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

Monthly Archives: May 2020

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.

For complete newcomers to this blog, I should preface this post with four statements of fact (evidence to support them can be found in numerous previous posts on this blog or in my book entirely dedicated to homeopathy):

  1. Homeopathic remedies are usually so highly diluted that they do not contain enough active molecules to have any effect whatsoever.
  2. The evidence from clinical trials fails to show that homeopathic remedies are more than placebos.
  3. Boiron is the world’s largest manufacturer of homeopathic remedies.
  4. Therapeutic claims made for homeopathic remedies are bogus.

_____________

BOIRON USA, seem to employ someone who does little else but tweet irresponsible advertisements that mislead and endanger the public. On 5/5/2020, for instance, I saw within a matter of just hours in my Twitter timeline dozens of advertisements by Boiron USA . I copied a few examples:

  • Oscillococcinum USA Clinical studies show that Oscillococcinum reduces the duration and severity of flu-like symptoms such as body aches, headache, fever, chills, and fatigue.*
  • Boiron USA Ignatia amara relieves a lump in throat, hypersensitivity or intolerance to light, noise, or smells, frequent sighing, difficulty breathing, spasms, & cramps related to stress. It may help those who feel moody or emotional from added #stress. Claim basis: bit.ly/2VaVt0o
  • Boiron USA Calendula officinalis (Garden marigold) offers more than its good looks. This flower has healing power! Calendula has been used for centuries as a healing and soothing substance for skin irritations like cuts, scrapes, chafing, minor burns and sunburn. bit.ly/2srZqPI

And here are four more from 6/5/2020:

  • #Homeopathic Sabina relieves profuse and painful periods with red blood clots and pain spreading to the tops of the thighs. Dosage: Dissolve 5 pellets under the tongue 4 times a day. Decrease frequency with improvement. Claim basis: bit.ly/2I1L3sN
  • Colocynthis 6C relieves abdominal & menstrual cramps improved by bending over, strong pressure and heat. Dosage: Dissolve 5 pellets under the tongue every 30 minutes. Decrease frequency with improvement. Claim basis: bit.ly/2oMa9RX
  • Caulophyllum thalictroides 30C relieves menstrual cramps occurring at the onset of periods, with scanty flow. Dosage: Dissolve 5 pellets under the tongue 4 times a day. Decrease frequency with improvement, Claim basis: bit.ly/2q7Ea2Q
  • #Homeopathic Cimicifuga racemosa 6C relieves cramps associated with #PMS and aggravated by cold and humidity. Dosage: Dissolve 5 pellets under the tongue twice a day. Decrease frequency with improvement. Claim basis: bit.ly/2Kj57Yk

(Please do click on the links for ‘claim basis’ and be surprised!)

As far as I can tell, Boiron USA have been doings this sort of thing incessantly since years. Why does someone not stop them? All of these advertisements make claims that are bogus, unethical, and potentially harmful for many consumers. How can this be legal? Should there not be some sort of consumer protection?

But perhaps there is something all of my US readers can do quite effortlessly: on their website, Boiron USA state that they are

committed to providing top-quality products to our customers. Subject to the Terms, Conditions and Limitations below, if within 30 days of purchase, you are not completely satisfied with our medicines for any reason, we’ll give you your money back.

To receive your refund, please send us the following items within 30 days of purchase at the address below:

    • Your name, address and telephone number
    • The original UPC from the Boiron product purchased
    • The original dated cashier register receipt with the purchase price circled

Boiron Information Center
Attn: Refunds
4 Campus Boulevard
Newtown Square, PA 19073

So, how about buying the preparations advertised and then insisting on a refund, if they did not achieve what was promised in their advertisement on Twitter? That might soon stop them misleading the public!

In March, 2020, the International Chiropractors Association (ICA), a US based chiropractic organization, posted a report claiming that chiropractic adjustments can boost immune function with the implication that it might be helpful in preventing COVID-19. In their report, the ICA stated that: “Although there are no clinical trials to substantiate a direct causal relationship between the chiropractic adjustment and increased protection from the COVID-19 virus, there is a growing body of evidence that there is a relationship between the nervous system and the immune system” and “The observation that those who use chiropractic regularly and do not become ill with cold, flu, or other community shared illnesses is frequent within the profession and should not be ignored”.

Such misleading information is obviously unethical, irresponsible and dangerous. It prompted some chiropractors to do the research and find out what evidence exists that chiropractic might affect the immune system. They have now published their findings in a paper; here is its abstract:

Background

In the midst of the coronavirus pandemic, the International Chiropractors Association (ICA) posted reports claiming that chiropractic care can impact the immune system. These claims clash with recommendations from the World Health Organization and World Federation of Chiropractic. We discuss the scientific validity of the claims made in these ICA reports.

Main body

We reviewed the two reports posted by the ICA on their website on March 20 and March 28, 2020. We explored the method used to develop the claim that chiropractic adjustments impact the immune system and discuss the scientific merit of that claim. We provide a response to the ICA reports and explain why this claim lacks scientific credibility and is dangerous to the public. More than 150 researchers from 11 countries reviewed and endorsed our response.

Conclusion

In their reports, the ICA provided no valid clinical scientific evidence that chiropractic care can impact the immune system. We call on regulatory authorities and professional leaders to take robust political and regulatory action against those claiming that chiropractic adjustments have a clinical impact on the immune system.

It is not often that I praise the actions of chiropractors, I know. But today, I unreservedly applaud the above-quoted paper.

WELL DONE, AND THANK YOU.

(And while we are on the subject, may I encourage the authors to carry on their good work and do similar assessments of the rest of the hundreds of false claims made by so many of their colleagues day-in, day-out?)

 

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.

Bach-Flower Remedies (BFRs) are often confused with homeopathics. Like them, they contain no active molecule; unlike them, they are not potentised nor used according to the ‘like cures like’ assumption. Both have in common that they are as popular as implausible.

Few studies have tested BFRs; my own systematic review of controlled clinical trials was published in 2010:

Bach flower remedies continue to be popular and its proponents make a range of medicinal claims for them. The aim of this systematic review was to critically evaluate the evidence for these claims. Five electronic databases were searched without restrictions on time or language. All randomised clinical trials of flower remedies were included. Seven such studies were located. All but one were placebo-controlled. All placebo-controlled trials failed to demonstrate efficacy. It is concluded that the most reliable clinical trials do not show any differences between flower remedies and placebos.

Now a new study has emerged. This trial from the Department of Pedodontics and Preventive Dentistry, DY Patil University – School of Dentistry, Navi Mumbai, Maharashtra, India, compared the effects of Bach Flower Therapy (BFT) and music therapy (MT) on the dental anxiety in paediatric patients. A total of 120 children (aged 4-6 years) were selected and randomly allocated to one of three groups:

  • BFT group: Children from this group were administered orally four drops of “rescue remedy” diluted in 40 mL of water 15 min before the treatment. Children were asked to wear headphones without playing any music during the dental treatment
  • MT group: Children from this group were provided with a headphone, and Indian classical instrumental music (Raag Sohni played by Pandit Shiv Kumar Sharma on santoor) was played during the scheduled dental treatment. Children were also given 40 mL plain water to drink 15 min before the treatment
  • Control group: Children from this group were given 40 mL plain water 15 min before the treatment. During the treatment, children were asked to wear the headphone without playing any music.

All children received oral prophylaxis and fluoride treatment (no further details provided). Dental anxiety was evaluated using

  • North Carolina Behavior Rating Scale (NCBRS), the primary outcome measure,
  • Facial Image Scale (FIS),
  • and physiological parameters.

Significantly better behaviour was seen in children from the BFT group as compared to the control group (P = 0.014). FIS scores measured postoperatively did not show significant differences among the groups.

Table 2: Comparison of North Carolina Behavior Rating Scale scores of child's behavior measured during the dental procedure between the three groups

Table 3: Comparison of postoperative patient-reported dental anxiety as measured by Facial Image Scale among the three groups

Children from the BFT and MT groups showed a significant decrease in the pulse rates intraoperatively from the preoperative period. Intraoperative systolic blood pressure in children from the MT group was significantly lower than both the BFT and the control groups. Diastolic blood pressure significantly increased in the control group intra-operatively, whereas other groups showed a decrease.

The authors concluded that the results of this study demonstrate significant effects of both single dose of BFT and exposure to MT, on reduction of dental anxiety in children aged between 4 and 6 years.

I find these findings most puzzling (like all BFRs, Rescue Remedies do not contain a single active molecule that could explain them) and strongly recommend that we wait until we have an independent replication before accepting these results as trustworthy.

Dr. Dhanunjaya Lakkireddy, a cardiologist at the Kansas City Heart Rhythm Institute in the US, has started a trial of prayer for corona-virus infection. The study will involve  1000 patients with COVID-19 infections severe enough to require intensive care. The four-month study will investigate “the role of remote intercessory multi-denominational prayer on clinical outcomes in COVID-19 patients,” according to a description provided to the National Institutes of Health.

Inclusion Criteria:

  • Male or female greater than 18 years of age
  • Confirmed positive for COVID-19
  • Patient admitted to Intensive Care Unit

Exclusion Criteria:

  • Patients admitted to ICU for diagnosis that is not COVID-19 positive

(Not giving informed consent is not listed as an exclusion criterion!)

Half of the patients, randomly chosen, will receive a “universal” prayer offered in five denominational forms, via:

  • Buddhism,
  • Christianity,
  • Hinduism,
  • Islam,
  • Judaism.

The other 500 patients in the control group will not be prayed for by the prayer group. All the patients will receive the standard care prescribed by their medical providers. “We all believe in science, and we also believe in faith,” Lakkireddy claims. “If there is a supernatural power, which a lot of us believe, would that power of prayer and divine intervention change the outcomes in a concerted fashion? That was our question.”

The outcome measures in the trial are

  • the time patients remain on ventilators,
  • the number of patients who suffer from organ failure,
  • the time patients have to stay in intensive care,
  • the mortality rate.

On this blog, we have seen many other ‘corona-quacks’ come forward with their weird ideas. I ask myself why we give them not the opportunity to test their concepts as well? Why do we not spend our resources testing:

In my recent book, I included a short review of the literature on prayer as a medical intervention. This is what I wrote:

  1. Prayer can be defined as the solemn request or thanksgiving to God or other object of worship.
  2. Intercessory prayer is practised by people of all faiths and involves a person or group setting aside time for petitioning god on behalf of another person who is in need. Intercessory prayer is organised, regular, and committed. Those who practise it usually do not ask for payments because they hold a committed belief.
  3. The mechanisms by which prayer might work therapeutically are unknown, and hypotheses about its mode of action will depend to a large extent on the religious beliefs in question. People who believe in the possibility that prayers might improve their health assume that god could intervene on their behalf by blessing them with healing energy.
  4. These assumptions lack scientific plausibility.
  5. Numerous clinical trials have been conducted. Most of them fail to adequately control for bias, and their findings are not uniform.
  6. A systematic review of all these studies is available. It included 10 trials with a total of 7646 patients. The authors concluded that the findings are equivocal and, although some of the results of individual studies suggest a positive effect of intercessory prayer, the majority do not and the evidence does not support a recommendation either in favour or against the use of intercessory prayer. We are not convinced that further trials of this intervention should be undertaken and would prefer to see any resources available for such a trial used to investigate other questions in health care.[1]

[1] https://www.ncbi.nlm.nih.gov/pubmed/19370557

Lakkireddy says he has no idea what he will find. “But it’s not like we’re putting anyone at risk,” he says. “A miracle could happen. There’s always hope, right?”

Personally, I have a pretty good idea what he will find. I also find Lakkireddy not all that honest and think his assumptions are deeply mistaken:

  • Lakkireddy cites an extensive list of references; however, the Cochrane review (usually the most reliable and independent source of evidence) that arrived to the conclusions I quoted above, he somehow ‘forgot’ to mention.
  • As the review-authors tried to indicate, further trials of prayer are a waste of resources.
  • There are many much more promising interventions to be tested, and by conducting this study, he is diverting research funds that are badly needed elsewhere.
  • The study seems to have several ethical problems, e.g. informed consent.
  • Contrary to Lakkireddy’s belief, he will harm in more than one way; apart from wasting resources, his study undermines rational thought and public trust in clinical research.

PERSONALLY, I FIND THIS PROJECT DESPICABLE!

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.

Hard to believe but apparently true: it has been reported that the state government of Kerala distributed homeopathic medicines to people across the state as ‘immunity boosters’. A total of 4.5 million samples have already been distributed.

Map

No, these reports were not dated 1 April!

They are only two days old.

Dr. B Vijayakumar, a member of the State level expert group of the Indian Homoeopathic Medical Association (IHMA’s) revealed that homoeopathy has had a long history in treating and preventing epidemics ever since its inception including those such as Dengue, Chikungunya, Chickenpox and Typhoid. “Its effectiveness in the management of viral diseases has proved beyond doubt many a time. Homeopathy, being one of the most sought after the alternative system of medicine all over the world.”

VK Prasanth, MLA who has been the former mayor of Thiruvananthapuram was the first to launch the distribution of homeopathic medicine in his constituency. “The centre has recognised the homoeopathy medicine to boost the immunity and thereby work as a preventive. When I associated with it, first I was criticised, but now the medicine is in high demand across the state.” said Prasanth.

The Indian Homoeopathic Medical Association (IHMA) is part of the Kerala Government’s RAECH (Rapid Action Epidemic Control Cell, Homoeopathy) programme which officially looks after all the epidemic activities in Kerala.

The government of Kerala even has a ‘Department of Homeopathy. Its stated vision is:

  • Permanent establishment of Homoeopathic Health care facility to all Panchayaths in our state.
  • To open more specialities OP’S in vulnerable locations like coastal belt, tribal areas, metros etc. And Speciality IP’s In our district Hospitals.
  • To extent elaborate laboratory facilities in our district hospitals.
  • To formulate Research & Development wing in Department of Homoeopathy.
  • Computerization of all Dispensaries.
  • As per the Central Govt. Decision and Direction by Supreme Court primary Health care in the periphery i.e. Panchayats shall be designed in such a way that all the three systems i.e. Homoeopathy, Allopathy and Ayurveda Should come under one roof.

We have, of course, discussed the track record of homeopathy in epidemics before on this blog. It is simply not true that the evidence is convincing. It is also not true that homeopathy has ever been shown to boost any parameter indicative of the immune response. It is finally also untrue that there is good evidence that any homeopathic remedy is an effective treatment of any viral infection (or any other condition).

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