"PLEASE BE AWARE THAT THIS IS SENT ON AN OPEN LETTER BASIS
Dear Dr Hill,
http://www.medicalnewstoday.com/medicalnews.php?newsid=47768&nfid=crss
Your proposed trial of homeopathy in pruritic dogs has been brought to my attention. Clearly it is a good thing that homeopathic treatment is subject to the rigours of clinical trial.
However, some features of the trial design, as alluded to in the press release, give significant cause for concern. Specifically,
"Phase one, which is really intended to establish proof of principle, is an open clinical trial in which the main measure of assessment will be the level of itching."
What is the principle that is being proven by that phase? If you have a well-formed hypothesis then what purpose does that phase serve?
I hope you are aware that the homeopathic community has taken studies equivalent to that phase to be complete in and of themselves, for instance the notorious Bristol Homeopathic Hospital study;
Homeopathic treatment for chronic disease: a six-year University-Hospital Outpatient Observational Study. Dr. D.S Spence, Dr. E A Thompson & S J Barron. J. Altern. Complement. Med. 2005; 11:5:793-798
The Society of Homeopaths noted its results thus, in a recent press release;
"In fact, there is considerable evidence to show that homeopathy is effective in the treatment of a wide range of illnesses, including a large study at the end of 2005, of the outcomes from 6,500 patients at the Bristol Homeopathic Hospital, over a period of six years, in which 75% reported improvement."
This was an unblinded, open study based on a questionnaire, yet you can see how its results were portrayed by the homeopathic lobby.
A significant danger in the design that is proposed is that the one phase will show apparent success and the controlled phase will not. The track record of the homeopathic community in these circumstances is then to reject the controlled trial as unhomeopathic in some way- wrong duration, limited assessment parameters, the excuses are endless. The open phase then risks being used as was the Spence study.
Do you have any protection built into the agreement with the participants to prevent this misuse from happening?
I look forward to hearing from you,
BSM."