MD, PhD, FMedSci, FSB, FRCP, FRCPEd

conflict of interest

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In my previous post, I mentioned the current volume of the ‘Allgemeinen Homöopathischen Zeitung’ which contains the abstracts of the ‘Homeopathic World Congress 2017’ (btw: the remarkable opening speech for the WORLD CONFERENCE ON HOMEOPATHY 1937, in Berlin might also be of interest; excerpts from it can be found here). Amongst these abstracts, the collector can find many true gems. Today I have for you a few more abstracts that I found remarkable; they are from what I call pre-clinical (or non-clinical) research.

Homeopathy has a polarized image. Many people experience homeopathic cure, but critics say this is only a placebo-effect. However, there, are 3800 studies and evidence is steadily growing. All comprehensive investigations prove that homeopathy is more efficient than placebo. What are the reasons for this controversy? How do we improve the image of homeopathy? Methods Data collection regarding effectiveness, benefits and mechanisms over 30 years. Order development to archive all data according to their scientific content. Systematic analysis of criticisms towards homeopathy over the last 12 years. Discussions with sceptics to understand their rejections. Findings Main reasons for controversy are: ▪ Since homeopathy does not meet the contemporary scientific concepts, people believe that homeopathy is implausible. ▪ Different homeopathic methods appear contradictory. ▪ Conventional medicine rejects homeopathy.  Missing overview regarding scientific principles. ▪ Modern studies are no more understandable. Due to our fast-moving times, people quickly form opinion with their own personal logic, influenced by media information. This causes a systematic interpretation bias. Results The knowledge of homeopathy and potentized remedies will be publicly illustrated: ▪ Information about different methods. ▪ Basics of holistic thinking and limitations of science in medicine. ▪ State of the art regarding effectiveness and benefits. ▪ Scientific principles and body of evidence. ▪ Correcting wrong media information. A special didactic structure was developed to provide this information at the portal: “Homeopathy & potentized medicines” (www.dellmour.org, available autumn 2016). Physicians and patients will find comprehensible information to aquire a plausible picture of homeopathy.

The use of agrochemicals has been associated with environmental and ecological damages. Excessive use of fertilizers, for example, can lead to the groundwater contamination with nitrate, rendering it unfit for consumption by humans or livestock. Water containing large concentrations of nitrate can poison animals by partial immobilization of the hemoglobin in blood, reducing the ability to transport oxygen. These and other environmental effects in the use of agrochemicals are unfortunate consequences in the application of these chemical tools. Researchers are constantly searching for non-chemical solutions in dealing with many of these agricultural needs. Much attention is being paid, for example, to developing “organic” methods of enhancing soil fertility and dealing with pests. The application of homeopathy in agriculture (agrohomeopathy) is an alternative that can help solve the problems caused by agrochemicals. Several countries have begun to implement this new option to solve the problems that have been caused by agrochemicals. The use of agrohomeopathy allows a control of diseases in plants, caused by bacteria, fungi, viruses and pests, it also helps to improve and promote seed germination, as well as by enhancing the growth of plants. Moreover, with the application of agrohomeopathy it is possible to decontaminate soils that have been exposed to agrochemical treatments. The goal of this study is to analyze the major results obtained in agrohomeopathy. Also we demonstrate the importance of botanical models to find out or clarify the mechanism of homeopathy in living organisms.

Dr. Hahnemann improvised homeopathy to such an extent, that his discovery of potentization of homeopathic medicines questioned the fundamental belief systems of the basic sciences. This resulted in a constant disapproval of homeopathic system by the main stream science and was accused as a placebo therapy, yet the clinical efficacy of homeopathy remained unquestionable. Objectives The present study was done to analyze the presence/absence of particles in aurum metallicum 6C to CM and carbo vegetabilis 6C to CM potencies. This is a part of the 31 homeopathic drugs studied by using HRTEM&EDS and FESEM&EDS in Centesimal scale 6C, 30, 200, 1M, 10M, 50M and CM and LM scale in LM1, LM6, LM12, LM18, LM24 and LM30 potencies. Method HRTEM (High Resolution Transmission Electron Microscope), FESEM (Field Emission Scanning Electron Microscope) and EDS (Energy dispersive Spectroscopy) were used for the analysis of samples. Results Plenty of particles in nanometer and Quantum Dots (QD – less than 10nm) scale were seen in aur. with presence of gold in all the potencies of aur. Enormous particles were identified in all the potencies of carb-v. in nanometer scale composed of carbon and oxygen. Conclusion The presence of NPs & QDs in all potencies must be the reason for the cure in diseases and also produce signs and symptoms in Hahnemannian drug proving. This discovery of NPS in all the drug potencies is an important evidence which substantiate the individualized drug selection and place homeopathy an established “individualized nanomedicine” with 200 years of collective clinical experience.

In March 2015, the Australian National Health and Medical Research Council (NHMRC) published an Information Paper on homeopathy. This document, designed for the general public, provides a summary of the findings of a review of systematic reviews, carried out by NHMRC to assess the evidence base for effectiveness of homeopathy in humans. ’The Australian report’, concludes that ”there are no health conditions for which there is reliable evidence that homeopathy is effective … no goodquality, well-designed studies with enough participants for a meaningful result reported either that homeopathy caused greater health improvements than placebo, or caused health improvements equal to those of another treatment”. Such overly-definitive negative conclusions are immediately surprising, being inconsistent with the majority of comprehensive systematic reviews on homeopathy. In-depth analysis has revealed the report’s multiple methodological flaws, which explain this inconsistency. Most crucially, NHMRC’s findings hinge primarily on their definition of reliable evidence: for a trial to be deemed ’reliable’ it had to have at least 150 participants and a quality score of 5/5 on the Jadad scale (or equivalent on other scales). Trials that failed to meet either of these criteria were dismissed as being of ’insufficient quality and/or size to warrant further consideration of their findings’. Setting such a high quality threshold is highly unusual, but the n=150 minimum sample size criterion is arbitrary, without scientific justification, and unprecedented in evidence reviews. Out of 176 trials NHMRC included in the homeopathy review, only 5 trials met their definition of ’reliable’, none of which, according to their analysis, demonstrated effectiveness of homeopathy. This explains why NHMRC concluded there is ’no reliable evidence’ that homeopathy is effective. A distillation of other detailed findings, presented at conference, reveals further significant flaws in this highly influential report, providing critical awareness of its misrepresentation of the homeopathy evidence base.

An extensive review of the literature dealing on the results obtained by homeopathy during epidemics has revealed important findings about the efficacy of homeopathic treatment. The main findings of this research are: ▪ With more than 25,000 volumes, the homeopathic literature is vast and rich in reports about results obtained by homeopathy during epidemics. The speaker has uncovered over 7,000 references addressing this subject. ▪ Results obtained by homeopathy during epidemics reveal a very important and clear constancy: a very low mortality rate. This constancy remains, regardless of the physician, time, place or type of epidemical disease, including diseases carrying a very high mortality rate, such as cholera, smallpox, diphtheria, typhoid fever, yellow fever and pneumonia. ▪ Interestingly, this low mortality rate is always superior to the results obtained not only by allopathy practiced at that particular time but, as a rule, by allopathy of today, despite benefiting from modern nursing and hygienic care. ▪ Even the lesser-trained homeopaths obtained, as a rule, better results than the highest authorities of the allopathic school. However, the most consistent, predictable and impressive results were obtained by the ones who practiced genuine homeopathy whom are known as Hahnemannians. ▪ Homeopathic remedies have been successfully used to protect large segments of the population from upcoming infectious diseases. Homeopathic prophylaxis is safe and effective combining inexpensive costs. ▪ The results obtained by homeopathy during epidemics cannot be explained by the placebo effect.

It is often considered that a physico-chemical explanation of homeopathy would require a major rewriting of much of physics, chemistry and biochemistry. Yet, despite the fact that the bio-activity of homeopathic dilutions appears to fly in the face of modern science, such an upheaval might not actually be necessary. The aim of this presentation is to demonstrate that we can indeed formulate a plausible and testable theory of homeopathy based on current physics and chemistry. We will start by going over the requirements made of an explanation of homeopathy, such as: memory of the starting substance, compatibility with the dilution/succussion process and finally bio-activity. We will then formulate a minimal set of physical assumptions able to explain the experimental results found in homeopathy. We will show how these assumptions are validated both from the theoretical physics and experimental physico-chemistry side. On the one hand we have, the theoretical predictions of Preparata and DelGuidice of the existence in water structures. These predict the formation of distinct water domains through the stabilising effect of electromagnetic oscillations. On the other hand, we will present a set of experiments from within and outside the field of homeopathy (Demangeat, Elia, Pollack and others). These experiments support the idea that water does form relatively stable structures under certain conditions and that these structures have electromagnetic properties, which could be at the root of the specific biological effects seen in clinical and animal studies. Thus we will show that it is possible to formulate a plausible physico-chemical explanation of homeopathy based on current physic and chemistry. Crucially this formulation is testable, providing important parameters and suggestions for the design of future experiments.

Hilarious, isn’t it? There are many sentences that are memorable treasures in these abstracts. One is almost tempted to book a ticket to Leipzig and listen to the presentations. I particularly love the following statements:

  • All comprehensive investigations prove that homeopathy is more efficient than placebo…
  • …the clinical efficacy of homeopathy remained unquestionable…
  • …overly-definitive negative conclusions are immediately surprising…
  • Homeopathic prophylaxis is safe and effective…
  • …we can indeed formulate a plausible and testable theory of homeopathy based on current physics and chemistry…

The naivety, ignorance and chutzpa that we observed in the abstracts of clinical studies is mirrored here very clearly.  I am therefore inclined to repeat the questions I asked in part 1 of this post: How can a scientific committee reviewing these abstracts let them pass and allow the material to be presented at the ‘World Congress’? How can a Health Secretary accept the patronage of such a farce?

The NHMRC report on homeopathy is the most thorough, independent and reliable investigation into the value of homeopathy ever. As its conclusions are devastatingly negative about the value of homeopathy, it is hardly surprising that homeopaths tried everything and anything to undermine it. This new article gives what I believe to be a fair account of the allegations and their validity:

START OF QUOTE

Since the NHMRC declared homeopathy to be ineffective in treating any health condition, a number of disputes have been made by major organisations in favour of homeopathy. Australia’s two peak industry organisations, Complementary Medicines Australia (CMA) and the AHA, both argue in their letters to the NHRMC that the position was prejudiced based on a draft position statement leaked in 2012 stating it is unethical for health practitioners to treat patients using homeopathy, for the reason that homeopathy (as a medicine or procedure) has been shown not to be efficacious [19,20]. Furthermore, both the CMA and AHA highlight serious concerns regarding the prelude to and instigation of the work of the NHMRC’s HWC as well as the conduct of the review itself to finalise their conclusion on the use of homeopathy. Several grave issues were raised in both letters with five common key flaws cited: (1) no explanation was provided as to why level 1 evidence including randomised control trials were excluded from the review; (2) the database search used was not broad enough to capture complementary medicine and homeopathic specific content, and excluded non-human and non-English studies; (3) no homeopathic expert was appointed in the NHMRC Review Panel; (4) prior to publication, the concerns raised over the methodology and selective use of data by research contractor(s) engaged for the HWC review were abandoned for unknown reasons; and (5) no justification was provided as to why only systematic reviews were used [19,20]. Other serious accusations made by the AHA in their response letter to the NHMRC involved the blatant bias of the NHMRC evident by: the leakage of their draft position statement in April 2011 and early release of the HWC Draft Review regarding homeopathy to the media; no discussion of prophylactic homeopathy i.e. preventative healthcare; and no reference to the cost-effectiveness, safety, and quality of homeopathic medicines [19].

Despite the NHMRC findings being strongly disputed, they are further supported by positions taken by a number of large and respected organisations. For example, in 2009, the World Health Organization (WHO) advised against the use of homeopathic medicines for various serious diseases following significant concerns being raised by major health authorities, pharmaceutical industries, and consumers regarding its safety and quality [21]. They reported the clinical effects were compatible with placebo effects [21]. Similarly, in Australia, the Australian Medical Association (AMA) further supports the NHMRC findings by stating in their position statement released in 2012 that there is limited efficacy evidence regarding most complementary medicines, thereby posing a risk to patient health [22]. More recently, in May 2015, the Royal College of General Practitioners (RACGPs) strongly advocated in their position statement against general practitioners prescribing homeopathic medicines, and pharmacists against supporting or recommending it, given the lack of evidence regarding its efficacy [23]. This is particularly pertinent to conventional vaccines given the recent case between the Australian Competition and Consumer Commission (ACCC) vs. Homeopathy Plus! Australia Pty Ltd. The Federal Court found Homeopathy Plus! Australia Pty Ltd guilty of contravening the Australian Consumer Law by engaging in misleading and deceptive conduct through claiming that homeopathic remedies were a proven, safe, and effective alternative to the conventional vaccine against whooping cough [24].

The positions of the NHMRC, WHO, AMA, and the RACGPs regarding homeopathy is further supported by Cochrane reviews, which provide high-quality evidence with minimal bias [25]. Of the twelve homeopathy Cochrane reviews available in the database, only seven address homeopathic remedies directly and were related to the following conditions: irritable bowel syndrome [26], attention deficit/hyperactivity disorder or hyperkinetic disorder [27], chronic asthma [28], dementia [29], induction of labour [30], cancer [31], and influenza [32]. Given most of these reviews were authored by homeopaths, bias against homeopathy is unlikely [26-32]. The overarching conclusions from these reviews fail to reveal compelling evidence regarding the efficacy of homeopathic remedies [26-32]. For example, Mathie, Frye and Fisher show that there is “no significant difference between the effects of homeopathic Oscillococcinum® and placebo in prevention of influenza-like illness: risk ratio (RR) = 0.48, 95% confidence interval (CI) 0.17-1.34, p-value = 0.16 [31]. The key reasons given for this failure to provide compelling evidence relate to low quality or unclear data, and lack of replicability, suggesting homeopathic remedies are unlikely to have clinical effects beyond placebo [26-32].

Sadly, the ACCC vs. Homeopathy Plus! Australia Pty Ltd is not the only case that has made headlines in Australia in recent years. An article in the Journal of Law and Medicine coincided with the NHMRC report regarding the number of deaths attributable to favouring homeopathy over conventional medical treatment in recent years [33]. One such case was that of Jessica Ainscough, who passed away earlier this year after losing her battle with a rare form of cancer “epithelioid sarcoma“ after rejecting conventional treatment in favour of alternative therapies [34]. Although doctors recognise Ms. Ainscough’s right to choose her own cancer treatments and understand why she refused the disfiguring surgery to save her life, they fear her message may influence others to reject conventional treatments that could ultimately save their lives [35]. Another near death case was that of an eight-month-old boy whose mother was charged with “reckless grievous bodily harm and failure to provide for a child causing danger to death” after ceasing conventional medical and dermatological treatment for her son’s eczema as advised by her naturopath (an umbrella term that includes homeopathy) [36]. The all-liquid treatment plan left the boy severely malnourished and consequently, he now suffers from developmental issues [37]. This case is rather similar to that of R vs. Sam in 2009, where the parents of a nine-month-old girl were convicted of manslaughter by criminal negligence after favouring homeopathic treatment over conventional medical treatment for their daughter’s eczema. The girl died from septicaemia after her eczema became infected [36,37].

[references are provided in the original document]

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The NHMRC report stated that

Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness. People who are considering whether to use homeopathy should first get advice from a registered health practitioner. Those who use homeopathy should tell their health practitioner and should keep taking any prescribed treatments.

Few other reports have previously expressed our concerns about homeopathy so clearly – little wonder then that the world of homeopathy was (and still is) up in arms.

The last time something similar happened was during the Third Reich when homeopathy had been evaluated thoroughly by leading scientists and the conclusions turned out to be just as devastatingly negative. At the time, German homeopaths allegedly made the report disappear, and all we have today about this comprehensive research programme is a very detailed eye witness report of a homeopath who had been intimately involved in the research.

Today, it is thankfully no longer possible to make major research documents disappear. So, homeopaths have to think of other strategies to defend their trade. In the case of the NHMRC report, they act like all cults tend to do and resort to misleading statements and slanderous allegations. This, I feel, is unsurprising and will inevitably turn out to be unsuccessful.

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 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

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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.

We have discussed this notorious problem before: numerous charities (such as one that treats HIV and malaria with homeopathy in Botswana, or the one claiming that homeopathy can reverse cancer) are a clear danger to public health. I have previously chosen the example of ‘YES TO LIFE’ and explained that they promote unproven and disproven alternative therapies as cures for cancer (and if you want to get really sickened, look who act as their supporters and advisors). It is clear to me that such behaviour can hasten the death of many vulnerable patients.

Yet, many such charities get tax and reputational benefits by being registered charities in the UK. The question is CAN THIS SITUATION BE JUSTIFIED?

Currently, the UK Charity commission want to answer it. Specifically, they are asking you the following question:

  • Question 1: What level and nature of evidence should the Commission require to establish the beneficial impact of CAM therapies?
  • Question 2: Can the benefit of the use or promotion of CAM therapies be established by general acceptance or recognition, without the need for further evidence of beneficial impact? If so, what level of recognition, and by whom, should the Commission consider as evidence?
  • Question 3: How should the Commission consider conflicting or inconsistent evidence of beneficial impact regarding CAM therapies?
  • Question 4: How, if at all, should the Commission’s approach be different in respect of CAM organisations which only use or promote therapies which are complementary, rather than alternative, to conventional treatments?
  • Question 5: Is it appropriate to require a lesser degree of evidence of beneficial impact for CAM therapies which are claimed to relieve symptoms rather than to cure or diagnose conditions?
  • Question 6: Do you have any other comments about the Commission’s approach to registering CAM organisations as charities?

I am sure that most readers of this blog have something to say about these questions. So, please carefully study the full document, go on the commission’s website, and email your response to: legalcharitablestatus@charitycommission.gsi.gov.uk . Don’t delay it; do it now!

THANK YOU!

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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