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

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I have mentioned lymph drainage before. It is a gentle massage technique applied along the lymph vessels and nodes to stimulate lymph flow. All sorts of extraordinary claims are made for this treatment. In  particular, lymphoedema after surgery for breast cancer, which can be a debilitating complication, is claimed to be preventable with this approach. This seems vaguely plausible, but does it really work?

This study tested whether manual lymphatic drainage (MLD) or active exercise (AE) are associated with improvements in shoulder range of motion (ROM), wound complication and changes in the lymphatic parameters after breast cancer (BC) surgery, and whether these parameters have an association with lymphoedema formation in the long run.

The researchers conducted a clinical trial with 106 women undergoing radical BC surgery. Women were matched for staging, age and body mass index and were allocated to AE or MLD, twice weekly during one month after surgery. The wound was evaluated two months after surgery. ROM, upper limb circumference measurement and upper limb lymphoscintigraphy were performed before surgery, and 2 and 30 months after surgery.

The incidence of seroma, dehiscence and infection did not differ between groups. Both groups showed ROM deficit of flexion and abduction in the second month postoperative and partial recovery after 30 months. Cumulative incidence of lymphoedema was 23.8% and did not differ between groups (p = 0.29). Concerning the lymphoscintigraphy parameters, there was a significant convergent trend between baseline degree uptake (p = 0.003) and velocity visualization of axillary lymph nodes (p = 0.001) with lymphoedema formation. A reduced marker uptake before or after surgery predicted lymphedema formation in the long run (>2 years). None of the lymphoscintigraphy parameters were shown to be associated with the study group. Age ≤39 years was the factor with the greatest association with lymphedema (p = 0.009). In women with age ≤39 years, BMI >24Kg/m2 was significantly associated with lymphedema (p = 0.017). In women over 39 years old, women treated with MLD were at a significantly higher risk of developing lymphedema (p = 0.011).

The authors concluded that lymphatic abnormalities precede lymphedema formation in BC patients. In younger women, obesity seems to be the major player in lymphedema development and, in older women, improving muscle strength through AE can prevent lymphedema. In essence, MLD is as safe and effective as AE in rehabilitation after breast cancer surgery.

I am not sure I agree with these conclusions; to me, they seem a bit over-optimistic. The results fail to show that MLD is clinically effective, as both AE and MLD might be equally ineffective. In fact, in the discussion section of the paper the authors state that their study suggests that AE may be more effective than MLD for the prevention of lymphedema in women older than 39 years.

So far, only very few controlled clinical trials tested the MLD effects in the prevention of lymphedema after  breast cancer. Some suggested that MLD administered early in the postoperative period can effectively prevent lymphedema, whereas others failed to find positive effects of MLD. Thus the question whether MLD is effective for lymphoedema after breast cancer remains open.

For once, the call for more and better research seems justified.

As this press-release is important and entirely self-explanatory, I will post it here without comment (other than congratulating the CFI for their action and encouraging organisations in other countries to follow suit) :

The Center for Inquiry has filed a lawsuit in the District of Columbia on behalf of the general public against drug retailer CVS for consumer fraud over its sale and marketing of useless homeopathic medicines. CFI, an organization advancing reason and science, accused the country’s largest drug retailer of deceiving consumers through its misrepresentation of homeopathy’s safety and effectiveness, wasting customers’ money and putting their health at risk.

Click here to access the official complaint (PDF).

Homeopathy is an 18th-century pseudoscience premised on the absurd, unscientific notion that a substance that causes a particular symptom is what should be ingested to alleviate it. Dangerous substances are diluted to the point that no trace of the active ingredient remains, but its alleged effectiveness rests on the nonsensical claim that water molecules have “memories” of the original substance. Homeopathic treatments have no effect whatsoever beyond that of a placebo.

“Homeopathy is a total sham, and CVS knows it. Yet the company persists in deceiving its customers about the effectiveness of homeopathic products,” said Nicholas Little, CFI’s Vice President and General Counsel. “Homeopathics are shelved right alongside scientifically-proven medicines, under the same signs for cold and flu, pain relief, sleep aids, and so on.”

“If you search for ‘flu treatment’ on their website, it even suggests homeopathics to you,” said Little. “CVS is making no distinction between those products that have been vetted and tested by science, and those that are nothing but snake oil.”

Apart from being a waste of money, choosing homeopathic treatments to the exclusion of evidence-based medicines can result in worsened or prolonged symptoms, and in some cases, even death. Several products have been found to contain poisonous ingredients which have affected tens of thousands of adults and children in just the last few years.

“CVS is taking cynical advantage of their customers’ confusion and trust in the CVS brand, and putting their health at risk to make a profit,” said Little. “And they can’t claim ignorance. If the people in charge of the country’s largest pharmacy don’t know that homeopathy is bunk, they should be kept as far away from the American healthcare system as possible.”

“We made a number of efforts to discuss this situation with CVS, but the concerns we raised were ignored,” said Robyn Blumner, president and CEO of CFI. “Homeopathy is a multi-billion dollar consumer fraud. If CVS would rather line its pockets than protect Americans’ health, we have no choice but to take this fight to the courts.”

CFI has for many years lobbied for tighter regulation of homeopathic products, and has been invited by the Food and Drug Administration and the Federal Trade Commission to provide expert testimony. As a result, the FTC declared in 2016 that the marketing of homeopathic products for specific diseases and symptoms is only acceptable if consumers are told: “(1) there is no scientific evidence that the product works and (2) the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.” And last year, the FDA announced a new “risk-based” policy of regulatory action against homeopathic products.

“CVS should be warned, the evidence for our case is extremely strong,” said Blumner. “And if CVS’s endorsement of homeopathy is any indication, evidence will not be their strong suit.”

Live Blood Analysis (LBA) is a diagnostic tool used by some SCAM practitioners (e. g. chiropractors, naturopaths, medics). It marks a new era of scientific discovery, at least this is what its proponents claim. LBA sounds impressive, looks impressive, commands impressive revenue – but, once we investigate a little closer, it turns out to be rather unimpressive.

The principle of LBA is fairly simple: a drop of blood is taken from your fingertip, put on a glass plate and viewed via a dark field microscope on a video screen. Despite the claims made for it, LBA is by no means new; using his lately developed microscope, Antony van Leeuwenhoek observed in 1686 that living blood cells changed shape during circulation. Ever since, doctors, scientists and others have studied blood samples in this and many other ways.

New, however, is what today’s SCAM practitioners claim to be able to do with LBA. Proponents believe that the method provides information about the state of the immune system, possible vitamin deficiencies, amount of toxicity, pH and mineral imbalance, areas of concern and weaknesses, fungus and yeast infections, as well as just about everything else you can imagine.

LBA is based on assumptions that are not plausible and on a misinterpretation of phenomena that are well-understood (some of them were the subject of research I did some 4 decades ago). What is more, the reliability of LBA as a diagnostic tool has never been verified. The results of the only two studies suggest that the method is not reliable:

1st study:

BACKGROUND: Dark field microscopy according to Enderlin claims to be able to detect forthcoming or beginning cancer at an early stage through minute abnormalities in the blood. In Germany and the USA, this method is used by an increasing number of physicians and health practitioners (non-medically qualified complementary practitioners), because this easy test seems to give important information about patients’ health status.

OBJECTIVE: Can dark field microscopy reliably detect cancer?

MATERIALS AND METHODS: In the course of a prospective study on iridology, blood samples were drawn for dark field microscopy in 110 patients. A health practitioner with several years of training in the field carried out the examination without prior information about the patients.

RESULTS: Out of 12 patients with present tumor metastasis as confirmed by radiological methods (CT, MRI or ultra-sound) 3 were correctly identified. Analysis of sensitivity (0.25), specificity (0.64), positive (0.09) and negative (0.85) predictive values revealed unsatisfactory results.

CONCLUSION: Dark field micoroscopy does not seem to reliably detect the presence of cancer. Clinical use of the method can therefore not be recommended until future studies are conducted.

2nd study:

CONTEXT: In 1925, the German zoologist Günther Enderlein, PhD, published a concept of microbial life cycles. His observations of live blood using darkfield microscopy revealed structures and phenomena that had not yet been described. Although very little research has been conducted to explain the phenomena Dr. Enderlein observed, the diagnostic test is still used in complementary and alternative medicine.

OBJECTIVE: To test the interobserver reliability and test-retest reliability of 2 experienced darkfield specialists who had undergone comparable training in Enderlein blood analysis.

SETTING: Inpatient clinic for internal medicine and geriatrics.

METHODS: Both observers assessed 48 capillary blood samples from 24 patients with diabetes. The observers were mutually blind and assessed their findings according to a specific item randomization list that allowed observers to specify whether Enderlein structures were visible or not.

RESULTS: The interobserver reliability for the visibility of various structures was kappa = .35 (95% CI: .27-.43), the test-retest reliability was kappa = .44 (95% CI: .36-.53).

CONCLUSIONS: This pilot study indicates that Enderlein darkfield analysis is very difficult to standardize and that the reliability of the diagnostic test is low.

So what?, some might think. It might be a SCAM, but it is a harmless one!

Wrong!

LBA is likely to produce false-positive and false-negative diagnoses.

A false-positive diagnosis is a condition which the patient does not truly have. This means she will receive treatments that are not necessary, potentially harmful and financially wasteful.

A false-negative diagnosis would mean that the patient is told she is healthy, while in fact she is not. This can cost valuable time to start an effective therapy and, in extreme cases, it would hasten the death of that patient.

The conclusion is thus clear: LBA is an ineffective, potentially dangerous diagnostic method for exploiting gullible consumers. My advice is to avoid practitioners who employ this technique.

An article has just been published announcing the reform of the German Heilpraktiker, the profession of alternative practitioners that has been discussed repeatedly on this blog and criticised recently by the ‘Muensteraner Kreis’. As the new article is in German, I will try to summarise the essence of it here:

The health ministers of all German counties have decided yesterday that they will start reforming the profession of the Heilpraktiker that has attracted much criticism in recent months. The current laws are no longer fit for purpose. There is neither a mandatory agreement for the education of the Heilpraktiker, nor a uniform regulation of the profession.

The senator for health from Hamburg stated: “We feel that the Heilpraktiker should not be allowed to do certain thing, but be permitted to do plenty of activities that remain legal.” At present, the Heilpraktiker is allowed to treat fractures, malignancies, give injections, and even manufacture certain medicines. “We believe there is a need for regulation to protect patients.”

Now a working group will be formed to investigate and produce a report within a year. Remarkably, the German health secretary avoided commenting. In a statement, it was said that patients must be empowered to make decisions on the basis of quality-assured information.

The full German text is below.

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Nach mehreren deutschlandweit Aufsehen erregenden Todesfällen beispielsweise von Krebspatienten, die kurz nach der Therapie durch einen Heilpraktiker in Brüggen-Bracht starben, will die Politik sich nun diesen Berufszweig vornehmen. Die Gesundheitsminister aller Bundesländer haben am Donnerstag beschlossen, eine Reform anzugehen. „Das unzureichend regulierte Heilpraktikerwesen mit seiner umfassenden Heilkundebefugnis steht unverändert in der Kritik“, heißt es in einer Erklärung. Das Heilpraktikergesetz könne dem heutigen Anspruch an den Gesundheitsschutz der Patienten nicht mehr gerecht werden. Für Heilpraktiker gebe es weder verbindliche Regeln zur Ausbildung noch eine einheitliche Berufsordnung. Andere Gesundheitsberufe müssten hingegen strenge Qualifikationskriterien erfüllen.

„Wir sehen es als kritisch an, dass einige Tätigkeiten zwar den Heilpraktikern untersagt sind, aber es noch eine Fülle von Tätigkeiten gibt, die zugelassen sind“, sagte die Hamburger Senatorin für Gesundheit, Cornelia Prüfer-Storcks, auf einer Pressekonferenz – sie hatte die Initiative maßgeblich  vorangetrieben.  So dürfen Heilpraktiker Knochenbrüche therapieren, schwere und bösartige Erkrankungen behandeln und Injektionen geben. Selbst die Herstellung von Arzneimitteln für bestimmte Patienten sei Heilpraktikern erlaubt. „Ohne die Prüfmechanismen, die wir normalerweise haben, wenn wir Arzneimittel zulassen und produzieren“, kritisierte Prüfer-Storcks. „Wir glauben, dass es hier Regelungsbedarf gibt aus Sicht des Patientenschutzes.“

„Die Ministerinnen und Minister, Senatorinnen und Senatoren für Gesundheit sehen eine zwingende Reformbedürftigkeit des Heilpraktikerwesens“, heißt es in dem kurzen, MedWatch vorliegenden Beschluss. „Der Bund wird gebeten, eine Bund-Länder-Arbeitsgruppe einzurichten, die eine grundlegende Reform des Heilpraktikerwesens prüft.“ Das Ergebnis der Prüfung solle bis zur Gesundheitsministerkonferenz in einem Jahr vorgelegt werden.

Bundesgesundheitsminister Jens Spahn erklärte auf der Pressekonferenz das Patientenwohl zwar zum entscheidenden Maßstab für die Gesundheitspolitik. „Deshalb finde ich es richtig, dass die Gesundheitsministerkonferenz bei der Patientenorientierung ihren Schwerpunkt setzt“, sagte er. Auf mögliche Reformen des Heilpraktikerberufes ging der Minister bei der Pressekonferenz jedoch nicht ein. Inwiefern sein Haus die von den Landesministern geforderte Reform des Heilpraktikerwesens mit unterstützen wird, bleibt offen. Auf Nachfrage, ob das Ministerium eine Bund-Länder-Arbeitsgruppe unterstützen würde, versteckte sich eine Sprecherin bereits im Mai hinter der Mini-Reform von Gröhe. Mit Blick auf die kurze Zeit seit Inkrafttreten dieser Änderungen sei es angemessen, zunächst zu prüfen, ob und inwieweit diese zum Schutz des Patientenwohles beiträgt, erklärte sie – „ehe weitere gesetzliche Maßnahmen in Betracht gezogen werden sollten“.

In einem Grundsatzbeschluss sprach sich die Gesundheitsministerkonferenz außerdem für „Patientenorientierung als Element einer zukunftsweisenden Gesundheitspolitik“ aus. „Das heißt, dass der Patient natürlich das Heft in der Hand haben muss, dass er versteht, was mit ihm gemacht wird, warum es mit ihm gemacht wird, mit welchen Chancen die Behandlung verbunden ist“, sagte NRW-Gesundheitsminister Karl Laumann. Auch in der Ausbildung des Gesundheitspersonals sollten diese Aspekte einen großen Stellenwert bekommen, betonte Laumann – und erwähnte zwar Ärzte als Berufsgruppe explizit, nicht aber Heilpraktiker. Der frühere Bundespatientenbeauftragte forderte außerdem mehr Transparenz ein. In Teilen des Gesundheitssystems gebe es wegen mangelnder Transparenz „eine gewisse Misstrauenskultur“, sagte er.

Die Minister wollen laut dem Beschluss die Patientensouveränität und der Orientierung im Gesundheitswesen verbessern, die Gesundheitskompetenz und gesundheitliche Eigenverantwortung beispielsweise durch die Einrichtung eines nationalen Gesundheitsportals deutlich stärken und Kommunikation und Wissenstransfer zwischen Patienten und allen Beteiligten im Gesundheitswesen fördern. „Patienten sollen so in die Lage versetzt werden, ihre Interessen besser zu vertreten und ihre Entscheidungen auf der Basis qualitätsgesicherter Informationen zu treffen“, heißt es.

Kommunikationskompetenz und wertschätzende Beziehungsgestaltung sei im Gesundheitswesen von wesentlicher Bedeutung für die Partizipation, Qualität, Sicherheit und den Erfolg der gesundheitlichen Prävention und der medizinischen Behandlung, betonen die Minister. Allgemeinverständliche „Patientenbriefe“ sollen als erster Schritt die Informiertheit von Patienten nach Krankenhausbehandlungen erhöhen. Außerdem soll das Bundesgesundheitsminister eine Pflicht schaffen, dass niedergelassene Ärzte ihren Patienten neutrale und evidenzbasierte schriftliche Informationen zu Zusatzangeboten – sogenannten „Individuellen Gesundheitsleistungen“ – zur Verfügung stellen müssen.

Bei Behandlungsfehlern sollen nach Ansicht der Landesminister auf Bundesebene weitere Erleichterungen umgesetzt werden: Die Beweislast und das Beweismaß soll zu Gunsten von Patienten überarbeitet werden. Außerdem sollten Krankenkassen gesetzlich verpflichtet werden, Patienten beim Nachweis eines Behandlungsfehlers besser zu unterstützen.

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I have been banging on about the German Heilpraktiker, its infamous history and its utter inadequacy since many years. This is what I published in 1996, for instance:

Complementary medicine is increasing in popularity. In most countries its practice is in the hands of non-medically trained practitioners, professions which are often not properly regulated. When discussing solutions to this problem the German “Heilpraktiker” is often mentioned. The history and present situation of this profession are briefly outlined. The reasons why the “Heilpraktiker concept” is not an optimal solution are discussed. It is concluded that the best way forward consists of regulation and filling the considerable gaps in knowledge relating to complementary medicine.

It goes without saying that, after so many tears of warning about the risks involved in allowing poorly trained practitioners, who are all too often unable to see the limits of their competency (and after many unnecessary fatalities), I am delighted that progress seems finally to be on the horizon.

Alternative medicine is riddled with a multitude of serious ethical problems. In our recent book, we made an attempt to look at them systematically and critically (I am not aware of anyone having done this before). Essentially, we arrive at the conclusion that, for many types of alternative medicine, it is not possible to practise them according to fundamental demands of healthcare.

Homeopathy is one of them. I recently had a look at the CODE OF ETHICS of the UK Society of Homeopaths (last updated 2015). There I almost instantly stumbled over perhaps the most significant hurdle of practising homeopathy ethically. Here is what the SoH demands of its members:

1) To ensure that the patient is always able to make informed choices with regard to their healthcare, registered and student clinical members must give full and clear information about their services when commencing homeopathic treatment. This will include written information about the nature of the treatment, charges, availability for advice, confidentiality and security of records.

2) To ensure that the patient or their authorised representative is able to give valid consent with regard to healthcare, registered and student clinical members must give clear and sufficient information about the nature of homeopathic treatment, its scope and its limitations, before treatment begins and as appropriate during treatment… 

The SoH is absolutely correct, full, sufficient and clear information before commencing treatment and consent to that treatment are two preconditions for any type of healthcare. However, the SoH is a bit shy about explaining what ‘full information’ must entail. As I have mentioned before, full and sufficient information must include:

  1. the diagnosis,
  2. its natural history,
  3. the most effective treatment options available,
  4. the proposed therapy,
  5. its effectiveness,
  6. its risks,
  7. its cost,
  8. a rough treatment plan.

So, let’s imagine a patient who suffers from stomach pains consulting his homeopath. Following the above 8 points, here is what she would need to tell him:

  1. I don’t know what your diagnosis is; I am not medically trained.
  2. I therefore can tell you nothing about its natural history.
  3. And nothing about the most effective treatment for your condition.
  4. I nevertheless propose to treat you with a homeopathic remedy.
  5. There is no good evidence that it will work beyond a placebo effect.
  6. The remedy is harmless, but not giving you an effective treatment might, of course, cause considerable harm.
  7. The cost of the consultation is £80, and the remedy will cost you around £15.
  8. I suggest you come again in a week or two; perhaps we need quite a few consultations altogether.

After hearing this, almost any patient would get up, thank the homeopath for the full information and look for a clinician who is able to offer an effective therapy. In other words, the SoH is inhibiting its members from practising homeopathy (alright, they don’t spell it out in such clear terms, but that is what full and sufficient information amounts to).

Why do they do that?

Because they have to!

Not supplying full and sufficient information would simply be unethical. And unethical healthcare cannot be tolerated.

Many of you will know that JAMA is one of the most respected medical journals. It is therefore surprising that, within the period of a few days, they published not one but two dodgy RCTs of alternative treatments.

The new trial was aimed at determining whether the addition of chiropractic care to usual medical care results in better pain relief and pain-related function when compared with usual medical care alone.

The study was designed as a pragmatic comparative effectiveness clinical trial using adaptive allocation was conducted from September 28, 2012, to February 13, 2016, at three US military medical centres. Eligible participants were active-duty US service members aged 18 to 50 years with low back pain from a musculoskeletal source. The intervention period was 6 weeks. Usual medical care included self-care, medications, physical therapy, and pain clinic referral. Chiropractic care included spinal manipulative therapy in the low back and adjacent regions and additional therapeutic procedures such as rehabilitative exercise, cryotherapy, superficial heat, and other manual therapies.

Primary outcomes were low back pain intensity (Numerical Rating Scale; scores ranging from 0 [no low back pain] to 10 [worst possible low back pain]) and disability (Roland Morris Disability Questionnaire; scores ranging from 0-24, with higher scores indicating greater disability) at 6 weeks. Secondary outcomes included perceived improvement, satisfaction (Numerical Rating Scale; scores ranging from 0 [not at all satisfied] to 10 [extremely satisfied]), and medication use.

In total, 750 patients were enrolled. Statistically significant site × time × group interactions were found in all models. Adjusted mean differences in scores at week 6 were statistically significant in favour of usual medical care plus chiropractic care compared with usual medical care alone overall for low back pain intensity (mean difference, −1.1; 95% CI, −1.4 to −0.7), disability (mean difference, −2.2; 95% CI, −3.1 to −1.2), and satisfaction (mean difference, 2.5; 95% CI, 2.1 to 2.8) as well as at each site. Adjusted odd ratios at week 6 were also statistically significant in favour of usual medical care plus chiropractic care overall for perceived improvement (odds ratio = 0.18; 95% CI, 0.13-0.25) and self-reported pain medication use (odds ratio = 0.73; 95% CI, 0.54-0.97). No serious adverse events were reported.

The authors concluded that chiropractic care, when added to usual medical care, resulted in moderate short-term improvements in low back pain intensity and disability in active-duty military personnel. This trial provides additional support for the inclusion of chiropractic care as a component of multidisciplinary health care for low back pain, as currently recommended in existing guidelines. However, study limitations illustrate that further research is needed to understand longer-term outcomes as well as how patient heterogeneity and intervention variations affect patient responses to chiropractic care.

Regular readers will have spotted it straight away: This trial follows the infamous ‘A+B versus B’ design. It will almost always generate a positive result – so much so that it is a waste of time to run the study because we know its findings before it has started. And if this is so, the trial is arguably even unethical.

The reason is, of course, that the study design does not control for placebo effects. And this means that even an utterly useless treatment will produce a (false-positive) result as long as it generates a placebo effect. Some of the authors of the present study are experienced researchers and clearly know all this. This is why they call their study a ‘pragmatic’ trial. But even with pragmatic trials, one cannot get away with murder!

As far as I can see, there are even two ‘murders’ here:

  1. The authors stated that their aim was to determine whether the addition of chiropractic care to usual medical care results in better pain relief and pain-related function when compared with usual medical care alone. I would argue that their study did not live up to this aim. As it did not control for placebo effects, it cannot possibly test the effectiveness of chiropractic care per se.
  2. The authors concluded that their trial provides additional support for the inclusion of chiropractic care as a component of multidisciplinary health care for low back pain. I would argue that this is quite simply wrong. The results are in perfect agreement with the assumption that chiropractic care is a placebo, and few would argue that the inclusion of a pure placebo can be recommended.

Compared to these major issues, my other concerns are mere trivialities:

  1. The trial tested spinal manipulation plus a whole bunch of physiotherapeutic intervention. I bet my last shirt that the chiro-community will claim that it demonstrated the effectiveness of chiropractic spinal manipulations. Already the very first sentence of the present paper’s discussion section goes into this direction: The changes in patient-reported pain intensity and disability as well as satisfaction with care and low risk of harms favoring UMC with chiropractic care found in this pragmatic clinical trial are consistent with the existing literature on spinal manipulative therapy…
  2. In their abstract, the authors (several of whom are chiropractors) state that there were no serious adverse effects (the paper is extremely thin on providing details about how adverse effects were assessed, verified, categorised etc.). What about non-serious adverse effects (arguably LBP is a minor condition, so minor adverse effects are relevant!)? In the paper, they enlighten us that  of the 43 adverse effects reported by participants receiving UMC with chiropractic care, 38 were described as muscle or joint stiffness attributed to chiropractic care (37 events) or physical therapy (1 event), 1 was reported as indistinct symptoms following an epidural injection, 3 were described as pain, tingling, or sensitivity in an extremity without reference to a specific treatment, and 1 was a lower-extremity burning sensation for 20 minutes following spinal manipulative therapy. In my view, this is sufficiently important to be mentioned also in the abstract.
  3. The authors remain totally silent when it comes to the discussion of the effect sizes. To me, they seem to be moderate. Are they at all clinically relevant. I feel that the discussion of a PRAGMATIC trial must include this pragmatically important issue.

Guest post by Frank van der Kooy

TCM and the importance of having a Minister of Health with knowledge of health!

An analogy

You’re sitting on a beach when suddenly not far from you, you notice a commotion. Your fear is confirmed when you see lifeguards dashing into the ocean and moments later they drag a lifeless body of a young child from the waves. Because the lifeguards are well trained, they manage to revive the child, resulting in a collective sigh of relief from the gathered crowd. Happy endings like this make people feel good – it is good news. But this is not where it ends. Suddenly you hear screaming and to your shock you witness something truly amazing. The parents of this boy sprints down the beach, bursts through the crowd, all the while shouting that they will save their child. To your amazement they pull the child, still gasping for air, from the arms of the lifeguards back into the ocean where they hold his head under water until he drowns!

I don’t know if anything like this has ever happened but I’m almost convinced that the crowd, after recovering from their shock, will most likely attack the parents and more people might die that day.

Now, one of the hallmarks of a fake healthcare system is the fact that just about everything works. Think of rhino horn, acupuncture, homeopathy etc. but also something such as slapping therapy – everything works. Surely, if you allow a practitioner into your clinic to provide people, including children, slapping therapy then you acknowledge that it works? If not, you are intentionally misleading your patients (interesting catch 22.) But let me explain the analogy. These parents suffer from a level of delusion that most people simply cannot understand and sadly this type of scenario plays out far more often than most people would like. And if the Chinese Communist Party (CCP) has its way, these tragedies will increase significantly and it might even become quite common. Take for example the tragic slapping death tragedy.

The poor parents were misled into believing that they can cure their 6yo son of diabetes type 1 by attending an expensive ‘slapping therapy’ workshop in Sydney. The child was taken off his medication (out of professional care) and was slapped (allowing the sea to finish the job) in the belief that this will cure him. It did not, and the child died. The slapping therapist and the parents are now facing court, but this should be seen as treating the symptom while the cause, the people responsible for creating this level of delusion, are continuing to relentlessly disseminate their misinformation regarding ‘integrative medicine’.

From the website of ‘Master’ Hongchi Xiao. Left, an 8yo boy who suffers from a serious kidney disease, right, the leg a 13yo suffering from diabetes. The type of injuries caused by the slapping therapy is easily visible (it is unknown if these children survived or how many victims Master Xiao made).

The unseen war that’s being fought

To use war terminology might be a bit far-fetched but I don’t think it’s unreasonable. This war is being fought between an army of pseudoscientists (backed by the CCP and others) and a few scientists (backed by, uhm, no one) and it’s about the ‘integration’ of fake medicine and medical procedures with evidence-based healthcare under the umbrella term – ‘Integrative medicine’. For most people, hitting a young defenceless child to such a degree that he dies of his injuries and/or lack of medication, is surely a heinous crime. But others apparently see this practice to be okay, and these deaths should be considered ‘collateral damage’. After all, many innocent people die in war zones, and although undesirable it is an inadvertent consequence of achieving the greater good – to win the war.

Slapping therapy is part of the pseudoscientific Traditional Chinese Medicine (TCM) industry, and because of the sheer economic size of this industry, the CCP decided to revive it, protect it and promote it nationally but also internationally. Any critique of TCM within China is met with the long arm of the law. Quite recently a Chinese doctor was jailed for three months after he wrote an opinion piece regarding the dangers of a specific TCM remedy. So, TCM is here to stay and is also one way of how the CCP is exerting its influence overseas.

Their current excursion is to steamroll over science (and the few scientists willing to defend it) via some Australian universities (who in turn derives financial benefit) by creating ‘scientific’ legitimacy for TCM and thereby increase their Australian (and western) market penetration. They use the billions of dollars that Australian universities receive from (Chinese) international students as a silent threat in order to keep these universities in check and dancing to their tune. Via some Australian academics, they have infiltrated and now have the support of Australian regulators and politicians. All in all, it is going quite well with their plans to internationalise TCM.

The main problem is that they have vast resources which most scientists don’t have. Take for example the National Institute of Complementary Medicine (NICM). They’re about 50 people with Western Sydney University (WSU) pumping millions of taxpayer dollars into their coffers every year. Controversial companies such as Blackmores also donates millions and much more money is flowing in from China – all of these resources are being used to integrate dis/unproven complementary and alternative medicine, with a specific focus on TCM. For example; the clinic, Tasly Healthpac, that promoted and hosted the slapping therapy workshop was founded and is managed by Dr Ven Tan whereas Prof Alan Bensoussan, director of the NICM, collaborated with Dr Tan to integrate fake healthcare (slapping, acupuncture, TCM etc.). A MoU was signed between Tasly and the NICM in 2011, which states that the NICM will provide “assistance in the development of an Integrative Care Model: to assist the Tasly Healthpac Centre of Excellence in Integrative medicine so that its structure aims to integrate TCM and western medical diagnostics and treatments in an integrated, patient centred way.”

Clockwise from left. Dr Ven Tan; Master Hongchi Xiao, the slapping therapist; Prof Alan Bensoussan giving a speech in Beijing after receiving a prestigious prize for his work on integrating TCM; the signing of a MoU witnessed by Prof Bensoussan (standing left) and Dr Tan (standing 3rd from the right).

Facing this tsunami of misinformation, and defending the battlefront, you have a few lonely scientists. Nobody is pumping millions into warning people about fake healthcare systems, because there is no money to be made from it, and hence with their meagre resources, they simply do it because their conscience demands it.

I have written about the Australian academics who facilitated the CCPs plans to internationalise TCM, mainly by lobbying for the national registration of TCM practitioners, and also about the Australian politicians (former trade minister Andrew Robb and PM Tony Abbott etc.) who were lobbied to include a free flow of TCM practitioners into Australia under the Free Trade Agreement signed in 2015. TCM producers such as Tong Ren Tang were, of course, elated with this arrangement because “….we will have an increasingly wider road, and open more and more branch stores in Australia.”

In this article, I will focus on the role of the former Minister of Health for New South Wales, Ms Jillian Skinner, and her role in this calamity.Former PM Tony Abbott (red tie) and Dr Ven Tan (to the right of Mr Abbott) here in his capacity as Executive Vice Chairman of the CCP-linked ‘Australia-China Economics, Trade & Culture Association’

The Minister of Health and the tale of two letters

Two letters were sent to Min. Skinner, one warning her about integrating TCM (and other disproven and unproven healthcare systems), the other letter promoting TCM. So which one had an impact?

A word of warning

Any health minister would surely understand the dangers in supporting the principles of TCM which is that disease is caused by disturbances in your (pseudoscientific) life force, or Chi, that flows through ‘meridians’. Inserting needles (acupuncture), taking Chinese herbs or slapping yourself all ‘aim’ to influence and/or restore your life force and cure you of whatever ails you. That some herbs might be beneficial is a given but it is because they contain very specific compounds (and very few do) – this has nothing to do with your life force! Supporting the integration of pseudoscientific healthcare with real healthcare is very dangerous as was illustrated by the slapping therapy death. Hence, one might expect that the minister would be accompanying Dr Tan/Prof Bensoussan to the police station, because something like this should surely not be allowed?

To warn the Minister about the NICMs modus operandi I’ve sent her a letter and attached a 6000-word document detailing my concerns (a shortened version can be found here). It can be summed up as follow:

The NICM supports and promote any form of complementary, alternative or traditional (CAT) medicine and do not advise the public, as claimed, about the dangers of disproven CAT medicines such as homeopathy, TCM etc. because most of their funding depends mainly on misleading the public.

In my email dated 4 February 2016 I stated that; ‘These concerns are of such a nature that I believe the public is in danger of suffering injury or even death as a result. I have shared my concerns with the NICM management as well as the vice-chancellor of WSU (in June 2015). Needless to say, the WSU management do not share my concerns and hence my urgent call on your office to investigate this matter further.’

One example in my letter, to illustrate the problem, was the NICMs response to the well-known NHMRCs report regarding the ineffectiveness and dangers of homeopathy. It is fascinating how they pumped misinformation, via their partner ‘Complementary Medicines Australia’, into the world. Their response, entitled “The Five Fundamental Flaws of the NHMRCs Homeopathy report” is currently being used by homeopaths around the world to ignore the urgent advice that ‘Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness”. The press release ends with the ‘wise’ words “Homeopathy has been around for hundreds of years, and I am sure will be around a lot longer than some of the critics.”

People, including children, die because of this misinformation. But for some reason, the courts only take action when children are involved. Here is another tragic example of a 9-month old baby that died. And just recently the Australian government even ignored the recommendations of a new review and decided that; “Homeopathic products will continue to be sold in Australian pharmacies, despite a long-awaited review warning the government the practice could compromise the health of consumers.” Obviously, their lobbying has been quite successful to date!

But this shows that the NICM and their partners will defend just about any fake ‘medicine’ including TCM because they derive funding from it. This cunning ability to mislead the public, regulators and politicians was at least rewarded with the Bent Spoon award for quackery in 2017 – for what it’s worth.

A letter with impact

The NICMs job regarding TCM is to open the floodgates into Australia (and the world), but to do this they need the support from Australian politicians and hence, Alan and people like Marcus Blackmore (CEO of Blackmores), endlessly lobby politicians (you can read about this here). Here you can find one such letter (May 2014) written by the NICM and send to Min. Skinner. This letter contains the predictable praises of the integrative medicine industry, the ‘importance’ of integrating CAT with conventional healthcare, and the world-class standards of the NICM etc. but there is one sentence that stands out above the rest. And this is what it’s all about;

“….NICM needs this positioning if it is to help consumers and health professionals choose safe and effective complementary medicine (and discard ineffective treatments)…”

If you consider the fact that they were involved with the slapping therapy workshop (people died), their response to the NHMRC Homeopathy report (people died), and even that one of their business partners were send to jail after being caught importing rhino horn into Australia (endangered animals died) – all of the above ineffective remedies or treatments, then this sentence is not misleading, it is a blatant lie.

The slapping therapy death occurred in April 2015, and although I noticed it in the newspaper at the time, I was not aware that the NICM was intricately involved (I was actually quite busy trying to get out of there). What came as a shock a couple of years later was when I accidentally came across a travel itinerary of Min Skinner. It turns out that she invited Dr Tan and Prof Bensoussan to accompany her, not to a police station, but to China in April 2016, barely 2 months after I’ve send my letter to her office. The reason for this trip was to garner support for their plans to integrate TCM with conventional healthcare in Australia. To quote from her travel itinerary “To assist the University of Western Sydney’s National Institute of Complementary Medicine (NICM) secure investor and donor support for the NICM’s integrative Chinese medicine facility medicine/treatment on the Westmead Campus and related complementary medicine research initiatives.”

Left. Minister Skinner (seated in red) signing a MoU with Vice Governor of Shandong Province, the Hon Wang Suilian. Right. Min Skinner (in red) witnessing the signing a MoU between TCM producer Tong Ran Teng and Ramsay Healthcare.

Their trip to China also caught the attention of the media because she decided that integrating quackery was more important than solving real health problems in Australia. “Ms Skinner defended the trip, taken with NSW Chief Health Officer Kerry Chant, saying it led to an agreement between Westmead Hospital and Shandong’s Qilu Hospital designed to ­ enhance … understanding of traditional Chinese medicine” and “The MOU will establish formal links between Westmead Hospital and Shandong’s Qilu Hospital and is designed to enhance NSW’s understanding of traditional Chinese medicine.”

But here is a fun fact. Close to 100% of clinical trials on TCM conducted in China gives positive results, coupled to the fact that any scientific criticism of TCM can see you get jailed, then surely, the minister must know that they are dealing with a fake healthcare system? Apparently not, or they just ignore the obvious because the potential economic stimulus seemingly overrides the political risks associated with causing a number of preventable deaths. It is a scary thought that former Min Skinner now serves as a director at the Children’s Cancer Institute (I requested her contact details from the institute in order to give her the opportunity to respond but no response was received thus far.)

But did the NICM break the law?

Min. Skinner eventually responded (Nov 2016) but then only by referring me to the Federal Minister of Health, Sussan Ley (who also resigned around this time), but by then the damage was already done. Clearly, the NICM managed to get funding from China because they will be moving into their new TCM hospital pretty soon. This hospital will be co-occupied (and managed) by the CCP linked Beijing University of Chinese Medicine (BUCM). In their document ‘some brief notes regarding the BUCM collaboration’ they state; “It represents an unprecedented opportunity for the advancement of Chinese medicine in Australia, including the development of the Chinese medicine market in the West; promoting Chinese heritage and culture; and integrating Chinese medicine with the Australian healthcare system.”

But did they do anything illegal? I am no expert in the law but I believe that providing misleading and/or false information to ministers, who then based on this promote the integration of ineffective healthcare might indeed break the law – especially when this results in the death of members of the public. Did they provide former Trade Minister Andrew Robb (discussed here) and Min Skinner with correct and unbiased info about what TCM is? Well, their letter tells me that they did not. As far as I can tell, neither of these former ministers have a background in science, and as such, can easily be misled when it comes to complex scientific issues. But then again, you need to be receptive to these ideas and propaganda, because at the end of the day they signed off on it.

I sometimes just wonder where all of this will end. If organisations such as the NICM (they are not the only ones) are not reeled in now, how will the Australian (or western) healthcare system look like in 10-20 years’ time? They are masters of deceit with a clear intention to mislead the public for the sake of making money. For example; their new TCM ‘hospital’ in Westmead will not be called exactly that, they have chosen a much more mundane and misleading name; ‘Western Sydney Integrative Health Centre’ – it will fool many, because it is right next to the southern hemispheres’ biggest health complex and it is backed by an Australian university to give it even more credibility.

Concluding remarks

I used the phrase ‘China Power and Influence’ in this article as well as in two previous articles that you can find here and here. But this is only one side of the bigger picture because most people are well aware that China, as an upcoming super-power, wants to exert its influence in various ways in various countries. But I do hope that I’ve managed to highlight that TCM is also part of this and as such, a threat, not only to the health of people, but also wildlife. The reasons why China included TCM in their plans are probably complex and likely multifactorial and I will attempt to deal with this question in a next article.

But the main message that I wanted to get across is that although China is the source of TCM, and hence the problem, any country can quite easily recognise it as such and say; ‘no thank you, we will stick with modern evidence-based healthcare, but will gladly collaborate with you in other areas.’ This has not happened in Australia. And this is the message. There are Australian citizens in positions of power who has gone out of their way to legitimise and normalise TCM in Australia and hence aided the CCP in executing their plans for the sake of, mainly money.  Some people are capable of doing strange things for money and some even have the ability to completely switch off their conscience.

All of this is now playing out in Australia (where and how it will end is anyone’s guess), but will this be all that different than what is happening regarding TCM in other western countries?  I fear not.

A recent comment by Richard Rawlins stated: “In healthcare, people who act as wannabe doctors and make false claims are quacks. If they make money at it, they are frauds. But fools they are not.”

I hope you agree that this is a notion well-worth exploring a bit closer. Specifically, I want to try and differentiate the ‘fools’ from the ‘frauds’.

But how?

Perhaps by listing some of the qualities that characterise the two categories.

FRAUDS

The hallmarks of a fraud in medicine are, I think, that a) he is lying and b) he is trying to get at your money (as much of it as possible). By ‘lying’ I mean presenting untruths as facts, despite knowing they are not correct. Essentially, this means that a fraud is dishonest and might even be guilty of a criminal offence (in turn, this means that we ought to be able to take legal action against him).

Frauds are egoistic and do not care much about their clients or the fact that they might cause harm.

FOOLS

By contrast, fools in medicine are naïve and deluded. They are not necessarily dishonest because, even though they tell untruths, they believe them to be true (in a way, fools have fallen for their own lies). Like frauds, fools might also try to get at your money (some of it), but they would claim that they simply need to be paid for their services in order to make a living.

Fools often live under the impression of being altruistic and they are convinced they do a lot of good.

WHO IS WHO?

The distinction between fools and frauds in the realm of alternative medicine is often less than obvious; there is plenty of overlap between the two. I have met hundreds of alternative practitioners and, if I try to retrospectively allocate them into either of the two categories, I run into considerable difficulties. Many belong to neither of them; and most have qualities that are reminiscent of both. But if I was forced to make a binary choice, I would probably put most of them in the camp of fools. Perhaps I was fortunate, but I have not many outright frauds amongst alternative practitioners.

WHO IS MORE DANGEROUS?

Did I say I was ‘fortunate’? Yes, fortunate for not having to deal all that often with dishonest crooks. But in terms of potential for harm, there is nothing fortunate about the fools. For the consumer, frauds are usually easier to recognise than fools, and once identified, they become far less harmful. Fools are often so convinced of their ‘truths’ that desperate patients easily fall for their falsehoods. And this is precisely what constitutes the main danger of fools in (alternative) medicine: they tend to be so convincing and so sure of doing something positive that people tend to find them credible. Consequently, many consumers, patients, politicians, journalists etc. follow their foolish and often harmful advice.

CONCLUSION

We tend to find frauds immoral and despicable and are often perceive fools as ethically and socially more acceptable. However, considering their potential for doing harm, the fools are frequently far worse than the frauds. I therefore conclude we must be vigilant about frauds but, at the same time, become more weary about fools.

 

 

There seem to be plenty of myths and misunderstandings about homeopathy in India.

Homeopathy was first introduced to India by a German doctor from Siebenbuergen, Martin Honigberger (1795 – 1869). He first came to India in 1829 as a conventionally trained physician and treated amongst other personalities the Maharaja Ranjit Singh of Punjab. In 1834, he returned to Europe, met Hahnemann, and became a convert of homeopathy. Subsequently he returned to India, in 1839, and brought homeopathy to this country. Initially, homeopathy was practised mainly by lay practitioners. Mahendra Lal Sircar is said to have been the first Indian who became a homeopathic physician, and he is often called the ‘Hering of India’. The ‘Calcutta Homeopathic Medical College’ was established in 1881 and assumed a crucial role in popularising homeopathy.

Today, we are often being told that homeopathy is incredibly popular in India. For instance, the HINDUSTAN TIMES recently published the following article:

The government on Tuesday said homeopathy is ‘clinically effective’ and there has been a 50 % rise in the number of patients seeking homeopathic treatment in the country in the past five years.

“In India, at 23 Institutes/ Units under the Central Council for Research in Homeopathy (CCRH), there is 50 % more footfall of patients seeking homeopathic treatment during the last five years,” said AYUSH Minister of State (Independent Charge) Shripad Yesso Naik.

“Homeopathy is not a pseudoscience. The conclusion of most comprehensive systematic reviews of studies based on classical homeopathy has concluded that it has a positive and specific effect greater than placebo alone,” he said in a written reply in the upper house.

“Homeopathy is being promoted as it is not only safe and effective but also due to its high acceptance through high quality surveys of use of homeopathy,” said Naik, adding that there is evidence that homeopathy is beneficial.

“There is evidence based data (not anecdotal) with CCRH that warrants the promotion or acceptance of homeopathy in India,” said the Minister.

END OF QUOTE

In my view, this foremost begs one question: How does Shripad Yesso Naik get away with evidently false statements?

The minister describes himself as a ‘business person’ (not sure what this means, but it clearly does not describe a medical expert). Wikipedia has this interesting information on him: On March 25, 2016, Shripad Naik publicly stated he had access to research which proved that diseases such as cancer could be cured by yoga. He further stated that his Ministry was a year away from granting an endorsement to such techniques and research. The statement was challenged by medical researchers and doctors, who advocated caution in claiming a cure to cancer on the basis of unproven and unpublished research.

The AUYSH-ministry (AYUSH stands for ayurveda, yoga, siddha and homeopathy) seems to have the purpose of promoting homeopathy not on the basis of evidence but despite the evidence. For that purpose, it has set up a committee at the Central Council for Research in Homeopathy (CCRH) to “deal with issues related to false propaganda against homeopathy”. They claim to have written to Nobel laureate Venkatraman Ramakrishnan, who correctly stated that homeopathy and astrology were “bogus”… “No one in chemistry believes in homeopathy. It works because of placebo effect”. The director general of the CCRH countered that “The propaganda is coming from the West and it is picked up by newspapers here. They present homeopathy in a disproportionate and negative light, and it creates confusion… ” The CCRH has also been writing letters, rejoinders and counter-editorials to others to combat “false propaganda.”

I do not need to repeat here the evidence on homeopathy (we have dealt with it regularly on this blog); suffice to state that it fails to show that highly diluted homeopathic remedies differ from placebos. This, in turn, means that the accusation of ‘false propaganda’ must be directed not at the sceptics but at the AYUSH-ministry.

And what about the claim that homeopathy is currently so hugely popular in India? It seems that it is bogus too. A recent survey conducted by ‘Indian National Sample Survey Office’ revealed that 90% of the Indian population rely on conventional medicine. Merely 6% trust what the investigators chose to call ‘Indian systems of medicine’, e. g. ayurveda, yoga, siddha and homeopathy, often abbreviated as AYUSH.

The message that seems to emerge from all this is that, in India, homeopathy is being promoted on the basis of exaggerations and untruths – much like in many other countries, I hasten to add.

by Norbert Aust as ‘guest blogger’ and Edzard Ernst

Professor Frass has repeatedly stated that his published criticism of the Lancet meta-analysis has never been refuted, and therefore homeopathy is a valid therapy. The last time we heard him say this was during a TV discussion (March 2018) where he said that, if one succeeded in scientifically refuting the arguments set out in his paper, one would show the ineffectiveness of homeopathy.

In today’s post, we quote the paper Frass refers to, published as a ‘letter to the editor’ (published in the journal Homeopathy) by Frass et al (bold typing), and provide our rebuttal (in normal print) of it:

Even with careful selection, it remains problematic to compare studies of a pool of 165 for homeopathy vs 4200,000 for conventional medicine. This factor of 41000 already contains asymmetry.

We see no good reasons why the asymmetry poses a problem; it does not conceivably impact on the outcome, nor does it bias the results. In fact, such asymmetries are common is research.

Furthermore, it appears that there is discrimination when publications in English (94/110, 85% in the conventional medicine group vs 58/110, 53% in the homeopathy group) are rated higher quality (Table 2).

We cannot confirm that the table demonstrates such a discrimination, nor do we understand how this would disadvantage homeopathy.

Neither the Summary nor the Introduction clearly specify the aim of the study.

The authors stated that they “analysed trials of homoeopathy and conventional medicine and estimated treatment effects in trials least likely to be affected by bias”. It is hardly difficult to transform this into their aim: the authors aimed at analysing trials of homoeopathy and conventional medicine and estimating treatment effects in trials least likely to be affected by bias.

Furthermore, the design of the study differs substantially from the final analysis and therefore the prolonged description of how the papers and databases were selected is misleading: instead of analysing all 110 studies retrieved by their defined inclusion and exclusion criteria, the authors reduce the number of investigated studies to ‘larger trials of higher quality’. By using these sub-samples, the results seem to differ between conventional medicine and homeopathy.

This statement discloses a misconception of the approach used in the meta-analysis.  The meta-analysis of all 110 trials found some advantages of homeopathy. When the authors performed a sensitivity analysis with high quality and larger studies, this advantage disappeared. The sensitivity analysis was to determine whether the overall treatment effect seen in the initial analysis was real or false-positive. In the case of homeopathy, it turned out to be false (and presumably for this reason, the authors hardly mention it in their paper), whereas for the trials of conventional medicines, it was real. This procedure is in keeping with the authors’ stated aims.

The meta-analysis does not compare studies of homeopathy vs studies of conventional medicine, but specific effects of these two methods in separate analyses. Therefore, a direct comparison must not be made from this study.

We fail to see the significance in terms of the research question stated by the authors. Even Frass et al use direct comparisons above.

However, there remains great uncertainty about the selection of the eight homeopathy and the six conventional medicine studies: the cut-off point seems to be arbitrarily chosen: if one looks at Figure 2, the data look very much the same for both groups. This holds true even if various levels of SE are considered. Therefore, the selection of larger trials of higher quality is a post-festum hypothesis but not a pre-set criterion.

This is not true, Shang et al clearly stated in their paper: “Trials with SE (standard error) in the lowest quartile were considered larger trials.” It is common, reasonable and in keeping with the authors’ aims to conduct sensitivity analyses using a subset of trials that seem more reliable than the average.

The question remains: was the restriction to larger trials of higher quality part of the original protocol or was this a data-driven decision? Since we cannot find this proposed reduction in the abstract, we doubt that it was included a priori.

We are puzzled by this statement and fail to understand why Frass et al insist that this information should have been in the abstract.

However, even if one assumes that this was a predefined selection, there are still some problems with the authors’ interpretation: for larger trials of higher reported methodological quality, the odds ratio was 0.88 (CI 95%: 0.65–1.19) based on eight trials of homeopathy: although this finding does not prove an effect of the study design on the 5% level, neither does it disprove the hypothesis that the results might have been achieved by homeopathy. For conventional medicine, the odds ratio was 0.58 (CI 95% 0.39–0.85), which indicates that the results may not be explained by mere chance with a 5% uncertainty.

As the outcome failed to reach the level of significance, the null-hypothesis (“there is no difference”) cannot be discarded, and this is sufficient evidence to show that there is no evidence for the effectiveness of homeopathy. The comment by Frass et al seems to be based on a misunderstanding how science operates.

Although the authors acknowledge that ‘to prove a negative is impossible’ the authors clearly favour the view that there is evidence that homoeopathy exhibits no effect beyond the placebo-effect. However, this conclusion was drawn after a substantial modification of the original protocol which considerably weakens its validity from the methodological point of view. After acquiring the trials by their original inclusion- and exclusion criteria they introduced a further criterion, ‘larger trials of higher reported methodological quality’. Thus, eight trials (=46% of the larger trials) in the homoeopathy group were left and only six (32%) in conventional medicine group (an odds ratio of 0.75 in favour of homoeopathy).

As explained above, the authors’ reasoning was clear and rational; it did not follow the logic suggested by Frass et al. which confirms our suspicion already mentioned above that Frass et al misunderstood the concept of the Shang meta-analysis.

But the decisive point is that it is unlikely that these six trials are still matched to the eight samples of homoeopathy (although each of the 110 in the original was matched). Consequently, one cannot conclude that these trials are still comparable. Thus, any comparisons of results between them are unjustified.

Further evidence that Frass et al misunderstood the concept of the Shang meta-analysis.

The rationale for this major alteration of the study protocol was the assumption, that these larger, higher quality trials are not biased, but no evidence or databased justification is given. Neither the actual data (odds ratio, matching parameters…) nor a funnel plot (to indicate that there is no bias) of the final 14 trials are supplied although these parameters constitute the ground of their conclusion.

Further evidence that Frass et al misunderstood the concept of the Shang meta-analysis.

The other 206 trials (94% of the originally selected according to the protocol) were discarded because of possible publication biases as visualized by the funnel plots. However, the use of funnel plots is also questionable. Funnel plots are thought to detect publication bias, and heterogeneity to detect fundamental differences between studies.

Further evidence that Frass et al misunderstood the concept of the Shang meta-analysis.

New evidence suggests that both of these common beliefs are badly flawed. Using 198 published meta-analyses, Tang and Liu demonstrate that the shape of a funnel plot is largely determined by the arbitrary choice of the method to construct the plot. When a different definition of precision and/or effect measure was used, the conclusion about the shape of the plot was altered in 37 (86%) of the 43 meta-analyses with an asymmetrical plot suggesting selection bias. In the absence of a consensus on how the plot should be constructed, asymmetrical funnel plots should be interpreted cautiously.

Further evidence that Frass et al misunderstood the concept of the Shang meta-analysis.

These findings also suggest that the discrepancies between large trials and corresponding meta-analyses and heterogeneity in metaanalyses may also be determined by how they are evaluated. Researchers tend to read asymmetric funnel plots as evidence of publication bias, even though metaanalyses without publication bias frequently have asymmetric plots and meta-analysis with publication bias frequently have symmetric plots, simply due to chance.

Perhaps we should mention that the senior author of the Lancet meta-analysis, Mathias Egger, is the clinical epidemiologist who invented the funnel plot and certainly knows how to use and interpret it.

Use of funnel plots is even more unreliable when there is heterogeneity. Apart from the questionable selection of the samples there is a further aspect of randomness which further weakens their conclusion: the odds ratio of the eight trials of homoeopathy was 0.88 (CI 0.65–1.19), which might be significant around the 7–8% level. Actually, the reader might be interested to know at which exact level homeopathy would have become significant. Thus, there is no support of their conclusion any more when you shift the level of significance by mere, say 2–3%.

What number of grains is required to build a heap? Certainly there is such a limit. Five grains are not a heap, five billion are. But if you select any specific value, you will find it hard to explain if one grain less changes the characteristic of a heap to become a number of grains only. Same here. If p = 0.05 is the limit of significance, p = 0.05001 is not significant, let alone, when p is 2-3%higher than that.

In addition, with such controversial hypotheses the scientific community would tend to use a level of significance of 1% in which case the odds ratio of the conventional studies would not be significant either.

The level of 5% is commonly applied in medical research; it is the accepted standard. Frass et al also apply it in their studies; but here they want to change it. Why, to suit their preconceived ideas?

From a statistical point of view, the power of the test, considering the small sample sizes, should have been stated, especially in the case of a nonsignificant result.

This might have been informative but is rarely done in meta-analyses.

Above all, the choice of which trials are to be evaluated is crucial. By choosing a different sample of eight trials (eg the eight trials in ‘acute infections of the upper respiratory tract’, as mentioned in the Discussion section) a radically different conclusion would have had to be drawn (namely a substantial beneficial effect of homeopathy—as the authors state).

Further evidence that Frass et al misunderstood the concept of the Shang meta-analysis.

The authors may not be aware that larger trials are usually not ‘classical’ homeopathic interventions, because the main principle of homeopathy, individualization are difficult to apply in large trials. In this respect, the whole study lacks sound understanding of what homeopathy really is.

This is a red herring; firstly the authors did not aim to evaluate individualised homeopathy. Secondly, Frass et al know very well that clinical homeopathy is not individualised and regarded as entirely legitimate by homeopaths. And finally, the largest trial of individualised homeopathy included in Mathie’s review of individualized homeopathy had 251 participants.


So, why has so far no rebuttal of this ‘letter to the Editor’ been published? We suspect that the journal Homeopathy has little incentive to publish a critical response, and critics of homeopathy have even less motivation to submit one to this journal. Other journals have no reason at all to pursue a discussion started in ‘Homeopathy’. In other words, Frass et al were safe from any rebuttal – until today, that is.

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