MD, PhD, MAE, FMedSci, FRSB, FRCP, FRCPEd.

cost-effectiveness

Being a dedicated crook and a liar himself, Donald Trump has long had an inclination to surround himself with crooks and liars. As discussed repeatedly, this preferance naturally extends into the realm of healthcare, Some time ago, he sought the advice of Andrew Wakefield, the man who published the fraudulent research that started the myth about a causal link between MMR-vaccinations and autism.

Early November this year, Trump stated that, if he wins the election, he’ll “make a decision” about whether to outlaw some vaccines based on the recommendation of Robert F. Kennedy Jr., a notorious vaccine critic without any medical training. The president doesn’t have authority to ban vaccines but he can influence public health with appointments to federal agencies that can change recommendations or potentially revoke approvals.

Now that he did win the election, Trump suggested that Robert F. Kennedy Jr., his pick to run Health and Human Services, will investigate supposed links between autism and childhood vaccines, a discredited connection that has eroded trust in the lifesaving inoculations.

“I think somebody has to find out,” Trump said in an exclusive interview with “Meet the Press” moderator Kristen Welker. Welker noted in a back-and-forth that studies have shown childhood vaccines prevent about 4 million deaths worldwide every year, have found no connection between vaccines and autism, and that rises in autism diagnoses are attributable to increased screening and awareness.

Trump, too stupid to know the difference between correlation and causation, replied: “If you go back 25 years ago, you had very little autism. Now you have it.” “Something is going on,” Trump added. “I don’t know if it’s vaccines. Maybe it’s chlorine in the water, right? You know, people are looking at a lot of different things.” It was unclear whether Trump was referring to opposition by Kennedy and others to fluoride being added to drinking water.

Kennedy, the onetime independent presidential candidate who backed Trump after leaving the race, generated a large following through his widespread skepticism of the American health care and food system. A major component of that has been his false claims linking autism to childhood vaccinations. Kennedy is the founder of a prominent anti-vaccine activist group, Children’s Health Defense. The agency Trump has tasked him with running supports and funds research into autism, as well as possible new vaccines.

The debunked link between autism and childhood vaccines, particularly the inoculation against mumps, measles and rubella, was first claimed in 1998 by Andrew Wakefield who was later banned from practicing medicine in the UK. His research was found to be fraudulent and was subsequently retracted. Hundreds of studies have found childhood vaccines to be safe.

Autism diagnoses have risen from about 1 in 150 children in 2000 to 1 in 36 today. This rise has been shown to be due to increased screening and changing definitions of the condition. Strong genetic links exist to autism, and many risk factors occurring before birth or during delivery have been identified.

If Trump does, in fact, ‘outlaw’ certain vaccinations, he would endanger the health of the US as well as the rest of the world. Will he really be that stupid?

“Is Chiropractic Worth the Taxpayer’s Expense?” is the interesting question asked in this article by Ikenna Idika Ogbu from the Department of Neurosurgery, University Hospitals of North Midlands, UK and Chandrasekaran Kaliaperumal from the Department of Clinical Neurosciences, Royal Infirmary of Edinburgh, UK. Here is the abstract:

Chiropractic remains a service provided outside the NHS in the United Kingdom and the argument for inclusion has been ongoing since the 90’s. There are significant patient-reported benefits from chiropractic backed by evidence in specific use-cases as cervicogenic headaches and there are significant potential cost-savings from the inclusion of chiropractic as an NHS service. The evidence, however, does not particularly favour the use case of chiropractic, especially in the context of Low Back Pain (LBP) and the benefits of chiropractic are unclear. Considering the potential cost-savings for the NHS and the society, there should be consideration for its inclusion. However, the evidence will need to be clearer to argue for inclusion of chiropractic in the NHS spectrum of services, especially for spinal services.

So, the authors confirm that, even for back pain, “the benefits of chiropractic are unclear”, and in the next sentence they advocate “consideration for its inclusion.”

Does that make sense?

No!

Let’s be clear: the least expensive way to proceed in the short term is usually to do nothing. No treatment is invariably less expensive than treatment! Yet, this logic obviously does not account for the two most important factors in this equation: risk and benefit.

  • Not treating a condition can cause prolonged, needless suffering.
  • Not treating a condition can cause significant follow-up costs.
  • Treating it can cause adverse effects and additional suffering.
  • Adverse effects can cause significant follow-up costs.
  • Treating the condition effectively will result in less suffering.
  • Treating the condition effectively will result in less follow-up costs.

It follows that we should treat health problems:

  1. effectively,
  2. with few risks of side-effects,
  3. as cheaply as possible.

It also follows that costs are by no means the only factor in this complex equation. Cost-effectiveness without effectiveness is not possible. Moreover, cost-effectiveness withoout an acceptable degree of safety is unlikely.

In the case of chiropractic, we have hardly reliable proof of effectiveness or safety. And this means that, before we can consider chiropractic to be paid for from public money, we first need solid evidence for its safey and efficacy – each for the relevant health problem to be treated. Once we have reliable data about all this – AND ONLY THEN – might we consider including chiropractic into the public healthcare budget.

In other words, the above cited paper is naive and ill-informed to the extreme.

 

 

The JOURNAL OF BUSINESS ETHICS (I did not even know such a journal existed) recently carried a most interesting article. Here is its abstract:

Consumers spend billions of dollars per year on homeopathic products. But there is powerful evidence that these products don’t work, i.e., they are not medically effective. Should homeopathic products be for sale? I give reason for thinking that the answer is ‘no.’ It has been suggested that the sale of homeopathic products involves deception. This might be so in some cases, but the problem is simpler: it is that these products don’t do what people buy them to do. More precisely, homeopathic products don’t meet the “desire-satisfaction condition,” according to which products for sale in markets should satisfy the desires that people buy them to satisfy. I defend my view against objections, and conclude by acknowledging some of the practical difficulties of banning products people want to buy.

Allow me to introduce you to the logic of the author, Jeffrey Moriarty, in a little more detail. Essentially, he argues as follows:

  • There is powerful evidence that homeopathic products don’t work, i.e., they are not medically effective. As we have discussed ad nauseam on my blog, this is certainly true.
  • Thus they don’t meet the “desire-satisfaction condition,” according to which the sale of a product should satisfy the desire(s) that people buy it to satisfy. Regulators prohibit retailers from advertising in ways that cause reasonable people to have materially false beliefs. It doesn’t matter to regulators whether advertisers cause false beliefs intentionally, and therefore deceive consumers, or unintentionally, and therefore merely mislead them. The point is to prevent consumers from acting on false information; however, they acquire it.
  • If a product doesn’t meet the “desire-satisfaction condition” condition, then there is a presumption against selling it. When people act on false information in markets, they are likely to make themselves worse off. We can understand how this works in terms of the satisfaction of desires. People engage in market exchanges in order to satisfy their desires. When their desires are satisfied as a result of market exchange, they are better off. You want a car that runs and seek to buy one. When you purchase the car, and it does run, you are better off. But when people act on false information, they are likely to frustrate rather than satisfy their desires. As a result, they are likely to be worse off. If the car you purchase doesn’t run, you are worse off. You spent your money on something you didn’t want.
  • The products people buy should satisfy the desires they buy them to satisfy. This is the “desire-satisfaction condition” for market exchange. Transactions that reliably don’t result in desire-satisfaction are problematic. Because desires aren’t satisfied, this is evidence that value isn’t being created; the party whose desires are not satisfied is worse off. Since markets should make people better off, there is a presumption against allowing these transactions.
  • The author states that his arguments also apply to other medicines and medical treatments that we have powerful reason to believe don’t work.

Jeffrey Moriatry concludes: When people purchase homeopathic products, they act on false information, and in doing so, fail to satisfy their desires. This is a sign that the purchase does not create value for them. Since market transactions should create value, there is a presumption in favor of prohibiting this transaction … we give states broad authority to decide what sorts of products can and can’t be sold, including medicines. This suggests that people generally think that banning the sale of certain products, despite the costs of doing so, is worth it. It also suggests that people think that the state uses its power competently and fairly—or at least that it doesn’t use it so incompetently and unfairly that it is better for the state not to have this power. The state would be doing nothing out of the ordinary in prohibiting the sale of homeopathic products. 

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These arguments are interesting and relevant (sorry, if I have not represented them fully; I recommend reading the full article). Personally, I have never argued that the sales of homeopathics should be banned; I felt that good and responsible information is essential and would eventually reduce sales to an insignificant level. Yet, after reading this paper, I have to admit that its arguments make sense.

I’d love to hear what you think about them.

This study aimed to investigate the clinical effectiveness and cost-effectiveness of an individualised, progressive walking and education intervention to prevent the recurrence of low back pain.

WalkBack was a two-armed, randomised clinical trial, which recruited adults (aged 18 years or older) from across Australia who had recently recovered from an episode of non-specific low back pain that was not attributed to a specific diagnosis, and which lasted for at least 24 h. Participants were randomly assigned to an individualised, progressive walking and education intervention facilitated by six sessions with a physiotherapist across 6 months or to a no treatment control group (1:1). The randomisation schedule comprised randomly permuted blocks of 4, 6, and 8 and was stratified by history of more than two previous episodes of low back pain and referral method. Physiotherapists and participants were not masked to allocation. Participants were followed for a minimum of 12 months and a maximum of 36 months, depending on the date of enrolment. The primary outcome was days to the first recurrence of an activity-limiting episode of low back pain, collected in the intention-to-treat population via monthly self-report. Cost-effectiveness was evaluated from the societal perspective and expressed as incremental cost per quality-adjusted life-year (QALY) gained. The trial was prospectively registered (ACTRN12619001134112)

Between Sept 23, 2019, and June 10, 2022, 3206 potential participants were screened for eligibility, 2505 (78%) were excluded, and 701 were randomly assigned (351 to the intervention group and 350 to the no treatment control group). Most participants were female (565 [81%] of 701) and the mean age of participants was 54 years (SD 12). The intervention was effective in preventing an episode of activity-limiting low back pain (hazard ratio 0·72 [95% CI 0·60–0·85], p=0·0002). The median days to a recurrence was 208 days (95% CI 149–295) in the intervention group and 112 days (89–140) in the control group. The incremental cost per QALY gained was AU$7802, giving a 94% probability that the intervention was cost-effective at a willingness-to-pay threshold of $28 000. Although the total number of participants experiencing at least one adverse event over 12 months was similar between the intervention and control groups (183 [52%] of 351 and 190 [54%] of 350, respectively, p=0·60), there was a greater number of adverse events related to the lower extremities in the intervention group than in the control group (100 in the intervention group and 54 in the control group).

The authors concluded that an individualised, progressive walking and education intervention significantly reduced low back pain recurrence. This accessible, scalable, and safe intervention could affect how low back pain is managed.

Rigorous clinical trials of excercise therapy are difficult to conceive and conduct because of a range of methodological issues. For instance, there is no obvious placebo and thus it is hardly possible to control for placebo effects. Nonetheless, the benefits of exercise therapy for back pain is undoubted. As previously discussed on this blog, a recent systematic review concluded that “the relative benefit of individualized exercise therapy on chronic low back pain compared to other active treatments is approximately 38% which is of clinical importance.”

I have always been convinced of the health benefits of excercise. In fact, 40 years ago, when I did my inaugural lecture at the University of Munich (LMU), excercise was its topic and I concluded that, if exercise were a pharmaceutical product, it would out-sell any drug. The new study only confirms my view. It adds to our knowledge by suggesting that exercise also reduces the risk of recurrences.

Forget about spinal manipulation, acupuncture, etc., despite the undeniable weaknesses in the evidence, exercise is by far the most promissing treatment for back pain

‘Chiropractic economics’ might be when chiropractors manipulate their bank accounts or tax returns, I thought. But, no, it is a publication! And a weird one at that – it even promotes the crazy idea of maintenance care:

The concept of chiropractic maintenance care has evolved significantly. Initially seen as a method for managing chronic pain, it now includes a broader range of patients and focuses on overall wellness. Modern maintenance care aims to keep patients healthy regardless of their symptoms or history, alleviating and preventing pain through regular, prolonged care. This approach is largely preventive, serving as both secondary and tertiary care.  Studies show chiropractic maintenance care often includes diverse treatments such as manual therapy, stress managementnutrition advice and more, with flexible intervals typically around three months. This evolution underscores the importance of evidence-based, individualized patient care. This article shares the evolution of chiropractic maintenance care, looks at what a modern maintenance care appointment can include and explores best practices for DC maintenance care in 2024. 

Knowledge of chiropractic maintenance care has evolved over the years. In the past, maintenance care in the chiropractic world was often viewed as a way to keep patients going; particularly those suffering from chronic conditions that needed routine care for pain management and prevention. In the last several years, chiropractic maintenance care has changed; no longer does it only involve pain prevention and management for those with chronic conditions. It now encompasses all sorts of patients; no matter their history, symptoms or reasons for seeking a DC…

An interview study of Danish chiropractic care showed maintenance care sessions included a range of treatment modalities, including manual treatment and ordinary examinations alongside multiple packages of holistic additions, like stress management, diet, weight loss, advice on ergonomics, exercise and more. In other anecdotal accounts, chiropractic maintenance care seemed to follow a more traditional guideline of lower back pain management and adjustment. The study hypothesized that maintenance care could also help patients from a knowledge perspective, stating, “DCs could obviously play an important role here as ‘back pain coaches,’ as the long-term relationship would ensure knowledge of the patient and trust towards the DC.” 

Researchers found that three-month intervals were the most common spacing of maintenance care treatments for patients. Most commonly, patients sought or scheduled chiropractic maintenance care over the course of one to three months.  

Chiropractic maintenance care has evolved past simply being a method of ongoing chronic pain management. Today’s patients want to achieve overall wellness, and regular trips to their DC can become a part of that if you work to transition patients into a wellness plan after their acute phase of care is over. 

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The author of this article seems to have forgotten two little details:

  1. Chiropractic maintenance care is not supported by sound evidence, particularly in relation to economics (even the above cited paper stated: “We found no studies of cost-effectiveness of Maintenance Care”).
  2. Chiropractic maintenance only serves one economic purpose: it boosts the chiropractors’ income.

Yes, easy to forget, particularly if your name is ‘Chiropractic Economics’.

And also easy to forget that maintenance care would, of course, require informed consent. How would that look like?

Chiro (C) to patient (P):

If you agree, we will start a program that we call maintenance care.

P: Can you explain?

C: It consists of regular sessions of spinal manipulations.

P: That’s all?

C: No, I will also give you advice on keeping fit and living healthily.

P: Why do I need that?

C: It’s a bit like servicing your car so that it works reliably when you need it.

P: Is it proven to work?

C: Yes, of course, there are tons of evidence to show that a healthy life style is good for you.

P: I know, but I don’t need a chiro for that – what I meant do the manipulations keep my body healthy even if I have no symptoms?

C: The evidence is not really great.

P: And the risks?

C: Well, yes, if I’m honest, spinal manipulations can cause harm.

P: So, to be clear: you ask me to agree to a program that has no proven benefit and might cause harm?

C: I would not put it like that.

P: And how much would it cost?

C: Not much; just a couple of hundred per year.

P: Thanks – but no thanks.

This review updated and extended a previous one on the economic impact of homeopathy. A systematic literature search of the terms ‘cost’ and ‘homeopathy’ from January 2012 to July 2022 was performed in electronic databases. Two independent reviewers checked records, extracted data, and assessed study quality using the Consensus on Health Economic Criteria (CHEC) list.

Six studies were added to 15 from the previous review. Synthesizing both health outcomes and costs showed homeopathic treatment being at least equally effective for less or similar costs than control in 14 of 21 studies. Three studies found improved outcomes at higher costs, two of which showed cost-effectiveness for homeopathy by incremental analysis. One found similar results and three similar outcomes at higher costs for homeopathy. CHEC values ranged between two and 16, with studies before 2009 having lower values (Mean ± SD: 6.7 ± 3.4) than newer studies (9.4 ± 4.3).

The authors concluded that, although results of the CHEC assessment show a positive chronological development, the favorable cost-effectiveness of homeopathic treatments seen in a small number of high-quality studies is undercut by too many examples of methodologically poor research.

I am always impressed by the fantastic and innovative phraseology that some authors are able to publish in order to avaid calling a spade a spade. The findings of the above analysis clearly fail to be positive. So why not say so? Why not honestly conclude something like this:

Our analysis failed to show conclusive evidence that homeopathy is cost effective.

To find an answer to this question, we need not look all that far. The authors’ affiliations give the game away:

  • 1Department of Psychology and Psychotherapy, Witten/Herdecke University, Witten, Germany.
  • 2Medical Scientific Services/Medical Affairs, Deutsche Homöopathie-Union DHU-Arzneimittel GmbH & Co. KG, Karlsruhe, Germany.
  • 3Institute of Integrative Medicine, Witten/Herdecke University, Herdecke, Germany.
  • 4Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.

Another rather funny give-away is the title of the paper: the “…evaluation for…”comes form the authors’ original title (Overview and quality assessment of health economic evaluations for homeopathic therapy: an updated systematic review) and it implies an evaluation in favour of. The correct wording would be “evaluation of”, I think.

I rest my case.

Guest post by Udo Endruscheit

Switzerland is probably the European country with the strangest complementary and alternative medicine (CAM) regulations in the health insurance system. A total of five different CAM methods have been included in the benefits catalogue of basic insurance for several years. However, this is subject to a strange proviso. How did this come about?

As almost everywhere in Europe, there was a desire in Switzerland in the 1990s to include CAM in the public healthcare system, with homeopathy naturally once again taking pole position. Initially, the urge to include five CAM modalities in basic care was granted, but only provisionally. A major project called the “Complementary Medicine Evaluation Programme” (PEK) was launched in 1999 to evaluate the procedures. Even back then, the criteria of efficacy, appropriateness and cost-effectiveness were prerequisites for reimbursement in health insurance. PEK was intended to create clarity here.

One part of PEK has been the well-known Shang/Egger (2005) study on homeopathy “Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy”, which was to become a bone of contention without precedent. However, this did not change the negative result for homeopathy.

In any case, clear conclusions were drawn in Switzerland not only from this study, but also from the results of the other evaluations: the provisional inclusion of the methods in statutory basic insurance was terminated.

This in turn enraged the supporters of CAM methods, who thought they had already reached their goal with the provisional decision in their favour. Apparently, they had not even considered the possibility that scientific evaluations could actually lead to a sudden end to their wishes, which they believed had already been fulfilled.

In fact, in 2009, the friends of ineffective methods succeeded in bringing about one of the referendums for which Switzerland is known under the catchphrase “direct democracy”. And they prevailed – around two thirds of the votes cast were in favour of CAM and its inclusion in the Swiss Federal Constitution. However, it should be borne in mind that the two-thirds figure is put into perspective if the approval, including the low voter turnout, is converted to the proportion of the total electorate. This leaves just 17 per cent who voted for the CAM. And a closer look at the issue of the constitution also reveals that no unconditional protection space has been created for CAM. This is more or less a kind of good behaviour clause for CAM methods, but not rules that could render laws null and void.

The Swiss government was faced with the question of how to avoid simply ignoring the result of the referendum, while at the same time complying with the still valid requirements for reimbursement in basic insurance. So the representatives of the five CAM directions were actually asked to come to the Federal Office of Public Health with their proof of efficacy and economic efficiency. This was done in 2011.

Of course, this was a little bizarre at this stage – and of course nothing came of it. Or actually it did: once again, no proof could be provided. Meanwhile, a lot of time had passed again and a new Federal Council was forced to take up the matter.

The latter, Alain Berset, came up with the plan that the necessary proof of efficacy could actually be postponed until after the methods had been included in the catalogue of basic insurance benefits. In other words, he gave the methods a governmental leap of faith (which, in view of the long-year history of the case, meant closing several eyes) and postulated that this should be the matter until someone applied for an evaluation of one of the methods.

This is what happened in the year of our Lord 2017. Apparently everyone was able to make their peace with it, which is hardly surprising after ten years of moving around and around. Only the umbrella organisation of health insurers, Santesuisse, grumbled about it and predicted that the announced cost neutrality of such a measure could hardly be expected. Which Santesuisse did indeed prove in a dossier two years later.

The exhausted Swiss have so far left it at that. Homeopathy remained untouched. This was also unfortunate for the reason that the fairy tale of the clever and innovative Switzerland, which knew how important the wishes and preferences of its patients were, was propagated in Germany. The rather strange result of more than ten years of struggle was even passed around by German homeopaths under the name “Swiss model”. Even the leading Swiss press was embarrassed by this and published a clarifying article. And unfortunately, the Swiss began to get used to the existence of hocus-pocus in their basic insurance and to take it for granted.

Until now. Even in Switzerland, the fact that homeopathy is coming under increasing criticism everywhere has probably not gone unnoticed. And the Swiss are actually a rather critical and resistant people. And so it happened that a single brave inhabitant of the country recently decided to exercise his right to demand a new evaluation of homeopathy. The Federal Office of Public Health must have been surprised – or perhaps they were desperately waiting for it? Perhaps. In any case, the application was accepted without hesitation. Meanwhile, a notification has been issued that the hearing procedure for the evaluation has been initiated. The representatives of homeopathy (the service providers), the representatives of the Swiss medical profession and the representatives of the health insurance companies – the aforementioned Santesuisse – will be heard. The final decision will then be made by the Swiss government’s Department of Home Affairs.

How many attempts at an evaluation has this actually been – the third? The fourth? We can’t keep up … We have seen the consequences of scientific questions being decided by majorities. It is to be hoped that Switzerland will not add another chapter to the drama that has been going on since 2005. Mr Berset’s successor, who has been in office since the beginning of the year, should only be given a brief reminder: in Switzerland, too, homeopathy has no effect beyond contextual effects. And that is not enough to prove efficacy, appropriateness and cost-effectiveness.

But cheers to the courageous descendant of William Tell, who is about to single-handedly bring down homeopathy in the Swiss healthcare system!

I had the rare pleasure to give an interview for the ‘Frankfurter Allgemeine’. As it was, of course, in German, I took the liberty to translate it for my non-German speaking readers:

You have researched so-called alternative medicine over several decades, including homeopathy. What is your conclusion?

We are talking about far more than 400 methods – to draw one conclusion about all of them
is completely impossible. Except perhaps for this one: if something sounds too good to be true, it probably is.

Does this apply to homeopathy?

Highly diluted homeopathic remedies are popular because they have no side-effects. But there is also no effect. They are touted as a panacea. This is certainly not the case, on the contrary, they are
ineffective. And any therapy that is ineffective and promoted as a panacea is also dangerous.

How do you explain the fact that so many people swear by homeopathy?

There are several reasons for this. In Germany, homeopathy has an unbroken tradition, it was, for instance, promoted by the Nazis and later in the Federal Republic of Germany. It has a reputation for being gentle and effective. It might be gentle, but it is certainly not effective. It is also supported by lobby groups such as the manufacturers. And most people who use it don’t even understand what it actually is.

In any case, the placebo effect helps. What’s so bad about that??

Nothing at all, on the contrary: it is to be advocated. When we talk about placebo effects, we subsume many things under this umbrella that do not actually belong to it, such as the extensive, empathetic conversation that homeopaths often have with their patients. Besides, a common cold goes away whether you treat it or not. If you then use homeopathy, you can easily get the impression that it worked. Every good, empathetic doctor tries to maximize the placebo effect. To put it bluntly: you don’t need a placebo to generate a placebo effect. Patients also benefit from it when I give an effective remedy with empathy. In addition they benefit from the specific effect of my therapy, which should make up the lion’s share of the therapeutic response. If I withhold the most important thing I mistreat my patient.

But there are diseases for which there are no good remedies.

I often hear that argument. But there is practically always something we can do that at least
improves symptoms. Otherwise you should also say that instead of lying and recommending homeopathy – and thinking that, although there is nothing in it and it doesn’t work, but the patient, being an idiot, should take it nevertheless. It is unethical to use placebos as much as it is to use homeopathy.

Neurophysiologically, the placebo effect is becoming better and better understood.

The Italian neuroscientist Fabrizio Benedetti in particular has done very good work.  But he also warns that this does not justify the use of homeopathy, for example.

Are there any studies on whether the placebo effect of homeopathy with its esoteric superstructure is greater than that giving just a piece of sugar?

There are analyses of what makes a particularly effective placebo. From this, we can learn that effective therapies in evidence-based medicine must be applied with empathy and sufficient time in order to maximize the ever-present placebo effect. So-called alternative medicine often does this quite well, and we can learn something from it. But the reason is that it often has nothing else. Homeopaths are a serious danger because they see homeopathy as a panacea. If someone has homeopathically treated their cold “successfully” for years and then gets cancer, they might think of turning to homeopathy for their cancer. It sounds crazy, but many homeopaths do offer cancer treatments on the internet, for instance. That sends shivers down my spine.

How should doctors and pharmacists react to the demand for homeopathic remedies?

Pharmacists are not primarily salespeople, they are a medical profession – they have to adhere to ethical guidelines. In this respect, evidence-based information of their clients/patients is very important.

Thomas Benkert, President of the German Federal Chamber of Pharmacists, has stated that he would not be able to stop giving advice if he always had to explain the lack of proof of efficacy.

He should perhaps read up on what his ethical duty to patients is.

What if doctors or pharmacists themselves believe in the effect?

Belief should not play a role, but evidence should.

Are you pleased with Lauterbach’s plan to no longer reimburse homeopathy?

I think it’s a shame that he justifies it by saying it’s ineffective. That is true. But the justification should be that it’s esoteric nonsense and therefore ineffective – and dangerous.

In the end, the Bundestag will decide.

I think Lauterbach has a good chance because things have started to move. Medical associations in Germany have spoken out against the additional designation of homeopathy, for example, and overall the wind has changed considerably.

What is it like in the UK, where you live?

The UK healthcare system, NHS, said goodbye to reimbursement of homeopathy about five years ago, even before France. The pharmacists’ association has distanced itself very clearly from homeopathy. However, most pharmacists still sell the remedies and many continue to support them.

You have also had disputes with the current head of state, King Charles. How did that come about?

A few years ago, he commissioned a paper claiming that so-called alternative medicine could save the British health service a lot of money. I protested against this – Charles accused me of leaking it to The Times before it was published. My university launched an investigation, which eventually found me innocent, but it led to the demise of my department. That caused me to retire two years early.

So Charles managed to close down the only research unit in the world that conducted critical and systematic research into so-called alternative medicine. Most researchers in this field only want to confirm their own prejudices and not disprove hypotheses. This is a serious misunderstanding of how science works. If someone reports only positive results for their favorite therapy in all conditions, something is wrong.

Some people say that homeopathy should not be researched because nothing positive can come out of it anyway.

There are certainly some SCAMs that are so nonsensical that they should not be researched, as is currently the case with homeopathy. I put it this way because I have researched homeopathy myself and, from my point of view, the situation was not so crystal clear 30 years ago.

Would you say that you have approached the matter with a sufficiently open mind?

No one can be completely unbiased. That’s why it’s important to do science properly, then you minimize bias as much as possible. When I took up my position at Exeter in 1993, I was perhaps somewhat biased towards homeopathy in a positive sense, because I had learned and used it myself, as well as other alternative medicine methods. The fact that the results then turned out to be negative in the vast majority of cases initially depressed me. But I have to live with that.

Every researcher prefers positive results, also because they are easier to publish. It was clear to me that, if I had succeeded in proving homeopathy right, I wouldn’t get one Nobel Prize, but two. Who wouldn’t want that?

(The interview was conducted by Hinnerk Feldwisch-Drentrup.)

Low back pain (LBP) affects almost all of us at some stage. It is so common that it has become one of the most important indications for most forms of so-called alternative medicine (SCAM). In the discussions about the value (or otherwise) of SCAMs for LBP, we sometimes forget that there are many conventional medical options to treat LBP. It is therefore highly relevant to ask how effective they are. This overview aimed to summarise the evidence from Cochrane Reviews of the efficacy, effectiveness, and safety of systemic pharmacological interventions for adults with non‐specific LBP.

The Cochrane Database of Systematic Reviews was searched from inception to 3 June 2021, to identify reviews of randomised controlled trials (RCTs) that investigated systemic pharmacological interventions for adults with non‐specific LBP. Two authors independently assessed eligibility, extracted data, and assessed the quality of the reviews and certainty of the evidence using the AMSTAR 2 and GRADE tools. The review focused on placebo comparisons and the main outcomes were pain intensity, function, and safety.

Seven Cochrane Reviews that included 103 studies (22,238 participants) were included. There was high confidence in the findings of five reviews, moderate confidence in one, and low confidence in the findings of another. The reviews reported data on six medicines or medicine classes: paracetamol, non‐steroidal anti‐inflammatory drugs (NSAIDs), muscle relaxants, benzodiazepines, opioids, and antidepressants. Three reviews included participants with acute or sub‐acute LBP and five reviews included participants with chronic LBP.

Acute LBP

Paracetamol

There was high‐certainty evidence for no evidence of difference between paracetamol and placebo for reducing pain intensity (MD 0.49 on a 0 to 100 scale (higher scores indicate worse pain), 95% CI ‐1.99 to 2.97), reducing disability (MD 0.05 on a 0 to 24 scale (higher scores indicate worse disability), 95% CI ‐0.50 to 0.60), and increasing the risk of adverse events (RR 1.07, 95% CI 0.86 to 1.33).

NSAIDs

There was moderate‐certainty evidence for a small between‐group difference favouring NSAIDs compared to placebo at reducing pain intensity (MD ‐7.29 on a 0 to 100 scale (higher scores indicate worse pain), 95% CI ‐10.98 to ‐3.61), high‐certainty evidence for a small between‐group difference for reducing disability (MD ‐2.02 on a 0‐24 scale (higher scores indicate worse disability), 95% CI ‐2.89 to ‐1.15), and very low‐certainty evidence for no evidence of an increased risk of adverse events (RR 0.86, 95% CI 0. 63 to 1.18).

Muscle relaxants and benzodiazepines

There was moderate‐certainty evidence for a small between‐group difference favouring muscle relaxants compared to placebo for a higher chance of pain relief (RR 0.58, 95% CI 0.45 to 0.76), and higher chance of improving physical function (RR 0.55, 95% CI 0.40 to 0.77), and increased risk of adverse events (RR 1.50, 95% CI 1. 14 to 1.98).

Opioids

None of the included Cochrane Reviews aimed to identify evidence for acute LBP.

Antidepressants

No evidence was identified by the included reviews for acute LBP.

Chronic LBP

Paracetamol

No evidence was identified by the included reviews for chronic LBP.

NSAIDs

There was low‐certainty evidence for a small between‐group difference favouring NSAIDs compared to placebo for reducing pain intensity (MD ‐6.97 on a 0 to 100 scale (higher scores indicate worse pain), 95% CI ‐10.74 to ‐3.19), reducing disability (MD ‐0.85 on a 0‐24 scale (higher scores indicate worse disability), 95% CI ‐1.30 to ‐0.40), and no evidence of an increased risk of adverse events (RR 1.04, 95% CI ‐0.92 to 1.17), all at intermediate‐term follow‐up (> 3 months and ≤ 12 months postintervention).

Muscle relaxants and benzodiazepines

There was low‐certainty evidence for a small between‐group difference favouring benzodiazepines compared to placebo for a higher chance of pain relief (RR 0.71, 95% CI 0.54 to 0.93), and low‐certainty evidence for no evidence of difference between muscle relaxants and placebo in the risk of adverse events (RR 1.02, 95% CI 0.67 to 1.57).

Opioids

There was high‐certainty evidence for a small between‐group difference favouring tapentadol compared to placebo at reducing pain intensity (MD ‐8.00 on a 0 to 100 scale (higher scores indicate worse pain), 95% CI ‐1.22 to ‐0.38), moderate‐certainty evidence for a small between‐group difference favouring strong opioids for reducing pain intensity (SMD ‐0.43, 95% CI ‐0.52 to ‐0.33), low‐certainty evidence for a medium between‐group difference favouring tramadol for reducing pain intensity (SMD ‐0.55, 95% CI ‐0.66 to ‐0.44) and very low‐certainty evidence for a small between‐group difference favouring buprenorphine for reducing pain intensity (SMD ‐0.41, 95% CI ‐0.57 to ‐0.26).

There was moderate‐certainty evidence for a small between‐group difference favouring strong opioids compared to placebo for reducing disability (SMD ‐0.26, 95% CI ‐0.37 to ‐0.15), moderate‐certainty evidence for a small between‐group difference favouring tramadol for reducing disability (SMD ‐0.18, 95% CI ‐0.29 to ‐0.07), and low‐certainty evidence for a small between‐group difference favouring buprenorphine for reducing disability (SMD ‐0.14, 95% CI ‐0.53 to ‐0.25).

There was low‐certainty evidence for a small between‐group difference for an increased risk of adverse events for opioids (all types) compared to placebo; nausea (RD 0.10, 95% CI 0.07 to 0.14), headaches (RD 0.03, 95% CI 0.01 to 0.05), constipation (RD 0.07, 95% CI 0.04 to 0.11), and dizziness (RD 0.08, 95% CI 0.05 to 0.11).

Antidepressants

There was low‐certainty evidence for no evidence of difference for antidepressants (all types) compared to placebo for reducing pain intensity (SMD ‐0.04, 95% CI ‐0.25 to 0.17) and reducing disability (SMD ‐0.06, 95% CI ‐0.40 to 0.29).

The authors concluded as follows: we found no high‐ or moderate‐certainty evidence that any investigated pharmacological intervention provided a large or medium effect on pain intensity for acute or chronic LBP compared to placebo. For acute LBP, we found moderate‐certainty evidence that NSAIDs and muscle relaxants may provide a small effect on pain, and high‐certainty evidence for no evidence of difference between paracetamol and placebo. For safety, we found very low‐ and high‐certainty evidence for no evidence of difference with NSAIDs and paracetamol compared to placebo for the risk of adverse events, and moderate‐certainty evidence that muscle relaxants may increase the risk of adverse events. For chronic LBP, we found low‐certainty evidence that NSAIDs and very low‐ to high‐certainty evidence that opioids may provide a small effect on pain. For safety, we found low‐certainty evidence for no evidence of difference between NSAIDs and placebo for the risk of adverse events, and low‐certainty evidence that opioids may increase the risk of adverse events.

This is an important overview, in my opinion. It confirms what I and others have been stating for decades: WE CURRENTLY HAVE NO IDEAL SOLUTION TO LBP.

This is regrettable but true. It begs the question of what one should recommend to LBP sufferers. Here too, I have to repeat myself: (apart from staying as active as possible) the optimal therapy is the one that has the most favourable risk/benefit profile (and does not cost a fortune). And this option is not drugs, chiropractic, osteopathy, acupuncture, or any other SCAM – it is (physio)therapeutic exercise which is cheap, safe, and (mildly) effective.

Advocates of so-called alternative medicine (SCAM) often sound like a broken record to me. They bring up the same ‘arguments’ over and over again, no matter whether they happen to be defending acupuncture, energy healing, homeopathy, or any other form of SCAM. Here are some of the most popular of these generic ‘arguments’:

1. It helped me
The supporters of SCAM regularly cite their own good experiences with their particular form of treatment and think that this is proof enough. However, they forget that any symptomatic improvement they may have felt can be the result of several factors that are unrelated to the SCAM in question. To mention just a few:

  • Placebo
  • Regression towards the mean
  • Natural history of the disease

2. My SCAM is without risk
Since homeopathic remedies, for instance, are highly diluted, it makes sense to assume that they cannot cause side effects. Several other forms of SCAM are equally unlikely to cause adverse effects. So, the notion is seemingly correct. However, this ‘argument’ ignores the fact that it is not the therapy itself that can pose a risk, but the SCAM practitioner. For example, it is well documented – and, on this blog, we have discussed it often – that many of them advise against vaccination, which can undoubtedly cause serious harm.

3. SCAM has stood the test of time
It is true that many SCAMs have survived for hundreds or even thousands of years. It is also true that millions still use it even today. This, according to enthusiasts, is sufficient proof of SCAM’s efficacy. But they forget that many therapies have survived for centuries, only to be proved useless in the end. Just think of bloodletting or mercury preparations from past times.

4 The evidence is not nearly as negative as skeptics pretend
Yes, there are plenty of positive studies on some SCAMs This is not surprising. Firstly, from a purely statistical point of view, if we have, for instance, 1 000 studies of a particular SCAM, it is to be expected that, at the 5% level of statistical significance, about 50 of them will produce a significantly positive result. Secondly, this number becomes considerably larger if we factor in the fact that most of the studies are methodologically poor and were conducted by SCAM enthusiasts with a corresponding bias (see my ALTERNATIVE MEDICINE HALL OF FAME on this blog). However, if we base our judgment on the totality of the most robust studies, the bottom line is almost invariably that there is no overall convincingly positive result.

5. The pharmaceutical industry is suppressing SCAM
SCAM is said to be so amazingly effective that the pharmaceutical industry would simply go bust if this fact became common knowledge. Therefore Big Pharma is using its considerable resources to destroy SCAM. This argument is fallacious because:

  1. there is no evidence to support it,
  2. far from opposing SCAM, the pharmaceutical industry is heavily involved in SCAM (for example, by manufacturing homeopathic remedies, dietary supplements, etc.)

6 SCAM could save a lot of money
It is true that SCAMs are on average much cheaper than conventional medicines. However, one must also bear in mind that price alone can never be the decisive factor. We also need to consider other issues such as the risk/benefit balance. And a reduction in healthcare costs can never be achieved by ineffective therapies. Without effectiveness, there can be no cost-effectiveness.

7 Many conventional medicines are also not evidence-based
Sure, there are some treatments in conventional medicine that are not solidly supported by evidence. So why do we insist on solid evidence for SCAM? The answer is simple: in all areas of healthcare, intensive work is going on aimed at filling the gaps and improving the situation. As soon as a significant deficit is identified, studies are initiated to establish a reliable basis. Depending on the results, appropriate measures are eventually taken. In the case of negative findings, the appropriate measure is to exclude treatments from routine healthcare, regardless of whether the treatment in question is conventional or alternative. In other words, this is work in progress. SCAM enthusiasts should ask themselves how many treatments they have discarded so far. The answer, I think, is zero.

8 SCAM cannot be forced into the straitjacket of a clinical trial
This ‘argument’ surprisingly popular. It supposes that SCAM is so individualized, holistic, subtle, etc., that it defies science. The ‘argument’ is false, and SCAM advocates know it, not least because they regularly and enthusiastically cite those scientific papers that seemingly support their pet therapy.

9 SCAM is holistic
This may or may not be true, but the claim of holism is not a monopoly of SCAM. All good medicine is holistic, and in order to care for our patients holistically, we certainly do not need SCAM.

1o SCAM complements conventional medicine
This argument might be true: SCAM is often used as an adjunct to conventional treatments. Yet, there is no good reason why a complementary treatment should not be shown to be worth the effort and expense to add it to another therapy. If, for instance, you pay for an upgrade on a flight, you also want to make sure that it is worth the extra expenditure.

11 In Switzerland it works, too
That’s right, in Switzerland, a small range of SCAMs was included in basic health care by referendum. However, it has been reported that the consequences of this decision are far from positive. It brought no discernible benefit and only caused very considerable costs.

I am sure there are many more such ‘arguments’. Feel free to post your favorites!

My point here is this:

the ‘arguments’ used in defense of SCAM are not truly arguments; they are fallacies, misunderstandings, and sometimes even outright lies. 

 

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