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

pseudo-science

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If you thought that lousy research in so-called alternative medicine (SCAM) is confined to human medicine, you were wrong. The papers published in veterinary medicine is just one of many examples to suggest that it is, in fact, even worse. Take, for instance, this study of homeopathy.

This Indian study was conducted to evaluate the ameliorative potential of homeopathic drugs in combination (Sulfur 30C, Thuja 30C, Graphites 30C, and Psorinum 30C) in 16 dogs affected with oral papillomatosis which had not undergone any previous treatment. Papillomas are benign epithelial tumours caused by infection with species-specific DNA papilloma-viruses. They tend to disappear within 6-12 months.

Dogs affected with oral papillomatosiswere randomly divided into two groups, namely, homeopathic treatment group (n=8) and placebo control group (n=8). The homeopathic combination of drugs and placebo drug (distilled water) was administered orally twice daily for 15 days. The 4 homeopathy drugs were used in the 30C potency and given orally at 2 drops per 5 kg body weight. The clinical evaluation in both groups of dogs was performed by the same investigator throughout the period of study (12 months). All  dogs were clinically scored for oral lesions on days 0, 5, 7, 10, 15, 20, 25, 30, 45, 60, 90, 120, and 150 after initiation of treatment.

The homeopathic treatment group showed early recovery with a significant reduction in oral lesions reflected by a clinical score in comparison to placebo-treated group. Oral papillomatous lesions regressed in the homeopathic group between 7 and 15 days, whereas regression of papilloma in the placebo group occurred between 90 and 150 days. The homeopathic treated group was observed for 12 months post-treatment period and no recurrence of oral papilloma was observed.

The authors concluded that the result of this investigation proves that the combination of homeopathic drugs (Sulfur 30+Thuja 30+Graphites 30+Psorinum 30) offers an attractive, non-invasive and most economical way of treating COP. A combination of homeopathic drugs is a novel approach for treating canine oral papilloma and further studies are needed to elucidate the use of homeopathic combination as a veterinary oncological therapeutics and to explore the mechanism of action of these homeopathic drugs in ameliorating oral papilloma.

The graph says it all. Very rarely is any medical treatment as effective as to produce such impressive results.

So, are we witnessing a scientific sensation?

Is this the breakthrough homeopaths have been waiting for?

Should the Nobel committee be informed?

Perhaps not!

A group size of 8 is underwhelming, to say the least. It is not sufficient to generate a reliable result. The results, even if true, ‘prove‘ nothing other than the authors’ ignorance of research methodology.

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%

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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.

THE WORLD FOUNDATION OF SCIENCE had been unknown to me, I must admit (I came across it when googling ‘Schuessler salts’). The name does, I suspect, attract many people who search for reliable, science-based information. Its website contains all sorts of amazing articles, for instance:

On the subject of Schuessler salts (also called Tissue salts), their website informs us that:

… Dr. Schüßler found out that functional organ disorders are often caused by a lack of one or more minerals. To treat the disorder, these minerals are supplied in homeopathic potency to stimulate the body to improve the absorption and transport of the mineral in question. In the treatment of colds or to strengthen the immune system, very good results can be achieved with Schuessler salts.

Colds

On the first signs:
Schuessler Salt no. 3 Ferrum phosphoricum D12

For coughs, colds, hoarseness, sore throat, earache:
Schuessler Salt No. 4 Potassium chloratum D6

For persistent colds with yellowish secretions:
Schuessler Salt No. 6 Potassium sulfuricum D6
Schuessler Salt No. 12 Calcium sulfuricum D6

With a fever below 39 degrees Celsius/102.2 degrees Fahrenheit:
Schuessler Salt No. 3 Ferrum phosphoricum D12

With a fever of more than 39 degrees Celsius/102.0 degrees Fahrenheit:
Schuessler Salt No. 5 Potassium phosphoricum D6…

 

I wonder how many patients with persistent cough have followed their advice and taken Schuessler Salt No. 6 Potassium sulfuricum D6 and/or Schuessler Salt No. 12 Calcium sulfuricum D6.

And why not?

I’ll tell you why not: persistent cough can be a sign for corona-virus or other serious infections. And if it’s not due to an infection, it might be due to cancer.

IF YOU HAVE A PERSISTENT COUGH, PLEASE SEE YOUR DOCTOR!

Back to Schuessler salts (I have written about them before here and here). They are a derivative of homeopathy in the sense that they are highly diluted (Schuessler was a German homeopath). But they do not follow the ‘like cures like’ assumption. Many homeopaths are thus indignant, if Schuessler salts get confused with homeopathics. Yet, they shouldn’t be: both Schuessler salts and homeopathics have one important feature in common: they are ineffective.

Some years ago, I published a systematic review of all clinical studies of Schuessler salts (sorry, I cannot find the reference at the moment). That was an easy task, because there are none (one ought to ask why there is not a single trial of Schuessler salts. I suspect the manufacturers do not want one, because they already know the result). This renders the recommendation of the THE WORLD FOUNDATION OF SCIENCE all the more enraging.

I think I will therefore rename this organisation; I shall call it

THE WORLD FOUNDATION OF ANTI-SCIENCE.

Low-level laser therapy has been used clinically to treat musculoskeletal pain; however, there is limited evidence available to support its use. The current Cochrance review fails to be positive: there are insufficient data to draw firm conclusions on the clinical effect of LLLT for low‐back pain. So, perhaps studies on animals generate clearer answers?

The objective of this study was to evaluate the clinical effectiveness of low-level laser therapy and chiropractic care in treating thoracolumbar pain in competitive western performance horses. The subjects included 61 Quarter Horses actively involved in national western performance competitions judged to have back pain. A randomized, clinical trial was conducted by assigning affected horses to either:

  • laser therapy,
  • chiropractic,
  • or combined laser and chiropractic treatment groups.

Low-level laser therapy was applied topically to local sites of back pain. The laser probe contained four 810-nm laser diodes spaced 15-mm apart in a square array that produced a total optical output power of 3 watts. Chiropractic treatment was applied to areas of pain and stiffness within the thoracolumbar and sacral regions. A single application of a high velocity, low-amplitude (HVLA) manual thrust was applied to affected vertebral segments using a reinforced hypothenar contact and a body-centered, body-drop technique. The HVLA thrusts were directed dorsolateral to ventromedial (at a 45° angle to the horizontal plane) with a segmental contact near the spinous process with the goal of increasing extension and lateral bending within the adjacent vertebral segments. If horses did not tolerate the applied chiropractic treatment, then truncal stretching, spinal mobilization, and the use of a springloaded, mechanical-force instrument were used as more conservative forms of manual therapy in these acute back pain patients.

Outcome parameters included a visual analog scale (VAS) of perceived back pain and dysfunction and detailed spinal examinations evaluating pain, muscle tone, and stiffness. Mechanical nociceptive thresholds were measured along the dorsal trunk and values were compared before and after treatment. Repeated measures with post-hoc analysis were used to assess treatment group differences.

Low-level laser therapy, as applied in this study, produced significant reductions in back pain, epaxial muscle hypertonicity, and trunk stiffness. Combined laser therapy and chiropractic care produced similar reductions, with additional significant decreases in the severity of epaxial muscle hypertonicity and trunk stiffness. Chiropractic treatment by itself did not produce any significant changes in back pain, muscle hypertonicity, or trunk stiffness; however, there were improvements in trunk and pelvic flexion reflexes.

The authors concluded that the combination of laser therapy and chiropractic care seemed to provide additive effects in treating back pain and trunk stiffness that were not present with chiropractic treatment alone. The results of this study support the concept that a multimodal approach of laser therapy and chiropractic care is beneficial in treating back pain in horses involved in active competition.

Let me play the devil’s advocate and offer a different conclusion:

These results show that horses are not that different from humans when it comes to responding to treatments. One placebo has a small effect; two placebos generate a little more effects.

I was alerted to an article entitled ‘Energy Medicine: Current Status and Future Perspectives‘ by Christina L Ross, Wake Forest Center for Integrative Medicine, Medical Center Boulevard, Winston-Salem, USA. Dr Ross’ paper , she tells us, was supported by the Wake Forest Center for Integrative Medicine. The Center for Integrative Medicine at Wake Forest School of Medicine aims to expand knowledge of integrative medicine through research and educational opportunities.

The article in question is lengthy yet intriguing. Here, I will present just two short excerpts.

In the abstract, the author concisely explains the nature of energy medicine:

Quantum physics teaches us there is no difference between energy and matter. All systems in the human being, from the atomic to the molecular level, are constantly in motion-creating resonance. This resonance is important to understanding how subtle energy directs and maintains health and wellness in the human being. Energy medicine (EM), whether human touch or device-based, is the use of known subtle energy fields to therapeutically assess and treat energetic imbalances, bringing the body’s systems back to homeostasis (balance).

In the paper itself, the author explains what this means in relation to various SCAM modalities, such as acupuncture:

Acupuncture can be considered an electromagnetic phenomenon due to the ionic charge between 2 acupuncture points. This has been demonstrated by Mussat and others. Acupuncture needles with 1 metal (copper, silver, bronze, or an alloy) for the shaft and another metal for the handle, form tiny batteries. Some acupuncture therapies use additional electrical stimulation (2–4 Hz) applied to the needles. From this electrical perspective, each organ in the body is like a battery housed in a sac of electrolytes, with a positive potential on the surface of the sac that is the aggregate result of electrical processes in the tissues of the organs. The positive potential at the needle tip attracts negatively charged ions from the interstitial medium until a saturation equilibrium is achieved. The normal functions of an organ tend to generate stronger and more harmonic ionic effects than organs with trauma or disease. Acupuncture is considered a wiring system in the body, as is the analog perineural nervous system, and ion transfer within blood plasma. It is difficult to use a voltmeter to measure the voltage in organs because voltages pulse in the body. It is common to use an ohm meter to measure the voltage and convert ohms to volts using Ohm’s law (voltage = ohms × amps).

Table 1 shows frequencies that correspond to organ function. Assuming amperage is constant, then ohms = voltage.

Frequencies Associated With Normal Organ Function.

Organ Frequency (MHz)
Brain 70–78
Thyroid 62–68
Lungs 58–65
Thymus 65–68
Heart 67–70
Spleen 60–80
Liver 55–60
Stomach 58–65
Colon 70–78

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Is that what the Wake Forest School of Medicine considers to be ‘expanding knowledge … through research and educational opportunities’ ? Where is the actual research that backs up any of the weird claims made above? Is it truly knowledge that is being expanded here … or is it perhaps total, utter BS?

The objective of this RCT was to compare the effects of

  • spinal thrust-manipulation + electrical dry needling + various medications (TMEDN-group)
  • to non-thrust peripheral joint/soft-tissue mobilization + exercise + interferential current + various medications(NTMEX-group)

on pain and disability in patients with subacromial pain syndrome (SAPS).

Patients with SAPS were randomized into the TMEDN group (n=73) or the NTMEX group (n=72). Primary outcomes included the shoulder pain and disability index (SPADI) and the numeric pain rating scale (NPRS). Secondary outcomes included Global Rating of Change (GROC) and medication intake. The treatment period was 6 weeks; with follow-up at 2 weeks, 4 weeks, and 3 months.

At 3 months, the TMEDN group experienced significantly greater reductions in shoulder pain and disability compared to the NTMEX group. Effect sizes were large in favour of the TMEDN group. At 3 months, a greater proportion of patients within the TMEDN group achieved a successful outcome (GROC≥+5) and stopped taking medication.

The authors concluded that cervicothoracic and upper rib thrust-manipulation combined with electrical dry needling resulted in greater reductions in pain, disability and medication intake than non-thrust peripheral joint/soft-tissue mobilization, exercise and interferential current in patients with SAPS. These effects were maintained at 3 months.

The authors of this trial have impressive looking affiliations:

  • American Academy of Manipulative Therapy Fellowship in Orthopaedic Manual Physical Therapy, Montgomery, AL.
  • Montgomery Osteopractic Physiotherapy & Acupuncture Clinic, Montgomery, AL.
  • Research Physical Therapy Specialists, Columbia, SC.
  • Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Alcorcón, Spain.
  • Cátedra de Clínica, Investigación y Docencia en Fisioterapia: Terapia Manual, Punción Seca y Ejercicio, Universidad Rey Juan Carlos, Alcorcón, Madrid, Spain.
  • Copper Queen Community Hospital, Bisbee, AZ.
  • BenchMark Physical Therapy, Atlanta, GA.
  • Eastside Medical Care Center, El Paso, TX.
  • Department of Physical Therapy, Georgia State University, Atlanta, GA.
  • Tybee Wellness & Osteopractic, Tybee Island, Georgia, GA.

If one expected a well-designed study from all this collective expertise, one would have been disappointed.

Any such clinical trial should be answering a simple question: is therapy XX effective? It is about pinning an observed effect on to a treatment. It is about establishing cause and effect. It is about finding an answer to a clinically relevant question.

The above study does none of that. Even if we accepted its result as valid, it could be interpreted as meaning one of many different things, for instance:

  1. Acupuncture was effective.
  2. Dry needling was effective.
  3. The electrical current was effective.
  4. Mobilisation made things worse.
  5. Exercise made things worse.
  6. one or multiple positive or negative interactions between the therapies.
  7. The drugs in the experimental group were more effective than those taken by controls.
  8. The experimental group adhered to their drug prescriptions better than controls.
  9. Any mixture of the above.

So, the reader of this paper can chose which of the interpretations he or she prefers. I suggest that:

  • Any researcher who designs a foreseeably nonsensical trial should go back to school.
  • Any ethics committee that passes such a study needs to retire.
  • Any funder who gives money for it wastes scarce resources.
  • Any reviewer who recommends publication needs to learn about trial design.
  • Any editor who publishes such a trial needs to go.

The point I am trying to make is that conducting a clinical trial comes with responsibilities. Poorly designed studies are not just a waste of resources, they are a disservice to patients, they undermine the public’s trust in science and they are unethical.

Or perhaps not?
Here is the announcement:

Research by a reputable independent research company done for Securivita a German insurance company shows that those receiving homeopathic care were much better off. Over 15,700 patients were involved in the study which also used a comparison group.

The study showed that in a wide range of patients with various pathological problems that if they had homeopathic care they faired dramatically better than those just getting conventional medicine.

Children having homeopathy treatment from birth, were particularly healthier and with less problems. Over the three year study period, the number of children needing antibiotics decreased by 16.7 per cent in the homeopathy group, whereby it increased by 73.9 per cent in the conventional medical comparison group!

The number of hospitalizations in the comparison group increased by 32.6 per cent whereby in the homeopathy treatment group it decreased by 9.8 per cent!

Adults and children treated homoeopathically had dramatic improvements in allergies, dermatitis, asthma, just to name a few.

These are just a few examples of the remarkable benefits of homeopathic treatment outlined in the study by by the Leipzig Health Forum , an independent analytical institute specializing in health services conducted for Securvita Krankenkasse Insurer.

“We don’t need fewer, but more homeopathic doctors who will continue on this successful path,” says Götz Hachtmann , director of the health insurance company Securvita.

The study is in German and can be found here.

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Blessed are those who don’t read German (at least in this instance)!

As I am not amongst the blessed, I ought to tell you a bit about the ‘massive’ study. The OHR, the ‘OFFICIAL HOMEOPATHIC RESOURCE’ (btw what makes the OHR ‘official’?) claims that the study can be found here. The OHR is evidently not well enough resourced for translating the German text into English; if they were, they would know that the link goes not to a ‘study’ but to some kind of a glossy marketing brochure about the ‘study’ (there is no actual published scientific paper on the ‘study’). It provides hardly any relevant information; all we learn is that 15 700 individuals who regularly consulted homeopathic physicians were compared over a three year period to an equally sized control group who did not consult homeopathic doctors… And that’s essentially it! No further relevant details are offered.

By contrast, quite a bit of information is offered about the findings, for instance:

  • In the homeopathy group, the hospitalisation rate of depressive patients dropped by 10%, while it increased in controls by 33%.
  • The days off work dropped by 17% vs an increase in controls of 17%.
  • The use of antibiotics decreased by 17% vs an increase of 74%.

And how do they explain these differences?

Yes, you guessed it:

they are due to homeopathy!

One does not need to have a perfumer’s nose to smell a few badly decomposing rats here, for example:

  1. We do not learn how many variables were tested in this ‘study’. Therefore, it is likely that the ‘results’ provided are the positive ones, while the not so positive potential effects of homeopathy remained unmentioned. Perhaps the death rate was higher in the homeopathy group? Perhaps they suffered more heart attacks? Perhaps they had a lower quality of life? Perhaps they caused more costs? Perhaps they committed more suicides? etc. etc.
  2. Even more obvious is the stench of selection bias. The individuals in the homeopathy group were clearly different from the controls to start with. They might have been more health conscious. They clearly were more cautious about antibiotics. They might have been of better general health. They might have been younger. They could have contained more women. They might have been more afraid of going into a hospital. They might have been keener to attend work. In fact, the only variable in which the two groups were comparable is sample size.

Even if we eventually we see this ‘study’ published in a peer-reviewed journal with full methodological details etc., it will not allow even the smartest spin-doctor to establish cause and effect. Its findings would not be more conclusive than those of previously discussed attempts to produce positive evidence for homeopathy. The ‘positive’ findings could have been the result of hundreds of causes, none of which are related to homeopathy.

In a nutshell: this new German ‘study’ is a textbook example for arguing in favour of conducting proper research rather that rampant pseudo-research.

But I must not always be so negative!!!

So, let me try to point out the positive sides of this ‘study’:

The ‘massive independent study’ is a true masterpiece of advertising and marketing for both Securivita and homeopathy.

Well done guys!

I am proud of you!

  • That’s exactly the stuff needed for successfully misleading the public.
  • That’s precisely the info required to increase your cash flow.
  • That’s helpful ‘research’ for convincing politicians.
  • That’s definitely the type of baloney to impresses the Ullmanns of this world.
  • That’s even the sort of ‘science’ which the ‘OFFICIAL HOMEOPATHIC RESOURCE’ cannot recognise for what it truly is:

invalid junk.

This recent review claimed to evaluate the evidence on the use of human and veterinary homeopathy, evidence level 1a studies were considered. Focusing on the external evidence on the use of homeopathy in infections, some evidence level 1a, 1b, 2c studies, and a case report, are described in more detail.

In conclusion, evidence for the effectiveness of human and veterinary homeopathy in general, and in particular, of homeopathic treatment for infections, is available. Especially, individualized homeopathy demonstrates effects at all quality levels according to Cochrane criteria, even in the methodologically high-quality studies. As in most areas of veterinary medicine and medicine, further good/excellent studies are necessary. In compliance with the principles of homeopathy, further methodologically high-quality trials focusing on the homeopathic treatment of infections are the next logical step. The selection of the simile (individually fitting homeopathic medicinal product) by appropriately trained homeopathic doctors/veterinarians is essential for the effectiveness of homeopathy. Implementation of studies at university facilities is a prerequisite for quality assurance. Consequently, further integration of homeopathy at universities is a necessary requirement for the patients’ best interests.

Who wrote this bizarre paper?

The authors who state to have no conflicts of interest are P Weiermayer 1M Frass 2T Peinbauer 3L Ellinger 4

  • 1Tierärztin, Tierarztpraxis Dr. Weiermayer, Diplom der Europ. Akademie für Veterinärhomöopathie (EAVH), Fachtierärztin für Homöopathie, Sprecherin der Sektion Forschung der Wissensch. Gesellsch. für Homöopathie (WissHom), Präsidentin ÖGVH, Wien, Österreich.
  • 2Facharzt für Innere Medizin und Internistische Intensivmedizin, em. Professor für Innere Medizin der Medizinischen Universität Wien, Diplom der Österreichischen Ärztekammer (ÖÄK) für Homöopathie sowie für Begleitende Krebsbehandlung, Wien, Österreich.
  • 3Arzt für Allgemeinmedizin, ÖÄK-Diplom für Homöopathie, Universitätslektor für Allgemeinmedizin und Modulbeauftragter für Komplementärmedizin, Medizinische Fakultät, Johannes Kepler Universität Linz, Österreich.
  • 4Tierärztin, Centaurea, Apeldoorn, Holland.

This already explains quite a lot, I think.

The paper itself is in German, so I will try to make some sense of part of it for you.

In their ‘methods section’, the authors explain that they evaluated meta-analyses and systematic reviews (SRs) of homeopathy for various conditions. Furthermore, they considered the ‘1st and 2nd’ NHMRC reports. Specifically for the question whether homeopathy is the answer to antibiotic resistance, the authors also considered RCTs, observational studies, heath service research and even case-studies. The authors then elaborate at length on the assumptions of homeopathy, on legal issues and on the nature of evidence-based medicine all of which I disregard for the moment (suffice to say that this material has been often and better reviewed before).

When finally discussing the evidence on homeopathy for human conditions, the authors state that, up until 2014, six comprehensive SRs had been published. In their opinion, these are the following 6 papers:

  1. Kleijnen, J., Knipschild, P., Ter Riet, G. (1991): Clinical trials
    of homeopathy. BMJ 302(6772): 316-23.
  2. Linde, K., Clausius, N., Ramirez, G., Melchart, D., Eitel, F.,
    Hedges, L.V., Jonas, W.B. (1997): Are the clinical effects of
    homeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet 350(9081): 834–843.
  3. Linde, K., Scholz, M., Ramirez, G., Clausius, N., Melchart,
    D., Jonas, W.B. (1999): Impact of study quality on outcome
    in placebo-controlled trials of homeopathy. J Clin Epidemiol 52(7): 631–636.
  4. Cucherat, M., Haugh, M.C., Gooch, M., Boissel, J.P. (2000): Evidence of clinical efficacy of homeopathy. A meta-analysis of clinical trials. HMRAG. Homeopathic Medicines Research Advisory Group. Eur J Clin Pharmacol 56(1): 27–33.
  5. Mathie, R.T., Lloyd, S.M., Legg, L.A., Clausen, J., Moss, S.,Davidson, J.R.T., Ford, I. (2014a): Randomised placebocontrolled trials of individualised homeopathic treatment: systematic review and meta-analysis. Syst Rev 3: 142.
  6. Shang, A., Huwiler-Müntener, K., Nartey, L., Jüni, P., Dörig, S., Sterne, J.A.C., Pewsner, D., Egger, M. (2005): Are the clinical effects of homeopathy placebo effects? Comparative study of placebo-controlled trials of homeopathy and allopathy. Lancet 366(9487): 726–32.

(As it happens, I have reviewed these papers here and come to very different conclusions)

Without bothering about a critical assessment of these papers, the authors report that all arrived at a positive conclusion, except the last one. They then claim that the ‘1st’ NHMRC report was partly positive but was initially suppressed by the Australian government. Instead it was replaced with the 2nd NHMRC report which was designed to arrive at a wholly negative conclusion. Likewise, the ‘EASAC Statement’ neglected some of the available positive evidence. These facts, the authors believe, discredits all of these negative reports.

The authors then discuss the various reviews by Mathie et al and point out that, in their view, these papers are superior to all other documents as they arrive at very clearly positive conclusions.

Next the authors focus on the field of veterinary homeopathy, while admitting weaker and weaker evidence, inclusing case-reports. This is also where I lost the will to live and gave up my detailed criticism of the text; the task is too tedious and simply not worth it, I felt.

In summary, here are few points relating to the human evidence:

The authors seem to have no intention of conducting an objective, systematic review. Such a project is essentially based on two principles. Firstly, it needs to include all eligible evidence according to pre-defined criteria. Secondly, it must include a critical evaluation of the admitted evidence. This review fails on both of these principles.

There are virtually dozens of systematic reviews which the authors decided to ignore. Here are just six of them:

  1. … homoeopathy as a whole may be considered as a placebo treatment.
  2. We tested whether p-curve accurately rejects the evidential value of significant results obtained in placebo-controlled clinical trials of homeopathic ultramolecular dilutions. Our results suggest that p-curve can accurately detect when sets of statistically significant results lack evidential value.
  3. We found no evidence to support the efficacy of homeopathic medicinal products
  4. … no firm conclusions regarding the effectiveness and safety of homeopathy for the treatment of IBS can be drawn.
  5. Due to both qualitative and quantitative inadequacies, proofs supporting individualized homeopathy remained inconclusive.
  6. … the use of homeopathy currently cannot claim to have sufficient prognostic validity where efficacy is concerned.

Why do they do it? A reasonable reply to this question might be, because their findings did not fit the preconceived ideas of the authors. This omission alone makes the article little more than a poorly conceived marketing brochure.

Even more important is the second omission. The paper  lacks any kind of critical evaluation of the included evidence. On the contrary, the authors praise the evidence that generated what they think was a positive result (even in cases where the actual result was not all that positive; for instance: A meta-analysis of all extractable data leads to rejection of our null hypothesis, but analysis of a small sub-group of reliable evidence does not support that rejection. Reliable evidence is lacking in condition-specific meta-analyses, precluding relevant conclusions) and bash all negative findings. This goes as far as perpetuating untruth about the two NHMRC reports: what they call the 1st report was a draft that had been rejected because it was deemed to be of sub-standard quality. What is here called the ‘2nd’ report is thus the only valid document ever published. Similarly, the authors pretend that the Mathie reviews were all clearly positive and fail to mention even the most obvious problems with these articles, such as the facts that Mathie was paid by a homeopathy-lobby group or that even he included important caveats in his conclusions.

As to the focus of the review, the question whether homeopathy might be a solution to antibiotic resistance, the authors found virtually no compelling evidence from trials directly comparing antibiotics with homeopathy. This seems to bother the authors little – they conclude that “the data demonstrate the potential of a significant reduction of antibiotic usage through homeopathic treatments”. They seem to have reached this conclusion by turning a blind eye to all the evidence that does not fit their preconceived idea.

As the paper is published in German and in a journal which hardly anyone will ever read, one could easily argue that none of all this does really matter because it is merely a storm in a very small tea cup. Perhaps that’s true. But this paper nevertheless might attain some significance because it is already being heavily promoted by the homeopathy lobby. And no doubt, it will thus be cited in the English literature which, in turn, will be read by people who do not read German, unable to check the original and are thus likely to believe the nonsense promoted by Frass and friends.

For this reason, I want to conclude by making it quite clear that

this ‘review’ is a dilettante attempt to white-wash the evidence on homeopathy and mislead the public.

 

Researchers from the Department of Physiotherapy, Guru Jambheshwar University of Science and Technology, Hisar, Haryana, India, and the Mother Teresa Saket College of Physiotherapy, Saket, Panchkula, Haryana, India, have just published a systematic review which is remarkable in several ways. Let me therefore present to you the abstract unaltered:

Background: Spinal pain or misalignment is a very common disorder affecting a significant number of populations resulting in substantial disability and economic burden. Various manual therapeutic techniques such as spinal manipulations and mobilizations can be used to treat and manage pain and movement dysfunctions such as spinal mal-alignments and associated complications. These manual therapeutic techniques can affect the cardiovascular parameters.

Objective: The objective of this systematic review and meta-analysis is to assess the effect of spinal manipulation and mobilization on cardiovascular parameters.

Methods: We conducted a systematic review and meta-analysis to assess the effects of spinal mobilization and manipulation on cardiovascular responses. Mean changes in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Heart Rate (HR) were primary outcome measures. RevMan 5.3 software was used for the meta-analyses. Quality of the included studies was assessed by PEDro Rating scale. Risk of bias was assessed by Cochrane collaboration tool of risk of bias.

Results: Results of meta-analysis showed that there was statistically significant decrease in SBP ( MD=-4.56 , 95% CI=-9.20 , 0.08; p≤0.05 ) with moderate heterogeneity ( I2=75% , p<0.0002 ) in experimental group as compared to control group. There was statistically non-significant decrease in DBP ( MD=-1.96 , 95% CI=-4.60 , 0.69; p=0.15 ) with high heterogeneity ( I2=91% , p<0.00001 ), Change HR was statistically non-significant ( MD=-0.24 , 95% CI=-3.59 , 3.11; p=0.89 ) with moderate heterogeneity ( I2=60% , p=0.01 ). Exclusion of short duration studies in sensitivity analysis revealed a statistically significant change in DBP ( MD=-0.94 , 95% CCI=-1.85 , -0.03 ; p=0.04 ). However, the result was statistically non-significant for HR after sensitivity analysis.

Conclusion: Spinal manipulations and mobilizations may result in significant decrease of systolic as well as diastolic Blood Pressure.

After reading the full paper, I was uncertain whether to laugh or to cry. Then I decided for the former option.

Any paper that starts with the statement ‘spinal pain or misalignment is a very common disorder affecting a significant number of populations resulting in substantial disability and economic burden‘ can only be a hoax! In case you are uncertain about the reason of my amusement: spinal pain is not the same as spinal misalignment, and spinal misalignment (in the sense it is used here) is the figment of the imagination of a 18 carat charlatan called DD Palmer.

The rest of the article offers more superb hilarity: the authors write, for instance, that spinal malalignments (such as scoliosis) are mainly caused by body’s abnormal posture, asymmetries in bone growth and abnormalities of neuromuscular system. Scoliosis is an abnormal lateral curvature of the spine, not a spinal malalignment and certainly not one that can be treated with spinal manipulation.

Then the authors state that spinal pain and malalignment mainly occur due to structure deterioration, altered biomechanics and abnormal posture. Workplace physical and psychosocial factors, emotional problems, smoking, poor job satisfaction, awkward posture and poor work environment can be the possible risk factors for spinal pain and malalignment. This leads to various musculoskeletal, psychosomatic, cardiovascular and respiratory dysfunctions which affect the functional capacity of the patient as well as quality of life. Oh really?

So, the findings of the authors’ meta-analysis do suggest a tiny effect on blood pressure.

Compared to what?

In the paper, the review authors repeatedly try to make us believe it is compared to placebo. However, this is not true; mostly it was compared to no treatment.

Was the hypotensive effect verified in hypertensive patients?

No, it was measured mostly in healthy volunteers.

Is the effect clinically relevant?

No, I don’t think so!

Is it comparable to or better than the one achievable with established treatments for hypertension?

No! In fact it is much smaller.

Does that bother the authors?

No, on the contrary, they state that in this meta-analysis, spinal manipulation and mobilization resulted in statistically significant reduction in SBP. Therefore, it can be used as an adjuvant therapy for the management of hypertension.

Were the studies using spinal manipulation as an adjuvant therapy?

No, mostly not.

Is the effect lasting long enough to be relevant for the management of hypertension?

No.

I better stop here because already my whole body hurts from laughing so much. Please, do read the full text, if you are in need of some comic relief.

And, I almost forgot: many thanks to the Indian researchers for this hilarious hoax!

Or did you perhaps mean all that seriously?

A 2020 article that I just came across concluded with this rather remarkable statement:

High-dose enzyme therapy is a natural cancer protocol that has been highly successful in treating this much-feared disease.

Since we can find a plethora of similar claims on social media and elsewhere, it is high time, I think, to dedicate a post to this alleged cancer cure.

Enzyme therapy involves the administration of proteolytic enzymes by mouth. Proteolytic enzymes are large molecules that are nevertheless said to be absorbed in the gut before they are dispersed into different compartments of the body where they can be detected in various concentrations. Proteolytic enzymes (serine endopeptidases such as trypsin or chymotrypsin and cysteine endo-proteinases such as bromelain and papain or combinations of those enzymes) have long been available for diverse medical indications, including cancer. They are claimed to exert anticancer activities by restoring the reduced cytotoxic activity of patients’ sera.

Enzyme therapy has been subjected to experimental investigations and to a few studies in cancer patients. A systematic review claimed that, for plasmacytoma patients, systemic enzyme therapy was shown to increase the response rates, the duration of remissions, and the overall survival times.[1]

This statement is based on just one study. Here is its abstract[2]:

Purpose: To evaluate the impact of an additive therapy with an oral enzyme (OE) preparation given for more than 6 months additionally to standard combination chemotherapy (vincristine/melphalan/cyclophosphamide/prednisone (VMCP)- or methylprednisolone/ vincristine/CCNU/cyclophosphamide/melphalan (MOCCA)-regimen) in the primary treatment of patients with multiple myeloma stages I-III.

Methods: A cohort of 265 patients with multiple myeloma stages I-III was consecutively treated at our institution in two parallel groups (control group (n = 99): chemotherapy +/-OE for less than 6 months; OE-group (n = 166): chemotherapy + OE for more than 6 months). The median follow-up time in the stages I, II, and III for the OE-group was 61, 37, and 46.5 months, respectively; for the control group the respective values were 33, 51.5, and 31.5 months. The primary endpoint of the study was disease-specific survival. Secondary endpoints were response to therapy, duration of first response and side effects. The chosen method for evaluation was the technique of a retrolective cohort analysis with a concurrent control group. Survival analysis was performed by the Kaplan-Meier method and multivariate analysis was done with the Cox proportional hazards model.

Results: Significantly higher overall response rates and longer duration of remissions were observed in the OE-group. Primary responders showed a longer mean survival time than non-responders. Additive therapy with OE given for more than 6 months decreased the hazard of death for patients at all stages of disease by approximately 60%. Observation time was not long enough to estimate the median survival for patients at stages I and II; for stage III patients it was 47 months in the control group versus 83 months for the patients treated with OE (P = 0.0014) which means a 3-year gain of survival time. Significant prognostic factors for survival, in the Cox regression analysis, were stage of disease and therapy with OE. The OE-therapy was generally well tolerated (3.6% of patients with mild to moderate gastrointestinal symptoms).

Conclusion: OEs represent a promising new additive therapy in multiple myeloma which will be further evaluated in a randomized phase III trial in the USA.

My searches located no prospective clinical trials supporting the notion that enzyme therapy is an effective cancer cure for any type of human cancer. So, what about the bold statement quoted above? In my view, it is a dangerous and highly irresponsible claim that endangers the lives of many vulnerable cancer patients desperately looking for alternative cancer cures.

REFERENCES

[1] Beuth J. Proteolytic enzyme therapy in evidence-based complementary oncology: fact or fiction? Integr Cancer Ther. 2008 Dec;7(4):311-6. doi: 10.1177/1534735408327251. PMID: 19116226.

[2] Sakalová A, Bock PR, Dedík L, Hanisch J, Schiess W, Gazová S, Chabronová I, Holomanova D, Mistrík M, Hrubisko M. Retrolective cohort study of an additive therapy with an oral enzyme preparation in patients with multiple myeloma. Cancer Chemother Pharmacol. 2001 Jul;47 Suppl:S38-44. doi: 10.1007/s002800170008. PMID: 11561871.

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