MD, PhD, FMedSci, FSB, FRCP, FRCPEd

medical ethics

We have discussed the risks of (chiropractic) spinal manipulation more often than I care to remember. The reason for this is simple: it is an important subject; making sure that as many consumers know about it will save lives, I am sure. Therefore, any new paper on the subject is likely to be reported on this blog.

Objective of this review was to identify characteristics of 1) patients, 2) practitioners, 3) treatment process and 4) adverse events (AE) occurring after cervical spinal manipulation (CSM) or cervical mobilization. Systematic searches were performed in 6 electronic databases. Of the initial 1043 studies, 144 studies were included.

They reported 227 cases. 117 cases described male patients with a mean age of 45 (SD 12) and a mean age of 39 (SD 11) for females. Most patients were treated by chiropractors (66%) followed by non-clinicians (5%), osteopaths (5%), physiotherapists (3%) and other medical professions. Manipulation was reported in 95% of the cases (mobilisations only in 1.7%), and neck pain was the most frequent indication.

Cervical arterial dissection (CAD) was reported in 57% of the cases and 46% had immediate onset symptoms; in 2% onset of symptoms took for more than two weeks. Other complications were disc rupture, spinal cord swelling and thrombus. The most frequently reported symptoms included disturbance of voluntary control of movement, pain, paresis and visual disturbances.

In most of the reports, patient characteristics were described poorly. No clear patient profile, related to the risk of AE after CSM, could be extracted. However, women seem more at risk for CAD.

The authors concluded that there seems to be under-reporting of cases. Further research should focus on a more uniform and complete registration of AE using standardized terminology.

I do not want to repeat what I have stated in previous posts on this subject. So,let me just ask this simple question: IF THERE WERE A DRUG MARKTED FOR NECK PAIN BUT NOT SUPPORTED BY GOOD EVIDENCE FOR EFFICACY, DO YOU THINK IT WOULD BE ON THE MARKET AFTER 227 CASES OF SEVERE ADVERSE EFFECTS HAD BEEN DESCRIBED?

I think the answer is NO!

If we then consider the huge degree of under-reporting in this area which might bring the true figure up by one or even two dimensions, we must ask: WHY IS CERVICAL MANIPULATION STILL USED?

A recent article in the Guardian revealed that about one third of Australian pharmacists are recommending alternative medicines with little-to-no evidence for their efficacy, including useless homeopathic products and potentially harmful herbal products.

For this survey of 240 Australian pharmacies, mystery shoppers were sent in to speak to a pharmacist at the prescription dispensing counter and ask for advice about feeling stressed. The results show that three per cent of the pharmacists recommended homeopathic products, despite a comprehensive review of all existing studies on homeopathy finding that there is no evidence they work in treating any condition and that ‘people who choose homeopathy may put their health at risk if they reject or delay treatments’. Twenty-six percent of all pharmacists recommended Bach flower remedies to relieve stress. A comprehensive review of all existing studies on Bach flower remedies found no difference between the remedies and placebos. Fifty-nine per cent of people were just told the complementary and alternative product recommended to them worked, and 24% were told the product was scientifically proven, without any evidence being provided to them.

Asked about these findings, Dr Ken Harvey, a prominent Australian expert, said they demonstrated that some pharmacists were failing in their professional duty to consumers. “Pharmacists are giving crazy advice, and it is dangerous in some cases,” he said. “My view is that pharmacists, if they are going to sell these products, need to have a big shining sign over the shelves of the complementary and alternative medicine section that says ‘these products have not been assessed by the government regulators to see if they work, please talk to pharmacist’.Pharamacists are giving poor advice and they clearly have a conflict of interest,” Harvey said.

If you had hoped that in other countries pharmacists behave more responsibly, I must disappoint you. The information available shows that, when it comes to alternative medicine, pharmacists across the globe act much more like shop-keepers than like health care professionals. They are in the habit of putting profit before their duty to abide by the rules of evidence-based practice. And, in doing do, they violate their own ethical codes so regularly that I ask myself why they bothered to even implement one.

On this blog I have written so often about this issue that one could come to the conclusion that I have a bee under my bonnet:

The truth, however, is not that I am the victim of a bee.

The truth is that this is a very important public health issue.

The truth is that pharmacists show little signs of even trying to get to grips with it.

The truth is that pharmacists who sell bogus medicines put profit before professional ethics.

The truth is that such behaviour is not that of health care professionals but that of shop-keepers.

The truth is that I intend to carry on reminding these pharmacists that they are behaving like charlatans.

Although many conservative management options are being promoted for shoulder conditions, there is little evidence of their effectiveness. This review investigated one manual therapy approach, thrust manipulation, as a treatment option.

A systematic search was conducted of the electronic databases from inception to March 2016: PubMed, PEDro, ICL, CINAHL, and AMED. Two independent reviewers conducted the screening process to determine article eligibility. Inclusion criteria were manuscripts published in peer-reviewed journals with human participants of any age. The intervention included was thrust, or high-velocity low-amplitude, manipulative therapy directed to the shoulder and/or the regions of the cervical or thoracic spine. Studies investigating secondary shoulder pain or lacking diagnostic confirmation procedures were excluded. Methodological quality was assessed using the PEDro scale and the Cochrane risk-of-bias tool.

The initial search rendered 5041 articles. After screening titles and abstracts, 36 articles remained for full-text review. Six articles studying subacromial impingement syndrome met inclusion criteria. Four studies were randomized controlled trials (RCTs) and two were uncontrolled clinical studies. Five studies included one application of a thoracic spine thrust manipulation and one applied 8 treatments incorporating a shoulder joint thrust manipulation. Statistically significant improvements in pain scores were reported in all studies. Three of 4 RCTs compared a thrust manipulation to a sham, and statistical significance in pain reduction was found within the groups but not between them. Clinically meaningful changes in pain were inconsistent; three studies reported that scores met minimum clinically important difference, one reported scores did not, and two were unclear. Four studies found statistically significant improvements in disability; however, two were RCTs and did not find statistical significance between the active and sham groups.

The authors concluded that there is limited evidence to support or refute thrust manipulation as a solitary treatment for shoulder pain or disability associated with subacromial impingement syndrome. Studies consistently reported a reduction in pain and improvement in disability following thrust manipulation. In RCTs, active treatments were comparable to shams suggesting that addressing impingement issues by manipulation alone may not be effective. Thrust manipulative therapy appears not to be harmful, but AE reporting was not robust. Higher-quality studies with safety data, longer treatment periods and follow-up outcomes are needed to develop a stronger evidence-based foundation for thrust manipulation as a treatment for shoulder conditions.

This is yet another very odd conclusion from an otherwise almost acceptable analysis (but why include non-randomised studies on a subject where randomised trials are available?) . If pain reductions are found within groups but not between real and sham manipulation, the evidence is as clear as it can be: manipulations have no specific effects. In other words, they are a pure placebo therapy.

And what about this nonsense: there is limited evidence to support or refute thrust manipulation as a solitary treatment for shoulder pain? For responsible healthcare, we don’t need such weasel words, all we need is to stress loud and clear that there is no good positive evidence. This means the therapy is not evidence-based and we therefore should not recommend or use manipulation for shoulder pain.

But, in my view, the worst part in the conclusion section is this: thrust manipulative therapy appears not to be harmful, but AE reporting was not robust. Even if there had been adequate reporting of side-effects and even if this had not disclosed any problems, the safety of manipulation cannot be judged on the basis of such a small sample. Any responsible researcher should make it abundantly clear that the nasty habit by chiropractic pseudo-researchers of not reporting adverse effects is unethical and totally unacceptable.

My conclusion from all this: yet another attempt to white-wash a dodgy alternative therapy.

 

The British Homeopathic Association (BHA) is a registered charity founded in 1902. Their objectives are “to promote and develop the study and practice of homeopathy and to advance education and research in the theory and practice of homeopathy…” and their priority is “to ensure that homeopathy is available to all…” The BHA believes that “homeopathy should be fully integrated into the healthcare system and available as a treatment choice for everyone…”

This does not bode well, in my view. Specifically, it does not seem as though we can expect unbiased information from the BHA. Yet, from a charity we certainly do not expect a packet of outright lies – so, let’s have a look.

The BHA have a website (thank you Greg for reminding me of this source; I have long known about it and used it often for lectures when wanting to highlight the state of homeopathic thinking) where they provide “THE EVIDENCE FOR HOMEOPATHY“. I find the data presented there truly remarkable, so much so that I present a crucial section from it below:

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The widely accepted method of proving whether or not a medical intervention works is called a randomised controlled trial (RCT). One group of patients, the control group, receive placebo (a “dummy” pill) or standard treatment, and another group of patients receive the medicine being tested. The trial becomes double-blinded when neither the patient nor the practitioner knows which treatment the patient is getting. RCTs are often referred to as the “gold standard” of clinical research.

Up to the end of 2014, a total of 104 papers reporting good-quality placebo-controlled RCTs in homeopathy (on 61 different medical conditions) have been published in peer-reviewed journals. 41% of these RCTs have reported a balance of positive evidence, 5% a balance of negative evidence, and 54% have not been conclusively positive or negative. For full details of all these RCTs and more in-depth information on the research in general, visit the research section of the Faculty of Homeopathy’s website. Also, see 2-page evidence summary with full references.

END OF QUOTE

Impressive!

But is it true?

Let’s have a closer look at the percentage figures: according to the BHA

  • 41% of all RCT are positive,
  • 5% are negative,
  • 54% are inconclusive.

These numbers are hugely important because they are being cited regularly across the globe as one of the most convincing bit of evidence to date in support of homeopathy. If they were true, many more RCT would be positive than negative. They would, in fact, constitute a strong indicator suggesting that homeopathic remedies are more than placebos.

One does not need to look far to find that these figures are clearly not correct! To disclose the ‘mistake’, we do not even need to study any of the 104 RCTs in question, we only need to straighten out the BHA’s ‘accounting error’ and ask: what on earth is an ‘inconclusive’ RCT?

A positive RCT obviously is one where homeopathy generated better outcomes than the placebo; similarly a negative RCT is one where the opposite was the case; in other words, where the placebo generated better outcomes than homeopathy. But what is an ‘inconclusive’ RCT? It turns out that, according to the BHA, it is one where there was no significant difference between the results obtained with placebo and homeopathy.

WHAT???

Yes, you understood correctly!

Outside homeopathy such RCTs are categorised as negative studies – they fail to show that homeopathy out-performs placebo and therefore confirm the null-hypothesis. An RCT is a test of the null-hypothesis (the experimental treatment is not better than the control) and can only confirm or reject this hypothesis. Certainly finding that the experimental treatment is not better than the control is not inconclusive bit a confirmation of the null-hypothesis. In other words it is a negative result.

So, let’s look at the little BHA – statistic again, and this time let’s do the accounting properly:

  • 41% of all RCTs are positive,
  • 59% are negative.

This means that, according to this very simplistic method, the majority of RCTs is negative. I say ‘very simplistic’ because, for a proper analysis of the trial evidence, we need to account, of course, for the quality of each trial. If the quality of the positive RCTs is, on average, less rigorous than that of the negative RCTs, the overall result would become yet more clearly negative. Most assessments of homeopathy that consider this essential factor do, in fact, confirm that this is the case.

Once all this has been analysed properly, we still have to account for factors like publication bias. Negative trials get often not published and therefore the overall picture gets easily distorted and generates a false-positive image. At the end of a sound evaluation along these lines, the result would fail to show that homeopathy differs from placebo.

Regardless of all these necessary and important considerations, the BHA website then tells us that the RCT method is problematic when it comes to testing homeopathy: “The RCT model of measuring efficacy of a drug poses some challenges for homeopathic research. In homeopathy, treatment is usually tailored to the individual. A homeopathic prescription is based not only on the symptoms of disease in the patient but also on a host of other factors that are particular to that patient, including lifestyle, emotional health, personality, eating habits and medical history. The “efficacy” of an individualised homeopathic intervention is thus a complex blend of the prescribed medicine together with the other facets of the in-depth consultation and integrated health advice provided by the practitioner; under these circumstances, the specific effect of the homeopathic medicine itself may be difficult to quantify with precision in RCTs.”

What are they trying to say here?

I am not sure.

Are they perhaps claiming that, even if an independent scientist disclosed their ‘accounting error’ and demonstrated that, in fact, the RCT evidence fails to support homeopathy, the BHA would still argue that homeopathy works?

I think so!

It looks to me that the BHA is engaged in the currently popular British past-time: THEY WANT THE CAKE AND EAT IT.

All this is more than a little disturbing, and I think it begs several questions:

  • Is this type of behaviour in keeping with the charitable status of the BHA?
  • Does it really ‘promote and develop the study and practice of homeopathy and to advance education and research’?
  • Is it not rather unethical to mislead the public in such a gross and dishonest fashion?
  • Is it not fraudulent to insist on false accounting?

I would be interested to get your views on this.

Homeopathy is never far from my mind, it seems. and this is reflected by the many posts on the subject that I continue to publish. Homeopaths get more than a little irritated by what they see as my ‘obsession’ with their beloved therapy. They thus try anything – yes, I mean anything – to undermine my credibility. One very popular way of doing this is to claim that I am sitting in the ‘ivory tower’ of academia and have no real inkling of the life on the ‘coal face’ of healthcare.

Because this is an argument that I find difficult to counter – I have indeed not routinely seen patients for over 20 years! – I was immensely pleased to read this article by an Australian GP. I take the liberty of quoting a section from it below:

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…An intricate web of lies protects the pernicious practice of homeopathy in Australia. Homeopathy is one of the most widespread disciplines of alternative medicines, with an estimated one million Australian consumers. It’s very popular. It also doesn’t work. At all. No better than a sugar pill, anyway. Turns out, vials of homeopathic remedies are chemically indistinguishable from water. Numerous international investigations and a scientific review of over 1800 studies by the National Medical Health Research Council could not be clearer: there is zero evidence that homeopathy is an effective treatment for medical conditions.

And yet the practice of homeopathy in Australia goes largely unchecked. The industry is overwhelmingly self-regulated by its own board, lending it an undue air of legitimacy. Meanwhile homeopaths advertise their ability to treat everything from autism to haemorrhoids with near impunity. Most obscenely, homeopathic therapies attract rebates under private health insurance policies that are funded by public taxes.

The justifications for allowing homeopathy are convoluted. One of the most common defences is that if the remedies truly are ineffective vials of water, then they are harmless. This is perhaps the most toxic myth about these therapies. Giving people a false cure for real symptoms is dangerous, because it delays correct diagnosis and treatment.

As a general practitioner I have observed the consequences of this in practice, seeing patients of homeopaths with conditions ranging from undiagnosed autoimmune disorders to mistreated blood pressure. These experiences mirror more notorious incidents – one West Australian coronial inquest in 2005 revealed a case where a homeopath treated rectal cancer, leading to the patient’s death. In 2009, a nine-month-old child with severe eczema was treated by her homeopath father who was later found guilty of manslaughter by denying her conventional medical care.

These are the kind of horror stories that prompt bureaucracies into symbolic action. Enter the Victorian Health Complaints Commission: a brand new watchdog unveiled last week to reign in, as Premier Daniel Andrews called them, “dodgy health providers”. The idea is that “health service providers” in Victoria, whether officially registered or not, will have to follow a general code of conduct. Included in this category are all homeopaths, and practitioners of other completely debunked practices such as reiki and iridology. The idea seems good on paper. The new code demands practitioners are truthful about their treatments, and act in the patient’s best interest. But here’s the catch – the commission will only take action on complaints lodged against individual practitioners.

This system is clearly geared towards only chasing a handful of rogue practitioners. But the problem isn’t a few rogue practitioners – it’s entirely rogue industries. The discipline of homeopathy, by its very nature, is untruthful.

Perhaps we can begin by following the lead of the United States, where the Federal Trade Council has ruled that homeopathic medicine labels must state that there is no scientific evidence backing homeopathic health claims. You have to admit, it’s bold stuff. It leaves our ACCC looking quite impotent. Real change requires the kind of courage that is in short supply.

That’s what it comes down to – cowardice. Homeopathy, along with an array of debunked complementary and alternative health disciplines, are tolerated by authorities to avoid an inconvenient confrontation. They let it slide to avoid upsetting delusional practitioners, misinformed customers, and anyone profiting from the practice. The presence of disproved medicines has insidiously embedded itself so deeply into our culture that curtailing a false cure is a huge political risk. So the status quo prevails, lest we rock the boat. Never mind that it’s heading straight down a waterfall.

END OF QUOTE

This clearly is a deeply felt and well-expressed article. It reiterates what we have regularly been trying to get across on this blog. But it is much better than anything I could ever contribute to the subject; it comes from someone who encounters the ‘pernicious practice of homeopathy’ on a regular basis and who knows about the harm it can do.

All I need to add is this: WELL DONE DOCTOR VYOM  SHARMA!

According to our friend Dana Ullman, “homeopathy has had a long tradition within Russia. Even though it was not officially recognized during the Communist regime, it was tolerated. And perhaps in part because it did not receive governmental sanction, the Russian people developed a trust in homeopathy. Due to the fact that homeopathic physicians worked outside of governmental medicine, homeopathy was a part of Russia’s “new economy”. People had to pay for homeopathic care, rather than receive it for free.

Homeopathy is still the minority practice. I was told that there are approximately one million medical doctors in Russia and its surrounding republics, with 15,000 medical doctors who use homeopathic medicines regularly, and about 3,000 medical doctors who specialize in classical homeopathy.”

But the ‘free ride’ of homeopathy seems to come to an end. We have seen this happening, for instance in the US, UK, Australia, and Germany. And now it is happening also in Russia:

It has just been reported that the Russian Academy of Sciences (RAS) has labelled homeopathic medicine a health hazard. The organization is now petitioning Russia’s Ministry of Health to abandon the use of homeopathic medicine in the country’s state hospitals, the RBC news outlet reported Monday.

A RAS committee warns that some patients were rejecting standard medicine for serious conditions in favour of homeopathic remedies, a move that almost inevitably puts their lives in danger. The committee also noted that, because of sloppy quality control during the manufacturing processes, some unlicensed homeopathic remedies contain toxic substances which harm patients in a direct fashion.

“The principles of homeopathy contradict known chemical, physical and biological laws and persuasive scientific trials proving its effectiveness are not available,” the committee stated in its report.

The move forms part of a growing backlash against homeopathy in Russia. Last month, students at the First Moscow State Medical University filed a petition to ban homeopathic principles from being taught in medical schools. Russia’s Federal Customs Service also introduced new rules in November 2016, forcing manufacturers to prove the effectiveness of any homeopathic products that they wish to sell.

To this, I have little to add; perhaps just this: ABOUT TIME TOO!

Yes, homeopaths are incredibly fond of the notion that homeopathy has been proven to work in numerous population studies of outbreaks of infectious diseases. The argument is bound to come up in any discussion with a ‘well-informed’ homeopathy fan. Therefore, it might be worth addressing it once and for all.

This website offers a fairly good summary of what homeopaths consider to be convincing evidence. It also provides links to the original articles which is valuable for all who want to study them in full detail. I will therefore present the crucial passage here unchanged.

START OF QUOTE

By the end of year 2014, there have been 19 papers published on Epidemiological studies on 7 epidemic diseases (scarlet fever, typhus fever, Cholera, Dengue, meningococcal, influenza and Leptospirosis) in 11 peer-reviewed (beyond year 1893) journals in evidence of Homeopathy including 2 Randomised Controlled Trials.

1. Samuel Hahnemann, “The Cure and prevention of scarlet fever”, Zeitschrift für Praktischen Medizin (Journal of Practical Medicine), 1801, Republished in Lesser Writings. B.Jain Publishing, New Delhi

Preventive use of homeopathy was first applied in 1799 during an epidemic of scarlet fever in Königslütter, Germany, when Dr. Hahnemann prescribed a single dose of Belladonna, as the remedy of the genus epidemicus to susceptible children in the town with more than 95% success rate. In this paper, he also specified how the Belladonna has to be potentised to 1/24,000,000 dilution. His recommended dose of Belladonna was 0.0416 nanograms to be repeated every 72 hrs. This is the first recorded nano dose of medicine used in treatment of any disease [6]. It was another 125 years before Gladys Henry and George Frederick developed a vaccine for scarlet fever in 1924.

2. Samuel Hahnemann, “Scarlet fever and Purpura miliaris, two different diseases”, Zeitschrift für Praktischen Medizin, vol. 24, part. 1, 1806

3. Samuel Hahnemann, “Observations on scarlet fever”, Allgemeine Reichanzeiger (General Reich Gazette), No. 160, Germany, 1808

4. Samuel Hahnemann, “Reply to a question about the prophylactic for scarlet fever”, Zeitschrift für Praktischen Medizin, vol. 27, part. 4, p. 152-156, 1808

5. Samuel Hahnemann, “Treatment of typhus & fever at present prevailing”, Allgemeine Reichanzeiger, No. 6, Jan. 1814.

6. Hufeland, Prophylactic powers of Belladonna against Scarlet Fever , The Lancet, 1829
The proper use of belladonna has, in most cases, prevented infection. Numerous observations have shown that, by the general use of belladonna, epidemics of scarlet fever have actually been arrested. In those few instances where the use of belladonna was insufficient to prevent infection, the disease has been invariably slight. The Prussian (German Empire) Government ordered the use of the prophylactic during all scarlet fever epidemics

7. Samuel Hahnemann, “Cure and prevention of Asiatic cholera”, Archiv für die homöopathische Heilkunst (Archives for the Homoeopathic Healing Art), Vol. 11, part 1, 1831.
Cuprum 30c once every week as preventive medicine

8. Samuel Hahnemann, “On the contagiousness of cholera”. British Homoeopathic Journal, Vol. 7, 1849

9. Samuel Hahnemann, “Appeal to Thinking Philanthropists Respecting the Mode of Propagation of the Asiatic Cholera”, 20 pages, 1831. Republished in British Homoeopathic Journal, Oct 1849.

He said, “On board ships – in those confined spaces, filled with mouldy watery vapours, the cholera-miasm finds a favourable element for its multiplication, and grows into an enormously increased brood of those excessively minute, invisible, living creatures, so inimical to human life, of which the contagious matter of the cholera most probably consists millions of those miasmatic animated beings, which, at first developed on the broad marshy banks or the tepid Ganges– on board these ships, I say, this concentrated aggravated miasm kills several of the crew …” [7].
It was another 59 years (1890) before Koch saw these organisms, and later on orthodox medicine gave them the name ‘germs’

10. Charles Woodhull Eaton, The Facts about Variolinum, Transactions of the American Institute of Homoeopathy, 1907
2806 patients were treated prophylactically with Variolinum 30 (a nosode) for prevention of smallpox in Iowa. Of the 547 patients definitely exposed, only 14 developed the disease. Efficacy rate of 97.5%

11. Taylor Smith A, Poliomyelitis and prophylaxis British Homoeopathic Journal, 1950
In 1950 during an epidemic of poliomyelitis, Dr Taylor Smith of Johannesburg, South Africa protected 82 people with homoeopathic Lathyrus sativus. Of the 82 so immunised, 12 came into direct contact with disease. None were infected.

12. Oscillococcinum 200c in the treatment of influenza during epidemic in France from 1984-1987, British Journal of Clinical Pharmacology (1989)
A DBRPCT, Oscillococcinum 200c taken twice daily for 5 days significantly increased the rate of cure within two days (n=487, 237 treated and 241 on placebo), absence of symptoms at 48 hours, relative risk estimate significantly favour homeopathy (p=0.048), no pain and no fever (p=0.048), recovery rate (headache, stiffness, articular pain, shivering reduction) at 48 hours better in homeopathy group (p=0.032)

13. Bernard Leary, Cholera 1854 Update, British Homoeopathic Journal, 1994
Sir William Wilde, the well-known allopathic doctor of Dublin, which in his work entitled “Austria and its Institutions”, wrote: “Upon comparing the report of the treatment of Cholera in the Homeopathic hospital testified to by two allopathic medical inspectors appointed by Government with that of the treatment of the same disease in the other hospitals of Vienna during the same period the epidemic of 1836, it appeared that while two-thirds of the cases treated by Dr. Fleischmann the physician of the Homeopathic hospital, recovered, two-thirds of those treated by the ordinary methods in the other hospitals died.”

14. Meningococcinum – its protective effect against meningococcal disease, Homeopathy Links, 2001 (2001)
A total of 65,826 people between the ages of 0–20 were immunised homeopathically to protect against meningococcal disease while 23,532 were not. Over a year period, 4 out of 65,826 protected homeopathically developed meningococcal infection. 20 out of 23,532 not protected developed meningococcal infection. Based on the infection rate in the unprotected group, 58 cases of infection could have been expected in the homeopathically protected group. Instead, there were only four cases of meningococcal infection. Statistical analysis showed that homeopathic immunisation offered 95% protection in the first six months and 91% protection over the year against meningococcal disease. [8]

15. Contribution of homeopathy to the control of an outbreak of dengue epidemic in Macaé, Rio de Janeiro, Brazil in 2007-8 , International Journal of High Dilution Research, 2008
In a campaign ‘Homeopathy campaign against dengue’ by Brazilian Govt, “156,000 doses of homeopathic remedy were freely distributed in April and May 2007 to asymptomatic patients and 129 doses to symptomatic patients treated in outpatient clinics, according to the notion of genus epidemicus . The remedy used was a homeopathic complex against dengue containing Phosphorus 30c, Crotalus horridus 30c and Eupatorium perfoliatum 30c. The incidence of the disease in the first three months of 2008 fell 93% by comparison to the corresponding period in 2007, whereas in the rest of the State of Rio de Janeiro there was an increase of 128%.”

16. Marino R. Eupatorium perfoliatum 30c for the Dengue Epidemics in Brazil in 2007. International Journal of High Dilution Research, 2008
In May 2001, prophylactic use of Eupatorium perfoliatum 30c single dose was given during a dengue outbreak to 40% of residents in the most highly affected neighbourhood which resulted in significant decrease in dengue incidence by 81.5% (p<0.0001) when compared with those neighbourhoods that did not receive homeopathic prophylaxis.

17. Bracho et. al. Application of 200C potency of bacteria for Leptospirosis epidemic control in Cuba 2007-8 (2010)
Conducted by the Finlay Institute, a vaccines producer in Cuba gave 2.308562 million (70% of the target population above the age of 1 year) people in Cuba given two doses (1 dose=5 drops) of 200C potency of a nosode prepared from Leptospirosis bacteria, each (7-9 days apart), for protection against Leptospirosis (fever+jaundice+ inflammation in kidney+enlargement of spleen) with 84% decrease in disease incidence and only 10 reported cases. Dramatic decrease in morbidity within two weeks and zero morbidity of hospitalised patients, non-treated (8.8 millions) area saw an increase in number of cases from 309 cases in 2007 to 376 in 2008 representing a 21% increase. The cost of homeopathic immunization =1/15th of conventional vaccine.

18. Effect of individualized homoeopathic treatment in influenza like illness, Indian Journal of Research in Homeopathy (2013)
A multicenter, single blind, randomized, placebo controlled study to evaluate the effect of homoeopathic medicines in the treatment of Influenza like illness and to compare the efficacy of LM (50 millisimal) potency vis-à-vis centesimal (C) potency. In LM group (n=152), C group (n=147) or placebo (n=148) group. The study revealed the significant effect of individualized homoeopathic treatment in the patients suffering from ILI with no marked difference between LM and Centesimal groups. The medicines which were commonly prescribed were: Arsenic album, Bryonia alba, Rhus tox., Belladonna, Nux vomica, Sepia, Phosphorus, Gelsemium, Sulphur, Natrum mur. and Aconitum napellus. [9]

19. Reevaluation of the Effectiveness of Homoeoprophylaxis Against Leptospirosis in Cuba in 2007-8, Journal of Evidence-based Complementary & Alternative Medicine (2014)
The results support the previous conclusions that homoeoprophylaxis can be used to effectively immunize people against targeted infectious diseases such as leptospirosis.

References
[1] Iman Navab, Lives saved by Homeopathy in Epidemics and Pandemics, https://drnancymalik.wordpress.com/2013/01/23/epidemics-and-pandemics/

[2] Reshu Agarwal, Natural History of Disease and Homeopathy at different levels of Intervention, http://www.homeorizon.com/homeopathic-articles/homeopathic-philosophy/disease-history

[3] Homoeopathy- Science of Gentle Healing, Deptt. of AYUSH, Ministry of Health & Family Welfare, Govt, of India, 2013, http://www.ccrhindia.org/Dossier/content/page22.html

[4] Conversation with David Little, http://hpathy.com/homeopathy-papers/conversations-with-david-little/

[5] Nancy Malik, Principles of Homeopathy Explained, 2015, https://drnancymalik.wordpress.com/article/homeopathy-explained/

[6] Nancy Malik, Recent Advances in Nanoparticle Research in Homeopathy, Homeopathy 4 Everyone, Vol.12, Issue 6, 18 June 2015, http://hpathy.com/scientific-research/recent-advances-in-nanoparticle-research-in-homeopathy/

[7] Samuel Hahnemann, “Appeal to Thinking Philanthropists Respecting the Mode of Propagation of the Asiatic Cholera”, 20 pages, 1831, Translated by R E Dudgeon, M.D. in The Lesser Writings of Samuel Hahnemann, 1851, B Jain Publishers, reproduced edition, 2002, p. 758

[8] Fran Sheffield, Homeoprophylaxis: Human Records, Studies and Trials, 2014, http://homeopathyplus.com/Homeoprophylaxis-Human-Records-Studies-Trials.pdf

[9] Homoeopathy in Flu-like Illness- Factsheet, Central Council for Research in Homoeopathy, Deptt. of AYUSH, Ministry of Health & Family Welfare, Govt, of India, 2015, http://ccrhindia.org/pdf/swineflu.pdf

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Whenever I read articles of this nature, I get a little embarrassed. It seems obvious to me that the authors of such reviews have done some ‘research’ and believe strongly in the correctness in what they write. It embarrasses me to see how such people, full of good will, can be so naïve, ignorant and wrong. They clearly fail to understand several crucial issues. To me. this seems like someone such as me lecturing others about car mechanics, quantum physics or kite flying. I have no idea about these subjects, and therefore it would be idiotic to lecture others about them. But homeopaths tend to be different! And this is when my embarrassment quickly turns into anger: articles like the above spread nonsense and misguide people about important issues. THEY ARE DANGEROUS! There is little room for embarrassment and plenty of room for criticism. So, let’s criticise the notions advanced above.

In my recent book, I briefly touched upon epidemics in relation to homeopathy:

Epidemics are outbreaks of disease occurring at the same time in one geographical area and affecting large number of people. In homeopathy, epidemics are important because, in its early days, they seemed to provide evidence for the notion that homeopathy is effective. The results of homeopathic treatment seemed often better than those obtained by conventional means. Today we know that this was not necessarily due to the effects of homeopathy per se, but might have been a false impression caused by bias and confounding.

This tells us the main reason why the much-treasured epidemiological evidence of homeopaths is far from compelling. The review above does not mention these caveats at all. But it is lousy also for a whole host of other reasons, for instance:

  • The text contains several errors (which I find too petty to correct here).
  • The list of studies is the result of cherry-picking the evidence.
  • It confuses what epidemiological studies are; RCTs are certainly not epidemiological studies, for instance.
  • It also omits some of the most important epidemiological studies suggesting homeopathy works.
  • It cites texts that are clearly not epidemiological studies.
  • Several studies are on prevention of illness rather than on treatment.
  • Some studies do not even employ homeopathy at all.

In the typical epidemiological case/control study, one large group of patients [A] is retrospectively compared to another group [B]. By large, I mean with a sample size of thousands of patients. In our case, group A has been treated homeopathically, while group B received the treatments available at the time. It is true that several of such reports seemed to suggest that homeopathy works. But this does by no means prove anything; the result might have been due to a range of circumstances, for instance:

  • group A might have been less ill than group B,
  • group A might have been richer and therefore better nourished,
  • group A might have benefitted from better hygiene in the homeopathic hospital,
  • group A might have received better care, e. g. hydration,
  • group B might have received treatments that made the situation not better but worse.

Because these are RETROSPECTIVE studies, there is no way to account for these and many other factors that might have influenced the outcome. This means that epidemiological studies of this nature can generate interesting results which, in turn, need testing in properly controlled studies where these confounding factors are adequately controlled for. Without such tests, they are next to worthless for recommendations regarding clinical practice.

As it happens, the above author also included two RCT in the review (these are NOT epidemiological studies, as I already mentioned). Let’s have a quick look at them.

The first RCT is flawed for a range of reasons and has been criticised many times before. Even its authors state that “the result cannot be explained given our present state of knowledge, but it calls for further rigorously designed clinical studies.” More importantly, the current Cochrane review of Oscillococcinum, the remedy used in this study, concluded: “There is insufficient good evidence to enable robust conclusions to be made about Oscillococcinum® in the prevention or treatment of influenza and influenza-like illness.”

The second RCT is equally flawed; for instance, its results could be due to the concomitant use of paracetamol, and it seems as though the study was not double blind. The findings of this RCT have so far not been confirmed by an independent replication.

What puzzles me most with these regularly voiced notions about the ‘epidemiological evidence’ for homeopathy is not the deplorable ineptitude of those who promote them, but it is this: do homeopaths really believe that conventional medics and scientists would ignore such evidence, if it were sound or even just encouraging? This assumes that all healthcare professionals (except homeopaths) are corrupt and cynical enough not to follow up leads with the potential to change medicine for ever. It assumes that we would supress knowledge that could save the lives of millions for the sole reason that we are against homeopathy or bribed by ‘BIG PHARMA’.

Surely, this shows more clearly than anything else how deluded homeopaths really are!!!

 

Today is WORLD CANCER DAY.

Yesterday I prepared you for this event by alerting you to a disgusting cancer scam, and today I want to contrast this with more encouraging news from the strange world of alternative medicine. So I searched Medline for a fitting, recent publication showing at least some value of an alternative therapy. Believe me, such papers are few and far between.

But here is one:

The aim of this Cochrane review was to assess effects of yoga on health-related quality of life, mental health and cancer-related symptoms among women with a diagnosis of breast cancer who are receiving active treatment or have completed treatment. The authors conducted extensive literature searches and applied no language restrictions. RCTs were eligible, if they (1) compared yoga interventions to no therapy or to any other active therapy in women with a diagnosis of breast cancer, and (2) assessed at least one of the primary outcomes on patient-reported instruments, including health-related quality of life, depression, anxiety, fatigue or sleep disturbances.

Two review authors independently collected data on methods and results. The risk of publication bias was assessed through visual analysis of funnel plot symmetry and heterogeneity between studies. Subgroup analyses were conducted for current treatment status, time since diagnosis, stage of cancer and type of yoga intervention.

Twenty-four studies with a total of 2166 participants were included, 23 of which provided data for meta-analysis. Thirteen studies had low risk of selection bias, five studies reported adequate blinding of outcome assessment and 15 studies had low risk of attrition bias. Seventeen studies that compared yoga versus no therapy provided moderate-quality evidence showing that yoga improved health-related quality of life, reduced fatigue and reduced sleep disturbances in the short term. There was an overall low risk of publication bias.

Yoga did not appear to reduce depression or anxiety in the short term and had no medium-term effects on health-related quality of life or fatigue. Four studies that compared yoga versus psychosocial/educational interventions provided moderate-quality evidence indicating that yoga can reduce depression, anxiety and fatigue in the short term. Very low-quality evidence showed no short-term effects on health-related quality of life or sleep disturbances. Three studies that compared yoga to exercise presented very low-quality evidence showing no short-term effects on health-related quality of life or fatigue. No trial provided safety-related data.

The authors concluded that moderate-quality evidence supports the recommendation of yoga as a supportive intervention for improving health-related quality of life and reducing fatigue and sleep disturbances when compared with no therapy, as well as for reducing depression, anxiety and fatigue, when compared with psychosocial/educational interventions. Very low-quality evidence suggests that yoga might be as effective as other exercise interventions and might be used as an alternative to other exercise programmes.

As I said, this is most encouraging. Many women are attracted by yoga, and the news that it can improve their symptoms is clearly positive. I have said it often, but I say it again: in supportive and palliative cancer care there might be an important role for several forms of CAM. One has to make sure though that they do not interfere with conventional treatments, and – this is very important – cancer patients must not be misled to believe that they can be used to treat or cure cancer. Finally, patients should not pitch their hopes too high: the effect sizes of alternative treatments in cancer care are invariably small or modest which means that they can help to reduce symptoms but are unlikely to get rid of them completely.

On an even more sober note, I have to reiterate that none of the trials included in the above review reported safety data (yoga is not totally devoid of adverse-effects!). This is an almost stereotypical finding when assessing clinical trials of alternative therapies. It discloses a clear and unacceptable breach of publication ethics. How can we ever get a realistic impression of the risks of alternative medicine, if adverse effects remain unreported? It is high time that researchers, authors, journal editors and reviewers get this message and behave accordingly.

Tomorrow is WORLD CANCER DAY. To mark this important occasion, I intend to publish not just one but two posts. Today’s post discloses one of the more sickening alternative cancer scams I have seen for a long time (tomorrow’s post will be a lot more encouraging): baking soda as a cancer cure. Here is what some charlatans tell the most vulnerable of our patients.

START OF QUOTE

Even the most aggressive cancers which have metastasized have been reversed with baking soda cancer treatments… Doctors and pharmaceutical companies make money from it. That’s the only reason chemotherapy is still used. Not because it’s effective, decreases morbidity, mortality or diminishes any specific cancer rates. In fact, it does the opposite. Chemotherapy boosts cancer growth and long-term mortality rates and oncologists know it…

Studies have shown that dietary measures to boost bicarbonate levels can increase the pH of acidic tumors without upsetting the pH of the blood and healthy tissues. Animal models of human breast cancer show that oral sodium bicarbonate does indeed make tumors more alkaline and inhibit metastasis. Based on these studies, plus the fact that baking soda is safe and well tolerated, world renowned doctors such as Dr. Julian Whitaker have adopted successful cancer treatment protocols as part of an overall nutritional and immune support program for patients who are dealing with the disease…

When taken orally with water, especially water with high magnesium content, and when used transdermally in medicinal baths, sodium bicarbonate becomes a first-line medicinal for the treatment of cancer, and also kidney disease, diabetes, influenza and even the common cold. It is also a powerful buffer against radiation exposure, so everyone should be up to speed on its use. Everybody’s physiology is under heavy nuclear attack from strong radioactive winds that are circling the northern hemisphere…

The pH of our tissues and body fluids is crucial and central because it affects and mirrors the state of our health or our inner cleanliness. The closer the pH is to 7.35-7.45, the higher our level of health and wellbeing. Staying within this range dramatically increases our ability to resist acute illnesses like colds and flues as well as the onset of cancer and other diseases. Keeping our pH within a healthy range also involves necessary lifestyle and dietary changes that will protect us over the long term while the use of sodium bicarbonate gives us a jump-start toward increased alkalinity…

Basically, malignant tumors represent masses of rapidly growing cells. The rapid rate of growth experienced by these cells means that cellular metabolism also proceeds at very high rates. Therefore, cancer cells are using a lot more carbohydrates and sugars to generate energy in the form of ATP (adenosine triphosphate). However, some of the compounds formed from the energy production include lactic acid and pyruvic acid. Under normal circumstances, these compounds are cleared and utilized as soon as they are produced. But cancer cells are experiencing metabolism at a much faster rate. Therefore, these organic acid accumulate in the immediate environment of the tumor. The high level of extracellular acidity around the tumor is one of the chief driving force behind the metastasis of cancer tumors. Basically, cancer cells need an acidic environment to grow and spread rapidly…

One does not have to be a doctor to practice pH medicine. Every practitioner of the healing arts and every mother and father needs to understand how to use sodium bicarbonate. Bicarbonate deficiency is a real problem that deepens with age so it really does pay to understand and appreciate what baking soda is all about.

END OF QUOTE

I am sure you agree: this is not just unethical and irresponsible; it is vile!

There are far too many falsehoods in this text (and most of them are too obvious) for me to even begin to correct them.

Why do I post this just before WORLD CANCER DAY?

Because I believe that cancer patients need to be protected from people and institutions who tout dangerous nonsense. Sadly, in the realm of alternative medicine, there are many of such charlatans.

One of the questions I hear frequently is ‘HOW CAN I BE SURE THIS STUDY IS SOUND’? Even though I have spent much of my professional life on this issue, I am invariably struggling to provide an answer. Firstly, because a comprehensive reply must inevitably have the size of a book, perhaps even several books. And secondly, to most lay people, the reply would be intensely boring, I am afraid.

Yet many readers of this blog evidently search for some guidance – so, let me try to provide a few indicators – indicators, not more!!! – as to what might signify a good and a poor clinical trial (other types of research would need different criteria).

INDICATORS SUGGESTIVE OF A GOOD CLINICAL TRIAL

  • Author from a respected institution.
  • Article published in a respected journal.
  • A clear research question.
  • Full description of the methods used such that an independent researcher could repeat the study.
  • Randomisation of study participants into experimental and control groups.
  • Use of a placebo in the control group where possible.
  • Blinding of patients.
  • Blinding of investigators, including clinicians administering the treatments.
  • Clear definition of a primary outcome measure.
  • Sufficiently large sample size demonstrated with a power calculation.
  • Adequate statistical analyses.
  • Clear presentation of the data such that an independent assessor can check them.
  • Understandable write-up of the entire study.
  • A discussion that puts the study into the context of all the important previous work in this area.
  • Self-critical analysis of the study design, conduct and interpretation of the results.
  • Cautious conclusion which are strictly based on the data presented.
  • Full disclosure of ethics approval and informed consent,
  • Full disclosure of funding sources.
  • Full disclosure of conflicts of interest.
  • List of references is up-to-date and includes also studies that contradict the authors’ findings.

I told you this would be boring! Not only that, but each bullet point is far too short to make real sense, and any full explanation would be even more boring to a lay person, I am sure.

What might be a little more fun is to list features of a clinical trial that might signify a poor study. So, let’s try that.

WARNIG SIGNALS INDICATING A POOR CLINICAL TRIAL

  • published in one of the many dodgy CAM journals (or in a book, blog or similar),
  • single author,
  • authors are known to be proponents of the treatment tested,
  • author has previously published only positive studies of the therapy in question (or member of my ‘ALT MED HALL OF FAME’),
  • lack of plausible rationale for the study,
  • lack of plausible rationale for the therapy that is being tested,
  • stated aim of the study is ‘to demonstrate the effectiveness of…’ (clinical trials are for testing, not demonstrating effectiveness or efficacy),
  • stated aim ‘to establish the effectiveness AND SAFETY of…’ (even large trials are usually far too small for establishing the safety of an intervention),
  • text full of mistakes, e. g. spelling, grammar, etc.
  • sample size is tiny,
  • pilot study reporting anything other than the feasibility of a definitive trial,
  • methods not described in sufficient detail,
  • mismatch between aim, method, and conclusions of the study,
  • results presented only as a graph (rather than figures which others can re-calculate),
  • statistical approach inadequate or not sufficiently detailed,
  • discussion without critical input,
  • lack of disclosures of ethics, funding or conflicts of interest,
  • conclusions which are not based on the results.

The problem here (as above) is that one would need to write at least an entire chapter on each point to render it comprehensible. Without further detailed explanations, the issues raised remain rather abstract or nebulous. Another problem is that both of the above lists are, of course, far from complete; they are merely an expression of my own experience in assessing clinical trials.

Despite these caveats, I hope that those readers who are not complete novices to the critical evaluation of clinical trials might be able to use my ‘warning signals’ as a form of check list that helps them to tell the chaff from the wheat.

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