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

conflict of interest

The COVID-19 pandemic has posed an unprecedented challenge to global health. Classical homeopathy may, according to homeopaths, have a role to play in alleviating this burden. The objective of this study was to curate data on the treatment effect of classical homeopathy for COVID-19 in a real-world scenario to guide future scientific investigations.

Classical homeopaths from the International Academy of Classical Homeopathy (IACH) were asked to provide details on cases they treated by filling out a standardized questionnaire. COVID-19 cases were defined according to World Health Organization (WHO) criteria as suspected/probable/confirmed cases, with intervention provided being either stand-alone classical homeopathy or combined with conventional therapy for COVID-19. Cases were followed up with main outcomes being ‘improved’, ‘not improved’, or ‘progressed’ post-treatment. Details of the homeopathic remedies used and the main symptoms at the presentation were gathered. Factors associated with main outcomes were investigated with correlational and regression analyses.

367 patients (male 166, female 201) met eligibility criteria (mean age 42.75 years). The mean follow-up period was 6.5 (standard deviation, SD=5.3) days. 255 were confirmed COVID-19 cases, with 61 probable and 51 suspected cases, respectively. The most used remedy was Arsenicum album. Over 73% of COVID-19 patients (and about 79% of severe cases) improved under classical homeopathic treatment. The number of remedies required per individual was negatively correlated to improvement (P< 0.01). Fever, the most common symptom at presentation (74.4%), was associated with an increased likelihood of improvement (P<0.01). Improvement was negatively associated with advanced age, but not associated with sex (P<0.01).

The authors conclude that this study suggests that classical homeopathy was associated with improvement in COVID-19, including severe cases. Despite limitations from study design and data sources, our findings should prompt further studies on the role of classical homeopathy in the management of COVID-19.

I BEG TO DIFFER!

These cases suggest nothing of the sort. If anything, these highly selected cases suggest that about 27% of the exemplary patients did not improve, perhaps they even died. This implies to me that classical homeopathy worsens the prognosis of patients infected with COVID-19.

The ‘International Academy of Classical Homeopathy‘ is led by the ‘Ueber-Homeopath’, George Vithoulkas. His vision is that this Academy will become a center of real knowledge which will provide an education that will far exceed the technical and strictly “medical” aspect of one’s learning. One might ask what fanatics like he truly want to achieve – is it perhaps the promotion of ‘euthanasia homoeopathica’?

The General Chiropractic Council (GCC) “regulates chiropractors in the UK to ensure the safety of patients undergoing chiropractic treatment”. One might have assumed that they thus fulfill the important role of controlling the profession. Yet, one would have assumed wrongly. Instead of controlling, the GCC usually prefers promoting the profession. Their recent Chiropractic Patient Satisfaction and Experience is a good example. Let me show you several important sections of this document:

The outcomes reported here highlight two key findings:
• Overwhelmingly, chiropractic patients report high levels of satisfaction and positive experiences with their care. This was true both in the literature that examined international patient cohorts as well as the specific data collected from UK based chiropractic patients.
• A strong therapeutic relationship and good communication between patient and chiropractor underpins high satisfaction scores and a positive experience. This was confirmed both in the international literature and through both quantitative and qualitative analysis of specific data collected from UK based chiropractic patients.

Conclusion
This report shows that both existing literature and de novo data collection from patients receiving chiropractic care in the UK highlight excellent perceived experience and high satisfaction with such care.
Factors such as therapeutic alliance and communication are strongly associated with these positive perceptions by patients although other factors such as treatment beliefs were also significantly associated with satisfaction scores.

Recommendations
• To offer the highest quality of care, both in terms of clinical outcomes and patient experience, chiropractors should be explicitly skilled at curating excellent therapeutic alliances and communication with patients.
• Such skills and competences within chiropractic care delivery should receive higher visibility within the chiropractic profession generally and more specifically through advocacy within leading institutions and core emphasis within chiropractic curricula.

__________________________

By changing a few words, I have adapted the above excerpts to become a Customer Satisfaction and Experience Report of a fictitious hamburger joint published by the Hamburger General Council (HGC) of Great Britain which regulates hamburger joints in the UK to ensure the safety of consumers undergoing hamburger nutrition:

The outcomes reported here highlight two key findings:
• Overwhelmingly, customers report high levels of satisfaction and positive experiences with their restaurant. This was true both in the literature that examined international consumer cohorts as well as the specific data collected from UK based customers.
• A strong professional relationship and good communication between customer and service personell underpins high satisfaction scores and a positive experience. This was confirmed both in the international literature and through both quantitative and qualitative analysis of specific data collected from UK based hamburger consumers.

Conclusion
This report shows that both existing literature and de novo data collection from consumers eating hamburgers in the UK highlight excellent perceived experience and high satisfaction with such service.
Factors such as personal alliance and communication are strongly associated with these positive perceptions by consumers although other factors such as appetite were also significantly associated with satisfaction scores.

Recommendations
• To offer the highest quality of service, both in terms of profit and patient experience, hamburger vendors should be explicitly skilled at curating excellent professional alliances and communication with customers.
• Such skills and competences within hamburger delivery should receive higher visibility within the gastronomic trade generally and more specifically through advocacy within leading institutions and core emphasis within servers’ curricula.

___________________________

If you get the impression that I am taking the Mickey of the GCC, you are not mistaken. Yet, this post also has slightly more serious purposes. I wanted to 1) show how, in the chiropractic profession, pure BS is often disguised as research, and 2) question whether the GCC is fit for purpose.

On a more constructive note: there are many open questions that urgently need addressing in the realm of chiropractic (e.g. do chiropractors more good than harm?). I, therefore, suggest that the GCC stops publishing idiotic promotional documents disguised as research and gets on with its responsibilities.

 

 

Lumbosacral Radicular Syndrome (LSRS) is a condition characterized by pain radiating in one or more dermatomes (Radicular Pain) and/or the presence of neurological impairments (Radiculopathy). So far, different reviews have investigated the effect of HVLA (high-velocity low-amplitude) spinal manipulations in LSRS. However, these studies included ‘mixed’ population samples (LBP patients with or without LSRS) and treatments other than HVLA spinal manipulations (e.g., mobilisation, soft tissue treatment, etc.). Hence, the efficacy of HVLAT in LSRS is yet to be fully understood.

This review investigated the effect and safety of HVLATs on pain, levels of disability, and health-related quality of life in LSRS, as well as any possible adverse events.

Randomized clinical trials (RCTs) published in English in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (PubMed), EMBASE, PEDro, and Web of Science were identified. RCTs on an adult population (18-65 years) with LSRS that compared HVLATs with other non-surgical treatments, sham spinal manipulation, or no intervention were considered. Two authors selected the studies, extracted the data, and assessed the methodological quality through the ‘Risk of Bias (RoB) Tool 2.0’ and the certainty of the evidence through the ‘GRADE tool’. A meta-analysis was performed to quantify the effect of HVLA on pain levels.

A total of 308 records were retrieved from the search strings. Only two studies met the inclusion criteria. Both studies were at high RoB. Two meta-analyses were performed for low back and leg pain levels. HVLA seemed to reduce the levels of low back (MD = -1.48; 95% CI = -2.45, -0.50) and lower limb (MD = -2.36; 95% CI = -3.28, -1.44) pain compared to other conservative treatments, at three months after treatment. However, high heterogeneity was found (I² = 0.0%, p = 0.735). Besides, their certainty of the evidence was ‘very low’. No adverse events were reported.

The authors stated that they cannot conclude whether HVLA spinal manipulations can be helpful for the treatment of LSRS or not. Future high-quality RCTs are needed to establish the actual effect of HVLA manipulation in this disease with adequate sample size and LSRS definition.

Chiropractors earn their living by applying HVLA thrusts to patients suffering from LSRS. One would therefore have assumed that the question of efficacy has been extensively researched and conclusively answered. It seems that one would have assumed wrongly!

Now that this is (yet again) in the open, I wonder whether chiropractors will, in the future, tell their patients while obtaining informed consent: “I plan to give you a treatment for which sound evidence is not available; it can also cause harm; and, of course, it will cost you – I hope you don’t mind.”

This systematic review was aimed at determining if there has been a change in the reporting of adverse events associated with spinal manipulation in randomized clinical trials (RCTs) since 2016.

Databases were searched from March 2016 to May 2022: MEDLINE (Ovid), Embase, CINAHL, ICL, PEDro, and Cochrane Library. The following search terms and their derivatives were adapted for each platform: spinal manipulation; chiropractic; osteopathy; physiotherapy; naprapathy; medical manipulation and clinical trial.

Domains of interest (pertaining to adverse events) included: completeness and location of reporting; nomenclature and description; spinal location and practitioner delivering manipulation; methodological quality of the studies and details of the publishing journal. Frequencies and proportions of studies reporting on each of these domains were calculated. Univariable and multivariable logistic regression models were fitted to examine the effect of potential predictors on the likelihood of studies reporting on adverse events.

There were 5399 records identified by the electronic searches, of which 154 (2.9%) were included in the analysis. Of these, 94 (61.0%) reported adverse events with only 23.4% providing an explicit description of what constituted an adverse event. Reporting of adverse events in the abstract had increased (n=29, 30.9%) while reporting in the results section had decreased (n=83, 88.3%) over the past 6 years. Spinal manipulation was delivered to 7518 participants in the included studies. No serious adverse events were reported in any of these studies.

The authors concluded that, while the current level of reporting of adverse events associated with spinal manipulation in RCTs has increased since our 2016 publication on the same topic, the level remains low and inconsistent with established standards. As such, it is imperative for authors, journal editors and administrators of clinical trial registries to ensure there is more balanced reporting of both benefits and harms in RCTs involving spinal manipulation.

In fact, it is an ethical imperative to accurately report adverse effects. Not reporting adverse effects amounts to a violation of medical research ethics. Adverse effects of spinal manipulation occur in about 50% of all patients. This means that investigators reporting significantly lower figures are likely guilty of under-reporting. And under-reporting of adverse events is also a breach of ethical standards.

My conclusion thus is that the vast majority of trials of spinal manipulation are unethical and should be discarded.

This study investigated the potential benefits of auricular point acupressure on cerebrovascular function and stroke prevention among adults with a high risk of stroke.

A randomized controlled study was performed with 105 adults at high risk for stroke between March and July 2021. Participants were randomly allocated to receive either

  • auricular point acupressure with basic lifestyle interventions (n = 53) or
  • basic lifestyle interventions alone (n = 52) for 2 weeks.

The primary outcome was the kinematic and dynamic indices of cerebrovascular function, as well as the CVHP score at week 2, measured by the Doppler ultrasonography and pressure transducer on carotids.

Of the 105 patients, 86 finished the study. At week 2, the auricular point acupressure therapy with lifestyle intervention group had higher kinematic indices, cerebrovascular hemodynamic parameters score, and lower dynamic indices than the lifestyle intervention group.

The authors concluded that ccerebrovascular function and cerebrovascular hemodynamic parameters score were greater improved among the participants undergoing auricular point acupressure combined with lifestyle interventions than lifestyle interventions alone. Hence, the auricular point acupressure can assist the stroke prevention.

Acupuncture is a doubtful therapy.

Acupressure is even more questionable.

Ear acupressure is outright implausible.

The authors discuss that the physiological mechanism underlying the effect of APA therapy on cerebrovascular hemodynamic function is not fully understood at present. There may be two possible explanations.

  • First, a previous study has demonstrated that auricular acupuncture can directly increase mean blood flow velocity in the middle cerebral artery.
  • Second, cerebrovascular hemodynamic function is indirectly influenced by the effect of APA therapy on blood pressure.

I think there is a much simpler explanation: the observed effects are directly or indirectly due to placebo. As regular listeners of this blog know only too well by now, the A+B versus B study design cannot account for placebo effects. Sadly, the authors of this study hardly discuss this explanation – that’s why they had to publish their findings in just about the worst SCAM journal of them all: EBCAM.

Numerous qualitative studies and a few quantitative studies have linked vaccine hesitancy or refusal with the belief in the efficacy of so-called alternative medicine (SCAM). Yet, large-scale data on this topic are scarce. In this study, the French researchers investigated the factors associated with the coverage rates of seven childhood vaccines or vaccine groups in the ninety-six metropolitan French departments. One of the factors investigated was the local interest in SCAM. In order to assess this interest, they built an Alternative Medicine Index based on departmental internet searches regarding SCAM—internet searches being a reliable indicator of the public’s actual interest in a given topic. They then conducted multiple regression analyses, which showed that this Index is a significant explanatory factor for the departmental variance in vaccination coverage rates, exceeding in importance the effect of other relevant local sociodemographic factors.

A further recent study from France adds to the picture. It presents the results of a survey conducted in July 2021 among a representative sample of the French mainland adult population (n = 3087). Using cluster analysis, the researchers identified five profiles of SCAM attitudes and found that even among the most pro-SCAM group, very few respondents disagreed with the idea that SCAM should only be used as a complement to conventional medicine. They then compared these SCAM attitudes to vaccine attitudes. Attitudes to SCAM had a distinct impact as well as a combined effect on attitudes to different vaccines and vaccines in general. They found that:

  • attitudes to SCAM provide a very limited explanation of vaccine hesitancy;
  • among the hesitant, pro-SCAM attitudes are often combined with other traits associated with vaccine hesitancy such as distrust of health agencies, radical political preferences, and low income.

Both SCAM endorsement and vaccine hesitancy are more prevalent among the socially disadvantaged. Drawing on these results, the researchers argue that, to better understand the relationship between SCAM and vaccine hesitancy, it is necessary to look at how both can reflect a lack of access and recourse to mainstream medicine and distrust of public institutions.

The fact that the enthusiasm for SCAM is associated with vaccine hesitancy has been discussed on this blog many times before, e.g.:

What seems fairly clear to me is that a cross-correlation exists: an attitude against modern medicine and the ‘scientific establishment’ determines both the enthusiasm for SCAM and the aversion to vaccination. What is, however, far from clear to me is what we could do about it.

Yes, better education seems important – and that’s precisely what I aim at achieving with this blog. Sadly, judging from some of the comments we receive, it does not seem crowned with much success.

Any other ideas?

Menopausal symptoms are systemic symptoms that are associated with estrogen deficiency after menopause. Although widely practiced, homeopathy remains under-researched in menopausal syndrome in terms of quality evidence, especially in randomized trials. The efficacy of individualized homeopathic medicines (IHMs) was evaluated in this double-blind, randomized, placebo-controlled trial in the treatment of the menopausal syndrome.

Group 1 (n = 30) received IHMs plus concomitant care, while group 2 (n = 30) had placebos plus concomitant care. The primary outcome measures were the Greene Climacteric Scale (GCS) total score and the menopause rating scale (MRS) total score. The secondary endpoint was the Utian quality of life (UQOL) total score. Measurements were taken at baseline and every month up to 3 months.

Intention-to-treat sample (n = 60) was analyzed. Group differences were examined by two-way (split-half) repeated-measure analysis of variance, primarily taking into account all the estimates measured at monthly intervals, and secondarily, by unpaired t-tests comparing the estimates obtained individually every month. The level of significance was set at p < 0.025 two-tailed. Between-group differences were nonsignificant statistically—GCS total score (F1, 58 = 1.372, p = 0.246), MRS total score (F1, 58 = 0.720, p = 0.4), and UQOL total scores (F1, 58 = 2.903, p = 0.094). Some of the subscales preferred IHMs significantly against placebos—for example, MRS somatic subscale (F1, 56 = 0.466, p < 0.001), UQOL occupational subscale (F1, 58 = 4.865, p = 0.031), and UQOL health subscale (F1, 58 = 4.971, p = 0.030). Sulfur and Sepia succus were the most frequently prescribed medicines. No harm or serious adverse events were reported from either group.

The authors concluded that, although the primary analysis failed to demonstrate clearly that the treatment was effective beyond placebo, some significant benefits of IHMs over placebo could still be detected in some of the subscales in the secondary analysis.

The article was published in the recently re-named JICM, a journal that, when it was still called JCAM, featured regularly on this blog. As such, the paper is remarkable: who would have thought that this journal might publish a trial of homeopathy with a squarely negative result?

Yes, I know, the surprise is tempered by the fact that the authors make much in the conclusions of their article about the significant findings related to secondary analyses. Should we tell them that these results are all but irrelevant?

Better not!

The decline of homeopathy, the ‘medicine’ that doesn’t cure anything” is the title of a remarkable article in EL PAIS of which I take the liberty of showing you a few key passages:

In the more than 200 years that have passed since its invention, no one has been able to prove that homeopathy is actually capable of curing anything with its alleged medicines that have no active ingredients…

…EL PAÍS reached out to some of its main promoters, such as the pharmaceutical company Boiron, leader in the sector; the Spanish Association of Homeopathy Pharmacists and the Spanish Society of Homeopathic Doctors. In the absence of a response from all three, the explanations are given by experts who are more critical of the discipline.

Many people who used to consume homeopathy were not even aware that this was the case. Fernando Frías, one of the activists who worked to undermine the discipline’s remaining prestige, recalls that people did not believe them when they were told that compounds with diluted Berlin Wall were sold to overcome the feelings of oppression and anxiety. This was actually commercialized under the premise that “like cures like”: if the Berlin Wall oppressed, a piece of it diluted in water should remedy it. “Many were under the impression that it was just a natural therapy and that we were making things up to attack it,” says Frías…

… There has been a lot of debate about how to regulate an alleged drug whose only effect is, in truth, the placebo effect. In 2001, the European Parliament issued a directive that covered its use in countries with a homeopathic tradition; sources explain that this happened due to the pressure exerted by both the industries and the governments of countries where pseudoscience is deep-rooted, such as France (where Boiron is headquartered) or Germany, where its consumption is much higher than in others, such as Spain.

“Having regard to the particular characteristics of these homeopathic medicinal products, such as the very low level of active principles they contain and the difficulty of applying to them the conventional statistical methods relating to clinical trials, it is desirable to provide a special, simplified registration procedure for those homeopathic medicinal products which are placed on the market without therapeutic indications in a pharmaceutical form and dosage which do not present a risk for the patient,” states the directive.

In its more than two centuries of history, this is not the first time that homeopathy loses ground. Still, Frías warns, it cannot be ruled out that at some point something will come up that will make it fashionable again. “Look at the example of chemtrails [the condensation trails left by airplanes that some conspiracy theorists believe are a way of poisoning the population from the air]. It seemed that no one remembered them anymore, but now they’re back,” he says. Frías cites the astrophysicist and disseminator Javier Armentia, who states that beliefs are like a rubber duck: no matter how much they sink, they always resurface. “Especially if there is money behind,” he adds.

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As reported previously, homeopathy and other forms of so-called alternative medicine (SCAM) have come under fire in Spain. In 2017, ‘HOMEOPATHY PLUS‘ reported that “in a reversal of the 2015 Royal Legislative Decree, the Minister of Health has withdrawn homeopathic remedies and outlawed the practice in Spain’s national health services.” In 2018, more than 400 people signed an open letter triggered by the case of a cancer patient who died after preferring homeopathy to regular treatment. “Let’s be clear: pseudoscience kills,” begins the letter. Since then, the struggle of Spanish rational thinkers to stop misleading information about SCAM in general and homeopathy, in particular, has only intensified.

Spain is thus joining other European countries in opposing misinformation about homeopathy. Contrary to what some have claimed (for instance, in the comments section of this blog), most of the opponents do not want to restrict the public’s choice. People who wish to use homeopathy should be able to do so (but should pay for it themselves). However, the choice must be based on evidence-based information.

An explanatory sequential mixed methods study with three separate phases was conducted in Danish patients with lumbar radiculopathy receiving a standardized chiropractic care package (SCCP). Lumbar radiculopathy is pain and other neurological symptoms caused by the pinching of nerve roots where they leave your spinal cord in the lumbar region.

Phase one of the study was a quantitative analysis based on a survey in a prospective cohort of patients with lumbar radiculopathy in an SCCP from 2018 to 2020. Patients rated their satisfaction with the examination, information, treatment effect, and overall management of their problem on a 0–10 scale. In phase two, six semi-structured interviews conducted in 2021 were used to gain further explanatory insights into the findings from phase one. Data were analyzed using systematic text condensation. In phase three, the quantitative and qualitative data were merged in a narrative joint display to obtain a deeper understanding of the overall results.

Here I am only interested in the patients’ perception of the treatment effect. Of 303 eligible patients, 238 responded to the survey. Of these, 50% were very satisfied with the treatment effect.

The authors stated that patients in their study expected a rapid and persistent decrease in symptoms, which, unfortunately, does not match the prognosis of lumbar radiculopathy. Although the prognosis is considered good, the improvement happens gradually and often with fluctuating pain patterns, and it is not unusual to have milder symptoms for three months or longer.

So, only half of the patients who had chosen to consult chiropractors for their lumbar radiculopathy were very satisfied with the treatment results. In most patients, the symptoms decreased only gradually often with fluctuating pain patterns, and the authors comment that symptoms frequently last for three months or longer with a SCCP.

Impressive?

Might I point out that what is being described here looks to me very much like the natural history of lumbar radiculopathy? About 90% of patients with back pain caused by disc herniation see improvements within three months without therapy. Are the authors aware that their observational study is in accordance with the notion that the SCCP does nothing or very little to help patients suffering from lumbar radiculopathy?

It has been reported, at the German Medical Congress (DÄT) a year ago, that it was decided to delete the additional title of homeopathy from the model further training regulations of the German Medical Association. And Federal Health Minister Karl Lauterbach (SPD) tweeted applause: “Homeopathy has no place in modern medicine.”

Now the ‘ Bundesverband der Pharmaziestudierenden in Deutschland’ (BPhD), the German Pharmacists Organization, even goes a few steps further. The position paper distinguishes between evidence-based medicine (EBM) and unproven therapeutic methods. According to the BPhD, these include homeopathy, but also anthroposophy, traditional Chinese medicine, and traditional medicines.

Among other things, the BPhD is disturbed by the way homeopathy presents itself as an alternative, because an alternative means “a choice between two equally suitable possibilities” to achieve a goal, and this is not the case. Compared to evidence-based medicine (EBM), homeopathy is a “constructed, illusory concept” and “the principles of homeopathic teachings and principles” are to be rejected as “unscientific”. According to the BPhD, a designation as “alternative” for advertising purposes should no longer be allowed.

They would also like to see a demarcation from naturopathy; the clear distinction between homeopathy and phytopharmacy has been lacking up to now. The advertising attribute “natural” should therefore also be banned in order to prevent equalization in advertising, the position paper states.

Like doctors, pharmacy students point to the lack of proof of efficacy beyond the placebo effect. According to the BPhD, the dogma WER HEILT HAT RECHT, “he who heals is right” would “disregard all processes that work towards healing and glorify the result”. The “gold standard” of EBM – randomized, double-blind studies with placebo control – should in future also have to be fulfilled by homeopathic medicines, experience reports are not sufficient, it continues.

Homeopathic medicines are only registered as medicinal products without indication, which requires neither proof of efficacy nor clinical studies. The BPhD, therefore, demands that a warning be placed on the preparations that they have “no proven efficacy beyond the placebo effect”. Up to now, without this warning, patients have been “deceived about the efficacy”, and there is an “urgent need for detailed public information and counseling on homeopathy since its unjustified reputation poses a danger of not seeking treatment”. The BPhD also demands that the status of homeopathic medicines is withdrawn and that the pharmacy obligation for the preparations is abolished…

“In the health professions, no trivialization of unproven therapeutic procedures should be tolerated, as inadequate counseling or ignorance poses a danger to patients,” the BPhD said.

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When I first read this article – I translated and shortened it for those who cannot read German- I was truly dazzled. These are the suggestions that I have been making for around 20 years now, not specifically for Germany but for pharmacists in general. For many years, the Germans seemed the least likely to agree with me. But now they seem to be ahead of everyone else in Europe!

How come?

I suspect and hope that our recent initiative might have something to do with it.

Let’s hope that the pharmacists of other countries follow the German example.

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