stratification, blinding and placebo effect in a randomized, double blind placebo-controlled clinical trial of gold bead implantation in dogs with hip dysplasia分层,致盲和安慰剂效应的随机、双盲安慰剂对照临床试验的黄金珠子植入犬髋关节发育不良.pdfVIP

Acta vet. scand. 2005, 46, 57-68. Stratification, Blinding and Placebo Effect in a Randomized, Double Blind Placebo-controlled Clinical Trial of Gold Bead Implantation in Dogs with Hip Dysplasia 1 2 3 By G. T. Jæger , S. Larsen and L. Moe 1Department of Companion Animal Clinical Sciences, 2Department of Production Animal Clinical Sciences, 1,2,3 Norwegian School of Veterinary Science, Oslo Norway. Jæger GT, Larsen S, Moe L: Stratification, Blinding and Placebo Effect in a Ran- domized, Double Blind Placebo-controlled Clinical Trial of Gold Bead Implanta- tion in Dogs with Hip Dysplasia. Acta vet. Scand. 2005, 46, 57-68. – The purpose of this study was to investigate the need for and choice of stratification factors, and the ef- fects of blinding and placebo in a clinical experiment. Eighty dogs with canine hip dys- plasia (CHD) were included in a randomized, placebo-controlled and double blind clin- ical 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 im- plantation and 42 to placebo. After six months, 33 of the 42 placebo-treated dogs re- ceived 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 treat- ment 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 thos