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

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I started my full-time research into so-called alternative medicine (SCAM) at Exeter in 1993. It became soon clear to me that the most urgent subject to investigate was the safety of SCAM. Safety is more important than efficacy for treatments that are already out there. My decision to prioritise safety quickly led to the bewilderment of the SCAM community. They pointed out that SCAM was safe and that the true risks in healthcare were with conventional medicine. Belief was strong, but data were scarce.

My counter arguments therefore were:

  1. Safety is too important a subject to leave it to belief, and we need evidence.
  2. SCAM is hugely popular and it was my ethical duty to provide data on safety.

The SCAM community were unconvinced by my logic. But that did not stop me.

In the course of dozens of investigations, we then found that adverse effects of SCAM do exist and some can be quite dramatic. Again, I was told that this might be so, but the real dangers surely lie elsewhere, namely in conventional medicine.

Meanwhile, I began to find that, while the direct risks of SCAM were real, the indirect risks were much more important. During virtually every talk I gave and in most papers I published, I started including this message:

EVEN A HARMLESS SCAM WILL BECOME LIFE-THREATENING, IF IT IS USED AS AN ALTERNATIVE TO CONVENTIONAL CARE FOR A SERIOUS CONDITION.

Even though the statement seems quite clear, it does not really capture the complexity of the issues involved. Let’s take (yet again) the example of homeopathy (because it is one of the most clear-cut cases).

The remedy is normally harmless; after all it contains nothing. Therefore, there are no or very few adverse effects. If a patient is naïve enough to use homeopathy in an attempt to cure a life-threatening condition, it is hardly the fault of homeopathy – at least this is what some defenders of the homeopathic realm claim. So why blame homeopathy?

Indeed, this could be unfair, because then we would have to say that water is dangerous because you can easily kill yourself with it.

But the water companies do not recommend abusing water for suicidal purposes!

And homeopaths do unquestionably recommend homeopathy for serious conditions!

So, it is not the remedy and not homeopathy itself that makes it dangerous. What makes it risky is the combination of two things:

  1. the inertness of the remedy
  2. the unsubstantiated claims that are being made for it.

The two together create a potentially deadly mixture. Without false claims, nobody could classify homeopathy as life-threatening. Due to the plethora of false claims, nobody can reasonably deny that it is.

What follows is simple, I think: one would only need to stop the claims. Subsequently, homeopathy – and many other forms of SCAM – could be classified as harmless (yes, I know, this is purely theoretical because in practice this will never happen). They would still be ineffective, of course, but safety was and is the priority.

In a recent 3-part series of posts, I have demonstrated how very unconvincing the evidence for acupuncture really is. But new studies emerge all the time and many of them suggest that acupuncture does work. Take this one, for instance.

This new study compared the effects and safety of acupuncture for the treatment of irritable bowel syndrome (IBS) with those of polyethylene glycol (PEG) 4000 and pinaverium bromide.

This multicentre randomized clinical trial was conducted in 7 hospitals in China. The researchers enrolled participants who met the Rome III diagnostic criteria for IBS between May 3, 2015, and June 29, 2018. Participants were first stratified into constipation-predominant or diarrhoea-predominant IBS groups. Patients from each group were randomly assigned in a 2:1 ratio to receive acupuncture (18 sessions) or PEG 4000 (20 g/d, for IBS-C)/pinaverium bromide (150 mg/d, for IBS-D) over a 6-week period, followed by a 12-week follow-up. The primary outcome was the change in total IBS-Symptom Severity Score from baseline to week 6.

531 patients were randomized and 519 (344 in the acupuncture group and 175 in the PEG 4000/ pinaverium bromide group) were included in the full analysis set. From baseline to 6 weeks, the total IBS-Symptom Severity Score decreased by 123.51 (95% CI, 116.61 to 130.42) in the acupuncture group and by 94.73 (95% CI, 85.03 to 104.43) in the PEG 4000/pinaverium bromide group. The between-group difference was 28.78 (95% CI, 16.84 to 40.72; P<.001). No participant experienced severe adverse effects.

The authors concluded that acupuncture may be more effective than PEG 4000 or pinaverium bromide for the treatment of IBS, with effects lasting up to 12 weeks.

I am not impressed by this study.

Here are a few reasons why:

  • There was no attempt to control for placebo effects or to blind patients. The placebo response rate varies in randomized controlled trials of IBS from 20 to 70% and can persist for up to 1 year based and does not wane after 1 or 2 months.
  • The design of the study is odd. I suspect that, as an equivalence trial with 175 patients in the control group which was split up into two sub-groups, it may have been under-powered.
  • The control treatments might not be as effective as the authors try to make us believe. This could be particularly true, if the allocation to the two sub-groups within the control group was suboptimal.
  • According to previous studies, acupuncture does not seem to have specific effects in IBS. The current Cochrane review concluded that sham-controlled RCTs have found no benefits of acupuncture relative to a credible sham acupuncture control for IBS symptom severity or IBS-related quality of life.

I think that this study shows just one very unsurprising phenomenon: spending a total of 9 extra hours with empathetic therapists (who must have been highly motivated to encourage patients to experience less symptoms) has a positive effect on IBS patients – no matter what treatment the therapist might apply. I find it regrettable that supposedly decent journals publish such papers without even the slightest attempt of a critical discussion of its findings.

Homeopathy International‘, is a London-based membership organisation which connects practitioners of homeopathic medicine, homeopathy colleges and the homeopathy profession. They currently issue the following ‘COVID-19 advice‘:

Homeopathic medicines have a long history of use in respiratory tract infections, infections with flu-like symptoms and in epidemics.

Homeopathy is a system of medicine that is individualised for each person rather than for a named disease, however there are a group of remedies that are frequently used in flu-like and respiratory tract infections.

Choose the homeopathic medicine that best fits your particular symptoms.

Commonly used homeopathic remedies for influenza – like symptoms.

Aconite: When it starts suddenly, a fever with chilliness, throbbing pulses, Feeling restless and anxious. After being out in cold dry weather and bitter winds.

Gelsemium: The opposite of Aconite. Comes on slowly. A feeling of heaviness and tiredness in the body and limbs, head feels to heavy to hold up. Chills in the back. A bursting headache. No thirst.

Bryonia: Comes on slowly. Thirsty for cold drinks. Headache, irritability, wants to be in own home, left alone. Everything is worse for movement and better for pressure.

Eupatorium perf:  Severe aches in limbs and back, a feeling “like broken bones”.  Dare not move for pain. A bursting headache. Sore eyeballs. Feels better for talking to someone.

Baptisia: Rapid onset, then falls into a kind of stuporous state with a red face and looks drugged. Falls asleep while talking. May be strange feelings as if limbs are distorted or out of place. May be vomiting and diarrhoea and mucous in the chest.

I am lost for words when I read such irresponsible nonsense. And my amazement is not reduced by studying the rest of their website:

… We provide the public with the facts about homeopathy so they can understand its potential as a viable alternative, and explain the ongoing threat at work to prevent patient access to this safe, effective, sustainable system of medicine.

Our six member Steering Committee is made up of homeopathic practitioners both medical and professional and patients who between them have worked with homeopathic medicine for more than 170 years. They have witnessed its potential as well as the campaign waged against it, and as a group are committed to protect access to this precious alternative at a time when it is needed more than ever…

It is not widely known but as a patient it is your right to choose the kind of medicine you want to use to resolve your issues and maintain your health. Your GP is legally obliged to provide you with information about options so that you can make an informed choice. That is your legal right and your GP’s legal obligation…

Our Steering Group is composed of:

Michael O’Brien Acting Lay Chair
Paul Burnett Communication Lead
Carol Boyce Education Lead
Dr Noel Thomas Practitioner Representative
Karyse Day Lay Representative
Barry Tanner Regulatory Adviser
Ursula Kraus-Harper Specialist Adviser EASE

I feel that these people should be ashamed of themselves.

Do they not have a code of ethics?

Yes they do!

Here it is:

As a member of Homeopathy International, you are personally accountable for your practice. In caring for patients and clients you must:

♦   Respect the patient or client as an individual and honour their integrity as well as respecting their customs, creed, race, ability, sexuality, economic status, lifestyle, political beliefs and religion.

♦   Obtain consent before you give any treatment or care and work according to holistic principles.

♦   Protect confidential information.

♦   Recognise the value of other therapies and health care professionals, both within complementary and conventional medicine and work with other practitioners and refer when it is in the patient’s/client’s best interests. A practitioner must not treat a patient/client in any case which exceeds his/her capacity, training, and competence.

♦   Maintain your professional knowledge and competence on a continuous basis so that you may offer the very best standard of treatment.

♦   Be trustworthy and not exploit the patient or client. Members must maintain the highest morals and behave with courtesy, respect, dignity, discretion and tact.

♦   Act to identify and minimise risk to patient and clients.

These people clearly violate their own code of ethics in more than one way:

  • they do not behave morally,
  • they do not offer the best standard of treatment,
  • they lack the competence to advise the public about the current pandemic.

YES, YOU GUESSED IT: I FEEL SICK!

There is much uncertainty about the value of dietary advice and dietary supplements. If these interventions do anything at all, then surely this would show in malnourished patients. And if any effect can be demonstrated, then surely with a hard endpoint, such as survival. This study tested the hypothesis; it investigated the effect on survival after 6 months of treatment involving individual dietary advice and oral nutritional supplements in older malnourished adults after discharge from hospital.

This multicentre randomised controlled trial was supported by grants from Region Västmanland, Uppsala-Örebro Regional Research Foundation (RFR), and the Swedish National Board of Health and Welfare. It included 671 patients aged 65 years who were malnourished or at risk of malnutrition when admitted to hospital between 2010 and 2014, and followed up after 8.2 years (median 4.1 years). Patients were randomised to receive:

  • dietary advice,
  • oral nutritional supplements,
  • a combination of both,
  • routine care.

The intervention started at discharge from the hospital and continued for 6 months, with survival being the main outcome measure.

During the follow-up period 398 (59.3%) participants died. At follow-up, the survival rates were

  • 36.9% for dietary advice,
  • 42.4% for oral nutritional supplements,
  • 40.2% for dietary advice combined with oral nutritional supplements,
  • 43.3% for the control group.

Figure

After stratifying the participants according to nutritional status, survival still did not differ significantly between the treatment arms (log-rank test p = 0.480 and p = 0.298 for the 506 participants at risk of malnutrition and the 165 malnourished participants, respectively).

The authors concluded that oral nutritional supplements with or without dietary advice, or dietary advice alone, do not improve the survival of malnourished older adults. These results do not support the routine use of supplements in older malnourished adults, provided that survival is the aim of the treatment.

The findings of this trial seem perhaps counter-intuitive and they contradict the current Cochrane review on the subject. I nevertheless feel that this is an interesting, rigorous and important study. It deserves to be publicised widely – perhaps more widely than the ‘Upsala Journal of Medical Science’ would afford.

President Trump is not the only head of government who has discovered his talents as a scientist saving the world from the corona-virus pandemic. It has been reported that shipments of a herbal tea are being sent to neighbouring countries by the President of Madagascar, Andry Rajoelina (below having a sip of his herbal drink). He claims that his tea is a powerful remedy against the corona-virus and hopes to distribute across West Africa and beyond.

Baptised ‘Covid-Organics’, the tea is derived from artemisia, a plant containing artemisinin which has efficacy in malaria treatment. Artemisia is cultivated in Cameroon, Kenya, Ethiopia, South Africa, Mozambique, Tanzania, Uganda and Zambia – all in high-altitude regions and regions with a pronounced cool periods. The tea reportedly also contains other indigenous herbs, such as ravintsaraRavintsara is derived from the Cinnamomum camphora tree which is a native of Madagascar. This species of tree is different from the Asian camphor species; its leaves have a very different chemical composition.

‘Covid-Organics’ is being marketed after being tested on fewer than 20 people over a period of three weeks.

After Equatorial Guinea on Thursday, Guinea-Bissau is the second country to take delivery of the potion that Andry Rajoelina claims cures Covid-19 patients within 10 days.

The World Health Organisation has said that the herbal tea’s effects have not been tested, and there are no published scientific studies of the potion.

Embalo’s chief of staff Califa Soares Cassama told reporters that part of Saturday’s shipment was to be passed along to the other 14 members of the Economic Community of West African States (Ecowas). He said that he will test the potion from Madagascar on leading government members, including the premier. (Some readers of this blog might feel that the same should have been done in the US when Trump seemed to promote disinfectant for the corona-virus infection.)

Back in Madagascar, unarmed soldiers have been going from door to door in the capital Antananarivo handing out Covid-Organics. When launching the distribution last month, Rajoelina said two people had already been cured thanks to the potion, and added: “We can change the history of the entire world.”

Personally, I wonder whether a potion against hubris would not also be needed in these desperate times.

Guest post by Christian Lehman

How I would have loved it if a brilliant genius, in the style of Jeff Goldblum in Jurassic Park, had discovered, on a corner of a grubby lab bench, THE miracle treatment for Sars-cov-2! How I would have clapped if, working fast, very fast, too fast for the eyes of mere mortals, this magnificent hero had blazed brilliantly ahead and saved millions of lives, so proving the accuracy of his hypothesis before an awestruck world. But we’re not in a Hollywood style blockbuster.

When Didier Raoult launched his first study on chloroquine he was basing it on three things: a verifiable fact, an assertion, and an intuition.

The verifiable fact is that in a test-tube (in vitro), and not in tests in humans (in vivo), chloroquine is active against SARS-cov-2 , the virus of Covid19. The fact that this in vitro action exists in a number of other viruses, without ever having given good results in humans, even increasing mortality in the case of chikungunya, would suggest the need for some degree of caution.

A reservation swept aside by Raoult’s following assertion: a Chinese study has just emerged which demonstrates that chloroquine brings about spectacular improvement and is recommended for all clinically positive infections involving the Chinese corona virus. Unfortunately, nearly two months after this scoop the world still awaits the slightest corroboration of what seems more and more like an elaborate media bluff.

Finally, intuition is what Didier Raoult is still defending today, stubbornly, in ever weirder videos. The idea that a researcher outside the select Parisian elite, who has been knocking around for a long time, a practical man, can see at once straight to the heart of the matter, while a horde of followers bogged down in their standard procedures would take months to get going.

So Didier Raoult launches studies, raising great hopes by his attitude of complete certainty, his media facility. Hopes so great that nobody, in the media or at the heart of politics, thinks of questioning him. Who would imagine that a respected scientist with an impressive CV would throw himself blindly into a con?

Didier Raoult’s studies follow one after another, piling up errors and approximations, crazily rigged.

Thus, in the first study, out of 42 patients, among those treated by the Didier Raoult procedure, one dies, and three are hospitalised because of deterioration in their condition. And by a wave of a magic wand (which in France and elsewhere should be called a fraud)… all four are excluded from the results when they should have been considered as failures of hydroxychloroquine.

Somewhere along the way Didier Raoult will add Azithromycine to Hydroxychloroquine, and will conclude that the combination is more efficacious than HCQ alone, though the difference, on six patients only, is not significant.

The criterion established to judge the success of the trial was to be a check for the virus in the nasal passages around 14 days. The study will be halted on the sixth day, and the diminution in the intranasal viral load will be treated as a proof of efficacity/effectiveness (without any knowledge of whether this disappearance might simply indicate the migration of the virus to the pulmonary level).

Children of 10 years old will be included in one of the extensions of the study, without their consent.

A second study will be launched as a follow-up, while the first will be published under doubtful conditions and immediately disowned by the International Society of Antibacterial Chemotherapy, and this second study in which Didier Raoult and his team choose which patients to treat (thus intervening in their therapy in an illness offering 95% of spontaneous recoveries) is declared as a simple observational study (without intervention by doctors on the development of events), instead of an interventional study. This means that obtaining the obligatory agreement from the Agence Nationale de Securite du Medicament can be avoided.

All this takes place as if, paralysed by the obvious shambles of the government’s management of the epidemic, nobody dares to utter an objection. Bypassing any requirement to seek the agreement of the ethical committee, the Marseille Institute awards itself a blessing and at the end of March treats 80 patients with Hydroxychloroquine, because “that is what we are told to do by the Hippocratic oath which we have taken”. So Didier Raoult, on a hunch, will prescribe potentially cardiotoxic and untested medicines to asymptomatic patients, in violation of the fundamental rules of ethics concerning the prescription of medicines.

There would be, there will be much to be said on the inaction of agencies, of institutions, of politicians, faced with the forward flight of a man who trails behind him tens of thousands of frightened people, thousands of conspiracy theorists and hundreds of hate-filled trolls who have turned themselves into virologists in a couple of hours spent on YouTube gobbling down the videos of their Guru.

But what most interests me in the first place is Didier Raoult’s rationale, that certainty that the Hippocratic oath (which at no point mentions the right to enter into freestyle experimentation on human beings), his medical degree, and personal intuition, constitute a sort of trump card. Let us remind ourselves one more time. Didier Raoult is a microbiologist, a specialist in viruses and bacteria. He has no experience of therapeutic research, and the gross errors which he commits in the development of his studies and in the analysis of his results and his publication procedures are not linked, as he would like us to believe, to the emergence of a new paradigm, but to the rancid re-emergence of something which we hoped had disappeared, the overweening power of untouchable and tyrannical “mandarins” , medical overlords incapable of allowing themselves to be called into question.

Coming in worldwide, the results of the first correctly executed studies carried out on Hydroxychloroquine, are globally negative. The only line of defence which appears to be left to Didier Raoult is the excuse of having acted in an emergency. Comparing himself one day to Clemenceau, the next to Foch, he sees himself as a fantasy wartime leader, alone capable of facing up to the situation, far from the prevarications of the dismal adherents to scientific method. All that the media seem to have retained from his recent video, entitled “The Lesson of Short Epidemics” is his assertion that Covid19 is a seasonal illness, destined to disappear, and that “in a month there will be no more new cases”. The work of all of us who wrote articles and posted warnings on social media: ordinary GPs, cardiologists, emergency and resuscitation specialists, would seem to have borne fruit. The assertion of the mighty soothsayer who in January scoffed as he told us “when three Chinese who die, that sparks off a world alert” will not wash any longer. But how many people realise that, if Didier Raoult is pushing his latest intuition, it is because only a short epidemic will allow him to justify a posteriori having acted brazenly in an emergency. If Covid19 settles in the long-term, he will not be able to escape a minutely detailed autopsy of his statements and his actions. And the result will be devastating.

I am sure that most of us have wondered how we might be able to boost our immune defence in order to minimise the risk of catching the corona-virus. Many have asked, what role does nutrition play? There is, of course, a substantial amount of research on this topic, but are there any clinical trials at all? And if  such studies have been published, how rigorous are they?

Here is a brand-new paper that might answer these questions.

In this review, the 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 authors concluded that nutrition principles based on these data could be useful in possible prevention and management of COVID-19.

Given the current concern of millions of people, this is a most useful review, in my view. The paper also has a table recommending the following nutrients from food or as dietary supplements as possibly effective:

  • Vitamin A
  • Vitamin D
  • Zinc
  • Selenium
  • Copper
  • Garlic
  • Fish
  • Cranberry
  • Broccoli sprouts
  • Probiotics

I am not sure that the evidence is sufficiently strong for such explicit advice, but I am quite certain that the recommendations are nevertheless more suitable than Trump’s little ramblings on disinfectant.

‘Acupuncture in the Treatment of COVID-19: An Exploratory Study’ is the title of a paper that I was alerted to. Here is its abstract:

The coronavirus COVID-19 has presented a serious new threat to humans
since the first case was reported in Wuhan, China on 31 December 2019.
By the end of February 2020 the virus has spread to 57 countries with
nearly 86,000 cases, and there is currently no effective vaccination
available. Chinese herbal medicine has been used in this epidemic with
encouraging results, but with concerns regarding disturbance of patients’
digestive function. This study aims to explore the role of acupuncture in
treating COVID-19 by investigating relevant current literature along with
classical Chinese medicine texts on epidemics. Based on this analysis,
acupuncture points and strategies are suggested for practitioners to use
as a guide to treatment.

The paper is largely devoid of what I would call evidence. Here are a few excerpts to give you a flavour:

Epidemic qi attacks the body rapidly and violently,
therefore clinical features can change dramatically and vary
significantly between cases. Severe symptoms can develop
within just a few days. The following clinical possibilities
should be borne in mind:
• Once damp-cold becomes significant, it can: a) block
the Lungs causing dypnoea; b) attack the Pericardium
causing chest tension, nausea, cold sweat and shock;
c) cause Kidney yang failure, inducing haematuria,
dehydration, abnormal urination and weight loss; and
d) damage the Stomach and Spleen, leading to vomiting
and diarrhoea.
• Once damp-cold turns to heat, it will occlude the Lungs
and yangming (Stomach and Large Intestine) resulting
in fever, coughing, chest tension and shortness of breath,
fatigue, poor appetite, nausea, vomiting, bloating,

diarrhoea or constipation, eventually destroying the
body’s yin and evolving into endogenous wind syndrome.

How can one avoid contracting such a ferocious epidemic
virus? The Nei jing (Inner Classic) provides the answer:
people with strong zheng (upright) qi will avoid the
worst effects of epidemic infection despite the fact
that everybody, no matter their age or gender, may be
affected.24 Because each individual has a different physical
constitution, the manifestations of the disease will vary,
and so a single herbal prescription cannot be universally
effective for every patient. Acupuncture is conducted
with patients on a one-to-one basis, and is oriented more
to provide symptomatic relief than the generic herbal
decoctions applied during epidemic periods. The relevant
acupuncture protocols, based on the Chinese government
four-stage differentiation scheme for treating COVID-19,
are outlined below.

Oddly, the authors come closest to providing actual clinical evidence in their strange and somewhat lengthy conclusions:

… Historically, acupuncture has been used effectively to treat epidemic
infectious diseases, and despite historical neglect, it could
become a crucial weapon in the battle against COVID-19
and other future epidemics. Of course, practitioners should
ensure that they are properly protected when working with
infected patients, which means wearing a protective suit
and administering acupuncture in a hospital environment
(which brings its own challenges).
Inspiring evidence of the role of acupuncture has been
appearing since the beginning of March 2020. Professor
Zou Xu is a critical care medical expert from Guangdong
TCM hospital. As one of the supporting medical staff in
Wuhan Leishenshan hospital, he always takes acupuncture
needles during his ward inspections to help COVID-19
infected patients, especially those with acute symptoms
such as shortness of breath, coughing, dizziness, insomnia,
restlessness, palpitations, diarrhoea or vomiting. The
effect of his acupuncture was often instantaneous. A 72
year old female patient with high blood pressure and
diabetic chronic illness complained of a lower back ache,
whereupon Zou needled the point Taixi KID-3 and the
patient was able to stand upright immediately. Zou
explains that acupuncture can improve the patients’
oxygen supply and consumption, helping them regain
yuan-original qi while blocking the toxicity attacking the
Lung. Most importantly, acupuncture is not aiming to
destroy the epidemic qi, but instead it can influence the
conditions of its survival in the body.31 Zou’s team was in
charge of 16 patients, of which six patients
volunteered for Chinese medicine treatment alone;
as of 1st March 2020, all six have fully recovered and
have been discharged from hospital. In another ‘Report
from the Front Line in Wuhan’, Professor Liu Li Hong has
also documented the work of his team treating patients
with COVID-19 in Wuhan, emphasising the importance
of acupuncture in helping patients immediately with
symptoms such as stuffiness in the chest, shortness of
breath, abdominal discomfort, itchy throat, cough,
dizziness, pain and sweating.

In my view, this sentence alone merits an admission to my ‘corona-virus quackery club’ (CVQC): Historically, acupuncture has been used effectively to treat epidemic infectious diseases, and despite historical neglect, it could become a crucial weapon in the battle against COVID-19 and other future epidemics. And, of course, there are plenty other acupuncturists claiming similar things on the Inernet.

So:

Welcome to the CVQV, traditional acupuncturists!

Guest post by Björn Leifsson

I stumbled upon a web-article (in Icelandic) in which a local homeopath expresses her concerns over a public statement made by the national medical society suggesting that mention of homeopathic “drugs” should be removed from the legislation because homeopathy was an outdated approach and belief that is “neither based on scientific knowledge nor research”. The indignant homeopath referred to a YouTube video (really!) in support of her claim that many studies exist about the efficacy of homeopathy, as evidenced in the video.

Curiosity led me to browse through it. Towards the end of the video, Rachel Richards, a homeopath described, a seemingly remarkable study on hundreds of piglets that showed homeopathic treatment to significantly reduce infectious diarrhoea in newborn piglets. This, she claimed, is proof that homeopathy works through more than the placebo effect because placebo does not work on animals, right?

Here is the abstract of the paper:

Background: The use of antibiotics in the livestock sector is increasing to such an extent that it threatens negative consequences for human health, animal health and the environment. Homeopathy might be an alternative to antibiotics. It has therefore been tested in a randomised placebo-controlled trial to prevent Escherichia coli diarrhoea in neonatal piglets.

Method: On a commercial pig farm 52 sows of different parities, in their last month of gestation, were treated twice a week with either the homeopathic agent Coli 30K or placebo. The 525 piglets born from these sows were scored for occurrence and duration of diarrhoea.

Results: Piglets of the homeopathic treated group had significantly less E. coli diarrhoea than piglets in the placebo group (P<.0001). Especially piglets from first parity sows gave a good response to treatment with Coli 30K. The diarrhoea seemed to be less severe in the homeopathically treated litters, there was less transmission and duration appeared shorter.

This is a badly written paper. The description of methods and material is unclear and confusing. But I am not going to delve into the curious design and reporting details, such as their vague and conflicting description of the blinding or the rather peculiar description of the treatment procedure. I find the statistical design and analysis incriminating enough.

The study was conducted in four groups (batches). The researchers treated in total 52 sows; 26 were randomly allocated to an arm treated by spraying either dissolved “Coli, 30C” nosode sugar tablets. Another 26 sows were sprayed with the same liquid but without the homeopathic substance. They describe how they sprayed the stuff in[sic] the sow’s vulva’s, twice a week, during four weeks before expected delivery. How they sprayed “in” the vulva of the sows escapes my understanding. Perhaps they just misspelled “in” for “on”? Anyway, the authors curiously postulate that the “homeopathic substance” is absorbed from the vulva.

Ah, I forget… I did not plan to delve into the minor oddities of this eccentric opus.

So, 26 sows were “treated” with the good stuff and 26 with the fake. So far so good.

But this only produces a very small study, nothing more than a pilot – really. Not so good.

Instead of carrying on with this inexpensive study to procure proper power for the analysis, the authors counted the piglets! Approximately ten piglets were produced per sow so the total number of observed piglets became 525! That can certainly seem an impressive number of research subjects. Counting the piglets and not the sows, increased the study material tenfold, making it appear to be well powered study.

This is cheating in my opinion, nothing less, nothing more.

But why not do it this way?

In the week after the piglets were delivered, an observer, blinded to the treatment allocation, regularly noted which piglets got diarrhoea typical for enteropathogenic E. coli infection.

The authors made a big deal about confounding factors such as parity (how many prior litters the sow has produced) and its purported effect on piglet infection risk. They use an elaborate statistical program to perform an advanced (and wrong) analysis called “GLM – Generalised Linear Modelling”, and entered corrections for parity, season and treatment group (batch). But they forgot (omitted?) to correct for the obvious common risk factors to piglets in a litter.

On average ten piglets in each litter shared at least two litter-dependent risk factors, i.e. a sow (mother) and a pen. Thus the risk exposure is not independent between piglets, only between litters/sows.

Sow and pen dependent factors are likely to affect the number of infected piglets in affected litters. If a sow or pen is colonised, a number if not all piglets in that litter may be affected, by a common cause, thereby erroneously multiplying the effect of the studied endpoint. Possible genetic paternal and/or maternal factors may also be at play to affect the vulnerability of the litter as a group rather than individually.

In short, the authors did not have 525 study subjects, only 50.

But they might have tried to make do with this. There was actually an apparent difference between the groups, favouring the nosode arm as shown in the table. To an untrained reader (which most people are) this could easily be interpreted as proof  that the stuff really worked. One might see only the double number of affected litters in the placebo group? But this is far from relevant because the study is severely under-powered. To be able to call this study significant they would at the very least have needed to double this number. You would then still need to individually confirm the results in other separate studies, not the least for an extremely unlikely drug candidate as sugar dissolved in water.

The authors must have somehow realised that their study is abjectly under-powered and therefore resorted to using this veritable trick of mirrors and theatrical smoke to make it look like this was a trustworthy study of over 500 subjects.

Treatment:
Outcome: E. coli nosode Placebo Row totals:
Diarrhoea 7 16 23
No diarrhoea 17 10 27
Column totals: 24 26 Grand total: 50

Table showing the relative ratios of infected litters.

If we do a statistical test despite it being pointless, the P-value (Chi square) is 0.02176. Any P-value that falls below the 0.05 limit may seem important to the novice reader and probably be super exciting to a believer in homeopathy. But in this very small study such a result suggests absolutely nothing. It may be due to a multitude of factors other than the tested treatment, most likely pure chance perhaps aided by some flaws in the exclusion of bias.

And then there is the big problem with interpreting P-values.

My assessment is that, in compliance with Hanlon’s razor, this charade of scientific method is most likely due to a combination of incompetence and religiously wishful thinking rather than deliberate fraud. It being published in Homeopathy says much about that paper’s lacking editorial qualities.

Papillomas of dogs are benign growths caused by the canine papillomavirus. The oral mucosa and commissures of the lip are most frequently involved. Papillomas often regress spontaneously within a few weeks, and treatment is usually not necessary.

This Indian study tested the combination of 4 homeopathic drugs (Sulfur 30C, Thuja 30C, Graphites 30C, and Psorinum 30C) in 16 dogs affected with oral papillomatosis which was not undergone any previous treatment. Dogs affected with oral papillomatosis, which have not undergone any initial treatment and fed with a regular diet. They were randomly divided into two groups, namely, homeopathic treatment group (n=8) and placebo control group (n=8). The homeopathic combination and placebo (distilled water) was administered orally twice daily for 15 days. Clinical evaluation in both groups of dogs was performed by the same investigator during 12 months. 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 clinical score (p<0.001) 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.

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The authors concluded that the current study proves that the combination of homeopathy drugs aids in fastening the regression of canine oral papilloma and proved to be safe and cost-effective.

This could well become the worst SCAM study of 2020. In case you have not already spotted its flaws, here are some of them:

  • the trial was truly tiny; thus the results could easily be false-positive;
  • to make any conclusion about safety after treating 16 subjects is nonsensical;
  • cost-effectiveness was not assessed and therefore conclusions about it are not warranted; if, however, one made a ‘back of the envelope’ calculation, one would be hard-pressed to not find tap water more cost-effective than 4 homeopathic remedies;
  • the graph looks to me very suspect – could it be that someone has been busy prettifying the data?

Nevertheless, I think this paper is remarkable, if only in the way it teaches us how NOT to formulate conclusions of a study. Even if we had 200 dogs in this trial, its findings would not PROVE the efficacy of the intervention. Proof is something a single trial will never deliver. Proof is a debatable concept even after several independent replications, particularly when dealing with something as implausible as homeopathy.

In any case, if your dog has papillomas, do me a favour and avoid homeopathic vets!

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