scientific misconduct
Removing the chest tube in cardiac patients after surgery is one of the worst experiences of hospitalization in the intensive care units. Various pharmacological and non-pharmacological methods are available to control pain in these patients. This study aimed to investigate the combined effect of reflexology massage and respiratory relaxation on pain following chest tube removal in cardiac surgery patients of Shahid Beheshti Hospital in Shiraz, Iran, in 2023.
The study was a double-blind randomized clinical trial performed on 140 patients who underwent heart surgery and had a chest tube in Shiraz, Iran. The samples were randomly divided into four groups:
1- control group,
2- respiratory relaxation group,
3- foot reflex massage group,
4- a combination of respiratory relaxation and reflexology massage.
To collect data, two demographic questionnaires, and a visual analog scale were used.
The participants of the 4 groups were not meaningfully different in terms of age, BMI, duration of surgical operation, gender, job, education, place of residency, number of chest tubes, history of operation (P = 0.99, 0.31, 0.06, 0.81, 0.97, 0.96, 0.17, 0.10, 0.89 respectively).
The mean scores of pain intensity during chest tube removal, and 15 min after chest tube removal were not statistically different among the 4 groups. However, just after chest tube removal, the mean scores of pain intensity differed meaningfully among four groups (P = 0.008).
The authors concluded that the results showed that reflexology massage and respiratory relaxation both reduce pain immediately after chest tube removal in heart surgery patients. Also, the combination of these two techniques was more effective in reducing patients’ average pain.
Double blind?
Really?
How did they do that?
Here is their description:
“For the blinding purpose of the study, a nurse who worked at the ICU had to record the pain intensity and the data, so the possible researcher bias did not impact the results. Also, the patients knew the concept of the study but did not know that there were whether in single relaxation groups or mixed methods groups and did not know that other patients had different methods used for them. Also, the pain intensity data for the control group was routinely checked by the nurses, and along with the fact that they had no information that some of the patients were in the intervention groups and received complementary and alternative therapies, therefore, their data were also considered blinded. Therefore, the study could have their initial aim to use the double-blinded design.”
Double blind usually means that the therapist and the patient were masked as to the group alloca. Blinding the nurse is fine, but the therapists were not blind and could therefore have influenced the patients via verbal and non-verbal communications.
According to the authors, patients did not know whether they were “in single relaxation groups or mixed methods groups”. I think that cannot be true. Even if it were, what about the control group? Surely every patient knows whether or not he/she receives a reflexology massage!
It follows, I think, that the study was NOT double-blind, not even single-blind!
Does that matter?
Yes!
Firstly, I don’t want to be misled in this way.
Secondly, as blinding did not happern, the findings can be explaind by the effects of patient expectation and might therefore NOT be the result of the therapies. In other words, the conclusions drawn by the authors are not warranted.
This study evaluated the recurrence of acute upper respiratory tract infections (aURTI) and the number of antibiotic prescriptions within 12-month follow-up in patients prescribed with either homeopathic medicines or medicines from one of four conventional medication classes for aURTI therapy.
This explorative cohort study used real-world electronic healthcare data from the Disease Analyzer database (IQVIA). Included were patients of all ages from Germany with an index diagnosis of a URTI between 2010 and 2018, who had prescriptions for either homeopathic, conventional cough & cold, nasal, or throat medicines, or nonopioid analgesics on the day of diagnosis or within six days afterwards. URTI recurrences were assessed by multivariable logistic regression, the number of antibiotic prescriptions by multivariable negative binomial regression.
From 3,628,295 patients with aURTI diagnosis initially identified in the database in the relevant time interval, a total of 610,118 patients, fulfilling the in- and not violating the exclusion criteria, were retained for analysis. In the multivariate analyses on all patients, prescriptions of nasal medicines were associated with a significant, slightly higher (OR: 1.18, CI: 1.10-1.26, p<0.001) risk of aURTI recurrence compared to homeopathic medicines within 12 months. Prescriptions of cough & cold (OR: 0.92, CI: 0.86-0.97, statistically significant, p=0.005) as well as throat medicines (OR: 0.93, CI: 0.86-1.01, p=0.086), and nonopioid analgesics (OR: 0.95, CI: 0.89-1.02, p=0.181) were associated with slightly lower risk of aURTI recurrence compared to homeopathic medicines. In the analysis of the age-dependent subgroups, there were some deviations from the overall population in terms of statistical significance; however, the directions of the effect estimates were unchanged. Almost all results of negative binomial regression analyses assessing differences in the frequency of antibiotic prescriptions during follow-up, both in all patients and in the age-dependent subgroups were statistically significant in favor of homeopathic medicines.
The authors concluded that the study demonstrated that follow-up recurrence and antibiotic prescriptions in patients with uncomplicated aURTI are at least comparable between patients treated with homeopathic and conventional medicines in real-world practice. Despite some methodological limitations inherent to the used database, the results of this study indicate that homeopathic medicines present a valuable therapeutic option for managing aURTI.
This study has a long list of fatal or near-fatal flaws:
- The patients who received homeopathic prescriptions surely differed in many ways from those who had conventional prescriptions.
- Information on medicines used without prescription were not accounted for.
- There is no way of telling who took the prescibed medicines and who did not.
- The database does not contain information on the severity or duration of the URTIs.
- The database does not contain information on socioeconomic status and lifestyle-related
risk factors such as smoking, alcohol consumption or physical activity. - URTI recurrences were not verified, and the primary outcome measure is thus not reliable.
- The observation of patients is limited to a single practice each. Patients who initially consulted a homeopaths and suffered a recurrence might have gone to consult a conventional doctor. In this case, their recurrence was not registered.
- Most patients self-prescribe medicines for URTIs; this phenomenon was not accounted for.
- The lower use of antibiotics and other conventional drugs in one group merely shows that 1) homeopaths tend to avoid these medications, 2) patients who consult homeopaths often reject conventional drugs.
So, does the study provide any useful information?
No!
Why was it conceived, conducted and published then?
The conflict of interest and funding statements give us a clue:
- NB has received a fee from Deutsche Homöopathie-Union for providing advice during preparation of the manuscript. SDJ and SN are employees of Deutsche Homöopathie-Union, TR is employee of Dr. Willmar Schwabe GmbH & Co.KG.
- The analysis of the available data from Disease Analyzer Database by IQVIA was commissioned and funded by Deutsche Homöopathie-Union (DHU-Arzneimittel GmbH & Co. KG. 76227 Karlsruhe, Germany).
So, what does all this amount to:
- A flawed study?
- Pseudoscience?
- Scientific misconduct?
- Fraud?
Please let me know.
Do you remember the case of Katie May who died “as the result of visiting a chiropractor for an adjustment, which ultimately left her with a fatal tear to an artery in her neck”?
Here is the abstract:
A 34-year-old female suffered a fatal stroke 7.5 h after cervical spine manipulation (CSM) performed by a chiropractic physician. Imaging noted vertebral artery dissection (VAD), basilar artery occlusion, and thromboembolic stroke. The medical examiner opined that CSM caused the VAD which embolized to cause the fatal stroke. However, causation of VAD by CSM is not supported by the research.
We utilized an intuitive approach to causation analysis to determine the cause of the VAD and the stroke. Causation of the VAD and the stroke by CSM could not be established as more likely than not. The malpractice case was settled by bringing allegations of misdiagnosis and failure to diagnose and refer the VAD to medical emergency.
We conclude that in the absence of convincing evidence that CSM could cause VAD, forensic professionals should consider VAD as a presenting symptom prior to CSM in such cases. Adherence to the standard of care for the chiropractic profession with attention to differential diagnosis could prevent such cases.
The author states that the objectives of this case report were to:
- Perform a forensic analysis to determine the most likely causal mechanism of the VAD.
- Perform a forensic analysis to determine the most likely causal mechanism of the stroke.
- Perform a medicolegal analysis of the standard of care with the aim of determining how this case could have been prevented, and how future such cases could be prevented.
There are, as far as I can see, at least three major problems with these objectives:
- The author is not qualified as a forensic analyst.
- He is merely a chiro (and acupuncturist) with a massive conflict of interest.
- Neither does he seem to be medically nor legally qualified for doing a medicolegal analysis (Dr. Brown received his undergraduate degree in Philosophy and History from Illinois State University in 1989. He went on to attend one semester of Law school at California Western School of Law in San Diego.)
The author even states that his information was taken from publicly available court documents. Background information was taken from publicly available investigative journalism and media coverage of this case. Any information that has not been made public is not reflected in this analysis. Images of the forensic microscopic review of the vertebral arteries were not available for review.
So, how valuable is chiro Brown’s medicolegal second opinion?
A new paper with the promising title “Chiropractic Care in Children: A Review of Evidence and Safety” caught my attention. Here is its full abstract:
Complementary therapies are used to treat many pediatric symptoms and health conditions, and chiropractic care is one of the most commonly used forms of complementary therapies by children and adolescents. Research studies have investigated the evidence behind and safety of chiropractic care in pediatrics with various musculoskeletal and non-musculoskeletal conditions. There are limited data with a range of findings and often no definite conclusion. Despite the paucity of evidence of benefits of chiropractic care in children, the considerations around safety, and the differing opinions regarding pediatric chiropractic practice inside and outside the field, many pediatric patients visit chiropractors, and chiropractors often care for pediatric patients. Pediatric health care providers should discuss the use of all complementary therapies with patients, so guidance can be optimal with a focus on promoting health and safety.
Specifically on safety the authors state this:
Many pediatricians are concerned about the safety of chiropractic care in their patients. There are little data on adverse events from chiropractic care, but serious adverse events are rare. Unlike the high-velocity, low-amplitude thrust manipulations used with adults, most techniques used in pediatric patients are gentle, low-force, and appear to be safe. According to a 2015 review study of 31 articles, serious adverse events in infants and children receiving chiropractic care are rare, and no deaths had been reported. However, significant adverse events have been documented with chiropractic care in pediatric patients such as subarachnoid hemorrhage, recurrent stroke, paraplegia, severe headache, and midback soreness as well as delays of diagnosis and inappropriate use of chiropractic care for severe illness.
I find it regrettable that the authors fail to mention the lack of a monitoring system and instead make the categorical claim: “serious adverse events are rare”. How do they know?
Regarding another important issue, ethics, the authors state this:
The ethics of using chiropractic care in children is complex, particularly due to the lack of robust scientific evidence regarding its safety and efficacy. Ethical considerations must prioritize every child’s well-being, ensuring that care is based on the best available evidence. However, since there is very limited funding for chiropractic care research, robust studies are rarely performed. Informed consent is crucial. Parents need clear communication of potential risks, benefits, and alternatives. Using unproven treatments in children may risk harm, whether physical or by diverting resources away from more effective interventions. In addition, the fact that some chiropractors hold anti-vaccine views adds another ethical layer, as it can undermine public health efforts and influence parents away from proven, life-saving interventions. However, respecting parents’ autonomy in making health care decisions for their children is important, provided that they are fully informed of the evidence and possible outcomes. Pediatric health care professionals must weigh all these factors carefully as they guide their patients and families.
I find this passage also slightly odd:
- The authors confirm that there is a lack of robust scientific evidence regarding its safety and efficacy. And in the nexy sentence they state that care must be based on the best available evidence. Would it not be more ethical to be blunt and suggest that employing chiropractic care for kids is ethically questionable in the absence of sound data?
- The authors also say that very only limited funding for chiropractic care research is available and therefore robust studies are rarely performed. To me, this looks like an excuse and an attempt to white-wash this situation. Would it not be more ethical to be blunt and suggest that the burden for funding and conducting the research is on the chiros and failing this challange amounts to unethical behavior?
My most important criticism of this new “Review of Evidence and Safety” is that its title implies a broad and laudable aim that its methodology cannot even nearly fulfill. The paper contains no methods section at all. Thus the authors are at liberty to pick and choose the evidence for review that they like – and this is precisely what they did. The review is based on carefully cherry-picked evidence. It thus is an apt example of what is wrong with the entire field of chiropractic: it is an area that is based on wishful thinking, very poor science and a denial of the most obvious facts.
“An American doctor invented a drug that claims to cure COPD within three days.” Does this announcement herald a medical sensation or a bogus and potentially dangerous falsehood?
The inventors proudly opt for the former: “we have created a revolutionary pill that combines over 60 natural herbs specifically designed to treat respiratory diseases such as chronic obstructive pulmonary disease, chronic bronchitis, and pulmonary fibrosis”
There are also videos promoting a “revolutionary pill” that allegedly cured chronic obstructive pulmonary disease (COPD) “within three days” went viral on Facebook. The videos featured public figures like Fox News anchor Jesse Watters, as well as the alleged developer of the drug, surgeon and TV personality Mehmet Oz, popularly known as “Dr. Oz”. Although the images used in the videos varied from post to post, all the videos we found used the exact same narration and promised “to pay one million dollars” if the drug failed to cure COPD. However, these videos showed clear signs of manipulation.
Altered or artificial intelligence-generated videos featuring celebrities and major TV networks have been profusely used for scams over the past few years. Science Feedback documented several examples of such doctored videos falsely promoting diabetes cures and cannabidiol (CBD) gummies as a treatment for a wide range of medical conditions. “Dr. Oz” has often been mentioned either as a developer of these products or as endorsing them, though he’s repeatedly denied any involvement in these ads. In a 2019 article for the Wall Street Journal that he also shared on Facebook and Twitter, Oz stated that these ads weren’t “legit” and warned about potential scams exploiting his image.
Likewise, the COPD videos posted on Facebook are also false. First, COPD currently has no known cure, so any product claiming to cure it is simply a scam. Second, the poor synchronization between video and audio suggests that the audio isn’t authentic.
‘SCIENCE FEEDBACK‘ thus conclused as follows:
Chronic obstructive pulmonary disease (COPD) is a chronic progressive lung disease for which no cure currently exists. Along with medication, lifestyle changes like quitting smoking, avoiding polluted environments, and keeping physically active can help manage the symptoms and slow down the progression of the disease. Products claiming to cure COPD are deceptive and potentially dangerous, as they may contain harmful ingredients or interact with medications in unpredictable ways.
I could not agree more and might add that – as always in suspect cases – if it sounds too good to be true, it probably is.
In this case study, the authors describe an adult patient who struggled with persistent warts on the plantar surface of the foot for several years. All medical therapies were exhausted, so the patient turned to medical hypnosis as a last resort.
The patient experienced complete resolution of all his warts after three sessions of medical hypnosis. The suggestions used in the treatment included:
- strengthening the immune system,
- increasing blood flow in the foot,
- visualizing immune mechanisms destroying infected cells,
- the regrowth of healthy tissue.
After 3 years, the authors are still in contact with the patient, and he reports no recurrence of the disease.
The authors concluded that this case report adds to the existing body of the literature supporting the use of medical hypnosis in the treatment of warts. It demonstrates that medical hypnosis can be a valuable complementary or alternative treatment option for patients with persistent warts who have not responded to conventional therapies. It also highlights the need for further research to better understand the mechanisms by which hypnosis influences the resolution of warts and to identify the most effective types of suggestions for treatment.
Oh, dear!
Warts are viral infections. They can persist for months and years and disappear suddenly without apparent reason. What the authors of this case report observed is exactly this phenomenon of spontaneous recovery. There is no sound evidence that hypnotherapy or any similar treatment will speed up the disappearance of warts.
Many years ago, we did a trial of ‘distant healing’ for warts. It confirmed the ineffectiveness of this approach:
Purpose: Distant healing, a treatment that is transmitted by a healer to a patient at another location, is widely used, although good scientific evidence of its efficacy is sparse. This trial was aimed at assessing the efficacy of one form of distant healing on common skin warts.
Subjects and methods: A total of 84 patients with warts were randomly assigned either to a group that received 6 weeks of distant healing by one of 10 experienced healers or to a control group that received a similar preliminary assessment but no distant healing. The primary outcomes were the number of warts and their mean size at the end of the treatment period. Secondary outcomes were the change in Hospital Anxiety and Depression Scale and patients’ subjective experiences. Both the patients and the evaluator were blinded to group assignment.
Results: The baseline characteristics of the patients were similar in the distant healing (n = 41) and control groups (n = 43). The mean number and size of warts per person did not change significantly during the study. The number of warts increased by 0.2 in the healing group and decreased by 1.1 in the control group (difference [healing to control] = -1.3; 95% confidence interval = -1.0 to 3.6, P = 0.25). Six patients in the distant healing group and 8 in the control group reported a subjective improvement (P = 0.63). There were no significant between-group differences in the depression and anxiety scores.
Conclusion: Distant healing from experienced healers had no effect on the number or size of patients’ warts.
My conclusion of the above case study is therefore very different from that of the original authors:
This case report adds nothing to the existing body of the literature on medical hypnosis or on the treatment of warts other than misleading the public.
The aim of this article was to review the use of homeopathy in rheumatic diseases (RDs). PubMed and Embase databases were examined for literature on homeopathy and RDs between 1966 and April 2023. 15 articles were included.
The diseases treated were
- osteoarthritis (n=3),
- rheumatoid arthritis (n=3),
- ankylosing spondylitis (n=1),
- hyperuricemia (n=1),
- tendinopathy (n=1).
The age of the patients varied from 31 to 87 years, and male gender ranged from 56.7% to 100%. The homeopathic treatments varied from a fixed medicine to an individualized homeopathy.
Most studies (9/15) demonstrated improvements after homeopathy. Side effects were not seen or minimal and were comparable to those of the placebo groups.
The authors concluded that this review shows homeopathy is a promising and safe therapy for RD treatment. However, the data needs to be reproduced in future more extensive studies, including other rheumatic conditions.
This paper amounts to an insult of its readership!
Not only is it badly written but also [and more importantly] it is missing almost everything that makes a systematic review. Despite this the authors claim that it “adhered to PRISMA standards”. This is certainly not true.
Amongst the missing items, the most important ones are probably the evaluation of the methodological quality of the inclued primary studies as well as a critical assessment of the evidence. The authors concede that their paper has limitations: “the number of participants was low. Second, a few RDs were evaluated: osteoarthritis, rheumatoid arthritis, fibromyalgia, hyperuricemia, ankylosing spondylitis, and
tendinopathy.”
When reading this, I asked myself: are they clueless or dishonest?
In my view, the authors (from Brasil and Israel) and peer-reviewers of this paper should be ashamed of such shoddy work and the editors of the journal publishing this nonsense should withdraw the paper asap.
The ‘LIGA MEDICORUM HOMOEOPATHICA INTERNATIONALIS’ recently held its 77th ‘World Homeopathic Congress’ in Seville, Spain. No, I was not invited and did not attend, but I have seen the abstract of a keynote lecture by Prof. Josef M Schmidt from the
Ludwig-Maximilians-University of Munich, Germany (the university where I studied and worked for many years). I find it quite remarkable and hope you agree:
Today, homeopathy is having to face massive campaigns targeted at excluding it from what is considered to be scientific medicine, as well as from participation in markets. These attacks are based on philosophical and political presuppositions without which this could not happen.
The common denominator of these ideologies is a reductionist world view, in terms of a money-driven rationality, with a neglect of other dimensions of life. Within this mediocre frame of thought and judgment, there would be little choice left for homeopathy other than to fight for its recognition and market access by means of administrative standards established by their competitors, i.e. by randomised clinical trials, onerous approval procedures, etc.
In reality, however, homeopathy can be said to encompass far more dimensions of being than just lógos-thinking in terms of measurability, reproducibility, commodifiability and the like. Its theory and practice also rests on hómoion- and iásthai-thinking, i.e. on the principles of similarity and healing, as has been recently suggested by medical historical research and presented at the last LMHI congresses (Istanbul 2022, Bogotá 2023).
In order to exploit the unique multidimensionality of homeopathy and its potential impact on the current scientific discourse, another framework for homeopathy within medical and political theory may well be needed. First, the reductionistic view of man advocated by the “buffered selves” of modernity (Charles Taylor) would have to be challenged and overcome, then, a wider and richer anthropology as well as educational and political ideals be advocated and, finally, homeopathy be presented as an exemplary art of healing, in terms of reasonability, efficiency and safety. Only thus may it become clear that, given its multidimensionality, homeopathy may have much more to give and to offer than continually partaking in a desperate struggle to fulfill the one-dimensional requirements their opponents use to impose upon it.
Schmidt has a remarkable CV:
1. Academic Education
Medical School at the Ludwig Maximilian’s University of Munich 1973–1980
Doctoral Degree in Medicine (MD) at the Ludwig Maximilian’s University of Munich in 1980
PhD-Program in Philosophy, Theology, and History of Medicine at the Ludwig Maximilian’s University of Munich 1982–1988
Doctoral Degree in Philosophy (PhD) at the Ludwig Maximilian’s University of Munich in 1990
Habilitation (venia legendi) for the History of Medicine at the Ludwig Maximilian’s University of Munich in 2005
2. Professional Career
Resident at the Clinical Center of the Technical University of Munich (Klinikum rechts der Isar der TUM) and other hospitals and medical offices in Munich 1981, 1989–1991, 1993–1994
Medical Specialization (Consultant) in General Practice (Family Medicine) in 1994
Additional Medical Qualifications in Homeopathy (1985), Naturopathy (1990) and Quality Management (1999)
Trial Investigator and Physician at the Hospital of Naturopathy in Munich (Krankenhaus für Naturheilweisen) 1995–2001
Head of the Library of the Hospital of Naturopathy in Munich 1989–2003
Research Associate (freelance) at the Institute of the History of Medicine at the Ludwig Maximilian’s University of Munich 1988–2007
Research Associate at the University of California, San Francisco, USA, 1991–1992
Associate Lecturer (Lehrbeauftragter) for the History of Medicine at the Ludwig Maximilian’s University of Munich 1992–2005
Private Lecturer (Privatdozent) for the History of Medicine at the Ludwig Maximilian’s University of Munich 2005–2013
Research Associate (Wissenschaftlicher Mitarbeiter) at the Institute of the History of Medicine at the Ludwig Maximilian’s University of Munich 2007–2011
Research Associate (freelance) at the Institute of Ethics, History, and Theory of Medicine at the Ludwig Maximilian’s University of Munich since 2011
Adjunct Professor (außerplanmäßiger Professor) for the History of Medicine at the Ludwig Maximilian’s University of Munich since 2013
3. Awards
Scholarship of the Robert Bosch Foundation 1987–1988
Scholarship of the German Research Association (DFG) 1991–1992
Professor Alfons Stiegele Research Award for Homeopathy in 1993
Science Award Samuel Hahnemann of the Town of his Birth Meißen 2015
Honorary Membership of the German Central Association of Homeopathic Physicians 2016
Even more remarkably, Schmidt has 25 Medline-listed publications all on homeopathy. As far as I can see, only one of them relates to a clinical trial. Here is its abstract:
Objective: To test whether an ultramolecular dilution of homeopathic Thyroidinum has an effect over placebo on weight reduction of fasting patients in so-called ‘fasting crisis’.
Design: Randomised, placebo-controlled, double-blind, parallel group, monocentre study.
Setting/location: Hospital for internal and complementary medicine in Munich, Germany.
Subjects: Two hundred and eight fasting patients encountering a stagnation or increase of weight after a weight reduction of at least 100 g/day in the preceding 3 days.
Intervention: One oral dose of Thyroidinum 30cH (preparation of thyroid gland) or placebo.
Outcome measures: Main outcome measure was reduction of body weight 2 days after treatment. Secondary outcome measures were weight reduction on days 1 and 3, 15 complaints on days 1-3, and 34 laboratory findings on days 1-2 after treatment.
Results: Weight reduction on the second day after medication in the Thyroidinum group was less than in the placebo group (mean difference 92 g, 95% confidence interval 7-176 g, P=0.034). Adjustment for baseline differences in body weight and rate of weight reduction before medication, however, weakened the result to a non-significant level (P=0.094). There were no differences between groups in the secondary outcome measures.
Conclusions: Patients receiving Thyroidinum had less weight reduction on day 2 after treatment than those receiving placebo. Yet, since no significant differences were found in other outcomes and since adjustment for baseline differences rendered the difference for the main outcome measure non-significant, this result must be interpreted with caution. Post hoc evaluation of the data, however, suggests that by predefining the primary outcome measure in a different way, an augmented reduction of weight on day 1 after treatment with Thyroidinum may be demonstrated. Both results would be compatible with homeopathic doctrine (primary and secondary effect) as well as with findings from animal research.
So, Schmidt turned an essentially negative finding into a (cautiously) positive one by starting his conclusion with the sentence: Patients receiving Thyroidinum had less weight reduction on day 2 after treatment than those receiving placebo.
Altogether this seems to me to be a herculean effort that merits admission into my ALTERNATIVE MEDICINE HALL OF FAME where he joins all of the following members:
- Meinhard Simon (homeopathy0
- Richard C. Niemtzow (acupuncture)
- Helmut Kiene (anthroposophical medicine)
- Helge Franke (osteopathy, Germany)
- Tery Oleson (acupressure , US)
- Jorge Vas (acupuncture, Spain)
- Wane Jonas (homeopathy, US)
- Harald Walach (various SCAMs, Germany)
- Andreas Michalsen ( various SCAMs, Germany)
- Jennifer Jacobs (homeopath, US)
- Jenise Pellow (homeopath, South Africa)
- Adrian White (acupuncturist, UK)
- Michael Frass (homeopath, Austria)
- Jens Behnke (research officer, Germany)
- John Weeks (editor of JCAM, US)
- Deepak Chopra (entrepreneur, US)
- Cheryl Hawk (chiropractor, US)
- David Peters (osteopathy, homeopathy, UK)
- Nicola Robinson (TCM, UK)
- Peter Fisher (homeopathy, UK)
- Simon Mills (herbal medicine, UK)
- Gustav Dobos (various SCAMs, Germany)
- Claudia Witt (homeopathy, Germany/Switzerland)
- George Lewith (acupuncture, UK)
- John Licciardone (osteopathy, US)
I was recently invited to give a lecture to the local medical association in Graz Austria. It was a pleasure to be in Austria again and a delight to visit the beautiful town of Graz. They had given me the following subject:
Mythen in der sogenannten Alternativmedizin [Myths of so-called alternative medicine (SCAM)]
In my lecture, I thought it prudent to relate to the situation of SCAM in Austria which is rather special:
- The seem to Austrians love the SAM; the 1-year prevalence of use is 36%!
- In Austria, SCAM is only allowed to be practised by doctors.
- Often SCAM is paid for by patients out of their own pocket.
- For many, SCAM is a question of belief.
- SCAM is being promoted by VIPs and loved by journalists; one politician even sells his own brand of dietary supplements!
- In Austria, SCAM is heavily promoted by the Austrian Medical Association who currently runs courses and issues several SCAM diplomas.
The Austrian newspaper DER STANDARD then decided to interview me on these issues. The interview has been published today, and I thought I might take the liberty of translating the central part for you:
Q: In Austria, the Medical Association offers diplomas in various alternative methods. Why is this problematic?
A: I am aware of no less than 11 such diplomas offered by the Austrian Medical Association. While in England, France or Germany, for example, homeopathy has been considerably restricted by the medical profession due to the largely negative evidence, in Austria it continues to be promoted by the medical associations. This makes Austrian medicine the laughing stock of the rest of the world. More importantly, it violates the principles of evidence-based medicine. And even more importantly, it seems to me that the Austrian Medical Association is neglecting its ethical duty towards patients for purely pecuniary reasons.
Q: But the Medical Association is only complying with the regulations.
A: The Medical Association boasts that the quality of medical care and patient safety are at the centre of its work. In view of these diplomas, this mission almost sounds like a bad joke. They claim that the diplomas comply with the regulations. But firstly, this is a question of interpretation and secondly, regulations can – I would say must – be changed if they run counter to the quality of medical care. Finally, according to its own statements, the Association is obliged to adapt the Austrian healthcare system to changing conditions. This means nothing other than that it must take account of changing evidence – for example in the field of homeopathy.
Q: And what do the many doctors who use homeopathy say?
A: They often claim that they are only following the wishes of their patients when they prescribe homeopathic remedies. This may be true, but it is certainly not a valid argument. It ignores the fact that it is a doctor’s damned duty to provide patients with evidence-based information and to treat them accordingly. After all, medicine is not a supermarket where customers can simply choose whatever they happen to like.
It should also be emphasised that the practitioners of homeopathy also earn a good living from it. The fact that there is resistance from them when it comes to prioritising evidence rather than earnings in this area is thus hardly surprising.
But of course there are also a few doctors who use homeopathy primarily because they are fully convinced of its effectiveness. I think that these colleagues should consider self-critically whether they are not violating their ethical duty to be at the cutting edge of current knowledge and to act accordingly.
Perhaps unsurprisingly, my lecture prompted a lively discussion. Those doctors in the audience who spoke were unanimously in favour of my arguments. I was later told that many of those people who are responsible for the 11 diplomas were in the audience. Sadly, none of them felt like discussing any of the issues with me.
Perhaps the interview succeeds in starting a critical discussion about SCAM in Austria?
This pragmatic, randomised controlled trial was conducted between September 2018 and February 2021 and compared the difference between primary homoeopathic and conventional paediatric care in treating acute illnesses in children in their first 24 months of life. It was conducted at the Central Council for Research in Homoeopathy (CCRH) Collaborative Outpatient Department of the Jeeyar Integrated Medical Services (JIMS) Hospital in Telangana, India, a tertiary-care hospital that provides integrated patient-centric care, using homoeopathy and Ayurveda alongside conventional medicine.
One hundred eight Indian singleton newborns delivered at 37 to 42 weeks gestation were randomised at birth (1:1) to receive either homoeopathic or conventional primary care for any acute illness over the study period. In the homoeopathic group, conventional medical treatment was added when medically indicated. Clinicians and parents were unblinded.
The study’s primary outcome was a comparison of the number of sick days due to an acute illness experienced during the first 24 months of life by children receiving homoeopathic vs. conventional treatment. Sick days were defined as days with any acute illness (febrile or afebrile) reported by the parent and confirmed by the physician. Febrile illness was recorded when body temperature, measured via the ear canal, exceeded 37.5 °C.
The secondary outcomes compared were as follows:
- The number of sickness episodes, defined as illness events (febrile or afebrile), reported by the parent and confirmed by the physician.
- Number of respiratory illness episodes and days during the 24 months. Respiratory illnesses included infections in any part of the respiratory tract (nose, middle ear, pharynx, larynx, trachea, bronchi, bronchioles, and lungs) .
- Number of diarrhoeal episodes and days during the 24 months. Diarrhoea was defined as three or more episodes of watery stool/day, with or without vomiting, with indications of dehydration, weight loss, or defective weight gain.
- Anthropometric data included weight (measured by electronic scales to the nearest 5 g), height (measured in triplicate to the nearest 0.2 cm using a rigid-length board), head circumference (HC), and mid-upper arm circumference (MUAC) (measured with a standard measuring tape to the nearest 0.2 cm every 3 months until the 24th month).
- Developmental status was evaluated according to the Developmental Assessment Scales for Indian Infants (DASII) every 6 months from the age of 6 to 24 months.
- Direct cost of treatment for illnesses during the 24 months, including cost of medications, inpatient admissions, investigations, supplements, and treatment outside the hospital facility or study site (consultation and/or medicines).
- Use of antibiotics during the 24 months, defined as the number of antibiotic episodes during the study.
- Mortality: death due to any acute illness episode.
The results show that children in the homoeopathic group experienced significantly fewer sick days than those in the conventional group (RR: 0.37, 95% CI: 0.24-0.58; p < 0.001), with correspondingly fewer sickness episodes (RR: 0.53, 95% CI: 0.32-0.87; p = .013), as well as fewer respiratory illnesses over the 24-month period. They were taller (F (1, 97) = 8.92, p = .004, partial eta squared = 0.84) but not heavier than their conventionally treated counterparts. They required fewer antibiotics, and their treatment cost was lower.
The authors concluded that homoeopathy, using conventional medicine as a safety backdrop, was more effective than conventional treatment in preventing sick days, sickness episodes, and respiratory illnesses in the first 24 months of life. It necessitated fewer antibiotics and its overall cost was lower. This study supports homoeopathy, using conventional medicine as a safety backdrop, as a safe and cost-effective primary care modality during the first 2 years of life.
Here we have another study designed in such a way that a positive result was inevitable. Both groups of children received the necessary conventional care and treatment. The verum group received homeopathy in addition. There were no placebo controls and everyone knew which child belonged to which group. Thus the verum group benefitted from a poweful placebo effect, while the control group experience disappointment over not receiving the extra attention and medication. One might argue that newborn babies cannot experience a placebo response nor disappointment. Yet, one would be wrong and in need of reading up about placebo effects by proxy.
A+B is always more than B alone
To boldy entitle the paper ‘Homoeopathy vs. conventional primary care in children during the first 24 months of life’ and state that the trial aimed to “compared the difference between primary homoeopathic and conventional paediatric care in treating acute illnesses in children in their first 24 months of life”, is as close to scientific misconduct as one can get, in my view!
Yet again, I might ask: what do we call a study that is designed in such a way that a positive result was inevitable?
- misleading?
- waste of resources?
- unethical?
- fraud?
And again, I let you decide.
PS
I feel disappointed that a decent journal published this paper without even a critical comment!
