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

BMC Veterinary Research

Peter Muir¹  Gerianne Holzman¹  Jason A Bleedorn¹  Susan L Schaefer¹  Elizabeth M Cozzi²  Peer B Jacobson²  Brett Nemke¹  Zeev Schwartz¹  Susannah J Sample¹  Sarah Malek¹ 

[1] Comparative Orthopaedic Research Laboratory, School of Veterinary Medicine, University of Wisconsin-Madison, Madison, WI, USA;Abbott Laboratories, 100 Abbott Park Road, Abbott Park, IL, USA

关键词: ABT-116;    Tramadol;    Carprofen;    Clinical trial;    Outcome measures;    Osteoarthritis;    Hip;    Dog;   

Others  :  1119702
DOI  :  10.1186/1746-6148-8-185

 received in 2012-03-29, accepted in 2012-09-17,  发布年份 2012

【 摘 要 】

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.

【 授权许可】

   
2012 Malek et al.; licensee BioMed Central Ltd.

【 图 表 】

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