The 30 Second Skinny A study into a homeopathic preparation of the neem tree has been promoted as evidence that homeopathy can be used against malaria. However, the study raises many concerns. Results of the two year trial were being published after only six months, but no later version of the paper seems to exists. It also didn't compare the treatment against a placebo, and recruited people who had had malarial attacks in the last twelve months, making its six month reporting of little value. It is worrying that advocates of homeopathy deny clinical trials are capable of proving homeopathy works, yet at the same time use flawed trials in order to claim homeopathy has some robust evidence supporting it.
Merseyside Skeptics recently made the point, in their 10:23 campaign, that it is pretty mcuh a waste of time debating whether or not homeopathy is effective for anything with people who believe in it because there is little consistency or logic to their argument. This was exemplified in the evidence check recently where a homeopathic entrepreneur explained that the problem with a lot of the meta-analyses (which tend to suggest homeopathy is not effective) are flawed because they rely on studies with small sample sizes. Later on in the panel, he was asked if he could name a double-blind randomised placebo-controlled clinical trial and decided to eschew his previous misgivings and refer to a small sample study. It is not just that proponents of CAM cherry pick their evidence, they also will routinely flip-flop over their position on clinical proof itself. Homeopathy is "clinical trial proof" until a trial comes along that seems to demonstrate efficacy.
An example of this came to light from the Twitterverse being waved by @ltlmtnhomeopath. It is particularly incendiary because it suggests homeopathy can be used as a preventative measure for malaria. Homeopathic treatment for malaria has become a bit of a cornerstone for the UK skeptic movement, inasmuch as it shows the ugly dangerous side of something that most run-of-the-mill people who prefer a bit of evidence with their physic consider to be a pointless but harmless treatment. Here's a blogpost from DC's Improbable Science that goes into this in more detail.
Anyway enough yakking, here's the evidence that @ltlmtnhomeopath feels it worth her while to publicise, and to save you the jump, here's the abstract...
Introduction
In natural medicine, the neem tree (Azadirachta indica) is recognized as an effective treatment for many diseases and is used for treatment of bacterial, viral, fungal infections and for the treatment of malaria. A homeopathic formulation has been used since the year 20001 for the prevention and treatment of malaria and appears to be safe and effective. Resistance to neem has not been found in many hundreds of years of use across the world.2
Materials and methods
The purpose of the study was to research whether the daily use of homeopathic neem medication decreases the number of malaria attacks within 6 months and up to 2 years of treatment in a population of both children and adults in the area of Musoma, Tanzania. This was a single arm3, prospective, observational trial in subjects with recurrent malaria attacks in an at-home setting. The 6 months follow-up data are presented here. Efficacy data was based on subject reports gathered by questionnaires. Malaria symptoms were not objectified by a clinical diagnosis. The homeopathic medicine used in the trial is an ethanol based tincture carrying the medicinal properties of the neem leaves4.
Results
152 patients were enrolled in the trial: 79 children with a mean age of 11 years (4-18) and 73 adults with a mean age of 37 years (19-93). The group of children consisted of 37 girls and 42 boys. All subjects reported at least one malaria episode in the previous 12 months. In the study population as a whole, 5% reported an increase of malaria attacks at 3 months and 7% at 6 months. 38% reported no change at 3 months, decreasing to 13% at 6 months. The percentage of subjects who reported a decrease of malaria episodes increased from 57% at 3 months to 81% after 6 months of treatment. Compliance was low in the first 3 months of treatment in the children group. Up to 68% of the children took less than the prescribed amount of study medicine in the first 3 months. This improved after adding the remedy to drinking water in the following 3 months. In contrast, 89% of the adults took the remedy as intended or took more than the intended prophylactic dose. There were no reports of side-effects during the treatment.
Conclusions
The homeopathic neem preparation has shown to be effective for the reduction of malaria attacks in a highly endemic area for plasmodium falciparum5. The treatment is safe in the short term and the low cost of manufacturing renders this treatment especially attractive for developing countries as the purchase cost is well within the range of an average household budget.6
Notes arising...
1 A homeopathic treatment ought to cure like with like; here it seems a homeopathic preparation of a herbal remedy is being used.
2 There is no clinical proof of efficacy prior to this trial, so there can be no proof of "resistance" or otherwise to neem. I suspect that all malaria is resistant to homeopathic neem, but don't let my bias spoil things.
3 This is a single arm trial; the results cannot be compared against a no treatment or placebo arm, so we will find out exactly nothing from it. I hope this was made clear when recruiting the 152 people to the trial.
4 Again it is unclear as to whether this is genuinely a homeopathic remedy or some aqua vita.
5 This is supposed to be a prospective study, so the suggestion is that positive results will encourage further research in a more controlled way. Suddenly, though, we have leapt to a declaration that neem works and...
6 ...is easily marketable.
What I find most appalling about this is that it is talking about repeat malarial attacks, use a selection criteria that specifies at least a single attack in the last twelve months, but publishes its results after six months, long before the end of what was apparently supposed to be a two year trial. Also, much of the data is hidden away in percentages and arbitrary groupings. People kept diaries to keep tabs on their malarial attacks, so we ought to know at least how many attacks they suspected they had in the previous year (this was part of the selection criteria after all) and how many attacks occured in the six months covered by the diaries. In fact the number of attacks during the trial are not taken into account. The report states "Subjects were asked to indicate whether the frequency of malaria attacks had decreased, remained the same or increased after the start of the study treatment," (emphasis added). The statistics do not come from the number of attacks, but on the subjective views of the individual test subjects.
Imagine that you had a single malarial attack eight months prior to joining the trial, and then subsequently had no malarial attacks for the first three months. You certainly couldn't say that your attacks had increased if you'd had none at all, which leaves you with the possibility that you'd experienced no change, which would be the safest option, or if you were a happy camper, you might feel that you were experiencing fewer attacks than you'd had in the previous twelve months. Three months is less than twelve months, so I would hope very much that the study indicated high scores for "no change" or "reduction in attacks". The context of the attacks of the previous year would also be worth exploring, along with any changes of behaviour as a result of that attack. Did their brush with death lead them to beg, borrow or steal a mosquito net, for instance?
The data covers a period in 2005. I'd be very keen to see how the study progressed. I'd be very keen to know if the study was even concluded, so sure the writers seem in their conclusions. I'd be very keen to know if any of the subjects died during the trial, which was a tragic likelihood even across the six month span of data scrutinised by this paper.
But the point isn't really to demonstrate how the trial was run in such a way that a positive result seemed inevitable, it is that people who believe in homeopathy feel vindicated by these pieces of shoddy research, and never seem to show any interest in applying rigour in their reading of them. They would rather embrace and publicise flawed evidence, and to hell with the consequences. To echo Merseyside Skeptics, there is rarely much to be gained from discussing the evidence with them. They probably feel the same way about us "dinosaurs" with our 21st century evidence based attitude to their 19th century magic. Much better to save our energies for protest and action that will genuinely make a difference, to campaign for an evidential base to the policies of entities commercial and governmental concerning treatments for which their remains little or no evidence, to turn our attentions to NICE and Boots, rather than to attempt to change the beliefs of @ltlmtnhomeopath and her like, dangerous as they are.
1 A homeopathic treatment ought to cure like with like; here it seems a homeopathic preparation of a herbal remedy is being used.
2 There is no clinical proof of efficacy prior to this trial, so there can be no proof of "resistance" or otherwise to neem. I suspect that all malaria is resistant to homeopathic neem, but don't let my bias spoil things.
3 This is a single arm trial; the results cannot be compared against a no treatment or placebo arm, so we will find out exactly nothing from it. I hope this was made clear when recruiting the 152 people to the trial.
4 Again it is unclear as to whether this is genuinely a homeopathic remedy or some aqua vita.
5 This is supposed to be a prospective study, so the suggestion is that positive results will encourage further research in a more controlled way. Suddenly, though, we have leapt to a declaration that neem works and...
6 ...is easily marketable.
What I find most appalling about this is that it is talking about repeat malarial attacks, use a selection criteria that specifies at least a single attack in the last twelve months, but publishes its results after six months, long before the end of what was apparently supposed to be a two year trial. Also, much of the data is hidden away in percentages and arbitrary groupings. People kept diaries to keep tabs on their malarial attacks, so we ought to know at least how many attacks they suspected they had in the previous year (this was part of the selection criteria after all) and how many attacks occured in the six months covered by the diaries. In fact the number of attacks during the trial are not taken into account. The report states "Subjects were asked to indicate whether the frequency of malaria attacks had decreased, remained the same or increased after the start of the study treatment," (emphasis added). The statistics do not come from the number of attacks, but on the subjective views of the individual test subjects.
Imagine that you had a single malarial attack eight months prior to joining the trial, and then subsequently had no malarial attacks for the first three months. You certainly couldn't say that your attacks had increased if you'd had none at all, which leaves you with the possibility that you'd experienced no change, which would be the safest option, or if you were a happy camper, you might feel that you were experiencing fewer attacks than you'd had in the previous twelve months. Three months is less than twelve months, so I would hope very much that the study indicated high scores for "no change" or "reduction in attacks". The context of the attacks of the previous year would also be worth exploring, along with any changes of behaviour as a result of that attack. Did their brush with death lead them to beg, borrow or steal a mosquito net, for instance?
The data covers a period in 2005. I'd be very keen to see how the study progressed. I'd be very keen to know if the study was even concluded, so sure the writers seem in their conclusions. I'd be very keen to know if any of the subjects died during the trial, which was a tragic likelihood even across the six month span of data scrutinised by this paper.
But the point isn't really to demonstrate how the trial was run in such a way that a positive result seemed inevitable, it is that people who believe in homeopathy feel vindicated by these pieces of shoddy research, and never seem to show any interest in applying rigour in their reading of them. They would rather embrace and publicise flawed evidence, and to hell with the consequences. To echo Merseyside Skeptics, there is rarely much to be gained from discussing the evidence with them. They probably feel the same way about us "dinosaurs" with our 21st century evidence based attitude to their 19th century magic. Much better to save our energies for protest and action that will genuinely make a difference, to campaign for an evidential base to the policies of entities commercial and governmental concerning treatments for which their remains little or no evidence, to turn our attentions to NICE and Boots, rather than to attempt to change the beliefs of @ltlmtnhomeopath and her like, dangerous as they are.
Little Mountain Homeopath? Ah, Sonya McLeod. http://www.littlemountainhomeopathy.com/ It is worth reading Skeptic North's stuff on her including http://www.somecanadianskeptic.com/2009/09/homeopathy-attempting-to-strike-in.html
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