MD, PhD, FMedSci, FSB, FRCP, FRCPEd

conflict of interest

Acupuncture is often recommended as a treatment for shoulder pain, but its effectiveness is far from proven. A new study has just been published; but does it change this uncertainty?

A total of 227 patients with subacromial pain syndrome were recruited to this RCT. The patients were allocated to three groups who received either A) group exercise, B) group exercise plus acupuncture or C) group exercise plus electro-acupuncture. The primary outcome measure was the Oxford Shoulder Score. Follow-up was post treatment, and at 6 and 12 months. Data were analysed on intention-to-treat principles with imputation of missing values.

Treatment groups were similar at baseline. All treatment groups demonstrated improvements over time. Between-group estimates were, however, small and non-significant.

The authors concluded that neither acupuncture nor electro-acupuncture were found to be more beneficial than exercise alone in the treatment of subacromial pain syndrome. 

Well, that was to be expected!… I hear the rationalists amongst us exclaim.

Actually, I am not so sure.

One could easily have expected that the acupuncture groups (B and C) show a significant advantage over group A.

Why?

Because acupuncture is a ‘theatrical placebo’, a ritual that impresses patients and thus impacts on results, particularly on subjective outcomes like pain. If the results had shown a benefit for acupuncture + exercise (groups B and C) versus exercise alone (group A), what would we have made of it? Acupuncture fans would surely have claimed that it is evidence confirming acupuncture’s effectiveness. Sceptics, on the other hand, would have rightly insisted that it demonstrates nothing of the sort – it merely confirms that placebo effects can affect clinical outcomes such as pain.

As it turned out, however, this trial results happened to indicate that these placebo-effects can be so small that they fail to reach the level of statistical significance.

I think there is one noteworthy message here: RCTs with such a design (no adequate control for placebo effects) can easily generate false-positive results (in this case, this did not happen, but it was nevertheless a possible outcome). Such studies are popular but utterly useless: they don’t advance our knowledge one single iota. If that is so, we should not waste our resources on them because, in the final analysis, this is not ethical. In other words, we must stop funding research that has little or no chance of advancing our knowledge.

Whenever a level-headed person discloses that a specific alternative therapy is not based on good evidence, you can bet your last shirt that a proponent of the said treatment responds by claiming that conventional medicine is not much better.

There are several variations to this theme. Today I want to focus on just one of them, namely the counter-claim that, only a short while ago, conventional medicine was not much better than the said alternative therapy (the implication is that it must be unfair to demand evidence from alternative medicine, while accepting a similar state of affairs in conventional medicine). The argument has recently been formulated by one commentator on this blog as follows:

“Trepanation, leeches for UTI’s, and bloodletting are all historical treatments of medical doctors…It’s hypocritical… to impute mainstream chiropractice to the profession’s beginnings and yet not admit that medicine’s founding and evolution was inbued with consistently scientific rigor.”

Sadly, some people seem to be convinced by such words, and this is why they are being repeated ad nauseam by interested parties. Yet the argument is fallacious for a range of reasons.

  • Firstly, it is based on the classical ‘tu quoque’ fallacy (appeal to hypocrisy).
  • Secondly – unless we happen to be historians – it is not the healthcare of the past that is relevant to our discussions. The question cannot be what this or that group of clinicians used to do; the question is HOW DO THEY TREAT THEIR PATIENTS TODAY?

As soon as we focus on this issue, it is impossible to deny that conventional medicine has made lots of progress and moved light years away from treatments such as trepanation, leeches, bloodletting and many others.

Why?

Why did we make such huge progress?

Because research showed that many of the traditional treatments were ineffective, unsafe and/or implausible (thus demonstrating that hundreds of years of experience – which alternative therapists rate so very highly – is of more than dubious value), and because we consequently developed and tested new therapies and subsequently used those treatments that passed these tests and were proven to do more good than harm.

By contrast, in the last decades, centuries and millennia, homeopathy, chiropractic, acupuncture, paranormal healing etc. did make no (or very little) progress. So much so that Hahnemann, for instance, would pass any exam for  homeopathy today. (If you disagree with this statement, please post a list of those treatments that have been given up by alternative therapists in the last 100 years or so.) Come to think of it, it is a hallmark of alternative medicine that it does not progress in the way conventional medicine does. It is almost completely static, a fact, that renders it akin to a dogma or a cult.

But why? Why is there no real progress in alternative medicine?

Don’t tell me that there is no research, research funding, etc. There are now hundreds of studies of homeopathy or chiropractic, thousands of acupuncture, and dozens of paranormal healing, for instance. The trouble is not the paucity of such research but its findings! The totality of the evidence in each of these areas fails to show that the therapy in question is efficacious.

And there we have, I think, another hallmark of alternative medicine: it is an area where research is only acted upon, if its findings are in line with the preconceptions and aspirations of its proponents.

I find this interesting!

It means, amongst other things, that research into alternative medicine tends not to be used for finding the truth or establishing new knowledge; it is mainly employed for the promotion of the therapy in question, regardless of what the truth about it might be (this would disqualify this exercise from being research and qualify it as PSEUDO-RESEARCH). If the research findings are such that they cannot be used for promotion, they are simply ignored or defamed as inadequate.

Trump says he never mocked a disabled journalist.

YET THE WHOLE WORLD SAW HIM DO IT!

UK Brexit politicians such as Boris Johnson claim they never promised £ 350 million per week of EU funds for the NHS.

BUT WE ALL SAW THE PICTURES OF THE CAMPAIGN BUS!

These are just two of the numerous, obvious and highly significant lies that we have been told in recent months. In fact, we have heard so many lies recently that some of us seem to be getting used to them. We even have a new term for the phenomenon: the ‘post-truth society’.

Personally I don’t like the word at all: it seems to reflect a tacit acceptance of lies and their legitimisation.

I find it dangerous to put up with falsehoods in that way. And I think the truth is far too valuable to abandon it without a fight. I will therefore continue to call a lie a lie!

And, by Jove, in alternative medicine, we have no shortage of them:

  • Homeopaths claiming to be able to treat any condition with their ‘high potency remedies’.
  • Chiropractors who claim that spinal manipulation improves health.
  • Healers who state that their paranormal healing affects symptoms.
  • Alternative practitioners who claim that they treat the root cause of diseases.
  • Naturopaths who pretend they can treat childhood conditions.
  • Acupuncturists who say that rebalancing yin and yang affects health.
  • Alternative practitioners who insist they can detox our bodies.
  • Politicians who claim that TCM save lives.
  • Slapping therapists who say they can cure diabetes.
  • Journalists who publish that Paleo-diet can cure inflammatory bowel diseases.
  • Entrepreneurs who promote their unproven products as diabetes cures.
  • Academics who teach homeopathy to medical students.
  • Homeopaths who claim that their remedies are effective alternatives for vaccinations.

Do I need to go on?

These are not ‘post-truths’ – these are just lies, pure and simple.

We must not be lulled into complacency or false tolerance. Lies are lies, and they are wrong and unethical. In many instances they can even kill. To ignore or accept a steady stream of lies is not a solution; on the contrary, it can easily become part of the problem.

So, let’s continue to call them by their proper name – no matter whether they originate from the dizzy heights of world politics or the low lands of quackery.

Can intercessory prayer improve the symptoms of sick people?

Why should it? It’s utterly implausible!

Because the clinical evidence says so?

No, the current Cochrane review concluded that [the] findings are equivocal and, although some of the results of individual studies suggest a positive effect of intercessory prayer, the majority do not and the evidence does not support a recommendation either in favour or against the use of intercessory prayer. We are not convinced that further trials of this intervention should be undertaken and would prefer to see any resources available for such a trial used to investigate other questions in health care.

Yet, not all seem to agree with this; and some even continue to investigate prayer as a medical therpy.

For this new study (published in EBCAM), the Iranian investigators randomly assigned 92 patients in 2 groups to receive either 40 mg of propranolol twice a day for 2 month (group “A”) or 40 mg of propranolol twice a day for 2 months with prayer (group “B”). At the beginning of study and 3 months after intervention, patients’ pain was measured using the visual analogue scale.

All patients who participate in present study were Muslim. At the beginning of study and before intervention, the mean score of pain in patients in groups A and B were 5.7 ± 1.6 and 6.5 ± 1.9, respectively. According to results of independent t test, mean score of pain intensity at the beginning of study were similar between patients in 2 groups (P > .05). Three month after intervention, mean score of pain intensity decreased in patients in both groups. At this time, the mean scores of pain intensity were 5.4 ± 1.1 and 4.2 ± 2.3 in patients in groups A and B, respectively. This difference between groups was statistically significant (P < .001).

figure

The above figure shows the pain score in patients before and after the intervention.

The authors concluded that the present study revealed that prayer can be used as a nonpharmacologic pain coping strategy in addition to pharmacologic intervention for this group of patients.

Extraordinary claims require extraordinary proof. This study is, in fact, extraordinary – but only in the sense of being extraordinarily poor, or at least it is extraordinary in its quality of reporting. For instance, all we learn in the full text article about the two treatments applied to the patient groups is this: “The prayer group participated in an 8-week, weekly, intercessory prayer program with each session lasting 45 minutes. Pain reduction was measured at baseline and after 3 months, by registered nurses who were specialist in pain management and did not know which patients were in which groups (control or intervention), using a visual analogue scale.”

Intercessory prayer is the act of praying on behalf of others. This mans that the patients receiving prayer might have been unaware of being ‘treated’. In this case, the patients could have been adequately blinded. But this is not made clear in the article.

More importantly perhaps, the authors fail to provide any numeric results. All that we are given is the above figure. It is not possible therefore to run any type of check on the data. We are simply asked to believe what the authors have written. I for one have great difficulties in doing so. All I do believe in relation to this article is that

  • the journal EBCAM is utter trash,
  • constantly publishing rubbish is unethical and a disservice to everyone,
  • prayer does not need further research of this nature,
  • and poor studies often generate false-positive findings.

Is acupuncture a pseudoscience? An interesting question! It was used as the title of a recent article. Knowing who authored it, the question unfortunately promised to be rhetorical. Dr Mike Cummings is (or was?) the ‘Medical Director at British Medical Acupuncture Society’ – hardly a source of critical or sceptical thinking about acupuncture, I’d say. The vast majority of his recent publications are in ‘ACUPUNCTURE IN MEDICINE’ and his blog post too is for that journal. Nevertheless, his thoughts might be worth considering, and therefore I present the essence of his post below [the footnotes refer to my comments following Cummings’ article]:

…Wikipedia has branded acupuncture as pseudoscience and its benefits as placebo [1]. ‘Acupuncture’ is clearly is not pseudoscience; however, the way in which it is used or portrayed by some may on occasion meet that definition. Acupuncture is a technique that predates the development of the scientific method [2] … so it is hardly fair to classify this ancient medical technique within that framework [3]. It would be better to use a less pejorative classification within the bracket of history when referring to acupuncture and other ancient East Asian medical techniques [4]. The contemporary use of acupuncture within modern healthcare is another matter entirely, and the fact that it can be associated with pre-scientific medicine does not make it a pseudoscience.

The Wikipedia acupuncture page is extensive and currently runs to 302 references. But how do we judge the quality or reliability of a text or its references? … I would generally look down on blogs, such as this, because they lack … hurdles prior to publication [5]. Open peer review was introduced relatively recently associated with immediate publication. But all this involves researchers and senior academics publishing and reviewing within their own fields of expertise. Wikipedia has a slightly different model built on five pillars. The second of those pillars reads:


Wikipedia is written from a neutral point of view: We strive for articles that document and explain major points of view, giving due weight with respect to their prominence in an impartial tone. We avoid advocacy and we characterize information and issues rather than debate them. In some areas there may be just one well-recognized point of view; in others, we describe multiple points of view, presenting each accurately and in context rather than as “the truth” or “the best view”. All articles must strive for verifiable accuracy, citing reliable, authoritative sources, especially when the topic is controversial or is on living persons. Editors’ personal experiences, interpretations, or opinions do not belong.


Experts within a field may be seen to have a certain POV (point of view), and are discouraged from editing pages directly because they cannot have the desired NPOV (neutral POV). This is a rather unique publication model in my experience, although the editing and comments are all visible and traceable, so there is no hiding… apart from the fact that editors are allowed to be entirely anonymous. Have a look at the talk page behind the main acupuncture page on Wikipedia. You may be shocked by the tone of much of the commentary. It certainly does not seem to comply with the fourth of the five pillars, which urges respect and civility, and in my opinion results primarily from the security of anonymity. I object to the latter, but there is always a balance to be found between freedom of expression (enhanced for some by the safety of anonymity) and cyber bullying (almost certainly fuelled in part by anonymity). That balance requires good moderation, and whilst there was some evidence of moderation on the talk page, it was inadequate to my mind… I might move to drop anonymity from Wikipedia if moderation is wanting.

Anyway my impression, for what it’s worth, is that the acupuncture page on Wikipedia is not written from an NPOV, but rather it appears to be controlled by semi professional anti-CAM pseudosceptics [6]. I have come across these characters [6] regularly since I was introduced to the value of needling in military general practice. I have a stereotypical mental image: plain or scary looking bespectacled geeks and science nuts [6], the worst are often particle physicists … Interacting with them is at first intense, but rapidly becomes tedious as they know little of the subject detail [6], fall back on the same rather simplistic arguments [6] and ultimately appear to be motivated by eristic discourse rather than the truth [6].

I am not surprised that they prefer to close the comments, because I imagine that some people might object rather strongly to many of the statements made in this text.

Here are my short comments:

[1] I should perhaps stress that I am not the author of nor a contributor to this Wiki (or any other) page.

[2] Is this an attempt to employ the ‘appeal to tradition’ fallacy?

[3] The Wiki page does by no means classify the ancient history of acupuncture as pseudoscience.

[4] I have always felt that classification of science or medicine according to geography is nonsensical; they should not be classified as Western or Asian but as sound or not, effective or not, etc.

[5] As we have often seen on this blog, the ‘hurdles’ (peer-review) are often laughable, particularly in the realm of alternative medicine.

[6] This article is essentially trying to show that the Wiki page is biased. Yet it ends with a bonanza of insults which essentially reveal the profound bias of the author.

IS ACUPUNCTURE PSEUDOSCIENCE? Cummings’ article promised to address this question. Sadly it did nothing of the sort. It  turned out to be an incompetent rant about a Wiki page. If anything, Cummings contributed to the neutral reader of his text getting convinced that, indeed, acupuncture IS a pseudoscience! At least Wiki used facts, arguments, evidence etc. and it went a lot further in finding a rational answer to this intriguing question.

We had HOMEOPATHS WITHOUT BORDERS and now, I suggest, we acknowledge a similar organisation which could aptly be called CHIROPRACTORS WITHOUT SCRUPLES. This remarkable text from NATURAL NEWS explains it all, I think:

START OF QUOTE

The following chiropractors are speaking up to inform the public about the dangers of vaccines.

Dr. David Jockers, D.C.

Vaccines are one of medicine’s prized attempts to improve human performance. They use artificial laboratory derived medical technology to produce an immune response within the body in hopes it will lead to a long-term positive antibody response.

The vaccine ideology is based on the belief that people are created with inferior immune systems that are unable to keep up with the demands of the environment and need modern technology in the form of man-made vaccine formulations in order to bolster immunity.

According to the Centers for Disease Control, “The following substances are found in flu vaccines: aluminum, antibiotics, formaldehyde, human aborted fetal apparatus (dead human tissue), monosodium glutamate (MSG), and thimerosal (mercury).” Many of these same ingredients are in childhood vaccines. They are all very toxic for human physiology and have a track record for insulting the body’s immune system.

I would prefer to trust the innate ability of the body to overcome infectious microorganisms and I will fully support my body through healthy diet and lifestyle along with natural supplements and proper spinal alignment. I absolutely reject the idea that injecting a group of toxic, immune insulting chemicals into my bloodstream will improve someone’s long-term immune response.

Nancy Tarlow, D.C.

When you inject chemicals into your body that are toxic, there will be an effect. It may not be obvious at first. A child might have a fever that the doctor says is “normal”, but it isn’t. A fever or screaming could be that the brain is swelling and causing damage. The real problem is that children cannot convey to us how they feel. It’s not like an adult who can tell us that they felt great prior to a vaccination but then started having health problems.

Dr. Haroot Tovanyan, D.C.

I am a doctor of Chiropractic and I primarily work with autistic children.

Every single parent in my practice that has an autistic child has the same story. Child was born normal; child was developing normal. Child went in for their 12-month, 18-month, normal usually 24 or 36-month shots and regressed. This may be anecdotal, but when you hear it over and over and over again, there’s something to be said. These are children that have severe neurological issues. They’re not verbal; 8-10-year-old children that are still wearing diapers.

I have a quadriplegic niece in my family who received 4 shots, a total of 10 vaccines in 1 day. She was born normal. She developed normal until about a year and a half. At a year and a half she received 4 shots, 1, 2, 3, 4, and she … This was 1990 when they started doing multiple vaccines and they also quadrupled the number of shots that you’re normally receiving. She basically regressed. She’s a vegetable. I mean, she became a quadriplegic. Nowhere in nature would your child go to get exposed to let’s say 6 or 7 or 8 or 9, or in the case of my niece, 10 viruses and bacteria at the same time.

In nature that just doesn’t happen. They don’t co-exist like that. It’s not natural to put a combination of vaccines, combinations of viruses and bacteria that just don’t belong together or don’t co-exist in nature in a vial and inject it into a child and expect them to be healthy. The CDC schedule has never been tested for safety. There have never been double-blind studies. It’s never been tested for synergistic effect. They’ve refused to study un-vaccinated versus vaccinated.

END OF QUOTE

On this blog, we have discussed the issues related to chiropractic and immunisations repeatedly (for instance here, here, here and here).

In case you wonder about the origins of this odd and unethical behaviour, you best look into the history of chiropractic. D. D. Palmer, the magnetic healer who ‘invented’ chiropractic some 120 years ago, left no doubt about his profound disgust for immunisation: “It is the very height of absurdity to strive to ‘protect’ any person from smallpox and other malady by inoculating them with a filthy animal poison… No one will ever pollute the blood of any member of my family unless he cares to walk over my dead body… ” (D. D. Palmer, 1910)

D. D. Palmer’s son, B. J. Palmer  provided a more detailed explanation for chiropractors’ rejection of immunisation: “Chiropractors have found in every disease that is supposed to be contagious, a cause in the spine. In the spinal column we will find a subluxation that corresponds to every type of disease… If we had one hundred cases of small-pox, I can prove to you, in one, you will find a subluxation and you will find the same condition in the other ninety-nine. I adjust one and return his function to normal… There is no contagious disease… There is no infection…The idea of poisoning healthy people with vaccine virus… is irrational. People make a great ado if exposed to a contagious disease, but they submit to being inoculated with rotten pus, which if it takes, is warranted to give them a disease” (B. J. Palmer, 1909)

We are often told that such opinions have all but died out in today’s chiropractic profession. But is this true? I see precious little evidence to assume this to be true.

Today the anti-vaxx notions of chiropractors are mostly expressed in a less abrupt, more politically correct language: The International Chiropractors Association recognizes that the use of vaccines is not without risk. The ICA supports each individual’s right to select his or her own health care and to be made aware of the possible adverse effects of vaccines upon a human body. In accordance with such principles and based upon the individual’s right to freedom of choice, the ICA is opposed to compulsory programs which infringe upon such rights. The International Chiropractors Association is supportive of a conscience clause or waiver in compulsory vaccination laws, providing an elective course of action for all regarding immunization, thereby allowing patients freedom of choice in matters affecting their bodies and health.

Yes, I do realise that some chiropractors now acknowledge that immunisations have been one of the most successful interventions in the history of medicine. Yet, far too many others still vehemently adhere to the gospel of the Palmers, and statements like the following abound:

Vaccines. What are we taught? That vaccines came on the scene just in time to save civilization from the ravages of infectious diseases. That vaccines are scientifically formulated to confer immunity to certain diseases; that they are safe and effective. That if we stop vaccinating, epidemics will return…And then one day you’ll be shocked to discover that … your “medical” point of view is unscientific, according to many of the world’s top researchers and scientists. That many state and national legislatures all over the world are now passing laws to exclude compulsory vaccines….

Our original blood was good enough. What a thing to say about one of the most sublime substances in the universe. Our original professional philosophy was also good enough. What a thing to say about the most evolved healing concept since we crawled out of the ocean. Perhaps we can arrive at a position of profound gratitude if we could finally appreciate the identity, the oneness, the nobility of an uncontaminated unrestricted nervous system and an inviolate bloodstream. In such a place, is not the chiropractic position on vaccines self-evident, crystal clear, and as plain as the sun in the sky?

So, the opinions by chiropractors cited above seem more the rule than the exception. NATURAL NEWS is not normally one of my favourite publications; on this occasion, however, I am thankful to the editor for alerting us to what I might call CHIROPRACTORS WITHOUT SCRUPLES.

HOMEOPATHIC REMEDIES CANNOT POSSIBLY  PLACEBOS BECAUSE THEY WORK IN ANIMALS!

How often have we heard this argument?

And how often have we pointed out that it is wrong on more than one level?

On this blog alone, we have done so here, here, here and here, for instance. But homeopaths and their followers seem to be strangely immune to facts. Presumably, they will therefore also ignore a recent paper that re-confirms what has already been said so often.

This new systematic review assessed the efficacy of homeopathy in cattle, pigs and poultry. Only peer-reviewed publications dealing with homeopathic remedies, which could possibly replace or prevent the use of antibiotics in the case of infective diseases or growth promotion in livestock were included. Search results revealed a total number of 52 trials performed within 48 publications fulfilling the predefined criteria. Twenty-eight trials were in favour of homeopathy, with 26 trials showing a significantly higher efficacy in comparison to a control group, whereas 22 showed no medicinal effect. Cure rates for the treatments with antibiotics, homeopathy or placebo varied to a high degree, while the remedy used did not seem to make a big difference. No study had been repeated under comparable conditions. Consequently, the use of homeopathy cannot claim to have sufficient prognostic validity where efficacy is concerned. When striving for high therapeutic success in treatment, the potential of homeopathy in replacing or reducing antibiotics can only be validated if evidence of efficacy is confirmed by randomised controlled trials under modified conditions.

I think this, together with the previous systematic reviews on the subject, speaks for itself, and there is little to add – except perhaps the bravely outspoken letter by Oliver Kamm in THE TIMES which alludes to the above named paper:

START OF QUOTE

Using highly diluted substances to cure ailments is a better idea than the medieval practices of bloodletting by leeches or administering hemlock as an anaesthetic. That’s the best you can say for homeopathy: it isn’t outright dangerous. As medicine, however, it’s junk. Study after study has confirmed that homeopathic remedies are inert and no more effective than either a placebo or just allowing an illness to run its course.

Now research published in the Veterinary Record concludes that there is insufficient evidence to support the use of homeopathic treatments in livestock, either, as a way to prevent or treat infectious diseases. Two scientists from the university of Kassel in Germany reviewed studies of the effectiveness of homeopathic treatments in cattle, pigs and poultry. They say the “evidence in favour of homeopathy lacks reproducibility and therefore cannot claim to have sufficient prognostic validity”.

Over 200 years, homeopaths have failed to substantiate their claims. It may seem bizarre that anyone in the 21st century could take seriously the notion of homeopathic treatments for animals. But that is to reckon without the Prince of Wales and his lifetime enthusiasm for zaniness on science, medicine, aesthetics and linguistics. He once gave a speech declaring himself proud for having been “accused once of being the enemy of the Enlightenment”. A few months ago he stunned a conference of scientists and public officials by disclosing that he uses only homeopathic remedies when treating his cattle and sheep on his country estate at Highgrove.

Prince Charles’s knowledge of science may be a joke but his contributions to public debate aren’t funny. They bestow prestige on atavistic superstitions that have no place in modern healthcare and animal welfare. NHS guidelines are clear there “is no good-quality evidence that homeopathy is effective as a treatment for any health condition”. Likewise in veterinary medicine. Out of more than 20,000 vets licensed in the UK, around 50 practise homeopathy. That is 50 too many. The same is true of the roughly 500 farmers who employ homeopathy. They can’t even claim a placebo effect as the animals are unaware of their purported medical treatment.

Yet the quacks are undaunted. The British Association of Homeopathic Veterinary Surgeons even claims success in curing dogs of cancer through homeopathy. This is nonsense — and if it persuades farmers and pet owners to forgo evidence-based treatments, it’s also wanton cruelty. It’s past time to shut these people down.”

END OF QUOTE

The boom of alternative medicine in the US – and consequently in the rest of the developed world – is intimately connected with a NHI centre now called NCCIH (National Center for Complementary and Integrative Health). It was founded in the early 1990s because some politicians were bent on promoting quackery. Initially the institution had modest funding but, after more political interference, it had ample cash to pursue all sorts of activities, including sponsoring research into alternative therapies at US universities. A most interesting video summarising the history of the NCCIH can be seen here.

No other institution in the world had more funds for research into alternative medicine than the NCCIH, and it soon became the envy of alt med researchers globally. I have been invited by the NCCHI on several occasions and invariably was impressed by their apparent affluence. While we Europeans usually had to do our research on a shoe-string, our American colleagues seemed to be ‘rolling in it’.

I was often far less impressed with the research they sponsored. Not only it was invariably eye-wateringly expensive, but also its quality seemed often dismal. Sometimes, I even got the impression that research was used as a means of mainstreaming quackery for the unsuspecting American – and consequently world-wide – public.

An example of this mainstreaming is an article in JAMA published yesterday. Here is a short but telling excerpt:

Researchers led by Richard L. Nahin, PhD, MPH, lead epidemiologist at the NIH’s National Center for Complementary and Integrative Health (NCCIH), examined efficacy and safety evidence in 105 randomized controlled trials (RCTs) conducted between January 1966 and March 2016. The review—geared toward primary care physicians as part of the journal’s Symposium on Pain Medicine—focused on popular complementary approaches to common pain conditions.

Unlike a typical systematic review that assigns quality values to the studies, the investigators conducted a narrative review, in which they simply looked at the number of positive and negative trials. “If there were more positives than negatives then we generally felt the approach had some value,” Nahin explained. “If there were more negatives, we generally felt the approach had less value.” Trials that were conducted outside of the United States were excluded from the review.

Based on a “preponderance” of positive vs negative trials, complementary approaches that may offer pain relief include acupuncture and yoga for back pain; acupuncture and tai chi for osteoarthritis of the knee; massage therapy for neck pain; and relaxation techniques for severe headaches and migraine. Several other techniques had weaker evidence, according to the qualitative assessments, for specific pain conditions (see “Selected Complementary Health Approaches for Pain”). The treatments were generally safe, with no serious adverse events reported.

To me, this looks that NCCIH has now managed to persuade even the editors of JAMA to white-wash their dodgy science. The review referred to here is a paper we discussed some time ago on this blog. I then stated about it the following:

Reading the article carefully, it is impossible not to get troubled. Here are a few points that concern me most:

  • the safety of a therapy cannot be evaluated on the basis of data from RCTs (particularly as it has been shown repeatedly that trials of alternative therapies often fail to report adverse effects); much larger samples are needed for that; any statements about safety in the aims of the paper are therefore misplaced;
  • the authors talk about efficacy but seem to mean effectiveness;
  • the authors only included RCTs from the US which must result in a skewed and incomplete picture;
  • the article is from the National Center for Complementary and Integrative Health which is part of the NIH but which has been criticised repeatedly for being biased in favour of alternative medicine;
  • not all of the authors seem to be NIH staff, and I cannot find a declaration of conflicts of interest;
  • the discussion of the paper totally lacks any critical thinking;
  • there is no assessment of the quality of the trials included in this review.

My last point is by far the most important. A summary of this nature that fails to take into account the numerous limitations of the primary data is, I think, as good as worthless. As I know most of the RCTs included in the analyses, I predict that the overall picture generated by this review would have changed substantially, if the risks of bias in the primary studies had been accounted for.

I find it puzzling that the ‘lead epidemiologist at the NIH’s National Center for Complementary and Integrative Health’ would publish such dubious research. Why does he do it? If you have watched the video mentioned above, you are inclined to think that it might be because of political interference.

However, I suggest another, in a way much more damming reason or contributing factor: the NCCIH has so long indulged in such poor science that even its top people have forgotten what good science looks like. I know this is a bold hypothesis; so, let me try to support it with some data.

Several years ago, my team together with several other researches have looked at the NCCIH-sponsored research systematically according to 4 different subject areas. Here are the conclusions of our articles reporting the findings:

ACUPUNCTURE

Seven RCTs had a low risk of bias. Numerous methodological shortcomings were identified. Many NCCAM-funded RCTs of acupuncture have important limitations. These findings might improve future studies of acupuncture and could be considered in the ongoing debate regarding NCCAM-funding. [Focus on Alternative and Complementary Therapies Volume 17(1) March 2012 15–21]

HERBAL MEDICINE

This independent assessment revealed a plethora of serious concerns related to NCCAM studies of herbal medicine. [Perfusion 2011; 24: 89-102]

ENERGY MEDICINE

In conclusion, the NCCAM-funded RCTs of energy medicine are prime examples of misguided investments into research. In our opinion, NCCAM should not be funding poor-quality studies of implausible practices. The impact of any future studies of energy medicine would be negligible or even detrimental. [Focus on Alternative and Complementary Therapies Volume 16(2) June 2011 106–109 ]

CHIROPRACTIC

In conclusion, our review demonstrates that several RCTs of chiropractic have been funded by the NCCAM. It raises numerous concerns in relation to these studies; in particular, it suggests that many of these studies are seriously flawed. [https://www.ncbi.nlm.nih.gov/pubmed/21207089]

I think I can rest my case and urge you to watch the video mentioned above.

This randomized, double-blind study evaluated the efficacy of a homeopathic treatment in preventing excessive weight gain during pregnancy in overweight or obese women who were suspected of having a common mental disorder. For the homeopathic group (n=62), 9 homeopathic remedies were pre-selected: (1) Pulsatilla nigricans, (2) Sepia succus, (3) Lycopodium clavatum, (4) sulphur, (5) Lachesis trigonocephalus, (6) Nux vomica, (7) Calcarea carbonica, (8) phosphorus; and (9) Conium maculatum. From those 9 drugs, one was prioritized for administration for each participant. After the first appointment, a re-selection or selection of a new, more appropriate drug occurred, using the list of preselected drugs. The dosage was 6 drops orally 2 ×/day, in the morning and at night, on 4 consecutive days each week, with an interval of 3 d between doses, up until the next appointment medical appointment. The control group (n=72) took placebos. Both groups also received a diet orientation.

Weight change during pregnancy was defined as the difference between the body mass index (BMI) at the initial evaluation and that recorded at the final evaluation, adjusted for 40 weeks of gestation. In addition, the APGAR index in the newborn  (a measure of the health of the baby) was evaluated. The mean variation between baseline BMI and BMI at week 40 of gestation was +4.95 kg/m2 in the control group and +5.05 kg/m2 in the homeopathy group. The difference between the two groups was not significant. APGAR 10 at 5 min (59.6% in the homeopathy group and 36.4% in the control group) was statistically significant (P = .016).

The authors concluded that homeopathy does not appear to prevent excessive body mass gain in pregnant women who are overweight or obese and suspected of having a common mental disorder. Homeopathy did not change the APGAR score to modified clinical attention at delivery room. However, the evidence observed at APGAR 10 at minute 5 suggests that  homeopathy had a modulating effect on the vitality of newborns, warranting further studies designed to investigate it.

I have seen many odd studies in my time, but this must be one of the oddest?

  • What is the rationale for assuming that homeopathy might affect body weight?
  • Why take pregnant women with a weight problem who were suspected of having a common mental disorder?
  • Why try to turn a clearly negative result into a finding that is (at least partly) positive?

The last point seems the most important one to me. The primary outcome measure of this study (weight gain) was clearly defined and was not affected by the therapy. Yet the authors feel it justified to add to their conclusions that homeopathy had a modulating effect on the vitality of newborns (almost certainly nothing but a chance finding).

Are they for real?

I suppose they are: they are real pseudo-scientific promoters of quackery!

You probably remember: the US Federal Trade Commission’s (FTC) has issued a statement announcing that unsupported claims for homeopathic remedies will be no longer allowed. Specifically, they said that, in future, homeopathic remedies have to be held to the same standard as other medicinal products. In other words, American companies must now have reliable scientific evidence for health-related claims that their products can treat specific conditions and illnesses.

Now the AMERICAN INSTITUTE OF HOMEOPATHY (AIH) has published a rebuttal. It is hilarious and embarrassing in equal measure. Here it is in full (I have only omitted their references – they can be seen in the linked original –  and added footnotes in bold square brackets with my very short comments):

START OF QUOTE

November 30, 2016

The American Institute of Homeopathy applauds the Federal Trade Commission’s (FTC) goal of protecting the American public from false advertising claims, but in a recent circumstance we believe the FTC has overstepped its jurisdictional bounds and promulgated false information in what appears to be a bid to restrict health care choices [1] available to the American public.

In Response to the recent Enforcement Policy Statement1 and a Consumer Information Blog,2 both issued by the FTC on November 15, 2016, the American Institute of Homeopathy registers our strong concern regarding the content of the following inaccurate statements:

  1. “Homeopathy… is based on the view that disease symptoms can be treated by minute doses of substances that produce similar symptoms…”

Homeopathy is not based on a “view” or an opinion. It is based on reliable, reproducible, clinically acquired, empiric evidence [2] gathered through two centuries of corroborated data, assisted by thousands of practitioners worldwide [3], demonstrating the actions of different medicinal substances in living systems, aka: the science of homeopathy. In fact, the homeopathic scientific community were pioneers of the modern scientific method including the widespread adoption of blinded and placebo controlled studies in 1885 [4], decades before conventional medicine.3

Homeopathy is not based on a theory or on conjecture, but on principles that have been confirmed by long-studied clinical data, meticulously gathered and analyzed over many years [5].

  1. “Many homeopathic products are diluted to such an extent that they no longer contain detectable levels of the initial substance.”

While the dilution and succussion process of formulating homeopathic medicines does reduce the concentration (and the toxicity) of the original substances, detectable amounts of these materials remain quantifiable in the form of nanoparticles [6] dispersed throughout.4 Multiple independent laboratories, worldwide have confirmed that these nanoparticles persist,5 and that they are biologically active.6 Many other homeopathic products (particularly those sold OTC and described as “low potency”) have dilute amounts of the original substance [7] that remain chemically detectable by straightforward titration.

  1. “…homeopathic product claims are not based on modern scientific methods…”

This statement is false and misleading. The active ingredients within most OTC homeopathic products have hundreds or thousands of case reports from physicians who have used these medicines [8]. These reports of direct clinical experiences establish a collective, real-world dataset that demonstrates which conditions have been observed to respond to treatment. Such historical data is similar to the types of information used to demonstrate effectiveness for many conventional OTC medicines on the market today [9].

The Homeopathic Pharmacopeia Convention of the United States (HPCUS) maintains a formulary describing the appropriate manufacturing standards for homeopathic medicines [10]. Every homeopathic manufacturer member of the American Association of Homeopathic Pharmacists in good ethical standing complies with both manufacturing and labeling standards set by the HPCUS. Consumers should be cautious when using any products that are not distinguished by conformance with “HPUS” on the label.

  1. “…the case for efficacy is based solely on traditional homeopathic theories…”

This statement is false. Neither homeopathy nor homeopathic efficacy is based on any theories. Efficacy for various homeopathic medicines has been established by scientifically reproducible clinical empiric research evidence [11] and cured patient cases followed over many years [12]. Homeopathy is an evidence-based medical subspecialty rooted in patient care.

  1. “…there are no valid studies using current scientific methods showing the product’s efficacy.”

While this statement may have limited accuracy with respect to some OTC products, it is false and misleading with respect to most homeopathic medicines listed in the Homeopathic Pharmacopeia of the United States. Hundreds of state-of-the-art double-blinded, randomized, placebo-controlled studies, many in peer-reviewed journals, demonstrate the superior efficacy of homeopathic medicines in a wide range of conditions, including asthma,7 depression and anxiety,8 chronic illness,9 allergic rhinitis,10 hypertension,11 headaches/migraines,12 sepsis,13 mild traumatic brain injury,14 otitis media,15 cancer,16 and many other conditions [13]. The American Institute of Homeopathy maintains and continually updates an extensive database, available free to the public, with over 6,000 research articles [14].17

Multiple meta-analyses published in peer reviewed medical journals that conclude that homeopathic medicine effects are superior to placebo [15] and that additional study of this therapeutic system is warranted.18,19,20,21,22,23  To that end, we encourage the National Institutes of Health to reverse their current position of blocking funding for homeopathic trials.24

  1. “…marketing claims that such homeopathic products have a therapeutic effect lack a reasonable basis and are likely misleading…”

The conclusion of whether a product has a “reasonable basis” is entirely irrelevant if that product has demonstrable clinical effectiveness. The important question, when it comes to homeopathy, is whether it is effective in clinical settings, not whether it has a “reasonable basis” for how it works. The mechanism by which homeopathy works differs from conventional medicines [16], but this fact does not make these products “misleading”.

Several recent class-action lawsuits brought against homeopathic manufacturers confirm that marketing practices were neither deceptive nor misleading [17].25

The FTC’s inability to formulate a reasonable basis for why homeopathic medicines work should not enter into any governmental enforcement policy statement. The FTC is not a medical organization, lacks expertise in interpreting scientific research [18], and is not qualified to make any comment on the validity of any field of medicine. To be less misleading, the FTC should exclude opinions from its policy statements.

  1. “Homeopathy: Not backed by modern science”

Homeopathy, as a system of medicine, does not fall under the purview of the FTC. Therefore, the FTC has been reckless in expressing an opinion of this magnitude. In this situation, the FTC’s comments can only be construed as being prejudicially biased and intentionally discriminatory against homeopathy. Such statements cause unwarranted harm to public trust and damage to a respected traditional system of medicine in the United States [19].

The American Institute of Homeopathy strongly objects to the FTC’s characterization of the entire field of homeopathic medicine as being without scientific evidence of efficacy. These comments are unqualified and wholly lacking in merit. The release of this Enforcement Policy Statement serves only to align the FTC with several recently released scientifically fraudulent [20] reports by a variety of pseudoscientists [21] and lowers the credibility of this valued consumer protection agency.

This type of misinformation should be embarrassing to a government organization striving to be nonpartisan and objective. The FTC owes an apology to the American Institute of Homeopathy as well as the many consumer groups that look toward this agency for fair and accurate information.

END OF QUOTE

My comments:

1 In healthcare, choice must be restricted to treatments which demonstrably generate more good than harm.

2 The AIH seems to be unaware of the difference between the nature of evidence, anecdote and experience.

3 Fallacy – appeal to popularity.

4 The first randomized, placebo-controlled study of homeopathy was, in fact, published in 1835 – its results were negative.

5 Fallacy – appeal to tradition.

6 The nano-particle explanation of homeopathy is but a theory (at best).

7 Fallacy – appeal to tradition.

8 Fallacy – appeal to authority.

9 Really? Which ones? Examples would help, but I doubt they exist.

10 The proper manufacturing of nonsense must still result in nonsense.

11 See footnote number 2

12 Fallacy – appeal to tradition.

13 For all of these conditions, the totality of the reliable evidence fails to demonstrate efficacy.

14 In this context, only clinical trials are relevant, and their number is nowhere near 6,000.

15 Most of the independent systematic reviews fail to be positive.

16 The mechanism is well-known and is called ‘placebo-effect’.

17 Many class actions also went against the manufacturers of homeopathic preparations.

18 I assume they ‘bought in’ the necessary expertise.

19 Surely, the damage is only to the cash-flow of firms selling bogus products.

20 Really? Name the report you libel here or be quiet!

21 Name the individuals you attack in this way or be quiet!

I must say, I had fun reading this. In fact, I cannot remember having seen a document by an organisation of healthcare professionals which was so embarrassingly nonsensical that it becomes comedy gold. If one of my PhD students, for instance, had submitted such drivel, I would have had no choice but to fail him or her.

Having said that, I need to stress to the AIH:

FULL MARKS FOR AMUSEMENT!!!

 

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