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Originally Posted by colmcq
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Interesting.
The aim of that protocol seems to be similar to mine: no interference in the homoeopath/patient interaction by letting the homoeopath do exactly what he normally does in his homoeopathic treatment of the patient. And he achieves this in the same way by introducing randomisation and blinding only at the point of the dispensary. And the endpoints are chosen by the homoeopath just as in my protocol. The main difference is that he has the patient answer a questionaire to assess effectiveness, whereas I am happy to let the homoeopath do this.
Here is an interesting and relevant quote from someone called "Andy" where he answers questions posed by the homoeopath.
(Unfortunately, he tends to be a little agressive in his attitude)
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Let’s answer these questions…
If you have an idea of a successful trial design to assess the efficacy of homeopathy, is homeopathic treatment to be provided in a clinically typical methodology?
Yes
How will you deal with the lack of homogeneity presented by individualised treatment?
Individualise as much as you like - the trial is randomised and blinded at the point of dispensary.
Will the conditions you select to include in the trial be according to biomedical or homeopathic diagnoses?
Choose whatever conditions you like. We can choose generic endpoints, like how patients feel about their health - any ‘holistic’ measure you like.
Is the fate of homeopathy in the study to be based on the prescribing skills of a single homeopath or of multiple well-qualified homeopaths?
Don’t care - whatever is best for maximising the chance of success for the homeopaths.
How will you quantify the impact of the homeopaths’ confidence in their remedy selections and how will you separate out any measure of their success from any effect of the remedies they prescribe?
Is this important? We want to see if patients feel better.
Will you allow for reassessment of prescriptions after an initial response period?
Yes. If homeopathy is working we should see more reassessments in the placebo group.
How will you treat those randomly allocated to placebo?
Exactly the same as those thinking they are getting homeopathic remedies. That is the point of blinding.
If subjects are to go through the same consultation procedure as those allocated to verum and if the homeopath is to be blinded as well, how will you control for the impact of the consultation and the homeopath’s decision on what remedy they should receive?
Let the homeopath prescribe what they like. It is at the point of dispensary that randomisation takes place.
If this is a valid component of successful treatment, how will you separate it from the response to placebo, and how will you decide on whether or not the therapy is effective?
Those with the real therapy will score better than those on placebo.
How will you measure response?
In whatever way you think is appropriate for a homeopathic consultation. How does a homeopath judge success?
Will you have typical global and multiple local homeopathic outcomes systematically assessed in the study?
If you wish. There appears to be an assumption that DBRCTs need to test one remedy at a time. That is not true. We are testing the impact of the potentized pills on the process. Does the act of homeopathic prescription make any difference to outcomes? That is what we are testing.
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