MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

bias

The fact that some alternative medicine (the authors use the abbreviation ‘CAM’) practitioners recommend against vaccination is well-known and often-documented. Specifically implicated are:

As a result, children consulting homeopaths, naturopaths or chiropractors are less likely to receive vaccines and more likely to get vaccine-preventable diseases. These effects have been noted for several childhood infections but little is known about how child CAM-usage affects influenza vaccination.

A new nationally representative study fills this gap; it analysed ∼9000 children from the Child Complementary and Alternative Medicine File of the 2012 National Health Interview Survey. Adjusting for health services use factors, it examined influenza vaccination odds by ever using major CAM domains: (1) alternative medical systems (AMS; eg, acupuncture); (2) biologically-based therapies, excluding multivitamins/multi-minerals (eg, herbal supplements); (3) multi-vitamins/multi-minerals; (4) manipulative and body-based therapies (MBBT; eg, chiropractic manipulation); and (5) mind-body therapies (eg, yoga).

Influenza vaccination uptake was lower among children ever (versus never) using AMS (33% vs 43%; P = .008) or MBBT (35% vs 43%; P = .002) but higher by using multivitamins/multiminerals (45% vs 39%; P < .001). In multivariate analyses, multivitamin/multimineral use lost significance, but children ever (versus never) using any AMS or MBBT had lower uptake (respective odds ratios: 0.61 [95% confidence interval: 0.44-0.85]; and 0.74 [0.58-0.94]).

The authors concluded that children who have ever used certain CAM domains that may require contact with vaccine-hesitant CAM practitioners are vulnerable to lower annual uptake of influenza vaccination. Opportunity exists for US public health, policy, and medical professionals to improve child health by better engaging parents of children using particular domains of CAM and CAM practitioners advising them.

There is hardly any need to point out that CAM-use is associated with low vaccination-uptake. We have discussed this on my blog ad nauseam – see for instance here, here, here and here. Too many CAM practitioners have an irrational view of vaccinations and advise against their patients against them. Anyone who needs more information might find it right here by searching this blog. Anyone claiming that this is all my exaggeration might look at these papers, for instance, which have nothing to do with me (there are plenty more for those who are willing to conduct a Medline search):

  • Lehrke P, Nuebling M, Hofmann F, Stoessel U. Attitudes of homeopathic physicians towards vaccination. Vaccine. 2001;19:4859–4864. doi: 10.1016/S0264-410X(01)00180-3. [PubMed]
  • Halper J, Berger LR. Naturopaths and childhood immunizations: Heterodoxy among the unorthodox. Pediatrics. 1981;68:407–410. [PubMed]
  • Colley F, Haas M. Attitudes on immunization: A survey of American chiropractors. Journal of Manipulative and Physiological Therapeutics. 1994;17:584–590. [PubMed]

One could, of course, argue about the value of influenza vaccination for kids, but the more important point is that CAM practitioners tend to be against ANY immunisation. And the even bigger point is that many of them issue advice that is against conventional treatments of proven efficacy.

In a previous post I asked the question ‘Alternative medicine for kids: when is it child-abuse?’ I think that evidence like the one reported here renders this question all the more acute.

How often have I pointed out that most studies of chiropractic (and other alternative therapies) are overtly unethical because they fail to report adverse events? And if you think this is merely my opinion, you are mistaken. This new analysis by a team of chiropractors aimed to describe the extent of adverse events reporting in published RCTs of Spinal Manipulative Therapy (SMT), and to determine whether the quality of reporting has improved since publication of the 2010 Consolidated Standards Of Reporting Trials (CONSORT) statement.

The Physiotherapy Evidence Database and the Cochrane Central Register of Controlled Trials were searched for RCTs involving SMT. Domains of interest included classifications of adverse events, completeness of adverse events reporting, nomenclature used to describe the events, methodological quality of the study, and details of the publishing journal. Data were analysed using descriptive statistics. Frequencies and proportions of trials reporting on each of the specified domains above were calculated. Differences in proportions between pre- and post-CONSORT trials were calculated with 95% confidence intervals using standard methods, and statistical comparisons were analysed using tests for equality of proportions with continuity correction.

Of 7,398 records identified in the electronic searches, 368 articles were eligible for inclusion in this review. Adverse events were reported in 140 (38.0%) articles. There was a significant increase in the reporting of adverse events post-CONSORT (p=.001). There were two major adverse events reported (0.3%). Only 22 articles (15.7%) reported on adverse events in the abstract. There were no differences in reporting of adverse events post-CONSORT for any of the chosen parameters.

The authors concluded that although there has been an increase in reporting adverse events since the introduction of the 2010 CONSORT guidelines, the current level should be seen as inadequate and unacceptable. We recommend that authors adhere to the CONSORT statement when reporting adverse events associated with RCTs that involve SMT.

We conducted a very similar analysis back in 2012. Specifically, we evaluated all 60 RCTs of chiropractic SMT published between 2000 and 2011 and found that 29 of them did not mention adverse effects at all. Sixteen RCTs reported that no adverse effects had occurred (which I find hard to believe since reliable data show that about 50% of patients experience adverse effects after consulting a chiropractor). Complete information on incidence, severity, duration, frequency and method of reporting of adverse effects was included in only one RCT. Conflicts of interests were not mentioned by the majority of authors. Our conclusion was that adverse effects are poorly reported in recent RCTs of chiropractic manipulations.

The new paper suggests that the situation has improved a little, yet it is still wholly unacceptable. To conduct a clinical trial and fail to mention adverse effects is not, as the authors of the new article suggest, against current guidelines; it is a clear and flagrant violation of medical ethics. I blame the authors of such papers, the reviewers and the journal editors for behaving dishonourably and urge them to get their act together.

The effects of such non-reporting are obvious: anyone looking at the evidence (for instance via systematic reviews) will get a false-positive impression of the safety of SMT. Consequently, chiropractors are able to claim that very few adverse effects have been reported in the literature, therefore our hallmark therapy SMT is demonstrably safe. Those who claim otherwise are quite simply alarmist.

The website of BMJ Clinical Evidence seems to be popular with fans of alternative medicine (FAMs). That sounds like good news: it’s an excellent source, and one can learn a lot about EBM when studying it. But there is a problem: FAMs don’t seem to really study it (alternatively they do not have the power of comprehension to understand the data); they merely pounce on this figure and cite it endlessly:

They interpret it to mean that only 11% of what conventional clinicians do is based on sound evidence. This is water on their mills, because now they feel able to claim:

THE MAJORITY OF WHAT CONVENTIONAL CLINICIANS DO IS NOT EVIDENCE-BASED. SO, WHY DO SO-CALLED RATIONAL THINKERS EXPECT ALTERNATIVE THERAPIES TO BE EVIDENCE-BASED? IF WE NEEDED PROOF THAT THEY ARE HYPOCRITES, HERE IT IS!!!

The question is: are these FAMs correct?

The answer is: no!

They are merely using a logical fallacy (tu quoque); what is worse, they use it based on misunderstanding the actual data summarised in the above figure.

Let’s look at this in a little more detail.

The first thing we need to understand the methodologies used by ‘Clinical Evidence’ and what the different categories in the graph mean. Here is the explanation:


So, arguably the top three categories amounting to 42% signify some evidential support (if we decided to be more rigorous and merely included the two top categories, we would still arrive at 35%). This is not great, but we must remember two things here:

  • EBM is fairly new;
  • lots of people are working hard to improve the evidence base of medicine so that, in future, these figures will be better (by contrast, in alternative medicine, no similar progress is noticeable).

The second thing that strikes me is that, in alternative medicine, these figures would surely be much, much worse. I am not aware of reliable estimates, but I guess that the percentages might be one dimension smaller.

The third thing to mention is that the figures do not cover the entire spectrum of treatments available today but are based on ~ 3000 selected therapies. It is unclear how they were chosen, presumably the choice is pragmatic and based on the information available. If an up-to date systematic review has been published and provided the necessary information, the therapy was included. This means that the figures include not just mainstream but also plenty of alternative treatments (to the best of my knowledge ‘Clinical Evidence’ makes no distinction between the two). It is thus nonsensical to claim that the data highlight the weakness of the evidence in conventional medicine. It is even possible that the figures would be better, if alternative treatments had been excluded (I estimate that around 2 000 systematic reviews of alternative therapies have been published [I am the author of ~400 of them!]).

The fourth and possibly the most important thing to mention is that the percentage figures in the graph are certainly NOT a reflection of what percentage of treatments used in routine care are based on good evidence. In conventional practice, clinicians would, of course, select where possible those treatments with the best evidence base, while leaving the less well documented ones aside. In other words, they will use the ones in the two top categories much more frequently than those from the other categories.

At this stage, I hear some FAMs say: how does he know that?

Because several studies have been published that investigated this issue in some detail. They have monitored what percentage of interventions used by conventional clinicians in their daily practice are based on good evidence. In 2004, I reviewed these studies; here is the crucial passage from my paper:

“The most conclusive answer comes from a UK survey by Gill et al who retrospectively reviewed 122 consecutive general practice consultations. They found that 81% of the prescribed treatments were based on evidence and 30% were based on randomised controlled trials (RCTs). A similar study conducted in a UK university hospital outpatient department of general medicine arrived at comparable figures; 82% of the interventions were based on evidence, 53% on RCTs. Other relevant data originate from abroad. In Sweden, 84% of internal medicine interventions were based on evidence and 50% on RCTs. In Spain these percentages were 55 and 38%, respectively. Imrie and Ramey pooled a total of 15 studies across all medical disciplines, and found that, on average, 76% of medical treatments are supported by some form of compelling evidence — the lowest was that mentioned above (55%),6 and the highest (97%) was achieved in anaesthesia in Britain. Collectively these data suggest that, in terms of evidence-base, general practice is much better than its reputation.”

My conclusions from all this:

FAMs should study the BMJ Clinical Evidence more thoroughly. If they did, they might comprehend that the claims they tend to make about the data shown there are, in fact, bogus. In addition, they might even learn a thing or two about EBM which might eventually improve the quality of the debate.

The new guidelines by the American College of Physicians entitled ‘Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians’ have already been the subject of the previous post. Today, I want to have a closer look at a small section of these guidelines which, I think, is crucial. It is entitled ‘HARMS OF NONPHARMACOLOGIC THERAPIES’. I have taken the liberty of copying it below:

“Evidence on adverse events from the included RCTs and systematic reviews was limited, and the quality of evidence for all available harms data is low. Harms were poorly reported (if they were reported at all) for most of the interventions.

Low-quality evidence showed no reported harms or serious adverse events associated with tai chi, psychological interventions, multidisciplinary rehabilitation, ultrasound, acupuncture, lumbar support, or traction (9,95,150,170–174). Low-quality evidence showed that when harms were reported for exercise, they were often related to muscle soreness and increased pain, and no serious harms were reported. All reported harms associated with yoga were mild to moderate (119). Low-quality evidence showed that none of the RCTs reported any serious adverse events with massage, although 2 RCTs reported soreness during or after massage therapy (175,176). Adverse events associated with spinal manipulation included muscle soreness or transient increases in pain (134). There were few adverse events reported and no clear differences between MCE and controls. Transcutaneous electrical nerve stimulation was associated with an increased risk for skin site reaction but not serious adverse events (177). Two RCTs (178,179) showed an increased risk for skin flushing with heat compared with no heat or placebo, and no serious adverse events were reported. There were no data on cold therapy. Evidence was insufficient to determine harms of electrical muscle stimulation, LLLT, percutaneous electrical nerve stimulation, interferential therapy, short-wave diathermy, and taping.”

The first thing that strikes me is the brevity of the section. Surely, guidelines of this nature must include a full discussion of the risks of the treatments in question!

The second thing that is noteworthy is the fact that the authors confirm the fact I have been banging on about for years: clinical trials of alternative therapies far too often fail to mention adverse effects.  I have often pointed out that the failure to report adverse effects in clinical trials is an unacceptable violation of medical ethics. By contrast, the guideline authors seem not to feel strongly about this omission.

The third thing that is noteworthy is that the guidelines evaluate the harms of the treatments purely on the basis of the adverse effects reported in the clinical trials and systematic reviews included in their efficacy assessments. This is nonsensical for at least two reasons:

  1. The guideline authors themselves are aware that the trials very often fail to mention adverse effects.
  2. For any assessment of harm, one has to go far beyond the evidence of clinical trials, because trials tend to be too small to pick up rare adverse effects, and because they are always conducted under optimally controlled conditions where adverse effects are less likely to occur than in real life.

Together, these features of the assessment of harms explain why the guideline authors arrive at conclusions which are oddly misguided; I would even feel that they resemble a white-wash. Here are two of the most overt misjudgements:

  • no harms associated with acupuncture,
  • only trivial harm associated with spinal manipulations.

The best evidence we have today shows that acupuncture leads to mild adverse effects in about 10% of all cases and is also associated with very severe complications (e.g. pneumothorax, cardiac tamponade, infections, deaths) in an unknown number of patients. More details can be found for instance here, here, here and here.

And the best evidence available shows that spinal manipulation leads to moderately severe adverse effects in ~50% of all cases. In addition, we know of hundreds of cases of very severe complications resulting in stroke, permanent neurological deficits or deaths. More details can be found for instance here, here, here and here.

In the introduction, I stated that this small section of the guidelines is crucial.

Why?

The reason is simple: any responsible therapeutic decision has to be based not just on the efficacy of the treatment in question but on its risk/benefit balance. The evidence shows that the risks of some alternative therapies can be considerable, a fact that is almost totally neglected in the guidelines. Therefore, the recommendations of the new guidelines by the American College of Physicians entitled ‘Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians’ are in several aspects not entirely correct and need to be reconsidered.

It has been pointed out that many of the discussions we have on this blog are like pigeon chess. The term comes from a comment made by Scott D. Weitzenhoffer about Evolution vs. Creationism: An introduction: “Debating creationists on the topic of evolution is rather like trying to play chess with a pigeon — it knocks the pieces over, craps on the board, and flies back to its flock to claim victory.”

Debating a fan of alternative medicine is frequently just like that: ignorant of the basics of science and logic, he nevertheless insists on playing with you, knocks over the pieces, defecates on the board, flies back to his flock to boast of victory, only to come back a little later to start over again.

The sequence of events is comically stereotypical: in order to start this game, the evangelist of alternative medicine does his best to appear rational and interested in the subject. Once a discussion has commenced, he begins to make more and more irrational claims. When asked to provide evidence for them, he evades the challenge. Instead, he issues all sorts of accusations to you. Some of the favourites include:

  • being not competent to discuss the issue at hand,
  • having a closed mind,
  • being paid by BIG PHARMA,

As the accusations continue, it can be almost impossible to remain polite. Your reminders to produce evidence for the evangelist’s irrational claims become more and more pressing. He then decides to focus on a triviality and pesters you with questions about it which are too silly to answer. Consequently, the temperature of the exchange rises until his accusations become offensive or turn into overt insults (in the past I have sometimes deleted insulting comments and I intend to continue doing this on hopefully rare occasions). The aims of the evangelist are 1) to arrive at a point where you lose your temper and 2) to distract from the fact that he is unable to provide any evidence for his outlandish claims. Eventually your patience is exhausted and you finally start paying him back in the same coinage as he dispensed.

At this stage, the evangelist indignantly shouts:

  • YOU HAVE INSULTED ME!!!
  • YOU HAVE INSULTED ANYONE WHO DISAGREES WITH YOU!!!
  • THIS SHOWS WHAT A BAD, BAD PERSON YOU ARE!!!

Consequently, you give him a real piece of your mind and tell him what you really think of people who are belligerent,  ignorant on their chosen subject, provocatively irrational and unable or unwilling to learn. The reaction of the evangelist is predictable: he says THAT’S IT, I AM NOT TALKING TO YOU ANYMORE, announces that he is the winner of the argument, and flies off triumphantly promising never to return.

Finally!

We all give a sigh of relief. The evangelist has now returned to his fellow conspiracy theorists where he defames you the best he can. Eventually he disappoints your hope of peace and rationality by returning to the table. He pretends nothing has happened and starts over again.

So, what is the solution?

I am not sure there is an ideal way out.

Personally I intend to do the following in future (and I invite others to follow my example): before I reach the point where I lose my temper completely and regrettably, I will refer the evangelist to this blog post entitled ‘A method of ending discussions with belligerent twits’. At the same time, I will inform him (rarely it is a ‘her’) that I am about to break off the discussion with him because I fear that otherwise I might be openly rude, and perhaps even tell him: YOU ARE A FLAMING IDIOT WHO POSTS FAR TO MUCH NONSENSE TO BE TAKEN SERIOUSLY.

This, I hope will get my message across without actually ever tempting me to post a rude word again.

Failing this, I will block him completely, a measure to which so far I only needed rarely to resort.

The BMJ has always been my favourite Medical journal. (Need any proof for this statement? A quick Medline search tells me that I have over 60 publications in the BMJ.) But occasionally, the BMJ also disappoints me a great deal.

One of the most significant disappointments was recently published under the heading of STATE OF THE ART REVIEW. A review that is ‘state of the art’ must fulfil certain criteria; foremost it should be informative, unbiased and correct. The paper I am discussing here has, I think, neither of these qualities. It is entitled ‘Management of chronic pain using complementary and integrative medicine’, and here is its abstract:

Complementary and integrative medicine (CIM) encompasses both Western-style medicine and complementary health approaches as a new combined approach to treat a variety of clinical conditions. Chronic pain is the leading indication for use of CIM, and about 33% of adults and 12% of children in the US have used it in this context. Although advances have been made in treatments for chronic pain, it remains inadequately controlled for many people. Adverse effects and complications of analgesic drugs, such as addiction, kidney failure, and gastrointestinal bleeding, also limit their use. CIM offers a multimodality treatment approach that can tackle the multidimensional nature of pain with fewer or no serious adverse effects. This review focuses on the use of CIM in three conditions with a high incidence of chronic pain: back pain, neck pain, and rheumatoid arthritis. It summarizes research on the mechanisms of action and clinical studies on the efficacy of commonly used CIM modalities such as acupuncture, mind-body system, dietary interventions and fasting, and herbal medicine and nutrients.

The full text of this article is such that I could take issue with almost every second statement in it. Obviously, this would be too long and too boring for this blog. So, to keep it crisp and entertaining, let me copy the (tongue in cheek) ‘letter to the editor’ some of us published in the BMJ as a response to the review:

“Alternative facts are fashionable in politics these days, so why not also in healthcare? The article by Chen and Michalsen on thebmj.com provides a handy set of five instructions for smuggling alternative facts into medicine.

1. Create your own terminology: the term ‘complementary and integrated medicine’ (CIM) is nonsensical. Integrated medicine (a hotly disputed field) already covers complementary and conventional medicine.

2. Pretend to be objective: Chen and Michalsen elaborate on the systematic searches they conducted. But they omit hundreds of sources which do not support their message, which cherry-picks only evidence for the efficacy of the treatments they promote.

3. Avoid negativity: they bypass any material that might challenge what they include. For instance, when discussing therapeutic risks, they omit the disturbing lack of post-marketing surveillance: the reason we lack information on adverse events. They even omit to mention the many fatalities caused by their ‘CIM’.

4. Create an impression of thoroughness: Chen and Michalsen cite a total of 225 references. This apparent scholarly attention to detail masks their misuse of many of they list. Reference 82, for example, is employed to back up the claim that “satisfaction was lowest among complementary medicine users with rheumatoid arthritis, vasculitis, or connective tissue diseases”. In fact, it shows nothing of the sort.

5. Back up your message with broad generalisations: Chen and Michalsen conclude that “Taken together, CIM has an increasing role in the management of chronic pain, but high quality research is needed”. The implication is that all the CIMs mentioned in their figure 1 are candidates for pain control – even discredited treatments such as homeopathy.

In our view, these authors render us a service: they demonstrate to the novice how alternative facts may be used in medicine.”

James May, Edzard Ernst, Nick Ross, on behalf of HealthWatch UK

END OF QUOTE

I am sure you have your own comments and opinions, and I encourage you to post them here or (better) submit them to the BMJ or (best) both.

The website of the HOMEOPATHY HUB gives us intriguing access to the brain of a homeopath. It tells us that “protecting patient choice is at the heart of everything we do. Homeopathy, which is the second largest system of medicine in the world, is a form of treatment which plays a vital role in the lives of hundreds of thousands of people across the UK. There is, however, a movement to try and withdraw homeopathy from the public and make homeopathic medicines difficult to secure. Our intention is to be a central “hub” for accurate information on current campaigns to retain access to homeopathy and details on how you can get involved and make your voice heard. Without public and patient support we will not be successful.”

Here are a few of the above statements that I find doubtful:

  • protecting patient choice – choice requires reliable information; as we will see, this is not provided here;
  • second largest system of medicine in the world – really?
  • plays a vital role – where is the evidence for that claim?
  • movement to try and withdraw homeopathy from the public and make homeopathic medicines difficult to secure – nobody works towards this aim, some people are trying to stop wasting public funds on useless therapies, but that’s quite different, I find;

The HOMEOPATHY HUB recently alerted its readers to the fact that the Charity Commission (CC) is currently conducting a public consultation on whether organisations promoting the use of complementary and alternative medicines (CAM) should have charitable status (https://www.gov.uk/government/consultations/consultation-on-complementary-and-alternative-medicines) and urged its readers to defend homeopathy by responding to the CC offering a “few helpful points” to raise. These 7 points give, I think, a good insight into the thinking of homeopaths. I therefore copy them here and add a few of my own comments below:

  1. there are many types of evidence that should be considered when evaluating the effectiveness of a therapy. These include scientific studies, patient feedback and the clinical experience of  doctors  who  have trained in a CAM discipline.  Within Homeopathy there is considerable evidence which can be found (https://www.hri-research.org)
  2. many conventional therapies and drugs  have inconclusive evidence or prove to be useful in only some cases, for example SSRIs (anti-depressants).  Inconsistent evidence is often the result  of the complexity of both  the medical  condition being treated and the therapy being used. It is not indicative of a therapy that doesn’t work
  3. removing all therapies or interventions that  have inconsistent or inconclusive evidence would seriously limit the  public and the medical profession’s  ability to help treat and ease patients suffering.
  4. all over the world there are doctors, nurses, midwives, vets  and other healthcare professional  who integrate  CAM therapies into their daily  practice because they see effectiveness. They would not use these therapies if they  did  not see their patients  benefitting from them.  For example in the UK, within the NHS hospital setting, outcome studies demonstrate effectiveness of homeopathy. (http://www.britishhomeopathic.org/evidence/results-from-the-homeopathic-hospitals/)
  5. practitioners of many CAM therapies belong to registering bodies which expect their members to comply to the highest professional standards in regards to training and practice
  6. In the UK the producers and suppliers of  CAM treatments (homeopathy, herbal medicine etc) are strictly regulated
  7. as well as  providing valuable information to the  growing  number of people seeking to use CAM as part of their healthcare, CAM charities frequently fund treatment for those people, particularly the elderly and those on a low income, whose health has benefitted from these therapies but who cannot  afford them. This meets the charity’s criterion of  providing a public benefit.

MY COMMENTS

  1. “Patient feedback and the clinical experience of  doctors” may be important but is not what can be considered evidence of therapeutic effectiveness.
  2. Yes, in medicine evidence is often inconsistent; this is why we need to rely on proper assessments of the totality of the reliable data. If that fails to be positive (as is the case for homeopathy and several other forms of alternative medicine), we are well advised not to employ the treatment in question in routine healthcare.
  3. Removing all treatments for which the best evidence fails to show effectiveness – such as homeopathy – would greatly improve healthcare and reduces cost. It is one of the aims of EBM and an ethical imperative.
  4. Yes, some healthcare professionals do use useless therapies. They urgently need to be educated in the principles of EBM. Outcome studies have normally no control groups and therefore are no adequate tools for testing the effectiveness of medical interventions.
  5. The highest professional standards in regards to training and practice of nonsense will still result in nonsense.
  6. The proper regulation of nonsense can only generate proper nonsense.
  7. Yes, CAM charities frequently fund bogus treatments; hopefully (and with the help of readers of this blog), the CC will put an end to this soon.

I think these 7 points by the HOMEOPATHY HUB are a very poor defence of homeopathy. In fact, they are so bad that it is not worth analysing more closely than I did above. Yet, they do provide us with an insight into the homeopathic mind-set and show how illogical, misguided and wrong the arguments of homeopathy enthusiasts really are.

I do encourage you to give your response to the CC – it wound be hard to use better arguments than the homeopaths!!!

Regular readers of this blog will have noticed: when homeopathy-fans run out of arguments, they tend to conduct an ‘ad hominem’ attack. They like to do this in several different ways, but one of the most popular version is to shout with indignation: YOU ARE NOT QUALIFIED!!!

The aim of this claim is to brand the opponent as someone who does not know enough about homeopathy to make valid comments about it. As this sort of thing comes up regularly, it is high time to ask: WHO ACTUALLY IS AN EXPERT IN HOMEOPATHY?

This seems to be an easy question to answer, but – come to think of it – it is more complex that one first imagines. Someone could be an expert in homeopathy in more than one way; for instance, one could be an expert:

  • in the history of homeopathy,
  • in the manufacture of homeopathics,
  • in the regulation of homeopathy,
  • in the clinical use of homeopathy in human patients,
  • in the clinical use of homeopathy in animals,
  • in the use of homeopathy in plants (no, I am not joking!),
  • in basic research of homeopathy,
  • in clinical research of homeopathy.

This blog is almost entirely devoted to clinical research; therefore, we should, for the purpose of this post, narrow down the above question to: WHO IS AN EXPERT IN CLINICAL RESEARCH OF HOMEOPATHY?

I had always assumed to be such an expert – until I was accused of being a swindler and pretender, that is. I have no formal qualifications for practising homeopathy (and never claimed otherwise), and this fact has prompted many homeopathy-fans to claim that I am not qualified to comment on the value of homeopathy. Do they have a point?

Rational thinkers have often pointed out that one does not need such qualifications for practicing homeopathy. In many countries, anyone can be a homeopath, regardless of background. In all the countries I know, one certainly can practise homeopathy, if one is qualified as a doctor. Crucially, do you really need to know how to practice homeopathy for conducting a clinical trial or a systematic review of homeopathy? Homeopaths seem to think so. I fear, however, that they are wrong: you don’t need to be a surgeon, psychiatrist or rheumatologist to organise a trial or conduct a review of these subjects!

Anyway, my research of homeopathy is not valid, homeopaths say, because I lack the formal qualifications to call myself a homeopath. Let me remind them that I have:

  1. been trained by leading homeopaths,
  2. practised homeopathy for quite some time,
  3. headed a team of scientists conducting research into homeopathy,
  4. conducted several clinical trials of homeopathy,
  5. published several systematic reviews of homeopathy,
  6. no conflicts of interest in regards to homeopathy.

However, this does not impress homeopath, I am afraid. They say that my findings and conclusions about their pet therapy cannot be trusted. In their eyes, I am not a competent expert in clinical research of homeopathy. They see me as a fraud and as an impostor. They prefer the real experts of clinical research of homeopathy such as:

  • Robert Mathie
  • Jos Kleinjen
  • Klaus Linde

These three researchers who are fully accepted by homeopaths; not just accepted, loved and admired! They all have published systematic reviews. Intriguingly, their conclusion all contradict my results in one specific aspect: THEY ARE POSITIVE.

I do not doubt their expertise for a minute, yet have always found this most amusing, even hilarious.

Why?

Because none of these experts (I know all three personally) is a qualified homeopath, none of them has any training in the practice of homeopathy, none of them has ever practised homeopathy on human patients, none of them has even worked for any length of time as a clinician.

What can we conclude from these insights?

We could, of course, descend to the same level as homeopaths tend to do and conclude that homeopathy-fans are biased, barmy, bonkers, stupid, silly, irrational, deluded, etc. However, I prefer to draw a different and probably more accurate conclusion: according to homeopathy-fans, an expert in clinical research of homeopathy is someone who has published articles that are favourable to their trade. Anyone who fails to do likewise is by definition not competent to issue a reliable verdict about it.

As the data suggesting that homeopathy is effective for improving health is – to put it mildly – less than convincing, a frantic search is currently on amongst homeopaths and their followers to identify a specific condition for which the evidence is stronger than for all conditions pooled into one big analysis. If they could show that it works for just one disease, they could celebrate this finding and henceforth use it for refuting doubters stating that highly diluted homeopathic remedies are pure placebos. One such condition is allergic rhinitis; there have been several trials suggesting that homeopathy might be effective for it, and therefore it is only logical that homeopathy-promoters want to summarise these data in order to silence sceptics once and for all.

A new paper ought to be seen in this vein. It is systematic review by the Mathie group with the stated aim “to evaluate the efficacy and effectiveness of homeopathic intervention in the treatment of seasonal or perennial allergic rhinitis (AR).”

Randomized controlled trials evaluating all forms of homeopathic treatment for AR were included in a systematic review (SR) of studies published up to and including December 2015. Two authors independently screened potential studies, extracted data, and assessed risk of bias. Primary outcomes included symptom improvement and total quality-of-life score. Treatment effect size was quantified as mean difference (continuous data), or by risk ratio (RR) and odds ratio (dichotomous data), with 95% confidence intervals (CI). Meta-analysis was performed after assessing heterogeneity and risk of bias.

Eleven studies were eligible for SR. All trials were placebo-controlled except one. Six trials used the treatment approach known as isopathy, but they were unsuitable for meta-analysis due to problems of heterogeneity and data extraction. The overall standard of methods and reporting was poor: 8/11 trials were assessed as “high risk of bias”; only one trial, on isopathy for seasonal AR, possessed reliable evidence. Three trials of variable quality (all using Galphimia glauca for seasonal AR) were included in the meta-analysis: nasal symptom relief at 2 and 4 weeks (RR = 1.48 [95% CI 1.24-1.77] and 1.27 [95% CI 1.10-1.46], respectively) favoured homeopathy compared with placebo; ocular symptom relief at 2 and 4 weeks also favoured homeopathy (RR = 1.55 [95% CI 1.33-1.80] and 1.37 [95% CI 1.21-1.56], respectively). The single trial with reliable evidence had a small positive treatment effect without statistical significance. A homeopathic and a conventional nasal spray produced equivalent improvements in nasal and ocular symptoms.

The authors concluded that the low or uncertain overall quality of the evidence warrants caution in drawing firm conclusions about intervention effects. Use of either Galphimia glauca or a homeopathic nasal spray may have small beneficial effects on the nasal and ocular symptoms of AR. The efficacy of isopathic treatment of AR is unclear.

Extracts of Galphimia glauca (GG) have been used traditionally in South America for the treatment of allergic conditions, with some reports suggesting effectiveness. A 1997 meta-analysis of 11 clinical trials (most of them of very poor quality) of homeopathic GG suggested this therapy to be effective in the treatment of AR. In 2011, I published a review (FACT 2011, 16 200-203) focussed exclusively on the remarkable set of RCTs of homeopathic Galphimia glauca (GG). My conclusions were as follows: three of the four currently available placebo-controlled RCTs of homeopathic GG suggest this therapy is an effective symptomatic treatment for hay fever. There are, however, important caveats. Most essentially, independent replication would be required before GG can be considered for the routine treatment of hay fever. Since then, no new studies have emerged.

I am citing this for two main reasons:

  • There is nothing homeopathic about the principle of using GG for allergic conditions; according to homeopathic theory GG extracts would need to cause allergies for GG to have potential as a homeopathic allergy remedy. Arguably, the GG trials should therefore have been excluded from this meta-analysis for not following the homeopathic principal of ‘like cures like’.
  • All the RCTs of GG were done by the same German research group. There is not a single independent replication of their findings!

Seen from this perspective, the conclusion by Mathie et al, that the use of either Galphimia glauca … may have small beneficial effects on the nasal and ocular symptoms of AR, seems more than a little over-optimistic.

On this blog, we have had (mostly unproductive) discussions with homeopath so often that sometimes they sound like a broken disk. I don’t want to add to this kerfuffle; what I hope to do today is to summarise  a certain line of argument which, from the homeopaths’ point of view, seems entirely logical. I do this in the form of a fictitious conversation between a scientist (S) and a classical homeopath (H). My aim is to make the reader understand homeopaths better so that, future debates might be better informed.

HERE WE GO:

S: I have studied the evidence from studies of homeopathy in some detail, and I have to tell you, it fails to show that homeopathy works.

H: This is not true! We have plenty of evidence to prove that patients get better after seeing a homeopath.

S: Yes, but this is not because of the remedy; it is due to non-specific effect like the empathetic consultation with a homeopath. If one controls for these factors in adequately designed trials, the result usually is negative.

I will re-phrase my claim: the evidence fails to show that highly diluted homeopathic remedies are more effective than placebos.

H: I disagree, there are positive studies as well.

S: Let’s not cherry pick. We must always consider the totality of the reliable evidence. We now have a meta-analysis published by homeopaths that demonstrates the ineffectiveness of homeopathy quite clearly.

H: This is because homeopathy was not used correctly in the primary trials. Homeopathy must be individualised for each unique patient; no two cases are alike! Remember: homeopathy is based on the principle that like cures like!!!

S: Are you saying that all other forms of using homeopathy are wrong?

H: They are certainly not adhering to what Hahnemann told us to do; therefore you cannot take their ineffectiveness as proof that homeopathy does not work.

S: This means that much, if not most of homeopathy as it is used today is to be condemned as fake.

H: I would not go that far, but it is definitely not the real thing; it does not obey the law of similars.

S: Let’s leave this to one side for the moment. If you insist on individualised homeopathy, I must tell you that this approach can also be tested in clinical trials.

H: I know; and there is a meta-analysis which proves that it is effective.

S: Not quite; it concluded that medicines prescribed in individualised homeopathy may have small, specific treatment effects. Findings are consistent with sub-group data available in a previous ‘global’ systematic review. The low or unclear overall quality of the evidence prompts caution in interpreting the findings. New high-quality RCT research is necessary to enable more decisive interpretation.

If you call this a proof of efficacy, I would have to disagree with you. The effect was tiny and at least two of the best studies relevant to the subject were left out. If anything, this paper is yet another proof that homeopathy is useless!

H: You simply don’t understand homeopathy enough to say that. I tried to tell you that the remedy must be carefully chosen to fit each unique patient. This is a very difficult task, and sometimes it is not successful – mainly because the homeopaths employed in clinical trials are not skilled enough to find it. This means that, in these studies, we will always have a certain failure rate which, in turn, is responsible for the small average effect size.

S: But these studies are always conducted by experienced homeopaths, and only the very best, most experienced homeopaths were chosen to cooperate in them. Your argument that the trials are negative because of the ineffectiveness of the homeopaths – rather than the ineffectiveness of homeopathy – is therefore nonsense.

H: This is what you say because you don’t understand homeopathy!

S: No, it is what you say because you don’t understand science. How else would you prove that your hypothesis is correct?

H: Simple! Just look at individual cases from the primary studies within this meta-analysis . You will see that there are always patients who did improve. These cases are the proof we need. The method of the RCT is only good for defining average effects; this is not what we should be looking at, and it is certainly not what homeopaths are interested in.

S: Are you saying that the method of the RCT is wrong?

H: It is not always wrong. Some RCTs of homeopathy are positive and do very clearly prove that homeopathy works. These are obviously the studies where homeopathy has been applied correctly. We have to make a meta-analysis of such trials, and you will see that the result turns out to be positive.

S: So, you claim that all the positive studies have used the correct method, while all the negative ones have used homeopathy incorrectly.

H: If you insist to put it like that, yes.

S: I see, you define a trial to have used homeopathy correctly by its result. Essentially you accept science only if it generates the outcome you like.

H: Yes, that sounds odd to you – because you don’t understand enough of homeopathy.

S: No, what you seem to insist on is nothing short of double standards. Or would you accept a drug company claiming: some patients did feel better after taking our new drug, and this is proof that it works?

H: You see, not understanding homeopathy leads to serious errors.

S: I give up.

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