conflict of interest
Some of the recent comments on this blog have been rather emotional, a few even irrational, and several were, I am afraid, outright insulting (I usually omit to post the worst excesses). Moreover, I could not avoid the impression that some commentators have little understanding of what the aim of this blog really is. I tried to point this out in the very first paragraph of my very first post:
Why another blog offering critical analyses of the weird and wonderful stuff that is going on in the world of alternative medicine? The answer is simple: compared to the plethora of uncritical misinformation on this topic, the few blogs that do try to convey more reflected, sceptical views are much needed; and the more we have of them, the better.
My foremost aim with his blog is to inform consumers through critical analysis and, in this way, I hope to prevent harm from patients in the realm of alternative medicine. What follows, are a few simple yet important points about this blog which I try to spell out here as clearly as I can:
- I am not normally commenting on issues related to conventional medicine – not because I feel there is nothing to criticise in mainstream medicine, but because my expertise has long been in alternative medicine. So commentators might as well forget about arguments like “more people die because of drugs than alternative treatments”; they are firstly fallacious and secondly not relevant to this blog.
- I have researched alternative medicine for many years (~ 40 clinical studies, > 300 systematic reviews etc.) and my readers can be confident that I know what I am talking about. Thus comments like ‘he does not know anything about the subject’ are usually not well placed and just show the ignorance of those who post them.
- I am not in the pocket of anyone. I do not receive payments for doing this blog, nor did I, as an academic, receive any financial or other inducements for researching alternative medicine (on the contrary, I have often been given to understand that my life could be made much easier, if I adopted a more promotional stance towards my alternative medicine). I also do not belong to any organisation that is financed by BIG PHARMA or similar power houses. So my critics might as well abandon their conspiracy theories and focus on a more promising avenue of criticism.
- My allegiance is not with any interest group in (or outside) the field of alternative medicine. For instance, I do not see it as my job to help chiropractors, homeopaths etc. getting their act together. My task here is to point out the deficits in chiropractic (or any other area of alternative medicine) so that consumers are better protected. (I should think, however, that this also creates pressure on professions to become more evidence-based – but I see this as a mere welcome side-effect.)
- If some commentators seem to find my arguments alarmist or see it as venomous scare-mongering, I suggest they re-examine their own position and learn to think a little more (self-) critically. I furthermore suggest that, instead of claiming such nonsense, they point out where they think I have gone wrong and provide evidence for their views.
- Some people seem convinced that I have an axe to grind, that I have been personally injured by some alternative practitioner, or had some other unpleasant or traumatic experience. To those who think so, I have to say very clearly that none of this has ever happened. I recommend they inform themselves of the nature of critical analysis and its benefits.
- This is a blog, not a scientific journal. I try to reach as many lay people as I can and therefore I tend to use simple language and sometimes aim to be entertaining. Those who feel that this renders my blog more journalistic than scientific are probably correct. If they want science, I recommend they look for my scientific articles in the medical literature; I can assure them that they will find plenty.
- I very much invite an open and out-spoken debate. But ad hominem attacks are usually highly counterproductive – they only demonstrate that the author has no rational arguments left, or had none in the first place. Authors of insults also risks being banned from this blog.
- Finally, I fear that some readers of my blog might sometimes get confused in the arguments and counter-arguments, and end up uncertain which side is right and which is wrong. To those who have this problem, I recommend a simple method for deciding where the truth is usually more likely to be found: ask yourself who might be merely defending his/her self-interest and who might be free of such conflicts of interest and thus more objective. For example, in my endless disputes with chiropractors, one could well ask: do the chiropractors have an interest in defending their livelihood, and what interest do I have in questioning whether chiropractors do generate more good than harm?
Acute tonsillitis (AT) is an upper respiratory tract infection which is prevalent, particularly in children. The cause is usually a viral or, less commonly, a bacterial infection. Treatment is symptomatic and usually consists of ample fluid intake and pain-killers; antibiotics are rarely indicated, even if the infection is bacterial by nature. The condition is self-limiting and symptoms subside normally after one week.
Homeopaths believe that their remedies are effective for AT – but is there any evidence? A recent trial seems to suggest there is.
It aimed, according to its authors, to determine the efficacy of a homeopathic complex on the symptoms of acute viral tonsillitis in African children in South Africa.
The double-blind, placebo-controlled RCT was a 6-day “pilot study” and included 30 children aged 6 to 12 years, with acute viral tonsillitis. Participants took two tablets 4 times per day. The treatment group received lactose tablets medicated with the homeopathic complex (Atropa belladonna D4, Calcarea phosphoricum D4, Hepar sulphuris D4, Kalium bichromat D4, Kalium muriaticum D4, Mercurius protoiodid D10, and Mercurius biniodid D10). The placebo consisted of the unmedicated vehicle only. The Wong-Baker FACES Pain Rating Scale was used for measuring pain intensity, and a Symptom Grading Scale assessed changes in tonsillitis signs and symptoms.
The results showed that the treatment group had a statistically significant improvement in the following symptoms compared with the placebo group: pain associated with tonsillitis, pain on swallowing, erythema and inflammation of the pharynx, and tonsil size.
The authors drew the following conclusions: the homeopathic complex used in this study exhibited significant anti-inflammatory and pain-relieving qualities in children with acute viral tonsillitis. No patients reported any adverse effects. These preliminary findings are promising; however, the sample size was small and therefore a definitive conclusion cannot be reached. A larger, more inclusive research study should be undertaken to verify the findings of this study.
Personally, I agree only with the latter part of the conclusion and very much doubt that this study was able to “determine the efficacy” of the homeopathic product used. The authors themselves call their trial a “pilot study”. Such projects are not meant to determine efficacy but are usually designed to determine the feasibility of a trial design in order to subsequently mount a definitive efficacy study.
Moreover, I have considerable doubts about the impartiality of the authors. Their affiliation is “Department of Homoeopathy, University of Johannesburg, Johannesburg, South Africa”, and their article was published in a journal known to be biased in favour of homeopathy. These circumstances in itself might not be all that important, but what makes me more than a little suspicious is this sentence from the introduction of their abstract:
“Homeopathic remedies are a useful alternative to conventional medications in acute uncomplicated upper respiratory tract infections in children, offering earlier symptom resolution, cost-effectiveness, and fewer adverse effects.”
A useful alternative to conventional medications (there are no conventional drugs) for earlier symptom resolution?
If it is true that the usefulness of homeopathic remedies has been established, why conduct the study?
If the authors were so convinced of this notion (for which there is, of course, no good evidence) how can we assume they were not biased in conducting this study?
I think that, in order to agree that a homeopathic remedy generates effects that differ from those of placebo, we need a proper (not a pilot) study, published in a journal of high standing by unbiased scientists.
Rigorous research into the effectiveness of a therapy should tell us the truth about the ability of this therapy to treat patients suffering from a given condition — perhaps not one single study, but the totality of the evidence (as evaluated in systematic reviews) should achieve this aim. Yet, in the realm of alternative medicine (and probably not just in this field), such reviews are often highly contradictory.
A concrete example might explain what I mean.
There are numerous systematic reviews assessing the effectiveness of acupuncture for fibromyalgia syndrome (FMS). It is safe to assume that the authors of these reviews have all conducted comprehensive searches of the literature in order to locate all the published studies on this subject. Subsequently, they have evaluated the scientific rigor of these trials and summarised their findings. Finally they have condensed all of this into an article which arrives at a certain conclusion about the value of the therapy in question. Understanding this process (outlined here only very briefly), one would expect that all the numerous reviews draw conclusions which are, if not identical, at least very similar.
However, the disturbing fact is that they are not remotely similar. Here are two which, in fact, are so different that one could assume they have evaluated a set of totally different primary studies (which, of course, they have not).
One recent (2014) review concluded that acupuncture for FMS has a positive effect, and acupuncture combined with western medicine can strengthen the curative effect.
Another recent review concluded that a small analgesic effect of acupuncture was present, which, however, was not clearly distinguishable from bias. Thus, acupuncture cannot be recommended for the management of FMS.
How can this be?
By contrast to most systematic reviews of conventional medicine, systematic reviews of alternative therapies are almost invariably based on a small number of primary studies (in the above case, the total number was only 7 !). The quality of these trials is often low (all reviews therefore end with the somewhat meaningless conclusion that more and better studies are needed).
So, the situation with primary studies of alternative therapies for inclusion into systematic reviews usually is as follows:
- the number of trials is low
- the quality of trials is even lower
- the results are not uniform
- the majority of the poor quality trials show a positive result (bias tends to generate false positive findings)
- the few rigorous trials yield a negative result
Unfortunately this means that the authors of systematic reviews summarising such confusing evidence often seem to feel at liberty to project their own pre-conceived ideas into their overall conclusion about the effectiveness of the treatment. Often the researchers are in favour of the therapy in question – in fact, this usually is precisely the attitude that motivated them to conduct a review in the first place. In other words, the frequently murky state of the evidence (as outlined above) can serve as a welcome invitation for personal bias to do its effect in skewing the overall conclusion. The final result is that the readers of such systematic reviews are being misled.
Authors who are biased in favour of the treatment will tend to stress that the majority of the trials are positive. Therefore the overall verdict has to be positive as well, in their view. The fact that most trials are flawed does not usually bother them all that much (I suspect that many fail to comprehend the effects of bias on the study results); they merely add to their conclusions that “more and better trials are needed” and believe that this meek little remark is sufficient evidence for their ability to critically analyse the data.
Authors who are not biased and have the necessary skills for critical assessment, on the other hand, will insist that most trials are flawed and therefore their results must be categorised as unreliable. They will also emphasise the fact that there are a few reliable studies and clearly point out that these are negative. Thus their overall conclusion must be negative as well.
In the end, enthusiasts will conclude that the treatment in question is at least promising, if not recommendable, while real scientists will rightly state that the available data are too flimsy to demonstrate the effectiveness of the therapy; as it is wrong to recommend unproven treatments, they will not recommend the treatment for routine use.
The difference between the two might just seem marginal – but, in fact, it is huge: IT IS THE DIFFERENCE BETWEEN MISLEADING PEOPLE AND GIVING RESPONSIBLE ADVICE; THE DIFFERENCE BETWEEN VIOLATING AND ADHERING TO ETHICAL STANDARDS.
One of the problems regularly encountered when evaluating the effectiveness of chiropractic spinal manipulation is that there are numerous chiropractic spinal manipulative techniques and clinical trials rarely provide an exact means of differentiating between them. Faced with a negative studies, chiropractors might therefore argue that the result was negative because the wrong techniques were used; therefore they might insist that it does not reflect chiropractic in a wider sense. Others claim that even a substantial body of negative evidence does not apply to chiropractic as a whole because there is a multitude of techniques that have not yet been properly tested. It seems as though the chiropractic profession wants the cake and eat it.
Amongst the most commonly used is the ‘DIVERSIFIED TECHNIQUE’ (DT) which has been described as follows: Like many chiropractic and osteopathic manipulative techniques, Diversified is characterized by a high velocity low amplitude thrust. Diversified is considered the most generic chiropractic manipulative technique and is differentiated from other techniques in that its objective is to restore proper movement and alignment of spine and joint dysfunction.
Also widely used is a technique called ‘FLEXION DISTRACTION’ (FD) which involves the use of a specialized table that gently distracts or stretches the spine and which allows the chiropractor to isolate the area of disc involvement while slightly flexing the spine in a pumping rhythm.
The ‘ACTIVATOR TECHNIQUE’ (AT) seems a little less popular; it involves having the patient lie in a prone position and comparing the functional leg lengths. Often one leg will seem to be shorter than the other. The chiropractor then carries out a series of muscle tests such as having the patient move their arms in a certain position in order to activate the muscles attached to specific vertebrae. If the leg lengths are not the same, that is taken as a sign that the problem is located at that vertebra. The chiropractor treats problems found in this way moving progressively along the spine in the direction from the feet towards the head. The activator is a small handheld spring-loaded instrument which delivers a small impulse to the spine. It was found to give off no more than 0.3 J of kinetic energy in a 3-millisecond pulse. The aim is to produce enough force to move the vertebrae but not enough to cause injury.
There is limited research comparing the effectiveness of these and the many other techniques used by chiropractors, and the few studies that are available are usually less than rigorous and their findings are thus unreliable. A first step in researching this rather messy area would be to determine which techniques are most frequently employed.
The aim of this new investigation was to do just that, namely to provide insight into which treatment approaches are used most frequently by Australian chiropractors to treat spinal musculoskeletal conditions.
A questionnaire was sent online to the members of the two main Australian chiropractic associations in 2013. The participants were asked to provide information on treatment choices for specific spinal musculoskeletal conditions.
A total of 280 responses were received. DT was the first choice of treatment for most of the included conditions. DT was used significantly less in 4 conditions: cervical disc syndrome with radiculopathy and cervical central stenosis were more likely to be treated with AT. FD was used almost as much as DT in the treatment of lumbar disc syndrome with radiculopathy and lumbar central stenosis. More experienced Australian chiropractors use more AT and soft tissue therapy and less DT compared to their less experienced chiropractors. The majority of the responding chiropractors also used ancillary procedures such as soft tissue techniques and exercise prescription in the treatment of spinal musculoskeletal conditions.
The authors concluded that this survey provides information on commonly used treatment choices to the chiropractic profession. Treatment choices changed based on the region of disorder and whether neurological symptoms were present rather than with specific diagnoses. Diversified technique was the most commonly used spinal manipulative therapy, however, ancillary procedures such as soft tissue techniques and exercise prescription were also commonly utilised. This information may help direct future studies into the efficacy of chiropractic treatment for spinal musculoskeletal disorders.
I am a little less optimistic that this information will help to direct future research. Critical readers might have noticed that the above definitions of two commonly used techniques are rather vague, particularly that of DT.
Why is that so? The answer seems to be that even chiropractors are at a loss coming up with a good definition of their most-used therapeutic techniques. I looked hard for a more precise definition but the best I could find was this: Diversified is characterized by the manual delivery of a high velocity low amplitude thrust to restricted joints of the spine and the extremities. This is known as an adjustment and is performed by hand. Virtually all joints of the body can be adjusted to help restore proper range of motion and function. Initially a functional and manual assessment of each joint’s range and quality of motion will establish the location and degree of joint dysfunction. The patient will then be positioned depending on the region being adjusted when a specific, quick impulse will be delivered through the line of the joint in question. The direction, speed, depth and angles that are used are the product of years of experience, practice and a thorough understanding of spinal mechanics. Often a characteristic ‘crack’ or ‘pop’ may be heard during the process. This is perfectly normal and is nothing to worry about. It is also not a guide as to the value or effectiveness of the adjustment.
This means that the DT is not a single method but a hotchpotch of techniques; this assumption is also confirmed by the following quote: The diversified technique is a technique used by chiropractors that is composed of all other techniques. It is the most commonly used technique and primarily focuses on spinal adjustments to restore function to vertebral and spinal problems.
What does that mean for research into chiropractic spinal manipulation? It means, I think, that even if we manage to define that a study was to test the effectiveness of one named chiropractic technique, such as DT, the chiropractors doing the treatments would most likely do what they believe is required for each individual patient.
There is, of course, nothing wrong with that approach; it is used in many other area of health care as well. In such cases, we need to view the treatment as something like a ‘black box'; we test the effectiveness of the black box without attempting to define its exact contents, and we trust that the clinicians in the trial are well-trained to use the optimal mix of techniques as needed for each individual patient.
I would assume that, in most studies available to date, this is precisely what already has been implemented. It is simply not reasonable to assume that a trial the trialists regularly instructed the chiropractors not to use the optimal treatments.
What does that mean for the interpretation of the existing trial evidence? It means, I think, that we should interpret it on face value. The clinical evidence for chiropractic treatment of most conditions fails to be convincingly positive. Chiropractors often counter that such negative findings fail to take into account that chiropractors use numerous different techniques. This argument is not valid because we must assume that in each trial the optimal techniques were administered.
In other words, the chiropractic attempt to have the cake and eat it has failed.
Some time ago, my wife and I had the visit of a French couple. They came from Britany by ferry, and when we picked them up in Plymouth we saw two very pale, sick individuals staggering from the boat. It had been a rough crossing, and they had been sea-sick for 7 hours – enough to lose the will to live! “Why did you not take something against it?” we asked. “But we did”, they replied, “we even went especially to a pharmacy at home to get professional advice. They sold us this medication, but it just did not work.” To my amazement they showed me a homeopathic remedy marketed against sea-sickness in France.
I am sure most readers would have similar, perhaps even better stories to tell. But what do you do with people who happily sell you bogus treatments? Most of us do very little – and that is wrong, I think, very wrong. We need to protest in the sharpest terms each and every time this happens. I would even suggest we do like Mark Twain.
In 1905, Mark Twain sent the following letter to J. H. Todd, a salesman who had just attempted to flog a bogus medicine to the author by way of a letter and leaflet delivered to his home. According to the literature Twain received, the “medicine” in question — called “The Elixir of Life” — could cure such ailments as meningitis (which had previously killed Twain’s daughter in 1896) and diphtheria (which killed his 19-month-old son). Twain, himself of ill-health at the time and recently widowed after his wife suffered heart failure, was furious and dictated this reply.
Your letter is an insoluble puzzle to me. The handwriting is good and exhibits considerable character, and there are even traces of intelligence in what you say, yet the letter and the accompanying advertisements profess to be the work of the same hand. The person who wrote the advertisements is without doubt the most ignorant person now alive on the planet; also without doubt he is an idiot, an idiot of the 33rd degree, and scion of an ancestral procession of idiots stretching back to the Missing Link. It puzzles me to make out how the same hand could have constructed your letter and your advertisements. Puzzles fret me, puzzles annoy me, puzzles exasperate me; and always, for a moment, they arouse in me an unkind state of mind toward the person who has puzzled me. A few moments from now my resentment will have faded and passed and I shall probably even be praying for you; but while there is yet time I hasten to wish that you may take a dose of your own poison by mistake, and enter swiftly into the damnation which you and all other patent medicine assassins have so remorselessly earned and do so richly deserve.
Adieu, adieu, adieu!
(Source: Berry Hill & Sturgeon)
Whenever I give a public lecture about homeopathy, I explain what it is, briefly go in to its history, explain what its assumptions are, and what the evidence tells us about its efficacy and safety. When I am finished, there usually is a discussion with the audience. This is the part I like best; in fact, it is the main reason why I made the effort to do the lecture in the first place.
The questions vary, of course, but you can bet your last shirt that someone asks: “We know it works for animals; animals cannot experience a placebo-response, and therefore your claim that homeopathy relies on nothing but the placebo-effect must be wrong!” At this stage I often despair a little, I must admit. Not because the question is too daft, but because I did address it during my lecture. Thus I feel that I have failed to get the right message across – I despair with my obviously poor skills of giving an informative lecture!
Yet I need to answer the above question, of course. So I reiterate that the perceived effectiveness of homeopathy relies not just on the placebo-effect but also on phenomena such as regression towards the mean, natural history of the condition etc. I also usually mention that it is erroneous to assume that animals cannot benefit from placebo-effects; they can be conditioned, and pets can react to the expectations of their owners.
Finally, I need to mention the veterinary clinical evidence which – just like in the case of human patients – fails to show that homeopathic remedies are better than placebos for treating animals. Until recently, this was not an easy task because no systematic review of randomised placebo-controlled trials (RCTs) of veterinary homeopathy was available. Now, I am happy to announce, this situation has changed.
Using Cochrane methods, a brand-new review aimed to assess risk of bias and to quantify the effect size of homeopathic interventions compared with placebo for each eligible peer-reviewed trial. Judgement in 7 assessment domains enabled a trial’s risk of bias to be designated as low, unclear or high. A trial was judged to comprise reliable evidence, if its risk of bias was low or was unclear in specified domains. A trial was considered to be free of vested interest, if it was not funded by a homeopathic pharmacy.
The 18 RCTs found by the researchers were disparate in nature, representing 4 species and 11 different medical conditions. Reliable evidence, free from vested interest, was identified in only two trials:
- homeopathic Coli had a prophylactic effect on porcine diarrhoea (odds ratio 3.89, 95 per cent confidence interval [CI], 1.19 to 12.68, P=0.02);
- individualised homeopathic treatment did not have a more beneficial effect on bovine mastitis than placebo intervention (standardised mean difference -0.31, 95 per cent CI, -0.97 to 0.34, P=0.35).
The authors conclusions are clear: Mixed findings from the only two placebo-controlled RCTs that had suitably reliable evidence precluded generalisable conclusions about the efficacy of any particular homeopathic medicine or the impact of individualised homeopathic intervention on any given medical condition in animals.
My task when lecturing about homeopathy has thus become a great deal easier. But homeopathy-fans are not best pleased with this new article, I guess. They will try to claim that it was a biased piece of research conducted, most likely, by notorious anti-homeopaths who cannot be trusted. So who are the authors of this new publication?
They are RT Mathie from the British Homeopathic Association and J Clausen from one of Germany’s most pro-homeopathic institution, the ‘Karl und Veronica Carstens-Stiftung’.
DOES ANYONE BELIEVE THAT THIS ARTICLE IS BIASED AGAINST HOMEOPATHY?
After the usually challenging acute therapy is behind them, cancer patients are often desperate to find a therapy that might improve their wellbeing. At that stage they may suffer from a wide range of symptoms which can seriously limit their quality of life. Any treatment that can be shown to restore them to their normal mental and physical health would be more than welcome.
Most homeopaths believe that their remedies can do just that, particularly if they are tailored not to the disease but to the individual patient. Sadly, the evidence that this might be so is almost non-existent. Now, a new trial has become available; it was conducted by Jennifer Poole, a chartered psychologist and registered homeopath, and researcher and teacher at Nemeton Research Foundation, Romsey.
The aim of this study was to explore the benefits of a three-month course of individualised homeopathy (IH) for survivors of cancer. Fifteen survivors of any type of cancer were recruited from a walk-in cancer support centre. Conventional treatment had to have taken place within the last three years. Patients saw a homeopath who prescribed IH. After three months of IH, they scored their total, physical and emotional wellbeing using the Functional Assessment of Chronic Illness Therapy for Cancer (FACIT-G). The results show that 11 of the 14 women had statistically positive outcomes for emotional, physical and total wellbeing.
The conclusions of the author are clear: Findings support previous research, suggesting CAM or IH could be beneficial for survivors of cancer.
This article was published in the NURSING TIMES, and the editor added a footnote informing us that “This article has been double-blind “.
I find this surprising. A decent peer-review should have picked up the point that a study of that nature cannot possibly produce results which tell us anything about the benefits of IH. The reasons for this are fairly obvious:
- there was no control group,
- therefore the observed outcomes are most likely due to 1) natural history, 2) placebo, 3) regression towards the mean and 4) social desirability; it seems most unlikely that IH had anything to do with the result
- the sample size was tiny,
- the patients elected to receive IH which means that had high expectations of a positive outcome,
- only subjective outcome measures were used,
- there is no good previous research suggesting that IH benefits cancer patients.
On the last point, a recent systematic review showed that the studies available on this topic had mixed results either showing a significantly greater improvement in QOL in the intervention group compared to the control group, or no significant difference between groups. The authors concluded that there existed significant gaps in the evidence base for the effectiveness of CAM on QOL in cancer survivors. Further work in this field needs to adopt more rigorous methodology to help support cancer survivors to actively embrace self-management and effective CAMs, without recommending inappropriate interventions which are of no proven benefit.
All this new study might tell us is that IH did not seem to harm these patients – but even this finding is not certain; to be sure, we would need to include many more patients. Any conclusions about the effectiveness of IH are totally unwarranted. But are there ANY generalizable conclusions that can be drawn from this article? Yes, I can think of a few:
- Some cancer patients can be persuaded to try the most implausible treatments.
- Some journals will publish any rubbish.
- Some peer-reviewers fail to spot the most obvious defects.
- Some ‘researchers’ haven’t got a clue.
- The attempts of misleading us about the value of homeopathy are incessant.
One might argue that this whole story is too trivial for words; who cares what dodgy science is published in the NURSING TIMES? But I think it does matter – not so much because of this one silly article itself, but because similarly poor research with similarly ridiculous conclusions is currently published almost every day. Subsequently it is presented to the public as meaningful science heralding important advances in medicine. It matters because this constant drip of bogus research eventually influences public opinion and determines far-reaching health care decisions.
Recently, I was invited to give a lecture about homeopathy for a large gathering of general practitioners (GPs). In the coffee break after my talk, I found myself chatting to a very friendly GP who explained: “I entirely agree with you that homeopathic remedies are pure placebos, but I nevertheless prescribe them regularly.” “Why would anyone do that?” I asked him. His answer was as frank as it was revealing.
Some of his patients, he explained, have symptoms for which he has tried every treatment possible without success. They typically have already seen every specialist in the book but none could help either. Alternatively they are patients who have nothing wrong with them but regularly consult him for trivial or self-limiting problems.
In either case, the patients come with the expectation of getting a prescription for some sort of medicine. The GP knows that it would be a hassle and most likely a waste of time to try and dissuade them. His waiting room is full, and he is facing the following choice:
- to spend valuable 15 minutes or so explaining why he should not prescribe any medication at all, or
- to write a prescription for a homeopathic placebo and get the consultation over with in two minutes.
Option number 1 would render the patient unhappy or even angry, and chances are that she would promptly see some irresponsible charlatan who puts her ‘through the mill’ at great expense and considerable risk. Option number 2 would free the GP quickly to help those patients who can be helped, make the patient happy, preserve a good therapeutic relationship between GP and the patient, save the GP’s nerves, let the patient benefit from a potentially powerful placebo-effect, and be furthermore safe as well as cheap.
I was not going to be beaten that easily though. “Basically” I told him “you are using homeopathy to quickly get rid of ‘heart sink’ patients!”
“And you find this alright?”
“No, but do you know a better solution?”
I explained that, by behaving in this way, the GP degrades himself to the level of a charlatan. “No”, he said “I am saving my patients from the many really dangerous charlatans that are out there.”
I explained that some of these patients might suffer from a serious condition which he had been able to diagnose. He countered that this has so far never happened because he is a well-trained and thorough physician.
I explained that his actions are ethically questionable. He laughed and said that, in his view, it was much more ethical to use his time and skills to the best advantage of those who truly need them. In his view, the more important ethical issue over-rides the relatively minor one.
I explained that, by implying that homeopathy is an effective treatment, he is perpetuating a myth which stands in the way of progress. He laughed again and answered that his foremost duty as a GP is not to generate progress on a theoretical level but to provide practical help for the maximum number of patients.
I explained that there cannot be many patients for whom no treatment existed that would be more helpful than a placebo, even if it only worked symptomatically. He looked at me with a pitiful smile and said my remark merely shows how long I am out of clinical medicine.
I explained that doctors as well as patients have to stop that awfully counter-productive culture of relying on prescriptions or ‘magic bullets’ for every ill. We must all learn that, in many cases, it is better to do nothing or rely on life-style changes; and we must get that message across to the public. He agreed, at least partly, but claimed this would require more that the 10 minutes he is allowed for each patient.
I explained….. well, actually, at this point, I had run out of arguments and was quite pleased when someone else started talking to me and this conversation had thus been terminated.
Since that day, I am wondering what other arguments exist. I would be delighted, if my readers could help me out.
Twenty years ago, when I started my Exeter job as a full-time researcher of complementary/alternative medicine (CAM), I defined the aim of my unit as applying science to CAM. At the time, this intention upset quite a few CAM-enthusiasts. One of the most prevalent arguments of CAM-proponents against my plan was that the study of CAM with rigorous science was quite simply an impossibility. They claimed that CAM included mind and body practices, holistic therapies, and other complex interventions which cannot not be put into the ‘straight jacket’ of conventional research, e. g. a controlled clinical trial. I spent the next few years showing that this notion was wrong. Gradually and hesitantly CAM researchers seemed to agree with my view – not all, of course, but first a few and then slowly, often reluctantly the majority of them.
What followed was a period during which several research groups started conducting rigorous tests of the hypotheses underlying CAM. All too often, the results turned out to be disappointing, to say the least: not only did most of the therapies in question fail to show efficacy, they were also by no means free of risks. Worst of all, perhaps, much of CAM was disclosed as being biologically implausible. The realization that rigorous scientific scrutiny often generated findings which were not what proponents had hoped for led to a sharp decline in the willingness of CAM-proponents to conduct rigorous tests of their hypotheses. Consequently, many asked whether science was such a good idea after all.
But that, in turn, created a new problem: once they had (at least nominally) committed themselves to science, how could they turn against it? The answer to this dilemma was easier that anticipated: the solution was to appear dedicated to science but, at the same time, to argue that, because CAM is subtle, holistic, complex etc., a different scientific approach was required. At this stage, I felt we had gone ‘full circle’ and had essentially arrived back where we were 20 years ago – except that CAM-proponents no longer rejected the scientific method outright but merely demanded different tools.
A recent article may serve as an example of this new and revised stance of CAM-proponents on science. Here proponents of alternative medicine argue that a challenge for research methodology in CAM/ICH* is the growing recognition that CAM/IHC practice often involves complex combination of novel interventions that include mind and body practices, holistic therapies, and others. Critics argue that the reductionist placebo controlled randomized control trial (RCT) model that works effectively for determining efficacy for most pharmaceutical or placebo trial RCTs may not be the most appropriate for determining effectiveness in clinical practice for either CAM/IHC or many of the interventions used in primary care, including health promotion practices. Therefore the reductionist methodology inherent in efficacy studies, and in particular in RCTs, may not be appropriate to study the outcomes for much of CAM/IHC, such as Traditional Korean Medicine (TKM) or other complex non-CAM/IHC interventions—especially those addressing comorbidities. In fact it can be argued that reductionist methodology may disrupt the very phenomenon, the whole system, that the research is attempting to capture and evaluate (i.e., the whole system in its naturalistic environment). Key issues that surround selection of the most appropriate methodology to evaluate complex interventions are well described in the Kings Fund report on IHC and also in the UK Medical Research Council (MRC) guidelines for evaluating complex interventions—guidelines which have been largely applied to the complexity of conventional primary care and care for patients with substantial comorbidity. These reports offer several potential solutions to the challenges inherent in studying CAM/IHC. [* IHC = integrated health care]
Let’s be clear and disclose what all of this actually means. The sequence of events, as I see it, can be summarized as follows:
- We are foremost ALTERNATIVE! Our treatments are far too unique to be subjected to reductionist research; we therefore reject science and insist on an ALTERNATIVE.
- We (well, some of us) have reconsidered our opposition and are prepared to test our hypotheses scientifically (NOT LEAST BECAUSE WE NEED THE RECOGNITION THAT THIS MIGHT BRING).
- We are dismayed to see that the results are mostly negative; science, it turns out, works against our interests.
- We need to reconsider our position.
- We find it inconceivable that our treatments do not work; all the negative scientific results must therefore be wrong.
- We always said that our treatments are unique; now we realize that they are far too holistic and complex to be submitted to reductionist scientific methods.
- We still believe in science (or at least want people to believe that we do) – but we need a different type of science.
- We insist that RCTs (and all other scientific methods that fail to demonstrate the value of CAM) are not adequate tools for testing complex interventions such as CAM.
- We have determined that reductionist research methods disturb our subtle treatments.
- We need pragmatic trials and similarly ‘soft’ methods that capture ‘real life’ situations, do justice to CAM and rarely produce a negative result.
What all of this really means is that, whenever the findings of research fail to disappoint CAM-proponents, the results are by definition false-negative. The obvious solution to this problem is to employ different (weaker) research methods, preferably those that cannot possibly generate a negative finding. Or, to put it bluntly: in CAM, science is acceptable only as long as it produces the desired results.
If you believe herbalists, the Daily Mail or similarly reliable sources, you come to the conclusion that herbal medicines are entirely safe – after all they are natural, and everything that is natural must be safe. However, there is plenty of evidence that these assumptions are not necessarily correct. In fact, herbal medicines can cause harm in diverse ways, e. g. because:
- one or more ingredients of a plant are toxic,
- they interact with prescribed drugs,
- they are contaminated, for instance, with heavy metals,
- they are adulterated with prescription drugs.
There is no shortage of evidence for any of these 4 scenarios. Here are some very recent and relevant publications:
German authors reviewed recent case reports and case series that provided evidence for herbal hepatotoxicity caused by Chinese herbal mixtures. The implicated remedies were the TCM products Ban Tu Wan, Chai Hu, Du Huo, Huang Qin, Jia Wei Xia Yao San, Jiguja, Kamishoyosan, Long Dan Xie Gan Tang, Lu Cha, Polygonum multiflorum products, Shan Chi, ‘White flood’ containing the herbal TCM Wu Zhu Yu and Qian Ceng Ta, and Xiao Chai Hu Tang. the authors concluded that stringent evaluation of the risk/benefit ratio is essential to protect traditional Chinese medicines users from health hazards including liver injury.
A recent review of Nigerian anti-diabetic herbal remedies suggested hypoglycemic effect of over 100 plants. One-third of them have been studied for their mechanism of action, while isolation of the bioactive constituent(s) has been accomplished for 23 plants. Several plants showed specific organ toxicity, mostly nephrotoxic or hepatotoxic, with direct effects on the levels of some liver function enzymes. Twenty-eight plants have been identified as in vitro modulators of P-glycoprotein and/or one or more of the cytochrome P450 enzymes, while eleven plants altered the levels of phase 2 metabolic enzymes, chiefly glutathione, with the potential to alter the pharmacokinetics of co-administered drugs
US authors published a case of a 44-year-old female who developed subacute liver injury demonstrated on a CT scan and liver biopsy within a month of using black cohosh to resolve her hot flashes. Since the patient was not taking any other drugs, they concluded that the acute liver injury was caused by the use of black cohosh. The authors concluded: we agree with the United States Pharmacopeia recommendations that a cautionary warning about hepatotoxicity should be labeled on the drug package.
Hong Kong toxicologists recently reported five cases of poisoning occurring as a result of inappropriate use of herbs in recipes or general herbal formulae acquired from books. Aconite poisoning due to overdose or inadequate processing accounted for three cases. The other two cases involved the use of herbs containing Strychnos alkaloids and Sophora alkaloids. These cases demonstrated that inappropriate use of Chinese medicine can result in major morbidity, and herbal formulae and recipes containing herbs available in general publications are not always safe.
Finally, Australian emergency doctors just published this case-report: A woman aged 34 years presented to hospital with a history of progressive shortness of breath, palpitations, decreased exercise tolerance and generalised arthralgia over the previous month. A full blood count revealed normochromic normocytic anaemia and a haemoglobin level of 66 g/L. The blood film showed basophilic stippling, prompting measurement of lead levels. Her blood lead level (BLL) was 105 µg/dL. Mercury and arsenic levels were also detected at very low levels. On further questioning, the patient reported that in the past 6 months she had ingested multiple herbal preparations supplied by an overseas Ayurvedic practitioner for enhancement of fertility. She was taking up to 12 different tablets and various pastes and powders daily. Her case was reported to public health authorities and the herbal preparations were sent for analytical testing. Analysis confirmed high levels of lead (4% w/w), mercury (12% w/w), arsenic and chromium. The lead levels were 4000 times the maximum allowable lead level in medications sold or produced in Australia. Following cessation of the herbal preparations, the patient was commenced on oral chelation therapy, iron supplementation and contraception. A 3-week course of oral DMSA (2,3-dimercaptosuccinic acid) was well tolerated; BLL was reduced to 13 µg/dL and haemoglobin increased to 99 g/L. Her symptoms improved over the subsequent 3 months and she remains hopeful about becoming pregnant.
So, how safe are herbal medicines? Unfortunately, the question is unanswerable. Some herbal medicines are quite safe, others are not. But always remember: whenever you administer a treatment you should ask yourself one absolutely crucial question: do the documented benefits outweigh the risks? There are several thousand different herbal medicines, and for less than a dozen of them can the honest answer to this question be YES.