The developed world is in the middle of a major obesity epidemic. It is predicted to cause millions of premature deaths and billions of dollars, money that would be badly needed elsewhere. The well-known method of eating less and moving more is most efficacious but sadly not very effective, that is to say people do not easily adopt and adhere to it. This is why many experts are searching for a treatment that works and is acceptable to all or at least most patients.
Entrepreneurs of alternative medicine have long jumped on this band waggon. They have learnt that the regulations are lax or non-existent, that consumers are keen to believe anything they tell them and that the opportunities to make a fast buck are thus enormous. Today, they are offering an endless array of treatments which are cleverly marketed, for instance via the Internet.
Since many years, my research team are involved in a programme of assessing the alternative slimming aids mostly through systematic reviews and occasionally also through conducting our own clinical trials. Our published analyses include the following treatments:
Supplements containing conjugated linoleic acid
There are, of course, many more but, for most, no evidence exist at all. The treatments listed above have all been submitted to clinical trials. The results show invariably that the outcomes were not convincingly positive: either there were too few data, or there were too many flaws in the studies, or the weight reduction achieved was too small to be clinically relevant.
Our latest systematic review is a good example; its aim was to evaluate the evidence from randomized controlled trials (RCTs) involving the use of the African Bush Mango, Irvingia gabonensis, for body weight reduction in obese and overweight individuals. Three RCTs were identified, and all had major methodological flaws. All RCTs reported statistically significant reductions in body weight and waist circumference favoring I. gabonensis over placebo. They also suggested positive effects of I. gabonensis on blood lipids. Adverse events included headache and insomnia. Despite these apparently positive findings, our conclusions had to be cautious: “Due to the paucity and poor reporting quality of the RCTs, the effect of I. gabonensis on body weight and related parameters are unproven. Therefore, I. gabonensis cannot be recommended as a weight loss aid. Future research in this area should be more rigorous and better reported.”
People who want to loose weight are often extremely desperate and ready to try anything. They are thus easy victims of the irresponsible promises that are being made on the Internet and elsewhere. Despite the overwhelmingly evidence to the contrary, consumers are led to believe that alternative slimming aids are effective. What is more, they are also misled to assume they are risks-free. This latter assumption is false too: apart from the harm done to the patient’s bank account, many alternative slimming aids are associated with side-effects which, in some cases, are serious and can even include death.
The conclusion from all this is short and simple: alternative slimming aids are bogus.
When I retired a few months ago, I began to sort out hundreds of old files and, in the course of doing so, I stumbled across my inauguration lecture given at Exeter in late 1993. Because so many people have been puzzled, bewildered or annoyed by my post, my attitude, my remit, my writings, my errors, my perceived lack of support for CM or my alleged inconsistencies, I have now decided to reproduce the most important sections of this publication here (unfortunately, the article is not available on line but I will send a PDF to anyone who asks for it). For clarity, the original text is in italics; where i needed to add something, I put it in square brackets so that there can be no misunderstandings.
… there are some common denominators [for all different types of CM]: an all encompassing theory (sometimes more a philosophy than a theory) the view of health as a balance of forces within the body and healing as the restoration of this balance, the holistic approach, and the emphasis on each individual’s own responsibility for health. It is noteworthy that the latter two characteristics are, of course, an integral part of (good) orthodox medicine.
…[CM] often lacks an adequate theoretical basis, its diagnoses are usually not in line with science, and it has failed to demonstrate clinical effectiveness convincingly. CM may thus be defined as those branches of the art and science of health care that are not in accordance with current medical thought, scientific knowledge or university teaching…
… no one doubts that today’s modern, orthodox medicine is more successful than any of its predecessors in diagnosing, treating and preventing disease. Yet the public chooses complementary medicine in vast numbers. Why? There must be many reasons, ranging from dissatisfaction with high-tech medicine to a fascination with mysticism, from grabbing ‘the last straw’ to looking for more empathy, to falling victim to the Barnum-Effect or the Health Information Fatigue Phenomenon. Whatever the reasons are (and no doubt they need to be researched in much more detail), they represent a severe criticism to the content and style of today’s medicine. Orthodoxy might be well advised to try and learn a lesson from the apparent success and obvious popularity of CM…
CM also accepts more and more its own limitations, the fact that it may also do harm and the urgent need for much more scientific proof – a remarkable change considering that the scientific method was formerly said to be nothing short of naive reductionism representing an over-simplified mechanistic philosophy, which does injustice to the complexities of the human being.
… the medical establishment is gradually becoming more open-minded and prepared to look into the matter seriously. It realises that it must abandon old prejudice and differentiate between various approaches – maybe not everything in CM is bad after all! A wry and useful classification is the schematic listing of CM in 3 categories: the frankly fraudulent, the foolishly harmless, and the possibly useful. It is clear that only rigorous research will be able to differentiate one from the other.
…why do we need controlled trials, some proponents of CM would argue, when everyday experience shows us that our treatments work? The answer is disarmingly simple: clinical experience can be totally and repeatedly misleading. Medical history abounds with examples. Blood-letting, the panacea of the middle-ages, killed probably more people than it ever helped. Yet clinicians thought to witness its benefit for centuries. Every time in the past, present and future, when a patient’s cure is solely attributed to a treatment, two important factors are neglected: the natural history of the disease, and the placebo effect. There is only one way to be sure, and that is to conduct randomised controlled trials. The notion that they are not feasible, desirable or conclusive is blatantly wrong; not to believe in controlled trials is not to care about the effectiveness of one’s doings and to adopt a quasi-religious attitude towards medicine.
I find some of the points I made back in 1993 remarkable. To be honest, I could not stop smiling when I re-read my text after almost 20 years. Rather than discussing the messages of my own lecture, I will leave the critical assessment of these points to the probably lively comment section that will follow this post. In closing, I do, however, want to briefly highlight two aspects.
1) Many CM proponents have attacked me because they feel that I am too critical and some even assume that I am in the pockets of BIG PHARMA and got the Exeter job under false pretences. The University of Exeter should have employed an outspoken champion of CM, they argue. I think my inaugural lecture shows beyond any doubt that they always knew who they were getting and it suggests that, at least initially (before Prince Charles intervened), they wanted me because universities need scientists, not promoters.
2) Since 1993, about 10 000 articles have been published on the subject of CM (my estimate), and yet we do not seem to have advanced all that much. The title “changing attitudes” might thus have been more than a little optimistic on my part!
Whenever I have the occasion to discuss with practitioners of alternative medicine the pros and cons of their methods, I hear sooner or later the argument “WE TREAT THE ROOT CAUSES OF DISEASE !!!” This remark emerges regularly regardless of the type of treatment the practitioner uses, and regardless of what disease we might have been talking about.
The statement is regularly pronounced with such deep conviction (and almost audible exclamation marks) that I am inclined to conclude these practitioners fully and wholeheartedly believe it. The implication usually is that, in conventional medicine, we only treat the symptoms of our patients. Quite often, this latter notion is not just gently implied but also forcefully expressed.
I have often wondered where this assumption and the fierce conviction with which it is expressed come from. The answer, I have come to conclude after many years of having such debates, is quite simple: it is being taught over and over again during the practitioners’ training, and it constitutes a central message of most ‘textbooks’ for the aspiring alternative practitioner.
It is not difficult to find the actual origin of all this. The notion that alternative practitioners treat the root causes is clearly based on the practitioners’ understanding of aetiology. If a traditional acupuncturist, for instance, becomes convinced that all disease is the expression of an imbalance of life-forces, and that needling acupuncture points will re-balance these forces thus restoring health, he must automatically assume that he is treating the root causes of any condition. If a chiropractor believes that all diseases are due to ‘subluxations’ of the spine, it must seem logical to him that spinal ‘adjustment’ is synonymous with treating the root cause of whatever complaint his patient is suffering from. If a Bowen therapist is convinced that “the Bowen Technique aims to balance the whole person, not just the symptoms“, he is bound to be equally sure that “practically any problem can potentially be addressed” by this intervention.
Let us assume for a minute that all these practitioners are correct in believing that their interventions are causal treatments, i.e. therapies directed against the cause of a disease. Successful treatment of any root cause can only mean that the therapy in question completely heals the problem at hand. If we abolish the cause of a disease, we would expect the disease to disappear for good.
This, I think, begs a crucial question: ARE THERE ANY DISEASES WHICH ARE REPRODUCIBLY CURED BY AN ALTERNATIVE THERAPY?
I have contemplated it frequently and discussed it often with practitioners but, so far, I have not identified a single one. I have no problem naming diseases which conventional medicine can cure – but, in alternative medicine, I only draw blanks. Even those alternative therapies which might be effective are not causal but symptomatic by nature. Honestly, I have not yet come across a single alternative treatment for which there is compelling evidence proving that it can produce more than symptom-relief.
But, of course, I might be wrong, over-critical, blind, bought by the pharmaeutical industry, dishonest or stupid. So, the purpose of this post is to clarify this issue once and for all. I herewith invite practitioners to name a disease for which there is sound evidence proving that it can be cured by their therapy.
A few weeks ago, The College of Chiropractors, a Company Limited by guarantee, was given a royal charter. A royal charter is a formal document issued by a monarch, granting a right or power to an individual or an corporate body. They are used to establish significant organisations such as cities or universities.
This is how the event was protrayed by chiropractors [link disabled by admin due to possible malware]:
Rarely granted, a Royal Charter signals permanence and stability and, in the College of Chiropractors’ case, a clear indication to others of the leadership value and innovative approach the College brings to the development of the chiropractic profession. The Royal Charter essentially formalises the College’s position as a unique, apolitical, consultative body, recognising its role in promoting high practice standards and certifying quality and thus securing public confidence.
For those of us who are not familiar with the College, here is how they describe themselves and their history:
On the advice of a senior medical figure, an organisational model similar to that of a Medical Royal College was devised. Thus, the College of Chiropractors was conceived during 1997 and incorporated in 1998 as an independent body to develop, encourage and maintain the highest possible standards of chiropractic practice for the benefit of patients.
Over the next couple of years the embryonic ‘College’ grew with a regional faculty infrastructure, the mainstay of the organisation, becoming firmly established in order to foster education locally. As an independent body, separate from any of the political groups, members were able to share information and expertise from all areas of the profession. Following its incorporation in October 1998, the College of Chiropractors was formally launched on 28th April 1999 at the King’s Fund.
The College is now an academic membership organisation with almost 3000 members worldwide, and the following objectives:
- to promote the art, science and practice of chiropractic;
- to improve and maintain standards in the practice of chiropractic for the benefit of the public;
- to promote awareness and understanding of chiropractic amongst medical practitioners and other healthcare professionals and the public;
- to educate and train practitioners in the art, science and practice of chiropractic;
- to advance the study of and research in chiropractic.
From my perspective, this begs numerous questions; here are just some of them:
1) Have UK chiropractors truly been promoting “high practice standards and certifying quality and thus securing public confidence”?
I would argue that they have been doing the opposite. They made bogus therapeutic claims by the hundreds on their websites, and when Simon Singh had the courage to make this public, they sued him for libel. Call me old-fashioned, but I fail to see how this maintains “the highest possible standards of chiropractic practice for the benefit of patients” nor how this might “promote the art, science and practice of chiropractic.”
I would have thought that this is a serious disservice to the people and the health of the nation and believe it reflects an irresponsible disregard of the precautionary principle in health care.
3) How can we accord the high aims of the College with the fact that UK chiropractors demonstrably violate fundamental rules of medical ethics, e.g. informed consent, and that their professional bodies must be aware of this fact, yet have so far failed to do anything about it?
I think there is a discrepancy here that needs explaining.
4) Does the College truly “advance the study of and research in chiropractic?”
We have shown that UK research into chiropractic has not increased but decreased since statutory regulation. This leads me to suspect that regulation is being abused as a means of gaining recognition and not as a mechanism to protect the public.
Considering all this, I find that the status of the other Royal Colleges has been de-valued by the ascent of this organisation. And I ask myself WHAT NEXT? A COLLEGE OF WINDOW SALES-MEN, perhaps? Or would this giving a bad name to the poor window-salesmen?
Several months ago, my co-workers and I once again re-visited the contentious issue of acupuncture’s safety. We published several articles on the topic none of which, I am afraid to say, was much appreciated by the slightly myopic world of acupuncture. The paper which created overt outrage and prompted an unprecedented amount of hate-mail was the one on deaths after acupuncture. This publication reported that around 90 fatalities associated with acupuncture had been documented in the medical literature.
The responses from acupuncturists ranged from disbelief to overt hostility. Acupuncturists the world over seemed to agree that there was something profoundly wrong with me personally and with my research; they all knew that acupuncture was entirely safe and that I was maliciously incorrect and merely out to destroy their livelihood.
So, am I alarmist or am I just doing my duty in reporting important facts? Two new articles might go some way towards answering this intriguing question.
The first is a review by Chinese acupuncturists who summarised all the adverse events published in the Chinese literature, a task which my article may have done only partially. The authors found 1038 cases of serious adverse events, including 35 fatalities. The most frequent non-fatal adverse events were syncope (468 cases), pneumothorax (307 cases), and subarachnoid hemorrhage (64 cases). To put this into context, we ought to know that the Chinese literature is hopelessly biased in favour of acupuncture. Thus the level of under-reporting can be assumed to be even larger than in English language publications.
The second new article is by a Swedish surgeon who aimed at systematically reviewing the literature specifically on vascular injuries caused by acupuncture. His literature searches found 31 such cases; the majority of these patients developed symptoms in direct connection with the acupuncture treatment. Three patients died, two from pericardial tamponade and one from an aortoduodenal fistula. There were 7 more tamponades, 8 pseudoaneurysms, two with ischemia, two with venous thrombosis, one with compartment syndrome and 7 with bleeding (5 in the central nervous system). The two patients with ischemia suffered lasting sequeleae.
The answer to the question asked above seems thus simple: the Chinese authors, the Swedish surgeon (none of whom I know personally or have collaborated with) and I are entirely correct and merely report the truth. And the truth is that acupuncture can cause severe complications through any of the following mechanisms:
1) puncturing the lungs resulting in a pneumothorax,
2) puncturing the heart causing a cardiac tamponade,
3) puncturing blood vessels causing haemorrhage,
4) injuring other vital structures in the body,
5) introducing bacteria or viruses resulting in infections.
Any of these complications can be severe and might, in dramatic cases, even lead to the death of the patient.
But we have to have the right perspective! These are extremely rare events! Most other treatments used in medicine are much much more risky! To keep banging on about such exotic events is not helpful! I can hear the acupuncture world shout in unison.
True, these are almost certainly rare events – but we have no good idea how rare they are. There is no adverse event reporting scheme in acupuncture, and the published cases are surely only the tip of the ice-berg. True, most other medical treatments carry much greater risks! And true, we need to have the right perspective in all of this!
So let’s put this in a reasonable perspective: with most other treatments, we know how effective they are. We can thus estimate whether the risks outweigh the benefit, and if we find that they do, we should (and usually do) stop using them. I am not at all sure that we can perform similar assessments in the case of acupuncture.
Clinical trials of acupuncture can be quite challenging. In particular, it is often difficult to make sure that any observed outcome is truly due to the treatment and not caused by some other factor(s). How tricky this can be, shows a recently published study.
A new RCT has all (well, almost all) the features of a rigorous study. It tested the effects of acupuncture in patients suffering from hay fever. The German investigators recruited 46 specialized physicians in 6 hospital clinics and 32 private outpatient clinics. In total, 422 patients with IgE sensitization to birch and grass pollen were randomized into three groups: 1) acupuncture plus rescue medication (RM) (n= 212), 2) sham acupuncture plus RM (n= 102), or 3) RM alone (n= 108). Twelve acupuncture sessions were provided in groups 1 and 2 over 8 weeks. The outcome measures included changes in the Rhinitis Quality of Life Questionnaire (RQLQ) overall score and the RM score (RMs) from baseline to weeks 7, 8 and 16 in the first year as well as week 8 in the second year after randomization.
Compared with sham acupuncture and with RM, acupuncture was associated with improvement in RQLQ score and RMS. There were no differences after 16 weeks in the first year. After the 8-week follow-up phase in the second year, small improvements favoring real acupuncture over sham were noted.
Based on these results, the authors concluded that “acupuncture led to statistically significant improvements in disease-specific quality of life and antihistamine use measures after 8 weeks of treatment compared with sham acupuncture and with RM alone, but the improvements may not be clinically significant.”
The popular media were full of claims that this study proves the efficacy of acupuncture. However, I am not at all convinced that this conclusion is not hopelessly over-optimistic.
It might not have been the acupuncture itself that led to the observed improvements; they could well have been caused by several factors unrelated to the treatment itself. To understand my concern, we need to look closer at the actual interventions employed by the investigators.
The real acupuncture was done on acupuncture points thought to be indicated for hay fever. The needling was performed as one would normally do it, and the acupuncturists were asked to treat the patients in group 1 in such a way that they were likely to experience the famous ‘de-qi’ feeling.
The sham acupuncture, by contrast, was performed on non-acupuncture points; acupuncturists were asked to use shallow needling only and they were instructed to try not to produce ‘de-qi’.
This means that the following factors in combination or alone could have caused [and in my view probably did cause] the observed differences in outcomes between the acupuncture and the sham group:
1) verbal or non-verbal communication between the acupuncturists and the patient [previous trials have shown this factor to be of crucial importance]
2) the visibly less deep needling in the sham-group
3) the lack of ‘de-qi’ experience in the sham-group.
Sham-treatments in clinical trials serve the purpose of a placebo. They are thus meant to be indistinguishable from the verum. If that is not the case [as in the present study], the trial cannot be accepted as being patient-blind. If a trial is not patient-blind, the expectations of patients will most certainly influence the results.
Therefore I believe that the marginal differences noted in this study were not due to the effects of acupuncture per se, but were an artifact caused through de-blinding of the patients. De facto, neither the patients nor the acupuncturists were blinded in this study.
If that is true, the effects were not just not clinically relevant, as noted by the authors, they also had nothing to do with acupuncture. In other words, acupuncture is not of proven efficacy for this condition – a verdict which is also supported by our systematic review of the subject which concluded that “the evidence for the effectiveness of acupuncture for the symptomatic treatment or prevention of allergic rhinitis is mixed. The results for seasonal allergic rhinitis failed to show specific effects of acupuncture…”
Once again, we have before us a study which looks impressive at first glance. At closer scrutiny, we find, however, that it had important design flaws which led to false positive results and conclusions. In my view, it would have been the responsibility of the authors to discuss these limitations in full detail and to draw conclusions that take them into account. Moreover, it would have been the duty of the peer-reviewers and journal editors to pick up on these points. Instead the editors even commissioned an accompanying editorial which displays an exemplary lack of critical thinking.
Having failed to do any of this, they are in my opinion all guilty of misleading the world media who reported extensively and often uncritically on this new study thus misleading us all. Sadly, the losers in this bonanza of incompetence are the many hay fever sufferers who will now be trying (and paying for) useless treatments.
Still in the spirit of ACUPUNCTURE AWARENESS WEEK, I have another critical look at a recent paper. If you trust some of the conclusions of this new article, you might think that acupuncture is an evidence-based treatment for coronary heart disease. I think this would be a recipe for disaster.
This condition affects millions and eventually kills a frighteningly large percentage of the population. Essentially, it is caused by the fact that, as we get older, the blood vessels supplying the heart also change, become narrower and get partially or even totally blocked. This causes lack of oxygen in the heart which causes pain known as angina pectoris. Angina is a most important warning sign indicating that a full blown heart attack might be not far.
The treatment of coronary heart disease consists in trying to let more blood flow through the narrowed coronaries, either by drugs or by surgery. At the same time, one attempts to reduce the oxygen demand of the heart, if possible. Normalisation of risk factors like hypertension and hypercholesterolaemia are key preventative strategies. It is not immediate clear to me how acupuncture might help in all this – but I have been wrong before!
The new meta-analysis included 16 individual randomised clinical trials. All had a high or moderate risk of bias. Acupuncture combined with conventional drugs (AC+CD) turned out to be superior to conventional drugs alone in reducing the incidence of acute myocardial infarction (AMI). AC+CD was superior to conventional drugs in reducing angina symptoms as well as in improving electrocardiography (ECG). Acupuncture by itself was also superior to conventional drugs for angina symptoms and ECG improvement. AC+CD was superior to conventional drugs in shortening the time to onset of angina relief. However, the time to onset was significantly longer for acupuncture treatment than for conventional treatment alone.
From these results, the authors [who are from the Chengdu University of Traditional Chinese Medicine in Sichuan, China] conclude that “AC+CD reduced the occurrence of AMI, and both acupuncture and AC+CD relieved angina symptoms and improved ECG. However, compared with conventional treatment, acupuncture showed a longer delay before its onset of action. This indicates that acupuncture is not suitable for emergency treatment of heart attack. Owing to the poor quality of the current evidence, the findings of this systematic review need to be verified by more RCTs to enhance statistical power.”
As in the meta-analysis discussed in my previous post, the studies are mostly Chinese, flawed, and not obtainable for an independent assessment. As in the previous article, I fail to see a plausible mechanism by which acupuncture might bring about the effects. This is not just a trivial or coincidental observation – I could cite dozens of systematic reviews for which the same criticism applies.
What is different, however, from the last post on gout is simple and important: if you treat gout with a therapy that is ineffective, you have more pain and eventually might opt for an effective one. If you treat coronary heart disease with a therapy that does not work, you might not have time to change, you might be dead.
Therefore I strongly disagree with the authors of this meta-analysis; “the findings of this systematic review need NOT to be verified by more RCTs to enhance statistical power” — foremost, I think, the findings need to be interpreted with much more caution and re-written. In fact, the findings show quite clearly that there is no good evidence to use acupuncture for coronary heart disease. To pretend otherwise is, in my view, not responsible.
There might be an important lesson here: A SEEMINGLY SLIGHT CORRECTION OF CONCLUSIONS OF SUCH SYSTEMATIC REVIEWS MIGHT SAVE LIVES.
This week is acupuncture awareness week, and I will use this occasion to continue focusing on this therapy. This first time ever event is supported by the British Acupuncture Council who state that it aims to “help better inform people about the ancient practice of traditional acupuncture. With 2.3 million acupuncture treatments carried out each year, acupuncture is one of the most popular complementary therapies practised in the UK today.“
Right, let’s inform people about acupuncture then! Let’s show them that there is often more to acupuncture research than meets the eye.
My team and I have done lots of research into acupuncture and probably published more papers on this than any other subject. We had prominent acupuncturists on board from the UK, Korea, China and Japan, we ran conferences, published books and are proud to have been innovative and productive in our multidisciplinary research. But here I do not intend to dwell on our own achievements, rather I will highlight several important new papers in this area.
Korean authors just published a meta-analysis to assess the effectiveness of acupuncture as therapy for gouty arthritis. Ten RCTs involving 852 gouty arthritis patients were included. Six studies of 512 patients reported a significant decrease in uric acid in the treatment group compared with a control group, while two studies of 120 patients reported no such effect. The remaining four studies of 380 patients reported a significant decrease in pain in the treatment group.
The authors conclude “that acupuncture is efficacious as complementary therapy for gouty arthritis patients”.
We should be delighted with such a positive and neat result! Why then do I hesitate and have doubts?
I believe that this paper reveals several important issues in relation to systematic reviews of Chinese acupuncture trials and studies of other TCM interventions. In fact, this is my main reason for discussing the new meta-analysis here. The following three points are crucial, in my view:
1) All the primary studies were from China, and 8 of the 10 were only available in Chinese.
2) All of them had major methodological flaws.
3) It has been shown repeatedly that all acupuncture-trials from China are positive.
Given this situation, the conclusions of any review for which there are only Chinese acupuncture studies might as well be written before the actual research has started. If the authors are pro-acupuncture, as the ones of the present article clearly are, they will conclude that “acupuncture is efficacious“. If the research team has some critical thinkers on board, the same evidence will lead to an entirely different conclusion, such as “due to the lack of rigorous trials, the evidence is less than compelling.“
Systematic reviews are supposed to be the best type of evidence we currently have; they are supposed to guide therapeutic decisions. I find it unacceptable that one and the same set of data could be systematically analysed to generate such dramatically different outcomes. This is confusing and counter-productive!
So what is there to do? How can we prevent being misled by such articles? I think that medical journals should refuse to publish systematic reviews which so clearly lack sufficient critical input. I also believe that reviewers of predominantly Chinese studies should provide English translations of these texts so that they can be independently assessed by those who are not able to read Chinese – and for the sake of transparency, journal editors should insist on this point.
And what about the value of acupuncture for gouty arthritis? I think I let the readers draw their own conclusion.
Everyone knows, I think, that smoking is bad for our health. Why then do so many of us still smoke? Because smoking is addictive – and addictions are, by definition, far from easy to get rid of. Many smokers try acupuncture, and acupuncturists are making a ‘pretty penny’ on the assumption that their treatment is an effective way to stop the habit. But what does the best evidence tell us?
A new randomized, double-blind, placebo-controlled clinical trial with 125 smokers was conducted to determine whether ear acupuncture with electrical stimulation (auriculotherapy) once a week for 5 consecutive weeks is more effective than sham treatment.
The results showed that there was no difference in the rate of smoking cessation between the two groups. After 6 weeks, the auriculotherapy group achieved a rate of 20.9% abstinence which was not significantly different from the 17.9% in the sham group.
The authors of this study concluded that “the results … do not support the use of auriculotherapy to assist with smoking cessation. It is possible that a longer treatment duration, more frequent sessions, or other modifications of the intervention protocol used in this study may result in a different outcome. However, based on the results of this study, there is no evidence that auriculotherapy is superior to placebo when offered once a week for 5 weeks, as described in previous uncontrolled studies.”
Of course, they are correct to state that, theoretically, a different treatment regimen might have generated different outcomes. But how likely is that in reality?
To answer this question, we might consult the Cochrane review on the subject (which incidentally is close to my heart: I initiated it many years ago and was its senior author until it was plagiarised by my former co-worker and my name was replaced by that of his new boss [never a dull day in alternative medicine research!]).
The latest version of this article concludes that “there is no consistent, bias-free evidence that acupuncture, acupressure, laser therapy or electrostimulation are effective for smoking cessation, but lack of evidence and methodological problems mean that no firm conclusions can be drawn. Further, well designed research into acupuncture, acupressure and laser stimulation is justified since these are popular interventions and safe when correctly applied, though these interventions alone are likely to be less effective than evidence-based interventions”
This is a very, very (yes, I meant very, very) odd conclusion, I think. If I had still been an author of this plagiarised paper, I would have suggested something a little more straightforward: 33 studies of various types of acupuncture for smoking cessation are currently available (if we include the new trial, the number is 34). The totality of this evidence fails to show that acupuncture is effective. Therefore acupuncture should NOT be considered a valid option for this indication.
“They would say that, wouldn’t they?” is the quote attributed to Mandy Rice-Davies giving witness in the Profumo affair. I think, it aptly highlights some of the issues related to conflicts of interest in health care.
These days, when a researcher publishes a paper, he will in all likelihood have to disclose all conflicts of interest he might have. The aim of this exercise is to be as transparent as possible; if someone has received support from a commercial company, for example, this fact does not necessarily follow that his paper is biased, but it is important to lay open the fact so that the readers can make up their own minds.
The questionnaires that authors have to complete prior to publication of their article focus almost exclusively on financial issues. For instance, one has to disclose any sponsorship, fees, travel support or shares that one might own in a company. In conventional medicine, these matters are deemed to be the most important sources for potential conflicts of interest.
In alternative medicine, financial issues are generally thought to be far less critical; it is generally seen as an area where there is so little money that it is hardly worth bothering. Perhaps this is the reason why few journals in this field insist on declarations of conflicts of interests and few authors disclose them.
After having been a full-time researcher of alternative medicine for two decades, I have become convinced that conflicts of interest are at least as prevalent and powerful in this field as in any other area of health care. Sure, there is less money at stake, but this fact is more than compensated by non-financial issues. Quasi-evangelic convictions abound in alternative medicine and it is, I think, obvious that they can amount to significant conflicts of interest.
During their training, alternative practitioners are being taught many things which are unproven, have no basis in fact or are just plainly wrong. Eventually this schooling can create a belief system which often is adhered to regardless of the scientific evidence and which tends to be defended at all cost. As some of my readers are bound to object to this remark, I better cite an example: during their training, students of chiropractic develop a more and more firm stance against immunization which in all likelihood is due to the type of information they receive at the chiropractic college. There is no question in my mind that creeds can represent an even more powerful conflict of interest than financial matters.
Moreover, this belief is indivisibly intertwined with existential issues. In alternative medicine, there may not be huge amounts of money at stake but practitioners’ livelihoods are perceived to be at risk. If an acupuncturist, for instance, argues in favour of his therapy, he also consciously or sub-consciously is trying to protect his income.
Some might say that this not different from conventional medicine, but I disagree: if we take away one specific therapy from a doctor because it turns out to be useless or unsafe, he will be able to use another one; if we take the acupuncture needle away from an acupuncturist, we have deprived him of his livelihood.
This is why conflicts of interest in alternative medicine tend to be very acute, powerful and personal. And this is why enthusiasts of alternative medicine are incapable or unwilling to look upon any type of critical assessment of their area as anything else than an attack on their income, their beliefs, their status, their training or their person. If anyone should doubt it, I recommend studying the comments I received to previous posts of this blog.
When Mandi Rice-Davies gave evidence during the trial of Stephen Ward, the osteopath who had introduced her to influential clients, the prosecuting council noted that Lord Astor denied having had an affair with her. Mrs Rice-Davies allegedly replied “Well, he would say that, wouldn’t he?” (Actually, she did not say these exact words but something rather similar) When I read the comments following my posts on this blog, I am often reminded of this now classical quote.
When chiropractors deny that neck manipulations carry a risk, when herbalists insist that traditional herbalism is based on good evidence, when homeopaths claim that their remedies are more than placebos, I believe we should ask who, in these debates, might have a conflict of interest.
Is there a circumstance of one party in the discussion where personal interests might benefit from the argument? Who is more likely to be objective, the person whose livelihood is endangered or the independent expert who studied the subject in depth but has no axe to grind? If you ask these questions, you might conclude as I frequently do: “they would say that, wouldn’t they?”