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一项随机、盲法、交叉研究,旨在评估一种饲料补充剂缓解 32 匹马摇头临床症状的疗效。

A randomised, blinded, crossover study to assess the efficacy of a feed supplement in alleviating the clinical signs of headshaking in 32 horses.

机构信息

University of Liverpool, Neston, Wirral, UK.

出版信息

Equine Vet J. 2013 May;45(3):293-7. doi: 10.1111/j.2042-3306.2012.00618.x. Epub 2012 Sep 19.

Abstract

REASONS FOR PERFORMING STUDY

Feed supplements are commonly used by owners to alleviate headshaking; however, randomised, controlled trials are required to assess their efficacy.

OBJECTIVE

To determine the efficacy of a feed supplement for alleviation of the clinical signs of headshaking using a randomised, blinded, placebo-controlled trial.

METHODS

Using a crossover design, 44 horses previously diagnosed with chronic idiopathic headshaking received both the supplement and a matching placebo per os for 28 days with a washout period between of 14 days. Video recordings were taken at rest and exercise prior to the study and at the end of both periods of treatment. The degree of headshaking was assessed in a blinded, randomised manner by 2 veterinary surgeons. At the same time points, owners completed a questionnaire to assess the severity of headshaking signs. A Wilcoxon signed rank test was used to compare the scores while on supplement and placebo.

RESULTS

Using the video assessments, there was no significant difference between scores while on supplement compared with placebo (P = 0.7). Using the questionnaire responses, there was no significant difference between scores for any activity when the placebo and the supplement were compared with each other. However, owners reported significant improvement during all activities for both placebo and supplement compared with pretreatment scores.

CONCLUSIONS AND POTENTIAL RELEVANCE

The supplement offered no benefit over a placebo in alleviating the clinical signs of headshaking. There appeared to be a significant proxy placebo effect when the outcome was based on subjective owner perception of clinical signs. This study demonstrated no beneficial effect of this supplement on the clinical signs of headshaking. The study did show a significant placebo effect, thereby highlighting the necessity of properly conducted, randomised controlled trials, with blinding, to assess true treatment effects in trials in animals.

摘要

研究原因

主人常使用饲料补充剂来缓解摇头症状;然而,需要进行随机对照试验来评估其疗效。

目的

使用随机、双盲、安慰剂对照试验确定一种饲料补充剂缓解慢性特发性摇头临床症状的疗效。

方法

采用交叉设计,44 匹先前被诊断为慢性特发性摇头的马,经口给予补充剂和匹配的安慰剂,每种药物治疗 28 天,洗脱期为 14 天。在研究前和治疗结束时,在休息和运动时进行视频记录。两名兽医以盲法、随机方式评估摇头程度。在相同的时间点,主人完成一份问卷,以评估摇头症状的严重程度。使用 Wilcoxon 符号秩检验比较补充剂和安慰剂时的评分。

结果

使用视频评估,补充剂与安慰剂相比,评分无显著差异(P = 0.7)。使用问卷回答,与安慰剂相比,补充剂和安慰剂在任何活动时的评分均无显著差异。然而,与治疗前相比,主人报告在所有活动中,安慰剂和补充剂均有显著改善。

结论和潜在相关性

补充剂在缓解摇头临床症状方面与安慰剂相比没有优势。当结果基于主人对临床症状的主观感知时,似乎存在显著的代理安慰剂效应。本研究表明该补充剂对摇头临床症状无有益作用。该研究确实显示出显著的安慰剂效应,从而强调了在动物试验中进行适当设计的、随机对照试验,进行盲法评估的必要性,以评估真实的治疗效果。

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