MD, PhD, FMedSci, FSB, FRCP, FRCPEd

critical thinking

‘THE HINKLEY TIMES’ is not a paper that I read often, I have to admit – but maybe I should! It was there that I found the following remarkable article:

Bosworth MP David Tredinnick has asked questions in the House of Commons about the growing problem of antibiotic resistance within hospitals, suggesting herbal remedies could be answer.

The Tory MP, who has a keen interest in alternative medicine particularly herbal curatives, asked Jeremy Hunt, Secretary of State for Health, whether the problem was being discussed at the very top level.

He said: “Does my right honourable friend agree that a critical problem that A and E units will face in the future is antibiotic resistance? Is he aware that the science and technology committee, of which I am a member, has been looking at this issue and it also interests the health committee, of which I am also a member? Can he assure me that he is talking to the Prime Minister about how to stimulate new antibiotic research, and will he also remember that nature has its own remedies, such as tea tree oil?”

In reply Mr Hunt said: “My honourable friend is right about the seriousness of the issue of antimicrobial resistance. Some 25,000 people die in Europe every year as a result of the failure of antibiotics – more than die in road traffic accidents. I raised the issue at the World Health Assembly and I have discussed it closely with the Prime Minister.”

David Tredinnick is no stranger to strange ideas. Wikipedia (yes I know, many people do not like it as a source) sums it up quite succinctly:

He is a supporter of complementary and alternative medicine (CAM). He has made supportive comments in Parliament on homeopathy, despite continued lack of evidence of its effectiveness. He has supported chiropractic and mentioned the influence of the Moon on blood clotting. In this same debate he characterised scientists as “racially prejudiced”. He has tabled several early day motions in support of homeopathy’s continued funding on the National Health Service.Tredinnick’s views continue to cause amused disbelief in some quarters and a spokesman for the Royal College of Surgeons of England said they would “laugh their heads off” at the suggestion they could not operate at the full moon.

At the 2010 general election, in addition to candidates from the two main parties, Tredinnick was opposed by New Scientist journalist Dr. Michael Brooks who objected to “Tredinnick’s outspoken promotion of complementary and alternative medicine.”During a hustings debate called by Brooks to “highlight the scientific literacy of the UK’s elected representatives” Brooks claimed that Tredinnick regarded homeopathy as a suitable treatment for Malaria and HIV, which Tredinnick did not deny. Tredinnick in turn argued that “alternative treatments are incredibly good value for money” and stated his belief that randomised controlled trials are not effective at evaluating very dilute preparations.

In March 2013 Tredinnick was ridiculed as “nonsensical” by the government’s outgoing chief scientist, Sir John Beddington, who said the MP had fallen for the “Galileo fallacy” (Galileo was laughed at but was right, therefore since I am laughed at I must be right).

In July 2013 Tredinnick sponsored an EDM congratulating a farmer on his decision to use homeopathy with what were claimed to be positive results.The motion was supported by one other MP but the British veterinary association says there is no evidence of any benefit.

Tredinnick is a supporter of astrology especially the use of it in medical practice.In November 2009, he spoke at a meeting organised by the Astrological Association of Great Britain, where he related his personal experience of astrology and illness, advocating that astrology be integrated into the NHS.

Tredinnick’s appointment to the Health committee in June 2010 was criticised in two science reports in the Guardian. Martin Robbins said his appointment was “an extremely disturbing development” even though “Tredinnick is a figure unlikely to be taken seriously by policymakers” whilst Nature‘s Adam Rutherford described Tredinnick as “misinformed about a great many things” and said that “giving [him] influence on medical policy ..is a bad move.”The Telegraph writer Ian Douglas also described it as “a problem.”

His appointment to the Science and technology committee also drew criticism. Andy McSmith in the Independent, cited his views that homeopathy could cure HIV, TB, malaria, urinary infections, diarrhoea, skin eruptions, diabetes, epilepsy, eye infections, intestinal parasites, cancer, and gangrene amongst others and quoted Imran Khan, head of the Campaign for Science and Engineering, as saying that “someone with such incredibly odd views is not helpful”. Tom Whipple in the Times said his appointment caused despair,whilst Elizabeth Gibney in the Times Higher Education quoted the Skeptical Voter website as saying that Tredinnick is “perhaps the worst example of scientific illiteracy in government”…

In 2009 Tredinnick attempted to claim the £125 cost of attending a course on “intimate relationships” through his Parliamentary expenses. He was also found to have used expenses to purchase astrology software, claiming it was for a debate on alternative medicine.

Compared to some of theses bizarre activities, the notion that herbal remedies might provide the solution for antibiotic resistance seems almost reasonable and clever.

ALMOST!!!

Tredinnick does not seem to know that:

  • many antibiotics originate from plants or other natural substances,
  • several large pharmaceutical companies are feverishly looking for more such substances from plants,
  • most plants do actually contain substances which have antibiotic activity,
  • however, most cannot be used as medicines, for instance, because they are far too toxic (tea tree oil is a good example for this),
  • once a pure compound has been isolated from a plant and is used therapeutically, it ceases to be herbal medicine (which is defined as the use of full plant extracts),
  • it is thus unlikely that full plant extracts, i. e. herbal medicine, will ever provide a solution to antibiotic resistance.

I have little doubt that Tredinnick will continue to mislead parliament and the public with his nonsensical views about alternative medicine. And even if it might have no effect whatsoever, I will continue to point out just how nonsensical they are.

Some time ago, I published a post entitled HOW TO BECOME A CHARLATAN. This prompted ‘THE NORWEGIAN ACADEMY OF SCIENCE AND LETTERS’ to invite me to give a lecture on the subject, a great honour, I am sure. Consequently, I have thought about this somewhat unusual subject quite a lot.

Obviously, my thoughts come from the perspective of someone who has researched alternative medicine for many years. Pseudoscientists seem to love alternative medicine and proponents of alternative medicine love pseudoscience. As a result, alternative medicine is densely populated by pseudoscientists.

But what is the characteristic of pseudoscience? Reflecting on this question, I found not one but several hallmarks (and for each of them, there are many posts on this blog which provide further explanations):

Based on these 12 hallmarks, one could create a simple score which indicates the likelihood of the presence of pseudoscience. In other words, it might be useful to consider pseudoscience in terms of a sliding scale. Some things in alternative medicine can be just a bit pseudoscientific, others quite a lot, while others again are hopelessly so.

The issue of pseudoscience is by no means just academic; it is very real problem and has many important, practical implications. The most important one probably is that, in health care (and other areas as well), pseudoscience can be harmful, even to the point that it costs lives of vulnerable patients who believe that everything masquerading as science can be relied upon.

Tai Chi has been suggested to have many health benefits. Might it even prolong life? There are many enthusiasts who claim just that, but is there any evidence?

This study is a retrospective cross-sectional investigation to compare the rejuvenating and anti-ageing effects among a Tai Chi group (TCC) and a brisk walking group (BW) and a no exercise habit group (NEH) of volunteers. Thirty-two participants were separated into three groups: the TCC group (practicing TC for more than 1 year), the BW group (practicing BW for more than 1 year), and the NEH group. The CD34+ cell counts in peripheral blood of the participants was determined, and the Kruskal‐Wallis test was used to evaluate and compare the antiaging effects of the three groups. The results show that the participants in the TCC group (N = 10) outperformed the NEH group (N = 12) with respect to the number of CD34+ progenitor cells. No significant difference was found between the TCC group and the BW group. The authors of this study conclude that TCC practice sustained for more than 1 year may be an intervention against aging as effective as BW in terms of its benefits on the improvement of CD34+ number.

I was alerted to this new paper by several rather sensational headlines in the daily press which stated that Tai chi (TC) had anti-aging effects. So I searched for the press release about the article where I found the following quotes:

“It is possible that Tai Chi may prompt vasodilation and increase blood flow,” said Lin. “Considering that BW may require a larger space or more equipment, Tai Chi seems to be an easier and more convenient choice of anti-aging exercise.” “This study provides the first step into providing scientific evidence for the possible health benefits of Tai Chi.” said Dr. Paul R. Sanberg, distinguished professor at the Center of Excellence for Aging and Brain Repair, Morsani College of Medicine, University of South Florida, Tampa, FL. “Further study of how Tai Chi can elicit benefit in different populations and on different parameters of aging are necessary to determine its full impact.”

Personally, I find both the press release and the original conclusions of the authors quite amazing. If anyone wanted to write a textbook on how not to do such things, he/she could use them as excellent examples.

Seen with just a tinge of critical thinking the paper reports a flimsy case-control study comparing three obviously self-selected groups of people who had chosen to follow different exercise regimen for several months. In all likelihood they also differed in terms of life-style, nutrition, sleeping pattern, alcohol intake, smoking habits and a million other things. These rather tiny groups were then compared according to a surrogate measure for ageing and some differences were identified.

BIG DEAL!

To conclude from this, or even to imply, that TC has anti-ageing effects is as far-fetched as claiming the tooth fairy has money problems.

This story could be just funny or trivial or boring – however, I think, it is also a bit worrying. It shows, I fear, how uncritical researchers in conjunction with some naïve press officer are able to induce silly journalists and headline-writers to mislead the public.

Auricular acupuncture (AA), according to the ‘COLLEGE OF AURICULAR ACUPUNCTURE’, has its origins in Modern Europe. In 1957 Dr. Paul Nogier, a neurologist from Lyons in France, observed a locum doctor treating sciatica by cauterizing an area of the ear. This prompted extensive research culminating in the development of the somatopic correspondence of specific parts of the body to the ear based upon the concept of an inverted foetus. Dr. Nogier believed that pain and other symptoms in the body could be alleviated by needling, massaging or electronically stimulating the corresponding region of the ear. Auricular Acupuncture is a specialized complementary therapy where acupuncture points on the outer ear are treated, using either needles or acupunctoscopes (electrical location and stimulation machines) to help relieve many chronic complaints. There are over 200 acupuncture points on the ear, each point named after an area of our anatomy. The outer ear acts like a switchboard to the brain. Each acupuncture point being treated, triggers electrical impulses from the ear via the brain, to the specific part of the body being treated.

Sounds odd? Well, that’s because it is odd!

But just because something is odd does not mean it is ineffective – so, what does the reliable evidence tell us? Here are some conclusions from systematic reviews:

The evidence that auricular acupuncture reduces postoperative pain is promising but not compelling.

The evidence for the effectiveness of AA for the symptomatic treatment of insomnia is limited.

The benefit of ear-acupressure for symptomatic relief of allergic rhinitis is unknown…

All of these analyses point out that the quality of the studies is usually very poor, and stress that more and better research is required. It is therefore interesting to note that a new study has just been published. Perhaps it could settle the question about the effectiveness of AA?

The aim of this study was 1) to evaluate whether auricular acupuncture effective for reducing health care provider stress and anxiety and 2) to determine, if auricular acupuncture impacts provider capacity for developing caring relationships with patients. Pre-intervention and post-intervention surveys were evaluated to see, if auricular acupuncture was associated with changes in State-Trait Anxiety Inventory (STAI), Professional Quality of Life, and Caring Ability Inventory scores. The results indicate that, compared with baseline, participants had a significant reduction in state anxiety (STAI), trait anxiety (STAI), burnout, and secondary traumatic stress scores (Professional Quality of Life). Significant increases were noted in courage and patience, two dimensions of the Caring Ability Inventory.

From these findings, the authors conclude that auricular acupuncture is an effective intervention for the relief of stress/anxiety in providers and supports heightened capacity for caring.

Sounds odd again? Yes, because it is odd!

I would argue that a study of any controversial therapy that has already been tested repeatedly in poor quality trials must have sufficient scientific rigor to advance the field of inquiry. If it does not fulfil this criterion, it is quite simply not ethical. The new study does not even have a control group; we can therefore not begin to tell whether the observed outcomes were due to non-specific effects, the natural history of the condition or regression towards the mean (to mention but a few of the possible sources of bias). To conclude that AA is ‘an effective intervention’ is therefore utterly barmy.

All of this could be entirely trivial and inconsequential. I am afraid, however, that it is not. Alternative medicine is littered with such unethically flawed research conducted by naïve and clueless pseudo-scientists who arrive at outrageous conclusions. This relentless flow of false-positive findings misleads consumers, health care professionals, decision makers and everyone else to draw the wrong conclusions about bogus therapies. And, in the end, this sort of thing even does a grave disfavour to any branch of alternative medicine that might have some degree of respectability.

IT IS HIGH TIME THAT THIS NONSENSE STOPS! IT BORDERS ON SCIENTIFIC MISCONDUCT.

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.

A recent US study found that belief in conspiracy theories is rife in health care. The investigators presented people with 6 different conspiracy theories, and the one that was most widely believed was the following:

THE FOOD AND DRUG ADMINISTRATION IS DELIBERATELY PREVENTING THE PUBLIC FROM GETTING NATURAL CURES FOR CANCER AND OTHER DISEASES BECAUSE OF PRESSURE FROM DRUG COMPANIES.

A total of 37% agreed with this statement, 31% had no opinion on the matter, and 32% disagreed. What is more, the belief in this particular conspiracy correlated positively with the usage of alternative medicine.

Essentially, this implies that the current popularity of alternative medicine is at least partly driven by the conviction that there is a sinister plot by the FDA or more generally speaking ‘the establishment’ that prevents people from benefitting from the wonders of alternative treatments.

I think it was Woody Allen who noted that, just because you are paranoid does not mean that they are not following you. So, let’s look for evidence suggesting that the FDA or any similar organisation is suppressing alternative medicine.

A prime candidate is, of course, the often implicated, thoroughly evil ‘BIG PHARMA‘. I am not a fan of the pharmaceutical industry and I know few people who are. But where is the evidence for BIG PHARMA’s conspiracy against alternative medicine? In the many years of researching this sector, I have never come across a jot of evidence to support this notion. On the contrary, BIG PHARMA seems all to keen to jump on to the alternative bandwagon and make a few quick bucks from the gullibility of the consumer.

What about the rest of the medical establishment? All I see is that universities, hospitals, charities and other organisations in health care currently bend over backwards in order to accommodate as much alternative medicine as they possibly can get away with in view of the often embarrassing lack of convincing evidence for the treatments in question. Conspiracy against alternative medicine? I don’t think so.

The closer we look, the more we arrive at the conclusion that the conspiracy against alternative medicine is a myth and a figment of the imagination of those who religiously believe in alternative medicine. They seem to long for an explanation why their favourite therapy is not in even more wide-spread use. Cognitive dissonance seems to prevent them to consider that the lack of evidence has anything to do with this situation. Consequently, they prefer to invent a conspiracy theory.

And this is where an interesting question emerges, in my view: do people who believe that the FDA or other organisations prevent the public from getting more alternative medicine really need more alternative medicine, or do they perhaps just need an effective treatment for their paranoia?

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.

It is not often that we see an article of the great George Vithoulkas, the ‘über-guru‘ of homeopathy, in a medical journal. In fact, this paper, which he co-authored with several colleagues, seems to be a rare exception: in his entire career, he seems to have published just 15 Medline- listed articles most of which are letters to the editor.

According to Wikipedia, Vithoulkas has been described as “the maestro of classical homeopathy” by Robin Shohet; Lyle Morgan says he is “widely considered to be the greatest living homeopathic theorist”; and Scott Shannon calls him a “contemporary master of homeopathy.” Paul Ekins credited Vithoulkas with the revival of the credibility of homeopathy.

In his brand new paper, Vithoulkas provides evidence for the notion that homeopathy can treat infertility. More specifically, the authors present 5 cases of female infertility treated successfully with the use of homeopathic remedies.

Really?

Yes, really! The American Medical College of Homeopathy informs us that homeopathy has an absolute solution that can augment your probability of conception. Homeopathic treatment of Infertility addresses both physical and emotional imbalances in a person. Homeopathy plays a role in treating Infertility by strengthening the reproductive organs in both men and women, by regulating hormonal balance, menstruation and ovulation in women, by escalating blood flow into the pelvic region, by mounting the thickness of the uterine lining and preventing the uterus from contracting hence abating chances of a miscarriage, and by increasing quality and quantity of sperm count in men. It can also be advantageous in reducing anxiety so that the embryo implantation can take place in a favourable environment. Homoeopathy is a system of medicine directed at assisting the body’s own healing process.

Imagine: the 5 women in Vithoulkas ‘study’ wanted to have children; they consulted homeopaths because they did not get pregnant in a timely fashion. The homeopaths prescribed individualised homeopathy and treated them for prolonged periods of time. Eventually, BINGO!, all of the 5 women got pregnant.

What a hoot!

It beggars belief that this result is being credited to the administration of homeopathic remedies. Do the authors not know that, in many cases, it can take many months until a pregnancy occurs? Do they not think that the many women they treated unsuccessfully for the same problem should raise some doubts about homeopathy? Do they really believe that their remedies had any causal relationship to the 5 pregnancies?

Vithoulkas was a recipient of the Right Livelihood Award in 1996. I hope they did not give it to him in recognition of his scientific achievements!

 

 

Mohamed Khalifa is a therapist who works in Austria and has been practicing manual therapy for more than 30 years. His treatment, the so-called “Khalifa therapy”, is based on rhythmically applying manual pressure on parts of the body. Khalifa claims to be able to speed the self-healing processes of the human body. He has treated many top-athletes from all over the world; however, his method has never been investigated in detail within interdisciplinary scientific studies.

Now the first RCT of Khalifa therapy has become available.

Rupture of the anterior cruciate ligament (ACL) is an injury which usually needs to be treated surgically. It does not heal spontaneously, although some claim this commonly accepted knowledge to be not true. This randomized, controlled, observer-blinded, multicentre study was performed to test the effectiveness of Khalifa therapy for ACL. Thirty patients with complete ACL rupture, magnetic resonance imaging (MRI) verified, were included. Study examinations (e.g., international knee documentation committee (IKDC) score) were performed at inclusion (t 0). Patients were randomized to receive either standardised physiotherapy (ST) or additionally 1 hour of Khalifa therapy at the first session (STK). Twenty-four hours later, study examinations were performed again (t 1). Three months later control MRI and follow-up examinations were performed (t 2).

Initial status was comparable between both groups. There was a highly significant difference of mean IKDC score results at t 1 and t 2. After 3 months, 47% of the STK patients, but no ST patient, demonstrated an end-to-end homogeneous ACL in MRI. Clinical and physical examinations were significantly different in t 1 and t 2. ACL healing can be improved with manual therapy. Physical activity could be performed without pain and nearly normal range of motion after one treatment of specific pressure.

The authors of this study concluded that spontaneous healing of ACL rupture is possible within 3 months after lesion, enhanced by Khalifa therapy. The effect sizes of 1.6 and 2.0 standard deviations after treatment and after 3 months are considerable and prompt further work. Further progress in understanding the underlying mechanisms including placebo will be possible when more experience with the manual pressure therapy has been gathered by other therapists.

The authors of this RCT state that according to common knowledge, it (ACL) does not heal spontaneously. Other authors disagree with this notion:

Observations on 14 patients with ACL, for instance, indicated an acutely injured ACL may eventually spontaneously heal without using an extension brace, allowing return to athletic activity. Another study suggested that an acutely injured ACL has healing capability. It also suggests that conservative management of the acute ACL injury can yield satisfactory results in a group of individuals who have low athletic demands and continuous ACL on MRI, provided the patients are willing to accept the slight risk of late ACL reconstruction and meniscal injury.

So yes, the authors of the new RCT are correct in stating: spontaneous healing of ACL rupture is possible within 3 months … but the healing might indeed be SPONTANEOUS, i.e. unrelated to the Khalifa therapy. Before we can accept that Khalifa therapy is anything but a theatrical placebo, this RCT needs independent replication. Generally speaking, it seems a bad idea to make exaggerated claims on the basis of one single trial, particularly for treatments that are as implausible as this one.

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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