Osteopathic visceral manipulation (VM) is a bizarre so-called alternative medicine (SCAM) that has been featured on this blog with some regularity, e.g.:
- Osteopathic visceral manipulation: a new study fails to convince anyone
- Visceral manipulation…you couldn’t make it up
- Intravaginal manipulations by (German) osteopaths: a new low point for clinical research into alternative medicine?
- Visceral osteopathy is implausible and does not work … SO, LET’S FORGET ABOUT IT ONCE AND FOR ALL
Rigorous trials fail to show that it works for anything. So, the obvious solution to this dilemma is to conduct dodgy trials!
This study tested the effects of VM on dysmenorrhea, irregular, delayed, and/or absent menses, and premenstrual symptoms in PCOS patients.
Thirty Egyptian women with polycystic ovary syndrome (PCOS), with menstruation-related complaints and free from systematic diseases and/or adrenal gland abnormalities, participated in a single-blinded, randomized controlled trial. They were recruited from the women’s health outpatient clinic in the faculty of physical therapy at Cairo University, with an age of 20-34 years, and a body mass index (BMI) ≥25, <30 kg/m2. Patients were randomly allocated into two equal groups (15 patients); the control group received a low-calorie diet for 3 months, and the study group that received the same hypocaloric diet added to VM to the pelvic organs and their related structures for eight sessions over 3 months. Evaluations for body weight, BMI, and menstrual problems were done by weight-height scale, and menstruation-domain of Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ), respectively, at baseline and after 3 months from interventions. Data were described as mean, standard deviation, range, and percentage whenever applicable.
Of 60 Egyptian women with PCOS, 30 patients were included, with baseline mean age, weight, BMI, and a menstruation domain score of 27.5 ± 2.2 years, 77.7 ± 4.3 kg, 28.6 ± 0.7 kg/m2, and 3.4 ± 1.0, respectively, for the control group, and 26.2 ± 4.7 years, 74.6 ± 3.5 kg, 28.2 ± 1.1 kg/m2, and 2.9 ± 1.0, respectively, for the study group. Out of the 15 patients in the study group, uterine adhesions were found in 14 patients (93.3%), followed by restricted uterine mobility in 13 patients (86.7%), restricted ovarian/broad ligament mobility (9, 60%), and restricted motility (6, 40%). At baseline, there was no significant difference (p>0.05) in any of the demographics (age, height), or dependent variables (weight, BMI, menstruation domain score) among both groups. Post-study, there was a statistically significant reduction (p=0.000) in weight, and BMI mean values for the diet group (71.2 ± 4.2 kg, and 26.4 ± 0.8 kg/m2, respectively) and the diet + VM group (69.2 ± 3.7 kg; 26.1 ± 0.9 kg/m2, respectively). For the improvement in the menstrual complaints, a significant increase (p<0.05) in the menstruation domain mean score was shown in the diet group (3.9 ± 1.0), and the diet + VM group (4.6 ± 0.5). On comparing both groups post-study, there was a statistically significant improvement (p=0.024) in the severity of menstruation-related problems in favor of the diet + VM group.
The authors concluded that VM yielded greater improvement in menstrual pain, irregularities, and premenstrual symptoms in PCOS patients when added to caloric restriction than utilizing the low-calorie diet alone in treating that condition.
WHERE TO START?
- Tiny sample size.
- A trail design (A+B vs B) which will inevitably generate a positive result.
- Questionable ethics.
VM is a relatively invasive and potentially embarrassing intervention for any woman; I imagine that this is all the more true in Egypt. In such circumstances, it is mandatory to ask whether a planned study is ethically justifiable. I would answer this question related to an implausible treatment like VM with a straight NO!
I realize that there may be people who disagree with me. But even those guys should accept that, at the very minimum, such a study must be designed such that it leads to a clear answer – is VM effective or not? The present trial merely suggests that the placebo effect associated with VM is powerful (which is hardly surprising for a therapy like VM).
Acupuncture is often promoted as a therapeutic option for obesity and weight control. The aim of this study was to investigate the effects of electroacupuncture (EA) on body weight, body mass index (BMI), skin fold thickness, waist circumference and skin temperature of the abdominal region in non-obese women with excessive abdominal subcutaneous fat.
A total of 50 women with excessive abdominal subcutaneous fat (and average BMI of 22) were randomly assigned to one of two groups:
- an EA group (n = 25) receiving 10 EA sessions (insertion of needles connected to an electrical stimulator at a frequency of 40 Hz for 40 min),
- a control group (n = 25) that received no treatment.
Outcome measures evaluated included waist circumference, supra-iliac and abdominal skinfolds, body composition and superficial skin temperature (measured by cutaneous thermography) before and after treatment.
Compared with the untreated group, women in the EA group exhibited decreased supra-iliac and abdominal skin folds (p < 0.001), waist circumference (p < 0.001), percentage body fat (p = 0.001) and percentage abdominal fat (p < 0.001). In addition, the EA group showed an elevated skin temperature at the site of the treatment. However, EA did not significantly impact body weight (p = 0.01) or BMI (p = 0.2).
The authors concluded that EA promoted a reduction in abdominal waist circumference, supra-iliac and abdominal skin folds, and percentage body and abdominal fat in women of normal BMI with excessive abdominal subcutaneous fat, as well as an increase in the superficial skin temperature of the abdominal region.
If we did not know that acupuncture researchers were all honest investigators testing hypotheses the best they can, we could almost assume that some are trying to fool us. The set-up of this study is ideally suited to introduce a proper placebo treatment. All one has to do is to not switch on the electrical stimulator in the control group. Why did the researchers not do that? Surely not because they wanted to increase the chances of generating a positive result; that would have been dishonest!!!
So, as it stands, what does the study tell us? I think it shows that, compared to patients who receive no treatment, patients who do receive the ritual of EA are better motivated to adhere to calorie restrictions and dietary advice. Thus, I suggest to re-phrase the conclusions of this trial as follows:
The extra attention of the EA treatment motivated obese patients to eat less which caused a reduction in abdominal waist circumference, supra-iliac and abdominal skin folds, and percentage body and abdominal fat in women of normal BMI with excessive abdominal subcutaneous fat.
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 16.00–18.00 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.
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’
MEP Interest Group on Wishful Thinking and Promotion of Quackery
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.
This meta-analysis was conducted by researchers affiliated to the Evangelical Clinics Essen-Mitte, Department of Internal and Integrative Medicine, Faculty of Medicine, University of Duisburg-Essen, Germany. (one of its authors is an early member of my ALTERNATIVE MEDICINE HALL OF FAME). The paper assessed the safety of acupuncture in oncological patients.
The PubMed, Cochrane Central Register of Controlled Trials, and Scopus databases were searched from their inception to August 7, 2020. Randomized controlled trials in oncological patients comparing invasive acupuncture with sham acupuncture, treatment as usual (TAU), or any other active control were eligible. Two reviewers independently extracted data on study characteristics and adverse events (AEs). Risk of bias was assessed using the Cochrane Risk of Bias Tool.
Of 4590 screened articles, 65 were included in the analyses. The authors observed that acupuncture was not associated with an increased risk of intervention-related AEs, nonserious AEs, serious AEs, or dropout because of AEs compared with sham acupuncture and active control. Compared with TAU, acupuncture was not associated with an increased risk of intervention-related AEs, serious AEs, or dropout because of AEs but was associated with an increased risk for nonserious AEs (odds ratio, 3.94; 95% confidence interval, 1.16-13.35; P = .03). However, the increased risk of nonserious AEs compared with TAU was not robust against selection bias. The meta-analyses may have been biased because of the insufficient reporting of AEs in the original randomized controlled trials.
The authors concluded that the current review indicates that acupuncture is as safe as sham acupuncture and active controls in oncological patients. The authors recommend researchers heed the CONSORT (Consolidated Standards of Reporting Trials) safety and harm extension for reporting to capture the side effects and better investigate the risk profile of acupuncture in oncology.
You might think this article is not too bad. So, why do I feel that this paper is so bad?
One reason is that the authors included evidence up to August 2020. Since then, there must have been hundreds of further papers on acupuncture. The article was therefore out of date before it was published.
But that is by no means my main reason. We know from numerous investigations that acupuncture studies often fail to report AEs (and thus violate publication ethics). This means that this new analysis is merely an amplification of the under-reporting. It is, in other words, a means of perpetuating a wrong message.
Yes, you might say, but the authors acknowledge this; they even state in the abstract that “The meta-analyses may have been biased because of the insufficient reporting of AEs in the original randomized controlled trials.” True, but this fact does not erase the mistake, it merely concedes it. At the very minimum, the authors should have phrased their conclusion differently, e.g.: the current review confirms that AEs of acupuncture are under-reported in RCTs. Therefore, a meta-analysis of RCTs is unable to verify whether acupuncture is safe. From other types of research, we know that it can cause serious AEs.
An even better solution would have been to abandon or modify the research project when they first came across the mountain of evidence showing that RCTs often fail to mention AEs.
As it stands, the conclusion that acupuncture is as safe as sham acupuncture is simply not true. Since the article probably looks sound to naive readers, I feel that is a particularly good candidate for the WORST PAPER OF 2022 COMPETITION.
For those who are interested, here are 4 of my own peer-reviewed articles on the safety of acupuncture (much more can, of course, be found on this blog):
- Patient safety incidents from acupuncture treatments: a review of reports to the National Patient Safety Agency – PubMed (nih.gov)
- Acupuncture–a critical analysis – PubMed (nih.gov)
- Prospective studies of the safety of acupuncture: a systematic review – PubMed (nih.gov)
- The risks of acupuncture – PubMed (nih.gov)
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.
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 segment, ABC 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?
Harad Matthes, the boss of the anthroposophical Krankenhaus Havelhoehe and professor for Integrative and Anthroposophical Medicine at the Charite in Berlin, has featured on my blog before (see here and here). Now he is making headlines again.
‘Die Zeit‘ reported that Matthes went on German TV to claim that the rate of severe adverse effects of COVID-19 vaccinations is about 40 times higher than the official figures indicate. In the MDR broadcast ‘Umschau’ Matthes said that his unpublished data show a rate of 0,8% of severe adverse effects. In an interview, he later confirmed this notion. Yet, the official figures in Germany indicate that the rate is 0,02%.
How can this be?
Die ZEIT ONLINE did some research and found that Matthes’ data are based on extremely shoddy science and mistakes. The Carite also distanced themselves from Matthes’ evaluation: “The investigation is an open survey and not really a scientific study. The data are not suitable for drawing definitive conclusions regarding incidence figures in the population that can be generalized” The problems with Matthes’ ‘study’ seem to be sevenfold:
- The data are not published and can thus not be scrutinized.
- Matthes’ definition of a severe adverse effect is not in keeping with the generally accepted definition.
- Matthes did not verify the adverse effects but relied on the information volunteered by people over the Internet.
- Matthes’ survey is based on an online questionnaire accessible to anyone. Thus it is wide open to selection bias.
- The sample size of the survey is around 10 000 which is far too small for generalizable conclusions.
- There is no control group which makes it impossible to differentiate a meaningful signal from mere background noise.
- The data contradict those from numerous other studies that were considerably more rigorous.
Despite these obvious flaws Matthes insisted in a conversation with ZEIT ONLINE that the German official incidence figures are incorrect. As Germany already has its fair share of anti-vaxxers, Matthes’ unfounded and irresponsible claims contribute significantly to the public sentiments against COVID vaccinations. They thus endangering public health.
In my view, such behavior amounts to serious professional misconduct. I, therefore, feel that his professional body, the Aerztekammer, should look into it and prevent further harm.
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:
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.
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.
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.
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.
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 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.