Use of client-specific outcome measures to assess treatment effects in geriatric, arthritic dogs: controlled clinical evaluation of a nutraceutical.
A questionnaire method was designed for dog owners to monitor the orthopedic disabilities of their pets for evaluation of a nutraceutical with joint health claims. Fifty large-breed dogs, 7 to 12 years of age, presenting with signs of osteoarthritis, were randomly allocated to placebo and active treatment groups. Degree of disability was assessed by physical examination, a standard questionnaire on daily activities, and a case-specific questionnaire that monitored specific impairments of each dog. The test product was a special milk protein concentrate (SMPC) from hyperimmunized cows, previously shown to express antiinflammatory and antiarthritic activity in humans. After a 1-week run-in period of dosing with placebo, each dog was randomly assigned to a treatment and given gelatin capsules containing either SMPC or a placebo twice daily for 8 weeks. Overall improvement was noted in 68% and 35% of the SMPC and placebo groups, respectively. Significant (P <.05) improvement in mean standardized and patient- specific questionnaire scores and in owner global assessments was detected in the SMPC group but not in the placebo group. Compared with the placebo group, the treatment response was significantly better in the SMPC group with regard to case-specific scores (P <.001) and owner global assessments (P =.004). The product was well tolerated and serum chemistry findings remained within normal limits.