Leggete qui: http://avmajournals.avma.org/doi/abs/10.2460/javma.241.10.1314
e qui: http://actavetscand.biomedcentral.com/articles/10.1186/1751-0147-46-57
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Copio incollo gli Abstract.
"Abstract
November 15, 2012, Vol. 241, No. 10, Pages 1314-1319
doi: 10.2460/javma.241.10.1314
Caregiver placebo effect for dogs with lameness from osteoarthritis
Michael G. Conzemius, DVM, PhD, DACVS; Richard B. Evans, PhD
Department of Veterinary Clinical Sciences, College of Veterinary Medicine, University of Minnesota, Saint Paul, MN 55108. (Conzemius); Department of Veterinary Clinical Sciences, College of Veterinary Medicine, University of Illinois, Champaign, IL 61801. (Evans)
Objective—To document the caregiver placebo effect in owners and veterinarians of dogs with lameness from osteoarthritis.
Design—Prospective, randomized, double-blinded, placebo-controlled, multicenter clinical trial.Animals—58 dogs with lameness secondary to osteoarthritis.
Procedures—Dogs enrolled in the placebo arm of an FDA-approved study were evaluated to determine the relationship between subjective (caregiver responses) and objective (force platform gait analysis) patient outcome measures.
Results—A caregiver placebo effect for owners evaluating their dog's lameness occurred 39.7% of the time. A caregiver placebo effect occurred 44.8% of the time when veterinarians examined dogs for lameness at a walk, 44.8% of the time when veterinarians examined dogs for lameness at a trot, and 43.1% of the time when veterinarians evaluated dogs for signs of pain on palpation of the joint. This effect was significantly enhanced with time. Mean ground reaction forces (GRFs) remained unchanged for dogs during treatment with the placebo. Individually, of 58 dogs, 5 had GRFs that worsened by ≥ 5% over 42 days, 7 had GRFs that improved by ≥ 5% over 42 days, and 46 had GRFs that remained unchanged.
Conclusions and Clinical Relevance—A caregiver placebo effect was common in the evaluation of patient response to treatment for osteoarthritis by both pet owners and veterinarians. Force platform gait analysis was an unbiased outcome measure for dogs with lameness from osteoarthritis. A caregiver placebo effect should be considered when interpreting owner and veterinary reports of patient response to treatment.
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e
Stratification, Blinding and Placebo Effect in a Randomized, Double Blind Placebo-controlled Clinical Trial of Gold Bead Implantation in Dogs with Hip Dysplasia
- GT Jæger,
- S Larsen and
- L Moe
Acta Veterinaria Scandinavica200546:57
DOI: 10.1186/1751-0147-46-57
© The Author(s) 2002
Received: 27 May 2004
Accepted: 21 February 2005
Published: 30 June 2005
Abstract
The purpose of this study was to investigate the need for and choice of stratification factors, and the effects of blinding and placebo in a clinical experiment. Eighty dogs with canine hip dysplasia (CHD) were included in a randomized, placebo-controlled and double blind clinical trial with stratified parallel group design, in which body weight and degree of CHD were used as stratification factors. Thirty-eight dogs were allocated to gold bead implantation and 42 to placebo. After six months, 33 of the 42 placebo-treated dogs received gold bead implantation in an open study lasting a further 18 months. The main outcome variable in the study was change in pain signs of CHD as assessed by the owner. No significant difference in the main outcome variable, regardless of the treatment given, could be detected in the two chosen stratification factors. The only factor to influence the main outcome variable significantly was age. The blinding procedure used in the study, in which 60% of the owners correctly guessed the treatment given, was found sufficient. Of those who guessed the treatment erroneously, 88% believed the treatment given was gold bead implantation. The treatment efficacy after six months in the blinded treatment group was found to be significantly larger compared to the efficacy obtained in the open study. A significant placebo effect was therefore detected. Conclusion and Clinical Relevance: The age of the dogs influenced the outcome of the CHD treatment, and is recommended as a stratification factor. A significant placebo effect has to be expected and an optimal blinding procedure is necessary in similar clinical studies. Keywords: canine study design hip dysplasia.
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