A pilot study testing the efficacy of Calmer Canine on dogs with separation anxiety was completed by Dr. Judy Korman VMD working in concert with Dr. Margaret E. Gruen, and Emily Griffith at the North Carolina State University College of Veterinary Medicine.
Nine dogs with moderate to severe separation anxiety completed an open-label pilot study. Each dog was treated with an active tPEMF (Calmer Canine) device placed over the dog’s head twice daily. Treatment sessions lasted 15 minutes each and were spaced eight to ten hours apart during the day. Dogs were treated for six weeks.
Dogs ranged from age 3 to 12 years. Dogs with concomitant thunder/noise phobia and dogs on multiple CSA medications were excluded from the study.
A 60-minute video and Owner Questionnaire rating the dog’s severity level among five signs of CSA (vocalization, rearranging, destruction, urination, defecation) and overall were used to establish a baseline for each dog. Ten CSA signs were evaluated by video including destruction, rearranging, restlessness/pacing, orienting to the environment, panting, whining, barking/howling, yawning, urinating and defecating.
Subsequent videos and owner assessments via a questionnaire were used to collect data periodically throughout the treatment phase (one, two, four and six weeks after the start of treatment). In addition, a final owner questionnaire and video was taken two weeks after the cessation of treatments to determine if there was any long-lasting or residual benefit to therapy.
Primary endpoints were reduction in the level of severity of CSA signs as assessed by the owners (owner questionnaires) and reduction in signs of CSA as assessed by video analysis of the dogs when the owners left them home. Success criteria for the questionnaires and video analysis are as follows:
After a month of treatment, 100% of cases achieved success. Even accounting for a 50% placebo effect, this data is statistically significant. Looking at the data in terms of cases, 56% of cases had at least a one-point reduction in their overall severity score, as evaluated by their owners after only 1 week of therapy. After six weeks of therapy, 50% of owners reported their dogs resolved of CSA signs irrespective of their starting point.
Furthermore, video data revealed that nearly 80% of dogs in the study had at least one sign improve more than 50% and half of the dogs saw at least one CSA sign disappear after a month of treatment with Calmer Canine. No side effects were reported.
The dogs in the pilot study exhibited a range of signs of CSA at baseline. Ten signs were evaluated via video analysis. Individual dogs ranged from exhibiting anywhere from one of the ten CSA signs to up to five CSA signs. At baseline, the group of nine dogs, as a whole, exhibited 24 signs of CSA. These signs largely appeared responsive to treatment with Calmer Canine. After a month of treatment, two-thirds of the signs improved, over half of the signs improved by at least 50% and the mean level of improvement (i.e. the average percentage reduction in signs that improved) was 77%. Of special interest is the fact that the results showed further improvement of the signs of CSA, even after treatment had been discontinued for two weeks.
Between the various analyses, both a reduction in negative behaviors and an increase in positive behaviors was seen. Compared to baseline, the average time spent in positive behaviors (resting, grooming or playing) increased by 25% with one month of therapy and by 44% by the end of the study.
One of the most interesting findings of this pilot study is that fact that the effects of the treatment appear to be long-lasting in some dogs. According to owner assessments, there was no deterioration of treatment success during the two weeks after treatment was discontinued in 56% of the dogs; 95% CI=(0.21,0.86). In addition, after the dogs received six weeks of treatment followed by two weeks without any treatment, nearly three quarters of the CSA signs retained their level of improvement or improved further.
Assisi, in collaboration with NCSU, is conducting a larger, double-blind, placebo-controlled study to further support the significant results found in the pilot study. This new study aims to enroll 40 dogs with moderate to severe separation anxiety with similar efficacy endpoints to the pilot study. Dr. Margaret Gruen and Dr. Katherine Pankratz are the lead investigators.
Margaret E. Gruen1, Emily Griffith2, Judy Korman3
1North Carolina State University College of Veterinary Medicine (firstname.lastname@example.org); 2 North Carolina State University College of Sciences; 3 Assisi Animal Health
Presented July 2019 at the IVBM Conference, Washington DC
Canine separation anxiety is a common disorder in dogs and affects an estimated 14-17% of the pet dog population in the United States. Separation anxiety is associated with significant distress to both dogs and owners, with dogs showing a variety of clinical signs including hypersalivation, destruction of property, excessive vocalization, and self-injurious behavior when left alone. While pharmacologic treatments are available, these may not be indicated for every case, and a safe, non-pharmacologic treatment is needed. Treatment with pulsed electromagnetic fields (PEMFs) has been used in the management of mood disorders in humans and has the potential to modulate anxiety in dogs. In this pilot open trial study, nine dogs with separation anxiety were treated with a PEMF device placed on the head twice daily for 15 minutes, for six weeks. Owners completed questionnaires on Days 0, 7, 14, 28, and 42, and took videos of their dogs while home alone on Days 0, 28, and 42. On Days 28 and 42, all nine dogs had a reduction in overall anxiety scores (Wald score interval = 0.66 - 1.00 for each), with five showing resolution of clinical signs on Day 42 (95% CI = 0.21 - 0.85). Videos were coded for positive and negative behaviors, and results from Days 28 and 42 were compared to Day 0. Positive behavior included resting without orientation to the environment, while negative behaviors included barking, pacing, destruction, and house soiling, among others. For at least one negative behavior, a reduction of greater than 10% from Day 0 was seen for nine dogs at Day 28 and seven dogs at Day 42. While a caregiver placebo effect cannot be ruled out, this would not be expected to affect the video results. This proof-of-concept study provides promising evidence to warrant further evaluation in a sham-device controlled trial.
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