Edzard Ernst

MD, PhD, FMedSci, FSB, FRCP, FRCPEd

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?

Yes, it’s true: we all suffer from potentially poor health due to subluxations of our vertebrae. If they have not yet made us ill, they will do so shortly. But luckily, there is hope: rush to your chiropractor, get adjusted (pay cash) and all will be well.

If you don’t believe me, read what a chiropractor wrote on his website. The message could not be clearer:

Today you are going to learn what it is that causes your spinal misalignments or subluxations. Remember that a subluxation is a partial or incomplete dislocation of a vertebra. And contrary to what you may have been told or think or believe, we all have them. It is virtually impossible for all 24 of your spinal vertebrae to remain in their correct anatomical position because what causes a subluxation is stress. And each and every one of us is affected by stress each and every single day of our lives. The best way for me to explain stress is with the 3 T’s. The 3 T’s are traumas, thoughts and toxins. Traumas are those physical stresses that can affect our body. Examples are the birth process, the falls we have as toddlers as we learn to stand, walk and run, all the bumps, bruises and falls we suffer throughout our childhood, sporting injuries, car accidents, pregnancy, texting on a cell phone and prolonged sitting at a desk (computer). Thoughts are those mental/emotional stresses that can affect our body. Examples are job insecurity, relationship difficulties, being bullied at school and witnessing your parents go through a separation/divorce as a child. Toxins are the chemical stresses that can affect our body. The absolute number 1 chemical stressor is vaccines and immunizations. Other examples of chemical stressors are antibiotics, medications, recreational drugs, tobacco, alcohol and of course a poor diet. As human beings we can never escape the collective effects of stress. Some people have more physical stress, others more mental/emotional and others more chemical stress. But we all are affected by all 3 types of stress which means that we are always at risk of getting subluxations in our spine. What I would like you to do is think what the biggest source of stress is in your life and your children’s lives. Is it traumas, thoughts or toxins?

Yes, yes, yes: ‘The absolute number 1 chemical stressor is vaccines and immunizations.’ And those evil doctors – no, not doctors of chiropractic, doctors of medicine who have managed to steal the title that belongs to chiropractors – are all out to poison us! They are being paid by BIG PHARMA so that our kids are forced to get injected with pure poison.

These so-called doctors also prescribe antibiotics and other medications. As though anyone would ever need them! They are based on what is called the ‘germ theory of disease’. As chiropractors, we have long refuted this ridiculous theory; it is absurd: germs do not cause disease – subluxations are responsible for all that ails humans. But this simple yet important message has been suppressed by the medical mafia since the last 120 years.

So, do yourself a favour and immediately take your entire family to a chiropractor. He is your ideal and only primary care physician. No drugs, no immunizations – just adjustments to benefit your health (and the chiropractor’s cash flow).

PS

In case someone is not quite switched on today: THIS IS A JOKE! DON’T FOLLOW THIS ADVICE, IT MIGHT HARM YOUR HEALTH IRREPARABLY.

What a question, you might say. And you would be right, it’s a most awkward one, so much so that I cannot answer it for myself.

I NEED YOUR HELP.

Here is the story:

Ten years ago, with the help of S Lejeune and an EU grant, my team conducted a Cochrane review of Laertrile. To do the ‘ground work’, we hired an Italian research assistant, S Milazzo, who was supervised mainly by my research fellow Katja Schmidt. Consequently, the review was published under the names of all main contributors: Milazzo, Ernst, Lejeune, Schmidt.

In 2011, an update was due for which the help of Dr Markus Horneber, the head of a German research team investigating alt med in relation to cancer, was recruited. By then, Milazzo and Schmidt had left my unit and, with my consent, Horneber, Milazzo and Schmidt took charge of the review. I was then sent a draft of their update and did a revision of it which consisted mostly in checking the facts and making linguistic changes. The article was then published under the following authorship: Milazzo S, Ernst E, Lejeune S, Boehm K, Horneber M (Katja had married meanwhile, so Boehm and Schmidt are the same person).

A few days ago, I noticed that a further update had been published in 2015. Amazingly, I had not been told, asked to contribute, or informed that my name as co-author had been scrapped. The authors of the new update are simply Milazzo and Horneber (the latter being the senior author). Katja Boehm had apparently indicated that she did no longer want to be involved; I am not sure what happened to Lejeune.

I know Markus Horneber since donkey’s years and had co-authored several other papers with him in the past, so I (admittedly miffed about my discovery) sent him an email and asked him whether he did not consider this behaviour to amount to plagiarism. His reply was, in my view, unhelpful in explaining why I had not been asked to get involved and Horneber asked me to withdraw the allegation of plagiarism (which I had not even made) – or else he would take legal action (this was the moment when I got truly suspicious).

Next, I contacted the responsible editor at the Cochrane Collaboration, not least because Horneber had claimed that she had condoned the disputed change of authorship. Her reply confirmed that “excluding previous authors without giving them a chance to comment is not normal Cochrane policy” and that she did, in fact, not condone the omission of my name from the list of co-authors.

The question that I am asking myself (not for the first time, I am afraid – a similar, arguably worse case has been described in the comments section of this post) is the following: IS THIS A CASE OF PLAGIARISM OR NOT? In the name of honesty, transparency and science, it requires an answer, I think.

Even after contemplating it for several days, I seem to be unable to find a conclusive response. On the one hand, I did clearly not contribute to the latest (2015) update and should therefore not be a co-author. On the other hand, I feel that I should have been asked to contribute, in which case I would certainly have done so and remained a co-author.

For a fuller understanding of this case, I here copy the various sections of the abstracts of the 2011 update (marked OLD) and the 2015 update without my co-authorship (marked NEW):

 

OLD

Laetrile is the name for a semi-synthetic compound which is chemically related to amygdalin, a cyanogenic glycoside from the kernels of apricots and various other species of the genus Prunus. Laetrile and amygdalin are promoted under various names for the treatment of cancer although there is no evidence for its efficacy. Due to possible cyanide poisoning, laetrile can be dangerous.

NEW

Laetrile is the name for a semi-synthetic compound which is chemically related to amygdalin, a cyanogenic glycoside from the kernels of apricots and various other species of the genus Prunus. Laetrile and amygdalin are promoted under various names for the treatment of cancer although there is no evidence for its efficacy. Due to possible cyanide poisoning, laetrile can be dangerous.

OBJECTIVES:

OLD

To assess the alleged anti-cancer effect and possible adverse effects of laetrile and amygdalin.

NEW

To assess the alleged anti-cancer effect and possible adverse effects of laetrile and amygdalin.

SEARCH METHODS:

OLD

We searched the following databases: CENTRAL (2011, Issue 1); MEDLINE (1951-2011); EMBASE (1980-2011); AMED; Scirus; CancerLit; CINAHL (all from 1982-2011); CAMbase (from 1998-2011); the MetaRegister; the National Research Register; and our own files. We examined reference lists of included studies and review articles and we contacted experts in the field for knowledge of additional studies. We did not impose any restrictions of timer or language.

NEW

We searched the following databases: CENTRAL (2014, Issue 9); MEDLINE (1951-2014); EMBASE (1980-2014); AMED; Scirus; CINAHL (all from 1982-2015); CAMbase (from 1998-2015); the MetaRegister; the National Research Register; and our own files. We examined reference lists of included studies and review articles and we contacted experts in the field for knowledge of additional studies. We did not impose any restrictions of timer or language.

SELECTION CRITERIA:

OLD

Randomized controlled trials (RCTs) and quasi-RCTs.

NEW

Randomized controlled trials (RCTs) and quasi-RCTs.

DATA COLLECTION AND ANALYSIS:

OLD

We searched eight databases and two registers for studies testing laetrile or amygdalin for the treatment of cancer. Two review authors screened and assessed articles for inclusion criteria.

NEW

We searched eight databases and two registers for studies testing laetrile or amygdalin for the treatment of cancer. Two review authors screened and assessed articles for inclusion criteria.

MAIN RESULTS:

OLD

We located over 200 references, 63 were evaluated in the original review and an additional 6 in this update. However, we did not identify any studies that met our inclusion criteria.

NEW

We located over 200 references, 63 were evaluated in the original review, 6 in the 2011 and none in this update. However, we did not identify any studies that met our inclusion criteria.

AUTHORS’ CONCLUSIONS:

OLD

The claims that laetrile or amygdalin have beneficial effects for cancer patients are not currently supported by sound clinical data. There is a considerable risk of serious adverse effects from cyanide poisoning after laetrile or amygdalin, especially after oral ingestion. The risk-benefit balance of laetrile or amygdalin as a treatment for cancer is therefore unambiguously negative.

NEW

The claims that laetrile or amygdalin have beneficial effects for cancer patients are not currently supported by sound clinical data. There is a considerable risk of serious adverse effects from cyanide poisoning after laetrile or amygdalin, especially after oral ingestion. The risk-benefit balance of laetrile or amygdalin as a treatment for cancer is therefore unambiguously negative.

END OF ABSTRACT

I HOPE THAT YOU, THE READER OF THIS POST, ARE NOW ABLE TO TELL ME:

HAVE I BEEN PLAGIARISED?

P S

After the response from the Cochrane editor, I asked Horneber whether he wanted to make a further comment because I was thinking to blog about this. So far, I have not received a reply.

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.

The nice thing about New Year is that one sometimes tries to get some order into the chaos of one’s files and thus finds things that were long forgotten. Such a thing, for instance, is the 1996 book ‘DURCH AEHNLICHES HEILEN‘ edited by the Austrian homeopath, Perter Koenig. It contains lots of uncritical, pro-homeopathy articles by homeopaths, but also an article I wrote upon invitation.

When I composed it, I had just started my research in Exeter after leaving my post in Vienna. The subject I had been asked to address was ‘THE PLACE OF HOMEOPATHY WITHIN MEDICAL SCHOOLS’. My short article arrives at the following conclusions (as it is in German, I did a quick translation):

What place does homeopathy have in medical schools? An extremely low one! Even homeopathic optimists cannot reasonably doubt this answer. And how can its position be improved? Only through systematic research! This research should best be conducted in cooperation between experienced homeopaths and university-based methodologists. It must fill the existing gaps in our current knowledge, particularly in respect to the proof of homeopathy’s clinical effectiveness, and the research methods must comply with the currently accepted quality standards. History demonstrates fairly clearly that conventional medicine has changed according to new knowledge. In homeopathy, such a demonstration is so far missing.

Would I change this conclusion now that 20 years worth of research is available?

Yes!

The cooperative evaluation of homeopathy that I had in mind has happened.

And what are its conclusion?

The Australian National Health and Medical Research Council (NH&MRC) has made the most thorough and independent assessment of homeopathy in its history. On 11/3/2015, the NH&MRC has released its final report on homeopathy. In essence, it concluded that there is no scientific basis for homeopathy and no quality evidence of its efficacy: Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness. People who are considering whether to use homeopathy should first get advice from a registered health practitioner. Those who use homeopathy should tell their health practitioner and should keep taking any prescribed treatments.

In view of this, I would today revise my conclusions as follows:

What place does homeopathy have in medical schools? Its place is in the history books of medicine! Even homeopathic optimists cannot reasonably doubt this answer. Systematic research in cooperation between experienced homeopaths and university-based methodologists complying with the currently accepted quality standards has filled the gaps in our knowledge, particularly in respect to the proof of homeopathy’s clinical effectiveness. Now it is up to homeopaths to demonstrate that they are sufficiently responsible to adapt to this new knowledge in the best interest of their patients. If they don’t, they cannot be considered to be members of the community of ethical health care professionals. 

At this time of the year, journalists like to review what has happened during the previous year. I am not a journalist, just an alt med researcher, and I don’t want to review the 10 most important events but the non-events, that is 10 relevant things that should have happened in the realm of alt med but unfortunately didn’t happen. Needless to say: my choice is subjective, personal and highly biased.

Here we go, in no particular order:

WHO

In 2014, the WHO published the WHO TRADITIONAL MEDICINE STRATEGY 2014 – 2023. Amazingly, it has all the hallmarks of a promotional document that lacks critical input: “The strategy aims to support Member States in developing proactive policies and implementing action plans that will strengthen the role TM plays in keeping populations healthy.” In my view, those officials within the WHO who are capable of critical assessment should have spotted the danger of this strategy and, by 2015, have managed to withdraw this shameful paper, as it can only discredit this otherwise reputable organisation.

BCA

After suing my friend Simon Singh and losing the case, lots of money and even more reputation, the BCA and the chiropractic profession at large should have not only apologised to Simon but also taken more decisive actions to ensure that chiropractors around the world stop misleading the public about what they can contribute to human health. Sadly this blog has shown more than once that bogus claims still abound and chiropractors are still unable to criticise even the most extreme excesses of quackery in their ranks.

HOMEOPATHY

The International Council for Homeopathy (ICH) “is the international professional platform representing professional homeopaths and the practice of homeopathy around the world. ICH presently consists of 31 professional associations of homeopaths from 28 countries in four continents, and aims eventually to have member associations in all continents. Through networking and dialogue, members of ICH engage in the promotion and evaluation of the status of homeopathy in every part of the world; with emphasis on the development of international guidelines promoting freedom of access to the highest possible standard of homeopathic care.” With such high, self-declared aims, the ICH would have been in the ideal position to inform its members that the most transparent and thorough investigation of homeopathy concluded that “Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness. People who are considering whether to use homeopathy should first get advice from a registered health practitioner. Those who use homeopathy should tell their health practitioner and should keep taking any prescribed treatments.” Sadly, homeopaths all over the world prefer to go into a state of denial and carry on as before – to the detriment of public health worldwide.

FISHER

Peter Fisher, the homeopath of the Queen, has been shown to have published an important lie about me. In the interest of honesty, of his reputation and that of homeopathy, he should have retracted it and apologised. The fact that he has chosen to remain silent is, I think, a telling tale about the standards of truth in homeopathy.

PRINCE CHARLES

Prince Charles is one of the most prominent promoters of INTEGRATED MEDICINE. He may not have the wit to understand the issues involved but he certainly has access to the best advisors money can buy. By now, he should have realised that the yes-men he has been using are not up to the job of providing reasonable advice on alt med. Therefore he should have recruited proper experts who would have told him that adding unproven treatments to evidence-based medicine is not going to be an improvement. Sadly, Charles’ promotion of quackery continues unabated.

BOIRON

Christian Boiron, the General Manager of the world’s largest manufacturer of homeopathic remedies, ‘BOIRON’, recently stated that the critics of homeopathy are like the Ku Klux Klan. This embarrassing statement reflects a level of stupidity and arrogance that can only be harmful to his firm and homeopathy in general. The fact that it was not withdrawn does not bode well for either of them.

ULLMAN

Dan Ullman is one of the tireless [and tiresome] entrepreneurs in US homeopathy. I recently dedicated a blog-post to him where he commented copiously and was subsequently shown to be wrong on many issues. This would have been the right moment for him to give up selling bogus drugs and misleading literature. Unfortunately, the comments did not offer any hope that fanatics like him can be brought to their senses. This sad course of events suggests, I fear, that homeopathic delusions of this nature are too severe to cure.

SCIENTIFIC FRAUD

During these discussions, one commentator provided disturbing suspicions that one of the recent ‘flag-ship’ evidence for homeopathy might be fraudulent. The author of the paper in question, who had been a keen participant of the discussions, should have responded and argued his case. Instead his comments on this blog abruptly stopped, a fact that most experts might interpret as an admission of guilt.

SMITH

My Vice Chancellor at Exeter, Steve Smith, should have read 2015 my memoire, which suggests that he behaved less than honourably, and he should then have responded to it. Instead, Exeter opted to ignore not only my book but also the award of the John Maddox Prize 2015. It is up to the reader to decide how this non-action ought to be interpreted.

PHARMACISTS

The ‘INTERNATIONAL PHARMACEUTICAL FEDERATION’ has the slogan ‘advancing pharmacy worldwide’ in their logo. Therefore it seems to be the right organisation to remind pharmacists across the globe that they are not shopkeepers but a healthcare profession with ethical codes and moral responsibilities. Therefore they should have reminded community pharmacists, pharmacy chains and other interested parties that selling disproven remedies like homeopathy, Bach Flower Remedies, ineffective cough syrups etc. is a violation of pharmacists’ codes of ethics.

Any post about non-events and missed opportunities is a somewhat frustrating affaire. At the same time, it also offers hope: perhaps 2016 will see (some of) them happening?

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