MD, PhD, FMedSci, FSB, FRCP, FRCPEd

research methodology

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A new RCT of Reiki healing has been published by US authors from the following institutions: Union Institute & University, Psychology Program, Brattleboro, VT, Coyote Institute, Augusta and Bangor, ME, Eastern Maine Medical Center and Acadia Hospital, Bangor, ME, University of New England College of Osteopathic Medicine, Biddeford, ME, Coyote Institute, Orono, ME. The purpose of this study was to determine if 30 minutes of healing touch could reduce burnout in community mental health clinicians.

The authors utilized a crossover design to explore the efficacy of Reiki versus sham Reiki, a pseudo treatment performed by volunteers who had no experience with Reiki and pretended to be healers vis-à-vis the patients. This sham control intervention was designed to mimic true Reiki.

Subjects were randomized to whether they started with Reiki or sham. The Maslach Burnout Inventory-Human Services Survey (MBI-HSS) and the Measure Your Medical Outcome Profile Version 2 (MYMOP-2) were used as outcome measures. Multilevel modeling was used to represent the relations among variables.

The results showed that real Reiki was significantly better than sham Reiki in reducing burnout among community mental health clinicians. Reiki was significant in reducing depersonalization, but only among single people. Reiki reduced the primary symptom on the MYMOP also only among single people.

The authors concluded that the effects of Reiki were differentiated from sham Reiki. Reiki could be helpful in community mental health settings for the mental health of the practitioners.

My team has published on Reiki (see here and here, for instance), and on this blog I have repeatedly been expressed my doubts that Reiki is more than an elaborate placebo (see here and here, for instance). Do these new results mean that I need to eat my words and henceforth praise the wonders of Reiki? No, I don’t think so!

Having conducted studies on ‘energy healing’ myself, I know only too well of the many pitfalls and possibilities of generating false-positive findings with such research. This new study has many flaws, but we need not look far to find the reason for the surprising and implausible finding. Here is my explanation why this study suggests one placebo to be superior to another placebo.

The researchers had to recruit 16 Reiki healers and several non-Reiki volunteers to perform the interventions on the small group of patients. It goes without saying that the Reiki healers were highly motivated to demonstrate the value of their therapy. This means they (unintentionally?) used verbal and non-verbal communication to maximise the placebo effect of their treatment. The sham healers, of course, lacked such motivation. In my view, this seemingly trivial difference alone is capable of producing the false-positive result above.

There are, of course, ways of minimising the danger of such confounding. In our own study of ‘energy healing’ with sham healers as controls, for instance, we instructed both the healers and the sham healers to abstain from all communication with their patients, we filmed each session to make sure, and we asked each patient to guess which treatment they had received. None of these safeguards were incorporated in the present study – I wonder why!

In the realm of alternative medicine, we encounter many therapeutic claims that beggar belief. This is true for most modalities but perhaps for none more than chiropractic. Many chiropractors still adhere to Palmer’s gospel of the ‘inate’, ‘subluxation’ etc. and thus they believe that their ‘adjustments’ are a cure all. Readers of this blog will know all that, of course, but even they might be surprised by the notion that a chiropractic adjustment improves the voice of a choir singer.

This, however, is precisely the ‘hypothesis’ that was recently submitted to an RCT. To be precise, the study investigated the effect of spinal manipulative therapy (SMT) on the singing voice of male individuals.

Twenty-nine subjects were selected among male members of a local choir. Participants were randomly assigned to two groups: (A) a single session of chiropractic SMT and (B) a single session of non-therapeutic transcutaneous electrical nerve stimulation (TENS). Recordings of the singing voice of each participant were taken immediately before and after the procedures. After a 14-day wash-out period, procedures were switched between groups: participants who underwent SMT on the first occasion were now subjected to TENS and vice versa. Recordings were assessed via perceptual audio and acoustic evaluations. The same recording segment of each participant was selected. Perceptual audio evaluation was performed by a specialist panel (SP). Recordings of each participant were randomly presented thus making the SP blind to intervention type and recording session (before/after intervention). Recordings compiled in a randomized order were also subjected to acoustic evaluation.

No differences in the quality of the singing on perceptual audio evaluation were observed between TENS and SMT.

The authors concluded that no differences in the quality of the singing voice of asymptomatic male singers were observed on perceptual audio evaluation or acoustic evaluation after a single spinal manipulative intervention of the thoracic and cervical spine.

Laughable? Yes!

There is nevertheless an important point to be made here, I feel: some claims are just too silly to waste resources on. Or, to put it in more scientific terms, hypotheses require much more than a vague notion or hunch.

To set up, conduct and eventually publish an RCT as above requires expertise, commitment, time and money. All of this is entirely wasted, if the prior probability of a relevant result approaches zero. In the realm of alternative medicine, this is depressingly often the case. In the final analysis, this suggests that all too often research in this area achieves nothing other than giving science a bad name.

The press officers of journals like to send out press-releases of articles which are deemed to be particularly good and important. Sadly, it is not often that articles on alternative medicine fulfil these criteria. I was therefore excited to receive this press-release which seemed encouraging, to say the least:

Medical evidence supports the potential for acupuncture to be significantly more effective in the treatment of dermatologic conditions such as dermatitis, pruritus, and urticaria than alternative treatment options, “placebo acupuncture,” or no treatment, according to a review of the medical literature published in The Journal of Alternative and Complementary Medicine, a peer-reviewed publication from Mary Ann Liebert, Inc., publishers

The abstract was equally promising:

Objectives: Acupuncture is a form of Traditional Chinese Medicine that has been used to treat a broad range of medical conditions, including dermatologic disorders. This systematic review aims to synthesize the evidence on the use of acupuncture as a primary treatment modality for dermatologic conditions.

Methods: A systematic search of MEDLINE, EMBASE, and the Cochrane Central Register was performed. Studies were limited to clinical trials, controlled studies, case reports, comparative studies, and systematic reviews published in the English language. Studies involving moxibustion, electroacupuncture, or blood-letting were excluded.

Results: Twenty-four studies met inclusion criteria. Among these, 16 were randomized controlled trials, 6 were prospective observational studies, and 2 were case reports. Acupuncture was used to treat atopic dermatitis, urticaria, pruritus, acne, chloasma, neurodermatitis, dermatitis herpetiformis, hyperhidrosis, human papillomavirus wart, breast inflammation, and facial elasticity. In 17 of 24 studies, acupuncture showed statistically significant improvements in outcome measurements compared with placebo acupuncture, alternative treatment options, and no intervention.

Conclusions: Acupuncture improves outcome measures in the treatment of dermatitis, chloasma, pruritus, urticaria, hyperhidrosis, and facial elasticity. Future studies should ideally be double-blinded and standardize the control intervention.

One has to read the actual full text article to understand that the evidence presented here is dodgy to the extreme. In fact, one has to go into the tedious details of the methods section to find the reasons why:  All searches were limited to clinical trials, controlled studies, case reports, comparative studies, and systematic reviews published in the English language.

There are many more weaknesses of this review, but the inclusion of uncontrolled studies and even anecdotes is, in my view, a virtual death sentence to its credibility. It means that no general conclusions about the effectiveness of acupuncture, such as the authors have decided to make, are possible.

Such overt exaggerations are sadly no rarities in the realm of alternative medicine.  I think, this begs a number of serious questions:

  1. Does this cross the line between flawed research and scientific misconduct?
  2. Why did the reviewers not pick up these flaws?
  3. Why did the editor pass this article for publication?
  4. How can the publisher tolerate such dubious behaviour?
  5. Should this journal (which I have commented on before here and which is one with the highest impact factor of all the alt med journals) be de-listed from Medline?

I don’t think that we will get answers from the people responsible for this disgrace, but I would like to learn my readers’ opinions.

This post is dedicated to all homeopathic character assassins.

Some ardent homeopathy fans have reminded me that, some 25  years ago, I published (OH, WHAT A SCANDAL!!!) a positive trial of homeopathy; I even found a website that proudly announces this fact. Homeopaths seem jubilant about this discovery (not because they now need to revise their allegations that I never did any trials; or the other, equally popular claim, that I have always been squarely against their trade but) because the implication is that even I have to concede that homeopathic remedies are better than placebo. In their view, this seems to beg the following important and embarrassing questions:

  • Why did I change my mind?
  • Am I not contradicting myself?
  • Who has bribed me?
  • Am I in the pocket of Big Pharma?
  • Does this ‘skeleton in my closet’ discredit me for all times?

I remember the trial in question quite well. We conducted it during my time in Vienna, and I am proud of several innovative ideas that went into it. Here is the abstract in full:

The aim of this study was to test the effectiveness of a combined homeopathic medication in primary varicosity. A well-defined population of 61 patients was randomized into active medication (Poikiven®) or placebo. Both were given for 24 d. At the start of the trial, after 12 d medication and at the end of the study, objective and subjective parameters were recorded: venous filling time, leg volume, calf circumference, haemorheological measurements and patients’ symptoms such as cramps, itching, leg heaviness, pain during standing and the need to elevate the legs. The results show that venous filling time is changed by 44% towards normal in the actively-treated group. The average leg volume fell significantly more in this group, but calf circumferences did not change significantly and blood rheology was not altered in any relevant way. None of the patients reported side-effects. Subjective complaints were relieved significantly more by Poikiven than by placebo. These results suggest that the oral treatment of primary varicosity using Poikiven is feasible.

So, there we have it: a homeopathic remedy (as tested by me) is clearly better than placebo normalising important objective parameters as well as subjective symptoms of varicose veins. Is that not a contradiction of what I keep saying today, namely that homeopathy is a placebo therapy?

YES AND NO! (But much more NO than YES)

Yes, because that was clearly our result, and I never tried to deny it.

No, because our verum was far from being a homeopathic, highly diluted remedy. It contained Aesculus D1 12,5 ml, Arnica D1 2,5 ml, Carduus marianus D1 5 ml, Hamamelis D1 10 ml, Lachesis D6 5 ml, Lycopodium D4 5 ml, Melilotus officinalis D1 10 ml. Take just the first of these ingredients, Aesculus or horse chestnut. This is a herbal medicine that has been well documented (even via a Cochrane review) to be effective for the symptoms of varicose veins, and it contains Aesculus in the D1 potency. This means that it is diluted merely by a factor of 1:10. So, for all intents and purposes, our verum was herbal by nature, and there is no surprise at all that we found it to be effective.

[Here is a little ‘aside': Aesculus is a proven treatment for varicose veins. Homeopathy must always rely on the ‘like cures like’ principle. Therefore, if Aesculus had been used in the homeopathic way, would it not, according to homeopathic dogma, had to worsen the symptoms of our patients rather than alleviating them?]

All of this would be trivial to the extreme, if it did not touch upon an important and confusing point which is often used as an ‘escape route’ by homeopaths when they find themselves between a rock and a hard place. Some trials of homeopathy are positive because they use medications which are homeopathic only by name. This regularly creates considerable confusion. In the recent BMJ debate I tried to address this issue head on by stating at the outset: ” Nobody questions, of course, that some substances used in homeopathy, such as arsenic or strychnine, can be pharmacologically active, but homeopathic medicines are typically far too dilute to have any effect.”

And that’s the point: homeopathic remedies beyond a C12 potency contain nothing, less dilute ones contain little to very little, and D1 potencies are hardy diluted at all and thus contain substantial amounts of active ingredients. Such low potencies are rarely used by homeopaths and should be called PSEUDO-HOMEOPATHIC, in my view. Homeopaths tend to use this confusing complexity to wriggle out of difficult arguments, and often they rely on systematic reviews of homeopathic trials which can generate somewhat confusing overall findings because of such PSEUDO-HOMEOPATHIC remedies.

To make it perfectly clear: the typical homeopathic remedy is far too dilute to have any effect. When scientists or the public at large speak of homeopathic remedies, we don’t mean extracts of Aesculus or potent poisons like Arsenic D1 (has anyone heard of someone claiming to have killed rats with homeopathy?); we refer to the vast majority of remedies which are highly dilute and contain no or very few active molecules – even when we do not explain this somewhat complicated and rather tedious circumstance each and every time. I therefore declare once and for all that, unless I indicate otherwise, I do NOT mean potencies below C6 when I speak of a ‘homeopathic remedy’ (sorry homeopathy fans, perhaps I should have done this when I started this blog).

What if our Vienna study all those years ago had tested not the pseudo-homeopathic ‘Poikiven’ but a highly dilute, real homeopathic remedy and had still come up with a positive finding? Would that make me inconsistent, dishonest, untrustworthy or corrupt? Certainly not!

I have always urged people to not go by the results of single trials. There are numerous reasons why a single study can produce a misleading result. We should therefore, wherever possible, rely on systematic reviews that critically evaluate the totality of the evidence (I would always mistrust even my own trial data, if it contradicted the totality of the reliable evidence) – and such analyses clearly fail to show that homeopathy is more than a placebo.

And even, if none of this had happened, and I had just changed my mind about homeopathy because

  • the evidence changed,
  • I had become wiser,
  • I had learnt how to think like a scientist,
  • I had managed to see behind the smokescreen many homeopaths put up to hide the truth?

Would that discredit me? I don’t think so! As someone once said, being able to change one’s mind is a sign of intelligence.

I am sure that the weird world of homeopathic character assassination will soon find something else to discredit me – but for now…

I REST MY CASE.

Chiropractors are back pain specialists, they say. They do not pretend to treat non-spinal conditions, they claim.

If such notions were true, why are so many of them still misleading the public? Why do many chiropractors pretend to be primary care physicians who can take care of most illnesses regardless of any connection with the spine? Why do they continue to happily promote bogus treatments? Why do chiropractors, for instance, claim they can treat gastrointestinal diseases?

This recent narrative review of the literature, for example, was aimed at summarising studies describing the management of disorders of the gastrointestinal (GI) tract using ‘chiropractic therapy’ broadly defined here as spinal manipulation therapy, mobilizations, soft tissue therapy, modalities and stretches.

Twenty-one articles were found through searching the published literature to meet the authors’ inclusion criteria. The retrieved articles included case reports to clinical trials to review articles. The majority of articles chronicling patient experiences under chiropractic care reported that they experienced mild to moderate improvements in GI symptoms. No adverse effects were reported.

From this, the authors concluded that chiropractic care can be considered as an adjunctive therapy for patients with various GI conditions providing there are no co-morbidities.

I think, we would need to look for a long time to find an article with conclusions that are more ridiculous, false and unethical than these.

The old adage applies: rubbish in, rubbish out. If we include unreliable reports such as anecdotes, our finding will be unreliable as well. If we do not make this mistake and conduct a proper systematic review, we will arrive at very different conclusions. My own systematic review, for instance, of controlled clinical trials drew the following conclusion: There is no supportive evidence that chiropractic is an effective treatment for gastrointestinal disorders.

That probably says it all. I only want to add a short question: SHOULD THIS LATEST CHIROPRACTIC ATTEMPT TO MISLEAD THE PUBLIC BE CONSIDERED ‘SCIENTIFIC MISCONDUCT’ OR ‘FRAUD’?

The last time I had contact with Dr Fisher was when he fired me from the editorial board of his journal ‘Homeopathy’. He did that by sending me the following letter:

Dear Professor Ernst,

This is to inform you that you have been removed from the Editorial Board of Homeopathy.  The reason for this is the statement you published on your blog on Holocaust Memorial Day 2013 in which you smeared homeopathy and other forms of complementary medicine with a ‘guilt by association’ argument, associating them with the Nazis.

I should declare a personal interest….[Fisher goes on to tell a story which is personal and which I therefore omit]…  I mention this only because it highlights the absurdity of guilt by association arguments.

Sincerely

Peter Fisher Editor-in-Chief, Homeopathy

I did not expect to have any more dealings with him after this rather unpleasant encounter. But, as it turns out, I recently did have a further encounter.

When the BMJ invited me to write a debate article about the question whether homeopathy should continue to be available on the NHS, I accepted (with some reservations, I hasten to add). At the time, I did not know who would do the ‘other side’ of this debate. It turned out to be Peter Fisher, and our two articles have just been published.

As one would expect from a good journal, the articles were both peer reviewed. One of the peer-reviewers of my piece was most scathing of it essentially claiming that it was entirely worthless. Feeling that this was a bit harsh and very impolite, I was keen to see who this reviewer had been; it was none other than Andrew Vickers. This is remarkable because Vickers had not only published several homeopathic papers with Fisher, but also had been in the employment of the ‘Royal London Homeopathic Hospital’ under Fisher. To the best of my knowledge, his conflicts of interested had not been disclosed. I did point that out to the BMJ, but they seemed to think nothing of it.

Anyway, I was pleased to eventually (the whole procedure took many months) see the articles published, but at the same time somewhat irritated by Fisher’s piece. It contained plenty of misleading information that the peer-reviewers obviously had failed to correct. Here is a small sample from Fishers piece:

… recent overviews have had more favourable conclusions, including a health technology assessment commissioned by the Swiss federal government that concluded that homeopathy is “probably” effective for upper respiratory tract infections and allergies.

Readers interested in the clinical evidence can access the CORE-HOM database of clinical research in homeopathy free of charge (www.carstens-stiftung.de/core-hom). It includes 1117 clinical trials of homeopathy, of which about 300 are randomised controlled trials.

In the podcast that accompanies the articles Fisher insists that, on this database, there are well over 300 RCT, and I had to admit that this was new to me. Keen to learn more, I registered with the database and had a look. What I found startled me. True, the database does claim that almost 500 RCTs are available, but just a very superficial scrutiny of these studies reveals that

  • some are not truly randomised,
  • some are not even clinical trials,
  • the list includes dual publications, re-analyses of already published studies as well as aborted trials,
  • many have never been peer-reviewed,
  • many are not double-blind,
  • many are not placebo controlled,
  • the majority are of poor methodological quality.

As to the other thing mentioned in the above excerpt from Fisher’s article, the famous ‘health technology assessment commissioned by the Swiss federal government’, I can refer my readers to a blog post by J W Nienhuys which probably says it all, if not, there is plenty more criticism of this report available on the Internet.

My conclusion from all this?

THE QUEEN’S HOMEOPATH USES ARGUMENTS THAT SEEM JUST AS BOGUS AS HOMEOPATHY ITSELF.

Osteopathy is a difficult subject. In the US, osteopaths are (almost) identical with doctors who have studied conventional medicine and hardly practice any manipulative techniques at all. Elsewhere, osteopaths are alternative healthcare providers specialising in what they like to call ‘osteopathic manipulative therapy’ (OMT). As though this is not confusing enough, osteopaths are doing similar things as chiropractors but are adamant that they are a distinct profession. Despite these assertions, I have seen little to clearly differentiate the two – with one exception perhaps: osteopaths tend to use techniques that are less frequently associated with severe harm.

Despite this confusion, or maybe because of it, we need to ask: DOES OMT WORK?

A recent study was aimed at assessing the effectiveness of OMT on chronic migraineurs using HIT-6 questionnaire, drug consumption, days of migraine, pain intensity and functional disability. All patients admitted to the Department of Neurology of Ancona’s United Hospitals, Italy, with a diagnosis of migraine and without chronic illness, were considered eligible for this 3-armed RCT.

Patients were randomly divided into three (1) OMT+medication therapy, (2) sham+medication therapy and (3) medication therapy only and received 8 treatments during 6 months. Changes in the HIT-6 score were considered as the main outcome measure.

A total of 105 subjects were included. At the end of the study, OMT significantly reduced HIT-6 score, drug consumption, days of migraine, pain intensity and functional disability.

The investigators concluded that these findings suggest that OMT may be considered a valid procedure for the management of migraineurs.

Similar results have been reported elsewhere:

One trial, for instance, concluded: “This study affirms the effects of OMT on migraine headache in regard to decreased pain intensity and the reduction of number of days with migraine as well as working disability, and partly on improvement of HRQoL. Future studies with a larger sample size should reproduce the results with a control group receiving placebo treatment in a long-term follow-up.”

Convinced? No, I am not.

Why? Because the studies that do exist seem a little too good to be true; because they are few and far between, because the few studies tend to be flimsy and have been published in dodgy journals, because they lack independent replications, and because critical reviews seem to conclude that OMT is nowhere near as promising as some osteopaths would like us to believe: “Further studies of improved quality are necessary to more firmly establish the place of physical modalities in the treatment of primary headache disorders. With the exception of high velocity chiropractic manipulation of the neck, the treatments are unlikely to be physically dangerous, although the financial costs and lost treatment opportunity by prescribing potentially ineffective treatment may not be insignificant. In the absence of clear evidence regarding their role in treatment, physicians and patients are advised to make cautious and individualized judgments about the utility of physical treatments for headache management; in most cases, the use of these modalities should complement rather than supplant better-validated forms of therapy.”

A paper entitled ‘Real world research: a complementary method to establish the effectiveness of acupuncture’ caught my attention recently. I find it quite remarkable and think it might stimulate some discussion on this blog.  Here is its abstract:

Acupuncture has been widely used in the management of a variety of diseases for thousands of years, and many relevant randomized controlled trials have been published. In recent years, many randomized controlled trials have provided controversial or less-than-convincing evidence that supports the efficacy of acupuncture. The clinical effectiveness of acupuncture in Western countries remains controversial.

Acupuncture is a complex intervention involving needling components, specific non-needling components, and generic components. Common problems that have contributed to the equivocal findings in acupuncture randomized controlled trials were imperfections regarding acupuncture treatment and inappropriate placebo/sham controls. In addition, some inherent limitations were also present in the design and implementation of current acupuncture randomized controlled trials such as weak external validity. The current designs of randomized controlled trials of acupuncture need to be further developed. In contrast to examining efficacy and adverse reaction in a “sterilized” environment in a narrowly defined population, real world research assesses the effectiveness and safety of an intervention in a much wider population in real world practice. For this reason, real world research might be a feasible and meaningful method for acupuncture assessment. Randomized controlled trials are important in verifying the efficacy of acupuncture treatment, but the authors believe that real world research, if designed and conducted appropriately, can complement randomized controlled trials to establish the effectiveness of acupuncture. Furthermore, the integrative model that can incorporate randomized controlled trial and real world research which can complement each other and potentially provide more objective and persuasive evidence.

In the article itself, the authors list seven criteria for what they consider good research into acupuncture:

  1. Acupuncture should be regarded as complex and individualized treatment;
  2. The study aim (whether to assess the efficacy of acupuncture needling or the effectiveness of acupuncture treatment) should be clearly defined and differentiated;
  3. Pattern identification should be clearly specified, and non-needling components should also be considered;
  4. The treatment protocol should have some degree of flexibility to allow for individualization;
  5. The placebo or sham acupuncture should be appropriate: knowing “what to avoid” and “what to mimic” in placebos/shams;
  6. In addition to “hard evidence”, one should consider patient-reported outcomes, economic evaluations, patient preferences and the effect of expectancy;
  7. The use of qualitative research (e.g., interview) to explore some missing areas (e.g., experience of practitioners and patient-practitioner relationship) in acupuncture research.

Furthermore, the authors list the advantages of their RWR-concept:

  1. In RWR, interventions are tailored to the patients’ specific conditions, in contrast to standardized treatment. As a result, conclusions based on RWR consider all aspects of acupuncture that affect the effectiveness.
  2. At an operational level, patients’ choice of the treatment(s) decreases the difficulties in recruiting and retaining patients during the data collection period.
  3. The study sample in RWR is much more representative of the real world situation (similar to the section of the population that receives the treatment). The study, therefore, has higher external validity.
  4. RWR tends to have a larger sample size and longer follow-up period than RCT, and thus is more appropriate for assessing the safety of acupuncture.

The authors make much of their notion that acupuncture is a COMPLEX INTERVENTION; specifically they claim the following: Acupuncture treatment includes three aspects: needling, specific non-needling components drove by acupuncture theory, and generic components not unique to acupuncture treatment. In addition, acupuncture treatment should be performed on the basis of the patient condition and traditional Chinese medicine (TCM) theory.

There is so much BS here that it is hard to decide where to begin refuting. As the assumption of acupuncture or other alternative therapies being COMPLEX INTERVENTIONS (and therefore exempt from rigorous tests) is highly prevalent in this field, let me try to just briefly tackle this one.

The last time I saw a patient and prescribed a drug treatment I did all of the following:

  • I greeted her, asked her to sit down and tried to make her feel relaxed.
  • I first had a quick chat about something trivial.
  • I then asked why she had come to see me.
  • I started to take notes.
  • I inquired about the exact nature and the history of her problem.
  • I then asked her about her general medical history, family history and her life-style.
  • I also asked about any psychological problems that might relate to her symptoms.
  • I then conducted a physical examination.
  • Subsequently we discussed what her diagnosis might be.
  • I told her what my working diagnosis was.
  • I ordered a few tests to either confirm or refute it and explained them to her.
  • We decided that she should come back and see me in a few days when her tests had come back.
  • In order to ease her symptoms in the meanwhile, I gave her a prescription for a drug.
  • We discussed this treatment, how and when she should take it, adverse effects etc.
  • We also discussed other therapeutic options, in case the prescribed treatment was in any way unsatisfactory.
  • I reassured her by telling her that her condition did not seem to be serious and stressed that I was confident to be able to help her.
  • She left my office.

The point I am trying to make is: prescribing an entirely straight forward drug treatment is also a COMPLEX INTERVENTION. In fact, I know of no treatment that is NOT complex.

Does that mean that drugs and all other interventions are exempt from being tested in rigorous RCTs? Should we allow drug companies to adopt the RWR too? Any old placebo would pass that test and could be made to look effective using RWR. In the example above, my compassion, care and reassurance would alleviate my patient’s symptoms, even if the prescription I gave her was complete rubbish.

So why should acupuncture (or any other alternative therapy) not be tested in proper RCTs? I fear, the reason is that RCTs might show that it is not as effective as its proponents had hoped. The conclusion about the RWR is thus embarrassingly simple: proponents of alternative medicine want double standards because single standards would risk to disclose the truth.

One could define alternative medicine by the fact that it is used almost exclusively for conditions for which conventional medicine does not have an effective and reasonably safe cure. Once such a treatment has been found, few patients would look for an alternative.

Alzheimer’s disease (AD) is certainly one such condition. Despite intensive research, we are still far from being able to cure it. It is thus not really surprising that AD patients and their carers are bombarded with the promotion of all sorts of alternative treatments. They must feel bewildered by the choice and all too often they fall victim to irresponsible quacks.

Acupuncture is certainly an alternative therapy that is frequently claimed to help AD patients. One of the first websites that I came across, for instance, stated boldly: acupuncture improves memory and prevents degradation of brain tissue.

But is there good evidence to support such claims? To answer this question, we need a systematic review of the trial data. Fortunately, such a paper has just been published.

The objective of this review was to assess the effectiveness and safety of acupuncture for treating AD. Eight electronic databases were searched from their inception to June 2014. Randomized clinical trials (RCTs) with AD treated by acupuncture or by acupuncture combined with drugs were included. Two authors extracted data independently.

Ten RCTs with a total of 585 participants were included in a meta-analysis. The combined results of 6 trials showed that acupuncture was better than drugs at improving scores on the Mini Mental State Examination (MMSE) scale. Evidence from the pooled results of 3 trials showed that acupuncture plus donepezil was more effective than donepezil alone at improving the MMSE scale score. Only 2 trials reported the incidence of adverse reactions related to acupuncture. Seven patients had adverse reactions related to acupuncture during or after treatment; the reactions were described as tolerable and not severe.

The Chinese authors of this review concluded that acupuncture may be more effective than drugs and may enhance the effect of drugs for treating AD in terms of improving cognitive function. Acupuncture may also be more effective than drugs at improving AD patients’ ability to carry out their daily lives. Moreover, acupuncture is safe for treating people with AD.

Anyone reading this and having a friend or family member who is affected by AD will think that acupuncture is the solution and warmly recommend trying this highly promising option. I would, however, caution to remain realistic. Like so very many systematic reviews of acupuncture or other forms of TCM that are currently flooding the medical literature, this assessment of the evidence has to be taken with more than just a pinch of salt:

  • As far as I can see, there is no biological plausibility or mechanism for the assumption that acupuncture can do anything for AD patients.
  • The abstract fails to mention that the trials were of poor methodological quality and that such studies tend to generate false-positive findings.
  • The trials had small sample sizes.
  • They were mostly not blinded.
  • They were mostly conducted in China, and we know that almost 100% of all acupuncture studies from that country draw positive conclusions.
  • Only two trials reported about adverse effects which is, in my view, a sign of violation of research ethics.

As I already mentioned, we are currently being flooded with such dangerously misleading reviews of Chinese primary studies which are of such dubious quality that one could do probably nothing better than to ignore them completely.

Isn’t that a bit harsh? Perhaps, but I am seriously worried that such papers cause real harm:

  • They might motivate some to try acupuncture and give up conventional treatments which can be helpful symptomatically.
  • They might prompt some families to spend sizable amounts of money for no real benefit.
  • They might initiate further research into this area, thus drawing money away from research into much more promising avenues.

IT IS HIGH TIME THAT RESEARCHERS START THINKING CRITICALLY, PEER-REVIEWERS DO THEIR JOB PROPERLY, AND JOURNAL EDITORS STOP PUBLISHING SUCH MISLEADING ARTICLES.

Regular readers of this blog will have noticed: I recently published a ‘memoir‘.

Of all the books I have written, this one was by far the hardest. It covers ground that I felt quite uncomfortable with. At the same time, I felt compelled to write it. For over 5 years I kept at it, revised it, re-revised it, re-conceived the outline, abandoned the project altogether only to pick it up again.

When it eventually was finished, we had to find a suitable title. This was far from easy; my book is not a book about alternative medicine, it is a book about all sorts of things that have happened to me, including alternative medicine. Eventually we settled for A SCIENTIST IN WONDERLAND. A MEMOIR OF SEARCHING FOR TRUTH AND FINDING TROUBLE. This seemed to describe its contents quite well, I thought (the German edition is entitled NAZIS, NADELN UND INTRIGEN. ERINNERUNGEN EINES SKEPTIKERS which indicates why it was so difficult to put the diverse contents into a short title).

Then a further complication presented itself: at the very last minute, my publisher insisted that the text had to be checked by libel lawyers. This was not only painful and expensive, following their advice and thus changing or omitting passages also took some of the ‘edge’ off it.

Earlier this year, my ‘memoir’ was finally published; to say that I was nervous about how it might be received must be the understatement of the year. As it turned out, it received so many reviews that today I feel deeply humbled (and very proud), particularly as they were all full of praise and appreciation. In case you are interested, I provide some quotes and the links to the full text reviews below.

[Ah, yes! Some people will surely claim that I did all this for the money. To those of my critics, I respond by saying that, had I done paper rounds or worked as a gardener or a window-cleaner during all the time I spent on this book, I would today be considerably better off. As it stands, the costs for the libel read are not yet covered by the income generated through the sales of this book.]

AND HERE ARE THE PROMISED QUOTES

Times Higher Education Book of the Week

Times Higher Education – Helen Bynum, Jan 29, 2015

“[F]or all its trenchant arguments about evidence-based science, the second half of A Scientist in Wonderland remains a very human memoir, and Ernst’s account of the increasingly personal nature of the attacks he faced when speaking to CAM practitioners and advocacy groups is disturbing… Ben Goldacre’s 2012 book Bad Pharma created a storm via its exposure of the pharmaceutical industry’s unhealthy links with mainstream medicine. Ernst’s book deserves to do the same for the quackery trading under the name of complementary and alternative medicine.”

Spectator article

The Spectator – Nick Cohen, Jan 31, 2015

“If you want a true measure of the man, buy Edzard Ernst’s memoir A Scientist in Wonderland, which the Imprint Academic press have just released. It would be worth reading [even] if the professor had never been the victim of a royal vendetta.”

The Bookbag review

The Bookbag – Sue Magee, Jan 28, 2015

“Ernst isn’t just an academic – he’s also an accomplished writer and skilled communicator. He puts over some quite complex ideas without resorting to jargon and I felt informed without ever struggling to understand, despite being a non-scientist. I was pulled into the story of his life and read most of the book in one sitting… I was impressed by what Ernst had to say and the way in which he said it.”

Science-Based Medicine review

Science-Based Medicine – Harriet Hall, Feb 3, 2015

“Edzard Ernst is one of those rare people who dare to question their own beliefs, look at the evidence without bias, and change their minds… In addition to being a memoir, Dr. Ernst’s book is a paean to science… He shows how misguided ideas, poor reasoning, and inaccurate publicity have contributed to the spread of alternative medicine… This is a well-written, entertaining book that anyone would enjoy reading and that advocates of alternative medicine should read: they might learn a thing or two about science, critical thinking, honesty, and the importance of truth.”

Nature review

Nature – Barbara Kiser, Feb 5, 2015

“[T]his ferociously frank autobiography… [is] a clarion call for medical ethics.”

Times review

The Times – Robbie Millen, Feb 9, 2015

A Scientist in Wonderland is a rather droll, quick read… [and] it’s an effective antidote to New Age nonsense, pseudo-science and old-fashioned quackery.”

AntiCancer review

AntiCancer.org.uk – Pan Pantziarka, Feb 19, 2015

“It should be required reading for everyone interested in medicine – without exception.”

Mail Online review

Mail Online – Katherine Keogh, Feb 28, 2015

“In his new book, A Scientist In Wonderland: A Memoir Of Searching For Truth And Finding Trouble, no one from the world of alternative medicine is safe from Professor Edzard Ernst’s firing line.”

James Randi Educational Foundation review

James Randi Educational Foundation – William M. London, Mar 9, 2015

“The writing in A Scientist in Wonderland is clear and engaging. It combines good storytelling with important insights about medicine, science, and analytic thinking. Despite all the troubles Ernst encountered, I found his story to be inspirational. I enthusiastically recommend the book to scientists, health professionals, and laypersons who like to see nonsense and mendacity exposed to the light of reason.”

The Pharmaceutical Journal review

The Pharmaceutical Journal – Andrews Haynes, Mar 26, 2015

“This engaging book is a memoir by a medical researcher whose passion for discovering the truth about untested therapies eventually forced him out of his job… [This] highly readable book concentrates on fact rather than emotion. It should be required reading for anyone interested in medical research.”

Skepticat review

Skepticat – Maria MacLachlan, Apr 18, 2015

A Scientist in Wonderland is more than an autobiography and I’m not sure I can do justice to the riches to be found in its pages. Sometimes it’s reminiscent of a black comedy, other times it’s almost too painful to read.”

Spiked! review

Spiked! – Robin Walsh ,May 15, 2015

“Ernst’s book is a reminder of the need to have the courage to tell the truth as you understand it, and fight your corner against those in authority, while never losing a compassion for patients and a commitment to winning the debate. ”

Australasian Science review

Australasian Science – Loretta Marron, Jun 10, 2015

“Edzard Ernst is a living legend… The book is easy to read and hard to put down. I would particularly recommend it to anyone, with an open mind, who is interested in the truth or otherwise of CAM.”

Journal of the Royal Society of Medicine Review

JRSM – Michael Baum, June 2015

“This is a deeply moving and deeply disturbing book yet written with a light touch, humour and self-deprecation.”

THE BUFFALO NEWS

These enlightening books await summer readers. 21 June 2015

“Medical researcher Edzard Ernst spent most of his career stepping on toes. He first exposed the complicity of the German medical profession in the Nazi genocide. Then he accepted appointment as the world’s first chairman of alternative medicine at England’s University of Exeter. There he studied systematically the claims of the proponents of complementary medicine, a field dominated by evangelic and enthusiastic promoters, including Prince Charles. Needless to say, they did not take kindly to his exposures of many of their widely accepted therapies. His book, “A Scientist in Wonderland: A Memoir of Searching for Truth and Finding Trouble,” is a charming account of a committed life.”

Skeptical Inquirer

http://www.csicop.org/si/show/truth_trouble_and_research_exposing_alt_med?utm_source=twitterfeed&utm_medium=twitter

Chris French

“The book is first and foremost a memoir. Even those of us who have long followed Ernst’s research may well find a few surprises here…[Ernst] did not quite behave as many people expected him to after taking up his post in Exeter. He was committed to carrying out high-quality research into the efficacy and safety of CAM, not simply promoting its use in an uncritical manner. This admirable attitude won him much respect in the eyes of fellow scientists and the wider skeptical community.

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