MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

This new study is amazing in several respects. It was conducted in Spain by otolaryngologists, and one of its authors is an employee of Boiron, the world’s biggest manufacturer of homeopathic products. It was designed as a double blind, placebo-controlled RCT. Patients aged 2 months to 12 years suffering from otitis media with effusion (OME), as diagnosed by pneumatic otoscopy (PNO) and tympanometry, were randomized into two groups. Both groups received aerosol therapy (mucolytics and corticosteroids). In addition, the experimental group received a homeopathic remedy of Agraphis nutans 5CH, Thuya Occidentalis 5CH, Kalium muriaticum 9CH and Arsenicum iodatum. The placebo group received placebos instead. Both of the treatments were continued for 3 months. Patients were evaluated by PNO examination and tympanometry at baseline, at 45 and 90 days.

A total of 97 patients were enrolled in this study. In the homeopathy group, 61.9% of individuals were cured according to PNO results by the 3rd visit compared with 56.8% of patients treated with placebo. 4.8% of patients in the homeopathy group suffered a recurrence (positive PNO in the 2nd visit changed to negative in the 3rd visit), while 11.4% did in the placebo group. These inter-group differences were not statistically significant. Adverse events were distributed similarly, except in the case of upper respiratory tract infections, which were less frequent in homeopathic group.

The authors of this new RCT concluded that the homeopathic scheme used as adjuvant treatment cannot be claimed to be an effective treatment in children with OME.

No surprises then – we already know that homeopathic remedies are placebos!

Sure, but at least two amazing features need to be pointed out:

  • I am delighted that the authors did not try to spin the results such that they appear to be positive. Some investigators might have emphasised the fact that there was a (non-significant) trend in favour of homeopathy, and that, for a secondary outcome measure (upper respiratory infections), it even reached the level of statistical significance.
  • Considering that this study was obviously Boiron-sponsored and its list of authors included an employee of this firm, such honesty can’t have been easy to maintain.
  • The design of this RCT is also worth a mention: most alt med proponents seem to think that ‘adjunctive’ use of alt med needs to be tested via the infamous ‘A+B vs B’ design which fails to control for placebo effects and therefore invariably produces false positive findings. The authors of this trial did the right thing by randomising their patients into usual care + homeopathy vs usual care + placebo. This is very simple and has the advantage to actually provide a meaningful result.

In view of all this, I raise my hat to the Spanish researchers: very well done!!!

If all trials of homeopathy were conducted and reported in this honourable fashion, the collective evidence would be in a much better state and far less confusing.

15 Responses to Homeopathy for otitis media: a new trial fails to show significant effects

  • Perhaps the results of this study would be more accurately stated by Edzard such that Agraphis nutans 5CH, Thuya Occidentalis 5CH, Kalium muriaticum 9CH and Arsenicum iodatum at the prescribed potencies cannot be claimed to be an effective treatment in children with OME? It seems that Edzard’s invoking the general term “homeopathy” might lead a reader to surmise that any and all remedies within homeopathy would, according to this study, yield the same ineffective outcome for OME. Of course, this would be inductive, speculative(in this case), and farcical reasoning.

    If one were to test the effects of tetracycline on the healing of a femoral fracture with the finding of no benefit for the therapy when compared to placebo, would Edzard state that “modern medicine” had failed to show significant effects for femoral fracture healing? I’m dubious that he would. Rather, he would likely, and more accurately, state that tetracycline is ineffective for femoral fracture healing, with no mention of the profession within which the research was performed. I wonder why he chose to reference homeopathy as having failed to be effective in this study?

    Even when Edzard compliments a CAM study, he is compelled to diss the CAM profession either blatantly or, in this case, subtly. LMAO….you simply can’t make up this stuff!

    • no, you couldn’t! because one needs a minimum of critical thinking to assess trial evidence.

      • It’s a pity you didn’t think of that before you condemned homeopathy in general as being ineffective for OME. You are hilarious, Edzard. Still LMAO.

        Be well

        • I ‘condemned’ a homeopathic remedy that is marketed for OME

          • What L-B is saying is that they need to test all ~3000 different remedies in any combination from one to five together, before they can infer that shaken water on sugar pills is useless for a usually self limiting condition.

          • something like that!
            plus that my headline should have already disclosed the entire details of the story.

          • Geir, My post was simply worded and to the point. Edzard’s title was “Homeopathy for otitis media.” I merely pointed out that the title should have been specific to the remedy(s) which were tested.

            Be well

        • Ernst:

          “In view of all this, I raise my hat to the Spanish researchers: very well done!!!”

          The sample in the trial: 97 patients were enrolled.

          The NHMRC guideline:

          Mean of no reliable evidence: patients with sample < 50 is very small. For 50 to 149 patients, is a small sample.

          The conclusion of this trial, based on the same arguments of Glaziou believers, is this: the trial is not conclusive. LMAO!

      • If you believe that all homeoapthic research is consistent with the placebo effect, as you believe in the all posts, you’re acting irrational. I notice a distinct “vision” when I read your new book:

        1. Lack of plausibility: you cite the Weymayr beliefs:

        “Scientability is a term coined by the German Journalist C. Weymayr, suggesting that some subjects, e.g., homeopathy, entirely lack plausibility and thus do not merit scientific investigation.”

        Well done! believe what you want to believe. On Scientabilität – eine Antwort auf Homöopathie?, the reply of Weymayr, Mattes wrote:

        Allerdings ist die Unkenntnis eines plausiblen Wirkmechanismus kein Beweis für die Abwesenheit einer Wirkung

        Ernst, you can try learn some basis of epistemology before write and sell any pamphlet on Springer.

        2. The outragenous belief of Ernst!

        “For instance, some experiments have suggested that water molecules can, in fact, form structures which might preserve the memory of the substances previously contained in that water… could provide a scientific explanation for homeopathy’s mechanism of action. Unfortunately, all of these theories have one very obvious thing in common: they are just theories!”

        Ernst, all you wombats do is hear of stories and claims and watch these pseudophilosopers as Massimo Pigliucci or Randi pump out ignorant youtube videos or twitter comments. As matter of fact any scientiffic theory need based on facts! When you wrote the ignorant sentence of the memory water based only in theories, yes! the memory water are based on theories. What Ernst’s fanboys don’t tell you? The theories of water memory are based on experimental data! )I remember the classic pseudoarguments of creactionism believers: Darwin test based only in theories!. As you can see, your behaviour is very similar: dogmatic, irrational and cherry picked.

        3. Evidence? In the pampleth:

        “Today about 300 such trials have been published. Unsurprisingly, their findings are not entirely uniform; some studies show a positive result but many do not. Faced with such contradictions, it might be tempting to cherry-pick. A recent report, often alleged to be by the Swiss government, is frequently cited by homeopaths as being
        equivalent or even superior to a systematic review. It concluded that, for certain conditions, homeopathic treatment is effective. However, acritical assessment of this report finds reasons to doubt its conclusions. It is not by the Swiss government; in fact,it was written by 13 advocates of homeopathy who have no connection with any government. They decided to employ their own, unusual criteria for what constitutes evidence. For instance, they included case reports and case series, redefined what is meant by effectiveness, cherry-picked the articles they included, and assessed only a very narrow range of indications. This report cannot therefore be taken as reliable evidence”

        Wow! But your letters and other mistakes still exist nowadays. On A critique of the Swiss report Homeopathy in Healthcare you wrote:

        “It is would be incorrect to claim that this document is a report of the Swiss government; it is in fact a pamphlet written by 13 proponents of CAM.”

        David Shaw, your colleague, wrote the mistake in SMW journal: “The Swiss report on homeopathy: a case study of research misconduct” by David Martin Shaw, not the 13 proponents of CAM. Illiterate goose. Learn how to cite before you have your say. Ignorant.

        4. Misreport.

        “Systematic reviews avoid cherry-picking and include a critical analysis of the included data. Today, about 50 systematic reviews of homeopathy have been published. In order to avoid cherry-picking on this level, it is therefore necessary to summarise the totality of all such articles. Exactly this has recently been done by a panel of independent experts, the National Health and Medicine Research Council (NHMRC) of Australia.”

        Actually, it’s something called cherry picking. THE NHMRC include some reviews, they select some reviews only published in english! Since most of the RCT are of “poor quality” (when they rated as high quality in another reviews), it is not honest to discard all “lower level” studies especially if they give consistent results to discard the placebo effect independently of the clinical condition discussed. The orginally conclusion of the NHMRC (not the Glaziou or Friends of Science, Ilovescience or lobby opinions based on the think thanks BigMedia pseudoskepticism megacorporations or the utterly biased opinions of Molecules in Reactions staff) that it could not make conclusions regarding homeopathy for the clinical conditions analyzed. Are you Göobbels proponent?

        5. Manipulation

        “The argument turns out to be based on a simple accounting trick: statistics supporting it divide the trials into three categories: (1) positive, (2) negative, and (3) inconclusive. The first category comprises all the studies suggesting homeopathy to be superior to placebo; the second includes all the trials where placebo turned out to
        be superior to homeopathy; and the third (and by far the largest) category is composed of those studies which showed no difference between homeopathy and placebo… Once we do the proper accounting of these figures by merging categories 2 and 3 into one category of negative trials, we find that the majority of trials of homeopathy are in fact negative.”

        James Randi tricks remains relevant more than ever! You can make an hocus pocus trick and transform the inclusive results as “negative”. Well, if you accept the challenge: we find that majority of inconclusive trials of “conventional” medicine are in fact negative. Well done Ernst, fatality!

        6. Again:

        “Firstly, it is not true that animals do not respond to placebos; in fact, part of the phenomenon that constitutes the placebo response, classical conditioning, was discovered by Pavlov in dogs”

        Some animals responds to placebos in some cases, and not any animal species responds to placebos! I love the look of cognitive dissonance on the faces of the Alan Henness and biotech-pharma guys as you.

        7. Another:

        “Some advocates of homeopathy misunderstand criticism of their favourite therapy as a conspiracy organised by powerful, dark forces. The culprit behind such alleged intrigues is often assumed to be the pharmaceutical industry.‘BigPharma’is,according to this assumption, so impressed by the effectiveness of homeopathic medicines that it has to take action against them or else their profits would dwindle and their shareholders would protest.

        Dark forces? Behing? No Ernst, no. The “conspiracy” is that in you and the lobbies arranged by related fake institutes, the twitter massive bots (all days in all week as Guy Chapman), and more less the massi media corromped in their association. Considering the massive misreport, cherry picking bibliography in your book, the main conclusion observed during the chapters were very biased. The book is ranked in the poorest level of quality. I will write a review.

        • “If you believe that all homeoapthic research is consistent with the placebo effect, as you believe in the all posts, you’re acting irrational.”

          where did I say that?

          cherry-picking?

          I have always insisted that the totality of the evidence fails to be positive.

          INFORM YOURSELF PROPERLY BEFORE YOU UTTER SUCH NONSENSE.

          • “where did I say that?”

            Repeated in all posts.

            “I have always insisted that the totality of the evidence fails to be positive.”
            “INFORM YOURSELF PROPERLY BEFORE YOU UTTER SUCH NONSENSE.”

            Yes, informed properly before read your utterly biased books and articles. Well done, more personal beliefs based on the Ernst law:

            If research is very poor quality and the conclusion is negative: Ernst applaud!
            If research is very poor quality and the conclusion is positive: Ernst defame!

            If research is very high quality and the conclusion is negative: Ernst applaud!
            If research is very high quality and the conclusion is positive: Ernst defame!

            Are you a robot, a human or SAS bot?

        • “Zit” is proving three things with this risible rant, which contains nothing that has not been thoroughly dealt with in this blog:

          1. That he or she has not followed or read Ernst’s blog before and/or is too slow-minded to assimilate information.
          2. That Homeopathy does not help for emotional instability.
          3. Ernst’s law.

    • The curious case of Ernst E.

      “The fact that there was a (non-significant) trend in favour of homeopathy”

      In the paper:

      “This finding was not clinically or statistically 337 significant

      An incidental finding of this study, was the lower rate of URTI (laryngitis, 345 tonsillitis, pharyngitis) recorded as AEs in EG (3 vs. 13).

      Wow! Complex homeopathic show lower rate of URTI’s versus placebo. The fact is consistent with the 12 trials of URTI’s included in the Shang et al meta-analysis.

      Logos-bios:

      The fact is this (I called Ernst law of pseudoskepticism based on cherry picking data):

      When Boiron did well research with “positive” outcomes: Ernst defame!
      When Boiron did well research with “negative” outcomes: Ernst raise his hat!

      LMAO!

      • “Wow! Complex homeopathic show lower rate of URTI’s versus placebo. The fact is consistent with the 12 trials of URTI’s included in the Shang et al meta-analysis.”
        READ MY BLOG AGAIN, TRY TO UNDERSTAND IT AND STOP WRITING NONSENSE!

        • I’ve read again letter by letter. I view this utterly no sense contradition:

          “No surprises then – we already know that homeopathic remedies are placebos!

          Well done, in your pampleth:

          “Not all homeopaths became slavish followers of Hahnemann’s dogma and some naturally developed their own ideas”

          The product tested in the spanish trial is a complex potency!

          “Yet clinical trials are not perfect. They can have flaws and have rightly been criticised for amyriad of inherent limitations.”

          Yaw! In my comment: The NHMRC guideline mean of no reliable evidence: patients with sample < 50 is very small. For 50 to 149 patients, is a small sample. The conclusion of this trial, based on the same arguments of Glasziou believers, is this: the trial is not conclusive. LMAO!

          And…

          some suggest that a given treatment is effective, while others suggest the opposite. Homeopathy is no exception; well over 300 clinical trials of homeopathy are currently available, and predictably some are positive, while others are negative”

          In your own words:

          “Several well-conducted clinical studies of homeopathy with positive results have been published. It is therefore not true to claim that there is no good trial evidence at all.”

          ROFL!

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