Letters
Management of fear of fireworks in dogs SIR, – We have been approached by a company to independently coordinate a clinical trial of a homeopathic remedy for the management of fear of fireworks in dogs. However, we should emphasise we are not applying for the recognition of the study by the James Randi Educational Foundation (VR, October 1, 2005, vol 157, p 424), but are simply aiming to apply the criteria relating to efficacy evaluation that are applied to many veterinary medicines and treatments during their development. As scientists we keep an open mind on these matters, even if we cannot understand them, as we think it is important not to confuse absence of evidence with evidence of absence. The proposal is for a placebo-controlled study using the non-potentised formulation as a control. The study will be triple-blinded, which means that neither the owner, their vet nor ourselves knows whether a dog has been given the actual remedy (verum) or the placebo. We are using a block randomisation procedure meaning that in every 10 cases, five are verum and five are placebo, but each bottle has a unique identification number, so we have no means of determining which is which within a batch. Once data have been gathered, analysis will be undertaken following partial unblinding allowing us to allocate each subject to treatment group A or B. Only once the analysis is complete will we then determine the nature of A and B. All clients will also be provided with basic behavioural advice on how to manage the immediate impact of fireworks on their dogs, and clients will be free to try any other intervention if they are not satisfied with the response that they see. Indeed, the switch to other treatments will be one of the efficacy variables assessed. The protocol has been developed in consultation with the Home Office and has already received ethical approval by the University of Lincoln. The assessment of change in subjects and many other aspects of this study are based on protocols that have been used successfully by us previously in the evaluation of non-homeopathic remedies for this problem. We have also conducted initial power calculations to estimate the desired sample size based on the anticipated effect suggested from previous data. It is suggested that we will need approximately 150 participants to have a good 564
chance of detecting a true difference. We believe this is a unique opportunity for the profession to work together to try to address an important issue, but recruiting subjects is perhaps our biggest hurdle. We are therefore currently looking for veterinary practices to assist us in this work, regardless of their predisposition towards homeopathy. Their role will be to enlist suitable willing clients on to the trial, which will take place over the New Year firework season. Any practice wishing to receive an information pack about the study should contact us at the address below or e-mail: ncracknell@lincoln.ac.uk Daniel Mills, Nina Cracknell, Animal Behaviour Clinic, University of Lincoln, Riseholme Park, Lincoln LN2 2LG
The Veterinary Record, October 29, 2005