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

Monthly Archives: July 2019

I have to admit, I do not often read the ‘Aargauer Zeitung’. But perhaps I should? Certainly this article from yesterday’s issue is most interesting.

It reported that the University of Basel will soon have a new chair. Apparently, the move has created a fiercely controversial debate within the university. But the decision to go ahead with the plan has been made, and Carsten Gründemann has been formally invited to become the new professor for «translationale Komplementärmedizin». (I am sure in Basel they know what «translationale Komplementärmedizin» is, however, I don’t.)

As it turns out, the term seems entirely irrelevant, because the chair will be in anthroposophical medicine. In case you are not familiar with this SCAM, here is a short explanation copied from my new book:

Anthroposophic medicine is a form of healthcare developed in the 1920s by Rudolf Steiner (1861–1925) in collaboration with the physician Ita Wegman (1876–1943). It is based on Steiner’s mystical ideas of anthroposophy. Steiner had developed his ‘philosophy’ of anthroposophy from personal experiences, occult notions and mystical concepts. Ita Wegman studied medicine after having met Steiner in 1902. She pioneered an ‘alternative cancer treatment’ with a fermented mistletoe extract, according to Steiner’s ideas. Together, Wegman and Steiner wrote Steiner’s last book entitled ‘Extending Practical Medicine’ which was meant as a theoretical basis for their anthroposophical medicine. Wegman was also a co-founder of the pharmaceutical firm ‘Weleda’ which became the biggest producer of anthroposophical remedies. Proponents of anthroposophic medicine make several irrational assumptions, for instance, they claim that our past lives influence our present health, or that the course of an illness is determined by our ‘karmic’ destiny. Practitioners of anthroposophic medicine are usually medically trained; they employ a variety of treatments including massage, exercise, counselling, and a range of remedies (more than 1 300 different anthroposophic medicinal products are currently on the market). Most of the remedies are, like homeopathic remedies, highly diluted but they are not normally prescribed according to the ‘like cures like’ principle and are therefore distinct from homeopathy.

The report mentions that the creation of the new chair caused wide-spread anger amongst the science-based faculties at Basel. The head of Pharmacy, Christoph Meier, is quoted stating: «Indem die Professur in den Forschungsbetrieb eingebunden wird, bieten wir keine Hand zur Scharlatanerie.» [As the professorship will be tied into research, we offer no opportunity for quackery.]

Carsten Gründemann studied Biochemistry/Biology at the University of Tübingen and Freiburg (Germany) and received his Ph.D. in Experimental Immunology from the University of Tübingen (Germany). He was awarded the Karl und Veronica Carstens (KVC) Science Award 2018 for his research in the field of complementary medicine for multiple sclerosis (MS). He is currently based at the Center for Complementary Medicine, Institute for Environmental Health Sciences, University Medical Center Freiburg. Much of his past research seems to focus on anthroposophical medicines, including those produced by Weleda, the world’s largest manufacturer of anthroposophical preparations. Here is one of his 32 Medline-listed abstracts:

BACKGROUND:

Preparations from anthroposophical medicine (AM) are clinically used to treat inflammatory disorders. We wanted to investigate effects of a selection of AM medications for parenteral use in cell-based systems in vitro.

METHODS:

Colchicum officinale tuber D3, Mandragora D3, Rosmarinus officinale 5% and Bryophyllum 5% were selected for the experiments. Induction of apoptosis and necrosis (human lymphocytes and dendritic cells [DCs]) and proliferation of lymphocytes as well as maturation (expression of CD14, CD83 and CD86) and cytokine secretion (IL-10, IL12p70) of DCs were analyzed. Furthermore, proliferation of allogeneic human T lymphocytes was investigated in vitro in coculture experiments using mature DCs in comparison to controls.

RESULTS:

The respective preparations did not induce apoptosis or necrosis in lymphocytes or DCs. Lymphocyte proliferation was dose-dependently reduced by Colchicum officinale tuber D3 while the viability was unchanged. Rosmarinus officinale 5%, but not the other preparations, dose-dependently inhibited the maturation of immature DCs, reduced secretion of IL-10 and IL-12p70 and slightly inhibited proliferation of allogeneic CD4(+) T-lymphocytes in coculture experiments with DCs.

CONCLUSION:

The selected preparations from AM for parenteral use are nontoxic to lymphocytes and DCs. Rosmarinus officinale 5% has immunosuppressive properties on key functions of the immune system which propose further investigation.

The new chair is contractually bound to adhere to the ‘anthroposophical model’ (which probably is a synonym for ‘Steiner cult’). It will be financed to the tune of 3 million Swiss Franks, money that comes from the ‘Software AG Stiftung‘, Weleda, Beatrice Oeri, and other anthroposophical institutions.

The effectiveness of spinal manipulative therapy (SMT) for improving athletic performance in healthy athletes (or anything else for that matter) is unclear. The objective of this systematic review was to systematically review the literature on the effect of SMT on performance-related outcomes in asymptomatic adults.

The authors searched electronic databases from 1990 to March, 2018. Inclusion criteria was any study examining a performance-related outcome of SMT in asymptomatic adults. Methodological quality was assessed using the SIGN criteria. Studies with a low risk of bias were considered scientifically admissible for a best evidence synthesis.

Of 1415 articles screened, 20 studies had low risk of bias, seven were randomized crossover trials, 10 were randomized controlled trials (RCT) and three were RCT pilot trials. Four studies showed SMT had no effect on physiological parameters at rest or during exercise. There was no effect of SMT on scapular kinematics or transversus abdominus thickness. Three studies identified changes in muscle activation of the upper or lower limb, compared to two that did not. Five studies showed changes in range of motion (ROM). One study showed an increase lumbar proprioception and two identified changes in baropodometric variables after SMT. Sport-specific studies showed no effect of SMT except for a small increase in basketball free-throw accuracy.

The authors, who are all affiliated to the Canadian Memorial Chiropractic College, concluded that the preponderance of evidence suggests that SMT in comparison to sham or other interventions does not enhance performance-based outcomes in asymptomatic adult population. All studies are exploratory with immediate effects. In the few studies suggesting a positive immediate effect, the importance of such change is uncertain. Further high-quality performance specific studies are required to confirm these preliminary findings.

I think, this says it (almost) all: yet another lucrative claim made by many chiropractors and osteopaths turns out to be not backed up by good evidence. The only thing worth adding is the fact that only 4 of the studies mentioned adverse effects. This means the vast majority of studies failed to comply with this basic requirement of research ethics – and this really says it all!

Chiropractors often claim that they are working tirelessly towards increasing public health. But how seriously should we take such claims?

The purpose of this study was to investigate weight-loss interventions offered by Canadian chiropractors. It is a secondary analysis of data from the Ontario Chiropractic Observation and Analysis STudy (Nc = 42 chiropractors, Np = 2162 patient encounters). Its results show that around two-thirds (61.3%) of patients who sought chiropractic care were either overweight or had obesity. Very few patients had weight loss managed by their chiropractor. Among patients with body mass index equal to or greater than 18.5 kg/m2, guideline recommended weight management was initiated or continued by Ontario chiropractors in only 5.4% of encounters. Chiropractors did not offer weight management interventions at different rates among patients who were of normal weight, overweight, or obese (P value = 0.23). Chiropractors who graduated after 2005 who may have been exposed to reforms in chiropractic education to include public health were significantly more likely to offer weight management than chiropractors who graduated between 1995 and 2005.

The authors concluded that the prevalence of weight management interventions offered to patients by Canadian chiropractors in Ontario was low. Health care policy and continued chiropractic educational reforms may provide further direction to improve weight-loss interventions offered by doctors of chiropractic to their patients.

This paper seems to confirm my suspicion that the claim of chiropractors working for public heath is little more than an advertising gimmick. If we also consider the often negative attitude of chiropractors towards vaccination, the claim even deteriorates into a sick joke. Chiropractors, I have previously argued, are undermining public health and are being educated to become a danger to public health.

The current debate about homeopathy is intense and often emotional. Yet, many people who discuss the loudest seem not even to know what homeopathy is; others are unaware that there is not one but many forms of homeopathy. The following passages from my book are an attempt to define some of them:

Agrohomeopathy is a somewhat exotic fringe area of homeopathy. It is the term describing the use of homeopathic remedies to treat gardens and crops. Its proponents claim that it is an effective, chemical free, non-toxic method of growing plants. They also believe that agrohomeopathy renders plants resistant to disease by strengthening them ‘from the inside out’. Agrohomeopathy, they say, can even treat a trauma retained in the ‘biological memory’ of the plant resulting from conditions such as forced hybridization, moving to places outside their natural habitats, or exaggerated fertilization. There is no evidence, however, that any of these assumptions are correct.

Classical homeopathy is the term used to describe the type of homeopathy that adheres to the principles, instructions and methods published by Hahnemann. As Hahnemann’s texts are by no means free of contradictions, classical homeopathy is not a well-defined concept. As it is practised today, it incorporates ideas that originate not from Hahnemann but also from other prominent homeopaths, such as Kent. Thus some might use the term ‘classical homeopathy’ to denote the highly individualised prescribing of Hahnemann and to contrast it with the symptom-orientated prescribing of ‘clinical homeopathy’. Others might employ it to differentiate those homeopaths who would practise no method other than homeopathy from those who regularly combine homeopathy with conventional medicine. Others again might take it to mean unicist homeopathy administering one single remedy at a time, the way Hahnemann mostly did.

Clinical Homeopathy While ‘classical homeopathy’ relies on individualised prescribing according to the ‘like cures like’ principle and selects the optimal remedy for each patient based on the findings from provings, clinical homeopathy resembles more the way drugs are prescribed in conventional medicine; it selects the appropriate remedy according to the condition of the patient, while largely disregarding the ‘like cure like’ principle. However, clinical and classical homeopathy are not mutually exclusive; in fact, there is considerable overlap between the two approaches, and they are often used in parallel by the same clinician. In other words, if the symptoms of a patient reveal a very clear indication for a certain homeopathic remedy, clinical homeopathy is used even by classical homeopaths. For instance, Arnica is considered a clear indication for cuts and bruised; so is Coffea for insomnia, Drosera for cough, Opium for constipation etc., and these remedies would be employed regularly by classical homeopaths. Clinical homeopathy is also used by many non-homeopaths as well as by consumers when they self-prescribe. It does not require an understanding any of the principles of homeopathy nor its fine details. Moreover, clinical homeopathy is also the predominant approach in veterinary homeopathy.

Complex homeopathy is the use of preparations which contain more than one homeopathic remedy. Even though it is not in line with Hahnemann’s teachings, complex homeopathy is currently highly popular and commercially successful. Homeopathic combination remedies can be bought over the counter and usually contain a range of different remedies which, according to the concepts of clinical homeopathy, are most likely to cure a given condition.

Homeo-prophylaxis Some homeopaths advise their patients against immunisations and instead recommend homeopathic immunisations or ‘homeo-prophylaxis’. This normally entails the oral administration of homeopathic remedies, called nosodes. Such remedies are potentised remedies based on pathogenic material like bodily fluids or pus. There is no evidence that homeopathic immunisations are effective. After conventional immunisations, patients develop immunity against the infection in question which can be monitored by measuring the immune response to the intervention. No such evidence exists for homeopathic immunisations. Despite this lack of evidence, some homeopaths – particularly those without medical training – continue to recommend homeopathic immunisations. A recent US conference on the topic was advertised with the slogan ‘homeo-prophylaxis is a gentle, non-toxic alternative’. Such promotion constitutes a serious risk for public health: once rates for conventional immunisations fall below a certain threshold, the population would lose its herd immunity, subsequently even those individuals who were immunised are at risk of acquiring the infection.

Homotoxicology is a method inspired by homeopathy which was developed by Hans Heinrich Reckeweg (1905 – 1985). He believed that all or most illness is caused by an overload of toxins in the body. The toxins originate, according to Reckeweg, both from the environment and from the malfunction of physiological processes within the body. His treatment consists mainly in applying homeopathic remedies which usually consist of combinations of single remedies, because health cannot be achieved without ridding the body of toxins. The largest manufacturer and promoter of remedies used in homotoxicology is the German firm Heel.

Isopathy is the use of potentised remedies which are derived from the causative agent of the disease that is being treated. It thus does not follow the supreme law of homeopathy; instead of ‘like cures like’, instead it postulates that identical cures identical. An example of isopathy is the use of potentised grass pollen to treat patients suffering from hay fever. Some of the methodologically best trials that generated a positive result were done using isopathy; they therefore did not test homeopathy and its principal assumption, the ‘like cures like’ theory. They are nevertheless regularly used by proponents of homeopathy to argue that homeopathy is effective.

Pluralist homeopathy is a variation of Hahnemann’s original concepts. It allows or even encourages the use of more than one homeopathic remedy to treat a patient at one time. The remedies may cover different aspects of the patient’s illness. Hahnemann was very clear in his instructions that normally one patient should get only one single remedy at one time.

Purist homeopathy A purist homeopath is a clinician who adheres strictly to the instructions of Hahnemann. Since the early days of homeopathy, homeopaths were divided by this issue: some purists believe that any deviation from Hahnemann’s dictum is a travesty that renders homeopathy ineffective, while others are convinced that clinicians have an ethical responsibility to incorporate new medical knowledge into their practice. An editorial in the British Homeopathic Journal of 1944, for instance, stated that ‘to shut one’s eyes to the discoveries of chemotherapy…is…foolishness. The ‘pure’ homeopath so called is a crank living in his own little cell. The complete physician is he who endeavours to know all, and knowing all, to choose what is best for the patient.’

Unicist Homeopathy School of homeopathy that insists on following Hahnemann’s dictum of using only one single remedy for one patient at any one time. See also pluralist homeopathy.

____________________________________________________________

One would be forgiven for being confused in view of this plethora of variations. Is there anything these treatments have in common?, you may well ask. The answer is yes:

THEY ALL ARE BIOLOGICALLY IMPLAUSIBLE AND NOT SUPPORTED BY GOOD EVIDENCE OF EFFECTIVENESS.

 

 

The use of  so-called alternative medicine (SCAM) for changing the natural history of cancer (rather than for alleviating symptoms) is a dangerous thing. Here is yet another study confirming this statement.

The purpose of this cross-sectional study was to investigate the patterns of SCAM use and its association with time to conventional treatment. The study was performed in Thailand at the Chonburi Cancer Hospital. Chart reviews and interviews were performed for 426 patients with various cancers between May and December 2018.

The results indicated that 45% of all patients reported using SCAMs; herbal products were the most common type. Approximately 34% of these medicines involved unlabelled herbal products with unidentifiable components. The rates of SCAM use were significantly elevated for men and for patients with stage IV cancer. The multivariable linear regression analysis of the relationship between factors and the time until conventional treatment was received revealed that the regression coefficient of the use of SCAM was 56.3 (95% confidence interval [27.9-84.6]). This coefficient corresponded to an additional 56.3 days of time until conventional treatment, relative to patients who did not use SCAM.

The authors concluded that these findings demonstrated that there is a relatively moderate prevalence of CAM use among Thai cancer patients, with most of the CAM treatments involving homemade herbal products. The use of CAM was significantly associated with a prolonged time to conventional treatment. Nevertheless, these findings do not imply that CAM should be banned for all patients, although healthcare providers should recommend that patients aim to use CAM treatments that are considered safe and will not interfere with conventional treatments.

This study would in itself not be very important. Its relevance, in my view, lies in the fact that it is an independent confirmation of many studies published previously showing that cancer patients ought to be cautious about SCAM; for instance:

My recommendation to people who have been diagnosed with cancer is to resist the many temptations and promises of SCAM, discuss the issues with their oncology team, and follow their advice. This may sound a little boring, but it just might save your life.

The NHS England has stopped paying for homeopathy in 2017. France has just announced to do likewise. What about Germany, the homeland of homeopathy?  

In Germany there are about 150,000 doctors, and around 7,000 specialize in homeopathy. Multiple surveys confirm that Germans do like their SCAMs, particularly homeopathy. Two examples:

  • A 2016 cross-sectional analysis conducted among all patients being referred to the Department of Internal and Integrative Medicine at Essen, Germany, over a 3-year period showed that 35% of the 2,045 respondents reported having used homeopathy for their primary medical complaint.  359 (50.2%) patients reported benefits and 15 (2.1%) reported harm.
  • More recently, a questionnaire survey concerning current and lifetime use of SCAM was distributed to German adults with autism spectrum disorder (ASD). The results suggested that 45% of the respondents were currently using or had used at least one SCAM modality in their life. Homeopathy and acupuncture were most frequently used SCAMs, followed by mind-body interventions.

But since a few years, the German opposition to homeopathy has become much more active. In particular the INH, the GWUP, and the Muensteraner Kreis have been instrumental in informing the public about the uselessness and dangers of homeopathy. The press has now taken up this message and, as this article explains, now the debate about homeopathy has finally reached the political level.

The head of the main doctors’ association and the SPD’s health specialist have called for an end to refunds for homeopathy treatments in Germany. The head of the National Association of Statutory Health Insurance Physicians (KBV), which represents 150,000 doctors and psychotherapists in Germany, recently urged health insurance companies to stop funding homeopathic services. “There is insufficient scientific evidence for the efficacy of homeopathic procedures,” Andreas Gassen told the Rheinische Post. “If people want homeopathic remedies, they should have them — but not at the expense of the community.

Gassen’s comments follow those of the Social Democrat (SPD) health issues specialist and lawmaker Karl Lauterbach who has pressed for a law banning refunds for homeopathy. “We have to talk about it in GroKo,” Lauterbach said earlier this month, suggesting a discussion in the government grand coalition. He said the benefits paid for by insurers should be medically and economically sensible. He has the support of the Federal Joint Committee which decides on what is covered by payments from the statutory health funds.

So, what is going to happen?

As I have written previously, one can only be sure of this:

  • The German homeopathy lobby will not easily give up; after all, they have half a billion Euros per year to lose.
  • They will not argue on the basis of science or evidence, because they know that neither are in their favour.
  • They will fight dirty and try to defame everyone who stands in their way.
  • They will use their political influence and their considerable financial power.

AND YET THEY WILL LOSE!

Not because we are so well organised or have great resources – in fact, as far as I can see, we have none – but because, in medicine, the evidence is invincible and will eventually prevail. Progress might be delayed, but it cannot be halted by those who cling to an obsolete dogma.

 

 

Treating children is an important income stream for chiropractors and osteopaths. There is plenty of evidence to suspect that their spinal manipulations generate more harm than good; on this blog, we have discussed this problem more often than I care to remember (see for instance here, here, here, here and here). Yet, osteopaths and chiropractors carry on misleading parents to abuse their children with ineffective and dangerous spinal manipulations. A new and thorough assessment of the evidence seems to confirm this suspicion.

This systematic review evaluated the evidence for effectiveness and harms of specific SMT techniques for infants, children and adolescents. Controlled studies, describing primary SMT treatment in infants (<1 year) and children/adolescents (1-18 years), were included to determine effectiveness.

Of the 1,236 identified studies, 26 studies were eligible. Infants and children/adolescents were treated for various (non-)musculoskeletal indications, hypothesized to be related to spinal joint dysfunction. Studies examining the same population, indication and treatment comparison were scarce. The results showed that:

  • Due to very low quality evidence, it is uncertain whether gentle, low-velocity mobilizations reduce complaints in infants with colic or torticollis, and whether high-velocity, low-amplitude manipulations reduce complaints in children/adolescents with autism, asthma, nocturnal enuresis, headache or idiopathic scoliosis.
  • Five case reports described severe harms after HVLA manipulations in 4 infants and one child. Mild, transient harms were reported after gentle spinal mobilizations in infants and children, and could be interpreted as side effect of treatment.

The authors concluded that due to very low quality of the evidence, the effectiveness of gentle, low-velocity mobilizations in infants and HVLA manipulations in children and/or adolescents is uncertain. Assessments of intermediate outcomes are lacking in current pediatric SMT research. Therefore, the relationship between specific treatment and its effect on the hypothesized spinal dysfunction remains unclear. Gentle, low-velocity spinal mobilizations seem to be a safe treatment technique. Although scarcely reported, HVLA manipulations in infants and young children could lead to severe harms. Severe harms were likely to be associated with unexamined or missed underlying medical pathology. Nevertheless, there is a need for high quality research to increase certainty about effectiveness and safety of specific SMT techniques in infants, children and adolescents. We encourage conduction of controlled studies that focus on the effectiveness of specific SMT techniques on spinal dysfunction, instead of concluding about SMT as a general treatment approach. Large observational studies could be conducted to monitor the course of complaints/symptoms in children and to gain a greater understanding of potential harms.

The situation regarding spinal manipulation for children might be summarised as follows:

  1. Spinal manipulations are not demonstrably effective for paediatric conditions.
  2. They can cause serious direct and indirect harm.
  3. Chiropractors and osteopaths are not usually competent to treat children.
  4. They nevertheless treat children regularly.

In my view, this is unethical and can amount to child abuse.

It is not that long ago that I published a post entitled HOMEOPATHY IN FRANCE: A TRIUMPH OF PROFIT OVER REASON. Today, I am pleased to post one with the reverse title.

It has taken a few years (compared to the UK where it has taken a few decades, it was nevertheless fast), but now it is done. Very briefly, this is what happened:

  • In 2014, our book was published in French. I might be fooling myself, but I do hope that it helped starting a ball rolling in France where, up to then, homeopathy had enjoyed a free ride.
  • Subsequently, French sceptics began raising their voices against quackery in general and homeopathy in particular.
  • In 2018, they got organised and 124 doctors published an open letter criticising the use of alternative medicine as dangerous practised by charlatans of all kinds.
  • In the same year, the Collège National des Généralistes Engseignants, the national association for teaching doctors, pointed out that there was no rational justification for the reimbursement of homeopathics nor for the teaching of homeopathy in medical schools stating that It is necessary to abandon these esoteric methods, which belong in the history books.
  • Also in 2018, the University of Lille announced its decision to stop its course on homeopathy. The faculty of medicine’s dean, Didier Gosset, said: It has to be said that we teach medicine based on proof – we insist on absolute scientific rigour – and it has to be said that homeopathy has not evolved in the same direction, that it is a doctrine that has remained on the margins of the scientific movement, that studies on homeopathy are rare, that they are not very substantial. Continuing to teach it would be to endorse it.
  • In 2019, the French Academies of Medicine and Pharmacy have published a document entitled ‘L’homéopathie en France : position de l’Académie nationale de médecine et de l’Académie nationale de pharmacie’. It stated that L’homéopathie a été introduite à la fin du XVIIIe siècle, par Samuel Hahnemann, postulant deux hypothèses : celle des similitudes (soigner le mal par le mal) et celle des hautes dilutions. L’état des données scientifiques ne permet de vérifier à ce jour aucune de ces hypothèses. Les méta-analyses rigoureuses n’ont pas permis de démontrer une efficacité des préparations homéopathiques. The academies concluded that no French university should offer degrees in homeopathy, and that homeopathy should no longer be funded by the public purse: “no homeopathic preparation should be reimbursed by Assurance Maladie [France’s health insurance] until the demonstration of sufficient medical benefit has been provided. No university degree in homeopathy should be issued by medical or pharmaceutical faculties … The reimbursing of these products by the social security seems aberrant at a time when, for economic reasons, we are not reimbursing many classic medicines because they are more or less considered to not work well enough …”
  • Only weeks later, the French health regulator (HAS) has recommended with a very large majority (only one vote against) for the discontinuation of the reimbursement of homeopathic products.
  • The health minister, Agnès Buzyn, announced “Je me tiendrai à l’avis de la Haute Autorité de santé”.
  • Consequently, the powerful French homeopathy lobby created political pressure in multiple ways, including a petition with over 1000000 signatures and the last minute press-release below.

It is important, I think, to use this occasion for considering the main arguments of the homeopathy lobby in their defence of homeopathy.

  1. Homeopathy is effective. This argument is demonstrably false and can only be made, if one abuses the published evidence. One way to demonstrate this is to look at the official verdicts from around the globe.
  2. Homeopathy may only be a placebo, but it prevents patients taking dangerous drugs instead. This argument is tricky but wrong. If patients are ill, they need an effective therapy and not homeopathy. If they are not ill, they need reassurance and not a placebo. We need to educate the public and doctors to understand this simple message rather than pulling wool over their eyes.
  3. Discontinuing homeopathy is an undesirable curtailment of our freedom of choice. This is a pseudo-argument, because nobody forbids anyone using homeopathy. All we advocate is that the public purse should only pay for effective treatments. Any other strategy means that we jeopardise funds for effective therapies.
  4. Homeopathy employs over 1000 workers, and any cut in reimbursement would jeopardise these jobs. This argument is also tricky (and it is probably the one that created a headache for politicians). It is, however, spurious. Firstly, job preservation is only a good thing, if the jobs in question are worth preserving. If they serve no good service to the public, they are probably not worth preserving. (We don’t need to all start smoking, for instance, in order to preserve the jobs in the tobacco industry.) Secondly, the argument contradicts the other arguments of the homeopathy lobby. If homeopathy were effective and helpful, people would carry on buying homeopathics regardless of any cut in reimbursement. Thirdly, I suspect the figure of > 1000 will turn out to be hugely exaggerated. Fourthly, arguments of this kind are deeply regressive; they have historically stood in the way of progress whenever an innovation was inescapable (think of the industrial revolution, for instance), and they have never succeeded.

To contemplate these arguments carefully is important, I feel, because this will help other rational thinkers to fight for progress, optimal healthcare and good science. There is still plenty of quackery out there. So, let’s celebrate the French triumph (à votre santé, Agnès Buzyn!!!) – and then roll up our sleeves and get cracking!

Researchers from the National Institute of Homoeopathy (an autonomous organisation under the Ministry of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homeopathy, Government of India) tested a Dysentery Compound (DC), a ‘bowel nosode’, against individualized homeopathy (IH) in the treatment of irritable bowel syndrome (IBS). For this purpose, they used an open, randomized (1:1), parallel arms, pragmatic, non-inferiority, pilot trial with 60 IBS patients. IBS Quality of Life (IBS-QOL) questionnaire was used as the primary outcome measure; assessed at baseline and after 3 months.

Six subjects dropped out. Groups were comparable at baseline (all p>0.01). Though intra-group changes were higher favouring IH over DC, group differences were statistically non-significant (all p>0.01). Non-inferiority was not demonstrated by DC against IH over 3 months (mean difference= −3.3, SE=5.2, lower 95% confidence limit −11.9, t= −0.453, p=0.674). No adverse events were reported from either group.

The authors concluded that non-inferiority of DC against IH in treatment of IBS was not demonstrated though it appeared as safe; still, being a pilot trial, no definite conclusion could be drawn. Further exploration of both efficacy and effectiveness of either of the therapies is necessary by adequately powered trials and independent replications.

This trial is a treasure trove of methodological flaws. Here I want to focus on merely one of them: The idea of conducting a non-inferiority study of two treatments, none of which have previously been shown to be effective.

Most clinical trials are ‘superiority studies’ designed to test whether one treatment is more effective than another one. This is fundamentally different in non-inferiority or equivalence studies. They aim to test whether one treatment is as effective as another therapy that has already been fully researched and is generally accepted to be effective for the condition in question. This approach avoids the ethical problems that can arise in superiority studies from giving placebos to patients who require an effective treatment for their condition. Equivalence studies can have many of the features of superiority studies but require a different statistical approach and usually need much larger sample sizes.

This means that the new study never had the slightest chance to generate a result that was in any way meaningful. Such a waste of resources is hardly surprising in the realm of homeopathy; over the years, we have become used to it. But, coming from the National Institute of Homeopathy, it is significant. On their website, the Institute claims this:

The mission of National Institute of Homoeopathy is to foster excellence in Homoeopathic Medical Education and Research, to educate and train undergraduate, post graduate students and research scholars of homoeopathy in accordance with highest professional standards and ethical values unfettered by the barriers of nationality, language, culture, plurality, religion and to meet the healthcare needs of the community through dissemination of knowledge and service. 

Excellence in homeopathic research?

Well, you could have fooled me!

 

George Vithoulkas, has been mentioned on this blog repeatedly. He is a lay homeopath – one that has no medical background – and has, over the years, become an undisputed hero within the world of homeopathy. Yet, Vithoulkas’ contribution to homeopathy research is perilously close to zero. Judging from a recent article in which he outlines the rules of rigorous research, his understanding of research methodology is even closer to zero. Here is a crucial excerpt from this paper intercepted by a few comment from me in brackets and bold print.

Which are [the] homoeopathic principles to be respected [in clinical trials and meta-analyses]?

1. Homoeopathy does not treat diseases, but only diseased individuals. Therefore, every case may need a different remedy although the individuals may be suffering from the same pathology. This rule was violated by almost all the trials in most meta-analyses. (This statement is demonstrably false; there even has been a meta-analysis of 32 trials that respect this demand)

2. In the homoeopathic treatment of serious chronic pathology, if the remedy is correct usually a strong initial aggravation takes place []. Such an aggravation may last from a few hours to a few weeks and even then we may have a syndrome-shift and not the therapeutic results expected. If the measurements take place in the aggravation period, the outcome will be classified negative. (Homeopathic aggravations exist only in the mind of homeopaths; our systematic review failed to find proof for their existence.)

This factor was also ignored in most trials []. At least sufficient time should be given in the design of the trial, in order to account for the aggravation period. The contrary happened in a recent study [], where the aggravation period was evaluated as a negative sign and the homoeopathic group was pronounced worse than the placebo []. (There are plenty of trials where the follow-up period is long enough to account for this [non-existing] phenomenon.)

3. In severe chronic conditions, the homoeopath may need to correctly prescribe a series of remedies before the improvement is apparent. Such a second or third prescription should take place only after evaluating the effects of the previous remedies []. Again, this rule has also been ignored in most studies. (Again, this is demonstrably wrong; there are many trials where the homeopath was able to adjust his/her prescription according to the clinical response of the patient.)

4. As the prognosis of a chronic condition and the length of time after which any amelioration set in may differ from one to another case [], the treatment and the study-design respectively should take into consideration the length of time the disease was active and also the severity of the case. (This would mean that conditions that have a short history, like post-operative ileus, bruising after injury, common cold, etc. should respond well after merely a short treatment with homeopathics. As this is not so, Vithoulkas’ argument seems to be invalid.)

5. In our experience, Homeopathy has its best results in the beginning stages of chronic diseases, where it might be possible to prevent the further development of the chronic state and this is its most important contribution. Examples of pathologies to be included in such RCTs trials are ulcerative colitis, sinusitis, asthma, allergic conditions, eczema, gangrene rheumatoid arthritis as long as they are within the first six months of their appearance. (Why then is there a lack of evidence that any of the named conditions respond to homeopathy?)

In conclusion, three points should be taken into consideration relating to trials that attempt to evaluate the effectiveness of homoeopathy.

First, it is imperative that from the point of view of homoeopathy, the above-mentioned principles should be discussed with expert homoeopaths before researchers undertake the design of any homoeopathic protocol. (I am not aware of any trial where this was NOT done!)

Second, it would be helpful if medical journals invited more knowledgeable peer-reviewers who understand the principles of homoeopathy. (I am not aware of any trial where this was NOT done!)

Third, there is a need for at least one standardized protocol for clinical trials that will respect not only the state-of-the-art parameters from conventional medicine but also the homoeopathic principles []. (Any standardised protocol would be severely criticised; a good study protocol must always take account of the specific research question and therefore cannot be standardised.)

Fourth, experience so far has shown that the therapeutic results in homeopathy vary according to the expertise of the practitioner. Therefore, if the objective is to validate the homeopathic therapeutic modality, the organizers of the trial have to pick the best possible prescribers existing in the field. (I am not aware of any trial where this was NOT done!)

Only when these points are transposed and put into practice, the trials will be respected and accepted by both homoeopathic practitioners and conventional medicine and can be eligible for meta-analysis.

___________________________________________________________________

I suspect what the ‘GREAT VITHOULKAS’ really wanted to express are ‘THE TWO ESSENTIAL PRINCIPLES OF HOMEOPATHY RESEARCH’:

  1. A well-designed study of homeopathy can always be recognised by its positive result.
  2. Any trial that fails to yield a positive finding is, by definition, wrongly designed.
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