Target Animal Studies:

Canine Efficacy Study7

7Gingerich DA, Strobel JD. Use of Client-Specific Outcome Measures to Assess
Treatment Effects in Geriatric, Arthritic Dogs: Controlled Clinical Evaluation of
a Nutraceutical. Veterinary Ther. 2003; 4(1): 56-66.

SUMMARY

The efficacy of special milk protein concentrate (SMPC, also known as MicroLactin®) was evaluated in a placebo-controlled, double-blinded, randomized, parallel trial of 50 geriatric, large-breed dogs. Over all improvement was seen by owners in 67% of the MicroLactin®-treated dogs, whereas only 35% of the owners of dogs in the placebo group reported improvement during the 8-week study period. The treatment group also displayed a greater degree of improvement than the placebo group in regard to orthopedic score (P < 0.001) and owner global assessments (P = 0.004).

Objective: Evaluate the efficacy of special milk protein concentrate (SMPC, also known as MicroLactin) in geriatric, large-breed dogs with signs of osteoarthritis.

STUDY DESIGN

Test population: Fifty, client-owned, large-breed dogs ranging from 7 to 12 years of age were randomly assigned to either the treatment or control groups. All participants displayed clinical signs consistent with osteoarthritis. Obese patients or those with underlying disorders that required overlapping treatments (e.g., NSAIDs, steroids, analgesics) were excluded. Five companion animal practices in the Cincinnati area evaluated the dogs on an outpatient basis.

Treatments: The treatment group received 2 grams of SMPC (MicroLactin®) per day, whereas the placebo group received rice flour. The study period lasted 8 weeks after a 1-week placebo run-in period. The capsules and bottles were identical, and veterinarians and owners were blinded to the group assignments.

Evaluations: Owners evaluated their dogs utilizing an overall assessment, a standardized questionnaire and a case-specific questionnaire. Veterinarians assigned a global assessment score and performed physical exams at 0, 4 and 8 weeks. A complete blood count and standard chemistry profile were performed at the beginning and end of the treatment period. The global assessment score evaluated whether the patient had improved, which ranged from -1 (worse) to 3+ (excellent). The standardized questionnaire form was identical for all patients. The case-specific questionnaire, which is known as “Cincinnati Orthopedic Disability Index” (CODI), identifies the arthritic impairments specific to each patient’s clinical signs. Owners completed both questionnaire types biweekly.

RESULTS

Thirty-five dogs (17 in the placebo and 18 in the treatment group) completed the study. Owners reported an overall improvement in 66.7% of the MicroLactin®-treated dogs but in only 35.3% of the placebo-treated dogs. There was also a significant degree of improvement in the MicroLactin®-treated group. The owner global assessments and questionnaire scores (both standardized and case-specific) improved significantly in the MicroLactin® group over the course of the study (P < 0.01). The placebo group did not improve significantly over the course of the study. The owner’s overall assessment and the case-specific questionnaire (CODI) scores improved significantly from the placebo group (P < 0.05). The physical examination findings of both the treatment and placebo groups improved slightly but significantly. According to published orthopedic standards, MicroLactin® had a large effect on the owner overall assessments and on the case-specific questionnaire scores, intermediate effect on veterinarians’ overall assessments and standardized test scores, and negligible effect on the physical examination findings. Both the MicroLactin® and the placebo were well-tolerated, except that one participant from each group needed to withdraw from the study due to vomiting.

Significance

This placebo-controlled, double-blinded, prospective, randomized study evaluated the efficacy of MicroLactin® by examining the owner’s assessment of their dog’s clinical improvement. The results suggest that MicroLactin has therapeutic value in dogs with signs of osteoarthritis. It is a well-tolerated alternative for the long-term management of musculoskeletal conditions, especially in geriatric dogs.

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