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Hematology, serum chemistry and physical examinations were performed at each visit. Pharmacokinetics revealed an elimination half-life of 4. Routine nonsteroidal anti-inflammatory drug NSAID treatments, though efficacious, may not provide adequate relief of pain due to osteoarthritis OA and might have potential side effects that preclude its use, particularly in geriatric patients with certain comorbidities, such as kidney or gastrointestinal pathologies 1 — 4.
Although other pharmacological agents are advocated, such as gabapentin or amantadine, there is little evidence regarding their efficacy in dogs with chronic or neuropathic pain related to OA. Recent medical interest in alternative therapies and modalities for pain relief has led many pet owners to seek hemp related products rich in cannabinoids. The endocannabinoid receptor system is known to play a role in pain modulation and attenuation of inflammation 5 — 7. Cannabinoid receptors CB1 and CB2 are widely distributed throughout the central and peripheral nervous system 8 — 10 and are also present in the synovium However, the psychotropic effects of certain cannabinoids prevent extensive research into their use as single agents for pain relief 5 , The cannabinoids are a group of as many as 60 different compounds that may or may not act at CB receptors.
One class of cannabinoids, cannabidiol CBD , may actually be an allosteric non-competitive antagonist of CB receptors In lower vertebrates, CBD is also reported to have immunomodulatory 14 , anti-hyperalgesic 15 , 16 , antinociceptive 17 , 18 , and anti-inflammatory actions 5 , 19 , making it an attractive therapeutic option in dogs with OA.
Currently there are several companies distributing nutraceutical derivatives of industrial hemp, rich in cannabinoids for pets, yet little scientific evidence regarding safe and effective oral dosing exists. The objectives of this study were to determine: Our underlying hypotheses were that appropriate dosing of CBD-rich oil would safely diminish perceived pain and increase activity in dogs with OA.
Client owned dogs were enrolled after informed consent in accordance with the Declaration of Helsinki. An initial investigation into single-dose oral pharmacokinetics was performed with 4 beagles 3. The dogs were fed 2 h after dosing. Physical examination was performed at 0, 4, 8, and 24 h after dosing. Five milliliters of blood was collected at time 0, 0.
Blood samples were obtained via jugular venipuncture and transferred to a coagulation tube for 20 min. CBD was extracted from canine serum using a combination of protein precipitation and liquid-liquid extraction using n-hexane as previously described 20 , with minor modifications for microflow ultra-high pressure liquid chromatography UHPLC. Hexane extract was removed and concentrated to dryness under laboratory nitrogen.
Prior to LC-MS analysis, samples were resuspended in 0. A standard curve using the CBD analytical standard was prepared in canine serum non-exposed to CBD and extracted as above.
For this assay, the limits of detection LOD and limits of quantification LOQ represent the lower limits of detection and quantification for each compound in the matrix of this study 23 , Pharmacokinetic variables were estimated by means of non-compartmental analysis, utilizing a pharmacokinetic software package PK Solution, version 2.
The study population consisted of client-owned dogs presenting to Cornell University Hospital for Animals for evaluation and treatment of a lameness due to OA. Dogs were considered for inclusion in the study if they had radiographic evidence of OA, signs of pain according to assessment by their owners, detectable lameness on visual gait assessment and painful joint s on palpation. Elevations in alkaline phosphatase ALP , alanine aminotransferase ALT , and aspartate aminotransferase AST were allowed if prior hepatic ultrasound was deemed within normal limits except for potential non-progressive nodules possible hepatic nodular hyperplasia.
All owners completed a brief questionnaire to define the affected limb s , duration of lameness, and duration of analgesic or other medications taken. All dogs underwent radiographic examination of affected joints and a radiologist confirmed the presence or absence of OA, and excluded the presence of concomitant disease that might preclude them from enrolment i. Other analgesic medications used, such as gabapentin and tramadol, were discontinued at least 2 weeks prior to enrolment.
Dogs were excluded if they had evidence of renal, uncontrolled endocrine, neurologic, or neoplastic disease, or were undergoing physical therapy. Every dog was fed its regular diet with no change allowed during the trial. The study was a randomized, placebo-controlled, owner and veterinarian double-blind, cross-over trial. Dogs received each of two treatments in random order Randomizer iPhone Application: Each treatment was administered for 4 weeks with a 2-week washout period in between treatments.
Blood was collected to repeat complete blood counts and chemistry analysis at weeks 2 and 4 for each treatment. At each visit, each dog was evaluated by a veterinarian based on a scoring system previously reported 25 as well as by its owner canine brief pain inventory [CBPI], Hudson activity scale before treatment initiation and at weeks 2 and 4 thereafter 26 — Initial power analysis was performed to assess number of dogs needed for this study as a cross over design with a power set 0.
When calculated it was assumed that 14 dogs would be necessary to find differences in outcomes of interest Statistical analysis was performed with a commercially available software package JMP All continuous data were assessed utilizing a Shapiro—Wilk test for normality. For ordinal veterinary scoring data a similar linear mixed model was used, but differences from baseline were first calculated to approximate a normal distribution to meet assumptions for a mixed model analysis.
Residual diagnostics of all final models showed that residuals were normally distributed and fulfilled the assumption of homoscedasticity, and assumptions where therefore met. To control for baseline differences and therefore the possible difference in relative change in CBPI pain, and activity interference assessments and Hudson scoring across dogs, the initial CPBI or Hudson Scores were included for these analyses as a covariate.
Pairwise comparisons between all-time points of both groups were corrected for multiple comparisons with Tukey's post-hoc tests to examine the interaction of time and treatment variables, and to assess differences between change from baseline at any time point as they related to treatment.
A p -value of less than 0. Pharmacokinetics demonstrated that CBD half-life of elimination median was 4. Median maximal concentration of CBD oil was Twenty-two client-owned dogs with clinically and radiographically confirmed evidence of osteoarthritis were recruited. Sixteen of these dogs completed the trial and were included in the analyses; their breed, weight, age, sex, worse affected limb, radiographic findings, use of NSAIDs and sequence of treatments are summarized in Table 2.
Characteristics of dogs enrolled in a placebo-controlled study investigating the effects of CBD on osteoarthritis. No other veterinary pain comparisons were statistically significant. No changes were observed in weight-bearing capacity when evaluated utilizing the veterinary lameness and pain scoring system Table 3.
Canine Brief Pain Inventory Pain and Activity questions and Hudson Scale mean and standard deviation; lameness, weight-bearing and pain scores median and ranges at each time for cannabidiol CBD and placebo oils.
Chemistry analysis and CBC were performed at each visit. No significant change in the measured CBC values was noted in either the CBD oil or placebo treated dogs data not shown. Other notable significances in serum chemistry values were associated with primarily age or NSAID use.
Box-and-whisker plot of serum alkaline phosphatase ALP activity at each time for treatment and placebo oils.
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