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.
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.
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.
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.
“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?”
In 2010, I have reviewed the deaths which have been reported after chiropractic treatments. My article suggested that 26 fatalities had been published in the medical literature and many more might have remained unpublished. The alleged pathology usually was a vascular accident involving the dissection of a vertebral artery. Whenever I write about the risks of spinal manipulation, chiropractors say that I am irresponsible and alarmist. Yet I believe I am merely doing my duty in alerting health care professionals and the public to the possibility that this intervention is associated with harm and that caution is therefore recommended.
Fortunately, I am not alone, as a new report from China shows.This review summarised published cases of injuries associated with cervical manipulation in China, and to describe the risks and benefits of the therapy.
A total of 156 cases met the inclusion criteria. They included the following problems: syncope = 45 cases , mild spinal cord injury or compression = 34 cases, nerve root injury = 24 cases, ineffective treatment or symptom increased = 11 cases ; cervical spine fracture = 11 cases, dislocation or semiluxation = 6 cases, soft tissue injury = 3 cases, serious accident = 22 cases including paralysis, death and cerebrovascular accident. Manipulation including rotation was involved in 42.00%, 63 cases). 5 patients died.
The authors conclude that “it is imperative for practitioners to complete the patients’ management and assessment before manipulation. That the practitioners conduct a detailed physical examination and make a correct diagnosis would be a pivot method of avoiding accidents. Excluding contraindications and potential risks, standardizing evaluation criteria and practitioners’ qualification, increasing safety awareness and risk assessment and strengthening the monitoring of the accidents could decrease the incidence of accidents” (I do apologize for the authors’ poor English).
It is probable that someone will now calculate that the risk of harm is minute. Chinese traditional healers seem to use spinal manipulation fairly regularly, so the incidence of complications would be one in several millions.
Such calculations are frequently made by chiropractors in an attempt to define the incidence rates of risks associated with chiropractic in the West. They look convincing but, in fact, they are complete nonsense.
The reason is that under-reporting can be huge. Clinical trials of chiropractic often omit any mention of adverse effects (thus violating publication ethics) and, in our case-series, under-reporting was precisely 100% (none of the cases we discovered had been recorded anywhere). This means that these estimates are entirely worthless.
I sincerely hope that the risk turns out to be extremely low – but without a functioning reporting system for such events, we might as well read tea-leaves.
Since weeks I have been searching for new (2013) studies which actually report POSITIVE results. I like good news as much as the next man but, in my line of business, it seems awfully hard to come by. Therefore I am all the more delighted to present these two new articles to my readers.
The first study is a randomized trial with patients suffering from metastatic cancer who received one of three interventions: massage therapy, no-touch intervention or usual care. Primary outcomes were pain, anxiety, and alertness; secondary outcomes were quality of life and sleep. The mean number of massage therapy sessions per patient was 2.8.
The results show significant improvement in the quality of life of the patients who received massage therapy after 1-week follow-up which was not observed in either of the other groups. Unfortunately, the difference was not sustained at 1 month. There were also trends towards improvement in pain and sleep of the patients after massage. No serious adverse events were noted.
The authors conclude that “providing therapeutic massage improves the quality of life at the end of life for patients and may be associated with further beneficial effects, such as improvement in pain and sleep quality. Larger randomized controlled trials are needed to substantiate these findings“.
The second study examined the effectiveness of a back massage for improving sleep quality in 60 postpartum women suffering from poor sleep. They were randomized to either the intervention or the control group. Participants in both groups received the same care except for the back massages. The intervention group received one 20-minutes back massage at the same time each evening for 5 consecutive days by a certified massage therapist. The outcome measure was the Pittsburgh Sleep Quality Index (PSQI). The results showed that the changes in mean PSQI were significantly lower in the intervention group than in controls indicating a positive effect of massage on sleep quality.
The authors’ conclusions were clear: “an intervention involving back massage in the postnatal period significantly improved the quality of sleep.”
Where I was trained (Germany), massage is not deemed to be an alternative but an entirely mainstream treatment. Despite this fact, there is precious little evidence to demonstrate that it is effective. Our own research has found encouraging evidence for a range of conditions, including autism, cancer palliation, constipation, DOMS and back pain. In addition, we have shown that massage is not entirely free of risks but that its potential for harm is very low (some might say that this was never in question but it is good to have a bit more solid evidence).
The new studies are, of course, not without flaws; this can hardly be expected in an area where logistical, financial and methodological problems abound. The fact that there are many different approaches to massage does not make things easier either. The new evidence is nevertheless encouraging and seems to suggest that massage has relaxing effects which are clinically relevant. In my view, massage is a therapy worth considering for more rigorous research.
Acupuncture remains a highly controversial treatment: its mechanism of action is less than clear and the clinical results are equally unconvincing. Of course, one ought to differentiate between different conditions; the notion that acupuncture is a panacea is most certainly nonsense.
In many countries, acupuncture is being employed mostly in the management of pain, and it is in this area where the evidence is perhaps most encouraging. Yet, even here the evidence from the most rigorous clinical trials seems to suggest that much, if not all of the effects of acupuncture might be due to placebo.
Moreover, we ought to be careful with generalisations and ask what type of pain? One very specific pain is that caused by aromatase inhibitors (AI), a medication frequently prescribed to women suffering from breast cancer. Around 50 % of these patients complain of AI-associated musculoskeletal symptoms (AIMSS) and 15 % discontinue treatment because of these complaints. So, can acupuncture help these women?
A recent randomised, sham-controlled trial tested whether acupuncture improves AIMSS. Postmenopausal women with early stage breast cancer, experiencing AIMSS were randomized to eight weekly real or sham acupuncture sessions. The investigators evaluated changes in the Health Assessment Questionnaire Disability Index (HAQ-DI) and pain visual analog scale (VAS). Serum estradiol, β-endorphin, and proinflammatory cytokine concentrations were also measured pre and post-intervention. In total, 51 women were enrolled of whom 47 were evaluable (23 randomized to real and 24 to sham acupuncture).
Baseline characteristics turned out to be balanced between groups with the exception of a higher HAQ-DI score in the real acupuncture group. The results failed to show a statistically significant difference in reduction of HAQ-DI or VAS between the two groups. Following eight weekly treatments, a significant reduction of IL-17 was noted in both groups. No significant modulation was seen in estradiol, β-endorphin, or other proinflammatory cytokine concentrations in either group. No difference in AIMSS changes between real and sham acupuncture was seen.
Even though this study was not large, it was rigorously executed and well-reported. As many acupuncturists claim that their treatment alleviates pain and as many women suffering from AM-induced pain experience benefit, acupuncture advocates will nevertheless claim that the findings of this study are wrong, misleading or irrelevant. The often remarkable discrepancy between experience and evidence will again be the subject of intense discussions. How can a tiny trial overturn the experience of so many?
The answer is: VERY EASILY! In fact, the simplest explanation is that both are correct. The trial was well-done and its findings are thus likely to be true. The experience of patients is equally true – yet it relies not on the effects of acupuncture per se, but on the context in which it is given. In simple language, the effects patients experience after acupuncture are due to a placebo-response.
This is the only simple explanation which tallies with both the evidence and the experience. Once we think about it carefully, we realise that acupuncture is highly placebo-genic:
It is exotic.
It is invasive.
It is slightly painful.
It involves time with a therapist.
It involves touch.
If anyone had the task to develop a treatment that maximises placebo-effects, he could not come up with a better intervention!
Ahhh, will acupuncture-fans say, this means that acupuncture is a helpful therapy. I don’t care how it works, as long as it does help. Did we not just cover this issues in some detail? Indeed we did – and I do not feel like re-visiting the three fallacies which underpin this sentence again.
During the last decade, Professor Claudia Witt and co-workers from the Charite in Berlin have published more studies of homeopathy than any other research group. Much of their conclusions are over-optimistic and worringly uncritical, in my view. Their latest article is on homeopathy as a treatment of eczema. As it happens, I have recently published a systematic review of this subject; it concluded that “the evidence from controlled clinical trials… fails to show that homeopathy is an efficacious treatment for eczema“. The question therefore arises whether the latest publication of the Berlin team changes my conclusion in any way.
Their new article describes a prospective multi-centre study which included 135 children with mild to moderate atopic eczema. The parents of the kids enrolled in this trial were able to choose either homeopathic or conventional doctors for their children who treated them as they saw fit. The article gives only scant details about the actual treatments administered. The main outcome of the study was a validated symptom score at 36 months. Further endpoints included quality of life, conventional medicine consumption, safety and disease related costs at six, 12 and 36 months.
The results showed no significant differences between the groups at 36 months. However, the children treated conventionally seemed to improve quicker than those in the homeopathy group. The total costs were about twice higher in the homoeopathic compared to the conventional group. The authors conclude as follows: “Taking patient preferences into account, while being unable to rule out residual confounding, in this long-term observational study, the effects of homoeopathic treatment were not superior to conventional treatment for children with mild to moderate atopic eczema, but involved higher costs“.
At least one previous report of this study has been available for some time and had thus been included in my systematic review. It is therefore unlikely that this new analysis might change my conclusion, particularly as the trial by Witt et al has many flaws. Here are just some of the most obvious ones:
Patients were selected according to parents’ preferences.
This means expectations could have played an important role.
It also means that the groups were not comparable in various, potentially important prognostic variables.
Even though much of the article reads as though the homeopaths exclusively employed homeopathic remedies, the truth is that both groups received similar amounts of conventional care and treatments. In other words, the study followed a ‘A+B versus B’ design (here is the sentence that best gives the game away “At 36 months the frequency of daily basic skin care was… comparable in both groups, as was the number of different medications (including corticosteroids and antihistamines)…”). I have previously stated that this type of study-design can never produce a negative result because A+B is always more than B.
Yet, at first glance, this new study seems to prove my thesis wrong: even though the parents chose their preferred options, and even though all patients were treated conventionally, the addition of homeopathy to conventional care failed to produce a better clinical outcome. On the contrary, the homeopathically treated kids had to wait longer for their symptoms to ease. The only significant difference was that the addition of homeopathy to conventional eczema treatments was much more expensive than conventional therapy alone (this finding is less than remarkable: even the most useless additional intervention costs money).
So, is my theory about ‘A+B versusB’ study-designs wrong? I don’t think so. If B equals zero, one would expect exactly the finding Witt et al produced: A+0=A. In turn, this is not a compliment for the homeopaths of this study: they seem to have been incapable of even generating a placebo-response. And this might indicate that homeopathy was not even usefull as a means to generate a placebo-response. Whatever interpretation one adopts, this study tells us very little of value (as children often grow out of eczema, we cannot even be sure whether the results are not simply a reflection of the natural history of the disease); in my view, it merely demonstrates that weak study designs can only create weak findings which, in this particular case, are next to useless.
The study was sponsored by the Robert Bosch Stiftung, an organisation which claims to be dedicated to excellence in research and which has, in the past, spent millions on researching homeopathy. It seems doubtful that trials of this caliber can live up to any claim of excellence. In any case, the new analysis is certainly no reason to change the conclusion of my systematic review.
To their credit, Witt et al are well aware of the many weaknesses of their study. Perhaps in an attempt to make them appear less glaring, they stress that “the aim of this study was to reflect the real world situation“.Usually I do not accept the argument that pragmatic trials cannot be rigorous – but I think Witt et al do have a point here: the real word tells us that homeopathic remedies are pure placebos!