FC‐39 Successful management of canine atopic dermatitis using a plant extract: a randomized,double‐blinded,placebo‐controlled trial

This study evaluated the efficacy of Phytopica^TM, a proprietary blend of standardised plant extracts, in canine atopic dermatitis (AD). One hundred twenty dogs with perennial AD were recruited on the basis of history and clinical signs, and a positive intradermal allergen test or rFcεRIα serology to perennial allergens. Other pruritic dermatoses were eliminated by antimicrobial treatment, skin scrapings, Sarcoptes serology, flea control and a 6‐week food trial. Exclusion criteria included antimicrobial therapy within 7 days, antihistamines within 14 days, oral/topical glucocorticoids or cyclosporin within 28 days, and parenteral glucocorticoids, essential fatty acids or immunotherapy within 56 days of entry into the study. Dogs [minimum Canine Atopic Dermatitis Extent and Severity Index (CADESI) = 25] were randomly allocated to receive placebo, 100, 200 or 400 mg/kg Phytopica^TM daily for 12 weeks. Their CADESI was assessed every 4 weeks. A modified intention‐to‐treat population was analysed. The mean reductions in CADESI scores at the end of treatment compared to baseline were 4.4% (100 mg/kg; n = 30), 23.4% (200 mg/kg; n = 29, P < 0.01), 8.5% (400 mg/kg; n = 29) and 3.9% (placebo; n = 29). For more severely affected dogs (minimum CADESI ≥ 50 at baseline), there was significant reduction in mean CADESI score (29.3%, P = 0.038) only in the 200 mg/kg treatment group (n = 14). In conclusion, this study demonstrates that Phytopica^TM is an effective nonsteroidal treatment for canine AD. Funding: Phytopharm plc.     

Doxorubicin and cyclophosphamide for the treatment of canine lymphoma: a randomized,placebo‐controlled study*

Median survival times (STs) for doxorubicin‐treated canine lymphoma range from 5.7 to 9 months. Because dogs treated with multi‐agent protocols have longer STs, we sought to evaluate whether adding cyclophosphamide would improve outcome in canine lymphoma patients while maintaining an acceptable level of toxicity. Thirty‐two dogs with stage III–V multicentric lymphoma were treated with doxorubicin every 3 weeks for five total cycles and prednisone at a tapering dose for the first 4 weeks. Dogs were randomized to receive either cyclophosphamide or placebo concurrently. Seventeen dogs received doxorubicin and placebo, while 15 dogs received doxorubicin and cyclophosphamide. Response, toxicity, progression‐free interval (PFI) and ST were evaluated. The combination of doxorubicin and cyclophosphamide was well tolerated, causing no increase in adverse events over doxorubicin alone. Despite a numeric improvement in outcome in cyclophosphamide treated dogs, the addition of cyclophosphamide did not result in statistically improved response rate, PFI or ST.     

A double‐blind,placebo‐controlled,randomized study to evaluate the weight gain drug,mirtazapine transdermal ointment,in cats with unintended weight loss

Mirtazapine is classified as a weight gain drug in cats, and the purpose of this study was to evaluate its efficacy in cats experiencing unintended weight loss. This was a multi‐center, double‐blind, placebo‐controlled, randomized clinical study in client‐owned cats ≥1 year of age, weighing ≥2 kg, with a documented loss (≥5%) in body weight. Cats were treated once daily with either 2 mg/cat mirtazapine transdermal ointment (n = 83) or placebo (n = 94) (Per Protocol population) applied to the inner surface of the pinna for 14 ± 3 days. Physical examination, body weight, complete blood count, serum chemistry, and urinalysis were performed prior to treatment and on Day 14. Changes in body weight between the mirtazapine and placebo groups were evaluated from Day 1 to Day 14 and compared using a two‐sample t test. The mean percent change in body weight was +3.9% (standard deviation ±5.4%) in the mirtazapine group and +0.4% (±3.3%) in the placebo group (p < 0.0001). The most common adverse event was mild erythema at the application site in 17.4% of placebo and 10.4% of mirtazapine‐treated cats. Application of mirtazapine transdermal ointment was well tolerated both topically and systemically and resulted in significant weight gain in cats experiencing unintended weight loss associated with various underlying diseases.     

Investigation of the clinical efficacy of 0.2% topical stannous fluoride for the treatment of canine superficial pyoderma: a prospective,randomized, double‐blinded,placebo‐controlled trial

Stannous fluoride (SF) is an antibacterial compound that has been successfully used to treat gingivitis in people and dogs, and cutaneous bacterial infections in horses. The purpose of this prospective, double‐blinded, placebo‐controlled clinical trial was to investigate the efficacy of 0.2% SF spray (BacDerm^®; Emerald 3 Enterprises Inc., Camdenton, MO, USA) for the treatment of canine superficial pyoderma. Twenty‐six privately owned dogs with bacterial skin infections diagnosed on clinical signs, cytology and aerobic culture were enrolled. Dogs were randomly assigned to vehicle only or active ingredient treatment groups. The product was applied topically to affected areas once daily for 28 days, with assessments at days 0, 14, 28 and 42. Clinical and cytological evaluations were performed by the same investigators at each visit. Owners scored the improvement of hair coat, odour, pruritus and overall improvement at each recheck. Linear mixed models showed significant effects of treatment (P < 0.0001) and time (P = 0.0037) for investigator’s scores, and a significant time effect for owners’ haircoat (P = 0.0077) and odour (P = 0.0170) improvement scores. Dogs in both placebo and SF groups showed some improvement over time, and the investigator’s scores on days 0 and 28 were not significantly different between groups for both (t‐test P > 0.05). Spearman’s rho correlation coefficients revealed a significant negative correlation between investigator’s scores and all categories of owners’ assessment scores in dogs of both groups. Although some dogs improved on SF, this study does not support the use of 0.2% SF as sole therapy for canine superficial pyoderma.     

Tiludronate infusion in the treatment of bone spavin: A double blind placebo‐controlled trial

Reasons for performing study: Tiludronate regulates bone remodelling through a decrease of the resorptive process and should therefore ameliorate the remodelling processes active in osteoarthritis of the distal tarsal joints (‘bone spavin’) and alleviate pain associated with abnormal bone lysis. Objective: To confirm the efficacy of tiludronate, administered as a single infusion at a dose of 1 mg/kg bwt, in the treatment of bone spavin in the horse. Methods: A double blind placebo controlled trial on 108 clinical cases of bone spavin was undertaken. The lameness score of the lamest limb was assessed following distal tarsal analgesia of the contralateral limb and followed‐up using the same procedure throughout the study. Bone spavin in the lamest limb was confirmed by distal tarsal analgesia and radiography. Horses were treated at Day 0 and reassessed 60 days later after controlled exercise. A second nonblinded treatment was given to unresponsive horses and all horses were re‐examined at Day 120. Exercise levels were recorded at each examination. Results: Eighty‐seven horses completed the trial as per the protocol. The tiludronate horses were significantly less lame than the placebo horses (P = 0.0318). Horses treated at Day 60 with tiludronate showed further improvement in lameness at Day 120 (P = 0.0096 and P = 0.0034 for horses treated with tiludronate and placebo at Day 0, respectively). The only significant difference in radiographic findings between tiludronate and placebo was for presence of periarticular osteophytes (P = 0.006). Conclusions: Tiludronate treatment is proven to be effective in bone spavin in horses in association with a controlled exercise programme. Clinical relevance: Tiludronate in combination with controlled exercise offers an alternate medical treatment for bone spavin.     

A multicentre placebo‐controlled clinical trial on the efficacy of oral ciclosporin A in the treatment of canine idiopathic sebaceous adenitis in comparison with conventional topical treatment

Canine idiopathic sebaceous adenitis (ISA) is an inflammatory reaction of sebaceous glands, potentially resulting in their complete loss. It is considered a T‐cell‐mediated disease, but its precise pathogenesis is still unknown. Topical treatment with oil soaks, humectants and shampoos is effective but laborious. Ciclosporin A (CsA), an immunomodulatory drug, has recently been shown to ameliorate the clinical picture of ISA and to reduce inflammation greatly. It is, however, an expensive treatment option. The objective of this multicentre, partly double‐blinded, randomized controlled study was to evaluate the efficacy of ciclosporin A, either alone or with topical therapy, in comparison to conventional topical treatment alone, as measured by the primary end‐points alopecia and scaling, and multiple histopathological secondary objectives. Thirty‐four dogs with an established diagnosis were treated for 4–6 months and were evaluated before, during and after therapy. Both CsA and topical therapy demonstrated efficacy in this study. Differences between the treatment protocols were marginal. Topical treatment, both alone and in combination with CsA, appeared to reduce scaling more effectively than CsA alone. Both therapies reduced alopecia. There is evidence of a synergistic benefit on both scaling and alopecia, if both treatment options are combined. Inflammation of the sebaceous glands is also best reduced by a combination of both CsA and topical therapy. There is evidence that regeneration of sebaceous glands is best achieved by CsA, either given alone or in combination with topical treatment.