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

economic evaluation

Robert Verkerk, Executive & scientific director, Alliance for Natural Health (ANH), seems to adore me (maybe that’s why I kept this post for Valentine’s Day?). In 2006, he published this article about me (it is lengthy, and I therefore shortened a bit, but feel free to study it in its full beauty):

START OF QUOTE

PROFESSOR EDZARD ERNST, the UK’s first professor of complementary medicine, gets lots of exposure for his often overtly negative views on complementary medicine. He’s become the media’s favourite resource for a view on this controversial subject…

The interesting thing about Prof Ernst is that he seems to have come a long way from his humble beginnings as a recipient of the therapies that he now seems so critical of. Profiled by Geoff Watts in the British Medical Journal, the Prof tells us: ‘Our family doctor in the little village outside Munich where I grew up was a homoeopath. My mother swore by it. As a kid I was treated homoeopathically. So this kind of medicine just came naturally. Even during my studies I pursued other things like massage therapy and acupuncture. As a young doctor I had an appointment in a homeopathic hospital, and I was very impressed with its success rate. My boss told me that much of this success came from discontinuing main stream medication. This made a big impression on me.’ (BMJ Career Focus 2003; 327:166; doi:10.1136/bmj.327.7425.s166)…

After his early support for homeopathy, Professor Ernst has now become, de facto, one of its main opponents. Robin McKie, science editor for The Observer (December 18, 2005) reported Ernst as saying, ‘Homeopathic remedies don’t work. Study after study has shown it is simply the purest form of placebo. You may as well take a glass of water than a homeopathic medicine.’ Ernst, having done the proverbial 180 degree turn, has decided to stand firmly shoulder to shoulder with a number of other leading assailants of non-pharmaceutical therapies, such as Professors Michael Baum and Jonathan Waxman. On 22 May 2006, Baum and twelve other mainly retired surgeons, including Ernst himself, bandied together and co-signed an open letter, published in The Times, which condemned the NHS decision to include increasing numbers of complementary therapies…

As high profile as the Ernsts, Baums and Waxmans of this world might be—their views are not unanimous across the orthodox medical profession. Some of these contrary views were expressed just last Sunday in The Sunday Times (Lost in the cancer maze, 10 December 2006)…

The real loser in open battles between warring factions in healthcare could be the consumer. Imagine how schizophrenic you could become after reading any one of the many newspapers that contains both pro-natural therapy articles and stinging attacks like that found in this week’s Daily Mail. But then again, we may misjudge the consumer who is well known for his or her ability to vote with the feet—regardless. The consumer, just like Robert Sandall, and the millions around the world who continue to indulge in complementary therapies, will ultimately make choices that work for them. ‘Survival of the fittest’ could provide an explanation for why hostile attacks from the orthodox medical community, the media and over-zealous regulators have not dented the steady increase in the popularity of alternative medicine.

Although we live in a technocratic age where we’ve handed so much decision making to the specialists, perhaps this is one area where the might of the individual will reign. Maybe the disillusionment many feel for pharmaceutically-biased healthcare is beginning to kick in. Perhaps the dictates from the white coats will be overruled by the ever-powerful survival instinct and our need to stay in touch with nature, from which we’ve evolved.

END OF QUOTE

Elsewhere, Robert Verkerk even called me the ‘master trickster of evidence-based medicine’ and stated that Prof Ernst and his colleagues appear to be evaluating the ‘wrong’ variable. As Ernst himself admitted, his team are focused on exploring only one of the variables, the ‘specific therapeutic effect’ (Figs 1 and 2). It is apparent, however, that the outcome that is of much greater consequence to healthcare is the combined effect of all variables, referred to by Ernst as the ‘total effect’ (Fig 1). Ernst does not appear to acknowledge that the sum of these effects might differ greatly between experimental and non-experimental situations.

Adding insult to injury, Ernst’s next major apparent faux pas involves his interpretation, or misinterpretation, of results. These fundamental problems exist within a very significant body of Prof Ernst’s work, particularly that which has been most widely publicised because it is so antagonistic towards healing cultures that have in many cases existed and evolved over thousands of years.

By example, a recent ‘systematic review’ of individualised herbal medicine undertaken by Ernst and colleagues started with 1345 peer-reviewed studies. However, all but three (0.2%) of the studies (RCTs) were rejected. These three RCTs in turn each involved very specific types of herbal treatment, targeting patients with IBS, knee osteoarthritis and cancer, the latter also undergoing chemotherapy, respectively. The conclusions of the study, which fuelled negative media worldwide, disconcertingly extended well beyond the remit of the study or its results. An extract follows: “Individualised herbal medicine, as practised in European medical herbalism, Chinese herbal medicine and Ayurvedic herbal medicine, has a very sparse evidence base and there is no convincing evidence that it is effective in any [our emphasis] indication. Because of the high potential for adverse events and negative herb-herb and herb-drug interactions, this lack of evidence for effectiveness means that its use cannot be recommended (Postgrad Med J 2007; 83: 633-637).

Robert Verkerk has recently come to my attention again – as the main author of a lengthy report published in December 2018. Its ‘Executive Summary’ makes the following points relevant in the context of this blog (the numbers in his text were added by me and refer to my comments below):

  • This position paper proposes a universal framework, based on ecological and sustainability principles, aimed at allowing qualified health professionals (1), regardless of their respective modalities (disciplines), to work collaboratively and with full participation of the public in efforts to maintain or regenerate health and wellbeing. Accordingly, rather than offering ‘fixes’ for the NHS, the paper offers an approach that may significantly reduce the NHS’s current and growing disease burden that is set to reach crisis point given current levels of demand and funding.
  • A major factor driving the relentlessly rising costs of the NHS is its over-reliance on pharmaceuticals (2) to treat a variety of preventable, chronic disorders. These (3) are the result — not of infection or trauma — but rather of our 21st century lifestyles, to which the human body is not well adapted. The failure of pharmaceutically-based approaches to slow down, let alone reverse, the dual burden of obesity and type 2 diabetes means wider roll-out of effective multi-factorial approaches are desperately needed (4).
  • The NHS was created at a time when infectious diseases were the biggest killers (5). This is no longer the case, which is why the NHS must become part of a wider system that facilitates health regeneration or maintenance. The paper describes the major mechanisms underlying these chronic metabolic diseases, which are claiming an increasingly large portion of NHS funding. It identifies 12 domains of human health, many of which are routinely thrown out of balance by our contemporary lifestyles. The most effective way of treating lifestyle disorders is with appropriate lifestyle changes that are tailored to individuals, their needs and their circumstances. Such approaches, if appropriately supported and guided, tend to be far more economical and more sustainable as a means of maintaining or restoring people’s health (6).
  • A sustainable health system, as proposed in this position paper, is one in which the individual becomes much more responsible for maintaining his or her own health and where more effort is invested earlier in an individual’s life prior to the downstream manifestation of chronic, degenerative and preventable diseases (7). Substantially more education, support and guidance than is typically available in the NHS today will need to be provided by health professionals (1), informed as necessary by a range of markers and diagnostic techniques (8). Healthy dietary and lifestyle choices and behaviours (9) are most effective when imparted early, prior to symptoms of chronic diseases becoming evident and before additional diseases or disorders (comorbidities) have become deeply embedded.
  • The timing of the position paper’s release coincides not only with a time when the NHS is in crisis, but also when the UK is deep in negotiations over its extraction from the European Union (EU). The paper includes the identification of EU laws that are incompatible with sustainable health systems, that the UK would do well to reject when the time comes to re-consider the British statute books following the implementation of the Great Repeal Bill (10).
  • This paper represents the first comprehensive attempt to apply sustainability principles to the management of human health in the context of our current understanding of human biology and ecology, tailored specifically to the UK’s unique situation. It embodies approaches that work with, rather than against, nature (11). Sustainability principles have already been applied successfully to other sectors such as energy, construction and agriculture.
  • It is now imperative that the diverse range of interests and specialisms (12) involved in the management of human health come together. We owe it to future generations to work together urgently, earnestly and cooperatively to develop and thoroughly evaluate new ways of managing and creating health in our society. This blueprint represents a collaborative effort to give this process much needed momentum.

My very short comments:

  1. I fear that this is meant to include SCAM-practitioners who are neither qualified nor skilled to tackle such tasks.
  2. Dietary supplements (heavily promoted by the ANH) either have pharmacological effects, in which case they too must be seen as pharmaceuticals, or they are useless, in which case we should not promote them.
  3. I think ‘some of these’ would be more correct.
  4. Multifactorial yes, but we must make sure that useless SCAMs are not being pushed in through the back-door. Quackery must not be allowed to become a ‘factor’.
  5. Only, if we discount cancer and arteriosclerosis, I think.
  6. SCAM-practitioners have repeatedly demonstrated to be a risk to public health.
  7. All we know about disease prevention originates from conventional medicine and nothing from SCAM.
  8. Informed by…??? I would prefer ‘based on evidence’ (evidence being one term that the report does not seem to be fond of).
  9. All healthy dietary and lifestyle choices and behaviours that are backed by good evidence originate from and are part of conventional medicine, not SCAM.
  10. Do I detect the nasty whiff a pro-Brexit attitude her? I wonder what the ANH hopes for in a post-Brexit UK.
  11. The old chestnut of conventional medicine = unnatural and SCAM = natural is being warmed up here, it seems to me. Fallacy galore!
  12. The ANH would probably like to include a few SCAM-practitioners here.

Call me suspicious, but to me this ANH-initiative seems like a clever smoke-screen behind which they hope to sell their useless dietary supplements and homeopathic remedies to the unsuspecting British public. Am I mistaken?

Chronic back pain is often a difficult condition to treat. Which option is best suited?

A review by the US ‘Agency for Healthcare Research and Quality’ (AHRQ) focused on non-invasive nonpharmacological treatments for chronic pain. The following therapies were considered:

  • exercise,
  • mind-body practices,
  • psychological therapies,
  • multidisciplinary rehabilitation,
  • mindfulness practices,
  • manual therapies,
  • physical modalities,
  • acupuncture.

Here, I want to share with you the essence of the assessment of spinal manipulation:

  • Spinal manipulation was associated with slightly greater effects than sham manipulation, usual care, an attention control, or a placebo intervention in short-term function (3 trials, pooled SMD -0.34, 95% CI -0.63 to -0.05, I2=61%) and intermediate-term function (3 trials, pooled SMD -0.40, 95% CI -0.69 to -0.11, I2=76%) (strength of evidence was low)
  • There was no evidence of differences between spinal manipulation versus sham manipulation, usual care, an attention control or a placebo intervention in short-term pain (3 trials, pooled difference -0.20 on a 0 to 10 scale, 95% CI -0.66 to 0.26, I2=58%), but manipulation was associated with slightly greater effects than controls on intermediate-term pain (3 trials, pooled difference -0.64, 95% CI -0.92 to -0.36, I2=0%) (strength of evidence was low for short term, moderate for intermediate term).

This seems to confirm what I have been saying for a long time: the benefit of spinal manipulation for chronic back pain is close to zero. This means that the hallmark therapy of chiropractors for the one condition they treat more often than any other is next to useless.

But which other treatments should patients suffering from this frequent and often agonising problem employ? Perhaps the most interesting point of the AHRQ review is that none of the assessed nonpharmacological treatments are supported by much better evidence for efficacy than spinal manipulation. The only two therapies that seem to be even worse are traction and ultrasound (both are often used by chiropractors). It follows, I think, that for chronic low back pain, we simply do not have a truly effective nonpharmacological therapy and consulting a chiropractor for it does make little sense.

What else can we conclude from these depressing data? I believe, the most rational, ethical and progressive conclusion is to go for those treatments that are associated with the least risks and the lowest costs. This would make exercise the prime contender. But it would definitely exclude spinal manipulation, I am afraid.

And this beautifully concurs with the advice I recently derived from the recent Lancet papers: walk (slowly and cautiously) to the office of your preferred therapist, have a little rest there (say hello to the staff perhaps) and then walk straight back home.

 

In 1995, Dabbs and Lauretti reviewed the risks of cervical manipulation and compared them to those of non-steroidal, anti-inflammatory drugs (NSAIDs). They concluded that the best evidence indicates that cervical manipulation for neck pain is much safer than the use of NSAIDs, by as much as a factor of several hundred times. This article must be amongst the most-quoted paper by chiropractors, and its conclusion has become somewhat of a chiropractic mantra which is being repeated ad nauseam. For instance, the American Chiropractic Association states that the risks associated with some of the most common treatments for musculoskeletal pain—over-the-counter or prescription nonsteroidal anti-inflammatory drugs (NSAIDS) and prescription painkillers—are significantly greater than those of chiropractic manipulation.

As far as I can see, no further comparative safety-analyses between cervical manipulation and NSAIDs have become available since this 1995 article. It would therefore be time, I think, to conduct new comparative safety and risk/benefit analyses aimed at updating our knowledge in this important area.

Meanwhile, I will attempt a quick assessment of the much-quoted paper by Dabbs and Lauretti with a view of checking how reliable its conclusions truly are.

The most obvious criticism of this article has already been mentioned: it is now 23 years old, and today we know much more about the risks and benefits of these two therapeutic approaches. This point alone should make responsible healthcare professionals think twice before promoting its conclusions.

Equally important is the fact that we still have no surveillance system to monitor the adverse events of spinal manipulation. Consequently, our data on this issue are woefully incomplete, and we have to rely mostly on case reports. Yet, most adverse events remain unpublished and under-reporting is therefore huge. We have shown that, in our UK survey, it amounted to exactly 100%.

To make matters worse, case reports were excluded from the analysis of Dabbs and Lauretti. In fact, they included only articles providing numerical estimates of risk (even reports that reported no adverse effects at all), the opinion of exerts, and a 1993 statistic from a malpractice insurer. None of these sources would lead to reliable incidence figures; they are thus no adequate basis for a comparative analysis.

In contrast, NSAIDs have long been subject to proper post-marketing surveillance systems generating realistic incidence figures of adverse effects which Dabbs and Lauretti were able to use. It is, however, important to note that the figures they did employ were not from patients using NSAIDs for neck pain. Instead they were from patients using NSAIDs for arthritis. Equally important is the fact that they refer to long-term use of NSAIDs, while cervical manipulation is rarely applied long-term. Therefore, the comparison of risks of these two approaches seems not valid.

Moreover, when comparing the risks between cervical manipulation and NSAIDs, Dabbs and Lauretti seemed to have used incidence per manipulation, while for NSAIDs the incidence figures were bases on events per patient using these drugs (the paper is not well-constructed and does not have a methods section; thus, it is often unclear what exactly the authors did investigate and how). Similarly, it remains unclear whether the NSAID-risk refers only to patients who had used the prescribed dose, or whether over-dosing (a phenomenon that surely is not uncommon with patients suffering from chronic arthritis pain) was included in the incidence figures.

It is worth mentioning that the article by Dabbs and Lauretti refers to neck pain only. Many chiropractors have in the past broadened its conclusions to mean that spinal manipulations or chiropractic care are safer than drugs. This is clearly not permissible without sound data to support such claims. As far as I can see, such data do not exist (if anyone knows of such evidence, I would be most thankful to let me see it).

To obtain a fair picture of the risks in a real life situation, one should perhaps also mention that chiropractors often fail to warn patients of the possibility of adverse effects. With NSAIDs, by contrast, patients have, at the very minimum, the drug information leaflets that do warn them of potential harm in full detail.

Finally, one could argue that the effectiveness and costs of the two therapies need careful consideration. The costs for most NSAIDs per day are certainly much lower than those for repeated sessions of manipulations. As to the effectiveness of the treatments, it is clear that NSAIDs do effectively alleviate pain, while the evidence seems far from being conclusively positive in the case of cervical manipulation.

In conclusion, the much-cited paper by Dabbs and Lauretti is out-dated, poor quality, and heavily biased. It provides no sound basis for an evidence-based judgement on the relative risks of cervical manipulation and NSAIDs. The notion that cervical manipulations are safer than NSAIDs is therefore not based on reliable data. Thus, it is misleading and irresponsible to repeat this claim.

 

An article alerted me to a new report on alternative medicine in the NHS. The report itself is so monumentally important that I cannot find it anywhere (if someone finds a link, please let us know). Behind it is our homeopathy-loving friend David Tredinnick MP, chair of the All-Party Parliamentary Group. I am sure you remember him; he is ‘perhaps the worst example of scientific illiteracy in government’. And what has David been up to now?

His new report by the All-Party Parliamentary Group for Integrated Healthcare is urging the NHS to embrace more medicine to ease the mounting burden on service provision. It claims that more patients suffer from two or more long-term health conditions than ever before, and that their number will amount to 18 million by 2025.

And the solution?

Isn’t it obvious?

David Tredinnick MP, chair of the All-Party Parliamentary Group, insists that the current approach being taken by the government is unsustainable for the long-term future of the country. “Despite positive signs that ministers are proving open to change, words must translate into reality. For some time our treasured NHS has faced threats to its financial sustainability and to common trust in the system. Multimorbidity is more apparent now in the UK than at any time in our recent history. As a trend it threatens to swamp a struggling NHS, but the good news is that many self-limiting conditions can be treated at home with the most minimal of expert intervention. Other European governments facing similar challenges have considered the benefits of exploring complementary, traditional and natural medicines. If we are to hand on our most invaluable institution to future generations, so should we.”

Hold on, this sounds familiar!

Wasn’t there something like it before?

Yes, of course, the ‘Smallwood Report‘, commissioned over a decade ago by Prince Charles. It also proclaimed that the NHS could save plenty of money, if it employed more bogus therapies. But it was so full of errors and wrong conclusions that its impact on the NHS was close to zero. At the time, I concluded that the ‘Smallwood report’ is one of the strangest examples of an attempt to review CAM that I have ever seen. One gets the impression that its conclusions were written before the authors had searched for evidence that might match them. Both Mr Smallwood and the ‘Freshminds’ team told me that they understand neither health care nor CAM. Mr Smallwood stressed that this is positive as it prevents him from being ‘accused of bias’. My response was that ‘severely flawed research methodology almost inevitably leads to bias’.

And which other European countries might the Tory Brexiter David refer to?

Not Spain?

Not France?

Not Austria?

Not Germany?

Sadly, I have not seen Tredinnick’s  new oeuvre and do not know its precise content. What I do know, however, that the evidence, for alternative medicine’s cost effectiveness has not improved; if anything, it has become more negative. From that, one can safely conclude that Tredinnick’s notions of NHS-savings through more use of alternative medicine are erroneous. Therefore, I suspect the new report will swiftly and deservedly go the same way as its predecessor, the ‘Smallwood Report’: straight into the bins of Westminster.

Alternative medicine is an odd term (but it is probably as good or bad as any other term for it). It describes a wide range of treatments (and diagnostic techniques which I exclude from this discussion) that have hardly anything in common.

Hardly anything!

And that means there are a few common denominators. Here are 7 of them:

  1. The treatments have a long history and have thus stood the ‘test of time’.
  2. The treatments enjoy a lot of support.
  3. The treatments are natural and therefore safe.
  4. The treatments are holistic.
  5. The treatments tackle the root causes of the problem.
  6. The treatments are being suppressed by the establishment.
  7. The treatments are inexpensive and therefore value for money.

One only has to scratch the surface to discover that these common denominators of alternative medicine turn out to be unmitigated nonsense.

Let me explain:

The treatments have a long history and have thus stood the ‘test of time’.

It is true that most alternative therapies have a long history; but what does that really mean? In my view, it signals but one thing: when these therapies were invented, people had no idea how our body functions; they mostly had speculations, superstitions and myths. It follows, I think, that the treatments in question are built on speculations, superstitions and myths.

This might be a bit too harsh, I admit. But one thing is absolutely sure: a long history of usage is no proof of efficacy.

The treatments enjoy a lot of support.

Again, this is true. Alternative treatments are supported by many patients who swear by them, by thousands of clinicians who employ them as well as by royalty and other celebrities who make the headlines with them.

Such support is usually based on experience or belief. Neither are evidence; quite the opposite, remember: the three most dangerous words in medicine are ‘IN MY EXPERIENCE’. To be clear, experience and belief can fool us profoundly, and science is a tool to prevent us being misled by them.

The treatments are natural and therefore safe.

Here we have two fallacies moulded into one. Firstly, not all alternative therapies are natural; secondly, none is entirely safe.

There is nothing natural about diluting the Berlin Wall and selling it as a homeopathic remedy. There is nothing natural about forcing a spinal joint beyond its physiological range of motion and calling it spinal manipulation. There is nothing natural about sticking needles into the skin and claiming this re-balances our vital energies.

Acupuncture, chiropractic, herbal medicine, etc. are burdened with their fair share of adverse effects. But the real danger of alternative medicine is the harm done by neglecting effective therapies. Anyone who decides to forfeit conventional treatments for a serious condition, and uses alternative therapies instead, runs the risk of shortening their lives.

The treatments are holistic.

Alternative therapists try very hard to sell their treatments as holistic. This sounds good and must be an excellent marketing gimmick. Alas, it is not true.

There is nothing less holistic than seeing subluxations, yin/yang imbalances, auto-intoxications, energy blockages, etc. as the cause of all illness. Holism is at the heart of all good healthcare; the attempt by alternative practitioners to hijack it is merely a transparent attempt to boost their business.

The treatments tackle the root causes of the problem.

Alternative therapists claim that they can identify the root causes of all conditions and thus treat them more effectively than conventional clinicians who merely treat their symptoms. Nothing could be further from the truth. Conventional medicine has been so spectacularly successful not least because we always aim at identifying the cause that underlie a symptom and, whenever possible, treat that cause (often in addition to treating symptoms). Alternative practitioners may well delude themselves that energy imbalances, subluxations, chi-blockages etc. are root causes, but there simply is no evidence to support their deluded claims.

The treatments are being suppressed by the establishment.

The feeling of paranoia seems endemic in alternative medicine. Many practitioners are so affected by it that they believe everyone who doubts their implausible notions and misconceptions is out to get them. Big Pharma’ or whoever else they feel prosecuted by are more likely to smile at such wild conspiracy theories than to fear for their profit margins. And whenever ‘Big Pharma’ does smell a fast buck, they do not hesitate to jump on the alternative band-waggon joining them in ripping off the public by flogging dubious supplements, homeopathics, essential oils, vitamins, flower remedies, detox-remedies, etc.

The treatments are inexpensive and therefore value for money.

It is probably true that the average cost of a homeopathic remedy, an acupuncture treatment or an aromatherapy session costs less than the average conventional treatment. However, to conclude from it that alternative therapies are value for money is wrong. To be of real value, a treatment needs to generate more good than harm; but very few alternative treatments fulfil this criterion. To use a blunt analogy, if someone offers you a used car, it may well be inexpensive – if, however, it does not run and is beyond repair, it cannot be value for money.

As I already stated: alternative medicine is so diverse that its various branches are almost entirely unrelated, and the few common denominators of alternative medicine that do exist are unmitigated nonsense.

It is no secret to regular readers of this blog that chiropractic’s effectiveness is unproven for every condition it is currently being promoted for – perhaps with two exceptions: neck pain and back pain. Here we have some encouraging data, but also lots of negative evidence. A new US study falls into the latter category; I am sure chiropractors will not like it, but it does deserve a mention.

This study evaluated the comparative effectiveness of usual care with or without chiropractic care for patients with chronic recurrent musculoskeletal back and neck pain. It was designed as a prospective cohort study using propensity score-matched controls.

Using retrospective electronic health record data, the researchers developed a propensity score model predicting likelihood of chiropractic referral. Eligible patients with back or neck pain were then contacted upon referral for chiropractic care and enrolled in a prospective study. For each referred patient, two propensity score-matched non-referred patients were contacted and enrolled. We followed the participants prospectively for 6 months. The main outcomes included pain severity, interference, and symptom bothersomeness. Secondary outcomes included expenditures for pain-related health care.

Both groups’ (N = 70 referred, 139 non-referred) pain scores improved significantly over the first 3 months, with less change between months 3 and 6. No significant between-group difference was observed. After controlling for variances in baseline costs, total costs during the 6-month post-enrollment follow-up were significantly higher on average in the non-referred versus referred group. Adjusting for differences in age, gender, and Charlson comorbidity index attenuated this finding, which was no longer statistically significant (p = .072).

The authors concluded by stating this: we found no statistically significant difference between the two groups in either patient-reported or economic outcomes. As clinical outcomes were similar, and the provision of chiropractic care did not increase costs, making chiropractic services available provided an additional viable option for patients who prefer this type of care, at no additional expense.

This comes from some of the most-renowned experts in back pain research, and it is certainly an elaborate piece of investigation. Yet, I find the conclusions unreasonable.

Essentially, the authors found that chiropractic has no clinical or economical advantage over other approaches currently used for neck and back pain. So, they say that it a ‘viable option’.

I find this odd and cannot quite follow the logic. In my view, it lacks critical thinking and an attempt to produce progress. If it is true that all treatments were similarly (in)effective – which I can well believe – we still should identify those that have the least potential for harm. That could be exercise, massage therapy or some other modality – but I don’t think it would be chiropractic care.


References

Comparative Effectiveness of Usual Care With or Without Chiropractic Care in Patients with Recurrent Musculoskeletal Back and Neck Pain.

Elder C, DeBar L, Ritenbaugh C, Dickerson J, Vollmer WM, Deyo RA, Johnson ES, Haas M.

J Gen Intern Med. 2018 Jun 25. doi: 10.1007/s11606-018-4539-y. [Epub ahead of print]

PMID: 29943109

I have often pointed out that, in contrast to ‘rational phytotherapy’, traditional herbalism of various types (e. g. Western, Chinese, Kampo, etc.) – characterised by the prescription of an individualised mixture of herbs by a herbalist – is likely to do more harm than good. This recent paper provides new and interesting information about the phenomenon.

Specifically, it explores the prevalence with which Australian Western herbalists treat menstrual problems and their related treatment, experiences, perceptions, and inter-referral practices with other health practitioners. Members of the Practitioner Research and Collaboration Initiative practice-based research network identifying as Western Herbalists (WHs) completed a specifically developed, online questionnaire.

Western Herbalists regularly treat menstrual problems, perceiving high, though differential, levels of effectiveness. For menstrual problems, WHs predominantly prescribe individualised formulas including core herbs, such as Vitex agnus-castus (VAC), and problem-specific herbs. Estimated clients’ weekly cost (median = $25.00) and treatment duration (median = 4-6 months) covering this Western herbal medicine treatment appears relatively low. Urban-based women are more likely than those rurally based to have used conventional treatment for their menstrual problems before consulting WHs. Only 19% of WHs indicated direct contact by conventional medical practitioners regarding treatment of clients’ menstrual problems despite 42% indicating clients’ conventional practitioners recommended consultation with WH.

The authors concluded that Western herbal medicine may be a substantially prevalent, cost-effective treatment option amongst women with menstrual problems. A detailed examination of the behaviour of women with menstrual problems who seek and use Western herbal medicine warrants attention to ensure this healthcare option is safe, effective, and appropriately co-ordinated within women’s wider healthcare use.

Apart from the fact, that I don’t see how the researchers could possibly draw conclusions about the cost-effectiveness of Western herbalism, I feel that this survey requires further comments.

There is no reason to assume that individualised herbalism is effective and plenty of reason to fear that it might cause harm (the larger the amount of herbal ingredients in one prescription, the higher the chances for toxicity and interactions). The only systematic review on the subject concluded that there is a sparsity of evidence regarding the effectiveness of individualised herbal medicine and no convincing evidence to support the use of individualised herbal medicine in any indication.

Moreover, VAC (the ‘core herb’ for menstrual problems) is hardly a herb that is solidly supported by evidence either. A systematic review concluded that, although meta-analysis shows a large pooled effect of VAC in placebo-controlled trials, the high risk of bias, high heterogeneity, and risk of publication bias of the included studies preclude a definitive conclusion. The pooled treatment effects should be viewed as merely explorative and, at best, overestimating the real treatment effect of VAC for premenstrual syndrome symptoms. There is a clear need for high-quality trials of appropriate size examining the effect of standardized extracts of VAC in comparison to placebo, selective serotonin reuptake inhibitors, and oral contraceptives to establish relative efficacy.

And finally, VAC is by no means free of adverse effects; our review concluded that frequent adverse events include nausea, headache, gastrointestinal disturbances, menstrual disorders, acne, pruritus and erythematous rash. No drug interactions were reported. Use of VAC should be avoided during pregnancy or lactation. Theoretically, VAC might also interfere with dopaminergic antagonists.

So, to me, this survey suggests that the practice of Western herbalists is:

  1. not evidence-based;
  2. potentially harmful;
  3. and costly.

In a nutshell: IT IS BEST AVOIDED.

Switzerland seems to be something like the ‘promised land’ for homeopaths – at least this is what many homeopaths seem think. However, homeopaths’ thinking is rarely correct, and the situation of homeopathy in Switzerland is not quite what they believe it to be.

This article explains (my English explanations are below for all those you cannot do German):

________________________________________________________________________________

Die Schweiz bekommt die steigenden Gesundheitskosten einfach nicht in den Griff. In den 20 Jahren zwischen 1996 und 2016 haben sie sich um rund 255,2 Prozent erhöht…
Einer der Gründe für den Anstieg: Seit 2017 sind Komplementärmedizinische Methoden wie beispielsweise Homöopathie auch in der Grundversorgung inbegriffen. Das Volk hatte im Jahr 2009 einen entsprechenden Verfassungsartikel angenommen. Damals hoffte man noch, dass mit dem erleichterten Zugang zur Komplementärmedizin die Gesundheitskosten sinken würden.
Doch es kam anders. Die Komplementärmedizin verursachte letztes Jahr zusätzliche Kosten von 30 Millionen Franken, wie Sandra Kobelt, Sprecherin Krankenkassenverbandes Santésuisse, gegenüber BLICK bestätigt.

Die Komplementärmedizin sorgt entsprechend weiter für Diskussionen. Auch, weil zum Beispiel die Wirkung der beliebten Globuli-Kügeli bis heute höchst umstritten bleibt. Doch auch sie werden laut neuem Gesetz in jedem Fall von der Krankenkasse bezahlt, sofern sie von einem Homöopathen mit medizinischem Fachausweis verschrieben wurden…

Aus wissenschaftlicher Sicht macht diese Bevorzugung der Homöopathie wenig Sinn. Denn: In einem Statement aus dem Jahr 2017 bestritten insgesamt 25 europäische Wissenschaftsvereinigungen die Wirksamkeit von Globuli. Darunter auch die Akademien der Wissenschaft Schweiz, die mit den Schweizer Hochschulen zusammenarbeiten. Sie halten fest, dass Homöopathie sogar gefährlich sein kann, da zu ihren Gunsten eine schulmedizinische Therapie aufgeschoben oder gar abgelehnt wird.

Dieser Meinung ist auch Beda Stadler, der ehemalige Leiter des Instituts für Immunologie an der Uni Bern. «Globuli verursachen nur unnötige Gesundheitskosten», sagt er. Man habe das Volk 2009 getäuscht, indem man ihm erzählte, Globuli wären ja günstig. «Doch viele Allergiker setzen die Globuli nicht ab, nachdem sie keine Wirkung festgestellt haben. Stattdessen schlucken sie noch zusätzlich medizinische Tabletten – das verursacht doppelte Kosten», so Stadler.

Homöopathin und Ärztin Doktor Gisela Etter hält dagegen. «Ich erlebe jeden Tag, wie Homöopathie bei Allergikern wirkt. Bei vielen treten die Symptome nach einiger Zeit überhaupt nicht mehr auf», sagt sie. Das Problem: Den Wirkungsmechanismus der Globuli kann die Medizinerin nicht erklären. «Das ist mit den herkömmlichen Naturwissenschaften gar nicht möglich», so Etter…

_________________________________________________________________________

Let me try to translate the key points of this article:

  • The costs for healthcare have exploded in Switzerland; an increase of > 255% during the last 10 years.
  • One reason for this development is that, since 2017, the Swiss get various alternative therapies reimbursed, including homeopathy.
  • That move has cost 30 000 000 Francs last year.
  • The efficacy of homeopathic remedies is controversial.
  • Yet they are being paid for by Swiss health insurances, provided they are prescribed by a qualified doctor.
  • This does not make sense from a scientific perspective.
  • In 2017, 25 European scientific societies, including the Swiss academies, stated that homeopathy does not work and can even be dangerous, if it replaces effective treatments.
  • Beda Stadler, former director of the Institute of Immunology, Uni Bern said “Globuli only cause unnecessary healthcare costs”
  • Homoeopath Gisela Etter said “I see every day how homeopathy works for allergies… to explain the mechanism of action is not possible with conventional science.”

__________________________________________________________________________________

I suppose, we will have to wait for some unconventional science then!

THE CONVERSATION recently carried an article shamelessly promoting osteopathy. It seems to originate from the University of Swansea, UK, and is full of bizarre notions. Here is an excerpt:

To find out more about how osteopathy could potentially affect mental health, at our university health and well-being academy, we have recently conducted one of the first studies on the psychological impact of OMT – with positive results.

For the last five years, therapists at the academy have been using OMT to treat members of the public who suffer from a variety of musculoskeletal disorders which have led to chronic pain. To find out more about the mental health impacts of the treatment, we looked at three points in time – before OMT treatment, after the first week of treatment, and after the second week of treatment – and asked patients how they felt using mental health questionnaires.

This data has shown that OMT is effective for reducing anxiety and psychological distress, as well as improving patient self-care. But it may not be suitable for all mental illnesses associated with chronic pain. For instance, we found that OMT was less effective for depression and fear avoidance.

All is not lost, though. Our results also suggested that the positive psychological effects of OMT could be further optimised by combining it with therapy approaches like acceptance and commitment therapy (ACT). Some research indicates that psychological problems such as anxiety and depression are associated with inflexibility, and lead to experiential avoidance. ACT has a positive effect at reducing experiential avoidance, so may be useful with reducing the fear avoidance and depression (which OMT did not significantly reduce).

Other researchers have also suggested that this combined approach may be useful for some subgroups receiving OMT where they may accept this treatment. And, further backing this idea up, there has already been at least one pilot clinical trial and a feasibility study which have used ACT and OMT with some success.

Looking to build on our positive results, we have now begun to develop our ACT treatment in the academy, to be combined with the osteopathic therapy already on offer. Though there will be a different range of options, one of these ACT therapies is psychoeducational in nature. It does not require an active therapist to work with the patient, and can be delivered through internet instruction videos and homework exercises, for example.

Looking to the future, this kind of low cost, broad healthcare could not only save the health service money if rolled out nationwide but would also mean that patients only have to undergo one treatment.

END OF QUOTE

So, they recruited a few patients who had come to receive osteopathic treatments (a self-selected population full of expectation and in favour of osteopathy), let them fill a few questionnaires and found some positive changes. From that, they conclude that OMT (osteopathic manipulative therapy) is effective. Not only that, they advocate that OMT is rolled out nationwide to save NHS funds.

Vis a vis so much nonsense, I am (almost) speechless!

As this comes not from some commercial enterprise but from a UK university, the nonsense is intolerable, I find.

Do I even need to point out what is wrong with it?

Not really, it’s too obvious.

But, just in case some readers struggle to find the fatal flaws of this ‘study’, let me mention just the most obvious one. There was no control group! That means the observed outcome could be due to many factors that are totally unrelated to OMT – such as placebo-effect, regression towards the mean, natural history of the condition, concomitant treatments, etc. In turn, this also means that the nationwide rolling out of their approach would most likely be a costly mistake.

The general adoption of OMT would of course please osteopaths a lot; it could even reduce anxiety – but only that of the osteopaths and their bank-managers, I am afraid.

Have you ever wondered whether doctors who practice homeopathy are different from those who don’t.

Silly question, of course they are! But how do they differ?

Having practised homeopathy myself during my very early days as a physician, I have often thought about this issue. My personal (and not very flattering) impressions were noted in my memoir where I describe my experience working in a German homeopathic hospital:

some of my colleagues used homeopathy and other alternative approaches because they could not quite cope with the often exceedingly high demands of conventional medicine. It is almost understandable that, if a physician was having trouble comprehending the multifactorial causes and mechanisms of disease and illness, or for one reason or another could not master the equally complex process of reaching a diagnosis or finding an effective therapy, it might be tempting instead to employ notions such as dowsing, homeopathy or acupuncture, whose theoretical basis, unsullied by the inconvenient absolutes of science, was immeasurably more easy to grasp. 

Some of my colleagues in the homeopathic hospital were clearly not cut out to be “real” doctors. Even a very junior doctor like me could not help noticing this somewhat embarrassing fact… 

But this is anecdote and not evidence!

So, where is the evidence?

It was published last week and made headlines in many UK daily papers.

Our study was aimed at finding out whether English GP practices that prescribe any homeopathic preparations might differ in their prescribing of other drugs. We identified practices that made any homeopathy prescriptions over six months of data. We measured associations with four prescribing and two practice quality indicators using multivariable logistic regression.

Only 8.5% of practices (644) prescribed homeopathy between December 2016 and May 2017. Practices in the worst-scoring quartile for a composite measure of prescribing quality were 2.1 times more likely to prescribe homeopathy than those in the best category. Aggregate savings from the subset of these measures where a cost saving could be calculated were also strongly associated. Of practices spending the most on medicines identified as ‘low value’ by NHS England, 12.8% prescribed homeopathy, compared to 3.9% for lowest spenders. Of practices in the worst category for aggregated price-per-unit cost savings, 12.7% prescribed homeopathy, compared to 3.5% in the best category. Practice quality outcomes framework scores and patient recommendation rates were not associated with prescribing homeopathy.

We concluded that even infrequent homeopathy prescribing is strongly associated with poor performance on a range of prescribing quality measures, but not with overall patient recommendation or quality outcomes framework score. The association is unlikely to be a direct causal relationship, but may reflect underlying practice features, such as the extent of respect for evidence-based practice, or poorer stewardship of the prescribing budget.

Since our study was reported in almost all of the UK newspapers, it comes as no surprise that, in the interest of ‘journalistic balance’, homeopaths were invited to give their ‘expert’ opinions on our work.

Margaret Wyllie, head of the British Homeopathic Association, was quoted commenting: “This is another example of how real patient experience and health outcomes are so often discounted, when in actuality they should be the primary driver for research to improve our NHS services. This study provides no useful evidence about homeopathy, or about prescribing, and gives absolutely no data that can improve the health of people in the UK.”

The Faculty of Homeopathy was equally unhappy about our study and stated: “The study did not include any measures of patient outcomes, so it doesn’t tell us how the use of homeopathy in English general practice correlates with patients doing well or badly, nor with how many drugs they use.”

Cristal Summer from the Society of Homeopathy said that our research was just a rubbish bit of a study.

Peter Fisher, the Queen’s homeopath and the president of the Faculty of Homeopathy, stated: “We don’t know if these measures correlate with what matters to patients – whether they get better and have side-effects.”

A study aimed at determining whether GP practices that prescribe homeopathic preparations differ in their prescribing habits from those that do not prescribe homeopathics can hardly address these questions, Peter. A test of washing machines can hardly tell us much about the punctuality of trains. And an investigation into the risks of bungee jumping will not inform us about the benefits of regular exercise. Call me biased, but to me these comments indicate mainly one thing: HOMEOPATHS SEEM TO HAVE GREAT DIFFICULTIES UNDERSTANDING SCIENTIFIC PAPERS.

I much prefer the witty remarks of Catherine Bennett in yesterday’s Observer: Homeopath-GPs, naturally, have mustered in response and challenge Goldacre’s findings, with a concern for methodology that could easily give the impression that there is some evidential basis for their parallel system, beyond the fact that the Prince of Wales likes it. In fairness to Charles, his upbringing is to blame. But what is the doctors’ excuse?

Recent Comments

Note that comments can be edited for up to five minutes after they are first submitted but you must tick the box: “Save my name, email, and website in this browser for the next time I comment.”

The most recent comments from all posts can be seen here.

Categories