conflict of interest
It has been reported that a former model almost died trying to cure her cancer with a juice diet. Medics tried to get Irena Stoynova to use conventional cancer treatments after she was diagnosed with non-Hodgkin lymphoma in June 2021, but she ‘shut them out’. Instead of chemotherapy, she sought out so-called alternative medicine (SCAM) online and took the advice of a social media influencer who claims the body can ‘heal itself’ with help of a radical lifestyle and diet changes.
Ms Stoynova thus followed various diets and holistic therapies for two-and-a-half years, which left her emaciated and with fluid on her lungs.
Doctors said she was on the verge of death when she was taken to Frimley Park Hospital by ambulance in May last year. She was told by Dr Clare Rees that she would likely die without treatment for her stage three cancer. But Ms Stoynova continued to refuse for a number of days before finally agreeing to receive chemotherapy. Ms Stoynova then spent 50 days in the hospital’s acute dependency unit.
She said when she was first diagnosed that she decided against traditional treatments after ‘reading about and watching many doctors and professors talk about the success rate of alternative therapies online’. The 39-year-old, who now works in sales, said she did a juice diet for two-and-a-half years, but also tried a raw diet, intermittent fasting, boiling herbs and special teas.
Speaking about her diagnosis, she said: ‘I was devastated, the whole world just closed around me and I felt really alone.’ She said that she was advised to start chemotherapy, but instead turned to the internet to find alternative advice. ‘I found an American guy who has millions of followers who promoted holistic treatment,’ she said. ‘He had a podcast where he interviewed very knowledgeable doctors and professors who are talking about holistic treatment and they called standard treatment “outrageous”. ‘They said that people who had chemotherapy are “lazy” and don’t want to put in the hard work of holistic treatment.’ Ms Stoynova continued: ‘The guy has three or four books on how to heal cancer holistically – how to make salads, use different herbs, juicing, intermittent fasting – there were so many testimonials, so many people that did it. ‘I spent £2,000 on juicers – one for smoothies, one for carrots, one for citrus and one for everything else. I spent two to three hours a day making juice for the next day.
_________________________
The ‘juice diet’ seems to have been the Gerson therapy or a variation of it. We have discussed this particular SCAM several times before, e.g.:
- The Gerson Therapy: possibly the worst cancer quackery of them all
- ‘Censored for curing cancer’: the Gerson therapy re-visited
- Gerson therapy: a treatment to avoid at all cost
I just wish Irena Stoynova had read my blog instead of following the criminal quackery of the ‘American guy’.
My conclusion:
reading this blog and telling others about it can saave lives
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…
___________________________
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!
This systematic review and meta-analysis investigated the effectiveness and safety of manual therapy (MT) interventions compared to oral or topical pain medications in the management of neck pain.
The investigators searched from inception to March 2023, in Cochrane Central Register of Controller Trials (CENTRAL), MEDLINE, EMBASE, Allied and Complementary Medicine (AMED) and Cumulative Index to Nursing and Allied Health Literature (CINAHL; EBSCO) for randomized controlled trials that examined the effect of manual therapy interventions for neck pain when compared to oral or topical medication in adults with self-reported neck pain, irrespective of radicular findings, specific cause, and associated cervicogenic headaches. Trials with usual care arms were also included if they prescribed medication as part of the usual care and they did not include a manual therapy component. The authors used the Cochrane Risk of Bias 2 tool to assess the potential risk of bias in the included studies, and the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach to grade the quality of the evidence.
Nine trials with a total of 779 participants were included in the meta-analysis.
- low certainty of evidence was found that MT interventions may be more effective than oral pain medication in pain reduction in the short-term (Standardized Mean Difference: -0.39; 95% CI -0.66 to -0.11; 8 trials, 676 participants),
- moderate certainty of evidence was found that MT interventions may be more effective than oral pain medication in pain reduction in the long-term (Standardized Mean Difference: −0.36; 95% CI −0.55 to −0.17; 6 trials, 567 participants),
- low certainty evidence that the risk of adverse events may be lower for patients who received MT compared to the ones that received oral pain medication (Risk Ratio: 0.59; 95% CI 0.43 to 0.79; 5 trials, 426 participants).
The authors conluded that MT may be more effective for people with neck pain in both short and long-term with a better safety profile regarding adverse events when compared to patients receiving oral pain medications. However, we advise caution when interpreting our safety results due to the different level of reporting strategies in place for MT and medication-induced adverse events. Future MT trials should create and adhere to strict reporting strategies with regards to adverse events to help gain a better understanding on the nature of potential MT-induced adverse events and to ensure patient safety.
Let’s have a look at the primary studies. Here they are with their conclusions (and, where appropriate, my comments in capital letters):
- For participants with acute and subacute neck pain, spinal manipulative therapy (SMT) was more effective than medication in both the short and long term. However, a few instructional sessions of home exercise with (HEA) resulted in similar outcomes at most time points. EXERCISE WAS AS EFFECTIVE AS SMT
- Oral ibuprofen (OI) pharmacologic treatment may reduce pain intensity and disability with respect to neural mobilization (MNNM and CLG) in patients with CP during six weeks. Nevertheless, the non-existence of between-groups ROM differences and possible OI adverse effects should be considered. MEDICATION WAS BETTER THAN MT
- It appears that both treatment strategies (usual care + MT vs usual care) can have equivalent positive influences on headache complaints. Additional studies with larger study populations are needed to draw firm conclusions. Recommendations to increase patient inflow in primary care trials, such as the use of an extended network of participating physicians and of clinical alert software applications, are discussed. MT DOES NOT IMPROVE OUTCOMES
- The consistency of the results provides, in spite of several discussed shortcomings of this pilot study, evidence that in patients with chronic spinal pain syndromes spinal manipulation, if not contraindicated, results in greater improvement than acupuncture and medicine. THIS IS A PILOT STUDY, A TRIAL TESTING FEASIBILITY, NOT EFFECTIVENESS
- The consistency of the results provides, despite some discussed shortcomings of this study, evidence that in patients with chronic spinal pain, manipulation, if not contraindicated, results in greater short-term improvement than acupuncture or medication. However, the data do not strongly support the use of only manipulation, only acupuncture, or only nonsteroidal antiinflammatory drugs for the treatment of chronic spinal pain. The results from this exploratory study need confirmation from future larger studies.
- In daily practice, manual therapy is a favorable treatment option for patients with neck pain compared with physical therapy or continued care by a general practitioner.
- Short-term results (at 7 weeks) have shown that MT speeded recovery compared with GP care and, to a lesser extent, also compared with PT. In the long-term, GP treatment and PT caught up with MT, and differences between the three treatment groups decreased and lost statistical significance at the 13-week and 52-week follow-up. MT IS NOT SUPERIOR [SAME TRIAL AS No 6]
- In this randomized clinical trial, for patients with chronic neck pain, Chuna manual therapy was more effective than usual care in terms of pain and functional recovery at 5 weeks and 1 year after randomization. These results support the need to consider recommending manual therapies as primary care treatments for chronic neck pain.
- In patients with chronic spinal pain syndromes, spinal manipulation, if not contraindicated, may be the only treatment modality of the assessed regimens that provides broad and significant long-term benefit. SAME TRIAL AS No 5
- An impairment-based manual physical therapy and exercise (MTE) program resulted in clinically and statistically significant short- and long-term improvements in pain, disability, and patient-perceived recovery in patients with mechanical neck pain when compared to a program comprising advice, a mobility exercise, and subtherapeutic ultrasound. THIS STUDY DID NOT TEST MT ALONE AND SHOULD NOT HAVE BEEN INCLUDED
I cannot bring myself to characterising this as an overall positive result for MT; anyone who can is guilty of wishful thinking, in my view. The small differences in favor of MT that (some of) the trials report have little to do with the effectiveness of MT itself. They are almost certainly due to the fact that none of these studies were placebo-controlled and double blind (even though this would clearly be possible). In contrast to popping a pill, MT involves extra attention, physical touch, empathy, etc. These factors easily suffice to bring about the small differences that some studies report.
It follows that the main conclusion of the authors of the review should be modified:
There is no compelling evidence to show that MT is more effective for people with neck pain in both short and long-term when compared to patients receiving oral pain medications.
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.
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.
The Academy of Homeopathy Education is a US-based accredited teaching institution offering homeopathy education services to professional and medically licensed homeopathy students. This study reports on clinical outcomes from the teaching clinic from 2020 to 2021.
Data were collected using the patient-generated outcome measure, the Measure Yourself Concerns and Wellbeing (MYCaW). Mean MYCaW values for initial and subsequent consultations were analyzed for the degree of change across the intervention period in 38 clients. Each client listed up to two complaints. MYCaW scores between initial and subsequent consultations were analyzed for the degree of change (delta) across the intervention period.
A total of 95 body system-related symptoms were analyzed for change in intensity following the homeopathic intervention. Statistically significant improvements in the intensity of main symptoms were observed between initial and subsequent follow-ups. The main symptom scores showed a mean change in intensity (delta MYCaW) of −0.79 points (95% confidence interval (CI), −1.29 to −0.29; p = 0.003) at first follow-up, a mean change of −1.67 points (95% CI, −2.34 to −0.99; p = 0.001) at second follow-up compared with the initial visit, and a mean change of −1.93 points (95% CI, −3.0 to −0.86; p = 0.008) at third follow-up compared with the initial visit. For clients with four or more follow-ups, the mean delta MYCaW was −1.57 points (95% CI, −2.86 to −0.28; p = 0.039).
The authors concluded that statistically significant improvements as well as some clinically meaningful changes in symptom intensity were found across a diverse group of individuals with a variety of long-term chronic conditions. The improvement was evident across different body systems and different levels of chronicity. There are limitations to the generalizability of the study due to the research design. Further research and investigation are warranted given the promising results of this work.
There are, of course, not just limits to the generalizability of this study! I’d say there are limits to the interpretation of any of its findings.
What was the cause of the improvements?
Here are just a few questions that I asked myself while reading this paper:
- Are the guys from the Academy of Homeopathy Education not aware of the fact that even chronic conditions often get better by themselves?
- Have they heard of the placebo effect?
- Are they trying to tell us that the patients did not also use conventional treatments for their chronic conditions?
- What about regression towards the mean?
- What about social desirability?
- Why do they think that further research is needed?
- Are these really results that look ‘promising for homeopathy?
To answer just the last question: No, these findings are in perfect agreement with the fact that highly diluted homeopathic remedies are pure placebos (to be honest, they would even be in agreement with such remedies being mildly harmful).
