MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

critical thinking

Non-validated diagnostic methods, like those in abundant use in alternative medicine, run an unacceptably high risk of producing false positive or false negative diagnoses. The former would be a diagnosis that the patient is, in fact, not suffering from; this enables the charlatan to get rich on treating something that is not even there. The latter would be missing an illness that might even kill the patient. Thus both scenarios are unquestionably harmful.

It is now 21 years ago that I published a review of alternative diagnostic techniques entitled ‘WHICH CRAFT IS WITCHCRAFT?’. Here is the abstract:

The prevalence of complementary medicine in most industrialised countries is impressive and increasing. Discussions of the topic often focus on therapeutic approaches and neglect diagnostic methods specific for complementary medicine. The paper summarises the data available on such “alternative” diagnostics. Scientific evaluations of these are scant, and most techniques have never been properly validated. The ones that have can be demonstrated to be not reproducible, sensitive, or specific. The ones that have not should be regarded as such until shown otherwise by rigorous testing. Therefore it seems that “alternative” diagnostic methods may seriously threaten the safety and health of patients submitted to them. Orthodox doctors should be aware of the problem and inform their patients accordingly.

Exactly 15 years after the publication of this paper, PRINCE CHARLES published his book ‘HARMONY‘ where is covers amongst many other topic also the subject of alternative diagnostics. This is what he tells us about them:

I have also learn from leading experts how we can understand a great deal about the causes of ill health through more traditional methods of diagnosis – for example, through examination of the iris, ears, tongue, feet and pulse, very much the basis of the Indian Ayurvedic system. This is not to say that modern diagnostic techniques do not have a role, but let us not forget what we can gain by using the knowledge and wisdom accumulated over thousands of years by pioneers who did not have access to today’s technology. In fact, an over-reliance can often mean that the subtle signs of imbalance revealed by the examination of the eyes, pulse and tongue are totally missed. Including the fruits of such knowledge, gleaned over 8 000 years of studying the relationship of the human body to the rest of Nature and to the Universe, can but only provide an extra, valuable resource to doctors as they seek to make a full diagnosis. Why persist in denying the immense value of such accumulated wisdom when it can tell us so much about the whole person – mind, body and spirit? Employing the best of the ancient and modern in a truly integrated way is another example of harmony and balance at work.

Charles is talking here about iridology, amongst other methods. Iridologists try to diagnose disease or susceptibility to disease by analysing the colour pattern of a patient’s iris. It happens to be a technique that has repeatedly been put to the test. In 1999, I published a systematic review of the evidence and concluded that the validity of iridology as a diagnostic tool is not supported by scientific evaluations. Patients and therapists should be discouraged from using this method.

Given that the evidence for alternative diagnostic techniques is either negative or absent, why does the heir to the throne advocate using them? Does he not know that he has considerable influence and endangers the health of those who believe him? Why does he call this nonsense valuable? The answer probably is that he does not know better.

There is nothing wrong with Charles’ ignorance, of course. He is not a medic (if he were, his quackery might get him struck off the register!) and does not need to know such things! But, if he is ignorant about certain technicalities, should he write about them? At the very least, when giving such concrete medical advice about diagnostic methods, should he not recruit the expertise of people who do know about such matters?

In Charles’ defence, I should mention that apparently he did ask several physicians for help with his book. Two of those who he acknowledged in HARMONY have been mentioned on this blog before: Mosaraf Ali and Michael Dixon.

I MIGHT BE MISTAKEN, BUT IT SEEMS TO ME THAT CHARLES IS NOT JUST IGNORANT ABOUT MEDICINE BUT ALSO ABOUT THE ART OF CHOOSING EXPERTS.

Chronic pain is a common and serious problem for many patients. Treatment often includes non-pharmacological approaches despite the mostly flimsy evidence to support them. The objective of this study was to measure the feasibility and efficacy of hypnosis (including self-hypnosis) in the management of chronic pain in older hospitalized patients.

A single center randomized controlled trial using a two arm parallel group design (hypnosis versus massage). Inclusion criteria were chronic pain for more than 3 months with impact on daily life activities, intensity of > 4; adapted analgesic treatment; no cognitive impairment. Fifty-three patients were included. Pain intensity decreased significantly in both groups after each session. Average pain measured by the brief pain index sustained a greater decrease in the hypnosis group compared to the massage group during the hospitalization. This was confirmed by the measure of intensity of the pain before each session that decreased only in the hypnosis group over time. Depression scores improved significantly over the time only in the hypnosis group. There was no effect in either group 3 months post hospitals discharge.

The authors concluded that hypnosis represents a safe and valuable tool in chronic pain management of hospitalized older patients. In hospital interventions did not provide long-term post discharge relief.

So, hypnotherapy is better than massage therapy when administered as an adjunct to conventional pain management. As it is difficult to control for placebo effects, which might be substantial in this case, we cannot be sure whether hypnotherapy per se was effective or not.

Who cares? The main thing is to make life easier for these poor patients!

There are situations where I tend to agree with this slightly unscientific but compassionate point of view. Yes, the evidence is flimsy, but we need to help these patients. Hypnotherapy has very few risks, is relatively inexpensive and might help badly suffering individuals. In this case, does it really matter whether the benefit was mediated by a specific or a non-specific mechanism?

We all hope that serious complications after chiropractic care are rare. However, this does not mean they are unimportant. Multi-vessel cervical dissection with cortical sparing is an exceptional event in clinical practice. Such a case has just been described as a result of chiropractic upper spinal manipulation.

Neurologists from Qatar published a case report of a 55-year-old man who presented with acute-onset neck pain associated with sudden onset right-sided hemiparesis and dysphasia after chiropractic manipulation for chronic neck pain.

Magnetic resonance imaging revealed bilateral internal carotid artery dissection and left extracranial vertebral artery dissection with bilateral anterior cerebral artery territory infarctions and large cortical-sparing left middle cerebral artery infarction. This suggests the presence of functionally patent and interconnecting leptomeningeal anastomoses between cerebral arteries, which may provide sufficient blood flow to salvage penumbral regions when a supplying artery is occluded.

The authors concluded that chiropractic cervical manipulation can result in catastrophic vascular lesions preventable if these practices are limited to highly specialized personnel under very specific situations.

Chiropractors will claim that they are highly specialised and that such events must be true rarities. Others might even deny a causal relationship altogether. Others again would claim that, relative to conventional treatments, chiropractic manipulations are extremely safe. You only need to search my blog using the search-term ‘chiropractic’ to find that there are considerable doubts about these assumptions:

  • Many chiropractors are not well trained and seem mostly in the business of making a tidy profit.
  • Some seem to have forgotten most of the factual knowledge they may have learnt at chiro-college.
  • There is no effective monitoring scheme to adequately record serious side-effects of chiropractic care.
  • Therefore the incidence figures of such catastrophic events are currently still anyone’s guess.
  • Publications by chiropractic interest groups seemingly denying this point are all fatally flawed.
  • It is not far-fetched to fear that under-reporting of serious complications is huge.
  • The reliable evidence fails to demonstrate that neck manipulations generate more good than harm.
  • Until sound evidence is available, the precautionary principle leads most critical thinkers to conclude that neck manipulations have no place in routine health care.

When given the diagnosis ‘CANCER’, most people go into some sort of shock. Once they have recovered, they are likely to learn that they now face many months of very aggressive treatments which will reduce their quality of life to almost zero. This, they are told, is no guarantee but will merely increase their chances to survive the cancer.

Understandably, before they make what might be the most important decision of their lives, patients are desperate and tempted to look elsewhere to find out for themselves what their options are. It would be foolish to simply accept what their team of health care professionals have been saying. With decisions as important as this one, it is wise to listen to second and possibly third opinions. Who could argue with this logic?

Most cancer patients then go on the Internet and have a look at what alternatives are on offer. Here they find virtually millions of sites offering information. A person with pancreatic cancer might thus be unfortunate enough to stumble over a site called What Alternative Medicine works best against Pancreatic Cancer? If she does, her life is at risk.

You think I am exaggerating? In this case, let me quote from this website (I made no changes whatsoever, not even corrections of the spelling mistakes):

Just to remind you this particular thread is concerned with alternative treatments for cancer. People here are seeking information about alternative medicine. Now we all know that immunotherapy represents potentially a great leap forward in the treatment of cancer in the mainstream medical community although the stats are still pretty low for repsonse most of which have been done on melanoma patients. Nonetheless impresive compared to the useless toxic treatments peddled by the drug industry over the last 30 years. Interferon being one of the worst treatments inflicted on many a poor cancer patient along with chemo and radiation for which many cancers have little or no response and are extremely toxic. I make no false claims about the work of Dr Kelley or Dr Gonzalez for that matter. For those willing to dig a little and research their work they will find a body of good evidence for their protocol.

You might say that this is an extreme exception of irresponsible, life-threatening misinformation. But I disagree. The Internet is full with sites of this nature. They promote treatments for which there is no good evidence; what is worse, they encourage patients to forego conventional treatments which might save their lives. If anyone then dares to point this out, he will be attacked for being in the pocket of ‘Big Pharma’.

I know, a little insignificant post like mine will change very little, but I also feel strongly that, if I do not keep banging on about this issue, who else will warn patients that misinformation from the Internet and other sources can kill?

In 2009, we published a systematic review of studies testing acupuncture as a treatment of menopausal hot flushes. We searched the literature using 17 databases from inception to October 10, 2008, without language restrictions. We only included randomized clinical trials (RCTs) of acupuncture versus sham acupuncture. Their methodological quality was assessed using the modified Jadad score. In total, six RCTs could be included. Four RCTs compared the effects of acupuncture with penetrating sham acupuncture on non-acupuncture points. All of these trials failed to show specific effects on menopausal hot flush frequency, severity or index. One RCT found no effects of acupuncture on hot flush frequency and severity compared with penetrating sham acupuncture on acupuncture points that are not relevant for the treatment of hot flushes. The remaining RCT tested acupuncture against non-penetrating acupuncture on non-acupuncture points. Its results suggested favourable effects of acupuncture on menopausal hot flush severity. However, this study was too small to generate reliable findings. At the time, we concluded that sham-controlled RCTs fail to show specific effects of acupuncture for control of menopausal hot flushes. We also argued that more rigorous research is warranted.

It seems that such research has just become available.

The aim of a brand-new study – a stratified, blind (participants, outcome assessors, and investigators, but not treating acupuncturists were blinded to treatment allocation), parallel, randomized, sham-controlled trial with equal allocation – was to assess the efficacy of Chinese medicine acupuncture against sham acupuncture for menopausal hot flushes (HFs). It was funded by the Australian National Health and Medical Research Council.

Women older than 40 years were recruited; they had to be in the late menopausal transition or postmenopause with at least 7 moderate HFs daily, meeting criteria for Chinese medicine diagnosis of kidney yin deficiency. These patients received 10 treatments over 8 weeks of either standardized Chinese medicine needle acupuncture designed to treat ‘kidney yin deficiency’ or they got the same amount of non-insertive sham acupuncture. The primary outcome was HF score at the end of treatment. Secondary outcomes included quality of life, anxiety, depression, and adverse events. Participants were assessed at 4 weeks, the end of treatment, and then 3 and 6 months after the end of treatment. Intention-to-treat analysis was conducted with linear mixed-effects models.

In total, 327 women were randomly assigned to acupuncture (n = 163) or sham acupuncture (n = 164). At the end of treatment, 16% of participants in the acupuncture group and 13% in the sham group were lost to follow-up. Mean HF scores at the end of treatment period were 15.36 in the acupuncture group and 15.04 in the sham group. No serious adverse events were reported.

The authors concluded that Chinese medicine acupuncture was not superior to non-insertive sham acupuncture for women with moderately severe menopausal HFs.

The trial has several strengths: it includes a large sample size and the patients were adequately blinded to eliminate the effects of expectations. It was published in a top journal, and we can therefore assume that it was properly peer-reviewed. Combined with the evidence from our previous systematic review, this indicates that acupuncture has no effect beyond placebo.

In other words: ACUPUNCTURE IS NOTHING BUT A THEATRICAL PLACEBO.

One does not need to be a clairvoyant to predict that acupuncturists will now find what they perceive as a flaw in the new study and claim that its results were false-negative. Subsequently they will probably conduct their own trial which, because it is wide open to bias, will generate the finding they were hoping for.

This sequence of poor quality positive and high quality negative studies could go on ad infinitum.

This begs the question: how can such wasteful pseudo-research be stopped?

In theory, applications to ethics committees for research that is not aimed at answering open and important questions should get rejected. In practice, however, this is unlikely to happen. In my experience, the main reason preventing such actions is that, when it comes to alternative medicine, ethics committees tend to be too lenient (attempting to be ‘politically correct’), too uninterested (thinking that alternative medicine is not really a serious area of research) and too uninformed (failing to insist on a rigorous assessment of the already available evidence).

The Nobel laureate Venkatraman Ramakrishnan recently called homeopathy ‘bogus’. “They (homeopaths) take arsenic compounds and dilute it to such an extent that just a molecule is left. It will not make any effect on you. Your tap water has more arsenic. No one in chemistry believes in homeopathy. It works because of placebo effect,” he was quoted saying.

But what does he know about homeopathy? This was the angry question of homeopaths around the world when the Nobel laureate’s views became international headlines.

Nothing! Exclaimed the furious homeopaths with one voice.

If we want to get an informed opinion, we a true expert.

The Queen’s homeopath Dr Fisher? No, he has been known to tell untruths.

Doctor Michael Dixon, the adviser to Prince Charles who recently defended homeopathy? No, he is not even a homeopath.

Dana Ullman, the voice of US homeopathy? Heavens, he is a homeopath but not one who is known to be objective.

Alan Schmukler perhaps? He too seems to have difficulties with critical thinking.

Perhaps we need to ask an experienced and successful homeopath like doctor Akshay Batra; someone with both feet on the ground who knows about the coal face of health care today. He recently spoke out for the virtues of homeopathy explaining that it is based on the ingenious idea that ‘like cures like: “For example if you are suffering from constant watering eyes, you will be given allium cepa which comes from onions, something that causes eyes to water. Homeopathy works like a vaccine”. Dr Batra claims that the failure of allopathy (mainstream medicine) is causing the present boom in homeopathy. “With the amount of deaths taking place due to allopathic medicine and its side effects, we can see people resorting to homeopathy,” he said. “Certain children using asthma inhalers suffer from growth issues or develop unusual facial hair. Homeopathy avoids that and uses a natural remedy that treats the root cause,” he added.

The top issues treated with homeopathy, according to Dr Batra, are hair and skin problems. “A lot of ailments today effecting hair and skin are because of internal diseases. Hair loss in women has become very prevalent and can be due to cystic ovaries, low iron levels or hormonal imbalance due to thyroid,” explained Dr Batra. “We find the root cause and treat that, since hair loss could just be a symptom and we need to treat the ailment permanently. Allopathic medicines just give you a quick fix, and not treat the root cause, while we give a more long term, complete solution,” he added. Homeopathy is mind and body medicine: “A lot of people today are under pressure and stress. Homeopathic treatment also helps in relieving tension hence treating the patient as a whole,” said Dr Batra.

I bet you now wonder who is this fabulous expert and homeopath, doctor Batra.

He has been mentioned on this blog before, namely when he opened the first London branch of his chain of homeopathic clinics claiming that homeopathy could effectively treat the following conditions:

Yes, Dr Akshay Batra is the managing director and chairman of Dr Batra’s Homeopathic Clinic, an enterprise that is currently establishing clinics across the globe.

And now we understand, I think, why the Nobel laureate and the homeopathy expert have slightly different views on the subject.

Who would you believe, I wonder?

Consensus recommendations to the ‘National Center for Complementary and Integrative Health from Research Faculty in a Transdisciplinary Academic Consortium for Complementary and Integrative Health and Medicine’ have just been published. It appeared in this most impartial of all CAM journals, the ‘Journal of Alternative and Complementary Mededicine’. Its authors are equally impartial: Menard MB 1, Weeks J 2, Anderson 3, Meeker 4, Calabrese C 5, O’Bryon D 6, Cramer GD 7

They come from these institutions:

  • 1 Crocker Institute , Kiawah Island, SC.
  • 2 Academic Consortium for Complementary and Alternative Health Care , Seattle, WA.
  • 3 Pacific College of Oriental Medicine , New York, NY.
  • 4 Palmer College of Chiropractic , San Jose, CA.
  • 5 Center for Natural Medicine , Portland, OR.
  • 6 Association of Chiropractic Colleges , Bethesda, MD.
  • 7 National University of Health Sciences , Lombard, IL

HERE IS THE ABSTRACT OF THE DOCUMENT IN ITS FULL AND UNABBREVIATED BEAUTY:

BACKGROUND:

This commentary presents the most impactful, shared priorities for research investment across the licensed complementary and integrative health (CIH) disciplines according to the Academic Consortium for Complementary and Alternative Health Care (ACCAHC). These are (1) research on whole disciplines; (2) costs; and (3) building capacity within the disciplines’ universities, colleges, and programs. The issue of research capacity is emphasized.

DISCUSSION:

ACCAHC urges expansion of investment in the development of researchers who are graduates of CIH programs, particularly those with a continued association with accredited CIH schools. To increase capacity of CIH discipline researchers, we recommend National Center for Complementary and Integrative Health (NCCIH) to (1) continue and expand R25 grants for education in evidence-based healthcare and evidence-informed practice at CIH schools; (2) work to limit researcher attrition from CIH institutions by supporting career development grants for clinicians from licensed CIH fields who are affiliated with and dedicated to continuing to work in accredited CIH schools; (3) fund additional stand-alone grants to CIH institutions that already have a strong research foundation, and collaborate with appropriate National Institutes of Health (NIH) institutes and centers to create infrastructure in these institutions; (4) stimulate higher percentages of grants to conventional centers to require or strongly encourage partnership with CIH institutions or CIH researchers based at CIH institutions, or give priority to those that do; (5) fund research conferences, workshops, and symposia developed through accredited CIH schools, including those that explore best methods for studying the impact of whole disciplines; and (6) following the present NIH policy of giving priority to new researchers, we urge NCCIH to give a marginal benefit to grant applications from CIH clinician-researchers at CIH academic/research institutions, to acknowledge that CIH concepts require specialized expertise to translate to conventional perspectives.

SUMMARY:

We commend NCCIH for its previous efforts to support high-quality research in the CIH disciplines. As NCCIH develops its 2016-2020 strategic plan, these recommendations to prioritize research based on whole disciplines, encourage collection of outcome data related to costs, and further support capacity-building within CIH institutions remain relevant and are a strategic use of funds that can benefit the nation’s health.

AND WHY DID THIS SURPRISE ME?

Well, I would have expected that such an impartial, intelligent bunch of people who are doubtlessly capable of critical analysis would have come up with a totally different set of recommendations. For instance:

  1. Integrative health makes no sense.
  2. Integrative medicine is a disservice to patients.
  3. Integrative health is a paradise for charlatans.
  4. No more research is required in this area.
  5. Research already under way should be stopped.
  6. Money ear-marked for integrative health should be diverted to other investigators researching areas that show at least a glimpse of promise.

Alright, you are correct – my suggestions are neither realistic nor constructive. One cannot expect that they will turn down all these lovely research funds and give it to real scientists. One has to offer them something constructive to do with the money. How about projects addressing the following research questions?

  1. How many integrative health clinics offer evidence-based treatments?
  2. Is the promotion of bogus treatments in line with the demands of medical ethics?
  3. If we need to render health care more holistic, humane, patient-centred, why not reform conventional medicine?
  4. Is the creation of integrative medicine a divisive development for health care?
  5. Is humane, holistic, patient-centred care really an invention of integrative medicine, and what is its history?
  6. Which of the alternative treatments used in integrative medicine can be shown to do more good than harm?
  7. What are the commercial drivers behind the integrative health movement?
  8. Is there a role for critical thinking within integrative health?
  9. Is integrative health creating double standards within medicine?
  10. What is better for public health, empty promises about ‘the best of both worlds’ or sound evidence?

Cancer-related fatigue (CRF) is one of the most common symptoms reported by cancer patients, and it is a symptom that is often difficult to treat. As always in such a situation, there are lots of alternative therapies on offer. Yet the evidence for most is flimsy, to put it mildly.

But perhaps there is hope? The very first RCT with a 2016 date to be reviewed on this blog investigated the efficacy of the amino acid jelly Inner Power(®) (IP), a semi-solid, orally administrable dietary supplement containing coenzyme Q10 and L-carnitine, in controlling CRF in breast cancer patients in Japan.

Breast cancer patients with CRF undergoing chemotherapy were randomly assigned to receive IP once daily or regular care for 21 days. The primary endpoint was the change in the worst level of fatigue during the past 24 h (Brief Fatigue Inventory [BFI] item 3 score) from day 1 (baseline) to day 22. Secondary endpoints were change in global fatigue score (GFS; the average of all BFI items), anxiety and depression assessed by the Hospital Anxiety and Depression Scale (HADS), quality of life assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and EORTC Breast Cancer-Specific QLQ (EORTC QLQ-BR23), and adverse events.

Fifty-nine patients were enrolled in the study, of whom 57 were included in the efficacy analysis. Changes in the worst level of fatigue, GFS, and current feeling of fatigue were significantly different between the intervention and control groups, whereas the change in the average feeling of fatigue was not significantly different between groups. HADS, EORTC QLQ-C30, and EORTC QLQ-BR23 scores were not significantly different between the two groups. No severe adverse events were observed.

The authors concluded that ‘IP may control moderate-severe CRF in breast cancer patients.’

The website of the manufacturer provides the following information on IP:

Inner Power is a functional food that provides various nutrients, such as zinc and copper. Zinc is a nutrient that your body needs to maintain your sense of taste. Zinc is also vital in keeping the skin and mucous membranes healthy and in regulating metabolism of proteins and nucleic acids. Copper helps the body form red blood cells and bones and regulates many enzymes that are found in the body. One pouch of Inner Power each day is the recommended daily serving.

  • Consuming a large amount of the product will not cure any underlying disease or improve your health condition.
  • Do not consume too much of the product because excessive zinc intake may inhibit the absorption of copper.
  • Observe the recommended daily serving of the product. This product should not be given to infants or children.

The recommended daily serving of the product (1 pouch/day) contains 43% of the reference daily intake of zinc and 50% of the reference daily intake of copper. Inner Power is neither categorized as a food for special dietary use nor approved individually by the Ministry of Health, Labour, and Welfare. You should eat well-balanced meals consisting of staple foods, including a main dish and side dishes.

I cannot say that this inspires me with confidence.

What about the trial itself?

To be honest, I am not impressed. The most obvious flaw is, I think, that there was not the slightest attempt to control for placebo effects. As I pointed out so many times before: with the ‘A+B versus B’ design, one can make any old placebo appear to be effective.

MORE than £150,000 was spent by NHS Grampian on homeopathic treatments last year. Referrals to homeopathic practitioners cost £37,000 and referrals to the Glasgow Homoeopathic Hospital cost £7,315 in 2014-15. In view of the fact that highly diluted homeopathic remedies are pure placebos, any amount of tax payers’ money spent on homeopathy is hard to justify. Yet an NHS Grampian spokeswoman defended its use of by the health board with the following words:

“We have a responsibility to consider all treatments available to NHS patients to ensure they offer safe, effective and person-centred care. We also have a responsibility to use NHS resources carefully and balance our priorities across the population as well as individuals. We also recognise that patient reported outcome and experience measures are valued even when objective evidence of effectiveness is limited. Homeopathy can be considered in this arena and we remain connected with the wider debate on its role within the NHS while regularly reviewing our local support for such services within NHS Grampian.”

Mr Spence, a professional homeopath, was also invited to defend the expenditure on homeopathy: “When a friend started talking to me about homeopathy I thought he had lost his marbles. But it seemed homeopathy could fill a gap left by orthodox medicine. Homeopathy is about treating the whole person, not just the symptoms of disease, and it could save the NHS an absolute fortune. If someone is in a dangerous situation or they need surgery then they need to go to hospital. It’s often those with chronic, long-term problems where conventional treatment has not worked that can be helped by homeopathy.”

What do these arguments amount to, I ask myself.

The answer is NOTHING.

The key sentence in the spokeswomen’s comment is : “patient reported outcome and experience measures are valued even when objective evidence of effectiveness is limited.” This seems to admit that the evidence fails to support homeopathy. Therefore, so the argument, we have to abandon evidence and consider experience, opinion etc. This seemingly innocent little trick is nothing else than the introduction of double standards into health care decision making which could be used to justify the use of just about any bogus therapy in the NHS at the tax payers’ expense. It is obvious that such a move would be a decisive step in the wrong direction and to the detriment of progress in health care.

The comments by the homeopath are perhaps even more pitiful. They replace arguments with fallacies and evidence with speculation or falsehoods.

There is, of course, a bright side to this:

IF HOMEOPATHY IS DEFENDED IN SUCH A LAUGHABLE MANNER, ITS DAYS MUST BE COUNTED.

The randomized, placebo-controlled, double-blind trial is usually the methodology to test the efficacy of a therapy that carries the least risk of bias. This fact is an obvious annoyance to some alt med enthusiasts, because such trials far too often fail to produce the results they were hoping for.

But there is no need to despair. Here I provide a few simple tips on how to mislead the public with seemingly rigorous trials.

1 FRAUD

The most brutal method for misleading people is simply to cheat. The Germans have a saying, ‘Papier ist geduldig’ (paper is patient), implying that anyone can put anything on paper. Fortunately we currently have plenty of alt med journals which publish any rubbish anyone might dream up. The process of ‘peer-review’ is one of several mechanisms supposed to minimise the risk of scientific fraud. Yet alt med journals are more clever than that! They tend to have a peer-review that rarely involves independent and critical scientists, more often than not you can even ask that you best friend is invited to do the peer-review, and the alt med journal will follow your wish. Consequently the door is wide open to cheating. Once your fraudulent paper has been published, it is almost impossible to tell that something is fundamentally wrong.

But cheating is not confined to original research. You can also apply the method to other types of research, of course. For instance, the authors of the infamous ‘Swiss report’ on homeopathy generated a false positive picture using published systematic reviews of mine by simply changing their conclusions from negative to positive. Simple!

2 PRETTIFICATION

Obviously, outright cheating is not always as simple as that. Even in alt med, you cannot easily claim to have conducted a clinical trial without a complex infrastructure which invariably involves other people. And they are likely to want to have some control over what is happening. This means that complete fabrication of an entire data set may not always be possible. What might still be feasible, however, is the ‘prettification’ of the results. By just ‘re-adjusting’ a few data points that failed to live up to your expectations, you might be able to turn a negative into a positive trial. Proper governance is aimed at preventing his type of ‘mini-fraud’ but fortunately you work in alt med where such mechanisms are rarely adequately implemented.

3 OMISSION

Another very handy method is the omission of aspects of your trial which regrettably turned out to be in disagreement with the desired overall result. In most studies, one has a myriad of endpoints. Once the statistics of your trial have been calculated, it is likely that some of them yield the wanted positive results, while others do not. By simply omitting any mention of the embarrassingly negative results, you can easily turn a largely negative study into a seemingly positive one. Normally, researchers have to rely on a pre-specified protocol which defines a primary outcome measure. Thankfully, in the absence of proper governance, it usually is possible to publish a report which obscures such detail and thus mislead the public (I even think there has been an example of such an omission on this very blog).

4 STATISTICS

Yes – lies, dam lies, and statistics! A gifted statistician can easily find ways to ‘torture the data until they confess’. One only has to run statistical test after statistical test, and BINGO one will eventually yield something that can be marketed as the longed-for positive result. Normally, researchers must have a protocol that pre-specifies all the methodologies used in a trial, including the statistical analyses. But, in alt med, we certainly do not want things to function normally, do we?

5 TRIAL DESIGNS THAT CANNOT GENERATE A NEGATIVE RESULT

All the above tricks are a bit fraudulent, of course. Unfortunately, fraud is not well-seen by everyone. Therefore, a more legitimate means of misleading the public would be highly desirable for those aspiring alt med researchers who do not want to tarnish their record to their disadvantage. No worries guys, help is on the way!

The fool-proof trial design is obviously the often-mentioned ‘A+B versus B’ design. In such a study, patients are randomized to receive an alt med treatment (A) together with usual care (B) or usual care (B) alone. This looks rigorous, can be sold as a ‘pragmatic’ trial addressing a real-fife problem, and has the enormous advantage of never failing to produce a positive result: A+B is always more than B alone, even if A is a pure placebo. Such trials are akin to going into a hamburger joint for measuring the calories of a Big Mac without chips and comparing them to the calories of a Big Mac with chips. We know the result before the research has started; in alt med, that’s how it should be!

I have been banging on about the ‘A+B versus B’ design often enough, but recently I came across a new study design used in alt med which is just as elegantly misleading. The trial in question has a promising title: Quality-of-life outcomes in patients with gynecologic cancer referred to integrative oncology treatment during chemotherapy. Here is the unabbreviated abstract:

OBJECTIVE:

Integrative oncology incorporates complementary medicine (CM) therapies in patients with cancer. We explored the impact of an integrative oncology therapeutic regimen on quality-of-life (QOL) outcomes in women with gynecological cancer undergoing chemotherapy.

PATIENTS AND METHODS:

A prospective preference study examined patients referred by oncology health care practitioners (HCPs) to an integrative physician (IP) consultation and CM treatments. QOL and chemotherapy-related toxicities were evaluated using the Edmonton Symptom Assessment Scale (ESAS) and Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire, at baseline and at a 6-12-week follow-up assessment. Adherence to the integrative care (AIC) program was defined as ≥4 CM treatments, with ≤30 days between each session.

RESULTS:

Of 128 patients referred by their HCP, 102 underwent IP consultation and subsequent CM treatments. The main concerns expressed by patients were fatigue (79.8 %), gastrointestinal symptoms (64.6 %), pain and neuropathy (54.5 %), and emotional distress (45.5 %). Patients in both AIC (n = 68) and non-AIC (n = 28) groups shared similar demographic, treatment, and cancer-related characteristics. ESAS fatigue scores improved by a mean of 1.97 points in the AIC group on a scale of 0-10 and worsened by a mean of 0.27 points in the non-AIC group (p = 0.033). In the AIC group, MYCAW scores improved significantly (p < 0.0001) for each of the leading concerns as well as for well-being, a finding which was not apparent in the non-AIC group.

CONCLUSIONS:

An IP-guided CM treatment regimen provided to patients with gynecological cancer during chemotherapy may reduce cancer-related fatigue and improve other QOL outcomes.

A ‘prospective preference study’ – this is the design the world of alt med has been yearning for! Its principle is beautiful in its simplicity. One merely administers a treatment or treatment package to a group of patients; inevitably some patients take it, while others don’t. The reasons for not taking it could range from lack of perceived effectiveness to experience of side-effects. But never mind, the fact that some do not want your treatment provides you with two groups of patients: those who comply and those who do not comply. With a bit of skill, you can now make the non-compliers appear like a proper control group. Now you only need to compare the outcomes and BOB IS YOUR UNCLE!

Brilliant! Absolutely brilliant!

I cannot think of a more deceptive trial-design than this one; it will make any treatment look good, even one that is a mere placebo. Alright, it is not randomized, and it does not even have a proper control group. But it sure looks rigorous and meaningful, this ‘prospective preference study’!

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