MD, PhD, FMedSci, FSB, FRCP, FRCPEd

placebo

Placebo effects are important and often misunderstood. This is perhaps nowhere more true than in the realm of alternative medicine. Here they are often used to justify bogus treatments with the argument ‘I DON’T CARE HOW IT WORKS AS LONG AS IT DOES HELP PATIENTS, EVEN IF THIS SHOULD BE VIA A PLACEBO EFFECT’.

A recent article published in the prestigious NEJM sheds some light on these issues – all the more so, as one of its authors has a background as an advocate of alternative medicine. Here are a few passages from this paper which I think are particularly relevant:

… placebo effects are improvements in patients’ symptoms that are attributable to their participation in the therapeutic encounter, with its rituals, symbols, and interactions. These effects are distinct from those of discrete therapies and are precipitated by the contextual or environmental cues that surround medical interventions, both those that are fake and lacking in inherent therapeutic power and those with demonstrated efficacy…

So what have we learned about placebo effects to date, and what does our current understanding say about medicine?

First, though placebos may provide relief, they rarely cure. Although research has revealed objective neurobiologic pathways and correlates of placebo responses, the evidence to date suggests that the therapeutic benefits associated with placebo effects do not alter the pathophysiology of diseases beyond their symptomatic manifestations; they primarily address subjective and self-appraised symptoms…

Second, placebo effects are not just about dummy pills: the effects of symbols and clinician interactions can dramatically enhance the effectiveness of pharmaceuticals…

Third, the psychosocial factors that promote therapeutic placebo effects also have the potential to cause adverse consequences, known as nocebo effects. Not infrequently, patients perceive side effects of medications that are actually caused by anticipation of negative effects or heightened attentiveness to normal background discomforts of daily life in the context of a new therapeutic regimen…

… research on placebo effects can help explain mechanistically how clinicians can be therapeutic agents in the ways they relate to their patients in connection with, and separate from, providing effective treatment interventions. Of course, placebo effects are modest as compared with the impressive results achieved by lifesaving surgery and powerful, well-targeted medications. Yet we believe such effects are at the core of what makes medicine a healing profession.

So what about the claim that it is fine to use homeopathy, for instance, because it might help via a placebo effect? There are several reasons why this is not a good idea some of which are hinted at in the above article:

  1. placebo effects are not usually powerful,
  2. they are not normally long-lasting,
  3. they are not reliable,
  4. they are merely symptomatic,
  5. they are not always risk-free,
  6. they usually require deceiving patients, and that is not ethical,
  7. pretending that a bogus treatment is alright can undermine rationality in general,
  8. happily using bogus treatments because they generate placebo effects is a disincentive to find effective treatments,
  9. we do not need a placebo to generate placebo effects because any empathetic therapeutic encounter will do that too.

My conclusion is deliberately flippant and provocative: PLACEBO EFFECTS ARE TOO IMPORTANT TO LEAVE THEM TO QUACKS AND CHARLATANS.

If you talk to advocates of homeopathy, you are bound to hear claims that are false or misleading; in fact, you hear them so regularly that you might begin to doubt the truth. For those who have such doubts or are in need of some correct counter-arguments, I have listed here those 12 bogus claims which, in my experience, are most common together with short, suitable, and factual rebuttals.

1) THERE IS NOTHING MYSTERIOUS ABOUT HOMEOPATHY’S MODE OF ACTION, IT WORKS LIKE VACCINATIONS

This argument is used by enthusiasts in response the fact that most homeopathic remedies are too highly diluted to have pharmacological effects. Vaccines are also highly diluted and they are, of course, very effective; therefore, so the bogus notion, there is nothing odd about homeopathy.

The argument is wrong on several levels; the easiest way to refute, I think, it is to point out that vaccines contain measurable amounts of material and lead to measurable changes in the immune system. By contrast, the typical homeopathic remedy (beyond the C12 potency) contains not a single molecule of an active substance and leads to no measurable changes in any system.

2) SIGNIFICANTLY MORE CONTROLLED CLINICAL TRIALS OF HOMEOPATHY ARE POSITIVE THAN NEGATIVE

Several websites of homeopathic organisations make this claim and even provide simple statistics to back it up. Consequently, many homeopathy fans have adopted it.

The statistics they present show that x % of studies are positive, y % are negative and z % are neutral; the whole point is that x is larger than y. The percentage figures may even be correct but they rely on the spurious definitions used: positive = superior to placebo, negative = placebo superior to homeopathy, neutral = no difference between homeopathy and placebo. The latter category was created so that homeopathy comes out trumps.

For all intents and purposes, a study where the experimental treatment is no better than placebo is not a study neutral but a negative result. Thus the negative category in such statistics must be y + z which is, of course, larger than x. In other words, the majority of trials is, in truth, negative.

3) HOMEOPATHY IS SUPPORTED BY NOBEL PRIZE WINNERS

I don’t know of a single Nobel Prize winner who has stated or implied that homeopathy works better than a placebo. Some have tried to find a mechanism of action for homeopathy by doing some basic research and have published theories about it. None of those has been accepted by science.

And if there ever should be a Nobel Prize winner or similarly brilliant person who supports homeopathy, this would merely show that even bright individuals can make mistakes!

4) HOMEOPATHY IS SAFE

Tell that to the child that has just been reported to have died because her parents used homeopathy for an ear infection which (could have been easily treated with antibiotics but) degenerated into a brain abscess with homeopathic therapy. There are many more such tragic cases than I care to remember.

The risks of homeopathy are, of course, minor compared to many conventional treatments, but the risk/benefit balance of homeopathy can never be positive because, unlike those high risk conventional treatments, it has no benefit.

5) HOMEOPATHY DOES NOT LEND ITSELF TO BEING TESTED IN CLINICAL TRIALS

The best way to disprove this argument is to point out that ~ 250 controlled clinical trials are currently available. Every homeopath on the planet boasts about clinical trials – provided they are positive.

6) HOMEOPATHY WORKS VIA QUANTUM ENTANGLEMENT

I do not understand quantum mechanics and, I suspect, neither do the homeopaths who use this argument. But physicists who do understand this subject well are keen to stress that homeopathy cannot be explained in this way.

7) THERE IS NO PROOF THAT HOMEOPATHY DOES NOT WORK

The absence of evidence is not the same as evidence of absence, homeopaths like to exclaim. And they are, of course, correct! However, they forget that, science cannot prove a negative and that, in routine health care, we do not even look for a proof of ineffectiveness. We use those treatments that have a positive proof of effectiveness – everything else is irresponsible.

8) EVEN IF HOMEOPATHY WERE JUST A PLACEBO, IT STILL HELPS PATIENTS AND IS THEREFORE A USEFUL TREATMENT

It is true, of course, that placebo effects can help patients. But it is not true that, for generating a placebo response, we need a placebo. If a clinician administers an effective treatment with compassion, the patient will benefit from a placebo response plus from the specific effects of the treatment. Only giving placebos is therefore tantamount to cheating the patient.

9) THERE IS A WORLDWIDE CONSPIRACY AGAINST HOMEOPATHY

In a way, this argument merely suggests that homeopathic remedies are ineffective in treating paranoia. I have not ever seen a jot of evidence for it – and neither can anyone who uses this claim produce any.

10) YOU NEED TO BE A HOMEOPATH TO BE ABLE TO UNDERSTAND AND ADEQUATELY JUDGE THE VALUE OF HOMEOPATHY

With this notion, homeopaths want to claim that the critics of homeopathy are incompetent. It is like saying that only people who believe in god are allowed to criticise religion. By definition, homeopaths are believers, and therefore they are unlikely to be free of bias when judging the value of homeopathy. Homeopathy is a health technology that must be evaluated like all other health technologies: by independent scientists who know their job.

11) HOMEOPATHY HAS BEEN PROVEN TO WORK FOR LITTLE CHILDREN AND ANIMALS

The argument here is that animals and children cannot possibly respond to placebo. Therefore homeopathy must be more than a placebo.

This notion is twice wrong. Firstly, both animals and children can respond to placebo, if only ‘by proxy’, i.e. via their carers. Secondly, if we consider the totality of the reliable data, we find that neither for children nor for animals is the evidence convincingly positive.

12) HOMEOPATHY HAS BEEN USED VERY SUCCESSFULLY IN MAJOR EPIDEMICS, AND THAT FACT IS PROOF ENOUGH FOR ITS EFFICACY

Yes, there are some rather fascinating historical accounts which homeopaths interpret in this fashion. But if we look a little closer, we invariably find explanations which are much more plausible than the assumption of homeopathy’s effectiveness. Epidemiological observations of this nature can almost never establish cause and effect, and the clinical outcome could have been due to a myriad of confounders unrelated to homeopathy.

On 26/5/2015, I received the email reproduced below. I thought it was interesting, looked up its author (“Shawn is a philosopher and writer educated at York University in Toronto, and the author of two books. He’s also worked with Aboriginal youth in the Northwest Territories of Canada”) and decided to respond by writing a blog-post rather than by answering Alli directly.

Hello Dr. Ernst, this is Shawn Alli from Canada, a blogger and philosopher. I recently finished a critical article on James Randi’s legacy. It gets into everything from ideological science, manipulation, ESP, faith healing, acupuncture and homeopathy.

Let me know what you think about it:

http://www.shawnalli.com/james-randi-disingenuous-legacy.html

It’s quite long so save it for a rainy day.

So far, the reply from skeptical organizations range from: “I couldn’t read further than the first few paragraphs because I disagree with the claims…” to one word replies: “Petty.”

It’s always nice to know how open-minded skeptical organizations are.

Hopefully you can add a bit more.

Sincerely,

Shawn

Yes, indeed, I can but try to add a bit more!

However, Alli’s actual article is far too long to analyse it here in full. I therefore selected just the bit that I feel most competent commenting on and which is closest to my heart. Below, I re-produce this section of Alli’s article in full. I add my comments at the end (in bold) by inserting numbered responses which refer to the numbers (in round brackets [the square ones refer to Alli’s references]) inserted throughout Alli’s text. Here we go:

Homeopathy & Acupuncture:

A significant part of Randi’s legacy is his war against homeopathy. This is where Randi shines even above mainstream scientists such as Dawkins or Tyson.

Most of his talks ridicule homeopathy as nonsense that doesn’t deserve the distinction of being called a treatment. This is due to the fact that the current scientific method is unable to account for the results of homeopathy (1). In reality, the current scientific method can’t account for the placebo effect as well (2).

But then again, that presents an internal problem as well. The homeopathic community is divided by those who believe it’s a placebo effect and those that believe it’s more than that, advocating the theory of water memory, which mainstream scientists ridicule and vilify (3).

I don’t know what camp is correct (4), but I do know that the homeopathic community shouldn’t follow the lead of mainstream scientists and downplay the placebo effect as, it’s just a placebo (5).

Remember, the placebo effect is downplayed because the current scientific method is unable to account for the phenomenon (3, 5). It’s a wondrous and real effect, regardless of the ridicule and vilification (6) that’s attached to it.

While homeopathy isn’t suitable as a treatment for severe or acute medical conditions, it’s an acceptable treatment for minor, moderate or chronic ones (7). Personally, I’ve never tried homeopathic treatments. But I would never tell individuals not to consider it. To each their own, as long as it’s within universal ethics (8).

A homeopathic community in Greece attempts to conduct an experiment demonstrating a biological effect using homeopathic medicine and win Randi’s million dollar challenge. George Vithoulkas and his team spend years creating the protocol of the study, only to be told by Randi to redo it from scratch. [29] (9) I recommend readers take a look at:

The facts about an ingenious homeopathic experiment that was not completed due to the “tricks” of Mr. James Randi.

Randi’s war against homeopathy is an ideological one (10). He’ll never change his mind despite positive results in and out of the lab (11). This is the epitome of dogmatic ideological thinking (12).

The same is true for acupuncture (13). In his NECSS 2012 talk Randi says:

Harvard Medical School is now offering an advanced course for physicians in acupuncture, which has been tested endlessly for centuries and it does not work in any way. And believe me, I know what I’m talking about. [30]

Acupuncture is somewhat of a grey area for mainstream scientists and the current scientific method. One ideological theory states that acupuncture operates on principles of non-physical energy in the human body and relieving pressure on specific meridians. The current scientific method is unable to account for non-physical human energy and meridians.

A mainstream scientific theory of acupuncture is one of neurophysiology, whereby acupuncture works by affecting the release of neurotransmitters. I don’t know which theory is correct; but I do know that those who do try acupuncture usually feel better (14).

In regards to the peer-reviewed literature, I believe (15) that there’s a publication bias against acupuncture being seen as a viable treatment for minor, moderate or chronic conditions. A few peer-reviewed articles support the use of acupuncture for various conditions:

Eight sessions of weekly group acupuncture compared with group oral care education provide significantly better relief of symptoms in patients suffering from chronic radiation-induced xerostomia. [31]

It is concluded that this study showed highly positive effects on pain and function through the collaborative treatment of acupuncture and motion style in aLBP [acute lower back pain] patients. [32]

Given the limited efficacy of antidepressant treatment…the present study provides evidence in supporting the viewpoint that acupuncture is an effective and safe alternative treatment for depressive disorders, and could be considered an alternative option especially for patients with MDD [major depressive disorder] and PSD [post-stroke depression], although evidence for its effects in augmenting antidepressant agents remains controversial. [33]

In conclusion: We find that acupuncture significantly relieves hot flashes and sleep disturbances in women treated for breast cancer. The effect was seen in the therapy period and at least 12 weeks after acupuncture treatment ceased. The effect was not correlated with increased levels of plasma estradiol. The current study showed no side effects of acupuncture. These results indicate that acupuncture can be used as an effective treatment of menopausal discomfort. [34]

In conclusion, the present study demonstrates, in rats, that EA [electroacupuncture] significantly attenuates bone cancer induced hyperalgesia, which, at least in part, is mediated by EA suppression of IL-1…expression. [35]

In animal model of focal cerebral ischemia, BBA [Baihui (GV20)-based Scalp acupuncture] could improve IV [infarct volume] and NFS [neurological function score]. Although some factors such as study quality and possible publication bias may undermine the validity of positive findings, BBA may have potential neuroprotective role in experimental stroke. [36]

In conclusion, this randomized sham-controlled study suggests that electroacupuncture at acupoints including Zusanli, Sanyinjiao, Hegu, and Zhigou is more effective than no acupuncture and sham acupuncture in stimulating early return of bowel function and reducing postoperative analgesic requirements after laparoscopic colorectal surgery. Electroacupuncture is also more effective than no acupuncture in reducing the duration of hospital stay. [37]

In conclusion, we found acupuncture to be superior to both no acupuncture control and sham acupuncture for the treatment of chronic pain…Our results from individual patient data meta-analyses of nearly 18000 randomized patients in high-quality RCTs [randomized controlled trials] provide the most robust evidence to date that acupuncture is a reasonable referral option for patients with chronic pain. [38]

While Randi and many other mainstream scientists will argue (16) that the above claims are the result of ideological science and cherry picking, in reality, they’re the result of good science going up against dogmatic (17) and profit-driven (17) ideological (17) science.

Yes, the alternative medicine industry is now a billion dollar industry. But the global pharmaceutical medical industry is worth hundreds of trillions of dollars. And without its patients (who need to be in a constant state of ill health), it can’t survive (18).

Individuals who have minor, moderate, or chronic medical conditions don’t want to be part of the hostile debate between alternative medicine vs. pharmaceutical medical science (19). They just want to get better and move on with their life. The constant war that mainstream scientists wage against alternative medicine is only hurting the people they’re supposed to be helping (20).

Yes, the ideologies (21) are incompatible. Yes, there are no accepted scientific theories for such treatments. Yes, it defies what mainstream scientists currently “know” about the human body (22).

It would be impressive if a peace treaty can exist between both sides, where both don’t agree, but respect each other enough to put aside their pride and help patients to regain their health (23).

END OF ALLI’S TEXT

And here are my numbered comments:

(1) This is not how I understand Randi’s position. Randi makes a powerful point about the fact that the assumptions of homeopathy are not plausible, which is entirely correct – so much so that even some leading homeopaths admit that this is true.

(2) This is definitely not correct; the placebo effect has been studied in much detail, and we can certainly ‘account’ for it.

(3) In my 40 years of researching homeopathy and talking to homeopaths, I have not met any homeopaths who “believe it’s a placebo effect”.

(4) There is no ‘placebo camp’ amongst homeopaths; so this is not a basis for an argument; it’s a fallacy.

(5) They very definitely are mainstream scientists, like F Benedetti, who research the placebo effect and they certainly do not ‘downplay’ it. (What many people fail to understand is that, in placebo-controlled trials, one aims at controlling the placebo effect; to a research-naïve person, this may indeed LOOK LIKE downplaying it. But this impression is wrong and reflects merely a lack of understanding.)

(6) No serious scientist attaches ‘ridicule and vilification’ to it.

(7) Who says so? I know only homeopaths who hold this opinion; and it is not evidence-based.

(8) Ethics demand that patients require the best available treatment; homeopathy does not fall into this category.

(9) At one stage (more than 10 years ago), I was involved in the design of this test. My recollection of it is not in line with the report that is linked here.

(10) So far, we have seen no evidence for this statement.

(11) Which ones? No examples are provided.

(12) Yet another statement without evidence – potentially libellous.

(13) Conclusion before any evidence; sign for a closed mind?

(14) This outcome could be entirely unrelated to acupuncture, as anyone who has a minimum of health care knowledge should know.

(15) We are not concerned with beliefs, we concerned with facts here, aren’t we ?

(16) But did they argue this? Where is the evidence to support this statement?

(17) Non-evidence-based accusations.

(18) Classic fallacy.

(19) The debate is not between alt med and ‘pharmaceutical science’, it is between those who insist on treatments which demonstrably generate more good than harm, and those who want alt med regardless of any such considerations.

(20) Warning consumers of treatments which fail to fulfil the above criterion is, in my view, an ethical duty which can save much money and many lives.

(21) Yes, alt med is clearly ideology-driven; by contrast conventional medicine is not (if it were, Alli would have explained what ideology it is precisely). Conventional medicine changes all the time, sometimes even faster than we can cope with, and is mainly orientated on evidence which is not an ideology. Alt med hardly changes or progresses at all; for the most part, its ideology is that of a cult celebrating anti-science and obsolete traditions.

(22) Overt contradiction to what Alli just stated about acupuncture.

(23) To me, this seems rather nonsensical and a hindrance to progress.

In summary, I feel that Alli argues his corner very poorly. He makes statements without supporting evidence, issues lots of opinion without providing the facts (occasionally even hiding them), falls victim of logical fallacies, and demonstrates an embarrassing lack of knowledge and common sense. Most crucially, the text seems bar of any critical analysis; to me, it seems like a bonanza of unreason.

To save Alli the embarrassment of arguing that I am biased or don’t know what I am talking about, I’d like to declare the following: I am not paid by ‘Big Pharma’ or anyone else, I am not aware of having any other conflicts of interest, I have probably published more research on alt med (some of it with positive conclusions !!!) than anyone else on the planet, my research was funded mostly by organisations/donors who were in favour of alt med, and I have no reason whatsoever to defend Randi (I only met him personally once). My main motivation for responding to Alli’s invitation to comment on his bizarre article is that I have fun exposing ‘alt med nonsense’ and believe it is a task worth doing.

The FDA just made the following significant announcement:

The Food and Drug Administration (FDA) is announcing a public hearing to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products. These products include prescription drugs and biological products labeled as homeopathic and over-the-counter (OTC) drugs labeled as homeopathic. FDA is seeking participants for the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, and industry. FDA is seeking input on a number of specific questions, but is interested in any other pertinent information participants would like to share.

Date

April 20-21, 2015

Time

9:00 am to 4:00 pm

Location

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503A (Great Room)
Silver Spring, Maryland 20993

Attendance, Registration, and Oral Presentations

Registration is free and available on a first-come, first-served basis. If you wish to attend or make an oral presentation, please reference section III of the forthcoming Federal Register Notice (Attendance and/or Participation in the Public Hearing) for information on how to register and the deadline for registration.

Webcast Information

If you cannot attend in person, information about how you can access a live Webcast will be located at Homeopathic Product Regulation

Agenda

The agenda will be posted soon

And this is what Reuters reported about the planned event:

The hearing, scheduled for April 20-21, will discuss prescription drugs, biological products, and over-the-counter drugs labeled homeopathic, a market that has expanded to become a multimillion dollar industry in the United States. The agency is set to evaluate its regulatory framework for homeopathic products after a quarter century. (http://1.usa.gov/1Hxwup3) An Australian government study released this month concluded that homeopathy does not work. (http://bit.ly/1BheAmR) The FDA issued a warning earlier this month asking consumers not to rely on asthma products labeled homeopathic that are sold over the counter. (http://1.usa.gov/1EEuKrC) Homeopathic medicines include pellets placed under the tongue, tablets, liquids, ointments, sprays and creams. The basic principles of homeopathy, formulated by German physician Samuel Hahnemann in the late 18th century, are based on a theory that a disease can be treated using small doses of natural substances that in a healthy person would produce symptoms of the disease. The agenda for the hearing will be posted soon, the FDA said on Tuesday.

In my view, this is an important occasion for experts believing in evidence to make their position regarding homeopathy heard. I therefore encourage all my readers who have an evidence-based opinion on homeopathy to submit it to the hearing.

The other day, I received a request from THE GUARDIAN: could I write a piece on homeopathy in relation to the Australian report which had just come out; they gave me ~700 words and all of 3 hours to do it. I had an extremely busy day, but accepted the challenge nevertheless.

My article was published the next day and the ‘headliner’ at THE GUARDIAN had elected to call it There is no scientific case for homeopathy: the debate is over.

What followed was a flurry of debate – well over 2200 comments – which was more than a little ironic, considering the headline.

Essentially, my article had repeated the well-rehearsed arguments which have so often been made on this blog and elsewhere:

Our trials failed to show that homeopathy is more than a placebo.

Our reviews demonstrated that the most reliable of the 230 or so trials of homeopathy ever published are also not positive.

Studies with animals confirmed the results obtained on humans.

Surveys and case reports suggested that homeopathy can be dangerous.

The claims made by homeopaths to cure conditions like cancer, asthma or even Ebola were bogus.

The promotion of homeopathy is not ethical.

The comments that followed were mixed, of course; those that disagreed with me used a range of counter-arguments; in no specific order, these were the following:

  1. For several reasons, I cannot be trusted.
  2. I even once stated that I have treated my wife homeopathically.
  3. The Australian report was neither thorough nor reliable.
  4. The Australian expert panel were bought by Big Pharma.
  5. Homeopathic treatment must be individualised and can therefore not be tested in RCTs.
  6. Just because we don’t understand how homeopathy works, we should not conclude that it is ineffective.
  7. 200 years of positive experience with homeopathy clearly prove that it works.
  8. The huge popularity of homeopathy worldwide demonstrated its effectiveness.
  9. The fact that some very clever people support homeopathy shows that it works.
  10. Homeopathy works in animals and little children, therefore it cannot be just a placebo.
  11. The Queen and my aunt Doris use homeopathy.
  12. Placebos work.
  13. Patients must be able to choose; patient choice is an important principle in all health care.
  14. There’s more to evidence than just RCTs.
  15. Homeopathy works like vaccines.

With such an abundance of counter-arguments, the debate is clearly NOT over! Or is it? Let’s see how solid the arguments really are.

1) I cannot be trusted

Ad hominem attacks are no arguments at all; they are merely a sign that the person using them has no real arguments left.

2) I treated my wife homeopathically

This is true. At one stage in my life, I treated anyone who couldn’t run fast enough to escape me with homeopathy. What does that show? It simply shows that I can make mistakes too.

3) The Australian report was flawed

Perhaps it was not entirely faultless (no report ever is), but it certainly was rigorous – more so than any previous document in the entire history of homeopathy. If it excluded certain types of evidence, like the observational studies (which are so much loved by homeopaths), it did so because such data are wide open to bias.

4) The panel was not independent

Yes, it was! It even included a homeopath. The Australian National Health and Medical Research Council is internationally highly respected, and to defame it without evidence is, in a way, just another ad hominem attack.

5) Homeopathy must be individualised

This is a half-truth: classical homeopathy is mostly individualised, but lots of homeopathic prescribing is not individualised. And in any case, we have recently seen how totally unconvincing the results of strictly individualised trials of homeopathy are. This argument turns out to be a red herring.

6) We currently don’t understand how homeopathy works

What we do understand perfectly well, however, is the fact that no explanation exists which would not require throwing over board big chunks of the laws of nature. But even if we accepted that the mode of action is unknown, this would not change the lack of homeopathy’s clinical effectiveness. Lots of treatments work without us understanding how.

7) Experience shows it works

Experience is a very unreliable indicator of effectiveness; there are simply far too many confounders such as placebo effects, regression towards the mean or natural history of the disease. This is why we need evidence to be sure, and historically medicine finally started making progress when this lesson had been learnt.

8) The amazing popularity of homeopathy is proof of its effectiveness

This is the ‘argumentum ad populum’ fallacy. Think of the popularity of blood-letting to see how wrong this argument can be.

9) Homeopathy is backed by some very clever people

So what? Clever people are not always correct – look at me (just joking!)

10) Homeopathy works in animals and little children which proves that it is more than a placebo

First, animals and children do also show placebo-responses.

Second, the animal owner/parent might respond to placebo and thus mimic a placebo-response in the patient.

Third, the evidence for homeopathy is not positive neither in animals nor in children.

11) The Queen swears by homeopathy

Yes, so much so that, as soon as she is really ill, she makes use of what the very best of conventional medicine has to offer.

12) Placebos work

For sure! But that does not mean that we should prescribe placebos. If an effective treatment is given with compassion and empathy, the patient will also profit from a placebo effect – in addition to the effect of the treatment. Merely administering placebos means withholding the latter and is thus not in the best interest of the patient.

13) Patient choice

Yes, patient choice is important. However, it only applies to the choice between treatments that are demonstrably effective – if not choice becomes arbitrariness.

14) Evidence is more than just RCTs

True, there are many study designs other than RCTs. They all have their place in research – but when the research question is to test whether a treatment is effective beyond placebo, they are all open to different types of bias. The one that minimises bias best and thus produces more reliable findings than any other study design is the placebo-controlled, double-blind RCT.

15) Homeopathy works like vaccines

No! The ‘like cures like principle’ appears to be similar to the principles of vaccination, but this appearance is misleading. Vaccines contain small amounts of active material, while the typical homeopathic remedy doesn’t. Vaccines use the substance that causes the illness, e. g. (parts of) a virus, while homeopathy doesn’t.

So, is there still a debate? Obviously there is – the Guardian headliner was wrong – but it is a debate without reasonable arguments. And in the public domain, the debate is dominated by enthusiasts who endlessly repeat nonsensical notions which have been shown to be wrong over and over again.

In a nutshell:

Yes, there continues to be a debate.

No, there is no reasonable debate.

 

I have argued since many years that pharmacists should not be selling or promoting homeopathic and other remedies for which there is no proof of efficacy – the last time I published my view on this matter is even less than a week ago: Personally, I would go another step further and remind pharmacists who sell homeopathic remedies to the unsuspecting public that it is unethical to pretend they are more than placebos.

Despite my insistence and despite the fact that many agree with me (at least privately), there are precious few pharmacists who actually do something meaningful about the current situation. And there is very little visible change: in the UK, it is currently hard to find a pharmacy where homeopathic remedies are not on the shelves, and certainly all the major chains seem to put money before health care ethics.

I am, of course, speaking about the situation in the UK, France, Germany and some other European countries. Perhaps elsewhere things are different?

A NZ website seems to indicate that ‘down under’ the pharmacists are getting more active. Some strongly argue against unproven or disproven remedies in pharmacies:

Firstly, …it’s not a case that “pharmacists ‘should’ only be selling health products for which there is credible evidence of efficacy” (alterations mine, emboldened) but that they are obliged to—but choose not to. Their ethical guidelines state –

[PHARMACISTS] MUST:… Only purchase, supply or promote any medicine, complementary therapy, herbal remedy or other healthcare product where there is no reason to doubt its quality or safety and when there is credible evidence of efficacy.

…Secondly, the argument that ‘other businesses sell junk remedies therefore we shall’ is unsound. One of the key points about the ethical regulations for pharmacies is that customers should be able to walk into a store and have an expectation that the remedies within the store are basically sound. If other businesses elect to be unsound, that’s poor health practice, but no justification to do likewise. On the face of it, it would seem that the profit motive is ruling over sound and ethical practice.

Thirdly, that some GPs subscribe placebos should have no standing in this. There is some arguments for GPs to prescribe placebo remedies in some cases; others would argue that education is a better response in most cases. Either way—and just my opinion—it seems to me that GPs prescribing homeopathic remedies encourages people to think these have real remedial effects. I don’t work within the industry, but I am sure are ways of offering placebos that avoid using off-the-shelf commercial products. One might be that patients only get placebo ‘treatments’ via prescription.

…Fourthly, Pharmacy Today encourages that “pharmacies need to reconsider their stance in the light of this report”***. While this is an excellent idea, and one I thoroughly support, I suspect the underlying driver isn’t the report, but media presence on the topic. There is a long trail of evidence over many years showing that homeopathic remedies are not effective for anything.

The Australian study*** that prompted the latest round of interest drew this statement,

Based on the assessment of the evidence of effectiveness of homeopathy, NHMRC concludes that there are no health conditions for which there is reliable evidence that homeopathy is effective.

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.

The National Health and Medical Research Council expects that the Australian public will be offered treatments and therapies based on the best available evidence.

…Why were the relevant professional bodies not onto this evidence sooner?…

GOOD QUESTION!

I might add another one: why are the European professional bodies of pharmacy doing so little about this ongoing breach of their own ethical codes?

(*** the report that the author refers to is the one by the Australian National Health and Medical Research Council we discussed on this blog a few days ago.)

The discussion whether acupuncture is more than a placebo is as long as it is heated. Crucially, it is also quite tedious, tiresome and unproductive, not least because no resolution seems to be in sight. Whenever researchers develop an apparently credible placebo and the results of clinical trials are not what acupuncturists had hoped for, the therapists claim that the placebo is, after all, not inert and the negative findings must be due to the fact that both placebo and real acupuncture are effective.

Laser acupuncture (acupoint stimulation not with needle-insertion but with laser light) offers a possible way out of this dilemma. It is relatively easy to make a placebo laser that looks convincing to all parties concerned but is a pure and inert placebo. Many trials have been conducted following this concept, and it is therefore highly relevant to ask what the totality of this evidence suggests.

A recent systematic review did just that; specifically, it aimed to evaluate the effects of laser acupuncture on pain and functional outcomes when it is used to treat musculoskeletal disorders.

Extensive literature searches were used to identify all RCTs employing laser acupuncture. A meta-analysis was performed by calculating the standardized mean differences and 95% confidence intervals, to evaluate the effect of laser acupuncture on pain and functional outcomes. Included studies were assessed in terms of their methodological quality and appropriateness of laser parameters.

Forty-nine RCTs met the inclusion criteria. Two-thirds (31/49) of these studies reported positive effects. All of them were rated as being of high methodological quality and all of them included sufficient details about the lasers used. Negative or inconclusive studies mostly failed to demonstrate these features. For all diagnostic subgroups, positive effects for both pain and functional outcomes were more consistently seen at long-term follow-up rather than immediately after treatment.

The authors concluded that moderate-quality evidence supports the effectiveness of laser acupuncture in managing musculoskeletal pain when applied in an appropriate treatment dosage; however, the positive effects are seen only at long-term follow-up and not immediately after the cessation of treatment.

Surprised? Well, I am!

This is a meta-analysis I always wanted to conduct and never came round to doing. Using the ‘trick’ of laser acupuncture, it is possible to fully blind patients, clinicians and data evaluators. This eliminates the most obvious sources of bias in such studies. Those who are convinced that acupuncture is a pure placebo would therefore expect a negative overall result.

But the result is quite clearly positive! How can this be? I can see three options:

  • The meta-analysis could be biased and the result might therefore be false-positive. I looked hard but could not find any significant flaws.
  • The primary studies might be wrong, fraudulent etc. I did not see any obvious signs for this to be so.
  • Acupuncture might be more than a placebo after all. This notion might be unacceptable to sceptics.

I invite anyone who sufficiently understands clinical trial methodology to scrutinise the data closely and tell us which of the three possibilities is the correct one.

Getting good and experienced lecturers for courses is not easy. Having someone who has done more research than most working in the field and who is internationally known, might therefore be a thrill for students and an image-boosting experience of colleges. In the true Christmas spirit, I am today making the offer of being of assistance to the many struggling educational institutions of alternative medicine .

A few days ago, I tweeted about my willingness to give free lectures to homeopathic colleges (so far without response). Having thought about it a bit, I would now like to extend this offer. I would be happy to give a free lecture to the students of any educational institution of alternative medicine. I suggest to

  • do a general lecture on the clinical evidence of the 4 major types of alternative medicine (acupuncture, chiropractic, herbal medicine, homeopathy) or
  • give a more specific lecture with in-depth analyses of any given alternative therapy.

I imagine that most of the institutions in question might be a bit anxious about such an idea, but there is no need to worry: I guarantee that everything I say will be strictly and transparently evidence-based. I will disclose my sources and am willing to make my presentation available to students so that they can read up the finer details about the evidence later at home. In other words, I will do my very best to only transmit the truth about the subject at hand.

Nobody wants to hire a lecturer without having at least a rough outline of what he will be talking about – fair enough! Here I present a short summary of the lecture as I envisage it:

  • I will start by providing a background about myself, my qualifications and my experience in researching and lecturing on the matter at hand.
  • This will be followed by a background on the therapies in question, their history, current use etc.
  • Next I would elaborate on the main assumptions of the therapies in question and on their biological plausibility.
  • This will be followed by a review of the claims made for the therapies in question.
  • The main section of my lecture would be to review the clinical evidence regarding the efficacy of therapies in question. In doing this, I will not cherry-pick my evidence but rely, whenever possible, on authoritative systematic reviews, preferably those from the Cochrane Collaboration.
  • This, of course, needs to be supplemented by a review of safety issues.
  • If wanted, I could also say a few words about the importance of the placebo effect.
  • I also suggest to discuss some of the most pertinent ethical issues.
  • Finally, I would hope to arrive at a few clear conclusions.

You see, all is entirely up to scratch!

Perhaps you have some doubts about my abilities to lecture? I can assure you, I have done this sort of thing all my life, I have been a professor at three different universities, and I will probably manage a lecture to your students.

A final issue might be the costs involved. As I said, I would charge neither for the preparation (this can take several days depending on the exact topic), nor for the lecture itself. All I would hope for is that you refund my travel (and, if necessary over-night) expenses. And please note: this is  time-limited: approaches will be accepted until 1 January 2015 for lectures any time during 2015.

I can assure you, this is a generous offer  that you ought to consider seriously – unless, of course, you do not want your students to learn the truth!

(In which case, one would need to wonder why not)

THIS POST IS DEDICATED TO HRH, THE PRINCE OF WALES WHO CELEBRATES HIS 66TH BIRTHDAY TODAY AND HAS SUPPORTED HOMEOPATHY ALL HIS LIFE

Like Charles, many people are fond of homeopathy; it is particularly popular in India, Germany, France and parts of South America. With all types of health care, it is important to make therapeutic decisions in the knowledge of the crucial facts. In order to aid evidence-based decision-making, I will summarise a few things you might want to consider before you try homeopathy – either by buying homeopathic remedies over the counter, or by consulting a homeopath.

  1. Homeopathy was invented by Samuel Hahnemann, a charismatic German doctor, about 200 years ago. At the time, our understanding of the laws of nature was woefully incomplete, and therefore Hahnemann’s ideas seemed far less implausible than they actually are. Moreover, the conventional treatments of this period were often more dangerous than the disease they were supposed to cure; consequently homeopathy was repeatedly shown to be better than ‘allopathy’ (a term coined by Hahnemann to insult conventional medicine). Thus Hahnemann’s treatments were an almost instant worldwide success. When, about 100 years later, more and more effective conventional therapies were discovered, homeopathy all but disappeared, only to be re-discovered in developed countries as the baby-boomers started their recent love-affair with alternative medicine.
  2. Many consumers confuse homeopathy with herbal medicine; yet the two are fundamentally different. Herbal medicines are plant extracts with potentially active ingredients. Homeopathic remedies may be based on plants (or any other material as well) but are typically so dilute that they contain absolutely nothing. The most frequently used dilution (homeopaths call them ‘potencies’) is a ‘C30′; a C30-potency has been diluted 30 times at a ratio of 1:100. This means that one drop of the staring material is dissolved in 1 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 drops of diluent – and that equates to one molecule of the original substance per all the molecules of many thousand universes.
  3. Homeopaths know all of this, of course, and they thus claim that their remedies do not work via pharmacological effects but via some ‘energy’ or ‘vital force’. They are convinced that the process of preparing the homeopathic dilutions (they shake the mixtures at each dilution step) transfers some ‘vital energy’ from one to the next dilution. They cite all sorts of fancy theories to explain how this ‘energy transfer’ might come about, however, none of them has ever been accepted by mainstream scientists.
  4. Homeopathic remedies are usually prescribed according to the ‘like cures like’ principle. For instance, if you suffer from runny eyes, a homeopath might prescribe a remedy made of onion, because onion make our eyes water. This and all other basic assumptions of homeopathy contradict the known laws of nature. In other words, we do not just fail to understand how homeopathy works, but we understand that it cannot work unless the known laws of nature are wrong.
  5. The clinical trials of homeopathy are broadly in agreement with these insights from basic science. Today, more than 200 such studies have been published; if we look at the totality of this evidence, we have to conclude that it fails to show that homeopathic remedies are anything other than placebos.
  6. This is, of course, in stark contrast to what many enthusiasts of homeopathy insist upon; they swear by homeopathy and claim that it has helped them (or their pet, aunt, child etc.) repeatedly. Nobody doubts their accounts; in fact, it is indisputable that many patients do get better after taking homeopathic remedies. The best evidence available today clearly shows, however, that this improvement is unrelated to the homeopathic remedy per se. It is the result of an empathetic, compassionate encounter with a homeopath, a placebo-response or other factors which experts often call ‘context effects’.
  7. The wide-spread notion that homeopathy is completely free of risks is not correct. The remedy itself might be harmless (except, of course, for the damage it creates to your finances, and the fact that irrational nonsense about ‘vital energy’ etc. undermines rationality in general) but this does not necessarily apply to the homeopath. Whenever homeopaths advise their patients, as they often do, to forgo effective conventional treatments for a serious condition, they endanger lives. This phenomenon is documented, for instance, in relation to the advice of many homeopaths against immunisations. Any treatment that has no proven benefit, while carrying a finite risk, cannot generate more good than harm.

‘Healing, hype or harm? A critical analysis of complementary or alternative medicine’ is the title of a book that I edited and that was published in 2008. Its publication date coincided with that of ‘Trick or Treatment?’ and therefore the former was almost completely over-shadowed by the latter. Consequently few people know about it. This is a shame, I think, and this post is dedicated to encouraging my readers to have a look at ‘Healing, hype or harm?’

One reviewer commented on Amazon about this book as follows: Vital and informative text that should be read by everyone alongside Ben Goldacre’s ‘Bad Science’ and Singh and Ernt’s ‘Trick or Treatment’. Everyone should be able to made informed choices about the treatments that are peddled to the desperate and gullible. As Tim Minchin famously said ‘What do you call Alternative Medicine that has been proved to work? . . . Medicine!’

This is high praise indeed! But I should not omit the fact that others have commented that they were appalled by our book and found it “disappointing and unsettling”. This does not surprise me in the least; after all, alternative medicine has always been a divisive subject.

The book was written by a total of 17 authors and covers many important aspects of alternative medicine. Some of its most famous contributors are Michael Baum, Gustav Born, David Colquhoun, James Randi and Nick Ross. Some of the most important subjects include:

  • Compassion
  • Quackademia
  • Impartiality
  • Ethics
  • Politics
  • Holism
  • Vitalism
  • Placebo

As already mentioned, our book is already 6 years old; however, this does not mean that it is now out-dated. The subject areas were chosen such that it will be timely for a long time to come. Nor does this book reflect one single point of view; as it was written by over a dozen different experts with vastly different backgrounds, it offers an entire spectrum of views and attitudes. It is, in a word, a book that stimulates critical thinking and thoughtful analysis.

I sincerely think you should have a look at it… and, in case you think I am hoping to maximise my income by telling you all this: all the revenues from this book go to charity.

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