If you start reading the literature on chiropractic, you are bound to have surprises. The paucity of rigorous and meaningful research is one of them. I am constantly on the look-out for such papers but am regularly frustrated. Over the years, I got the impression that chiropractors tend to view research as an exercise in promotion – that is promotion of their very own trade.
Take this article, for instance. It seems to be a systematic review of chiropractic for breastfeeding. This is an interesting indication; remember: in 1998, Simon Singh wrote in the Guardian this comment “The British Chiropractic Association claims that their members can help treat children with colic, sleeping and feeding problems, frequent ear infections, asthma and prolonged crying, even though there is not a jot of evidence. This organisation is the respectable face of the chiropractic profession and yet it happily promotes bogus treatments.” As a consequence, he got sued for libel; he won, of course, but ever since, chiropractors across the world are trying to pretend that there is some evidence for their treatments after all.
The authors of the new review searched Pubmed [1966-2013], Manual, Alternative and Natural Therapy Index System (MANTIS) [1964-2013] and Index to Chiropractic Literature [1984-2013] for the relevant literature. The search terms utilized “breastfeeding”, “breast feeding”, “breastfeeding difficulties”, “breastfeeding difficulty”, “TMJ dysfunction”, “temporomandibular joint”, “birth trauma” and “infants”, in the appropriate Boolean combinations. They also examined non-peer-reviewed articles as revealed by Index to Chiropractic Literature and conducted a secondary analysis of references. Inclusion criteria for their review included all papers on breastfeeding difficulties regardless of peer-review. Articles were excluded if they were not written in the English language.
The following articles met the inclusion criteria: 8 case reports, 2 case series, 3 cohort studies and 6 manuscripts (5 case reports and a case series) that involved breastfeeding difficulties as a secondary complaint. The findings revealed a “theoretical and clinical framework based on the detection of spinal and extraspinal subluxations involving the cervico-cranio-mandibular complex and assessment of the infant while breastfeeding.”
Based on these results, the authors concluded that chiropractors care of infants with breastfeeding difficulties by addressing spinal and extraspinal subluxations involving the cervico-cranio-mandibular complex.
Have I promised too much?
I had thought that chiropractors had abandoned the subluxation nonsense! Not really, it seems.
I had thought that systematic reviews are about evidence of therapeutic effectiveness! Not in the weird world of chiropractic.
I would have thought that we all knew that ‘chiropractors care of infants with breastfeeding difficulties’ and do not need a review to confirm it! Yes, but what is good for business deserves another meaningless paper.
I would have thought that the conclusions of scientific articles need to be appropriate and based on the data provided! It seems that, in the realm of chiropractic, these rules do not apply.
An appropriate conclusion should have stated something like THERE IS NO GOOD EVIDENCE THAT CHIROPRACTIC CARE AIDS BREASTFEEDING. But that would have been entirely inappropriate from the chiropractic point of view because it is not a conclusion that promotes the sort of quackery most chiropractors rely upon for a living. And the concern over income is surely more important than telling the truth!
When it comes to alternative medicine, the public relies heavily on the writings of health journalists. We therefore have to count ourselves lucky to have some that are outstanding in their ability to inform the public honestly, objectively and responsibly. Here is an excerpt of what one particularly gifted and ethical heath journalist (and consultant!!!) just published regarding the treatment of babies and kids on a highly visible, popular website:
Homeopathy, or homeopathic medicine, is based on the principle that “like cures like.” Instead of treating an individual’s illness, homeopathy treats individual symptoms with substances from plants and minerals that are highly diluted and “succussed,” or shaken to release energy, said Sara Chana Silverstein, a homeopath, master herbalist and an international board-certified lactation consultant…Although homeopathy isn’t meant to replace Western medicine, it can be a complementary or alternative approach for ailments like colds, the stomach flu and teething. For example, if your pediatrician has diagnosed your baby with an upper respiratory infection, there’s not much you can do other than offer lots of fluids, rest and possibly acetaminophen or ibuprofen. In this case, a homeopathic remedy might help. Plus, since antibiotic overuse and antimicrobial resistance remain a major concern in the U.S., and antibiotics often have side effects, homeopathy could help heal without the need for a prescription. In fact, a study in the journal Homeopathy found that homeopathy for ear infections was just as effective as conventional treatment but patients in the homeopathic group had a faster improvement in symptoms. Although some studies show promising results, more research is needed to determine who homeopathic remedies work best for and in what situations, said Dr. Hilary McClafferty, chair of the American Academy of Pediatrics’ Section on Complementary and Integrative Medicine…
“In the United, States, the homeopathic products that carry the label, HPUS—
Homeopathic Pharmacopeia of the United States— are prepared with a very standardized, procedural monograph. So there is a map and regulations that ensure what’s on the label is what’s in the bottle,” McClafferty said…The only adverse effect of homeopathy, according to Silverstein, is that if a baby consumed a remedy too frequently, such as every hour for 10 hours, they would “prove” the remedy, or create the symptoms the remedy was trying to heal. “But if you gave it to a child 3 times a day at a low dose, personally I do not believe it could injure a child in anyway whatsoever,” she said…Your best bet is to see a trained homeopath who will target individual symptoms and give you pellets in the size that’s appropriate for your child’s age, Silverstein said. The bottom line when it comes to deciding between homeopathy, a medication or another remedy? “You want to be well educated, conservative and in touch with your pediatrician,” McClafferty said.
Julie Revelant is a health journalist and a consultant who provides content marketing and copywriting services for the healthcare industry. She’s also a mom of two. Learn more about Julie at revelantwriting.com.
As I said: outstanding!
With so much sound information about homeopathy and its merits in the treatment of childhood conditions, we are inclined to forgive the few tiny errors and marginally misleading statements that might require corrections such as:
- homeopathy is very much meant as a replacement of conventional medicine by its inventor Hahnemann who was adamant that it must not be combined with other treatments because it is the only true healing art;
- there is no good evidence that homeopathy is anything else than a placebo for children or, indeed, for anyone else;
- the study in the journal ‘Homeopathy’ was lousy and does not allow any conclusions whatsoever about the effectiveness of homeopathy;
- to state “some studies show promising results” is very misleading; the totality of the reliable evidence is negative;
- more research is not needed to determine who benefits from homeopathy; there is no longer a debate about homeopathy within science;
- the label of a typical homeopathic preparation does not tell you what’s in the bottle, at best it tells you what used to be there;
- the main risk of homeopathy is that diseases are not treated effectively; in this way, homeopathy can kill.
Yes, these are but very minor flaws, I know. They should not distract from this journalist’s great achievement of getting her brilliantly informative article read by the widest possible audience. If Prince Charles offered an award for the best science writer of the year (why has he not yet thought of this publicity stunt?), she would certainly be a candidate.
This seems to be the question that occupies the minds of several homeopaths.
So was I!
Let me explain.
In 1997, Linde et al published their now famous meta-analysis of clinical trials of homeopathy which concluded that “The results of our meta-analysis are not compatible with the hypothesis that the clinical effects of homeopathy are completely due to placebo. However, we found insufficient evidence from these studies that homeopathy is clearly efficacious for any single clinical condition. Further research on homeopathy is warranted provided it is rigorous and systematic.”
This paper had several limitations which Linde was only too happy to admit. The authors therefore conducted a re-analysis which, even though published in an excellent journal, is rarely cited by homeopaths. Linde et al stated in their re-analysis of 2000: “there was clear evidence that studies with better methodological quality tended to yield less positive results.” It was this phenomenon that prompted me and my colleague Max Pittler to publish a ‘letter to the editor’ which now – 15 years later – seems the stone of homeopathic contention.
A blog-post by a believer in homeopathy even asks the interesting question: Did Professor Ernst Sell His Soul to Big Pharma? It continues as follows:
Edzard Ernst is an anti-homeopath who spent his career attacking traditional medicine. In 1993 he became Professor of Complementary Medicine at the University of Exeter. He is often described as the first professor of complementary medicine, but the title he assumed should have fooled no-one. His aim was to discredit medical therapies, notably homeopathy, and he then published some 700 papers in ‘scientific’ journals to do so.
Now, Professor Robert Hahn, in his blog, has made an assessment of the quality of his work… In the interests of the honesty and integrity in science, it is an important assessment. It shows, in his view, how science has been taken over by ideology (or as I would suggest, more accurately, the financial interests of Big Corporations, in this case, Big Pharma). The blog indicates that in order to demonstrate that homeopathy is ineffective, over 95% of scientific research into homeopathy has to be discarded or removed!
So for those people who, like myself, cannot read the original German, here is an English translation of the blog…
“I have never seen a science writer so blatantly biased as Edzard Ernst: his work should not be considered of any worth at all, and discarded” finds Sweden’s Professor Robert Hahn, a leading medical scientist, physician, and Professor of Anaesthesia and Intensive Care at the University of Linköping, Sweden.
Hahn determined therefore to analyze for himself the ‘research’ which supposedly demonstrated homeopathy to be ineffective, and reached the shocking conclusion that:
“only by discarding 98% of homeopathy trials and carrying out a statistical meta-analysis on the remaining 2% negative studies, can one ‘prove’ that homeopathy is ineffective”.
In other words, all supposedly negative homeopathic meta-analyses which opponents of homeopathy have relied on, are scientifically bogus…
Who can you trust? We can begin by disregarding Edzard Ernst. I have read several other studies that he has published, and they are all untrustworthy. His work should be discarded…
In the case of homeopathy, one should stick with what the evidence reveals. And the evidence is that only by removing 95-98% of all studies is the effectiveness of homeopathy not demonstrable…
So, now you are wondering, I am sure: HOW MUCH DID HE GET FOR SELLING HIS SOUL TO BIG PHARMA?
No? You are wondering 1) who this brilliant Swedish scientist, Prof Hahn, is and 2) what article of mine he is criticising? Alright, I will try to enlighten you.
Here I can rely on a comment posted on my blog some time ago by someone who can read Swedish (thank you Bjorn). He commented about Hahn as follows:
A renowned director of medical research with well over 300 publications on anesthesia and intensive care and 16 graduated PhD students under his mentorship, who has been leading a life on the side, blogging and writing about spiritualism, and alternative medicine and now ventures on a public crusade for resurrecting the failing realm of homeopathy!?! Unbelievable!
I was unaware of this person before, even if I have lived and worked in Sweden for decades.
I have spent the evening looking up his net-track and at his blog at roberthahn.nu (in Swedish).
I will try to summarise some first impressions:
Hahn is evidently deeply religious and there is the usual, unmistakably narcissistic aura over his writings and sayings. He is religiously confident that there is more to this world than what can be measured and sensed. In effect, he seems to believe that homeopathy (as well as alternative medical methods in general) must work because there are people who say they have experienced it and denying the possibility is akin to heresy (not his wording but the essence of his writing).
He has, along with his wife, authored at least three books on spiritual matters with titles such as (my translations) “Clear replies from the spiritual world” and “Connections of souls”.
He has a serious issue with skeptics and goes on at length about how they are dishonest bluffers[sic] who willfully cherry-pick and misinterpret evidence to fit their preconceived beliefs.
He feels that desperate patients should generally be allowed the chance that alternative methods may offer.
He believes firmly in former-life memories, including his own, which he claims he has found verification for in an ancient Italian parchment.
His main arguments for homeopathy are Claus Linde’s meta analyses and the sheer number of homeopathic research that he firmly believes shows it being superior to placebo, a fact that (in his opinion) shows it has a biological effect. Shang’s work from 2005 he dismisses as seriously flawed.
He also points to individual research like this as credible proof of the biologic effect of remedies.
He somewhat surprisingly denies recommending homeopathy despite being convinced of its effect and maintains that he wants better, more problem oriented and disease specific studies to clarify its applicability. (my interpretation)
If it weren’t for his track record of genuine, acknowledged medical research and him being a renowned authority in a genuine, scientific medical field, this man would be an ordinary, religiously devout quack.
What strikes me as perhaps telling of a consequence of his “exoscientific” activity, is that Hahn, who holds the position of research director at a large city trauma and emergency hospital is an “adjungerad professor”, which is (usually) a part time, time limited, externally financed professorial position, while any Swedish medical doctor with his very extensive formal merits would very likely hold a full professorship at an academic institution.
END OF QUOTE
MY 2000 PAPER THAT SEEMS TO IRRITATE HAHN
This was a short ‘letter to the editor’ by Ernst and Pittler published in the J Clin Epidemiol commenting on the above-mentioned re-analysis by Linde et al which was published in the same journal. As its text is not available on-line, I re-type parts of it here:
In an interesting re-analysis of their meta-analysis of clinical trials of homeopathy, Linde et al conclude that there is no linear relationship between quality scores and study outcome. We have simply re-plotted their data and arrive at a different conclusion. There is an almost perfect correlation between the odds ratio and the Jadad score between the range of 1-4… [some technical explanations follow which I omit]…Linde et al can be seen as the ultimate epidemiological proof that homeopathy is, in fact, a placebo.
And that is, as far as I can see, the whole mysterious story. I cannot even draw a conclusion – all I can do is to ask a question:
DOES ANYONE UNDERSTAND WHAT THEY ARE GOING ON ABOUT?
On a blog about alternative medicine, the issue of ‘pseudoscience’ can never be far. Several posts have already focussed specifically on this topic. Recently, I came across an excellent article on homeopathy (which is well worth reading in full). It concluded by listing the techniques commonly used in pseudoscience.
I think this is important and relevant to much of the discussions about alternative medicine. Therefore I take the liberty to cite it here in full. According to the authors of this article,, the techniques are as follows:
- Ignore settled issues in science: We know a great deal about the behavior of water (and evolution, and other contentious topics), but there are many efforts to introduce new science without ever addressing the existing body of knowledge. As such, many of the basic tenets of topics such as homeopathy appear to be ungrounded in reality as we understand it.
- Misapplication of real science: Quantum mechanics is an undeniably successful description of parts of the natural world, but the limitations of its applicability are widely recognized by the scientific community, if not the general public. Pseudoscientists such as homeopaths appear to cynically target this sort of ignorance by applying scientific principles to inappropriate topics.
- Rejection of scientific standards: Over the centuries, science has established standards of evidence and experiment to ensure that data remains consistent and reproducible. But these strengths are presented as weaknesses that make science impervious to new ideas, a stance that is often accompanied by…
- Claims of suppression: Pseudoscience is rejected because it does not conform to the standards held by the scientific community. That community is depicted as a dangerous hegemony that rejects new ideas in order to perpetuate a stifling orthodoxy. This happens in spite of many examples of radical ideas that have rapidly gained not only acceptance, but major prizes, when they were properly supported by scientific evidence.
- A conclusion/evidence gap: Many areas of pseudoscience do not set out to examine a phenomenon but rather have the stated goal of supporting a preordained conclusion. As such, they often engage in excessive logical leaps when the actual data is insufficient to support the desired conclusion.
- Focusing on the fringes: All areas of science have anomalous data and anecdotal findings that are inconsistent with the existing understanding. But those anomalies should not obscure the fact that the vast majority of current data does support the predominant theories. In the hands of a pseudoscientist, these unconnected edge cases are presented as a coherent body of knowledge that supports the replacement of existing understandings.
Perhaps the clearest theme running through many areas of pseudoscience, however, is the attempt to make a whole that is far, far greater than the sum of its parts. Enlarging a collection of terminally-flawed trivia does not somehow strengthen its scientific significance. This is especially true when many of the components of the argument don’t form a coherent whole. For example, quantum entanglement, structured water, and silica are essentially unrelated explanations, and any support for one of them makes no difference to the others. Yet, somehow, presenting them all at once is supposed to make the case for water’s memory harder to dismiss.
END OF QUOTE
Who – apart from quacks – would not want to get rid of all quackery, once and for all? It would be a huge improvement to medicine, save thousands of lives, and reduce our expenditure for health care considerably.
But how? How can we possibly get rid of something that is as ancient as medicine itself?
All we need to do is to employ the existing ethical imperatives. I am thinking in particular about INFORMED CONSENT.
Informed consent is a process for obtaining permission from a patient before treating him/her. It requires the patient’s clear and full understanding of the relevant facts, implications, and consequences of the treatment. It is a ‘condition sine qua non’; no health care professional must commence a treatment without it.
And how would informed consent get rid of all quackery?
This is perhaps best explained by giving an example. Imagine a patient is about to receive a quack treatment – let’s take crystal healing (we could have chosen any other implausible non-evidence based therapy, e. g. homeopathy, chiropractic, Bach Flower Remedies, faith-healing, etc.) – for his/her condition – let’s say diabetes (we could have chosen any other condition, e. g. cancer, asthma, insomnia, etc.). Informed consent would require that, before starting the intervention, the therapist informs the patient about the relevant facts, implications and consequences of having crystal healing for diabetes. This would include the following:
- the therapy is not plausible, it is not in line with the laws of nature as we understand them today,
- there is no evidence that the treatment will cure your condition or ease your symptoms beyond a placebo-effect,
- the treatment may harm you in several ways: 1) it might cause direct harm (unlikely with crystal healing but not with chiropractic, for instance), 2) it will harm your finances because the therapist wants to be paid, 3) most importantly, if you believe that it could help you and therefore forego effective therapy for your diabetes, it could easily kill you within a few days.
It is impossible to dispute that these facts are true and relevant, I think. And if they are relevant, the practitioner must convey them in such a way that they are fully appreciated by the patient. If the patient comprehends the implications fully, he/she is unlikely to agree to the treatment. If most patients refuse to be treated, the market for crystal healing quickly collapses, and crystal healers move into other, more productive jobs. This might even help the general economy!
But quacks are not in the habit of obtaining fully informed consent, I hear you say. I agree, and this is why they must be taught to do so in their quack colleges. If informed consent was taught to all budding quacks, they would soon realise that quackery is not a viable business and go to a proper school where they lean something useful (this too might help the economy). If that happens, the quack colleges would soon run out of money and close.
Meanwhile, one could remind the existing quacks that they break the law, if they neglect informed consent. In the interest of the patient, one could closely monitor the consent giving process, and even think of increasingly heavy finds for those who break the law.
As we see, almost all the means for rendering health care quack-free already exist. All we need to do is implement them. That shouldn’t be difficult, should it?
AND NOW I STOP DAY-DREAMING AND DO SOMETHING USEFUL.
No, this post is not about the pop duo ‘EURYTHMICS’, it is about ‘EURYTHMY’ which pre-dates the pop duo by a few decades.
Eurythmy is a movement therapy of anthroposophic medicine which, according to its proponents, has positive effects on a person’s physical body, spirit, and soul. It is involves expressive movements developed by Rudolf Steiner in conjunction with Marie von Sivers in the early 20th century. It is used as a performance art, in education, especially in Steiner schools, and – as part of anthroposophic medicine – for therapeutic purposes. Here is what one pro-eurymthy website tells us about it:
Eurythmy is one of Rudolf Steiner’s proudest achievements. To better understand what Steiner says about eurythmy, you should read his self-titled “A Lecture on Eurythmy” Not always one to boast, Steiner says:
EURYTHMY has grown up out of the soil of the Anthroposophical Movement, and the history of its origin makes it almost appear to be a gift of the forces of destiny.
Steiner, Rudolf. A Lecture on Eurythmy, 1923
Clearly, Steiner felt that eurythmy was something very special, and of great importance. As such, eurythmy is a tool of Anthroposophy used to reveal and bring about a certain “spiritual impulse” in our age:
For it is the task of the Anthroposophical Movement to reveal to our present age that spiritual impulse which is suited to it.I speak in all humility when I say that within the Anthroposophical Movement there is a firm conviction that a spiritual impulse of this kind must now, at the present time, enter once more into human evolution. And this spiritual impulse must perforce, among its other means of expression, embody itself in a new form of art. It will increasingly be realised that this particular form of art has been given to the world in Eurythmy.
Steiner, Rudolf. A Lecture on Eurythmy
The question is, of course, whether as a therapy eurythmy works. A recent publication might give an answer.
The aim of this systematic review was to update and summarize the relevant literature on the effectiveness of eurythmy in a therapeutic context since 2008. It is thus an up-date of a previously published review. This paper found 8 citations which met the inclusion criterion: 4 publications referring to a prospective cohort study without control group (the AMOS study), and 4 articles referring to 2 explorative pre-post studies without control group, 1 prospective, non-randomized comparative study, and 1 descriptive study with a control group. The methodological quality of studies ranged in from poor to good, and in sample size from 5 to 898 patients. In most studies, EYT was used as an add-on, not as a mono-therapy. The studies described positive treatment effects with clinically relevant effect sizes in most cases.
For the up-date, different databases like PubMed, MEDPILOT, Research Gate, The Cochrane Library, DIMDI, Arthe and also the journal databases Der Merkurstab and the European Journal of Integrative Medicine were searched for prospective and retrospective clinical trials in German or English language. There were no limitations for indication, considered outcome or age of participants. Studies were evaluated with regard to their description of the assembly process and treatment, adequate reporting of follow-ups, and equality of comparison groups in controlled trials.
Eleven studies met the inclusion criteria. These included two single-arm, non-controlled pilot studies, two publications on the same non-randomized controlled trial and one case study; six further studies referred to a prospective cohort study, the Anthroposophic Medicine Outcome Study. Most of these studies described positives treatment effects with varying effect sizes. The studies were heterogynous according to the indications, age groups, study design and measured outcome. The methodological quality of the studies varied considerably.
The authors who all come from the Institute of Integrative Medicine, anthroposophical University of Witten/Herdecke in Germany draw the following conclusions: Eurythmy seems to be a beneficial add-on in a therapeutic context that can improve the health conditions of affected persons. More methodologically sound studies are needed to substantiate this positive impression.
I am puzzled! How on earth could they reach this conclusion? There is not a single trial that would allow to establish cause and effect!!! The way I read the evidence from the therapeutic trials included in this and the previous reviews, the only possible conclusion is that EURYTHMY IS A WEIRD THERAPY FOR WHICH THERE IS NOT GOOD EVIDENCE WHATSOEVER.
Medical ethics comprise a set of rules and principles which are essential for all aspects of medicine, including of course research. The main issues are:
- Respect for autonomy – patients must have the right to refuse or choose their treatments.
- Beneficence – researchers and clinicians must act in the best interest of the patient.
- Non-maleficence – the expected benefits of interventions must outweigh their risks.
- Justice – the distribution of health resources must be fair.
- Respect for persons – patients must be treated with dignity.
- Truthfulness and honesty – informed consent is an essential element in research and clinical practice.
While all of this has long been fairly standard in conventional health care, it is often neglected in alternative medicine. It is therefore timely to ask, how much of research in the realm of alternative medicine abides by the rules of medical ethics?
After more than two decades of involvement in this sector, I have serious and growing concerns. The subject is, of course complex, but the way I see it, in alternative medicine there are two main areas where medical ethics are violated with some regularity.
- Nonsensical research projects
- Lack of informed consent
NONSENSICAL RESEARCH PROJECTS
At best, nonsensical research is a waste of precious resources, at worst it violates the beneficence principle. In alternative medicine, nonsensical research seems to happen ad nauseam. Regular readers of this blog will have seen plenty of examples of such abuse – for instance, if researchers conduct a clinical trial of chiropractic spinal manipulation for improving the singing voices of choir singers, or homeopaths test whether their remedies enhance female fertility. Often, nonsensical research happens when naïve enthusiasts decide to dabble a bit in science in order to promote their trade – but without realising that research would require a minimum of education.
But there are other occasions when it seems that the investigators know only too well what they are doing. Take for instance the plethora of ‘pragmatic’ trials which are currently so much ‘en vogue’ in alternative medicine. They can be designed in such a way that their results must produce what the researchers intended to show; the ‘A+B versus B’ study design is a prominent and obvious example of this type of abuse which I have repeatedly written about on this blog.
I use the term ‘abuse’ intentionally, because that is precisely what it is, in my view. Nonsensical research abuses the willingness of patients to participate by misleading them that it is a worthwhile sacrifice. In reality it is an unethical attempt to generate findings that can mislead us all. Moreover, it gives science a bad name and can lead to patients’ unwillingness to take part in research that does need doing. The damage done by nonsensical research projects is therefore immeasurable.
Informed consent is essential in research for protecting the interests of the volunteering patients. When a clinical trial is first conceived, the researchers need to work out all the details, write a protocol and submit it to their ethics committee. Their submission has to give evidence that all the participating patients have given informed consent in writing before they are enrolled into the study. That means, they have to be told the essential details about what might happen to them during the trial.
In a placebo-controlled trial of homeopathy, for instance, they might be told that they will receive either a homeopathic remedy or a placebo during the study period. They might also be informed that there is some encouraging evidence that the former works, and that the trial is designed to define to what extend this is so. Generating this knowledge, they might further be told, will help future patients and will be an important contribution to improving health care. Based on such phraseology, the ethics committee is likely to allow the study to go ahead, and patients are likely to agree to take part.
But, of course, this information is less than truthful. An honest and full information for patients would need to include the following points:
- you will receive either a homeopathic remedy or a placebo,
- the former contains no active molecules and the totality of the most reliable evidence does not show that it works for your condition,
- this means that you will receive either a homeopathic or a conventional placebo,
- neither of these can possibly help your condition,
- the study can therefore not advance our knowledge in any way,
- during the trial your condition will remain untreated which is likely to increase your suffering unnecessarily.
If any research team would truthfully disclose this information, no ethics committee would pass their protocol. If by some weird mistake they did, no patients would volunteer to participate in the study.
I have chosen here the example of homeopathy (because most readers will understand it quite easily), but I could have used almost any other alternative treatment. The issues are identical or very similar: informed consent is usually misinformed consent. If it were fully and truthfully informed, it would neither pass the hurdle of the essential ethics approval nor would it lend itself to recruiting sufficiently large numbers of patients.
There are, I think, very serious concerns about the ethical standards in alternative medicine research. I have been banging on about these issues since many years (for instance here and here and here and here). Predictably, this did not find much resonance in the realm of alternative medicine. Regrettably, very few ethicists have so far taken this subject seriously; they seem to feel that these problems are trivial compared to the important issues medical ethics face in conventional health care. I remain unconvinced that this is true and believe it is high time to systematically address the ethics of alternative medicine.
Conventional cough syrups do not have the best of reputations – but the repute of homeopathic cough syrups is certainly not encouraging. So what should one do with such a preparation? Forget about it? No, one conducts a clinical trial, of course! Not just any old trial but one where science, ethics and common sense are absent. Here are the essentials of a truly innovative study that, I think, has all of these remarkable qualities:
The present prospective observational study investigated children affected by wet acute cough caused by non-complicated URTIs, comparing those who received the homeopathic syrup versus those treated with the homeopathic syrup plus antibiotic. The aims were: 1) to assess whether the addition of antibiotics to a symptomatic treatment had a role in reducing the severity and duration of acute cough in a pediatric population, as well as in improving cough resolution; 2) to verify the safety of the two treatments. Eighty-five children were enrolled in an open study: 46 children received homeopathic syrup alone for 10 days and 39 children received homeopathic syrup for 10 days plus oral antibiotic treatment (amoxicillin/clavulanate, clarithromycin, and erythromycin) for 7 days. To assess cough severity we used a subjective verbal category-descriptive (VCD) scale. Cough VCD score was significantly (P < 0.001) reduced in both groups starting from the second day of treatment (−0.52 ± 0.66 in the homeopathic syrup group and −0.56 ± 0.55 in children receiving homeopathic syrup plus oral antibiotic treatment). No significant differences in cough severity or resolution were found between the two groups of children in any of the 28 days of the study. After the first week (day 8) cough was completely resolved in more than one-half of patients in both groups. Two children (4.3 %) reported adverse effects in the group treated with the homeopathic syrup alone, versus 9 children (23.1 %) in the group treated with the homeopathic syrup plus antibiotics (P = 0.020).
Our data confirm that the homeopathic treatment in question has potential benefits for cough in children as well, and highlight the strong safety profile of this treatment. Additional antibiotic prescription was not associated with a greater cough reduction, and presented more adverse events than the homeopathic syrup alone.
Let us be clear about what has happened here. I think, the events can be summarised as follows:
- the researchers come across a homeopathic syrup (anyone who understands respiratory problems and/or therapeutics would be more than a little suspicious of this product, but this team is exceptional),
- they decide to do a trial with it (a decision which would make some ethicists already quite nervous, but the ethics committee is exceptional too),
- the question raises, what should the researchers give to the control group?
- someone has the idea, why not compare our dodgy syrup against something that is equally dodgy, perhaps even a bit unsafe?
- the researchers are impressed and ask: but what precisely could we use?
- let’s take antibiotics; they are often used for acute coughs, but the best evidence fails to show that they are helpful and they have, of course, risks,
- another member of the team adds: let’s use children, they and their mothers are unlikely to understand what we are up to,
- the team is in agreement,
- Boiron, the world’s largest producer of homeopathic products, accepts to finance the study,
- a protocol is written,
- ethics approval is obtained,
- the trial is conducted and even published by a journal with the help of peer-reviewers who are less than critical.
And the results of the trial? Contrary to the authors’ conclusion copied above, they show that two bogus treatments are worse that one.
BOB’S YOUR UNCLE!
EVERYONE SEEMS HAPPY: THE RESEARCHERS CAN ADD AN ARTICLE TO THEIR PUBLICATION LIST, BOIRON HAS MORE ‘EVIDENCE’ IN FAVOUR OF HOMEOPATHY, AND THE ETHICS COMMITTEE SLEEP JUST AS SOUNDLY AS THE PEER-REVIEWERS.
While my last post was about the risk following some naturopaths’ advice, this one is about the effectiveness of naturopathic treatments. This is a complex subject, not least because naturopaths use a wide range of therapies (as the name implies, they pride themselves of employing all therapeutic means supplied by nature). Some of these interventions are clearly supported by good evidence; for instance, nobody would doubt the effectiveness of a healthy diet or the benefits of regular exercise. But what about all the other treatments naturopaths use? The best approach to find an answer might be to assess not each single therapy but to evaluate the entire package of the naturopathic approach, and not a single study but all such trials.
This is precisely what US researchers have recently done. The purpose of this interesting, new systematic review was to compile and consolidate research that has investigated the whole practice of naturopathic medicine as it is practiced in community settings in order to better assess the quantity and quality of the research, and clinical effect, if any.
In order to get included into the review, studies had to report results from multi-modal treatment delivered by North American naturopathic doctors. The effect size for each study was calculated; no meta-analysis was undertaken.
Fifteen studies met the authors’ inclusion criteria. They covered a wide range of chronic diseases. Most studies had low to medium risks of bias including acknowledged limitations of pragmatic trials. Effect sizes for the primary medical outcomes varied and were statistically significant in 10 out of 13 studies. A quality of life metric was included in all of the RCTs with medium effect size and statistical significance in some subscales.
The authors concluded that previous reports about the lack of evidence or benefit of naturopathic medicine (NM) are inaccurate; a small but compelling body of research exists. Further investigation is warranted into the effectiveness of whole practice NM across a range of health conditions.
This sounds like good news for naturopathy! However, there are several important caveats:
- the authors seem to have only looked at US studies (naturopathy is a European tradition!),
- the searches were done three years ago, and more recent data were thus omitted,
- the authors included all sorts of investigations, even uncontrolled studies; only 6 were RCTs,
- rigorous trials were very scarce; and for each condition, they were even more so,
- the authors mention the PRISMA guidelines for systematic reviews implying that they followed them but, in fact, they did not.
My biggest concern, however, is something else. It relates to the interventions tested in these studies. The authors claim that their results table provides full details on this issue but this is unfortunately not true. All we have by way of an explanation is the authors’ remark that the interventions tested in the studies of their review included diet counseling and nutritional recommendations, specific home exercises and physical activity recommendations, deep breathing techniques or other stress reduction strategies, dietary supplements including vitamins, hydrotherapy, soft-tissue manual techniques, electrical muscle stimulation, and botanical medicines.
Survey data from two US states tell us that the most commonly prescribed naturopathic therapeutics are botanical medicines (51% of visits in Connecticut, 43% in Washington), vitamins (41% and 43%), minerals (35% and 39%), homeopathy (29% and 19%) and allergy treatments (11% and 13%). They also inform us that the mean length of a consultation with an US naturopath is about 40 minutes.
I think, this puts things into perspective. If I advise a patient with diabetes or hypertension or coronary heat disease to follow an appropriate diet, exercise and to adhere to some stress reduction program, if in addition I show empathy and compassion during a 40 minute consultation and make sure that my advise is taken seriously and subsequently adhered to, the outcome is likely to be positive. Naturopaths may elect to call this package of intervention ‘naturopathy’, however, I would call it good conventional medicine.
The problem, I think is clear: good therapeutic advice is effective but it is not naturopathy, and it cannot be used to justify the use of doubtful interventions like homeopathy or all sorts of dodgy supplements. Testing whole treatment packages of this nature can therefore lead to highly misleading results, particularly if the researchers draw unwarranted conclusions about specific schools of health care.
When I come across a study with the aim to “examine the effectiveness of acupuncture to relieve symptoms commonly observed in patients in a hospice program” my hopes are high. When I then see that its authors are from the ‘New England School of Acupuncture’, the ‘All Care Hospice and the ‘Tufts University School of Medicine, Boston, my hopes for a good piece of science are even higher. So, let’s see what this new paper has to offer.
A total of 26 patients participated in this acupuncture ‘trial’, receiving a course of weekly treatments that ranged from 1 to 14 weeks. The average number of treatments was five. The Edmonton Symptom Assessment Scale (ESAS) was used to assess the severity of pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and dyspnoea. A two-tailed, paired t test was applied to the data to compare symptom scores pre- versus post-acupuncture treatment. Patients enrolled in All Care Hospice’s home care program were given the option to receive acupuncture to supplement usual care offered by the hospice team. Treatment was provided by licensed acupuncturists in the patient’s place of residence.
The results indicated that 7 out of 9 symptoms were significantly improved with acupuncture, the exceptions being drowsiness and appetite. Although the ESAS scale demonstrated a reduction in symptom severity post-treatment for both drowsiness and appetite, this reduction was not found to be significant.
At tis stage, I have lost most of my hopes for good science. This is not a ‘trial’ but a glorified case-series. There is no way that the stated aim can be pursued with this type of methodology. There is no reason whatsoever to assume that the observed outcome can be attributed to acupuncture; the additional attention given to these patients is but one of several factors that are quite sufficient to explain their symptomatic improvements.
This is yet another disappointment then from the plethora of ‘research’ into alternative medicine that, on closer inspection, turns out to be little more than thinly disguised promotion of quackery. These days, I can bear such disappointments quite well – after all, I had many years to get used to them. What I find more difficult to endure is the anger that overcomes me when I read the authors’ conclusion: Acupuncture was found to be effective for the reduction and relief of symptoms that commonly affect patient QOL. Acupuncture effectively reduced symptoms of pain, tiredness, nausea, depression, anxiety, and shortness of breath, and enhanced feelings of well-being. More research is required to assess the long-term benefits and symptom reduction of acupuncture in a palliative care setting.
This is not disappointing; in my view, this is scientific misconduct by
- the authors,
- the institutions employing the authors,
- the ethics committee that has passed the ‘research’,
- the sponsors of the ‘research’,
- the peer-reviewers of the paper,
- the journal and its editors responsible for publishing this paper.
The fact that this sort of thing happens virtually every day in the realm of alternative medicine does not render this case less scandalous, it merely makes it more upsetting.