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

progress

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The aim of this RCT was to investigate the effects of an osteopathic manipulative treatment (OMT) which includes a diaphragm intervention compared to the same OMT with a sham diaphragm intervention in chronic non-specific low back pain (NS-CLBP).

Participants (N=66) with a diagnosis of NS-CLBP lasting at least 3 months were randomized to receive either an OMT protocol including specific diaphragm techniques (n=33) or the same OMT protocol with a sham diaphragm intervention (n=33), conducted in 5 sessions provided during 4 weeks.

The primary outcomes were pain (evaluated with the Short-Form McGill Pain Questionnaire [SF-MPQ] and the visual analog scale [VAS]) and disability (assessed with the Roland-Morris Questionnaire [RMQ] and the Oswestry Disability Index [ODI]). Secondary outcomes were fear-avoidance beliefs, level of anxiety and depression, and pain catastrophization. All outcome measures were evaluated at baseline, at week 4, and at week 12.

A statistically significant reduction was observed in the experimental group compared to the sham group in all variables assessed at week 4 and at week 12. Moreover, improvements in pain and disability were clinically relevant.

The authors concluded that an OMT protocol that includes diaphragm techniques produces significant and clinically relevant improvements in pain and disability in patients with NS-CLBP compared to the same OMT protocol using sham diaphragm techniques.

This seems to be a rigorous study. The authors describe in detail their well-standardised interventions in the full text of their paper. This, of course, will be essential, if someone wants to repeat the trial.

I have but a few points to add:

  1. What I fail to understand is this: why the authors call the interventions osteopathic? The therapist was a physiotherapist and the techniques employed are, if I am not mistaken, as much physiotherapeutic as osteopathic.
  2. The findings of this trial are encouraging but almost seem a little too good to be true. They need, of course, to be independently replicated in a larger study.
  3. If that is done, I would suggest to check whether the blinding of the patient was successful. If not, there is a suspicion that the diaphragm technique works partly or mostly via a placebo effect.
  4. I would also try to make sure that the therapist cannot influence the results in any way, for instance, by verbal or non-verbal suggestions.
  5. Finally, I suggest to employ more than one therapist to increase generalisability.

Once all these hurdles are taken, we might indeed have made some significant progress in the manual therapy of NS-CLBP.

Samuel Hahnemann invented homeopathy about 200 years ago. His placebos were better than (or not as bad as) the ‘heroic’ medicine of his time which frequently was more dangerous than the disease it aimed to cure. Thus, homeopathy took Germany by storm. When, about 100 years ago, medicine finally became scientific and was able to offer more and more effective treatments, the popularity of homeopathy began to wane. Yet, before its natural demise, during the Third Reich, it received a significant boost from Nazi-greats such as Hess and Himmler. After this nightmare was over, German homeopathy went into another slow decline. But when the New Age movement and the current boom in alternative medicine reached Germany, homeopathy seemed to thrive once again.

In the 1990s evidence-based medicine (EBM) grew into one of the central concepts of medicine. In Germany, however, EBM had a relatively hard time to get established. This might be one of the reasons why homeopathy continued to prosper, despite the arrival of ever clearer evidence that highly diluted homeopathic remedies are pure placebos. While, in the UK, we had an increasingly lively debate about the uselessness of homeopathy, Germany remained the promised land of homeopathy. Sales figures of homeopathics continued to increase steadily and reached a level of about half a billion Euros per annum.

The golden age of German homeopathy had dawned:

  • The media, often sponsored by homeopathic interest groups, kept on promoting homeopathy largely unopposed.
  • The mighty Carstens Stiftung worked tirelessly to promote it.
  • Homeopathy became established in many medical schools.
  • Homeopathy was available and often advertised in almost all pharmacies.
  • The public was convinced that homeopathy worked.
  • The Heilpraktiker adopted homeopathy fully.
  • The medical and other conventional healthcare professions embraced it to a large degree.
  • The adult education institutes (Volkshochschulen) offered courses.
  • Politicians were squarely on the side of homeopathy,
  • Health insurances, paid for it.

Of course, there were also some (and always had been) opposing voiced and organisations, such as the GWUP (the German sceptic organisation), for example. But somehow, they remained relatively low-key. When, every now and then, courageous journalists dared to think of a critical take on homeopathy, they had to search far and wide to find a German-speaking expert who was willing or able to tell them the truth: that homeopathy is neither biologically plausible nor evidence-based and therefore an expensive, potentially harmful waste of money that makes a mockery of EBM. During this period, journalists (far too) often asked me for some critical comments. I hardly ever published my research in German, but they nevertheless would find me via my Medline-listed papers. I often felt like a very lone voice in a German desert.

For the German homeopathic industry, I evidently was more than just a lone voice. Unbeknown to me, they clubbed together and financed a PR-man/journalist (at the tune of Euro 30 000/year) to write as many defamatory articles about me as he could muster. First, I was bewildered by his activity, then I tried to communicate with him (only to get mis-quoted), and eventually I ignored his writings. Yet, a German investigative journalist found Fritzsche’s one-sided activities offensive and started investigating. His research and subsequent article disclosed the fact that he was being paid by the homeopathic industry. Once I learn about this scandal, I wrote to some of the financiers directly and asked for an explanation. As a result, they discontinued their sponsorship. Shortly afterwards, Fritzsche committed suicide.

At heart, I have always been an optimist and strongly believe that in medicine the truth, in this case the evidence, will always prevail, no matter what obstacles others might put in its way. Recent developments seem to suggest that I might be right.

In the last few years, several individuals in Germany have, from entirely different angles, taken a fresh look at the evidence on homeopathy and found it to be desperately wanting. Independent of each other, they published articles and books about their research and insights. Here are 5 examples:

Die Homöopathie-Lüge: So gefährlich ist die Lehre von den weißen KügelchenChristian Weymayr, Nicole Heißmann, 2012

In Sachen Homöopathie: Eine Beweisaufnahme, Norbert Aust, 2013

Homöopathie neu gedacht: Was Patienten wirklich hilft, Natalie Grams, 2015

Der Glaube an die Globuli: Die Verheißungen der HomöopathieNorbert Schmacke, Bernd Hontschik, 2015

Der wahrscheinlich teuerste Zucker der Welt: Was Sie über Homöopathie und Alternativmedizin wissen sollten, Oliver Grunau, 2017

Inevitably, these individuals came into contact with each other and subsequently founded several working-groups to discuss their concerns and coordinate their activities. Thus the INH and the Muensteraner Kreis were born. So, now we have at least three overlapping groups of enthusiastic, multidisciplinary experts who voluntarily work towards informing the German public that paying for homeopathy out of public funds is unethical, nonsensical and not in the interest of progress:

  • the GWUP,
  • the INH
  • and the Muensteraner Kreis.

No wonder then, that the German homeopathic industry and other interested parties got worried. When they realised that (presumably due to the work of these altruistic enthusiasts) the sales figures of homeopathics in Germany had, for the first time since many years, started declining, they panicked.

Their reaction was, as far as I can see, similar to their previous response to criticism: they started a media campaign in an attempt to sway public opinion. And just like before, they have taken to employing PR-people who currently spend their time defaming all individuals voicing criticism of homeopathy in Germany. Their prime targets are those experts who are most exposed to activities of responsibly informing the public about homeopathy via lectures, publications social media, etc. All of us currently receive floods of attack, insults and libellous defamations. As before (innovation does not seem to be a hallmark of homeopathy), these attacks relate to claims that:

  • we are incompetent,
  • we do not care about the welfare of patients,
  • we are habitual liars,
  • we are on the payroll of the pharmaceutical industry,
  • we aim at limiting patient choice,
  • we do what we do because we crave the limelight.

So, what is going to happen?

I cannot read tea leaves but am nevertheless sure of a few things:

  • 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.

Medline is the biggest electronic databank for articles published in medicine and related fields. It is therefore the most important source of information in this area. I use it regularly to monitor what new papers have been published in the various fields of alternative medicine.

As the number of Medline-listed papers dated 2018 on homeopathy has just reached 100, I thought it might be the moment to run a quick analysis on this material. The first thing to note is that it took until August for 100 articles dated 2018 to emerge. To explain how embarrassing this is, we need a few comparative figures. At the same moment (6/9/18), we have, for instance:

  • 126576 articles for surgery
  • 5001 articles or physiotherapy
  • 30215 articles for psychiatry
  • 60161 articles for pharmacology

Even compared to other types of alternative medicine, homeopathy is being dwarfed. Currently the figures are, for instance:

  • 2232 for herbal medicine
  • 1949 for dietary supplements
  • 1222 for acupuncture

This does not look as though homeopathy is a frightfully active area of research, if I may say so. Looking at the type of articles (yes, I did look at all the 100 papers and categorised them the best I could) published in homeopathy, things get even worse:

  • 29 were comments, letters, editorials, etc.
  • 16 were basic and pre-clinical papers,
  • 12 were non-systematic reviews,
  • 10 were surveys,
  • 7 were case-reports,
  • 5 were pilot or feasibility studies,
  • 5 were systematic reviews,
  • 5 were controlled clinical trials,
  • 2 were case series,
  • the rest of the articles was not on homeopathy at all.

I find this pretty depressing. Most of the 100 papers turn out to be no real research at all. Crucial topics are not being covered. There was, for example, not a single paper on the risks of homeopathy (no, don’t tell me it is harmless; it can and does regularly cost the lives of patients who trust the bogus claims of homeopaths). There was no article investigating the important question whether the practice of homeopathy does not violate the rules of medical ethics (think of informed consent or the imperative to do more harm than good). And a mere 5 clinical trials is just a dismal amount, in my view.

In a previous post, I have already shown that, in 2015, homeopathy research was deplorable. My new analysis suggests that the situation has become much worse. One might even go as far as asking whether 2018 might turn out to be the year when homeopathy research finally died a natural death.

PROGRESS AT LAST!!!

If you thought that Chinese herbal medicine is just for oral use, you were wrong. This article explains it all in some detail: Injections of traditional Chinese herbal medicines are also referred to as TCM injections. This approach has evolved during the last 70 years as a treatment modality that, according to the authors, parallels injections of pharmaceutical products.

The researchers from China try to provide a descriptive analysis of various aspects of TCM injections. They used the the following data sources: (1) information retrieved from website of drug registration system of China, and (2) regulatory documents, annual reports and ADR Information Bulletins issued by drug regulatory authority.

As of December 31, 2017, 134 generic names for TCM injections from 224 manufacturers were approved for sale. Only 5 of the 134 TCM injections are documented in the present version of Ch.P (2015). Most TCM injections are documented in drug standards other than Ch.P. The formulation, ingredients and routes of administration of TCM injections are more complex than conventional chemical injections. Ten TCM injections are covered by national lists of essential medicine and 58 are covered by China’s basic insurance program of 2017. Adverse drug reactions (ADR) reports related to TCM injections account for  over 50% of all ADR reports related to TCMs, and the percentages have been rising annually.

The authors concluded that making traditional medicine injectable might be a promising way to develop traditional medicines. However, many practical challenges need to be overcome by further development before a brighter future for injectable traditional medicines can reasonably be expected.

I have to admit that TCM injections frighten the hell out of me. I feel that before we inject any type of substance into patients, we ought to know as a bare minimum:

  • for what conditions, if any, they have been proven to be efficacious,
  • what adverse effects each active ingredient can cause,
  • with what other drugs they might interact,
  • how reliable the quality control for these injections is.

I somehow doubt that these issues have been fully addressed in China. Therefore, I can only hope the Chinese manufacturers are not planning to export their dubious TCM injections.

A few days ago, I published an article in the ‘Sueddeutsche Zeitung’ (a truly rare event, as I have never done this before) where I argued that German pharmacists should consider stopping the sale of homeopathic remedies. It violates their ethical code, I suggested.

While this discussion has been going on for a while in the UK (British pharmacists have stopped inviting me to their gatherings because I get on their nerves with banging on about this!), it is relatively novel in Germany.

After I had submitted my copy to the SZ, an article was published which is highly relevant to this subject. Here I first copy an extract of the German original, and below I try to briefly explain its content to those who do not read German.

________________________________________________________________________________

In vielen Apotheken werden Kunden nicht hinreichend gut zu Homöopathika beraten. Zu diesem Ergebnis kommt Professor Tilmann Betsch, an der Universität Erfurt Leiter der Professur für Sozial-, Organisations- und Wirtschaftspsychologie, der mit seinem Team 100 zufällig ausgewählte Apotheken in Stuttgart, Erfurt, Leipzig und Frankfurt auf Herz und Nieren geprüft hat. Im Mittelpunkt der Kundengespräche stand eine Beratung zu einem erkälteten Familienmitglied.

“Zum einen zeigen unsere Ergebnisse, dass im Falle eines grippalen Infektes die überwiegende Mehrzahl von ihnen zu schulmedizinischen Präparaten rät, die mit hoher Wahrscheinlichkeit zu einer Linderung der Symptome führen”, erläutert Betsch. Was die Wirkung von Homöopathika betreffe, so zeichne das Untersuchungsergebnis ein eher düsteres Bild, ergänzt er. Denn in nur fünf Prozent aller Beratungsgespräche sei gesagt worden, dass es für die Wirkung von Homöopathie keine wissenschaftlichen Belege gäbe. In 30 Prozent sei dagegen behauptet worden, die Wirkung von Homöopathie sei entweder in Studien nachgewiesen oder ergebe sich aus dem Erfahrungswissen.

“Nach den Leitlinien der Bundesapothekenkammer soll jedoch die Beurteilung der Wirksamkeit von Präparaten nach pharmakologisch-toxikologischen Kriterien erfolgen. Zumindest was die Begründung ihrer Empfehlungen betrifft, folgte die überwiegende Mehrheit der von uns befragten Apotheker diesen Leitlinien nicht”, so Betschs Fazit. Während die Empfehlungen der Apotheker in der Regel nachweislich wirksame Medikamente enthalten hätten, habe sich ihr Wissen über die Wirkung von Homöopathie mehrheitlich nicht von Laien-Meinungen unterschieden.

____________________________________________________________________________________

Professor Tilmann Betsch has conducted a study showing that German pharmacists fail their customers when advising them on homeopathy. His team went under cover as patients with flue-like symptoms to 100 randomly selected pharmacists. Only 5% of the pharmacists admitted that homeopathics have no proven efficacy, while 30% claimed homeopathics have been proven to work in studies and through experience. This behaviour, Betsch explains, violates the current guidelines for pharmacists.

_____________________________________________________________________________________

I am delighted with these findings; they confirm my arguments perfectly.

Since, in Germany, homeopathics are sold only in pharmacies, German pharmacists have a pivotal role here. They are ethically bound to inform their customers based on the current best evidence. So, in my day-dreams, I imagine a dialogue between a customer and an ethical pharmacist:

CUSTOMER: I have a flu, is there a homeopathic remedy against it?

PHARMACIST: Yes, there is.

CUSTOMER: Can I have it please?

PHARMACIST: If you insist; but I must warn you: it has been shown not to work, and there is absolutely nothing in it that could possibly work.

CUSTOMER: What? Why do you sell it then?

PHARMACIST: Because some people like it.

CUSTOMER: Even though it does not work?

PHARMACIST: Yes.

CUSTOMER: Is it expensive?

PHARMACIST: Yes.

CUSTOMER: And some people still buy it?

PHARMACIST: Yes.

CUSTOMER: Well, not I! I am not a fool. But thank you for your honest information. Can I have something else that alleviates my symptoms?

PHARMACIST: With pleasure!

________________________________________________________________________________

The fate of homeopathy in Germany is largely in the hands of pharmacists, it seems.

But, is it in good, ethical hands? Is there hope that progress can be made?

We will see – so far, I have heard of just one!!! pharmacy that has stopped displaying homeopathics on its shelves.

The aim of palliative care is to improve quality of life for patients with serious illnesses by treating their symptoms, often in situations where all the possible causative therapeutic options have been exhausted. In many palliative care settings, complementary and alternative medicine (CAM) is used for this purpose. In fact, this is putting it mildly; my impression is that CAM seems to have flooded palliative care. The question is therefore whether this approach is based on sufficiently good evidence.

This review was aimed at evaluating the available evidence on the use of CAM in hospice and palliative care and to summarize their potential benefits. The researchers conducted thorough literature searches and located 4682 studies of which 17 were identified for further evaluation. The therapies considered included:

  • acupressure,
  • acupuncture,
  • aromatherapy massage,
  • breathing,
  • hypnotherapy,
  • massage,
  • meditation,
  • music therapy,
  • reflexology,
  • reiki.

Many studies demonstrated a short-term benefit in symptom improvement from baseline with CAM, although a significant benefit was not found between groups.

The authors concluded that CAM may provide a limited short-term benefit in patients with symptom burden. Additional studies are needed to clarify the potential value of CAM in the hospice or palliative setting.

When reading research articles in CAM, I often have to ask myself: ARE THEY TAKING THE MIKEY?

??? “Many studies demonstrated a short-term benefit in symptom improvement from baseline with CAM, although a significant benefit was not found between groups.” ???

Really?!?!?

Controlled clinical trials are only about comparing the outcomes between the experimental and the control groups (and not about assessing improvements from baseline which can be [and often is] unrelated to any effect caused by the treatment per se). Therefore, within-group changes are irrelevant and should not even deserve a mention in the abstract. Thus the only finding worth reporting in the abstract is this:

No significant benefit was found.

It follows that the above conclusions are totally out of line with the data.

They should, according to what the researchers report in their abstract, read something like this:

CAM HAS NO PROVEN BENEFIT IN PALLIATIVE CARE. ITS USE IN THIS AREA IS THEREFORE HIGHLY PROBLEMATIC.

How often do we hear this sentence: “I know, because I have done my research!” I don’t doubt that most people who make this claim believe it to be true.

But is it?

What many mean by saying, “I know, because I have done my research”, is that they went on the internet and looked at a few websites. Others might have been more thorough and read books and perhaps even some original papers. But does that justify their claim, “I know, because I have done my research”?

The thing is, there is research and there is research.

The dictionary defines research as “The systematic investigation into and study of materials and sources in order to establish facts and reach new conclusions.” This definition is helpful because it mentions several issues which, I believe, are important.

Research should be:

  • systematic,
  • an investigation,
  • establish facts,
  • reach new conclusions.

To me, this indicates that none of the following can be truly called research:

  • looking at a few randomly chosen papers,
  • merely reading material published by others,
  • uncritically adopting the views of others,
  • repeating the conclusions of others.

Obviously, I am being very harsh and uncompromising here. Not many people could, according to these principles, truthfully claim to have done research in alternative medicine. Most people in this realm do not fulfil any of those criteria.

As I said, there is research and research – research that meets the above criteria, and the type of research most people mean when they claim: “I know, because I have done my research.”

Personally, I don’t mind that the term ‘research’ is used in more than one way:

  • there is research meeting the criteria of the strict definition
  • and there is a common usage of the word.

But what I do mind, however, is when the real research is claimed to be as relevant and reliable as the common usage of the term. This would be a classical false equivalence, akin to putting experts on a par with pseudo-experts, to believing that facts are no different from fantasy, or to assume that truth is akin to post-truth.

Sadly, in the realm of alternative medicine (and alarmingly, in other areas as well), this is exactly what has happened since quite some time. No doubt, this might be one reason why many consumers are so confused and often make wrong, sometimes dangerous therapeutic decisions. And this is why I think it is important to point out the difference between research and research.

The following announcement was made by the NHS on 7 August 2018:

The Governing Body of Bristol, North Somerset and South Gloucestershire (BNSSG) Clinical Commissioning Group (CCG) today approved changes that mean NHS funded homeopathy will only be available in exceptional circumstances in the area. The changes will mean the CCG’s Individual Funding Request (IFR) Panel would need a clinician to set out why the patient is clinically exceptional before treatment could be provided.

The decision comes after the publication of a report, which took evidence from local people, clinicians, patient groups, providers of homeopathic treatments and national guidelines.

CCG Clinical Chair Dr Jonathan Hayes said, “We are working hard to become an evidence-informed organisation because we need to make the best use of all resources to offer treatment and care to the widest range of people. The decision on homeopathy funding today is a step towards this and brings us in line with national guidelines.”

It is estimated that 41 patients receiving NHS funded homeopathic consultations in the area cost the local NHS £109,476 in the 2017/2018 financial year.

END OF QUOTE

R.I.P. NHS #homeopathy 5 July 1948 - 7 August 2018

The move is the result of 4 years of excellent work by the GOOD THINKING SOCIETY, a charity dedicate to the promotion of rational thinking.

Michael Marshall, its Project Director, said: “We are very pleased to see the Bristol CCGs take this decision to cease funding for homeopathy – every other CCG across the country has made it clear that homeopathic remedies are no better than placebo and such there is simply no place for homeopathy on the NHS.

“With the end to homeopathy funding in Bristol, the region joins NHS bodies across the rest the country in recognising that homeopathy is not a valid use of limited NHS resources. There is now no CCG in England where homeopathic pills or consultations can be routinely funded with NHS money – instead, funding can be directed towards treatments that have been shown to actually work.”

Does that not call for a knighthood for Mr Marshall?

One would have thought so!

Who will tell Prince Charles to get the ball rolling?

And while we are all waiting for the big event, you might as well donate a few £s to this truly splendid charity.

Please be generous!!!

It is no secret to regular readers of this blog that chiropractic’s effectiveness is unproven for every condition it is currently being promoted for – perhaps with two exceptions: neck pain and back pain. Here we have some encouraging data, but also lots of negative evidence. A new US study falls into the latter category; I am sure chiropractors will not like it, but it does deserve a mention.

This study evaluated the comparative effectiveness of usual care with or without chiropractic care for patients with chronic recurrent musculoskeletal back and neck pain. It was designed as a prospective cohort study using propensity score-matched controls.

Using retrospective electronic health record data, the researchers developed a propensity score model predicting likelihood of chiropractic referral. Eligible patients with back or neck pain were then contacted upon referral for chiropractic care and enrolled in a prospective study. For each referred patient, two propensity score-matched non-referred patients were contacted and enrolled. We followed the participants prospectively for 6 months. The main outcomes included pain severity, interference, and symptom bothersomeness. Secondary outcomes included expenditures for pain-related health care.

Both groups’ (N = 70 referred, 139 non-referred) pain scores improved significantly over the first 3 months, with less change between months 3 and 6. No significant between-group difference was observed. After controlling for variances in baseline costs, total costs during the 6-month post-enrollment follow-up were significantly higher on average in the non-referred versus referred group. Adjusting for differences in age, gender, and Charlson comorbidity index attenuated this finding, which was no longer statistically significant (p = .072).

The authors concluded by stating this: we found no statistically significant difference between the two groups in either patient-reported or economic outcomes. As clinical outcomes were similar, and the provision of chiropractic care did not increase costs, making chiropractic services available provided an additional viable option for patients who prefer this type of care, at no additional expense.

This comes from some of the most-renowned experts in back pain research, and it is certainly an elaborate piece of investigation. Yet, I find the conclusions unreasonable.

Essentially, the authors found that chiropractic has no clinical or economical advantage over other approaches currently used for neck and back pain. So, they say that it a ‘viable option’.

I find this odd and cannot quite follow the logic. In my view, it lacks critical thinking and an attempt to produce progress. If it is true that all treatments were similarly (in)effective – which I can well believe – we still should identify those that have the least potential for harm. That could be exercise, massage therapy or some other modality – but I don’t think it would be chiropractic care.


References

Comparative Effectiveness of Usual Care With or Without Chiropractic Care in Patients with Recurrent Musculoskeletal Back and Neck Pain.

Elder C, DeBar L, Ritenbaugh C, Dickerson J, Vollmer WM, Deyo RA, Johnson ES, Haas M.

J Gen Intern Med. 2018 Jun 25. doi: 10.1007/s11606-018-4539-y. [Epub ahead of print]

PMID: 29943109

“Non-reproducible single occurrences are of no significance to science”, this quote by Karl Popper often seems to get forgotten in medicine, particularly in alternative medicine. It indicates that findings have to be reproducible to be meaningful – if not, we cannot be sure that the outcome in question was caused by the treatment we applied.

This is thus a question of cause and effect.

The statistician Sir Austin Bradford Hill proposed in 1965 a set of 9 criteria to provide evidence of a relationship between a presumed cause and an observed effect while demonstrating the connection between cigarette smoking and lung cancer. One of his criteria is consistency or reproducibility: Consistent findings observed by different persons in different places with different samples strengthens the likelihood of an effect.

By mentioning ‘different persons’, Hill seems to also establish the concept of INDEPENDENT replication.

Let me try to explain this with an example from the world of SCAM.

  1. A homeopath feels that childhood diarrhoea could perhaps be treated with individualised homeopathic remedies.  She conducts a trial, finds a positive result and concludes that the statistically significant decrease in the duration of diarrhea in the treatment group suggests that homeopathic treatment might be useful in acute childhood diarrhea. Further study of this treatment deserves consideration.
  2. Unsurprisingly, this study is met with disbelieve by many experts. Some go as far as doubting its validity, and several letters to the editor appear expressing criticism. The homeopath is thus motivated to run another trial to prove her point. Its results are consistent with the finding from the previous study that individualized homeopathic treatment decreases the duration of diarrhea and number of stools in children with acute childhood diarrhea.
  3. We now have a replication of the original finding. Yet, for a range of reasons, sceptics are far from satisfied. The homeopath thus runs a further trial and publishes a meta-analysis of all there studies. The combined analysis shows a duration of diarrhoea of 3.3 days in the homeopathy group compared with 4.1 in the placebo group (P = 0.008). She thus concludes that the results from these studies confirm that individualized homeopathic treatment decreases the duration of acute childhood diarrhea and suggest that larger sample sizes be used in future homeopathic research to ensure adequate statistical power. Homeopathy should be considered for use as an adjunct to oral rehydration for this illness.

To most homeopaths it seems that this body of evidence from three replication is sound and solid. Consequently, they frequently cite these publications as a cast-iron proof of their assumption that individualised homeopathy is effective. Sceptics, however, are still not convinced.

Why?

The studies have been replicated alright, but what is missing is an INDEPENDENT replication.

To me this word implies two things:

  1. The results have to be reproduced by another research group that is unconnected to the one that conducted the three previous studies.
  2. That group needs to be independent from any bias that might get in the way of conducting a rigorous trial.

And why do I think this latter point is important?

Simply because I know from many years of experience that a researcher, who strongly believes in homeopathy or any other subject in question, will inadvertently introduce all sorts of biases into a study, even if its design is seemingly rigorous. In the end, these flaws will not necessarily show in the published article which means that the public will be mislead. In other words, the paper will report a false-positive finding.

It is possible, even likely, that this has happened with the three trials mentioned above. The fact is that, as far as I know, there is no independent replication of these studies.

In the light of all this, Popper’s axiom as applied to medicine should perhaps be modified: findings without independent replication are of no significance. Or, to put it even more bluntly: independent replication is an essential self-cleansing process of science by which it rids itself from errors, fraud and misunderstandings.

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