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

pseudo-science

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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.

____________________________

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.

Recently, I had a notable comment on one of my posts:

“these treatments are not the best we can offer to LBP-patients.”
Have to agree with you. As a stand alone treatment the research is underwhelming. When used as part of a suite of therapies they have some utility. All therapeutic approaches when studied in isolation are underwhelming (including exercise and rehab). Research needs to reflect how chiro’s/physio’s/osteo’s practice.

The post was about a new RCT suggesting that neither spinal manipulation nor spinal mobilization is effective treatments for chronic low back pain. And the comment came, of course, from an ardent defender of chiropractic. As I have heard this type of argument so often – from virtually all types of providers of so-called alternative medicine (SCAM) – it is perhaps worth considering it in more detail.

What does it mean?

It means that those SCAM-providers who believe in the argument think that, in order for their SCAM to work, it needs to be accompanied by some other therapy. To me, this assumption has always raised doubts.

  • My fake 5£ note is worth nothing, unless you add a real fiver to it.
  • This mine sweeper will work fine, as long as you use another one in parallel.
  • This drink is very strong, but you need a double vodka in order to feel it.

Yes, of course, I am exaggerating. So, let’s use a few more sensible examples from the realm of healthcare:

  • This new medication is effective only if you combine it with the standard drug for this disease.
  • Ultrasound therapy reduces shoulder pain, as long as you also take a pain-killer.
  • This slimming aid works wonders, if you stop eating while you take it.
  • Chiropractic manipulations work wonders, but you need to combine them with exercise therapy.
  • Crystal healing is very effective, as long as you don’t discontinue your conventional treatments.

A + B is only more than B, if A amounts to more than zero.

If A is zero, A + B = B.

If A is negative, A + B is less than B.

Of course, the argument could also mean that treatment A needs the addition of treatment B, because there is a synergism between the two. Synergism is the interaction of treatments such that the total effect is greater than the sum of the individual effects. It is a phenomenon that occurs with certain medications; it can be studied and must be proven before we can accept it as relevant. Has synergism been studied for any of the SCAMs? No, not as far as I am aware. This means, in SCAM, it is unproven. Until it is proven, we thus should not claim it.

So, what does it mean when SCAM-providers say AS A STAND-ALONE THERAPY MY SCAM IS NO GOOD; IT NEEDS ANOTHER TREATMENT TO WORK?

Call me a cynic, but I think it is an admission that the SCAM in question is ineffective (or perhaps even detrimental).

Prof. Shailendra Ramchandra Vishampayan is the 1st author of the paper we discussed yesterday. He was kind enough to repeatedly join us in the comments section, and I was therefore keen to learn more about him. On his website, he says about himself that he is a renowned academician and famous homeopath, enriched with decades of ideal experiences and quality services. He is registered medical practitioner (M.D), performs all the duties of registered medical practitioner following the law of land in India. Globally he is considered as homeopath and known as “Dr.V”. He is a registered member of Society of Homeopaths (overseas).

Dr. V, is a practicing homeopath with clinical experience of over 20 years. In course of his years of practice he had successfully helped more than 250 happy families globally, with various kinds of cases like thyroid, immune compromised, epilepsy, endocrine disorders, paediatric, gynaecological disorders addictions, psychiatric disorder, children with special needs, pets and plants.

He is famous for his path breaking concept and novel idea of creating an organization called ‘Folk Homeopathy ‘, which is dedicated to professional enrichment of homeopathic practitioners helping them to improve their clinical acumen with spot on prescription.

His practical approach in solving cases has earned him accolades and fame throughout the globe.

Dr. V is the author of ‘Kinder Garten Materia Medica’ a reference book for beginners widely used by homeopathic students in India. It is a book with unique combination of pictorial and pneumonic.

He is a Professor (PG) at D.Y.Patil Homeopathy Medical College (Pune). He has a teaching experience of over 16 years in teaching UG and PG. He has drawn large number of followers through webinars which is accessible throughout the globe. He has given more than 50 international seminar ,workshops and webinars in countries like USA, Ireland, Malaysia, with presentations on Homeopathic approach to female hormonal imbalance cases at OMICS Conference of Alternative Medicine, presentation on Psychiatric cases at Asian Homeopathic League. And various presentation at University of Cyberjaya, Malaysia, California Homeopathic Medical society, San Diego and also at Corte Madera, 98th FOH Congress, Liverpool and Kinvara Co Galway, Ireland.

And on the same site, we also learn that ‘Dr V’ is particularly adept at treating diabetes:

India is now considered as the diabetes capital of the world. Approximately 8.7 percent of Indians between the age of 20 to 70 years are diabetic. This translates to approximately 62.5 million diabetics living in India, according to estimates by the World Health Organisation (W.H.O.) The economic burden of managing this disease is also substantial since this is a combination of cost of treatment and loss of productivity in such a high number of diabetics. Diabetes can affect multiple organ systems resulting in a wide range of serious issues in patients. Many of these complications in a diabetic do not have any specific treatment with conventional medicines. However, an indication of the popularity of homeopathy amongst diabetics is that the doctors at our clinic treat approximately two hundred cases of diabetes or diabetes related issues every day. We have, in fact, developed specific diabetes management protocols for patients based on the experience of thousands of cases we have seen over four decades.

This is interesting, I thought, and conducted a few Medline searches to see whether there is any evidence to show that homeopathy is an effective therapy for diabetes. I am afraid, I found no papers of ‘Dr V’ to suggest such an effect. But what I did find was certainly fascinating.

Last year, Italian diabetologists published an review entitled ‘Alternative treatment or alternative to treatment? A systematic review of randomized trials on homeopathic preparations for diabetes and obesity‘. Here is what they reported:

The searches failed to retrieve any trial comparing homeopathic remedies with placebo or any active drug for the treatment of either diabetes or obesity.

These authors commented that

… if homeopathy is used as an alternative to available and effective treatments, the consequences can be catastrophic, particularly in some conditions such as insulin-requiring diabetes. In conclusion, there is no scientific evidence on efficacy and no demonstration of safety of homeopathy in diabetes and obesity…

I agree with my Italian colleagues and I have previously expressed this view bluntly; I even entitled one of my posts ‘This is how homeopathy could kill millions‘.

‘Dr V’ will probably point out that he is a fully qualified doctor and uses homeopathy merely as an adjunct to conventional anti-diabetic treatments; thus he kills nobody.

I certainly hope this is so! But, even in this case, I must still ask: WHERE IS THE EVIDENCE THAT HOMEOPATHY IS AN EFFECTIVE ADJUNCT TO CONVENTIONAL MEDICINE?

Indian homeopaths published a remarkable article in the journal ‘HOMEOPATHY’ proposing Mercurius solubilis as genus epidemicus for the current pandemic. Here it is:

From mid-June to mid-July 2020, our team of homeopathic doctors treated 104 patients in two COVID treatment centers—Pandit Bhimsen Joshi Hospital and Sheth P.V. Doshi Hospital—on the outskirts of Mumbai, India, with adjuvant homeopathy. It was observed by the patients, hospital staff, and the management that those patients on adjuvant homeopathy were discharged 3 to 7 days earlier than other comparable patients in the same wards, allowing us gradually to accommodate more severely ill patients who required oxygen, continuous positive airway pressure, or a ventilator.

Twenty-five different homeopathic medicines in total were prescribed to the patients, each receiving individualized treatment according to his or her symptoms. After collecting 143 clinical and individualizing (homeopathic) symptoms of 104 patients and converting those symptoms into rubrics, we repertorized the combined data with the help of the software Hompath, with an aim to arrive at a genus epidemicus. We observed that the medicine Merc Sol was at the top of the combined repertorization chart. After reviewing repertory sheets of all 104 patients, we discovered that Merc Sol was at the fourth or fifth place of all individual repertorization charts as well.

To substantiate our deduction, we studied the Materia Medica of Merc Sol from the original provings of Hahnemann[1] and other sourcebooks.[2] [3] [4] We also searched research articles and case studies about toxicological effects of mercury.[5] [6] [7] [8] These showed that acute exposure to mercury produces an acute respiratory distress syndrome-like presentation, a picture similar to the COVID symptomatology. Moreover, anosmia, aphthae, gastrointestinal and ocular manifestations that are seen in patients with COVID-19 were produced also by mercury the toxin and mercury the homeopathy-proved medicine. This finding is in accordance with the homeopathic Law of Similars: a substance producing a symptom in a healthy person is able to cure a similar symptom in a sick person.

To confirm our hypothesis, we identified 13 common symptoms of Merc Sol, such as indented tongue, salivation, perspiration, and night aggravation, which were present in various intensities in the previously treated 104 patients. We created a 13-point questionnaire and, after obtaining suitable Ethics Committee approval and individual informed consent from the patients, we evaluated 68 further patients in the above-mentioned COVID hospitals. People with at least eight confirmed symptoms from the questionnaire were prescribed Merc Sol 200c thrice a day for a week. In our 2-week study at both the locations, we observed a speedy recovery and a hospital stay reduction by 5 to 7 days in all the 68 patients when Merc Sol was used along with the standard Indian Council of Medical Research clinical protocol. Many of them were not newly admitted patients but were those who exceeded the mandatory minimum hospital stay. We are now using Merc Sol as a preventive medicine for over 1,000 people in a COVID hot-spot area in Powai, Mumbai, with the expressed permission of local authorities.

Following the Hahnemannian method of arriving at a genus epidemicus [9] (§ 99–103), and deducing it from the combined data of symptoms of more than 100 patients, we arrived at the conclusion that Merc Sol, “the deceitful malefic mercury” known for various symptomatic presentations and tissue destruction, is genus epidemicus of this pandemic. Our efforts are in accordance with the logic of homeopathy proffered by Dr. Stuart Close[10]: exact observation, correct interpretation, rational explanation, and scientific construction.

We now appeal to the global homeopathy community to test our findings in their respective areas, designing specific research projects to explore the utility of Mercurius solubilis in the COVID-19 pandemic as genus epidemicus.

If it were not such a serious matter, I might joke that everyone with a dental amalgam filling must be protected from COVID-19. But it is rather too serious to make fun, I am afraid. Therefore, I will just point out to all those homeopaths across the globe who follow their Indian colleagues’ appeal something rather basic: it is bad science to confirm their hypothesis. Science works by falsifying hypotheses. And a proper hypothesis needs, of course, more that the implausible hunches of some evangelic believers in the homeopathic cult.

Guest post by Ken McLeod

‘Ayurvedic Medicine,’ or Ayurveda, is an alternative medicine system which originated in India as long as 5,000 years ago, according to its proponents.  Science-based medicine refers to it  as pseudoscientific and the Indian Medical Association (IMA) characterises  it as quackery. [1] Ayurvedic practitioners claim that its popularity through the ages vindicates it as safe and effective.

That last bit is of course the appeal to antiquity, or the appeal to tradition (also known as argumentum ad antiquitatem. [2] This proposes that if something was supported by people for a long time it must be valid.   That is bunkum; many ancient ideas have long since been discredited; the Earth is not flat, no matter for how long people thought it was.

Nevertheless, ‘Ayurvedic Medicine’ has many practitioners and supporters in the supposedly rational West, including Bondi Junction here in Australia.  Despite the many warnings about it, [3] people still go to practitioners, and occasionally they are injured.

One such injury and the consequent complaint to the New South Wales regulator, the Health Care Complaints Commission, (HCCC), has resulted in a Public Warning dated 18 September concerning levels of heavy metals in Ayurvedic Medication.  [4]

The HCCC said:

‘The NSW Health Care Complaints Commission is concerned about a complaint received regarding the prescription of “Manasamithra Vatika,” (Manasamitram Pills) an Ayurvedic medication.

‘The complaint related to prescription of this medication to a child for treatment of autism.

‘This medication was found to contain concerning levels of lead and other heavy metals.’

That’s all very bland, no headlines there.  But then it got into:

“The Commission strongly urges those individuals seeking alternative therapies to be vigilant in their research prior to proceeding with any natural therapy medications or medicines and to discuss any such proposed therapies with their treating registered health practitioner.”

Not so bland there; that’s very comprehensive; ‘any natural therapy medications or medicines’ and ‘discuss any such proposed therapies with their treating registered health practitioner.” ‘Note the HCCC’s emphasis on “registered.”  That rules out Ayurvedic Medicine practitioners, homeopaths, and other assorted cranks; go to a real doctor.

Surely that is headline material; a regulator responsible for promoting the health of citizens warns them to go to real doctors before going to these quacks.

Then it gets better, (or worse if you are an Ayurvedic Medicine practitioner).  At the same time the HCCC issued an Interim Prohibition Order against Mr Rama Prasad (“Ayurveda Doctor Rama Prasad.”) [5] The HCCC’s Order says:

‘The NSW Health Care Complaints Commission (“the Commission”) is currently investigating Mr Rama Prasad in relation to his prescribing of the Ayurvedic Medication “Manasamithra Vatika” (Manasamitram Pills) to both children and adults and about his claims that his treatments can reverse several aspects of autism in children.

‘The Ayurvedic Medication “Manasmithra Vatika” (Manasamitram Pills) was found to contain elevated levels of lead and other heavy metals.

‘One case with mildly elevated blood level was notified to the South Eastern Sydney Public Health Unit after consuming this product.

‘Clients residing in NSW who are considered to have been placed at possible risk have now been contacted by NSW Health public health personnel.

‘The Commission has issued an interim prohibition order in relation to Mr Rama Prasad, under section 41AA of the Health Care Complaints Act 1993 (‘The Act’). Mr Prasad is currently prohibited from providing any health services, either in paid employment or voluntarily, to any member of the public.

‘This interim prohibition order will remain in force for a period of eight weeks and may be renewed where appropriate in order to protect the health or safety of the public.’

That should send chills down the spine of any Ayurvedic Medicine practitioner.  A complete Prohibition Order ordering Prasad not to engage in providing any health service as defined in the Act  [6] for eight weeks, which may be renewed or even made permanent, depending on what the investigation finds.  The Act includes a comprehensive list of activities that comprise a ‘health service’:

‘health service includes the following services, whether provided as public or private services:

  • (a)  medical, hospital, nursing and midwifery services,
  • (b)  dental services,
  • (c)  mental health services,
  • (d)  pharmaceutical services,
  • (e)  ambulance services,
  • (f)  community health services,
  • (g)  health education services,
  • (h)  welfare services necessary to implement any services referred to in paragraphs (a)–(g),
  • (i)  services provided in connection with Aboriginal and Torres Strait Islander health practices and medical radiation practices,
  • (j)  Chinese medicine, chiropractic, occupational therapy, optometry, osteopathy, physiotherapy, podiatry and psychology services,
  • (j1)  optical dispensing, dietitian, massage therapy, naturopathy, acupuncture, speech therapy, audiology and audiometry services,
  • (k)  services provided in other alternative health care fields,
  • (k1)  forensic pathology services,’

Note the inclusion of ‘health education.’  This is where so many cranks fall foul of the law;  setting yourself up as a health educator makes you subject to the Act.   Even if you claim to be a master chef, homeopath or Ayurvedic Medicine Practitioner, you are not exempt.

It’s early days yet in this particular saga, and there are many questions to be answered, for example:

  • – How did this “medicine” get past Australia’s Therapeutic Goods Administration, (Australia’s equivalent to the US FDA)?
  • – Did the TGA list or register it?
  • – If not why not? If it was who is responsible?
  • – Was this detected only after a child was so sickened that they were taken to hospital?
  • – Why is the practitioner concerned still advertising his Ayurvedic medicine courses? [7]  Is this a breach of his Prohibition Order which prohibits ‘health education services’?’

So stay tuned for updates as this case progresses.  In the meantime note that an Australian Health regulator is advising the public to seek advice from real doctors before going to alternative therapists, including ‘Ayurvedic Medicine’ practitioners.  That is a real headline.

[1] https://en.wikipedia.org/wiki/Ayurveda

[2] https://en.wikipedia.org/wiki/Appeal_to_tradition

[3] Such as from the Victoria Dept of Health at https://www.betterhealth.vic.gov.au/health/conditionsandtreatments/ayurveda

[4] https://www.hccc.nsw.gov.au/decisions-orders/public-statements-and-warnings/public-warning-under-s94a-of-the-health-care-complaints-act-concerning-levels-of-heavy-metals-in-ayurvedic-medication

[5] https://www.hccc.nsw.gov.au/decisions-orders/media-releases/2020/mr-rama-prasad-ayurveda-doctor-rama-prasad-interim-prohibition-order

[6] Health Care Complaints Act 1993 https://www.legislation.nsw.gov.au/view/html/inforce/current/act-1993-105

[7] https://www.enlightenedevents.com.au/events/certificate-in-clinical-ayurveda-dr-rama-prasad

Sorry, I have been neglecting my ‘heedless homeopathy’ series of articles – it’s all too human to forget, I suppose. Here are a few remedies which also seem ‘all to human’, but in a very different sense. As far as I can see, they all originate from human tissues or materials.

I was tempted to call these products cannibalistic homeopathy, but then I decided against it; after all, the remedies contain nothing at all, only their mother tinctures are based on human materials.

In any case, I thought you might be amused (or perhaps mildly disgusted?) by my list:

Looking at the list, I cannot help asking what these remedies might be used for. Applying the twisted logic of homeopathy, while mixing it with that of isopathy, I can just about understand that:

  • MASTITIS MILK is for treating mastitis,
  • LAC HUMANUM might be for a mother wanting to stop breast feeding,
  • DENTAL PLAQUE could be against … yes, dental plaque!

But what might some of the other remedies on the list be for? Assuming that the human tissues are from biopsies or cadaveric material of (formerly) healthy individuals, I have to conclude that:

  • VERTEBRAL DISC is for someone who is keen to have back problems.
  • UTERUS is for a woman who wants to see more of her gynaecologist.
  • SEMEN HUMANUM could be an anti-baby pill for men.
  • MENSES might be an alternative for an oral contraceptive.
  • etc. etc.

As many homeopathy-fans have been pointing out endlessly, I am not a truly qualified homeopath. This means that I am merely guessing here.

So, could a member of the homeopathic fraternity PLEASE enlighten me?

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