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

In my last post, I claimed that researchers of alternative medicine tend to be less than rigorous. I did not link this statement to any evidence at all. Perhaps I should have at least provided an example!? As it happens, I just came across a brand new paper which nicely demonstrates what I meant.

According to its authors, this non-interventional study was performed to generate data on safety and treatment effects of a complex homeopathic drug. They treated 1050 outpatients suffering from common cold with a commercially available homeopathic remedy for 8 days. The study was conducted in 64 German outpatient practices of medical doctors trained in CAM. Tolerability, compliance and the treatment effects were assessed by the physicians and by patient diaries. Adverse events were collected and assessed with specific attention to homeopathic aggravation and proving symptoms. Each adverse effect was additionally evaluated by an advisory board of experts.

The physicians detected 60 adverse events from 46 patients (4.4%). Adverse drug reactions occurred in 14 patients (1.3%). Six patients showed proving symptoms (0.57%) and only one homeopathic aggravation (0.1%) appeared. The rate of compliance was 84% for all groups. The global assessment of the treatment effects resulted in the verdict “good” and “very good” in 84.9% of all patients.

The authors concluded that the homeopathic complex drug was shown to be safe and effective for children and adults likewise. Adverse reactions specifically related to homeopathic principles are very rare. All observed events recovered quickly and were of mild to moderate intensity.

So why do I think this is ‘positively barmy’?

The study had no control group. This means that there is no way anyone can attribute the observed ‘treatment effects’ to the homeopathic remedy. There are many other phenomena that may have caused or contributed to it, e. g.:

  • a placebo effect
  • the natural history of the condition
  • regression to the mean
  • other treatments which the patients took but did not declare
  • the empathic encounter with the physician
  • social desirability

To plan a study with the aim as stated above and to draw the conclusion as cited above is naïve and unprofessional (to say the least) on the part of the researchers (I often wonder where, in such cases, the boundary between incompetence and research misconduct might lie). To pass such a paper through the peer review process is negligent on the part of the reviewers. To publish the article is irresponsible on the part of the editor.

In a nut-shell: COLLECTIVELY, THIS IS ‘POSITIVELY BARMY’!!!

24 Responses to Homeopathy is implausible – some research into this subject is positively barmy

  • Good grief! “Positively barmy” is something of an understatement, Edzard!
     
    I was intrigued to read the expression “complex” homeopathic drug appear twice in your post. This was new to me so I read the paper. It states that “complex homeopathy usually uses combinations of different preparations, mostly in the form of low dilutions or even the homeopathic mother tinctures”. In other words, it’s herbalism. So people who confuse herbalism and homeopathy are not necessarily wrong after all!
     
    The paper refers to a 2003 systematic review of Edzard’s which concluded there was “unclear evidence” for the so-called “homeopathic aggravations” taken as evidence of toxicity in the study, despite which neither referees nor editor seems to have judged it unreasonable to publish. To establish adverse events the “homeopathic aggravations” were distinguished from “disease-related aggravations”, and “homeopathic proving symptoms”. This was done by the attending physicians, but in addition “an advisory board for pharmacovigilance with specific experience in safety issues related to the principles of homeopathy and herbal therapy” also scrutinized the data. In other words, the whole thing was done in terms of the gobbledygook comprehended only by pious believers in homeopathy. Please will all those who want to see quacks regulate themselves note this! Yet this was all supposed to accord with “the recommendations of the German drug regulatory authority” as published in 2010.
     
    Edzard’s post picks up the most serious objections to the study. It’s neither science nor medicine, just lunacy. I wondered how a journal entitled “Regulatory Toxicology and Pharmacology”, with an impact factor over 2, might come to publish something this pointless. The Chief Editor, Gio B Gori, has been funded for years by the tobacco industry and has claimed the (US) Environmental Protection Agency used junk science to distort the effects of second-hand smoke. Among the six Associate Editors, Jay I. Goodman is a Professor at Michigan State University Center for Integrative Toxicology. Hmm. “Integrative toxicology” has the feel of medical witchcraft about it. The other five Associate Editors all appear to be good, mainstream toxicologists.
     
    Sometimes the quality of a journal shows through in small ways. Its list of Associate Editors mis-spells the name of Marcello Lotti, and its graphs of bibliometric data such as impact factor are barcharts without any y-axis scale! (These two points came up for me purely as a casual website visitor seeking merely to find the journal’s impact factor and who were its major editorial academics.)

    • FrankO, you have demonstrated why I always strongly suggest that it is a huge mistake to classify homeopathy as pseudoscience. It is NOT pseudoscience: it is nothing other than despicable exploitative anti-science; it is so extremely focussed on the well-being and survival of itself that it will use any means necessary to fight for its survival.

      Its patients are (and always have been) just sacrificial pawns in its drawn-out game — a devious long-term game plan formulated by Christian Friedrich Samuel Hahnemann, then ever deviously modified to wriggle out of its continual failures to provide evidence of its health claims. Its only truthful claims are that it is still popular and that it has been a lucrative business empire. For how much longer those claims will remain true is currently unknown.

      • Pete, I understand why your feelings on this are so strong, but let’s take a gentler view (essentially Hanlon’s razor — never attribute to malevolence what is adequately explained by stupidity). I don’t know (and have no intention of learning) much about Hahnemann. Compared to his late 18th century contemporaries, his ideas that created homeopathy don’t seem wildly different in style. He invented new concepts (from thin air), gave them new names then did half-witted experiments that were meant to validate them. That is pseudo-science by any definition I know.
         
        Whether Hahnemann deliberately set out to create a major business empire from homeopathy, or whether he just convinced himself of the truth of what he’d (mis)conceived I’ve no idea, but I’d swing in the direction of Hanlon’s razor from what little I know of the history. The modern-day proponents of homeopathy unquestionably include some quick-buck charlatans, but most of the homeopaths (a word perhaps to be pronounced with the same inbuilt negative feeling as ‘psychopath’ and ‘naturopath’) who post on this blog come over equally deluded as their customers. They just can’t seem to comprehend the finer points of reason, but in that respect they’re no different from those who believe in things like gods, ghosts, psychokinesis, dowsing and clairvoyance, as well as the members of other branches of the Big Snakeoil industry.
         
        As long as there are folk willing to testify to the positive benefits they experienced from homeopathy (and the rest) there will be practitioners convinced they are in the right. The patients are, indeed, a form of sacrificial pawn, but the high priests are not all necessarily dishonest; just humanly daft and fallible. We might get through to some with efforts at education, but contempt is, in my view, an unproductive approach.
         
        I like Edzard’s repeated use of the term ‘barmy’. It neatly sums up a state of mind that is deluded and unreasonable without necessarily implying pathological derangement. I’ve a friend who uses ‘dotty’ in a similar way, but that feels too feeble to my sense of language.

        • Sorry, Frank, I have to disagree with you — it seems that you have pushed both Hanlon’s razor and the principle of charity far beyond their limits in the case of homeopathy.

          Please read Quackery Unmasked by Dan King, published in 1858 (157 years ago!):
          https://en.wikisource.org/wiki/Quackery_Unmasked

          • @Pete
            Thanks. That’s a wonderful link I wish I’d known about a long time ago! I shall try to be less charitable to charlatans, while still seeking some empathy with their victims. OK?

  • We would advise to be scientifically correct:
    A NIS as it was planned, conducted and published is a regulatory condition for some drugs and – by definiton- has no control group, in conventional as in comeplementary medicine.
    The aim of NIS is to assess safety, which was stated clearly. Efficacy was not shown and not claimed to be shown. Effectiveness includes nonspecific effects.
    But you should know all this.
    The conclusions describe what was found, which is scientifically correct.
    All authors are no adherents of homeopathy.
    It is clear that homeopathy is controversial and not liked by the author,
    however it would be greatly appreciated to comment research in a way that is in line with the scientific and study-related facts.

    • @Michalsen

      All authors are no adherents of homeopathy.

      Nonsense. All three work for the Immanuel Krankenhaus in Berlin, which is a naturopathic hospital. (Naturopathy covers all forms of Big Snakeoil, including homeopathy and herbalism.) The senior author has a focus on herbal medicine.

      A NIS as it was planned, conducted and published is a regulatory condition for some drugs and – by definiton- has no control group

      Agreed, but such studies normally involve documenting side-effects, not unscientific and undefinable terms. “The primary focus of the study was on adverse effects, with special attention given to adverse effects related to the principles of homeopathic therapy, i.e., initial aggravations and proving symptoms.” If you’re going to work in terms of a therapeutic approach that remains unproven after 200 years, then a control group where the investigators don’t know who got which therapy is the least one can ask for to lend some credibility to their findings.
       
      The study design is claimed to be based on two prior publications. I’ve been unable to track down the first one, a German publication. The second is a European Medicines Agency “Reflection paper on ethanol content in herbal medicinal products and traditional herbal medicinal products used in children.” It has nothing in it obviously to do with the way the safety study was carried out.

      The conclusions describe what was found, which is scientifically correct.

      OK, I firmly believe that standing on one leg at midday and calling “wokky wokky wokky” is a cure for the common cold. I observed 22 patients suffering from colds who followed this regime, and in 18 of them all cold symptoms had gone within 6 days. I’ve described what I found, so it’s scientifically correct. It also happens to be complete horse manure.
       
      The purpose of the original post in this thread was to provide a concrete example illustrating Edzard Ernst’s opinion that researchers of alternative medicine tend to be less than rigorous. The paper he cites is an egregious piece: “less than rigorous” is an understatement. It is a scandalous example of lousy, lazy, ludicrous medical non-science that should never have been accepted for publication in a journal presumed to hold standards of quality.

    • “Effectiveness includes nonspecific effects” BRILLIANT! where does this come from? it means absolutely everything is ‘effective’. very convenient for proponents of bogus treatments!!!

      • C´mon , as researcher you should know the difference betwen efficacy and effectiveness. This is pharmacological basic knowledege. Specific (efficacy) + nonspecific effects = effectiveness. And, in fact, everything can be effective – because of nonspecific or placebolike effects. That does not mean that efficacy is existent.
        And some last comment on another reply: naturopathy does not include homeopathy. It is established in Germany as the application of nutritional therapy, exercise, herbal medicine, balneotherapy and stress reduction, defined by the German Board of Physicians. In conclusion, my general and last suggestion to these kinds of comments and blogs: Please first learn the facts and then comment

        • “In medicine, effectiveness relates to how well a treatment works in practice, as opposed to efficacy, which measures how well it works in clinical trials or laboratory studies.” [ http://en.wikipedia.org/wiki/Effectiveness ]
          In your ‘study’, the outcome cannot be attributed to the treatment because it could be due to all sorts of phenomena, e. g. natural history of the condition.

        • @Michalsen

          And some last comment on another reply: naturopathy does not include homeopathy.

          “A Naturopath is a health practitioner who applies natural therapies. Her/his spectrum comprises far more than fasting, nutrition, water, and exercise; it includes approved natural healing practices such as Homeopathy, Acupuncture, and Herbal Medicine, as well as the use of modern methods like Bio-Resonance, Ozone-Therapy, and Colon Hydrotherapy.” First paragraph from the website of the College of Naturopathic Medicine (itself the first hit when I googled ‘naturopathy’). Italics mine.
          Please first learn the facts and then comment.

          • the Germans often have a different understanding of their term ‘Naturheilkunde’ – but then they use English terms and get it wrong. Even in German the terminology is deeply muddled: I worked in the ‘Krankenhaus fuer Naturheilweisen’ in Munich, and it was dominated by homeopathy. which ever way you turn it, Michalsen has no solid ground to stand on.

        • And some last comment on another reply: naturopathy does not include homeopathy.

          http://naturheilkunde.immanuel.de/homoeopathie-berlin/

        • @Michalsen

          …naturopathy does not include homeopathy
          .

          Well, you’re majestically wrong.
           
          Homeopathy, the acid test of scientific ignorance, is very much a part of naturopathic education indoctrination and practice all over the world.
           
          Here’s an analysis as good as any. If you’re not convinced, just follow some of the links in there.

    • @Michalsen

      No, it is not at all scientifically correct. In medicine, it is the risk-benefit ratio that needs to be established. When the benefit is zero (beyond placebo), as has been proven to be the case with homeopathy, then the risk:benefit ratio is infinity therefore it is very much worse than just being benign yet useless.

      If, and only if, a drug has already been established to be effective might it then be appropriate to conduct a risk-only study.

      You are, of course, fully aware of these facts so I’ll it to the readers to judge your motives and agenda rather than offer my opinion.

      • Doh! That should’ve been: I’ll leave it to the readers to judge …

        I’m glad that I refrained from offering my opinion because it would very likely have contained an unfortunate typo!

    • The conclusion that the “drug was shown to be safe” seems reasonable, but the “and effective” is completely unsupported by the results given in the abstract. To claim that it was shown to be “effective” is an abuse of language, when no effectiveness results are given at all.

  • It’s barmy that the editor/reviewers even gave it time of day… when its title includes the oxymoron ‘homeopathic drug’ – there is, of course, no such thing.

  • I’ve just got rid of a cold after doing nothing about it for 8 days.

    I am now confused. Was I treating it homeopathically every time I had a drink of water?

    • Only as long as you didn’t put coffee in your water…

    • L. Barton,

      It depends on whether you washed your drinking glass by hand or in a dishwasher.

      A dishwasher is actually a homeopathic remedy preparation device because it operates by sequential dilution and succussion. Unfortunately, the manufacturers do not state the potency of its preparations. One would hope that it’s greater than 3X.

      Theory of operation… When we start a viral or bacterial infection we transfer some of the infectious agent to our glassware, crockery, and cutlery. The dishwasher prepares a homeopathically potentized version of it (based on the doctrine of like cures like) that is just missing the final step, which is completed when we pour water into the drinking glass (or cup or mug) and drink from it.

      The reason that we should regularly clean our dishwasher is to make it forget what has previously been in it: this enables the machine to optimally prepare homeopathic remedies that we currently need, rather than it continuing to prepare more potent versions of remedies that we needed previously, but no longer require.

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