MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

Clinical trials are a most useful tool, but they can easily be abused. It is not difficult to misuse them in such a way that even the most useless treatment appears to be effective. Sadly, this sort of thing happens all too often in the realm of alternative medicine. Take for instance this recently published trial of homeopathy.

The objective of this study was to investigate the usefulness of classical homeopathy for the prevention of recurrent urinary tract infections (UTI) in patients with spinal cord injury (SCI). Patients were admitted to this trial, if they had chronic SCI and had previously suffered from at least three UTI/year. They were treated either with a standardized prophylaxis alone, or with a standardized prophylaxis in combination with homeopathy. The number of UTIs, general and specific quality of life (QoL), and satisfaction with homeopathic treatment were assessed prospectively over the period of one year. Ten patients were in the control group and 25 patients received adjunctive homeopathic treatment. The median number of self-reported UTI in the homeopathy group decreased significantly, whereas it remained unchanged in the control group. The domain incontinence impact of the KHQ improved significantly, whereas the general QoL did not change. The satisfaction with homeopathic care was high.

The authors concluded that adjunctive homeopathic treatment lead to a significant decrease of UTI in SCI patients. Therefore, classical homeopathy could be considered in SCI patients with recurrent UTI.

Where to begin?

Here are just some of the most obvious flaws of and concerns with this study:

  1. There is no plausible rationale to even plan such a study.
  2. The sample size was far too small for allowing generalizable conclusions.
  3. There was no adequate randomisation and patients were able to chose the homeopathy option.
  4. The study seems to lack objective outcome measures.
  5. The study design did not allow to control for non-specific effects; therefore, it seems likely that the observed outcomes are unrelated to the homeopathic treatments but are caused by placebo and other non-specific effects.
  6. Even if the study had been rigorous, we would need independent replications before we draw such definitive conclusions.
  7. Two of the authors are homeopaths, and it is in their clinics that the study took place.
  8. Some of the authors have previously published a very similar paper – except that this ‘case series’ included no control group at all.
  9. The latter paper seems to have been published more than once.
  10. Of this paper, one of the authors claimed that ” the usefulness of classical homeopathy as an adjunctive measure for UTI prophylaxis in patients with NLUTD due to SCI has been demonstrated in a case series”. He seems to be unaware of the fact that a case series cannot possible lend itself to demonstrate this.
  11. I do wonder: did they just add a control group to their case series thus pretending it became a controlled clinical trial?

What strikes me most with such pseudo-research is its abundance and the naivety – or should I call it ignorance? – of the enthusiasts who conduct it. Most of them, I am fairly sure do not mean to do harm; but by Jove they do!

 

32 Responses to Homeopathy works? … Yes, provided the trial has enough flaws to produce a false-positive result

  • This is also very funny (first paragraph of the Results section):

    “From 12/2011 to 06/2015, a total of 46 patients provided written informed consent. The recruitment was stopped before the full number of study participants was enrolled, because the majority of potential study participants refused written informed consent because they did not want to be randomized to the control group. The recruitment was therefore closed after ten patients from the control group had completed the study. Consequently, treatment allocation by randomization was abandoned.”

    • If I read the results well, they found in the homeopathy group (n=25) that the number of UTIs went from 9 per year to 2 in the year that the patients were in the study. In the control group it stayed the same, 3 UTIs per year. We must assume that the numbers are in fact per person and not totals for the group, although the figures are only given as whole numbers, without decimals.
      This is beyond silly.

  • Sorry Professor, but we need evidence to support your contention that: “Most of them (enthusiasts for homeopathy) , I am fairly sure do not mean to do harm”.

    Given they must surely know the very faults your review of their paper points out, and given they (and others of like-mind), publish nonetheless, it is at least possible they mean to take advantage of the vulnerable and gullible, to defraud patients, mislead them and to harm them thereby.

    Whence cometh your ‘surety’ they are acting in good faith?

    If it makes a noise like a quack, practices like a quack and publishes like a quack – its a quack.

    And that is unacceptably unethical – as pointed out in the excellent new book More Harm than Good ?

    • I did say “I am FAIRLY sure”! …benefit of the doubt and all that…
      for once I try to be British, and you fall into my back – how mean can you get?

  • I believe this piece of error-strewn specious nonesense is – not unsurprisingly – being waved around by one D. Ullman esq as further conclusive proof of the miraculous powers of his favourite sugar pills.

    My powers of critical appraisal are minimal and even I could see many of the glaring flaws in this garbage purporting to be a study. This selective blindness to the abysmal quality of their evidence that homeopaths so often display is curious. I know they sometimes like to claim that the laws of statistics do not apply to them. This appears to be another example of this.

  • I assume that the Journal of Spinal Cord Medicine is peer-reviewed? So the usual two questions arise:

    1. What ethics committee approved the protocol?
    2. Who were the peer reviewers?

    Such studies should never get started, never mind appear in journals.

  • You forgot: 0. A vs A+B design.
    I’ve read it enough on this blog to spot it immediately 🙂

  • Of course it’s not only non-randomised it’s unblinded, did they self report previous “UTI”s?

    It couldn’t be much more flawed.

  • Edzard

    “Clinical trials are a most useful tool, but they can easily be abused. It is not difficult to misuse them in such a way that even the most useless treatment appears to be effective. Sadly, this sort of thing happens all too often in the realm of alternative medicine”
    Very well said. Now for the benefit of science based medicine explain these events:

    https://www.theguardian.com/business/2017/oct/05/over-half-of-new-cancer-drugs-show-no-benefits-for-survival-or-wellbeing
    “The team found that after a follow-up period of between three to eight years, 49% of approved uses were linked to no clear sign of improvement in survival or quality of life. Where survival benefits were shown, the team said these were clinically meaningless in almost half of the cases.”
    This is after successful trial.

    Another one:
    https://www.betterbones.com/osteoporosis/osteoporosis-risks-vs-benefits-of-osteoporosis-drugs/
    For example, the above information tells us that Fosamax reduces fracture risk by about 1% (absolute risk reduction), so 100 people would have to be treated for one to benefit from fracture risk — the NNT is 100, in this case. In essence, the NNT is telling us that for every single person who is benefitting from these drugs, 99 more are getting no benefit at all!

    https://medicine.wustl.edu/news/clot-busting-drugs-not-recommended-most-patients-with-blood-clots/
    The study showed that clearing the clot with drugs and specialized devices did not reduce the likelihood that patients would develop post-thrombotic syndrome, a complication that can leave patients with chronic limb pain and swelling, and can lead to difficulty walking or carrying out their daily activities. Use of the potent drugs did, however, raise the chance that a patient would experience a dangerous bleed.

    http://www.bmj.com/content/357/bmj.j2097
    The Cancer Drugs Fund (CDF) has not “delivered meaningful value” to patients with cancer and may have exposed them to “toxic side effects of drugs,” an analysis has found. “From 2010 when it started to 2016 when it closed, the Cancer Drugs Fund cost the UK taxpayer a total of £1.27bn [€1.51bn; $1.64bn], the equivalent of one year’s total spend on all cancer drugs in the NHS.

    https://www.usatoday.com/story/news/nation/2017/02/09/new-cancer-drugs-do-little-improve-survival/97712858/
    Overall cancer survival has barely changed over the past decade. The 72 cancer therapies approved from 2002 to 2014 gave patients only 2.1 more months of life than older drugs, according to a study in JAMA Otolaryngology–Head & Neck Surgery.
    Two-thirds of cancer drugs approved in the past two years have no evidence showing that they extend survival at all.
    The result: For every cancer patient who wins the lottery, there are many others who get little to no benefit from the latest drugs.

    And misuse:
    http://www.latimes.com/science/sciencenow/la-sci-sn-dementia-medications-benefit-20140908-story.html
    Despite slim evidence for their use, those medications often cause side effects such as fainting and arrhythmia, which put patients at high risk of hip fractures, and urinary retention. More than a third of the study’s 5,406 nursing home residents with severe dementia were taking one or more of these medications.

    Have you got your focus misplaced? This is what you continued to promote for 25 years at the cost of complementary medicine.

    • Iqbal, will you ever understand the `tu quoque’ fallacy? Here’s a handy explanation:

      https://en.wikipedia.org/wiki/Tu_quoque

      If all this is “at the cost of complementary medicine”, you will have to provide evidence for that. Complementary medicine seems to be doing very well by fleecing the gullible. You also need to back up your accusation regarding whatever Prof Ernst “continued to promote for 25 years”.

      You do realise of course that you are cherry-picking articles in order to derail the discussion? The rationalists here are not going to fall for that.

      • Les Rose

        `tu quoque’ fallacy?

        We are a little beyond the tu quoque phrase.

        The clinical trials, completed with no flaws, producing positive results, allowing release of drugs to customers in the market place: and the outcome?
        “49% of approved uses were linked to no clear sign of improvement in survival or quality of life.”
        “the NNT is telling us that for every single person who is benefitting from these drugs, 99 more are getting no benefit at all!”
        “The Cancer Drugs Fund (CDF) has not “delivered meaningful value” to patients with cancer and may have exposed them to “toxic side effects of drugs,” an analysis has found”
        “The result: For every cancer patient who wins the lottery, there are many others who get little to no benefit from the latest drugs.”

        “You do realise of course that you are cherry-picking articles in order to derail the discussion?”
        CHERRY PICKING? Get a new set of reading glasses:

        Overall cancer survival has barely changed over the past decade. (10 year outcome is based upon cherries?)

        The 72 cancer therapies approved from 2002 to 2014 gave patients only 2.1 more months of life than older drugs, according to a study in JAMA Otolaryngology–Head & Neck Surgery. (The outcome is to be calculated after 1000 trials results over the next 150 years?)

        Two-thirds of cancer drugs approved in the past two years have no evidence showing that they extend survival at all. ( The scientists and researchers took a sabbatical for 2 years?)

        The result: For every cancer patient who wins the lottery, there are many others who get little to no benefit from the latest drugs.
        This is great: Science is mandatory for alternative medicine: science based medicine is for the LUCKY ones!!!!!

        What is the rationale of Clinical trials: “Most of them, I am fairly sure do not mean to do harm; but by Jove they do!”
        EDZARD hit the nail on the head.

        • Meaningful debate is impossible with those who refuse to keep on-topic.

        • So, if i read correctly, 51% of approved uses are linked to clear signs of improval in survival or quality of life. But no reading glasses will allow Iqbal to read that.

          According to Iqbal, a good alternative to the problems of medicine would be to do nothing.

          • James

            Are you meaning that 49% clinical trials are fake?

            Not that you are at it, why not try and explain the luck aspect link to successful clinical trials:
            “the result: For every cancer patient who wins the lottery, there are many others who get little to no benefit from the latest drugs.”

            OR:
            “The 72 cancer therapies approved from 2002 to 2014 gave patients only 2.1 more months of life than older drugs, according to a study in JAMA Otolaryngology–Head & Neck Surgery.”

            12 years of hard work of running extensive clinical trials costing millions (or is it billions) to provide 2.1 months extra life: allows a patient to write his will if his brain function is not clouded by chemotherapy drugs.

            OR:
            “The Cancer Drugs Fund (CDF) has not “delivered meaningful value” to patients with cancer and may have exposed them to “toxic side effects of drugs,” an analysis has found. “From 2010 when it started to 2016 when it closed, the Cancer Drugs Fund cost the UK taxpayer a total of £1.27bn.” (Edzard is trying to save £127 from chiropractors!!!!!!! A classic case of “Penny wise pound foolish!”)

            What happened to research output in scientific medicine? Did they miss the safety analysis to allow drugs to go through with “toxic side effects” and help kill patients faster?

            Please take your time

          • I am sorry, it is what the sources say. You focus on the 49% wihout seeing the rest 51%, because this is positive and you don’t seem to like positive, huh?

            And, are you saying these people are not worth two extra months in their lives? Better let people die in peace? You said drugs help kill patients faster. I am sorry but drugs don’t kill patients faster, they provide extra months of life, 2.1 months, according to your sources. Your opinion is absolutely contradictory. Did you forget your 2nd paragraph when writing the 5th? You will have to decide, are two additional months of life worth? Should we let patients die 2 months sooner?

            And, since you are so keen, do you have anything better to propose for cancer? Are you hiding something?

          • @Iqbal

            “The 72 cancer therapies approved from 2002 to 2014 gave patients only 2.1 more months of life than older drugs, according to a study in JAMA Otolaryngology–Head & Neck Surgery.”

            Compare and contrast: “Those who skipped or delayed conventional treatment to use alternative ones had as much as a 5.7-fold increased risk of dying within five years than those who stuck with conventional medicine, the researchers reported in the Journal of the National Cancer Institute.” [https://arstechnica.com/science/2017/08/alternative-medicines-toll-on-cancer-patients-death-rate-up-to-5x-higher/]

            “The Cancer Drugs Fund (CDF) has not “delivered meaningful value” to patients with cancer and may have exposed them to “toxic side effects of drugs,” an analysis has found.”

            The CDF was set up in the UK in response to intense lobbying from cancer patients and charities to allow the NHS to dispense ‘promising’ new drugs that had not yet completed the formal evidence gathering of clinical trials required for approval. At the time, many predicted the fund would not deliver meaningful value, but politicians set it up anyway, to ease patients’ access to new therapies they’d read about on the web. You shouldn’t quote the CDF in your tu quoques as the conclusion is strongly supportive of a proper evidence-based approach to cancer treatment.

          • Frank Odds

            “[https://arstechnica.com/science/2017/08/alternative-medicines-toll-on-cancer-patients-death-rate-up-to-5x-higher/]”
            Is this not running against “The result: For every cancer patient who wins the lottery, there are many others who get little to no benefit from the latest drugs.”
            “The Cancer Drugs Fund (CDF) has not “delivered meaningful value” to patients with cancer and may have exposed them to “toxic side effects of drugs,” an analysis has found. “From 2010 when it started to 2016 when it closed, the Cancer Drugs Fund cost the UK taxpayer a total of £1.27bn [€1.51bn; $1.64bn], the equivalent of one year’s total spend on all cancer drugs in the NHS.”

            “The CDF was set up in the UK in response to intense lobbying from cancer patients and charities to allow the NHS to dispense ‘promising’ new drugs that had not yet completed the formal evidence gathering of clinical trials required for approval.”

            Researchers passed off their responsibility only when they found they were extremely incompetent and a complete failure. Because there was no benefit, what would you expect patients to do? For how long is the treatment protocol -surgery, radiation and chemotherapy- not necessarily in that order- and research in cancer continuing?

            ” You shouldn’t quote the CDF in your tu quoques as the conclusion is strongly supportive of a proper evidence-based approach to cancer treatment.”

            Evidence based: surely.

            Rigorous replication effort succeeds for just two of five cancer papers
            “But scientists at Bayer and Amgen wouldn’t say which experiments they examined, so their work raised many questions but left no way for scientists to answer them.
            “Three of the five show very, very striking differences from the original,”
            It seems that all that has been supposedly achieved is because of patient’s luck.

            And it is not only for cancer patients.
            https://hms.harvard.edu/news/when-doctors-away-0

          • Hahaha, Iqbal almost ignores Frank’s source and argument and continues with his own. This is not a platform/shoot ’em up game fellow Iqbal.

          • @Iqbal Krishna

            Really, you are just going to deflect from the statistic that death rate is 5 TIMES higher with “alternative” “treatments” than scientific medicine? 5 TIMES improvement is just a lottery for you? Tell that to a patient with cancer.

            > Rigorous replication effort succeeds for just two of five cancer papers

            There is such a thing as tumor heterogeneity, which means that there is considerable variation in tumor cell types, within the SAME tumor, making it hard to collect uniform populations.

            You don’t have enough education to grasp this. The ENTIRE concept of homeopathic “Provings”, the entire claimed basis for selecting between sugar pills is a scam. Your so-called “Provings” have ZERO replicability (meaning: they are BUNK, so much hot air). For anyone with a minimal (and actual) chemistry education, this should be obviously. But for you, homeo water is like holy water – People rotate an aarti 3 times around a deity and think magic infused everything in the plate. You think a few bangs on a book gives it super-natural powers. No difference. This is a religion for you.

            First, prove that your provings can be replicated in a double-blind setting. You can’t because this is just imaginative fiction. Every single line in your Clark’s presciber is horse manure. Every.single.line. Not an occasional error, here and there, but every single thing.

            I think homeopaths know how daft the concept of proving is, given that we understand these methodological issues for a very long time now, which seems to be why they are very quiet in critically vetting something that is so easy to experiment on. I think we should have TV shows where the scam of the homeopathic provings is exposed in exactly the same way as the Forer effect.

          • Ravi, you are effectively talking to a wall, though one that talks back in this case. His brain is flooded with irrationality. Whenever his infants start a fever, he gives them some shaken potion, and their fever…keeps increasing! And this is proof that homeopathic preparations aggravate the symptoms when the organism responds to the treatment.

            No hope at all!

          • @James

            > Ravi, you are effectively talking to a wall

            My exact words to Iqbal at Nirmukta, exactly a month ago. That and his cherry-picking tactic. We are all coming to the same conclusions independently.

            > though one that talks back in this case

            And boy, does it talk. I have been rebutting his short article length posts for almost an year and half at Nirmukta, he has not learned one thing yet. And it was frustrating to discover that he was repeating the same arguments ad infinitum, even after they have been properly debunked at either place and some additional sites as well.

            > His brain is flooded with irrationality.

            There is a name for this: Closed circuit thinking.

            http://mediusinternational.com/main/index.php/2017/02/25/the-impenetrable-mystery-of-closed-circuit-thinking/

            > Whenever his infants start a fever, he gives them some shaken potion

            Right, closed circuit thinking at its finest.

            Fever resolved? – Victory!!
            Fever increased? It is being “aggravated” towards cure – Victory!!

            His household seems to have gotten a routine viral fever. He confidently diagnosed it as Malaria, presumably without any verification for the parasite, on just the fever pattern, looked up his book of fiction aka. Clark Prescriber, gave a “personalized” treatment mind you, and when the fever inevitably went away, claimed victory.

            He literally argues that since Malaria research resulted in 4 Nobels, we should not be having Malaria in the world by now at all. That there still is in poor countries, is proof for him that medical science is not legit.

            His closed circuit goes like this:
            1.) The concept of vaccines is flawed.
            2.) Vaccines work, but it was Homeopathic idea all along.
            3.) Vaccines work, but we don’t know what horrible things might happen because we eradicate diseases with them.

            So he will argue on all sides, as long as he can conclude that homeopathy good – modern medicine bad, all the while deflecting from the elephant in the room: no aspect of Homeopathy has any better evidence than Witchcraft does. Even Witchcraft may have an actual herb or two with symptomatic relief. No chance of even that in Homeopathy.

            I tried explaining to him how what Hahnemann called “Allopathy” was in fact what is now called Unani in India and that Ayurveda is the same thing. But that does not fit into his belief framework. So that dropped off like a water drop on a wax paper.

            The most intense presentation of Dunning-Kruger effect I have seen so far, and we see a few at rationalist sites.

          • Yes, it is not worth arguing with him, I have been doing this for about a year now, as well. He is impenetrable to reason, even if you’d keep trying for a lifetime. Plus there is absolutely no coherence in his line of reasoning or argumentation.

            The problem is that he is inevitably endangering the lives of his children, and…that he is going to raise a new generation of closed-minded thinkers. It is a pity to screw the lives of your children so early on.

      • > You do realise of course that you are cherry-picking articles in order to derail the discussion? The rationalists here are not going to fall for that.

        Indian rationalist here. He has been doing that cherry-picking all over.

        http://nirmukta.com/2012/03/17/a-response-to-dr-b-m-hegde/
        (Nirmukta is an Indian rationalist community that writes about pseudoscience and irrationality in our society. It is not specific to medicine).

        No acknowledgement of ANY successes of modern medicine. Wipe them all under the rug. But put under a magnifying glass, any challenges such as adverse events and uncertainties in doing actual medicine, all with little context.. all the while deflecting from the utter fantasy bullcrap that is homeopathy. He has not studied any Biology, but seems to have been raised by a Homeopath. So this seems to be an article of faith for him.

        • Yes, this blog has experienced his incoherent fantasizing for a long time now, of which I have only had first hand interaction for only a fraction. Raising someone to believe in homeopathy is, though putting one’s life at risk, one’s own prerogative. But raising someone to hate medicine is almost criminal, because it really screws up their life.

          Sadly, it is an article of true faith for him and there is little hope for him to get over this bunk. Let’s just hope he retains his health for years to come and his young children never fall in need of actual serious healthcare.

        • Ravi

          I selected two names for you. Please finalize one:

          Jaichand or Mir Jafar.

          We will continue from there.

          • I have one for you. Mr. Dunning-Kruger.

            Sure why not? When all else fails, drape your struggle as patriotic. That is the last refuge.

    • Here, Iqbal: https://www.ncbi.nlm.nih.gov/pubmed.

      Type your delusions in the search box at the top and avoid Google, as it needs special instructions on how to use correctly. Also, avoid the words complementary or alternative in the journal titles.

      Then we can talk.

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