Edzard Ernst – Desperate Times Call for Desperate Measures?

It’s been a while, but after the recent accusations of bias, cherry picking and conflicts of interest from denialists who continue to use the UK Parliamentary Evidence Check to support their claims, this latest example from homeopathy’s ‘academic nemesis’ needed a blog post.

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The homeopathic community and its supporters are well used to rising above the continued onslaught of the anti-homeopathy campaign. With limited resources they choose their battles carefully. Imagine their delight then when on Jan 28th 2013 three positive pieces about homeopathy hit the mainstream news :

In the Canadian National PostHomeopathy Offers Hope

From The Times of London an op ed piece: I’d rather be ‘cured’ by a placebo than rely on science and remain ill

And on CBS’s Doctor Oz show : The Heart of Homeopathy: Like Cures Like    (The video is hard to find but it’s there.)

After Doctor Oz’s chatty piece on the usefulness of homeopathy, follow up information was posted on his website along with a paragraph entitled: Could Homeopathy Be Dangerous? 
The paragraph warned about

“a wide range of adverse effects, including abdominal pain, headaches, nausea, rashes, and pancreas or liver damage.”

and that

“There have also been some reports of serious side effects, including kidney failure, seizures and death.”

WHAT!?

Intriguingly the warning followed up with:

“…it’s always very important to consult a homeopathy expert before taking any treatments or giving formulations to children.”

Well that’s good news – advice to consult a homeopathy expert. Not a medical doctor who usually knows little to nothing about homeopathy. Hope yet.

But what about the adverse effects that had been reported?
The paper cited was: Adverse effects of homeopathy: a systematic review of published case reports and case series published in the December 2012 International Journal of Clinical Medicine.

It sounded serious. The article reported that

“..The total number of patients who experienced (adverse effects) of homeopathy amounted to 1159. Overall, (adverse effects) ranged from mild-to-severe and included four fatalities.” And concluded that: “.. Homeopathy has the potential to harm patients and consumers in both direct and indirect ways. Clinicians should be aware of its risks and advise their patients accordingly.”

To a homeopath this is shocking!

In opposition to the current trend of reading the title and conclusion of a study and running to press, the article needed to be tracked back to its source and that’s where any surprise ended.
The authors are Paul Posadzki and Edzard Ernst, former director of the Complementary Medicine department at the Peninsula Medical School in Exeter and self-proclaimed world expert on CAMs. Together they have penned a number of warning papers about the dangers of complementary medicine. Even though Ernst’s position at the school has been eliminated, Posadzki, on faculty, continues in the steps of their erstwhile leader.
The authors have called their study a “Systematic review” which, of course, suggests in depth, rigorous research.

It’s worth taking a close look at their review.

First what they propose:

“The aim of this systematic review was to provide a summary and critical evaluation of the published evidence regarding direct and indirect (adverse effects) associated with homeopathy.”

And then their methodology:

“Five electronic databases were searched to identify all relevant case reports and case series – from their inception and without language restrictions.”

So that’s any cases reported in MEDLINE, EMBASE, AMED, CINHAL and ISI in any language, from anywhere and with no restrictions on time of publication.
And to make sure nothing was missed:

” …our own extensive department files were hand-searched for further articles.”

So a thorough search of all available data.

” To be included, (cases) had to pertain to (adverse effects) associated with the use of any type of homeopathic treatment in human patients. Data from spontaneous reporting systems were included as well. We also included reports where harm was not because of a homeopathic remedy, but was associated with the use of homeopathy as a replacement of conventional treatments.”

And how was the information from the cases chosen?

“Information from the included (cases) were extracted according to predefined criteria and assessed by two independent reviewers.”

What were those predefined criteria and who were the independent reviewers? The authors don’t give this information.

“Causality was estimated based on the description provided by the authors of the primary articles. Any disagreements were settled through discussion.” (My bolding)

Which brings us to the results.

“ The searches generated 378 articles of which 340 had to be excluded. So 38 articles met the eligibility criteria. And of those, 30 pertained to direct (adverse effects) of homeopathic remedies.”

The authors divide the results into two tables – one for adverse effects associated with the use of homeopathy, the other for cases where conventional care was substituted by homeopathy to the perceived detriment of the patient.

“The total number of patients who experienced (adverse effects) of homeopathy amounted to 1159. Overall, (adverse effects) ranged from mild-to-severe and included four fatalities.” (My bolding)

There’s no way to distinguish in those 1159 effects what might have been mild symptoms of an aggravation of course. But that’s still a lot of adverse effects and there’s still the shock of 4 fatalities associated with homeopathic medication.

And so to the tables themselves.

In fact the table for adverse effects associated with homeopathic medicines seems to show reports of 2 fatalities, with another 2 fatalities in the table for substitution of homeopathy for conventional medicine – one of which took a while to find since it was listed under condition rather than outcome.

In the table of adverse effects “directly related to homeopathy” the authors assigned a level of causality as follows:

Certain: 2 cases
Almost certain: 25 cases
Likely: 46 cases
Unclear: 1,070 cases

It seems important to take a look at that series of 1,070 cases of “unclear” causality. All 1,070 cases were reported in a study of childhood poisoning events from a region of Germany. 17,533 cases were investigated, 16,463 were apparently the result of accidental poisoning with allopathic drugs of one kind or another. 1,070 were ascribed to “homeopathic drugs” – the “remedies unspecified”, the causation was “unclear” and the symptoms reported were “mostly mild symptoms (no details provided).”

From a research standpoint there is zero clarifying information. There is no way to know what the study authors defined as a “homeopathic drug” or the circumstances of its use. Given the general confusion about what a homeopathic medicine is, it’s possible these cases were not associated with homeopathy at all and if they were, they were “mostly mild” and possibly homeopathic aggravations.

If this systematic review had not been published in a respected peer reviewed journal it might be suggested that the 1,070 cases had been included to dramatically boost the numbers.

From a homeopathic standpoint and as a scientist – questioning the inclusion of these 1,070 cases seems justified, so that leaves a total of 73 cases of adverse events reported over a span of 33 years which, after discussion, the authors have agreed are apparently directly attributed to homeopathy.

If this number is broken down further using the provided table – of these 73 cases, the authors rate 2 cases as “certain” and 25 cases “almost certain” in terms of causality. After discussion between the authors, the remaining 46 cases have been assigned a “likely” causality.

As just one example of “likely” causation, the adverse effect is listed as “extreme agitation” in a patient using alcohol and amphetamines who also took “Loco X112” whatever that is, apparently “homeopathic slimming drops”. No identification of the contents of the medication is given but we can be sure it was not prescribed according to homeopathic principles. How the “likely” causation was distinguished from the alcohol and amphetamines is not explained.

A review of cases in the “likely” category suggests they should be put aside for now.

Giving the authors, and their systematic review, the benefit of the doubt, it can be concluded that there have been 27 adverse reactions, including two deaths, reported in 33 years. Of course for a homeopath practicing the gentle healing art, that would still be too many – but it’s important to keep some perspective. Allopathic medicine is now reported as one of the leading causes of death in the US, with in excess of 100,000 deaths per annum. Two deaths possibly associated with homeopathic medicine (neither are described by the authors as of certain causality) still compares favorably with the estimated 3.3 million deaths from allopathic medicine over the same period.

A closer look at the fatal cases is interesting.  Two are described as “likely” effects of homeopathy. In one case an unspecified homeopathic medicine was given to a patient with

“… a history of neck swelling, cough, haemoptysis, shortness of breath, fever and weight loss.”

The adverse effect is described as

“arsenical keratosis and cancer caused by Arsenic intoxication”

as judged by the author of the case report. Chemotherapy was administered and/but the patient died. No indication of the potency or dosage was given for the homeopathic medicine so it is impossible to know what it was and if the substance was diluted beyond its material level.

In the second “likely” case, death was from acute pancreatitis and necrosis of the head of the pancreas in patient already taking the diabetic drug Glimepride (Amyrl). Both diabetes and the drug Amryl have known associations with acute pancreatitis – of which necrosis of the head of the pancreas is a known complication. Nonetheless, Nux vomica and Rhus toxicodendron were assigned blame with no dosage or potency given.

The third and fourth fatal cases were in the table of 16 cases where homeopathy was apparently substituted for conventional medicine and described as of “certain” causality.  One case involved a patient suffering “Pneumococcal pneumonia with purulent pericarditis and coma“.  It is described as negligence of care by the authors and “certain” that “unspecified remedies” were responsible.  Any homeopath would agree that such a patient should be in intensive care.

The fourth fatal case is listed under conditions as “malnutrition, sepsis and death” due to negligence of care and attributed to “unspecified remedies”.  No other information is given about the circumstances of this patient.

Both these cases, however tragic, say nothing whatsoever about the possible dangers of homeopathy but about dangerous decision making – which can, and does, occur with patients  in any therapeutic method.

Such is the rigor of this systematic review.

The authors devote half of the discussion section to 16 cases between 1987 and 2011 where homeopathy had replaced conventional medicine apparently to the detriment of the patient.

In the rest of the discussion the authors are at pains to point out that homeopaths might well claim many, if not most, of the adverse effects reported are actually homeopathic aggravations. But in another separate “systematic review of the evidence” for and against the concept of homeopathic aggravations, Ernst et al have concluded that their

“systematic review of 24 placebo controlled trials reporting aggravations ……does not provide clear evidence that homeopathic aggravations exist.”

Not that there is no evidence – but that their ‘systematic review’ didn’t provide any. Semantics are important. Shang et al anyone?

And what kind of homeopathy is this? What is the definition of homeopathic medicines that the authors use in their review? From the published paper this is unclear and where any information is given, seems to encompass a wide range of multiple medicines prescribed for the same patient plus a number of medications with strange names like Loco X112 with unspecified ingredients.
Where the Law of Similars was used is hard to fathom.
It might be interesting to trawl through the original case reports and discover who the prescribers were.

“In the majority of cases, the possible mechanism of action involved allergic reactions or ingestion of toxic substances. Preparations of heavy metals, such as arsenic, cadmium, mercury or iron, which are frequently used in homeopathy can be toxic, if not highly diluted. Other poisons regularly employed in homeopathy include aconitum, kerosene or thallium, which also can lead to serious health problems in sufficiently low dilutions.”

Which once more is to deliberately misunderstand the fundamentals of homeopathic principles. It’s not called the gentle healing art for nothing.

And there’s more intriguing “cake and eat it” from the authors.

“A systematic review of the (adverse effects) of homeopathy, concluded that the incidence of (adverse effects) of homeopathic remedies was greater than that of placebo in controlled clinical trials; adverse effects included headache, tiredness, skin eruptions, dizziness, bowel dysfunctions and allergic reactions.”

Happily cited by Ernst, who can almost single handedly claim credit for the “homeopathy is no better than water” mantra chanted by his skeptic followers. And so the authors returned to their familiar circular conundrum: “Homeopathy, there’s nothing in it” – well except for whatever it is that causes the adverse effects greater than placebo.

Which is it to be Edzard?

In a last word from the authors, the review:

“… does not tell us anything (My bolding) about the incidence of (adverse effects). Considering the widespread use of homeopathy worldwide and the relative paucity of the reported adverse effects, it might be very low. (My bolding) Collectively, these limitations render our review less conclusive than we had hoped.”

The question that really needs to be answered is how did this review, with its known bias of authors, indistinct identification of homeopathic medicines, questionable determination of causality, self-identified paucity of reported adverse effects and general overall glaring lack of rigor, get published in the peer-reviewed INTERNATIONAL JOURNAL of CLINICAL PRACTICE?

Shang et al anyone?

In December 2012 the National Centre for Research Methods reported that:

“…. more than half of UK adults appear to believe that homeopathy is as effective or more effective than conventional medicine.”

Seems that the skeptics’ past assertion that attacking homeopaths was ‘like shooting fish in a barrel’, has turned into Ernst et al scraping the very bottom of the barrel.  What next Edzard, bringing the Nazis into the debate?

Desperation anyone? Just sayin’.

But on more serious notes :

Does this work foreshadow a shift in direction? Having failed to convince with claims of placebo, is effort being shifted into warnings about danger? What’s next on that agenda – take over by the pharmaceutical industry?  See Merck and New Era….  And would it be wise to look more closely at the many other systematic reviews published by Ernst and the Peninsula Medical School’s CAM department?

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22 Comments

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22 responses to “Edzard Ernst – Desperate Times Call for Desperate Measures?

  1. Acleron

    The comparison of drug death rates is totally meaningless without the risk-benefit ratio. The overall evidence from high quality trials is that homeopathy is no better than placebo, so any deaths or adverse events may be safely avoided by avoiding homeopathy.

    While Ernst may be rightly applauded for rigorously examining alt-medicine, the phrase, ‘it’s only water’, has been in use for over thirty years, ever since Benveniste’s unwise foray into scientifically proving homeopathy.

    • vonsyhomeopath

      Thanks for your post.
      Ahh yes risk benefit ratio – looking at 3,000 current interventions used in the NHS – only 11% are known to be beneficial, 24% likely to be beneficial and 7% a trade off between benefits and harm. The remaining 58% are ineffective / harmful or of unknown effectiveness. Not very impressive.

      http://clinicalevidence.bmj.com/x/set/static/cms/efficacy-categorisations.html

      As for the placebo argument, I am assuming you refer to the Shang et al Lancet paper of 2005 – shown at the time to be flawed – and the systematic reviews since then carried out by the author who wrote this paper in question……By any standard sir, this was not a rigorous examination of anything.
      Yes you are correct, the phrase “it’s only water” has been in use for over thirty years, I remember it well – but I didn’t give Ernst credit for coining the phrase but for turning it into a mantra.

      • na

        LOL! Try reading what the bmj actually say, not what you’d like it to say.

        Besides, homeopathy is known to have 0% specific effectiveness, so it’s got a VERY long way to go!

      • vonsyhomeopath

        na – perhaps YOU should try reading the actual systematic review that this post is about! 🙂
        Whatever you think about homeopathy there is NO defense for the publication of a paper so lacking in scientific integrity as the one referenced in this blog post. NONE. If you want to make a case against homeopathy then make one that stands up to scrutiny – not one that fails in the first few paragraphs.
        And by the way – if you took the time to read the actual research that has been done, rather than repeating politically motivated comments by those not qualified to make them, you might be surprised.

  2. fransheffield

    Excellent critique, Not-so-Young.
    It has been interesting to watch “skeptic” responses since this paper was first published. There have been very few, possibly because touting it would leave a huge hole in their “placebo” and, “there’s nothing in it” mantras. The most disturbing aspect is how and why a respected journal such as IJCP allowed itself to be sullied by such a paper – the lack of scientific rigour certainly taints the authors.

  3. Reflector

    Perhaps Ernst and co. have realised this paper shows them up as unscientific charlatans and they don’t like what they see. Time to remind them, set up the mirrors and reflect back to them their true nature!

  4. Y

    You obviously have not the slightest clue about science, how to argue rationally or how to critically appraise anything – particularly something that dares to questions your cherished belief system.

    Keep it up – we all need a good laugh every now and again!

    • vonsyhomeopath

      Very glad to have entertained you. Did you read the post? Did you read the original article? It’s not about “something daring to question” a belief system – it’s about a flawed paper calling itself a systematic review and misrepresenting data to force a conclusion that means nothing as a result – and that must surely call into question the peer review system used by the (previously) respected journal who published it.

  5. Once again a homeopath tries to explain away the evidence that homeopathy has no effect greater than a placebo by alluding to its popularity. Popularity is in no way sufficient evidence to support claims of homeopathic “remedies” effectiveness and would not be accepted as sufficient evidence to support the use of any genuine medical treatment. About 20% of the UK population smoke, but tobacco companies could hardly claim it was a healthy habit in the same way that homeopaths claim about their therapies. The popularity of homeopathy is not due to its effectiveness but rather a campaign of advertising and misinformation by homeopaths. Ironically, they accuse skeptics of narrow-mindedness and “flat-earth thinking” while themselves ignoring the overwhelming body of evidence that homeopathy has no place in the treatment of any medical condition.

    • vonsyhomeopath

      Jim, did you read the post? Of course popularity of a therapy is not evidence of it’s effectiveness! Duh….
      I mentioned the popularity simply to highlight the fact that despite all the efforts of the “skeptics” it doesn’t seem to be making any difference.
      As for the “campaign of advertising” by homeopaths that has lead to its popularity – I think you’d be hard pressed to name one!
      The problem with the critics of homeopathy is that they don’t UNDERSTAND the model. Seriously. They have no business criticizing what they have no clue about. Learn something and then pass comment. Ernst claims to understand homeopathy so he must deliberately misrepresent it – and the rest of the “skeptics” read the title and the conclusion and follow along. Pretty sad actually.

  6. homeopathy4health

    Reblogged this on Homeopathy4health.

  7. Thanks for the mention of my piece (“Homeopathy offers hope”), Not-so-young. And nice job of tearing apart this scrap of scientific Kleenex of a paper. I’ve got my own research maven looking at it now so we’ll put something together for http://www.extraordinarymedicine.org. At the very least.

  8. whatsamattayu

    First it’s “just water”, then it’s “just a placebo”… now (gasp!) it’s killing people. The most interesting of these is someone who was given chemo. and then died and Ernst wants to attribute it to homeopathy?!
    80% of MDs wouldn’t take chemo or advise it to their own families. The latest study shows that it actually accelerates tumor growth!
    What’s really disgusting is the misleading info. in the Abstract, then the Conclusion in the body of the full study that totally questions the validity of the whole endeavour.
    If this is what passes for Science at Exeter students should demand a refund and go elsewhere.

  9. Bethany

    Brilliant article! I wish Dr. Oz would post this!!!

  10. Deborah mccarthy

    Excellent press! A real shoot yourself in the foot report with many flaws . Installing personnel within a faculty devoid of real fact (regarding Homeopathy) quality research and non judgement nee accurate statements provides a fertile ground for the growth of future doctors destined to judge badly . Or, will such flagrant disregard for the peoples desire to find truth and seek to improve quality and freedom in health and Healing, then such press is inadvertently welcome. As the ‘wasp to the flower’ can be a little scary for a child, lets provide a ‘garden’ and start seeing freedom of choices in health, healing and real research. Furthering knowledge and sustaining growth in Homeopathy. Only a ‘loser’ fights a dirty war Mr’s Posadszi & Ernst.

    • vonsyhomeopath

      It does beg the question “what were they thinking” when they wrote this paper – but for me the bigger question that needs to be asked is what was the previously respected International Journal of Clinical Medicine thinking when they published this paper. Surely having published a paper which so obviously massages statistics to serve the author’s agenda, it must call into question the integrity of other papers that they have published – if not the journal itself?

    • Paul Posadzki

      Losers like you! It is Posadzki- go to a primary school, learn to read and write properly!

      • vonsyhomeopath

        This is from Paul Posadzski, co-author of the systematic review in question, to Deborah McCarthy who made an error in the spelling of his name. Quite an extreme response I thought.

  11. Go homeopaths! We shall rise above them! Or perhaps just Keep Calm and Carry On. Good work, Not-so-young, keep it up.

  12. Pete F

    The following well-researched article is a detailed examination of the recent witch-hunt against homeopethy in the UK, with suggestions for resisting the attack:

    Moral panic: British case and its implications for homeopathy
    by Roxanne Friedenfels [chair of the Sociology Department at Drew University].

    http://www.similima.com/moral-panic-british-case-and-its-implications-for-homeopathy

  13. ChristyRedd

    Glad to see your post and all the information about this paper. Forewarned is forearmed.

    It seems to me that it does foreshadow a shift, at least in part, from “it’s just water” or “placebo only” to “homeopathy harms”. Two “skeptics” posted to Michelle Beckett’s article “Homeopathy – Most of us are Ignorant and it isn’t Bliss” (February, UK HuffPost) that friends with bipolar disorder died because they stopped using lithium, one at the supposed suggestion of a homeopath. Michelle Beckett posted in response “This and many other cases are the reason I wrote this article, as people are being harmed.”

    What a shame that people, animals, plants and the earth itself should be so disrespected, held in so little regard, and all in the name of profits or ideology.

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