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安慰剂效应在犬癫痫试验中的作用。

Placebo effect in canine epilepsy trials.

机构信息

Department of Clinical Sciences, College of Veterinary Medicine, North Carolina State University, 4700 Hillsborough Street, Raleigh, NC 27606, USA.

出版信息

J Vet Intern Med. 2010 Jan-Feb;24(1):166-70. doi: 10.1111/j.1939-1676.2009.0407.x.

DOI:10.1111/j.1939-1676.2009.0407.x
PMID:19912522
Abstract

BACKGROUND

The placebo effect is a well-recognized phenomenon in human medicine; in contrast, little information exists on the effect of placebo administration in veterinary patients.

HYPOTHESIS

Nonpharmacologic therapeutic effects play a role in response rates identified in canine epilepsy trials.

ANIMALS

Thirty-four dogs with epilepsy.

METHODS

Meta-analysis of the 3 known prospective, placebo-controlled canine epilepsy trials. The number of seizures per week was compiled for each dog throughout their participation in the trial. Log-linear models were developed to evaluate seizure frequency during treatment and placebo relative to baseline.

RESULTS

Twenty-two of 28 (79%) dogs in the study that received placebo demonstrated a decrease in seizure frequency compared with baseline, and 8 (29%) could be considered responders, with a 50% or greater reduction in seizures. For the 3 trials evaluated, the average reduction in seizures during placebo administration relative to baseline was 26% (P = .0018), 29% (P = .17), and 46% (P = .01).

CONCLUSIONS AND CLINICAL IMPORTANCE

A positive response to placebo administration, manifesting as a decrease in seizure frequency, can be observed in epileptic dogs. This is of importance when evaluating open label studies in dogs that aim to assess efficacy of antiepileptic drugs, as the reported results might be overstated. Findings from this study highlight the need for more placebo-controlled trials in veterinary medicine.

摘要

背景

安慰剂效应是人类医学中一种公认的现象;相比之下,关于在兽医患者中给予安慰剂的效果的信息很少。

假设

非药物治疗效果在犬癫痫试验中确定的反应率中起作用。

动物

34 只癫痫犬。

方法

对 3 项已知的前瞻性、安慰剂对照犬癫痫试验进行荟萃分析。在试验过程中,为每只狗记录每周的癫痫发作次数。建立对数线性模型,以评估治疗期间和安慰剂相对于基线的癫痫发作频率。

结果

在接受安慰剂的 28 只狗中,有 22 只(79%)与基线相比癫痫发作频率降低,其中 8 只(29%)可被认为是应答者,癫痫发作减少 50%或更多。在评估的 3 项试验中,安慰剂治疗期间癫痫发作相对于基线的平均减少率为 26%(P =.0018)、29%(P =.17)和 46%(P =.01)。

结论和临床意义

在癫痫犬中可以观察到对安慰剂治疗的阳性反应,表现为癫痫发作频率降低。这在评估旨在评估抗癫痫药物疗效的犬开放性标签研究时很重要,因为报告的结果可能被夸大。本研究的结果强调了在兽医医学中进行更多安慰剂对照试验的必要性。

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