Monthly Archives: March 2020
Many hundreds of plants worldwide have a place in folk medicine as treatments for microbial infections and antimicrobial activity of extracts in vitro may be readily assessed in microbiology laboratories. Many so tested are reported to show inhibitory effects against a range of organisms. For less than responsible entrepreneurs, this is often enough reason to promote them as therapeutic options.
But laboratory testing can at best be only a very crude, though relatively inexpensive and rapid screen, while in vivo testing is very costly and time consuming. On this background, we conducted a review in 2003 to examine the range of plants or herbs that have been tested for antiviral properties in laboratories, animals and humans. Here is its abstract:
Background and aims: Many antiviral compounds presently in clinical use have a narrow spectrum of activity, limited therapeutic usefulness and variable toxicity. There is also an emerging problem of resistant viral strains. This study was undertaken to examine the published literature on herbs and plants with antiviral activity, their laboratory evaluation in vitro and in vivo, and evidence of human clinical efficacy.
Methods: Independent literature searches were performed on MEDLINE, EMBASE, CISCOM, AMED and Cochrane Library for information on plants and herbs with antiviral activity. There was no restriction on the language of publication. Data from clinical trials of single herb preparations used to treat uncomplicated viral infections were extracted in a standardized, predefined manner.
Results: Many hundreds of herbal preparations with antiviral activity were identified and the results of one search presented as an example. Yet extracts from only 11 species met the inclusion criteria of this review and have been tested in clinical trials. They have been used in a total of 33 randomised, and a further eight non-randomised, clinical trials. Fourteen of these trials described the use of Phyllanthus spp. for treatment of hepatitis B, seven reporting positive and seven reporting negative results. The other 10 herbal medicines had each been tested in between one and nine clinical trials. Only four of these 26 trials reported no benefit from the herbal product.
Conclusions: Though most of the clinical trials located reported some benefits from use of antiviral herbal medicines, negative trials may not be published at all. There remains a need for larger, stringently designed, randomised clinical trials to provide conclusive evidence of their efficacy.
One of the herbal remedies that seemed to show some promise specifically for upper respiratory infections was Andrographis paniculata. This evidence prompted us in 2004 to conduct a systematic review focused on this herb specifically. Here is its abstract:
Acute respiratory infections represent a significant cause of over-prescription of antibiotics and are one of the major reasons for absence from work. The leaves of Andrographis paniculata (Burm. f.) Wall ex Nees (Acanthaceae) are used as a medicinal herb in the treatment of infectious diseases. Systematic literature searches were conducted in six computerised databases and the reference lists of all papers located were checked for further relevant publications. Information was also requested from manufacturers, the spontaneous reporting schemes of the World Health Organisation and national drug safety bodies. No language restrictions were imposed. Seven double-blind, controlled trials (n = 896) met the inclusion criteria for evaluation of efficacy. All trials scored at least three, out of a maximum of five, for methodological quality on the Jadad scale. Collectively, the data suggest that A. paniculata is superior to placebo in alleviating the subjective symptoms of uncomplicated upper respiratory tract infection. There is also preliminary evidence of a preventative effect. Adverse events reported following administration of A. paniculata were generally mild and infrequent. There were few spontaneous reports of adverse events. A. paniculata may be a safe and efficacious treatment for the relief of symptoms of uncomplicated upper respiratory tract infection; more research is warranted.
Before you now rush to buy a dietary supplement of A. paniculata, let me stress this in no uncertain terms: the collective evidence is at best suggestive, but it is not compelling. Importantly, there is, to the best of my knowledge, no sound evidence that any herbal remedy is effective in preventing or treating Covid-19 infections.
I truly wished to be able to report more encouraging news, but the truth is the truth, even (I would argue, particularly) in desperate times.
The objective of this trial, just published in the BMJ, was to assess the efficacy of manual acupuncture as prophylactic treatment for acupuncture naive patients with episodic migraine without aura. The study was designed as a multi-centre, randomised, controlled clinical trial with blinded participants, outcome assessment, and statistician. It was conducted in 7 hospitals in China with 150 acupuncture naive patients with episodic migraine without aura.
They were given the following treatments:
- 20 sessions of manual acupuncture at true acupuncture points plus usual care,
- 20 sessions of non-penetrating sham acupuncture at heterosegmental non-acupuncture points plus usual care,
- usual care alone over 8 weeks.
The main outcome measures were change in migraine days and migraine attacks per 4 weeks during weeks 1-20 after randomisation compared with baseline (4 weeks before randomisation).
A total of 147 were included in the final analyses. Compared with sham acupuncture, manual acupuncture resulted in a significantly greater reduction in migraine days at weeks 13 to 20 and a significantly greater reduction in migraine attacks at weeks 17 to 20. The reduction in mean number of migraine days was 3.5 (SD 2.5) for manual versus 2.4 (3.4) for sham at weeks 13 to 16 and 3.9 (3.0) for manual versus 2.2 (3.2) for sham at weeks 17 to 20. At weeks 17 to 20, the reduction in mean number of attacks was 2.3 (1.7) for manual versus 1.6 (2.5) for sham. No severe adverse events were reported. No significant difference was seen in the proportion of patients perceiving needle penetration between manual acupuncture and sham acupuncture (79% v 75%).
The authors concluded that twenty sessions of manual acupuncture was superior to sham acupuncture and usual care for the prophylaxis of episodic migraine without aura. These results support the use of manual acupuncture in patients who are reluctant to use prophylactic drugs or when prophylactic drugs are ineffective, and it should be considered in future guidelines.
Considering the many flaws in most acupuncture studies discussed ad nauseam on this blog, this is a relatively rigorous trial. Yet, before we accept the conclusions, we ought to evaluate it critically.
The first thing that struck me was the very last sentence of its abstract. I do not think that a single trial can ever be a sufficient reason for changing existing guidelines. The current Cochrance review concludes that the available evidence suggests that adding acupuncture to symptomatic treatment of attacks reduces the frequency of headaches. Thus, one could perhaps argue that, together with the existing data, this new study might strengthen its conclusion.
In the methods section, the authors state that at the end of the study, we determined the maintenance of blinding of patients by asking them whether they thought the needles had penetrated the skin. And in the results section, they report that they found no significant difference between the manual acupuncture and sham acupuncture groups for patients’ ability to correctly guess their allocation status.
I find this puzzling, since the authors also state that they tried to elicit acupuncture de-qi sensation by the manual manipulation of needles. They fail to report data on this but this attempt is usually successful in the majority of patients. In the control group, where non-penetrating needles were used, no de-qi could be generated. This means that the two groups must have been at least partly de-blinded. Yet, we learn from the paper that patients were not able to guess to which group they were randomised. Which statement is correct?
This may sound like a trivial matter, but I fear it is not.
Like this new study, acupuncture trials frequently originate from China. We and others have shown that Chinese trials of acupuncture hardly ever produce a negative finding. If that is so, one does not need to read the paper, one already knows that it is positive before one has even seen it. Neither do the researchers need to conduct the study, one already knows the result before the trial has started.
You don’t believe the findings of my research nor those of others?
Excellent! It’s always good to be sceptical!
But in this case, do you believe Chinese researchers?
In this systematic review, all RCTs of acupuncture published in Chinese journals were identified by a team of Chinese scientists. An impressive total of 840 trials were found. Among them, 838 studies (99.8%) reported positive results from primary outcomes and two trials (0.2%) reported negative results. The authors concluded that publication bias might be major issue in RCTs on acupuncture published in Chinese journals reported, which is related to high risk of bias. We suggest that all trials should be prospectively registered in international trial registry in future.
So, at least three independent reviews have found that Chinese acupuncture trials report virtually nothing but positive findings. Is that enough evidence to distrust Chinese TCM studies?
But there are even more compelling reasons for taking evidence from China with a pinch of salt:
A survey of clinical trials in China has revealed fraudulent practice on a massive scale. China’s food and drug regulator carried out a one-year review of clinical trials. They concluded that more than 80 percent of clinical data is “fabricated“. The review evaluated data from 1,622 clinical trial programs of new pharmaceutical drugs awaiting regulator approval for mass production. According to the report, much of the data gathered in clinical trials are incomplete, failed to meet analysis requirements or were untraceable. Some companies were suspected of deliberately hiding or deleting records of adverse effects, and tampering with data that did not meet expectations. “Clinical data fabrication was an open secret even before the inspection,” the paper quoted an unnamed hospital chief as saying. Chinese research organisations seem have become “accomplices in data fabrication due to cutthroat competition and economic motivation.”
So, am I claiming the new acupuncture study just published in the BMJ is a fake?
Am I saying that it would be wise to be sceptical?
Sadly, my scepticism is not shared by the BMJ’s editorial writer who concludes that the new study helps to move acupuncture from having an unproven status in complementary medicine to an acceptable evidence based treatment.
Call me a sceptic, but that statement is, in my view, hard to justify!
The ‘Corona-Virus Quackery Club’ (CVQC) is getting positively crowded. You may remember, its members include:
- colloidal silver crooks,
- TCM practitioners,
- orthomolecular quacks,
- essential oil salesmen,
- and urine/dung peddlers.
Today we are admitting the herbalists. The reason is obvious: many of them have jumped on the corona band-wagon by trying to improve their cash-flow on the back of the pandemic-related anxiety of consumers. If you go on the Internet you will find many examples, I am sure. I have chosen this website for explaining the situation.
Herbs That Can Stop Coronavirus Reproduction
CoV multiplies fast in the lungs and the stomach and intestines. The more virus, the sicker you get. The herbs are in their scientific names and common names.
- Cibotium barometz – golden chicken fern or woolly fern grows in China and Southeast Asia.
- Gentiana scabra – known as Korean gentian or Japanese gentian seen in the United States and Japan.
- Dioscorea batatas or Chinese Yam grows in China and East Asia
- Cassia tora or Foetid cassia, The Sickle Senna, Wild Senna – grows in India and Central America
- Taxillus Chinensis – Mulberry Mistletoe
- Cibotium barometz – golden chicken fern or woolly fern grows in China and Southeast Asia.
Lectin Plants that Have Anti Coronavirus Properties
From the table above, all have anti coronavirus activity except for garlic. One plant that is effective but not listed is Stinging nettle.
Yes, very nice pictures – but sadly utterly unreliable messages. My advice is that, in case you have concerns about corona (or any other health problem for that matter), please do not ask a herbalist.
WELCOME TO THE CVQC, HERBALISTS!
Guest post by Richard Rawlins
Ever since its inception, Homeopathy has struggled to establish principled medical ethics amongst its practitioners. For sure, Samuel Hahnemann was good doctor who achieved much by denying his patients the bleeding, emetics, expectorants, laxatives and poly-pharmacy conventional at the turn of the nineteenth century. But he then lost his way in spiritism and vitalism, devised a system of care which could not, and did not, provide any benefit beyond placebo responses, and inveigled many colleagues to share his delusion. Many derided him.
As medicine in all developed countries became better regulated, so the associated ethics became better focussed. “First do no harm” is common to all systems, but in the UK, the four ‘A’s of avoiding adultery with a patient, alcohol whilst in a clinical situation, advertising, and association formed the next domain. ‘Association’ meant having a professional medical relationship with anyone not also a GMC registrant. Times, and standards have changed, but quackery, charlatanism and health care fraud has always been unethical. The problem for society has been the GMC’s reluctance to take any action against its registrants who lack integrity, promote quackery, or seek to defraud. The general response has been “we only act on complaints by a patient, health authority or fellow registrant – and complaints have to be specific.”
So it is that about 400 registrants of the GMC continue practising homeopathy with impunity. Sir Simon Stevens has now all but banned homeopathy from the NHS, but a medically qualified practitioner, in the private sector can do as they please, no matter how vulnerable and gullible the patient.
Doctors are of course required to obtain fully informed consent to treatment, and that should mean advising patients that homeopathic remedies are but placebos. Many patients so treated will declare they “feel better” and are content – but in practice, no explanation is offered to patients attending homeopaths. A classic charlatonnade (a charade promulgated by a charlatan).
But perhaps the vicissitudes of Covid-19 is exposing the hypocrisy of the GMC’s position, and might yet enable some redress for patients seeking redress for unethical medically qualified homeopathic attention.
The Guardian and Sunday Times of 22nd March 2020 reported that Dr Mark Ali allegedly made £1.7M profit in one week from selling kits to test for COVID -19.
“The GMC said no doctor should try to ‘profit from the fear and uncertainly caused by the pandemic…We would be concerned to learn that doctors are exploiting patient’s vulnerability or lack of medical knowledge, in order to profit from fear and uncertainty…’ “
The rationale for that fear is surely irrelevant – any health practice which takes advantage of the patient’s vulnerability or lack of medical knowledge is unethical. Simple.
“We also expect doctors… not to offer or recommend tests that are unproven, clinically unverified or otherwise unreliable.”
This is in the context of the serious issues of SARS-CoV-2 (the name of the corona virus which causes the illness COVID-19) – but it is helpful that the GMC’s ethical principles have been clearly stated.
May we take it the GMC will be equally as stringent with their registrants (doctors) who take advantage of the patient’s vulnerability or lack of medical knowledge, and recommend tests such as homeopathic provings “that are unproven, clinically unverified or otherwise unreliable.”?
And if not, why not?
All homeopathic remedy prescriptions are ‘tests’: “Take this, see how you go, I’ll adjust if needed…”. The German word pruefung used by Hahnemann (meaning ‘testing’ or ‘examination’) has been translated into English as ‘proving’. But the word for ‘to prove’ is beweisen, and that is not the word Hahnemann used. The use of ‘proving’ in English implies merit which is not deserved. All part of the delusion.
Clearly, any doctor who recommends homeopathic remedies, but does not explain the conventional view of the remedy, lacks integrity and is unethical – by definition. If the doctor is GMC registered (which a ‘doctor’ does not have to be – e.g., dentists are not) – they should be subject to sanction by the GMC. The GMC should do its duty to protect the public, and not wait for a crisis to stir them into action.
Sadly, if practitioners are not GMC registered, caveat emptor.
Lynne McTaggart and Bryan Hubbard, editors of What Doctors Don’t Tell You and Get Well magazines, are pleased to announce a series of four FREE weekly webinars, via Zoom, starting Thursday, April 2 designed to maximize your health and wellness in every way during these challenging times.
In these free hour-long sessions, Lynne and Bryan will interview a number of pioneering doctors and specialists, who will give you detailed advice about natural substances that kill viruses, the best supplements, foods and exercises to boost your immune system, and the best techniques to stay calm and centered during these challenging times.
Sign up to be sent the link for the live webinar where you can have the ability to ask your questions to these pioneers, get access to the recording of the webinars and receive a handout of helpful relevant tips to that webinar.
Thursday, April 2, 2020
9 am PDST/12pm EDST/5 pm BST/6 pm CSTThis webinar will feature the best substances and supplements proven to prevent the spread of viruses. Joining Lynne and Bryan are noted pioneer Dr. Damien Downing, president of the Society for Environmental Medicine, who was part of a team of orthomolecular doctors who devised a special supplement preventative against the coronavirus; Dr. Sarah Myhill, a British integrative doctor noted expert on vitamin C and other natural virus killers; and Dr. Robert Verkerk PhD, the founder and president of the Alliance for Natural Health and an expert on food and health.
Yesterday, it was announced that Prince Charles, a long-time advocate of so-called alternative medicine (SCAM), has been taken ill with the corona virus. Since then, I have been inundated with messages about this fact. Many thought that, because Charles and I have a bit of history (details here), I might now ‘have a cup of tea and a malicious smile on [my] face thinking about it’, as someone put it on Twitter. Others made sarcastic comments suggesting that he will be fine because of all the help of the homeopathic cult.
I cannot join these sentiments. On the contrary, I sincerely wish him well – not because he is royalty, but because I wish everyone well who has been infected with this virus.
And I honestly do not think that Charles will be popping homeopathic placebos to save his life. Whenever a member of his (usually pro-homeopathy) family had fallen seriously ill in the past, they very quickly sought the help of the very best evidence-based medicine could offer. Charles’ present illness will be no exception, I am sure. If his infection becomes serious, he will have the benefit of everything modern scientific healthcare has to offer.
When he recovers – and I do hope he does – he will have plenty of time to think. Chances are that he never before had been afflicted with a killer disease. This should make him see things from an entirely new perspective. He must realise that so-called alternative medicine (SCAM) is an option only as long as one is healthy. Once the battle for saving a life is on, real medicine must save the day.
I am a born optimist, and therefore I hope that Charles on his sick-bed might even think a little further. He might realise that a health crisis, like the current corona pandemic, regularly brings out the charlatans who are trying to flog their wares or services to the unsuspecting public. On my blog, I have discussed some of these irresponsible rogues:
- colloidal silver crooks,
- TCM practitioners,
- orthomolecular quacks,
- essential oil salesmen,
- urine/dung quacks,
- supplement peddlers.
With a bit of luck, Charles might even reflect that his past endorsement of these quacks has been less than helpful; in the present crisis, it might even cost lives. Charles, I hope, will thus reconsider his attitude towards medicine, heaven knows, he might even become an outspoken advocate fro EBM!
So yes, I am an incurable optimist. Yet, I realise, of course, that Charles might not have any of these insights. That would be regrettable, but it does not deter me from wishing him a speedy recovery:
GET WELL SOON, CHARLES!
[If you do not like black humour or sarcasm, please do NOT read this post!!!]
Donald Trump just announced that, at Easter, he wants to see churches packed, his way of saying the lock-down is over because it is damaging the economy. Many others have put forward similar arguments and have pointed out that caring for the vulnerable, sick, old, etc. creates an economic burden that might eventually kill more people than it saves (see for instance ‘Economic crash could cost more lives than coronavirus, study warns‘).
Many people have also argued that homeopathy is unjustly vilified because it is truly a wholesome and safe medicine that should be used routinely. The notion here is that, alright, the evidence is not brilliant, but 200 years of experience and millions of fans cannot be ignored.
I have been wondering whether these two lines of thinking could not be profitably combined. Here is my suggestion based on the following two axioms.
- The economy is important for all our well-being.
- Homeopaths have a point in that the value of experience must not be ignored.
What follows is surprisingly simple: in view of the over-riding importance of the economy, let’s prioritise it over health. As it would look bad to deny those poor corona victims all forms of healthcare, let’s treat them homeopathically. This would make lots of people happy:
- those who think the economy must take precedent,
- those who fear the huge costs of saving corona patients (homeopathy is very cheap),
- those who argued for decades that we never gave homeopathy a fighting chance to show its worth.
There is a downside, of course. There would be a most lamentable mortality rate. But, to paraphrase Dominic Cummings, if a few oldies have to snuff it, so be it!
Once we get used to this innovative approach – I suggest we call it integrative medicine – we might even consider adopting it for other critical situations. When we realise, for instance, that the pension pots are empty, we could officially declare that homeopathy is the ideal medicine for anybody over 60.
What do you think?
I have often stated jokingly that ‘HOMEOPATHY IS INCURABLE’; well, I was wrong! There seems to be a treatment that works quite reliably.
It’s called humour.
The Brits have been the pioneers in this field. One of the best examples is this classic by Mitchell and Webb.
In my view, it marked a turning point in UK homeopathy. After it’s enormous success, even the NHS re-considered its previously positive stance on homeopathy.
Now, a brilliant French comedian, Jeremy Ferrari, is having a similar success with his homeopathy-show in France. And it too marks the turning point where homeopathy is starting to be phased out from reimbursement in France.
So, are comedians the ones that bring consumers to reason when it comes to absurdities such as homeopathy? Or are comedians gifted at picking up the Zeitgeist and thus merely the ones who hammer the last nail into the coffin of homeopathy?
I think it is probably a bit of both.
But, whatever it is, these guys are brilliant! They achieve more good with their work than others writing clever articles in the Lancet and other medical journals. One good laugh seems to be more efficacious that pages of critical analysis.
If my blog has in the past stimulated some of these comedians to do their ingenious work – and I happen to know it has – I am both delighted and proud.
So far, our ‘Corona-Virus Quackery Club’ (CVQC) boasts the following membership:
- colloidal silver crooks,
- TCM practitioners,
- orthomolecular quacks,
- essential oil salesmen,
- and the urine/dung quacks.
It is time now, I think, to admit some supplement peddlers.
Many dietary supplement merchants seem to feel that the current pandemic is an excellent opportunity to flog their useless wares to the anxious public.
In order to support increasing worldwide demand for the LYMA supplement, we would like to inform new and existing customers that we have sufficient stock in place to ensure uninterrupted supply.”
This was the text of an email I received recently. It linked to a website that informed me of the following:
We continue to work with our scientific network and global supply chain to bring you the latest scientific developments as they arise.
Dr. Paul Clayton, PhD – Director of Science, LYMA
“Covid-19 is causing an enormous amount of illness and disruption. This is due to its high transmission rates, long incubation period, and the substantial numbers of people – 15 to 20% of those infected – who become ill enough to require hospitalisation. This last aspect is concerning as no health care system in the world has sufficient resources to cope with such an influx of seriously ill patients.
At the time of writing there are no specific treatments available. The only advice given is to avoid crowds, wash the hands frequently, and not touch the face. Some authorities recommend face masks and gloves; and we are increasingly being recommended to shelter in place.
But there may be more we can do to protect ourselves. Dysnutrition is common, due to our over-consumption of ultra-processed foods with little nutritional value. Supplements have a role to play in improving general nutritional status and general immunity. But we can take that further.
LYMA. The ultimate supplement.
Chronic stress reduces immuno-competence and makes us more vulnerable to infection. Adaptogens such as KSM-66 Ashwagandha in LYMA have the ability to alleviate the damaging effects of stress and have been shown to improve immunity. So have the Wellmune 1-3, 1-6 beta glucans in LYMA, with many hundreds of studies showing that these natural compounds increase resistance to infection.
These are just two elements that may improve our chances in the difficult times ahead.”
Dr. Paul Clayton, PhD – Director of Science, LYMA
In case the name ‘LYMA’ rings a bell: yes, we have previously discussed the ‘the world’s first super supplement’ and the many claims made for it. We even had the pleasure of an interesting exchange with the above-pictured Dr Paul Clayton in the comments section of that post. Given the above, I am more than happy to welcome him, his LYMA team, and all other supplement peddlers who try to make a fast buck in the present crisis to the CVQC.
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.
|Outcome:||E. coli nosode||Placebo||Row totals:|
|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.