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

Acute Otitis Media (AOM) is one of the most common acute infections in children and often injudiciously treated by antibiotics. Homeopathy has been claimed to work but is it really effective?

This open label, randomized, controlled, parallel arm trial was conducted on children (aged 0–12 years), suffering from AOM. The primary outcome was changes in Tympanic Membrane Examination scale (TMES) and Acute Otitis Media-Severity of Symptoms (AOM-SOS) scale, time to improvement in pain through Facial Pain Scale-Revised (FPS-R) over 10 days. The need for antibiotics in both groups and the recurrence of subsequent episodes of AOM over 12 months were also compared.

Intention-to-treat analysis was performed on 222 children; Homeopathy (n = 117) (H-group), Allopathy (A-group) (n = 105). There was a statistically significant reduction of scores in H-group compared with A-group at each time point: at day 3 (mean diff. ± sd: 1.71 ± 0.19; 95% CI: 1.34 to 2.07; p = 0.0001), at day 7 (mean diff. ± sd: 1.29 ± 0.24; 95% CI: 0.82 to 1.76; p = 0.0001) and at day 10 (mean diff. ± sd: 1.23 ± 0.25; 95% CI = 0.74 to 1.71; p = 0.0001) favoring homeopathy. Clinical failure by the third day of treatment was observed in 11% and 24% of children in H-group vs A-group (OR: 0.03; 95% CI: 0.001 to 0.52; p = 0.03). None of the children in the H-group required antibiotics, whereas 14 children in the A-group did.

The authors concluded that both therapies seemed to produce comparable effects and appeared safe. The study consolidated the findings observed during a pilot study, i.e., homeopathy is non-inferior to allopathy in managing AOM in children and antibiotics in children can be avoided.

This study was published in the journal ‘Homeopathy’ and originates from the Central Council for Research in Homeopathy, New Delhi, India. Sadly, I do not have the full text of the paper and cannot therefore scrutinize it adequately.

Let me just mention these three facts:

  1.  The journal ‘Homeopathy’ never publishes negative results.
  2. Indian researchers of homeopathy publish as good as no negative results.
  3. As far as I can see, the Central Council for Research in Homeopathy, New Delhi, has never published a negative result.

These points do, of course, not necessarily mean that the study is false-positive, but they do not inspire me with confidence. In any case, it seems wise to insist on better evidence. To render it credible, we would need:

  1. Several rigorous RCTs that test homeopathy for AOM against placebo.
  2. If (and only then) they show that homeopathy is better than placebo, at least one independent replication of the present study.

As the biological plausibility of all this is close to zero, the chances that this will happen are also zero.

19 Responses to A Comparative Randomised Controlled Trial of Homeopathy versus Allopathy in Acute Otitis Media

  • “None of the children in the H-group required antibiotics, whereas 14 children in the A-group did.”

    Who said so? On what was the decision based?

    It is TYPICAL for homeopaths to neglect their patients and to withhold medication based on scientific medicine. Homeopaths even boast with that. They use this as a lever to persuade politicians, claiming that homeopathy is less costly than scientific medicine. We observed this behavior several times in public.

    • Exactly! that phrase could be rewritten as: “The physicians chose not to give antibiotics to children that they knew were receiving homeopathic treatment”.

      • The P-value at day 3, day 7 and day 10 was so substantially signficant that these numbers were in the O, O, O, my God levels!

        Well, what a coincidence that those children who were prescribed a homeopathic medicine has this substantial difference with those prescribed conventional medications.

        Please show me any clinical trial were a placebo had THIS statistical significance with a conventional treatment of acute otitis media. There have been hundreds of such trials over the past several decades…and so, it should be EASY for any of you to cite such a study.

        However, something tells me that the silence that I will hear will be deafening.

        What fun!

        • did they not teach you about p-values and what they mean at Berkley, Dana?
          you should ask your fees back!

        • Did you notice sometging, Dana?

          “open label, randomized, controlled, parallel arm trial”

          I did.

          No blinding.

          It’s garbage. Nonsense. But of course you swallow it credulously.

          Run along, now.

        • The p-value and other statistical toys are irrelevant.

          Homeopathy is fraud. The use of non-working medication is fraud.

        • The p-value does NOT indicate somewhat like “truth” or “relevance” of a result. You’re misunderstanding God, Dana.

          “To pounce on tiny P values and ignore the larger question is to fall prey to the “seductive certainty of significance”, says Geoff Cumming, an emeritus psychologist at La Trobe University in Melbourne, Australia. But significance is no indicator of practical relevance, he says: “We should be asking, ‘How much of an effect is there?’, not ‘Is there an effect?’”

          https://www.nature.com/articles/506150a

  • Looks like – for some strange reason – “Congress abstract” and “Fulltext” are the very same at the publisher’s site.

    Weird…

    • They’re homeopaths – would we expect them to know the difference between “abstract” and “fulltext”? (something to do with dilutions perhaps?)

    • This study does not exist yet as a published paper. The header states ‘presentation abstracts / oral abstracts’. I guess we will have to wait until this breathtaking piece of science gets published. This may take some time, i presume, while they climb down the ladder of Journals, starting with ‘Nature’, working their way through BMJ and JAMA to finally end in the ‘Journal of irreproducible results’ or some other homeopathic magazine.

  • With all due respect, how many times has this been done? I am getting tired of only seeing reports over and over again proving homeopathy or some other obvious quackery is bogus. Why can’t your e-list (and others like Stephen Barrett’s healthfraud e-list) investigate more serious issues like aggressive coding, double billing and overcharging, pushing invasive procedures benefiting the practitioner not the patient, etc. These and others are more significant and costly health frauds plaguing our medical system today than obvious proven quackery.

  • The study protocol was registered in 2019 (see below).

    The study was presented by its corresponding author on 16 June 2023 at the Homeopathy Research Institute’s 5th International Research Conference (see below).

    Central Council for Research in Homoeopathy.
    A study protocol on comparative randomised controlled trial of Homoeopathy -vs- allopathy in acute otitis media and its recurrence in children.
    Indian J Res Homoeopathy 2019;13:177-83.
    doi:10.4103/ijrh.ijrh_57_19
    which has ⇩ Download URL:
    https://www.ijrh.org/cgi/viewcontent.cgi?article=1419&context=journal

    The Homeopathy Research Institute’s 5th International Research Conference, London, 16–18 June 2023.
    https://www.hrilondon2023.org/wp-content/uploads/2023/10/HRILondon2023_Programme.pdf

    Dr Roja Varanasi, Fri 16 June 2023, 12:00
    A comparative randomised controlled trial of homoeopathy versus allopathy in acute otitis media and its recurrence in children
    Roja Varanasi[𝟏], et al.

    [𝟏] Central Council for Research in Homoeopathy, New Delhi, India

  • Ernst: “The journal ‘Homeopathy’ never publishes negative results.”

    https://www.sciencedirect.com/science/article/abs/pii/S147549161100049X
    “The homeopathic preparation Plumbum metallicum had no effect, in this study, in terms of reducing serum lead in workers exposed to lead.”

    • well spotted: the needle in the hat stack.

      • Edzard-

        In my humble opinion, at the risk of being a skunk at a lawn party, I suggest that “double blind” as a verification of efficacy has been elevated beyond its significance. See https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7409478/

        To prove the value of any medical remedy, those purporting it should be required to explain the underlying mechanism by which the desired effect is obtained. Anything less seems to me somewhere between empiricism and magic..

        The question should go beyond “does it work” to “WHY does it work”. Otherwise, a double blind study may look like a collective anecdote, muddied by psychosomatic elements in either or both cohorts.

        I am an engineer, not in medicine – but I have reviewed this comment with my wife, who is a psychiatrist, and she agrees.

        • “it should be required to explain the underlying mechanism by which the desired effect is obtained”

          An effect, and the underlying mechanism for obtaining it, are orthogonal.

          In science, computing, and engineering, a black box is a system which can be viewed in terms of its inputs and outputs (or transfer characteristics), without any knowledge of its internal workings. Its implementation is “opaque” (black). The term can be used to refer to many inner workings, such as those of a transistor, an engine, an algorithm, the human brain, or an institution or government.

          https://en.m.wikipedia.org/wiki/Black_box

          An example of a reproducible effect where the exact mechanism behind it remains unknown:
          https://en.m.wikipedia.org/wiki/Sonoluminescence

        • @David Ecklein

          The question should go beyond “does it work” to “WHY does it work”.

          I beg to disagree.
          The above question implicitly asserts that it (i.e. homeopathy) works. This assertion is wrong.

          Before going into the question why something might work, it is essential that it is first established to work at all. This does not necessarily require double-blind randomized trials; other types of study can also be used, e.g. retrospective studies – so comparing health and sickness among a large group of homeopathy users with a matching group of people who do not use homeopathy. It’s just that these study types generally need larger populations and come with more caveats, such has controlling for the fact that homeopathy users may be more health-conscious than other people, and pay more attention to things such as food and exercise.

          Only when there are at least strong signals that something might indeed have an effect (beyond placebo, that is) is it justified to invest effort, time and money into searching for what causes that effect. So far, homeopaths have failed to come up with any homeopathic preparation that shows a clear, consistent and reproducible effect. This means that any research into how it works is doomed to fail from the onset, simply because there is no effect – and a clear, consistent effect is necessary to test any hypothesis about a mechanism of action.
          Worst case, homeopaths make themselves believe that they see effects, and build a complete house of cards upon nothing but that unproven belief.

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