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

bias

The PGIH (currently chaired by the Tory MP David Tredinnick) was founded in 1992 (in the mid 1990, they once invited me to give a lecture which I did with pleasure). Its overriding aim is to bring about improvements in patient care. The PGIH have conducted a consultation that involved 113 SCAM-organisations and other stakeholders. The new PGIH-report is based on their feedback and makes 14 recommendations. They are all worth studying but, to keep this post concise, I have selected the three that fascinated me most:

Evidence Base and Research

NICE guidelines are too narrow and do not fit well with models of care such as complementary, traditional and natural therapies, and should incorporate qualitative evidence and patient outcomes measures as well as RCT evidence. Complementary, traditional and natural healthcare associations should take steps to educate and advise their members on the use of Measure Yourself Medical Outcome Profiles (MYMOP), and patient outcome measures should be collated by an independent central resource to identify for what conditions patients are seeking treatment, and with what outcomes.

Cancer Care

Every cancer patient and their families should be offered complementary therapies as part of their treatment package to support them in their cancer journey. Cancer centres and hospices providing access to complementary therapies should be encouraged to make wider use of Measure Yourself Concerns and Wellbeing (MYCaW) to evaluate the benefits gained by patients using complementary therapies in cancer support care. Co-ordinated research needs to be carried out, both clinical trials and qualitative studies, on a range of complementary, traditional and natural therapies used in cancer care support.

Cost Savings

The government should run NHS pilot projects which look at non-conventional ways of treating patients with long-term and chronic conditions affected by Effectiveness Gaps, such as stress, arthritis, asthma and musculoskeletal problems, and audit these results against conventional treatment options for these conditions to determine whether cost savings and better patient outcomes could be achieved.

END OF QUOTE

Here are a few brief comments on those three recommendations.

Evidence base and research

NICE guidelines are based on rigorous assessments of efficacy, safety and costs. Such evaluations are possible for all interventions, including SCAM. Qualitative data are useless for this purpose. Outcome measures like the MYMOP are measures that can and are used in clinical trials. To use them outside clinical trials would not provide any relevant information about the specific effects of SCAM because this cannot account for confounding factors like the natural history of the disease, regression towards the mean, etc. The entire paragraph disclosed a remarkable level of naivety and ignorance about research on behalf of the PGIH.

Cancer care

There is already a significant amount of research on SCAM for cancer (see for instance here). It shows that no SCAM is effective in curing any form of cancer, and that only very few SCAMs can effectively improve the quality of life of cancer patients. Considering these facts, the wholesale recommendation of offering SCAM to cancer patients can only be characterised as dangerous quackery.

Cost savings

Such a pilot project has already been conducted at the behest of Price Charles (see here). Its results show that flimsy research will generate flimsy findings. If anything, a rigorous trial would be needed to test whether more SCAM on the NHS saves or costs money. The data currently available suggests that the latter is the case (see also here, here, here, here, etc.).

Altogether, one gets the impression that the PGIH need to brush up on their science and knowledge (if they invite me, I’d be delighted to give them another lecture). As it stands, it seems unlikely that their approach will, in fact, bring about improvements in patient care.

The objective of this ‘real world’ study was to evaluate the effectiveness of integrative medicine (IM) on patients with coronary artery disease (CAD) and investigate the prognostic factors of CAD in a real-world setting.

A total of 1,087 hospitalized patients with CAD from 4 hospitals in Beijing, China were consecutively selected between August 2011 and February 2012. The patients were assigned to two groups:

  1. Chinese medicine (CM) plus conventional treatment, i.e., IM therapy (IM group). IM therapy meant that the patients accepted the conventional treatment of Western medicine and the treatment of Chinese herbal medicine including herbal-based injection and Chinese patent medicine as well as decoction for at least 7 days in the hospital or 3 months out of the hospital.
  2. Conventional treatment alone (CT group).

The endpoint was a major cardiac event [MCE; including cardiac death, myocardial infarction (MI), and the need for revascularization].

A total of 1,040 patients finished the 2-year follow-up. Of them, 49.4% received IM therapy. During the 2-year follow-up, the total incidence of MCE was 11.3%. Most of the events involved revascularization (9.3%). Cardiac death/MI occurred in 3.0% of cases. For revascularization, logistic stepwise regression analysis revealed that age ⩾ 65 years [odds ratio (OR), 2.224], MI (OR, 2.561), diabetes mellitus (OR, 1.650), multi-vessel lesions (OR, 2.554), baseline high sensitivity C-reactive protein level ⩾ 3 mg/L (OR, 1.678), and moderate or severe anxiety/depression (OR, 1.849) were negative predictors (P<0.05); while anti-platelet agents (OR, 0.422), β-blockers (OR, 0.626), statins (OR, 0.318), and IM therapy (OR, 0.583) were protective predictors (P<0.05). For cardiac death/MI, age ⩾ 65 years (OR, 6.389) and heart failure (OR, 7.969) were negative predictors (P<0.05), while statin use (OR, 0.323) was a protective predictor (P<0.05) and IM therapy showed a beneficial tendency (OR, 0.587), although the difference was not statistically significant (P=0.218).

The authors concluded that in a real-world setting, for patients with CAD, IM therapy was associated with a decreased incidence of revascularization and showed a potential benefit in reducing the incidence of cardiac death or MI.

What the authors call ‘real world setting’ seems to be a synonym of ‘lousy science’, I fear. I am not aware of good evidence to show that herbal injections and concoctions are effective treatments for CAD, and this study can unfortunately not change this. In the methods section of the paper, we read that the treatment decisions were made by the responsible physicians without restriction. That means the two groups were far from comparable. In their discussion section, the authors state; we found that IM therapy was efficacious in clinical practice. I think that this statement is incorrect. All they have shown is that two groups of patients with similar diagnoses can differ in numerous ways, including clinical outcomes.

The lessons here are simple:

  1. In clinical trials, lack of randomisation (the only method to create reliably comparable groups) often leads to false results.
  2. Flawed research is currently being used by many proponents of  SCAM (so-called alternative medicine) to mislead us about the value of SCAM.
  3. The integration of dubious treatments into routine care does not lead to better outcomes.
  4. Integrative medicine, as currently advocated by SCAM-proponents, is a nonsense.

Belgian homeopaths, together with the ‘European Committee for Homeopathy’, have published a statement which I find too remarkable to withhold it from you:

START OF QUOTE

Users of homeopathic medicines can no longer remain silent about the untruths circulating in the media. These lies raise doubts which naïve and gullible people take on board all too easily and then see homeopathy as quackery. None of this is accurate!

Because they fear seeing some of their ‘certainties’ questioned, the SKEPP movement is firing off at anything that current science cannot yet explain with both barrels.

The contents of homeopathic medicines
SKEPP states that a homeopathic medicine is nothing more than a drop of water in a swimming pool and therefore has nothing in it. This is  wrong. Tests performed on a high homeopathic potency (30CH) of Gelsemium sempervirens (Yellow Jasmine, a very common homeopathic medicine) have detected 36 micrograms of a specific substance per gram of solution [1]. Opponents denounce homeopathic medicines as being nothing but water. This is  wrong. This water, the solvent itself, contains a specific signature of the active ingredient. Basic research has demonstrated this [2].

Clinical efficacy.
By asserting at every opportunity that there is no evidence of the clinical effectiveness of homeopathy, opponents sow doubt. Correction:  such proof [3] does exist.  The fact that critics refuse to look at or accept these data speaks volumes about their attitude to science.
What is true, however, is that there is  not enough  scientific evidence of effectiveness. Science demands a lot of such evidence – and rightly so. There would be more if the universities applied the rules correctly!  For example: The Professional Union of Homeopathic Physicians had accepted a double-blind research protocol for fibromyalgia which took account of homeopathy’s individualized approach. This research was to be carried out at the Rheumatology Department of a hospital in Brussels with the agreement of the Rector of the Faculty of Medicine. But the hospital’s ethics committee decided that it would be unethical to test a ‘placebo’ (the homeopathic medicine) versus another placebo! Making an a priori assumption that homeopathic medicine is just a placebo, even before beginning the study, flies in the face of scientific objectivity.

Patients are not stupid!
In the meantime, Pro Homeopathia, the Belgian association of homeopathy patients, is no longer able to contain its members’ exasperation. It has published an article [4]  which denounces in direct terms the accusations of credulity, or even stupidity levelled at patients, in blatant disregard of their therapeutic freedom of choice and their capacity for critical thought.

Dare to ask questions! 
Why all this misinformation in the press? Why do these ‘experts’, whose opinions on homeopathy above all betray their profound misunderstanding of this discipline, flood the media with fake news? What is the hidden agenda behind this campaign of systematic denigration? Homeopathy and many other complementary medicines only want to collaborate, both in medical practice and in scientific research … fair play! It’s called integrative medicine!

References
[1]Nanoparticle Characterization of Traditional Homeopathically-Manufactured Cuprum metallicum and Gelsemium Sempervirens Medicines and Controls. Novembre 2018: https://www.thieme-connect.de/DOI/DOI?10.1055/s-0038-1666864)
[2]Nuclear Magnetic Resonance characterization of traditional homeopathically-manufactured copper (Cuprum metallicum) and a plant (Gelsemium sempervirens) medicines and controls. Août 2017: https://doi.org/10.1016/j.homp.2017.08.001
[3]Model validity and risk of bias in randomized placebo-controlled trials of individualised homeopathic treatment. 2016: http://dx.doi.org/10.1016/j.ctim.2016.01.005 //Clinical verification in homeopathy and allergic conditions. 2012 http://dx.doi.org/10.1016/j.homp.2012.06.002 //Scientific framework of homeopathy 2017. www.lmhi.org/Article/Detail/42)
[4]http://www.homeopathie-unio.be/uploads/files/unprotected/Presse/Attaques%20Hom%C3%A9o-FR2.pdf

END OF QUOTE

For regular readers of this blog, any comment on this little article might well be superfluous. For newcomers, I nevertheless provide a few thoughts. In doing so, I simply follow the three headings used above.

The contents of homeopathic medicines

A homeopathic C30 potency (the one that is used most frequently) is a dilution of 1 part homeopathic stock to 1000000000000000000000000000000000000000000000000000000000000 parts of diluent. This amounts to little more than one molecule of stock per universe. This is an undeniable fact, and the reference provided (incidentally, the link to it is dead) does not change it in any way. The theory of ‘the memory of water’ is an implausible hypothesis that has no basis in reality. It is believed only by homeopaths, and ‘studies’ that seemingly support it are flimsy, false or biased, and usually only get published in journals such as ‘Homeopathy’ (where also the reference provided appeared).

Clinical efficacy

This is a subject that we have already discussed ad nauseam. Highly diluted homeopathic remedies are pure placebos. If someone does not believe this nor all the evidence provided on this blog, they perhaps trust the many independent international bodies that have looked at the totality of the reliable evidence for or against homeopathy. Their verdicts are unanimously negative. (The above-cited decision of the ethics committee is therefore the only one that is ethically possible.)

Patients are not stupid!

That is absolutely correct; patients are certainly not stupid. And their experiences are certainly real. What is often wrong, however, is the interpretation of their experiences. When a patient’s symptoms improve after taking a highly diluted remedy, the perceived improvement is due to a long list of factors that are unrelated to the remedy: placebo, natural history, regression towards the mean, etc.

Patients are not stupid, but the misinformation homeopaths incessantly publish might render them stupid – one more reason why such irresponsible nonsense ought to stop.

 

In 1995, Dabbs and Lauretti reviewed the risks of cervical manipulation and compared them to those of non-steroidal, anti-inflammatory drugs (NSAIDs). They concluded that the best evidence indicates that cervical manipulation for neck pain is much safer than the use of NSAIDs, by as much as a factor of several hundred times. This article must be amongst the most-quoted paper by chiropractors, and its conclusion has become somewhat of a chiropractic mantra which is being repeated ad nauseam. For instance, the American Chiropractic Association states that the risks associated with some of the most common treatments for musculoskeletal pain—over-the-counter or prescription nonsteroidal anti-inflammatory drugs (NSAIDS) and prescription painkillers—are significantly greater than those of chiropractic manipulation.

As far as I can see, no further comparative safety-analyses between cervical manipulation and NSAIDs have become available since this 1995 article. It would therefore be time, I think, to conduct new comparative safety and risk/benefit analyses aimed at updating our knowledge in this important area.

Meanwhile, I will attempt a quick assessment of the much-quoted paper by Dabbs and Lauretti with a view of checking how reliable its conclusions truly are.

The most obvious criticism of this article has already been mentioned: it is now 23 years old, and today we know much more about the risks and benefits of these two therapeutic approaches. This point alone should make responsible healthcare professionals think twice before promoting its conclusions.

Equally important is the fact that we still have no surveillance system to monitor the adverse events of spinal manipulation. Consequently, our data on this issue are woefully incomplete, and we have to rely mostly on case reports. Yet, most adverse events remain unpublished and under-reporting is therefore huge. We have shown that, in our UK survey, it amounted to exactly 100%.

To make matters worse, case reports were excluded from the analysis of Dabbs and Lauretti. In fact, they included only articles providing numerical estimates of risk (even reports that reported no adverse effects at all), the opinion of exerts, and a 1993 statistic from a malpractice insurer. None of these sources would lead to reliable incidence figures; they are thus no adequate basis for a comparative analysis.

In contrast, NSAIDs have long been subject to proper post-marketing surveillance systems generating realistic incidence figures of adverse effects which Dabbs and Lauretti were able to use. It is, however, important to note that the figures they did employ were not from patients using NSAIDs for neck pain. Instead they were from patients using NSAIDs for arthritis. Equally important is the fact that they refer to long-term use of NSAIDs, while cervical manipulation is rarely applied long-term. Therefore, the comparison of risks of these two approaches seems not valid.

Moreover, when comparing the risks between cervical manipulation and NSAIDs, Dabbs and Lauretti seemed to have used incidence per manipulation, while for NSAIDs the incidence figures were bases on events per patient using these drugs (the paper is not well-constructed and does not have a methods section; thus, it is often unclear what exactly the authors did investigate and how). Similarly, it remains unclear whether the NSAID-risk refers only to patients who had used the prescribed dose, or whether over-dosing (a phenomenon that surely is not uncommon with patients suffering from chronic arthritis pain) was included in the incidence figures.

It is worth mentioning that the article by Dabbs and Lauretti refers to neck pain only. Many chiropractors have in the past broadened its conclusions to mean that spinal manipulations or chiropractic care are safer than drugs. This is clearly not permissible without sound data to support such claims. As far as I can see, such data do not exist (if anyone knows of such evidence, I would be most thankful to let me see it).

To obtain a fair picture of the risks in a real life situation, one should perhaps also mention that chiropractors often fail to warn patients of the possibility of adverse effects. With NSAIDs, by contrast, patients have, at the very minimum, the drug information leaflets that do warn them of potential harm in full detail.

Finally, one could argue that the effectiveness and costs of the two therapies need careful consideration. The costs for most NSAIDs per day are certainly much lower than those for repeated sessions of manipulations. As to the effectiveness of the treatments, it is clear that NSAIDs do effectively alleviate pain, while the evidence seems far from being conclusively positive in the case of cervical manipulation.

In conclusion, the much-cited paper by Dabbs and Lauretti is out-dated, poor quality, and heavily biased. It provides no sound basis for an evidence-based judgement on the relative risks of cervical manipulation and NSAIDs. The notion that cervical manipulations are safer than NSAIDs is therefore not based on reliable data. Thus, it is misleading and irresponsible to repeat this claim.

 

Once again, I am indebted to the German homeopathy lobbyist, Jens Behnke (research officer at the Karl and Veronica Carstens-Foundation); this time for alerting me via a tweet to the existence of the ‘Institute for Scientific Homeopathy’ run by Dr K Lenger. Anyone who combines the terms ‘scientific’ and ‘homeopathy’ has my full attention.

The institution seems to be small (too small to have its own website); in fact, it seems to have just one member: Dr Karin Lenger. But size is not everything! Lenger has achieved something extraordinary: she has answered the questions that have puzzled many of us for a long time; she has found the ‘modus operandi’ of homeopathy by discovering that:

  • Homeopathy is a regulation therapy that acts (and reacts) as per the principle of resonance to deal hypo- and hyper-functions of pathological pathways.
  • As per resonance principle, the fundamental principles of homeopathy have the same frequencies so that the resonance principle can work.
  • Pathological pathways are cured by using their highly potentized substrates, inhibitors, and enzymes.
  • The efficacy of homeopathy now has a scientific base and is completely explained by applying biochemical and biophysical laws.

Progress at last!

If that is not noteworthy, what is?

But there is more!

This website, for instance, explains that Lenger Karin Dr.rer.nat., pursued Diploma in Biochem, studied Biochemistry at the Universities of Tubingen and Cologne. Her research topics revolved around enzymatic gene regulation, cancer research, enzymatic mechanisms of steroid hormones at the Medical University of Lubeck. In 1987 she became a Lecturer for Homeopathy at DHU ((Deutsche Homöopathie Union = German Homeopathy Union). Since 1995 she worked as a Homeopathic Practitioner and developed the “biochemical homeopathy” by using highly potentized substrates of pathological enzymes for her patients. She detected magnetic photons in high homeopathic potencies by two magnetic resonance methods and developed a model of physical and biochemical function of homeopathy.

Karin Lenger detected magnetic photons in highly diluted and potentized homeopathic remedies. Since the living body is an electromagnetic wavepackage (Einstein), the homeopathic law of Similars (Hahnemann 1755-1843) can be expressed as: the frequencies of the patient must match the frequencies of the remedies. Homeopathy is a regulation therapy curing hypo and hyperfunction of a pathological pathway by resonance: highly potentized substrates, inhibitors, enzymes, receptors of the distinct pathological pathways cure according to biochemical rules: A homeopathic symptom picture is obtained by poisoning a volunteer with a toxin. Simultaneously he develops psychological symptoms, the toxicological pathway and e.g. frequencies I-V. The highly potentized toxin has the frequencies I-V. The patient has symptoms as if he was poisoned by the toxin: during his illness he developed the toxicological pathway, frequencies I-V and psychological symptoms. The potentized toxin cures simultaneously the patient’s frequencies by resonance, his pathological pathway and the psychological symptoms. A stitch of honey bee, apis mellifica, causes a red oedema; a patient developing a red oedema at the finger-joint by rheumatism is cured by highly potentized Apis mellifica. Paralyses caused by a lack of the neurotransmitter acetylcholine bound to the acetylcholine-receptor at the post-synapsis can be healed by using these potentized remedies: the venom of cobra, Naja tripudians containing the receptor’s irreversible inhibitor cobrotoxin, the reversible inhibitor Atropine and Acetylcholine, daily applied. The availability of acetylcholine is maintained by glycolysis and fatty acid oxidation. This can be supported by giving these remedies: Lecithin, Lipasum, Glycerinum, Glucosum and Coenzyme A.

And in case, you are not yet fully convinced, a recent publication is bound to ball you over. Here is its abstract, if you need more, the link allows you to read the full paper as well:

Homeopathy, a holistic therapy, is believed to cure only acute symptoms of a beginning illness according to the Laws of Similars; but not deep, bleeding, septic wounds. The homeopaths refuse to heal according to special medical indications. Based on Lenger’s detection of magnetic photons in homeopathic remedies a biochemical and biophysical model of homeopathic healing was developed Biochemical, pathological pathways can be treated by their highly potentized substrates and inhibitors. Three groups of patients with moderate, severe and septic wounds had been successfully treated with the suitable remedies depending on the biochemical pathological state.

___________________________________________________________

Do I sense a Nobel Prize in the offing?

Surely!

Lenger’s clinical trial is baffling. But much more impressive are the ‘magnetic photons’ and the reference to Einstein. This is even more significant, if we consider what the genius (Einstein, not Lenger!) is reported to have said about homeopathy:  Einstein reflected for a little while and then said: “If one were to lock up 10 very clever people in a room and told them they were only allowed out once they had come up with the most stupid idea conceivable, they would soon come up with homeopathy.”

I would warn every parent who thinks that taking their child to a chiropractor is a good idea. For this, I have three main reasons:

  1. Chiropractic has not been shown to be effective for any paediatric condition.
  2. Chiropractors often advise parents against vaccinating their children.
  3. Chiropractic spinal manipulations can cause harm to kids.

The latter point seems to be confirmed by a recent PhD thesis of which so far only one short report is available. Here are the relevant bits of information from it:

Katie Pohlman has successfully defended her PhD thesis, which focused on the assessment of safety in pediatric manual therapy. As a clinical research scientist at Parker University, Dallas, Texas, she identified a lack of prospective patient safety research within the chiropractic population in general and investigated this deficit in the paediatric population in particular.

Pohlman used a cross-sectional survey to assess the barriers and facilitators for participation in a patient safety reporting system. At the same time, she also conducted a randomized controlled trial comparing the quantity and quality of adverse event reports in children under 14 years receiving chiropractic care.

The RCT recruited 69 chiropractors and found adverse events reported in 8.8% and 0.1% of active and passive surveillance groups respectively. Of the adverse events reported, 56% were considered mild, 26% were moderate and 18% were severe. The frequency of adverse events was more common than previously thought.

This last sentence from the report is somewhat puzzling. Our systematic review of the risks of spinal manipulation showed that data from prospective studies suggest that minor, transient adverse events occur in approximately half of all patients receiving spinal manipulation. The most common serious adverse events are vertebrobasilar accidents, disk herniation, and cauda equina syndrome. Estimates of the incidence of serious complications range from 1 per 2 million manipulations to 1 per 400,000. Given the popularity of spinal manipulation, its safety requires rigorous investigation.

The 8.8% reported by Pohlman are therefore not even one fifth of the average incidence figure reported previously in all age groups.

What could be the explanation for this discrepancy?

There are, of course, several possibilities, including the fact that infants cannot tell the clinician when their pain has increased. However, the most likely one, in my view, lies in the fact that RCTs are wholly inadequate for investigating risks because they typically include far too few patients to generate reliable incidence figures about adverse events. More importantly, clinicians included in such studies are self-selected (and thus particularly responsible/cautious) and are bound to behave most carefully while being part of a clinical trial. Therefore it seems possible – I would speculate even likely – that the 8.8% reported by Pohlman is unrealistically low.

Having said that, I do feel that the research by Kathie Pohlman is a step in the right direction and I do applaud her initiative.

The 2018 World Federation of Chiropractic ACC Education Conference was held on 24-27 October in London. It resulted in several consensus statements developed by the attendees. I happen to know this from a short report that has just been published; it can be found here.

Of the 10 points made in this consensus, I find only the following noteworthy:

“Chiropractic education programs have an ethical obligation to support an evidence-based teaching and learning environment.”

Perhaps it is me – English is not my first language – but I find the phraseology used in this sentence strangely complicated and confusing. I have been a teacher of medical students for most of my life, but I am not sure what an ‘evidence-based teaching and learning environment’ is. I know what ‘evidence-based’ means, of course. However, what exactly is:

  • a teaching environment?
  • a learning environment?
  • and how does ‘evidence-based’ apply to either of the two?

Is there evidence that some environments are better suited than others for teaching?

Is there evidence that some environments are better suited than others for learning?

I suppose the answer must be YES!

The environment, i. e. the space and conditions in which teaching and learning happen should, for instance, be/include:

  • quiet,
  • not cramped,
  • not too cold,
  • not too hot,
  • equipped with ergometric chairs and desks,
  • well-lit,
  • there should be visual aids,
  • access to computers,
  • a library,
  • good mentoring and support,
  • etc.

So, the consensus of the education conference wanted to optimise the environmental conditions of teaching and learning for chiropractic lecturers and students? Most laudable, I must say!

But still, it seems like a missed opportunity for an ‘Education Conference’ not to have stated something about the content of teaching and learning. Personally, I find it a pity that they did not state: Chiropractic education programs have an ethical obligation to be evidence-based.

Or is that what they really wanted to say?

Naaahh … come to think of it … they cannot possibly make such a demand.

Why?

Because, in this case, they would have to teach students not to become chiropractors.

Slowly, I seem to be turning into a masochist! Yes, I sometimes read publications like ‘HOMEOPATHY 360’. It carries articles that are enragingly ill-informed. But in my defence, I might say that some are truly funny. Here is the abstract of one that I found outstanding in that category:

The article explains about Gangrene and its associated amputations which is a clinically challenging condition, but Homeopathy offers therapy options. The case presented herein, details about how the Homeopathic treatment helped in the prevention of amputation of a body part. Homeopathy stimulates the body’s ability to heal through its immune mechanisms; consequently, it achieves wound healing and establishes circulation to the gangrenous part. Instead of focusing on the local phenomena of gangrene pathology, treatment focuses on the general indications of the immune system, stressing the important role of the immune system as a whole. The aim was to show, through case reports, that Homeopathic therapy can treat gangrene thus preventing amputation of the gangrenous part, and hence has a strong substitution for consideration in treating gangrene.

The paper itself offers no less than 13 different homeopathic treatments for gangrene:

  1. Arsenicum album– Medicine for senile gangrene;gangrene accompanied by foetid diarrhoea; ulcers extremely painful with elevated edges, better by warmth and aggravation from cold; great weakness and emaciation.
  2. Bromium – Hospital gangrene; cancerous ulcers on face; stony hard swelling of glands of lower jaw and throat.
  3. Carbo vegetabilis – Senile and humid gangrene in the persons who are cachectic in appearance; great exhaustion of vital powers; marked prostration; foul smell of secretions; indolent ulcers, burning pain; tendency to gangrene of the margins; varicose ulcers.
  4. Bothrops– Gangrene; swollen, livid, cold with hemorrhagic infiltration; malignant erysipelas.
  5. Echinacea– Enlarged lymphatics; old tibial ulcers; gangrene; recurrent boils; carbuncles.
  6. Lachesis– Gangrenous ulcers; gangrene after injury; bluish or black looking blisters; vesicles appearing here and there, violent itching and burning; swelling and inflammation of the parts; itching pain and painful spots appearing after rubbing.
  7. Crotalus Horridus– Gangrene, skin separated from muscles by a foetid fluid; traumatic gangrene; old scars open again.
  8. Secale cornatum– Pustules on the arms and legs, with tendency to gangrene; in cachectic, scrawny females with rough skin; skin shriveled, numb; mottled dusky-blue tinge; blue color of skin; dry gangrene, developing slowly; varicose ulcers; boils, small, painful with green contents; skin feels too cold to touch yet covering is not tolerated. Great aversion to heat;formication under skin.
  9. Anthracinum– Gangrene; cellular tissues swollen and oedematous; gangrenous parotitis; septicemia; ulceration, and sloughing and intolerable burning.
  10. Cantharis – Tendency to gangrene; vesicular eruptions; burns, scalds, with burning and itching; erysipelas, vesicular type, with marked restlessness.
  11. Mercurius– Gangrene of the lips, cheeks and gums; inflammation and swelling of the glands of neck; pains aggravated by hot or cold applications.
  12. Sulphuric acid– Traumatic gangrene; haemorrhages from wounds; dark pustules; blue spots like suggillations; bedsores.
  13. Phosphoric acid– Medicine for senile gangrene. Gunpowder, calendula are also best medicines.

But the best of all must be the article’s conclusion: “Homeopathy is the best medicine for gangrene.

I know, there are many people who will not be able to find this funny, particularly patients who suffer from gangrene and are offered homeopathy as a cure. This could easily kill the person – not just kill, but kill very painfully. Gangrene is the death of tissue in part of the body, says the naïve little caption. What it does not say is that it is in all likelihood also the death of the patient who is treated purely with homeopathy.

And what about the notion that homeopathy stimulates the body’s ability to heal through its immune mechanisms?

Or the assumption that it might establish circulation to the gangrenous part?

Or the claim that through case reports one can show the effectiveness of an intervention?

Or the notion that any of the 13 homeopathic remedies have a place in the treatment of gangrene?

ALL OF THIS IS TOTALLY BONKERS!

Not only that, it is highly dangerous!

Since many years, I am trying my best to warn people of charlatans who promise bogus cures. Sadly it does not seem to stop the charlatans. This makes me feel rather helpless at times. And it is in those moments that I decide to look at from a different angle. That’s when I try to see the funny side of quacks who defy everything we know about healthcare and just keep on lying to themselves and their victims.

Lumbar spinal stenosis (LSS) is a common reason for spine surgery. Several non-surgical LSS treatment options are also available, but their effectiveness remains unproven. The objective of this study was to explore the comparative clinical effectiveness of three non-surgical interventions for patients with LSS:

  • medical care,
  • group exercise,
  • individualised exercise plus manual therapy.

All interventions were delivered during 6 weeks with follow-up at 2 months and 6 months at an outpatient research clinic. Patients older than 60 years with LSS were recruited from the general public. Eligibility required anatomical evidence of central canal and/or lateral recess stenosis (magnetic resonance imaging/computed tomography) and clinical symptoms associated with LSS (neurogenic claudication; less symptoms with flexion). Analysis was intention to treat.

Medical care consisted of medications and/or epidural injections provided by a physiatrist. Group exercise classes were supervised by fitness instructors. Manual therapy/individualized exercise consisted of spinal mobilization, stretches, and strength training provided by chiropractors and physical therapists. The primary outcomes were between-group differences at 2 months in self-reported symptoms and physical function measured by the Swiss Spinal Stenosis questionnaire (score range, 12-55) and a measure of walking capacity using the self-paced walking test (meters walked for 0 to 30 minutes).

A total of 259 participants were allocated to medical care (n = 88), group exercise (n = 84), or manual therapy/individualized exercise (n = 87). Adjusted between-group analyses at 2 months showed manual therapy/individualized exercise had greater improvement of symptoms and physical function compared with medical care or group exercise. Manual therapy/individualized exercise had a greater proportion of responders (≥30% improvement) in symptoms and physical function (20%) and walking capacity (65.3%) at 2 months compared with medical care (7.6% and 48.7%, respectively) or group exercise (3.0% and 46.2%, respectively). At 6 months, there were no between-group differences in mean outcome scores or responder rates.

The authors concluded that a combination of manual therapy/individualized exercise provides greater short-term improvement in symptoms and physical function and walking capacity than medical care or group exercises, although all 3 interventions were associated with improvements in long-term walking capacity.

In many ways, this is a fairly rigorous study; in one important way, however, it is odd. One can easily see why one group received the usual standard care (except perhaps for the fact that standard medical care should also include exercise). I also understand why one group attended group exercise. Yet, I fail to see the logic in the third intervention, individualised exercise plus manual therapy.

Individualised exercise is likely to be superior to group exercise. If the researchers wanted to test this hypothesis, they should not have added the manual therapy. If they wanted to find out whether manual therapy is better that the other two treatments, they should not have added individualised exercise. As it stands, they cannot claim that either manual therapy or individualised exercise are effective (yet, I am sure that the chiropractic fraternity will claim that this study shows their treatment to be indicated for LSS [three of the authors are chiropractors and the 1st author seems to have a commercial interest in the matter!]).

Manual therapy procedures used in this trial included:

  • lumbar distraction mobilization,
  • hip joint mobilization,
  • side posture lumbar/sacroiliac joint mobilization,
  • and neural mobilization.

Is there any good reason to assume that these interventions work for LSS? I doubt it!

And this is what makes the new study odd, in my view. Assuming I am correct in speculating that individualised exercise is better than group exercise, the trial would have yielded a similarly positive result, if the researchers had offered, instead of the manual therapy, a packet of cigarettes, a cup of tea, a chocolate bar, or swinging a dead cat. In other words, if someone had wanted to make a useless therapy appear to be effective, they could not have chosen a better trial design.

And why do I find such studies objectionable?

Mainly because they deliberately mislead many of us. In the present case, many non-critical observers might conclude that manual therapy is effective for LSS. Yet, the truth could well be that it is useless or even harmful (assuming that the effect size of individualised exercise is large, adding a harmful therapy would still render the combination effective). To put it bluntly, such trials

  • could harm patients,
  • might waste money,
  • and hinder progress.

 

On their website, the UK ‘ROYAL COLLEGE OF CHIROPRACTORS (RCC) published a short statement regarding the safety of chiropractic. Here it is in full:

Experiencing mild or moderate adverse effects after manual therapy, such as soreness or stiffness, is relatively common, affecting up to 50% of patients. However, such ‘benign effects’ are a normal outcome and are not unique to chiropractic care.

Cases of serious adverse events, including spinal or neurological problems and strokes caused by damage to arteries in the neck, have been associated with spinal manipulation. Such events are rare with estimates ranging from 1 per 2 million manipulations to 13 per 10,000 patients; furthermore, due to the nature of the underlying evidence in relation to such events (case reports, retrospective surveys and case-control studies), it is very difficult to confirm causation (Swait and Finch, 2017).

For example, while an association between stroke caused by vertebral artery damage or ‘dissection’ (VAD) and chiropractor visits has been reported in a few case-control studies, the risk of stoke has been found to be similar after seeing a primary care physician (medical doctor). Because patients with VAD commonly present with neck pain, it is possible they seek therapy for this symptom from a range of practitioners, including chiropractors, and that the VAD has occurred spontaneously, or from some other cause, beforehand (Biller et al, 2014). This highlights the importance of ensuring careful screening for known neck artery stroke risk factors, or signs or symptoms that there is an ongoing problem, is performed prior to manual treatment of patients (Swait and Finch, 2017). Chiropractors are well trained to do this on a routine basis, and to urgently refer patients if necessary.

END OF QUOTE

The statement reads well but it might not be entirely free from conflicts of interest. Yet, in the name of accuracy, completeness and truthfulness, I take the liberty of making a few slight alterations. Here is my revised version:

Experiencing mild or moderate adverse effects after chiropractic spinal manipulations, such as pain or stiffness (usually lasting 1-3 days and strong enough to impair patients’ quality of life), is very common. In fact, it affects around 50% of all patients. 

Cases of serious adverse events, including spinal or neurological problems and strokes often caused by damage to arteries in the neck, have been reported after spinal manipulation. Such events are probably not frequent (several hundred are on record including about 100 fatalities).  But, as we have never established proper surveillance systems, nobody can tell how often they occur. Furthermore, due to our reluctance of introducing such surveillance, some of us are able to question causality.

An association between stroke caused by vertebral artery damage or ‘dissection’ (VAD) and chiropractic spinal manipulation has been reported in about 20 independent investigations. Yet one much-criticised case-control study found the risk of stoke to be similar after seeing a primary care physician (medical doctor). Because patients with VAD commonly have neck pain, it is possible they seek therapy for this symptom from chiropractors, and that the VAD has occurred spontaneously, or from some other cause, beforehand (Biller et al, 2014). Ensuring careful screening for known neck artery stroke risk factors, or signs that there is an ongoing problem would therefore be important (Swait and Finch, 2017). Sadly, no reliable screening tests exist, and neck pain (the symptom that might be indicative of VAD) continues to be one of the conditions most frequently treated by chiropractors.

I do not expect the RCC to adopt my improved version. In case I am wrong, let me state this: I am entirely free of conflicts of interest and will not charge a fee for my revision. In the interest of advancing public health, I herewith offer it for free.

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