Edzard Ernst

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

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?

There are many others who are much better placed to write about Randi who passed away on 20 October 2020. I only met him a few times and therefore cannot claim that I knew him well. Yet, I admired him, and he was one of my heroes. In that, I am certainly not alone; sceptics all over the world worshipped James Randi.

I will not attempt to do justice to his incredible legacy. I will merely try to offer my personal respects to a truly great man. I heard of JR first when he was recruited by the editor of Nature, John Maddox, to check out Benveniste’s lab and try to reproduce his surprising results on an in-vitro model of homeopathy. At the time, I thought this was a weird idea, but when I read up about JR’s background, it seemed a smart move. When he then identified the error in Benveniste’s work, I was not surprised. Randi had the gift of a sharp intellect, a detective and a arch sceptic.

Many years later, in 2008, I decided to edit a multi-author book entitled HEALING, HYPE OR HARM, and I invited JR to contribute a chapter. I felt honoured when he accepted the offer and sent me his chapter ‘AN AMATEUR’S VIEW OF THE SCAM SCENE’. In classical JR-style, it opened with the sentence: At the outset, let me make one thing perfectly clear: my qualifications concerning this subject, alternative/complementary medicine, here referred to as CAM, consist mostly of common sense, a wide-ranging experience of flimflam, and extensive exposure to a great variety of scam artists. After that, I received Christmas cards from him every year.

Eventually, I did meet JR in person. This was around 2010 on the occasion of sceptics meetings in New Orleans and Berlin. I introduced myself to him, he looked at me intensely, shook my hand and said: “Ahh, that’s you!”, and we had a little chat. By that time JR had become quite frail; his health was visibly in decline. This, however, did not stop him to remain active, influecial and inspirational; it seemed that JR was unstoppable.

His decades of achievements are perhaps best summarised by the hist of honours and awards bestowed on him. The list below is from his Wiki page:

Year Award or honor
1977 Visiting Magician of the Year, Academy of Magical Arts & Sciences at the Magic Castle in Hollywood.[158]
1978 Garden State Magicians’ award.[158]
1981 Asteroid 3163 Randi was named after James Randi,[159] who had always been an active amateur observer. His friend Carl Sagan encouraged his interest.[18]
Certificate of appreciation at the MIT Club of Boston.[158]
Designated Grand Master of Magic by Hocus Pocus Magazine.[158]
1983 Blackstone Cup, International Platform Association as Outstanding Speaker (won again in 1987).[158]
1984 Honorary membership, Bay Surgical Society of Los Angeles.[158]
1986 A $273,000 MacArthur Foundation Fellowship was awarded to James Randi for his investigations of the claims of Uri Geller and TV “faith healers[160]
Honorary membership, Israeli Society for Promoting the Art of Magic.[158]
1987 Special fellowship, Academy of Magical Arts & Sciences in Los Angeles.[158]
Certificate of Appreciation, Ring 254 of the International Brotherhood of Magicians.[158]
Award of Merit, Assembly 22 of the Society of American Magicians.[158]
1988 National Consumer Service Award, National Council Against Health Fraud.[158]
International Ambassador of Magic, Society of American Magicians.[158]
1989 Joseph A. Burton Forum Award, American Physical Society.[161]
Gold Medal, University of Ghent.[158]
1990 Humanist Distinguished Service Award, American Humanist Association.[158]
Thomas Paine Award, Baton Rouge Proponents of Rational Inquiry & Scientific Methods.[158]
1992 Commemorative Medal with Golden Wreath, Hungarian Society for the Dissemination of Scientific Knowledge.[158]
1996 Distinguished Skeptic Award, Committee for Skeptical Inquiry (CSICOP).[158][162]
1997 Lifetime Achievement Award, International Brotherhood of Magicians.[158]
“One of the 100 Best People in the World, people who make our lives richer or larger or happier,” Esquire magazine.[158]
Award, Science & Engineering Society of the National Security Agency.[158]
1999 “In Defense of Reason” Special Lifetime Achievement Award, Comitato Italiano per il Controllo dell Affermazioni sui Paranormale.[158]
2000 Distinguished Lecturer Award, Nova Southeastern University.[158]
2002 Presidential Citation, International Brotherhood of Magicians.[158]
2003 First Richard Dawkins Award.[30]
2007 Philip J. Klass Award.[163]
2008 Lifetime Achievement Award, Independent Investigations Group (IIG). Previous recipients Carl Sagan and Harry Houdini.[158][164]
2009 In Praise of Reason Award, Committee for Skeptical Inquiry.[158]
2010 Elected a Committee for Skeptical Inquiry Fellow.[165]
2012 Lifetime Achievement Fellowship, Academy of Magical Arts.[166]
Lifetime Achievement Award, American Humanist Association.[167]
2016 Heinz Oberhummer Award, 2016[168]
Lifetime Achievement Award, Humanist Association of Canada.[169]
James Randi is one of very few members of the UK Magic Circle to be granted their highest order: Member of the Inner Magic Circle With Gold Star (MIMC).

Randi finished the book chapter in my book with the following remark: … several aquaintances have described my work as being anti-Darwinian, in that it interfers with the natural selection process with which we are so familiar. I will leave you to ponder on that matter.

Now he has left us, and sceptics around the world will miss him dearly.

The new kid on the SCAM block seems to be hydrogen-rich water (HRW). It is pure water infused with hydrogen molecules and can be purchased in pouches and cans or made at home using special, commercially available devices. Health writers and entrepreneurs have been everything but timid in publishing claims about HRW. This is from one of thousands of sites promoting it:

1. Antioxidant And Anti-inflammatory Properties

Studies show that consuming hydrogen-rich water for a few weeks at a time can reduce reactive oxygen metabolites (ROMs) in the bloodstream, which can damage cells while sustaining blood oxidation levels needed to ensure health. The result is a reduction in and inflammation, which effectively reduces cell damage and leads to an improved quality of life. Decreased oxidative stress is also a valuable factor which helps prevent metabolic syndrome and soften the impact of neurodegenerative disease. Hydrogen-rich water, through its power to combat oxidative stress, is a promising remedy for these and other diseases. Its anti-inflammatory properties are already used to treat rheumatoid arthritis, one of the most prominent and debilitating conditions caused by high levels of inflammation in the body.

2. May Treat And Prevent Metabolic Syndrome

Metabolic syndrome, which includes obesity, high cholesterol, high blood pressure, and often causes a range of cardiovascular illnesses, is a rapidly growing problem among American adults. Early studies show that hydrogen-rich water health benefits include staving off metabolic syndrome and reversing negative metabolic symptoms because of its ability to reverse the effects of oxidative stress on the body. In fact, studies have shown that consuming hydrogen-rich water decreases the “bad” cholesterol, also known as serum-LDL cholesterol while improving HDL function — the “good” cholesterol.  This effect, in turn, prevents against the development of a number of debilitating cardiovascular issues.

3. Slows The Development Of Neurodegenerative Diseases

By fighting in important brain tissues, hydrogen-rich water fights a key cause of conditions like Parkinson’s disease and , both of which feature cognitive and behavioral impairment and decline. Because it consumes a high level of oxygen, the brain is prone to oxidative stress. Hydrogen-rich water elicits effects in the brain that counter the ability of oxidative stress to kill dopamine cells and damage proteins that maintain cognitive functioning. When used daily by patients of Alzheimer’s, hydrogen-rich water has been shown to restore neural proliferation, thereby inhibiting cognitive decline. Especially promising is the demonstrated ability of H2-rich water consumption to combat cognitive impairment even in its latest stages and to alleviate the harm of brain injury — again, because of its ability to ameliorate oxidative stress on brain tissue. In fact, some researchers recommend daily consumption of hydrogen-rich water as a long-term preventative treatment against dementia and neurodegenerative disease and as a part of a recovery program for brain injury from stroke or surgery.

4. May Treat And Prevent Insulin Resistance And Type 2 Diabetes

Recent studies demonstrate that hydrogen-rich water health benefits include having a normalizing effect on glucose in the body. In combination with powerful antioxidant properties, hydrogen-rich water improves insulin circulation and sensitivity, while also increasing levels of certain compounds that build insulin resistance. The end product is improved glucose metabolism, which can both prevent and slow the development of Type 2 Diabetes Mellitus and insulin resistance.

5. Improves Dental Health

As shown above, oxidative stress causes a number of ailments. One of the most common is dental decay. Fortunately, consuming hydrogen-rich water has been proven to treat conditions associated with dental deterioration, such as periodontal disease, because of its ability to fight oxidative stress, in addition to its effective anti-inflammatory properties. Drinking water containing molecular hydrogen targets periodontal disease at the source by suppressing inflammation in the oral tissue.  Hydrogen-rich water also prevents age-related oxidative damage to oral tissue, thereby offsetting dental decay.

6. Combats Muscle Fatigue

One compelling study of male soccer players found that, by consuming hydrogen-rich water before exercise, these athletes could reduce blood lactate levels and improve muscle function during exercise. After exercise, these athletes experienced lower levels of muscle fatigue and were able to recover faster. Because it also treats exercise-induced dehydration, hydrogen-rich water is a promising remedy for athletes. According to Biethan, “more and more athletes are picking up on it” to improve their athletic performance and recovery.

And how does HRW work? What is its mode of action? Nobody seems to know! During the last months, there have been several controlled clinical trials of HRW. Regardless of what condition they address, they all arrived at positive conclusions:

  1. In conclusion, these results suggest that supplementation with hydrogen-rich water may have a beneficial role in prevention of T2DM and insulin resistance.
  2. HRW significantly attenuates oxidative stress in CHB patients, but further study with long-term treatment is required to confirm the effect of HRW on liver function and HBV DNA level.
  3. Two weeks of HRW intake may help to maintain PPO in repetitive sprints to exhaustion over 30 minutes.
  4. Thus, hydrogen-rich water appeared to alleviate the mFOLFOX6-related liver injury.
  5. appears that orally administered H2 as a blend of hydrogen-generating minerals might be a beneficial agent in the management of body composition and insulin resistance in obesity.
  6. Although preliminary, the results of this trial perhaps nominate HRW as an adjuvant treatment for mild-to-moderate NAFLD. These observations provide a rationale for further clinical trials to establish safety and efficacy of molecular hydrogen in NAFLD.
  7. To conclude, acute pre-exercise supplementation with HRW reduced blood lactate at higher exercise intensities, improved exercise-induced perception of effort, and ventilatory efficiency.

Aprart from producing uniformly positive results, these studies have another common feature: they are methodologically flimsy. Probably the most rigorous trial of HRW was published earlier this year. Perhaps it is worth having a look at it:

An international team of researchers conducted a randomized, double-blinded, placebo-controlled trial in 60 subjects (30 men and 30 women) with metabolic syndrome. An initial observation period of one week was used to acquire baseline clinical data followed by randomization to either placebo or high-concentration HRW (> 5.5 millimoles of H2 per day) for 24 weeks.

High-concentration HRW was prepared via hydrogen-producing tablets (HRW Natural Health Products Inc., New Westminster BC, Canada) while the placebo was prepared as a placebo drink similar in taste, dissolution, and appearance to HRW. Placebo capsules, also donated by HRW Natural Health Products Inc. (New Westminster, BC, Canada), contained identical ingredients to the hydrogen supplement, but instead of metallic magnesium the placebo contained various forms of magnesium salts (i.e. tartrate, malate, chloride) and similar organic acids to prevent any pH buffering effect from the conjugate bases of the alkaline salts.

The participants consumed 1 tablet 3 x daily in 250 mL of 12-18°C water. They were advised to drink the product in one gulp as soon as the tablet finished dissolving on an empty stomach/morning. This method of H2 administration would provide >5.5 millimoles H2/day.

Supplementation with high-concentration HRW significantly reduced blood cholesterol and glucose levels, attenuated serum haemoglobin A1c, and improved biomarkers of inflammation and redox homeostasis as compared to placebo. Furthermore, H2 tended to promote a mild reduction in body mass index and waist-to-hip ratio.

The authors concluded that the results from our study suggest that supplementation with high-concentration HRW produced via H2-producing tablets improves body composition, favorably modulates fatty acid and glucose metabolism, and improves inflammation and redox homeostasis in subjects with metabolic syndrome. Therefore, long-term treatment with high-concentration hydrogen-rich water may be used as an adjuvant therapy to decrease the features of metabolic syndrome. However, a larger prospective clinical trial is warranted to further determine the biological effects of HRW in this subject population.

The authors of this study, which was conducted in Moradabad India and supported by Slovak Research and Development Agency; Scientific grant agency of the Ministry of Education of the Slovak Republic, and by HRW Natural Health Products Inc., have the following affiliations:

  • Centre of Experimental Medicine, Institute for Heart Research, Slovak Academy of Sciences, Bratislava, Slovak Republic.
  • Molecular Hydrogen Institute, Enoch, UT, USA.
  • Hospital and Research Institute, Moradabad, India.
  • Era Medical College, Lucknow, India.
  • Applied Bioenergetics Lab, Faculty of Sport and PE, University of Novi Sad, Novi Sad, Serbia.
  • Faculty of Health Sciences, University of Pécs, Pécs, Hungary.
  • Medical Faculty, Pharmacobiochemical Laboratory of 3rd Medical Department, Comenius University Bratislava, Bratislava, Slovakia.
  • Laboratory of Pathophysiology, Graduate School of Pharmaceutical Sciences, Kyushu University, Fukuoka, Japan.
  • Third Internal Clinic, Faculty of Medicine, Comenius University, Bratislava, Slovakia.
  • Center of Nutrition Research, International College of Nutrition, Moradabad, India.

In the last two years, the 1st author of this new trial has published over a dozen expeimental papers on HRW; all of them report positive findings. Whenever I see a treatment that never fails to produce positive results, regardless of the conditions it is applied to, I start asking myself, are these findings not too good to be true?

Am I the only one to smell a rat?

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.

I want to thank our friend ‘OLD BOB’ for alerting me to Patrick Holford’s comment on a recent trial of vitamin C for COVID-19. Here are three short quotes from Holford:

… Overall, 5 out 26 people (19%) died in the vitamin C group while 10 out of 28 (36%) receiving the placebo died. That means that vitamin C almost halved the number of deaths. Those on vitamin C were 60% more likely to survive.

… Of those most critically ill, 4 people (18%) in the vitamin C group died, compared to 10 (50%) in the placebo group. That’s two-thirds less deaths. Statistically this meant that of those most critically ill who were given vitamin C, they were 80% less likely to die…

… now there is another proven treatment – vitamin C…

And here is the abstract of the actual trial Holford refers to:

Background: No specific medication has been proven effective for the treatment of patients with severe coronavirus disease 2019 (COVID-19). Here, we tested whether high-dose vitamin C infusion was effective for severe COVID-19.

Methods: This randomized, controlled, clinical trial was performed at 3 hospitals in Hubei, China. Patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the ICU were randomly assigned in as 1:1 ratio to either the high-dose intravenous vitamin C (HDIVC) or the placebo. HDIVC group received 12 g of vitamin C/50 ml every 12 hours for 7 days at a rate of 12 ml/hour, and the placebo group received bacteriostatic water for injection in the same way. The primary outcome was invasive mechanical ventilation-free days in 28 days(IMVFD28). Secondary outcomes were 28-day mortality, organ failure, and inflammation progression.

Results: Only fifty-six critical COVID-19 patients were ultimately recruited due to the early control of the outbreak. There was no difference in IMVFD28 between two groups. During the 7-day treatment period, patients in the HDIVC group had a steady rise in the PaO2/FiO2 (day 7: 229 vs. 151 mmHg, 95% CI 33 to 122, P=0.01). Patients with SOFA scores ≥3 in the HDIVC group exhibited a trend of reduction in 28-day mortality (P=0.06) in univariate survival analysis. IL-6 in the HDIVC) group was lower than that in the placebo group (19.42 vs. 158.00; 95% CI -301.72 to -29.79; P=0.04) on day 7.

Conclusion: This pilot trial showed that HDIVC might show a potential signal of benefit for critically ill patients with COVID-19, improving oxygenation even though it failed to improve IMVFD28.

The following points are, I think, worth mentioning:

  • This was, according to its authors, a PILOT study.
  • It was far too small (n=56) to provide reliable results on mortality.
  • The trial authors know that and interpret their findings with sufficient caution.
  • The primary endpoint, the IMVFD28, showed NO significant difference between the groups.
  • The secondary endpoint: HDIVC infusion exhibited a non-significant trend of reduction in 28-day mortality (P=0.06).
  • In more severe patients (SOFA score ≥3), univariate survival analysis and Cox regression showed a similar results (P=0.07, HR, 0.32 [95% CI 0.10-1.06]).

And what does all of this mean? It means that, in this pilot study, vitamin C failed to produce a significant result. Only in a subgroup analysis related to a secondary endpoint was there a slight advantage of vitamin C. This effect is, of course, interesting and needs further investigation (I am sure that is happening as we speak). It could have some clinical significance but, just as likely, it could just be due to chance. There is not way of knowing which is which.

In other words, to hype the findings and to even make statements such as ‘now there is another proven treatment, vitamin C’ is not just exaggerated, it is irresponsible.

This begs the question: why does Mr Holford do it? In case you don’t already know about this man, go on the Internet, and you will quickly find possible answers. Here is an excerpt from his Wiki page which might give you a clue:

Patrick Holford is a British author and entrepreneur who endorses a range of controversial vitamin tablets. As an advocate of alternative nutrition and diet methods, he appears regularly on television and radio in the UK and abroad. He has 36 books in print in 29 languages. His business career promotes a wide variety of alternative medical approaches such as orthomolecular medicine, many of which are considered pseudoscientific by mainstream science and medicine.

Holford’s claims about HIV and autism are not in line with modern medical thought, and have been criticised for putting people in danger and damaging public health.

In 2006 Holford was discovered to be using his PR advisor to delete critical content from his Wikipedia page…

Holford has been the subject of criticism for his promotion of medically dubious techniques and products including hair analysis, his support of the now struck off doctor Andrew Wakefield, and advocating the use of “non-drug alternatives for mental health” for which he has been given an award by the Church of Scientology-backed Citizens Commission on Human Rights.

SAY NO MORE!

It is today exactly 8 years that I am writing this blog. To mark the occasion, I am trying to write my shortest post ever. It focusses on a question that has often occupied my mind and rarely leaves the comments sections of this blog: What makes a healthcare professional use a bogus SCAM therapy? Think, for instance, of any practitioner of homeopathy. What makes him or her tick? Why does (s)he practice homeopathy and not real medicine? After years of thinking about it, the answer turns out to be really quite simple. There are only three possibilities:

Practitioners who employ disproven treatments either

try to con you

or

they have been conned themselves

or

both.

________________________

Think of it, there is no other explanation!

If, however, you do know of another one, please let me know.

AND THANKS FOR MAKING THIS BLOG A SUCCESS.

 

 

I came across the following fascinating advertisement:
Post: Chief Operating Officer
Location: London office
(at least one day per week) and home/office based the rest of the time
Salary: £48,000 – £53,600
Contract Type: Permanent
Hours: 30 hours (flexible, but ideally over 4 days)
This is a fantastic opportunity to join the Faculty of Homeopathy; one of the world’s leading homeopathic membership organisations. The Faculty of Homeopathy is honoured to have HRH The Prince of Wales as its Patron.
We are looking for a strategic operational leader to work with the Executive Council and our Members to increase the Faculty’s presence on the world stage. The Faculty of Homeopathy is 176 years old; and has a rich and impressive history. Do you have the skills and enthusiasm to help us write the next chapter? If so, we would be delighted to hear from you.
Key Responsibilities:
* Providing leadership, management, and vision to help grow the membership
* Overseeing all day-to-day operations
* Responsible for external communications, including PR
* Writing bid or grant applications, and/or fundraising
* Brand ambassador for the Faculty of Homeopathy
Experience:
* Strong leadership and motivational skills
* Proven track record in income generation
* Excellent verbal, written, and interpersonal skills with a diverse audience
* Structured decision making skills
* Experience/knowledge of good governance, and working with non- executive or trustee boards
Desirable:
* Experience/knowledge of membership organisations
* Experience/knowledge of working with a charity or non-profit organisation
* Experience of managing external communications, PR, and reputational
   management
Note: Applicants must have a legal right to work in the UK
For further information or the full application pack please contact Liz Tucker
(M: 07879 434056 E: [email protected])
Closing date for applications is Friday 30 October 2020
__________________________________
No, I am not interested. But I find several aspects of the advertisement interesting:
  • The main concern of the FoH seems to be boosting their membership. This suggests that their numbers are dwindling sharply. I wonder why. Is it because of the nasty sceptics? Or is it because the public is slowly understanding that homeopathics are placebos?
  • No expertise or even previous exposure to science or healthcare seem to be needed. Considering that the successful candidate is expected to write grant applications, this seems surprising to say the least.
  • No knowledge of homeopathy seems required. I find this odd. How is the ‘Chief Operating Officer’ going to understand the weird and wonderful world he/she is supposed to immerse into?
  • Reputational management! What a great term! I had not heard it before. It makes sense in relation to Boris Johnson or Donald Trump. In connection with homeopathy, it is truly hilarious, I feel.

So, here it is:

  • they offer a decent salary;
  • they allow you to work from home most of the time;
  • they require skills and expertise only in homeopathic doses.

Come on, Sandra, Lollypop, Dana, Heinrich, RG, Roger, Old Bob:

GO FOR IT!

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