charlatan
The US Food and Drug Administration created the Tainted Dietary Supplement Database in 2007 to identify dietary supplements adulterated with active pharmaceutical ingredients (APIs). This article compared API adulterations in dietary supplements from the 10-year time period of 2007 through 2016 to the most recent 5-year period of 2017 through 2021. Its findings are alarming:
- From 2007 through 2021, 1068 unique products were found to be adulterated with APIs.
- Sexual enhancement and weight-loss dietary supplements are the most common products adulterated with APIs.
- Phosphodiesterase-5 inhibitors are commonly included in sexual enhancement dietary supplements.
- A single product can include up to 5 APIs.
- Sibutramine, a drug removed from the market due to cardiovascular adverse events, is the most included adulterant API in weight loss products.
- Sibutramine analogues, phenolphthalein (which was removed from the US market because of cancer risk), and fluoxetine were also included.
- Muscle-building dietary supplements were commonly adulterated before 2016, but since 2017 no additional adulterated products have been identified.
The authors concluded that the lack of disclosure of APIs in dietary supplements, circumventing the normal procedure with clinician oversight of prescription drug use, and the use of APIs that are banned by the Food and Drug Administration or used in combinations that were never studied are important health risks for consumers.
The problem of adulterated supplements is by no means new. A similar review published 4 years ago already warned that “active pharmaceuticals continue to be identified in dietary supplements, especially those marketed for sexual enhancement or weight loss, even after FDA warnings. The drug ingredients in these dietary supplements have the potential to cause serious adverse health effects owing to accidental misuse, overuse, or interaction with other medications, underlying health conditions, or other pharmaceuticals within the supplement.”
These papers relate to the US where supplement use is highly prevalent. The harm done by adulterated products is thus huge. If we focus on Chinese or Ayurvedic supplements, the problem might even be more serious. In 2002, my own review concluded that adulteration of Chinese herbal medicines with synthetic drugs is a potentially serious problem which needs to be addressed by adequate regulatory measures. Twenty years later, we seem to be still waiting for effective regulations that protect the consumer.
Progress in medicine, they say, is made funeral by funeral!
Today, I received an email advertising a book – nothing unusual, of course. But the book and its author are both quite unusual. Here is the text:
Dr. Farokh J. Master’s birth into homeopathy was in the year 1976, when he joined Bombay homeopathic medical college, after giving up his studies at the orthodox school of medicine. Dr Master was instrumental in starting homeopathic out-patient dept in many allopathic hospitals viz. Bombay Hospital, KEM Hospital & Ruby Hall, Pune. Besides his work as a senior Homeopath of the HHC, Dr. Farokh Master is teaching homeopathy (advanced level) at the Mumbai Homeopathic Medical College, part of Mumbai university. He is also teaching at other homeopathic colleges in India and abroad. He has given seminars in various countries like Austria, Australia, India, Japan etc…
Healing Cancer: A Homoeopathic Approach
As a homeopath one should not deter oneself in dealing with any type of cases, be it cancer. But for executing that an ultimate guidance is needed. Cancer is so much prevalent and challenging medical problem of today that a trustworthy source of accurate information becomes pertinent and this work of Dr. Farokh Master immediately propels at the top of quality books for cancer. Based on Master’s 40 years of experience this book was written for students to understand the basis of oncology and for practitioners for brushing-up of their knowledge in this growing discipline. Author says that to get a grasp on cancer cases we should believe in the potential of the homeopathic treatment, that healing from cancer refers to internal process of becoming whole and feeling harmonious with yourself and your environment.To even start with handling the cases of cancer one should be aware of understanding of cancer, its cause, pathophysiology, different types, conventional treatment and their side effects, integrative medicines, social problems in the treatment, such topics are well casted by Volume 1 of the book…• A whole chapter on Cadmium salts and cancer.• 51 “lesser known remedies” are briefly quoted and their usefulness in different situations and types of cancer exposed.• A long chapter deals with the “Indian drugs”, it is important that these remedies are used mostly in tincture or low potencies, as herbal or Ayurvedic remedies or food supplements relieving the patients. • The choice and differentiation between the remedies is then helped by the “Repertory of Cancer”, very well compiled and a highly useful section. “Clinical tips from my practice” given as a sub-chapter. • It ends with recommendations on how to deal with radiation illness and the side-effects of conventional treatment, as well as the treatment of pain and help with palliative care. For fighting and curing cancer and improving the quality and quantity of life of people, knowledge of Homeopathy, both philosophically and scientifically is needed which this work of art portrays delightfully.
__________________________
It is clear that Dr. Farokh J. Master does not suggest using homeopathy in addition to conventional cancer therapies. He foremost wants to employ it as an alternative cancer cure. It is also clear that, if his concepts were generally adopted, they could kill millions.
Some defenders of homeopathy might claim that this is not what most homeopaths would advocate; they would merely recommend homeopathy as an adjunct to conventional oncology. Yet, there are many examples to the contrary, and not just from India – after all, Hahnemann, the inventor of homeopathy, insisted that homeopathy must never be combined with ‘allopathic’ medicines.
So, the next time someone claims homeopathy to be harmless, please show them this post.
Ischemic heart disease (IHD) related to cardiovascular or cerebrovascular disease is the leading cause of mortality and an important issue of public health worldwide. The cost of long-term healthcare for IHD patients may result in a huge financial burden. This study analyzed the medical expenditure incurred for and survival of IHD patients treated with Chinese herbal medicine (CHM) and Western medicine.
Subjects were randomly selected from the National Health Insurance Research Database in Taiwan. The Cox proportional hazards regression model, Kaplan–Meier estimator, logrank test, chi-square test, and analysis of variance were applied. Landmark analysis was used to assess the cumulative incidence of death in IHD patients.
A total of 11,527 users were identified as CHM combined with Western medicine and 11,527 non-CHM users. CHM users incurred a higher medical expenditure for outpatient care within 1 (24,529 NTD versus 18,464 NTD, value <0.0001) and 5 years (95,345 NTD versus 60,367 NTD, value <0.0001). However, CHM users had shorter hospitalizations and lower inpatient medical expenditure (7 days/43,394 NTD in 1 year; 11 days/83,141 NTD in 5 years) than non-CHM users (11 days/72,939 NTD in 1 year; 14 days/107,436 NTD in 5 years).
The CHM group’s adjusted hazard ratio for mortality was 0.41 lower than that of the non-CHM group by Cox proportional hazard models with time-dependent exposure covariates. Danshen, Huang qi, Niu xi, Da huang, and Fu zi were the most commonly prescribed Chinese single herbs; Zhi-Gan-Cao-Tang, Xue-Fu-Zhu-Yu-Tang, Tian-Wang-Bu-Xin-Dan, Sheng-Mai-San, and Yang-Xin-Tang were the five most frequently prescribed herbal formulas in Taiwan.
The authors concluded that combining Chinese and Western medicine can reduce hospital expenditure and improve survival for IHD patients.
Why, you will ask, do I think that this study deserves to be in the ‘worst paper cometition’?
It is not so bad!
It is an epidemiological case-control study with a large sample size that generates interesting findings.
Agreed!
But, as a case-control study, it cannot establish a causal link between CHM and the outcomes. You might argue that the conclusions avoid doing this – “can … improve survival” is not the same as “does improve survival”. This may be true, yet the title of the article leaves little doubt about the interpretation of the authors:
Chinese Herbal Medicine as an Adjunctive Therapy Improves the Survival Rate of Patients with Ischemic Heart Disease: A Nationwide Population-Based Cohort Study
I find it difficult not to view this as a deliberate attempt of the authors, editors, and reviewers to mislead the public.
Looking at the details of the study, it is easy to see that the two groups were different in a whole range of parameters that were measured. More importantly, they most likely differ in a range of variables that were not measured and had significant influence on IHD survival. It stands to reason, for instance, that patients who elected to use CHM in addition to their standard care were more health conscious. They would thus have followed a healthier diet and lifestyle. It would be foolish to claim that such factors do not influence IHD survival.
The fact that the authors fail even to mention this possibility, interpret an association as a causal link, and thus try to mislead us all makes this paper, in my view, a strong contender for my
WORST PAPER OF 2022 COMPETITION
The purpose of this study was to examine the trends in the expenditure and utilization of chiropractic care in a representative sample of children and adolescents in the United States (US) aged <18 years.
The researchers evaluated serial cross-sectional data (2007-2016) from the Medical Expenditure Panel Survey. Weighted descriptive statistics were conducted to derive national estimates of expenditure and utilization, and linear regression was used to determine trends over time. Sociodemographic and clinical characteristics of chiropractic users were also reported.
A statistically significant increasing trend was observed for the number of children receiving chiropractic care (P <.05) and chiropractic utilization rate (P < .05). Increases in chiropractic expenditure and the number of chiropractic visits were also observed over time but were not statistically significant (P > .05). The mean annual number of visits was 6.4 visits, with a mean expenditure of $71.49 US dollars (USD) per visit and $454.08 USD per child. Children and adolescent chiropractic users in the United States were primarily 14 to 17 years old (39.6%-61.6%), White (71.5%-76.9%), male (50.6%-51.3%), and privately insured (56.7%-60.8%). Chiropractic visits in this population primarily involved low back conditions (52.4%), spinal curvature (14.0%), and head and neck complaints (12.8%).
The authors concluded that the number of children visiting a chiropractor and percent utilization showed a statistically significant, increasing trend from 2007 to 2016; however, total expenditure and the number of chiropractic visits did not significantly differ during this period. These findings provide novel insight into the patterns of chiropractic utilization in this understudied age group.
Why are these numbers increasing?
Is it because of increasing and sound evidence showing that chiropractors do more good than harm to kids?
No!
A recent systematic review of the evidence for effectiveness and harms of specific spinal manipulation therapy (SMT) techniques for infants, and children suggests the opposite.
Its authors searched electronic databases up to December 2017. Controlled studies, describing primary SMT treatment in infants (<1 year) and children/adolescents (1–18 years), were included to determine effectiveness. Controlled and observational studies and case reports were included to examine harms. One author screened titles and abstracts and two authors independently screened the full text of potentially eligible studies for inclusion. Two authors assessed the risk of bias in included studies and the quality of the body of evidence using the GRADE methodology. Data were described according to PRISMA guidelines and CONSORT and TIDieR checklists. If appropriate, a random-effects meta-analysis was performed.
Of the 1,236 identified papers, 26 studies were eligible. In all but 3 studies, the therapists were chiropractors. Infants and children/adolescents were treated for various (non-)musculoskeletal indications, hypothesized to be related to spinal joint dysfunction. Studies examining the same population, indication, and treatment comparison were scarce. Due to very low-quality evidence, it is uncertain whether gentle, low-velocity mobilizations reduce complaints in infants with colic or torticollis, and whether high-velocity, low-amplitude manipulations reduce complaints in children/adolescents with autism, asthma, nocturnal enuresis, headache or idiopathic scoliosis. Five case reports described severe harms after HVLA manipulations in 4 infants and one child. Mild, transient harms were reported after gentle spinal mobilizations in infants and children and could be interpreted as a side effect of treatment.
The authors concluded that, based on GRADE methodology, we found the evidence was of very low quality; this prevented us from drawing conclusions about the effectiveness of specific SMT techniques in infants, children and adolescents. Outcomes in the included studies were mostly parent or patient-reported; studies did not report on intermediate outcomes to assess the effectiveness of SMT techniques in relation to the hypothesized spinal dysfunction. Severe harms were relatively scarce, poorly described and likely to be associated with underlying missed pathology. Gentle, low-velocity spinal mobilizations seem to be a safe treatment technique in infants, children and adolescents. We encourage future research to describe effectiveness and safety of specific SMT techniques instead of SMT as a general treatment approach.
But chiros do more than just SMT, I hear some say.
Yes, they do!
But they nevertheless manipulate virtually every patient, and the additional treatments they use are merely borrowed from other disciplines.
So, why are the numbers increasing then?
I suggest this as a main reason:
chiropractors are systematically misleading the public about the value of their trade.
Guest post by Björn Geir
I have tried to find a form or type of quackery that can be confirmed to have died out and is no longer practised. Once I thought I had found one, but it turns out that phrenology is still “a thing” and is being practised by a few eccentrics.
I am almost convinced by now that any quackery or SCAM, as Professor Ernst has proposed to call it, never dies. Once someone has invented a SCAM, it will live on forever, like the proverbial zombie, neither dead nor properly alive and useful. Even bloodletting, the archetypical reject from the practice of medicine, is still being practised in some corners of this world. Google “Wet cupping” or “Hijama” if you don’t believe me.
The world will have to live with health-related scam and swindle but its popularity can and should be suppressed and held to an acceptable low. If truth and science are promoted and SCAM is vigilantly and constantly opposed, then public trust in it can be held back and even reversed as now has been shown in Norway.
My somewhat abridged translation of an article published on June 30th on the Norwegian state broadcasting services website.
————
Norwegians have become much more sceptical towards natural medicine
Fifteen years ago, most Norwegians had faith in natural medicine. Not anymore.
– This is dramatic. A total reversal of opinion, says John Spilling of Ipsos, a company that performs an annual survey of public opinion in Norway. About 3500 people have been interviewed every year since 1985.
The survey, called Norwegian Monitor, has shown that the alternative industry had its heyday in the 80´s and 90´s, at least according to the Norwegian population’s confidence in natural medicine.
On average, eight out of ten thought this kind of therapy and naturopaths could help when ordinary doctors had given up.
But after the turn of the millennium, something started to happen.
The confidence plummeted.
A screenshot from the article showing the representation of the annual Norwegian Monitor survey results for the statement: Naturopaths and natural medicine can often help when ordinary doctors and medicine fall short.
The results are represented as follows:
Black – Impossible to answer
Grey – No answer
Dark red – Totally disagree
Light red – Partially disagree
Dark blue – Partially agree
Light blue – Totally agree
The graph in the article is interactive so you can find the individual rates by hovering over the bars in the article online.
This year only three out of ten fully or partially agree that natural medicine and naturopaths can help. Mr. Spilling is surprised by the magnitude of change, which also has been steadily declining instead of the usual ups and downs seen in so many other areas.
– I see almost no parallels, he says.
The patients stopped coming
The article interviews Ms. Hilde Moldestad. A homeopath since many decades, now retired and leads the Norwegian Homeopathic Patient Association.
Ms. Moldestad marked the decline already while practising.
– The patients stopped coming, because the trends were such that no one was to believe that there was anything good about homeopathy.
She also noted a strongly declining interest within the patient association.
– There are less and less members. People are not so interested in being team members anymore, they want it free online.
Ms. Moldestad is determined that homeopathy works.
– The irony is that the more research that shows that homeopathy works, the stronger the opposition to using the method.
The [Norwegian] National Research Center for Alternative Medicine writes that there is no solid evidence that homeopathic medicines have an effect. And both the Norwegian Medicines Agency and the Norwegian Pharmacists’ Association believe that in practice the pills only contain water and sugar.
– But we are up in a paradigm shift. The damage that has been inflicted on humanity during the period in which school medicine has been allowed to dominate, can no longer be undermined, says Ms. Moldestad in the patient association.The article then interviews Mr. Gunnar Tjomlid, an active Norwegian sceptic who talks about some local background stories of local interest and speculates that perhaps this change correlates with the introduction and distribution of internet access in Norway.
Less use
It is not only the Norwegian Monitor survey that shows a decline for the alternative industry. Every two years, the National Research Center for Alternative Medicine (Nafkam) conducts a survey on, among other things, how often Norwegians visit alternative therapists.
– In 2012, you had just under 40 percent who had been to an alternative therapist. And in December 2020, it was 22 percent. So, there has been a declining trend, says Mr. Ola Lillenes, information director at Nafkam.
At the same time, self-treatment, especially with self-help techniques, has increased.
– Healing and homeopathy are probably among those who have fallen the most through these years.
Education and emotions
Jarle Botnen runs the Bø Institute of Natural Medicine in Telemark. In addition, he is part of the steering group in the association of alternative treatment organizations. Over 1000 therapists are affiliated with this organisation which is named Saborg.
– There is a noticeable decline, that is exactly correct, says Botnen.
He has several theories as to why Norwegians have become more sceptical of natural medicine.
Norwegians have received more education and have less trust in their own feelings.
People are used to simple solutions, such as over-the-counter painkillers. They do not treat the cause of the ailments, which takes more time.
It is difficult to distinguish charlatans from the serious [alternative practitioners]. The industry has also not managed to cooperate well enough, according to Botnen.
The pharmaceutical industry has been lobbying to get more of the market for alternative medicine.
The attitude in the media has changed from being positive to natural medicine to often the opposite.
Small brown glass bottles with homeopathic pills lie in a drawer in a pharmacy.
Sales of homeopathic medicines have declined at the same time as Norwegians have become more sceptical of natural medicine.
– We often hear remarks such as “we trust the authorities”, “the authorities have approved the preparation or treatment”. This is reflected in the consumption of chemical and synthetic medicine, which has increased somewhat formidably during this period, Botnen believes.
John Spilling in Ipsos says it is true that people have great confidence in the public sector. Confidence in hospitals and elderly care has also increased, while the alternative industry has had the opposite development.
– Most of Norway’s population does not trust this type of product. I can only understand that the situation of this industry is very different than in 2001.
End of article————-
These are indeed positive and convincing results. I suspect a similar trend has been happening in most other populations? It would be very interesting to know if a similar trend has been observed elsewhere.
I have previously reported that a Canadian naturopath, Jason Klop, is under investigation for selling fecal Microbiota transplants to treat autistic children. Now, there is a new twist in this story.
On Twitter, J.N. Stea summarized it nicely:
This naturopath is fighting a judge so that he can charge parents about $15,000 to give his nephew’s poop to children as a treatment for autism. His lawyer argues that he should be allowed to since naturopathy isn’t scientific anyway.
Klop’s lawyer defends the naturopath against an investigation into his business of selling fecal microbiota transplants to families of autistic children. The College of Naturopathic Physicians (CoN) had banned Klop for selling, advertising, and manufacturing pills made from human feces claiming that Klop has been engaging in conduct not acceptable for a naturopathic physician. Klop’s lawyer, Jason Gratl, argued this was difficult to prove in a field that has a few restrictions and some ambiguous boundaries.
“What does it take to be a naturopath and do something that is not appropriate in a field so wide-ranging and open to interpretation?” the lawyer, Gratl, asked the court suggesting that the lack of scientific evidence supporting the use of fecal Microbiota Transplants (FMT) to treat autism is not necessarily relevant in this instance.
“Naturopaths can rely on science in certain aspects, but they are not bound to science,” Gratl said. He explained that naturopathic practices could be based on anecdotes and historical knowledge. Later, he pointed out that the field also includes homeopathy, which, some believe, involves magical thinking. It is definitely not scientific in its core.” After describing the case as a “tragedy”, Gratl called the allegations against his client “entirely unverfounded and scurrilous.”
I suspect it is nothing new to most readers, yet I find it gratifying to hear from a lawyer that naturopathy
- is not science,
- relies on anecdote instead of evidence,
- and involves magical thinking.
I do think, however, that despite all this, naturopaths should not be allowed to do any odd nonsense that comes to their minds and fills their bank accounts quickly.
I only now learned of the death of one of the most bizarre proponents that the cult of homeopathy has ever produced in its 200-year history. From his official obituary, one would not suspect much weirdness:
John R. Benneth passed away Nov. 9, 2021 in Chico, Calif., after a long battle with Parkinson’s disease.
John shepherded the Pixieland Theatre in Lincoln City for many years, writing, directing, and acting in plays that kept audiences coming back. He appeared often on stage in Portland and became a familiar face in local and national commercials. In the mid-1980s he was the host, writer, and creative force behind The Portland Underground, a weekly, live, late-night local access show. He gave many local actors a chance to stretch their improv talents on that and his earlier show, Mysterious Planet. His was the voice of both Portland Talk Radio’s controversial Jack Hammer, and Kandu the Mystic. He later performed regularly as Mark Twain in Virginia City, Nev., and on cruises on Lake Tahoe. John started working as a private investigator in Portland in 1978, and in 1982, he founded the National Missing Children’s Locate Center, helping parents to find their children across the U.S. He later became internationally known for his research into and advocacy for Homeopathic Medicine and was invited to present a treatise on the subject at London’s Oxford University in 2010.
John was a member of both Hawthorne and Washington Masonic lodges and the Scottish Rite of Portland.
He was preceded in death by his parents, John and Bettiana Benneth; and by his wife, Catherine Benneth. He is survived by his brother, David; and his four sons, Horatio, Merlin, Cyrano and Evan.
The ‘Bolen report’ offers a little more, albeit weirdly unreliable information:
John Benneth, PG Hom.- London (Hons) is the renowned discoverer of the link between Homeopathy and Conventional Ionic Chemistry.
The first to accept a notorious challenge to Homeopathy, he forced the James Randi Educational Foundation (JREF), in 1999, to back down from a spurious offer to award $1,000,000 for a test identifying homeopathic solutes from their liquid aqueous vehicles.
In 2010, by invitation of Nobel laureate physicist Brian Josephson at Cambridge’s Cavendish Laboratory, he presented the Supramolecular Chemistry of the Homeopathic Remedy revealing structural changes and the physics of hydrolysis and molecular self assembling chain reactions.
He is the author of Ebola Prophylaxis and Cure detailing the use of FDA approved homeopathic pharmaceuticals in the treatment of hemorrhagic fevers, presented in advance of the reported successful use of homeopathic remedies to cure Ebola.
He is a proponent for the use of homeopathic pharmaceuticals to cure sepsis and other dire conditions for conventional use in hospital emergency and intensive care, and the Ionic Vaccine for the safe and effective non-molecular prevention of epidemic diseases.
To estimate the true extent of Benneth’s eccentricity, we need to read some of the posts by John himself johnbenneth.wordpress.com. Alternatively, we might access some of his appearances on youtube, quackometer, or even just a post I published several years ago.
I am sad that John is gone. I always thought he was mad like a hatter, but he had me in stitches whenever our paths crossed.
An epidemiological study from the US just published in the BMJ concluded that “the mortality gap in Republican voting counties compared with Democratic voting counties has grown over time, especially for white populations, and that gap began to widen after 2008.”
In a BMJ editorial, Steven Woolf comments on the study and provides further evidence on how politics influence health in the US. Here are his concluding two paragraphs:
Political influence on US mortality rates became overt during the covid-19 pandemic, when public health policies, controlled by states, were heavily influenced by party affiliation. Republican politicians, often seeking to appeal to President Trump and his supporters, challenged scientific evidence and opposed enforcement of vaccinations and safety measures such as masking. A macabre natural experiment occurred in 2021, a year marked by the convergence of vaccine availability and contagious variants that threatened unvaccinated populations: states led by governors who promoted vaccination and mandated pandemic control measures experienced much lower death rates than the “control” group, consisting of conservative states with lax policies and large unvaccinated populations. This behavior could explain why US mortality rates associated with covid-19 were so catastrophic, vastly exceeding losses in other high income countries.
Observers of health trends in the US should keep their eye on state governments, where tectonic shifts in policy are occurring. While gridlock in Washington, DC incapacitates the federal government, Republican leaders in dozens of state capitols are passing laws to undermine health and safety regulations, ban abortion, limit LGBT+ rights, and implement more conservative policies on voting, school curriculums, and climate policy. To understand the implications for population health, researchers must break with custom; although scientific literature has traditionally avoided discussing politics, the growing influence of partisan affiliation on policies affecting health makes this covariate an increasingly important subject of study.
_____________________
What has this to do with so-called alternative medicine (SCAM)?
Not a lot.
Except, of course, that Trump has been quite sympathetic to both quackery and quacks (see, for instance, here and here). Moreover, the embarrassing Dr. Oz, America’s charlatan-in-chief, is now a Republican candidate for the US senate. And the creation of the NHI office for alternative medicine, currently called NCCIH, was the idea of the Republican senator, Tom Harkin.
I think we get the drift: on the US political level, SCAM seems to be a right-wing thing.
Am I claiming that SCAM is the cause of the higher mortality in Republican counties?
No.
Do I feel that both are related to irresponsible attitudes towards healthcare issues?
Yes.
In India, the homeopathic remedy, Arsenicum Album 30C (prepared from arsenic trioxide) is widely prescribed and publicly supplied to adults and children for preventing COVID infections. Inorganic arsenic, known as the “king of poisons” is a highly toxic substance with the potential to cause acute as well as chronic injury to multiple organ systems, mainly skin, lung, liver, and kidneys.
Indian researchers present three cases of acute liver injury, leading to the death of one patient with underlying non-alcoholic steatohepatitis (NASH) cirrhosis, after consumption of the homeopathic remedy AA30 for COVID-19 prevention.
Case one
A 70-year-old man with compensated non-alcoholic steatohepatitis (NASH)-related cirrhosis and diabetes mellitus consumed the homeopathic IB AA30 as prescribed for 12 weeks prior to the onset of symptoms. He presented with jaundice and abdominal distension within four weeks after the onset of loss of appetite and well-being. The patient was not on any other hepatotoxic agents, over-the-counter medications, or herbal and dietary supplements. Investigations revealed the presence of conjugated hyperbilirubinemia, ascites, and abnormal coagulation, suggestive of acute-on-chronic liver failure (ACLF). Further investigations to identify known causes of acute deterioration of underlying cirrhosis were performed, including a transjugular liver biopsy. All competing causes for acute liver injury were meticulously ruled out. These included infections-tests for immunoglobulin M (IgM) for viral hepatitis A and E; hepatitis B surface antigen and IgM antibody to hepatitis B core antigen; nucleic acid tests via polymerase chain reaction for hepatitis C; IgM for herpes zoster and herpes simplex, cytomegalovirus, parvovirus, Epstein-Barr virus. Complete auto-antibody testing for autoimmune hepatitis (AIH) was negative. The Roussel Uclaf Causality Assessment (RUCAM) demonstrated “probable” (score 7) drug-induced liver injury (DILI) and simplified AIH score was less than 5, revealing the cause of acute liver injury leading to ACLF as the homeopathic remedy, AA30. The liver biopsy revealed multiacinar hepatocyte necrosis, lymphocytic, neutrophilic, and eosinophilic inflammation in the absence of interface hepatitis, which were predominantly portal-based in the background of cirrhosis, suggestive of DILI. Analysis of drugs consumed could not be performed in view of inadequate sample availability. The patient and family consented to arsenic analysis in nail and hair samples which revealed extremely high levels of the heavy metal, supportive of arsenic toxicity and associated liver injury in the patient. Evaluation of hair and hair samples of two family members (below detection limits, method detection limit being 0.1 mg/kg), staying in the same household did not reveal levels signifying cluster arsenic poisoning from water or soil sources. The patient succumbed to complications related to ACLF, nine months after the initial diagnosis.
Case two
A 68-year-old male with systemic hypertension controlled on telmisartan who ingested AA30 as prescribed for four weeks prior to the onset of symptoms. There was no associated jaundice or cholestatic symptoms, but liver tests revealed acute hepatitis with an elevation of liver enzymes. The patient was not on any other hepatotoxic agents, over-the-counter medications, or herbal and dietary supplements. Further investigations did not reveal the presence of underlying chronic liver disease or portal hypertension. All competing causes for acute liver injury were meticulously ruled out similar to the extensive workup that was done in case one. The RUCAM demonstrated “probable” (score 8) DILI and simplified AIH score was less than 5, revealing the cause of acute non-icteric hepatitis as the homeopathic remedy, AA30. The liver biopsy revealed perivenular hepatocyte necrosis, with predominantly portal-based mixed cellular inflammation consisting of plasma cells, eosinophils, lymphocytes, and scattered neutrophils. Additionally, ballooning of hepatocytes was marked with scattered rosettes and moderate interphase hepatitis in the presence of mild portal and sinusoidal fibrosis suggestive of DILI. Acute hepatitis resolved after drug withdrawal and finite course of steroids within three months, without any recurrence on follow-up.
Case three
A 48-year-old overweight woman consumed homeopathic AA30 pills as COVID-19 preventive for one week prior to the onset of her symptoms of cholestatic jaundice. Prior to the development of jaundice, she had nonspecific gastrointestinal symptoms such as nausea and progressive loss of appetite. Liver tests revealed conjugated hyperbilirubinemia with highly raised liver enzymes. The patient was not on any other hepatotoxic prescription drugs, over-the-counter medications, or herbal and dietary supplements. Further investigations did not reveal the presence of underlying chronic liver disease or portal hypertension. All competing causes for acute liver injury were meticulously ruled out similar to the extensive workup that was done in case one. The RUCAM demonstrated “probable” (score 7) DILI and simplified AIH score was less than 5, revealing the cause of acute cholestatic hepatitis as the homeopathic remedy, AA30. The liver biopsy revealed spotty, focal hepatocyte necrosis, with predominantly portal-based neutrophilic and eosinophil-rich inflammation, moderate steatosis, and mild interface hepatitis with underlying mild perisinusoidal fibrosis, suggestive of DILI. The acute cholestatic hepatitis resolved after drug withdrawal and a finite course of steroids within six months, without any recurrence on follow-up.
The chemical analysis and toxicology (inductively coupled optical emission spectroscopy and triple-quadrupole gas chromatography with tandem mass spectroscopy method) on two sets of AA30 samples retrieved from case three revealed D-mannose, melezitose, and arsenic respectively, demonstrating batch-to-batch variation due to poor manufacturing practices.
The authors draw the following conclusions: Health regulatory authorities, physicians, general and patient population must be aware of the potential harms associated with the large-scale promotion of untested, alternative medical systems during a medical emergency so as to prevent an “epidemic” of avoidable DILI within the ongoing pandemic. Even though ultra-diluted homeopathic remedies, found ineffective as shown in large-scale meta-analysis, are considered safe for use due to the absence of any active compound beyond 12C dilution. Nonetheless, poor manufacturing practices, use of concentrated tincture formulations, and adulteration and contamination of homeopathic remedies can still pose considerable toxicity in predisposed persons. From a scientific and evidence-based standpoint, it is imperative that the general population and at-risk persons understand that vaccination, and not untested, misleading IBs, remains the best available armamentarium against COVID-19 which helps in fighting back the pandemic.
Nausea and vomiting are common symptoms of patients with advanced cancer. While there is some evidence for acupuncture point stimulation in the treatment of these symptoms for patients having anticancer treatment, there is little for when they are not related to such treatment.
This study aimed to determine whether acupressure at the pericardium 6 sites can help treat nausea and vomiting suffered by palliative care patients with advanced cancer. The researchers conducted a double-blind randomized controlled trial-active versus placebo acupressure wristbands. In-patients with advanced cancer in two specialist palliative care units who fitted either or both of the following criteria were approached: nausea that was at least of moderate severity; vomiting daily on average for the prior 3 days.
A total of 57 patients were randomized to have either active or placebo acupressure wristbands. There was no difference in any of the outcome measures between the two groups:
- change from the baseline number of vomits;
- Visual Analogue Scale for ‘did acupressure wristbands help you to feel better?’;
- the total number of doses of antiemetic medication;
- the need for escalation of antiemetics.
The authors concluded that, in contrast to a previously published feasibility study, active acupressure wristbands were no better than placebo for specialist palliative care in patients with advanced cancer and nausea and vomiting.
When the research into acupuncture for nausea and vomiting began some 20 years ago, the evidence turned out to be encouraging. Later, as the studies became more and more rigorous, many trials failed to confirm the initial findings. Today, the totality of the evidence is far less convincing than it seemed years ago.
This is a phenomenon that can be observed not just in acupuncture research but in many types of treatment:
- Initially, over-enthusiastic researchers become victims of their own optimism.
- These investigators are less into testing hypotheses than into confirming their own wishful thinking.
- Thus, several positive trials emerge.
- These, however, turn out to be methodologically flawed.
- Eventually, the subject might be picked up by real scientists who truly test hypotheses.
- More and more negative studies thus emerge.
- Depending on how many flawed studies were initially published and how critical the authors of systematic reviews are, it can take years until the totality of the evidence depicts the true picture which discloses the initial findings as false-positive.
The message is, I think, clear: poor quality studies have the potential to mislead us for many years. Eventually, however, the self-cleansing ability of science should generate the truth about the value of any treatment. In other words:
poor-quality science is not just useless, it causes long-term harm
and
critical thinking prevents harm
