sham-acupuncture
3. No treatment
There was a plethora of outcome measures and time points on which they were measured. A broad range of parameters was defined as primary endpoints.
The conclusion reached by the authors essentially was that acupuncture affected several outcome measures in a positive sense, thus supporting the notion that acupuncture is efficacious [“Symptoms and quality of life improved significantly and were still continuing to improve 4 weeks after treatment ceased.”] This conclusion, however, is misleading and needs correcting.
The main reasons for this are as follows:
· Despite the fact that the authors did many dozens of statistical tests for significance, they did not correct for this multiplicity of tests. Consequently, some or most of the significant results are likely to be false positive.
· Many of the positive results of this paper were not obtained by comparing one group to another but by doing before/after comparisons within one group. This approach defies the principle of a controlled clinical trial. For doing intra-group comparisons, we obviously do not need any control group at all. The findings from intra-group comparisons are prominently reported in the paper, for instance in the abstract, giving the impression that they originate from inter-group comparisons. One has to read the paper very carefully to find that, when inter-group comparisons were conducted, their results did NOT confirm the findings from the reported intra-group comparisons. As this is the case for most of the symptomatic endpoints, the impression given is seriously misleading and needs urgent correction.
On the whole, the article is a masterpiece of obfuscation and misrepresentation of the actual data. I urge you to consider the harm than can be done by such a misleading publication. In my view, the best way to address this problem is to withdraw the article.
I look forward to your decision.
Regards
E Ernst
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I had to send several reminders but my most recent one prompted the following response dated 7/11/ 2016:
- Our editorial team recognizes that this is not the best clinical trial we have published in the Annals of Allergy, Asthma and Immunology. However, neither is is the worst. As in most published research studies, there are always things that could have been done better to make it a stronger paper. Never-the-less, the criticism falls fall short of any sort of remedy that would include withdrawal of the manuscript.
- Regarding your accusation that the multiple positive endpoint resulted in the authors making specific therapeutic claims, our assessment is that no specific therapeutic claim was made but rather the authors maintained that the data support the value of acupuncture in improving symptoms and quality of life in patients with AR. We do not believe there was overreach in those statements.
- The authors’ stated intent was to show immune changes associated with clinical markers of improvement in the active acupuncture group compared to controls. The authors maintain (and our editors agree) that their data assessments were primarily based upon three statistical tests not “dozens” (as stated in your original letter of complaint). The power analysis and sample size calculations were presented to us and deemed adequate , making the probability of a type I error quite low.
- The authors acknowledge in their paper that there could be limitations to their data interpretation based upon potential disparities between intra- and intergroup comparisons. The editors felt their transparency was adequately disclosed.
I have warned you before to be sceptical about Chinese studies. This is what I posted on this blog more than 2 years ago, for instance:
Imagine an area of therapeutics where 100% of all findings of hypothesis-testing research are positive, i.e. come to the conclusion that the treatment in question is effective. Theoretically, this could mean that the therapy is a miracle cure which is useful for every single condition in every single setting. But sadly, there are no miracle cures. Therefore something must be badly and worryingly amiss with the research in an area that generates 100% positive results.
Acupuncture is such an area; we and others have shown that Chinese trials of acupuncture hardly ever produce a negative finding. In other words, one does not need to read the paper, one already knows that it is positive – even more extreme: one does not need to conduct the study, one already knows the result before the research has started. But you might not believe my research nor that of others. We might be chauvinist bastards who want to discredit Chinese science. In this case, you might perhaps believe Chinese researchers.
In this systematic review, all randomized controlled trials (RCTs) of acupuncture published in Chinese journals were identified by a team of Chinese scientists. A total of 840 RCTs were found, including 727 RCTs comparing acupuncture with conventional treatment, 51 RCTs with no treatment controls, and 62 RCTs with sham-acupuncture controls. Among theses 840 RCTs, 838 studies (99.8%) reported positive results from primary outcomes and two trials (0.2%) reported negative results. The percentages of RCTs concealment of the information on withdraws or sample size calculations were 43.7%, 5.9%, 4.9%, 9.9%, and 1.7% respectively.
The authors concluded that publication bias might be major issue in RCTs on acupuncture published in Chinese journals reported, which is related to high risk of bias. We suggest that all trials should be prospectively registered in international trial registry in future.
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Now an even more compelling reason emerged for taking evidence from China with a pinch of salt:
A recent survey of clinical trials in China has revealed fraudulent practice on a massive scale. China’s food and drug regulator carried out a one-year review of clinical trials. They concluded that more than 80 percent of clinical data is “fabricated“. The review evaluated data from 1,622 clinical trial programs of new pharmaceutical drugs awaiting regulator approval for mass production. Officials are now warning that further evidence malpractice could still emerge in the scandal.
According to the report, much of the data gathered in clinical trials are incomplete, failed to meet analysis requirements or were untraceable. Some companies were suspected of deliberately hiding or deleting records of adverse effects, and tampering with data that did not meet expectations.
“Clinical data fabrication was an open secret even before the inspection,” the paper quoted an unnamed hospital chief as saying. Contract research organizations seem have become “accomplices in data fabrication due to cutthroat competition and economic motivation.”
A doctor at a top hospital in the northern city of Xian said the problem doesn’t lie with insufficient regulations governing clinical trials data, but with the failure to implement them. “There are national standards for clinical trials in the development of Western pharmaceuticals,” he said. “Clinical trials must be carried out in three phases, and they must be assessed at the very least for safety,” he said. “But I don’t know what happened here.”
Public safety problems in China aren’t limited to the pharmaceutical industry and the figure of 80 percent is unlikely to surprise many in a country where citizens routinely engage in the bulk-buying of overseas-made goods like infant formula powder. Guangdong-based rights activist Mai Ke said there is an all-pervasive culture of fakery across all products made in the country. “It’s not just the medicines,” Mai said. “In China, everything is fake, and if there’s a profit in pharmaceuticals, then someone’s going to fake them too.” He said the problem also extends to traditional Chinese medicines, which are widely used in conjunction with Western pharmaceuticals across the healthcare system.
“It’s just harder to regulate the fakes with traditional medicines than it is with Western pharmaceuticals, which have strict manufacturing guidelines,” he said.
According to Luo, academic ethics is an underdeveloped field in China, leading to an academic culture that is accepting of manipulation of data. “I don’t think that the 80 percent figure is overstated,” Luo said.
And what should we conclude from all this?
I find it very difficult to reach a verdict that does not sound hopelessly chauvinistic but feel that we have little choice but to distrust the evidence that originates from China. At the very minimum, I think, we must scrutinise it thoroughly; whenever it looks too good to be true, we ought to discard it as unreliable and await independent replications.
A website I recently came across promised to teach me 7 things about acupuncture. This sort of thing is always of interest to me; so I read them with interest and found them so remarkable that I decided to reproduce them here:
1. Addiction recovery
Acupuncture calms and relaxes the mind making it easier for people to overcome addictions to drugs, cigarettes, and alcohol by reducing the anxiety and stress they feel when quitting.
2. Helps the body heal itself
The body contains natural pain relief chemicals, such as endorphins and has an amazing capacity for self-healing. Acupuncture helps stimulate the natural healing mechanisms and causes the body to manufacture pain relieving chemicals.
3. Builds a stronger immune system
The body’s immune system is negatively affected by stress, poor diet, illness and certain medical treatments, but acupuncture targets the underlying imbalances naturally and helps it to regain balance.
4. Eliminate that killer hangover
While it may not have been the best choice to finish off that bottle of wine, acupuncture can help the body detox and flush out the morning side effects.
5. Mood stabilizer
If you find yourself snapping at friends, family, or co-workers for unexplained reasons, acupuncture can get to the root of the problem, find the imbalance and help your body return to a healthier state of mind.
6. Chronic stomach problems
Some people suffer from stomach problems and never find the cause. Acupuncture targets your whole body, including the digestive tract and helps it to work in harmony with the rest of the body’s systems.
7. Coping with death
Grief can have an overwhelming effect on the body and manifest itself physically. Acupuncture helps reduce the anxiety of dealing with loss and help you cope with the stress.
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The ‘7 things’ are remarkably mislabelled – they should be called 7 lies! Let me explain:
- There are several Cochrane reviews on the subject of acupuncture for various addictions. Here are their conclusions: There is currently no evidence that auricular acupuncture is effective for the treatment of cocaine dependence. The evidence is not of high quality and is inconclusive. Further randomised trials of auricular acupuncture may be justified. There is no clear evidence that acupuncture is effective for smoking cessation. There is currently no evidence that auricular acupuncture is effective for the treatment of cocaine dependence. The evidence is not of high quality and is inconclusive. Further randomised trials of auricular acupuncture may be justified.
- Even if the ‘endorphin story’ is true (in my view, it’s but a theory), there is no good evidence that acupuncture enhances our body’s self-healing mechanisms via endorphins or any other mechanism.
- Stronger immune system? My foot! I have no idea where this claim comes from, certainly not from anything resembling good evidence.
- Acupuncture for hangover or detox? This is just a stupid joke with no evidential support. I imagine, however, that it is superb marketing.
- The same applies to acupuncture to ‘stabilize’ your mood.
- Unexplained stomach problems? Go and see a doctor! Here is the conclusion of a Cochrane review related to IBS which is one of the more common unexplained stomach complaint: Sham-controlled RCTs have found no benefits of acupuncture relative to a credible sham acupuncture control for IBS symptom severity or IBS-related quality of life.
- I am not aware of any good evidence to show that acupuncture could ease the grieving process; I even doubt that this would be such a good or desirable thing: grieving is a necessary and essential process.
So, what we have here are essentially 7 fat lies. Yes, I know, the literature and the internet are full of them. And I suspect that they are a prominent reason why acupuncture is fairly popular today. Lies are a major marketing tool of acupuncturists – but that does not mean that we should let them get away with them!
Why?
Bogus claims may be good for the cash flow of alternative practitioners, but they are certainly not good for our health and well-being; in fact, they can cost lives!!!
IN THIS SPIRIT, LET ME ADD SEVEN THINGS YOU DO NEED TO KNOW ABOUT ACUPUNCTURE
- Traditional acupuncture is based on complete hocus pocus and is therefore implausible.
- ‘Western’ acupuncture is based on endorphin and other theories, which are little more than that and at best THEORIES.
- Acupuncture is often promoted as a ‘cure all’ which is implausible and not supported by evidence.
- Meridians, acupoints chi and all the other things acupuncturists claim to exist are pure fantasy.
- For a small list of symptoms, acupuncture is backed up by some evidence, but this is less than convincing and could well turn out to rely on little more than placebo.
- The claim of acupuncturists that acupuncture is entirely safe is false.
- Acupuncture studies from China cannot be trusted.
In alternative medicine, good evidence is like gold dust and good evidence showing that alternative therapies are efficacious is even rarer. Therefore, I was delighted to come across a brand-new article from an institution that should stand for reliable information: the NIH, no less.
According to its authors, this new article “examines the clinical trial evidence for the efficacy and safety of several specific approaches—acupuncture, manipulation, massage therapy, relaxation techniques including meditation, selected natural product supplements (chondroitin, glucosamine, methylsulfonylmethane, S-adenosylmethionine), tai chi, and yoga—as used to manage chronic pain and related disability associated with back pain, fibromyalgia, osteoarthritis, neck pain, and severe headaches or migraines.”
The results of this huge undertaking are complex, of course, but in a nutshell they are at least partly positive for alternative medicine. Specifically, the authors state that “based on a preponderance of positive trials vs negative trials, current evidence suggests that the following complementary approaches may help some patients manage their painful health conditions: acupuncture and yoga for back pain; acupuncture and tai chi for OA of the knee; massage therapy for neck pain with adequate doses and for short-term benefit; and relaxation techniques for severe headaches and migraine. Weaker evidence suggests that massage therapy, SM, and osteopathic manipulation might also be of some benefit to those with back pain, and relaxation approaches and tai chi might help those with fibromyalgia.”
This is excellent news! Finally, we have data from an authoritative source showing that some alternative treatments can be recommended for common pain conditions.
Hold on, not so fast! Yes, the NIH is a most respectable organisation, but we must not blindly accept anything of importance just because it appears to come form a reputable source. Let’s look a bit closer at the actual evidence provided by the authors of this paper.
Reading the article carefully, it is impossible not to get troubled. Here are a few points that concern me most:
- the safety of a therapy cannot be evaluated on the basis of data from RCTs (particularly as it has been shown repeatedly that trials of alternative therapies often fail to report adverse effects); much larger samples are needed for that; any statements about safety in the aims of the paper are therefore misplaced;
- the authors talk about efficacy but seem to mean effectiveness;
- the authors only included RCTs from the US which must result in a skewed and incomplete picture;
- the article is from the National Center for Complementary and Integrative Health which is part of the NIH but which has been criticised repeatedly for being biased in favour of alternative medicine;
- not all of the authors seem to be NIH staff, and I cannot find a declaration of conflicts of interest;
- the discussion of the paper totally lacks any critical thinking;
- there is no assessment of the quality of the trials included in this review.
My last point is by far the most important. A summary of this nature that fails to take into account the numerous limitations of the primary data is, I think, as good as worthless. As I know most of the RCTs included in the analyses, I predict that the overall picture generated by this review would have changed substantially, if the risks of bias in the primary studies had been accounted for.
Personally, I find it lamentable that such a potentially worthy exercise ended up employing such lousy methodology. Perhaps even more lamentable is the fact that the NIH (or one of its Centers) can descend that low; to mislead the public in this way borders on scientific misconduct and is, in my view, unethical and unacceptable.
The aim of a new meta-analysis was to estimate the clinical effectiveness and safety of acupuncture for amnestic mild cognitive impairment (AMCI), the transitional stage between the normal memory loss of aging and dementia. Randomised controlled trials (RCTs) of acupuncture versus medical treatment for AMCI were identified using six electronic databases.
Five RCTs involving a total of 568 subjects were included. The methodological quality of the RCTs was generally poor. Participants receiving acupuncture had better outcomes than those receiving nimodipine with greater clinical efficacy rates (odds ratio (OR) 1.78, 95% CI 1.19 to 2.65; p<0.01), mini-mental state examination (MMSE) scores (mean difference (MD) 0.99, 95% CI 0.71 to 1.28; p<0.01), and picture recognition score (MD 2.12, 95% CI 1.48 to 2.75; p<0.01). Acupuncture used in conjunction with nimodipine significantly improved MMSE scores (MD 1.09, 95% CI 0.29 to 1.89; p<0.01) compared to nimodipine alone. Three trials reported adverse events.
The authors concluded that acupuncture appears effective for AMCI when used as an alternative or adjunctive treatment; however, caution must be exercised given the low methodological quality of included trials. Further, more rigorously designed studies are needed.
Meta-analyses like this one are, in my view, perfect examples for the ‘rubbish in, rubbish out’ principle of systematic reviews. This may seem like an unfair statement, so let me justify it by explaining the shortfalls of this specific paper.
The authors try to tell us that their aim was “to estimate the clinical effectiveness and safety of acupuncture…” While it might be possible to estimate the effectiveness of a therapy by pooling the data of a few RCTs, it is never possible to estimate its safety on such a basis. To conduct an assessment of therapeutic safety, one would need sample sizes that go two or three dimensions beyond those of RCTs. Thus safety assessments are best done by evaluating the evidence from all the available evidence, including case-reports, epidemiological investigations and observational studies.
The authors tell us that “two studies did not report whether any adverse events or side effects had occurred in the experimental or control groups.” This is a common and serious flaw of many acupuncture trials, and another important reason why RCTs cannot be used for evaluating the risks of acupuncture. Too many such studies simply don’t mention adverse effects at all. If they are then submitted to systematic reviews, they must generate a false positive picture about the safety of acupuncture. The absence of adverse effects reporting is a serious breach of research ethics. In the realm of acupuncture, it is so common, that many reviewers do not even bother to discuss this violation of medical ethics as a major issue.
The authors conclude that acupuncture is more effective than nimodipine. This sounds impressive – unless you happen to know that nimodipine is not supported by good evidence either. A Cochrane review provided no convincing evidence that nimodipine is a useful treatment for the symptoms of dementia, either unclassified or according to the major subtypes – Alzheimer’s disease, vascular, or mixed Alzheimer’s and vascular dementia.
The authors also conclude that acupuncture used in conjunction with nimodipine is better than nimodipine alone. This too might sound impressive – unless you realise that all the RCTs in question failed to control for the effects of placebo and the added attention given to the patients. This means that the findings reported here are consistent with acupuncture itself being totally devoid of therapeutic effects.
The authors are quite open about the paucity of RCTs and their mostly dismal methodological quality. Yet they arrive at fairly definitive conclusions regarding the therapeutic value of acupuncture. This is, in my view, a serious mistake: on the basis of a few poorly designed and poorly reported RCTs, one should never arrive at even tentatively positive conclusion. Any decent journal would not have published such misleading phraseology, and it is noteworthy that the paper in question appeared in a journal that has a long history of being hopelessly biased in favour of acupuncture.
Any of the above-mentioned flaws could already be fatal, but I have kept the most serious one for last. All the 5 RCTs that were included in the analyses were conducted in China by Chinese researchers and published in Chinese journals. It has been shown repeatedly that such studies hardly ever report anything other than positive results; no matter what conditions is being investigated, acupuncture turns out to be effective in the hands of Chinese trialists. This means that the result of such a study is clear even before the first patient has been recruited. Little wonder then that virtually all reviews of such trials – and there are dozens of then – arrive at conclusions similar to those formulated in the paper before us.
As I already said: rubbish in, rubbish out!
Acupuncture Today is a much-read online publication for people interested in acupuncture. It informs us that Chinese medicine is quite complex and can be difficult for some people to comprehend. This is because TCM is based, at least in part, on the Daoist belief that we live in a universe in which everything is interconnected. What happens to one part of the body affects every other part of the body. The mind and body are not viewed separately, but as part of an energetic system. Similarly, organs and organ systems are viewed as interconnected structures that work together to keep the body functioning.
To me, this sounds suspiciously woolly. Do they think that conventional healthcare professionals view the various body-parts as separate entities? Do they feel that conventional practitioners see the mind entirely separate from the body? Do they believe others fail to realize that what affects the brain does not affect the rest of the body? These common preconceptions have always puzzled me. Intrigued, I read on.
Elsewhere we learn that Acupuncture Today and acupuncturetoday.com are the only complete news sources in the profession and we don’t take this honor lightly. The acupuncture and Oriental medicine profession is a blend of ancient traditions, healing styles and modern therapies. We provide content that is comprehensive enough to appeal to each of the profession’s diverse groups. In addition, we provide a complete suite of additional products including newsletters, calendars and classifieds that provide our advertisers with the contextual platform they need to communicate with our readers, their customers.
Acupuncture Today seems to reflect a lot of what many acupuncturists want to hear – and thus it might provide us with an important insight into the mind-set of acupuncturists. On their website, I found an article which fascinated me:
START OF QUOTE
A more efficient method for diagnosis and treatment by remote medical dowsing has been found and used in acupuncture with great success. The procedure involves a pendulum, a picture of the patient, an anatomy book, a steel pointer, and a very thin bamboo pointer.
Being a dentist, orthodontist, acupuncturist and dowser, I like to take the liberty of treating a person affected with lockjaw or temporal-mandibular joint ailments via remote dowsing…
…When the mandible cannot open due to a spasm, the chief symptom is pain. Until energy is restored, the muscle cannot lengthen and pain cannot be eliminated. Acupuncture is a good way to correct this condition without the use of a dental appliance. Dentists specializing in treating TMJ use a computerized equipment scan (electrosonography), surface electromyography and the myomonitor to relax the muscles.
Another procedure to treat TMJ is using dowsing. At this point, I will talk about dowsing procedures and information needed to successfully carry out the procedures. Remote dowsing requires the use of the pendulum, a slender bamboo pointer, an anatomy book, a picture of the patient and a steel pointer.
To treat a TMJ patient, the picture of the patient is dowsed holding a pendulum in the right hand while the left hand uses a bamboo pointer to touch the closing and opening muscles individually in the anatomy book. The closing muscles will have good energy (as evidenced by the circular movement of the pendulum) while the lower head of the lateral pterygoid will have no energy (as evidenced by little or no movement of the pendulum). Having advance information on TMJ acupuncture points helps, but these points will have to be tested if needling will supply energy. Master Tong has suggested a point between Liver 2 and Liver 3. I find Spleen 2, a distal point related to the lower head of the lateral pterygoid, to be more effective. This can be checked by having the patient hold the point of the steel pointer so it touches Spleen 2 on the large toe.
To treat a TMJ patient, the picture of the patient is dowsed holding a pendulum in the right hand while the left hand uses a bamboo pointer to touch the closing and opening muscles individually in the anatomy book. The closing muscles will have good energy (as evidenced by the circular movement of the pendulum) while the lower head of the lateral pterygoid will have no energy (as evidenced by little or no movement of the pendulum). Having advance information on TMJ acupuncture points helps, but these points will have to be tested if needling will supply energy. Master Tong has suggested a point between Liver 2 and Liver 3. I find Spleen 2, a distal point related to the lower head of the lateral pterygoid, to be more effective. This can be checked by having the patient hold the point of the steel pointer so it touches Spleen 2 on the large toe.
By dowsing the picture of the patient with the right hand and using a bamboo pointer to touch the lower head of the pterygoid muscle in the anatomy book with the left hand, it will be evident by the circular movement of the pendulum that these muscles now have good energy. This is done before the needle is inserted. In this manner all points can be checked for ailments such as TMJ, stroke, backaches, and neck and shoulder problems before needling. When the needles are placed and after the needling procedure, energy can be checked using the pendulum. By being very accurate on the location of acupuncture points, less treatments will be needed to obtain results. Another point is Small Intestine 19, a local point which is also very effective. Good results are obtained by careful and accurate needling. Therefore, the number of visits are few…
Dowsing is a diagnostic aid that has been used for other situations and can be very helpful to acupuncturists. In conclusion, I feel that remote dowsing is a great approach to diagnosis and treatment.
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If I had not seen alternative practitioners doing this procedure with my own eyes, I might have thought the article is a hoax. Sadly, this is the ‘real world’ of alternative medicine.
I tried to find some acupuncturists who had objected to this intense nonsense, but I was not successful in this endeavour. The article was published 6 years ago (no, not on 1 April!), yet so far, nobody has objected.
I have also tried to see whether articles promoting quackery of this nature are rare exceptions in the realm of acupuncture, or whether they are regular occurrences. My impression is that the latter is the case.
What can be concluded from all this?
In a previous post about quackery in chiropractic, I have argued that the tolerance of quackery must be one of the most important hallmarks of a quack profession. As I still believe this to be true, I have to ask to which extend THE TOLERANCE OF SUCH EXTREME QUACKERY MAKES ACUPUNCTURISTS QUACKS?
[I would be most interested to have my readers’ views on this question]What a silly question! At least this is what most sceptics would say: if we are not sure that it works, we do not need to spend any thoughts on a potential mechanism!
However, in the realm of acupuncture, the potential mode of action remains a hotly debated and fundamentally relevant issue.
The TCM folks, of course, ‘knew’ all along how acupuncture works: it re-balances the life-forces yin and yang. This is a nice theory – it has but one disadvantage: it has no bearing whatsoever on reality. Vitalistic ideas such as this one have long been proven to be nothing but fantasy.
Meanwhile, several more plausible hypotheses have been developed, and hundreds of papers have been published on the subject. One recent article, for instance, suggests a range of mechanisms including microinjury, increased local blood flow, facilitated healing, and analgesia. Acupuncture may trigger a somatic autonomic reflex, thereby affecting the gastric and cardiovascular functions. Acupuncture may also change the levels of neurotransmitters such as serotonin and dopamine, thereby affecting the emotional state and craving… By affecting other pain-modulating neurotransmitters such as met-enkephalin and substance P along the nociceptive pathway, acupuncture may relieve headache. Acupuncture may affect the hypothalamus pituitary axis and reduce the release of the luteinizing hormone…
Another article states that the Western explanation for acupuncture effectiveness is based upon more than half a century of basic and clinical research, which identified the activation of sensory system and the subsequent activity-dependent regulation of neurotransmitters, neurohormones, and several classes of neuromodulators as plausible mechanism for the acupuncture‘s therapeutic properties. The regulation of neurotrophins’ expression and activity is one of the possible neurophysiological mechanisms underlying acupuncture‘s effects on neuropathic pain, nerve injury, neurodegeneration, and even in the regulation of gonadal functions…
Recently Burnstock proposed that mechanical deformation of the skin by needles and application of heat or electrical current leads to release of large amounts of ATP from keratinocytes, fibroblasts and other cells in skin; the ATP then occupies specific receptor subtypes expressed on sensory nerve endings in the skin and tongue; the sensory nerves send impulses through ganglia to the spinal cord, the brain stem, hypothalamus and higher centres; the brain stem and hypothalamus contain neurons that control autonomic functions, including cardiovascular, gastrointestinal, respiratory, urinogenital and musculo-skeletal activity. Impulses generated in sensory fibres in the skin connect with interneurons to modulate (either inhibition or facilitation) the activities of the motoneurons in the brain stem and hypothalamus to change autonomic functions; specifically activated sensory nerves, via interneurons, also inhibit the neural pathways to the pain centres in the cortex.
A brand-new article in the journal SCIENTIFIC AMERICAN puts the hypothesis in perspective:
…scientists have been studying a roster of potential biological pathways by which needling might relieve pain. The most successful of these efforts has centered on adenosine, a chemical believed to ease pain by reducing inflammation. A 2010 mouse study found that acupuncture needles triggered a release of adenosine from the surrounding cells into the extracellular fluid that diminished the amount of pain the rodents experienced. The mice had been injected with a chemical that made them especially sensitive to heat and touch. The researchers reported a 24-fold increase in adenosine concentration in the blood of the animals after acupuncture, which corresponded to a two-thirds reduction in discomfort, as revealed by how quickly they recoiled from heat and touch. Injecting the mice with compounds similar to adenosine had the same effect as acupuncture needling. And injecting compounds that slowed the removal of adenosine from the body boosted the effects of acupuncture by making more adenosine available to the surrounding tissue for longer periods. Two years later a different group of researchers went on to show that an injection of PAP, an enzyme that breaks other compounds in the body down into adenosine, could relieve pain for an extended chunk of time by increasing the amount of adenosine in the surrounding tissue. They dubbed that experimental procedure “PAPupuncture.”
Both sets of findings have excited researchers—and for good reason. The current options for treating pain are limited and rely mostly on manipulating the body’s natural pain-management system, known as the opioid system. Opioid-based painkillers are problematic for several reasons. Not only does their efficacy tend to wane over time, but they have been linked to an epidemic of addiction and overdose deaths across the U.S.—so much so that the Centers for Disease Control and Prevention has recently advised doctors to seriously restrict their use. The available nonopioid pain treatments are few; many of them require multiple injections or catheterization to work; and they often come with side effects, such as impaired movement. Adenosine offers an entirely new mechanism to exploit for potential treatments—one that may come with fewer side effects and less potential for addiction. What is more, adenosine can be made to circulate in the body for prolonged stretches. Pharmaceutical companies are actively investigating adenosine-related compounds as potential drugs.
But however promising adenosine may be as a treatment, the findings from this research do not prove that acupuncture itself “works.” For one thing, the researchers did not show that the release of adenosine was specific to acupuncture. Acupuncture needles might cause adenosine to flood the surrounding tissue, but so might a hard pinch, or applied pressure, or any number of other physical insults. In fact, both of the studies found that when adenosine was turned on in mouse tissue by other mechanisms, the pain response was equal to or better than the response generated by acupuncture. For another thing, the study results offered no support for the use of acupuncture to treat any of the other conditions for which the procedure is often advertised. A localized adenosine response may mitigate localized pain. That does not mean it can also cure insomnia or infertility.
It may well be that the reams of research scientists have done on acupuncture have lit the path toward improved understanding of—and eventually better treatments for—intractable pain. But it may also be time to take whatever bread crumbs have been laid out by that work and move on.
END OF QUOTE
As we see, there is no shortage of potential explanations as to HOW acupuncture works. The most plausible theory still is that it works largely or even exclusively via a placebo effect.
Due to this type of mechanistic research, acupuncture has gained much credibility. The question is, does it deserve it? In my view, it would be much more fruitful to first make sure THAT acupuncture works (beyond a placebo response) and, if so, for what conditions. The question HOW it works is unquestionably interesting but in the final analysis it probably is secondary.
I am editor in chief of a journal called FACT. It has a large editorial board, and I am always on the look-out for people who might be a good, productive and colourful addition to it. On 3 June, I sent an invitation to Mel Koppelman, who is by now well known to regular readers of this blog. Here is a copy:
Hi Mel,
can I ask you a question?
would you consider joining the ed-board of FACT [as you mentioned it in one of your comments, I assume you know this journal – but you are wrong in implying that it has anything to do with the pharmaceutical or any other industry]? if you agree, we would expect you to write 2-3 ‘summaries/commentaries’ per year. in return you get a free subscription and, of course, can submit other articles.
no, this is not a joke or a set-up. I like to have the full spectrum of opinion/expertise on my ed-board, and I do think you understand science quite well. our opinions differ but that’s what I think is good for the journal.
think about it – please.
cheers
edzard
On 6 June, she replied as follows:
Hi Edzard,
Great to hear from you, I hope you enjoyed your weekend.
Thank you very much for the kind offer, it’s something I would consider. I certainly have no problem with, and in fact embrace, people who have different opinions and views from my own, so long as I feel that they have integrity in their approach.
Just a few questions / comments:
1) Regarding FACT’s affiliations, what I said in my comment was that it was a publication of the Royal Pharmaceutical Society. According to Wiley’s website, Focus on Alternative and Complementary Medicine is copyright by Royal Pharmaceutical Society. It’s also listed on the Pharmaceutical Press website.
Are you telling me that’s incorrect? That I’m “wrong” in saying there’s a relationship? I obviously need to understand the nature of the publication whose editorial board I’m considering joining. Very confusing that you as editor say there’s no relationship to the RPS and yet they claim copyright over your publication. Incidentally, is FACT self-sufficient, earning all of its income from subscriptions? Or does any financial support come from the publishers?
2) As enticing as a free subscription to FACT is, I have access to more high quality peer-reviewed reading material than I could enjoy in many lifetimes. Because my skills seem to be in high demand and because I already spend 10-20 hours per week doing unpaid volunteer work, any additional projects that I take on at this time would need to be financially compensated. I understand that this may be a deal-breaker.
3) While I have no issue with you having different views when it comes to medical research, in order to choose to work with your publication, it’s important to me that it’s run by people with a high level of academic integrity and put patient welfare at the forefront of it’s agenda.
In March, you came out in public support of the NICE draft guidelines. You were quoted in the Guardian as saying: “It is good to see that Nice have now caught up with the evidence. Neither spinal manipulation nor acupuncture are supported by good science when it comes to treating low back pain.”
Following this, it was brought to your attention that the recommendations were contrary to best evidence and that the conclusions were unsupportable. While you have the option of following this up to make sure that the record reflects best evidence, you have indicated that you have no interest in evaluating the situation and possibly admitting an error. This behaviour is concerning from the perspective of academic integrity, particularly when it directly leads to increased human suffering (policy in several countries has already been changed based on the draft), and I would be worried that by joining your board I could be associated with such unethical behaviour.
Perhaps if I understood better your position, which seems to be to ignore the situation, not follow up on the concerns raised, and leave your comments uncorrected even though they may be inaccurate and backing guidelines that cause harm to patients, that might allay certain reservations.
Anyways, these are my initial thoughts. I hope you have an opportunity to enjoy the beautiful weather, and I look forward to hearing from you.
Best wishes,
Mel
At that stage, I began to fear that I had made a mistake. But, giving her the benefit of the doubt, I swallowed my pride and replied as politely as I could to her concerns which, in my view, were odd, to say the least. This is what I wrote on 7 June:
Hi Mel,
Thank you for your reply to my invitation. Let me address your points in turn:
- I said that FACT has nothing to do with the pharma industry which is true [when you state that “you as editor say there’s no relationship to the RPS” – it suggests to me that you did not read my email properly]. In their own words, the RPS is “the professional membership body for pharmacists and pharmacy in Great Britain and an internationally renowned publisher of medicines information.” [http://www.rpharms.com/home/about-us.asp] They have a similar status as the Royal Colleges. In the 2 decades that I am running the journal, there has been not a single instance of interference of any kind. We use them simply as an excellent publishing house. And yes, FACT is to the best of my knowledge self-sufficient and survives without funds from 3rd parties.
- I am delighted to hear that your skills are in demand.
- I have stated my position regarding the draft NICE guideline ad nauseam: I prefer to wait until I see their next version of the draft before I make further comments on it. In my view, this is both reasonable and honourable. If you disagree, I can do little about it other than expressing my sincere regrets.
I hope these brief clarifications are helpful for you to arrive at a decision.
Regards
Edzard
On 8 June, I received Mel’s reply:
How interesting! Is he trying to ‘keep his enemies closer’ or am I being too skeptical? He has recognised your talents and dedication and intellect so he is not altogether stupid after all! I eagerly await his response to your reply.
Those who have studied with Ernst say that he’s a genuine chap and misunderstood – which I know is almost unimaginable given his behaviour – but we always have to allow for the possibility that we have misjudged people however remote! Also, people can turn – especially when they get older and near retirement. Alternatively he may just fancy you!…
Mel Koppelman Really enjoying hearing y’all’s thoughts on this. I just want to say that If I had thought that the chances of me being able to create positive change by joining FACT were high, I would have tempered the tone of my reply. But the simple fact that EE can’t even be factual or forthright about whose journal it is suggests an irreparable break with reality. And surely there’s an issue (academic? ethical? legal?) with recruiting someone to your board and denying an industry tie when there is one? Not to mention that if the RSP does fund his journal, he’s been lying about his conflicts of interest. Is that someone I want to spend time adding value to that could be spent with family, patients, time in nature or really making positive change by supporting the ANF? I’ll be interested to read his reply if there is one and especially how he responds regarding the relationship between FACT and RSP. Will keep y’all posted.
Max Forrester keep your friends close; keep your enemies closer…
John McDonald Healthy skepticism! Healthy journal! And it’s 99% fact-free!
I hope that you find these exchanges as amusing as I did – but are they important? Perhaps not exactly, but revealing certainly. They shed some light on the mind-set of acupuncturists and perhaps other alternative practitioners as well. Let me try to explain.
What struck me first was the degree of suspicion, even outright hostility from the acupuncturists. I had made it quite clear that I was asking Mel to join my Editorial-Board because of her views which vastly differ from mine. In science, differences of opinions and backgrounds can be stimulating and often generate progress. That is not something that seems to be wanted by alternative practitioners; they do not seem to tolerate criticism, different perspectives or views. One cannot help asking to what degree this attitude is immature or even dogmatic.
The next thing that baffled me was the speed with which conclusions are jumped upon. Everyone seemed to be instantly convinced that I was via my journal FACT in the pocket of the pharmaceutical industry. Nobody even bothered to look up what the Royal Pharmaceutical Society truly stand for and to verify that they do NOT represent ‘BIG PHARMA’. This blindness to the possibility of being wrong confirms my fear that alternative therapists are guided by strong beliefs which must not be questioned and are hard to influence, even with facts that take less than a minute to research.
And then there are, of course, the personal attacks which came quick, thick and fast. Its authors might think that such attacks get under my skin. If so, they are mistaken: if anything, they amuse me! I have long been of the opinion that they are important victories of reason. When an acupuncturist went as far as diagnosing me as being borderline psychopathic, I almost fell off my chair laughing! To me, this remark (which has emerged several times before) is emblematic, as it suggests several things at once:
- The author is obviously rude
- He/she is incompetent, even stupid
- He/she lacks empathy – after all, one would expect from a healthcare professional to show some understanding, if I were truly ill! And if not, one would expect more respect towards mentally ill patients.
- But, of course, he/she did not mean it like that; he/she merely meant to insult me. And employing mental health issues for this purpose shows a remarkable lack of professionalism, in my view.
Am I making too much of all this? Perhaps – sorry, I am almost done.
But first I need to briefly address Mel’s doubts about my integrity. She can, of course, question what she likes as often as she wants. My point is that repeating nonsensical arguments ad nauseam does not render then sensical.
Finally, there is Mel’s public claim that I have been lying about my conflict of interests. To me, it suggests a degree of desperation, perhaps even fanaticism, that is only surpassed by her inability to apologize after the truth had become undeniable even to her.
I know that there are some people who would have sued for libel.
Not I!
For that I find all this far too hilarious.
Guest post by Frank Van der Kooy
Some serious flaws in the scientific reporting of two acupuncture clinical trials, for the treatment of infertility and allergic rhinitis, were recently published on this blog. The overly positive way in which the researchers made their mostly negative results public, was also of concern. Both these studies were published by the researcher of the year, Prof Caroline Smith, of the National Institute of Complementary Medicine (NICM), Australia. The stream of comments and discussions that followed made me think of another commonly overlooked aspect when it comes to acupuncture clinical trials. Conflict of interest! In both these studies the authors declared to have no conflicts of interest and in other studies by this author this also seems to be the case. The question can be asked: If you are a practicing acupuncturist who runs a clinical trial of acupuncture, isn’t that, by default, a serious conflict of interest? The intention of this article is not an in-depth discussion of what a conflict of interest is, but rather to compare medical doctors with acupuncturists turned researchers. Let me explain.
Some medical doctors (GPs, surgeons etc.) decide to leave their practice after practicing 10-20 years to become full time researchers (and visa versa). Universities accept these people with open arms because they bring with them a wealth of knowledge regarding the practical side of medicine and healthcare in general. They are thus seen as an asset to any medical research project including clinical trials. Can the same be said about an acupuncturist? They also bring with them years of experience and thus they should also be a major asset to any acupuncture clinical trial. But I am afraid not!
Why? Medical doctors have a multitude of tools (drugs, surgical procedures, diagnostic tools etc.) at their disposal to treat all types of medical conditions. When will their background constitute a conflict of interest? When they publish a positive clinical trial of a specific medical intervention in which they have a vested interest. e.g owning shares in the company producing the medical intervention (financial interest) or if they have been staunch supporters of this intervention during their years of practice (emotional interest). Just imagine that you have prescribed a specific intervention to hundreds of patients over a long period of time, and you swore by it, and now you have to face them with a negative clinical trial result – that will be difficult. The former is easy to declare whilst the latter might be slightly more difficult.
Doctors also tend to focus on a specific disease e.g. cancer and will perform research with the existing tools at their disposal but also try to find new tools in order to improve the risk-benefit profile of the disease treatment. Thus, for a doctor there is the possibility that they might run into a conflict of interest, but due to the multitude of medical interventions out there this is by no means a given.
What about acupuncture practitioners turned researchers? An acupuncturist only has one tool at their disposal to treat all medical conditions. I can hear them say; but we stick needles in different places and depths etc. depending on the medical condition! Yes, but the fact remains that they can only stick needles into people – and that is a single intervention. So is this by default a conflict of interest? I would argue, yes, it is like having only one drug to treat all medical conditions. If you have treated hundreds of patients for various medical conditions with acupuncture and now suddenly you publish a negative clinical trial, you will not only be red faced when you run into your former patients – who paid for your evidence based acupuncture treatment – they might even sue you for misleading them. As an acupuncturist, you cannot allow the single tool that you have to be ineffective, otherwise people might start to question acupuncture. The fact that they have to protect acupuncture means that an acupuncturist will by default have a conflict of interest – no matter what medical condition they aim to treat.
If you have been emotionally and financially invested in acupuncture as a cure-all for 10-20 years, it will be very difficult, if not impossible, to publish a negative result as an acupuncture researcher.
Another aspect is that the acupuncture fraternity is a very tight knit community, where negative results are frowned upon because of everyone’s financial and emotional interests. Surely they will expel you from this community, if you publish negative results?
So how do acupuncture researchers go about running clinical trials? An example: Professors Smith and Bensoussan, both at the NICM, are currently registered as practicing acupuncturists. This means that they can legally practice acupuncture and, because they have been active for decades, they are also well known in the acupuncture fraternity. It is unknown, whether they are still actively practicing in their own practice or part-time in someone else’s practice, or if they have a financial stake in their former or someone else’s practice. Based on the fact that they are still registered as active acupuncturists, I can conclude that they do have an emotional and/or financial interest in the positive outcome of their acupuncture clinical trials.
Because of this inherent conflict of interest, and due to current strict clinical trial regulations, which makes it quite difficult (although not impossible) to fabricate or falsify data, they go for the next best thing – which is the design of their clinical trial e.g. the A+B versus A design. But it doesn’t stop there. As soon as a clinical trial fails to give a positive result, the results will be inflated to make it sound positive.
Why? Because they must prevent themselves from cognitive dissonance, they need to protect the single tool that they have, they must keep the acupuncture fraternity happy and they have to protect themselves against potential lawsuits from former (current) patients or a decrease in patient numbers (and thus financial income). On top of that – how would the media and the public react to an acupuncture clinical trial if the lead researcher declare that they have their own acupuncture clinic? Surely these factors together amount to a conflict of interest and should be declared as such?
So what, in this context, is the main difference between a doctor and an acupuncturist? A doctor has a multitude of medical interventions. He or she might have a conflict of interest, if they work on a specific intervention in which they have a vested interest. An acupuncturist only has one intervention and therefore they have a vested interest by default – which they never seem to declare!
Acupuncture, like most other alternative therapies, is particular popular for indications that are
- chronic,
- associated with a high burden of suffering,
- not easily treatable with conventional therapies,
- are frequently resolved without any intervention.
Infertility or subfertility tick most of these boxes. It is therefore not surprising that acupuncturists the world over claim that acupuncture can cure infertility. But is this claim based on evidence or on wishful thinking?
The objective of this new study was to find out. Specifically, the authors wanted to provide preliminary data to explore whether women with subfertility undergoing a course of acupuncture and lifestyle modification compared with an active control of lifestyle modification alone would demonstrate improved reproductive outcomes, improved menstrual cycles, and increased fertility awareness.
In a pragmatic randomised controlled trial, with the A+B versus B design, sub/infertile women were offered an intervention of acupuncture and lifestyle modification or lifestyle modification only. There was a statistically significant increase in fertility awareness in the acupuncture group (86.4%) compared to 40% of the lifestyle only participants. Changes in menstrual regularity were not statistically significant. There was no statistical difference in the pregnancy rate with seven women achieving pregnancy during the course of the study intervention. Those receiving the acupuncture conceived within an average of 5.5 weeks compared to 10.67 weeks for the lifestyle only group.
The authors concluded that the acupuncture protocol tested influenced women who received it compared to women who used lifestyle modification alone: their fertility awareness and wellbeing increased, and those who conceived did so in half the time.
The first sentences of the authors’ discussion are, I think, revealing: The main findings were that this acupuncture intervention, compared to lifestyle only, resulted in significant increases in fertility awareness and quality of life measures in relation to wellbeing; it increased the ability of the recipients to engage in desired activities, such as exercise or rest, and it shortened the time to conception by half. The findings provide preliminary evidence that the acupuncture intervention is acceptable and is not inert and that acupuncture dose may have a significant influence on outcomes.
In my view, the main findings of this study are entirely different. Let me propose alternatives:
- In alternative medicine, if you did a lousy study, you can just call it a ‘pilot study’ and all is forgiven.
- The infamous A+B vs B design continues to be popular for those who cannot bring themselves to publishing negative findings.
- It works perfectly for subjective parameters but less convincingly for objective ones, such as pregnancy rates.
- Doing such research on infertility is good for the cash flow of acupuncturists.
- Making women aware of fertility increases (surprise, surprise!) fertility awareness.
No need to be so cynical!, some will think. After all, the results showed that women receiving the acupuncture conceived within an average of 5.5 weeks compared to 10.67 weeks for the lifestyle only group. True! But there was no statistically significant difference between these two figures. And that means, the difference was a chance finding (which has no place in an abstract) which probably has no relevance whatsoever.
Or perhaps I am wrong?
I am told to always keep an open mind!
So, let’s keep our minds open to some truly alternative explanations. How about this one: regular acupuncture increases the rate of adultery, which, in turn, decreases the time to conception.
Makes sense, doesn’t it? Has anyone a better idea?
