quackery
This Phase IV randomized, double-blind, placebo-controlled clinical trial was “designed to demonstrate the efficacy and safety of the product Neurodoron (Kalium phosporicum comp., KPC) in patients with neurasthenia”.
The study was conducted in an outpatient German trial site. Women and men aged 18 and above were randomized to receive either KPC or placebo if they reported typical symptoms of neurasthenia and a severe psychiatric disorder could be excluded. The primary objectives were a reduction in characteristic symptoms of nervous exhaustion and perceived stress as well as improvement in general health status after 6 weeks of treatment.
In total, 204 patients underwent screening, 78 were randomized in each treatment group, and 77 patients each received treatment (intention-to-treat (ITT) population = 154 patients). For none of the primary efficacy variables, an advantage in favor of KPC could be demonstrated in the pre-specified analysis (p-values between 0.505-0.773, Student’s t-test). In a post-hoc analysis of intra-individual differences after 6 weeks treatment, a significant advantage of KPC vs. placebo was shown for characteristic symptoms of nervous exhaustion (irritability (p = 0.020); nervousness (p = 0.045), Student’s t-test). Adverse event (AE) rates were similar between treatment groups, in both groups six AEs were assessed as causally related to treatment (severity mild or moderate). No AE resulted in discontinuation of treatment.
The authors concluded that the trial treatment was well tolerated with only a few and minor AEs reported, confirming the markedly good safety of KPC. A significant improvement of neurasthenia was seen for the total study population at the end of the treatment period. Superiority of KPC vs. placebo could not be demonstrated with the pre-specified analysis with regards to a sum score of 12 typical symptoms, perceived stress, or general health status. However, the explorative post-hoc analysis revealed that KPC is superior to placebo in the characteristic symptoms irritability and nervousness. KPC could therefore be a beneficial treatment option for symptomatic relief of neurasthenia.
The very first thing one notices is the aim of the study. According to its authors, it was “designed to demonstrate the efficacy and safety of the product Neurodoron (Kalium phosporicum comp., KPC) in patients with neurasthenia“. Any group of researchers that is unaware of the fact that clinical trials are for TESTING and not for DEMONSTRATING should, in my view, be sent straight back to school. And while they are at it, they might as well take with them the editor of the journal as well as the peer-reviewers of the paper.
As it happens, I have published a post about Neurodoron before. Here is a short section from it:
Stress is associated with a multitude of physical and psychological health impairments. To tackle these health disorders, over-the-counter (OTC) products like Neurodoron® are popular since they are considered safe and tolerable. One tablet of this anthroposophic remedy contains the following active ingredients:
83.3 mg Aurum metallicum praeparatum trituration (trit.) D10,
83.3 mg Kalium phosphoricicum trit. D6,
8.3 mg Ferrum-Quarz trit. D2.
Experience reports and first studies indicate that Neurodoron® is efficient in the treatment of stress-associated health symptoms…
Apart from its above-mentioned aim, the new study is remarkable in one further aspect: in its conclusion, it makes a big deal out of the ‘good news’ that Neurodoron safe. As the trial was not designed to test safety, this can only be seen as an attempt to hide (as well as possible) the fact that the remedy turned out to be ineffective.
Why would researchers try to distract the reader from the main message of their work? The answer might lie in the affiliation of two of the authors: Clinical Research, Weleda AG, Schwäbisch Gmünd, Germany.
The BBC stands for reliable information, at least that’s what I used to believe. After reading a recent article published on the BBC website, I have my doubts, however. See for yourself; here are a few excerpts:
On a holiday to Kerala on India’s south-western Malabar Coast, Shilpa Iyer decided to visit Kotakkal, a town that became famous after the establishment of Arya Vaidya Sala, Kerala’s best-known centre for the practice of Ayurveda, in 1902. Seven days later, she left the historical treatment centre after completeing panchakarma, a cleansing and rejuvenating programme for the body, mind and consciousness.
“There was nothing really wrong, but I was always busy with the demands of modern life and plagued with continual aches and pains. So, I decided to focus on my own health,” Iyer says.
Panchakarma, a holistic Ayurvedic therapy, involves a series of detoxifying procedures. It integrates herbal medicines, cleansing therapies, personalised diet plans and wellness activities to eliminate the root cause of disease, revive and rejuvenate the body, and ensure health and longevity.
Iyer says she left “feeling lighter, healthier and better than ever before”. She isn’t the only one who signed up for an Ayurvedic treatment in Kerala; the holistic system of medicine is a way of life in this coastal paradise.
… Ayurveda translates to “knowledge of life” and originated in India more than 3,000 years ago. It is based on the ideology that health and wellness depend on a delicate balance between the mind, body, spirit and environment, and places great emphasis on preventive strategies rather than curative ones. The ancient system of medicine is centred on the idea of universal interconnectedness between prakriti (the body’s constitution) and doshas (life forces). Varied combinations of the five elements — aakash (sky), jal (water), prithvi (earth), agni (fire) and vayu (air) – create the three doshas.
Dr Gaurang Paneri, an Ayurveda practitioner, explains every person has the three doshas, vata, pitta and kapha, in varying strength and magnitude. “The predominant dosha determines their prakriti. Diseases arise when doshas are affected because of an external or internal stimulus (typically linked to eating habits, lifestyle or physical exercise). Ayurveda works to ensure harmony between the three,” he says…
The small state has more than 100 Ayurvedic government-run hospitals, 800 Ayurvedic pharmaceutical factories and 800 Ayurvedic medicine dispensaries. As many as 120 holiday resorts and private wellness centres offer specialised treatments such as kasti vvasti, an oil-based treatment for back pain and inflammation in the lumbosacral region; elakkizhi, a treatment with heated herbal poultices to tackles aches, pains and muskoskeletal trauma; njavara kizhi, a massage therapy for arthritis or chronic musculoskeletal discomfort; and shirodhara, a restorative therapy to ease stress and anxiety and that involves pouring warm, medicated oil over the forehead.
Most treatment centres offer therapies and treatments for a range of health issues, including immunity, mental health, anxiety, pain management, weight loss, skin and health care, sleep issues, psoriasis, eczema, eye care, arthritis, sciatica, gastric problems and paralysis. The treatments typically include dietary changes, herbal medicines, massage therapies, poultices, meditation and breath exercises…
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I find such advertisements disguised as journalism disturbing:
- No mention that the treatments in question lack conclusive evidence of effectiveness.
- Not a word about the fact that many can be outright dangerous.
- No mention of the often exorbitant fees visitors are asked to pay.
Please do better next time you report about health matters, BBC!
I am not in the habit of publishing emails that I receive – even though I did occasionally post and discuss some of the most spectacular insults that came my way, e.g.:
- Provocations, insults, and ad hominem attacks
- ‘Ad hominem’ attacks: my life would be so dull without them!
- Ad hominem attacks are signs of victories of reason over unreason
- Am I evil, ignorant and anti-science?
Today, however, I feel like being a trifle indiscrete. The reason is an email I received yesterday from a German homeopath who calls him/herself ‘M. Magic’. After reading an article about homeopathy (I am not sure which one), he/she felt compelled to write to me. Here is (my translation of) the second half of this email which I find simply too funny to keep it to myself:
… I can explain WHY homeopathy works and can even tell you your personal so-called constitutional remedy.
I don’t do that. But I can tell you who you are based on the fact that I know your remedy:
You have no self-confidence. You may be competent in your field … even the best, but deep down you have been moulded in a counterproductive way. A parent has always made you feel like you can’t do anything right or well! This has undermined your self-confidence forever or most of your life, no matter how capable you may be!
You tend to despise women and/or think you are weak and incapable. A projection of your unconscious self-belief.
A typical symptom of your personality type is digestive problems! The background to this is that you do not allow and process feelings. This is reflected in a digestive weakness.
This in a nutshell … the correctly chosen remedy would give you a healthy self-confidence, which may have stabilised to some extent in the meantime. I could also explain to you why this is the case … I am analytically inclined and can determine any background. You are probably also ANALYTICAL … absolute head person and proud of it, right? There’s no reason for that, but fine … It shows how little idea you have of how humans really work and what they could use to cure themselves of everything … and what effect that has …
You clueless people … all of you!
Greetings, M. Magic
_____________________
I replied thanking the author, mainly because I had not laughed so heartily for a long time. My response was followed by an instant secone email:
… a SO typical response for your constitutiona type.
You want to show me that you’re above it and ridicule me … (you’re not, of course; either).
Apparently I hit the nail on the head. (no, I’m not surprised; I know my trade)
And YOU are really a professor?
But nothing surprises me anymore! The blind leading the blind …
__________________________
I did not send a further reply.
If you google ‘chiropractic’ you might get the impression that an unusual number of US chiros are outright perverts. Here are four current cases that I found instantly without any in-depth seraching:
A “Christian chiropractor” is facing several criminal charges after at least eight former clients have accused him of rape and sexual assault. Roc Byrd, 61, of Danville, who worked as a chiropractor for Cornerstone Chiropractic in Avon, is facing one felony count of rape, five felony counts of sexual battery and four misdemeanor counts of battery. He is accused of raping a client, touching clients inappropriately over and under their clothes during appointments without consent and pressing his genitals up against multiple patients. Byrd identified himself as a practicing Christian and reportedly began each of his chiropractic appointments by praying with clients.
A Warren chiropractor faces significant legal problems and a criminal investigation into how he allegedly treated one of his patients. Officials say he sells himself as one of only a handful of Michigan “Chiropractic Neurologists,” but the former patient claims he is a sexual predator and offers video as apparent proof. The case involves Dr. John Pispidikis of the Spinal Recovery Center. The complaint was filed Friday (April 19) morning, which surprised the doctor. The patient involved remains unnamed in the civil court documents, but she claims the doctor groped her during a physical exam last February. But she had no proof, so she claims she went out and got some.
The Oklahoma Board of Chiropractic Examiners (OBCE) has ordered the Back Stop’s only chiropractor, Mark Kimble to surrender his license by next Monday after several sexual impropriety allegations against him have surfaced. Oklahoma Board of Chiropractic Examiners confirmed with KFOR that there are seven alleged victims of Kimble’s who have come forward.
The Los Angeles County Sheriff’s Department is looking for possible victims of a chiropractor accused of sexual assault. Richard Carnow, 65, was arrested by authorities on March 13 on four felony counts of sexual battery. Carnow is a chiropractor in San Dimas in the San Gabriel Valley, the Sheriff’s Department says. He’s accused of sexually assaulting multiple adult women between June 2023 and August 2023. Officials did not say if his alleged victims were current or former patients. Investigators say the nature of the alleged crimes have led them to believe there may be additional victims and they are asking for the public’s help to find them.
Yes, I know, these are (according to chiros’ assurances) regrettable, isolated cases – nothing to worry about!
But perhaps these assertions are wrong and there is a problem after all?
I am reminded of my post from 2021; let me refresh your memory:
Two chiropractors conducted a retrospective review of publicly available data from the California Board of Chiropractic Examiners. Their aim was to determine categories of offense, experience, and gender of disciplined doctors of chiropractic (DC) in California and compare them with disciplined medical physicians in California. The DC disciplinary categories, in descending order, were
- fraud (44%),
- sexual boundary issues (22%),
- other offences (13%),
- abuse of alcohol or drugs (10%),
- negligence or incompetence (6%),
- poor supervision (2%),
- mental impairment (.3%).
The authors concluded that the professions differ in the major reasons for disciplinary actions. Two thirds (67%) of the doctors of chiropractic were disciplined for fraud and sexual boundary issues, compared with 59% for negligence and substance misuse for medical physicians. Additional study in each profession may reveal methods to identify causes and possible intervention for those who are at high risk.
The abstract of the paper does not provide comparisons to with the medical profession. Here they are; relative to doctors, chiropractors are:
- 2 x more likely to be involved in malpractice,
- 9 x more likely to commit fraud,
- 2 x more likely to transgress sexual boundaries.
________________________
Could it be, I askmyself, that there is something deeply wrong with the chiropractic profession? Could it perhaps be that chiro schools do not have a good hand when it comes to student recruitment? Could it be that chiro schools teach too little medical ethics, or none at all?
Few of us are aware of the fact that there are such things as alternative diagnoses, i.e. diagnoses used by practitioners of so-called alternative medicine (SCAM) that have no basis in science. They are nonetheless popular with some SCAM practitioners and usually cause a wide range of non-specific symptoms.
In part 1 of this series of posts, I dealt with:
- adrenal fatigue,
- candidiasis hypersensitivity,
- chronic intoxications.
Today I will briefly discuss three further alternative diagnoses.
Chronic Lyme Disease
Lyme disease exists, of course; it is a bacterial infection attained via the bite of a tick. By contrast chronic lyme disease is pure fantasy. It is often used to explain persistent pain, fatigue, and neurocognitive symptoms in patients without any evidence of previous acute lyme disease.
Once this diagnosis is given, prolonged treatment with multiple antimicrobial agents as well as a multitude of SCAMs are advocated. The range includes intravenous infusions of hydrogen peroxide, electromagnetic frequency treatments, garlic supplements, even stem cell transplants.
Unsurprisingly, none of them has been shown to work for chronic lyme disease.
Electromagnetic hypersensitivity
Electromagnetic hypersensitivity (EHS) is a condition where individuals report symptoms attributed to exposure to electromagnetic fields. It is not a recognized medical diagnosis.
Symptoms of EHS include headache, fatigue, stress, sleep disturbances, skin prickling, burning sensations and rashes, pain, psychological distress and many other health problems. The true case seems psychosomatic and unrelated to electromagnetic fields.
Practitioners nevertheless recommend all sorts of SCAMs including chelation, detox, diets, tocopherols , carotenoids, vitamin C, curcumin, resveratrol, flavonoids, sauna, blue light therapy none of which have been shown to be effective.
Homosexuality
Yes, it’s true: some SCAM practitioners offer treatments for homosexuality which must mean that they consider it to be a disease.
As reported in a previous blog post, the German ‘Association of Catholic Doctors’, Bund Katholischer Ärzte, claims that homeopathic remedies can cure homosexuality. On their website, they advise that ‘…the working group HOMEOPATHY of the Association notes homeopathic therapy options for homosexual tendencies…repertories contain special rubrics pointing to characteristic signs of homosexual behaviour, including sexual peculiarities such as anal intercourse.
Say no more!
Acute tonsillitis, which includes tonsillopharyngitis, is a common condition, particularly in childhood. It is mostly caused by a viral infection. Symptomatic treatment is of high importance. But which treatment is effective and which isn’t?
For this expert consensus, 53 physicians from Germany, Spain, Netherlands, Switzerland, Austria, and Hungary with at least one year of experience in anthroposophic paediatric medicine were invited to participate in an online Delphi process. The process comprised 5 survey rounds starting with open-ended questions and ending with final statements, which need 75% agreement of experts to reach consensus. Expert answers were evaluated by two independent reviewers using MAXQDA and Excel.
Response rate was between 28% and 45%. The developed recommendation included 15 subtopics. These covered clinical, diagnostic, therapeutic and psychosocial aspects of acute tonsillitis. Six subtopics achieved a high consensus (>90%) and nine subtopics achieved consensus (75-90%). The panel felt that AM was an adequate therapy for acute tonsillitis.
The authors of this paper concluded that the clinical recommendation for acute tonsillitis in children aims to simplify everyday patient care and provide decision-making support when considering and prescribing anthroposophic therapies. Moreover, the recommendation makes AM more transparent for physicians, parents, and maybe political stakeholders as well.
I found it hard to decide whether to cry or to laugh while reading this paper.
Experience in anthroposophic paediatric medicine does not make anyone an expert in anything other than BS.
Expert consensus and clinical guidelines are not conducted by assembling a few people who all are in favour of a certain therapy while ignoring the scientific evidence.
AM for acute tonsillitis in children is nonsense, whatever these pseudo-experts claim.
Imagine we run a Delphi process with a few long-standing members of ‘the flat earth society’ and ask them to tell us about the shape of the earth …
…I rest my case.
We all have heard of so-called alternative therapies but few of us are aware of the fact that there are also alternative diagnoses. These are diagnoses used regularly by practitioners of so-called alternative medicine (SCAM) that have no basis on science, or – to put it simply – that do not exist. They are nonetheless popular with SCAM practitioners and allegedly cause a wide range of non-specific symptoms such as:
- anxiety,
- brain fog,
- constipation,
- depression,
- dizziness,
- fatigue,
- headaches,
- heart palpitations,
- insomnia,
- irritability,
- muscle and joint pain,
- loss of appetite,
- loss of libido,
- weight gain.
In this series of posts, I will briefly discuss some of these diagnoses and list the treatments that SCAM practitioners might recommend for them.
Adrenal Fatigue
Adrenal fatigue is not the same as adrenal insufficiency or Addison’s disease; it is a term coined by a chiropractor who claimed that the stresses of modern life tire out the adrenal glands. In turn, this phenomenon allegedly leads to generalised weariness.
There is not evidence that this is true, nor that adrenal fatigue even exists. A systematic review of the evidence concluded that “there is no substantiation that adrenal fatigue is an actual medical condition.”
Yet, SCAM practitioners advise to cure adrenal fatigue with a range of dietary supplements (e.g. fish oil, ashwagandha, rhodiola rosea, schisandra and holy basil, licorice, magnesium, various vitamins), special diets, lifestyle adjustments, stress management and many other SCAMs. They all have in common that their effectiveness is not supported by convincing evidence from rigorous clinical trials.
Candidiasis hypersensitivity
Most of us are infected by the fungus Candida albicans without being affected by it in any way. Yet, many SCAM practitioners claim that candidiasis hypersensitivity is a condition that causes symptoms like fatigue, premenstrual tension, gastrointestinal symptoms, and depression and therefore needs treating.
But, candidiasis hypersensitivity does not exist. An RCT concluded that, “in women with presumed candidiasis hypersensitivity syndrome, nystatin does not reduce systemic or psychological symptoms significantly more than placebo.”
This, however, does not stop SCAM practitioners to recommend numerous forms of SCAM to treat the condition, e.g.: dietary supplements containing probiotics, milk thistle, red thyme, barberry, garlic, or external applications of coconut oil, essential oils of peppermint oil, lavender oil, oregano oil, and tea tree. No sound evidence exists to show that ant of these SCAMs can successfully treat the condition.
Chronic intoxications
Chronic intoxications do ecist, of course. But in the realm of SCAM, they are diagosed for the sole putpose of selling their various ‘detox’ treatments. The alleged rationale is that our bodies are overloaded with all sorts ot harmful substances, for instance, from the environment, from our food, from modern drugs, or from our own metabolism.
To eliminate them, we need to ‘detox’. For that purpose, SCAM practitioners recommend a very wide range of SCAMs; in fact, it is hardly possible to identify a single form of SCAM that is not said to detoxify our bodies. Yet, for none of them is there compelling evidence that it eliminates toxins from our body. Some of the most popular detox regimen include:
- acupuncture;
- CEASE therapy;
- chelation therapy;
- crystal healing;
- cupping;
- detox diets;
- detox supplements;
- gua sha;
- homeopathy;
- homotoxicology;
- Kombucha;
- oil pulling;
- vaginal steaming.
Interim conclusion: non-existing diagnoses are perfect opportunities for SCAM practitioners to rip off gullible patients.
We have repeatedly discussed financial and other fraud by (mostly US chiropractors, e.g.:
- Medicare fraud by chiropractors costs taxpayers millions
- Chiropractor accused of Medicare fraud exceeding $1 million
- A $2.6M Insurance Fraud by Chiropractors and Doctors?
- Fraud and sex offences by chiropractors
- Doctor gets 7-year sentence for multimillion-dollar fraud scheme
- The Dark Side of Chiropractic Care
Many of these cases are impressive in their illegality or even viciousness. Yet, this one takes the biscuit, I think:
It has been reported that a former chiropractor will be spending a long time behind bars following his conviction for running a colossal workers’ compensation fraud that bagged him $150 million over several years. Peyman Heidary has been sentenced to 54 years and 8 months in state prison on April 12, and will also have to shell out more than $23 million in fines, according to the Riverside County District Attorney’s Office.
Convicted in January of 68 counts including insurance fraud, conspiracy, and money laundering, Heidary’s scheme involved the control of fake health clinics and law firms from 2009 to 2014. He manipulated the workers’ comp system to exploit legitimately injured people and run up unnecessary treatments to inflate insurance billings, according to a Riverside County jury.
District Attorney Mike Hestrin made clear the gravity of Heidary’s exploitation: “The California workers’ compensation system is designed to help injured workers get back on their feet without ruining them financially,” Hestrin stated, adding “Sophisticated criminals like Mr. Heidary don’t just steal money, they take advantage of innocent patients”. The trial also heard from one such patient, Denise Rivera, a worker injured on the job who despite being promised care, was left untreated.
Originally pegged at $98 million, the fraud was ultimately revealed to have caused about $150 million in damages. Judge Charles Koosed, overseeing the sentencing, called out Heidary’s greed, exploiting his detailed knowledge of the workers’ compensation landscape, Judge Koosed noted, “’[Heidary] took advantage of that knowledge based on greed.”
Heidary used the sham law firm to recruit thousands of legitimately injured patients, referring them to his network of clinics to create unnecessary billing. One of the injured workers, Denise Rivera, slipped and fell while working as a certified nurse assistant for special needs children. Ms. Rivera testified that she was recruited into Heidary’s scheme, but never received any effective treatment. “[Heidary’s employees] released me,” Rivera told jurors. “They told me … basically I was okay. My knee was okay.” When asked during the trial if her knee actually was OK, she simply responded, “No.”
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It will probably not take long for some chiro to post a comment pointing out that dishonest chiropractors are extremely rare exceptions. Most are law-abiding and behave ethically, he/she will insist. It will then be useless, of course, to counter that, in fact, there is plenty of evidence that dishonesty is rife amongst chiropractors and more frequent than with other healthcare professionals. They will not accept that and would like me to withdraw the allegation.
Such arguments often remind me of the Labour politician, Dennis Skinner, who once stated in the UK Parliament: “Half the Tories opposite are crooks.” When the Speaker insisted he should retract this remark, he responded, “OK, half the Tories opposite aren’t crooks.
Prof Michael Frass is the undisputed star amongst researchers of homeopathy. Here are the awards and achievements that he mentions on his website:
- 1994 until 2019Head, Special Outpatient Clinic “Homeopathy in Malignant Diseases”, Department of Internal Medicine I, General Hospital of the City of Vienna
- 1992 until Feb. 2004Director, Intensivstation 13.i2, Klinik für Innere Medizin I
- 1994 until 1998 Medical Director Maimonides Center
- since May 1994Vice President of the “Medical Society for Classical Homeopathy” (ÄKH)
- since Oct. 1995Head of the Working Group for Homeopathy of the ÄKH in Vienna
- since Jan. 1998 Speaker of the ÄKH at training courses
- 1999 – 2012Training Officer of the Austrian Society for Internal and General Intensive Care Medicine (ÖGIAIM)
- 2001 until 2019 Coordinator of the lecture series “Selected chapters and scientific discussion of complementary medicine methods”, Med. Univ. Vienna, VO 560480
- May 2002 – Dec. 2005Director of the Ludwig Boltzmann Institute for Homeopathy
- since June 2003Member of the Scientific Advisory Board of the Vienna International Academy of Holistic Medicine
- 2004 until 2019Expert in Airway Management and Homeopathy in Intensive Care Medicine at the Center of Excellence in Internal Critical Care Medicine (CEMIC).
- 2005 until 2019Coordinator of the free elective “Homeopathy”, Med. Univ. Vienna, VO 562 923
- since June 2005Director, Institute for Homeopathy Research
- 2006 until 2019Member of the planning area + lecturer for the line element “Interdisciplinary Patient Management” (compulsory lecture for medical students)
- since June 2006President of the Austrian Umbrella Association for Medical Holistic Medicine.
- since Nov. 2010Chairman of the Scientific Society for Homeopathy (WissHom)
Many of my readers will remember the case of the Prof. Frass et al study of homeopathy for cancer. On this blog, we have seen several articles about it:
- Michael Frass’ research into homeopathy for cancer: “numerous breaches of scientific integrity”
- An update on the dubious cancer study by Prof Michael Frass et al
- A thorough analysis of Prof M. Frass’ recent homeopathy trial casts serious doubts on its reliability
- Homeopathy prolongs survival of lung cancer patients … Can it be true?
The study and the suspicion of scientific misconduct it raised eventually resulted in an official complaint by the Viennese Medical School to the authority that deals with suspicions of publication fraud, the ‘Austrian Agency for Scientific Integrity’. It took a very long time, but recently they have published their final on-line summary of their assessment of the case; here is my translation:
Enquiry A 2021/10:
After an Austrian university was informed externally and by name of possible scientific misconduct in a study and the resulting publication, the institution concerned submitted the already publicised suspected case in the field of applied natural sciences to the OeAWI with a request for examination by the Commission.
After establishing sufficient suspicion of various violations of good scientific practice, the Commission declared itself responsible and initiated proceedings. In the course of this, the principal investigator was given the opportunity to submit a written statement and to provide the Commission for Research Integrity Annual Report 2022 material that would help to clarify the facts of the case, which the accused submitted in large quantities.
In a very complex, comprehensive investigation, which required, among other things, the on-site inspection of original documents, the Commission was able to substantiate the suspicion of data falsification, fabrication and manipulation. In a final statement, the study director, who no longer works for the university in question, and the numerous co-authors were informed in detail about the course and results of the commission’s investigation and informed of the recommendations to the university and journal. The Commission recommended that the university concerned should consider investigating its own responsibilities and act accordingly, and that the publication should be withdrawn as a matter of urgency. The journal responsible for the publication was asked to withdraw the publication on the basis of the findings of the investigation.
Nobody who has studied the Frass paper in some detail can be surprised by the verdict. I do applaud the ‘Austrian Agency for Scientific Integrity’ for their work. Yet, I do also have some criticism: health fraud on the scale of Frass can easily costs lives. I find it therefore unacceptable that the verdict took so long to get published.
Even worse is, in my view, the fact that the journal, ‘Oncologist’, is still offering this paper today, albeit with this ‘expression of concern’:
This is an Expression of Concern regarding: Michael Frass, Peter Lechleitner, Christa Gründling, Claudia Pirker, Erwin Grasmuk-Siegl, Julian Domayer, Maximilian Hochmair, Katharina Gaertner, Cornelia Duscheck, Ilse Muchitsch, Christine Marosi, Michael Schumacher, Sabine Zöchbauer-Müller, Raj K. Manchanda, Andrea Schrott, Otto Burghuber, Homeopathic Treatment as an Add-On Therapy May Improve Quality of Life and Prolong Survival in Patients with Non-Small Cell Lung Cancer: A Prospective, Randomized, Placebo-Controlled, Double-Blind, Three-Arm, Multicenter Study, The Oncologist, Volume 25, Issue 12, December 2020, Pages e1930–e1955, https://doi.org/10.1002/onco.13548
In August 2022, the journal editors received credible information from the Austrian Agency for Research Integrity about potential data falsification and data manipulation in this article.*** While The Oncologist editorial team investigates and communicates with the corresponding author, the editors are publishing this Expression of Concern to alert readers that, pending the outcome and review of a full investigation, the research results presented may not be reliable.
Cancer patients will thus still read the dangerously misleading conclusions of the Frass fabrication: “Quality of life (QoL) improved significantly in the homeopathy group compared with placebo. In addition, survival was significantly longer in the homeopathy group versus placebo and control. A higher QoL might have contributed to the prolonged survival. The study suggests that homeopathy positively influences not only QoL but also survival. Further studies including other tumor entities are warranted.” And lives of cancer patients remain needlessly at risk. In my view, this is seriously unethical.
***As far as I know, they received credible information from others long before that!
This review updated and extended a previous one on the economic impact of homeopathy. A systematic literature search of the terms ‘cost’ and ‘homeopathy’ from January 2012 to July 2022 was performed in electronic databases. Two independent reviewers checked records, extracted data, and assessed study quality using the Consensus on Health Economic Criteria (CHEC) list.
Six studies were added to 15 from the previous review. Synthesizing both health outcomes and costs showed homeopathic treatment being at least equally effective for less or similar costs than control in 14 of 21 studies. Three studies found improved outcomes at higher costs, two of which showed cost-effectiveness for homeopathy by incremental analysis. One found similar results and three similar outcomes at higher costs for homeopathy. CHEC values ranged between two and 16, with studies before 2009 having lower values (Mean ± SD: 6.7 ± 3.4) than newer studies (9.4 ± 4.3).
The authors concluded that, although results of the CHEC assessment show a positive chronological development, the favorable cost-effectiveness of homeopathic treatments seen in a small number of high-quality studies is undercut by too many examples of methodologically poor research.
I am always impressed by the fantastic and innovative phraseology that some authors are able to publish in order to avaid calling a spade a spade. The findings of the above analysis clearly fail to be positive. So why not say so? Why not honestly conclude something like this:
Our analysis failed to show conclusive evidence that homeopathy is cost effective.
To find an answer to this question, we need not look all that far. The authors’ affiliations give the game away:
- 1Department of Psychology and Psychotherapy, Witten/Herdecke University, Witten, Germany.
- 2Medical Scientific Services/Medical Affairs, Deutsche Homöopathie-Union DHU-Arzneimittel GmbH & Co. KG, Karlsruhe, Germany.
- 3Institute of Integrative Medicine, Witten/Herdecke University, Herdecke, Germany.
- 4Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
Another rather funny give-away is the title of the paper: the “…evaluation for…”comes form the authors’ original title (Overview and quality assessment of health economic evaluations for homeopathic therapy: an updated systematic review) and it implies an evaluation in favour of. The correct wording would be “evaluation of”, I think.
I rest my case.
