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

homeopathy

Exactly 20 years ago, I published a review concluding that the generally high and possibly growing prevalence of complementary/alternative medicine use by children renders this topic an important candidate for rigorous investigation. Since then, many papers have emerged, and most of them are worrying in one way or another. Here is the latest one.

This Canadian survey assessed chiropractic (DC) and naturopathic doctors’ (ND) natural health product (NHP) recommendations for paediatric care. It was developed in collaboration with DC and ND educators, and delivered as an on-line national survey. NHP dose, form of delivery, and indications across paediatric age ranges (from newborn to 16 years) for each practitioner’s top five NHPs were assessed. Data were analysed using descriptive statistics, t-tests, and non-parametric tests.

Of the 421 respondents seeing one or more paediatric patients per week, 172 (41%, 107 DCs, 65 NDs) provided 440 NHP recommendations, categorized as:

  • vitamins and minerals (89 practitioners, 127 recommendations),
  • probiotics (110 practitioners, 110 recommendations),
  • essential fatty acids (EFAs: 72 practitioners, 72 recommendations),
  • homeopathics (56 practitioners, 66 recommendations),
  • botanicals (29 practitioners, 31 recommendations),
  • other NHPs (33 practitioners, 34 recommendations).

Indications for the NHP recommendations were tabulated for NHPs with 10 or more recommendations in any age category:

  • 596 total indications for probiotics,
  • 318 indications for essential fatty acids,
  • 138 indications for vitamin D,
  • 71 indications for multi-vitamins.

Good evidence regarding the efficacy, safety, and dosing for NHP use in children is scarce or even absent. Therefore, the finding that so many DCs and NDs recommend unproven NHPs for use in children is worrying, to say the least. It seems to indicate that, at least in Canada, DCs and NDs are peddling unproven, mostly useless  and potentially harmful children.

In an earlier, similar survey the same group of researchers had disclosed that the majority of Canadian DCs and NDs seem to see infants, children, and youth for a variety of health conditions and issues, while, according to their own admission, not having adequate paediatric training.

Is this a Canadian phenomenon? If you think so, read this abstract:

AIM:

This systematic review is aimed at estimating the prevalence of complementary and alternative medicine (CAM)-use by paediatric populations in the United Kingdom (UK).

METHOD:

AMED, CINAHL, COCHRANE, EMBASE and MEDLINE were searched for English language peer-reviewed surveys published between 01 January 2000 and September 2011. Additionally, relevant book chapters and our own departmental files were searched manually.

RESULTS:

Eleven surveys were included with a total of 17,631 paediatric patients. The majority were of poor methodological quality. Due to significant heterogeneity of the data, a formal meta-analysis was deemed inappropriate. Ten surveys related to CAM in general, while one was specifically on homeopathy. Across all surveys on CAM in general, the average one-year prevalence rate was 34% and the average lifetime prevalence was 42%. In surveys with a sample size of more than 500, the prevalence rates were considerably lower than in surveys with the sample size of lower than 500. Herbal medicine was the most popular CAM modality, followed by homeopathy and aromatherapy.

CONCLUSIONS:

Many paediatric patients in the UK seem to use CAM. Paediatricians should therefore have sufficient knowledge about CAM to issue responsible advice.

This means, I fear, that children are regularly treated by SCAM practitioners who are devoid of the medical competence to do so, and  who prescribe or recommend treatments of unknown value, usually without the children needing them.

Why are regulators not more concerned about this obvious abuse?

The aim of this new systematic review was to evaluate the controlled trials of homeopathy in bronchial asthma. Relevant trials published between Jan 1, 1981, and Dec 31, 2016, were considered. Substantive research articles, conference proceedings, and master and doctoral theses were eligible. Methodology was assessed by Jadad’s scoring, internal validity by the Coch-rane tool, model validity by Mathie’s criteria, and quality of individualization by Saha’s criteria.

Sixteen trials were eligible. The majority were positive, especially those testing complex formulations. Methodological quality was diverse; 8 trials had “high” risk of bias. Model validity and individualization quality were compromised. Due to both qualitative and quantitative inadequacies, proofs supporting individualized homeopathy remained inconclusive. The trials were positive (evidence level A), but inconsistent, and suffered from methodological heterogeneity, “high” to “uncertain” risk of bias, incomplete study reporting, inadequacy of independent replications, and small sample sizes.

The authors of this review come from:

  • the Department of Homeopathy, District Joint Hospital, Government of Bihar, Darbhanga, India;
  • the Department of Organon of Medicine and Homoeopathic Philosophy, Sri Sai Nath Postgraduate Institute of Homoeopathy, Allahabad, India;
  • the Homoeopathy University Jaipur, Jaipur, India;
  • the Central Council of Homeopathy, Hooghly,
  • the Central Council of Homeopathy, Howrah, India

They state that they have no conflicts of interest.

The review is puzzling on so many accounts that I had to read it several times to understand it. Here are just some of its many oddities:

  • According to its authors, the review adhered to the PRISMA-P guideline; as a co-author of this guideline, I can confirm that this is incorrect.
  • The authors claim to have included all ‘controlled trials (randomized, non-randomized, or observational) of any form of homeopathy in patients suffering from persistent and chronic bronchial asthma’. In fact, they also included uncontrolled studies (16 controlled trials and 12 uncontrolled observational studies, to be precise).
  • The authors included papers published between Jan 1, 1981, and Dec 31, 2016. It is unacceptable, in my view, to limit a systematic review in this way. It also means that the review was seriously out of date already on the day it was published.
  • The authors tell us that they applied no language restrictions. Yet they do not inform us how they handled papers in foreign languages.
  • Studies of homeopathy as a stand alone therapy were included together with studies of homeopathy as an adjunct. Yet the authors fail to point out which studies belonged to which category.
  • Several of the included studies are not of homeopathy but of isopathy.
  • The authors fail to detail their results and instead refer to an ‘online results table’ which I cannot access even though I have the on-line paper.
  • Instead, they report that 28 studies were included and ‘thus, the level of evidence was graded as A.’
  • No direction of outcome was provided in the results section. All we do learn from the paper’s discussion section is that ‘the majority of the studies were positive, and the level of evidence could be graded as A (strong scientific evidence)’.
  • Despite the high risk of bias in most of the included studies, the authors suggest a ‘definite role of homeopathy beyond placebo in the treatment of bronchial asthma’.
  • The current Cochrane review (also authored by a pro-homeopathy team) concluded that there is not enough evidence to reliably assess the possible role of homeopathy in asthma. Yet the authors of this new review do not even attempt to explain the contradiction.

Confusion?

Incompetence?

Scientific misconduct?

Fraud?

YOU DECIDE!

‘Mom’s Choice Awards’ have just honoured the homeopathic product ‘COLD CALM KIDS’. This remedy has the following ingredients:

  • Allium cepa 3C HPUS
  • Apis mellifica 15C HPUS
  • Eupatorium perfoliatum 3C HPUS
  • Gelsemium sempervirens 6C HPUS
  • Kali bichromicum 6C HPUS
  • Nux vomica 3C HPUS
  • Phytolacca decandra 6C HPUS
  • Pulsatilla 6C HPUS

3C = a dilution of 1:1000000

6C = a dilution of 1:1000000000000

15C = a dilution of 1:1000000000000000000000000000000

The ingredients are, according to this website, claimed to have the following effects:

  • Allium cepa 3C HPUS – Relieves sneezing and runny nose
  • Apis mellifica 15C HPUS – Relieves nasal congestion
  • Eupatorium perfoliatum 3C HPUS – Relieves aches associated with colds
  • Gelsemium sempervirens 6C HPUS – Relieves headaches associated with colds
  • Kali bichromicum 6C HPUS – Relieves nasal discharge
  • Nux vomica 3C HPUS – Relieves sneezing attacks
  • Phytolacca decandra 6C HPUS – Relieves mild fever
  • Pulsatilla 6C HPUS – Relieves colds with a loss of taste and smell

The formula could easily make Hahnemann turn in his grave! It goes against most of what he has been teaching. But I found these claims interesting nevertheless.

Are they true? To find out, I did some research. Here is what I found (in case anyone can find more evidence, I’d be most grateful to let me know):

  • Allium cepa 3C HPUS – Relieves sneezing and runny nose NO GOOD EVIDENCE FOR THIS CLAIM
  • Apis mellifica 15C HPUS – Relieves nasal congestion NO GOOD EVIDENCE FOR THIS CLAIM
  • Eupatorium perfoliatum 3C HPUS – Relieves aches associated with colds NO GOOD EVIDENCE FOR THIS CLAIM
  • Gelsemium sempervirens 6C HPUS – Relieves headaches associated with colds NO GOOD EVIDENCE FOR THIS CLAIM
  • Kali bichromicum 6C HPUS – Relieves nasal discharge NO GOOD EVIDENCE FOR THIS CLAIM
  • Nux vomica 3C HPUS – Relieves sneezing attacks NO GOOD EVIDENCE FOR THIS CLAIM
  • Phytolacca decandra 6C HPUS – Relieves mild fever NO GOOD EVIDENCE FOR THIS CLAIM
  • Pulsatilla 6C HPUS – Relieves colds with a loss of taste and smell NO GOOD EVIDENCE FOR THIS CLAIM

I am confused! If there is no good evidence, how come Boiron, the manufacturer of the product, is allowed to make these claims? And how come the product just was given an award?

The Mom’s Choice Awards® (MCA) evaluates products and services created for children, families and educators. The program is globally recognized for establishing the benchmark of excellence in family-friendly media, products and services. The organization is based in the United States and has reviewed thousands of items from more than 55 countries…

An esteemed panel of evaluators includes education, media and other experts as well as parents, children, librarians, performing artists, producers, medical and business professionals, authors, scientists and others.

MCA evaluators volunteer their time and are bound by a strict code of ethics which ensures expert and objective analysis free from any manufacturer association.

The evaluation process uses a proprietary methodology in which items are scored on a number of elements including production quality, design, educational value, entertainment value, originality, appeal and cost. Each item is judged on its own merit.

MCA evaluators are especially interested in items that help families grow emotionally, physically and spiritually; are morally sound and promote good will; and are inspirational and uplifting…

Now I am even more confused!

A benchmark of excellence?

A strict code of ethics?

Morally sound?

I must have misunderstood something! Or perhaps the award was for achieving a maximum of 8 false claims for one single product!? Can someone please enlighten me?

Whenever there are discussions about homeopathy (currently, they have reached fever-pitch both in France and in Germany), one subject is bound to emerge sooner or later: its cost. Some seemingly well-informed person will exclaim that USING MORE HOMEOPATHY WILL SAVE US ALL A LOT OF MONEY.

The statement is as predictable as it is wrong.

Of course, homeopathic remedies tend to cost, on average, less than conventional treatments. But that is beside the point. A car without an engine is also cheaper than one with an engine. Comparing the costs of items that are not comparable is nonsense.

What we need are proper analyses of cost-effectiveness. And these studies clearly fail to prove that homeopathy is a money-saver.

Even researchers who are well-known for their pro-homeopathy stance have published a systematic review of economic evaluations of homeopathy. They included 14 published assessments, and the more rigorous of these investigations did not show that homeopathy is cost-effective. The authors concluded that “although the identified evidence of the costs and potential benefits of homeopathy seemed promising, studies were highly heterogeneous and had several methodological weaknesses. It is therefore not possible to draw firm conclusions based on existing economic evaluations of homeopathy“.

Probably the most meaningful study in this area is an investigation by another pro-homeopathy research team. Here is its abstract:

OBJECTIVES:

This study aimed to provide a long-term cost comparison of patients using additional homeopathic treatment (homeopathy group) with patients using usual care (control group) over an observation period of 33 months.

METHODS:

Health claims data from a large statutory health insurance company were analysed from both the societal perspective (primary outcome) and from the statutory health insurance perspective (secondary outcome). To compare costs between patient groups, homeopathy and control patients were matched in a 1:1 ratio using propensity scores. Predictor variables for the propensity scores included health care costs and both medical and demographic variables. Health care costs were analysed using an analysis of covariance, adjusted for baseline costs, between groups both across diagnoses and for specific diagnoses over a period of 33 months. Specific diagnoses included depression, migraine, allergic rhinitis, asthma, atopic dermatitis, and headache.

RESULTS:

Data from 21,939 patients in the homeopathy group (67.4% females) and 21,861 patients in the control group (67.2% females) were analysed. Health care costs over the 33 months were 12,414 EUR [95% CI 12,022-12,805] in the homeopathy group and 10,428 EUR [95% CI 10,036-10,820] in the control group (p<0.0001). The largest cost differences were attributed to productivity losses (homeopathy: EUR 6,289 [6,118-6,460]; control: EUR 5,498 [5,326-5,670], p<0.0001) and outpatient costs (homeopathy: EUR 1,794 [1,770-1,818]; control: EUR 1,438 [1,414-1,462], p<0.0001). Although the costs of the two groups converged over time, cost differences remained over the full 33 months. For all diagnoses, homeopathy patients generated higher costs than control patients.

CONCLUSION:

The analysis showed that even when following-up over 33 months, there were still cost differences between groups, with higher costs in the homeopathy group.

A recent analysis confirms this situation. It concluded that patients who use homeopathy are more expensive to their health insurances than patients who do not use it. The German ‘Medical Tribune’ thus summarised the evidence correctly when stating that ‘Globuli are m0re expensive than conventional therapies’. This quote mirrors perfectly the situation in Switzerland which as been summarised as follows: ‘Globuli only cause unnecessary healthcare costs‘.

But homeopaths (perhaps understandably) seem reluctant to agree. They tend to come out with ever new arguments to defend the indefensible. They claim, for instance, that prescribing a homeopathic remedy to a patient would avoid giving her a conventional treatment that is not only more expensive but also has side-effects which would cause further expense to the system.

To some, this sounds perhaps reasonable (particularly, I fear, to some politicians), but it should not be reasonable argument for responsible healthcare professionals.

Why?

Because it could apply only to the practice of bad and unethical medicine: if a patient is ill and needs a medical treatment, she does certainly not need something that is ineffective, like homeopathy. If she is not ill and merely wants a placebo, she needs assurance, compassion, empathy, understanding and most certainly not an expensive and potentially harmful conventional therapy.

To employ the above analogy, if someone needs transport, she does not need a car without an engine!

So, whichever way we twist or turn it, the issue turns out to be quite simple:

WHITHOUT EFFECTIVENESS, THERE CAN BE NO COST-EFFECTIVENESS!

There is much propaganda for homeopathic vaccinations or homeoprophylaxis (as homeopaths like to call it, in order to give it a veneer of respectability), and on this blog we have discussed it repeatedly. The concept is unproven and dangerous. Yet it is being promoted relentlessly. Currently, I get > 12 million websites when I google ‘homeopathic vaccination’, and there are hundreds of dangerously misleading books and newspaper articles on the subject.

One study that I therefore always wanted to conduct was a trial comparing homeopathic ‘vaccines’ to placebo in terms of immunological response in human volunteers. Somehow, I never managed to get it going. Thus, I was delighted when, a few weeks ago, I received an article for peer-review (I hope I am allowed to disclose this fact here); it was almost exactly the trial I had dreamt of doing one day: the first ever study to test whether there is an antibody response to homeopathic vaccines. Now I am even more delighted to see that it has been published.

Its aim was to compare the antibody response of homeopathic and conventional vaccines and placebo in young adults. The authors hypothesized that there would be no significant difference between homeopathic vaccines and placebo, while there would be a significant increase in antibodies in those received conventional vaccines.

A placebo-controlled, double-blind RCT was conducted where 150 university students who had received childhood vaccinations were assigned to diphtheria, pertussis, tetanus, mumps, measles homeopathic vaccine, placebo, or conventional diphtheria, pertussis, tetanus (Tdap) and mumps, measles, rubella (MMR) vaccines. The primary outcome was a ≥ two-fold increase in antibodies from baseline following vaccination as measured by ELISA. Participants, investigators, study coordinator, data blood drawers, laboratory technician, and data analyst were blinded.

None of the participants in either the homeopathic vaccine or the placebo group showed a ≥ two-fold response to any of the antigens. In contrast, of those vaccinated with Tdap, 68% (33/48) had a ≥ two-fold response to diphtheria, 83% (40/48) to pertussis toxoid, 88% (42/48) to tetanus, and 35% (17/48) of those vaccinated with MMR had a response to measles or mumps antigens (p < 0.001 for each comparison of conventional vaccine to homeopathic vaccine or to placebo). There was a significant increase in geometric mean titres of antibody from baseline for conventional vaccine antigens (p < 0.001 for each), but none for the response to homeopathic antigens or placebo.

The authors concluded that homeopathic vaccines do not evoke antibody responses and produce a response that is similar to placebo. In contrast, conventional vaccines provide a robust antibody response in the majority of those vaccinated.

I think this is in every respect an excellent trial. It should once and for all get rid of what is arguably the homeopathy-cult’s most dangerous idea, namely that highly diluted homeopathic remedies can protect humans against infectious diseases. On this blog, I once called it ‘a danger for both the public and the individual who might believe in it … promoting HP is unethical, irresponsible and possibly even criminal.’

I said it ‘should’ get rid of this nonsense, but will it?

As homeopaths have, for now 200 years, showed themselves utterly impervious to evidence, I for one am not holding my breath. Yet, thanks to this excellent study, we can, when confronted with the notion of homeopathic vaccinations, henceforth point out that it is not just totally implausible but that, in addition, it has also been experimentally shown to be false.

My thanks to the Canadian investigators!

In recent years, I have found myself getting irritated with researchers finishing their evaluation of a so-called alternative medicine (SCAM) with the sentence ‘MORE RESEARCH IS NEEDED’ (or similar). It is irritating because it fails to draw a line under assessments of even the most hopelessly implausible treatment. And, because it leaves things open, it seems to imply that, until further research is available, things can go on as before.

When I realised that plenty of my own papers ended with this statement, I was first taken aback and then even more irritated. How could I have been guilty of repeatedly publishing such nonsense?

Here are just 5 examples of my blundering:

further trials of high methodological quality with sufficient sample size and follow-up are needed

Future rigorous randomised clinical trials with larger sample sizes will be necessary

Future investigations in this area should overcome the multiple methodological weaknesses of the previous research.

More and larger long-term, high-quality trials are needed.

Larger and more rigorous trials are needed to objectively assess the effects of this herbal supplement.

But subsequently I re-considered and asked myself: what does ‘MORE RESEARCH IS NEEDED’, a phrase used by so many researchers, really mean?

Contrary to how it seems often to be understood in SCAM, it cannot (should not) mean that, until there is more evidence, we are all free to employ the treatment in question.

Let’s take my first two of my articles quoted above as examples. The first was an assessment of qigong for the primary prevention of cardiovascular disease, and the second an evaluation of acupuncture as a treatment of ankle sprains. When concluding that, in both cases, more research is needed, I did certainly not mean to issue a ‘carte blanche’ to clinicians for carrying on using an evidently unproven SCAM!

What the sentence ‘MORE RESEARCH IS NEEDED’ actually means is almost the opposite:

  1. at present, the evidence is insufficient;
  2. more research is needed for a firm verdict;
  3. currently, the effectiveness of the treatment is unproven;
  4. it is unwise and possibly even unethical to employ unproven treatments in clinical routine, particularly in situations for which evidence-based therapies are available.

And, if this is so, one also needs to express that NO MORE RESEARCH IS NEEDED, whenever this applies. In the realm of SCAM, this would be the case, if a therapy is hopelessly implausible, for instance. I am glad to say that, occasionally, I did do just that:

… There are hundreds of different homeopathic remedies which can be prescribed for thousands of symptoms in dozens of different dilutions. Thus we would probably need to work flat out for several lifetimes in order to arrive at a conclusion that fully substantiates my opening statement*.

This seems neither possible nor desirable. Perhaps it is preferable to simply combine common sense with the best existing knowledge. These two tell us that 1) homeopathy is biologically implausible, 2) its own predictions seem to be incorrect and 3) the clinical evidence is largely negative…

… the conundrum of homeopathy seems to be solved. ‘Heavens!’ I hear the homeopathic fraternity shout. ‘We need more research!’ But are they correct? How much research is enough to show that any treatment does not work (sorry, is not superior to placebo)? Here we go full circle: should we really spend several lifetimes in order to arrive at a more robust conclusion?

*homeopathy is not better than placebo

 

This article reported the case of a woman from West Bengal who presented with generalised weakness, weight loss, intermittent diffuse pain abdomen, anorexia, nausea, off and on diarrhoea for eight months. She also noticed darkening of her complexion for six months. Since last 4 months, she had intermittent headache of varying duration, frequency and intensity with tingling and numbness of all four limbs.

Her past medical history was unremarkable except for a chronic anxiety disorder for which she was treated by homeopathy medicine. A neurological examination showed preserved higher mental function, bilateral papilledema with intact other cranial nerves. There was mild motor weakness in both lower limbs, both proximal and distal accompanied by hypotonia without any motor weakness in upper limbs. There was distal sensory deficit in the form of glove and stocking hypoesthesia with reduced deep reflexes in all 4 limbs and bilateral flexor planter response. Gastrointestinal examination revealed non-tender enlarged liver with 16 cm span, mild splenomegaly and mild ascites. Investigations showed mild microcytic hypochromic anaemia (Hb- 9.2 g/dl, MCV-78 fl, MCH-26 pg, MCHC- 31.3 g/dl), low serum iron (27.5 mcg/dl), low TIBC (84.4 mcg/ dl), high serum ferritin (808.6 ng/ml), raised transaminases (AST- 40 IU/L, ALT- 98 IU/L), low serum total protein (4.6 g/dl), low serum albumin (1.9g/dl), globulin (2.7 g/dl) and raised alkaline phosphatase (789 IU/L). Nerve conduction velocity of all four limbs was suggestive of sensorimotor neuropathy.

Unexplained, apparently unrelated multi-system involvement including chronic diarrhoea, presence of liver disease, peripheral neuropathy, idiopathic intracranial hypertension (pseudotumor cerebri ) and characteristic skin lesions suggested chronic arsenicosis. Arsenic level in hair was found to be 1.06 μg/g (N= 0.02-0.2 μg/g) and arsenic level in nail was 1.24 μg/g (N= 0.02-0.5 μg/g) with normal arsenic content (0.03 mg/l) of the drinking water of the locality.

Further questioning revealed that the patient was taking arsenicum album for her anxiety depressive disorder for last one year. The drug was discontinued. Six months later the patient had fully recovered. The authors concluded that an apparently harmless homeopathy medicine may cause multisystem involvement.

The only other case reports of homeopathic arsenic poisoning is this paper:

Case 1 presented with melanosis and keratosis following short-term use of Arsenic Bromide 1-X followed by long-term use of other arsenic-containing homeopathic preparations. Case 2 developed melanotic arsenical skin lesions after taking Arsenicum Sulfuratum Flavum-1-X (Arsenic S.F. 1-X) in an effort to treat his white skin patches. Case 3 consumed Arsenic Bromide 1-X for 6 days in an effort to treat his diabetes and developed an acute gastrointestinal illness followed by leukopenia, thrombocytopenia, and diffuse dermal melanosis with patchy desquamation. Within approximately 2 weeks, he developed a toxic polyneuropathy resulting in quadriparesis. Arsenic concentrations in all three patients were significantly elevated in integument tissue samples. In all three cases, arsenic concentrations in drinking water were normal but arsenic concentrations in samples of the homeopathic medications were elevated. CONCLUSION: Arsenic used therapeutically in homeopathic medicines can cause clinical toxicity if the medications are improperly used.

The authors of the new paper fail to mention the potency of the homeopathic arsenic preparation taken by the patient. As far as I know, in Europe, only high potencies of arsenic are prescribed and dispensed; these remedies contain no or very little arsenic and can thus be considered harmless. In India, however, the 1-X potency seems to be popular, according to the second paper cited above. It describes a dilution of 1: 10 only. It is clear that taking such a remedy would quickly lead to severe toxicity.

This begs the questions: Is it legal to prescribe and dispense such remedies in India or anywhere else? And, in case it is legal, why?

The present trial evaluated the efficacy of homeopathic medicines of Melissa officinalis (MO), Phytolacca decandra (PD), and the combination of both in the treatment of possible sleep bruxism (SB) in children (grinding teeth during sleep).

Patients (n = 52) (6.62 ± 1.79 years old) were selected based on the parents report of SB. The study comprised a crossover design that included 4 phases of 30-day treatments (Placebo; MO 12c; PD 12c; and MO 12c + PD 12c), with a wash-out period of 15 days between treatments.

At baseline and after each phase, the Visual Analogic Scale (VAS) was used as the primary outcome measure to evaluate the influence of treatments on the reduction of SB. The following additional outcome measures were used: a children’s sleep diary with parent’s/guardian’s perceptions of their children’s sleep quality, the trait of anxiety scale (TAS) to identify changes in children’s anxiety profile, and side effects reports. Data were analyzed by ANOVA with repeated measures followed by Post Hoc LSD test.

Significant reduction of SB was observed in VAS after the use of Placebo (-1.72 ± 0.29), MO (-2.36 ± 0.36), PD (-1.44 ± 0.28) and MO + PD (-2.21 ± 0.30) compared to baseline (4.91 ± 1.87). MO showed better results compared to PD (p = 0.018) and Placebo (p = 0.050), and similar result compared to MO+PD (p = 0.724). The sleep diary results and TAS results were not influenced by any of the treatments. No side effects were observed after treatments.

The authors concluded that MO showed promising results in the treatment of possible sleep bruxism in children, while the association of PD did not improve MO results.

Even if one fully subscribed to the principles of homeopathy, this trial raises several questions:

  1. Why was it submitted and then published in the journal ‘Phytotherapy’. All the remedies were given as C12 potencies. This has nothing to do with phytomedicine.
  2. Why was a cross-over design chosen? According to homeopathic theory, a homeopathic treatment has fundamental, long-term effects which last much longer than the wash-out periods between treatment phases. This effectively rules out such a design as a means of testing homeopathy.
  3. MO is used in phytomedicine to induce sleep and reduce anxiety. According to the homeopathic ‘like cures like’ assumption, this would mean it ought to be used homeopathically to treat sleepiness or for keeping patients awake or for making them anxious. How can it be used for sleep bruxism?

Considering all this, I ask myself: should we trust this study and its findings?

What do you think?

I am being told to educate myself and rethink the subject of NAPRAPATHY by the US naprapath Dr Charles Greer. Even though he is not very polite, he just might have a point:

Edzard, enough foolish so-called scientific, educated assesments from a trained Allopathic Physician. When asked, everything that involves Alternative Medicine in your eyesight is quackery. Fortunately, every Medically trained Allopathic Physician does not have your points of view. I have partnered with Orthopaedic Surgeons, Medical Pain Specialists, General practitioners, Thoracic Surgeons, Forensic Pathologists and Others during the course, whom appreciate the Services that Naprapaths provide. Many of my current patients are Medical Physicians. Educate yourself. Visit a Naprapath to learn first hand. I expect your outlook will certainly change.

I have to say, I am not normally bowled over by anyone who calls me an ‘allopath’ (does Greer not know that Hahnemann coined this term to denigrate his opponents? Is he perhaps also in favour of homeopathy?). But, never mind, perhaps I was indeed too harsh on naprapathy in my previous post on this subject.

So, let’s try again.

Just to remind you, naprapathy was developed by the chiropractor Oakley Smith who had graduated under D D Palmer in 1899. Smith was a former Iowa medical student who also had investigated Andrew Still’s osteopathy in Kirksville, before going to Palmer in Davenport. Eventually, Smith came to reject Palmer’s concept of vertebral subluxation and developed his own concept of “the connective tissue doctrine” or naprapathy.

Dr Geer published a short article explaining the nature of naprapathy:

Naprapathy- A scientific, Evidence based, integrative, Alternative form of Pain management and nutritional assessment that involves evaluation and treatment of Connective tissue abnormalities manifested in the entire human structure. This form of Therapeutic Regimen is unique specifically to the Naprapathic Profession. Doctors of Naprapathy, pronounced ( nuh-prop-a-thee) also referred to as Naprapaths or Neuromyologists, focus on the study of connective tissue and the negative factors affecting normal tissue. These factors may begin from external sources and latently produce cellular changes that in turn manifest themselves into structural impairments, such as irregular nerve function and muscular contractures, pulling its’ bony attachments out of proper alignment producing nerve irritability and impaired lymphatic drainage. These abnormalities will certainly produce a pain response as well as swelling and tissue congestion. Naprapaths, using their hands, are trained to evaluate tissue tension findings and formulate a very specific treatment regimen which produces positive results as may be evidenced in the patients we serve. Naprapaths also rely on information obtained from observation, hands on physical examination, soft tissue Palpatory assessment, orthopedic evaluation, neurological assessment linked with specific bony directional findings, blood and urinalysis laboratory findings, diet/ Nutritional assessment, Radiology test findings, and other pertinent clinical data whose information is scrutinized and developed into a individualized and specific treatment plan. The diagnostic findings and results produced reveal consistent facts and are totally irrefutable. The deductions that formulated these concepts of theory of Naprapathic Medicine are rationally believable, and have never suffered scientific contradiction. Discover Naprapathic Medicine, it works.

What interests me most here is that naprapathy is evidence-based. Did I perhaps miss something? As I cannot totally exclude this possibility, I did another Medline search. I found several trials:

1st study (2007)

Four hundred and nine patients with pain and disability in the back or neck lasting for at least 2 weeks, recruited at 2 large public companies in Sweden in 2005, were included in this randomized controlled trial. The 2 interventions were naprapathy, including spinal manipulation/mobilization, massage, and stretching (Index Group) and support and advice to stay active and how to cope with pain, according to the best scientific evidence available, provided by a physician (Control Group). Pain, disability, and perceived recovery were measured by questionnaires at baseline and after 3, 7, and 12 weeks.

RESULTS:

At 7-week and 12-week follow-ups, statistically significant differences between the groups were found in all outcomes favoring the Index Group. At 12-week follow-up, a higher proportion in the naprapathy group had improved regarding pain [risk difference (RD)=27%, 95% confidence interval (CI): 17-37], disability (RD=18%, 95% CI: 7-28), and perceived recovery (RD=44%, 95% CI: 35-53). Separate analysis of neck pain and back pain patients showed similar results.

DISCUSSION:

This trial suggests that combined manual therapy, like naprapathy, might be an alternative to consider for back and neck pain patients.

2nd study (2010)

Subjects with non-specific pain/disability in the back and/or neck lasting for at least two weeks (n = 409), recruited at public companies in Sweden, were included in this pragmatic randomized controlled trial. The two interventions compared were naprapathic manual therapy such as spinal manipulation/mobilization, massage and stretching, (Index Group), and advice to stay active and on how to cope with pain, provided by a physician (Control Group). Pain intensity, disability and health status were measured by questionnaires.

RESULTS:

89% completed the 26-week follow-up and 85% the 52-week follow-up. A higher proportion in the Index Group had a clinically important decrease in pain (risk difference (RD) = 21%, 95% CI: 10-30) and disability (RD = 11%, 95% CI: 4-22) at 26-week, as well as at 52-week follow-ups (pain: RD = 17%, 95% CI: 7-27 and disability: RD = 17%, 95% CI: 5-28). The differences between the groups in pain and disability considered over one year were statistically significant favoring naprapathy (p < or = 0.005). There were also significant differences in improvement in bodily pain and social function (subscales of SF-36 health status) favoring the Index Group.

CONCLUSIONS:

Combined manual therapy, like naprapathy, is effective in the short and in the long term, and might be considered for patients with non-specific back and/or neck pain.

3rd study (2016)

Participants were recruited among patients, ages 18-65, seeking care at the educational clinic of Naprapathögskolan – the Scandinavian College of Naprapathic Manual Medicine in Stockholm. The patients (n = 1057) were randomized to one of three treatment arms a) manual therapy (i.e. spinal manipulation, spinal mobilization, stretching and massage), b) manual therapy excluding spinal manipulation and c) manual therapy excluding stretching. The primary outcomes were minimal clinically important improvement in pain intensity and pain related disability. Treatments were provided by naprapath students in the seventh semester of eight total semesters. Generalized estimating equations and logistic regression were used to examine the association between the treatments and the outcomes.

RESULTS:

At 12 weeks follow-up, 64% had a minimal clinically important improvement in pain intensity and 42% in pain related disability. The corresponding chances to be improved at the 52 weeks follow-up were 58% and 40% respectively. No systematic differences in effect when excluding spinal manipulation and stretching respectively from the treatment were found over 1 year follow-up, concerning minimal clinically important improvement in pain intensity (p = 0.41) and pain related disability (p = 0.85) and perceived recovery (p = 0.98). Neither were there disparities in effect when male and female patients were analyzed separately.

CONCLUSION:

The effect of manual therapy for male and female patients seeking care for neck and/or back pain at an educational clinic is similar regardless if spinal manipulation or if stretching is excluded from the treatment option.

_________________________________________________________________

I don’t know about you, but I don’t call this ‘evidence-based’ – especially as all the three trials come from the same research group (no, not Greer; he seems to have not published at all on naprapathy). Dr Greer does clearly not agree with my assessment; on his website, he advertises treating the following conditions:

Anxiety
Back Disorders
Back Pain
Cervical Radiculopathy
Cervical Spondylolisthesis
Cervical Sprain
Cervicogenic Headache
Chronic Headache
Chronic Neck Pain
Cluster Headache
Cough Headache
Depressive Disorders
Fibromyalgia
Headache
Hip Arthritis
Hip Injury
Hip Muscle Strain
Hip Pain
Hip Sprain
Joint Clicking
Joint Pain
Joint Stiffness
Joint Swelling
Knee Injuries
Knee Ligament Injuries
Knee Sprain
Knee Tendinitis
Lower Back Injuries
Lumbar Herniated Disc
Lumbar Radiculopathy
Lumbar Spinal Stenosis
Lumbar Sprain
Muscle Diseases
Musculoskeletal Pain
Neck Pain
Sciatica (Not Due to Disc Displacement)
Sciatica (Not Due to Disc Displacement)
Shoulder Disorders
Shoulder Injuries
Shoulder Pain
Sports Injuries
Sports Injuries of the Knee
Stress
Tendonitis
Tennis Elbow (Lateral Epicondylitis)
Thoracic Disc Disorders
Thoracic Outlet Syndrome
Toe Injuries

Odd, I’d say! Did all this change my mind about naprapathy? Not really.

But nobody – except perhaps Dr Greer – can say I did not try.

And what light does this throw on Dr Greer and his professionalism? Since he seems to be already quite mad at me, I better let you answer this question.

Dengue is a viral infection spread by mosquitoes; it is common in many parts of the world. The symptoms include fever, headache, muscle/joint pain and a red rash. The infection is usually mild and lasts about a week. In rare cases it can be more serious and even life threatening. There’s no specific treatment – except for homeopathy; at least this is what many homeopaths want us to believe.

This article reports the clinical outcomes of integrative homeopathic care in a hospital setting during a severe outbreak of dengue in New Delhi, India, during the period September to December 2015.

Based on preference, 138 patients received a homeopathic medicine along with usual care (H+UC), and 145 patients received usual care (UC) alone. Assessment of thrombocytopenia (platelet count < 100,000/mm3) was the main outcome measure. Kaplan-Meier analysis enabled comparison of the time taken to reach a platelet count of 100,000/mm3.

The results show a statistically significantly greater rise in platelet count on day 1 of follow-up in the H+UC group compared with UC alone. This trend persisted until day 5. The time taken to reach a platelet count of 100,000/mm3 was nearly 2 days earlier in the H+UC group compared with UC alone.

The authors concluded that these results suggest a positive role of adjuvant homeopathy in thrombocytopenia due to dengue. Randomized controlled trials may be conducted to obtain more insight into the comparative effectiveness of this integrative approach.

The design of the study is not able to control for placebo effects. Therefore, the question raised by this study is the following: can an objective parameter like the platelet count be influenced by placebo? The answer is clearly YES.

Why do researchers go to the trouble of conducting such a trial, while omitting both randomisation as well as placebo control? Without such design features the study lacks rigour and its results become meaningless? Why can researchers of Dengue fever run a trial without reporting symptomatic improvements?  Could the answer to these questions perhaps be found in the fact that the authors are affiliated to the ‘Central Council for Research in Homoeopathy, New Delhi?

One could argue that this trial – yet another one published in the journal ‘Homeopathy’ – is a waste of resources and patients’ co-operation. Therefore, one might even argue, such a study might be seen as unethical. In any case, I would argue that this study is irrelevant nonsense that should have never seen the light of day.

 

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