MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

bias

As I often said, I find it regrettable that sceptics often say THERE IS NOT A SINGLE STUDY THAT SHOWS HOMEOPATHY TO BE EFFECTIVE (or something to that extent). This is quite simply not true, and it gives homeopathy-fans the occasion to suggest sceptics wrong. The truth is that THE TOTALITY OF THE MOST RELIABLE EVIDENCE FAILS TO SUGGEST THAT HIGHLY DILUTED HOMEOPATHIC REMEDIES ARE EFFECTIVE BEYOND PLACEBO. As a message for consumers, this is a little more complex, but I believe that it’s worth being well-informed and truthful.

And that also means admitting that a few apparently rigorous trials of homeopathy exist and some of them show positive results. Today, I want to focus on this small set of studies.

How can a rigorous trial of a highly diluted homeopathic remedy yield a positive result? As far as I can see, there are several possibilities:

  1. Homeopathy does work after all, and we have not fully understood the laws of physics, chemistry etc. Homeopaths favour this option, of course, but I find it extremely unlikely, and most rational thinkers would discard this possibility outright. It is not that we don’t quite understand homeopathy’s mechanism; the fact is that we understand that there cannot be a mechanism that is in line with the laws of nature.
  2. The trial in question is the victim of some undetected error.
  3. The result has come about by chance. Of 100 trials, 5 would produce a positive result at the 5% probability level purely by chance.
  4. The researchers have cheated.

When we critically assess any given trial, we attempt, in a way, to determine which of the 4 solutions apply. But unfortunately we always have to contend with what the authors of the trial tell us. Publications never provide all the details we need for this purpose, and we are often left speculating which of the explanations might apply. Whatever it is, we assume the result is false-positive.

Naturally, this assumption is hard to accept for homeopaths; they merely conclude that we are biased against homeopathy and conclude that, however, rigorous a study of homeopathy is, sceptics will not accept its result, if it turns out to be positive.

But there might be a way to settle the argument and get some more objective verdict, I think. We only need to remind ourselves of a crucially important principle in all science: INDEPENDENT REPLICATIONTo be convincing, a scientific paper needs to provide evidence that the results are reproducible. In medicine, it unquestionably is wise to accept a new finding only after it has been confirmed by other, independent researchers. Only if we have at least one (better several) independent replications, can we be reasonably sure that the result in question is true and not false-positive due to bias, chance, error or fraud.

And this is, I believe, the extremely odd phenomenon about the ‘positive’ and apparently rigorous studies of homeopathic remedies. Let’s look at the recent meta-analysis of Mathie et al. The authors found several studies that were both positive and fairly rigorous. These trials differ in many respects (e. g. remedies used, conditions treated) but they have, as far as I can see, one important feature in common: THEY HAVE NOT BEEN INDEPENDENTLY REPLICATED.

If that is not astounding, I don’t know what is!

Think of it: faced with a finding that flies in the face of science and would, if true, revolutionise much of medicine, scientists should jump with excitement. Yet, in reality, nobody seems to take the trouble to check whether it is the truth or an error.

To explain this absurdity more fully, let’s take just one of these trials as an example, one related to a common and serious condition: COPD

The study is by Prof Frass and was published in 2005 – surely long enough ago for plenty of independent replications to emerge. Its results showed that potentized (C30) potassium dichromate decreases the amount of tracheal secretions was reduced, extubation could be performed significantly earlier, and the length of stay was significantly shorter. This is a scientific as well as clinical sensation, if there ever was one!

The RCT was published in one of the leading journals on this subject (Chest) which is read by most specialists in the field, and it was at the time widely reported. Even today, there is hardly an interview with Prof Frass in which he does not boast about this trial with truly sensational results (only last week, I saw one). If Frass is correct, his findings would revolutionise the lives of thousands of seriously suffering patients at the very brink of death. In other words, it is inconceivable that Frass’ result has not been replicated!

But it hasn’t; at least there is nothing in Medline.

Why not? A risk-free, cheap, universally available and easy to administer treatment for such a severe, life-threatening condition would normally be picked up instantly. There should not be one, but dozens of independent replications by now. There should be several RCTs testing Frass’ therapy and at least one systematic review of these studies telling us clearly what is what.

But instead there is a deafening silence.

Why?

For heaven sakes, why?

The only logical explanation is that many centres around the world did try Frass’ therapy. Most likely they found it does not work and soon dismissed it. Others might even have gone to the trouble of conducting a formal study of Frass’ ‘sensational’ therapy and found it to be ineffective. Subsequently they felt too silly to submit it for publication – who would not laugh at them, if they said they trailed a remedy that was diluted 1: 1000000000000000000000000000000000000000000000000000000000000 and found it to be worthless? Others might have written up their study and submitted it for publication, but got rejected by all reputable journals in the field because the editors felt that comparing one placebo to another placebo is not real science.

And this is roughly, how it went with the other ‘positive’ and seemingly rigorous studies of homeopathy as well, I suspect.

Regardless of whether I am correct or not, the fact is that there are no independent replications (if readers know any, please let me know).

Once a sufficiently long period of time has lapsed and no replications of a ‘sensational’ finding did not emerge, the finding becomes unbelievable or bogus – no rational thinker can possibly believe such a results (I for one have not yet met an intensive care specialist who believes Frass’ findings, for instance). Subsequently, it is quietly dropped into the waste-basket of science where it no longer obstructs progress.

The absence of independent replications is therefore a most useful mechanism by which science rids itself of falsehoods.

It seems that homeopathy is such a falsehood.

 

 

The plethora of dodgy meta-analyses in alternative medicine has been the subject of a recent post – so this one is a mere update of a regular lament.

This new meta-analysis was to evaluate evidence for the effectiveness of acupuncture in the treatment of lumbar disc herniation (LDH). (Call me pedantic, but I prefer meta-analyses that evaluate the evidence FOR AND AGAINST a therapy.) Electronic databases were searched to identify RCTs of acupuncture for LDH, and 30 RCTs involving 3503 participants were included; 29 were published in Chinese and one in English, and all trialists were Chinese.

The results showed that acupuncture had a higher total effective rate than lumbar traction, ibuprofen, diclofenac sodium and meloxicam. Acupuncture was also superior to lumbar traction and diclofenac sodium in terms of pain measured with visual analogue scales (VAS). The total effective rate in 5 trials was greater for acupuncture than for mannitol plus dexamethasone and mecobalamin, ibuprofen plus fugui gutong capsule, loxoprofen, mannitol plus dexamethasone and huoxue zhitong decoction, respectively. Two trials showed a superior effect of acupuncture in VAS scores compared with ibuprofen or mannitol plus dexamethasone, respectively.

The authors from the College of Traditional Chinese Medicine, Jinan University, Guangzhou, Guangdong, China, concluded that acupuncture showed a more favourable effect in the treatment of LDH than lumbar traction, ibuprofen, diclofenac sodium, meloxicam, mannitol plus dexamethasone and mecobalamin, fugui gutong capsule plus ibuprofen, mannitol plus dexamethasone, loxoprofen and huoxue zhitong decoction. However, further rigorously designed, large-scale RCTs are needed to confirm these findings.

Why do I call this meta-analysis ‘dodgy’? I have several reasons, 10 to be exact:

  1. There is no plausible mechanism by which acupuncture might cure LDH.
  2. The types of acupuncture used in these trials was far from uniform and  included manual acupuncture (MA) in 13 studies, electro-acupuncture (EA) in 10 studies, and warm needle acupuncture (WNA) in 7 studies. Arguably, these are different interventions that cannot be lumped together.
  3. The trials were mostly of very poor quality, as depicted in the table above. For instance, 18 studies failed to mention the methods used for randomisation. I have previously shown that some Chinese studies use the terms ‘randomisation’ and ‘RCT’ even in the absence of a control group.
  4. None of the trials made any attempt to control for placebo effects.
  5. None of the trials were conducted against sham acupuncture.
  6. Only 10 studies 10 trials reported dropouts or withdrawals.
  7. Only two trials reported adverse reactions.
  8. None of these shortcomings were critically discussed in the paper.
  9. Despite their affiliation, the authors state that they have no conflicts of interest.
  10. All trials were conducted in China, and, on this blog, we have discussed repeatedly that acupuncture trials from China never report negative results.

And why do I find the journal ‘dodgy’?

Because any journal that publishes such a paper is likely to be sub-standard. In the case of ‘Acupuncture in Medicine’, the official journal of the British Medical Acupuncture Society, I see such appalling articles published far too frequently to believe that the present paper is just a regrettable, one-off mistake. What makes this issue particularly embarrassing is, of course, the fact that the journal belongs to the BMJ group.

… but we never really thought that science publishing was about anything other than money, did we?

What an odd title, you might think.

Systematic reviews are the most reliable evidence we presently have!

Yes, this is my often-voiced and honestly-held opinion but, like any other type of research, systematic reviews can be badly abused; and when this happens, they can seriously mislead us.

new paper by someone who knows more about these issues than most of us, John Ioannidis from Stanford university, should make us think. It aimed at exploring the growth of published systematic reviews and meta‐analyses and at estimating how often they are redundant, misleading, or serving conflicted interests. Ioannidis demonstrated that publication of systematic reviews and meta‐analyses has increased rapidly. In the period January 1, 1986, to December 4, 2015, PubMed tags 266,782 items as “systematic reviews” and 58,611 as “meta‐analyses.” Annual publications between 1991 and 2014 increased 2,728% for systematic reviews and 2,635% for meta‐analyses versus only 153% for all PubMed‐indexed items. Ioannidis believes that probably more systematic reviews of trials than new randomized trials are published annually. Most topics addressed by meta‐analyses of randomized trials have overlapping, redundant meta‐analyses; same‐topic meta‐analyses may exceed 20 sometimes.

Some fields produce massive numbers of meta‐analyses; for example, 185 meta‐analyses of antidepressants for depression were published between 2007 and 2014. These meta‐analyses are often produced either by industry employees or by authors with industry ties and results are aligned with sponsor interests. China has rapidly become the most prolific producer of English‐language, PubMed‐indexed meta‐analyses. The most massive presence of Chinese meta‐analyses is on genetic associations (63% of global production in 2014), where almost all results are misleading since they combine fragmented information from mostly abandoned era of candidate genes. Furthermore, many contracting companies working on evidence synthesis receive industry contracts to produce meta‐analyses, many of which probably remain unpublished. Many other meta‐analyses have serious flaws. Of the remaining, most have weak or insufficient evidence to inform decision making. Few systematic reviews and meta‐analyses are both non‐misleading and useful.

The author concluded that the production of systematic reviews and meta‐analyses has reached epidemic proportions. Possibly, the large majority of produced systematic reviews and meta‐analyses are unnecessary, misleading, and/or conflicted.

Ioannidis makes the following ‘Policy Points’:

  • Currently, there is massive production of unnecessary, misleading, and conflicted systematic reviews and meta‐analyses. Instead of promoting evidence‐based medicine and health care, these instruments often serve mostly as easily produced publishable units or marketing tools.
  • Suboptimal systematic reviews and meta‐analyses can be harmful given the major prestige and influence these types of studies have acquired.
  • The publication of systematic reviews and meta‐analyses should be realigned to remove biases and vested interests and to integrate them better with the primary production of evidence.

Obviously, Ioannidis did not have alternative medicine in mind when he researched and published this article. But he easily could have! Virtually everything he stated in his paper does apply to it. In some areas of alternative medicine, things are even worse than Ioannidis describes.

Take TCM, for instance. I have previously looked at some of the many systematic reviews of TCM that currently flood Medline, based on Chinese studies. This is what I concluded at the time:

Why does that sort of thing frustrate me so much? Because it is utterly meaningless and potentially harmful:

  • I don’t know what treatments the authors are talking about.
  • Even if I managed to dig deeper, I cannot get the information because practically all the primary studies are published in obscure journals in Chinese language.
  • Even if I  did read Chinese, I do not feel motivated to assess the primary studies because we know they are all of very poor quality – too flimsy to bother.
  • Even if they were formally of good quality, I would have my doubts about their reliability; remember: 100% of these trials report positive findings!
  • Most crucially, I am frustrated because conclusions of this nature are deeply misleading and potentially harmful. They give the impression that there might be ‘something in it’, and that it (whatever ‘it’ might be) could be well worth trying. This may give false hope to patients and can send the rest of us on a wild goose chase.

So, to ease the task of future authors of such papers, I decided give them a text for a proper EVIDENCE-BASED conclusion which they can adapt to fit every review. This will save them time and, more importantly perhaps, it will save everyone who might be tempted to read such futile articles the effort to study them in detail. Here is my suggestion for a conclusion soundly based on the evidence, not matter what TCM subject the review is about:

OUR SYSTEMATIC REVIEW HAS SHOWN THAT THERAPY ‘X’ AS A TREATMENT OF CONDITION ‘Y’ IS CURRENTLY NOT SUPPORTED BY SOUND EVIDENCE.

On another occasion, I stated that I am getting very tired of conclusions stating ‘…XY MAY BE EFFECTIVE/HELPFUL/USEFUL/WORTH A TRY…’ It is obvious that the therapy in question MAY be effective, otherwise one would surely not conduct a systematic review. If a review fails to produce good evidence, it is the authors’ ethical, moral and scientific obligation to state this clearly. If they don’t, they simply misuse science for promotion and mislead the public. Strictly speaking, this amounts to scientific misconduct.

In yet another post on the subject of systematic reviews, I wrote that if you have rubbish trials, you can produce a rubbish review and publish it in a rubbish journal (perhaps I should have added ‘rubbish researchers).

And finally this post about a systematic review of acupuncture: it is almost needless to mention that the findings (presented in a host of hardly understandable tables) suggest that acupuncture is of proven or possible effectiveness/efficacy for a very wide array of conditions. It also goes without saying that there is no critical discussion, for instance, of the fact that most of the included evidence originated from China, and that it has been shown over and over again that Chinese acupuncture research never seems to produce negative results.

The main point surely is that the problem of shoddy systematic reviews applies to a depressingly large degree to all areas of alternative medicine, and this is misleading us all.

So, what can be done about it?

My preferred (but sadly unrealistic) solution would be this:

STOP ENTHUSIASTIC AMATEURS FROM PRETENDING TO BE RESEARCHERS!

Research is not fundamentally different from other professional activities; to do it well, one needs adequate training; and doing it badly can cause untold damage.

Dr. Dietmar Payrhuber is not famous – no, by no means. I had never heard of him until a watched this TV discussion about homeopathy (it’s in German, and well-worth watching, if you understand the language). I found the discussion totally mesmerising: Payrhuber is allowed to come out with case after case alleging he cured cancer of various types with homeopathy. Prof Frass is also there to defend the indefensible, but hardly intervenes, other than repeatedly and pompously stating that he is a professor with 200 publications who runs a homeopathy clinic at the university hospital of Vienna and therefore he is a cut above.

There are also three very bright and eloquent sceptical disputants who do their best to oppose Payrhuber’s moronic monstrosities. One of them even alerts us (and the broadcaster!) to the fact that some cancer patients might watch this and conclude that homeopathy cues cancer. Yes, TV can be dangerous!

After watching Payrhuber, I felt the urge to learn more about this man. On TV, he mentioned repeatedly his publications, so I first of all conducted a Medline search; it turns out that Medline lists not a single article in his name. However, I did find his (self-published) book: ‘HOMOEOPATHIE UND KREBS’ (HOMEOPATHY AND CANCER). It greatly impressed me – but not in a positive sense.

The preface (in English) is by Jan Scholten (who IS quite famous in the realm of homeopathy); here is a short quote from it:

[Payrhuber’s book] … is an important book for several reasons. The first reason is that it shows that homeopathy is a real healing art. Often homeopathy is seen as good for superficial, light and self-healing diseases such as colds, eczema’s, bronchitis and the like. Together with this view goes the opinion that it is not a real medicine, because it cannot treat „real diseases“. But this shows the opposite: cancer can be healed, cured with homeopathy. It shows that homeopathy can have very profound effect and can really cure deeply. Of course cancer was cured already in the past with homeopathy by famous homeopaths such as Grimmer and Resch. But Dietmar shows that it can be done in a consistent way. Homeopathy cannot be set aside as superficial anymore…

But it gets worse! Payrhuber himself is equally clear that homeopathy can cure cancer; here is a quote that I translated from his German text into English:

The book shows options to treat cancer; this is not an exclusive option of homeopathy. However, it offers an alternative for therapy-resistant and slow-responding cases treated conventionally… The question whether homeopathy is an alternative or a complementary therapy is superfluous. As the cases presented here demonstrate, homeopathy is part of medicine, a method which is more scientific than conventional medicine, because it has clear principles and laws. In certain cases or in certain phases of cancer, homeopathy is quite simply indicated! Homeopathy is holistic and puts the whole patient rather than a local symptom in the centre.

We must not keep homeopathy from cancer patients, because it offers in many cases a cure which cannot be achieved by other means.

(For those who can read German, here is the original: Das Buch zeigt Möglichkeiten auf, Krebs zu behandeln, es stellt keinen Alleinanspruch der Homöopathie dar. Es bietet allerdings alternative Möglichkeiten für therapieresistente und therapieträge Behandlungsverläufe bei konventioneller Therapie an…. 

Es erübrigt sich die Frage, ob Homöopathie eine alternative oder komplementäre Medizin ist. Wie die vorliegenden Fälle zeigen, ist sie ein Teil der Medizin, eine Methode, die „eher wissenschaftlicher ist als die Schulmedizin, weil die Homöopathie deutliche Prinzipien und Gesetze hat“. Die Homöopathie ist in bestimmten Fällen oder in bestimmten Phasen der Behandlung schlicht und einfach indiziert! Sie ist ganzheitlich, setzt den Menschen ins Zentrum und nicht das Lokalsymptom…

Die Homöopathie darf dem Patienten nicht vorenthalten werden, da sie in vielen Fällen Heilungsmöglichkeiten bietet, die auf andere Weise nicht erreicht werden können…)

END OF QUOTE

As I said, Payrhuber is not famous – he is infamous!

This sad story left me with three questions:

  1. Can someone please stop Payrhuber before he does more damage to cancer patients?
  2. And can someone please tell the medical faculty of the university of Vienna (my former employer) that running a homeopathy clinic for cancer patients is not ethical?
  3. Can someone please teach journalists that, in healthcare, giving a voice to dangerous nonsense can do serious harm?

The UK ACUPPUNCTURE RESEARCH RESOURCE CENTRE (ARRC) is a specialist resource for acupuncture research information; the only such resource in the land. It is funded by the British Acupuncture Council (BAcC) and was established in 1994 by the BAcC in partnership with the Foundation for Research in Traditional Chinese Medicine.

The ARRC organise an annual meeting. This year’s meeting is special because it is their 20th! It is scheduled to take place in London on 17th March. In case you are already busy that day, or you want to save the £120 registration fee, I have copied for you the programme below and am even able to inform you about the content of each lecture.

  1. Hugh MacPherson – Celebrating twenty years of acupuncture research
  2. Lee Hullender Rubin  – The Impact of Whole Systems Traditional Chinese Medicine on In Vitro Fertilization Outcomes – A Retrospective Cohort Study
  3. Robert Davis – Beyond Efficacy: Conducting and translating research for policy-makers considering acupuncture reimbursement in a small, rural US state
  4. Lee Hullender Rubin – Acupuncture Augmentation of Lidocaine Treatment of Provoked, localized Vulvodynia – a Feasability and Acceptability Pilot Study
  5. Florian Beissner – A TCM-based psychotherapy with acupuncture for endometriosis
  6. Beverley De Valois – Using moxa on St 36 to reduce chemotherapy-induced pancytopenia: a feasibility study
  7. Ian Appleyard – Warm needle acupuncture for osteoarthritis of the knee: a pilot study
  8. Ed Fraser – Stand Easy: An Evaluation of the acceptability and effectiveness of acupuncture as a treatment for post-traumatic stress disorder for veterans in Norfolk

Having attended plenty of such meetings in my time, I can give you a fairly good idea about the contents of the 8 lectures. Below, I provide succinct (and slightly satirical) summaries of what the presenters will tell their audience on the 17th:

  1. Despite difficult circumstances, we (the ARRC) have done very well indeed. We managed to publish lots of papers, and we made sure that not a single one reported a negative result. That would be bad for business. We are optimistic about the future provided we get some funding, of course.
  2. Whole Systems Traditional Chinese Medicine has a profoundly positive effect on the outcomes of In Vitro fertilization. We are totally balled over! Only the most pedantic sceptics would have reservations and might argue that the study had no controls and was retrospective. But who cares, we believe in positive results, and therefore, we never listen to criticism.
  3. Because efficacy is a sticky issue in the realm of acupuncture, it is much wiser to tackle policy makers by persuading them that they can save money (lots of it), if they implement the abundant use of acupuncture. The evidence for this notion is flimsy to say the least, but policy makers do not understand the science (and neither do we).
  4. Our study showed that Acupuncture Augmentation of Lidocaine Treatment is extremely good for vulvodynia. We are very impressed, over the moon even. Of course, this was a feasibility study and we should really only conclude that a full study may be feasible, but let’s not be nit-picking.
  5. Based on my very extensive experience, I am able to confirm that TCM-based psychotherapy with acupuncture is an excellent therapy for endometriosis. Rigorous, controlled clinical trials do not exist, but my findings are so clear that, quite honestly, we do not need them.
  6. Using moxa on St 36 to reduce chemotherapy-induced pancytopenia is feasible. Isn’t that lovely?
  7. My trial of warm needle acupuncture for osteoarthritis of the knee showed most encouraging results. Of course, this was only a pilot study, and from it we should really only conclude that a proper study may be feasible, but let’s not be holier than thou!
  8. Our results demonstrate that acupuncture as a treatment for post-traumatic stress disorder is amazingly effective. A breakthrough! What is more, veterans found it most acceptable. The study is not rigorous, but I don’t mind. I advocate this treatment to be rolled out nationally as a matter of urgency.

————————————————————————————————————————————

So, there you are; that’s all you need to know about the 20th annual meeting of the ARRC.

You don’t need to go.

I have thus saved you £120!

No, I don’t expect thanks – I prefer, if you would send half of this amount (£60) to my account.

 

Today, the BMJ published our ‘head to head‘ article on the above question. Dr Mike Cummings argues the pro-part, while Prof Asbjorn Horbjardsson and I argue against the notion.

The pro arguments essentially are the well-rehearsed points acupuncture-fans like to advance:

  • Some guidelines do recommend acupuncture.
  • Sham acupuncture is not a valid comparator.
  • The largest meta-analysis shows a small effect.
  • Acupuncture is not implausible.
  • It improves quality of life.

Cummings concludes as follows: In summary, the pragmatic view sees acupuncture as a relatively safe and moderately effective intervention for a wide range of common chronic pain conditions. It has a plausible set of neurophysiological mechanisms supported by basic science.12 For those patients who choose it and who respond well, it considerably improves health related quality of life, and it has much lower long term risk for them than non-steroidal anti-inflammatory drugs. It may be especially useful for chronic musculoskeletal pain and osteoarthritis in elderly patients, who are at particularly high risk from adverse drug reactions.

Our arguments are also not new; essentially, we stress that:

  • The effects of acupuncture are too small to be clinically relevant.
  • They are probably not even caused by acupuncture, but the result of residual bias.
  • Pragmatic trials are of little value in defining efficacy.
  • Acupuncture is not free of risks.
  • Regular acupuncture treatments are expensive.
  • There is no generally accepted, plausible mechanism.

We concluded that after decades of research and hundreds of acupuncture pain trials, including thousands of patients, we still have no clear mechanism of action, insufficient evidence for clinically worthwhile benefit, and possible harms. Therefore, doctors should not recommend acupuncture for pain.

Neither Asbjorn nor I have any conflicts of interests to declare.

Dr Cummings, by contrast, states that he is the salaried medical director of the British Medical Acupuncture Society, which is a membership organisation and charity established to stimulate and promote the use and scientific understanding of acupuncture as part of the practice of medicine for the public benefit. He is an associate editor for Acupuncture in Medicine, published by BMJ. He has a modest private income from lecturing outside the UK, royalties from textbooks, and a partnership teaching veterinary surgeons in Western veterinary acupuncture. He has participated in a NICE guideline development group as an expert adviser discussing acupuncture. He has used Western medical acupuncture in clinical practice following a chance observation as a medical officer in the Royal Air Force in 1989.

My question to you is this: WHICH OF THE TWO POSITION IS THE MORE REASONABLE ONE?

Please, do let us know by posting a comment here, or directly at the BMJ article (better), or both (best).

Do chiropractors even know the difference between promotion and research?

Probably a rhetorical question.

Personally, I have seen them doing so much pseudo-research that I doubt they recognise the real thing, even if they fell over it.

Here is a recent example that stands for many, many more such ‘research’ projects (some of which have been discussed on this blog).

But first a few sentences on the background of this new ‘study’.

The UD chiropractic profession is currently on the ‘opioid over-use bandwagon’ hoping that this move might promote their trade. Most chiropractors have always been against using (any type of) pharmaceutical treatment and advise their patients accordingly. D D Palmer, the founder of chiropractic, was adamant that drugs are to be avoided; he stated for instance that Drugs are delusive; they do not adjust anything. And “as the Founder intended, chiropractic has existed as a drug-free healthcare profession for better than 120 years.” To this day, chiropractors are educated and trained to argue against non-drug treatments and regularly claim that chiropractic is a drug-free alternative to traditional medicine.

Considering this background, this new piece of (pseudo) research is baffling, in my view.

The objective of this investigation was to evaluate the association between utilization of chiropractic services and the use of prescription opioid medications. The authors used a retrospective cohort design to analyse health insurance claims data. The data source was the all payer claims database administered by the State of New Hampshire. The authors chose New Hampshire because health claims data were readily available for research, and in 2015, New Hampshire had the second-highest age-adjusted rate of drug overdose deaths in the United States.

The study population comprised New Hampshire residents aged 18-99 years, enrolled in a health plan, and with at least two clinical office visits within 90 days for a primary diagnosis of low-back pain. The authors excluded subjects with a diagnosis of cancer. They measured likelihood of opioid prescription fill among recipients of services delivered by chiropractors compared with a control group of patients not consulting a chiropractor. They also compared the cohorts with regard to rates of prescription fills for opioids and associated charges.

The adjusted likelihood of filling a prescription for an opioid analgesic was 55% lower among chiropractic compared to non-chiropractic patients. Average charges per person for opioid prescriptions were also significantly lower among the former group.

The authors concluded that among New Hampshire adults with office visits for noncancer low-back pain, the likelihood of filling a prescription for an opioid analgesic was significantly lower for recipients of services delivered by doctors of chiropractic compared with nonrecipients. The underlying cause of this correlation remains unknown, indicating the need for further investigation.

The underlying cause remains unknown???

Really?

Let me speculate, or even better, let me extrapolate by drawing an analogy:

Employees by a large Hamburger chain set out to study the association between utilization of Hamburger restaurant services and vegetarianism. The authors used a retrospective cohort design. The study population comprised New Hampshire residents aged 18-99 years, who had entered the premises of a Hamburger restaurant within 90 days for a primary purpose of eating. The authors excluded subjects with a diagnosis of cancer. They measured the likelihood of  vegetarianism among recipients of services delivered by Hamburger restaurants compared with a control group of individuals not using meat-dispensing facilities. They also compared the cohorts with regard to the money spent in Hamburger restaurants.

The adjusted likelihood of being a vegetarian was 55% lower among the experimental group compared to controls. The average money spent per person in Hamburger restaurants were also significantly lower among the Hamburger group.

The authors concluded that among New Hampshire adults visiting Hamburger restaurants, the likelihood of vegetarianism was significantly lower for consumers frequenting Hamburger restaurants compared with those who failed to frequent such places. The underlying cause of this correlation remains unknown, indicating the need for further investigation.

Daaaahhhhhhh!

 

Yesterday, I saw a Tweet stating:

Homeopath in Cornwall specialising in Women’s Health #fertility #naturalconception #pcos #pms

It was followed by a list of specific indications:

  • Pregnancy
  • Infertility
  • PCOS
  • PMS
  • Fibroids
  • Depression
  • Anxiety and much more…

I responded to this Tweet by tweeting:

Homeopath in Cornwall specialising in misleading women

Minutes later I received a response from a homeopathy-fan:

That could be called libel Edzard. I would be careful.

So, should I be careful, and if so why?

Reading the thinly veiled threat, I wasn’t exactly shaking in my boots with fear (I was deeply involved in helping Simon Singh in his defence against the BCA’s libel action), but I nevertheless wanted to be sure of my position and conducted some ‘rough and ready’ searches for recent evidence to suggesting that homeopathy is effective for any of the conditions mentioned above. Here is what I found:

  • Pregnancy. Yes, there is an RCT! It concluded that “homeopathy does not appear to prevent excessive body mass gain in pregnant women…” And another one concluding that “neither Pentazocine, or Chamomilla recutita offer substantial analgesia during labor.”
  • Infertility. No RCT or other sound evidence.
  • PCOS. Nothing
  • PMS. No clinical trials.
  • Fibroids. No clinical trials
  • Depression. Even leading homeopaths seem to agree that there is no good evidence.
  • Anxiety. Again, I could not find any sound evidence.

Don’t get me wrong, these statements are not based on full systematic reviews; that would take a while and hardly seems worth it. (If you want a good systematic review, I recommend this one; it concluded: “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.“) But my quick glance at the evidence is enough, I think, to justify my statement that the above claims by a homeopath are misleading. In fact, I believe that I could have used much stronger terminology without the slightest risk of being sued.

PERHAPS NEXT TIME!

Yesterday, I received the following interesting tweet from my friend Natalie Grams:

Edzard, YOU are just influenced by ideological biases (they told me so yesterday – so it must be true;-)

If I understand it correctly, Natalie was a guest in a public discussion about homeopathy somewhere in Austria during which my name must have been mentioned, and some homeopath or homeopathy-fan made the above allegation about me. Sadly, I was not present (but it is typical that allegations against me are rarely made to me in person) to discuss it further.

I am very much used to allegations against me and, in a strange way, have even grown to enjoy them. Here are some of my favourites:

  • I have undeclared ties to the pharmaceutical industry.
  • I am incompetent or not even qualified.
  • I was employed at Exeter to ditch alternative medicine.
  • I have never done any original research.
  • I sit in the ivory towers of academia.
  • I have no clinical experience.
  • I am basically a liar.

Even though they have been repeated ad nauseam, all of these accusations are untrue and have been refuted so often that I do not want to go into them again (for those interested, see for instance here, here, here and here).However, the allegation that I am ‘influenced by ideological biases’ is a new one, at least to me. And therefore, it might deserve some serious consideration.

Let’s start by getting our definitions straight:

  • An ideology is a system of ideas and ideals.
  • Bias is an inclination or prejudice for or against one person or group, especially in a way considered to be unfair.

Now let’s see how these two terms apply to me and my work.

  • According to the definition above, I am clearly influenced by an ideology. Yes, I do have ideals! For instance, I believe in science, want to see sound evidence, hope to improve healthcare, insist that patients deserve the best treatments available, and feel that ethics are of paramount importance in healthcare.
  • To make things worse, I am even proud of this ideology and I pity those who do not share it.
  • What about bias? Do I hold a grudge against one person or a group of people? As I just stated, I pity those who do not share my ideals, and if I am brutally honest, I do not like charlatans, liars or entrepreneurs selling false hope.
  • The question is whether this attitude is unfair. Personally, I do not believe it is, but I have to not deny that this is merely my perspective. There may be – and clearly are – other viewpoints.

So, to conclude this somewhat rambling post, I ready to admit that the Austrian homeopaths might have had a point:

FROM THE PERSPECTIVE OF A CHARLATAN, I PROBABLY DO SEEM TO BE INFLUENCED BY ‘IDEOLOGICAL BIASES’.

The question whether spinal manipulative therapy (SMT) has any specific therapeutic effects is still open. This fact must irritate ardent chiropractors, and they therefore try everything to dispel our doubts. One way would be to demonstrate a dose-effect relationship between SMT and the clinical outcome. But, for several reasons, this is not an easy task.

This RCT was aimed at identifying the dose-response relationship between visits for SMT and chronic cervicogenic headache (CGH) outcomes; to evaluate the efficacy of SMT by comparison with a light massage control.

The study included 256 adults with chronic CGH. The primary outcome was days with CGH in the prior 4 weeks evaluated at the 12- and 24-week primary endpoints. Secondary outcomes included CGH days at remaining endpoints, pain intensity, disability, perceived improvement, medication use, and patient satisfaction. Participants were randomized to 4 different dose levels of chiropractic SMT: 0, 6, 12, or 18 sessions. They were treated 3 times per week for 6 weeks and received a focused light-massage control at sessions when SMT was not assigned. Linear dose effects and comparisons to the no-manipulation control group were evaluated at 6, 12, 24, 39, and 52 weeks.

A linear dose-response was observed for all follow-ups, a reduction of approximately 1 CGH day/4 weeks per additional 6 SMT visits (p<.05); a maximal effective dose could not be determined. CGH days/4 weeks were reduced from about 16 to 8 for the highest and most effective dose of 18 SMT visits. Mean differences in CGH days/4 weeks between 18 SMT visits and control were -3.3 (p=.004) and -2.9 (p=.017) at the primary endpoints, and similar in magnitude at the remaining endpoints (p<.05). Differences between other SMT doses and control were smaller in magnitude (p > .05). CGH intensity showed no important improvement nor differed by dose. Other secondary outcomes were generally supportive of the primary.

The authors concluded that there was a linear dose-response relationship between SMT visits and days with CGH. For the highest and most effective dose of 18 SMT visits, CGH days were reduced by half, and about 3 more days per month than for the light-massage control.

This trial would make sense, if the effectiveness of SMT for CGH had been a well-documented fact, and if the study had rigorously controlled for placebo-effects.

But guess what?

Neither of these conditions were met.

A recent review concluded that there are few published randomized controlled trials analyzing the effectiveness of spinal manipulation and/or mobilization for TTH, CeH, and M in the last decade. In addition, the methodological quality of these papers is typically low. Clearly, there is a need for high-quality randomized controlled trials assessing the effectiveness of these interventions in these headache disorders. And this is by no means the only article making such statements; similar reviews arrive at similar conclusions. In turn, this means that the effects observed after SMT are not necessarily specific effects due to SMT but could easily be due to placebo or other non-specific effects. In order to avoid confusion, one would need a credible placebo – one that closely mimics SMT – and make sure that patients were ‘blinded’. But ‘light massage’ clearly does not mimic SMT, and patients obviously were aware of which interventions they received.

So, an alternative – and I think at least as plausible – conclusion of the data provided by this new RCT is this:

Chiropractic SMT is associated with a powerful placebo response which, of course, obeys a dose-effect relationship. Thus these findings are in keeping with the notion that SMT is a placebo.

And why would the researchers – who stress that they have no conflicts of interest – mislead us by making this alternative interpretation of their findings not abundantly clear?

I fear, the reason might be simple: they also seem to mislead us about their conflicts of interest: they are mostly chiropractors with a long track record of publishing promotional papers masquerading as research. What, I ask myself, could be a stronger conflict of interest?

(Pity that a high-impact journal like SPINE did not spot these [not so little] flaws)

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