Cargando…

Effect of analgesic therapy on clinical outcome measures in a randomized controlled trial using client-owned dogs with hip osteoarthritis

BACKGROUND: Pain and impaired mobility because of osteoarthritis (OA) is common in dogs and humans. Efficacy studies of analgesic drug treatment of dogs with naturally occurring OA may be challenging, as a caregiver placebo effect is typically evident. However, little is known about effect sizes of...

Descripción completa

Detalles Bibliográficos
Autores principales: Malek, Sarah, Sample, Susannah J, Schwartz, Zeev, Nemke, Brett, Jacobson, Peer B, Cozzi, Elizabeth M, Schaefer, Susan L, Bleedorn, Jason A, Holzman, Gerianne, Muir, Peter
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2012
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3527270/
https://www.ncbi.nlm.nih.gov/pubmed/23035739
http://dx.doi.org/10.1186/1746-6148-8-185
_version_ 1782253685274836992
author Malek, Sarah
Sample, Susannah J
Schwartz, Zeev
Nemke, Brett
Jacobson, Peer B
Cozzi, Elizabeth M
Schaefer, Susan L
Bleedorn, Jason A
Holzman, Gerianne
Muir, Peter
author_facet Malek, Sarah
Sample, Susannah J
Schwartz, Zeev
Nemke, Brett
Jacobson, Peer B
Cozzi, Elizabeth M
Schaefer, Susan L
Bleedorn, Jason A
Holzman, Gerianne
Muir, Peter
author_sort Malek, Sarah
collection PubMed
description BACKGROUND: Pain and impaired mobility because of osteoarthritis (OA) is common in dogs and humans. Efficacy studies of analgesic drug treatment of dogs with naturally occurring OA may be challenging, as a caregiver placebo effect is typically evident. However, little is known about effect sizes of common outcome-measures in canine clinical trials evaluating treatment of OA pain. Forty-nine client-owned dogs with hip OA were enrolled in a randomized, double-blinded placebo-controlled prospective trial. After a 1 week baseline period, dogs were randomly assigned to a treatment (ABT-116 – transient receptor potential vanilloid 1 (TRPV1) antagonist, Carprofen – non-steroidal anti-inflammatory drug (NSAID), Tramadol - synthetic opiate, or Placebo) for 2 weeks. Outcome-measures included physical examination parameters, owner questionnaire, activity monitoring, gait analysis, and use of rescue medication. RESULTS: Acute hyperthermia developed after ABT-116 treatment (P < 0.001). Treatment with carprofen (P ≤ 0.01) and tramadol (P ≤ 0.001) led to improved mobility assessed by owner questionnaire. Nighttime activity was increased after ABT-116 treatment (P = 0.01). Kinetic gait analysis did not reveal significant treatment effects. Use of rescue treatment decreased with treatment in the ABT-116 and Carprofen groups (P < 0.001). Questionnaire score and activity count at the end of treatment were correlated with age, clinical severity at trial entry, and outcome measure baseline status (S(R) ≥ ±0.40, P ≤ 0.005). Placebo treatment effects were evident with all variables studied. CONCLUSION: Treatment of hip OA in client-owned dogs is associated with a placebo effect for all variables that are commonly used for efficacy studies of analgesic drugs. This likely reflects caregiver bias or the phenomenon of regression to the mean. In the present study, outcome measures with significant effects also varied between groups, highlighting the value of using multiple outcome measures, as well as an a priori analysis of effect size associated with each measure. Effect size data from the present study could be used to inform design of future trials studying analgesic treatment of canine OA. Our results suggest that analgesic treatment with ABT-116 is not as effective as carprofen or tramadol for treatment of hip arthritis pain in client-owned dogs.
format Online
Article
Text
id pubmed-3527270
institution National Center for Biotechnology Information
language English
publishDate 2012
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-35272702012-12-21 Effect of analgesic therapy on clinical outcome measures in a randomized controlled trial using client-owned dogs with hip osteoarthritis Malek, Sarah Sample, Susannah J Schwartz, Zeev Nemke, Brett Jacobson, Peer B Cozzi, Elizabeth M Schaefer, Susan L Bleedorn, Jason A Holzman, Gerianne Muir, Peter BMC Vet Res Research Article BACKGROUND: Pain and impaired mobility because of osteoarthritis (OA) is common in dogs and humans. Efficacy studies of analgesic drug treatment of dogs with naturally occurring OA may be challenging, as a caregiver placebo effect is typically evident. However, little is known about effect sizes of common outcome-measures in canine clinical trials evaluating treatment of OA pain. Forty-nine client-owned dogs with hip OA were enrolled in a randomized, double-blinded placebo-controlled prospective trial. After a 1 week baseline period, dogs were randomly assigned to a treatment (ABT-116 – transient receptor potential vanilloid 1 (TRPV1) antagonist, Carprofen – non-steroidal anti-inflammatory drug (NSAID), Tramadol - synthetic opiate, or Placebo) for 2 weeks. Outcome-measures included physical examination parameters, owner questionnaire, activity monitoring, gait analysis, and use of rescue medication. RESULTS: Acute hyperthermia developed after ABT-116 treatment (P < 0.001). Treatment with carprofen (P ≤ 0.01) and tramadol (P ≤ 0.001) led to improved mobility assessed by owner questionnaire. Nighttime activity was increased after ABT-116 treatment (P = 0.01). Kinetic gait analysis did not reveal significant treatment effects. Use of rescue treatment decreased with treatment in the ABT-116 and Carprofen groups (P < 0.001). Questionnaire score and activity count at the end of treatment were correlated with age, clinical severity at trial entry, and outcome measure baseline status (S(R) ≥ ±0.40, P ≤ 0.005). Placebo treatment effects were evident with all variables studied. CONCLUSION: Treatment of hip OA in client-owned dogs is associated with a placebo effect for all variables that are commonly used for efficacy studies of analgesic drugs. This likely reflects caregiver bias or the phenomenon of regression to the mean. In the present study, outcome measures with significant effects also varied between groups, highlighting the value of using multiple outcome measures, as well as an a priori analysis of effect size associated with each measure. Effect size data from the present study could be used to inform design of future trials studying analgesic treatment of canine OA. Our results suggest that analgesic treatment with ABT-116 is not as effective as carprofen or tramadol for treatment of hip arthritis pain in client-owned dogs. BioMed Central 2012-10-04 /pmc/articles/PMC3527270/ /pubmed/23035739 http://dx.doi.org/10.1186/1746-6148-8-185 Text en Copyright ©2012 Malek et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Article
Malek, Sarah
Sample, Susannah J
Schwartz, Zeev
Nemke, Brett
Jacobson, Peer B
Cozzi, Elizabeth M
Schaefer, Susan L
Bleedorn, Jason A
Holzman, Gerianne
Muir, Peter
Effect of analgesic therapy on clinical outcome measures in a randomized controlled trial using client-owned dogs with hip osteoarthritis
title Effect of analgesic therapy on clinical outcome measures in a randomized controlled trial using client-owned dogs with hip osteoarthritis
title_full Effect of analgesic therapy on clinical outcome measures in a randomized controlled trial using client-owned dogs with hip osteoarthritis
title_fullStr Effect of analgesic therapy on clinical outcome measures in a randomized controlled trial using client-owned dogs with hip osteoarthritis
title_full_unstemmed Effect of analgesic therapy on clinical outcome measures in a randomized controlled trial using client-owned dogs with hip osteoarthritis
title_short Effect of analgesic therapy on clinical outcome measures in a randomized controlled trial using client-owned dogs with hip osteoarthritis
title_sort effect of analgesic therapy on clinical outcome measures in a randomized controlled trial using client-owned dogs with hip osteoarthritis
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3527270/
https://www.ncbi.nlm.nih.gov/pubmed/23035739
http://dx.doi.org/10.1186/1746-6148-8-185
work_keys_str_mv AT maleksarah effectofanalgesictherapyonclinicaloutcomemeasuresinarandomizedcontrolledtrialusingclientowneddogswithhiposteoarthritis
AT samplesusannahj effectofanalgesictherapyonclinicaloutcomemeasuresinarandomizedcontrolledtrialusingclientowneddogswithhiposteoarthritis
AT schwartzzeev effectofanalgesictherapyonclinicaloutcomemeasuresinarandomizedcontrolledtrialusingclientowneddogswithhiposteoarthritis
AT nemkebrett effectofanalgesictherapyonclinicaloutcomemeasuresinarandomizedcontrolledtrialusingclientowneddogswithhiposteoarthritis
AT jacobsonpeerb effectofanalgesictherapyonclinicaloutcomemeasuresinarandomizedcontrolledtrialusingclientowneddogswithhiposteoarthritis
AT cozzielizabethm effectofanalgesictherapyonclinicaloutcomemeasuresinarandomizedcontrolledtrialusingclientowneddogswithhiposteoarthritis
AT schaefersusanl effectofanalgesictherapyonclinicaloutcomemeasuresinarandomizedcontrolledtrialusingclientowneddogswithhiposteoarthritis
AT bleedornjasona effectofanalgesictherapyonclinicaloutcomemeasuresinarandomizedcontrolledtrialusingclientowneddogswithhiposteoarthritis
AT holzmangerianne effectofanalgesictherapyonclinicaloutcomemeasuresinarandomizedcontrolledtrialusingclientowneddogswithhiposteoarthritis
AT muirpeter effectofanalgesictherapyonclinicaloutcomemeasuresinarandomizedcontrolledtrialusingclientowneddogswithhiposteoarthritis