MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

progress

Guest post by Nick Ross

If you’re a fan of Edzard Ernst – and who with a rational mind would not be – then you will be a fan of HealthWatch.

Edzard is a distinguished supporter. Do join us. I can’t promise much in return except that you will be part of a small and noble organisation that campaigns for treatments that work – in other words for evidence based medicine. Oh, and you get a regular Newsletter, which is actually rather good.

HealthWatch was inspired 25 years ago by Professor Michael Baum, the breast cancer surgeon who was incandescent that so many women presented to his clinic late, doomed and with suppurating sores, because they had been persuaded to try ‘alternative treatment’ rather than the real thing.

But like Edzard (and indeed like Michael Baum), HealthWatch keeps an open mind. If there are reliable data to show that an apparently weirdo treatment works, hallelujah. If there is evidence that an orthodox one doesn’t then it deserves a raspberry. HealthWatch has worked to expose quacks and swindlers and to get the Advertising Standards Authority to do its job regulating against false claims and flimflam. It has fought the NHS to have women given fair and balanced advice about the perils of mass screening. It has campaigned with Sense About Science, English Pen and Index to protect whistleblowing scientists from vexatious libel laws, and it has joined the AllTrials battle for transparency in drug trials. It has an annual competition for medical and nursing students to encourage critical analysis of clinical research protocols, and it stages the annual HealthWatch Award and Lecture which has featured Edzard (in 2005) and a galaxy of other champions of scepticism and good evidence including Sir Iain Chalmers, Richard Smith, David Colquhoun, Tim Harford, John Diamond, Richard Doll, Peter Wilmshurst, Ray Tallis, Ben Goldacre, Fiona Godlee and, last year, Simon Singh. We are shortly to sponsor a national debate on Lord Saatchi’s controversial Medical innovation Bill.

But we need new blood. Do please check us out. Be careful, because since we first registered our name a host of brazen copycats have emerged, not least Her Majesty’s Government with ‘Healthwatch England’ which is part of the Care Quality Commission. We have had to put ‘uk’ at the end of our web address to retain our identity. So take the link to http://www.healthwatch-uk.org/, or better still take out a (very modestly priced) subscription.

As Edmund Burke might well have said, all it takes for quackery to flourish is that good men and women do nothing.

I would have never thought that someone would be able to identify the author of the text I quoted in the previous post:

It is known that not just novel therapies but also traditional ones, such as homeopathy, suffer opposition and rejection by some doctors without having ever been subjected to serious tests. The doctor is in charge of medical treatment; he is thus responsible foremost for making sure all knowledge and all methods are employed for the benefit of public health…I ask the medical profession to consider even previously excluded therapies with an open mind. It is necessary that an unbiased evaluation takes place, not just of the theories but also of the clinical effectiveness of alternative medicine.

More often than once has science, when it relied on theory alone, arrived at verdicts which later had to be overturned – frequently this occurred only after long periods of time, after progress had been hindered and most acclaimed pioneers had suffered serious injustice. I do not need to remind you of the doctor who, more than 100 years ago, in fighting puerperal fever, discovered sepsis and asepsis but was laughed at and ousted by his colleagues throughout his lifetime. Yet nobody would today deny that this knowledge is most relevant to medicine and that it belongs to the basis of medicine. Insightful doctors, some of whom famous, have, during the recent years, spoken openly about the crisis in medicine and the dead end that health care has maneuvered itself into. It seems obvious that the solution is going in directions which embrace nature. Hardly any other form of science is so tightly bound to nature as is the science occupied with healing living creatures. The demand for holism is getting stronger and stronger, a general demand which has already been fruitful on the political level. For medicine, the challenge is to treat more than previously by influencing the whole organism when we aim to heal a diseased organ.

It is from the opening speech by Rudolf Hess on the occasion of the WORLD CONFERENCE ON HOMEOPATHY 1937, in Berlin. Hess, at the time Hitler’s deputy, was not the only Nazi-leader. I knew of the opening speech because, a few years ago, DER SPIEGEL published a theme issue on homeopathy, and they published a photo of the opening ceremony of this meeting. It shows many men in SS-uniform and, in the first row of the auditorium, we see Hess (as well as Himmler) ready to spring into action.

Hess in particular was besotted with alternative medicine which the Nazis elected to call NEUE DEUTSCHE HEILKUNDE. Somewhat to the dismay of today’s alternative medicine enthusiasts, I have repeatedly published on this aspect of alternative medicine’s past, and it also is an important part of my new book A SCIENTIST IN WONDERLAND which the lucky winner (my congratulations!) of my little competition to identify the author has won. The abstract of an 2001 article explains this history succinctly:

The aim of this article is to discuss complementary/alternative medicine (CAM) in the Third Reich. Based on a general movement towards all things natural, a powerful trend towards natural ways of healing had developed in the 19(th)century. By 1930 this had led to a situation where roughly as many lay practitioners of CAM existed in Germany as doctors. To re-unify German medicine under the banner of ‘Neue Deutsche Heilkunde’, the Nazi officials created the ‘Heilpraktiker’ – a profession which was meant to become extinct within one generation. The ‘flag ship’ of the ‘Neue Deutsche Heilkunde’ was the ‘Rudolf Hess Krankenhaus’ in Dresden. It represented a full integration of CAM and orthodox medicine. An example of systematic research into CAM is the Nazi government’s project to validate homoeopathy. Even though the data are now lost, the results of this research seem to have been negative. Even though there are some striking similarities between today’s CAM and yesterday’s ‘Neue Deutsche Heilkunde’ there are important differences. Most importantly, perhaps, today’s CAM is concerned with the welfare of the individual, whereas the ‘Neue Deutsche Heilkunde’ was aimed at ensuring the dominance of the Aryan race.

One fascinating aspect of this past is the fact that the NEUE DEUTSCHE HEILKUNDE was de facto the invention of what we today call ‘integrated medicine’. Then it was more like a ‘shot-gun marriage’, while today it seems to be driven more by political correctness and sloppy thinking. It did not work 70 years ago for the same reason that it will fail today: the integration of bogus (non-evidence based) treatments into conventional medicine must inevitably render health care not better but worse!

One does not need to be a rocket scientist to understand that, and Hess as well as other proponents of alternative medicine of his time had certainly got the idea. So they initiated the largest ever series of scientific tests of homeopathy. This research program was not just left to the homeopaths, who never had a reputation of being either rigorous or unbiased, but some of the best scientists of the era were recruited for it. The results vanished in the hands of the homeopaths during the turmoil of the war. But one eye-witness report of a homeopaths, Fritz Donner, makes it very clear: as it turned out, there was not a jot of evidence in favour of homeopathy.

And this, I think, is the other fascinating aspect of the story: homeopaths did not give up their plight to popularise homeopathy. On the contrary, they re-doubled their efforts to fool us all and to convince us with dodgy results (see recent posts on this blog) that homeopathy somehow does defy the laws of nature and is, in effect, very effective for all sorts of diseases.

My readers suggested all sorts of potential authors for the Hess speech; and they are right! It could have been written by any proponent of alternative medicine. This fact is amusing and depressing at the same time. Amusing because it discloses the lack of new ideas and arguments (even the same fallacies are being used). Depressing because it suggests that progress in alternative medicine is almost totally absent.

Recently I came across an interesting speech on alternative medicine which impressed me for a number of reasons. It made me think of a little game: the first person who correctly guesses who its author is, and posts the right answer as a comment on this blog, will receive a free copy of my new book A SCIENTIST IN WONDERLAND.

Here are 2 paragraphs from the speech in question:

It is known that not just novel therapies but also traditional ones, such as homeopathy, suffer opposition and rejection by some doctors without having ever been subjected to serious tests. The doctor is in charge of medical treatment; he is thus responsible foremost for making sure all knowledge and all methods are employed for the benefit of public health…I ask the medical profession to consider even previously excluded therapies with an open mind. It is necessary that an unbiased evaluation takes place, not just of the theories but also of the clinical effectiveness of alternative medicine.

More often than once has science, when it relied on theory alone, arrived at verdicts which later had to be overturned – frequently this occurred only after long periods of time, after progress had been hindered and most acclaimed pioneers had suffered serious injustice. I do not need to remind you of the doctor who, more than 100 years ago, in fighting puerperal fever, discovered sepsis and asepsis but was laughed at and ousted by his colleagues throughout his lifetime.  Yet nobody would today deny that this knowledge is most relevant to medicine and that it belongs to the basis of medicine. Insightful doctors, some of whom famous, have, during the recent years, spoken openly about the crisis in medicine and the dead end that health care has maneuvered itself into. It seems obvious that the solution is going in directions which embrace nature. Hardly any other form of science is so tightly bound to nature as is the science occupied with healing living creatures. The demand for holism is getting stronger and stronger, a general demand which has already been fruitful on the political level. For medicine, the challenge is to treat more than previously by influencing the whole organism when we aim to heal a diseased organ.

I know, it’s not really original to come up with the 10000th article on “10 things…” – but you will have to forgive me, I read so many of these articles over the holiday period that I can’t help but jump on the already over-crowded bandwagon and compose yet another one.

So, here are 10 things which could, if implemented, bring considerable improvement in 2015 to my field of inquiry, alternative medicine.

  1. Consumers need to get better at acting as bull shit (BS) detectors. Let’s face it, much of what we read or hear about this subject is utter BS. Yet consumers frequently lap up even the worst drivel like it were some source of deep wisdom. They could save themselves so much money, if they learnt to be just a little bit more critical.
  2. Dr Oz should focus on being a heart surgeon. His TV show has been demonstrated far too often to be promoting dangerous quackery. Yet as a heart surgeon, he actually might do some good.
  3. Journalists ought to remember that they have a job that extends well beyond their ambition to sell copy. They have a responsibility to inform the public truthfully and responsibly.
  4. Book publishers should abstain from churning out book after book that does little else but mislead the public about alternative medicine in a way that all to often is dangerous to the readers’ health. The world does not need the 1000th book repeating nonsense on detox, wellness etc.!
  5. Alternative practitioners must realise that claiming that therapy x cures condition y is not just slightly over-optimistic (or based on ‘years of experience’); if the claim is not based on sound evidence, it is what most people would call an outright lie.
  6. Proponents of alternative medicine should learn that it is neither fair nor productive to fiercely attack everyone personally who disagrees with their enthusiasm for this or that form of alternative medicine. In fact, it merely highlights the acute lack of rational arguments.
  7. Researchers of alternative medicine have to remember how important it is to think critically – an uncritical scientist is at best a contradiction in terms and at worst a pseudo-scientist who is likely to cause harm.
  8. Authorities should amass the courage, the political power and the financial means of going after those charlatans who ruthlessly exploit the public by making a fast and easy buck on the gullibility of consumers. Only if there is the likelihood of hefty fines will we see a meaningful decrease in the current epidemic of alternative health fraud.
  9. Politicians should realise that alternative medicine is not just a trivial subject with which one might win votes, if one issues platitudes to please the majority; alternative medicine is used by so many people that it has become an important public health issue.
  10. Prince Charles need to learn how to control himself and abstain from meddling in health politics by using every conceivable occasion to promote what he thinks is ‘integrated medicine’ but which, in fact, can easily be disclosed to be quackery.

As you see, my list almost instantly turned into a wish-list, and the big questions that follow from it are:

  1. How could we increase the likelihood of these wishes to come true?
  2. And would there be anything left of alternative medicine, if all of these wishes miraculously became true in 2015?

I do not pretend to have the answers, but I do feel strongly that a healthy dose of critical thinking in all levels of education – from kindergartens to schools, from colleges to universities etc. – would be a good and necessary starting point.

I know, my list is not just a wish list, it also is a wishful thinking list. It would be hopelessly naïve to assume that major advances will be made in 2015. I am realistic, sometimes even quite pessimistic, about progress in alternative medicine. But this does not mean that I or anyone else should just give up. 2015 will be a year where at least one thing is certain: you will see me continuing me my fight for reason, critical analysis, rational debate and good evidence – and that’s a promise!

This investigation was aimed at examining the messages utilised by the chiropractic profession around issues of scope and efficacy through website communication with the public. For this purpose, the authors submitted the website content of 11 major Canadian chiropractic associations and colleges, and of 80 commercial clinics to a mixed-methods analysis. Content was reviewed to quantify specific health conditions described as treatable by chiropractic care. A qualitative textual analysis identified the primary messages related to evidence and efficacy utilised by the websites.

The results show that chiropractic was claimed to be capable of addressing a wide range of health issues. Quantitative analysis revealed that association and college websites identified a total of 41 unique conditions treatable by chiropractic, while private clinic websites named 159 distinct conditions. The most commonly cited conditions included back pain, headaches/migraines and neck pain. Qualitative analysis revealed three prominent themes drawn upon in discussions of efficacy and evidence: grounded in science, the conflation of safety and efficacy and “natural” healing.

The authors concluded that the chiropractic profession claims the capacity to treat health conditions that exceed those more traditionally associated with chiropractic. Website content persistently declared that such claims are supported by research and scientific evidence, and at times blurred the lines between safety and efficacy. The chiropractic profession may be struggling to define themselves both within the paradigm of conventional science as well as an alternative paradigm that embraces natural approaches.

These findings strike me as being similar to the ones we published 4 years ago. At this stage, we had conducted a review of 200 chiropractor websites and 9 chiropractic associations’ World Wide Web claims in Australia, Canada, New Zealand, the United Kingdom, and the United States. The outcome measures were claims (either direct or indirect) regarding the eight reviewed conditions, made in the context of chiropractic treatment: asthma, headache/migraine, infant colic, colic, ear infection/earache/otitis media, neck pain, whiplash (not supported by sound evidence), and lower back pain (supported by some evidence).

We found evidence that 190 (95%) chiropractor websites made unsubstantiated claims regarding at least one of the conditions. When colic and infant colic data were collapsed into one heading, there was evidence that 76 (38%) chiropractor websites made unsubstantiated claims about all the conditions not supported by sound evidence. Fifty-six (28%) websites and 4 of the 9 (44%) associations made claims about lower back pain, whereas 179 (90%) websites and all 9 associations made unsubstantiated claims about headache/migraine. Unsubstantiated claims were made about asthma, ear infection/earache/otitis media, neck pain.

At the time, we concluded that the majority of chiropractors and their associations in the English-speaking world seem to make therapeutic claims that are not supported by sound evidence, whilst only 28% of chiropractor websites promote lower back pain, which is supported by some evidence. We suggest the ubiquity of the unsubstantiated claims constitutes an ethical and public health issue.

Comparing the two studies, what should we conclude? Of course, the new investigation was confined to Canada; we therefore cannot generalise its results to other countries. Nevertheless it provides a fascinating insight into the (lack of) development of chiropractic in this part of the world. My conclusion is that, at least in Canada, there is very little evidence that chiropractic is about to become an ethical and evidence-based profession.

The volume of medical research, as listed on Medline, is huge and increases steadily each year. This phenomenon can easily be observed with simple Medline searches. If we use search terms related to conventional medicine, we find near linear increases in the number of articles (here I do not make a distinction between types of articles) published in each area over time, invariably with a peak in 2013, the last year for which Medline listing is currently complete. Three examples will suffice:

PHARMACOTHERAPY        117 414 articles in 2013

PHARMACOLOGY               210 228 articles in 2013

ADVERSE EFFECTS              86 067 articles in 2013

Some of the above subjects are obviously heavily industry-dependent and thus perhaps not typical of the volume of research in health care generally. Let’s therefore look up three fields where there is no such powerful industry to support research:

PSYCHOTHERAPY              7 208 articles in 2013

PHYSIOTHERAPY                7 713 articles in 2013

SURGERY                           154 417 articles in 2013

Now, if we conduct similar searches for topics related to alternative medicine, the picture changes in at least three remarkable ways: 1) there is no linear increase of the volume per year; instead the curves look flat and shapeless (the only exception is ‘herbal medicine’ where the increase even looks exponential). 2) The absolute volume does not necessarily peak in 2013 (exceptions are ‘acupuncture’ and ‘herbal medicine’). 3) The number of articles in the year with the most articles (as listed below) is small or even tiny:

ACUPUNCTURE                    1 491 articles in 2013

CHIROPRACTIC                      283 articles in 2011

HERBAL MEDICINE           2 503 articles in 2013

HOMEOPATHY                        233 articles in 2005

NATUROPATHY                         69 articles in 2010

You may think: so what? But I find these figures intriguing. They demonstrate that the research output in alternative medicine is minimal compared to that in conventional medicine.  Moreover, they imply that this output is not only not increasing steadily, as it is in conventional medicine, but in the case of chiropractic, homeopathy and naturopathy, it has recently been decreasing.

To put this into context, we need to know that:

  1. there is a plethora of journals dedicated to alternative medicine which are keen to publish all sorts of articles,
  2. the peer-review process of most of these journals seems farcically poor,
  3. as a result, the quality of the research into alternative medicine is often dismal, as regularly disclosed on this blog,
  4. enthusiasts of alternative medicine often see rigorous research into their subject as a dangerous threat: it might disprove their prior beliefs.

In their defence, proponents of alternative medicine would probably claim that the low volume of research is due to a severe and unfair lack of funding. However, I fail to see how this can be the sole or even the main explanation: areas of conventional medicine that do not have industry support seem to manage a much higher output than alternative medicine (and I should stress that I have chosen 5 sections within alternative medicine that are associated with the highest number of articles per year). Research in these areas is usually sponsored by charitable and government sources, and it needs to be stressed that these are open to any researcher who submits good science.

What follows, I think, is simple: in general, alternative medicine advocates have little interest in research and even less expertise to conduct it.

The chiropractic profession have been reminded time and times again that their claim to be able to effectively treat paediatric conditions is bogus. Many experts have asked them to produce some compelling evidence or stop this dangerous nonsense. Yet most of them seem to remain in denial, famously documented by the British Chiropractic Association suing Simon Singh for libel after he disclosed that they happily promote bogus treatments.

Some chiropractors now say that things have changed and that chiropractors are finally getting their act together. If that is true, progress must be painfully slow – so slow, in fact, that it is hard to see it at all. There are still far too many chiropractors who carry on just as before. There are hundreds, if not thousands of articles promoting chiropractic for childhood conditions; a very basic Google search for ‘chiropractic for children’ returns more than 7 million hits many of which advertise this sort of approach. Take this website, for instance; it makes its bogus claims entirely unabashed:

Even as an infant your child may have spinal nerve stress, known as subluxations. Although subluxations may not be painful, they can pose serious threats to your child’s development. If your baby was in a difficult position in the womb, or experienced a traumatic birth they may have developed subluxations. A common condition attributed to subluxations in children is known as Blocked Atlantal Nerve Syndrome. This condition may be the primary cause of ear and upper respiratory infections, and chronic tonsillitis.

Even regular childhood activities such as tumbles taken while learning to walk and run, bike riding, and participation in sports can also cause stress on your child’s body. Emotional stress and trauma may also be a cause of subluxations. Unless they are corrected they can affect future nerve function and the development of your child’s nervous system. They can also cause problems as your child grows and develops into adulthood.

With regular chiropractic care your child may be at less risk for common childhood disease such as colds and fevers. Some children show a marked improvement in asthma symptoms with regular chiropractic care and nutritional counselling. While chiropractors do no treat disease or sickness, they can identify and remove subluxations which interfere with your child’s natural ability to heal. By removing this stress from your child’s spinal system their immune system may function more efficiently and your child may have a better defense to disease. Their overall health may improve as their natural healing power is released. Children who receive regular chiropractic care may also be able to handle emotional and physical stress better and this care may contribute to their natural development.

Your child is never too young to start chiropractic care. Well-child care starts are early as the first month of life. Doctors use a very gentle pressure to treat children (no more pressure than picking up a tomato in the grocery store) and their treatments are very soothing to your child. After their first visit it is recommended that they receive treatments every three months up to age three, and then every six to 12 month after that. You may also want to visit your chiropractor after major milestones in your child’s life such as learning to sit up, crawl, and walk. They should also be seen if they experience any falls or trauma, and if you notice any balance issues they may be experiencing. These may include head tilting and limping.

Pediatric chiropractic care has many benefits. Children as young as infants may see an improvement in their development and overall health with regular care. Doctors of chiropractic take a proactive approach to health by striving to return and maintain your body’s natural balance. If you are looking for an alternative or supplement to traditional medical care, look into chiropractic care for your entire family.

Just a few rotten apples!… the apologists would probably say. But this is clearly not true. I find it even hard to locate the non-rotten apples in this decomposing and disgusting mess. More importantly, if it were true that things were now changing, one would expect that the progressive sections of the chiropractic profession protest regularly, sharply and effectively to shame the many charlatans amongst their midst. Crucially, one would expect the chiropractic professional organisations  to oust their bogus members systematically and swiftly.

The sad truth, however, is that none of this is really happening – certainly not in the US or the UK. On the contrary, organisations like THE INTERNATIONAL PEDIATRIC ASSOCIATION, books entitled CHIROPRACTIC PEDIATRICS, and periodicals like the JOURNAL OF PEDIATRIC, MATERNAL AND FAMILY CHIROPRACTIC remain popular and respected within the chiropractic profession. A few lip-services here and there, yes. But truly effective action? No!

The tolerance of quackery, I would argue, must be one of the most important hallmarks of a quack profession.

Today, there are several dozens of journals publishing articles on alternative medicine. ‘The Journal of Alternative and Complementary Medicine’ is one of the best known, and it has one of the highest impact factors of them all. The current issue holds a few ‘gems’ which might be worthy of a comment or two. Here I have selected three articles reporting clinical studies, and I reproduce their abstracts (almost) in full (in italics) and add my comments (for clarity in bold). All the articles are available electronically, and I have provided the links for those who want to investigate beyond the abstracts.

STUDY No 1

The first ‘pilot study‘ was aimed to demonstrate the potential of auricular acupuncture (AAT) for insomnia in maintenance haemodialysis (MHD) patients and to prepare for a future randomized controlled trial.

Eligible patients were enrolled into this descriptive pilot study and received AAT designed to manage insomnia for 4 weeks. Questionnaires that used the Pittsburgh sleep quality index (PSQI) were completed at baseline, after a 4-week intervention, and 1 month after completion of treatment. Sleep quality and other clinical characteristics, including sleeping pills taken, were statistically compared between different time points.

A total of 22 patients were selected as eligible participants and completed the treatment and questionnaires. The mean global PSQI score was significantly decreased after AAT intervention (p<0.05). Participants reported improved sleep quality (p<0.01), shorter sleep latency (p<0.05), less sleep disturbance (p<0.01), and less daytime dysfunction (p=0.01). They also exhibited less dependency on sleep medications, indicated by the reduction in weekly estazolam consumption from 6.98±4.44 pills to 4.23±2.66 pills (p<0.01). However, these improvements were not preserved 1 month after treatment.

Conclusions: In this single-center pilot study, complementary AAT for MHD patients with severe insomnia was feasible and well tolerated and showed encouraging results for sleep quality.

My comments:

In alternative medicine research, it has become far too common (almost generally accepted) to call a flimsy trial a ‘pilot study’. The authors give their game away by stating that, by conducting this trial, they want to ‘demonstrate the potential of AAT’. This is not a legitimate aim of research; science is for TESTING hypotheses, not for PROVING them!

The results of this trial show that patients experienced improvements after receiving AAT which, however, did not last. As there was no placebo control group, the most likely explanation for these outcomes would be that AAT generated a short-lasting placebo effect.

A sample size of 22 is, of course, far to small to allow any conclusions about the safety of the intervention. Despite these obvious facts, the authors seem convinced that AAT is both safe and effective.

STUDY No 2

The aim of the second study was to compare the therapeutic effect of Yamamoto new scalp acupuncture (YNSA), a recently developed microcupuncture system, with traditional acupuncture (TCA) for the prophylaxis and treatment of migraine headache.

In a randomized clinical trial, 80 patients with migraine headache were assigned to receive YNSA or TCA. A pain visual analogue scale (VAS) and migraine therapy assessment questionnaire (MTAQ) were completed before treatment, after 6 and 18 sections of treatment, and 1 month after completion of therapy.

All the recruited patients completed the study. Baseline characteristics were similar between the two groups. Frequency and severity of migraine attacks, nausea, the need for rescue treatment, and work absence rate decreased similarly in both groups. Recovery from headache and ability to continue daily activities 2 hours after medical treatment showed similar improvement in both groups (p>0.05).

Conclusions: Classic acupuncture and YNSA are similarly effective in the prophylaxis and treatment of migraine headache and may be considered as alternatives to pharmacotherapy.

My comments:

This is what is technically called an ‘equivalence trial’, i.e. a study that compares an experimental treatment (YNSA) to one that is (assumed to be) effective. To demonstrate equivalence, such trials need to have large sample sizes, and this study is woefully underpowered. As it stands, the results show nothing meaningful at all; if anything, they suggest that both interventions were similarly useless.

STUDY No 3

The third study determined whether injection with hypertonic dextrose and morrhuate sodium (prolotherapy) using a pragmatic, clinically determined injection schedule for knee osteoarthritis (KOA) results in improved knee pain, function, and stiffness compared to baseline status.

The participants were 38 adults who had at least 3 months of symptomatic KOA and who were in the control groups of a prior prolotherapy randomized controlled trial (RCT) (Prior-Control), were ineligible for the RCT (Prior-Ineligible), or were eligible but declined the RCT (Prior-Declined).

The injection sessions at occurred at 1, 5, and 9 weeks with as-needed treatment at weeks 13 and 17. Extra-articular injections of 15% dextrose and 5% morrhuate sodium were done at peri-articular tendon and ligament insertions. A single intra-articular injection of 6 mL 25% dextrose was performed through an inferomedial approach.

The primary outcome measure was the validated Western Ontario McMaster University Osteoarthritis Index (WOMAC). The secondary outcome measure was the Knee Pain Scale and postprocedure opioid medication use and participant satisfaction.

The Prior-Declined group reported the most severe baseline WOMAC score (p=0.02). Compared to baseline status, participants in the Prior-Control group reported a score change of 12.4±3.5 points (19.5%, p=0.002). Prior-Decline and Prior-Ineligible groups improved by 19.4±7.0 (42.9%, p=0.05) and 17.8±3.9 (28.4%, p=0.008) points, respectively; 55.6% of Prior-Control, 75% of Prior-Decline, and 50% of Prior-Ineligible participants reported score improvement in excess of the 12-point minimal clinical important difference on the WOMAC measure. Postprocedure opioid medication resulted in rapid diminution of prolotherapy injection pain. Satisfaction was high and there were no adverse events.

Conclusions: Prolotherapy using dextrose and morrhuate sodium injections for participants with mild-to-severe KOA resulted in safe, significant, sustained improvement of WOMAC-based knee pain, function, and stiffness scores compared to baseline status.

My Comments:

This study had nothing that one might call a proper control group: all the three groups mentioned were treated with the experimental treatment. No attempt was made to control for even the most obvious biases: the observed effects could have been due to placebo or any other non-specific effects. The authors conclusions imply a causal relationship between the treatment and the outcome which is wrong. The notion that the experimental treatment is ‘safe’ is based on just 38 patients and therefore not reasonable.

IMPLICATION

All of this might seem rather trivial, and my comments could be viewed as a deliberate and vicious attempt to discredit one of the most respected journals of alternative medicine. Yet, considering that articles of this nature are more the rule than the exception in alternative medicine, I do think that this flagrant lack of scientific rigour is a relevant issue and has important implications.

As long as research in this area continues to be deeply flawed, as long as reviewers turn a blind eye to (or are not smart enough to detect) even the most obvious mistakes, as long as journal editors accept any rubbish in order to fill their pages, there is a great danger that we are being continuously being mislead about the supposed therapeutic value of alternative therapies.

Many who read this blog will, of course, have the capacity to think critically and might therefore not fall into the trap of accepting the conclusions of fatally flawed research. But many other people, including politicians, journalists and consumers, might not have the necessary appraisal skills and will thus not be able to tell that such studies can serve only one purpose: to popularise bogus treatments and thereby render health care less effective and more dangerous. Enthusiasts of alternative medicine are usually fully convinced that such studies amount to evidence and ram this pseudo-information down the throat of health care decision makers – the effects of such lobbying on public health can be disastrous.

And there is another downside to the publication of such dismal drivel: assuming (as I do) that not all of alternative medicine is completely useless, such embarrassingly poor research will inevitably have detrimental effects on the discipline of alternative medicine. After being exposed to a seemingly endless stream of pseudo-research, critics will eventually give up taking any of it seriously and might claim that none of it is worth the bother. In other words, those who conduct, accept or publish such nonsensical papers are not only endangering medical progress in general, they are also harming the very cause they try so desperately hard to advance.

I have often asked myself whether it is right/necessary to scientifically test things which are entirely implausible. Should we, for instance test the effectiveness of treatments which have a very low prior probability of generating a positive effect such as paranormal healing, homeopathy or Bach flower remedies? If you believe in the principles of evidence-based medicine you might focus on the clinical evidence and see biological plausibility as secondary. If you are a basic scientist, you are likely to do the reverse.

A recent article addressed this issue. The author points out that evaluating the absurd is absurd. Specifically, he noted that the empirical evaluation of a therapy would normally assume a plausible rationale regarding the mechanism of action. However, examination of the historical background and underlying principles for reflexology, iridology, acupuncture, auricular acupuncture, and some herbal medicines, reveals a rationale founded on the principle of analogical correspondences, which is a common basis for magical thinking and pseudoscientific beliefs such as astrology and chiromancy. Where this is the case, it is suggested that subjecting these therapies to empirical evaluation may be tantamount to evaluating the absurd.

This makes a lot of sense – but is it really entirely true? Are there no legitimate reasons at all for testing alternative treatments that lack biological plausibility? Ten or twenty years ago, I would have disagreed with the notion that plausibility is an essential prerequisite for scientific testing; today, I have changed my mind a little, but not as much as to agree completely with the assumption. In other words, I still see more than one good reason why evaluating the absurd might be reasonable or even advisable.

  1. Using plausibility as the only arbiter of scientific ‘evaluability’, assumes that we understand everything about plausibility there is to know. Yet it might just be possible that we mis-categorise something as implausible simply because we are not yet fully aware of all the facts.
  2. Declaring something as plausible and another thing as implausible are not hard and fast verdicts but judgements which, at least to some degree, are subjective. Sceptics find the axioms of homeopathy utterly implausible, for instance – but ask a homeopath, and you will hear all sorts of explanations which, at least to them, sound plausible.
  3. If an implausible alternative treatment is in wide-spread use, we arguably have a responsibility to test it scientifically in order to demonstrate the truth about it (to those proponents of that therapy who are willing to accept that rigorous science can find the truth). If we fail to do this, it will be the enthusiasts of that therapy who conduct less than rigorous science and produce false positive results. In turn, this will give the impression that the treatment is effective and mislead consumers, politicians, journalists etc. Seen from this perspective, it might even be unethical to not do the science.

So, I am in two minds about this (which might be a reflection of the fact that, during different periods of my life, I have been a clinician, a basic scientist and a clinical researcher). I realise that plausibility and prior probability are important – much more so than I appreciated years ago. But I think they should not be the only criteria. The clinical evidence should not be pushed aside completely.

I’d be interested to learn your views on this tricky issue.

Homeopathy is a deeply puzzling subject for many observers. Perhaps it gets a little easier to understand, if we consider the three main perspectives on homeopathy. For the purpose of this post, I take the liberty of exaggerating, almost caricaturizing, these perspectives in order to contrast them as clearly as possible.

THE SCEPTICS’ PERSPECTIVE

Sceptics take a brief look at the two main assumptions which underpin homeopathy (like cures like and potentiation/dilution/water memory) and henceforward are convinced that homeopathic remedies are pure placebos. Homeopathy flies in the face of science; if homeopathy is right, several laws of nature must be wrong, they love to point out. As this is most unlikely, they reject homeopathy outright, usually even without looking in any detail at what homeopaths consider to be evidence in support of their trade. If sceptics are forced to consider a positive study of homeopathy, they know before they have seen it that its results are wrong – due to an error caused by chance, faulty study design or fabrication. The sceptics’ conclusion on homeopathy: it is a placebo-therapy, no doubt about it; and further investment into research is a waste of scarce resources which must be stopped.

THE BELIEVERS’ PERSPECTIVE

The believers in homeopathy know from experience that homeopathy works. They therefore feel that they have no choice but to reject almost every word the sceptics might tell them. They cling on to the gospel of Hahnemann and elaborate on the modern but vague theories that might support the theoretical assumptions of homeopathy. They point to positive clinical trials and outcome studies, to 200 years of experience, and to the endorsement of homeopathy by VIPs. When confronted with the weaknesses of their arguments, they find even weaker ones, such as ‘much of conventional medicine is also not based on good evidence, and the mechanism of action of many mainstream drugs is also not fully understood’. Alternatively, they employ the phoniest argument of them all: ‘even if it works via a placebo effect, it still helps patients and therefore is a useful therapy’. When even this fails, they tend to resort to ad hominem attacks against their opponents. The believers’ conclusion on homeopathy: it is unquestionably a valuable type of therapy regardless of what anyone else might say; research is merely needed to confirm their belief.

THE PERSPECTIVE OF THE ADVOCATES OF EVIDENCE-BASED MEDICINE (EBM)

The perspective of EBM-advocates is pragmatic; they simply say: “show me the evidence!” If the majority of the most reliable clinical trials of homeopathic remedies (or anything else) suggests an effect beyond placebo, they conclude that they are effective. If that is not the case, they doubt the effectiveness. If the evidence is highly contradictory or incomplete, they are likely to advocate more rigorous research. Advocates of EBM are usually not all that concerned by the lack of plausibility of the interventions they evaluate. If it works, it works, they think – and if a plausible mechanism is currently not available, it might be found in due course. The advocates of EBM have no preconceived ideas about homeopathy. Their conclusion on homeopathy goes exactly where the available best evidence leads them.

COMMENT

The arguments and counter-arguments originating from the various perspectives would surely continue for another 200 years – unless, of course, two of the three perspectives merge and arrive at the same or very similar conclusions. And this is precisely what has now happened. As I have pointed out in a recent post, the most thorough and independent evaluation of homeopathy according to rigorous EBM-standards has concluded that “the evidence from research in humans does not show that homeopathy is effective for treating the range of health conditions considered.”

In other words, two of the three principal perspectives have now drawn conclusions which are virtually identical: there is a consensus between the EBM-advocates and the sceptics. This isolates the believers and renders their position no longer tenable. If we furthermore consider that the believers are heavily burdened with obvious conflicts of interest, while the other two groups are by definition much more independent and objective, it appears more and more as though homeopathy is fast degenerating into a cult characterised by the unquestioning commitment and unconditional submission of its members who are too heavily brain-washed to realize that their fervour has isolated them from the rational sections of society. And a cult is hardly what we need in heath care, I should think.

It seems to me therefore that these intriguing developments might finally end the error that homeopathy represented for nearly 200 years.

Progress at last?

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