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

bias

In 2004, my team published a review analysing the diversity of so-called alternative medicine (SCAM) research published in one single year (2002) across 7 European countries (Germany, United Kingdom, Italy, France, Spain, Netherlands, Belgium) and the US. In total 652 abstracts of articles were assessed. Germany and the UK were the only two European countries to publish in excess of 100 articles in that year (Germany: 137, UK: 183). The majority of articles were non-systematic reviews and comments, analytical studies and surveys. The UK carried out more surveys than any of the other countries and also published the largest number of systematic reviews. Germany, the UK and the US covered the widest range of interests across various SCAM modalities and investigated the safety of CAM. We concluded that important national differences exist in terms of the nature of SCAM research. This raises important questions regarding the reasons for such differences.

One striking difference was the fact that, compared to the UK, Germany had published far less research on SCAM that failed to report a positive result (4% versus 14%). Ever since, I have wondered why. Perhaps it has something to do with the biggest sponsor of SCAM research in Germany: THE CARSTENS STIFTUNG?

The Carstens Foundation (CF) was created by the former German President, Prof. Dr. Karl Carstens and his wife, Dr. Veronica Carstens. Karl Carstens (1914-1992) was the 5th President of federal Germany, from 1979 to 1984. Veronica Carstens (1923-2012) was a doctor of Internal Medicine with an interest in natural medicine and homeopathy in particular. She is quoted by the CF stating: „Der Arzt und die Ärztin der Zukunft sollen zwei Sprachen sprechen, die der Schulmedizin und die der Naturheilkunde und Homöopathie. Sie sollen im Einzelfall entscheiden können, welche Methode die besten Heilungschancen für den Patienten bietet.“ (Future doctors should speak two languages, that of ‘school medicine’ [Hahnemann’s derogatory term for conventional medicine] and that of naturopathy and homeopathy. They should be able to decide on a case by case basis which method offers the best chances of a cure for the patient.***)

Together, the two Carstens created the CF with the goal of sponsoring SCAM in Germany. More than 35 million € have so far been spent on more than 100 projects, fellowships, dissertations, an own publishing house, and a patient societyNatur und Medizin” (currently ~23 000 members) with the task of promoting SCAM. Projects the CF proudly list as their ‘milestones’ include: 

  • an outpatient clinic of natural medicine for cancer
  • a project ‘Natural medicine and homeopathy for children and adolescents’.

The primary focus of the CF clearly is homeopathy, and it is in this area where their anti-science bias gets most obvious. I do invite everyone who reads German to have a look at their website and be amazed at the plethora of misleading claims.

Their expert for all things homeopathic is Dr Jens Behnke (‘Referent für Homöopathieforschung bei der Karl und Veronica Carstens-Stiftung: Evidenzbasierte Medizin, CAM, klinische Forschung, Grundlagenforschung’). He is not a medical doctor but has a doctorate from the ‘Kulturwissenschaftlichen Fakultät der Europa-Universität Viadrina’ entitled ‘Wissenschaft und Weltanschauung. Eine epistemologische Analyse des Paradigmenstreits in der Homöopathieforschung’ (Science and world view. An epistemological analysis of the paradigm-quarrel in homeopathy research). His supervisor was Prof Harald Walach who has long been close to the CF.

Behnke claims to be an expert in EBM, clinical research and basic research but, intriguingly, he has not a single Medline-listed publication to his name. So, we only have his dissertation to assess his expertise.

The very 1st sentence of his dissertation is noteworthy, in my view: Die Homöopathie ist eine Therapiemethode, die seit mehr als 200 Jahren praktiziert wird und eine beträchtliche Zahl an Heilungserfolgen vorzuweisen hat (Homeopathy is a therapeutic method, that is being used since more than 200 years and which is supported by a remarkable number of therapeutic successes). In essence, the dissertation dismisses the scientific approach for evaluating homeopathy as well as the current best evidence that shows homeopathy to be ineffective.

Behnke dismisses my own research on homeopathy without even considering it. He first claims to have found an error in one of my systematic reviews and then states: Die Fragwürdigkeit der oben angeführten Methoden rechtfertigt das Übergehen sämtlicher Publikationen dieses Autors im Rahmen dieser Arbeit. Wenn einem Wissenschaftler die aufgezeigte absichtliche Falschdarstellung aufgrund von Voreingenommenheit nachgewiesen werden kann, sind seine Ergebnisse, wenn überhaupt, nur nach vorheriger systematischer Überprüfung sämtlicher Originalpublikationen und Daten, auf die sie sich beziehen, verwertbar. Essentially, he claims that, because he has found one error, the rest cannot be trusted and therefore he is entitled to reject the lot.

In the same dissertation, we read the following: Ernst konstatiert in allen … Arbeiten zur Homöopathie ausnahmslos, dass es keinerlei belastbare Hinweise auf eine Wirksamkeit homöopathischer Arzneimittel über Placeboeffekte hinaus gebe (Ernst states in all publications on homeopathy without exception that no solid suggestions exist at all for an effectiveness of homeopathic remedies). However, it is demonstrably wrong that all of my papers arrive at a negative judgement of homeopathy’s effectiveness; here are three that spring into my mind:

So, applying Behnke’s own logic outlined above, one should argue that, because I have found one error in his research, the rest of what Behnke will (perhaps one day be able to) publish cannot be trusted and therefore I am entitled to reject the lot.

That would, of course, be tantamount to adopting the stupidity of one’s own opponents. So, I will certainly not do that; instead, I will wait patiently for the sound science that Dr Behnke (and indeed the CF) might eventually produce.

 

***phraseology that is strikingly similar to that of Rudolf Hess on the same subject.

The Journal of Experimental Therapeutics and Oncology states that it is devoted to the rapid publication of innovative preclinical investigations on therapeutic agents against cancer and pertinent findings of experimental and clinical oncology. In the journal you will find review articles, original articles, and short communications on all areas of cancer research, including but not limited to preclinical experimental therapeutics; anticancer drug development; cancer biochemistry; biotechnology; carcinogenesis; cancer cytogenetics; clinical oncology; cytokine biology; epidemiology; molecular biology; pathology; pharmacology; tumor cell biology; and experimental oncology.

After reading an article entitled ‘How homeopathic medicine works in cancer treatment: deep insight from clinical to experimental studies’ in its latest issue, I doubt that the journal is devoted to anything.

Here is the abstract:

In the current scenario of medical sciences, homeopathy, the most popular system of therapy, is recognized as one of the components of complementary and alternative medicine (CAM) across the world. Despite, a long debate is continuing whether homeopathy is just a placebo or more than it, homeopathy has been considered to be safe and cost-effectiveness therapeutic modality. A number of human ailments ranging from common to serious have been treated with homeopathy. However, selection of appropriate medicines against a disease is cumbersome task as total spectrum of symptoms of a patient guides this process. Available data suggest that homeopathy has potency not only to treat various types of cancers but also to reduce the side effects caused by standard therapeutic modalities like chemotherapy, radiotherapy or surgery. Although homeopathy has been widely used for management of cancers, its efficacy is still under question. In the present review, the anti-cancer effect of various homeopathic drugs against different kinds of cancers has been discussed and future course of action has also been suggested.

I do wonder what possessed the reviewers of this paper and the editors of the journal to allow such dangerous (and badly written) rubbish to get published. Do they not know that:

  1. homeopathy is a placebo therapy,
  2. homeopathy can not cure any cancer,
  3. cancer patients are highly vulnerable to false hope,
  4. such an article endangers the lives of many cancer patients,
  5. they have an ethical, moral and possibly legal duty to prevent such mistakes?

What makes this paper even more upsetting is the fact that one of its authors is affiliated with the Department of Health Research, Ministry of Health and Family Welfare, Government of India.

Family welfare my foot!

This certainly is one of the worst violations of healthcare and publication ethic that I have come across for a long time.

 

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?

If so-called alternative medicine (SCAM) ever were to enter the Guinness Book of Records, it would most certainly be because it generates more surveys than any other area of medical inquiry. I have long been rather sceptical about this survey-mania. Therefore, I greet any major new survey with some trepidation.

The aim of this new survey was to obtain up-to-date general population figures for practitioner-led SCAM use in England, and to discover people’s views and experiences regarding access. The researchers commissioned a face-to-face questionnaire survey of a nationally representative adult quota sample (aged ≥15 years). Ten questions were included within Ipsos MORI’s weekly population-based survey. The questions explored 12-month practitioner-led SCAM use, reasons for non-use, views on NHS-provided SCAM, and willingness to pay.

Of 4862 adults surveyed, 766 (16%) had seen a SCAM practitioner. People most commonly visited SCAM practitioners for manual therapies (massage, osteopathy, chiropractic) and acupuncture, as well as yoga, pilates, reflexology, and mindfulness or meditation. Women, people with higher socioeconomic status (SES) and those in south England were more likely to access SCAM. Musculoskeletal conditions (mainly back pain) accounted for 68% of use, and mental health 12%. Most was through self-referral (70%) and self-financing. GPs (17%) or NHS professionals (4%) referred and/or recommended SCAM to users. These SCAM users were more often unemployed, with lower income and social grade, and receiving NHS-funded SCAM. Responders were willing to pay varying amounts for SCAM; 22% would not pay anything. Almost two in five responders felt NHS funding and GP referral and/or endorsement would increase their SCAM use.

The authors concluded that SCAM is commonly used in England, particularly for musculoskeletal and mental health problems, and by affluent groups paying privately. However, less well-off people are also being GP-referred for NHS-funded treatments. For SCAM with evidence of effectiveness (and cost-effectiveness), those of lower SES may be unable to access potentially useful interventions, and access via GPs may be able to address this inequality. Researchers, patients, and commissioners should collaborate to research the effectiveness and cost-effectiveness of SCAM, and consider its availability on the NHS.

I feel that a few critical thoughts are in order:

  1. The authors call their survey an ‘up-date’. The survey ran between 25 September and 18 October 2015. That is more than three years ago. I would not exactly call this an up-date!
  2. Authors (several of whom are known SCAM-enthusiasts) also state that practitioner-led SCAM use was about 5% higher than previous national (UK and England) surveys. This may relate to the authors’ wider SCAM definition, which included 11 more therapies than Hunt et al (a survey from my team), or increased SCAM use since 2005. Despite this uncertainty, the authors write this: Figures from 2005 reported that 12% of the English population used practitioner-led CAM. This 2015 survey has found that 16% of the general population had used practitioner-led CAM in the previous 12 months. Thus, they imply that SCAM-use has been increasing.
  3. The main justification for running yet another survey presumably was to determine whether SCAM-use has increased, decreased or remained the same (virtually everything else found in the new survey had been shown many times before). To not answer this main question conclusively by asking the same questions as a previous survey is just daft, in my view. We have used the same survey methods at two points one decade apart and found little evidence for an increase, on the contrary: overall, GPs were less likely to endorse CAMs than previously shown (38% versus 19%).
  4. The main reason why I have long been critical about such surveys is the manner in which their data get interpreted. The present paper is no exception in this respect. Invariably the data show that SCAM is used by those who can afford it. This points to INEQUALITY that needs to be addressed by allowing much more SCAM on the public purse. In other words, such surveys are little more that very expensive and somewhat under-hand promotion of quackery.
  5. Yes, I know, the present authors are more clever than that; they want the funds limited to SCAM with evidence of effectiveness and cost-effectiveness. So, why do they not list those SCAMs together with the evidence for effectiveness and cost-effectiveness? This would enable us to check the validity of the claim that more public money should fund SCAM. I think I know why: such SCAMs do not exist or, at lest, they are extremely rare.

But otherwise the new survey was excellent.

 

The PGIH (currently chaired by the Tory MP David Tredinnick) was founded in 1992 (in the mid 1990, they once invited me to give a lecture which I did with pleasure). Its overriding aim is to bring about improvements in patient care. The PGIH have conducted a consultation that involved 113 SCAM-organisations and other stakeholders. The new PGIH-report is based on their feedback and makes 14 recommendations. They are all worth studying but, to keep this post concise, I have selected the three that fascinated me most:

Evidence Base and Research

NICE guidelines are too narrow and do not fit well with models of care such as complementary, traditional and natural therapies, and should incorporate qualitative evidence and patient outcomes measures as well as RCT evidence. Complementary, traditional and natural healthcare associations should take steps to educate and advise their members on the use of Measure Yourself Medical Outcome Profiles (MYMOP), and patient outcome measures should be collated by an independent central resource to identify for what conditions patients are seeking treatment, and with what outcomes.

Cancer Care

Every cancer patient and their families should be offered complementary therapies as part of their treatment package to support them in their cancer journey. Cancer centres and hospices providing access to complementary therapies should be encouraged to make wider use of Measure Yourself Concerns and Wellbeing (MYCaW) to evaluate the benefits gained by patients using complementary therapies in cancer support care. Co-ordinated research needs to be carried out, both clinical trials and qualitative studies, on a range of complementary, traditional and natural therapies used in cancer care support.

Cost Savings

The government should run NHS pilot projects which look at non-conventional ways of treating patients with long-term and chronic conditions affected by Effectiveness Gaps, such as stress, arthritis, asthma and musculoskeletal problems, and audit these results against conventional treatment options for these conditions to determine whether cost savings and better patient outcomes could be achieved.

END OF QUOTE

Here are a few brief comments on those three recommendations.

Evidence base and research

NICE guidelines are based on rigorous assessments of efficacy, safety and costs. Such evaluations are possible for all interventions, including SCAM. Qualitative data are useless for this purpose. Outcome measures like the MYMOP are measures that can and are used in clinical trials. To use them outside clinical trials would not provide any relevant information about the specific effects of SCAM because this cannot account for confounding factors like the natural history of the disease, regression towards the mean, etc. The entire paragraph disclosed a remarkable level of naivety and ignorance about research on behalf of the PGIH.

Cancer care

There is already a significant amount of research on SCAM for cancer (see for instance here). It shows that no SCAM is effective in curing any form of cancer, and that only very few SCAMs can effectively improve the quality of life of cancer patients. Considering these facts, the wholesale recommendation of offering SCAM to cancer patients can only be characterised as dangerous quackery.

Cost savings

Such a pilot project has already been conducted at the behest of Price Charles (see here). Its results show that flimsy research will generate flimsy findings. If anything, a rigorous trial would be needed to test whether more SCAM on the NHS saves or costs money. The data currently available suggests that the latter is the case (see also here, here, here, here, etc.).

Altogether, one gets the impression that the PGIH need to brush up on their science and knowledge (if they invite me, I’d be delighted to give them another lecture). As it stands, it seems unlikely that their approach will, in fact, bring about improvements in patient care.

The objective of this ‘real world’ study was to evaluate the effectiveness of integrative medicine (IM) on patients with coronary artery disease (CAD) and investigate the prognostic factors of CAD in a real-world setting.

A total of 1,087 hospitalized patients with CAD from 4 hospitals in Beijing, China were consecutively selected between August 2011 and February 2012. The patients were assigned to two groups:

  1. Chinese medicine (CM) plus conventional treatment, i.e., IM therapy (IM group). IM therapy meant that the patients accepted the conventional treatment of Western medicine and the treatment of Chinese herbal medicine including herbal-based injection and Chinese patent medicine as well as decoction for at least 7 days in the hospital or 3 months out of the hospital.
  2. Conventional treatment alone (CT group).

The endpoint was a major cardiac event [MCE; including cardiac death, myocardial infarction (MI), and the need for revascularization].

A total of 1,040 patients finished the 2-year follow-up. Of them, 49.4% received IM therapy. During the 2-year follow-up, the total incidence of MCE was 11.3%. Most of the events involved revascularization (9.3%). Cardiac death/MI occurred in 3.0% of cases. For revascularization, logistic stepwise regression analysis revealed that age ⩾ 65 years [odds ratio (OR), 2.224], MI (OR, 2.561), diabetes mellitus (OR, 1.650), multi-vessel lesions (OR, 2.554), baseline high sensitivity C-reactive protein level ⩾ 3 mg/L (OR, 1.678), and moderate or severe anxiety/depression (OR, 1.849) were negative predictors (P<0.05); while anti-platelet agents (OR, 0.422), β-blockers (OR, 0.626), statins (OR, 0.318), and IM therapy (OR, 0.583) were protective predictors (P<0.05). For cardiac death/MI, age ⩾ 65 years (OR, 6.389) and heart failure (OR, 7.969) were negative predictors (P<0.05), while statin use (OR, 0.323) was a protective predictor (P<0.05) and IM therapy showed a beneficial tendency (OR, 0.587), although the difference was not statistically significant (P=0.218).

The authors concluded that in a real-world setting, for patients with CAD, IM therapy was associated with a decreased incidence of revascularization and showed a potential benefit in reducing the incidence of cardiac death or MI.

What the authors call ‘real world setting’ seems to be a synonym of ‘lousy science’, I fear. I am not aware of good evidence to show that herbal injections and concoctions are effective treatments for CAD, and this study can unfortunately not change this. In the methods section of the paper, we read that the treatment decisions were made by the responsible physicians without restriction. That means the two groups were far from comparable. In their discussion section, the authors state; we found that IM therapy was efficacious in clinical practice. I think that this statement is incorrect. All they have shown is that two groups of patients with similar diagnoses can differ in numerous ways, including clinical outcomes.

The lessons here are simple:

  1. In clinical trials, lack of randomisation (the only method to create reliably comparable groups) often leads to false results.
  2. Flawed research is currently being used by many proponents of  SCAM (so-called alternative medicine) to mislead us about the value of SCAM.
  3. The integration of dubious treatments into routine care does not lead to better outcomes.
  4. Integrative medicine, as currently advocated by SCAM-proponents, is a nonsense.

Belgian homeopaths, together with the ‘European Committee for Homeopathy’, have published a statement which I find too remarkable to withhold it from you:

START OF QUOTE

Users of homeopathic medicines can no longer remain silent about the untruths circulating in the media. These lies raise doubts which naïve and gullible people take on board all too easily and then see homeopathy as quackery. None of this is accurate!

Because they fear seeing some of their ‘certainties’ questioned, the SKEPP movement is firing off at anything that current science cannot yet explain with both barrels.

The contents of homeopathic medicines
SKEPP states that a homeopathic medicine is nothing more than a drop of water in a swimming pool and therefore has nothing in it. This is  wrong. Tests performed on a high homeopathic potency (30CH) of Gelsemium sempervirens (Yellow Jasmine, a very common homeopathic medicine) have detected 36 micrograms of a specific substance per gram of solution [1]. Opponents denounce homeopathic medicines as being nothing but water. This is  wrong. This water, the solvent itself, contains a specific signature of the active ingredient. Basic research has demonstrated this [2].

Clinical efficacy.
By asserting at every opportunity that there is no evidence of the clinical effectiveness of homeopathy, opponents sow doubt. Correction:  such proof [3] does exist.  The fact that critics refuse to look at or accept these data speaks volumes about their attitude to science.
What is true, however, is that there is  not enough  scientific evidence of effectiveness. Science demands a lot of such evidence – and rightly so. There would be more if the universities applied the rules correctly!  For example: The Professional Union of Homeopathic Physicians had accepted a double-blind research protocol for fibromyalgia which took account of homeopathy’s individualized approach. This research was to be carried out at the Rheumatology Department of a hospital in Brussels with the agreement of the Rector of the Faculty of Medicine. But the hospital’s ethics committee decided that it would be unethical to test a ‘placebo’ (the homeopathic medicine) versus another placebo! Making an a priori assumption that homeopathic medicine is just a placebo, even before beginning the study, flies in the face of scientific objectivity.

Patients are not stupid!
In the meantime, Pro Homeopathia, the Belgian association of homeopathy patients, is no longer able to contain its members’ exasperation. It has published an article [4]  which denounces in direct terms the accusations of credulity, or even stupidity levelled at patients, in blatant disregard of their therapeutic freedom of choice and their capacity for critical thought.

Dare to ask questions! 
Why all this misinformation in the press? Why do these ‘experts’, whose opinions on homeopathy above all betray their profound misunderstanding of this discipline, flood the media with fake news? What is the hidden agenda behind this campaign of systematic denigration? Homeopathy and many other complementary medicines only want to collaborate, both in medical practice and in scientific research … fair play! It’s called integrative medicine!

References
[1]Nanoparticle Characterization of Traditional Homeopathically-Manufactured Cuprum metallicum and Gelsemium Sempervirens Medicines and Controls. Novembre 2018: https://www.thieme-connect.de/DOI/DOI?10.1055/s-0038-1666864)
[2]Nuclear Magnetic Resonance characterization of traditional homeopathically-manufactured copper (Cuprum metallicum) and a plant (Gelsemium sempervirens) medicines and controls. Août 2017: https://doi.org/10.1016/j.homp.2017.08.001
[3]Model validity and risk of bias in randomized placebo-controlled trials of individualised homeopathic treatment. 2016: http://dx.doi.org/10.1016/j.ctim.2016.01.005 //Clinical verification in homeopathy and allergic conditions. 2012 http://dx.doi.org/10.1016/j.homp.2012.06.002 //Scientific framework of homeopathy 2017. www.lmhi.org/Article/Detail/42)
[4]http://www.homeopathie-unio.be/uploads/files/unprotected/Presse/Attaques%20Hom%C3%A9o-FR2.pdf

END OF QUOTE

For regular readers of this blog, any comment on this little article might well be superfluous. For newcomers, I nevertheless provide a few thoughts. In doing so, I simply follow the three headings used above.

The contents of homeopathic medicines

A homeopathic C30 potency (the one that is used most frequently) is a dilution of 1 part homeopathic stock to 1000000000000000000000000000000000000000000000000000000000000 parts of diluent. This amounts to little more than one molecule of stock per universe. This is an undeniable fact, and the reference provided (incidentally, the link to it is dead) does not change it in any way. The theory of ‘the memory of water’ is an implausible hypothesis that has no basis in reality. It is believed only by homeopaths, and ‘studies’ that seemingly support it are flimsy, false or biased, and usually only get published in journals such as ‘Homeopathy’ (where also the reference provided appeared).

Clinical efficacy

This is a subject that we have already discussed ad nauseam. Highly diluted homeopathic remedies are pure placebos. If someone does not believe this nor all the evidence provided on this blog, they perhaps trust the many independent international bodies that have looked at the totality of the reliable evidence for or against homeopathy. Their verdicts are unanimously negative. (The above-cited decision of the ethics committee is therefore the only one that is ethically possible.)

Patients are not stupid!

That is absolutely correct; patients are certainly not stupid. And their experiences are certainly real. What is often wrong, however, is the interpretation of their experiences. When a patient’s symptoms improve after taking a highly diluted remedy, the perceived improvement is due to a long list of factors that are unrelated to the remedy: placebo, natural history, regression towards the mean, etc.

Patients are not stupid, but the misinformation homeopaths incessantly publish might render them stupid – one more reason why such irresponsible nonsense ought to stop.

 

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.

 

Once again, I am indebted to the German homeopathy lobbyist, Jens Behnke (research officer at the Karl and Veronica Carstens-Foundation); this time for alerting me via a tweet to the existence of the ‘Institute for Scientific Homeopathy’ run by Dr K Lenger. Anyone who combines the terms ‘scientific’ and ‘homeopathy’ has my full attention.

The institution seems to be small (too small to have its own website); in fact, it seems to have just one member: Dr Karin Lenger. But size is not everything! Lenger has achieved something extraordinary: she has answered the questions that have puzzled many of us for a long time; she has found the ‘modus operandi’ of homeopathy by discovering that:

  • Homeopathy is a regulation therapy that acts (and reacts) as per the principle of resonance to deal hypo- and hyper-functions of pathological pathways.
  • As per resonance principle, the fundamental principles of homeopathy have the same frequencies so that the resonance principle can work.
  • Pathological pathways are cured by using their highly potentized substrates, inhibitors, and enzymes.
  • The efficacy of homeopathy now has a scientific base and is completely explained by applying biochemical and biophysical laws.

Progress at last!

If that is not noteworthy, what is?

But there is more!

This website, for instance, explains that Lenger Karin Dr.rer.nat., pursued Diploma in Biochem, studied Biochemistry at the Universities of Tubingen and Cologne. Her research topics revolved around enzymatic gene regulation, cancer research, enzymatic mechanisms of steroid hormones at the Medical University of Lubeck. In 1987 she became a Lecturer for Homeopathy at DHU ((Deutsche Homöopathie Union = German Homeopathy Union). Since 1995 she worked as a Homeopathic Practitioner and developed the “biochemical homeopathy” by using highly potentized substrates of pathological enzymes for her patients. She detected magnetic photons in high homeopathic potencies by two magnetic resonance methods and developed a model of physical and biochemical function of homeopathy.

Karin Lenger detected magnetic photons in highly diluted and potentized homeopathic remedies. Since the living body is an electromagnetic wavepackage (Einstein), the homeopathic law of Similars (Hahnemann 1755-1843) can be expressed as: the frequencies of the patient must match the frequencies of the remedies. Homeopathy is a regulation therapy curing hypo and hyperfunction of a pathological pathway by resonance: highly potentized substrates, inhibitors, enzymes, receptors of the distinct pathological pathways cure according to biochemical rules: A homeopathic symptom picture is obtained by poisoning a volunteer with a toxin. Simultaneously he develops psychological symptoms, the toxicological pathway and e.g. frequencies I-V. The highly potentized toxin has the frequencies I-V. The patient has symptoms as if he was poisoned by the toxin: during his illness he developed the toxicological pathway, frequencies I-V and psychological symptoms. The potentized toxin cures simultaneously the patient’s frequencies by resonance, his pathological pathway and the psychological symptoms. A stitch of honey bee, apis mellifica, causes a red oedema; a patient developing a red oedema at the finger-joint by rheumatism is cured by highly potentized Apis mellifica. Paralyses caused by a lack of the neurotransmitter acetylcholine bound to the acetylcholine-receptor at the post-synapsis can be healed by using these potentized remedies: the venom of cobra, Naja tripudians containing the receptor’s irreversible inhibitor cobrotoxin, the reversible inhibitor Atropine and Acetylcholine, daily applied. The availability of acetylcholine is maintained by glycolysis and fatty acid oxidation. This can be supported by giving these remedies: Lecithin, Lipasum, Glycerinum, Glucosum and Coenzyme A.

And in case, you are not yet fully convinced, a recent publication is bound to ball you over. Here is its abstract, if you need more, the link allows you to read the full paper as well:

Homeopathy, a holistic therapy, is believed to cure only acute symptoms of a beginning illness according to the Laws of Similars; but not deep, bleeding, septic wounds. The homeopaths refuse to heal according to special medical indications. Based on Lenger’s detection of magnetic photons in homeopathic remedies a biochemical and biophysical model of homeopathic healing was developed Biochemical, pathological pathways can be treated by their highly potentized substrates and inhibitors. Three groups of patients with moderate, severe and septic wounds had been successfully treated with the suitable remedies depending on the biochemical pathological state.

___________________________________________________________

Do I sense a Nobel Prize in the offing?

Surely!

Lenger’s clinical trial is baffling. But much more impressive are the ‘magnetic photons’ and the reference to Einstein. This is even more significant, if we consider what the genius (Einstein, not Lenger!) is reported to have said about homeopathy:  Einstein reflected for a little while and then said: “If one were to lock up 10 very clever people in a room and told them they were only allowed out once they had come up with the most stupid idea conceivable, they would soon come up with homeopathy.”

I would warn every parent who thinks that taking their child to a chiropractor is a good idea. For this, I have three main reasons:

  1. Chiropractic has not been shown to be effective for any paediatric condition.
  2. Chiropractors often advise parents against vaccinating their children.
  3. Chiropractic spinal manipulations can cause harm to kids.

The latter point seems to be confirmed by a recent PhD thesis of which so far only one short report is available. Here are the relevant bits of information from it:

Katie Pohlman has successfully defended her PhD thesis, which focused on the assessment of safety in pediatric manual therapy. As a clinical research scientist at Parker University, Dallas, Texas, she identified a lack of prospective patient safety research within the chiropractic population in general and investigated this deficit in the paediatric population in particular.

Pohlman used a cross-sectional survey to assess the barriers and facilitators for participation in a patient safety reporting system. At the same time, she also conducted a randomized controlled trial comparing the quantity and quality of adverse event reports in children under 14 years receiving chiropractic care.

The RCT recruited 69 chiropractors and found adverse events reported in 8.8% and 0.1% of active and passive surveillance groups respectively. Of the adverse events reported, 56% were considered mild, 26% were moderate and 18% were severe. The frequency of adverse events was more common than previously thought.

This last sentence from the report is somewhat puzzling. Our systematic review of the risks of spinal manipulation showed that data from prospective studies suggest that minor, transient adverse events occur in approximately half of all patients receiving spinal manipulation. The most common serious adverse events are vertebrobasilar accidents, disk herniation, and cauda equina syndrome. Estimates of the incidence of serious complications range from 1 per 2 million manipulations to 1 per 400,000. Given the popularity of spinal manipulation, its safety requires rigorous investigation.

The 8.8% reported by Pohlman are therefore not even one fifth of the average incidence figure reported previously in all age groups.

What could be the explanation for this discrepancy?

There are, of course, several possibilities, including the fact that infants cannot tell the clinician when their pain has increased. However, the most likely one, in my view, lies in the fact that RCTs are wholly inadequate for investigating risks because they typically include far too few patients to generate reliable incidence figures about adverse events. More importantly, clinicians included in such studies are self-selected (and thus particularly responsible/cautious) and are bound to behave most carefully while being part of a clinical trial. Therefore it seems possible – I would speculate even likely – that the 8.8% reported by Pohlman is unrealistically low.

Having said that, I do feel that the research by Kathie Pohlman is a step in the right direction and I do applaud her initiative.

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