MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

medical ethics

Today the GUARDIAN published an article promoting acupuncture on the NHS. The article is offensively misleading, I think, and therefore deserves a comment. I write these comments with a heavy heart, I should add, because the GUARDIAN is by far my favourite UK daily. In the following, I will cite key passages from the article in question and add my comments in bold.

Every woman needing pain relief while giving birth at University College London hospital (UCLH) is offered acupuncture, with around half of the hospital’s midwives specially trained to give the treatment. UCLH is far from typical in this respect, though: acupuncture is not standard throughout the UK and many health practitioners claim patients are often denied access to it through the NHS because of entrenched scepticism from sections of the medical establishment.

Entrenched scepticism? I would say that it could be perhaps be related to the evidence. The conclusions of the current Cochrane review on acupuncture for labour pain are cautious and do not seem strong enough to issue a general recommendation for general use in childbirth: “acupuncture and acupressure may have a role with reducing pain, increasing satisfaction with pain management and reduced use of pharmacological management. However, there is a need for further research.”

“There are conditions for which acupuncture works and others where it doesn’t. It is not a cure-all, and should be open to scrutiny. But the focus of my work is for acupuncture to become a standard part of midwifery training, and at the same time change perceptions among clinicians about its appropriate use for a whole range of other conditions.”

Open to scrutiny indeed! And if we scrutinise the evidence critically – rather than engaging in uncritical and arguably irresponsible promotion – we find that the evidence is not nearly as convincing as acupuncture fans try to make us believe.

The UK lags behind many other European countries in its support for acupuncture. Just 2,500 medical professionals here are qualified to practice it, compared with 45,000 in Germany. The National Institute for Clinical Excellence (Nice) recommends WMA specifically for the treatment of only two conditions – lower back pain (which costs the NHS £1bn a year) and headaches.

Yes, the UK also lags behind Germany in the use of leeches and other quackery. The ‘ad populum’ fallacy is certainly popular in alternative medicine – but surely, it is still a fallacy!

A growing body of healthcare practitioners believe it should be offered routinely for a variety of conditions, including pain in labour, cancer, musculoskeletal conditions and even irritable bowel syndrome (IBS).

Here we go, belief as a substitute for evidence and fallacies as a replacement of logical arguments. I had thought the GUARDIAN was better than this!

At a time of NHS cuts the use of needles at 8p per unit look attractive. In St Albans, where a group of nurse-led clinics have been using acupuncture since 2008 for patients with knee osteoarthritis, economics have been put under scrutiny. WMA was offered to 114 patients rather than a knee replacement costing £5,000, and 79% accepted. Two years later a third of them had not required a knee transplant, representing an annual saving of £100,000, as estimated by researchers to the St Albans local commissioning group.

This looks a bit like a ‘back of an envelope’ analysis. I would like to see this published in a reputable journal and see it scrutinised by a competent health economist.

So why is acupuncture not being used more widely? The difficulty of proving its efficacy is clearly one of the biggest stumbling blocks. An analysis of 29 studies of almost 18,000 patients found acupuncture effective in treating chronic pain compared with sham acupuncture.

This passage refers to an analysis by Vickers et al. It was severely and repeatedly criticised for being too optimistic and, more importantly, it is not nearly as positive as implied here. Its conclusions are in fact quite cautious: “acupuncture is effective for the treatment of chronic pain and is therefore a reasonable referral option. Significant differences between true and sham acupuncture indicate that acupuncture is more than a placebo. However, these differences are relatively modest, suggesting that factors in addition to the specific effects of needling are important contributors to the therapeutic effects of acupuncture.”

But even treatment proponents question whether a randomised controlled trial – the gold standard of medical research – works, given that faking treatment is nearly impossible.

What do you mean ‘even treatment proponents’? It is only proponents who question these sham needles! The reason: they frequently do not generate the results acupuncture fans had hoped for.

MY CONCLUSIONS

The article is clearly not the GUARDIAN’s finest hour. It lacks even a tinge of critical assessment. This is regrettable, I think, particularly as the truth about acupuncture is not that difficult to transmit to the public:

  • Much of the research is of woefully poor quality.
  • Its effectiveness is not proven beyond doubt for a single condition.
  • Serious adverse effects have been reported.
  • Because it requires substantial amounts of therapist time, it also is not cheap.

An Indian chain of homeopathic clinics, Dr Batra’s, has just opened its first branch in London. The new website is impressive. It claims homeopathy is effective for the following conditions:

Hair loss? Are they serious? Have they not seen pictures of Samuel Hahnemann?

I decided to look into the psoriasis claim a little closer. This is what they state regarding the homeopathic treatment of psoriasis:

Research-based evidences speak clear and loud of the success of homeopathy in treating psoriasis.

A study published in the Journal of the European Academy of Dermatology and Venereology, a conventional medical Journal, showed that psoriasis patients experienced significant improvement in their quality of life and reduction in their psoriasis symptoms with homeopathy. And this was without any kind of side-effects whatsoever. Of the 82 patients involved in the study that went on for 2 years, many had suffered psoriasis for as long as 15 years and had previously unsuccessfully tried conventional treatments.

At Dr. Batra’s we have successfully treated more than 25,000 cases of psoriasis with homeopathy over the last 35 years. Our safe and scientific solutions have brought smiles to many suffering patients of psoriasis. In fact, a study conducted by A.C. Nielson showed that as compared to general practitioners, specialists and local homeopaths, a higher than average improvement is seen at Dr. Batra’s in treatment of skin ailments.

To the reader who does not look deeper, this may sound fairly convincing. Sadly, it is not. The first study cited above was an uncontrolled trial. Here is its abstract:

Design Prospective multicentre observational study. Objective To evaluate details and effects of homeopathic treatment in patients with psoriasis in usual medical care. Methods Primary care patients were evaluated over 2 years using standardized questionnaires, recording diagnoses and complaints severity, health-related quality of life (QoL), medical history, consultations, all treatments, and use of other health services. Results Forty-five physicians treated 82 adults, 51.2% women, aged 41.6 +/- 12.2 (mean +/- SD) years. Patients had psoriasis for 14.7 +/- 11.9 years; 96.3% had been treated before. Initial case taking took 127 +/- 47 min. The 7.4 +/- 7.4 subsequent consultations (duration: 19.4 +/- 10.5 min) cumulated to 169.0 +/- 138.8 min. Patients received 6.0 +/- 4.9 homeopathic prescriptions. Diagnoses and complaints severity improved markedly with large effect sizes (Cohen’s d= 1.02-2.09). In addition, QoL improved (SF-36 physical component score d = 0.26, mental component score d = 0.49), while conventional treatment and health service use were considerably reduced. Conclusions Under classical homeopathic treatment, patients with psoriasis improved in symptoms and QoL.

It is clear that, due to the lack of a control group, no causal inference can be made between the treatment and the outcome. To claim that otherwise is in my view bogus.

I should mention that there is not a single controlled clinical trial of homeopathy for psoriasis that would support the claim that it is effective.

The second study is not listed in Medline. In fact, the only publication of an author by the name of ‘A C Nielson’ is entitled ‘Are men more intuitive when it comes to eating and physical activity?’. Until I see the evidence, I very much doubt that the study cited above produced strong evidence that homeopathy is an effective cure for psoriasis.

Dr Batra’s chain of clinics boasts to provide the best quality and the highest standards of services that percolate down to all levels in an organisation. Everyone in the institute and those associated with it strive for excellence in whatever they do. Measuring the degree of customer satisfaction was the fundamental concept on which this homeopathic institute’s commitment to become a patient-driven institution was built. 

Nice words! SHAME THAT THEY HAVE DECIDED TO DILUTE THEIR TRUTH HOMEOPATHICALLY!

All across the world we see initiatives to regulate alternative medicine. The most recent news in this sphere comes from Switzerland. The ‘Swissinfo’ website reported that the training of alternative medicine practitioners is to be regulated by creating a ‘COMPLEMENTARY MEDICINE DIPLOMA’.

The decision was welcomed by the Organisation of Swiss Alternative Medicine Professionals (OdA KT), which will conduct the exams for the diploma in question. The five therapies selected by the government for the complementary medicine diploma are yoga, ayurveda, shiatsu, craniosacral therapy and eutony. The first exams are expected to be held in 2016.

“Recognition by the state provides an important political basis for these therapies,” Christoph Q Meier, secretary general of OdA KT told swissinfo.ch. “The diploma will also improve the quality of therapy offered in Switzerland, as until now anybody could call themselves a therapist.” Meier estimates that there are between 12-15,000 practitioners of complementary therapies in Switzerland. Applicants for the national diploma will first have to pass a series of pre-exams. However, those with recognised qualifications and at least five years of experience could be exempt from the pre-exams. The exam is open to foreign nationals but will only be offered in German, French and Italian. In April this year, ayurveda was also included for a separate national diploma in naturopathy medicine along with Chinese and European traditional medicine, as well as homeopathy. Switzerland has around 3,000 naturopaths.

Whenever issues like this come up, I ask myself: IS REGULATION OF ALTERNATIVE MEDICINE A GOOD OR A BAD THING?

On the one hand, one might be pleased to hear that therapists receive some training and that not everyone who feels like it can do this job. On the other hand, it has to be said that regulation of nonsense will inevitably result in nonsense. What is more, regulation will also be misused by the practitioners to claim that their treatment is now well-established and supported by the government. This phenomenon can already be seen in the comments above and it misleads the public who understandably believe that, once a form of health care is regulated officially, it must be evidence-based.

So, what is the solution? I wish I knew the answer.

Any suggestion is welcomed.

Wet cupping is a therapy traditionally used in several cultures. It involves superficial injuries to the skin and subsequently the application of a vacuum cup over the injured site. This procedure would draw a small amount of blood into the cup, and this visible effect was taken as a sign that the humors or life forces or whatever are being restored.

The treatment is obviously painful and carries the risk of infection. But does it work? There are not many clinical trials of this form of alternative medicine, and I was therefore thrilled to find a new paper with a randomised clinical trial.

The aim of this clinical trial was to evaluate the effectiveness and safety of wet cupping therapy as the sole treatment for persistent nonspecific low back pain (PNSLBP). The investigators recruited 80 with PNSLBP lasting at least 3 months and randomly allocated them to an intervention group (n=40) or to a control group (n=40). The experimental group had 6 wet cupping sessions within 2 weeks, each of which were done at two bladder meridian (BL) acupuncture points. The control group had no such treatments. Acetaminophen was allowed as a rescue treatment in both groups. The Numeric Rating Scale (NRS), McGill Present Pain Intensity (PPI), and Oswestry Disability Questionnaire (ODQ) were used as outcome measures. Numbers of acetaminophen tablets taken were compared at 4 weeks from baseline. Adverse events were recorded.

At the end of the intervention, statistically significant differences in all three outcome measures favouring the wet cupping group compared with the control group were seen. These improvements continued for another two weeks after the end of the intervention. Acetaminophen was used less in the wet cupping group, but this difference was not statistically significant. No adverse events were reported.

The authors concluded that wet cupping is potentially effective in reducing pain and improving disability associated with PNSLBP at least for 2 weeks after the end of the wet cupping period. Placebo-controlled trials are needed.

Every now and then – well, actually in alternative medicine this is not so rare an event – I come across a study that ‘smells to high heaven’. This one certainly does; to be precise, it has the stench of TOO GOOD TO BE TRUE.

Apart from the numerous weaknesses of the study design, there is the fact that the results are do simply not seem plausible. Low back pain has a natural history that is well-studied. We therefore know that the majority of cases do get better fairly quickly regardless of whether we treat them or not. In this study, the control group did not improve at all, as shown on the impressive graph below (the grey line depicts the symptoms in the control group and the black one those of the cupping group).

To me, the improvement of the experimental group looks much like one might expect from the natural history of back pain. If this were true, the effect of wet cupping would by close to zero and the conclusion drawn by the authors of this trial would be false-positive.

But why was there no improvement in the control group?

I do not know the answer to this question. All I know is that it is this unexplained phenomenon which has created the impression of effectiveness of wet cupping.

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.

We used to call it ‘alternative medicine’ (on this blog, I still do so, because I believe it is a term as good or bad as any other and it is the one that is easily recognised); later some opted for ‘complementary medicine’; since about 15 years a new term is en vogue: INTEGRATED MEDICINE (IM).

Supporters of IM are adamant that IM is not synonymous with the other terms. But how is IM actually defined?

One of IM’s most prominent defenders is, of course Prince Charles. In his 2006 address to the WHO, he explained: “We need to harness the best of modern science and technology, but not at the expense of losing the best of what complementary approaches have to offer. That is integrated health – it really is that simple.”

Perhaps a bit too simple?

There are several more academic definitions, and it seems that, over the years, IM-fans have been busy moving the goal post quite a bit. The original principle of ‘THE BEST OF BOTH WORLDS’ has been modified considerably.

  • IM is a “comprehensive, primary care system that emphasizes wellness and healing of the whole person…” [Arch Intern Med. 2002;162:133-140]
  • IM “views patients as whole people with minds and spirits as well as bodies and includes these dimensions into diagnosis and treatment.” [BMJ. 2001; 322:119-120]

During my preparations for my lecture at the 16th European Sceptics Congress in London last week (which was on the subject of IM), I came across a brand-new (September 2015) definition. It can be found on the website of the COLLEGE OF MEDICINE  This Michael Dixon-led organisation can be seen as the successor of Charles’ ill-fated FOUNDATION FOR INTEGRATED HEALTH; it was originally to be called COLLEGE FOR INTEGRATED MEDICINE. We can therefore assume that they know best what IM truly is or aspires to be. The definition goes as follows:

IM is a holistic, evidence-based approach which makes intelligent use of all available therapeutic choices to achieve optimal health and resilience for our patients.

This may sound good to many who are not bothered or unable to think critically. It oozes political correctness and might therefore even impress some politicians. But, on closer scrutiny, it turns out to be little more than offensive nonsense. I feel compelled to publish a short analysis of it. I will do this by highlighting and criticising the important implications of this definition one by one.

1) IM is holistic

Holism has always been at the core of any type of good health care. To state that IM is holistic misleads people into believing that conventional medicine is not holistic. It also pretends that medicine might become more holistic through the addition of some alternative modalities. Yet I cannot imagine anything less holistic than diagnosing patients by merely looking at their iris (iridology) or assuming all disease stems from subluxations of the spine (chiropractic), for example. This argument is a straw-man, if there ever was one.

2) IM is evidence-based

This assumption is simply not true. If we look what is being used under the banner of IM, we find no end of treatments that are not supported by good evidence, as well as several for which the evidence is squarely negative.

3) IM is intelligent

If it were not such a serious matter, one could laugh out loud about this claim. Is the implication here that conventional medicine is not intelligent?

4) IM uses all available therapeutic choices

This is the crucial element of this definition which allows IM-proponents to employ anything they like. Do they seriously believe that patients should have ALL AVAILABLE treatments? I had thought that responsible health care is about applying the most effective therapies for the condition at hand.

5) IM aims at achieving optimal health

Another straw-man; it implies that conventional health care professionals do not want to restore their patients to optimal health.

In my lecture, which was not about this definition but about IM in general, I drew the following six conclusions:

  1. Proponents of IM mislead us with their very own, nonsensical terminology and definitions.
  2. They promote two main principles: use of quackery + holism.
  3. Holism is at the heart of all good medicine; IM is at best an unnecessary distraction.
  4. Using holism to promote quackery is dishonest and counter-productive.
  5. The integration of quackery will render healthcare not better but worse.
  6. IM flies in the face of common sense and medical ethics; it is a disservice to patients.

On this blog, we have repeatedly discussed the risks of acupuncture. Contrary to what we often hear, there clearly is potential for harm. Acupuncture is, of course most popular in China where it has been used for thousands of years. Therefore the Chinese literature, which is not easy to access for non-Chinese speakers and therefore often disregarded by Western researchers, might hold treasures of valuable information on the subject. It follows that a thorough review of this information might be helpful. A recent paper by Chinese scientists has tackled this issue.

The objective of this review was to determine the frequency and severity of adverse complications and events in acupuncture treatment reported from 1980 to 2013 in China. All first-hand case reports of acupuncture-related complications and adverse events that could be identified in the scientific literature were reviewed and classified according to the type of complication and adverse event, circumstance of the event, and long-term patient outcome. The selected case reports were published between 1980 and 2013 in 3 databases. Relevant papers were collected and analyzed by 2 reviewers.

Over the 33 years, 182 incidents were identified in 133 relevant papers. Internal organ, tissue, or nerve injury is the main complications of acupuncture especially for pneumothorax and central nervous system injury. Adverse effects also included syncope, infections, hemorrhage, allergy, burn, aphonia, hysteria, cough, thirst, fever, somnolence, and broken needles.

The authors of this review concluded that qualifying training of acupuncturists should be systemized and the clinical acupuncture operations should be standardized in order to effectively prevent the occurrence of acupuncture accidents, enhance the influence of acupuncture, and further popularize acupuncture to the rest of the world.

This is a bizarrely disappointing article followed by a most strange conclusion. The authors totally fail to discuss the most important issue and they arrive at conclusions which, I think, make little sense.

The issue to discuss here is, of course, under-reporting. We know that under-reporting in the Western literature is already huge. For every complication reported there could easily be 10 or even 100 that go unreported. There is no monitoring system for adverse effects, and acupuncturists have no incentive to publish their mistakes. Accurate and realistic prevalence data are therefore anybody’s guess.

In China, under-reporting is likely to be one or two orders of magnitude bigger. I say this because close to zero % of all Chinese papers on acupuncture report negative findings. For China, TCM is a huge export business, and the interest in reporting adverse effects is close to zero.

Seen from this perspective, it seems at first glance laudable that the Chinese authors dared to address this thorny issue. In the text of the article, they even mention that the included complications resulted in a total of 25 fatalities! This seems courageous. But one only needs to read the full article to get a strong suspicion that the authors are either in denial about the real figures, or their paper is a deliberate attempt to ‘white-wash’ acupuncture from its potential to do harm.

In 2010, we published a very similar review of the Chinese literature (unsurprisingly, it was not cited by the authors of the new paper). At the time, we found almost 500 published cases of serious adverse events and stated that we suspect that underreporting of such events in the Chinese-language literature is much higher than in the English-language literature.

The truth is that nobody knows how frequent adverse events of acupuncture truly are in China – or most other countries, for that matter. I believe that, before we “further popularize acupuncture to the rest of the world”, it would be ethical and necessary to 1) state this fact openly and 2) do something about it.

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?

Simple!

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.

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.

  1. Nonsensical research projects
  2. 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

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.

CONCLUSION

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).

Conclusions

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.

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