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

pseudo-science

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Individuals with large followings can influence public opinions and behaviors, especially during a pandemic. In the early days of the COVID pandemic, US president Donald J Trump endorsed the use of unproven therapies. Subsequently, a death attributed to the wrongful ingestion of a chloroquine-containing compound occurred.

This paper investigated Donald J Trump’s speeches and Twitter posts, as well as Google searches and Amazon purchases, and television airtime for mentions of hydroxychloroquine, chloroquine, azithromycin, and remdesivir. Twitter sourcing was catalogued with Factba.se, and analytics data, both past and present, were analyzed with Tweet Binder to assess average analytics data on key metrics. Donald J Trump’s time spent discussing unverified treatments on the United States’ 5 largest TV stations was catalogued with the Global Database of Events, Language, and Tone, and his speech transcripts were obtained from White House briefings. Google searches and shopping trends were analyzed with Google Trends. Amazon purchases were assessed using Helium 10 software.

From March 1 to April 30, 2020, Donald J Trump made 11 tweets about unproven therapies and mentioned these therapies 65 times in White House briefings, especially touting hydroxychloroquine and chloroquine. These tweets had an impression reach of 300% above Donald J Trump’s average. Following these tweets, at least 2% of airtime on conservative networks for treatment modalities like azithromycin and continuous mentions of such treatments were observed on stations like Fox News. Google searches and purchases increased following his first press conference on March 19, 2020, and increased again following his tweets on March 21, 2020. The same is true for medications on Amazon, with purchases for medicine substitutes, such as hydroxychloroquine, increasing by 200%.

The authors concluded that individuals in positions of power can sway public purchasing, resulting in undesired effects when the individuals’ claims are unverified. Public health officials must work to dissuade the use of unproven treatments for COVID-19.

Trump is by no means the only politician who misled the public in matters of healthcare through ignorance, or stupidity, or both. Other recent examples that we previously discussed include, for instance:

Yes, Trump is not the only, but he is the most influential and might well be the most ignorant one:

For this reason alone – and there are many more – I hope he will not soon become merely a dark and scary chapter in the history of the US.

This retrospective audit aimed to assess the clinical effectiveness of telehealth interventions in an out-patient, individualized homeopathy clinical setting for 305 individuals with symptoms of positive or probable COVID-19
by a team of professional homeopaths working together in the United States during spring and summer of
2020.

The audit lasted from March to August 2020. It examined the merits of the initiative considering accessibility, effectiveness, safety, efficiency, and appropriateness of the care model.

Positive intervention outcomes were found in every measure:

  • individual remedy prescriptions (83.4% positive),
  • final outcomes of interventions (76.2% positive),
  • degree of recovery following homeopathic interventions (74.4%).

Additionally, ease of access for a range of users, a high level of safety of the interventions, and efficiency of care and team resources indicated consistently positive outcomes.

The authors concluded that, given the significant strain on conventional healthcare systems during the early stages of the pandemic, the complementary medicine interventions studied here offer important considerations for meeting the demands for COVID-19 acute care with agile and adaptive complementary medicine models.

If one were to look for ridiculously poor studies in the realm of homeopathy, one would be spoilt for choice. Amongst the many such papers, this one would achieve a very high ranking. The investigation is nonsensical in:

  • concept,
  • design,
  • endpoints,
  • write-up,
  • conclusion.

The paper prompts me to ask a few questions (and some answers):

Whoever had the notion that an audit can “assess the clinical effectiveness” of a therapy?

Do the authors even know what an audit is?

What institutions are behind such embarrassingly poor work? They are:

  • ‘HOHM Foundation’, New York,
  • the ‘Academy of Homeopathy Education,
  • HOHM Foundation, Philadelphia.

Which journal publishes such rubbish?

It’s INTEGRATIVE MEDICINE REPORTS, a publication that claims to be a “high-quality open access journal”.

And who sponsors such idiocy?

This study was funded by donations to HOHM Partners and to Homeopathy Help Network by clients and community members.

Say no more!

The BBC has repeatedly misled the public on matters related to so-called alternative medicine (SCAM). Examples include:

Recently the BBC published an article about Ashwagandha. Here it is in its untouched beauty:

Ashwagandha is a herb (Withania somnifera) in the nightshade family, which also includes tomatoes and chilli peppers.  It has been used in traditional Indian medicine (Ayurveda) for thousands of years to make preparations for treating various ailments, from infectious diseases, like tuberculosis, to pain and inflammation, baldness and hiccups. In classic Ayurvedic texts, it’s also described as a ‘mental strength promoter’ (or ‘Balya’).

While lots of research has been done on ashwagandha, studies for specific conditions can be sparser. Perhaps the most recent assessment of its use for stress and anxiety comes from a 2022 review of studies by the Cochrane Collaboration, which is internationally recognised for its high-standard medical reviews. Although the Cochrane researchers were only able to find 12 studies on the subject, which together tested the herb on just 1,002 participants, their findings did suggest that ashwagandha can lower stress and anxiety. The researchers rated the ‘certainty’ of the evidence as ‘low’ and called for more detailed studies, though.

The benefits of ashwagandha are thought to be related to natural steroids called withanolides, but this group includes hundreds of compounds, with tens having been isolated from ashwagandha so far. As with any herbal remedy, the combination of compounds and the exact concoction you get depends on how and where the plant is grown, and how it’s prepared. This means that not all supplements based on the same plant are equal.

Remember, too, that herbal doesn’t mean risk-free. For some people, ashwagandha causes drowsiness and more serious side effects aren’t unknown. It’s best to treat it like a drug and not ‘just’ a herb.

The review cited in the article is this one:

Clinical trial studies revealed conflicting results on the effect of Ashwagandha extract on anxiety and stress. Therefore, we aimed to evaluate the effect of Ashwagandha supplementation on anxiety as well as stress. A systematic search was performed in PubMed/Medline, Scopus, and Google Scholar from inception until December 2021. We included randomized clinical trials (RCTs) that investigate the effect of Ashwagandha extract on anxiety and stress. The overall effect size was pooled by random-effects model and the standardized mean difference (SMD) and 95% confidence interval (CIs) for outcomes were applied. Overall, 12 eligible papers with a total sample size of 1,002 participants and age range between 25 and 48 years were included in the current systematic review and meta-analysis. We found that Ashwagandha supplementation significantly reduced anxiety (SMD: −1.55, 95% CI: −2.37, −0.74; p = .005; I2 = 93.8%) and stress level (SMD: −1.75; 95% CI: −2.29, −1.22; p = .005; I2 = 83.1%) compared to the placebo. Additionally, the non-linear dose–response analysis indicated a favorable effect of Ashwagandha supplementation on anxiety until 12,000 mg/d and stress at dose of 300–600 mg/d. Finally, we identified that the certainty of the evidence was low for both outcomes. The current systematic review and dose–response meta-analysis of RCTs revealed a beneficial effect in both stress and anxiety following Ashwagandha supplementation. However, further high-quality studies are needed to firmly establish the clinical efficacy of the plant.

This review is NOT a Cochrane Review; what is more (and more important), it seem rather uncritical.

The BBC article seems to down-play the safety issue related to Ashwagandha. As we have discussed on this blog, Ashwagandha is far from harmless. In fact, Ashwagandha has been shown to be a herb with a high risk of hepatobiliary toxicity as well as heart problems.

So, why does the BBC misinform the public?

Search me.

What is it about Reiki that fascinates me?

It must be the exemplary poor science that its proponents use trying to convince us that it is valid.

This randomized controlled trial investigated the effect of Reiki on pain, functional status, and holistic well-being in patients with knee osteoarthritis (OA). The sample consisted of 42 patients.

  • The control group received standardized treatment only.
  • The intervention group received face-to-face Reiki (nine positions; 39 minutes) and distance Reiki on two consecutive days in addition to standardized treatment in addition to standard treatment.

The results show that the Reiki group had lower pain scores than the control group as measured by the Visual Analog Scale (p < .001) and the Western Ontario and McMaster Universities Arthritis Index pain score (p < .001). Those participating in the Reiki group had improved holistic well-being scores specifically for the subscales of Sadness, Perception of Sadness, Spiritual Disruption, Cognitive Awareness, and General mood.

The authors concluded that Reiki is a safe, noninvasive, and cost-effective alternative treatment technique that has the potential to reduce symptoms of pain and improve holistic well-being in patients with knee OA.

So many falsehoods in one sentence!

Is this a new record?

Let’s analyse these conclusions a little, shall we?

  • Reiki is safe: this does not follow from the data because the sample was far too small for assessing rare safety issues, safety was not measured, and half of the Reiki group might have dropped dead a week after the study.
  • Reiki is non-invasive: that might be true.
  • Reiki is cost-effective: cost-effectiveness was not an endpoint; the statement is thus not supported by the data.
  • Reiki reduces the symptoms of pain and improve holistic well-being in patients with knee OA: I disagree! The observed outcomes are much more likely caused by the considerable amount of extra attention and treatment time given to the Reiki group, and the results were entirely unrelated to any specific effects of the therapy.

So, I feel the need for re-phrasing the conclusions as follows:

Reiki is an implausible treatment and the outcomes of this study are unrelated to any alleged specific effects of this therapy.

Several years ago, I reported on the range of conditions which, according to homeopaths, “respond best to homeopathic treatment” (basically any condition imaginable). To remind you, here is the list again:

ENT and bronchial problems

  • Ear infections,
  • rhinitis,
  • sinusitis,
  • pharyngitis,
  • tonsillitis,
  • tracheitis,
  • bronchitis,
  • asthma.

Digestive problems

  • Stomach complaints
  • acidity,
  • heartburn,
  • fullness,
  • poor digestion,
  • flatulence,
  • duodenal ulcer,
  • diarrhoea,
  • constipation,
  • nausea,
  • vomiting,
  • canker sores.

Cardiovascular problems

Osteoarticular complaints

All types of muscle and/or joint pain due to arthrosis or arthritis:

  • neck pain,
  • shoulder pain,
  • elbow pain,
  • wrist pain,
  • Back pain,
  • sciatica,
  • knee pain,
  • ankle pain,
  • Sprains,
  • contractures etc.

Traumas

Urological disorders

Gynaecological problems

Dermatological problems

  • Eczema, hives,
  • Acne vulgaris, acne rosacea,
  • Recurrent boils, verucas, plantar warts,
  • Molluscum contagiosum,
  • Herpes simple and zoster
  • Psoriasis

Neurological disorders

  • Headaches and migraines.
  • Eye problems
  • Conjunctivitis,
  • blepharitis,
  • styes, dacryocistitis,
  • uveitis.

Behavioural and psychiatric disorders

  • Anxiety,
  • depression,
  • stress,
  • mental fatigue,
  • Pediatric problems,
  • Ear infections,
  • tonsillitis,
  • bronchitis,
  • asthma,
  • diarrhoea,
  • vomiting,
  • skin complaints,
  • canker sores,
  • teething problems,
  • sleep disorders,
  • educational attainment issues,
  • behavioural issues.

Endocrine disorders

  • Obesity,
  • hypothyroidism,
  • hyperthyroidism,
  • Depleted immune defences,
  • Recurrent infections affecting the throat,
  • sinuses, nose, ears,
  • connective tissue, larynx,
  • bronchial tubes,
  • lungs,
  • skin,
  • bladder etc.

Palliative care

For the treatment of the diverse symptoms that appear over the course of the illness. Homeopathy can improve the patient’s general wellbeing and counteract the side effects of other treatments.

These are just a few examples, but the list could be endless – it is important to stress that homeopathy is very effective in pathologies that are difficult to establish or those with contradictory or paradoxical symptoms.

In recurrent illnesses, homeopathic medicines can boost the defences and help to regulate the sufferer’s body in order to prevent further relapses.

Homeopathy is an excellent preventive medicine.

_______________________

You will notice that SCIATICA is on the list.

Would they really be as daft as to use homeopathy for sciatica?

Not only that, they would even conduct a study on the subject. Here is this recently published trial:

Objectives: Sciatica is a debilitating condition that causes pain in its distribution or in the lumbosacral nerve root that is connected to it. Although there are claims that homeopathy can reduce sciatica pain, systematic scientific proof is currently lacking. The objective of the trial was to determine whether individualized homeopathic medicines (IHMs) were as effective as identical-looking placebos in treating sciatica pain. Design: This is a double-blind, randomized (1:1), two parallel arms, placebo-controlled trial. Setting: The study was conducted at Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Howrah, West Bengal, India. Subjects: Sixty participants with sciatica pain were included in this study. Interventions: Verum (n = 30; IHMs plus concomitant care) versus control (n = 30; placebos plus concomitant care). Outcome measures: Primary-Sciatica Bothersome Index (SBI) and Sciatica Frequency Index (SFI) scores and secondary-Roland Morris Pain and Disability Questionnaire (RMPDQ), Short Form McGill Pain Questionnaire (SF-MPQ), and Oswestry Low Back Pain Questionnaire (OLBPQ) scores: all of them were measured at baseline, and every month, up to 3 months. Results: Intention-to-treat sample (n = 60) was analyzed. Group differences were examined by two-way (split-half) repeated measure analysis of variance, primarily accounting for between groups and time interactions, and additionally, by unpaired t tests comparing the estimates obtained individually every month. The level of significance was set at p < 0.025 and <0.05 two tailed for the primary and secondary outcomes, respectively. Group differences could not achieve significance in SBI (p = 0.044), SFI (p = 0.080), and RMPDQ scores (p = 0.134), but were significant for SF-MPQ (p = 0.007) and OLBPQ (p = 0.036). Gnaphalium polycephalum (n = 6; 10%) was the most frequently prescribed medicine. No harm, serious adverse events, or intercurrent illnesses were recorded in either of the groups. Conclusions: The primary outcome failed to demonstrate evidently that homeopathy was effective beyond placebo, and the trial remained inconclusive. Independent replications are warranted to confirm the findings.

So, homeopathy does not work for sciatica.

Surprise, surprise!

Why not?

Simple: because homeopathy does not work for any condition.

Some papers on homeopathy are bad, others are very bad and others again create a new dimension of bad. Here is an example of the latter category (Research, Society and Development, v. 13, n. 7, e1413746050, 2024
(CC BY 4.0) | ISSN 2525-3409 | DOI: http://dx.doi.org/10.33448/rsd-v13i7.46050 ):

Objective: To research, through literature review, the use of homeopathy as an alternative treatment for many pathologies involved in dentistry field. Methodology: online searches using databases available at PUBMED Central and VHL/BIREME. Other platforms such as Web of Science, Science Direct and Google Academy. Results: Our search resulted in 25 articles. Conclusion: Despite the mysticism that surrounds it, the use of homeopathic medicines in dental treatments is, in fact, a scientifically proven alternative treatment, which helps in various pre and post surgical procedures, which has a low financial cost and great effectiveness, enabling a contribution to dental care. Scientific study in this area requires more research and clinical evidence, so that this practice is more widespread and used by dental surgeons, in addition to the application of homeopathy as a discipline in dentistry.

But that’s merely the abstract. Perhaps the article itself offers some convincing evidence. See for yourself; here is the only section of the paper that provides something akin to evidence:

In dentistry, homeopathic remedies have been proposed for a variety of conditions including oral ulcers, sialorrhea (excessive salivation), neuralgia, temporomandibular joint disorders (TMJ), xerostomia (dry mouth), lichen planus, bruxism (teeth grinding), minor acute illnesses, chronic pathologies, atypical facial pain, burning mouth syndrome, postoperative osteitis, and anxiety related to dental treatment (Steinchler, 2015; Fischer, 2005). They are often used as adjuncts to conventional treatments, especially in cases where traditional approaches have failed or are contraindicated (Amaral, 2021).

Homeopathic medicines for these conditions come in various forms such as tablets, pills, drops, liquids, granules, and creams (Darby, 2011). Some are designed to dissolve on or under the tongue for quick absorption. The instructions typically advise placing the medicine directly in the mouth, where it can be sucked or chewed to facilitate absorption (Darby, 2011).

The use of homeopathic remedies in dentistry offers several potential benefits, including cost-effectiveness, versatility across different dental specialties (such as orthodontics, stomatology, endodontics, pediatric dentistry, periodontics, and surgery), relative efficacy, safety, and ease of use (Eleutério, 2011; Mendonça, 2022; Almeida et al., 2023). This makes them a valuable option in integrative dental care, where they can complement conventional treatments and provide additional therapeutic options for patients.

______________________

As the Brazilian authors of the article fail to say it, allow me to do so:

The place of homeopathy in dentistry is nowhere! There is no reliable evidence that homeopathy is effective for any of the conditions listed above.

PS

This paper is nonetheless notable: it is certainly amongst the worst I have seen for a very long time.

International guidelines have recommended cognitive behavioural therapy, including acceptance and commitment therapy (ACT), as it offers validated benefits for managing fibromyalgia; however, it is inaccessible to most patients.  This study aimed to evaluate the effect of a 12-week, self-guided, smartphone-delivered digital ACT programme on fibromyalgia management.

In the PROSPER-FM randomised clinical trial conducted at 25 US community sites, adult participants aged 22–75 years with fibromyalgia were recruited and randomly assigned (1:1) to the digital ACT group or an active control group that offered daily symptom tracking and monitoring and access to health-related and fibromyalgia-related educational materials. Randomisation was done with a web-based system in permuted blocks of four at the site level. We used a blind-to-hypothesis approach in which participants were informed they would be randomly assigned to one of two potentially effective therapies under evaluation. Research staff were not masked to group allocation, with the exception of a masked statistics group while preparing statistical programming for the interim analysis. The primary endpoint was patient global impression of change (PGIC) response rate at week 12. Analyses were by intention to treat. The trial was registered with ClinicalTrials.govNCT05243511 (now fully closed).

Between Feb 8, 2022, and Feb 2, 2023, 590 individuals were screened, of whom 275 (257 women and 18 men) were randomly assigned to the digital ACT group (n=140) and the active control group (n=135). At 12 weeks, 99 (71%) of 140 ACT participants reported improvement on PGIC versus 30 (22%) of 135 active control participants, corresponding to a difference in proportions of 48·4% (95% CI 37·9–58·9; p<0·0001). No device-related safety events were reported.

The authors concluded that digital ACT was safe and efficacious compared with digital symptom tracking in managing fibromyalgia in adult patients.

___________________

These conclusions might well be valid – but then again, they might not!

Here is why I have my doubts:

  • The patients treated with digital ACT knew that they were getting a novel and thus exciting treatment.
  • The patients randomised to the control group, on the other hand, would most likely be disappointed not to receive this therapy. In other words, there were high expectations in the experimental group and disappointment in the control group.
  • In addition, the unmasked researchers would have had the ambition that their innovation would be successful. Thus they would have used verbal and non-verbal communications with the ACT patients to bring about the desired result.

It is therefore conceivable – I think even likely – that these factors would add up to generate a false-positive finding, particularly since the endpoint was entirely subjective.
In view of all this, I am surprised that a journal like THE LANCET has published such a flimsy study with such a over-optimistic conclusion, and I suggest re-phrasing the conclusions as follows:

Digital ACT seemed safe and effective compared with digital symptom tracking in managing fibromyalgia in adult patients. However, due to the design of the study, it is possible that digital ACT is entirely ineffective and the positive outcome is caused by a number of context effects.

To accuse anyone of an abuse of science is a hefty charge, I know. In the case of proponents of so-called alternative medicine (SCAM) doing science, it is, however, often justified. Let me explain this by using the example of chiropractors (I could have chosen homeopathy, faith heaalers, acupuncturists or almost any other type of SCAM professional, but in recent times it was the chiros who provided the clearest examples of abuse).

Science can be seen as a set of tools that is used to estabish the truth. In therapeutics, science is employed foremost to answer three questions:

  1. Is the therapy plausible?
  2. Is the therapy effective?
  3. Is the therapy safe?

The way to answer them is to falsify the underlying hypotheses, i.e. to demonstrate that:

  1. The therapy is not plausible.
  2. The therapy is not effective.
  3. The therapy is not safe.

Only if rigorous attempts at falsifying these hypotheses have falied can we conclude that:

  1. The therapy is plausible.
  2. The therapy is effective.
  3. The therapy is safe.

I know, this is rather elementary stuff. It is taught during the first lessons of any decent science course. Yet, proponents of SCAM are either not being properly taught or they are immune to even the most basic facts about science. On this blog, we regularly have the opportunity to observe exactly that when we read and are bewildered by the comments made by SCAM proponents. This is often clearest in the case of chiropractors.

  1. They cherry-pick the evidence to persuade us that their hallmark intervention, spinal manipulation, is plausible.
  2. They cherry-pick the evidence to persuade us that their hallmark intervention, spinal manipulation, is effective.
  3. They cherry-pick the evidence to persuade us that their hallmark intervention, spinal manipulation, is safe.

If they conduct research, they set up their investigations in such a way that they confirm their beliefs:

  1. Spinal manipulations are plausible.
  2. Spinal manipulations are effective.
  3. Spinal manipulations are safe.

In other words, they do not try to falsify hypotheses, but they do their very best to confirm them. And this, I am afraid, is nothing other than an abuse of science.

QED

And how can the average consumer (who may not always be in a position to realize whether a study is reliable or not) tell when such abuse of science is occurring? How can he or she decide who to trust and who not?

A simplest but sadly not fool-proof advice might consist in 2 main points:

  1. Never rely on a single study.
  2. Check whether there is a discrepancy in the results and views of SCAM proponents and independent experts; e.g.:
    • Chiropractors claim one thing, while independent scientists disagree or are unconvinced.
    • Homeopath claim one thing, while independent scientists disagree or are unconvinced.
    • Acupuncturists claim one thing, while independent scientists disagree or are unconvinced.
    • Energy healers claim one thing, while independent scientists disagree or are unconvinced.
    • Naturopaths claim one thing, while independent scientists disagree or are unconvinced.
    • Etc., etc.

In all of those cases, your alarm bells should ring and it might be wise to be cautious and avoid the treatment in question.

Yesterday, I stumbled across this remarkable notice. As it is in German, I took the libery of translating it for you:

Am 6. April 2024 war es wieder soweit: Die ÖGHM und die Schwabe Austria GmbH luden zur Verleihung des mit 4.000,- Euro dotierten Dr. Peithner Preises ein.

Dieses Mal wurde der Forschungspreis für die zwei eingereichte Arbeiten „Recommendations in the design and conduction of randomized controlled trials in human and veterinary homoeopathic medicine“ und „Recommendations for Designing, Conducting and Reporting Clinical Observational Studies in Homeopathic Veterinary Medicine“ an Katharina Gaertner, Klaus von Ammon, Philippa Fibert, Michael Frass, Martin Frei-Erb, Christien Klein-Laansma, Susanne Ulbrich-Zuerni und Petra Weiermayer vergeben.

Wir freuen uns sehr und gratulieren den Preisträger:innen zum verdienten Erfolg. Ein herzliches Dankeschön geht auch an die ÖGHM und die Schwabe Austria, die nicht nur mit diesem traditionellen Forschungspreis die Wissenschaft unterstützt.

Here is my translation:

On 6 April 2024, the time had come again: the ‘Austrian Society for Homeopathic Medicine’ (ÖGHM) and Schwabe Austria GmbH hosted the award ceremony for the Dr Peithner Prize, which is endowed with 4,000 euros.

This time, the research prize was awarded to Katharina Gaertner, Klaus von Ammon, Philippa Fibert, Michael Frass, Martin Frei-Erb, Christien Klein-Laansma, Susanne Ulbrich-Zuerni and Petra Weiermayer for the two submitted papers “Recommendations in the design and conduction of randomised controlled trials in human and veterinary homoeopathic medicine” and “Recommendations for Designing, Conducting and Reporting Clinical Observational Studies in Homeopathic Veterinary Medicine”.

We are delighted and congratulate the prizewinners on their well-deserved success. A big thank you also goes to the ÖGHM and Schwabe Austria, who support science with this traditional research prize.

______________________________

And where is the irony?

Firstly, homeopaths are not exactly the experts on how to conduct research.

Secondly, there are recommendations and guidelines for conducting clinical research (e.g. here), and there is no reason for homeopathy to not to adopt those.

Thirdly, and most importantly, to award a prize to Michael Frass for telling us how to do research is more than a little ironic. If anything, Frass could teach us a thing or two about how to falsify, fabricate and manipulate research results!

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