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

In one of his many comments, our friend Iqbal just linked to an article that unquestionably is interesting. Here is its abstract (the link also provides the full paper):

Objective: The objective was to assess the usefulness of homoeopathic genus epidemicus (Bryonia alba 30C) for the prevention of chikungunya during its epidemic outbreak in the state of Kerala, India.

Materials and Methods: A cluster- randomised, double- blind, placebo -controlled trial was conducted in Kerala for prevention of chikungunya during the epidemic outbreak in August-September 2007 in three panchayats of two districts. Bryonia alba 30C/placebo was randomly administered to 167 clusters (Bryonia alba 30C = 84 clusters; placebo = 83 clusters) out of which data of 158 clusters was analyzed (Bryonia alba 30C = 82 clusters; placebo = 76 clusters) . Healthy participants (absence of fever and arthralgia) were eligible for the study (Bryonia alba 30 C n = 19750; placebo n = 18479). Weekly follow-up was done for 35 days. Infection rate in the study groups was analysed and compared by use of cluster analysis.

Results: The findings showed that 2525 out of 19750 persons of Bryonia alba 30 C group suffered from chikungunya, compared to 2919 out of 18479 in placebo group. Cluster analysis showed significant difference between the two groups [rate ratio = 0.76 (95% CI 0.14 – 5.57), P value = 0.03]. The result reflects a 19.76% relative risk reduction by Bryonia alba 30C as compared to placebo.

Conclusion: Bryonia alba 30C as genus epidemicus was better than placebo in decreasing the incidence of chikungunya in Kerala. The efficacy of genus epidemicus needs to be replicated in different epidemic settings.

________________________________________________________________________________

I have often said the notion that homeopathy might prevent epidemics is purely based on observational data. Here I stand corrected. This is an RCT! What is more, it suggests that homeopathy might be effective. As this is an important claim, let me quickly post just 10 comments on this study. I will try to make this short (I only looked at it briefly), hoping that others complete my criticism where I missed important issues:

  1. The paper was published in THE INDIAN JOURNAL OF RESEARCH IN HOMEOPATHY. This is not a publication that could be called a top journal. If this study really shows something as revolutionarily new as its conclusions imply, one must wonder why it was published in an obscure and inaccessible journal.
  2. Several of its authors are homeopaths who unquestionably have an axe to grind, yet they do not declare any conflicts of interest.
  3. The abstract states that the trial was aimed at assessing the usefulness of Bryonia C30, while the paper itself states that it assessed its efficacy. The two are not the same, I think.
  4. The trial was conducted in 2007 and published only 7 years later; why the delay?
  5. The criteria for the main outcome measure were less than clear and had plenty of room for interpretation (“Any participant who suffered from fever and arthralgia (characteristic symptoms of chikungunya) during the follow-up period was considered as a case of chikungunya”).
  6. I fail to follow the logic of the sample size calculation provided by the authors and therefore believe that the trial was woefully underpowered.
  7. As a cluster RCT, its unit of assessment is the cluster. Yet the significant results seem to have been obtained by using single patients as the unit of assessment (“At the end of follow-ups it was observed that 12.78% (2525 out of 19750) healthy individuals, administered with Bryonia alba 30 C, were presented diagnosed as probable case of chikungunya, whereas it was 15.79% (2919 out of 18749) in the placebo group”).
  8. The p-value was set at 0.05. As we have often explained, this is far too low considering that the verum was a C30 dilution with zero prior probability.
  9. Nine clusters were not included in the analysis because of ‘non-compliance’. I doubt whether this was the correct way of dealing with this issue and think that an intention to treat analysis would have been better.
  10. This RCT was published 4 years ago. If true, its findings are nothing short of a sensation. Therefore, one would have expected that, by now, we would see several independent replications. The fact that this is not the case might mean that such RCTs were done but failed to confirm the findings above.

As I said, I would welcome others to have a look and tell us what they think about this potentially important study.

29 Responses to An RCT suggests that homeopathy can prevent epidemics!!! But how reliable is this evidence?

  • How come the rest of us don’t see Iqbal’s funnycomments?

  • Wasn’t this study actually flawed from the start as all participants were treated the same – all got placebos!

  • Have I got this wrong? The Rate Ratio is the ratio of those who suffered and treated/ suffered and were untreated over those not suffering and treated/not suffering and untreated.? If that is the case and I’m very open to being corrected, then significance is a significant difference from 1. A 95% confidence interval of 0.14 to 5.57 doesn’t appear significant at all.

  • Edzard

    “The paper was published in THE INDIAN JOURNAL OF RESEARCH IN HOMEOPATHY. This is not a publication that could be called a top journal.”

    This is nothing new: This Happens all the time. Big corporations ensure competitor news is buried in the 6th page.

    6) Despite the fact that the researchers had for decades published papers in the leading vaccine journals, none of these journals were willing to publish this groundbreaking trial – by all accounts, one of the largest ever conducted in medicine. What happened? Were the researchers no longer ‘experts?’ Did they forget how to conduct a proper trial? Was the trial of insufficient quality? No legitimate criticism has been registered to date and none was given by the journals.
    https://www.bmj.com/content/345/bmj.e6184/rr/616928

    “Several of its authors are homeopaths who unquestionably have an axe to grind, yet they do not declare any conflicts of interest.”
    You have worked with a clear purpose of running down complementary medicine. How many times have you declared conflict of interest?

    “The two are not the same, I think.”
    Usefulness can be defined as efficacy also. (google meaning of usefulness)

    “The trial was conducted in 2007 and published only 7 years later; why the delay?”
    When in doubt, ASK.

    “The criteria for the main outcome measure ..”
    ASK.

    “I fail to follow the logic of the sample size calculation ..”
    What did you calculate?

    “As a cluster RCT, its unit of assessment is the cluster…”
    You lost me here. Is not the individual number to be counted even if the cluster is checked separately? The bottom line will still be total individuals.

    “As we have often explained, this is far too low considering that the verum was a C30 dilution…….”
    ASK.

    “…….and think that an intention to treat analysis would have been better.”
    ASK. I am positive they would be happy to discuss.

    “If true, its findings are nothing short of a sensation..”
    Really? I thought this was common. Focus on outcome. If outcome is positive, while you have questions about trial, revisit the questions. If the process is incorrect, the correct answer would be a fluke and will happen only once. If the results are positive repeatedly, the questions about trial are wrong.

    Cuban homeopathic leptospirosis trial: what is the long term position?
    https://homeopathyplus.com/denguehomeopathy.pdf was subsequent to leptospirosis trial?

  • Oh, the leptospirosis trial. Are homeopaths still trying to tell us that a natural decline in cases after an outbreak was the effect of toy medicine ??
    This incredible (literally) story has been debunked so many times I have problems choosing which analysis to refer to.

    Perhaps this one is simple enough even for Iqbal, our uneducable homeopathist ?
    https://apgaylard.wordpress.com/2010/08/08/much-ado-about-nothing/

    • Björn Geir

      This is standard outcome. Once homeopathy intervenes, natural decline follows.

      • Once homeopathy intervenes, natural decline follows.

        Very well said, Iqbal. (Though not quite the way you meant, I’m sure.)

      • Leptospirosis did occur, it was suppressed with ring vaccination.

        The ‘trial’ was completely uncontrolled and therefore informed us of nothing.

      • Once homeopathy intervenes, natural decline follows

        Especially in epidemics and outbreaks, natural decline always follows, regardless of any intervention (or the nature thereof).
        This principle also extends to 80% of other, endemic health problems, and actually forms the very foundation of homeopathy:
        1. Give sick people a useless placebo;
        2. Wait for natural resolution – something that happens in the vast majority of cases;
        3. Claim another success for homeopathy.

      • This is standard outcome. Once homeopathy intervenes, natural decline follows.

        @Iqbal.

        Homeopathic intervention was executed during an outburst of Leptospirosis in 2007 in a defined region in Cuba resulting in a rapid decline of cases shortly after the intervention.
        In the same region, in both 2005 and 2006, very similar outbursts of the same disease showed exactly the same pattern of an outburst that rapidly declined after reaching culmen. The duration and amplitude of the two previous outbursts were almost identical but no homeopathic intervention was involved in these outbursts. The outburst in 2007 is believed to have been cut short by the homeopathic intervention.

        Now, Iqbal… Please try to focus on and answer the following question without starting off on something else:

        What do you think caused the rapid decline in the two previous outbursts in the same region of Cuba?

        • And just as important: no less than 96% of people received the homeopathic ‘prophylaxis’ in two regions. Yet after the epidemic, leptospirosis incidence there simply returned to pre-epidemic levels, NOT zero, as one would expect in an almost fully protected population. Which strongly suggests that the homeopathic intervention had no effect whatsoever.
          How does Iqbal explain this?

        • Is it possible that our friend Iqbal suddenly lost interest in the homeopathic management of leptospirosis? How can that be? And one would have thought the eminent Ullman would be all over this discussion of the biggest trial of homeopathy ever. Strange?

        • And an unspecified proportion of the most vulnerable in the intervention region were given the proven conventional Vax-Spiral prophylaxis (also developed by the Finlay Institute)..

          And they deemed homeopathy to have been successful by comparing the results to an unverified model.

    • I would not call Iqbal a homeopathist, rather a victim of homeopathy. Some delusion usually finds its way in almost all people, but here, we are talking about the grandest of degrees… He has experienced multiple generations of delusion, homeopathy is a dominantly inheritable disease, unfortunately.

  • Another reason why ‘studies’ like these are weak:
    Trials during an epidemic/outbreak run a high risk of meaningless results, as there are lots of confounders that can’t be controlled for. Epidemics are often rather chaotic, with several simultaneous, different efforts to curb spread of the disease and limit exposure, raise awareness among the public, and many more things. All this can produce large differences in several parameters, even on a geographically local scale, and on a short time scale.

    Anything that is collected in these circumstances is not data, but merely noise.

  • 1. “one must wonder why it was published in an obscure and inaccessible journal”

    Ironically, E. Ernst had published many papers in “obscure” journals. Alas, the FACT journal without Impact Factor!
    IJRH is an open access journal!

    2. “Several of its authors are homeopaths who unquestionably have an axe to grind, yet they do not declare any conflicts of interest.”

    Ironically, E. Ernst constantly repeated that he was a “trained homeopath”, and for this reason he was unbiased for his published works. Yet, E. Ernst do not declare any conflicts of interest with American Council On Science and Health lobby and his CSICOP affiliation!

    3. “The abstract states that the trial was aimed at assessing the usefulness of Bryonia C30, while the paper itself states that it assessed its efficacy. The two are not the same, I think.”

    This is not a methodological problem. For example, in your SR published in 2002 you tried evalute the plausibility of homeopathy, however your SR was a biased SR auto quoting your own analysis of Linde’s works.

    4. “The trial was conducted in 2007 and published only 7 years later; why the delay?”

    Many conventional papers rejects the CAM paper with positive outcomes.

    5. “The criteria for the main outcome measure were less than clear and had plenty of room for interpretation (“Any participant who suffered from fever and arthralgia (characteristic symptoms of chikungunya) during the follow-up period was considered as a case of chikungunya”).”

    E. Ernst a trialist without knowledge in epidemics or physicis trying to debunk papers published by experts. Really?

    6. “I fail to follow the logic of the sample size calculation provided by the authors and therefore believe that the trial was woefully underpowered.”

    “Believe”, oh, you can send your belief and put in a trash bin.

    7. “As a cluster RCT, its unit of assessment is the cluster. Yet the significant results seem to have been obtained by using single patients as the unit of assessment (“At the end of follow-ups it was observed that 12.78% (2525 out of 19750) healthy individuals, administered with Bryonia alba 30 C, were presented diagnosed as probable case of chikungunya, whereas it was 15.79% (2919 out of 18749) in the placebo group”). The p-value was set at 0.05. As we have often explained, this is far too low considering that the verum was a C30 dilution with zero prior probability.”

    So, if the standarized P valued contradics your beliefs, you set your personal p value.

    8- “Nine clusters were not included in the analysis because of ‘non-compliance’. I doubt whether this was the correct way of dealing with this issue and think that an intention to treat analysis would have been better.”

    Obviously, was an epidiomological analysis.

    9. “This RCT was published 4 years ago. If true, its findings are nothing short of a sensation. Therefore, one would have expected that, by now, we would see several independent replications. The fact that this is not the case might mean that such RCTs were done but failed to confirm the findings above.”

    The paper can be considered as a replication from historical and epidemiological data. You have not debunked the study.

    • who said I wanted to ‘debunk’ it?
      I tried to do a critical evaluation.

      • Where is the alleged critical evaluation, Edzard?
        You must lear the lesson, ad hominem and straw man attacks ARE NOT critical evaluations. Retract your biased papers.

    • @ManUll

      Thank you.

    • ManUll

      “The paper can be considered as a replication from historical and epidemiological data..”

      Er, no it can’t. Science doesn’t work like that. Edzard’s final point is the most important one. If the paper showed genuine results – which would be truly astounding – others would have been able to replicate them.

      This hasn’t happened, has it?

      Almost as if the original paper was an exercise in torturing data to shake something out of the noise and see a result which wasn’t actually there.

      • Oh Lenny, you would able to show the “torturing data”, but nothing of this is reported in your comments. If your are unable to discuss in simple terms, and you missed the poinit, think in the response of your guru:

        “who said I wanted to ‘debunk’ it?
        I tried to do a critical evaluation.”

      • “If the paper showed genuine results – which would be truly astounding – others would have been able to replicate them”.

        Like the researchers unable to replicate the Ernst’s papers??

        • It’s as if Edzard is was stood before Iqbal, light sabre raised.. “If you strike me down, I shall become more stupid than you can possibly imagine..”

          The beam fell.

          And ManUll was unleashed upon us.

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