I’ve heard it said that, unlike the medical world, there is no such beast as alternative physics.  Whilst it’s true that made up^* nonsense hasn’t penetrated physics education and practice in the same way as it has medicine, there is no shortage of people indulging in fantasy physics.  Perpetual-motion dreamers are prone to do this, as are advocates of so-called ‘energy medicine’.  In the case of the former, they are looking for excuses to support their claims for so-called ‘over-unity’ devices that are claimed to produce more energy than they consume.  The latter are looking for ‘explanations’ for how homeopathy, reiki etc. ‘work’.  Of course, neither of these communities actually have meaningful effects that require explanation.  This is about having some superficially ‘sciency’ prose to sell their wares, or reassure their devotees.

I’ve recently been pointed^** at a cracking example of ‘energy medicine’ advocates indulging in some fantasy physics.  It’s hosted on the PositiveHealthOnline website and is called, Spirals and Energy in Nature, attributed to Robert McCoy.   It’s worth a look as an exemplar of the desperate nonsense that elements of the ‘energy medicine’ community dabble in.  It’s so rich a vein of fantasy physics that I’m sure that I’ll end up overlooking some howlers.  If I do, please feel free to point them out in the comments.

“She was the first to develop the protocols and instrumentation necessary to detect and record the body’s high frequency energy fields with the spectral analysis of bioenergy patterns.  She discovered the neuromuscular patterns of non-verbal communication and her groundbreaking research has led to the first truly scientific understanding of the relationship between energy field disturbances, disease, emotional pathologies, human field communication and the energy spectrum of consciousness.”

Mentions of “bioenergy patters” and “the energy spectrum of consciousness”, amongst other things, flag Hunt as a pseudoscientist.  It appears that this was not always the case.  She has a PubMed publication record which reveals some (apparently) useful work in the 1960’s (Hunt and Weber, 1960; Hunt and Weber, 1964; Barrett, Hunt and Jones, 1967) before publishing study of Rolfing® the year before she retired (Weinberg and Hunt, 1979).  Rolfing®, sometimes called Structural Integration, has had many claims made for it.  A recent review by Natural Standard concluded that:

“There is little well-designed scientific research of this technique, and it is not known if Rolfing® structural integration is safe or effective for the treatment of any disease. People with fractures or spine disease, those at risk of bleeding, those with blood clots and pregnant women should avoid Rolfing® structural integration.”

During the latter part of her career at UCLA Hunt appears to have become quite taken with both Rolfing® and seeing evidence for fictitious concepts, such as chakras and ‘auric emission‘, in electrical signals associated with muscle movement.  Her enthusiasm for fantasy leaps off the page:

“Prior pilot studies during Rolfing, unconventional healing, meditation and altered states of consciousness had provided techniques for recording a high frequency low amplitude energy field not in the known muscular spectrum. This is believed to be an auric emission.  There was correspondence between these data and changes in chakra and auric field colors re-ported by aura readers.”  (Hunt et al, 1977)

However, it is this putative ‘high frequency low amplitude energy field’ that McCoy appears to have alighted on as some sort of mystical entity.  So, with this in mind, let’s have a look at some really bad physics.

Signal or Noise?

Hunt appears to have used electromyography (EMG), a method of recording the voltage potential generated by muscle cells when they are activated.

“What she discovered was a whole range of minute signals that had never been seen before – patterns below the pattern – like some sort of energetic Mandelbrot, they were in the audio range and could be amplified and heard as well as ‘seen’ by sensitives, as if they were the ‘sound of light’. No wonder no one had ever found them – who would have guessed! ‘Light’ you can listen to! And furthermore each one of these frequencies corresponded to a discrete characteristic of the human mind and body and each had a distinct waveform and colour. So frequency, waveform and colour were synonymous with different human characteristics.”

It sounds from the description like Hunt saw some meaningful small amplitude high frequency content in the signals she was measuring, or got carried away looking at noise in her experiments.  As there are no time histories or spectra presented, I can’t say one.  However, It’s not surprising that the little signals were in the audio range, to quote a manual on EMG (De Luca 2002):

“It is well established that the amplitude of the EMG signal is stochastic (random) in nature and can be reasonably represented by a Gausian distribution function. The amplitude of the signal can range from 0 to 10 mV (peak-to-peak) or 0 to 1.5 mV (rms). The usable energy of the signal is limited to the 0 to 500 Hz frequency range, with the dominant energy being in the 50-150 Hz range. Usable signals are those with energy above the electrical noise level.”

Here’s a time history and its frequency spectrum detected from the Tibialis Anterior muscle during a constant force isometric contraction at 50% of voluntary maximum (De Luca 2002).  It’s clear that there’s a lot of energy in the audio range (>20Hz).  It’s also true that muscles radiate acoustic energy (sound) that can be measured (AMG).  Now, for the comments attributed to Hunt.  Of course, if the electric signals in the audio range were amplified and sent to a loudspeaker they could be heard!  But that’s an artificial process and confers no special meaning.  The observation that these signals could be ‘seen’ by ‘sensitives’ (whatever they are) is nonsense. These electrical signals are not electromagnetic waves in the part of the spectrum that the eye can see.  The ‘sound of light’ idea presented here is physical nonsense as well.

The fanciful ideas now take full flight, “each one of these frequencies corresponded to a discrete characteristic of the human mind and body and each had a distinct waveform and colour.”  The author moves from an unremarkable electrical signal measured on the skin, to light, then undefined characteristics of the body and mind; a flight of fancy indeed.

Vectors and Scalars are easy: simply put, vectors have both magnitude (size) and direction, while scalars only have magnitude.  Common physical vectors include velocity: speed in a given direction.  On the other hand temperature is a scalar, having values at points within a physical system (i.e. ‘what’s the temperature here’) but no associated indication of direction.

In physics, fields are simply a region of space characterized by a physical quatity, such as temperature or velocity.  The quqntity must have a determinable value at every point in the region.  They can be either vector or scalar; this just refers to the type of physical quantity they are composed of.  For example, as temperature is a scalar, the distribution of temperature through the room you are sitting in is a scalar field.  Temperature takes specific values at each point in the room.  In contrast, if we think about the air velocity in the same room, its distribution through the room gives us a vector field, as velocity is a vector.  In this case we have two pieces of information at every point in the room: the speed of the air and its direction of motion.

A wave is a disturbance that travels through space and time, usually transporting energy.  If the direction of the disturbance is the same as its direction of travel, it’s a longitudinal wave.  Sound is an example of a wave of this type.   If the disturbance is at right angles (perpendicular) to the direction of motion, then it’s called a transverse wave.  If the disturbance is restricted to a single plane, then it’s called (plane) polarized.  From a wave perspective, light is a transverse electromagnetic wave; a combination of oscillating electric and magnetic fields. They oscillate perpendicular to each other and in a plane perpendicular to the direction of propagation (travel).  Light also has a vector nature, as both electric and magnetic fields are vector fields.

 ”…the waveforms she displayed on her slides were what are known as vector waveforms …”

Not if they were measurements of the electric signals produced by muscles.  EMG records changes in voltage potential at specific points, a scalar quantity, so any waveform would be of the scalar variety.

 ”… All known frequencies in the electromagnetic [EM] spectrum are vector waves.”

 Yes, but where has the electromagnetic (EM) radiation come from?  The actual measurements are electrical signals of relatively low-frequency.  No light, no EM signals of any kind.

 

“… Vector waves … can be displayed and measured.”

It’s not because of the vector nature though; as we have seen, scalars are by definition measurable to.

“… But there are other waves in physics that are known to be ‘below’ or ‘behind’ the vector waveforms that we can see and measure and these waveforms are referred to as scalars and they are not so easy to see or measure – or even describe.”

Scalars only underlie vectors in the sense that the magnitude part of the vector is a scalar.  As we have seen scalars are easy to describe – they are simpler than vectors after all.

 

“… scalars have been referred to, at times as the information ‘behind’ a vector waveform and that when a vector waveform is ‘collapsed’ the scalar information is ‘revealed’.”

The author appears to be confusing the quantum mechanical concept of wavefunction collapse, with a general property of vector waves.  This is silly.  As we have seen there is a sense in which scalars are ‘behind’ (actually part of) vector quantities, and it’s quite simple.

 ”This is generally done by running a vector through what is known as a Caduceus coil, a winding twisting pair of wires which wrap the wave back around on itself so as to combine the waveforms in such a way as to negate them, like a homeopathic. But the information left behind is not like a radio signal that was modulated onto a carrier wave – a small vector riding on the back of a bigger vector – it’s the information that formed the wave itself… and that survives its destruction.”

Complete nonsense.  The Caduceus is the staff carried the Greek mythological character Hermes.  It features two entwined serpents (as opposed to the single serpent seen on the medic’s mythological symbol, the rod of Asclepius.)  Some fantasists think that by entwining wires in the same pattern (Caduceus coil) they can generate occult scalar waves, tachyons, enable time travel and perpetual motion.  Of course, it cannot and does not.  Any mention of ‘homeopathic’ is a clear indication that we are dealing with entirely bogus explanations.

“If the sum of the internal motions is zero, the external object seems to be sitting still and motionless to us (though it’s still moving through time with – usually – uniform motion).”

Here’s a thought experiment: imagine a completely rigid, solid ball moving through the air.  The sum of all the internal motions is zero, and yet it is actually moving.  The sum of all the internal motions within an object tells us nothing about whether it’s moving or not.   Of course it’s still ‘moving through time’ we all are, and in a uniform manner!  There’s no ‘usually’ about it, unless time is mysteriously speeding up or slowing down.

“A simple vector – one 360 degree ‘roller coaster’ – is created from two longitudinally coupled scalars – IE two whirlpools abutted lengthwise, end to end so to speak. In eastern cosmology there is a phenomena that comes tantalizingly close to the description of such a coupling of whirlpools and it’s called a chakra … A chakra is two longitudinally coupled rotating standing waves.”

A google search for the expression, “longitudinally coupled scalars” only finds versions of this article.  That’s a pretty clear indication that it’s meaningless.^*** The meaningless babble continues apace: chakras are a myth, nothing more.  They have no physiological meaning and cannot be measured.

“As an analogy, a scalar is a system that is expanding or contracting on a sliding scale in multiple directions simultaneously – IE it’s changing its magnitude.”

Again, untrue: scalars don’t have to change, unless physical processes are at work, driving that change (like a fire in a room will change the scalar temperature field).  Neither do scalars exhibit directionality, that’s vectors!

“A vector translates directionally through space – IE spatially. So a vector that scales is a vector that expands or contracts in multiple directions simultaneously while translating in a specific direction through space.”

Vectors don’t move: they express size and direction at a point.  Waves move

“There is only one method in nature to accomplish that seamlessly and that is to spiral.”

And we have arrived at the spiral promised in the title of the article.  The journey has been both incoherent and nonsensical.  The nonsense wave propagating through the narrative now starts to build towards a peak.

“So could it be possible that what are often called ‘scalars’ in science may actually be coupled spinning pranic whirlpools composed of spiralling vectors, kinda like kundalini, and that this awe inspiring movement has not been adequately characterized?”

No, because these words have no physical meaning.

“Even ordinary analog vector signals are difficult to model so a three dimensional whirlpool – the ultimate compound analog device – at the level of a scalar, would most definitely be a forbidding challenge.”

Err, no, actually my day job involves very detailed models of three-dimensional vortices.  The two images below are taken from Computational Fluid Dynamics (CFD) simulations of the flow around the German ICE train.  On the left is a visualisation of the flow in the gap between two carriages, a spiraling trapped vortex.  On the right is the (near) wake, with a pair of strong counter-rotating vortices drawing air down the rear powercar before spiraling off into the wake.  I did this work over a decade ago (Gaylard, 2001), and the capabilities of both CFD software and computer hardware have come on in leaps and bounds in the years since this work was completed.  There are difficulties, complexities and uncertainties; but no forbidding challenge! Personally, I’m really into spiralling flow.

Now one of the favorite quack canards now gets an outing:

“And why is an object so central to eastern cosmology so conspicuously absent from mainstream western scientific investigation? You’d think energy was confined to railroad tracks and that transverse sinusoidal waves were the ‘bee’s knee’s’ – the end of the story – in some frozen, eternal trolley car world. Something had to shape that hurricane and hurricanes are certainly not short on energy. IE: spiralling storms don’t come from straight lines. Straight lines do.”

All I really want to say about this is that science (belonging neither to the west or east, but rather the world) as much to say about longitudinal scalar waves, like sound, or highly complex patterns of spiraling flow.  Robert McCoy is in serious need of an education.

“But one really begins to appreciate the view when one takes the opposite journey inward – beginning with our spiralling vector. If such a phenomena exists, one would naturally ask what would lie ‘beneath’ it or ‘behind’ it and the answer would have to be a scalar – but a scalar on a much smaller ‘scale’. And that scalar would in turn be composed of even smaller spiralling vectors composed of still smaller scalars and on and on – spiralling vectors enfolding spinning scalars enfolding spiralling vectors on into infinity – Planck Length be dammed – an infinitely enfolding energetic Mandelbrot.”

It’s certainly a change of pace for a ‘energy medicine’ advocate to disavow quantum mechanics.  They are quite often fond of quantum flapdoodle.  Reading this odd little paean to a fantasy continuum mechanics and it’s like the early 20^th century revolution in physics prompted by Planck never happened!  How quaint.  I’ve ignored quite a lot of mumbo-jumbo to arrive at the end of the article.  I’d just like to end on this delicious piece of straw clutching.

“…

western science is finally coming close to validating Valerie Hunt’s empirical discovery decades ago of ‘sound you can see’ – a sort of ‘Synesthesia’, long known to the initiated and familiar to sensitives, and experiencers alike, it’s been a ‘long time comin’. www.livescience.com/health/080818-seeing-sound.html “

Synesthesia is a neurological condition in which the stimulation of one sensory pathway leads to the involuntary stimulation of another.  In one form of the condition synesthetes hear a sound and this prompts an experience of colour.  All Hunt has done is measure electrical signals, notice that their frequency is in the audible range – if they had been sound – and claimed some ‘sensitives’ could ‘see’ something.  Synesthesia is neither a choice, nor a matter of training.  It is an involuntary characteristic of some peoples’ brains.

So, what to make of this article?  It’s almost complete nonsense, of course.  Its only value is as an exemplar of people who should know better misappropriating the language of science in the name of illusion.

This is not medical advice.  If you need that see a properly qualified and registered doctor.

** h/t @david_colquhoun
*** Scalars (and scalar fields) can, of course, be coupled. The value of the coupled scalar, being determined by the value of the scalar to which it is coupled. It’s the “longitudinal” part of this claim that’s unique.

Hunt VV, Weber ME. Body image projective test. Journal of projective techniques. 1960 Mar;24:3–10. Available from: http://view.ncbi.nlm.nih.gov/pubmed/14405438.

Hunt VV, Weber ME. Validation Of The Rathbone Manual Tension Test For Muscular Tension. Archives of physical medicine and rehabilitation. 1964 Oct;45:525–529. Available from: http://view.ncbi.nlm.nih.gov/pubmed/14200247.

Barrett ML, Hunt VV, Jones MH. Behavioral growth of cerebral palsied children from group experience in a confined space. Developmental medicine and child neurology. 1967 Feb;9(1):50–58. Available from: http://view.ncbi.nlm.nih.gov/pubmed/6031533.

Hunt, V., Massey, W., Weinberg, R., Bruyere, A., Hahn, P. (1977) Project Report: A Study of Structural Integration from Neuromuscular. Energy Field and Emotional Approaches. Boulder, CO. Rolf Institute of Structural Integration.  Precis available from: http://www.roygbiv.name/HuntStudy.htm

Weinberg R, Hunt VV. Effects of structural integration on state-trait anxiety. Journal of clinical psychology. 1979 Apr;35(2):319–322. Available from: http://view.ncbi.nlm.nih.gov/pubmed/457892.

Gaylard AP. 3. In: Rhodes N, editor. A Comparison of a Conventional RANS and a Lattice Gas Dynamics Simulation – A Case Study in High Speed Rail Aerodynamics. John Wiley & Sons; 2001. Available from: http://www.worldcat.org/isbn/9781860583520.

De Luca CJ. Surface Electromyography: Detection And Recording. DelSys Inc.; 2002. Available from: http://www.delsys.com/Attachments_pdf/WP_SEMGintro.pdf

I really hope that this is the last post I write about the homeoprophylaxis campaign against Leptospirosis in Cuba during 2007 – 2008 (Bracho et al, 2010).  Deep down I know that this uncontrolled, un-randomised poorly-reported trial published in a terrible pseudojournal, dealing with a highly variable disease which is amenable to personal protective measures, a real vaccine and antibiotic treatment is going to get thrown at me again and again.

Homeopathic propagandists will not worry that real medicines were also used in the treatment region, a media campaign raised awareness of the disease and the homeopaths intervened at the peak of a multi-year problem.  Neither will it bother them that the net outcome was a return to the same infection rate as the rest of Cuba or the Intervention Region in 2004, or that the paper was rejected by proper journals.

However, before I move on I think that the accompanying guest editorial by Roniger and Jacobs (2010) deserves some additional scrutiny. It’s entitled, “Prophylaxis against Leptospirosis using a nosode: Can this large cohort study serve as a model for future replications?”

Why bother, when the study it is editorialising on (Bracho et al, 2010) is so deeply flawed?  I have two reasons: first, as the title suggests, it appears that it is seen as being able to support a broader agenda.  Second, the lead author, Helmut Roniger, is a doctor who practises in the UK and works at the Royal London Homeopathic Hospital.  To see an NHS doctor going into print to argue for unethical trials is instructive.

One of the early points raised in the editorial follows a trend that I have seen repeatedly in writings of homeopathic apologists: happily abandoning homeopathic doctrine when it looks like one of the various, and often contradictory, homeopathic factions has found success.

Classical Homeopathy – an embarrassing friend?

Classical Homeopathy prides itself on individualised treatment based on finding the ‘true’ simillimum, respecting the traditions of the Master Hahnemann and his later disciples.  For these reasons, as the authors note:

“Homeoprophylaxis with nosodes has been practised for many years but is not typically used by practitioners of Classical Homeopathy.”

Homeoprophylaxis is not reconcilable with classical homeopathy.  There is no like-curing-like and no individualisation.  However, now that one homeopathic faction has apparently found success, the authors are prepared to snub Classical Homeopathy:

“the use of a nosode eliminates the interference of ideological prescribing variations.”

It looks to me like an argument of convenience.  They think they have found a ‘success’ so classical homeopathy can be dismissed.  However, I wonder if members of the homeopathic community will welcome their particular practise being described as ‘interfering’ with treatment?

The editorial then starts to discuss the merits of the trial.

How much does size matter?

In lauding the size of the trial Roniger and Jacobs (2010) present misconceptions that are astonishing for a doctor and medical academic:

“the size of the population treated and the dramatic decrease in disease incidence compared to previous years make it difficult to dismiss these results as spurious or occurring by chance.”

Size and coincidence, for them, outweigh any idea of basic plausibility or methodological rigour.  Their contention on the decrease in disease levels is just an appeal to the fallacy of Post hoc ergo propter hoc: B follows A, therefore A caused B.  Put more simply: I get up and the sun rises, therefore me getting up causes the sun to rise!

As for the size of the trial, given that there was no control group or randomization, this does not inoculate it against bias.  Particularly as infection risk is not evenly spread over the population.  Living near a contaminated water source, being in a high risk occupation or failing to take personal protective measures will raise the risk for particular people or places.  Given that these risks will vary within a large entity like a state, size alone cannot compensate for poor design.  It’s just a very large poor trial.

Not comparing like with like

One of the most egregious errors of fact contained in this editorial comes next.  Roniger and Jacobs (2010) describe the homeopathic nosode therapy as:

“Similar to a conventional vaccine”.

This is just straightforwardly untrue.  Real vaccines based on inactivated disease-causing organisms train the bodies’ immune system to recognize and kill any live examples that come its way.  For this to happen, it’s absolutely essential that there are inactivated bugs in the vaccine.  How else can the immune system be trained?

In contrast, the homeopathic preparations used in this work did not contain any dead bugs, being the result of diluting a solution carrying dead bacteria to one part in 10⁴⁰⁰ and 10²⁰⁰⁰⁰, respectively.  So, in the single most important respect –carrying an agent that will train the immune system – the nosode therapy was entirely different to a real vaccine.  Not similar at all.

The editorial then summarises the ‘scientific evidence’ for the use of nosodes.

Scientific evidence?

“The scientific evidence for the prevention of disease using nosodes thus far is sparse, as referenced in the article. It consists mainly of observational studies, one controlled clinical human study using Meningococcinum which was poorly reported,² two controlled animal studies on different organisms^3,4 and a plant based model.⁵“

To call this evidence sparse is an exaggeration.  Only one of the studies addressed people, and has nothing to do with Leptospirosis.  Moreover Mroninski, Adriano and Mattos (2001) was ‘published’ in Homœopathic Links.  This is not a scientific journal; neither is it indexed in PubMed.  It’s a vanity publication for homeopaths.  A “poorly reported” trial in a homeopathic pseudojournal is certainly not scientific evidence.  However, I can appreciate why Roniger and Jacobs (2010) have padded out this sparse list – they cannot cite any other people-relevant papers.

Jonas (1999) conducted laboratory tests on mice, as did de Almeida et al (2008).   This is not good evidence for effects on people.  Scratching the surface undermines this evidence further.  Jonas (1999) experimented with nosode treatment of Francisella tularensis.  In a trial with, “142 male C3H/HeN specific, pathogen-free mice”, six ‘levels’ of a nosode were used.  Mortality and time to death were measured after exposure to a, “potentially lethal dose (LD50 or LD75)”.   The author summarized the results:

“In a series of 15 trials (n = 142), the tularemia nosode consistently produced increased mean times to death. All but 2 of 15 trials showed reduced time to death in the nosode group and decreased mortality compared with controls. Protection rates averaged 22% over controls compared to 100% protection by standard vaccination.”

I only have access to the abstract of this paper, so I am unclear as to which nosode ‘level’ had an effect; Though a protection rate of only 22% of the standard vaccine does not sound convincing.

The study by de Almeida et al (2008) is even less convincing.  They investigated Trypanosoma cruzi infection in mice.  Eighty mice were allocated to five groups, “treated with biotherapy (nosode) of T. cruzi 12dH (12x) pre- and post-infection; Phosphorus 12dH post-infection; infected control treated with control solution and uninfected control.”  Lots of things were measured, “Parasitaemia was monitored, leukocyte and serological responses were evaluated at 0, 7, 14 and 42 days after infection. The prepatent and patent periods of parasitaemia, maximum of parasitaemia, day of maximum parasitaemia and mortality rates were compared between groups”.

The paper claims that one of the homeopathic interventions gave the lowest parasitaemias values on particular, arbitrary post-infection days: “9, 13, 15 (p<0.05), 17 (p<0.05), 22, 24 and 28″.  This looks like a case of multiple comparisons and temporal cherry-picking.

If mice are of little relevance, then including a paper on a plant model strikes me as desperate.  Shah-Rossi, Heusser and Baumgartner (2009) experimented on mouse-ear cress, infected with Pseudomonas syringae.  This study is notable for several reasons; first only four of thirty homeopathic preparations yielded statistically significant effects.  Then in a series of repeat experiments only one of these, “induced a significant reduction of the infection rate”.  This sounds less than convincing.  This ‘successful’ preparation was identified as a, “homeopathic complex remedy” known as Biplantol.  The next notable fact was that this only ‘worked’ in its original form, but not in a 30x preparation.  Finally, the authors note that, “The exact composition of Biplantol SOS is not known […] Scientific progress would be expedited if the exact composition would be disclosed to the public.”

Inconsistent results, lots of trials and the only preparation to have an effect had an unknown composition.  This is not really scientific evidence either.

Next the editorial falls into a very common trap.

Coincidentally …

“This extraordinarily large study provides impressive evidence that a nosode in ultramolecular potencies (200c, 10M) prevented a Leptospirosis epidemic following a natural flooding disaster.”

This just revisits the post hoc ergo propter hoc fallacy.  It was certainly large, but it is not impressive.  At best it’s a correlation observed in an un-randomised, un-controlled intervention for a highly variable weather-dependant disease, in a region where conventional measures were also used.  There is absolutely no evidence that the magic water prevented anything.

Of mountains and molehills

That Roniger and Jacobs (2010) are homeopathic propagandists is clearly seen in a masterly piece of obfuscation.

“The number of cases of Leptospirosis dropped from 38 cases/ week per 100,000 population at the beginning of the study to 3 – 4 cases/week per 100,000 population within three weeks.”

They fail to put this into context: this is the same infection rate that the treated region had in 2004 and the same rate that the ‘untreated’ region had during 2008.  And yet this is built up as a disaster:

“Incidence in the untreated rest of the country (8.8million persons) in both years followed historical trends and correlated with rainfall.”

They do not mention that the ‘intervention’ failed to beat these historical trends to any practically relevant degree.  The comment about rainfall is also misleading – In the rest of Cuba incidence was poorly correlated with rainfall.

For an academic medical researcher and a specialist doctor, the authors seem to have no idea of what constitutes a good trial design.

Well designed?

“The non-randomized cohort design may explain why this innovative and well-designed study with its remarkable results was rejected by conventional journals.”

It is hard to see how a trial with no meaningful control groups or randomisation of any kind can be described by serious medical researchers as “well-designed”.  Given its severe methodological flaws it’s easy to see how journals not run by homeopaths for homeopaths decided to pass.

“In retrospect, it has been suggested that randomization could have been done by province to maximize the rigor of the study design.”

This looks like part of the reason that journals with decent standards have declined to publish the paper.  To imply that the suggestion is unhelpful hindsight is to acknowledge that these authors didn’t take rigorous design seriously.  Randomization is an indispensible scientific tool, which should not be lightly cast aside.

“However, the lack of randomization is strongly counterbalanced by the sheer size of the study, the clear time correlations, and the large drop in incidence rates compared to historical trends.”

It is not possible to use size to counterbalance lack of randomisation.  Without randomisation to internal control groups there is no way to account for differences in the behaviour of individuals – important for a disease like this where personal protective measures matter, or the risk associated with locations – vital where the source of the infection is localised to contaminated water sources.

Neither are the time correlations clear.  The majority of the drop in the rate of incidence came two weeks into the exercise.  Accounting for a typical week-long incubation period this means that the bulk of the effect came within a week.  Although the authors do not say what coverage they had achieved by this point, the evidence in the paper suggests that this was around 40%.

Finally, the drop in incidence only returned the situation to that prevailing in the intervention region throughout 2004.

“[…] the clear time correlations, and the large drop in incidence rates compared to historical trends. It is hard to imagine that such an impressive study of a conventional medicine or vaccine would not be published in a major medical journal, especially given the sample size of 2.3 million subjects.”

Given the weaknesses in the trial methodology it would have been a huge surprise if this had been published in a major medical journal.  However, it is clear that something happened to lower infection rates in the intervention region.  If not homeopathy, then what was it?

No other explanation?

Roniger and Jacobs (2010) cannot see past homeopathy as the explanation.  Neither are they able to see that Bracho et al (2010) were not really interested in alternative explanations.

“Other possible explanations for these findings were explored by the authors but cannot explain the results.”

This statement is just not true.  They approached this question from the opposite direction – expounding the reasons it had to be the homeopathy that did it.  Here are three straightforward explanations that they did not consider in any serious way:

1. Improved implementation of personal protective measures due to the focus given to controlling Leptospirosis by health workers visiting nearly everybody four times during the full trial period, and an extensive media campaign.
2. Better identification of individuals at risk through health workers visiting nearly everybody four times during the full trial period, enabling more effective use of proven interventions (vaccine and antibiotic).
3. The good luck of intervening at the peak of a problem that had been building since 2005, benefitting from regression to the mean.

In fact, their “innovative” trial design means that these more plausible explanations cannot be excluded.  It looks like the approach taken by Bracho et al (2010) shows an extreme care to avoid testing their fragile hypothesis: very unscientific.

Further propagandising for the homeopathic cause is seen in the way that conventional interventions are discussed.

A level playing field?

“Conventional prophylactic measures like vaccination and chemoprophylaxis were evenly distributed over all provinces of Cuba and it was estimated that only 3% of the total population was vaccinated or treated with chemoprophylaxis.”

It’s extremely disingenuous of Roniger and Jacobs (2010) to paint the picture in this way.  Bracho et al (2010) concede that conventional measures were used for outbreak control.  This necessitates an uneven distribution of the measures – as outbreaks, by definition, are not evenly spread over the population.

“This contrasts with an astonishing coverage of 92% of the cohort with the homeopathic nosode,”

The conventional measures also have demonstrable efficacy, whereas the homeoprophylaxis does not.  The ‘coverage’ – an undefined term – is remarkable.  Unfortunately its just alcohol in water!

No apologia for homeopathy would be complete without a dig at the pharmaceutical industry.

The Big Farmer

“even a less effective homeoprophylactic nosode could be easily construed as competition since it is cheap, safe and can be quickly produced in large quantities – at least in Cuba.”

This is arguing that homeopathy may not be ideal, but it’s relatively cheap.  The idea of ‘treating’ people with a few drops of magic water seen in this context is dangerous.  It’s a con, a sop to the populace, pretence of helping.  The real issue is how to make effective measures available.

The editorial then moves on to discuss a wider agenda that they think this trial could help to advance.

Homeopaths running wild

“Homeoprophylaxis with nosodes could be a bridging device in a serious epidemic for the period until a fully effective vaccine is available. In less serious diseases, it could be the only prophylaxis offered. The lack of side effects, low cost, and rapid speed of manufacture and deployment would make it acceptable for use in large populations. Coverage of animal vector populations with the nosode may also be feasible.”

These are grand designs built on a foundation of sand. The trial that they are commenting on provides no evidence that homeopathic nosodes work.

“Future studies of homeopathic nosodes would be relatively easy to implement and should also assess in more detail the effect on morbidity and complication rates, as well as economic impact. Studies of homeoprophylaxis using nosodes in animals should also be considered, perhaps as a prelude to clinical testing in humans.”

This just promises more bad trials measuring more things in the hope of striking it lucky.

“However, research could be hindered by perceived competition with conventional vaccines. Therefore other common infections with significant morbidity and/or mortality lacking effective and/or feasible conventional treatment, such as dengue fever, malaria, and antibiotic-resistant bacterial infections should be targeted first. In spite of our lack of theoretical understanding of homeoprophylaxis, ethical approval of future studies will be facilitated by this impressive study by our Cuban colleagues.”

This position beggars belief.  First off, there are highly effective interventions for malaria ranging from vector control and bite prevention through to treatment (WHO, 2010).  For a medical doctor to suggest otherwise shows, at best, staggering ignorance; malaria is also serious and potentially life threatening.  It is highly unethical to propose the use of pretend medicine for a dangerous problem.

Whilst dengue is not, at present, treatable, vector control and bite prevention are vital.  Magic water is just a dangerous distraction.

Antibiotic resistant infections are treatable with specific antibiotics.  MRSA, for instance, is Methicillin-resistant and can be treated with some antibiotics.   Again, a keen focus on prevention is also vital.  For an NHS doctor to even suggest treating a significant problem afflicting hospital care with delusional interventions is worrying.

It’s disturbing that they confess a “lack of theoretical understanding of homeoprophylaxis” without seeing this as any sort of ethical impediment.  Of course there is a “lack of theoretical understanding”; there is no reasonable scientific hypothesis on the table to account for any putative “effects” of homeoprophylaxis.

“There is currently a crisis around the scientific credibility of homeopathy. The British Medical Association has called for a funding stop of Homeopathy on the NHS and all British Homeopathic NHS Hospitals. Additionally it is urging pharmacists to put homeopathic remedies on shelves labeled “placebos”. The Science and Technology Committee of the UK House of Commons recently declared that the question of homeopathy being a placebo is ‘scientifically settled’.⁹ While this was refuted by the British Homeopathic Association,¹⁰ we urgently need an easily replicable model for a line of research into ultramolecular effects. Homeoprophylaxis could be exactly that, demonstrating replicable results in potencies beyond Avogadro’s number. Infectious diseases are still the bane of humanity, particularly in the developing world. Effectively reducing their morbidity and mortality using homeopathic nosodes could have immediate practical and economic impacts.

There is not so much a “crisis around the scientific credibility of homeopathy” as a closer focus on the quality of the supporting evidence.  Judged against any reasonable scientific standards, homeopathy has no scientific credibility.  The balance of the clinical evidence demonstrates that any effect is a placebo effect (Shang et al, 2005).  Further, there is no evidence that homeopathy is effective for any single condition (Linde et al, 1997) – precisely the issue that concerns patients.

Given that there is no real evidence that it works, its not surprising that there is no credible mechanism by which “potencies beyond Avogadro’s number” could have any specific effect.  These are the considerations that informed the clear and well founded judgement of The Science and Technology Select Committee.

Could the British Homeopathic Association have really refuted this position?  Only in the sense of saying that they “refute” it.  Of course, saying something is so, doesn’t make it so.  The BHA’s response shows the usual reliance on counting numbers of RCTs and calling failure to outperform an entirely inert placebo ‘inconclusive’.   Of course, if you are looking for evidence to support the use of any intervention a failure to beat a placebo is a negative outcome.

In part 2^* of the BHA’s response they claim that:

“there have been 87 RCTs that studied the efficacy of a given homeopathic medicine: 37 of them reported positive findings (see also the BHA’s supplementary memorandum, Ev 53–59 of printed report).  Of 50 other RCTs of this nature, 2 were negative and 48 were inconclusive.”

This translates to 100 negative trials out of 137; or put another way 73% of the RCTs failed to demonstrate that homeopathy is anything more than a placebo.  Neither does that bare statistic account for the potential for bias in the “positive” trials, the 1-in-20 lottery of statistical significance or the question of clinical significance.  This is hardly a refutation of the Committee’s conclusion.  It’s more like a confirmation.

The idea that Homeoprophylaxis could be an, “easily replicable model” for, “ultramolecular effects” is not supported by the evidence.  Frankly, it’s a homeopathic pipe dream.  With no evidence of effect or credible mechanism, talking about economic benefits is pure fantasy.

“While homeoprophylaxis studies are in principle easy to replicate, one needs to consider that the credibility of study results also hinges on the reputation of the institution which produced it. Study designers should therefore seek the collaboration of respected research institutions.”

Roniger and Jacobs (2010) show some awareness of homeopathy’s credibility gap.  How do they seek to address this?  Rigorous trials perhaps?  No, they want to hitch their wagon to prestigious institutions.  I would say that such institutions should be careful not to allow homeopathic fantasists to ensnare them in this way.  Also, this provides yet more evidence of the desperation of these propagandists.

The bottom line

So, what do I make of this editorial?  Roniger and Jacobs (2010) make the usual mistake of assuming that correlation is causation, falling for the post hoc ergo propter hoc fallacy.  This is bad enough for medical researchers.  But, it gets worse when they try to argue that sheer size compensates for lack of control or randomisation with a disease that depends on local factors (water sources and weather), personal exposure and behaviour.  This shows a tremendously weak grasp of the principles of trial design, further evidenced when they argue that this study is “well-designed” and profess surprise that no decent journal would touch it.  These gaffes should be a source of acute embarrassment for an academic researcher and a doctor.

The obfuscation of the significance of the infection rates – declaring victory when this merely returned to the same level as the rest of the country and the level experienced in the intervention region in 2004 – and the inability to identify alternative explanations mark out the authors as homeopathic apologists and propagandists, not credible researchers.

Neither is it edifying to see an NHS doctor claim that an ethanol and water mix is in any way “similar to a conventional vaccine”.   Finally, the most worrying part of this for me is to see a doctor advancing an ethically indefensible research agenda:

“… other common infections with significant morbidity and/or mortality lacking effective and/or feasible conventional treatment, such as dengue fever, malaria, and antibiotic-resistant bacterial infections should be targeted first.”

This aim is advanced in spite of the homeopaths knowing that they don’t know how their magic water could work.  Claiming that malaria lacks “effective and/or feasible conventional treatment” is unworthy of a doctor.  Finally, antibiotic-resistant bacterial infections are a significant problem in the NHS; even considering treating them with magic water is unconscionable.  Going into print with this nonsense should be terminal for Roniger’s career.

Disclaimer

I try to make sure that what I write is both accurate and fair.  If you think that I have got anything wrong please let me know.  If you are right I will happily change what I have written.

This is not medical advice.  If you need that see a properly qualified and registered doctor.

Related Posts

Here Is the News – my review of The Faculty of Homeopathy press release.

Much ado about nothing – my review of Bracho et al (2010).

Homeoprophylaxis: An idea whose time has come—and gone – Peter Lipson’s more elegant dismissal of Bracho et al (2010) on Science Based Medicine.

Dilutions of Grandeur – my review of an even worse paper on homeopathic prophylaxis and treatment of dengue in Brazil.

Dengue: magic water and the great social mobilization – How  homeopathy can be used as a cover for improving conventional interventions.

Dengue: betting on homeopathy? – Another homeopathic press release.

Notes

* http://www.britishhomeopathic.org/media_centre/news/st_part2.html

References

Guidelines for the treatment of malaria. World Health Organization, 20, avenue Appia, 1211 Geneva 27, Switzerland: WHO Press; 2010. Available from: http://www.who.int/malaria/publications/atoz/9789241547925/en/index.html.

de Almeida LRR, Campos M, Herrera HMM, Bonamin LVV, da Fonseca AHH. Effects of homeopathy in mice experimentally infected with Trypanosoma cruzi. Homeopathy : the journal of the Faculty of Homeopathy. 2008 April;97(2):65–69. Available from: http://dx.doi.org/10.1016/j.homp.2008.02.009.

Bracho G, Varela E, Fernández R, Ordaz B, Marzoa N, Menéndez J, et al. Large-scale application of highly-diluted bacteria for Leptospirosis epidemic control. Homeopathy. 2010 July;99(3). Available from: http://dx.doi.org/10.1016/j.homp.2010.05.009

Jonas WB. Do homeopathic nosodes protect against infection?  An experimental test. Alternative therapies in health and medicine. 1999 September;5(5):36–40. Available from: http://view.ncbi.nlm.nih.gov/pubmed/10484829.

Linde K, Clausius N, Ramirez G, Melchart D, Eitel F, Hedges LV, et al. Are the clinical effects of homeopathy placebo effects?  A meta-analysis of placebo-controlled trials. Lancet. 1997 September;350(9081):834–843. Available from: http://view.ncbi.nlm.nih.gov/pubmed/9310601.

Mroninski CRL, Adriano EJ, Mattos G. Meningococcinum, Its protective effect against Meningococcal disease. Homoeopathic Links;14(4):230–234. Available from: http://www.medizinverlage.de/html/10192051.html.

Roniger H, Jacobs J. Prophylaxis against Leptospirosis using a nosode: Can this large cohort study serve as a model for future replications?  Homeopathy. 2010 July;99(3):153–155. Available from: http://dx.doi.org/10.1016/j.homp.2010.06.004.

Shah-Rossi D, Heusser P, Baumgartner S. Homeopathic treatment of Arabidopsis thaliana plants infected with Pseudomonas syringae. TheScientificWorldJournal. 2009;9:320–330. Available from: http://dx.doi.org/10.1100/tsw.2009.38.

Shang A, Huwiler-Müntener K, Nartey L, Jüni P, Dörig S, Sterne JA, et al. Are the clinical effects of homoeopathy placebo effects?  Comparative study of placebo-controlled trials of homoeopathy and allopathy. Lancet. 2005 September;366(9487):726–732. Available from: http://dx.doi.org/10.1016/S0140-6736(05)67177-2

Edits

None yet!

[BPSDB]

These days scientific papers are often accompanied by a press release.  It gives the journal or institution at which the work was done a chance to highlight what they think the main message from the work is.  Some might even see it as applying some PR spin.  The recent paper on a trial of homeopathy on a Leptospirosis outbreak in Cuba (Bracho et al, 2010) has its own accompanying press release.  It’s from the Faculty of Homeopathy, the representative body for the UK’s medically qualified homeopaths, whose stated aim is to promote, “… the academic and scientific development of homeopathy. It ensures the highest standards in the education, training and practice of homeopathy”.

It’s instructive to see what message the UK medical homeopath’s representative body is trying to get into the minds of press and public.

First it’s no surprise that they welcome this apparently successful trial with open arms.  Homeopathy, is the journal of The Faculty of Homeopathy.  The paper appears to confirm the view of The Faculty and provide some justification for its work.  So what message do they want people to take away from this publication?  Is it an accurate reflection of the work?  Let’s have a look and see:

“It provides fascinating evidence that a highly dilute substance, prepared according to homeopathic principles, may contribute to the prevention of Leptospirosis” [emphasis mine throughout]

This is misleading, and given the expert nature of the source of this press release I wonder whether this is deliberate or not.  The trial did not use “a highly dilute substance” it used a liquid that had been shaken in a container that had once contained the substance; but that was either 199 or 9,999 cycles of shaking and emptying ago.  The most concentrated form of the medicine diluted the initial preparation to one part in 10⁴⁰⁰.  Simply put, there’s no substance left in this homeopathic medicine; it’s all been washed away.

So why talk as though there is something left?  Is it perhaps a ruse to make the claims seem more believable to a general audience?  Maybe they are trying to by-pass the most obvious and oft made criticism of homeopathy: that there’s nothing in it.  There was a time when I thought that homeopaths used highly-dilute substances.  Just maybe the press release is aimed at this blind-spot in the collective consciousness.

Moving on to the press release’s interpretation of the paper, it makes this claim about Leptospirosis.

“Its incidence correlates closely with heavy rainfall and subsequent flooding”

It’s probably a reasonable general observation.  But it’s not a good piece of context for this work.  First, the paper only presents rainfall data for five years – a pretty short length of time over which to establish a correlation.  Second, my analysis of the data shows that while there appeared to be reasonable correlation in the area the homeopathic treatment was applied, in the rest of Cuba the correlation appears to be poor.  This indicates that conventional approaches can combat the risks posed by rain.

“Within a few weeks the number of cases had fallen from 38 to 4 cases per 100,000 per week, significantly fewer than the historically-based forecast for those weeks of the year.”

This clearly aims to make an impressive point, and it’s straight from the paper, so reflects it fairly.  However, the press release like Bracho et al (2010) fail to mention that this just returned the region to its 2004 level of Leptospirosis – when it didn’t use homeopathy – a level typical of the rest of the country.  This is quite a nice propaganda technique – presenting something that is true, but removing it from a context that would help someone draw ‘off message’ conclusions.

“The 8.8 million population of the other provinces did not receive homeopathic treatment and the incidence was as forecast.”

This tries to imply that something bad happened in the rest of the country, it did not.  The incidence rate for Leptospirosis for the whole of 2007 was 16.7 cases/week per 100,000 inhabitants for the Intervention Region (IR) and 3.5 in the rest of Cuba.  In 2008 these weekly rates ran at 2.7 and 4.3 respectively.

The un-spun truth is that in both treated and untreated regions, the Leptospirosis rate was in the same “3 – 4 cases/week per 100,000″ range over the course of 2008 (Roniger and Jacobs, 2010).  The untreated region did just as well as the treated one.  Not a message that the Faculty of Homeopathy wants anyone to spot.

“The effect appeared to be sustained: there was an 84% reduction in infection in the treated region in the following year (2008) when, for the first time, incidence did not correlate with rainfall.”

This is another nice bit of spin.  By mentioning “The effect” they are inviting the reader to see homeopathy as the cause.  All the paper presents is a temporal correlation in an un-controlled, un-randomized trial.  Correlation is, of course, not causation.  Also, the use of percentages will turn out to dramatise the relative changes.

“In the same period, incidence in the untreated region increased by 22%.”

Yes, in the untreated region weekly cases shot up from 3.5 cases/week per 100,000 to 4.3.  Still around 3 – 4 cases/week per 100,000.  This bit of the press release is basically spinning natural variation in the rate as some sort of indictment of not having homeoprophylaxis.  The percentages help sell the story.  This trick is popular with mainstream authors and journalists hoping to make an effect look more sizable.

Next, some expert homeopaths are deployed to sell the results.  It’s more persuasive to be told something by a named person.

“Infectious diseases are still the bane of humanity, particularly in the developing world”, states Dr Sara Eames, President of the Faculty of Homeopathy. “Anything which appears to reduce infection rates in a potentially fatal infection, particularly when it can be prepared and delivered quickly, safely and cost effectively, has to be taken seriously and studied further.”

There is nothing wrong with the first half of the statement.  It’s motherhood and apple pie.  The second half is another story.  The “Anything” which “appears” to work is not likely to include the homeopathy.  As I argued in my earlier piece on this paper, the most likely culprits are improved uptake of conventional controls, antibiotic and vaccine intervention in high-risk groups and outbreaks, or just regression to the mean.

Certainly looking at how to maximize the impact of conventional controls is a very important topic and should be, “taken seriously and studied further.”  However, with finite healthcare resources, magic water formulation and dispensation should not the taken seriously.  Further study would just be wasteful.

Cuba already has an effective vaccine.  Antibiotic treatment using Doxicycline, as the paper inadvertently shows, is highly effective for outbreak control.  Given that the authors attributed the rise in Leptospirosis in the IR from 2005 – 2007 to, “the implementation of policies promoting agriculture and animal breeding that caused rapid and continuous changes in the size and composition of risk groups, making identification difficult” attention should be given to better identification of those at risk.  Magic water is just a distraction.

This is a smoke-and-mirrors plea for indulgence.  It’s initially hard to argue with doing “anything” to help with “a potentially fatal infection”.  However, it is really arguing for the diversion of resources on a wild goose chase – that is not justifiable in dealing with an infection for which effective control strategies, prophylaxis and treatments already exist.

“Dr Peter Fisher, Editor of Homeopathy, notes “This is a very large study and its results, if confirmed, have huge potential impact.  We need more research into the effectiveness of homeopathic preparations in preventing infectious diseases, complications, and the economic viability of a homeopathic approach.””

Some caution is evident in the tone struck by the usually relatively sensible Dr Peter Fisher.  It implies the need for confirmation; however it’s essentially the same pitch for a diversion of resources from the effective to the delusional.  It also contains an element of the agenda explicitly developed in the accompanying editorial (Roniger and Jacobs, 2010): the expansion of homeoprophylaxis and treatment to other dangerous diseases.  Again, it’s slick media technique: use what you are promoting to advance your broader agenda.

All press releases accentuate the positive.  The techniques used here are all too common.  I find it interesting that this bunch of homeopaths seem keen to side-step the issue of what’s actually in their potions.

It’s worrying to see them use an uncontrolled, un-randomised trial badly reported in a pseudojournal to promote the idea that specially shaken water needs to be taken seriously for preventing infectious diseases.  Now that’s a positively dangerous message.

I try to make sure that what I write is both accurate and fair.  If you think that I have got anything wrong please let me know.  If you are right I will happily change what I have written.

This is not medical advice.  If you need that see a properly qualified and registered doctor.

Much ado about nothing – my review of Bracho et al (2010).

Homeoprophylaxis: An idea whose time has come—and gone – Peter Lipson’s more elegant dismissal of Bracho et al (2010) on Science Based Medicine.

Dilutions of Grandeur – my review of an even worse paper on homeopathic prophylaxis and treatment of dengue in Brazil.

Dengue: magic water and the great social mobilization – How  homeopathy can be used as a cover for improving conventional interventions.

Dengue: betting on homeopathy? – Another homeopathic press release.

Bracho G, Varela E, Fernández R, Ordaz B, Marzoa N, Menéndez J, et al. Large-scale application of highly-diluted bacteria for Leptospirosis epidemic control. Homeopathy. 2010 July;99(3). Available from: http://dx.doi.org/10.1016/j.homp.2010.05.009

Roniger H, Jacobs J. Prophylaxis against Leptospirosis using a nosode: Can this large cohort study serve as a model for future replications?  Homeopathy. 2010 July;99(3):153–155. Available from: http://dx.doi.org/10.1016/j.homp.2010.06.004.

13/08/2010 – Typo corrected and the status of The Faculty of Homeopathy better described. Thanks to David Waldock for spotting these.

[BPSDB]

So, the much-trailed^* paper on the homeopathic intervention in an outbreak of Leptospirosis in Cuba during 2007 has finally been published (Bracho et al, 2010) along with a very useful companion editorial (Roniger and Jacobs, 2010).

The editorial claims that, “the size of the population treated and the dramatic decrease in disease incidence compared to previous years make it difficult to dismiss these results as spurious or occurring by chance.”

Before finding it quite easy to dismiss these results, some background information on Leptospirosis is in order.

Humans catch the disease by coming into contact with animal urine, usually as a contaminant of water.  The spirochetes gain access through breaks in the skin, the eyes or mucous memranes.

The Encyclopædia Britannica (2010) goes on to point out that after an incubation period of around a week^**, “the first symptoms to arise in humans are the abrupt onset of fever, chills, muscle aches, headache, abdominal pain, and vomiting. Another characteristic symptom is congestion of the conjunctival blood vessels around the corneas of the eyes.”

Unpleasantly, “After a latent period of five to seven days, during which the infected person may improve, fever returns and the infection may involve the brain. In a less-common, but more-severe, form of the illness known as Weil disease or icteric (associated with jaundice) leptospirosis, the infected person turns yellow as a result of the destruction of red blood cells and liver disease. The death rate is approximately 30 percent of the severely ill and jaundiced patients.”

The Encyclopædia Britannica (2010) concludes by pointing out that the disease is diagnosed, “by identification of the causative organism in urine or blood and by blood cultures on special media.”

The disease can be treated with antibiotics; this should be done within the first four or five days, as “Antibiotic efficacy drops rapidly after day [five] of symptoms and can be of no benefit whatsoever after day [eight]. Ideally it should be initiated no later than 10 days after exposure”.

Prevention requires limiting exposure to freshwater or mud, covering cuts and grazes, washing after any exposure. If this is not possible, then using waterproof gloves and boots is recommended.  Finally, in affected areas, it is important to only drink sealed bottled water or fresh water that has been boiled.

For individuals who are at risk the antibiotic Doxycycline is used as a phrophylactic.

Clearly, this is a disease that poses relatively little risk in developed countries with good medical infrastructure.  Conversely, in the developing world it is a serious, and sometimes fatal, problem.

Although the Cuban Government has, quite remarkably, developed an effective vaccine for humans (vax-SPIRAL), according to Bracho et al (2010), they have been unable to produce it in sufficient quantities to meet the demand.  In stepped the homeopaths with the suggestion that they could knock something up cheaply and quickly to help with a crisis.

“four highly-diluted strains of inactivated leptospiras: L. interogans Serovar Canicola, L. interogans Serovar Copenhageni, L. kirschneri Serovar Mozdok and L. borgpetrsenii [sic] Serovar Ballum. ^***

As we shall see later, “highly diluted” is not so much an understatement as a misstatement.

They aimed to give this homeopathic prophylactic to:

“The entire population over 1 year of age from the provinces of Las Tunas (LT), Holguı´n (HG) and Granma (GR) in eastern region of Cuba”

This gave a target population of 2.4 million people, of whom they ultimately  ‘treated’ 2.3 million (96%).

The intervention started in week 45 of 2007, “with two oral doses of nosoLEP 200C with an interval between doses of 7 – 9 days. Ten to twelve months later, the schedule was completed by the administration of another two oral doses (7 – 9 days apart) of nosoLEP 10MC.”

How was each individual treated?:

“Each dose consisted of five drops (250 – 300 μL) administred [sic] sublingually 20 m away from eating, smoking or drinking. It was administered by about 5000 personnel of public health system of Cuba which included family doctors, nurses, social workers and paramedics that were trained in the administration procedure.”

This represents a huge effort from healthcare workers.  Although the cost of the preparation must have been small, I am left wondering about the opportunity cost of deploying so many skilled individuals on such a task.

They allowed the publication of specious quantum flapdoodle (Weingartner, 2007; Milgrom, 2007), just plain wrong assertions, childishly transparent ‘mathematical’ reasoning (Weingartner, 2007), obviously sloppy (Rao et al, 2007;  Rey, 2007) and incomplete experiments (Vybiral and Voracek, 2007), clutching at straws (Elia, Napoli and Germano, 2007), and missing the blindingly obvious (Beauvais, 2008) all topped off with authors drawing wild conclusions (e.g. Vybiral and Voracek, 2007).

To their credit, the editors did publish a number of critical letters; though this has had no discernable effect on standards at Homeopathy.  For instance in 2008 they published a ‘special’ homeopath-friendly version (Rutten and Stolper, 2008) of a paper (Lüdtke and Rutten, 2008) re-analyzing the allegedly controversial meta-analysis of Shang et al (2005, 2006).  This was shown to be partisan, error-strewn and rash (Wilson, 2009).  Comparing the two versions shows nicely that this journal is a mouthpiece for homeopathic propaganda^{† †}, not a respectable scientific journal.

Given the lack of scholastic standards at Homeopathy, then this comment from Roniger and Jacobs (2010) really says it all:

“The non-randomized cohort design may explain why this innovative and well-designed study with its remarkable results was rejected by conventional journals.”

A telling admission; it’s clearly been hawked around proper journals and has ended up in Homeopathy.  If it really was an “innovative and well designed study” then it would have been published elsewhere.  Clearly the authors would have preferred this.  Instead it’s ended up in the Homeopath’s trade journal; a remarkable story, given that even good journals can be quite homoeophile.

R Barker Bausell’s advice seems apt at this point^‡:

“Give more credence to trials published in well known medical journal and give no credence at all to those published in CAM journals.”

Good advice, I’m sure.  But in the interests of being overly fair, I’ll plough on anyway.

So the most concentrated form of the medicine diluted the initial preparation to one part in 10⁴⁰⁰!  The highest potency represents a dilution of one part in 10²⁰⁰⁰⁰!!

Given that there are something like 10⁵⁰ atoms in the world, one thing is crystal clear: the manufacturing process washed the bugs clean out of the medicine.  This fact alone rules out the homeopathic preparation having any specific effect against the disease.

Homeopaths may declaim about ‘the memory of water’, but there’s no evidence to support this effect (if you exclude hand waving theories and badly run experiments). It also contradicts the knowledge embodied in modern Chemistry and Physics.  Finally, homeopaths and their apologists tend to gloss over that often water is not the only dilutent.  In this case it’s 30% ethanol in water.  So, what the homeopaths need is ethanol/water memory.  It goes without saying that the evidence for this is even more dilute.

This incredible level of dilution leads to quite odd ‘quality control’ methods:

“The quality of final products was controlled by measuring the alcohol content, water quality, pH and microbiologic load.”

Sensible measures, no doubt, but making a product in which you cannot detect the alleged ‘active’ ingredients should be some sort of red flag.

Korsakovian dilutions, named for Semen Korsakov, essentially make each dilution by filling a container, emptying it, assuming that the volume of liquid adhering to the container wall is sufficient for the dilution ratio claimed, re-filling with dilutent, shaking and repeating the procedure for the desired number of dilutions.  Clearly this is more suited to industrial scale preparation, but seems to be based on a rash assumption.

In essence, the two potencies used were made by washing a flask that been drained of the ‘mother tincture’ either 199 or 9,999 times and accepting the next refill as medicine.  It’s just not plausible.

It also makes the title of the paper, “Large-scale application of highly-diluted bacteria for Leptospirosis epidemic control” misleading.  The bacteria are not “highly-diluted” they have been washed away.  The homeopaths know that to be true.  In the editorial Roniger and Jacobs (2010), bemoan the fact that they could not have this nosode preparation made in Europe because of the need to sterilise animal and disease products, resulting in, “mother tincture will either be free of infectious material or contain infectious organisms changed by heat to be beyond recognition by the immune system.”  They think that this is unfair because:

“… one could easily argue this to be unnecessary because after only a few by conventional definition potentisation steps homeopathic remedies would be sterile (usually 6C)”

Yes, they do understand the Avogadro limit, when it suits them.

Now, given that there is no trace of the inactivated bacteria in the preparations and no credible explanation as to how the washed away bacteria might have influenced the diluent any claims of a real effect would need to be based on an unimpeachable trial design, comprehensively and accurately reported.  However, this is not a well designed trial, as its rejection from credible journals evidences.

Moving on to the design of the trial; it has real problems.

The trial could have been designed with internal control regions.  It would then have been possible to introduce randomization.  A point alluded to in Roniger and Jacobs (2010) editorial:

“In retrospect, it has been suggested that randomization could have been done by province to maximize the rigor of the study design.”

It’s unclear why this wasn’t thought of by the homeopaths.  The slightly sniffy “in retrospect” dismisses a very important aspect of trail design.  Without randomization to an internal control group there is the very real chance that some other change could have caused the sudden, dramatic decline in reported cases.

Perhaps this is why no respectable journal would publish it?

So with no appropriate controls and no randomization, how do the homeopaths know that their intervention made the difference?  Well, actually they are not in a position to claim causation.  All they have is a correlation in an uncontrolled experiment. The authors attempt to address this by the use of predictive models.

Reliance on undefined models

One of their main approaches is to compare what happened in the IR and RC, with what might have been.  To do this they took five “available forecast models” and tested them for, “best fit to temporal series of Leptospirosis cases (dependent) and rainfall (independent variable)”

This seems a very simple approach, so I’m looking for a detailed description of what they did, along with some data to back up their claims.  The authors do provide a little more detail:

“To select the best fitting model, all were tested to determine how well they predicted the real temporal series of 2000 – 2004. The differences between forecast and real values (residual error) were analysed for statistical significance. All models gave similar forecast curves, but simple exponential smoothing was selected as no significant differences were observed when the residual errors were analysed in five out of five different tests with a 95% confidence level while the other five models all failed in one or more tests.”

This seems a very short period over which to calibrate the models, particularly as something happened to make the IR results very different to the rest of Cuba, from 2005 to 2007.

Given the central importance of this technique to the claims, I am surprised that the paper contains no real details of the model used and no results for this selection process.  We are just told that a, ” simple exponential smoothing” model worked best on five years of data.

The authors also say that, “Adjusted forecast curves, lower and upper confidence limits were validated with real data sets from different years”, with no description of how the forecast curves were adjusted.  There is an oblique comment that the models’ predictions were based on disease history and rainfall; indicating some sort of adjustment made on previous years’ data.  Overall the description of the modeling is wholly inadequate given the reliance placed upon it.

There is also something odd about the description of the model selection process.  Elsewhere we are told, “Unfortunately, no data on rainfall are available before 2004.”  If that’s the case how were these models run and assessed?  It could just be poor reporting, but it’s an obvious anomaly in the paper.

So when I’m told that, “A simple exponential smoothing model based on the 2004 – 2007 data was used to estimate the probable trend” I can’t really have much confidence in the predictions of case numbers during the trial period.  Particularly if it’s being taken to indicate that a few drops of 30% ethanol in water is preventing infection.

The campaign started during week 45 of 2007 and the bulk of the effect, for which credit is being claimed, is seen by the end of week 47.  Given a typical one week incubation period, this would mean these people would have been infected in week 46, were it not for the homeopathy.

What level of coverage, I wonder, had the homeopaths achieved by week 46?  The paper does not say, but includes some limited data on the progress of this campaign.  It reports 70% coverage after three weeks (week 48), 92% by week 50 and ultimately 96% coverage, presumably by the end of the year.  This looks to me like I would expect coverage in week 46 to be less than 40% (See below).  I could be wrong, but given the extraordinary nature of the claims made in this paper, I don’t think it unreasonable to query this.

They use this to argue that a peak in the number of reported cases is to be expected during the last few weeks of the year.  However, the range of these data is huge.  For instance, the last week of the year has an historic median of close to 100 cases, but the range runs from around 15 to close to 550.  Accounting for the fact that the IR holds about 21% of the population of Cuba, the bottom of the range could be around three cases for the last week of the year.

Now, this is taking the extreme end of the range of the data.  However, given the relatively short historical dataset (16 years) for a highly variable pattern of disease, the authors’ argument that the year end will always show a spike of Leptospirosis is less than convincing.

Given that they just handed out drops of a water/alcohol mix, I think that arguing that the year-end trends may not have been as the authors assume is not such a stretch.

The authors have an excuse:

“Double blind controlled and randomised clinical trials have been seen as the gold standard to demonstrate efficacy of any health intervention. One limitation of such trials is often the size of the population and the levels of exposure to risk factors. Thus, even when successful results are obtained from controlled trials demonstrating efficacy, the real effectiveness needs to be tested in large populations with high exposure to the target disease, preferably in endemic areas.”

It’s not very convincing.  Here they have access to a large population with substantial exposure to the risk factors.  It would seem that a large randomized control trial would have been well within their means.  But the authors argue that because RCTs produce false positives their uncontrolled, un-randomised methodology is preferable.  This, of course, is even more likely to provide a spurious positive outcome.

Surely it is unethical to subject a large population to an experiment in controlling a serious disease, without evidence from basic scientific investigation or smaller clinical trials to suggest that it might have some worth?

Although rainfall and the number of cases seem to correlate reasonably well for the IR, they don’t for the rest of Cuba (See above).  In fact, in 2008 the data from the IR show the poorest correlation with rainfall.  Rather than making the post-homeopathic treatment IR something special, it has just made it more like the rest of Cuba – where rainfall and Leptospirosis cases don’t seem to correlate very well. This can be seen in the simple plot presented below. The analysis, such as it is is simplistic (just fitting a trendline in Excel), but it’s more analysis than is contained in the paper.

The authors briefly discuss other changes in the IR:

“From 2004 and up to 2007 an increase in the annual incidence of the disease was observed in Cuba, particularly in the IR although there had been no modifications in the strategies for Leptospirosis control. The main cause of this observation is likely to be the implementation of policies promoting agriculture and animal breeding that caused rapid and continuous changes in the size and composition of risk groups, making identification difficult.”

It seems like changes in agricultural practice may have affected the IR, more than the rest of the country.  This seems to have changed who is at risk.  It’s not unreasonable to argue that organizing this study may have facilitated a better identification of those in risk groups.  This would have made the targeted conventional interventions more effective.  So maybe just organizing this trial has helped the interventions that work in the rest of Cuba work in the IR?

A second level of non-specific effect could relate to personal precautions.  As I noted earlier:

“Prevention requires limiting exposure to freshwater or mud, covering cuts and grazes, washing after any exposure. If this is not possible, then using waterproof gloves and boots is recommended.  Finally, in affected areas, it is important to only drink sealed bottled water or fresh water that has been boiled.”

An army of 5,000 health workers visiting (nearly) everybody twice may well have increased compliance with these precautions.  It should have been unconscionable for health workers to have put a few drops of the elixir under the tongue of each person without reminding them of what they could do to protect themselves.  This level of focus might also have made officials responsible for disease prevention look with more care at these regions.

The authors note, in their discussion of the ethics of this trial:

“Information about the product and the intervention was provided by local TV, radio programs, newspapers and was also free available through information desks spread over the IR.”

So there was a comprehensive publicity campaign as well.  Again, I would argue that putting this disease at the forefront of people’s minds is likely to increase compliance with personal protective measures.

“The individuals treated with either vaccination or chemoprophylaxis in the IR amounted to about 3% of the population. Individuals within risk groups were vaccinated when identified with two intramuscular doses (6 – 8 weeks apart) of vaxSpiral following manufacture’s instructions […] Chemoprophylaxis was applied mainly for focal treatment and outbreak control to high-risk groups when identified and consisted of a weekly oral dose of Doxicycline 100 mg.”

Although the reported percentage is small, it nevertheless means that 72,143 high-risk individuals in the IR were treated conventionally.  It is quite possible that this could make a significant impact on the number of cases reported for the IR as a whole.  Particularly as Doxicycline was used for, “focal treatment and outbreak control”.  And the paper does demonstrate the impact Doxicycline can have on an outbreak, and the effect that an outbreak can have on the overall results.

“In week 42 [2008] an outbreak of the disease was reported in a closed population of RC but fortunately was quickly controlled by chemoprophylaxis.”

During this week 116 cases were reported in the the rest of Cuba; by the following week there were around ten. The authors do not state how large this “closed population” was, but the term tends to imply that it’s relatively small. They should really clarify this.

As an aside, this directly contradicts one of the authors’ stated reasons why the homeopathic intervention was the cause.  Discussing the fall in reported cases in the IR during the closing weeks of 2007 they state:

“This sharp decrease of incidence does not suggest an expected effect of vaccination or chemoprophylaxis considering the time needed to induce a protective immune response by vaccines and the short temporal protection of antibiotics.”

And yet this outbreak was knocked on the head in a week, using conventional measures.

The grand claim that this paper makes for the homeopathic intervention is that it caused the fall in weekly cases of Leptospirosis, from 38 to around four, over a three week period.  However, there are no data or analysis in this paper that could rule out the effect being due to targeted intervention with conventional treatments in high-risk groups.

The authors do make a feeble attempt in their discussion section, as the third reason why the homeopathy must have caused the reductions, “coverage of conventional measurement [sic] of control including vaccination and chemoprophylaxis was similar in both regions since their application followed the current guidelines from MPHC”.  As we have seen, the extent of infections in the IR was much greater, so applying the same protocols should have resulted in more conventional intervention in the IR.

How plausible is this as a possible explanation?  If I have to choose between magic water and actual medicines as an explanation, the magic water loses.  If someone expects me to give the magic water credit, they will need something better than the contents of this paper.

Maybe not the strongest candidate for an explanation, but more plausible than magic water, certainly.

The five reasons the authors declare to demonstrate that they must be right are:

Yet, from 2005 – 2007 , the rest of Cuba did much better than the regions included in the IR without resorting to homeopathy.  Even after the improvements in the IR, the level of Leptospirosis is no better than in the rest of Cuba.

Yet more Leptospirosis in the IR should have driven more conventional intervention, if the same rules were used.

So, why couldn’t it have been the homeopathy?  Because there were no inactivated bacteria in the homeopathic preparation.  It would have been a miracle if someone has ingested a single dead bug.  They had all been washed away.

If not the homeopathy, then what caused the change?  No one can know for sure, but here are some massively more plausible explanations:

1. Improved implementation of conventional controls (including change in behaviour of individuals).
2. Conventional antibiotic intervention.
3. Regression to the mean

Finally, the accompanying editorial seeks to support a delusional and dangerous agenda with this flawed paper.

Now they want to move on to other dangerous things …

“However, research could be hindered by perceived competition with conventional vaccines. Therefore other common infections with significant morbidity and/or mortality lacking effective and/or feasible conventional treatment, such as dengue fever, malaria, and antibiotic-resistant bacterial infections should be targeted first. In spite of our lack of theoretical understanding of homeoprophylaxis, ethical approval of future studies will be facilitated by this impressive study by our Cuban colleagues.”

This is a most dangerous proposal.  Dengue fever may not have a specific treatment, but a keen focus on vector control is vital and should not be diluted by homeopathic distractions.  Homeopathic delusions already exist about preventing and treating this disease, it is dangerous to indulge them further.

Effective treatments and control methods do exist for malaria (WHO, 2010).  The editorial is not telling the truth.  Again, vector control and personal protection are vital.  There is no possible role, or ethical justification, for homeopathy in protecting people from this disease.  Delusional homeopaths are already dabbling in Africa, putting lives at risk.  Treating antibiotic resistant infections with magic water are unconscionable.  There is no reason to suppose that homeopathy can be of any benefit.  Using it for a life-threatening condition is a very dangerous proposal.

The idea that this trial could provide an ethical justification for this agenda is unfathomable.  It is an uncontrolled, un-randomized, poorly-reported, piece of homeopathic propaganda published in a pseudojournal.

It ignores plausible explanations in favour of the fantastical.  It’s a cracking example of Cargo Cult science.

The Leptospirosis Information Center

This is not medical advice.  If you need that see a properly qualified and registered doctor.

**NHS Choices summarises the incubation period as, “seven to 14 days after the initial contact with infection, although they can develop in as little as three days, or as long as 30 days.”

***See here for Serological classification and grouping.

†For a reasonably complete summary of the criticisms that were levelled at most of the papers in this ‘special’ issue see my round up, which includes the authors’ responses to the criticisms made, or visit the Journal Club which ran at Bad Science – where all the papers are available in full.  For a good example of the homeopathic apologists failing to engage with any sunstntial criticisms, see Kerr et al (2008) and the reply made by Rao (2008).

† † The authors did respond to the criticisms made by Wilson (2009), but failed to address the key issues.

‡ See mine and the inimitable Dr Aust‘s take on the alternative reality of CAM advocates and their use of ‘special’ journals to enable this.

‡ ‡ See also these articles by Wallace Sampson on the Science-Based Medicine blog: Homeocracy, Homeocracy II, Homeocracy 3, Homeocracy IV , which give a comprehensive analysis of Jacobs’ work in this area.

leptospirosis. (2010). In Encyclopædia Britannica. Retrieved August 05, 2010, from Encyclopædia Britannica Online: http://www.britannica.com/EBchecked/topic/336973/leptospirosis

Beauvais F. Memory of water and blinding. Homeopathy. 2008 January;97(1):41–42. Available from: http://dx.doi.org/10.1016/j.homp.2007.10.001.

Bracho G, Varela E, Fernández R, Ordaz B, Marzoa N, Menéndez J, et al. Large-scale application of highly-diluted bacteria for Leptospirosis epidemic control. Homeopathy. 2010 July;99(3). Available from: http://dx.doi.org/10.1016/j.homp.2010.05.009

Elia V, Napoli E, Germano R. The ’Memory of Water’: an almost deciphered enigma. Dissipative structures in extremely dilute aqueous solutions. Homeopathy. 2007 July;96(3):163–169. Available from: http://dx.doi.org/10.1016/j.homp.2007.05.007

Jacobs J, Gloyd SS, Gale JL, Jimenez LM, Crothers D. Treatment of Acute Childhood Diarrhea With Homeopathic Medicine: A Randomized Clinical Trial in Nicaragua. Pediatrics. 1994 May;93(5):719–725. Available from: http://pediatrics.aappublications.org/cgi/content/abstract/93/5/719.

Jacobs J, Guthrie BL, Montes GA, Jacobs LE, Mickey-Colman N, Wilson AR, et al. Homeopathic Combination Remedy in the Treatment of Acute Childhood Diarrhea in Honduras. The Journal of Alternative and Complementary Medicine. 2006 October;12(8):723–732. Available from: http://dx.doi.org/10.1089/acm.2006.12.723.

Kerr M, Magrath J, Wilson P, Hebbern C. Comment on “The defining role of structure (including epitaxy) in the plausibility of homeopathy”. Homeopathy : the journal of the Faculty of Homeopathy. 2008 January;97(1). Available from: http://dx.doi.org/10.1016/j.homp.2007.10.004.

Lüdtke R, Rutten AL. The conclusions on the effectiveness of homeopathy highly depend on the set of analyzed trials. Journal of Clinical Epidemiology. 2008 December;61(12):1197–1204. Available from: http://dx.doi.org/10.1016/j.jclinepi.2008.06.015.

Milgrom L. Conspicuous by its absence: the Memory of Water, macro-entanglement, and the possibility of homeopathy. Homeopathy. 2007 July;96(3):209–219. Available from: http://dx.doi.org/10.1016/j.homp.2007.05.002.

Rao M, Roy R, Bell I, Hoover R. The defining role of structure (including epitaxy) in the plausibility of homeopathy. Homeopathy. 2007 July;96(3):175–182. Available from: http://dx.doi.org/10.1016/j.homp.2007.03.009.

Rao M. Authors’ reply to Kerr et al. Homeopathy. 2008 January;97(1):45–46. Available from: http://dx.doi.org/10.1016/j.homp.2007.11.011.

Rey L. Can low-temperature thermoluminescence cast light on the nature of ultra-high dilutions?  Homeopathy. 2007 July;96(3):170–174. Available from: http://dx.doi.org/10.1016/j.homp.2007.05.004.

Roniger H, Jacobs J. Prophylaxis against Leptospirosis using a nosode: Can this large cohort study serve as a model for future replications?  Homeopathy. 2010 July;99(3):153–155. Available from: http://dx.doi.org/10.1016/j.homp.2010.06.004

Rutten AL, Stolper CF. The 2005 meta-analysis of homeopathy: the importance of post-publication data. Homeopathy. 2008 October;97(4):169–177. Available from: http://dx.doi.org/10.1016/j.homp.2008.09.008.

Rutten ALB, Stolper CF. Reply to Wilson. Homeopathy. 2009 April;98(2):129. Available from: http://dx.doi.org/10.1016/j.homp.2009.01.002.

Shang A, Huwiler-Müntener K, Nartey L, Jüni P, Dörig S, Sterne JA, et al. Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy. Lancet. 2005 September;366(9487):726–732. Available from: http://dx.doi.org/10.1016/S0140-6736(05)67177-2

Shang A, Jüni P, Sterne JAC, Huwiler-Müntener K, Egger M. Are the clinical effects of homoeopathy placebo effects? – Authors’ reply. The Lancet. 2006 January;366(9503):2083–2085. Available from: http://dx.doi.org/10.1016/S0140-6736(05)67881-6.

Vybiral B, Voracek P. Long term structural effects in water: autothixotropy of water and its hysteresis. Homeopathy. 2007 July;96(3):183–188. Available from: http://dx.doi.org/10.1016/j.homp.2007.03.007.

Weingartner O. The nature of the active ingredient in ultramolecular dilutions. Homeopathy. 2007 July;96(3):220–226. Available from: http://dx.doi.org/10.1016/j.homp.2007.05.005.

Wilson P. Analysis of a re-analysis of a meta-analysis: in defence of Shang et al. Homeopathy. 2009 April;98(2):127–128. Available from: http://dx.doi.org/10.1016/j.homp.2008.12.003.

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