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

commercial interests

I was alerted to the following conference announcement:

The MEP Interest Group on Integrative Medicine and Health is delighted to invite you to the event ‘Integrative Medicine and Health in prevention and management of COVID-19 and long COVID’ on Thursday 2 June 16.0018.00 CEST.

This event will give you in-depth information about:

Expert speakers will share their knowledge and insights about how:

• Complementary and Integrative Medicine and Health interventions can improve resilience to COVID-19 infection.

• Promoting resilience and health restoration can reduce the risk of severe COVID-19 or development of Long COVID.

• These interventions can improve the recovery from Long COVID.

Key speakers and topics:

Therapeutic strategies of complementary medicines in the COVID 19 pandemic and Long COVID in addition to conventional medicine

Dr Joanna Dietzel, MD Neurologist, Acupuncturist. Department for integrative & complementary medicine, Institute of social medicine, epidemiology and health economics, Charité – Universitätsmedizin Berlin, Germany.

Chinese herbal medicine treatment in cases of infections with SARS-CoV-2 – therapeutic strategies for COVID-19 and Long COVID

Dr Christian Thede, MD, General practitioner, specialised in Acupuncture and Chinese Medicine. Former lecturer in Chinese medicine, University of Witten-Herdecke, Germany

Instructor for Acupuncture and Chinese Medicine at International Society of Chinese Medicine (SMS).

Traditional and Complementary Medicine contributions to health system resilience during COVID-19 – the WHO perspective

Dr Geetha Kopalakrishna, MD, Bachelor of Ayurvedic Medicine & Surgery

Technical Officer at Traditional, Complementary & Integrative Medicine, Department of Service Delivery and Safety, World Health Organization, Geneva, Switzerland

Key member of the AYUSH-based COVID-19 response Task Force for the Government of India.

Research programme into integrative medicine’s contribution to improving resilience to COVID-19 infection and reducing the risk of severe COVID-19 or development of Long COVID

Dr Helene M. Langevin, Director at National Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, Maryland (MD), USA. Previously, Director of the Harvard Osher Center for Integrative Medicine and professor of medicine at Harvard Medical School, Boston (MA) and professor of neurological sciences at the Larner College of Medicine at the University of Vermont (VT).

Q&A sessions after the presentations.

Resilience to infections: a solution for COVID-19 and other infectious illnesses

Studies show that certain common medical conditions put people at higher risk for severe illness and death from COVID-19. Nearly two-thirds of COVID-19 hospitalizations could be attributed to obesity, diabetes, hypertension, and heart failure. There is increasing awareness that a health system that focuses on improving health could prevent all these conditions to a large extent.

Long COVID

More than 40% of people who have or had COVID-19 get long COVID, and among people who needed hospitalization, the statistics go up to 57%. The recovery from such post viral syndromes will be greatly helped by offering patients access to complementary and integrative medicine interventions that aim at restoring their health balance.

MEP Interest Group on Integrative Medicine and Health

The event is hosted by the members of the MEP Interest Group on Integrative Medicine & Health:

Michèle Rivasi, Greens/EFA, France

Sirpa Pietikäinen, EPP, Finland

Tilly Metz, Greens/EFA, Luxembourg

Margrete Auken, Greens/EFA, Denmark

Romana Jerković, S&D, Croatia

Manuela Ripa, Greens/EFA, Germany

I had not been aware of the ‘MEP Interest Group on Integrative Medicine & Health‘. Therefore, I looked it up and found this:

The newly established Interest Group on Integrative Medicine & Health continues the work of the former MEP Interest Group on CAM. This group brings together MEPs who work collectively to promote the inclusion of CAM as part of Integrative Medicine & Health in all possible European Parliament public health policy.

Why an Interest Group in the European Parliament?

One in two EU citizens uses complementary medicine either alongside or as an alternative to conventional biomedical care. This high demand is not yet reflected in EU or national health policy or provision. In addition, there is diversity in complementary medicine regulation across the EU. There are differences in who can practice complementary medicine, what qualifications are required and how services are offered and financed. These discrepancies mean that citizens experience practical and attitudinal barriers that limit their access to and use of TCIM.

The health sector in the EU Member States is facing considerable challenges, such as antimicrobial resistance (AMR), increasing prevalence of Non-Communicable Diseases (NCDs) and soaring costs. Complementary medicine can offer a significant contribution to meet these challenges. These modalities are “integrative”, offering patient-centered healthcare, based on evidence-informed integration of conventional biomedicine and complementary medicine. Integrative Medicine and Health focuses on the whole person and considers the individual in its physical, psychological, spiritual, social and environmental context. It is inclusive of all professions and practices that use this approach and meets the demand of EU citizens for a more holistic, patient-centered approach in medicine. At the same time, TCIM is at the center of political and scientific debate. In this context, a forum for discussion on Integrative and Complementary Medicine’s contribution to EU health systems will bring clarity and rationality to this debate.

Aims and objectives of the Interest Group on Integrative Medicine & Health

  • Establish and maintain a forum for discussion and action with all stakeholders regarding Integrative Medicine and Health.
  • Raise awareness of Integrative Medicine and its contribution to more sustainable healthcare systems in the EU and a more holistic approach to health.
  • Focus on the integration of complementary modalities into the health systems of the EU Member States.
  • Protect and promote citizens’ right to choose their own healthcare while providing access to Integrative Medicine and Health information.
  • Advocate for EU involvement in setting unified standards to regulation of Integrative Medicine and Health.

__________________________________

Unified standards? But what about high or perhaps just scientific standards? What about first doing the research and then making claims about CAM or TCIM or however you decide to call it? Has common sense gone out of fashion?

Yes, you guessed it: I am seriously underwhelmed by all this. To show you why, let me list just a few claims from the above two statements that are based purely on wishful thinking:

  • Complementary and Integrative Medicine and Health interventions can improve resilience to COVID-19 infection.
  • These interventions can improve the recovery from Long COVID.
  • Studies show that certain common medical conditions put people at higher risk for severe illness and death from COVID-19.
  • The recovery from such post viral syndromes will be greatly helped by offering patients access to complementary and integrative medicine interventions that aim at restoring their health balance.
  • One in two EU citizens uses complementary medicine either alongside or as an alternative to conventional biomedical care.
  • The health sector in the EU Member States is facing considerable challenges, such as antimicrobial resistance (AMR), increasing prevalence of Non-Communicable Diseases (NCDs) and soaring costs. Complementary medicine can offer a significant contribution to meet these challenges.
  • These modalities are “integrative”, offering patient-centered healthcare, based on evidence-informed integration of conventional biomedicine and complementary medicine.
  • Integrative medicine … meets the demand of EU citizens for a more holistic, patient-centered approach in medicine.

I find all this confusing and concerning in equal measure. I also seriously doubt that the forum for discussion on Integrative and Complementary Medicine will bring clarity and rationality to this debate. If they really wanted a debate, they would need to include a few critical thinkers; can anyone recognize one on the list of speakers? I cannot!

I fear the aim of the group and their meeting is to mislead us all into thinking that CAM, TCIM, etc. generate more good than harm without ever delivering the evidence for that assumption. Therefore, I suggest they rename both the conference as well as their group:

Wishful thinking in prevention and management of COVID-19 and long COVID

and

MEP Interest Group on Wishful Thinking and Promotion of Quackery

 

 

PS

As an antidote to wishful thinking, I recommend reading some proper science papers on the subject. Here are the conclusions of an up-to-date and wishful-thinking-free review on the subject of post-acute infection syndrome:

Unexplained post-acute infection syndromes (PAISs) appear to be an under-recognized feature of a spectrum of infectious diseases in a minority of patients. At present, our understanding of the underlying pathophysiologic mechanisms and etiologic factors is poor and there are no known objective markers or effective therapeutic options. More basic biomedical research is needed. The overlap of symptoms, signs, and general features of the individual PAISs suggests the involvement of shared pathological pathways and the possibility that common diagnostic markers, or even a unified etiological model, might be established.

However, some symptoms or clinical characteristics seem to be trigger-specific or more prevalent in one PAIS than in others, emphasizing the need for cohorts with a well-documented infectious trigger. The overall clinical picture of many PAISs often overlaps with the presentation of post-infectious ME/CFS or fibromyalgia, or resembles other fatiguing, neurological, or rheumatic disorders. Exploiting existing knowledge of these conditions might help guide future scientific discovery and progress in clinical care.

The SARS-CoV-2 pandemic uncovered a significant gap in knowledge about post-acute sequelae of infectious diseases and identified the need for better diagnostic care and clinical infrastructure for patients experiencing these long-term effects. In addition to basic biomedical research, more needs to be done to refine diagnostic criteria and obtain more reliable estimates of the prevalence and societal burden of these disorders to help shape health-policy decisions. Moreover, we call for unified nomenclature and better conceptualization of post-acute infection symptoms.

There is much to be done, but the unprecedented amount of attention and resources that have recently been allocated to the study of COVID-19-related pathology brings a promise of much-needed progress in the wider field of unexplained infection-associated chronic disability.

Ayush-64 is an Ayurvedic formulation, developed by the Central Council for Research in Ayurvedic Sciences (CCRAS), the apex body for research in Ayurveda under the Ministry of Ayush. Originally developed in 1980 for the management of Malaria, this drug has now been repurposed for COVID-19 as its ingredients showed notable antiviral, immune-modulator, and antipyretic properties. Its ingredients are:

Alstonia scholaris R. Br. Aqueous extract of (Saptaparna) Bark-1 part
Picrorhiza Kurroa Royle Aqueous extract of (Kutki) Rhizome-1 part
Swertia chirata Buch-Ham. Aqueous extract of (Chirata) Whole plant-1 part
Caesalphinia crista, Linn. Fine powder of seed (Kuberaksha) Pulp-2 parts

The crucial question, of course, is does AYUSH-64 work?

An open-label randomized controlled parallel-group trial was conducted at a designated COVID care centre in India with 80 patients diagnosed with mild to moderate COVID-19 and randomized into two groups. Participants in the AYUSH-64 add-on group (AG) received AYUSH-64 two tablets (500 mg each) three times a day for 30 days along with standard conventional care. The control group (CG) received standard care alone.

The outcome measures were:

  • the proportion of participants who attained clinical recovery on days 7, 15, 23, and 30,
  • the proportion of participants with negative RT-PCR assay for COVID-19 at each weekly time point,
  • change in pro-inflammatory markers,
  • metabolic functions,
  • HRCT chest (CO-RADS category),
  • the incidence of Adverse Drug Reaction (ADR)/Adverse Event (AE).

Out of 80 participants, 74 (37 in each group) contributed to the final analysis. A significant difference was observed in clinical recovery in the AG (p < 0.001 ) compared to CG. The mean duration for clinical recovery in AG (5.8 ± 2.67 days) was significantly less compared to CG (10.0 ± 4.06 days). Significant improvement in HRCT chest was observed in AG (p = 0.031) unlike in CG (p = 0.210). No ADR/SAE was observed or reported in AG.

The authors concluded that AYUSH-64 as adjunct to standard care is safe and effective in hastening clinical recovery in mild to moderate COVID-19. The efficacy may be further validated by larger multi-center double-blind trials.

I do object to these conclusions for several reasons:

  1. The study cannot possibly determine the safety of AYUSH-64.
  2. Even for assessing its efficacy, it was too small.
  3. The trial design followed the often-discussed A+B vs B concept and is thus prone to generate false-positive results.

I believe that it is highly irresponsible, during a medical crisis like ours, to conduct studies that can only produce unreliable findings. If there is a real possibility that a therapy might work, we do need to test it, but we should take great care that the test is rigorous enough to generate reliable results. This, I think, is all the more true, if – like in the present case – the study was done with governmental support.

Anyone who has followed this blog for a while will know that advocates of so-called alternative medicine (SCAM) are either in complete denial about the risks of SCAM or they do anything to trivialize them. Here is a dialogue between a SCAM proponent (P) and a scientist (S) that is aimed at depicting this situation. The conversation is fictitious, of course, but it is nevertheless based on years of experience in discussing these issues with practitioners of various types of SCAM. As we shall see, the arguments turn out to be perfectly circular.

P: My therapy is virtually free of risks.

S: How can you be so sure?

P: I am practicing it for decades and have never seen a single problem.

S: That could have several reasons; perhaps the patients who experience problems did simply not come back.

P: I find this unlikely.

S: I don’t, and I know of reports where patients had serious complications after the type of SCAM you practice.

P: These are isolated case reports. They do not amount to evidence.

S: How do you know they are isolated?

P: They must be isolated because, in the many clinical trials of my therapy available to date, you will not find any evidence of serious adverse effects.

S: That is true, but it has been repeatedly shown that these trials regularly fail to mention side effects altogether.

P: That’s because there aren’t any.

S: Not quite, clinical trials should always mention adverse effects, and if there were none, they should mention this too.

P: So, you admit that you have no evidence that my therapy causes adverse effects.

S: The thing is, I don’t need such evidence. It is you, the practitioners of this therapy, who should provide evidence that your treatments are safe.

P: We did! The complete absence of reports of side effects constitutes that evidence.

S: Except, there is some evidence. I already told you that there are several case reports of serious problems.

P: But case reports are anecdotes; they are no evidence.

S: Look, here is a systematic review of all the case reports. You cannot possibly deny that this is a concern.

P: It’s still merely a bunch of anecdotes, nothing more.

S: Only because your profession does nothing about it.

P: What do you think we need to do about it?

S: Like other professions, you need to systematically record adverse effects.

P: How would that help?

S: It would give us a rough indication of the size and severity of the problem.

P: This sounds expensive and complicated to organize.

S: Perhaps, but it is necessary if you want to be sure that your therapy is safe.

P: But we are sure already!

S: No, you believe it, but you don’t know it.

P: You are getting on my nerves with your obsession. Don’t you know that the true danger in healthcare is the adverse effects of pharmaceutical drugs?

S: But these drugs are also effective.

P: Are you saying my therapy isn’t?

S: What I am saying is that the drugs you claim to be dangerous do more good than harm, while this is not at all clear with your SCAM.

P: To me, that is very clear. My therapy helps many and harms nobody!

S: How do you know that it harms nobody?

 

 

… At this point, we have gone full circle and we can re-start this conversation from its beginning.

 

 

A recent article in LE PARISIEN entitled “L’homéopathie vétérinaire, c’est sans effet… mais pas sans risque” – Veterinary homeopathy is without effect … but not without risk, tells it like it is. Here are a few excerpts that I translated for you.

More than 77% of French people have tried homeopathy in their lifetime. But have you ever given it to your pet? Harmless in most cases, its use can be dangerous when it replaces a treatment whose effectiveness is scientifically proven … from a safety point of view, the tiny granules are indeed irreproachable: their use does not induce any drug interaction or undesirable side effects, nor does it run the risk of overdosing or addiction … homeopathic preparations owe their harmlessness to their lack of proper effects. “Neither in human medicine nor in veterinary medicine, at the current stage, clinical studies of all levels do not provide sufficient scientific evidence to support the therapeutic efficacy of homeopathic preparations”, stated the French Veterinary Academy in May 2021. These conclusions are in line with those of the French Academies of Medicine and Pharmacy, the British Royal College of Veterinary Surgeons, and all the international scientific bodies that have given their opinion on the subject.

Therefore, when homeopathy delays diagnosis or is used in place of proven effective treatments, its use represents a “loss of opportunity” for your pet. The greatest danger of homeopathy is not that the remedies are ineffective, but that some homeopaths believe that their therapies can be used as a substitute for genuine medical treatment,” summarizes a petition to the UK veterinary regulatory body signed by more than 1,000 British veterinarians. At best, this claim is misleading and, at worst, it can lead to unnecessary suffering and death.”

But how can we explain the number of testimonies from pet owners who say that “it works”? “I am very satisfied with the Kalium Bichromicum granules for my cat with an eye ulcer, which is healing very well”… These improvements, real or supposed, can be explained by “contextual effects”, among which the famous placebo effect (which is not specific to humans), your subjective interpretation of his symptoms, or the natural history of the disease.

When these contextual effects are ignored or misunderstood, the spontaneous resolution or reduction of the disease can be wrongly attributed to homeopathy, and thus maintain the illusion of its effectiveness. This confusion is all the more likely because homeopathy owes much of its popularity to its use to treat “everyday ailments”: nausea, allergies, fatigue, bruises, nervousness, etc., which tend to get better on their own with time, or which have a fluctuating expression…

In April 2019, the association published an open letter addressed to the National Council of the Order of Veterinarians, calling on it to take a position on the compatibility of homeopathy with the “ethical and scientific requirements” of the profession. The organization, whose official function is to guarantee the quality of the service rendered to the public by the 20,000 veterinarians practicing in France, issued its conclusions last October. It invited veterinary training centers to remove homeopathy from their curricula, under penalty of having their accreditation withdrawn, and thus their ability to deliver training credits.

In my view, this is a remarkably good and informative text. How often do homeopathy fans claim IT WORKS FOR ANIMALS AND THUS CANNOT BE A PLACEBO! The truth is that, as we have so often discussed on this blog, homeopathy does not work beyond placebo for animals. This renders veterinary homeopathy:

  • a waste of money,
  • potentially dangerous,
  • in the worst cases a form of animal abuse.

My advice is that, as soon as a vet recommends homeopathy, you look for the exit.

I was alerted to the following short article from ‘The Blackpool Gazette‘:

Criminals have been using the brand name Pfizer to sell fake homeopathic vaccines to residents, according to police. The white tablets are sold under the pretence that they are an alternative to traditional vaccines, but actually contain no active ingredient. Analysis conducted by Lancashire Police revealed the tablets were nothing more than sugar pills. “Please note Pfizer do not produce any tablets as a cure or prophylactic for COVID-19,” a spokesman for the force added.

What is homeopathy?

Homeopathy is a “treatment” based on the use of highly diluted substances, which practitioners claim can help the body heal itself, according to the NHS. A 2010 House of Commons Science and Technology Committee report on homeopathy said that homeopathic remedies perform no better than placebos. In 2017, NHS England said it would no longer fund homeopathy on the NHS as the lack of any evidence for its effectiveness did not justify the cost. This was backed by a High Court judgement in 2018.

I think there might be a slight misunderstanding here. The homeopathic remedy might not be fake, as it was produced according to the concepts of homeopathy. It is homeopathy itself that is fake. To me, it looks as though we are dealing with the German product I mentioned a while ago. Let me remind you:

Many people believe that homeopathy is essentially plant-based – but they are mistaken! Homeopathic remedies can be made from anything: Berlin wall, X-ray, pus, excrement, dental plaque, mobile phone rays, poisons … anything you can possibly think of. So, why not from vaccines?

This is exactly what a pharmacist specialized in homeopathy thought.

It has been reported that the ‘Schloss-Apotheke’ in Koblenz, Germany offered for sale a homeopathic remedy made from the Pfizer vaccine. This has since prompted not only the Chamber of Pharmacists but also the Paul Ehrlich Institute and Pfizer to issue statements. On Friday (30/4/2021) morning, the pharmacy had advertised homeopathic remedies based on the Pfizer/Biontech vaccine. The Westphalia-Lippe Chamber of Pharmacists then issued an explicit warning against it. “We are stunned by this,” said a spokesman. The offer has since disappeared from the pharmacy’s website.

On Friday afternoon, the manufacturer of the original vaccine also intervened. The Paul Ehrlich Institute released a statement making it clear that a vaccine is only safe “if it is administered in accordance with the marketing authorization.”

The Schloss-Apotheke had advertised the product in question with the following words:

“We have Pfizer/BioNTech Covid-19-Vaccine in potentized form up to D30 as globules or dilution (for discharge) in stock.”

The chamber of pharmacists countered with a warming under the heading “Facts instead of Fake News” on Facebook and Instagram:

“Whatever they might contain: These remedies are no effective protection against Covid-19.”

Pharmacy manager, Annette Eichele, of the Schloss-Apotheke claimed she had not sold homeopathic Corona vaccines and stressed that effective vaccines of this kind do not exist. According to Eichele, only an additional “mini drop” of the original Biontech vaccine had been used and “highly potentized” and prepared homeopathically. According to Eichele, Corona vaccinations that had already been administered were thus to have a “better and more correct effect with this supplementary product, possibly without causing side effects … but this is not scientifically proven”. The homeopathic product had been produced only on customer request and had been sold less than a dozen times in the past weeks. Ten grams of the remedy were sold for about 15 Euros. On Twitter, Eichele stated: „Wir haben nichts Böses getan, wir wollten nur Menschen helfen!“ (We have done nothing evil, we only wanted to help people). I am reminded yet again of Bert Brecht who observed:

“The opposite of good is not evil but good intentions”.

_______________________

If I am right, the remedy is not truly fake but a genuine product of a fake concept, namely homeopathy. In that case, the term ‘criminal’ might need to be applied to homeopathy itself – an interesting thought!

The cardiothoracic surgeon and famous US woo merchant, Dr. Mehmet Oz, is probably known to most readers. I have previously mentioned him several times, for instance, here and here. His institution, Columbia University in New York City, has had many (I’d say too many) years of patience with his relentless promotion of outright and often dangerous quackery. Now it has been reported that the university has finally cut ties with Dr. Oz:

“It took Columbia far too long to remove Oz from its otherwise distinguished medical faculty,” Henry Miller, MD, of the Pacific Research Institute in California, told MedPage Today via email. Miller stressed that “the ‘Oz controversy’ was never about free speech. It was about an unethical grifter whose claims and pronouncements were not supported by science and were injurious to consumers — in the interest of financial benefit to Oz himself. That constitutes professional misconduct.”

The university’s Irving Medical Center quietly ended its relationship with Oz at the end of April, according to The Daily Beast. He had been removed from several pages of the medical center’s website in mid-January. In 2018, Oz’s title had been changed to professor emeritus and special lecturer, according to reports. A spokesperson for Columbia University confirmed the 2018 change in an email to MedPage Today.

In 2015, Miller and colleagues sent a letter to Lee Goldman, MD, MPH, dean of the Faculties of Health Sciences and Medicine at the university, calling for Oz’s expulsion. Oz had “repeatedly shown disdain for science and for evidence-based medicine” and “manifested an egregious lack of integrity by promoting quack treatments and cures in the interest of personal financial gain,” according to Miller’s group…

In 2014, Oz was called to testify before the Senate Subcommittee on Consumer Protection, Product Safety, and Insurance during a hearing on false advertising in the diet and weight-loss industry. Senators grilled Oz regarding statements he made on “The Dr. Oz Show” that promoted green coffee bean extract as a “miracle pill” for weight loss.

But long before that hearing, tensions had built between Oz and the medical community because of his penchant for spouting dubious medical claims on his TV show and in the media. For example, in a 2011 segmentABC News‘ chief health and medical editor Richard Besser, MD, called out a purported “study” of arsenic in apple juice that Oz conducted for an episode of his show.

Besser charged that Oz’s science was shoddy because he reported total arsenic rather than the breakdown between organic and inorganic arsenic — only the latter of which is known to be toxic. Even the FDA sent the show a letter before the segment aired saying it would be “irresponsible and misleading” to report the results.

Oz again broke with medical science during the pandemic when he touted hydroxychloroquine as a cure for COVID-19, even as evidence mounted that it had no effect on disease course.

Oz is currently running for a U.S. Senate seat in Pennsylvania as a Republican candidate. Former President Trump endorsed Oz, touting Oz’s medical and academic credentials in a statement, according to NPR: “He even said that I was in extraordinary health, which made me like him even more (although he also said I should lose a couple of pounds!).”

__________________________

I have to admit that I find these reports somewhat puzzling. Don’t get me wrong: it’s not that I don’t think Oz deserves to be dismissed. In fact, he had already richly deserved it many years ago. What I find, however, odd is that giving someone the title ’emeritus professor’ can hardly be called ‘cutting ties’ with him. In some ways, it is even the opposite (I should know because I currently have this status).

When I looked up Oz, Columbia listed him as:

Oz, Mehmet C. (MD)
Special Lecturer in the Department of Surgery
Phone: 212.305.4434 · Fax: 212.342.3520
Location: MHB, Rm. 435-62

Similarly, the website of the Irving Medical Center is full of entries about Oz. Confusion is therefore more than justified, I think.

What is needed, I feel, is a clear statement from Columbia University about its relationship with Dr. Oz. Are they still proud of his considerable fame/notoriety, or did they in fact have the integrity to cut ties with one of the most self-aggrandizing woo merchants of all times?

There are many patients in general practice with health complaints that cannot be medically explained. Some of these patients attribute their problems to dental amalgam.

This study examined the cost-effectiveness of the removal of amalgam fillings in patients with medically unexplained physical symptoms (MUPS) attributed to amalgam compared to usual care, based on a prospective cohort study in Norway.

Costs were determined using a micro-costing approach at the individual level. Health outcomes were documented at baseline and approximately two years later for both the intervention and the usual care using EQ-5D-5L. Quality-adjusted life year (QALY) was used as the main outcome measure. A decision analytical model was developed to estimate the incremental cost-effectiveness of the intervention. Both probabilistic and one-way sensitivity analyses were conducted to assess the impact of uncertainty on costs and effectiveness.

In patients who attributed health complaints to dental amalgam and fulfilled the inclusion and exclusion criteria, amalgam removal was associated with a modest increase in costs at the societal level as well as improved health outcomes. In the base-case analysis, the mean incremental cost per patient in the amalgam group was NOK 19 416 compared to the MUPS group, while the mean incremental QALY was 0.119 with a time horizon of two years. Thus, the incremental costs per QALY of the intervention were NOK 162 680, which is usually considered to be cost-effective in Norway. The estimated incremental cost per QALY decreased with increasing time horizons, and amalgam removal was found to be cost-saving over both 5 and 10 years.

The authors concluded that this study provides insight into the costs and health outcomes associated with the removal of amalgam restorations in patients who attribute health complaints to dental amalgam fillings, which are appropriate instruments to inform health care priorities.

The group sizes were 32 and 28 respectively. This study was thus almost laughably small and therefore cannot lead to firm conclusions of any type. In this contest, a recent systematic review might be relevant; it concluded as follows:

On the basis of the available RCTs, amalgam restorations, if compared with resin-based fillings, do not show an increased risk for systemic diseases. There is still insufficient evidence to exclude or demonstrate any direct influence on general health. The removal of old amalgam restorations and their substitution with more modern adhesive restorations should be performed only when clinically necessary and not just for material concerns. In order to better evaluate the safety of dental amalgam compared to other more modern restorative materials, further RCTs that consider important parameters such as long and uniform follow up periods, number of restorations per patient, and sample populations representative of chronic or degenerative diseases are needed.

Similarly, a review of the evidence might be informative:

Since more than 100 years amalgam is successfully used for the functional restoration of decayed teeth. During the early 1990s the use of amalgam has been discredited by a not very objective discussion about small amounts of quicksilver that can evaporate from the material. Recent studies and reviews, however, found little to no correlation between systemic or local diseases and amalgam restorations in man. Allergic reactions are extremely rare. Most quicksilver evaporates during placement and removal of amalgam restorations. Hence it is not recommended to make extensive rehabilitations with amalgam in pregnant or nursing women. To date, there is no dental material, which can fully substitute amalgam as a restorative material. According to present scientific evidence the use of amalgam is not a health hazard.

Furthermore, there is evidence that the removal of amalgam fillings is not such a good idea. One study, for instance, showed that the mercury released by the physical action of the drill, the replacement material and especially the final destination of the amalgam waste can increase contamination levels that can be a risk for human and environment health.

As dental amalgam removal does not seem risk-free, it is perhaps unwise to remove these fillings at all. Patients who are convinced that their amalgam fillings make them ill might simply benefit from assurance. After all, we also do not re-lay electric cables because some people feel they are the cause of their ill-health.

Today is WORLD ASTHMA DAY, a good opportunity perhaps to revisit a few of our own evaluations of so-called alternative medicine (SCAM) for asthma. Here are the abstracts of some of our systematic reviews on the subject:

YOGA

Objective: The objective of this systematic review was to assess the effectiveness of yoga as a treatment option for asthma.

Method: Seven databases were searched from their inception to October 2010. Randomized clinical trials (RCTs) and non-randomized clinical trials (NRCTs) were considered, if they investigated any type of yoga in patients with asthma. The selection of studies, data extraction, and validation were performed independently by two reviewers.

Results: Six RCTs and one NRCT met the inclusion criteria. Their methodological quality was mostly poor. Three RCTs and one NRCT suggested that yoga leads to a significantly greater reduction in spirometric measures, airway hyperresponsivity, dose of histamine needed to provoke a 20% reduction in forced expiratory volume in the first second, weekly number of asthma attacks, and need for drug treatment. Three RCTs showed no positive effects compared to various control interventions.

Conclusions: The belief that yoga alleviates asthma is not supported by sound evidence. Further, more rigorous trials are warranted.

SPINAL MANIPULATION

Some clinicians believe that spinal manipulation is an effective treatment for asthma. The aim of this systematic review was to critically evaluate the evidence for or against this claim. Four electronic databases were searched without language restrictions from their inceptions to September 2008. Bibliographies and departmental files were hand-searched. The methodological quality of all included studies was assessed with the Jadad score. Only randomised clinical trials of spinal manipulation as a treatment of asthma were included. Three studies met these criteria. All of them were of excellent methodological quality (Jadad score 5) and all used sham-manipulation as the control intervention. None of the studies showed that real manipulation was more effective than sham-manipulation in improving lung function or subjective symptoms. It is concluded that, according to the evidence of the most rigorous studies available to date, spinal manipulation is not an effective treatment for asthma.

ACUPUNCTURE

Contradictory results from randomised controlled trials of acupuncture in asthma suggest both a beneficial and detrimental effect. The authors conducted a formal systematic review and meta-analysis of all randomised clinical trials in the published literature that have compared acupuncture at real and placebo points in asthma patients. The authors searched for trials published in the period 1970-2000. Trials had to measure at least one of the following objective outcomes: peak expiratory flow rate, forced expiratory volume in one second (FEV1) and forced vital capacity. Estimates of the standarised mean difference, between acupuncture and placebo were computed for each trial and combined to estimate the overall effect. Hetereogeneity was investigated in terms of the characteristics of the individual studies. Twelve trials met the inclusion criteria but data from one could not be obtained. Individual patient data were available in only three. Standardised differences between means ranging from 0.071 to 0.133, in favour of acupuncture, were obtained. The overall effect was not conventionally significant and it corresponds to an approximate difference in FEV1 means of 1.7. After exploring hetereogenenity, it was found that studies where bronchoconstriction was induced during the experiment showed a conventionally significant effect. This meta-analysis did not find evidence of an effect of acupuncture in reducing asthma. However, the meta-analysis was limited by shortcomings of the individual trials, in terms of sample size, missing information, adjustment of baseline characteristics and a possible bias against acupuncture introduced by the use of placebo points that may not be completely inactive. There was a suggestion of preferential publication of trials in favour of acupuncture. There is an obvious need to conduct a full-scale randomised clinical trial addressing these limitations and the prognostic value of the aetiology of the disease.

RELAXATION THERAPIES

Background: Emotional stress can either precipitate or exacerbate both acute and chronic asthma. There is a large body of literature available on the use of relaxation techniques for the treatment of asthma symptoms. The aim of this systematic review was to determine if there is any evidence for or against the clinical efficacy of such interventions.

Methods: Four independent literature searches were performed on Medline, Cochrane Library, CISCOM, and Embase. Only randomised clinical trials (RCTs) were included. There were no restrictions on the language of publication. The data from trials that statistically compared the treatment group with that of the control were extracted in a standardised predefined manner and assessed critically by two independent reviewers.

Results: Fifteen trials were identified, of which nine compared the treatment group with the control group appropriately. Five RCTs tested progressive muscle relaxation or mental and muscular relaxation, two of which showed significant effects of therapy. One RCT investigating hypnotherapy, one of autogenic training, and two of biofeedback techniques revealed no therapeutic effects. Overall, the methodological quality of the studies was poor.

Conclusions: There is a lack of evidence for the efficacy of relaxation therapies in the management of asthma. This deficiency is due to the poor methodology of the studies as well as the inherent problems of conducting such trials. There is some evidence that muscular relaxation improves lung function of patients with asthma but no evidence for any other relaxation technique.

HERBAL MEDICINE

Background: Asthma is one of the most common chronic diseases in modern society and there is increasing evidence to suggest that its incidence and severity are increasing. There is a high prevalence of usage of complementary medicine for asthma. Herbal preparations have been cited as the third most popular complementary treatment modality by British asthma sufferers. This study was undertaken to determine if there is any evidence for the clinical efficacy of herbal preparations for the treatment of asthma symptoms.

Methods: Four independent literature searches were performed on Medline, Pubmed, Cochrane Library, and Embase. Only randomised clinical trials were included. There were no restrictions on the language of publication. The data were extracted in a standardised, predefined manner and assessed critically.

Results: Seventeen randomised clinical trials were found, six of which concerned the use of traditional Chinese herbal medicine and eight described traditional Indian medicine, of which five investigated Tylophora indica. Three other randomised trials tested a Japanese Kampo medicine, marihuana, and dried ivy leaf extract. Nine of the 17 trials reported a clinically relevant improvement in lung function and/or symptom scores.

Conclusions: No definitive evidence for any of the herbal preparations emerged. Considering the popularity of herbal medicine with asthma patients, there is urgent need for stringently designed clinically relevant randomised clinical trials for herbal preparations in the treatment of asthma.

BREATHING TECHNIQUES

Breathing techniques are used by a large proportion of asthma sufferers. This systematic review was aimed at determining whether or not these interventions are effective. Four independent literature searches identified six randomized controlled trials. The results of these studies are not uniform. Collectively the data imply that physiotherapeutic breathing techniques may have some potential in benefiting patients with asthma. The safety issue has so far not been addressed satisfactorily. It is concluded that too few studies have been carried out to warrant firm judgements. Further rigorous trials should be carried out in order to redress this situation.

__________________________________

So, if you suffer from asthma, my advice is to stay away from SCAM. This might be easier said than done because SCAM practitioners are only too willing to lure asthma patients into their cult. In 2003, we have demonstrated this phenomenon by conducting a survey with chiropractors. Here is our short paper in full:

Classic chiropractic theory claims that vertebral subluxation blocks the flow of ‘‘innate intelligence’’ which, in turn, affects the health of asthma patients (1). Chiropractictors often use spinal manipulation (SM) to correct such malalignments and treat asthma (2). Several clinical trials of chiropractic SM exist, but the most rigorous ones are clearly negative (3,4). Chronic medication with corticosteroids can lead to osteoporosis, a condition, which is a contra-indication to chiropractic SM (5). Given this background, we aimed to determine whether chiropractors would advise an asthma patient on long-term corticosteroids (5 years) to try chiropractic as a treatment for this condition.

All 350 e-mail addresses listed at www.interadcom.com/chiro/html were randomised into two groups. A (deceptive) letter from a (fictitious) patient was sent to group A while group B was asked for advice on chiropractic treatment for asthma as part of a research project. Thus, groups A and B were asked the same question in di¡erent contexts: is chiropractic safe and e¡ective for an asthma patient on long-term steroids. After data collection, respondents from group A were informed that the e-mail had been part of a research project.

Of 97 e-mails in group A, we received 31 responses (response rate = 32% (95% CI, 0.23^ 0.41)). Seventy-four per cent (23 respondents) recommended visiting a chiropractor (95% CI, 0.59^ 0.89). Thirty-five per cent (11 respondents) mentioned minimal or no adverse effects of SM (95% CI, 0.18 ^ 0.52). Three chiropractors responded that some adverse e¡ects exist, e.g. risk of bone fracture, or stroke. Two respondents noted that other investigations (X-rays, spinal and neurological examination) were required before chiropractic treatment. Three respondents suggested additional treatments and one warned about a possible connection between asthma and the measles vaccine. Of 77 e-mails sent to group B, we received 16 responses (response rate = 21% (95% CI, 0.17^ 0.25)). Eleven respondents (69%) recommended visiting a chiropractor (95% CI, 0.46 ^ 0.91). Ten respondents mentioned minimal or no adverse effects of SM (95% CI, 0.39^ 0.87). Five chiropractors responded that adverse effects of SM exist (e.g. bone fracture). Five respondents suggested pre-testing the patient to check bone density, allergy, diet, exercise level, hydration and blood. Additional treatments were recommended by three respondents. The pooled results of groups A and B suggested that the majority of chiropractors recommend chiropractic treatment for asthma and the minority mention any adverse effects.

Our results demonstrate that chiropractic advice on asthma therapy is as readily available over the Internet as it is likely to be misleading. The majority of respondents from both groups (72%) recommended chiropractic treatment. This usually entails SM, a treatment modality which has been demonstrated to be ineffective in rigorous clinical trials (3,4,6). The advice may also be dangerous: the minority of the respondents of both groups (17%) caution of the risk of bone fracture. Our findings also suggest that, for the research question asked, a degree of deception is necessary. The response rate in group B was 12% lower than that of group A, and the answers received differed considerably between groups. In group A, 10% acknowledged the possibility of adverse e¡ects, this figure was 33% in group B. In conclusion, chiropractors readily provide advice regarding asthma treatment, which is often not evidence-based and has the potential to put patients at risk.

__________________________

As I stated above: if you suffer from asthma, my advice is to

stay away from SCAM.

Acupuncture for animals has a long history in China. In the West, it was introduced in the 1970s when acupuncture became popular for humans. A recent article sums up our current knowledge on the subject. Here is an excerpt:

Acupuncture is used mainly for functional problems such as those involving noninfectious inflammation, paralysis, or pain. For small animals, acupuncture has been used for treating arthritis, hip dysplasia, lick granuloma, feline asthma, diarrhea, and certain reproductive problems. For larger animals, acupuncture has been used for treating downer cow syndrome, facial nerve paralysis, allergic dermatitis, respiratory problems, nonsurgical colic, and certain reproductive disorders.Acupuncture has also been used on competitive animals. There are veterinarians who use acupuncture along with herbs to treat muscle injuries in dogs and cats. Veterinarians charge around $85 for each acupuncture session.[8]Veterinary acupuncture has also recently been used on more exotic animals, such as chimpanzees (Pan troglodytes)[9] and an alligator with scoliosis,[10] though this is still quite rare.

In 2001, a review found insufficient evidence to support equine acupuncture. The review found uniformly negative results in the highest quality studies.[11] In 2006, a systematic review of veterinary acupuncture found “no compelling evidence to recommend or reject acupuncture for any condition in domestic animals”, citing trials with, on average, low methodological quality or trials that are in need of independent replication.[1] In 2009, a review on canine arthritis found “weak or no evidence in support of” various treatments, including acupuncture.[12]

To put it in a nutshell: acupuncture for animals is not evidence-based.

How can I be so sure?

Because ref 1 in the text above refers to our paper. Here is its abstract:

Acupuncture is a popular complementary treatment option in human medicine. Increasingly, owners also seek acupuncture for their animals. The aim of the systematic review reported here was to summarize and assess the clinical evidence for or against the effectiveness of acupuncture in veterinary medicine. Systematic searches were conducted on Medline, Embase, Amed, Cinahl, Japana Centra Revuo Medicina and Chikusan Bunken Kensaku. Hand-searches included conference proceedings, bibliographies, and contact with experts and veterinary acupuncture associations. There were no restrictions regarding the language of publication. All controlled clinical trials testing acupuncture in any condition of domestic animals were included. Studies using laboratory animals were excluded. Titles and abstracts of identified articles were read, and hard copies were obtained. Inclusion and exclusion of studies, data extraction, and validation were performed independently by two reviewers. Methodologic quality was evaluated by means of the Jadad score. Fourteen randomized controlled trials and 17 nonrandomized controlled trials met our criteria and were, therefore, included. The methodologic quality of these trials was variable but, on average, was low. For cutaneous pain and diarrhea, encouraging evidence exists that warrants further investigation in rigorous trials. Single studies reported some positive intergroup differences for spinal cord injury, Cushing’s syndrome, lung function, hepatitis, and rumen acidosis. These trials require independent replication. On the basis of the findings of this systematic review, there is no compelling evidence to recommend or reject acupuncture for any condition in domestic animals. Some encouraging data do exist that warrant further investigation in independent rigorous trials.

This evidence is in sharp contrast to the misinformation published by the ‘IVAS’ (International Veterinary Acupuncture Society). Under the heading “For Which Conditions is Acupuncture Indicated?“, they propagate the following myth:

Acupuncture is indicated for functional problems such as those that involve paralysis, noninfectious inflammation (such as allergies), and pain. For small animals, the following are some of the general conditions which may be treated with acupuncture:

  • Musculoskeletal problems, such as arthritis, intervertebral disk disease, or traumatic nerve injury
  • Respiratory problems, such as feline asthma
  • Skin problems such as lick granulomas and allergic dermatitis
  • Gastrointestinal problems such as diarrhea
  • Selected reproductive problems

For large animals, acupuncture is again commonly used for functional problems. Some of the general conditions where it might be applied are the following:

  • Musculoskeletal problems such as sore backs or downer cow syndrome
  • Neurological problems such as facial paralysis
  • Skin problems such as allergic dermatitis
  • Respiratory problems such as heaves and “bleeders”
  • Gastrointestinal problems such as nonsurgical colic
  • Selected reproductive problems

In addition, regular acupuncture treatment can treat minor sports injuries as they occur and help to keep muscles and tendons resistant to injury. World-class professional and amateur athletes often use acupuncture as a routine part of their training. If your animals are involved in any athletic endeavor, such as racing, jumping, or showing, acupuncture can help them keep in top physical condition.

And what is the conclusion?

Perhaps this?

Never trust the promotional rubbish produced by SCAM organizations.

There is a lack of data describing the state of naturopathic or complementary veterinary medicine in Germany. This survey maps the currently used treatment modalities, indications, existing qualifications, and information pathways. It records the advantages and disadvantages of these medicines as experienced by veterinarians. Demographic influences are investigated to describe the distributional impacts of using veterinary naturopathy and complementary medicine.

A standardized questionnaire was used for the cross-sectional survey. It was distributed throughout Germany in a written and digital format from September 2016 to January 2018. Because of the open nature of data collection, the return rate of questionnaires could not be calculated. To establish a feasible timeframe, active data collection stopped when the previously calculated limit of 1061 questionnaires was reached.

With the included incoming questionnaires of that day, a total of 1087 questionnaires were collected. Completely blank questionnaires and those where participants did not meet the inclusion criteria were not included, leaving 870 out of 1087 questionnaires to be evaluated. A literature review and the first test run of the questionnaire identified the following treatment modalities:

  • homeopathy,
  • phytotherapy,
  • traditional Chinese medicine (TCM),
  • biophysical treatments,
  • manual treatments,
  • Bach Flower Remedies,
  • neural therapy,
  • homotoxicology,
  • organotherapy,
  • hirudotherapy.

These were included in the questionnaire. Categorical items were processed using descriptive statistics in absolute and relative numbers based on the population of completed answers provided for each item. Multiple choices were possible.

Overall 85.4% of all the questionnaire participants used naturopathy and complementary medicine. The treatments most commonly used were:

  • complex homoeopathy (70.4%, n = 478),
  • phytotherapy (60.2%, n = 409),
  • classic homoeopathy (44.3%, n = 301),
  • biophysical treatments (40.1%, n = 272).

The most common indications were:

  • orthopedic (n = 1798),
  • geriatric (n = 1428),
  • metabolic diseases (n = 1124).

Over the last five years, owner demand for naturopathy and complementary treatments was rated as growing by 57.9% of respondents (n = 457 of total 789). Veterinarians most commonly used scientific journals and publications as sources for information about naturopathic and complementary contents (60.8%, n = 479 of total 788). These were followed by advanced training acknowledged by the ATF (Academy for Veterinary Continuing Education, an organisation that certifies independent veterinary continuing education in Germany) (48.6%, n = 383). The current information about naturopathy and complementary medicine was rated as adequate or nearly adequate by many (39.5%, n = 308) of the respondents.

The most commonly named advantages in using veterinary naturopathy and complementary medicine were:

  • expansion of treatment modalities (73.5%, n = 566 of total 770),
  • customer satisfaction (70.8%, n = 545),
  • lower side effects (63.2%, n = 487).

The ambiguity and unclear evidence of the mode of action and effectiveness (62.1%, n = 483) and high expectations of owners (50.5%, n = 393) were the disadvantages mentioned most frequently. Classic homoeopathy, in particular, has been named in this context (78.4%, n = 333 of total 425). Age, gender, and type of employment showed a statistically significant impact on the use of naturopathy and complementary medicine by veterinarians (p < 0.001). The university of final graduation showed a weaker but still statistically significant impact (p = 0.027). Users of veterinary naturopathy and complementary medicine tended to be older, female, self-employed and a higher percentage of them completed their studies at the University of Berlin. The working environment (rural or urban space) showed no statistical impact on the veterinary naturopathy or complementary medicine profession.

The authors concluded that this is the first study to provide German data on the actual use of naturopathy and complementary medicine in small animal science. Despite a potential bias due to voluntary participation, it shows a large number of applications for various indications. Homoeopathy was mentioned most frequently as the treatment option with the most potential disadvantages. However, it is also the most frequently used treatment option in this study. The presented study, despite its restrictions, supports the need for a discussion about evidence, official regulations, and the need for acknowledged qualifications because of the widespread application of veterinary naturopathy and complementary medicine. More data regarding the effectiveness and the mode of action is needed to enable veterinarians to provide evidence-based advice to pet owners.

I can only hope that the findings are seriously biased and not a true reflection of the real situation. The methodology used for recruiting participants (it is fair to assume that those vets who had no interest in SCAM did not bother to respond) strongly indicates that this might be the case. If, however, the findings were true, one would have to conclude that, for German vets, evidence-based healthcare is still an alien concept. The evidence that the preferred SCAMs are effective for the listed conditions is very weak or even negative. If the findings were true, one would need to wonder how much of veterinary SCAM use amounts to animal abuse.

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