The US ‘Public Citizen‘ is an American non-profit, progressive consumer rights advocacy group, and think tank based in Washington, D.C. They recently published an article entitled “FDA Guidance on Homeopathic Drugs: An Ongoing Public Health Failure“. Here are a few excerpts:
In December 2022, the U.S. Food and Drug Administration (FDA) issued new guidance on homeopathic drug products. The guidance states that the agency now “intends to apply a risk-based enforcement approach to the manufacturing, distribution and marketing of homeopathic drug products.”
Under this new risk-based approach, the agency plans to target its enforcement actions against homeopathic drug products marketed without FDA approval that fall within the following limited categories:
- products with reports of injury that, after evaluation, raise potential safety concerns
- products containing or purportedly containing ingredients associated with potentially significant safety concerns (for example, infectious agents or controlled substances)
- products that are not administered orally or topically (for example, injectable drug products and ophthalmic drug products)
- products intended to be used to prevent or treat serious or life-threatening diseases
- products for vulnerable populations, such as immunocompromised individuals, infants and the elderly
- products with significant quality issues (for example, products that are contaminated with foreign materials or objectionable microorganisms)
But this new FDA guidance fails to adequately address the public health threat posed by the agency’s decades-long permissive approach to these illegal drug products.
Under FDA regulations, prescription and over-the-counter (OTC) homeopathic products are considered drugs and are supposed to be subject to the same review and approval requirements as all other prescription and OTC medications. However, under a flawed enforcement policy issued in 1988, the FDA has allowed these drug products to be marketed in the U.S. without agency review or approval. Thus, all products labeled as homeopathic are being marketed without the FDA having evaluated their safety, effectiveness or quality…
… there is no plausible physiologic or medical basis to support the theory underlying homeopathy, nor is there evidence from well-designed, rigorous clinical trials showing that homeopathic drugs are safe and effective.
The FDA should declare unequivocally that all unapproved homeopathic drug products are illegal and direct all manufacturers to immediately remove such products from the market. In the meantime, as we have recommended for many years, consumers should not use homeopathic products. At best, the products are a waste of money, given the lack of any evidence that they are effective. At worst, they could cause serious harm because of the lack of FDA oversight to ensure safety.
I fully agree with these sentiments. The harm caused by homeopathy is considerable and multi-facetted. Many previous posts have discudded these problems, e.g.:
- Nine cases of severe homeopathy-induced liver injuries
- Another death by homeopathy
- HOMEOPATHY – “It is not just irresponsible, it’s downright dangerous.”
- Adverse effects of homeopathy and aggravations at NAFKAM
- Homeopathy: it’s time to stop the double standards
- Homeopathy can cause serious harm – and finally, the NHS England has realised it
- Vidatox, homeopathy’s answer to cancer or outright fraud?
- Another child has died because of homeopathy
- Doctor homeopaths violate fundamental rules of ethics when practising homeopathy
- ‘Best homeopathy doctor in Delhi’ offers treatment for HIV/AIDS
- DIY-Homeopathy: how to kill your entire family
- The risks of homeopathy?
- The FDA has warned 4 manufacturers of unapproved injectable homeopathic drugs
- Is this the crown of the Corona-idiocy? Nosodes In Prevention And Management Of COVID -19
- The FDA has sent more warning letters to homeopathic manufacturers
- Walmart is being sued for selling homeopathic products
- Homoeopathic remedies may be safe, but do all homeopaths merit this attribute?
- Recommending homeoprophylaxis is unethical, irresponsible and possibly even criminal
- FDA: homeopathic teething remedies were toxic
- “Homeoprophylaxis, the homeopathic vaccine alternative, prevents disease through nosodes.”
- A truly dangerous homeopath
- The scandalous attitude of some homeopaths and their supporters towards immunisations
- Oh yes, let’s have homeopaths as primary care practitioners! But only in a parallel universe,please.
Having warned about the dangers of homeopathy for decades, I feel it is high time for regulators across the world to take appropriate action.
It has been reported that two London councils have written to parents to warn that children who are not vaccinated against measles may need to self-isolate for 21 days if a classmate is infected with the disease. It comes after modelling by the UK Health Security Agency (UKHSA) warned that up to 160,000 cases could occur in the capital alone as a result of low vaccination rates. Just three-quarters of London children have received the two required doses of the MMR jab, which protects against measles. This is 10 per cent lower than the national average.
Barnet Council wrote to parents on July 20 warning that any unvaccinated child identified as a close contact of a measles case could be asked to self-isolate for up to 21 days. “Measles is of serious concern in London due to low childhood vaccination rates. Currently we are seeing an increase in measles cases circulating in neighbouring London boroughs, so now is a good time to check that your child’s MMR vaccination – which not only protects your child against measles but also mumps and rubella – is up to date,” the letter reads. “Children who are vaccinated do not need to be excluded from school or childcare,” the letter added.
Neighbouring Haringey Council also warned that children without both MMR doses may be asked to quarantine for 21 days. Just over two-thirds (67.9 per cent) of children in the area had received both doses by the age of five. The councils stated that they had sent the letters based on guidance by the UKHSA, but the agency said that headteachers should consider “excluding” unvaccinated pupils who become infected with measles rather than instructing them to self-isolate.
Data published by the UKHSA showed that 128 cases of measles were recorded between January 1 and June 30 this year, compared to 54 cases in the whole of 2022. Two-thirds of the cases were detected in London. The agency have said that there is a high risk of cases linked to overseas travel leading to outbreaks in specific population groups such as young people and under-vaccinated communities.
Dr Vanessa Saliba, a consultant epidemiologist at UKHSA, said: “When there are measles cases or outbreaks in nurseries or schools, the UKHSA health protection team will assess the situation, together with the school and other local partners, and provide advice for staff and pupils. “Those who are not up to date with their MMR vaccinations will be asked to catch up urgently to help stop the outbreak and minimise disruption in schools.”
Measles is a significant concern with approximately 10 million people infected annually causing over 100,000 deaths worldwide. In the US before use of the measles vaccine, there were estimated to be 3 to 4 million people infected with measles annually, causing 400 to 500 deaths. Complications of measles include otitis media, diarrhea, pneumonia, and acute encephalitis. Measles is a leading cause of blindness in the developing world, especially in those who are vitamin A deficient. Malnourished children with measles are also at higher risk of developing noma (or cancrum oris), a rapidly progressive gangrenous infection of the mouth and face. Most deaths due to measles are caused by pneumonia, diarrhea, or neurological complications in young children, severely malnourished or immunocompromised individuals, and pregnant women. A rare sequela of measles is subacute sclerosing panencephalitis.
Back in 2003, we investigated what advice UK homeopaths, chiropractors and general practitioners give on measles, mumps and rubella vaccination programme (MMR) vaccination via the Internet. Online referral directories listing e-mail addresses of UK homeopaths, chiropractors and general practitioners and private websites were visited. All addresses thus located received a letter of a (fictitious) patient asking for advice about the MMR vaccination. After sending a follow-up letter explaining the nature and aim of this project and offering the option of withdrawal, 26% of all respondents withdrew their answers. Homeopaths yielded a final response rate (53%, n = 77) compared to chiropractors (32%, n = 16). GPs unanimously refused to give advice over the Internet. No homeopath and only one chiropractor advised in favour of the MMR vaccination. Two homeopaths and three chiropractors indirectly advised in favour of MMR. More chiropractors than homeopaths displayed a positive attitude towards the MMR vaccination. We concluded that some complementary and alternative medicine providers have a negative attitude towards immunisation and means of changing this should be considered.
The problem is by no means confined to the UK. German researchers, for instance, showed that belief in homeopathy and other parental attitudes indicating lack of knowledge about the importance of vaccinations significantly influenced an early immunisation. Moreover, being a German homeopath has been independently associated with lower own vaccination behavior. Data from France paint a similar picture.
Some homeopaths, of course, claim that ‘homeopathic vaccinations’ are effective and preferable. My advice is: DON’T BELIEVE THESE CHARLATANS! A recent study demonstrated that homeopathic vaccines do not evoke antibody responses and produce a response that is similar to placebo. In contrast, conventional vaccines provide a robust antibody response in the majority of those vaccinated.
Homeopathic remedies are highly diluted formulations without proven clinical benefits, traditionally believed not to cause adverse events. Nonetheless, published literature reveals severe local and non–liver-related systemic side effects. Here is the first series on homeopathy-related severe drug-induced liver injury (DILI) from a single center.
A retrospective review of records from January 2019 to February 2022 identified 9 patients with liver injury attributed to homeopathic formulations. Competing causes were comprehensively excluded. Chemical analysis was performed on retrieved formulations using triple quadrupole gas chromatography-mass spectrometry and inductively coupled plasma atomic emission spectroscopy.
Males predominated with a median age of 54 years. The most typical clinical presentation was acute hepatitis, followed by acute or chronic liver failure. All patients developed jaundice, and ascites were notable in one-third of the patients. Five patients had underlying chronic liver disease. COVID-19 prevention was the most common indication for homeopathic use. Probable DILI was seen in 77.8%, and hepatocellular injury predominated (66.7%). Four (44.4%) patients died (3 with chronic liver disease) at a median follow-up of 194 days. Liver histopathology showed necrosis, portal and lobular neutrophilic inflammation, and eosinophilic infiltration with cholestasis. A total of 29 remedies were consumed between 9 patients, and 15 formulations were analyzed. Toxicology revealed industrial solvents, corticosteroids, antibiotics, sedatives, synthetic opioids, heavy metals, and toxic phyto-compounds, even in ‘supposed’ ultra-dilute formulations.
The authors concluded that homeopathic remedies potentially result in severe liver injury, leading to death in those with underlying liver disease. The use of mother tinctures, insufficient dilution, poor manufacturing practices, adulteration and contamination, and the presence of direct hepatotoxic herbals were the reasons for toxicity. Physicians, the public, and patients must realize that Homeopathic drugs are not ‘gentle placebos.’
The authors also cite our own work on this subject:
A detailed systematic review of homeopathic remedies-induced adverse events from published case reports and case series by Posadzski and colleagues showed that severe side effects, some leading to fatality, are possible with classic and unspecified homeopathic formulations. The total number of patients included was 1159, of which 1142 suffered adverse events directly related to homeopathy. The direct adverse events had acute pancreatitis, severe allergic reactions, arsenical keratosis, bullous pemphigoid, neurocognitive disorders, sudden cardiac arrest and coma, severe dyselectrolytemia, interstitial nephritis, kidney injury, thallium poisoning, syncopal attacks, and focal neurological deficits as well as movement disorders. Fatal events involved advanced renal failure requiring dialysis, toxic polyneuropathy, and quadriparesis. The duration of adverse events ranged from a few hours to 7 months, and 4 patients died. The authors state that in most cases, the mechanism of action for side effects of homeopathy involved allergic reactions or the presence of toxic substances—the use of strong mother tinctures, drug contaminants, adulterants, or poor manufacturing (incorrect dilutions).
When we published our paper back in 2012, it led to a seies of angry responses from defenders of homeopathy who claimed that one cannot ‘have the cake and eat it’; either homeopathic remedies are placebos and thus harmless, or they have effects and thus also side-effects, they claimed. As the new publication by Indian researchers yet again shows, they were mistaken. In fact, homeopathy is dangerous in more than one way:
- the homeopathic remedies can do harm if not diluted or wrongly manufactured;
- the homeopaths can do harm through their often wrong advice in health matters;
- homeopathy erodes rational thinking (as, for instance, the resopnses to our 2012 paper demonstrated).
The objectives of this randomized double-blind placebo-controlled clinical trial were to determine if there:
- (a) is an overall effect of homeopathic treatment (homeopathic medicines plus consultation) in the treatment of ADHD;
- (b) are any specific effects the homeopathic consultation alone in the treatment of ADHD;
- (c) are any specific effects of homeopathic medicines in the treatment of ADHD.
Children aged 6–16 years diagnosed with ADHD were randomized to one of three arms:
- Arm 1 (Remedy and Consultation);
- Arm 2 (Placebo and Consultation);
- Arm 3 (Usual Care).
The primary outcome measure was the change of the Conner 3 Global Index-Parent T-score (CGI-P T score) between baseline and 28 weeks.
The results showed an improvement in ADHD symptoms as measured by the CGI-P T score in the two groups (Arms 1 and 2) that received consultations with a homeopathic practitioner when compared with the usual care control group (Arm 3). Parents of the children in the study who received homeopathic consultations (Arms 1 and 2) also reported greater coping efficacy compared with those receiving usual care (Arm 3). There was no difference in adverse events among the three study arms.
The authors concluded that, in this study, homeopathic consultations provided over 8 months with the use of homeopathic remedy was associated with a decrease in ADHD symptoms in children aging 6–16 years when compared with usual treatment alone. Children treated with homeopathic consultations and placebo experienced a similar decrease in ADHD symptoms; however, this finding did not reach statistical significance when correcting for multiple comparisons. Homeopathic remedies in and of themselves were not associated with any change in ADHD symptoms.
In the discussion section, the authors make their findings a little clearer: “The findings are generally consistent with a recent meta-analysis that concluded that (i)ndividualized homeopathy showed a clinically relevant and statistically robust effect in the treatment of ADHD. Similar to the meta-analysis, the authors found individualized homeopathy (consultation plus remedy) resulted in improvement in ADHD symptoms. However, the data suggest that this effect is not due to the remedy component of the intervention.”
The authors do not cite the (to the best of my knowledge) only study that had a very similar aim, namely differentiating between the effects of the homeopathic remedy and the homeopathic consultation. It was conducted by the late George Lweith who certainly was not against homeopathy. The conclusions of this trial were as follows: Homeopathic consultations but not homeopathic remedies are associated with clinically relevant benefits for patients with active but relatively stable rheumatoid arthritis.
Both trials confirm what rational thinkers have been saying for many years: the effects that many people experience after homeopathic therapy are not due to the homeopathic remedy but to the usually long and empathetic therapeutic encounter, the placebo effect, and other non-specific effects. To put it bluntly homeopathy is a kind of amateur psychotherapy.
Before someone now claims that this means homeopathy is fine, let me tell you this: no, it is not fine! If someone needs psychotherapy, he/she should see not an amateur but a professional, i.e. a psychologist who is properly trained in what she can and cannot do.
This study aimed to evaluate whether individualized homeopathic medicines have a greater adjunctive effect than adjunctive placebos in the treatment of moderate and severe cases of coronavirus disease 2019 (COVID-19). It was designed as a randomized, single-blind, placebo-controlled trial set in the clinical context of standard care. Patients admitted in a tertiary care hospital, suffering from moderate or severe COVID-19 and above 18 years of age were included. In total, 150 patients were randomly divided into two groups to receive either:
- individualized homeopathic medicines
- or placebos.
Both options were administered in addition to the standard treatment of COVID-19.
The primary outcome was time taken to achieve RT-PCR-confirmed virus clearance for COVID-19. Secondary outcomes were changes in the Clinical Ordinal Outcomes Scale (COOS) of the World Health Organization, the patient-reported MYMOP2 scale, and several biochemical parameters. Parametric data were analyzed using unpaired t-test. Non-parametric data were analyzed using the Wilcoxon signed rank test. Categorical data were analyzed using Chi-square test.
In total, 72 participants of the add-on homeopathy (AoH) group showed conversion of RT-PCR status to negative, in an average time of 7.53 ± 4.76 days (mean ± SD), as compared with 11.65 ± 9.54 days in the add-on placebo (AoP) group (p = 0.001). The mean COOS score decreased from 4.26 ± 0.44 to 3.64 ± 1.50 and from 4.3 ± 0.46 to 4.07 ± 1.8 in the AoH and AoP groups respectively (p = 0.130). The mortality rate for the AoH group was 9.7% compared with 17.3% in the AoP group. The MYMOP2 scores between the two groups differed significantly (p = 0.001), in favor of AoH. Inter-group differences in the pre- and post- mean values of C-reactive protein, fibrinogen, total leukocyte count, platelet count and alkaline phosphatase were each found to be statistically significant (p <0.05), favoring AoH; six other biochemical parameters showed no statistically significant differences.
The authors concluded that the study suggests homeopathy may be an effective adjunct to standard care for treating moderate and severe COVID-19 patients. More rigorous, including double-blinded, studies should be performed to confirm or refute these initial findings.
I do agree with the authors that more rigorous studies are needed before we can accept these findings. As it stands, this study seems to have multiple flaws:
- I fail to understand why they did not design their trial as a double-blind study. The reason given by the authors makes little sense to me.
- I also have my doubts that the study was even single-blind. If I understand it correctly, the placebo group was did not benefit from the detailed homeopathic history taking that is necessary to find the optimal homeopathic remedy. If that is so, unblinding of patients is inevitable.
- The authors themselves point out that the relevance of many outcome measures is questionable
Generally speaking, I find the results suspicious, implausible, and frankly too good to be true. I might also point out that the authors’ afilitation do not inspire much trust in their objectivity:
- 1Central Council for Research in Homoeopathy, New Delhi, India.
- 2Central Council for Research in Homoeopathy, Ministry of AYUSH, Govt. of India, New Delhi, India.
- 3Rejoice Health Foundation, New Delhi, India.
- 4Department of Onco-Anaesthesia and Palliative Medicine, Dr. B.R. Ambedkar Institute Rotary Cancer Hospital and National Cancer Institute, All India Institute of Medical Sciences, Ministry of Health and Family Welfare, New Delhi, India.
- 5Department of Onco-Anaesthesia and Palliative Medicine, All India Institute of Medical Sciences, Ministry of Health and Family Welfare, New Delhi, India.
Neither do these statements:
The study was funded by the Central Council for Research in Homoeopathy, Ministry of AYUSH, Government of India. The funder approved the study through its review committees, delegated/recruited staff for conducting the study, and facilitated all collaborative procedures.
Conflict of Interest
Lastly, I do wonder why the authors published their study in the 3rd class journal ‘Homeopathy’. Surely, such findings – if true – deserve to be published in a journal of a decent reputation!
‘Chiropractic Economics‘ focuses on “bridging the gap between what doctors of chiropractic learn about healthcare and what they need to know as entrepreneurs who command successful, thriving practices. We are the top-rated resource for chiropractic news, marketing, consulting, financial planning, attracting and retaining patients, and motivating and managing employees. We provide information for practicing chiropractors, with a focus on office management, patient relations, personal development, financial planning, legal, clinical and research data, and wellness and nutrition.”
The magazine recently published an article that is so wonderfully overflowing with BS that I cannot resist showing you a few hilarious excerpts from it:
HOMEOPATHY IS A NATURAL FOR CHIROPRACTORS — because it works with innate intelligence. Each tiny pellet of a homeopathic remedy is like a flash drive full of information that “reinstalls the software,” i.e., it reminds the body that “you know how to have a healthy nervous system” or strong and healthy bones or muscles.
A remedy for patient malady
Homeopathic remedies have much to offer your patients:
- Fast-acting: Some patients will actually feel the effects as soon as they ingest the remedy; it works faster than herbs or vitamins
- Easily available in health food stores, some drug stores and online
- Inexpensive: pennies per dose
- No rebound or withdrawal: Your patient can discontinue it without symptoms recurring
- No drug interactions: It can work well alongside meds and supplements
- Safe: Reactions are rare and serious side effects are unknown.1
Practitioners will benefit as well from recommending homeopathy as this unusual modality will set the chiropractor apart and patients will be grateful for the relief they feel. Homeopathy is available as single remedies, plus more unusual ones are also blended into combination formulas which chiropractors may choose to stock in their office, just as they stock nutritional supplement and glandular formulas.
How does it work?
Homeopathy is totally safe because there is nothing in it — not even one molecule of its original starting substance — yet it is powerful and fast-acting. How can we make these contradictory claims? Because it is information technology.
The manufacturing process imprints the healing information onto water like recording onto a flash drive. The process takes the starting substance through many stages of dilution (making it safe) and potentizes or energizes it at each step (making it powerful). Water behaves differently at these very high dilutions, becoming coherent or structured, as explained by the newly emerging field of ultra-high dilution physics. Two Nobel laureates have testified that their studies explain how homeopathy works.2
Now let’s look at some specific remedies.
Hypericum for the nervous system
Hypericum is almost a universal remedy for nerve-related symptoms: tingling and numbness, pain shooting along a nerve, and trauma to nerve-rich areas (like hitting a finger with a hammer or slamming it in a car door):
- Arnica for soft tissue trauma: homeopathy’s best-known remedy, Arnica is good for sore muscles, pulled muscles, sports injuries, sprains and strains, and bruising.
- Symphytum for fractures: This is the well-known herbal remedy comfrey, known traditionally as “knit-bone,” used to speed the healing of fractures and reduce bone pain.
- Bryonia for joints that hurt to move. When your patient is splinting or guarding, think bryonia, for a bruised rib that makes it painful to laugh or cough or sneeze, or knees that hurt from walking that make the patient take cautious steps.
- Rhus tox for “rusty gate” joints: This is for your patient who needs to limber up when first getting out of bed, or who needs to swing their leg a few times to loosen it up before getting up from a chair.
- Ruta grav. for connective tissue, cartilage and joints in general: sprains and strains, cracking joints, torn tendons and ligaments, and fascia. It has a special affinity for the knee, like the knee that goes out from under someone and for Baker’s cysts.
Three homeopathically-energized minerals to strengthen and heal bone need to be given in a special 6x potency and are known as cell salts or tissue salts:
- Calcarea fluorica (Calc. fluor.) 6x to soften and dissolve: This remedy can help dissolve bone spurs and hardened or condensed tissues like cataracts.
- Calcarea phosphorica (Calc. phos.) 6x to deposit minerals in the bones: This provides the template to send calcium and other minerals to bones and not deposit them elsewhere in the body.
- Silicea 6x strengthens bone as well as hair, skin and nails; you know silica as a supplement, and as a homeopathic remedy it provides the instructions for silica the mineral to go where it is needed. However, Silica 30c (full strength) can push foreign objects out of the body and should not be given to patients with a rod or plate and screws.
What could possibly go wrong?
Not much — an “overdose” in homeopathy is not harmful in the long run — in fact, too much of a remedy is pushing the patient too fast in the direction of cure and the long-term result can be positive. It can be uncomfortable in the short run, though.
The body can only process so much of the remedy’s information at once, and if the body is presented with more than it can handle, it pushes back in the form of increased symptoms, the same symptoms the remedy was intended to treat. This is called an “aggravation” in homeopathy. It’s often said that “You have to get worse before you get better” in homeopathy and this is absolutely not true as long as mild to moderate doses are used (the typical 30c dose in health food stores) and the patient is told to stop if the remedy starts to feel too intense. When in doubt, it’s always safe to stop the remedy and start again later.
The bottom line
Start by recommending these few remedies and you are likely to get good feedback from your patients. Or consider stocking combination remedies that include even more unusual remedies.
They may give even better results and keep patients coming back to you for more, since they are only available through professionals. And if you’re feeling exhausted beyond repair, try some Sepia for yourself.
END OF QUOTE
Yes, this is what a ‘top rated’ chiropractic resource mistakes for information on ‘clinical and research data, and wellness and nutrition’!
I didn’t promise too much, did I?
We discussed the 2015 Australian NHMRC report on homeopathy many times before, e.g.:
- Homeopathy: the 2015 NHMRC report and its criticism re-analysed
- HOMEOPATHY: the NHMRC report revisited
- Ombudsman investigates ‘flawed’ homeopathic study
- The final verdict on homeopathy: it’s a placebo
In a nutshell, the report was an hugely influential analysis of the effectiveness of homeopathy which came to squarely negative conclusions. Thus it was celebrated as a thorough and conclusive piece evidence demonstrating the madness of homeopathy. Unsurprisingly, homeopaths did not like it at all and produced various criticisms claiming that it was neither thorough nor conclusive.
Now the final evaluation of what has been going on was finally published (ISSUED BY THE COMMONWEALTH OMBUDSMAN, IAIN ANDERSON, ON 4 AUGUST 2023):
The Office of the Commonwealth Ombudsman (the Office) has finalised an investigation relating to the National Health and Medical Research Council’s (NHMRC) review of the evidence for the effectiveness of homeopathy, conducted between 2010 and 2015. We commenced this investigation in September 2017 in response to concerns raised with us about how the NHMRC review had proceeded.
The Office conducts its investigations in private, and the Ombudsman generally does not make a public statement in the absence of a formal report. In the circumstances of this matter, including that the then-Ombudsman released a public statement on 4 June 2021 which acknowledged the Office was investigating, we believe it is important to share publicly the information we can, now that the investigation is complete.
Our investigation was finalised in July 2023. We acknowledge the length of time the investigation has taken. This is in part due to the extensive efforts the Office made to source independent scientific expertise to advise us on some detailed and specific questions of scientific methodology that were raised with our Office, including some that were only brought to our attention as our investigation progressed. Despite our best efforts, it was not possible to engage an expert (or experts) to provide independent advice to our Office on this subject. In the absence of independent, expert scientific expertise we have not been able to conclusively determine those matters of scientific methodology. This did not prevent our Office from forming a view on other aspects of the matter.
Our investigation did not result in any adverse findings about the review or the NHMRC. When finalising investigations, we may offer comments and suggestions to an agency about areas for future improvement. In this instance, we offered comments and suggestions to the NHMRC about how it records and publicly explains decisions about its activities. The NHMRC also independently made several improvements to its processes during the course of our investigation.
In essence, this means that the conclusions of the report stand:
Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness. People who are considering whether to use homeopathy should first get advice from a registered health practitioner. Those who use homeopathy should tell their health practitioner and should keep taking any prescribed treatments.
Thus the matter is closed – that is closed for rational thinkers. For irrationalists, the matter will no doubt continue to be a stone of contention. No, homeopath will be able to accept these conclusions simply because a member of a cult ceases to be a cultist once he/she accepts the criticism agaist the cult.
Charles has a well-documented weakness for so-called alternative medicine (SCAM) – not just any SCAM but predominantly the type of SCAM that is both implausible and ineffective. Therefore, nobody can be all that surprised to read in THE TIMES that he has decided to use SCAM for helping women who have difficulties getting pregnant.
If one really wanted to employ SCAM for this aim one is spoilt for choice. In fact, there are only few SCAMs that don’t claim to be useful for this purpose.
A recent review, for instance, suggested that some supplements might be helpful. Other authors advocate SCAMs such as acupuncture, moxibustion, Chinese herbal medicine, psychological intervention, biosimilar electrical stimulation, homeopathy, or hyperbaric oxygen therapy.
Yes, I know! The evidence for these treatments is lousy, and I would never issue a recommendation based on such flimsy evidence.
Yet, the SCAM project at Dumfries House, the Scottish stately home Charles restored in 2007, offers acupuncture, reflexology, massage, yoga, and hypnotherapy for infertile women.
Reflexology, also called zone therapy, is a manual treatment where pressure is applied usually to the sole of the patient’s foot and sometimes also to other areas such as the hands or ears. According to its proponents, foot reflexology is more than a simple foot massage that makes no therapeutic claims beyond relaxation. It is based on the idea that the human body is divided into 10 zones each of which is represented on the sole of the foot. Reflexologists employ maps of the sole of the foot where the body’s organs are depicted. By massaging specific zones which are assumed to be connected to specific organs, reflexologists believe to positively influence the function of these organs. While reflexology is mostly used as a therapy, some therapists also claim they can diagnose health problems through feeling tender or gritty areas on the sole of the foot which, they claim, correspond to specific organs.
Reflexology is not merely implausible as a treatment for infertility, it also boasts of some fairly rigorous trial evidence. A clinical trial (perhaps even the most rigorous of all the trials of SCAM for female fertility problems) testing whether foot reflexology might have a positive effect on the induction of ovulation stated that “the results suggest that any effect on ovulation would not be clinically relevant”.
So, as so often before in the realm of SCAM, Charles has demonstrated that his lack of critical thinking leads him to the least promising options.
Well done, Your Majesty!
This review assessed the role of homoeopathy in the therapeutic management of substance use disorders (SUD) through a systematic web-based literature search. A comprehensive search was conducted online and manually to identify homoeopathic research studies published between 1993 and 2022 on SUD in international databases and the Central Council of Research in Homoeopathy library. Relevant studies were categorised and assessed in terms of study designs, number of participants, evidence grades and clinical outcome parameters. A total of 21 full-text studies were screened and evaluated. Risk of bias (RoB) was assessed for all studies and model validity was appraised for the included RCTs’.
10 studies were included:
- 3 Randomised Controlled Trials,
- 3 Observational studies,
- 1 Pilot study,
- 1 observational comparative study,
- 1 retrospective cohort study,
- 1 case series.
Three studies have a level of evidence of 1b with an ‘A’ grade of recommendation, which consists of the RCTs only. The most commonly prescribed medicines identified were:
- Arsenic album,
- Nux vomica,
A high risk of bias was elicited in most of the observational studies accentuating the need for more robust methodological studies.
The authors concluded that the majority of the studies have a small number of recruitments. Pragmatic studies with larger sample sizes and validated outcome measures may be designed further to validate the
promising role of homoeopathic medicines in SUDs and generate quality evidence.
The paper is surprising! Most of the studies are not RCTs and thus cannot come even near suggesting a causal effect of homeopathy. The three RCTs are the following:
- Manchanda RK, Janardanan Nair KR, Varanasi R, Oberai P, Bhuvaneswari R, Bhalerao R, et al. A randomised comparative trial in the management of alcohol dependence: Individualised homoeopathy versus standard allopathic treatment. Indian J Res Homoeopathy; 2016.
- Adler UC, Acorinte AC, Calzavara FO, et al. Double-blind evaluation of homeopathy on cocaine craving: A randomised controlled pilot study. J Integr Med. 2018; 16(3):178-184.
- Grover A, Bhushan B, Goel R. Double-blind placebo-controlled trial of homoeopathic medicines in the
management of withdrawal symptoms in opium addicts and its alkaloid derivatives dependents. Indian J Res Homoeopathy. 2009;3:41-4.
All of these 3 studies were assessed by the review authors as having major flaws. Only one is available on Medline:
Background: Brazil is among the nations with the greatest rates of annual cocaine usage. Pharmacological treatment of cocaine addiction is still limited, opening space for nonconventional interventions. Homeopathic Q-potencies of opium and Erythroxylum coca have been tested in the integrative treatment of cocaine craving among homeless addicts, but this setting had not proven feasible, due to insufficient recruitment.
Objective: This study investigates the effectiveness and tolerability of homeopathic Q-potencies of opium and E. coca in the integrative treatment of cocaine craving in a community-based psychosocial rehabilitation setting.
Design, setting, participants, and interventions: A randomized, double-blind, placebo-controlled, parallel-group, eight-week pilot trial was performed at the Psychosocial Attention Center for Alcohol and Other Drugs (CAPS-AD), Sao Carlos/SP, Brazil. Eligible subjects included CAPS-AD patients between 18 and 65 years of age, with an International Classification of Diseases-10 diagnosis of cocaine dependence (F14.2). The patients were randomly assigned to two treatment groups: psychosocial rehabilitation plus homeopathic Q-potencies of opium and E. coca (homeopathy group), and psychosocial rehabilitation plus indistinguishable placebo (placebo group).
Main outcome measures: The main outcome measure was the percentage of cocaine-using days. Secondary measures were the Minnesota Cocaine Craving Scale and 12-Item Short-Form Health Survey scores. Adverse events were reported in both groups.
Results: The study population comprised 54 patients who attended at least one post-baseline assessment, out of the 104 subjects initially enrolled. The mean percentage of cocaine-using days in the homeopathy group was 18.1% (standard deviation (SD): 22.3%), compared to 29.8% (SD: 30.6%) in the placebo group (P < 0.01). Analysis of the Minnesota Cocaine Craving Scale scores showed no between-group differences in the intensity of cravings, but results significantly favored homeopathy over placebo in the proportion of weeks without craving episodes and the patients’ appraisal of treatment efficacy for reduction of cravings. Analysis of 12-Item Short-Form Health Survey scores found no significant differences. Few adverse events were reported: 0.57 adverse events/patient in the homeopathy group compared to 0.69 adverse events/patient in the placebo group (P = 0.41).
Conclusions: A psychosocial rehabilitation setting improved recruitment but was not sufficient to decrease dropout frequency among Brazilian cocaine treatment seekers. Psychosocial rehabilitation plus homeopathic Q-potencies of opium and E. coca were more effective than psychosocial rehabilitation alone in reducing cocaine cravings. Due to high dropout rate and risk of bias, further research is required to confirm our findings, with specific focus on strategies to increase patient retention.
This study can hardly be said to show convincing evidence for homeopathy.
This paper is all the more surprising if we consider the affiliations of the authors:
- Clinical Research Unit (H), Aizawl under Central Council for Research in Homoeopathy, Ministry of AYUSH, Govt. of India, India.
- All India Institute of Ayurveda, New Delhi, India.
- Department of Materia Medica, Madhav Homoeopathic Medical College and Hospital, Madhav Hills,
Opposite Banas River, Abu Road, Rajasthan, India.
It is time, I think, that Indian officials and researchers learn some critical thinking and formulate the conclusions of reviews based on the evidence they produced. This would be a start:
Our review has not generated convincing evidence to suggest that homeopathy is effective in treating SUDs.
Guest post by Norbert Aust, Udo Endruscheit, and Edzard Ernst
How do we know whether a treatment is reasonable or just some so-called alternative medicine (SCAM) that is at best useless? A simple answer is that the former is evidence-based, while the latter is not. But how can we tell the difference? High-quality studies, with independent replications or even a systematic review, are the sort of things we are usually looking for. But there is an underlying assumption, namely that, in science, bogus studies are prevented from polluting the scientific database or, if such trials have emerged, there are ways to identify and eliminate them.
And what if this assumption is wrong?
What if respectable universities and research organizations venture into the realm of pseudoscience either knowingly or because it had slipped their attention?
What if the editorial board of a top journal passes bogus studies to peer review?
What if such a paper is eventually reviewed by a proponent of the implausible therapy?
What if the readers of the article, once it is published, are too lethargic to object and do not write letters to the editor in protest?
And what if skeptics do formulate a protest but the journal editor refuses to publish it?
Well, if all the checks that should prevent faulty results from entering the scientific knowledge fail, we have fake evidence: a study that looks like sound science but that, in fact, is invalid. It is not hard to imagine what would happen if SCAM therapies are supported by seemingly respectable studies published in top journals. The fake evidence would accumulate as part of the body of evidence and eventually enter mainstream clinical practice, education, politics, etc., etc. Thus the reputation of bogus therapies would grow unjustifiably.
If you think this cannot happen, you are in the wrong. After the infamous study by Frass et al about homeopathy as an add-on treatment for lung cancer, another homeopathy paper was published in 2022 by Gaertner et al. in Pediatric Research (PR), a Medline-indexed journal with a two-year impact factor of 3.95 belonging to the nature-group of journals. According to this meta-analysis ‘individualized homeopathy showed a clinically relevant and statistically robust effect in the treatment of ADHD’. Shortly after the publication of this paper, we sent a letter to the editor to point out the shortcomings of this study. Here it is:
with this letter we like to comment on the systematic review and meta-analysis on childhood ADHD by Gaertner et al. recently published in your journal.
First off, we are surprised, that your journal that is connected to nature does publish a paper on a treatment that has no a-priory probability at all and thus can only contain false positives if any. And this review is no exception as will be seen presently.
Our concerns are:
Out of the six studies included three were mere pilot trials (Fibert_2019, Jacobs_2005, Oberai_2013, ) which cannot provide any evidence for the shortcomings involved in pilots. Three of the six trials show severe issues in blinding (Fibert_2016, Fibert_2019, Oberai_2013), with two of them concerning both of the participants and the test personnel. This usually leads to massive bias in favour of the treatment [Zitat Cochrane Handbook].
Then we compared data from two trials with the data reported in the review and found some major misrepresentations:
(1) Jacobs et al. report an improvement in the T-score of their main outcome (CGI-P) of 4.1 for homeopathy and 9.1 for controls, that is placebo outperformed the homeopathic intervention. But the authors give an effect size of 0.272 in favour of homeopathy which is the opposite of the findings in the trial.
(2) Oberai et al. report effect sizes for their three main outcomes of 0.22, 0.59 and 0.54 (CPRS-R, CGISS, CGIIS repectively). There is no way that this yields a pooled effect size of 1.436 as given in the review.
We conclude that the positive result obtained by the authors is due to a combination of the inclusion of biased trials unsuitable to build evidence together with some major misreporting of study outcomes.
Our recommendation would be that the authors reconsider their review and improve their report. Maybe the editors would like to add a caution-notice to the paper – if not to withdraw it completely.
In June 2023, a full year after our submission, we were informed that Pediatric Research would not publish our criticism because the priority given to it was not sufficient to justify publication. But we were assured, that the journal would take the matter seriously, that they will investigate this matter and take appropriate editorial action. But as of today (End of June 2023) no expression of concern has been published.
Did the journal receive other comments or criticisms related to the paper in question? No, apparently there were none, at least none was published and the paper remains unchallenged to this day. This means that it might be taken for reliable evidence on the effectiveness of homeopathy and mislead patients, carers, practitioners, decision-makers, etc.
We feel this is unacceptable and therefore again wrote to the editors asking to reconsider their decision. Here is our letter:
together with my co-authors we would like to comment your decision about our letter to the editor about an extremely faulty and misleading paper that may well create harm to patients. In fact we find it very hard to accept your decision not to publish our comment.
We understand that Pediatric Research is a high impact journal with a 2-year IF of nearly 4. Your journal is member of COPE and is indexed with quite a few first rank institutions. By all standards, any reader will be convinced that a paper published in Pediatric Research is based on solid research and the results are derived by rigorous methodology and are as reliable as can be. Especially if this paper remains unchallenged by any reader’s comments for a full year after publication. This is your responsibility to the scientific community. And to the children that might receive treatment based on knowledge spread through your journal.
How then can it be, that an article about homeopathy, a thoroughly implausible lore, in the treatment of ADHD is published in Pediatric Research, where the authors come to the conclusion “that individualized homeopathy showed a clinically relevant and statistically robust effect in the treatment of ADHD”?
In our comment we point out that the authors made a lot of errors – to say it mildly. They deny the doubtful quality of the studies they included in their meta-analysis, they did not stick to their own exclusion criteria, the data the authors report do not resemble the findings of the studies they were allegedly taken from, the one study setting the results is a mere pilot study.
The reason you give for our letter not being published is that it was not given enough priority to justify publication. We would like to know: Which issues can conceivably receive higher priority than the fact that a paper in your journal is downright wrong and misleading?
What do you need to deem a comment important? Up to now the paper is unchallenged by any reader’s comments, so apparently there was no other letter to the editor that might be given higher priority than ours.
We ask you to review your decision, or better still, consider a retraction of the paper altogether. If so, an expression of concern should be issued at once. After all, the COPE-guidelines for retraction state “clear evidence, that the findings are unreliable, either as a result of major error (…), or as a result of fabrication (…) or faslification (…)’ as a reason to consider retraction.
Otherwise the malpractice of homeopathy will have a first class evidence that will be helpful to promote homeopathy to parents and their children.
Watch this space!