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Old 20th March 2009, 04:36 PM   #1
Badly Shaved Monkey
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Homeopathic "trial"

Vet Record 164 364-370 for those who have access.

15/20 dogs did not get better on homeopathy even in an open study!

3/5 dogs who improved while taking the sugar pills went on to a blinded phase. 3/3 owners guessed right as to which was placebo and which was verum.

They cite Rao (2007) and mysteriously forget to mention that this was holed below the waterline by our favourite moggy, Rolfe, and her colleagues. They also cite Linde (1997), perhaps assuming that no one would notice.

I'm waiting for the homs to issue a press release, that's when the fun will start.
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Old 20th March 2009, 06:08 PM   #2
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Oh, maybe I should tear open the poly bag on this one....

Rolfe.
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Old 20th March 2009, 07:22 PM   #3
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Whats the normal recovery rate for whatever was being studied?
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Old 21st March 2009, 01:42 AM   #4
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Originally Posted by Rolfe View Post
Oh, maybe I should tear open the poly bag on this one....

Rolfe.
The resemblance of that bag to a poop-scoop is not coincidental. May I suggest a clothespeg on your nose.

By the way, your JREF PM InBox is full. I've sent you an e-mail with some thoughts on a response.
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Old 21st March 2009, 01:54 AM   #5
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Originally Posted by geni View Post
Whats the normal recovery rate for whatever was being studied?
Well, there's one of many interesting points.

It was an open trial of n=20 with a tiny blinded phase at the end (3/20).

They assert that the literature suggests that atopy is a "incurable disease requiring lifelong management" based on a citation, but this presumably accords with dermatological orthodoxy.

They use that reasonable assertion to express interest that any of their 20 got better, which is less reasonable. Improvement of clinical signs in a minority over the period of study in a predominantly young population (median age 2y 7m) doesn't strike me as especially amazing, particularly in a study that followed them for only a few months where any improvement cannot meaningfully be equated with permanent resolution and in which they still received their steroids and immunotherapy desensitising injections. Only 1 out of 20 showed such improvement that all conventional treatment was withdrawn during the study period. That I do not find very impressive and nor do I regard that as fundamentally contradicting an assertion drawn from a textbook that the disease should be regarded as lifelong.
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Old 21st March 2009, 02:00 AM   #6
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p.s. I can already imagine the homs' usual passive-aggressive reaction.

[bleating voice]Please don't hit us with your full rhetorical armoury. We kept pointing out that it was only a pilot and only intended to establish the basis for a larger trial. Big boys made us get it published in Vet Record and include a whole load of unfounded speculation and duff literature citations. It's not fair of you to be nasty to us. We didn't mean half the abstract to be about the three dogs who got to the blinded phase. Haven't you ever published a multi-author paper in your leading professional journal by accident??[/bleat, whinge, whine]
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Old 21st March 2009, 03:47 AM   #7
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OK, this leads to one of my statistical questions.

(and this would be easier if even the abstract was available online, which it is not yet)

Behind this study is the assertion by one of the authors in communication with one of the others that they should expect a 60-70% positive response rate. I think I'd have predicted the same given the background of unblinded uncontrolled customer satisfaction surveys.

J Altern Complement Med. 2005 Oct;11(5):793-8.
Comment in:
J Altern Complement Med. 2006 Mar;12(2):103; author reply 103.
Homeopathic treatment for chronic disease: a 6-year, university-hospital outpatient observational study.

Spence DS, Thompson EA, Barron SJ.
RESULTS: A total of 6544 consecutive follow-up patients were given outcome scores. Of the patients 70.7% (n = 4627) reported positive health changes, with 50.7% (n = 3318) recording their improvement as better (+2) or much better (+3). CONCLUSIONS: Homeopathic intervention offered positive health changes to a substantial proportion of a large cohort of patients with a wide range of chronic diseases. Additional observational research, including studies using different designs, is necessary for further research development in homeopathy.

Homeopathy. 2007 Jan;96(1):27-34. Links
Erratum in:
Homeopathy. 2007 Apr;96(2):140.
Outcomes from homeopathic prescribing in veterinary practice: a prospective, research-targeted, pilot study.

Mathie RT, Hansen L, Elliott MF, Hoare J.
RESULTS: Practitioners submitted data regularly and punctually, and most data cells were completed. 767 individual patients were treated (547 dogs, 155 cats, 50 horses, 5 rabbits, 4 guinea-pigs, 2 birds, 2 goats, 1 cow, and 1 tortoise). Outcome from two or more homeopathic appointments per patient condition was obtained in 539 cases (79.8% showing improvement, 6.1% deterioration, 11.7% no change; outcome not recorded in 2.4% of follow-ups). Strongly positive outcomes (scores of +2 or +3) were achieved in: arthritis and epilepsy in dogs and, in smaller numbers, in atopic dermatitis, gingivitis and hyperthyroidism in cats. CONCLUSIONS: Systematic recording of data by veterinarians in clinical practice is feasible and capable of informing future research in veterinary homeopathy. A refined version of the spreadsheet can be used in larger-scale research-targeted veterinary data collection.


Having 75% failing to improve must have come as a bit of a blow. Given the structure of the study, they had only one properly testable hypothesis and that was that there should be a 60-70% positive response in the open phase.

What would be the appropriate way to test the predicted response rate versus actual response rate? Prediction 60%. Actually 5/20.
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Old 21st March 2009, 05:21 AM   #8
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Originally Posted by Badly Shaved Monkey View Post
15/20 dogs did not get better on homeopathy even in an open study!
Particularly striking when you realise that some of the reasons given for other owners who were invited but declined to participate in the trial were, "a desire to start conventional treatment" and, "reluctance to consider homeopathy" so any sceptics were automatically weeded out meaning that from the outset the population of owners in the trial was open to the possibility that homeopathy might help.

I predict that this will be lauded as a great triumph by the homs - 25% positive response rate when treating a condition incurable by conventional meds and published in a peer reviewed, core veterinary journal - too good an opportunity to miss.

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Old 21st March 2009, 06:09 AM   #9
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Originally Posted by Yuri Nalyssus View Post
I predict that this will be lauded as a great triumph by the homs - 25% positive response rate when treating a condition incurable by conventional meds and published in a peer reviewed, core veterinary journal - too good an opportunity to miss.
Funny you should say that (and, no, we don't have a press release yet), but here is what the authors themselves say;

In a study such as this, a consideration of the failure rate is required as well as of the potential successes

as well as????

This gem came quite late in the Discussion after an awful lot of puffery. I don't have a digital copy so I'll revert to a Hogwarts method of textual meta-analysis. The Discussion is 20.4 inches long. The necessity of considering reasons for failure comes at 15-inches.
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Old 21st March 2009, 01:46 PM   #10
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Originally Posted by Badly Shaved Monkey View Post
3/5 dogs who improved while taking the sugar pills went on to a blinded phase. 3/3 owners guessed right as to which was placebo and which was verum.

What did the blinded phase involve? And why were the other two not included?
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Old 21st March 2009, 02:55 PM   #11
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Link to the abstract here:

http://veterinaryrecord.bvapublicati...act/164/12/364
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Old 21st March 2009, 05:25 PM   #12
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Originally Posted by Mojo View Post
What did the blinded phase involve? And why were the other two not included?
One had no residual clinical signs that could be trialled on therapy.

The other was put to sleep after a status epilepticus episode. It had a prior diagnosis of epilepsy and was on treatment.

Strangely the idea that this might have been an aggravation or proving symptom seems not to have occurred to the authors, which was convenient.

The "blinded" was described as "blinded, randomised, placebo-controlled" and "cross-over". And, yes, that was with a grand total of n=3. No complete description of the blinding is given, but it is said that "The owners were blinded to the content of the vials". Sounds single blinded to me. We are not told whether the experimenters were in attendance or communication with the owners when they scored their animal's pruritus.
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Old 21st March 2009, 05:29 PM   #13
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From the abstract;

"In the other five cases, the owners believed that the homeopathic treatment was associated with a substantial improvement"

How the hell does a phrase like that get through any competent scrutineering process into a supposedly scientific journal. This is why you do blinded controlled studies, for feck's sake!
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Old 21st March 2009, 06:35 PM   #14
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The Vet Record's scrutineering process is a joke. A bad joke. Martin Alder has heard my opinion on it several times. They repeatedly and persistently do not send papers to people who can critique them properly. And that goes for mainstream papers as well. I don't know why the journal has the reputation it has. The only reason it has some very good papers is that some very good papers are submitted to it.

Rolfe.
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Old 21st March 2009, 06:51 PM   #15
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Originally Posted by Badly Shaved Monkey View Post
Well, there's one of many interesting points.

It was an open trial of n=20 with a tiny blinded phase at the end (3/20).

They assert that the literature suggests that atopy is a "incurable disease requiring lifelong management" based on a citation, but this presumably accords with dermatological orthodoxy.

They use that reasonable assertion to express interest that any of their 20 got better, which is less reasonable. Improvement of clinical signs in a minority over the period of study in a predominantly young population (median age 2y 7m) doesn't strike me as especially amazing, particularly in a study that followed them for only a few months where any improvement cannot meaningfully be equated with permanent resolution and in which they still received their steroids and immunotherapy desensitising injections. Only 1 out of 20 showed such improvement that all conventional treatment was withdrawn during the study period. That I do not find very impressive and nor do I regard that as fundamentally contradicting an assertion drawn from a textbook that the disease should be regarded as lifelong.
All the dogs were still receiving steroids?
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Old 21st March 2009, 07:02 PM   #16
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Wait a minute... dog number 16 was clairvoyant??!
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Old 22nd March 2009, 12:54 AM   #17
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Originally Posted by kellyb View Post
All the dogs were still receiving steroids?
Oh, yes. There is not enough detail to say what proportion of them were on what doses. The clients were also given steroids to use in the face of acute deteriorations. Which patients used how many steroids over the study is not reported. So we have no idea whether variations in conventional meds caused the variations in outcome. If this was applied to a larger set of animals they'd need a very large number to adequately balance the characteristics of these heterogeneous subjects.

Which is yet another reason why a design that leads them to burn through 85% of their experimental subjects before they even get to the controlled phase is doomed to failure.
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Old 22nd March 2009, 12:56 AM   #18
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Originally Posted by Rolfe View Post
The Vet Record's scrutineering process is a joke. A bad joke. Martin Alder has heard my opinion on it several times
And I think this needs to be pointed out in public and in private in our response to this.
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Old 22nd March 2009, 01:24 AM   #19
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Originally Posted by Badly Shaved Monkey View Post
Oh, yes. There is not enough detail to say what proportion of them were on what doses. The clients were also given steroids to use in the face of acute deteriorations. Which patients used how many steroids over the study is not reported. So we have no idea whether variations in conventional meds caused the variations in outcome. If this was applied to a larger set of animals they'd need a very large number to adequately balance the characteristics of these heterogeneous subjects.

Which is yet another reason why a design that leads them to burn through 85% of their experimental subjects before they even get to the controlled phase is doomed to failure.
WOW!
This is a really, amazingly terribly designed study.

eta:
The abstract seems inherently misleading if the dogs were still receiving steroids, too. It seems it should be titled "homeopathy as an adjuvant therapy for pruritus associated with atopic dermatitis in dogs"...
Right?

So, were the dog owners also regularly in contact with the (unblinded) homeopath (s?) who knew which dogs were receiving which water?

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Old 22nd March 2009, 03:59 AM   #20
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Originally Posted by kellyb View Post

So, were the dog owners also regularly in contact with the (unblinded) homeopath (s?) who knew which dogs were receiving which water?
It does not say explicitly but it is implied that it was only single blind. Which would be astonishing, but I think it is true.

Can you get access to the full-text online?

You also make a very good point about the title.
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Old 23rd March 2009, 06:11 AM   #21
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Originally Posted by Badly Shaved Monkey View Post
The other was put to sleep after a status epilepticus episode. It had a prior diagnosis of epilepsy and was on treatment.

Strangely the idea that this might have been an aggravation or proving symptom seems not to have occurred to the authors, which was convenient.

http://www.ncbi.nlm.nih.gov/pubmed/15532700

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Old 23rd March 2009, 06:34 AM   #22
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Originally Posted by Mojo View Post
Hey, it's like they think they're handing out real drugs.

Oh, I love it when they play at doctors. I'll bet they've even got white coats and little plastic stethoscopes.

"Stethoscope works, listen to the heartbeat!"
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Old 23rd March 2009, 12:14 PM   #23
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Well, it says the three dogs in the final analysis were on no medication throughout the study period. I vote accidental (or not so accidental, depending on your level of cynicism) unblinding.

But also...

Quote:
The owners were asked
to give the pills labelled X first and to score the level of pruritus seven
days later. The pills labelled Y were given two weeks after those labelled
X if the dog was still pruritic, or whenever pruritus recurred.
Doesn't it seem like that's setting the owners up to think X is the "remedy"?

Sure would be nice to know which ones got the "placebo" first. There's a chance that all of them got the placebo first. Which would completely explain the results.
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Old 23rd March 2009, 12:42 PM   #24
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OK, here's the spin:

Only a quarter of the dogs showed an improvement. This shows that it definitely wasn't the placebo effect, as this would have affected all the dogs equally. So the five positive reactions must have been caused by the homoeopathy.

If you think this argument is too dumb to be used even by homoeopaths, think again:
Originally Posted by metube View Post
If it was actually the placebo effect, why is the placebo effect so inconsistent? My belief in Homeopathy doesnt waiver, the pills are taken, I should be consistently getting cures and the subjective experience of the remedy taking hold. Why then do I only have success rate of say one in three or four? If its the placebo effect occuring, I would think it would be more reliable than that.
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Old 23rd March 2009, 12:58 PM   #25
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For the 5 dogs that got better over the course of the first 60 days, that could have been a genuine coincidental improvement. In fact, three of 5 are described as having "received intermittent glucocorticoids for two to four years before entering the study", implying that their allergies wax and wane. The first phase of 20 dogs simply selected the 5 in a natural "waning" phase.
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Old 23rd March 2009, 01:52 PM   #26
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Originally Posted by Mojo View Post
OK, here's the spin:

Only a quarter of the dogs showed an improvement. This shows that it definitely wasn't the placebo effect, as this would have affected all the dogs equally. So the five positive reactions must have been caused by the homoeopathy.

If you think this argument is too dumb to be used even by homoeopaths, think again:
Reminds me of the ridiculous "Psi-Missing" effect. The results are so bad, it MUST be magic!!!
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Old 23rd March 2009, 02:16 PM   #27
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OK, the homs are having difficulty spinning this one into very much.

http://www.facultyofhomeopathy.org/m...dog_study.html

Mind you they still seem to be labouring under that fatal misapprehension of what a trial is about;

"The other four dogs that responded well in this first phase were then put forward into a blinded randomised trial in which they received their homeopathic prescription at some times and placebo at other times. "

You don't get to call them responders unless you compare them to a control, which they didn't do.

Hey, I just rolled 20 dice and got two 6's. I propose that these two responders should be enrolled in a trial to study them further.

It's the usual pattern. They think they already know it works. Controlled trials are just for decoration and, by definition, any improvement seen in any patient is caused by homeopathy, but any deterioration will be ignored or boasted about depending on which version of their ever-changeable story they are trying to tell.

One wonders why the conventional vets didn't see how this would get misused. The shoddiness of the work and its reporting were all so predictable.
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Old 23rd March 2009, 02:21 PM   #28
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Originally Posted by kellyb View Post
Well, it says the three dogs in the final analysis were on no medication throughout the study period. I vote accidental (or not so accidental, depending on your level of cynicism) unblinding.

But also...



Doesn't it seem like that's setting the owners up to think X is the "remedy"?

Sure would be nice to know which ones got the "placebo" first. There's a chance that all of them got the placebo first. Which would completely explain the results.
Too late to edit...
I meant to say it seem like that's setting the owners up to think Y is the "remedy".
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Old 23rd March 2009, 02:35 PM   #29
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Originally Posted by Badly Shaved Monkey View Post
... It's the usual pattern. They think they already know it works. Controlled trials are just for decoration and, by definition, any improvement seen in any patient is caused by homeopathy, but any deterioration will be ignored or boasted about depending on which version of their ever-changeable story they are trying to tell.
Ah, the healing crisis. Yes, the patient is getting better, that's why he's getting worse.

Originally Posted by Alex Hankey
Characteristic reactions to prescribed remedies result in the most spectacular cases, differing completely from improvements seen in placebo cases, where pathology improves without a “healing crisis.” In my opinion, conducting trials on cases for which such extreme reactions may be expected would be the best way to demonstrate that potentized remedies do indeed have systematic, observable physiologic effects. If a “healing reaction” is induced by taking a homeopathic remedy, as often occurs on the path to cure, only the remedy could have produced it. What better proof could be given of actual physiologic effects of taking a potentized remedy?
http://www.liebertonline.com/doi/abs.../acm.2009.0069
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Old 23rd March 2009, 04:05 PM   #30
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Originally Posted by Badly Shaved Monkey View Post
it is said that "The owners were blinded to the content of the vials".
A vial of plain lactose tablets smells completely different to a vial which has been treated with a drop or two of homeopathic alcohol.

When attempting a small trial a few years ago the difference between the two was so obvious that I had to send to a homeopathic supplier for a vial of pure (non-homeopathic) alcohol to drop onto my blanks to make them smell the same as the "real" thing. The paper doesn't seem to say whether the placebos were prepared in this way, if they weren't it calls the blinding process into doubt.

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Old 23rd March 2009, 04:51 PM   #31
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Originally Posted by Badly Shaved Monkey View Post
Hey, I just rolled 20 dice and got two 6's. I propose that these two responders should be enrolled in a trial to study them further.

OK, confession, I haven't read this rubbish yet. But BSM, isn't that your letter to Alder? It's a cracker.

We could try for more signatories than there are words in the letter....

Rolfe.
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Old 24th March 2009, 07:26 AM   #32
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Originally Posted by Rolfe View Post
OK, confession, I haven't read this rubbish yet. But BSM, isn't that your letter to Alder? It's a cracker.

We could try for more signatories than there are words in the letter....

Rolfe.
Letter drafted. Very long at the moment. Not sure how much to cut out. I've included a bit about the dice, but you're right, the pithy version is just that sentence.
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Old 24th March 2009, 08:21 AM   #33
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A couple of comments.

The literature review doesn’t support their methodology. In the discussion on the nature of homeopathic remedies, they reference Rao et al. as evidence that different homeopathic remedies can be distinguished from one another, even though all should contain ‘nothing but water’. Of course Rao et al. worked with ethanol, not water. They use the same reference to speculate that nanobubbles resulting from succussion have gaseous inclusions that possibly contain the remedy source material! All of which is highly speculative and unsupported by the references they cite, but lets them say that ‘a fixation on the fundamental problem of Avogadro’s number may be innapropriate’.

But after having made the case for nanobubbles in water, what do they use for treating the dogs? Lactose tablets. Why homeopaths don’t see this as a problem is beyond me. They use Rao’s terribly designed study on ethanol remedies as support for epitaxy in water, then go on to run a trial that uses neither water nor ethanol based remedies.

The second thing that stuck with me is wondering what the hell the dermatologists were doing. We are told that the owners attended a homeopathic consultation conducted by a veterinary homeopath, with one of the dermatologists in attendance. The owners were asked questions about the dog’s skin problem, personality, general health etc. and the results entered in to MacRepertory, a homeopathic software programme. It must have been at this consultation that the homeopath learned, as did the attending dermatologist, that dog number 16 was clairvoyant. Pity dog number 18 who could only ‘anticipate owner’s actions’, a sure sign of undeveloped psychic abilities. Would an experienced dermatologist, trained in clinical diagnosis, not experience some hesitation on encountering a system of prescribing that accepts the existence of clairvoyant animals, and even incorporates clairvoyance into the treatment algorithm?

Obviously the dermatologists didn’t see this as a problem, and neither did the journal editor. I’d need a damn sight more evidence before I give up my fixation on Avogadro’s number, or accept the existence of psychic dogs.
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Old 24th March 2009, 11:45 AM   #34
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Originally Posted by Badly Shaved Monkey View Post
Letter drafted. Very long at the moment. Not sure how much to cut out. I've included a bit about the dice, but you're right, the pithy version is just that sentence.

They won't publish it if it's too long. We could go for more than one? You do the pith, I'll shred Rao (again)?

Rolfe.
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Old 24th March 2009, 01:23 PM   #35
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Originally Posted by Rolfe View Post
They won't publish it if it's too long. We could go for more than one? You do the pith, I'll shred Rao (again)?

Rolfe.
Awww....Mum, but it's such a big pile of manure that I need a really big shovel to shift it. It's not fair to make me use a teaspoon.

I'm happy to take the pith, though.
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Old 24th March 2009, 02:57 PM   #36
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I think we have to use a teaspoon.

Caveat. I haven't read it yet. But from what you said, I think the two points are the luducrous experimental design, and the reliance on discredited references.

I thought of something like, the take-home message is that even with clients who are initially well disposed to homoeopathy, there's less than a 25% chance of any benefit being perceived.

And then just briefly shred Rao, referencing the JREF letter (which I'm first author on) and Linde (referencing his own recantation).

What think you?

And your dice-tossing thing as almost a one-liner would be priceless.

Rolfe.
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Old 24th March 2009, 03:13 PM   #37
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Originally Posted by Rolfe View Post
I think we have to use a teaspoon.

Caveat. I haven't read it yet. But from what you said, I think the two points are the luducrous experimental design, and the reliance on discredited references.

I thought of something like, the take-home message is that even with clients who are initially well disposed to homoeopathy, there's less than a 25% chance of any benefit being perceived.

And then just briefly shred Rao, referencing the JREF letter (which I'm first author on) and Linde (referencing his own recantation).

What think you?

And your dice-tossing thing as almost a one-liner would be priceless.

Rolfe.
I think you're probably right. I'm going to be away for a few days, so I'll give it some more time next week.
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Old 24th March 2009, 03:37 PM   #38
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Email me a draft.

Rolfe.
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Old 25th March 2009, 09:53 AM   #39
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I have the pdf of this nestling snugly on a memory stick. (See, paying your BVA sub has its advantages....)

I now feel ready to go on the demolition job. All help gratefully received.

Does anyone want a quick peek? Health warning - very very very bad paper.

Rolfe.
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Old 26th March 2009, 04:51 AM   #40
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Just saying.

Rolfe.
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