“The body is a complex dance between stimuli and response.”
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Abstract from the Optic Neuritis trial paper.
An evaluation of a novel ' goat serum’ therapy (Aimspro) in multiple sclerosis.
Background: Anecdotal reports suggest dramatic immediate clinical improvement when HIV / B3 cel supernatant inoculated goat serum (Aimspro) is given to patients with Multiple Sclerosis (MS).
Objectives; This is the first randomised, double-
Methods; Twelve subjects (mean age 40.4 years, range 27-
Objective neuropsychological, functional magnetic resonance imaging and visual field assessments were performed and results compared between the two groups (Aimspro and placebo).
The study was powered to detect a 0.5% change in the fMRI primary outcome, with a estimated standard deviation of 0.4% allowing for 10% drop out.
Results; Both Aimspro and placebo were well tolerated and there were no serious adverse events.
Treatment with Aimspro showed no significant benefit in the primary or secondary outcomes: visual evoked potential amplitude or latency, or the amplitude of the BOLD response in the fMRI experiments.
There was a significant treatment effect in the tertiary outcome of visual field function (p=0.02).
Conclusions; This study was exploratory and only measured immediate change after three treatment doses. The major visual deficit in most patients was peripheral and the only outcome that assessed this area significantly improved with treatment.
____________________
J. A. Palace, G. Burke, A. Cavey, P.M. Matthews
University Dept. of Clinical Neurology, Radcliffe Infirmary, Woodstock Road,
Oxford, OX2 6HE, UK
(Funding for the study was provided by Daval International Ltd.
However, the study was designed independently by the investigators, who were responsible for the conduct, analysis and interpretation of the results.)
Additional comment
Essentially there were 3 outcome measures in the trial but these were not necessarily in order of importance, just convention. Certainly the primary and secondary ones (VEP & fBOLD measurements) showed no change in response to treatment and the tertiary one (visual fields, which was "the major visual deficit" in the test subjects) was clearly improved but without being "dramatic" or "outstanding".
These were objective and scientifically measurable features -
It says in the discussion of the results towards the end of the full paper, "For
these reasons, only a dramatic improvement in visual function would be expected to
show a significant treatment effect in these parameters." -
In other words there are very good reasons why the correlation between the first two outcome measures and the subjective benefits in sight to the test subjects is not direct and linear.
In plain English this means that any improvement that a patient may notice is not
automatically reflected in what the scientists can measure. Vice-
The choice of outcome measures doesn’t seem to have been especially intuitive in hindsight but then again these have to be chosen in the design stage of the trial and not once the effects have been seen.
Other comments on these results posted elsewhere on the web seem to focus on the key statement of “no improvement in the primary and secondary outcome measures” rather than on what was experienced by the subjects, who apparently all reported a subjective improvement in vision on.
It would seem,at least in some regards, better to have a treatment that enabled a patient to “see” an improvement (irrespective of what the scientists measurements said) than one which showed results in the laboratory but left the patient unaware of any change in their sight.
The vital role in clinical research is well understood and accepted, but it should not be forgotten that patients are the ultimate beneficiaries of any success and not scientific instruments.
Nor should an understanding of any research results be based on phrases taken out
of context-
Finally, a comment from one of Proventus’s members on the informed consent list...
“This trial was carried out over a very short time span (three weeks) and, from our own personal experience , I feel there was insufficient time to evaluate the true potential of the treatment, i.e.
Although my wife had an almost instant recovery in her left eye, it was only after eight weeks of treatment that the visual blurring had cleared and it was several months more before she could tolerate bright sunlight.
On the BBC web site 21st March 2005
