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

critical thinking

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If you thought that lousy research in so-called alternative medicine (SCAM) is confined to human medicine, you were wrong. The papers published in veterinary medicine is just one of many examples to suggest that it is, in fact, even worse. Take, for instance, this study of homeopathy.

This Indian study was conducted to evaluate the ameliorative potential of homeopathic drugs in combination (Sulfur 30C, Thuja 30C, Graphites 30C, and Psorinum 30C) in 16 dogs affected with oral papillomatosis which had not undergone any previous treatment. Papillomas are benign epithelial tumours caused by infection with species-specific DNA papilloma-viruses. They tend to disappear within 6-12 months.

Dogs affected with oral papillomatosiswere randomly divided into two groups, namely, homeopathic treatment group (n=8) and placebo control group (n=8). The homeopathic combination of drugs and placebo drug (distilled water) was administered orally twice daily for 15 days. The 4 homeopathy drugs were used in the 30C potency and given orally at 2 drops per 5 kg body weight. The clinical evaluation in both groups of dogs was performed by the same investigator throughout the period of study (12 months). All  dogs were clinically scored for oral lesions on days 0, 5, 7, 10, 15, 20, 25, 30, 45, 60, 90, 120, and 150 after initiation of treatment.

The homeopathic treatment group showed early recovery with a significant reduction in oral lesions reflected by a clinical score in comparison to placebo-treated group. Oral papillomatous lesions regressed in the homeopathic group between 7 and 15 days, whereas regression of papilloma in the placebo group occurred between 90 and 150 days. The homeopathic treated group was observed for 12 months post-treatment period and no recurrence of oral papilloma was observed.

The authors concluded that the result of this investigation proves that the combination of homeopathic drugs (Sulfur 30+Thuja 30+Graphites 30+Psorinum 30) offers an attractive, non-invasive and most economical way of treating COP. A combination of homeopathic drugs is a novel approach for treating canine oral papilloma and further studies are needed to elucidate the use of homeopathic combination as a veterinary oncological therapeutics and to explore the mechanism of action of these homeopathic drugs in ameliorating oral papilloma.

The graph says it all. Very rarely is any medical treatment as effective as to produce such impressive results.

So, are we witnessing a scientific sensation?

Is this the breakthrough homeopaths have been waiting for?

Should the Nobel committee be informed?

Perhaps not!

A group size of 8 is underwhelming, to say the least. It is not sufficient to generate a reliable result. The results, even if true, ‘prove‘ nothing other than the authors’ ignorance of research methodology.

The HOMEOPATHY RESEARCH INSTITUTE (HRI) – yes we did discuss its activities before – has just published an ‘update’ on clinical trials of homeopathy. Let me show it to you:

We are pleased to share the results of a recent collaboration with Dr Robert Mathie to update his analysis of randomised controlled trials of homeopathy.

The findings from the 5-year update from 2014-2019 are as follows:

Total number of randomised controlled trials

2014: 189 trials of homeopathic treatment for 100 medical conditions
2019: 221 trials of homeopathic treatment for 115 medical conditions

Placebo-controlled trials only

2014: 104 trials on 63 medical conditions
2019: 129 trials on 77 medical conditions

When considering the balance of positive, negative and inconclusive studies, it is interesting to observe the following shifts in the evidence base for homeopathy over this 5 year period:

Positive trials                Up from 41% to 45%
Negative trials              Down from 5% to 4%
Inconclusive trials        Down from 54% to 51%

__________________________________________________

Impressed?

Me too (but only about the profound ignorance of the HRI)!

One could now point out that the ‘pee counting’ method of reviewing clinical trial evidence is nonsense and leads almost invariably to irrelevant findings. All the positive trials could, for instance, be methodologically invalid, while the negative are rigorous. But this is not even necessary. The triumphant update can be invalidated much more easily.

All we need to do is to remind ourselves of what clinical trials are.

Simply put, they are experiments that test a hypothesis, to be precise, they test the ‘null-hypothesis’: the experimental therapy generates results that are not different from those in the control group. Depending on the data, the null-hypothesis must then be either rejected or accepted by the results of the clinical trial. If it is rejected, the therapy seems to be better than placebo. If it is accepted, the therapy seems to perform just like a placebo.

THERE IS NO SUCH THING AS NEITHER REJECTING NOR ACCEPTING!

The results can not say: “We like the null-hypothesis just as much as we dislike it.” Clinical trials always give a YES or NO answer.

This means the category of ‘inconclusive trials’ is entirely an invention of homeopaths and similar wishful thinkers. In their interpretation, it covers those trials where the null-hypothesis was accepted, while the ‘negative trials’ are studies where the control group had better results than the patients treated homeopathically. But trials that accept the null-hypothesis are negative!

So, what does the HRI’s ‘pee-counting’ update really show?

It reveals that, of the 221 RCTs of homeopathy, 45% are positive, i.e. they suggest that homeopathy was better than the control intervention. That is a sizable percentage, but we might ask how reliable these studies were, what control treatments they employed, and whether they all truly used homeopathy (I know, some used isopathy and some employ homotoxicology, for instance).

The majority of the 221 RCTs, however, are trials where the null-hypothesis had to be accepted. These are the studies failing to show that homeopathy works. In other words, the HRI’s triumphant ‘pee-counting’ update confirms what we have pointed out as nauseam for years:

THE MAJORITY OF THE EVIDENCE ON HOMEOPATHY IS NEGATIVE.

The spread of misinformation has accompanied the coronavirus pandemic, including topics such as immune boosting to prevent COVID-19. This study explores how immune boosting is portrayed on the internet during the COVID-19 pandemic. The researchers compiled a dataset of 227 webpages from Google searches in Canada and the USA using the phrase ‘boost immunity’ AND ‘coronavirus’ on 1 April 2020. They coded webpages for typology and portrayal of immune boosting and supplements. They recorded mentions of microbiome, whether the webpage was selling or advertising an immune boosting product or service, and suggested strategies for boosting immunity.

No significant differences were found between webpages that appeared in the searches in Canada and the USA. The most common types of webpages were from:

  • news (40.5%),
  • commercial (24.7%) websites.

The concept of immune boosting was portrayed as beneficial for avoiding COVID-19 in 85.5% of webpages and supplements were portrayed as beneficial in 40% of the webpages, but commercial sites were more likely to have these portrayals. The top immune boosting strategies were:

  • vitamin C (34.8%),
  • diet (34.4%),
  • sleep (34.4%),
  • exercise (30.8%),
  • zinc (26.9%).

Less than 10% of the webpages provide any critique of the concept of immune boosting.

The authors concluded that pairing evidence-based advice for maintaining one’s health (eg, healthy diet, exercise, sleep) with the phrase immune boosting and strategies lacking in evidence may inadvertently help to legitimise the concept, making it a powerful marketing tool. Results demonstrate how the spread of misinformation is complex and often more subtle than blatant fraudulent claims.

The authors did not search for evidence to check whether any of the named interventions have any influence on the immune system. As reported previously, this review did just that. Its authors aimed to evaluate evidence from clinical trials that studied nutrition-based interventions for viral diseases (with special emphasis on respiratory infections). Studies were considered eligible if they were controlled trials in humans, measuring immunological parameters, on viral and respiratory infections. Clinical trials on vitamins, minerals, nutraceuticals and probiotics were included.

A total 43 studies met the inclusion criteria:

  • vitamins: 13;
  • minerals: 8;
  • nutraceuticals: 18
  • probiotics: 4

Among vitamins, A and D showed a potential benefit, especially in deficient populations. Among trace elements, selenium and zinc have also shown favourable immune-modulatory effects in viral respiratory infections. Several nutraceuticals and probiotics may also have some role in enhancing immune functions. Micronutrients may be beneficial in nutritionally depleted elderly population.

There were 15 studies with a high score for methodological quality. Here is what their results showed:

  1. No significant difference in incidence of winter-time upper respiratory tract infection in children with high versus low dose vitamin D.
  2. Significantly less acute respiratory infections in elderly individuals with vitamin D versus placebo.
  3. Higher TGFbeta plasma level in response to influenza vaccination but no improved antibody response in elderly, vitamin D-deficient individuals with vitamin D versus placebo.
  4. No effect on lower respiratory tract infections; however, a protective effect was noted on upper respiratory tract infections in elderly individuals with vitamin E versus placebo.
  5. Neither daily multivitamin + mineral supplementation at physiological dose nor 200 mg of vitamin E showed a favourable effect on incidence and severity of acute respiratory tract infections in well-nourished, non- institutionalized elderly individuals.
  6. Better improvement in the clinical status, respiratory rate and oxygen saturation in children suffering from pneumonia with zinc sulphate versus placebo.
  7. Selenium-yeast increased Tctx-antibody-dependent cellular cytotoxicity cell counts in blood before flu vaccination + dose-dependent increase in T cell proliferation, IL-8 and IL-10 secretion after in vivo flu challenge in healthy volunteers.
  8. Frequency and duration of acute respiratory infections during the first two months was unaffected in healthy elderly with ginseng versus placebo.
  9. Broccoli sprout homogenate favourably affected immunological variables in healthy volunteers.
  10. The incidence of illness was not reduced, however significantly fewer symptoms were reported and the proliferation index of gd-T cells in culture was almost five times higher after 10 weeks of cranberry polyphenol supplements versus placebo.
  11. Higher antibody titres against all 3 strains contained in the seasonal influenza virus vaccine than the placebo in healthy elderly individuals with a sea-weed extract versus placebo.
  12. Non-inferiority was demonstrated for Echinacea compared to oseltamivir in early treatment of clinically diagnosed and virologically confirmed influenza virus infections.
  13. Significant reduction of cold duration and severity in air travellers with elderberry supplement versus placebo.
  14. Increased NK cell activity with probiotics versus placebo in tube-fed elderly patients.
  15. Titres against the influenza B strain increased significantly more with probiotics compared to placebo in healthy elderly individuals.

 

THE WORLD FOUNDATION OF SCIENCE had been unknown to me, I must admit (I came across it when googling ‘Schuessler salts’). The name does, I suspect, attract many people who search for reliable, science-based information. Its website contains all sorts of amazing articles, for instance:

On the subject of Schuessler salts (also called Tissue salts), their website informs us that:

… Dr. Schüßler found out that functional organ disorders are often caused by a lack of one or more minerals. To treat the disorder, these minerals are supplied in homeopathic potency to stimulate the body to improve the absorption and transport of the mineral in question. In the treatment of colds or to strengthen the immune system, very good results can be achieved with Schuessler salts.

Colds

On the first signs:
Schuessler Salt no. 3 Ferrum phosphoricum D12

For coughs, colds, hoarseness, sore throat, earache:
Schuessler Salt No. 4 Potassium chloratum D6

For persistent colds with yellowish secretions:
Schuessler Salt No. 6 Potassium sulfuricum D6
Schuessler Salt No. 12 Calcium sulfuricum D6

With a fever below 39 degrees Celsius/102.2 degrees Fahrenheit:
Schuessler Salt No. 3 Ferrum phosphoricum D12

With a fever of more than 39 degrees Celsius/102.0 degrees Fahrenheit:
Schuessler Salt No. 5 Potassium phosphoricum D6…

 

I wonder how many patients with persistent cough have followed their advice and taken Schuessler Salt No. 6 Potassium sulfuricum D6 and/or Schuessler Salt No. 12 Calcium sulfuricum D6.

And why not?

I’ll tell you why not: persistent cough can be a sign for corona-virus or other serious infections. And if it’s not due to an infection, it might be due to cancer.

IF YOU HAVE A PERSISTENT COUGH, PLEASE SEE YOUR DOCTOR!

Back to Schuessler salts (I have written about them before here and here). They are a derivative of homeopathy in the sense that they are highly diluted (Schuessler was a German homeopath). But they do not follow the ‘like cures like’ assumption. Many homeopaths are thus indignant, if Schuessler salts get confused with homeopathics. Yet, they shouldn’t be: both Schuessler salts and homeopathics have one important feature in common: they are ineffective.

Some years ago, I published a systematic review of all clinical studies of Schuessler salts (sorry, I cannot find the reference at the moment). That was an easy task, because there are none (one ought to ask why there is not a single trial of Schuessler salts. I suspect the manufacturers do not want one, because they already know the result). This renders the recommendation of the THE WORLD FOUNDATION OF SCIENCE all the more enraging.

I think I will therefore rename this organisation; I shall call it

THE WORLD FOUNDATION OF ANTI-SCIENCE.

Low-level laser therapy has been used clinically to treat musculoskeletal pain; however, there is limited evidence available to support its use. The current Cochrance review fails to be positive: there are insufficient data to draw firm conclusions on the clinical effect of LLLT for low‐back pain. So, perhaps studies on animals generate clearer answers?

The objective of this study was to evaluate the clinical effectiveness of low-level laser therapy and chiropractic care in treating thoracolumbar pain in competitive western performance horses. The subjects included 61 Quarter Horses actively involved in national western performance competitions judged to have back pain. A randomized, clinical trial was conducted by assigning affected horses to either:

  • laser therapy,
  • chiropractic,
  • or combined laser and chiropractic treatment groups.

Low-level laser therapy was applied topically to local sites of back pain. The laser probe contained four 810-nm laser diodes spaced 15-mm apart in a square array that produced a total optical output power of 3 watts. Chiropractic treatment was applied to areas of pain and stiffness within the thoracolumbar and sacral regions. A single application of a high velocity, low-amplitude (HVLA) manual thrust was applied to affected vertebral segments using a reinforced hypothenar contact and a body-centered, body-drop technique. The HVLA thrusts were directed dorsolateral to ventromedial (at a 45° angle to the horizontal plane) with a segmental contact near the spinous process with the goal of increasing extension and lateral bending within the adjacent vertebral segments. If horses did not tolerate the applied chiropractic treatment, then truncal stretching, spinal mobilization, and the use of a springloaded, mechanical-force instrument were used as more conservative forms of manual therapy in these acute back pain patients.

Outcome parameters included a visual analog scale (VAS) of perceived back pain and dysfunction and detailed spinal examinations evaluating pain, muscle tone, and stiffness. Mechanical nociceptive thresholds were measured along the dorsal trunk and values were compared before and after treatment. Repeated measures with post-hoc analysis were used to assess treatment group differences.

Low-level laser therapy, as applied in this study, produced significant reductions in back pain, epaxial muscle hypertonicity, and trunk stiffness. Combined laser therapy and chiropractic care produced similar reductions, with additional significant decreases in the severity of epaxial muscle hypertonicity and trunk stiffness. Chiropractic treatment by itself did not produce any significant changes in back pain, muscle hypertonicity, or trunk stiffness; however, there were improvements in trunk and pelvic flexion reflexes.

The authors concluded that the combination of laser therapy and chiropractic care seemed to provide additive effects in treating back pain and trunk stiffness that were not present with chiropractic treatment alone. The results of this study support the concept that a multimodal approach of laser therapy and chiropractic care is beneficial in treating back pain in horses involved in active competition.

Let me play the devil’s advocate and offer a different conclusion:

These results show that horses are not that different from humans when it comes to responding to treatments. One placebo has a small effect; two placebos generate a little more effects.

I was alerted to an article entitled ‘Energy Medicine: Current Status and Future Perspectives‘ by Christina L Ross, Wake Forest Center for Integrative Medicine, Medical Center Boulevard, Winston-Salem, USA. Dr Ross’ paper , she tells us, was supported by the Wake Forest Center for Integrative Medicine. The Center for Integrative Medicine at Wake Forest School of Medicine aims to expand knowledge of integrative medicine through research and educational opportunities.

The article in question is lengthy yet intriguing. Here, I will present just two short excerpts.

In the abstract, the author concisely explains the nature of energy medicine:

Quantum physics teaches us there is no difference between energy and matter. All systems in the human being, from the atomic to the molecular level, are constantly in motion-creating resonance. This resonance is important to understanding how subtle energy directs and maintains health and wellness in the human being. Energy medicine (EM), whether human touch or device-based, is the use of known subtle energy fields to therapeutically assess and treat energetic imbalances, bringing the body’s systems back to homeostasis (balance).

In the paper itself, the author explains what this means in relation to various SCAM modalities, such as acupuncture:

Acupuncture can be considered an electromagnetic phenomenon due to the ionic charge between 2 acupuncture points. This has been demonstrated by Mussat and others. Acupuncture needles with 1 metal (copper, silver, bronze, or an alloy) for the shaft and another metal for the handle, form tiny batteries. Some acupuncture therapies use additional electrical stimulation (2–4 Hz) applied to the needles. From this electrical perspective, each organ in the body is like a battery housed in a sac of electrolytes, with a positive potential on the surface of the sac that is the aggregate result of electrical processes in the tissues of the organs. The positive potential at the needle tip attracts negatively charged ions from the interstitial medium until a saturation equilibrium is achieved. The normal functions of an organ tend to generate stronger and more harmonic ionic effects than organs with trauma or disease. Acupuncture is considered a wiring system in the body, as is the analog perineural nervous system, and ion transfer within blood plasma. It is difficult to use a voltmeter to measure the voltage in organs because voltages pulse in the body. It is common to use an ohm meter to measure the voltage and convert ohms to volts using Ohm’s law (voltage = ohms × amps).

Table 1 shows frequencies that correspond to organ function. Assuming amperage is constant, then ohms = voltage.

Frequencies Associated With Normal Organ Function.

Organ Frequency (MHz)
Brain 70–78
Thyroid 62–68
Lungs 58–65
Thymus 65–68
Heart 67–70
Spleen 60–80
Liver 55–60
Stomach 58–65
Colon 70–78

______________________________

Is that what the Wake Forest School of Medicine considers to be ‘expanding knowledge … through research and educational opportunities’ ? Where is the actual research that backs up any of the weird claims made above? Is it truly knowledge that is being expanded here … or is it perhaps total, utter BS?

A study from the US found that belief in conspiracy theories is rife in health care. The investigators presented people with 6 different conspiracy theories, and the one that was most widely believed was the following:

THE FOOD AND DRUG ADMINISTRATION IS DELIBERATELY PREVENTING THE PUBLIC FROM GETTING NATURAL CURES FOR CANCER AND OTHER DISEASES BECAUSE OF PRESSURE FROM DRUG COMPANIES.

A total of 37% agreed with this statement, 31% had no opinion on the matter, and just 32% disagreed. What is more, the belief in this particular conspiracy correlated positively with the usage of alternative medicine.

The current popularity of so-called alternative medicine (SCAM) is at least partly driven by the conviction that there is a sinister plot by the FDA or more generally speaking ‘the establishment’ that prevents people from benefitting from the wonders of SCAM.

But where do those conspiracy theories come from?

How do they evolve?

A new article investigates these questions. Here is its abstract:

Although conspiracy theories are endorsed by about half the population and occasionally turn out to be true, they are more typically false beliefs that, by definition, have a paranoid theme. Consequently, psychological research to date has focused on determining whether there are traits that account for belief in conspiracy theories (BCT) within a deficit model. Alternatively, a two-component, socio-epistemic model of BCT is proposed that seeks to account for the ubiquity of conspiracy theories, their variance along a continuum, and the inconsistency of research findings likening them to psychopathology. Within this model, epistemic mistrust is the core component underlying conspiracist ideation that manifests as the rejection of authoritative information, focuses the specificity of conspiracy theory beliefs, and can sometimes be understood as a sociocultural response to breaches of trust, inequities of power, and existing racial prejudices. Once voices of authority are negated due to mistrust, the resulting epistemic vacuum can send individuals “down the rabbit hole” looking for answers where they are vulnerable to the biased processing of information and misinformation within an increasingly “post-truth” world. The two-component, socio-epistemic model of BCT argues for mitigation strategies that address both mistrust and misinformation processing, with interventions for individuals, institutions of authority, and society as a whole.

This makes a lot of sense to me, and it seems to apply well to the BCT in SCAM.

To mitigate BCT, the authors advocate asking:

  • Who do you trust or mistrust and why?
  • How do you decide what to believe?

Effective mitigation strategies, they state, may necessitate wholescale approaches that:

  1. confer resistance against BCT by utilizing inoculation strategies that counter misinformation where it occurs (e.g. online),
  2. teach analytic thinking within educational systems at an early age,
  3. restructure or otherwise impose restrictions on the digital architectures that distribute information in order to label or curb misinformation and promote “technocognition”.

These are no small challenges, and I am proud to say that, in the realm of SCAM, I am doing what I can to tackle them.

THE FIRST WORLDWIDE MANIFESTO AGAINST PSEUDOSCIENCE

2750 signatories from 44 countries have signed it [I was number 11] and today is its official launch. I am delighted to present to you the full text of the English version:

 

Let’s be clear: pseudoscience kills. And they are being used with total impunity thanks to European
laws that protect them.
They kill thousands of people, with names and families. People such as Francesco Bonifaz, a 7-yearold boy whose doctor prescribed homeopathy instead of antibiotics. He died in Italy [1]. People like Mario Rodríguez, who was 21 years old and was told to use vitamins to treat his cancer. He died in Spain [2]. People like Jacqueline Alderslade, a 55-year-old woman whose homeopath told her to stop taking her asthma medication. She died in Ireland [3]. People like Cameron Ayres, a 6-month-old baby, whose parents did not want to give their child “scientific medicine”. He died in England [4]. People like Victoria Waymouth, a 57-year-old woman who was prescribed a homeopathic medication to treat her heart problem. She died in France [5]. People like Sofia Balyaykina, a 25-year-old woman, who had a cancer that was curable with chemotherapy but was recommended an “alternative treatment”, a mosquito bite treatment. She died in Russia [6]. People like Erling Møllehave, a 71-year-old man whose acupuncturist pierced and damaged his lung with a needle. He died in Denmark [7]. People like Michaela Jakubczyk-Eckert, a 40-year-old-woman whose therapist recommended the German NewMedicine to treat her breast cancer. She died in Germany [8]. People like Sylvia Millecam, a 45-year-old woman whose New Age healer promised to cure her cancer. She died in the Netherlands [9].

European directive 2001/83/CE has made –and still makes— possible the daily deception of thousands of hundreds of European citizens [10]. Influential lobbyists have been given the opportunity to redefine what a medicine is, and now they are selling sugar to sick people and making them believe it can cure them or improve their health. This has caused deaths and will continue to do so until Europe admits an undeniable truth: scientific knowledge cannot yield to economic interests, especially when it means deceiving patients and violating their rights.

Europe is facing very serious problems regarding public health. Overmedication, multi-resistant bacteria and the financial issues of the public systems are already grave enough, without the additional problem of gurus, fake doctors or even qualified doctors claiming they can cure any disease by manipulating chakras, making people eat sugar or using “quantic frequencies”. Europe must not only stop the promotion of homeopathy but also actively fight to eradicate public health scams. More than 150 pseudo-therapies have been identified as being in use throughout Europe. Thousands of citizens lives depend on this being prevented. In fact, according to a recent research, 25.9 % of Europeans have used pseudo-therapies last year. In other words, 192 million patients have been deceived [11].

Some believe there is a conflict between freedom of choice for a treatment and the removal of pseudo-therapies, but this is not true. According to article 25 of the Universal Declaration of Human Rights, every person has a right to medical care. Lying to patients in order to sell them useless products that could kill them breaks their right to correct information about their health. This way, even if a citizen has a right to refuse medical treatment when he or she is properly informed, it is also true that nobody has the right to lie to obtain profit at the expense of someone else’s life. Only in a world in which lying to a sick person would be considered ethical, could homeopathy —or any other pseudo-therapy— be allowed to continue to be sold to citizens.

Effective treatments being replaced by false ones is not the only danger of pseudo-therapies. Obvious delays in therapeutic care occur when a person gets false products instead of medication at the early stages of a disease. Many times, it is then too late by the time they get treated with proper medicine. Moreover, several of these practices have serious effects on their own and may cause damage or even death because of their side effects.

Many pseudo-therapists argue that “the other medicine” comes with side effects as well, which is indeed true. However, the difference resides in that pseudo-therapies cannot cure a disease or improve your health, and because of that patients assume risks in exchange of promises that are a scam, according to the full weight of the scientific evidence available. Lying to a sick person is not another type of medicine, it is simply lying to a sick person.
Every country has to face the pseudo-therapies issue in its own ways. Yet it is not acceptable that European laws protect the distortion of scientific facts so that thousands of citizens can be deceived or even lead to their deaths.

We, the signatories of this manifest, therefore declare that:

1. Scientific knowledge is incompatible with what pseudo-therapies postulate, as in the case
of homeopathy.
2. European laws that protect homeopathy are not acceptable in a scientific and technological
society that respects the right of the patients not to be deceived.
3. Homeopathy is the best known pseudo-therapy, but it is not the only one nor the most
dangerous one. Others, such as acupuncture, reiki, German New Medicine, iridology,
biomagnetism, orthomolecular therapy and many more, are gaining ground and causing
victims.
4. Measures must be taken to stop pseudo-therapies, since they are harmful and result in
thousands of people being adversely affected.
5. Europe needs to work towards creating legislation that will help stop this problem.

Europe being concerned about the misinformation phenomena but at the same time protecting one the most dangerous types of it, health misinformation, is just not coherent. This is why the people signing this manifesto urge the governments of European countries to end a problem in which the name of science is being used falsely and which has already cost too many lives.

 

[1] Homeopathy boy died of encephalitis. Redazione ANSA, 2017.
http://www.ansa.it/english/news/general_news/2017/05/29/homeopathy-boy-died-of-encephalitis-3_13e02493-
4e62-4787-9162-12d831121ef6.html
[2] Grieving dad sues over ‘cure cancer with vitamins’ therapy, The local. Emma Anderson, 2016.
https://www.thelocal.es/20160412/grieving-father-sues-naturopath-over-son-cure-cancer-vitamins-leukaemia
[3] Asthmatic ‘told to give up drugs’. The Irish News, 2001.
https://www.independent.ie/irish-news/asthmatic-told-to-give-up-drugs-26063764.html
[4] Homeopaths warn of further tragèdies. BBC News, 2000.
http://news.bbc.co.uk/2/hi/health/702699.stm
[5] Alternative cure doctor suspended. BBC News, 2007.
http://news.bbc.co.uk/2/hi/uk_news/england/london/6255356.stm
[6] Футболист рассказал трагичную историю жены. Она умерла от рака в 25 лет. Sport24, 2018.
https://sport24.ru/news/football/2018-08-28-futbolist-rasskazal-tragichnuyu-istoriyu-zheny-ona-umerla-ot-raka-v-25-let
[7] Mand døde efter akupunktur – enke vil nu lægge sag an mod behandleren, TV2, 2018.
http://nyheder.tv2.dk/samfund/2018-01-23-mand-doede-efter-akupunktur-enke-vil-nu-laegge-sag-an-modbehandleren

[8] The price of refusing science-based medical and surgical therapy in breast càncer, Science Blogs, 2012.
https://scienceblogs.com/insolence/2012/08/30/the-price-of-refusing-science-based-medical-and-surgical-therapy-inbreast-cancer
[9] Psychic ‘misled actress to hopeless cancer death’. Expatica. 2004.
http://web.archive.org/web/20070208144309/http://www.expatica.com/actual/article.asp?subchannel_i
d=19&story_id=4821
[10] Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001.
https://ec.europa.eu/health/sites/health/files/files/eudralex/vol1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf
[11] Use of complementary and alternative medicine in Europe: Health-related and sociodemographic
determinants. Scandinavian Journal of Public Health. Laura M. Kemppainen et al. 2018.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5989251/

The aim of this RCT was to examine symptom responses resulting from a home-based reflexology intervention delivered by a friend/family caregiver to women with advanced breast cancer undergoing chemotherapy, targeted, and/or hormonal therapy.

Patient-caregiver dyads (N = 256) were randomized to 4 weekly reflexology sessions or attention control. Caregivers in the intervention group were trained by a reflexology practitioner in a 30-min protocol. During the 4 weeks, both groups completed telephone symptom assessments using the M. D. Anderson Symptom Inventory. Those who completed at least one weekly call were included in this secondary analysis (N = 209). Each symptom was categorized as mild, moderate, or severe using established interference-based cut-points. Symptom response meant an improvement by at least one category or remaining mild. Symptom responses were treated as multiple events within patients and analysed using generalized estimating equations technique.

Reflexology was more successful than attention control in producing responses for pain with no significant differences for other symptoms. In the reflexology group, greater probability of response across all symptoms was associated with lower number of comorbid condition and lower depressive symptomatology at baseline. Compared to odds of responses on pain (chosen as a referent symptom), greater odds of symptom response were found for disturbed sleep and difficulty remembering with older aged participants.

Adjusted odds ratios (ORs) of symptom responses for reflexology arm versus control (adjusted for age, number of comorbid conditions, depressive symptoms at baseline, and treatment type: chemotherapy with or without hormonal therapy versus hormonal therapy alone)
Symptom                                 OR      (95% CI)        p value
Fatigue                                    1.76      (0.99, 3.12)       0.06
Pain                                         1.84      (1.05, 3.23)       0.03
Disturbed sleep                         1.45      (0.76, 2.77)       0.26
Shortness of breath                   0.58      (0.26, 1.30)       0.19
Remembering                           0.96      (0.51, 1.78)       0.89
Lack of appetite                        1.05      (0.45, 2.49)       0.91
Dry mouth                               1.84      (0.86, 3.94)       0.12
Numbness and tingling              1.40     (0.75, 2.64)        0.29
Depression                              1.38      (0.78, 2.43)       0.27

The authors concluded that home-based caregiver-delivered reflexology was helpful in decreasing patient-reported pain. Age, comorbid conditions, and depression are potentially important tailoring factors for future research and can be used to identify patients who may benefit from reflexology.

This is certainly one of the more rigorous studies of reflexology. It is well designed and reported. How valid are its findings? To a large degree, this seems to depend on the somewhat unusual statistical approach the investigators employed:

Baseline characteristics were summarized by study group for outcome values and potential covariates. The unit of analysis was patient symptom; multiple symptoms were treated as nested within the patient being analyzed, using methodology described by Given et al. [24] and Sikorskii et al. [17]. Patient symptom responses were treated as multiple events, and associations among responses to multiple symptoms within patients were accounted for by specifying the exchangeable correlation structure in the generalized estimating equations (GEE) model. The GEE model was fitted using the GENMOD procedure in SAS 9.4 [25]. A dummy symptom variable with 9 levels was included in the interaction with the trial arm to differentiate potentially different effects of reflexology on different symptoms. Patient-level covariates included age, number of comorbid conditions, type of treatment (chemotherapy or targeted therapy with or without
hormonal therapy versus hormonal therapy only), and the CES-D score at baseline. Odds ratios (ORs) and their 95% confidence intervals (CIs) were obtained for the essential parameter of study group for each symptom.

Another concern is the fact that the study crucially depended on the reliability of the 256 carers. It is conceivable, even likely, I think, that many carers from both groups were less than strict in adhering to the prescribed protocol. This might have distorted the results in either direction.

Finally, the study was unable to control for the possibly substantial placebo response that a reflexology massage unquestionably provokes. Therefore, we are not able to tell whether the observed effect is due to the agreeable, non-specific effects of touch and foot massages, or to the postulated specific effects of reflexology.

The objective of this RCT was to compare the effects of

  • spinal thrust-manipulation + electrical dry needling + various medications (TMEDN-group)
  • to non-thrust peripheral joint/soft-tissue mobilization + exercise + interferential current + various medications(NTMEX-group)

on pain and disability in patients with subacromial pain syndrome (SAPS).

Patients with SAPS were randomized into the TMEDN group (n=73) or the NTMEX group (n=72). Primary outcomes included the shoulder pain and disability index (SPADI) and the numeric pain rating scale (NPRS). Secondary outcomes included Global Rating of Change (GROC) and medication intake. The treatment period was 6 weeks; with follow-up at 2 weeks, 4 weeks, and 3 months.

At 3 months, the TMEDN group experienced significantly greater reductions in shoulder pain and disability compared to the NTMEX group. Effect sizes were large in favour of the TMEDN group. At 3 months, a greater proportion of patients within the TMEDN group achieved a successful outcome (GROC≥+5) and stopped taking medication.

The authors concluded that cervicothoracic and upper rib thrust-manipulation combined with electrical dry needling resulted in greater reductions in pain, disability and medication intake than non-thrust peripheral joint/soft-tissue mobilization, exercise and interferential current in patients with SAPS. These effects were maintained at 3 months.

The authors of this trial have impressive looking affiliations:

  • American Academy of Manipulative Therapy Fellowship in Orthopaedic Manual Physical Therapy, Montgomery, AL.
  • Montgomery Osteopractic Physiotherapy & Acupuncture Clinic, Montgomery, AL.
  • Research Physical Therapy Specialists, Columbia, SC.
  • Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Alcorcón, Spain.
  • Cátedra de Clínica, Investigación y Docencia en Fisioterapia: Terapia Manual, Punción Seca y Ejercicio, Universidad Rey Juan Carlos, Alcorcón, Madrid, Spain.
  • Copper Queen Community Hospital, Bisbee, AZ.
  • BenchMark Physical Therapy, Atlanta, GA.
  • Eastside Medical Care Center, El Paso, TX.
  • Department of Physical Therapy, Georgia State University, Atlanta, GA.
  • Tybee Wellness & Osteopractic, Tybee Island, Georgia, GA.

If one expected a well-designed study from all this collective expertise, one would have been disappointed.

Any such clinical trial should be answering a simple question: is therapy XX effective? It is about pinning an observed effect on to a treatment. It is about establishing cause and effect. It is about finding an answer to a clinically relevant question.

The above study does none of that. Even if we accepted its result as valid, it could be interpreted as meaning one of many different things, for instance:

  1. Acupuncture was effective.
  2. Dry needling was effective.
  3. The electrical current was effective.
  4. Mobilisation made things worse.
  5. Exercise made things worse.
  6. one or multiple positive or negative interactions between the therapies.
  7. The drugs in the experimental group were more effective than those taken by controls.
  8. The experimental group adhered to their drug prescriptions better than controls.
  9. Any mixture of the above.

So, the reader of this paper can chose which of the interpretations he or she prefers. I suggest that:

  • Any researcher who designs a foreseeably nonsensical trial should go back to school.
  • Any ethics committee that passes such a study needs to retire.
  • Any funder who gives money for it wastes scarce resources.
  • Any reviewer who recommends publication needs to learn about trial design.
  • Any editor who publishes such a trial needs to go.

The point I am trying to make is that conducting a clinical trial comes with responsibilities. Poorly designed studies are not just a waste of resources, they are a disservice to patients, they undermine the public’s trust in science and they are unethical.

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