Edzard Ernst

MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

The Indian Supreme Court has ruled this week that homeopathic, ayurvedic and unani practitioners must not prescribe their respective so-called alternative medicines (SCAMs) as a cure for Covid-19.

Specifically, the judges noted that, according to the guidelines issued by the Ayush ministry in March, homeopaths are permitted only to prescribe certain homeopathic medicines as “…preventive, prophylactic, symptom management of Covid-19-like illnesses and add-on interventions to the conventional care”, but not as a cure.

“The high court, however, is right in its observation that no medical practitioner can claim that it can cure Covid-19. There is no such claim in other therapy including allopathy. The high court is right in observing that no claim for cure can be made in homeopathy. Homeopathy is contemplated to be used in preventing and mitigating Covid-19 as is reflected by the advisory and guidelines issued by the ministry of Ayush…,” Justices Ashok Bhushan, R. Subhash Reddy and M.R. Shah stated.

The Supreme Court passed the ruling while disposing of an appeal filed by the Kerala-based Dr AKB Sadbhavana Mission School of Homeo Pharmacy that was aggrieved by Kerala High Court’s direction on August 21 for action against homeopaths who claim cure in homeopathy for Covid-19 patients. However, the Supreme Court judgment established that the Ayush ministry guidelines clearly refer to certain homeopathy medicines as preventive, prophalytic and add-on interventions to the conventional therapy. “The above guidelines refer to homeopathy medicines as medicines for prophylaxis, amelioration and mitigation. The guidelines, however, specifically provide that ‘the prescription has to be given only by institutionally qualified practitioners’,” the bench said.

According to the court, homeopathic practitioners are bound by rules from prescribing medicines as cure for Covid-19. “When statutory regulations themselves prohibit advertisement, there is no occasion for homeopathic medical practitioners to advertise that they are competent to cure Covid-19 disease. When the scientists of the entire world are engaged in research to find out proper medicine/vaccine for Covid-19, there is no occasion for making any observation as contained in the paragraph with regard to homeopathic medical practitioners,the judges stated.

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Meanwhile, the number of COVID-19 cases in India exceeds 10 million, and that of COVID-related death is almost 150 000. If you ask me, promoters of homeopathic remedies should not be allowed to advertise or sell their placebos pretending they are effective for any purpose in connection with COVID-19 (or any other serious disease for that matter) – not as a curative therapy, not for prevention, and not as a symptomatic treatment either.

On this blog we have seen just about every variation of misdemeanors by practitioners of so-called alternative medicine (SCAM). Today, I will propose a scale and rank order of these lamentable behaviours. As we regularly discuss chiropractic and homeopathy here, I decided to use these two professions as examples (but I could, of course, have chosen almost any other SCAM).

  1. Treating conditions which are not indicated: SCAM practitioners of all types are often asked by their patients to treat conditions which their particular SCAM cannot not affect. Instead of honestly saying so, they frequently apply their SCAM, wait for the natural history of the condition to do its bit, and subsequently claim that their SCAM was effective.
  2. Over-charging: asking too much money for services or goods is common (not just) in SCAM. It raises the question, what is the right price? There is, of course, no easy answer to it. Over-charging is therefore mostly a judgement call and not something absolute.
  3. Misleading a patient: there are numerous ways in which patients can be misled by their SCAM practitioners. A chiropractor who uses the Dr title, without explaining that it is not a medical title, is misleading his/her patients. A homeopath who implies that the remedy he/she is selling is a proven treatment is also misleading his/her patients.
  4. Being economical with the truth: the line between lying (see below) and being economical with the truth is often blurred. In my view, a chiropractor who does not volunteer the information that acute back pain, in most cases, resolves within a few days regardless of whether he/she mapipulates the patient’s spine or not, is economical with the truth. Similarly, a homeopath who does not explain up front that the remedy he/she prescribes does not contain a single active molecule is economical with the truth.
  5. Employing unreasonably long series of therapy: A chiropractor or homeopath, who treats a patient for months without any improvement in the patient’s condition, should suggest to call it a day. Patients should be given a treatment plan at the first consultation which includes the information when it would be reasonable to stop the SCAM.
  6. Failing to refer: A chiropractor or homeopath, who treats a patient for months without any improvement in the patient’s condition should refer the patient to another, better suited healthcare provider. Failing to do so is a serious disservice to the patient.
  7. Unethical behaviour: there are numerous ways SCAM practitioners regularly violate healthcare ethics. The most obvious one, as discussed often before on this blog, is to cut corners around informed consent. A chiropractor might, for instance, not tell his/her patient before sarting the treatment that spinal manipulation is not supported by sound evidence for efficacy or safety. A homeopathy might not explain that homeopathy is generally considered to be implausible and not evidence-based.
  8. Neglect: medical neglect occurs when patients are harmed or placed at significant risk of harm by gaps in their medical care. If a chiropractor or a homeopath, for instance, claim to be able to effectively treat asthma and fail to insist that all prescribed asthma medications must nevertheless be continued – as both often do – they are guilty of neglect, in my view. Medical neglect can be a reason for starting legal proceedings.
  9. Lying: knowingly not telling the truth can also be a serious legal issue. An example would be a chiropractor who, after beeing asked by a patient whether neck manipulation can cause harm, answers that it is an entirely safe procedure which has never injured anyone. Similarly, if a homeopaths informs his/her patient that the remedy he/she is prescribing has been extensively tested and found to be effective for the patient’s condition, he must be lying. If these practitioners believe what they tell the patient to be true, they might not technically be lying, but they would be neglecting their ethical duty to be adequately informed and they would therefore present an even greater danger to thier patients.
  10. Abuse: means to use something for the wrong purpose in a way that is harmful or morally wrong. A chiropractor who tells the mother of a healty child that they need maintenance care in order to prevent them falling ill in the future is abusing her and the child, in my view. Equally, I think that a homeopath, who homeopathically treats a disease that would otherwise be curable with conventional treatments, abuses his patient.
  11. Fraud: fraud is a legal term referring to dishonest acts that intentionally use deception to illegally deprive another person or entity of money, property, or legal rights. It relies on the use of intentional misrepresentation of fact to accomplish the taking. Arguably, most of the examples listed above are fraud by this definition.
  12. Sexual misconduct: the term refers to any behaviour which is sexual in nature and which is unwelcome and engaged in without consent. It ranges from unwanted groping to rape. There is, for instance, evidence that sexual misconduct is not a rarety in the realm of chiropractic. I have personally served once as an expert witness against a SCAM practitioner is a court case at the Exeter Crown Court.

The 12 categories listed above are not nearly as clearly defined as one would wish, and there is plenty of overlap. I am not claiming that my suggested ‘scale of misdemeanors by SCAM practitioners‘ or the proposed rank order are as yet optimal or even adequate. I am, however, hoping that readers will help me with their suggestions to improve them. Perhaps your input might then generate a scale of practical use for the future.

Who does not like a nice fragrance?

Who would object to aromatherapy?

Nobody, I suppose.

But, if its called THERAPY, we surely must ask whether it is therapeutic. And is aromatherapy therapeutic? Let’s see:

This randomized, placebo-controlled clinical trial tested whether patients with post-dural puncture headache (PDPH) caused by spinal anesthesia would benefit from aromatherapy. A total od 50 patients received 15-minute inhalations of either lavender oil or liquid paraffin as placebo. The severity of headache was scored before (baseline) and after the intervention – immediately, 30, 60, 90, and 120 minutes after – using a visual analog scale. In addition, the dosage and frequency of the pain killers as well as adverse effects of the intervention were recorded.

Both groups showed a reduction in headache scores post intervention. However, the headache scores between the groups was significantly different immediately after the intervention in favor of lavender oil (difference: 1.60 ± 0.63, P = .015). Furthermore, it was observed that the mean changes of the headache scores compared to the baseline were significant at each time interval in favor of the placebo group (P < .05), except immediately after the intervention. No significant difference was observed in Diclofenac intake between groups (P = .440), and no adverse effects were noted.

The authors concluded that aromatherapy with lavender oil was observed to reduce the severity of PDPH only immediately after the intervention, while only minimal effects were observed at successive time intervals. However, it is noted that the study was likely underpowered and further studies are recommended to better understand the effects of lavender oil on PDPH and compare its effects to other herbal products or pharmacological agents commonly used for managing headaches.

I find it laudable that some researchers conduct clinical trials even of so-called alternative medicines (SCAMs) which many of us might view as trivial. I find it more laudable that they try to do this rigorously by adding a placebo control group to the study. And I would find it even more laudable, if they did this adequately.

Considering parafin oil to be a placebo in a study of lavender oil inhalation can hardly be called adequate. Placebos are used in clinical trials mostly to account for the expectation of patients. This means that, whenever possible, patients need to be blinded to the group aloocation and the placebo must be indistinguishable from the verum. In the present trial, the patients could obviously tell the difference between the smell of lavender and the absence of any smell in the control group. Thus, their expectation could easily suffice to bring about the findings observed in the study. This means that the trial does not neccessarily demonstrate the effects of armoatherapy, but might (and most probably does) merely show the power of expectation.

How can one design such a trial more rigorously? you will ask.

There are several options. For instance, for the control group, one could use an artificial fragrance not made from natural lavender. Alternatively, one could include only patients who are unfamiliar with the smell of lavender and use a similaryly pleasant fragrance from a different plant as the control intervention.

As it stands, the study – even though aimed at testing the hypothesis that aromatherpy with lavender has specific effects on pain – tells us next to nothing.

… except, of course that it is always worth thinking very carefully about the adequate way to conduct a clinical trial.

Adverse effects of so-called alternative medicine (SCAM) are, in my view, the most important and the most under-researched subject in the realm of SCAM. When I started my job at Exeter in 1993 declaring that I intended to make it a focus of my research, the SCAM scene was first puzzled and subsequently annoyed. SCAM proponents argued that the important risks in medicine are not in SCAM but in conventional medicine. I countered:

  1. that I would like to see some evidence to support this statement;
  2. that, as long as SCAM proponents would not produce sound evidence, the statement amounted to a mere assumption which needed urgent testing;
  3. that, when considering the safety of SCAM, we need to consider both the direct risks (for instance, adverse effects of a homeopathic or herbal remedy) and the indirect risks (for instance, the risks of consulting a homeopath or herbalist and adhering to their advice);
  4. that, in any case, the absolute risks were not as important as the risk/benefit balance for each SCAM;
  5. that we needed to research the risks of SCAMs much better in order to consider their risk/benefit profiles.

Since then, I have had hundreds (perhaps even thousands) of discussions, disputes and quarrels about this, repeatedly also in the comments section of this blog. Even though the issues are often complex, most of the ensuing circular argument can be condensed into a short dialogue between a fictional QUACK and a fictional SCIENTIST:

  • QUACK: There are no adverse effects associated with my SCAM; after all, it’s been around for a very long time and we would by now know about any problems.
  • SCIENTIST: But how can you be so sure without a reliable monitoring of adverse effects?
  • QUACK: There is no need for one, because my SCAM safe.
  • SCIENTIST: This what you think.
  • QUACK: Alright, then show me some peer-reviewed articles about adverse effects of SCAM.
  • SCIENTIST: How about this pile of papers reporting adverse effects of your SCAM?
  • QUACK: That’s just a collection of anecdotes! Anecdotes are not evidence! Show me the systematic research.
  • SCIENTIST: Here is a pile of systematic reviews on the subject. Happy?
  • QUACK: No, these are systematic reviews of case reports. Case reports are just anecdotes.
  • SCIENTIST: [slightly impatient] That’s because there is no monitoring of adverse effects in your field.
  • QUACK: There is no need, because it’s safe, and you have no evidence to show otherwise.
  • SCIENTIST: The burden of proof is not on my but on your shoulders.
  • QUACK: I have given you the proof – after hundreds of years of using my SCAM, there is no evidence of adverse effects.
  • SCIENTIST: [very impatient] Go yonder and multiply.
  • QUACK: You see, you have no evidence to prove that my SCAM is not safe, instead you just claim that it’s unsafe and even insult me.
  • SCIENTIST: I give up.

Instead of going through such discussions again and again, in future, I will just provide commentators on this blog with a link to this post. That should save both time and nerves.

The authors of this review wanted to determine similarities and differences in the reasons for using or not using so-called alternative medicine (SCAM) amongst general and condition-specific populations, and amongst populations in each region of the globe.

Quantitative or qualitative original articles in English, published between 2003 and 2018 were reviewed. Conference proceedings, pilot studies, protocols, letters, and reviews were excluded. Papers were appraised using valid tools and a ‘risk of bias’ assessment was also performed. Thematic analysis was conducted. Reasons were coded in each paper, then codes were grouped into categories. If several categories reported similar reasons, these were combined into a theme. Themes were then analysed using χ2 tests to identify the main factors related to reasons for CAM usage.

A total of 231 publications were included. Reasons for SCAM use amongst general and condition-specific populations were similar. The top three reasons were:

  • (1) having an expectation of benefits of SCAM (84% of publications),
  • (2) dissatisfaction with conventional medicine (37%),
  • (3) the perceived safety of SCAM (37%).

Internal health locus of control as an influencing factor was more likely to be reported in Western populations, whereas the social networks was a common factor amongst Asian populations (p < 0.05). Affordability, easy access to SCAM and tradition were significant factors amongst African populations (p < 0.05). Negative attitudes towards SCAM and satisfaction with conventional medicine were the main reasons for non-use (p < 0.05).

The authors concluded that dissatisfaction with conventional medicine and positive attitudes toward SCAM, motivate people to use SCAM. In contrast, satisfaction with conventional medicine and negative attitudes towards SCAM are the main reasons for non-use.

At this point, I thought: so what? This is all very obvious and does not necessitate an extensive review of the published literature. What it actually shows is that the realm of SCAM is obsessed with conducting largely useless surveys, a phenomenon, I once called ‘survey mania‘. But a closer look at the review does reveal some potentially interesting findings.

In less developed parts of the world, like Africa, SCAM use seems to be determined by affordability, accessibility and tradition. This makes sense and ties in with my impression that consumers in such countries would give up SCAM as soon as they can afford proper medicine.

This notion seems to be further supported by the reasons for not using SCAM. Asian consumers claim overwhelmingly that this is because they consider SCAM ineffective and unsafe.

In our review of 2011 (not cited in the new review), we looked at some of the issues from a slightly different angle and evaluated the expectations of SCAM users. Seventy-three articles met our inclusion criteria of our review. A wide range of expectations emerged. In order of prevalence, they included:

  • the hope to influence the natural history of the disease;
  • the desire to prevent disease and promote health/general well-being;
  • the hope of fewer side effects;
  • the wish to be in control over one’s health;
  • the hope for symptom relief;
  • the ambition to boost the immune system;
  • the hope to receive emotional support;
  • the wish to receive holistic care;
  • the hope to improve quality of life;
  • the expectation to relief of side effects of conventional medicine;
  • the desire for a good therapeutic relationship;
  • the hope to obtain information;
  • the hope of coping better with illness;
  • the expectation of supporting the natural healing process;
  • the availability of SCAM.

All of these aspects, issues and notions might be interesting, even fascinating to some, but we should not forget three important caveats:

  • Firstly, SCAM is such a diverse area that any of the above generalisations are highly problematic; the reasons and expectations of someone trying acupuncture may be entirely different from those of someone using homeopathy, for instance.
  • Secondly (and more importantly), the ‘survey mania’ of SCAM researchers has not generated the most reliable data; in fact, most of the papers are hardly worth the paper they were printed on.
  • Thirdly (and even more importantly, in my view), why should any of this matter? We have known about some of these issues for at least 3 decades. Has this line of research changed anything? Has it prevented consumers getting exploited by scrupulous SCAM entrepreneurs? Has it made consumers, politicians or anyone else more aware of the risks associated with SCAM? Has it saved many lives? I doubt it!

We are all prone to fall victim to the ‘post hoc ergo propter hoc’ fallacy. It describes the erroneous assumption that something that happened after an event was cased by that event. The fallacy is essentially due to confusing correlation with causation:

  • the sun does not rise because the rooster has crowed;
  • yellow colouring of the 2nd and 3rd finger of a smoker is not the cause of lung cancer;
  • some children developing autism after vaccinations does not mean that autism is caused by vaccination.

As I said, we are all prone to this sort of thing, even though we know better. Scientists, journal editors and reviewers of medical papers, however, should not allow themselves to be fooled by overt cases of the ‘post hoc ergo propter hoc’ fallacy. And if they do, they have lost all credibility – just like the individuals involved in a recent paper on animal homeopathy.

Pododermatitis in penguins usually occurs after changes in normal activity that result from being held captive. It is also called ‘bumlefoot’ (which fails to reflect the seriousness of the condition) and amounts to one of most frequent and important clinical complications in penguins kept in captivity or in rehabilitation centres.

This veterinary case study reports the use of oral homeopathic treatment on acute and chronic pododermatitis in five Magellanic penguins in a zoological park setting. During treatment, the patients remained in the penguins’ living area, and the effect of the treatment on the progression of their lesions was assessed visually once weekly. The treatment consisted of a combination of Arnica montana and Calcarea carbonica.

After treatment, the appearance of the lesions had noticeably improved: in the majority of penguins there was no longer evidence of infection or edema in the feet. The rate of recovery depended on the initial severity of the lesion. Those penguins that still showed signs of infection nevertheless exhibited a clear diminution of the size and thickness of the lesions. Homeopathic treatment did not cause any side effects.

The authors concluded that homeopathy offers a useful treatment option for pododermatitis in captive penguins, with easy administration and without side effects.

So, the homeopathic treatment happened before the recovery and, according to the ‘post hoc ergo propter hoc’ fallacy, the recovery must have been caused by the therapy!

I know, this is a tempting conclusion for a lay person, but it is also an unjustified one, and the people responsible for this paper are not lay people. Pododermitis does often disappear by itself, particularly if the hygenic conditions under which the penguins had been kept are improved. In any case, it is a potentially life-threatening condition (a bit like an infected bed sore in an immobilised human patient) that can be treated, and one should certainly not let a homeopath deal with it.

I think that the researchers who wrote the article, the journal editor who accepted it for publication, and the referees who reviewed the paper should all bow their heads in shame and go on a basic science course (perhaps a course in medical ethics as well) before they are let anywhere near research again.

In so-called alternative medicine (SCAM) – but certainly not just there – we regularly encouter reports about new research results that sound odd, implausible, too good to be true, or outright fantastic (like borne out of fantasy). What should one do with such news? Keep an open mind, yes sure, but what if the news leads us up the garden path? Here is what I usually do and what I recommend you might do as well:

  1. Check who published the story; some sources are clearly more trustworthy than others (think of ‘Natural News‘, or WDDTY, for instance).
  2. Try to find other outlets confirming the news; if none can be located, be extra sceptical.
  3. Identify the origin of the new research; an academic might be more trustworthy that a SCAM practitioner or a commercial firm.
  4. Find out where the study was originally published; some SCAM journals publish virtually any rubbish (think of EBCAM or JCAM).
  5. If you are still in doubt and continue to be interested, go on Medline and obtain the original article.
  6. If it’s behind a pay-wall, email the authors for a copy.
  7. Check the validity of the paper; this can be rather a big task for someone not trained in critical assessment of scientific papers, but there are certain pointers: in case of a clinical trial, for instance, check whether it was large or small, randomised or not, placebo-controlled or not, blind or not.
  8. If the findings look suspicious to you, find out more about the researchers: for example, do they have a track record of publishing results that look false-positive (think of M Frass or other members of the ‘ALTERNATIVE MEDICINE HALL OF FAME‘, for instance)?
  9. Identify studies by other researchers addressing the same research question; have similar findings been published, or do most of the previous investigations contradict the results of the new study?
  10. Find out who sponsored the new study.
  11. Look up what the authors declare in terms of conflicts of interest.
  12. If all of this leaves important questions unanswered, don’t be shy, write to the authors and ask.

When I have gone through all these steps, I usually have a fairly clear impression whether I can trust the research or not. Obviously keeping an open mind about new discoveries is sensible. But please. do remember that charlatans might (and often do) put a lot of BS in your mind, if you open it too wide for too long.

It has been reported that Karnataka’s Deputy Chief Minister, Dr CN Ashwathnarayan, has launched eight products, several of which fall in the category of so-called alternative medicine (SCAM), aimed at mitigating COVID-19, developed by various start-ups at Bangalore Bioinnovation Centre (BBC). Dr CN Ashwathnarayan said the launch of the products shows that Karnataka has emerged as a leading state in developing solutions to fight the COVID 19 pandemic.

Here are short descriptions of the innovations:

  • Padma Vitals +: Developed by Innovator start-up Dr. Madan Gopal of Cardiac Design labs,Padma Vitals + is a  centralized monitoring system for ECG, respiration, Spo2 and body temperature, which can measure the vitals continuously and the analysis sent through telemetry, with an alerting system embedded in it. The device is much needed for contactless monitoring of patients during COVID 19 Pandemic. The product has been validated at Narayana Hrudayalaya.
  • Malli’s Cordytea: Developed by Dr. Moushmi Mondal from Mallipatra Neutraceuticals, this product is an Immunity booster tea prepared from medicinal mushroom – Cordyceps. The mushroom variety grown under laboratory conditions is developed by the Innovator. Cordicepin, an active ingredient is known to have anti-viral properties too. In the COVID 19 times, it will be helpful in boosting the immunity levels. The product has been patented and is approved by FSSAI.
  • CD4 Shield : Developed by Dr. Vijay Lanka and his team from Stabicon, this product is a chewable tablet containing curcumin and Vitamin B12. Both the ingredients fight inflammation and infection. The product ensures activation of innate immunity by activating CD4+, CD8+ and IFN 1 to virus specific effect and has immunomodulatory properties. It also reduces cytokine storm in response to viral infection. The product is approved by FSSAI.
  • BeamRoti : Developed by Dr. Srinivas from Aspartika, the product is an immunity booster chapati having mixture of herbs recommended by AYUSH ministry. The ingredients have been prepared using supercritical fluid extraction technology to ensure optimum concentration of herbal extract reaches the body. The chapatis are easy to store with good shelf life and Patent application has been filed. The product is approved by FSSAI.
  • Immune booster daily drops: Developed by Dr. Srinivas from Aspartika, the product is an immunity booster drop having mixture of herbs recommended by AYUSH ministry. The ingredients have been prepared using supercritical fluid extraction technology to ensure optimum concentration of herbal extract reaches the body by mixing just one drop of the product in a glass of hot water. The product is approved by FSSAI.
  • VegPhal – Fruit and Vegetable Sanitizer: Developed by Deepak Bhajantri from Krimmi Biotech, this fruit and vegetable sanitizer is prepared using edible ingredients effective against microbes and removal of pesticides. It is chorine and alcohol free.
  • Water Sanitizer – Kitchen Tap: The product is developed by Ravi Kumar from Biofi and is a miniaturized version of UV purifier that can be attached to a water tap and kill 99% of microbes including viruses such as phages.
  • nti-Micobial HVAC module: The product is developed by Ravi Kumar from Biofi and is a module that can be fitted to HVAC system to ensure circulating air is sanitized. This is especially useful during COVID 19 times as many enclosed spaces in which AC circulated air may be contaminated. Based on UV-silver titanium dioxide technology, the product is patented and has been validated.

Karnataka is of course a state in the south western region of India. The region has so far about one million COVID-19 cases, while almost 12 000 people have died. One would therefore very much hope that the newly launched innovations can make a difference.

But will they?

As far as the SCAM-related products (e.g. ‘immune boosters’) are concerned, I see no convincing evidence to assume that they are effective. If anyone has information to the contrary, please let me know.

But why not? They can’t do any harm!

Sadly, I am am not so sure. I see the potential for considerable harm from all the useless SCAMs that are being promoted left right and centre for protecting the public against COVID-19. Firstly, there is the financial harm of paying for products that are useless. Secondly, ineffective effords might distract from finding and adhering to efforts that are effective. Thirdly, believing in a SCAM that does not work will create a sense of false security which, in turn, renders consumers more vulnerable to catch the virus.

As always in healthcare, even harmless interventions that do not work can become dangerous, as they lead to neglecting effective measures. I shudder to think of how many deaths have been caused by the many SCAM merchants who see the current pandemic as an opportunity.

In 2012, we published a systematic review of adverse effects of homeopathy. Here is its abstract:

Aim: The aim of this systematic review was to critically evaluate the evidence regarding the adverse effects (AEs) of homeopathy.

Method: Five electronic databases were searched to identify all relevant case reports and case series.

Results: In total, 38 primary reports met our inclusion criteria. Of those, 30 pertained to direct AEs of homeopathic remedies; and eight were related to AEs caused by the substitution of conventional medicine with homeopathy. The total number of patients who experienced AEs of homeopathy amounted to 1159. Overall, AEs ranged from mild-to-severe and included four fatalities. The most common AEs were allergic reactions and intoxications. Rhus toxidendron was the most frequently implicated homeopathic remedy.

Conclusion: Homeopathy has the potential to harm patients and consumers in both direct and indirect ways. Clinicians should be aware of its risks and advise their patients accordingly.

The paper prompted a number of angry reactions from proponents of homeopathy who claimed, for instance, that homeopathic remedies are highly diluted and thus safe. We responded that homeopaths can nevertheless be dangerous to patients through neglect and bad advice by homeopaths, and that not all homeopathic remedies are highly diluted, and that some might be toxic because of poor quality control of the manufacturing process.

Now, a different group of researchers have looked at the problem from a slightly different angle and with different methodologies. This systematic review and meta-analysis by researchers from NAFKAM focused on observational studies, as a substantial amount of the research base for homeopathy are observational.

Eight electronic databases, central webpages and journals were searched for eligible studies, and a total of 1,169 studies were identified, 41 were included in this review. Eighteen studies were included in a meta-analysis that made an overall comparison between homeopathy and control (conventional medicine and herbs).

Eighty-seven percent (n = 35) of the studies reported adverse effects. They were graded as CTCAE 1, 2 or 3 and equally distributed between the intervention and control groups. Homeopathic aggravations (homeopaths believe that, when the optimal remedy is given, patients will experience an aggravation of their presenting symptoms) were reported in 22,5% (n = 9) of the studies and graded as CTCAE 1 or 2. The frequency of adverse effects for control versus homeopathy was statistically significant (P < 0.0001). Analysis of sub-groups indicated that, compared to homeopathy, the number of adverse effects was significantly higher for conventional medicine (P = 0.0001), as well as other complementary therapies (P = 0.05).

The authors concluded that adverse effects of homeopathic remedies are consistently reported in observational studies, while homeopathic aggravations are less documented. This meta-analysis revealed that the proportion of patients experiencing adverse effects was significantly higher when receiving conventional medicine and herbs, compared to patients receiving homeopathy. Nonetheless, the development and implementation of a standardized reporting system of adverse effects in homeopathic studies is warranted in order to facilitate future risk assessments.

While these results are interesting, they have to be taken with a pinch of salt and beg a number of questions:

  • Is there proof that aggravations exist at all?
  • How can one differentiate them from adverse effects?
  • As even placebos are known to cause adverse effects (nocebo effects), how can one be sure that the adverse effects of homeopathy are not nocebo effects?
  • Is it a good reason to focus on largely inconclusive observational studies, because a substantial amount of the research base for homeopathy are observational?
  • Can one produce conclusive results by meta-analysing inconclusive studies?

For me, the most impressive findings of this review is that in total 86 studies had to be excluded by the authors because they reported no adverse effects or aggravations. I think this renders the interpretation of the evidence from the 41 studies they did include even more flimsy. In fact, I don’t see how any meaningful conclusion can be drawn at all – except of course that many researchers of homeopathy violate the rules of research ethics by not reporting adverse effects in their studies.

As to aggravations, we clearly need to rely on placebo controlled studies, if we want to find out whether they exist at all. This we have done in our 2003 paper:

Homeopathic aggravations have often been described anecdotally. However, few attempts have been made to scientifically verify their existence. This systematic review aimed at comparing the frequency of homeopathic aggravations in the placebo and verum groups of double-blind, randomised clinical trials. Eight independent literature searches were carried out to identify all such trials mentioning either adverse effects or aggravations. All studies thus found were validated and data were extracted by both authors. Twenty-four trials could be included. The average number of aggravations was low. In total, 50 aggravations were attributed to patients treated with placebo and 63 to patients treated with homoeopathically diluted remedies. We conclude that this systematic review does not provide clear evidence that the phenomenon of homeopathic aggravations exists.

What is interesting, from my perspective, is the fact that the NAFKAM authors chose to ignore our 2012 paper completely (even though it is highly relevant to their paper and was not published in an obscure journal) and elected to completely misinterpret the findings of our 2003 paper (stating this about it: Grabia and Ernst reported a total of 103 cases of homeopathic aggravations in 3437 participants (3%), while, in fact, our paper demonstrated that aggravations are a homeopathic figment of imagination).

I wonder why.

In the past, NAFKAM did not have the reputation of doing research that was overtly biased towards homeopathy. Recently, the head of the team retired and was replaced by Miek C. Jong who is a co-author of the present review (plus head of CAMcancer, an organisation of which I am a founding member and which did, I think, some good work in the past). She happens to have a long history as a homeopath or homeopathic researcher and is co-author of many papers in this area. Here are three of her conclusions:

Could it be that, within NAFKAM, the attitude towards homeopathy has changed?

Numerous so-called alternative medicines (SCAMs) have been touted as the solution for COVID-19. In fact, it is hard to find a SCAM that is not claimed to be useful for corona patients. Crucially, such claims are being made in the complete absence of evidence. A recent paper offers a bibliometric analysis of global research trends at the intersection of SCAM and COVID-19.

SCOPUS, MEDLINE, EMBASE, AMED and PSYCINFO databases were searched on July 5, 2020. All publication types were included, however, articles were only deemed eligible, if they made mention of one or more SCAMs for the potential prevention, treatment, and/or management of COVID-19 or a health issue indirectly resulting from the COVID-19 pandemic. The following eligible article characteristics were extracted: title; author names, affiliations, and countries; DOI; publication language; publication type; publication year; journal (and whether it is TICAM-focused); 2019 impact factor, and TICAMs mentioned.

A total of 296 eligible articles were published by 1373 unique authors at 977 affiliations across 56 countries. The most common countries associated with author affiliation included:

  • China,
  • the United States,
  • India,
  • Italy.

Four journals had published more that 10 papers each on the subject:

  • Chinese Traditional and Herbal Drugs,
  • Journal of Biomolecular Structure & Dynamics,
  • Zhongguo Zhongyao Zazhi (China Journal of Chinese Materia Medica),
  • Pharmacological Research

The vast majority of articles were published in English, followed by Chinese. Eligible articles were published across 157 journals, of which 33 were SCAM-focused; a total of 120 journals had a 2019 impact factor, which ranged from 0.17 to 60.392. A total of 327 different SCAMs were mentioned across eligible articles, with the most common ones including:

  • traditional Chinese medicine (n = 94),
  • vitamin D (n = 67),
  • melatonin (n = 16),
  • phytochemicals (n = 12),
  • general herbal medicine (n = 11).

The Canadian author concluded that this study provides researchers and clinicians with a greater knowledge of the characteristics of articles that been published globally at the intersection of COVID-19 and SCAM to date. At a time where safe and effective vaccines and medicines for the prevention and treatment of COVID-19 have yet to be discovered, this study provides a current snapshot of the quantity and characteristics of articles written at the intersection of SCAM therapies and COVID-19.

If anyone repeated the research today, I fear that the number of different SCAMs would have at least doubled. There is simply no form of SCAM that would not have joined the bandwagon of snake-oil salesmen trying to make a quick buck or satisfying their dangerous delusion of a panacea. Today (11/12/2020) my very quick Medline search on just a few SCAMs resulted in the following:

  • Herbal medicine: 253
  • Dietary supplement: 139
  • Acupuncture: 68
  • Homeopathy (not mentioned at all above): 20
  • Chiropractic: 13
  • Naturopathy: 6

One of the most chilling reads during my ‘rough and ready’ trawl through the literature was an article co-authored by a Viennese professor who has featured repeatedly on this blog. Here is its abstract:

Successful homeopathic prescriptions are based on careful individualization of symptoms, either for an individual patient or collectively in the case of epidemic outbreaks. The ongoing COVID-19 pandemic was initially represented as a severe acute respiratory illness, with eventual dramatic complications. However, over time it revealed to be a complex systemic disease with manifestations derived from viral-induced inflammation and hypercoagulability, thus liable to affect any body organ or system. As a result, clinical presentation is variable, in addition to variations associated with several individual and collective risk factors. Given the extreme variability of pathology and clinical manifestations, a single, or a few, universal homeopathic preventive Do not split medicine(s) do not seem feasible. Yet homeopathy may have a relevant role to play, inasmuch as the vast majority of patients only exhibit the mild form of disease and are indicated to self-care at home, without standard monitoring, follow-up, or treatment. For future pandemics, homeopathy agencies should prepare by establishing rapid-response teams and efficacious lines of communication.

The Canadian author of the above paper did not analyse how many of the papers he included would make therapeutic claims. I suspect that the majority did. In this context, one of the clearest indications of how deluded SCAM practitioners tend to be during these difficult times was provided by this paper:

Coronavirus disease 2019 (COVID-19), caused by a new coronavirus, first appeared in late 2019. What initially seemed to be a mild influenza quickly revealed itself as a serious and highly contagious disease, and the planet was soon faced with a significant morbidity and mortality associated with this pathogen. For homeopathy, shunned during its 200 years of existence by conventional medicine, this outbreak is a key opportunity to show potentially the contribution it can make in treating COVID-19 patients. This should be done through performance of impeccably controlled, prospective, randomized clinical trials, with publication of their findings in well-ranked conventional medicine journals. If the homeopathy community fails to take advantage of this rare opportunity, it might wait another century for the next major pandemic.

I must admit, I felt vaguely sick while reading it.

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