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

placebo

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Recently, I received this comment from a reader:

Edzard-‘I see you do not understand much of trial design’ is true BUT I wager that you are in the same boat when it comes to a design of a trial for LBP treatment: not only you but many other therapists. There are too many variables in the treatment relationship that would allow genuine , valid criticism of any design. If I have to pick one book of the several listed elsewhere I choose Gregory Grieve’s ‘Common Vertebral Joint Problems’. Get it, read it, think about it and with sufficient luck you may come to realize that your warranted prejudices against many unconventional ‘medical’ treatments should not be of the same strength when it comes to judging the physical therapy of some spinal problems as described in the book.

And a chiro added:

EE: I see that you do not understand much of trial design

Perhaps it’s Ernst who doesnt understand how to research back pain.

“The identification of patient subgroups that respond best to specific interventions has been set as a key priority in LBP research for the past 2 decades.2,7 In parallel, surveys of clinicians managing LBP show that there are strong views against generic treatment and an expectation that treatment should be individualized to the patient.6,22.”

Journal of Orthopaedic & Sports Physical Therapy
Published Online:January 31, 2017Volume47Issue2Pages44-48

Do I need to explain why the Grieve book (yes, I have it and yes, I read it) is not a substitute for evidence that an intervention or technique is effective? No, I didn’t think so. This needs to come from a decent clinical trial.

And how would one design a trial of LBP (low back pain) that would be a meaningful first step and account for the “many variables in the treatment relationship”?

How about proceeding as follows (the steps are not necessarily in that order):

  • Study the previously published literature.
  • Talk to other experts.
  • Recruit a research team that covers all the expertise you need (and don’t have yourself).
  • Formulate your research question. Mine would be IS THERAPY XY MORE EFFECTIVE THAN USUAL CARE FOR CHRONIC LBP? I know LBP is but a vague symptom. This does, however, not necessarily matter (see below).
  • Define primary and secondary outcome measures, e.g. pain, QoL, function, as well as the validated methods with which they will be quantified.
  • Clarify the method you employ for monitoring adverse effects.
  • Do a small pilot study.
  • Involve a statistician.
  • Calculate the required sample size of your study.
  • Consider going multi-center with your trial if you are short of patients.
  • Define chronic LBP as closely as you can. If there is evidence that a certain type of patient responds better to the therapy xy than others, that might be considered in the definition of the type of LBP.
  • List all inclusion and exclusion criteria.
  • Make sure you include randomization in the design.
  • Randomization should be to groups A and B. Group A receives treatment xy, while group B receives usual care.
  • Write down what A and B should and should not entail.
  • Make sure you include blinding of the outcome assessors and data evaluators.
  • Define how frequently the treatments should be administered and for how long.
  • Make sure all therapists employed in the study are of a high standard and define the criteria of this standard.
  • Train all therapists of both groups such that they provide treatments that are as uniform as possible.
  • Work out a reasonable statistical plan for evaluating the results.
  • Write all this down in a protocol.

Such a trial design does not need patient or therapist blinding nor does it require a placebo. The information it would provide is, of course, limited in several ways. Yet it would be a rigorous test of the research question.

If the results of the study are positive, one might consider thinking of an adequate sham treatment to match therapy xy and of other ways of firming up the evidence.

As LBP is not a disease but a symptom, the study does not aim to include patients that all are equal in all aspects of their condition. If some patients turn out to respond better than others, one can later check whether they have identifiable characteristics. Subsequently, one would need to do a trial to test whether the assumption is true.

Therapy xy is complex and needs to be tailored to the characteristics of each patient? That is not necessarily an unsolvable problem. Within limits, it is possible to allow each therapist the freedom to chose the approach he/she thinks is optimal. If the freedom needed is considerable, this might change the research question to something like ‘IS THAT TYPE OF THERAPIST MORE EFFECTIVE THAN THOSE EMPLOYING USUAL CARE FOR CHRONIC LBP?’

My trial would obviously not answer all the open questions. Yet it would be a reasonable start for evaluating a therapy that has not yet been submitted to clinical trials. Subsequent trials could build on its results.

I am sure that I have forgotten lots of details. If they come up in discussion, I can try to incorporate them into the study design.

 

 

Post-traumatic stress disorder (PTSD), previously known as battle fatigue syndrome or shell shock, is a condition that can be triggered by the experience of some frightening event. PTSD can be debilitating leading to the production of feelings of helplessness, intense fear, and horror. Numerous treatments of PTSD exist but few have been shown to be truly effective. A team of Canadian researchers explored the effects of cannabis on PTSD symptoms, quality of life (QOL), and return to work (RTW). Their systematic review also investigated harms such as adverse effects and dropouts due to adverse effects, inefficacy, and all-cause dropout rates.

Their electronic searches located one RCT and 10 observational studies (n = 4672). Risk of bias (RoB) was assessed with the Cochrane risk of bias tool and ROBINS-I. Evidence from the included studies was mainly based on studies with no comparators. Results from unpooled, high RoB studies suggested that cannabis was associated with a reduction in overall PTSD symptoms and improved QOL. Dry mouth, headaches, and psychoactive effects such as agitation and euphoria were the most commonly reported adverse effects. In most studies, cannabis was well tolerated. A small proportion of patients experienced a worsening of PTSD symptoms.

The authors concluded that the evidence in the current study primarily stems from low quality and high RoB observational studies. Further RCTs investigating cannabis effects on PTSD treatment should be conducted with larger sample sizes and explore a broader range of patient-important outcomes.

Various drugs are currently used for the treatment of PTSD including selective serotonin reuptake inhibitors; tricyclic antidepressants (amitriptyline and isocarboxazid); mood stabilizers (Divalproex and lamotrigine); atypical antipsychotics (aripiprazole and quetiapine) but their effectiveness has not been proven. A recent systematic review included 30 RCTs of a range of heterogeneous non-psychological and non-pharmacological interventions. There was emerging evidence for 6 different approaches:

  • acupuncture,
  • neurofeedback,
  • saikokeishikankyoto (a herbal preparation),
  • somatic experiencing,
  • transcranial magnetic stimulation,
  • yoga.

This list makes me wonder: are these treatments, including cannabis, truly promising, or is PTSD one of those conditions for which nearly every treatment works a little because of its placebo effect?

This systematic review assessed the effects and reliability of sham procedures in manual therapy (MT) trials in the treatment of back pain (BP) in order to provide methodological guidance for clinical trial development.

Different databases were screened up to 20 August 2020. Randomized controlled trials involving adults affected by BP (cervical and lumbar), acute or chronic, were included. Hand contact sham treatment (ST) was compared with different MT (physiotherapy, chiropractic, osteopathy, massage, kinesiology, and reflexology) and to no treatment. Primary outcomes were BP improvement, the success of blinding, and adverse effects (AE). Secondary outcomes were the number of drop-outs. Dichotomous outcomes were analyzed using risk ratio (RR), continuous using mean difference (MD), 95% CIs. The minimal clinically important difference was 30 mm changes in pain score.

A total of 24 trials were included involving 2019 participants. Most of the trials were of chiropractic manipulation. Very low evidence quality suggests clinically insignificant pain improvement in favor of MT compared with ST (MD 3.86, 95% CI 3.29 to 4.43) and no differences between ST and no treatment (MD -5.84, 95% CI -20.46 to 8.78).ST reliability shows a high percentage of correct detection by participants (ranged from 46.7% to 83.5%), spinal manipulation is the most recognized technique. Low quality of evidence suggests that AE and drop-out rates were similar between ST and MT (RR AE=0.84, 95% CI 0.55 to 1.28, RR drop-outs=0.98, 95% CI 0.77 to 1.25). A similar drop-out rate was reported for no treatment (RR=0.82, 95% 0.43 to 1.55).

The authors concluded that MT does not seem to have clinically relevant effect compared with ST. Similar effects were found with no treatment. The heterogeneousness of sham MT studies and the very low quality of evidence render uncertain these review findings. Future trials should develop reliable kinds of ST, similar to active treatment, to ensure participant blinding and to guarantee a proper sample size for the reliable detection of clinically meaningful treatment effects.

The optimal therapy for back pain does not exist or has not yet been identified; there are dozens of different approaches but none has been found to be truly and dramatically effective. Manual therapies like chiropractic and osteopathy are often used, and some data suggest that they are as good (or as bad) as most other options. This review confirms what we have discussed many times previously (e.g. here), namely that the small positive effect of MT, or specifically spinal manipulation, is largely due to placebo.

Considering this information, what is the best treatment for back pain sufferers? The answer seems obvious: it is a therapy that is as (in)effective as all the others but causes the least harm or expense. In other words, it is not chiropractic nor osteopathy but exercise.

My conclusion:

avoid therapists who use spinal manipulation for back pain.

“Time to say good-bye? Homeopathy, skeptics and thoughts on how to proceed” is the title of an article by two Swiss homeopaths which is almost touchingly naive. Here is its abstract:

Although homeopathy is frequently used by many health professionals, there are ongoing debates concerning its effectiveness. Currently no unifying explanation how homeopathy works exists. Homeopaths are frequently challenged by skeptics, and in public opinion, the swan song for homeopathy is frequently sung.

Content: Regarding the efficacy of homeopathy, several well-designed RCTs, observational studies, case studies, and case reports, have been published, demonstrating its clinical efficacy. Regarding its mode of action, the discovery of the working principle of homeopathy would be a major advance towards a thorough scientific recognition of homeopathy. Basic research has already discovered some milestones, e.g., significant and reproducible effects of homeopathic preparations in plants.

Summary: To overcome the distrust of skeptics and public opinion, the support of basic research is indispensable. Second, homeopaths should continue to design prospective randomized clinical studies in order to create robust clinical evidence for the efficacy of homeopathy. Third, they should continue to publish their treatment outcomes, as these publications document clinical effectiveness beyond doubts about its mode of action.

Outlook: These measures will not only support homeopaths in continuing their clinical work, but may lead to a better recognition of this treatment in both the scientific world and the public.

To this, I might add the following comments:

  • “ongoing debates concerning its effectiveness”: this debate has been ongoing for 200 years but it has now come to a conclusion, namely that homeopathy is a placebo therapy.
  • “no unifying explanation how homeopathy works exists”: we do know, however, that the laws of nature, as we understand them today, must be wrong if homeopathy did work.
  • “Homeopaths are frequently challenged by skeptics”: the main challenges currently come not from skeptics but from health experts who rightly insist on sound evidence.
  • “several well-designed RCTs, observational studies, case studies, and case reports, have been published, demonstrating its clinical efficacy”: arguably, this might be correct but misses the crucial point that the totality of the reliable evidence fails to show that homeopathy is efficacious for any condition of humans or animals.
  • “the discovery of the working principle of homeopathy would be a major advance”: yes, so much so that it would require rewriting whole sections of the textbooks of physics and chemistry.
  • “Basic research has already discovered some milestones”: these ‘milestones’ are so imposing that nobody outside the realm of homeopathy has ever recognized them.
  • “the support of basic research is indispensable”: not so much indispensable as non-existent, I would say.
  • “design prospective randomized clinical studies in order to create robust clinical evidence for the efficacy of homeopathy”: homeopaths believe research to be a tool for creating evidence that supports their creed; I have often tried to remind them that it is a tool for testing hypotheses – to no avail, it seems.
  • “publish their treatment outcomes, as these publications document clinical effectiveness”: I have also often tried to explain to them that treatment outcomes can be due to many factors other than the specific effect of the applied therapy – again to no avail.
  • “These measures will not only support homeopaths in continuing their clinical work, but may lead to a better recognition of this treatment in both the scientific world and the public”: these measures, if applied rigorously, will merely confirm what we already know, namely that homeopathy does not work beyond placebo.

This study was aimed at determining the effectiveness of electroacupuncture or auricular acupuncture for chronic musculoskeletal pain in cancer survivors.

The Personalized Electroacupuncture vs Auricular Acupuncture Comparativeness Effectiveness (PEACE) trial is a randomized clinical trial that was conducted from March 2017 to October 2019 (follow-up completed April 2020) across an urban academic cancer center and 5 suburban sites in New York and New Jersey. Study statisticians were blinded to treatment assignments. The 360 adults included in the study had a prior cancer diagnosis but no current evidence of disease, reported musculoskeletal pain for at least 3 months, and self-reported pain intensity on the Brief Pain Inventory (BPI) ranging from 0 (no pain) to 10 (worst pain imaginable).

Patients were randomized 2:2:1 to:

  1. electroacupuncture (n = 145),
  2. auricular acupuncture (n = 143),
  3. or usual care (n = 72).

Intervention groups received 10 weekly sessions of electroacupuncture or auricular acupuncture. Ten acupuncture sessions were offered to the usual care group from weeks 12 through 24.

The primary outcome was a change in the average pain severity score on the BPI from baseline to week 12. Using a gatekeeping multiple-comparison procedure, electroacupuncture and auricular acupuncture were compared with usual care using a linear mixed model. Noninferiority of auricular acupuncture to electroacupuncture was tested if both interventions were superior to usual care.

Among 360 cancer survivors (mean [SD] age, 62.1 [12.7] years; mean [SD] baseline BPI score, 5.2 [1.7] points; 251 [69.7%] women; and 88 [24.4%] non-White), 340 (94.4%) completed the primary end point. Compared with usual care, electroacupuncture reduced pain severity by 1.9 points (97.5% CI, 1.4-2.4 points; P < .001) and auricular acupuncture reduced by 1.6 points (97.5% CI, 1.0-2.1 points; P < .001) from baseline to week 12. Noninferiority of auricular acupuncture to electroacupuncture was not demonstrated. Adverse events were mild; 15 of 143 (10.5%) patients receiving auricular acupuncture and 1 of 145 (0.7%) patients receiving electroacupuncture discontinued treatments due to adverse events (P < .001).

The authors of this study concluded that, in this randomized clinical trial among cancer survivors with chronic musculoskeletal pain, electroacupuncture and auricular acupuncture produced greater pain reduction than usual care. However, auricular acupuncture did not demonstrate noninferiority to electroacupuncture, and patients receiving it had more adverse events.

I think the authors made a mistake in formulating their conclusions. Perhaps they allow me to correct it:

In this randomized clinical trial among cancer survivors with chronic musculoskeletal pain, electroacupuncture plus usual care and auricular acupuncture plus usual care produced greater pain reduction than usual care alone.

I know, I must sound like a broken record, but – because it followed the often-discussed ‘A+B versus B’ design – this study does simply not show what the authors conclude. In fact, it tells us very little about any effects caused by the two acupuncture versions per se. The study does not control for placebo effects and therefore its results are consistent with acupuncture itself having no effect at all.

Here is an attempt at explaining the ‘A+B versus B’ study design I posted previously:

As regularly mentioned on this blog, there are several ways to design a study such that the risk of producing a negative result is minimal. The most popular one in SCAM research is the ‘A+B versus B’ design…

Imagine you have an amount of money A and your friend owns the same sum plus another amount B. Who has more money? Simple, it is, of course your friend: A+B will always be more than A [unless B is a negative amount]. For the same reason, such “pragmatic” trials will always generate positive results [unless the treatment in question does actual harm]. Treatment as usual plus acupuncture is more than treatment as usual alone, and the former is therefore more than likely to produce a better result. This will be true, even if acupuncture is a pure placebo – after all, a placebo is more than nothing, and the placebo effect will impact on the outcome, particularly if we are dealing with a highly subjective symptom such as fatigue.

Imagine the two interventions had been a verbal encouragement or pat on the shoulder or a pat on the right shoulder for group 1 and one on the left for group 2. The findings could well have been very similar. To provide evidence that acupuncture PRODUCES PAIN REDUCTION, we need proper tests of the hypothesis. And to ‘determine the effectiveness of electroacupuncture or auricular acupuncture for chronic musculoskeletal pain in cancer survivors’, we need a different methodology.

This is, of course, all very elementary. Nothing elaborate or complicated! Scientists know it; editors know it; reviewers know it. Or at least they should know it. Therefore, I am at a loss trying to understand why even journals of high standing publish IMPROPER tests, better known as pseudo-science.

It is hard not to conclude that they deliberately try to mislead us.

Several previously published clinical trials have suggested that both acupuncture and sham acupuncture exert significant, non-specific effects on treatment outcomes when compared to no-treatment controls. A recently developed framework (mechanisms in orthodox and complementary and alternative medicine-MOCAM) suggests that the non-specific effects of acupuncture originate from multiple domains (e.g. patient characteristics, acupuncturist skill/technique, the patient-acupuncturist relationship, and the acupuncture environment). However, it remains to be determined precisely how these domains influence the non-specific effects of treatment among patients receiving acupuncture and sham acupuncture in clinical trials.

To address this issue, researchers conducted a systematic review to synthesize existing qualitative evidence on how trial participants randomized to acupuncture and sham acupuncture groups experience non-specific effects, regardless of the types of medical conditions investigated.

This systematic review included primary qualitative studies embedded in randomized controlled trials designed to investigate acupuncture or sham acupuncture interventions. Eligible studies published in English were derived from a search of five international databases. The methodological quality of included studies was evaluated using the Critical Appraisal Skills Programme (CASP) tool. Using a framework synthesis approach, the identified MOCAM framework was adapted based on the synthesis of the available qualitative evidence.

A total of 20 studies of high methodological quality were included. The proposed model indicated that the effects of acupuncture may be increased by:

  • maintaining a professional status,
  • applying a holistic treatment approach,
  • practicing empathy,
  • providing patients with an appropriate explanation of the theory behind acupuncture and sham acupuncture.

From the patient’s perspective, the efficacy of treatment can be increased by:

  • following the lifestyle modification advice provided by acupuncturists,
  • maintaining a positive attitude toward treatment efficacy,
  • actively engaging with acupuncturists during the consultation,
  • making behavioral changes based on experience gained during the trial.

The authors concluded that the results of this study may provide a basis for improving and standardizing key components of non-specific effects in acupuncture treatment, and for improving the isolation of specific effects in future clinical trials involving acupuncture and sham acupuncture.

The authors also state that having a positive attitude and high expectations regarding treatment efficacy can lead to positive health outcomes, along with a sense of curiosity and altruistic desire to join clinical trials. Indeed, previous clinical trials have reported that higher expectations regarding treatment effects may help to reduce fatigue and alleviate osteoarthritis in both acupuncture and sham acupuncture groups. Similar benefits of positive expectations have also been observed among patients with irritable bowel syndrome in sham acupuncture trials. 

SO CLOSE AND YET SO FAR!

So close to admitting that these findings indicate quite strongly that acupuncture is but a theatrical placebo.

We are living in difficult times, and few things are more difficult than spending the holidays in confinement alone or (possibly worse) with close family. If you do, you need all the help you can get. Here are a few homeopathic remedies (all available from Her Majesty’s homeopathic pharmacy) which, according to the ‘like cures like’ (LCL) axiom of homeopathy, might come in handy:

So, do take good care of yourselves, stay healthy, don’t over-dose the brandy butter, port, or anything else, and

MERRY CHRISTMAS!

 

Who does not like a nice fragrance?

Who would object to aromatherapy?

Nobody, I suppose.

But, if its called THERAPY, we surely must ask whether it is therapeutic. And is aromatherapy therapeutic? Let’s see:

This randomized, placebo-controlled clinical trial tested whether patients with post-dural puncture headache (PDPH) caused by spinal anesthesia would benefit from aromatherapy. A total od 50 patients received 15-minute inhalations of either lavender oil or liquid paraffin as placebo. The severity of headache was scored before (baseline) and after the intervention – immediately, 30, 60, 90, and 120 minutes after – using a visual analog scale. In addition, the dosage and frequency of the pain killers as well as adverse effects of the intervention were recorded.

Both groups showed a reduction in headache scores post intervention. However, the headache scores between the groups was significantly different immediately after the intervention in favor of lavender oil (difference: 1.60 ± 0.63, P = .015). Furthermore, it was observed that the mean changes of the headache scores compared to the baseline were significant at each time interval in favor of the placebo group (P < .05), except immediately after the intervention. No significant difference was observed in Diclofenac intake between groups (P = .440), and no adverse effects were noted.

The authors concluded that aromatherapy with lavender oil was observed to reduce the severity of PDPH only immediately after the intervention, while only minimal effects were observed at successive time intervals. However, it is noted that the study was likely underpowered and further studies are recommended to better understand the effects of lavender oil on PDPH and compare its effects to other herbal products or pharmacological agents commonly used for managing headaches.

I find it laudable that some researchers conduct clinical trials even of so-called alternative medicines (SCAMs) which many of us might view as trivial. I find it more laudable that they try to do this rigorously by adding a placebo control group to the study. And I would find it even more laudable, if they did this adequately.

Considering parafin oil to be a placebo in a study of lavender oil inhalation can hardly be called adequate. Placebos are used in clinical trials mostly to account for the expectation of patients. This means that, whenever possible, patients need to be blinded to the group aloocation and the placebo must be indistinguishable from the verum. In the present trial, the patients could obviously tell the difference between the smell of lavender and the absence of any smell in the control group. Thus, their expectation could easily suffice to bring about the findings observed in the study. This means that the trial does not neccessarily demonstrate the effects of armoatherapy, but might (and most probably does) merely show the power of expectation.

How can one design such a trial more rigorously? you will ask.

There are several options. For instance, for the control group, one could use an artificial fragrance not made from natural lavender. Alternatively, one could include only patients who are unfamiliar with the smell of lavender and use a similaryly pleasant fragrance from a different plant as the control intervention.

As it stands, the study – even though aimed at testing the hypothesis that aromatherpy with lavender has specific effects on pain – tells us next to nothing.

… except, of course that it is always worth thinking very carefully about the adequate way to conduct a clinical trial.

This challenge for all homeopaths of the world was inspired by an avid commentator to this blog who, at every fitting and unfitting occasion, insists that those who doubt homeopathy must do a homeopathic proving.

A homeopathic ‘proving’ (Arzneimittelpruefung in Hahnamann’s less confusing terminology) is a test where a healthy person takes a (usually potentised) homeopathic remedy and then carefully notes all the symptoms and sensations which appear subsequently. When Hahnemann ‘discovered’ homeopathy, he took some cinchona and thought to experience the symptoms of malaria. This was the reason why he, after further such experiments, postulated that LIKE CURES LIKE.

To the present day, homeopathy relies on such provings. If we cannot sleep after drinking coffee, it is not unlike a proving of coffee, and homeopaths conclude that potentised coffee is a remedy for insomnia. I have done several provings many years ago, but they never worked the way homeopaths expect. We also investigared whether a related phenomenon, homeopathic aggravations (the worsening of the presenting symptom after taking the a well-chosen homeopathic remedy), claimed by homeopaths do exist at all; the answer was simple: no! In fact, the only people who believe in provings and aggravations are the homeopaths.

All this inspired me to now issue

A challenge for all homeopaths of the world

Here is the deal:

  1. you, the convinced homeopath, name the 6 homeopathic remedies that you cannot possibly miss when doing a proving on yourself;
  2. I order them in the potency you wish (only condition: it must be higher than C12) from a reputable source;
  3. I have the bottles delivered unopened to a notary where I live;
  4. the notary fills them into containers marked 1-6 (if you wish, you can send the notary empty containers for that ppurpose);
  5. the notary keeps the code under lock and key that links the name of the remedies to the numbers 1-6;
  6. he then mails the coded 6 remedies to you;
  7. you can use the proving method which you consider best and do as many provings as you like (the only limiting factors are the number of globuli in the containers and the time you have to crack the code);
  8. I give you 100 days for conducting the provings;
  9. once you are ready, you send your verdicts to the notary (e.g. 1 = rhus, tox, 2 = sulfur, 3 = arsenic, etc., etc.);
  10. the notary looks up the code and lets us both know the result.

I am happy to pay all the costs involved in the experiment (notary, remedies, postage, etc.). We can also discuss some of the details of this challenge, in case they run counter to your views on provings, rigorous science, etc.

To make sure we both ‘mean business’, once we both accept these conditions (you can flesh out the missing details as you wish), we both transfer a sum Euro 2 000 to an account with the notary. If you want to increase the sum, please let me know; as I said, we can discuss most of the details of my challenge to suit your needs. If you manage to ‘crack the code’ 1-6, the notary will transfer the sum of Euro 4 000 (your deposit and mine) to your account. If you fail, he will transfer the same amount to my account.

SIMPLE!

The entry into the challenge closes at the end of the year 2020.

Why should you take on this challenge? I can see several reasons:

  1. You want to prove that provings are valid.
  2. You want to teach me, and all other critics of homeopathy, a lesson.
  3. You want to earn Euro 2 000 quickly and without much work.
  4. You want the sceptics of the world to know that homeopathy is valid (we will report about our experiment fairly and to publish the report not just on this blog, but anywhere you want [provided the editors accept the paper for publication]).

Why do I take on the risk of losing a significant amount of money? Here too, I see more than one reason:

  1. I do not consider it a great risk; as I said, I did several provings myself and am quite certain they don’t work.
  2. I know about the implausiblity of the assumption that a remedy which contains nothing has any effects beyond expectation.
  3. I could do with the extra Euro 2 000.
  4. If no homeopath takes on the challenge, I shall henceforce declare that homeopaths were unable to prove that their provings are valid.

 

The HOMEOPATHY RESEARCH INSTITUTE (HRI) – yes we did discuss its activities before – has just published an ‘update’ on clinical trials of homeopathy. Let me show it to you:

We are pleased to share the results of a recent collaboration with Dr Robert Mathie to update his analysis of randomised controlled trials of homeopathy.

The findings from the 5-year update from 2014-2019 are as follows:

Total number of randomised controlled trials

2014: 189 trials of homeopathic treatment for 100 medical conditions
2019: 221 trials of homeopathic treatment for 115 medical conditions

Placebo-controlled trials only

2014: 104 trials on 63 medical conditions
2019: 129 trials on 77 medical conditions

When considering the balance of positive, negative and inconclusive studies, it is interesting to observe the following shifts in the evidence base for homeopathy over this 5 year period:

Positive trials                Up from 41% to 45%
Negative trials              Down from 5% to 4%
Inconclusive trials        Down from 54% to 51%

__________________________________________________

Impressed?

Me too (but only about the profound ignorance of the HRI)!

One could now point out that the ‘pee counting’ method of reviewing clinical trial evidence is nonsense and leads almost invariably to irrelevant findings. All the positive trials could, for instance, be methodologically invalid, while the negative are rigorous. But this is not even necessary. The triumphant update can be invalidated much more easily.

All we need to do is to remind ourselves of what clinical trials are.

Simply put, they are experiments that test a hypothesis, to be precise, they test the ‘null-hypothesis’: the experimental therapy generates results that are not different from those in the control group. Depending on the data, the null-hypothesis must then be either rejected or accepted by the results of the clinical trial. If it is rejected, the therapy seems to be better than placebo. If it is accepted, the therapy seems to perform just like a placebo.

THERE IS NO SUCH THING AS NEITHER REJECTING NOR ACCEPTING!

The results can not say: “We like the null-hypothesis just as much as we dislike it.” Clinical trials always give a YES or NO answer.

This means the category of ‘inconclusive trials’ is entirely an invention of homeopaths and similar wishful thinkers. In their interpretation, it covers those trials where the null-hypothesis was accepted, while the ‘negative trials’ are studies where the control group had better results than the patients treated homeopathically. But trials that accept the null-hypothesis are negative!

So, what does the HRI’s ‘pee-counting’ update really show?

It reveals that, of the 221 RCTs of homeopathy, 45% are positive, i.e. they suggest that homeopathy was better than the control intervention. That is a sizable percentage, but we might ask how reliable these studies were, what control treatments they employed, and whether they all truly used homeopathy (I know, some used isopathy and some employ homotoxicology, for instance).

The majority of the 221 RCTs, however, are trials where the null-hypothesis had to be accepted. These are the studies failing to show that homeopathy works. In other words, the HRI’s triumphant ‘pee-counting’ update confirms what we have pointed out as nauseam for years:

THE MAJORITY OF THE EVIDENCE ON HOMEOPATHY IS NEGATIVE.

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