MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

critical thinking

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’!

The following short passage originates from the abstract of an article that I published in 1998; it is entitled TOWARDS A RISK BENEFIT EVALUATION OF PLACEBOS: the benefits of placebos are often not clearly defined. Generally speaking, the potential for benefit is considerable. The risks are similarly ill defined. Both direct and indirect risks are conceivable. On balance, the risk-benefit relation for placebo could be favourable. Under certain conditions, the clinical use of placebos might therefore be a realistic option. In the final analysis, however, our knowledge for a conclusive risk-benefit evaluation of placebo is incomplete.

Today, I would phrase my conclusion differently: the benefits of placebo therapy are uncertain, while its risks can be considerable. Therefore the use of placebos in clinical routine is rarely justified.

What brought about this change in my attitude?

Lots of things, is the answer; 18 years are a long time in research, and today we know much more about placebo. In my field of inquiry, alternative medicine, we know for instance that, because the mechanisms by which placebos operate are now better understood, some alt med enthusiasts are claiming that placebo effects are real and therefore justify the use of all sorts of placebo treatments, from homeopathy to faith healing. They say that these ineffective (i.e. no better than placebo) therapies are not really ineffective because they help many patients via the well-documented placebo response.

If you are of this opinion, please read the excellent article David Gorski recently published on this issue. Here I want to re-visit my question from above: WHAT DO WE KNOW ABOUT THE RISKS BENEFIT BALANCE OF PLACEBO?

The benefits of placebo can seem impressive on first glance: after receiving placebos, patients can feel better, have less symptoms, need less medication and improve their quality of life. Who would be against any of these outcomes, particularly considering that placebos are usually inexpensive and readily available everywhere?

However, before we get too enthusiastic about the benefits of placebos, we need to consider that they are unreliable. Nobody can predict who will respond to placebo and who won’t. Despite intensive research, it has not been possible to identify placebo-responders as a distinct group of individuals from non-responders. The usefulness of placebos in clinical routine is therefore quite limited. Furthermore, placebo effects are normally only of short duration. Therefore they are not suited for any long-term therapy.

Crucially, placebos almost never effect a cure. They may improve subjective symptoms, but they do not normally cure the disease or remove its causes. A placebo therapy will reduce pain, for instance, and thus it can ease the suffering. If a back pain is caused by a tumour, however, a placebo will not diminish its size or improve the prognosis.

The notion that placebos might cause harm seems paradoxical at first glance. A placebo pill contains no active ingredient – how can it then be harmful? As I have stressed so often before, ANY INEFFECTIVE TREATMENT BECOMES LIFE-THREATENING, IF IT IS USED AS A REPLACEMENT FOR AN EFFECTIVE THERAPY OF A SERIOUS DISEASE. And this warning also applies to placebos, of course.

Seen from this perspective, the much-praised symptomatic relief brought about by a placebo therapy can become a very mixed blessing indeed.

Let’s take the above example of the patient who has back pain. He receives a placebo and subsequently his agony becomes more bearable. Because this approach seems to work, he sticks with it for several month. Eventually the analgesic effect of the placebo wears off and the pain gets too strong to bear. Our patient finally consults a responsible doctor who diagnoses a bone cancer as the cause of his pain. The oncologist who is subsequently consulted regrets that the patient’s prolonged placebo therapy has seriously diminished his chances to cure the cancer.

This may look like an extreme example, but I don’t think it is. Exchange the term ‘placebo’ with almost any alternative treatment, or replace ‘back pain’ and ‘cancer’ with virtually any other conditions, and you will see that such events cannot be rare.

In most instances, placebos may seem helpful but, in fact, they offer little more than the illusion of a cure. They very rarely alter the natural history of a disease and usually achieve little more than a slight, short-term improvement of symptoms. In any case, they are an almost inevitable companion to any well-administered effective treatment. Prescribing pure placebos in clinical routine is therefore not responsible; in most instances, it amounts to fraud.

If the Flat Earth Society (FES) really exists at all, I must confess I know nothing about it. Here I use the term ‘FES’ merely as an analogy; you might replace FES with SoH or BHA or BAA or BCA or with most of the other acronyms used in my field of inquiry.

What I do know about is alternative medicine, particularly publications in this area, and the authors of such papers. As it happens, the members of my imaginary FES have a lot in common with the authors of articles on alternative medicine. Their publication policy, for instance, is remarkably simple yet astonishingly effective. Its aim is straight forward: mislead the public. As far as I can see, it is being pursued by just two main strategies.

1 SWAMP THE MARKET WITH TRASH

This is a simple and most successful strategy. It consists of publishing an ever-growing mountain of utter nonsense. Anyone who is  interested in alternative medicine and conducts a search would thus find tons of articles listed in Medline or other databases. This will instantly generate the impression that Flat Earth research is highly active. Those who can bear the pain might even try to read a few of these papers; they will soon give up in despair. Too many are hardly understandable; they are often badly written, lack essential methodological detail, and invariably arrive at positive conclusions.

The strategy can only work, if there are journals who publish such rubbish. I am glad to say, there is no shortage of them! To attain a veneer of credibility, the journals need to be peer-reviewed, of course. This is no real problem, as long as the peer-reviewers are carefully chosen to be ‘cooperative’. The trick is to make sure to ask the authors submitting articles to name two or three uncritical friends who might, one day, be happy to act as peer-reviewers for their own papers. This works very smoothly indeed: one pseudo-scientist is sure to help another in their desire to publish some pseudo-science in a ‘peer-reviewed’ journal.

To oil the system well, we need money, of course. Again, no problem: most of these journals ask for a hefty publication fee.

The result is as obvious as it is satisfying. The journal earns well, the pseudo-researchers can publish their pseudo-research at will, and the peer-reviewers know precisely where to go for a favour when they need one. Crucially, the first hurdle to misleading the public is taken with bravura.

2. REFUTE ANY EVIDENCE THAT IS UNFAVOURABLE

There are, of course, journals which refuse to play along. Annoyingly, they adhere to such old-fashioned things like standards and ethics; they have a peer-review system that is critical and independent; and they don’t rely on pseudo-scientists for their income. Every now and then, such a journal publishes an article on alternative medicine. It goes without saying that, in all likelihood, such an article is of high quality and therefore would not be in favour of Flat Earth assumptions.

This is a serious threat to the aim of the FES. What can be done?

No panic, the solution is simple!

An article is urgently needed to criticise the paper with the unfavourable evidence – never mind that it is of much better quality than the average paper in the Flat Earth-journals. If one looks hard enough, one can find a flaw in almost every article. And if there is none, the FES can always invent one. And if the proper science journal refuses to publish the pseudo-criticism as a comment, there are always enough pseudo-journals that are only too keen to oblige.

The important thing is to get something that vaguely looks like a rebuttal in print (the public will not realise that it is phony!).

Once this aim is achieved, the world is back in order again. As soon as someone dares to cite the high quality, negative evidence, the FES members can all shout with one voice: BUT THIS PAPER HAS BEEN HEAVILY CRITICISED; IT IS NOT RELIABLE! WHOEVER CITED THE PAPER IS ILL-INFORMED AND THEREFORE NOT CREDIBLE.

3. MISSION ACCOMPLISHED

The overall effect is clear. The public, journalists, politicians etc. get the impression that the earth is indeed flat – or, at the very minimum, they are convinced that there is a real scientific debate about the question.

In 1790, as Hahnemann was translating the Scottish physician’s, Cullen, ‘Treatise on Materia Medica’, he came across the passage where Cullen explains the actions of Peruvian (or China bark, [Cinchona officinalis]) which contains quinine, an effective treatment of malaria. Hahnemann disagreed with Cullen’s explanation that Cinchona worked through “a tonic effect on the stomach”. Therefore he decided to conduct experiments of his own to prove Cullen wrong.

Hahnemann thus ingested high doses of Cinchona and noticed that subsequently he developed several of the symptoms that are characteristic of malaria. This is how Hahnemann later described his experience:

I took for several days, as an experiment, four drams of good china daily. My feet and finger tips, etc., at first became cold; I became languid and drowsy; my pulse became hard and quick; an intolerable anxiety and trembling (but without rigor); trembling in all limbs; then pulsation in the head, redness in the cheeks, thirst; briefly, all those symptoms which to me are typical of intermittent fever, such as the stupefaction of the senses, a kind of rigidity of all joints, but above all the numb, disagreeable sensation which seems to have its seat in the periosteum over all the bones of the body – all made their appearance. This paroxysm lasted for two or three hours every time, and recurred when I repeated the dose and not otherwise. I discontinued the medicine and I was once more in good health.

Hahnemann repeated this experiment several times and eventually concluded that he had discovered something of great general importance: there seemed to be a similarity between the symptoms of a disease and the symptoms caused by the drug that is effective in treating that very disease.

After several more experiments, Hahnemann became convinced that he had, in fact, discovered a law of nature: similia similibus currentur (often translated as ‘like cures like’ yet meaning ‘like should be cured with like’). This became the basis of homeopathy and is, in fact, its definition.

In 1796, Hahnemann published his theory in an article entitled ‘Essay on a New Principle’. In 1806, he wrote a more detailed treatise ‘The Medicine of Experience’ and, in 1810, the first edition of his major work ‘The Organon’ followed. He continued to revise his ‘Organon’ throughout his long life, which thus saw a total of six editions (the last was only published well after his death).

Since Hahnemann’s days, several attempts have been made to reproduce Hahnemann’s quinine experiment. The results of the most rigorous of these replications have failed to confirm Hahnemann’s original findings: neither Cinchona bark nor its main ingredient, quinine, produce the symptoms of malaria in health individuals.

And what is the explanation?

The dose Hahnemann took contained about 400 to 500 milligrams of quinine. After ingesting it, he felt languid and drowsy (hypotension); he noticed palpitations (ventricular tachycardia), pulsation in the head (headache), redness in cheeks (rash), prostration through limbs (general weakness), thirst (fever) and cold fingers and feet with trembling which are indicative of an allergic reaction. One has to praise Hahnemann’s skills of (self-) observations. Unfortunately, his ability to interpret them correctly was, at least in this particular instance, wanting.

The most likely cause of his symptoms is, according to many experts who have analysed the case in much detail, an allergic reaction to quinine. Hahnemann described his symptoms accurately, yet he was mistaken in his interpretation of the event.

If this conclusion is correct – and I have little doubt that it is – the main assumption of homeopathy, the notion on which the entire school of homeopathy rests, is based on a misunderstanding.

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