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

Researchers from the National Institute of Homoeopathy (an autonomous organisation under the Ministry of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homeopathy, Government of India) tested a Dysentery Compound (DC), a ‘bowel nosode’, against individualized homeopathy (IH) in the treatment of irritable bowel syndrome (IBS). For this purpose, they used an open, randomized (1:1), parallel arms, pragmatic, non-inferiority, pilot trial with 60 IBS patients. IBS Quality of Life (IBS-QOL) questionnaire was used as the primary outcome measure; assessed at baseline and after 3 months.

Six subjects dropped out. Groups were comparable at baseline (all p>0.01). Though intra-group changes were higher favouring IH over DC, group differences were statistically non-significant (all p>0.01). Non-inferiority was not demonstrated by DC against IH over 3 months (mean difference= −3.3, SE=5.2, lower 95% confidence limit −11.9, t= −0.453, p=0.674). No adverse events were reported from either group.

The authors concluded that non-inferiority of DC against IH in treatment of IBS was not demonstrated though it appeared as safe; still, being a pilot trial, no definite conclusion could be drawn. Further exploration of both efficacy and effectiveness of either of the therapies is necessary by adequately powered trials and independent replications.

This trial is a treasure trove of methodological flaws. Here I want to focus on merely one of them: The idea of conducting a non-inferiority study of two treatments, none of which have previously been shown to be effective.

Most clinical trials are ‘superiority studies’ designed to test whether one treatment is more effective than another one. This is fundamentally different in non-inferiority or equivalence studies. They aim to test whether one treatment is as effective as another therapy that has already been fully researched and is generally accepted to be effective for the condition in question. This approach avoids the ethical problems that can arise in superiority studies from giving placebos to patients who require an effective treatment for their condition. Equivalence studies can have many of the features of superiority studies but require a different statistical approach and usually need much larger sample sizes.

This means that the new study never had the slightest chance to generate a result that was in any way meaningful. Such a waste of resources is hardly surprising in the realm of homeopathy; over the years, we have become used to it. But, coming from the National Institute of Homeopathy, it is significant. On their website, the Institute claims this:

The mission of National Institute of Homoeopathy is to foster excellence in Homoeopathic Medical Education and Research, to educate and train undergraduate, post graduate students and research scholars of homoeopathy in accordance with highest professional standards and ethical values unfettered by the barriers of nationality, language, culture, plurality, religion and to meet the healthcare needs of the community through dissemination of knowledge and service. 

Excellence in homeopathic research?

Well, you could have fooled me!

 

11 Responses to A new example of ‘excellence in homeopathic research’

  • It is interesting (and odd) that you’ve chosen P<0.01 as the determination of statistically significance, while the rest of the world determines it to be P<0.05.

    You love to move the "bar" to greater extremes when evaluating CAM treatments, but never use it to evaluate conventional treatments….but we all know this about you.

  • no, I have not ‘chosen’; I reported what their abstract said.

  • It is interesting (and odd) that defenders of quackery attack its critics from a position of intentional ignorance, thereby accidentally discrediting the quacks they intend to champion.

    • What is not mentioned here enough is the “quackery” in “scientific” medicine…. folks it does exist.

      I’ve witnessed as much quackery from MD’s as homeopathy.

      My step-father suffered a massive coronary heart attack when he was 40 years old. His heart was stopped for something in the order of 10 minutes time before getting acute medical attention. He went into a coma for a month. The doctors said he would never be more than a vegetable. They wanted to pull the plug on his life support, my mother wouldn’t have it, she would not give in and give the OK to end his life. Well, he eventually did come out of the coma. It took him a few years to relearn everything, but he was no veggie. He lived another 25 years.
      The moral of the story is, doctors think they know everything, but they don’t. I’m glad my mother didn’t listen to the doctors.
      If it quacks like a duck, it’s a duck.

      • no, the moral of the story is that you managed to write yet another daft comment: your story shows that MDs saved a life. they may have had little hope and were ready to stop the machines but they initially managed the acute event, subsequently kept him going and eventually followed your mothers wishes despite the balance of probabilities. in a nutshell, they were no homeopaths!

      • ..and your story does not make much sense RG, because ten minutes of asystoly without CPR and you’re definitely dead. OK; you were wrong about the ten minutes of stopped heart, then let’s look at the credibility of Dr’s wanting to pull the plug after only a month. That makes no sense either.
        You need to get your story straight RG. OK, perhaps you are right and the man regained consciousness after the doctors gave up hope on a brain that was not mushed beyond repair and showed reasonable activity, but that was definitely not just a month after the injury. A month is only the very beginning of recuperating after brain injury. No modern doctor would pull the plug so early unless the brain was damaged beyond hope.

        If you want to tell tall tales here, then make an effort to have them reasonably plausible and check on the facts.

        • LOL …. sure, I’m just telling tall tales…. try again.
          The audacity of you here that refute personal testimony because you want to be right.

          Pseudo-Logical Fallacies:
          The Argument from Incredulity: The popular fallacy of doubting or rejecting a novel claim or argument out of hand simply because it appears superficially “incredible,” “insane” or “crazy,” or because it goes against one’s own personal beliefs, prior experience or ideology. This cynical fallacy falsely elevates the saying popularized by Carl Sagan, that “Extraordinary claims require extraordinary proof,” to an absolute law of logic. See also Hoyle’s Fallacy. The common, popular-level form of this fallacy is dismissing surprising, extraordinary or unfamiliar arguments and evidence with a wave of the hand, a shake of the head, and a mutter of “that’s crazy!”

          Alternative Truth (also, Alt Facts; Counterknowledge; Disinformation; Information Pollution): A newly-famous contemporary fallacy of logos rooted in postmodernism, denying the resilience of facts or truth as such.
          “Is there someone in your life who insists things happened that didn’t happen, or has a completely different version of events in which you have the facts? It’s a form of mind control and is very common among families dealing with substance and behavior problems.” She suggests that such “Alternate Facts” work to “put you off balance,” “control the story,” and “make you think you’re crazy,” and she notes that “presenting alternate facts is the hallmark of untrustworthy people.” The Alternative Truth fallacy is related to the Big Lie Technique. See also Gaslighting, Blind Loyalty, The Big Brain/Little Brain Fallacy, and Two Truths

          Bjorn, I have the facts
          You have the Alternative Truth

          • 😀 You are so daft, dear RG, that you don’t even realise when you shoot yourself in the proverbial foot .

  • lol…. EE, you keep changing the subject. I dd not refer to ANY homeopathy. I’m referring to “Science” based medicine.

    I have always maintained that MD’s are valuable for acute issues, that is not in dispute here. I support that treatment… in general.

    The story gets better, or perhaps I should say worse.
    A few years later I became informed of human organ harvesting. I did some research into the hospital and the doctors group that attended to my step-father. I found out that there was some dark history, some cases of organ harvesting….and going to court for being accused of the same…. yup.
    Kinda stinks huh ?

    So either the doctors were completely wrong in their analysis, or they had evil motives. Either way it’s hard to erase the “quackery” of that experience to this day.
    Quack Quack Quack

    You see Edzard, anecdotal evidence has a value.

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