Shaken, Not Stirred

The government’s Science and Technology Sub-Committee recently heard evidence on the efficacy of Homeopathy from many experts and scientists in the field. Today, they have concluded that the NHS should cease funding homeopathy:

“It also concludes that the Medicines and Healthcare products Regulatory Agency (MHRA) should not allow homeopathic product labels to make medical claims without evidence of efficacy…

The Committee carried out an evidence check to test if the Government’s policies on homeopathy were based on sound evidence…..the Government acknowledges there is no evidence that homeopathy works beyond the placebo effect (where a patient gets better because of their belief in the treatment).”¹

Homeopathy is a commonly suggested remedy for pregnant women, babies and children. The NHS even has four homeopathic hospitals and estimates it spends around £4million a year on homeopathic treatments² (not including running and maintaining the hospitals). The USA is alleged to have spent close to half a billion dollars on homeopathy in 1999. Personally, I have heard of people having real success with teething granules and our midwife suggested homeopathic arnica tablets post birth. Others say there is no scientific evidence that homeopathy is any more effective than taking a sugar tablet.

Why is homeopathy so revered by some and reviled by others? Should you and your baby take homeopathic remedies?

What is Homeopathy?

The Society of Homeopaths describes homeopathy as

“a system of medicine which is based on treating the individual with highly diluted substances given in mainly tablet form, which triggers the body’s natural system of healing. Based on their experience of their symptoms, a homeopath will match the most appropriate medicine to the patient”

Homeopathy was discovered by Samuel Hahnemann (1755-1843) he believed that, by vigorously shaking the original substance in water, the substance leaves behind a “spirit-like” essence that while being “no longer perceptible to the senses” is “remembered” by the water. In Hahnemann’s day when curing illness the symptoms were the thing to focus on. He believed that “like cures like”, so the cure needed to replicate the symptoms. If a cold caused watery eyes and a runny nose, and so did an onion, then an onion was the thing to cure a cold. This approach would have the potential to aggravate the condition, which is not what the aim was, so he deduced that the way to cure the problem was to use diluted versions of these remedies. By reducing the medicines, Hahnemann noticed that their effects were less damaging (which makes sense – a small amount of arsenic is bound to be less damaging than a large amount, regardless of what you are hoping to cure with it) – he then came to

Homeopathic remedies are diluted to such a degree that no discernible molecules of the original substance remain.

the conclusion that this was because the more dilute the remedy, the more potent it was. So he took a natural substance (crushed), put it in water or alcohol, then took a drop of that solution and diluted it, and took a drop of that and diluted it, and so on. Between dilutions he would vigorously shake or bang the solution on a springy surface (known as succession).

The homeopathic “Principle of Similars” (the theory that “like cures like”) leads to an approach which allows the body to heal itself. However, this theory has been refuted.

So, how does it work? From the Society of Homeopaths:

“Scientifically it cannot yet be explained precisely how homeopathy works, but new theories in quantum physics are going some way towards shedding light on the process. What we do know is that a carefully selected homeopathic remedy acts as a trigger to the body’s healing processes.”

Quantum physics? OK, let’s start there.

Bear with me here, one of the guys who came up with Quantum theory has said it is so weird it is fundamentally incomprehensible…. Put simply, Quantum theory describes the relationship between energy and matter on the atomic and subatomic levels. Put very simply, Quantum mechanics explains how very very small things behave. Things so small we can’t actually see them; we can only ascertain what they are doing by the effect they have on other things. That is why the theory works so well for homeopathy – the molecules of the original substance that are left in the water are so small that we have to rely on the effect that they have on the person who consumes the tablet to know that they are there and working. Unfortunately, we know that something does not have to be potent in any way for it to have an effect on someone – that is why placebos (i.e. sugar tablets that people are told will make them feel better) work. More on this later. For me Quantum Theory does not give me any reason for homeopathy to work. So, the jury is still out as to why homeopathy succeeds – if it works at all.

There has been research that suggests that “homeopathic water” and ordinary water are not the same. For example, a popular article “proving” this claimed to show that even though they should be identical, the structure of hydrogen bonds in pure water is very different from that in

Does water have a memory?

homeopathic dilutions of salt solutions. This confuses me – it seems that the water only remembers what the homeopath wants it to – i.e. the “substance” being used to cure the disease. For some reason it doesn’t “remember” the tea bag seeped in it, the fish that drank it, or the urinary tract it once went through. This was raised in the recent Parliamentary briefing about homeopathy:

“Dr Harris [Member: Science and Technology Sub- Committee]: On that basis then why is it that when you have a solution of water that used to have some homeopathic substance in it but it has been diluted that the water is said to retain that memory but does not remember all the poo, you could call it, that has been in it, because all water has bits of our effluent.”³

Doubt has been cast on the research mentioned above. The researcher tested frozen samples bathed in radiation and measured the peaks of light released as they warmed up (the peaks are stored energy being released). The sample which had the diluted chemical (10^-30 grams per cubic centimetre) released different peaks to pure water and a saline solution. However, the process of freezing the water would have rearranged the hydrogen bonding. Also, tiny impurities or inefficient mixing could have lead to the same results³. Others disagree with these criticisms, saying that the research was carried out scrupulously and these possibilities could not account for the results.

The theory that water has a “memory” came from Jacques Benveniste⁴, who claimed to have found that water had a memory of a substance if it was violently shaken prior to dilution. When his study was replicated with other scientists, the results could not be replicated and further studies have also failed to replicate them⁶. Benveniste claimed this is because his original methods were not adequately followed. This would lead me to be concerned that – even “the water has memory” theory is true – if a group of scientists cannot replicate the effect under controlled conditions, how do we know that the people making homeopathic tablets are following the protocol strictly enough for it to work? This concern was touched on in the Parliamentary briefing:

“Dr Harris: How much do you have to shake it?

Dr Fisher [Director of Research, Royal London Homeopathic Hospital]: That has not been fully investigated.

Dr Harris: A random amount of shaking?

Dr Fisher: You have to shake it vigorously but exactly how much you have to shake it, no. If you just gently stir it, it does not work.”³

So, let’s look at the evidence that homeopathy works. Or doesn’t. Firstly, anecdotal – and here I point out very very fervently: the plural of anecdote is anecdotes, not data. Hundreds, thousands, probably millions of people swear by homeopathy. Unless they all took part in a randomised, controlled, double-blind, peer reviewed piece of research their experiences cannot be considered proof. Why not? Because there are many reasons why people experience a positive effect from treatment such as homeopathy that does not prove that the tablets have any potency.

The Placebo Effect

The placebo effect: tablets do not have to contain any active ingredients to have an effect

Don’t rule out the placebo effect, and don’t think that it means that the effect is not worth something. We have a long way to go to figure out why a placebo works, but measurable biochemical effects can be found following someone taking nothing more than a sugar tablet. The placebo effect is strongly linked to the cultural meaning of the treatment (4 sugar tablets clear up ulcers more quickly than 2 sugar tablets)⁸.

In fact, there is evidence that the placebo effect is becoming stronger (which is causing huge problems for drug companies who have to prove their drugs are better than a placebo). In November 2008, a new type of gene therapy for Parkinson’s disease was withdrawn from Phase II trials after it did not show a good enough effect against a placebo, trials for a treatment for Crohn’s disease were stopped after an “unusually high” response to placebo, and in the same year volunteers testing a drug for schizophrenia showed double the expected level of placebo response. Studies have also shown that the response to well known drugs (i.e. antidepressants) compared to a placebo has changed significantly since the 1980s, with some suggesting the placebo effect has nearly doubled⁹.

The “placebo effect” (or something similar) has been found to work in animals and babies – why is this? Well, babies and animals alike respond to their parents’ (or owners) expectations and behaviour⁸. When we think someone is ill, we usually treat them as if they are ill, if we think they are getting better we treat them differently. However, importantly, the placebo effect only works if people (or parents, or owners) do not know they are taking a placebo. Interestingly, there is also a “Nocebo” effect – if you have negative expectations, you may experience negative symptoms (which is why some people may experience side effects from a placebo¹²¹³¹⁴).

Other Effects

Another important reason for some homeopathic treatments to work that is slightly different from the placebo effect is the mode of delivery. The teething granules, for example, that many parents find to be helpful in relieving symptoms of teething, are (as their name suggests) granulated. Babies may find the granules themselves comforting or distracting and they therefore experience some relief.

Furthermore, medicines given at the same time can confuse the evidence when relying on anecdotes – using the example of the teething granules again, these are sometimes given alongside baby Bonjela or Calpol, making it impossible to know which treatment is the effective one.

Peer reviewed “scientific evidence”

“Chairman: In terms of Government policy in terms of homeopathy you are not really saying that it is evidence-based other than that there is a community who believe that they work?
Mr O’Brien: Yes.”³

“Chairman: …. do they work beyond the placebo effect?

Mr Bennett [Professional Standards Director and Superintendent Pharmacist, Boots]: I have no evidence before me to suggest that they are efficacious, and we look very much for the evidence to support that”³

This second quote is slightly alarming, inferring as it does, that those that sell homeopathic remedies – such as Boots – believe that there is no scientific evidence supporting homeopathy.

So, why do some people see evidence where others do not? Some research indicates that there is a measurable effect for homeopathy above that expected for a placebo. However, analyses of the available research indicates that the sample sizes are often very small (a review of 40 randomized controlled trials found that the median number of patients per group was only 28¹⁰). It seems that, for every article which proposes evidence supporting homeopathy, someone else can cite one that shows that it is no more effective than a placebo. One way of summarising the evidence is to look at meta-analyses of published papers – these analyses review the available literature and analyse the findings – in this case looking at papers on homeopathy and seeing whether, when you pool all the data, there is a clinically significant result. This means that these papers benefit from a much larger sample size than the original papers alone. These reviews, however, are not infallible – some research may be missed, and the researcher may unconsciously affect the results through their own bias.

There have been hundreds of systematic analyses of available studies. Rather than go through them all here, there is a paper that has done that for me – an analyses of the analyses. In 2002 Ernst attempted to review all available articles since 1997¹¹. He reviewed 17 meta analyses and found that there was no evidence that homeopathy is any more effective than a placebo and concludes that homeopathy should not be considered an evidence-based treatment – it is worth noting here, that Ernst is the Director of the Complementary Medicine Group at the Peninsula Medical School and a qualified Homeopath, so if any researcher bias was present one would expect it to be pro, rather than against homeopathy.

At the Science and Technology Sub-Committee evidence hearing, the British Homeopathic Association (BHA) claimed that:

“Four out of five comprehensive systematic reviews of RCTs in homeopathy have reached the qualified conclusion that homeopathy differs from placebo”²

However, on further investigation by Ernst disputed this. He analysed the five reviews:

1. The Kleijnen review is now 18 years old and thus outdated.
2. Boissel et al merely combined p-values of the included studies. This article is now also outdated. Furthermore it is not unambiguously positive.
3. Cucherat et al is the publication of the Boissel document which was a EU-sponsored report. [The authors themselves noted that “there is some evidence that homeopathic treatments are more effective than placebo; however, the strength of this evidence is low because of the low methodological quality of the trials.”
4. Linde et al has been re-analysed by various authors, including Linde himself, and all of the 6 re-analyses (none of which were cited in the BHA’s submission) have come out negative.
5. Shang et al very clearly arrived at a devastatingly negative overall conclusion.²

When presented with all the evidence, the Parliamentary Science and Technology Sub-Committee concluded that:

“In our view, the systematic reviews and meta-analyses conclusively demonstrate that homeopathic products perform no better than placebos. The Government shares our interpretation of the evidence. We asked the Minister, Mike O’Brien, whether the Government had any credible evidence that homeopathy works beyond the placebo effect and he responded: “the straight answer is no”"²

Conclusions

Could homeopathy cause harm to you or your baby? No, unless you take homeopathic remedies when you should be taking medicine that has been recommended by your medical professional. Other than a placebo effect, which you or your baby may experience, the only actual effect, it seems, will be to your bank balance. Some forms of homeopathic treatment, like teething granules, may help your baby due to their texture.

However, we should not rule out the placebo effect – it can be very potent and it does lead to people feeling better. It is not, however, evidence to support the widespread use of homeopathy.

References

http://www.parliament.uk/parliamentary_committees/science_technology/s_t_pn21_100222.cfm
http://www.publications.parliament.uk/pa/cm200910/cmselect/cmsctech/45/4504.htm#a4
http://www.publications.parliament.uk/pa/cm200910/cmselect/cmsctech/uc45-i/uc4502.htm
Youngson, R & Schott, I. 1996. Medical Blunders. Robinson Publishing Group; UK
E. Dayenas; F. Beauvais, J. Amara , M. Oberbaum, B. Robinzon, A. Miadonna, A. Tedeschit, B. Pomeranz, P. Fortner, P. Belon, J. Sainte-Laudy, B. Poitevin and J. Benveniste (30 June 1988). “Human basophil degranulization triggered by very dilute antiserum against IgE” (PDF). Nature 333: 816–818. doi:10.1038/333816a0.
P. Ball (8 August 2007). ”Here lies one whose name is writ in water”. Nature. doi:10.1038/news070806-6.
7. Milgrom, L. 2003. Icy claim that water has memory. New Scientist.
Goldacre, B. 2007. A Kind of Magic? The Guardian, Science. 16^th November 2007. http://www.guardian.co.uk/science/2007/nov/16/sciencenews.g2
Silberman, S. 2009. Placebos are getting more effective. Drug companies are desperate to know why. Wired Magazine. 17:09
Hill, C. & Doyon, F. 1990. Review of randomized trials of homeopathy. Rev Epidemiol Sante Publique. 38(2):139-47.
Ernst, E. 2002 A systematic review of systematic reviews of homeopathy Br J Clin Pharmacol. 54(6): 577–582.
Myers MG, Cairns JA, Singer J. 1987 The consent form as a possible cause of side effects. Clin Pharmacol Ther. 42(3):250-3.
Liccardi G, Senna G, Russo M, Bonadonna P, Crivellaro M, Dama A, D’Amato M, D’Amato G, Canonica GW, Passalacqua G. 2004 Evaluation of the nocebo effect during oral challenge in patients with adverse drug reactions. J Investig Allergol Clin Immunol. 14(2):104-7.
Levine, M.E, Stern, R.M., Koch. K.L. 2006. The Effects of Manipulating Expectations Through Placebo and Nocebo Administration on Gastric Tachyarrhythmia and Motion-Induced Nausea Psychosomatic Medicine 68:478-486

Baby: Manual Not Included