MD, PhD, FMedSci, FSB, FRCP, FRCPEd

placebo

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

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

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

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

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

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

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.

We could have expected it, couldn’t we? With so much homeopathy in the press lately, Dr Dixon (we have seen him on this blog before, for instance here, here and here) had to comment. His article in yesterday’s NURSING IN PRACTICE is far too perfect to abbreviate it; I just have to cite it in full (only the reference numbers are mine and refer to my comments below).

HERE WE GO

Should homeopathy be blacklisted in general practice?

I have not prescribed them myself but I know of many GPs and patients who find homeopathic preparations helpful, especially in clinical areas where there is no satisfactory conventional treatment [1]. They are cheap and entirely safe [2], which cannot always be said of conventional treatment [3]. Is the concern about cost? That is implausible as GP prescriptions cost a mere £100,000 per annum, approximately £10 per UK General Practice but effectively less as some patients will be paying for them and they may reduce other prescriptions or medical costs [4]. Is it about evidence? [5] Possibly, and that is because the necessary pragmatic trials on comparative cost effectiveness have never been done [6]. Homeopathy thus joins the frequently quoted 25% of general practice activity that has an insufficient evidence base… So, why not do the research rather than single out homeopathy for blacklisting [7]? Apparently, because it irritates a powerful fraternity of “scientists” [8] with a narrow biomedical perspective on health and healing, who feel the need to impose their atheism [9] on others. They seem opposed to “patient-centred medicine” which factors in the mindset, culture, history, wishes and hopes of each patient, and a wider concept of science that might take account of them [10]. Led by the World Health Organization, many countries are examining the appropriate role of complementary and traditional medicine (CAM). Indian Prime Minister Modi has created the first minister for medicine in this area (called AYUSH with the “H” standing for homeopathy). Australia, whose government and medical deans (unlike the UK ) are not intimidated by this breed of scientific fundamentalism, has invested money in research, regulated its herbal [11] practitioners and created important trade links with China in this area [12]. Meanwhile the UK invests 0% of its research budget on CAM and appears to have a closed mind [13]. General practice is at its best a subtle and complex blend of science and art combined in a heady mixture, which recognises personal belief and perspective and respects differences [14]. Blacklisting homeopathy would be the thin edge of the wedge. It would be a mean-minded act of outside interference by many who do not treat patients themselves, denying patient choice and signifying a new age of intolerance and interference [15]. It is a threat to the autonomy of general practice that should concern every GP and patient whatever their views on homeopathy [16].

About the Author

Mike Dixon

Chairman of the NHS Alliance and a GP

Mike Dixon, chairman of the NHS Alliance and a GP at College Surgery in Cullompton, Devon and a Royal College of General Practitioners presidential candidate.

END OF QUOTE AND BEGINNING OF MY DELIBERATELY BRIEF COMMENTS

  1. Whenever this argument comes up, people fail to cite an example. Are they afraid that we would point out what can be done for such a patient other than prescribing placebos?
  2. Actually, they are extremely expensive considering that they are just lactose or water. And the claim that homeopathy is safe merely displays an embarrassing lack of knowledge; see the many posts on this blog that deal with this issue.
  3. Classical ‘tu quoque’ fallacy; display of the ignorance of the risk/benefit concept for judging the value of medical interventions.
  4. Display of ignorance regarding the actual evidence, see here, for instance.
  5. Yes, it’s the evidence but also it’s the biological implausibility and the fact that disregarding it undermines rationality in general.
  6. Pure ignorance again, see my point 4.
  7. Are ~ 300 clinical trials and about 100 systematic reviews not enough? How much more money needs to be wasted?
  8. It seems that Dixon has a problem with science and those who pursue it to improve future health care for the benefit of patients.
  9. Does Dixon admit that homeopathy is a religion?
  10. Patient-centred medicine which factors in the mindset, culture, history, wishes and hopes of each patient, and a wider concept of science that might take account of them – does Dixon not know that all good medicine fits this description, but homeopathy certainly does not?
  11. Every one with an IQ above 50 knows by now that herbal is not homeopathic; is Dixon the exception?
  12. What about the Australian report which 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.”
  13. This is simply not true, and Dixon should know it.
  14. No reason to include disproven nonsense like homeopathy.
  15. Intolerance is on Dixon’s side, I think. Improving health care by abandoning disproven therapies in favour of evidence-based treatments is no interference, it’s progress.
  16. This can only be true, if we misunderstand autonomy as arbitrariness without rules, checks, ethics and controls. Good general practice has, like all medicine, be in the best interest of patients. An obsolete, expensive, unsafe, ineffective and implausible treatment is clearly not.

Regular readers of this blog will be aware of the many bogus claims made by chiropractors. One claim, however, namely the one postulating chiropractors can effectively treat low back pain with spinal manipulation, is rarely viewed as being bogus. Chiropractors are usually able to produce evidence that does suggest the claim to be true, and therefore even most critics of chiropractic back off on this particular issue.

But is the claim really true?

A recent trial might provide the answer.

The purpose of this study was to compare the effectiveness of chiropractic spinal manipulative therapy (cSMT) to a sham intervention on pain (Visual Analogue Scale, SF-36 pain subscale), disability (Oswestry Disability Index), and physical function (SF-36 subscale, Timed Up and Go) by performing a randomized placebo-controlled trial at 2 Veteran Affairs Clinics.

Older veterans (≥ 65 years of age) who were naive to chiropractic were recruited. A total of 136 who suffered from chronic low back pain (LBP) were included in the study – with 69 being randomly assigned to cSMT and 67 to the sham intervention. Patients were treated twice per week for 4 weeks. The outcomes were assessed at baseline, 5, and 12 weeks post baseline.

Both groups demonstrated significant decrease in pain and disability at 5 and 12 weeks. At 12 weeks, there was no significant difference in pain and a statistically significant decline in disability scores in the cSMT group when compared to the control group. There were no significant differences in adverse events between the groups.

The authors concluded that cSMT did not result in greater improvement in pain when compared to our sham intervention; however, cSMT did demonstrate a slightly greater improvement in disability at 12 weeks. The fact that patients in both groups showed improvements suggests the presence of a nonspecific therapeutic effect.

Hold on, I hear you say, this does not mean that cSMT is a placebo in the treatment of LBP! There are other studies that yield positive results. Let’s not cherry-pick our evidence!

Absolutely correct! To avoid cherry-picking, lets see what the current Cochrane review tells us about cSMT and chronic LBP. Here is the conclusion of this review based on 26 RCTs: High quality evidence suggests that there is no clinically relevant difference between SMT and other interventions for reducing pain and improving function in patients with chronic low-back pain.

Convinced?

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.)

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