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

bias

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Readers of this blog will know that few alternative treatments are more controversial and less plausible than homeopathy. Therefore they might be interested to read about the latest attempt of homeopathy-enthusiasts to convince the public that, despite all the clinical evidence to the contrary, homeopathy does work.

The new article was published in German by Swiss urologist and is a case-report describing a patient suffering from paralytic ileus. This condition is a typical complication of ileocystoplasty of the bladder, the operation the patient had undergone. The patient had also been suffering from a spinal cord injury which, due to a pre-existing neurogenic bowel dysfunction, increases the risk of paralytic ileus.

The paraplegic patient developed a massive paralytic ileus after ileocystoplasty and surgical revision. Conventional stimulation of bowel function was unsuccessful. But after adjunctive homeopathic treatment normalization of bowel function was achieved.

The authors conclude that adjunctive homeopathic therapy is a promising treatment option in patients with complex bowel dysfunction after abdominal surgery who do not adequately respond to conventional treatment.

YES, you did read correctly: homeopathic therapy is a promising treatment

In case anyone doubts that this is more than a trifle too optimistic, let me suggest three much more plausible reasons why the patient’s bowel function finally normalised:

  • It could have been a spontaneous recovery (in most cases, even severe ones, this is what happens).
  • It could have been all the conventional treatments aimed at stimulating bowel function.
  • It could have been a mixture of the two.

The article made me curious, and I checked whether the authors had previously published other material on homeopathy. Thus I found two further articles in a very similar vein:

Article No 2 (dated 2014):

We present the clinical course of a patient with an epididymal abscess caused by multiresistant bacteria. As the patient declined surgical intervention, a conservative approach was induced with intravenous antibiotic treatment. As the clinical findings did not ameliorate, adjunctive homeopathic treatment was used. Under combined treatment, laboratory parameters returned to normal, and the epididymal abscess was rapidly shrinking. After 1 week, merely a subcutaneous liquid structure was detected. Fine-needle aspiration revealed sterile purulent liquid, which was confirmed by microbiological testing when the subcutaneous abscess was drained. Postoperative course was uneventful.

As the risk for recurrent epididymitis is high in persons with spinal cord injury, an organ-preserving approach is justified even in severe cases. Homeopathic treatment was a valuable adjunctive treatment in the above-mentioned case. Therefore, prospective studies are needed to further elucidate the future opportunities and limitations of classical homeopathy in the treatment of urinary tract infections.

Article No 3 (dated 2012):

Recurrent urinary tract infections (UTI) in patients with spinal cord injury are a frequent clinical problem. Often, preventive measures are not successful. We present the case reports of five patients with recurrent UTI who received additional homeopathic treatment. Of these patients, three remained free of UTI, whereas UTI frequency was reduced in two patients. Our initial experience with homeopathic prevention of UTI is encouraging. For an evidence-based evaluation of this concept, prospective studies are required.

It seems clear that all of the three more plausible explanations for the patients’ recovery listed above also apply to these two cases.

One might not be far off speculating that J Pannek, the first author of all these three articles, is a fan of homeopathy (this suspicion is confirmed by a link between him and the HOMEOPATHY RESEARCH INSTITUE: Prof Jürgen Pannek on the use of homeopathy for prophylaxis of UTI’s in patients with neurogenic bladder dysfunction). If that is so, I wonder why he does not conduct a controlled trial, rather than publishing case-report after case-report of apparently successful homeopathic treatments. Does he perhaps fear that his effects might dissolve into thin air under controlled conditions?

Case-reports of this nature can, of course, be interesting and some might even deserve to be published. But it would be imperative to draw the correct conclusions. Looking at the three articles above, I get the impression that, as time goes by, the conclusions of Prof Pannek et al (no, I know nobody from this group of authors personally) are growing more and more firm on less and less safe ground.

In my view, responsible authors should have concluded much more cautiously and reasonably. In the case of the paralytic ileus, for instance, they should not have gone further than stating something like this: adjunctive homeopathic therapy might turn out to be a promising treatment option for such patients. Despite the implausibility of homeopathy, this case-report might deserve to be followed up with a controlled clinical trial. Without such evidence, firm conclusions are clearly not possible.

There must be well over 10 000 clinical trials of acupuncture; Medline lists ~5 000, and many more are hidden in the non-Medline listed literature. That should be good news! Sadly, it isn’t.

It should mean that we now have a pretty good idea for what conditions acupuncture is effective and for which illnesses it does not work. But we don’t! Sceptics say it works for nothing, while acupuncturists claim it is a panacea. The main reason for this continued controversy is that the quality of the vast majority of these 10 000 studies is not just poor, it is lousy.

“Where is the evidence for this outraging statement???” – I hear the acupuncture-enthusiasts shout. Well, how about my own experience as editor-in-chief of FACT? No? Far too anecdotal?

How about looking at Cochrane reviews then; they are considered to be the most independent and reliable evidence in existence? There are many such reviews (most, if not all [co-]authored by acupuncturists) and they all agree that the scientific rigor of the primary studies is fairly awful. Here are the crucial bits of just the last three; feel free to look for more:

All of the studies had a high risk of bias

All included trials had a high risk of bias…

The studies were not judged to be free from bias…

Or how about providing an example? Good idea! Here is a new trial which could stand for numerous others:

This study was performed to compare the efficacy of acupuncture versus corticosteroid injection for the treatment of Quervain’s tendosynovitis (no, you do not need to look up what condition this is for understanding this post). Thirty patients were treated in two groups. The acupuncture group received 5 acupuncture sessions of 30 minutes duration. The injection group received one methylprednisolone acetate injection in the first dorsal compartment of the wrist. The degree of disability and pain was evaluated by using the Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH) scale and the Visual Analogue Scale (VAS) at baseline and at 2 weeks and 6 weeks after the start of treatment. The baseline means of the Q-DASH and the VAS scores were 62.8 and 6.9, respectively. At the last follow-up, the mean Q-DASH scores were 9.8 versus 6.2 in the acupuncture and injection groups, respectively, and the mean VAS scores were 2 versus 1.2. Thus there were short-term improvements of pain and function in both groups.

The authors drew the following conclusions: Although the success rate was somewhat higher with corticosteroid injection, acupuncture can be considered as an alternative option for treatment of De Quervain’s tenosynovitis.

The flaws of this study are exemplary and numerous:

  • This should have been a study that compares two treatments – the technical term is ‘equivalence trial – and such studies need to be much larger to produce a meaningful result. Small sample sizes in equivalent trials will always make the two treatments look similarly effective, even if one is a pure placebo.
  • There is no gold standard treatment for this condition. This means that a comparative trial makes no sense at all. In such a situation, one ought to conduct a placebo-controlled trial.
  • There was no blinding of patients; therefore their expectation might have distorted the results.
  • The acupuncture group received more treatments than the injection group; therefore the additional attention might have distorted the findings.
  • Even if the results were entirely correct, one cannot conclude from them that acupuncture was effective; the notion that it was similarly ineffective as the injections is just as warranted.

These are just some of the most fatal flaws of this study. The sad thing is that similar criticisms can be made for most of the 10 000 trials of acupuncture. But the point here is not to nit-pick nor to quack-bust. My point is a different and more serious one: fatally flawed research is not just a ‘poor show’, it is unethical because it is a waste of scarce resources and, even more importantly, an abuse of patients for meaningless pseudo-science. All it does is it misleads the public into believing that acupuncture might be good for this or that condition and consequently make wrong therapeutic decisions.

In acupuncture (and indeed in most alternative medicine) research, the problem is so extremely wide-spread that it is high time to do something about it. Journal editors, peer-reviewers, ethics committees, universities, funding agencies and all others concerned with such research have to work together so that such flagrant abuse is stopped once and for all.

Niacin – also known as vitamin B3 or nicotinic acid – is a natural compound (formula C
6
H
5
NO
2
) and an essential nutrient for humans. It is water-soluble, which means it is not stored in the body. Excess amounts of the vitamin leave the body through the urine. That means we need a continuous supply of niacin in your diet.

Niacin is found in variety of foods, including liver, chicken, beef, fish, cereal, peanuts and legumes. It can also be synthesized from tryptophan, an essential amino acid found in protein. Niacin has long been an accepted treatment for high cholesterol. It is well-documented to increase the levels of high-density cholesterol (HDL or “good cholesterol”) and to decrease the levels of low-density cholesterol (LDL or “bad cholesterol”).

But what do these effects really mean? Do they translate into true health benefits? A brand-new study casts doubt on the value of niacin therapy:

After a pre-randomization run-in phase to standardize the background statin-based LDL cholesterol-lowering therapy and to establish participants’ ability to take extended-release niacin without clinically significant adverse effects, the researchers randomly assigned 25,673 adults with vascular disease to receive 2 g of extended-release niacin and 40 mg of laropiprant or a matching placebo daily. The primary outcome was the first major vascular event (non-fatal myocardial infarction, death from coronary causes, stroke, or arterial revascularization).

During a median follow-up period of 3.9 years, participants who were assigned to extended-release niacin-laropiprant had an LDL cholesterol level that was 10 mg per deciliter (0.25 mmol/l) lower and an HDL cholesterol level that was 6 mg per deciliter (0.16 mmol/l) higher than the levels in those assigned to placebo. Thus the lipid-effects of previous studies were confirmed.

However, assignment to niacin-laropiprant, as compared with assignment to placebo, had no significant effect on the incidence of major vascular events Niacin-laropiprant was associated with an increased incidence of disturbances in diabetes control that were considered to be serious and with an increased incidence of diabetes diagnoses as well as increases in serious adverse events associated with the gastrointestinal system, the musculoskeletal system, the skin and infections and bleeding.

Based of these data, the authors arrived at the following conclusion: among participants with atherosclerotic vascular disease, the addition of extended-release niacin-laropiprant to statin-based LDL cholesterol-lowering therapy did not significantly reduce the risk of major vascular events but did increase the risk of serious adverse events.

This extremely well-done trial is a poignant reminder of the fact that, in health care, we must never take our assumptions for granted. Here the underlying assumption was that the Niacin-induced lipid changes lead to a reduction of cardiovascular risks. Not only it proved to be erroneous but, through serious adverse effects, Niacin actually decreased patients’ health status.

The lessons from all this are straight forward, I think:

  • ‘Natural’ does not necessarily mean safe.
  • Long-established does not necessarily mean efficacious.
  • Assumptions are merely assumptions, nothing more; if we want to make sure that they hold, we need to test them.
  • When we finally do test assumptions, we better do it rigorously.

When someone has completed a scientific project, it is customary to publish it [‘unpublished science is no science’, someone once told me many years ago]. To do so, he needs to write it up and submit it to a scientific journal. The editor of this journal will then submit it to a process called ‘peer review’.

What does ‘peer review’ entail? Well, it means that 2-3 experts are asked to critically assess the paper in question, make suggestions as to how it can be improved and submit a recommendation as to whether or not the article deserves to be published.

Peer review has many pitfalls but, so far, nobody has come up with a solution that is convincingly better. Many scientists are under pressure to publish [‘publish or perish’], and therefore some people resort to cheating. A most spectacular case of fraudulent peer review has been reported recently in this press release:

SAGE statement on Journal of Vibration and Control

London, UK (08 July 2014) – SAGE announces the retraction of 60 articles implicated in a peer review and citation ring at the Journal of Vibration and Control (JVC). The full extent of the peer review ring has been uncovered following a 14 month SAGE-led investigation, and centres on the strongly suspected misconduct of Peter Chen, formerly of National Pingtung University of Education, Taiwan (NPUE) and possibly other authors at this institution.

In 2013 the then Editor-in-Chief of JVC, Professor Ali H. Nayfeh,and SAGE became aware of a potential peer review ring involving assumed and fabricated identities used to manipulate the online submission system SAGE Track powered by ScholarOne Manuscripts™. Immediate action was taken to prevent JVC from being exploited further, and a complex investigation throughout 2013 and 2014 was undertaken with the full cooperation of Professor Nayfeh and subsequently NPUE.

In total 60 articles have been retracted from JVC after evidence led to at least one author or reviewer being implicated in the peer review ring. Now that the investigation is complete, and the authors have been notified of the findings, we are in a position to make this statement.

While investigating the JVC papers submitted and reviewed by Peter Chen, it was discovered that the author had created various aliases on SAGE Track, providing different email addresses to set up more than one account. Consequently, SAGE scrutinised further the co-authors of and reviewers selected for Peter Chen’s papers, these names appeared to form part of a peer review ring. The investigation also revealed that on at least one occasion, the author Peter Chen reviewed his own paper under one of the aliases he had created.

Unbelievable? Perhaps, but sadly it is true; some scientists seem to be criminally ingenious when it comes to getting their dodgy articles into peer-reviewed journals.

And what does this have to do with ALTERNATIVE MEDICINE, you may well ask. The Journal of Vibration and Control is not even medical and certainly would never consider publishing articles on alternative medicine. Such papers go to one of the many [I estimate more that 1000] journals that cover either alternative medicine in general or any of the modalities that fall under this wide umbrella. Most of these journals, of course, pride themselves with being peer-reviewed – and, at least nominally, that is correct.

I have been on the editorial board of most of the more important journals in alternative medicine, and I cannot help thinking that their peer review process is not all that dissimilar from the fraudulent scheme set up by Peter Chen and disclosed above. What happens in alternative medicine is roughly as follows:

  • a researcher submits a paper for publication,
  • the editor sends it out for peer review,
  • the peer reviewers are either those suggested by the original author or members of the editorial board of the journal,
  • in either case, the reviewers are more than likely to be uncritical and recommend publication,
  • in the end, peer review turns out to be a farcical window dressing exercise with no consequence,
  • thus even very poor research and pseudo-research are being published abundantly.

The editorial boards of journals of alternative medicine tend to be devoid of experts who are critical about the subject at hand. If you think that I am exaggerating, have a look at the editorial board members of ‘HOMEOPATHY’ (or any other journal of alternative medicine) and tell me who might qualify as a critic of homeopathy. When the editor, Peter Fisher, recently fired me from his board because he felt I had tarnished the image of homeopathy, this panel lost the only person who understood the subject matter and, at the same time, was critical about it (the fact that the website still lists me as an editorial board member is merely a reflection of how slow things are in the world of homeopathy: Fisher fired me more than a year ago).

The point I am trying to make is simple: peer review is never a perfect method but when it is set up to be deliberately uncritical, it cannot possibly fulfil its function to prevent the publication of dodgy research. In this case, the quality of the science will be inadequate and generate false-positive messages that mislead the public.

Have you noticed?

Homeopaths, acupuncturists, herbalists, reflexologists, aroma therapists, colonic irrigationists, naturopaths, TCM-practitioners, etc. – they always smile!

But why?

I think I might know the answer. Here is my theory:

Alternative practitioners have in common with conventional clinicians that they treat patients – lots of patients, day in day out. This wears them down, of course. And sometimes, conventional clinicians find it hard to smile. Come to think of it, alternative practitioners seem to have it much better. Let me explain.

Whenever a practitioner (of any type) treats a patient, one of three outcomes is bound to happen:

  1. the patient gets better,
  2. the patients roughly remains how she was and experiences no improvement,
  3. the patient gets worse.

In scenario one, everybody is happy. Both alternative and conventional practitioners will claim with a big smile that their treatment was the cause of the improvement. There is a difference though: the conventional practitioner who adheres to the principles of evidence-based medicine will know that the assumption is likely to be true, while the alternative practitioner is probably just guessing. In any case, as long as the patient gets better, all is well.

In scenario two, most conventional clinicians will get somewhat concerned and find little reason to smile. Not so the alternative practitioner! He will have one of several explanations why his therapy has not produced the expected result all of which allow him to carry on smiling smugly. He might, for instance, explain to his patient:

  • You have to give it more time; another 10-20 treatment sessions and you will be as right as rain (unfortunately, further sessions will come at a price).
  • This must be because of all those nasty chemical drugs that you took for so long – they block up your system, you know; we will have to do some serious detox to get rid of all this poison (of course, at a cost).
  • You must realize that, had we not started my treatment when we did, you would be much worse by now, perhaps even dead.

In scenario three, any conventional clinician would have stopped smiling and begun to ask serious, self-critical questions about his diagnosis and treatment. Not so the alternative practitioner. He will point out with a big smile that the deterioration of the symptoms only appears to be a bad sign. In reality it is a very encouraging signal indicating that the optimal treatment for the patient’s condition has finally been found and is beginning to work. The acute worsening of the complaints is merely an ‘aggravation’ or’ healing crisis’. Such a course of events had to be expected when true healing of the root cause of the condition is to be achieved. The thing to do now is to continue with several more treatments (at a cost, of course) until deep healing from within sets in.

Many of us want the cake and eat it – but alternative practitioners, it seems to me, have actually achieved this goal. No wonder they smile!

A remarkable article about homeopathy and immunisation entitled THE IMMUNISATION DILEMMA came to my attention recently. Its abstract promised: “evidence quantifying the effectiveness of vaccination and HP (homeoprophylaxis) will be examined. New international research describing and analysing HP interventions will be reported. An evidence-based conclusion will be reached.”

Sounds interesting? Let’s see what the article really offers. Here is the relevant text:

…evidence does exist to support claims regarding the effectiveness of homeopathic immunisation is undeniable.

I was first invited to visit Cuba in December 2008 to present at an international conference hosted by the Finlay Institute, which is a W. H. O.-accredited vaccine manufacturer. The Cubans described their use of HP to control an outbreak of leptospirosis (Weilʼs syndrome – a potentially fatal, water-born bacterial disease) in 2007 among the residents of the three eastern provinces which were most severely damaged by a severe hurricane – over 2.2 million people [7]. 2008 was an even worse year involving three hurricanes, and the countryʼs food production was only just recovering at the time of the conference. The HP program had been repeated in 2008, but data was not available at the conference regarding that intervention.

I revisited Cuba in 2010 and 2012, each time to work with the leader of the HP interventions, Dr. Bracho, to analyse the data available. Dr. Bracho is not a homeopath; he is a published and internationally recognised expert in the manufacture of vaccine adjuvants. He worked in Australia at Flinders University during 2004 with a team trying to develop an antimalarial vaccine.

In 2012 we accessed the raw leptospirosis surveillance data, comprising weekly reports from 15 provinces over 9 years (2000 to 2008) reporting 21 variables. This yielded a matrix with 147 420 possible entries. This included data concerning possible confounders, such as vaccination and chemoprophylaxis, which allowed a careful examination of possible distorting effects. With the permission of the Cubans, I brought this data back to Australia and it is being examined by mathematicians at an Australian university to see what other information can be extracted. Clearly, there is objective data supporting claims regarding the effectiveness of HP.

The 2008 result was remarkable, and could only be explained by the effectiveness of the HP intervention. Whilst the three hurricanes caused immense damage throughout the country it was again worse in the east, yet the three homeopathically immunised provinces experienced a negligible increase in cases whilst the rest of the country showed significant increases until the dry season in January 2009 [8].

This is but one example – there are many more. It is cited to show that there is significant data available, and that orthodox scientists and doctors have driven the HP interventions, in the Cuban case. Many people internationally now know this, so once again claims by orthodox authorities that there is no evidence merely serves to show that either the authorities are making uninformed/unscientific statements, or that they are aware but are intentionally withholding information. Either way, confidence is destroyed and leads to groups of people questioning what they are told…

Final Conclusions

The attacks against homeopathy in general and HP in particular will almost certainly continue. If we can achieve a significant level of agreement then we would be able to answer challenges to HP with a single, cohesive, evidence-based, and generally united response. This would be a significant improvement to the existing situation.

 

Reference 7 is the following article: Bracho G, Varela E, Fernández R et al. Large-scale application of highly-diluted bacteria for Leptospirosis epidemic control. Homeopathy 2010; 99: 156-166. The crucial bit if this paper are as follows:

A homeoprophylactic formulation was prepared from dilutions of four circulating strains of Leptospirosis. This formulation was administered orally to 2.3 million persons at high risk in an epidemic in a region affected by natural disasters. The data from surveillance were used to measure the impact of the intervention by comparing with historical trends and non-intervention regions.

After the homeoprophylactic intervention a significant decrease of the disease incidence was observed in the intervention regions. No such modifications were observed in non-intervention regions. In the intervention region the incidence of Leptospirosis fell below the historic median. This observation was independent of rainfall.

The homeoprophylactic approach was associated with a large reduction of disease incidence and control of the epidemic. The results suggest the use of HP as a feasible tool for epidemic control, further research is warranted.

The paper thus describes little more than an observational study. It shows that one region was less affected than another. I think it is quite clear that this could have many reasons which are unrelated to the homeopathic immunisation. Even the authors are cautious and speak in their conclusions not of a causal effect but of an “association”.

The 2012 data cited in the text remains unpublished; until it is available for public scrutiny, it is impossible to confirm that it is sound and meaningful.

Reference 8 refers to this article: Golden I, Bracho G. Adaptability of homœoprophylaxis in endemic, epidemic and stable background conditions. Homœopathic Links 2009; 22: 211-213. I have no access to this paper (if someone does, please fill us in) but, judging from both its title and the way it is described in the text, it does not seem to show reliable data about the efficacy of homeopathic immunisation.

So, is it true that “evidence does exist to support claims regarding the effectiveness of homeopathic immunisation”?

I do not think so!

Immunisation is by no means a trivial matter; wrong decisions in this area have the potential to cost the lives of millions. Therefore proofs of efficacy need to be published in peer-reviewed journals of high standing. These findings need then be criticised, replicated and re-criticised and re-replicated. Only when there is a wide consensus about the efficacy/safety or lack of efficacy/safety of a new form of immunisation, can it be generally accepted and implemented into clinical practice.

The current consensus about homeopathic immunisation is that it is nothing less than dangerous phantasy. Those who promote this quackery should be publicly exposed as charlatans of the worst kind.

Yesterday, BBC NEWS published the following interesting text about a BBC4 broadcast entitled ‘THE ROYAL ACTIVIST’ aired on the same day:

Prince Charles has been a well-known supporter of complementary medicine. According to a… former Labour cabinet minister, Peter Hain, it was a topic they shared an interest in.

“He had been constantly frustrated at his inability to persuade any health ministers anywhere that that was a good idea, and so he, as he once described it to me, found me unique from this point of view, in being somebody that actually agreed with him on this, and might want to deliver it.”
Mr Hain added: “When I was Secretary of State for Northern Ireland in 2005-7, he was delighted when I told him that since I was running the place I could more or less do what I wanted to do.***
“I was able to introduce a trial for complementary medicine on the NHS, and it had spectacularly good results, that people’s well-being and health was vastly improved.

“And when he learnt about this he was really enthusiastic and tried to persuade the Welsh government to do the same thing and the government in Whitehall to do the same thing for England, but not successfully,” added Mr Hain.

*** obviously there is no homeopathic remedy for megalomania (but that’s a different story)

Oh really?

A TRIAL?

SPECTACULARLY GOOD RESULTS?

NO KIDDING?

Let’s have a look at the ‘trial’ and its results. An easily accessible report provides the following details about it:

From February 2007 to February 2008, Get Well UK ran the UK’s first government-backed complementary therapy pilot. Sixteen practitioners provided treatments including acupuncture, osteopathy and aromatherapy, to more than 700 patients at two GP practices in Belfast and Derry.   

The BBC made an hour long documentary following our trials and tribulations, which was broadcast on BBC1 NI on 5 May 2008.

Following the successful completion of the pilot, the results were analysed by Social and Market Research and recommendations were made to the Health Minister

Aims and Objectives 

The aim of the project was to pilot services integrating complementary medicine into existing primary care services in Northern Ireland. Get Well UK provided this pilot project for the Department for Health, Social Services and Public Safety (DHSSPS) during 2007.

The objectives were:

  • To measure the health outcomes of the service and monitor health improvements.
  • To redress inequalities in access to complementary medicine by providing therapies through the NHS, allowing access regardless of income.
  • To contribute to best practise in the field of delivering complementary therapies through primary care.
  • To provide work for suitably skilled and qualified practitioners.
  • To increase patient satisfaction with quick access to expert care.
  • To help patients learn skills to improve and retain their health.
  • To free up GP time to work with other patients.
  • To deliver the programme for 700 patients.

Results 

The results of the pilot were analysed by Social and Market Research, who produced this report.

The findings can be summarised as follows: 

Following the pilot, 80% of patients reported an improvement in their symptoms, 64% took less time off work and 55% reduced their use of painkillers.

In the pilot, 713 patients with a range of ages and demographic backgrounds and either physical or mental health conditions were referred to various complementary and alternative medicine (CAM) therapies via nine GP practices in Belfast and Londonderry. Patients assessed their own health and wellbeing pre and post therapy and GPs and CAM practitioners also rated patients’ responses to treatment and the overall effectiveness of the scheme.

Health improvement
• 81% of patients reported an improvement in their physical health
• 79% reported an improvement in their mental health
• 84% of patients linked an improvement in their health and wellbeing directly to their CAM treatment
• In 65% of patient cases, GPs documented a health improvement, correlating closely to patient-reported improvements
• 94% of patients said they would recommend CAM to another patient with their condition
• 87% of patient indicated a desire to continue with their CAM treatment

Painkillers and medication
• Half of GPs reported prescribing less medication and all reported that patients had indicated to them that they needed less
• 62% of patients reported suffering from less pain
• 55% reported using less painkillers following treatment
• Patients using medication reduced from 75% before treatment to 61% after treatment
• 44% of those taking medication before treatment had reduced their use afterwards

Health service and social benefits
• 24% of patients who used health services prior to treatment (i.e. primary and secondary care, accident and emergency) reported using the services less after treatment
• 65% of GPs reported seeing the patient less following the CAM referral
• Half of GPs said the scheme had reduced their workload and 17% reported a financial saving for their practice
• Half of GPs said their patients were using secondary care services less.

Impressed? Well, in case you are, please consider this:

  • there was no control group
  • therefore it is not possible to attribute any of the outcomes to the alternative therapies offered
  • they could have been due to placebo-effects
  • or to the natural history of the disease
  • or to regression towards the mean
  • or to social desirability
  • or to many other factors which are unrelated to the alternative treatments provided
  • most outcome measures were not objectively verified
  • the patients were self-selected
  • they would all have had conventional treatments in parallel
  • this ‘trial’ was of such poor quality that its findings were never published in a peer-reviewed journal
  • this was not a ‘trial’ but a ‘pilot study’
  • pilot studies are not normally for measuring outcomes but for testing the feasibility of a proper trial
  • the research expertise of the investigators was close to zero
  • the scientific community merely had pitiful smiles for this ‘trial’ when it was published
  • neither Northern Ireland nor any other region implemented the programme despite its “spectacularly good results”.

So, is the whole ‘trial’ story an utterly irrelevant old hat?

Certainly not! Its true significance does not lie in the fact that a few amateurs are trying to push bogus treatments into the NHS via the flimsiest pseudo-research of the century. The true significance, I think, is that it shows how Prince Charles, once again, oversteps the boundaries of his constitutional role.

Arnold Relman has died aged 91. He was a great personality, served for many years as editor-in-chief of ‘The New England Journal of Medicine’ and was professor of medicine and social medicine at Harvard Medical School. He also was an brilliantly outspoken critic of alternative medicine, and I therefore believe that he deserves to be remembered here. The following excerpts are from an article he wrote in 1998 about Andrew Weil, America’s foremost guru of alternative medicine; I have taken the liberty of extracting a few paragraphs which deal with alternative medicine in general terms.

Until now, alternative medicine has generally been rejected by medical scientists and educators, and by most practicing physicians. The reasons are many, but the most important reason is the difference in mentality between the alternative practitioners and the medical establishment. The leaders of the establishment believe in the scientific method, and in the rule of evidence, and in the laws of physics, chemistry, and biology upon which the modern view of nature is based. Alternative practitioners either do not seem to care about science or explicitly reject its premises. Their methods are often based on notions totally at odds with science, common sense, and modern conceptions of the structure and the function of the human body. In advancing their claims, they do not appear to recognize the need for objective evidence, asserting that the intuitions and the personal beliefs of patients and healers are all that is needed to validate their methods. One might have expected such thinking to alienate most people in a technologically advanced society such as ours; but the alternative medicine movement, and the popularity of gurus such as Weil, are growing rapidly…

That people usually “get better,” that most relatively minor diseases heal spontaneously or seem to improve with simple common remedies, is hardly news. Every physician, indeed every grandmother, knows that. Yet before we accept Weil’s contention that serious illnesses such as “bone cancer,” “Parkinson’s disease,” or “scleroderma” are similarly curable, or respond to alternative healing methods, we need at least to have some convincing medical evidence that the patients whom he reports in these testimonials did indeed suffer from these diseases, and that they were really improved or healed. The perplexity is not that Weil is using “anecdotes” as proof, but that we don’t know whether the anecdotes are true.

Anecdotal evidence is often used in the conventional medical literature to suggest the effectiveness of treatment that has not yet been tested by formal clinical trials. In fact, much of the mainstream professional literature in medicine consists of case reports — “anecdotes,” of a kind. The crucial difference between those case reports and the testimonials that abound in Weil’s books (and throughout the literature of alternative medicine) is that the case reports in the mainstream literature are almost always meticulously documented with objective data to establish the diagnosis and to verify what happened, whereas the testimonials cited by alternative medicine practitioners usually are not. Weil almost never gives any objective data to support his claims. Almost everything is simply hearsay and personal opinion.

To the best of my knowledge, Weil himself has published nothing in the peer-reviewed medical literature to document objectively his personal experiences with allegedly cured patients or to verify his claims for the effectiveness of any of the unorthodox remedies he uses. He is not alone in this respect. Few proponents of alternative medicine have so far published clinical reports that would stand the rigorous scientific scrutiny given to studies of traditional medical treatments published in the serious medical journals. Alternative medicine is still a field rich in undocumented claims and anecdotes and relatively lacking in credible scientific reports…

… Thus Weil can believe in miraculous cures even while claiming to be rational and scientific, because he thinks that quantum theory supports his views.

Yet the leading physicists of our time do not accept such an interpretation of quantum theory. They do not believe quantum theory says anything about the role of human consciousness in the physical world. They see quantum laws as simply a useful mathematical formulation for describing subatomic phenomena that are not adequately handled by classical physical theory, although the latter remains quite satisfactory for the analysis of physical events at the macro-level. Steven Weinberg has observed that “quantum mechanics has been overwhelmingly important to physics, but I cannot find any messages for human life in quantum mechanics that are different in any important way from those of Newtonian physics.” And overriding all discussions of the meaning of quantum physics is the fundamental fact that quantum theory, like all other scientific law, is only valid to the extent that it predicts and accords with the evidence provided by observation and objective measurement. Richard Feynman said it quite simply: “Observation is the ultimate and final judge of the truth of an idea.” Feynman also pointed out that scientific observations need to be objective, reproducible, and, in a sense, public — that is, available to all interested scientists who wish to check the observations for themselves.

Surely almost all scientists would agree with Feynman that, regardless of what theory of nature we wish to espouse, we cannot escape the obligation to support our claims with objective evidence. All theories must conform to the facts or be discarded. So, if Weil cannot produce credible evidence to validate the miraculous cures that he claims for the healing powers of the mind, and if he does not support with objective data the claims he and others make for the effectiveness of alternative healing methods, he cannot presume to wear the mantle of science, and his appeal to quantum theory cannot help him.

Some apologists for alternative medicine have argued that since their healing methods are based on a “paradigm” different from that of traditional medicine, traditional standards of evidence do not apply. Weil sometimes seems to agree with that view, as when he talks about “stoned thinking” and the “ambivalent” nature of reality, but more recently — as he seeks to integrate alternative with allopathic medicine — he seems to acknowledge the need for objective evidence. This, at least, is how I would interpret one of his most recent and ambitious publishing ventures, the editorship of the new quarterly journal Integrative Medicine***.

Integrative Medicine describes itself as a “peer-reviewed journal … committed to gathering evidence for the safety and efficacy of all approaches to health according to the highest standards of scientific research, while remaining open to new paradigms and honoring the healing power of nature.” The Associate Editors and Editorial Board include prominent names in both alternative medicine and allopathic medicine, who presumably support that mission. Yet the first two issues will disappoint those who were looking for original clinical research based on new, objective data. Perhaps subsequent issues will be different, but in any case it is hard to understand the need for Weil’s new journal if he truly intends to hold manuscripts to accepted scientific standards: there already exist many leading peer-reviewed medical journals that will review research studies of alternative healing methods on their merits. During the past decade or so, only a few such studies have passed rigorous review and have been published in first-rate journals. Recently, more studies have been published, but very few of them report significant clinical effects. And that is pretty much where matters now stand. Despite much avowed interest in research on alternative medicine and increased investment in support of such research, the evidentiary underpinnings of unconventional healing methods are still largely lacking…

The alternative medicine movement has been around for a long time, but it was eclipsed during most of this century by the success of medical science. Now there is growing public disenchantment with the cost and the impersonality of modern medical care, as well as concern about medical mistakes and the complications and side-effects of pharmaceuticals and other forms of medical treatment. For their part, physicians have allowed the public to perceive them as uninterested in personal problems, as inaccessible to their patients except when carrying out technical procedures and surgical operations. The “doctor knows best” attitude, which dominated patient-doctor relations during most of the century, has in recent decades given way to a more activist, consumer-oriented view of the patient’s role. Moreover, many other licensed health-care professionals, such as nurse-practitioners, psychotherapists, pharmacists, and chiropractors, are providing services once exclusively reserved to allopathic physicians.

The net result of all these developments has been a weakening of the hegemony that allopathic medicine once exercised over the health care system, and a growing interest by the public in exploring other healing approaches. The authority of allopathic medicine is also being challenged by a swelling current of mysticism and anti-scientism that runs deep through our culture. Even as the number and the complexity of urgent technological and scientific issues facing contemporary society increase, there seems to be a growing public distrust of the scientific outlook and a reawakening of interest in mysticism and spiritualism.

All this obscurantism has given powerful impetus to the alternative medicine movement, with its emphasis on the power of mind over matter. And so consumer demand for alternative remedies is rising, as is public and private financial support for their study and clinical use. It is no wonder that practicing physicians, the academic medical establishment, and the National Institutes of Health are all finding reasons to pay more attention to the alternative medicine movement. Indeed, it is becoming politically incorrect for the movement’s critics to express their skepticism too strongly in public…

There is no doubt that modern medicine as it is now practiced needs to improve its relations with patients, and that some of the criticisms leveled against it by people such as Weil — and by many more within the medical establishment itself — are valid. There also can be no doubt that a few of the “natural” medicines and healing methods now being used by practitioners of alternative medicine will prove, after testing, to be safe and effective. This, after all, has been the way in which many important therapeutic agents and treatments have found their way into standard medical practice in the past. Mainstream medicine should continue to be open to the testing of selected unconventional treatments. In keeping an open mind, however, the medical establishment in this country must not lose its scientific compass or weaken its commitment to rational thought and the rule of evidence.

There are not two kinds of medicine, one conventional and the other unconventional, that can be practiced jointly in a new kind of “integrative medicine.” Nor, as Andrew Weil and his friends also would have us believe, are there two kinds of thinking, or two ways to find out which treatments work and which do not. In the best kind of medical practice, all proposed treatments must be tested objectively. In the end, there will only be treatments that pass that test and those that do not, those that are proven worthwhile and those that are not. Can there be any reasonable “alternative”?

 

*** the journal only existed for a short period of time

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.

Traditional Chinese medicine (TCM) is often promoted as an effective therapy for cancer, and are numerous controlled clinical studies published in Chinese literature, yet no systematic analysis has been done of this body of evidence. This systematic review summarizes the evidence from controlled clinical studies published in Chinese on this subject.

The researchers looked for controlled clinical studies of TCM therapies for all kinds of cancers published in Chinese in four main Chinese electronic databases and found 2964 reports including 2385 randomized clinical trials and 579 non-randomized controlled studies.

The top seven cancer types treated were lung cancer, liver cancer, stomach cancer, breast cancer, esophagus cancer, colorectal cancer and nasopharyngeal cancer. The majority of studies (72%) applied TCM therapy combined with conventional treatments, whilst fewer (28%) applied only TCM therapy in the experimental groups. Herbal medicine was the most frequently tested TCM therapy (2677 studies, 90.32%).

The most frequently reported outcome was clinical symptom improvement (1667 studies, 56.24%) followed by biomarker indices (1270 studies, 42.85%), quality of life (1129 studies, 38.09%), chemo/radiotherapy induced side effects (1094 studies, 36.91%), tumor size (869 studies, 29.32%) and safety (547 studies, 18.45%). Completeness and adequacy of reporting appeared to improve with time.

The authors of this paper drew the following conclusion: data from controlled clinical studies of TCM therapies in cancer treatment is substantial, and different therapies are applied either as monotherapy or in combination with conventional medicine. Reporting of controlled clinical studies should be improved based on the CONSORT and TREND Statements in future. Further studies should address the most frequently used TCM therapy for common cancers and outcome measures should address survival, relapse/metastasis and quality of life.

Almost 3000 controlled clinical trials! This number is likely to impress many people – unless, of course, one knows that the quality of these studies is dismal. Interestingly, no formal assessment of study quality was included in this analysis. But it was mentioned that only 63 of these trials reported patient-blinding, and only 5 were deemed to be “relatively well designed” by the authors of this paper (who, incidentally, are strong proponents of TCM).

What I find the most interesting aspect of this article is the fact that the authors fail to mention how many of the studies reported a positive result – in a way, they don’t need to: there is plenty of evidence to show that virtually all of the Chinese studies of TCM are positive. In my view, this invalidates this body of evidence completely.

Analysis like the present one tend to lead us up the garden path. They suggest that there is a realistic hope for effective new treatments hidden in this difficult to access, large amount of data. This might lead other researchers to try to replicate some of the original studies. I fear that they would be wasting their time. From all I know, they are irreproducible.

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