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Budesonide versus prednisolone in the treatment of diarrhoea associated with canine inflammatory bowel disease

Clinical Scenario

Ms Taylor comes to see you with her 5 year old cocker spaniel, Donald.  You have been treating Donald for his inflammatory bowel disease (IBD) with food and antibiotics for a while, however Ms Taylor reports that his main clinical sign of diarrhoea has not improved and neither has the state of her carpets!  You suggest that steroid therapy is the next logical treatment in trying to manage Donald's clinical signs.  In the past Ms Taylor has been treated with prednisolone for lupus and doesn’t want Donald to experience the horrible side effects that she did. You have heard about budesonide being used as an alternative to prednisolone for IBD so wonder if there is any evidence to support its use in Donald’s case to resolve his chronic diarrhoea….

3-Part Question (PICO)

In [dogs with idiopathic inflammatory bowel disease] is [budesonide vs prednisolone] effective at [resolving the clinical signs of diarrhoea]?

Search Strategy and Summary of Evidence

Search Strategy

MEDLINE(R) In-Process & Other Non-Indexed Citations and MEDLINE(R) 1946 to Present using the OVID interface

(dog.mp. OR dogs.mp. OR canine.mp. OR canines.mp. OR canis.mp. OR exp Dogs/)

AND

(inflammatory bowel disease.mp. OR IBD.mp. OR steroid responsive diarrhoea.mp. OR steroid responsive diarrhea.mp. OR steroid responsive bowel disease.mp. OR SRD.mp. OR chronic enteropathy.mp. OR diarrhoea.mp. OR diarrhea.mp. OR loose stool.mp. OR loose stools.mp. OR loose faeces.mp. OR loose feces.mp OR exp inflammatory bowel diseases/ OR exp intestinal diseases/ OR exp gastrointestinal diseases/ OR exp diarrhea/)

AND

(budesonide.mp. OR non halogenated corticosteroid.mp. OR non-halogenated corticosteroid.mp. OR nonhalogenated corticosteroid.mp. OR non halogenated glucocorticoid.mp. OR non-halogenated glucocorticoid.mp. OR nonhalogenated glucocorticoid.mp. OR Budenofalk.mp. OR Entocort.mp. OR exp budesonide/ OR exp glucocorticoids/)

AND

(prednisolone.mp. OR prednisone.mp. OR corticosteroid.mp. OR corticosteroids.mp. OR glucocorticoid.mp. OR glucocorticoids.mp. OR prednicare.mp. OR steroid.mp. OR steroids.mp. OR corticoid.mp. OR corticoids.mp. OR PLT.mp. OR prednidale.mp. OR dermipred.mp. OR deltasone.mp. OR sterapred.mp. OR prednis-tab.mp. OR exp prednisolone/ OR exp prednisone/ OR exp glucocorticoids/ OR exp steroids/)

CAB Abstracts 1910 to Present using the OVID interface

(dog.mp. OR dogs.mp. OR canine.mp. OR canines.mp. OR canis.mp. OR exp Dogs/)

AND

(inflammatory bowel disease.mp. OR IBD.mp. OR steroid responsive diarrhoea.mp. OR steroid responsive diarrhea.mp. OR steroid responsive bowel disease.mp. OR SRD.mp. OR chronic enteropathy.mp. OR diarrhoea.mp. OR diarrhea.mp. OR loose stool.mp. OR loose stools.mp. OR loose faeces.mp. OR loose feces.mp. OR exp intestinal diseases/ OR exp diarrhoea/)

AND

(budesonide.mp. OR non halogenated corticosteroid.mp. OR non-halogenated corticosteroid.mp. OR nonhalogenated corticosteroid.mp. OR non halogenated glucocorticoid.mp. OR non-halogenated glucocorticoid.mp. OR nonhalogenated glucocorticoid.mp. OR Budenofalk.mp. OR Entocort.mp.)

AND

(prednisolone.mp. OR prednisone.mp. OR corticosteroid.mp. OR corticosteroids.mp. OR glucocorticoid.mp. OR glucocorticoids.mp. OR prednicare.mp. OR steroid.mp. OR steroids.mp. OR corticoid.mp. OR corticoids.mp. OR PLT.mp. OR prednidale.mp. OR dermipred.mp. OR deltasone.mp. OR sterapred.mp. OR prednis-tab.mp. OR exp prednisolone/ OR exp prednisone/ OR exp corticoids/ OR exp synthetic glucocorticoids/ OR exp glucocorticoids/ OR exp steroids/)

Search Outcome

MEDLINE

  • 138 papers found in MEDLINE search
  • 137 papers excluded as they don't meet the PICO question
  • 0 papers excluded as they are in a foreign language
  • 0 papers excluded as they are review articles/in vitro research/conference proceedings
  • 1 total relevant papers from MEDLINE

CAB Abstracts

  • 4 papers found in CAB search
  • 3 papers excluded as they don't meet the PICO question
  • 0 papers excluded as they are in a foreign language
  • 0 papers excluded as they are review articles/in vitro research/conference proceedings
  • 1 total relevant papers from CAB

Total relevant papers

1 relevant papers from both MEDLINE and CAB Abstracts

Comments

The paper identified uses prednisone, not prednisolone. Prednisolone is the active metabolite of prednisone. Prednisone is typically used in North America, whereas prednisolone is typically used in Europe. The dosing and efficacy of these two drugs are considered to be interchangable, therefore we have considered this paper relevant to the BET. 

Summary of Evidence

Dye et al. (2013), North America

Title:

Randomized, controlled trial of budesonide and prednisone for the treatment of idiopathic inflammatory bowel disease in dogs

Patient group:

40 dogs of at least 3kgs weight diagnosed with idiopathic inflammatory bowel disease on the basis of: persistent (>3 weeks duration) or recurrent gastrointestinal signs AND inadequate response to dietary and symptomatic therapies alone AND thorough diagnostic evaluation with exclusion of other causes of gastroenteritis AND histopathological evidence of mucosal inflammation. 

Treatments trialled:

Group A: Oral prednisone at 1mg/kg every 12 hours for the first 3 weeks then 0.5mg/kg every 12 hours for the next 3 weeks (20 dogs). 

Group B: Compounded preparation of powder-based budesonide in capsule form with dosage based on bodyweight. That dose remained constant for the 6 weeks of the trial (20 dogs).  

Study Type:

Randomised controlled trial

Outcomes:

Outcomes measured:

  • Age, sex, breed
  • At baseline, weeks 3 and 6: complete blood count; biochemistry; urinalysis
  • At baseline and week 6: endoscopic visual findings; endoscopic biopsy histopathology; composite endoscopic biopsy score; calculated Canine Inflammatory Bowel Disease Activitiy Index (CIBDAI)
  • Weekly during the trial: owner questionnaire about their dog's attitude and clincial signs, focused on adverse effects
  • Week 6 only: number of patients in remission (>75% reduction in CIBDAI)

Outcomes reported: 

  • Age, sex, breed
  • All baseline clinical, haematological, urine and endoscopic data
  • Calculated Canine Inflammatory Bowel Disease Activitiy Index (CIBDAI) at week 6
  • Number of patients in remission at week 6
  • Body weight at week 6
  • Serum albumin at week 6
  • Urine specific gravity at week 6
  • Serum ALT and ALP at week 6
  • Composite biopsy score at week 6
  • Composite owner reported data on incidence and severity of specified adverse effects
Key Results:
  • 40 dogs were enrolled in the trial, 20 in each arm.
  • 6 dogs dropped out: 4 dogs in the prednisone group, and 2 in the budesonide group.
  • Both treatments were effective in reducing CIBDAI scores from baseline with 68.8% of dogs treated with prednisone and 77.8% of dogs treated with budesonide being considered as in remission. 
  • There was no significant difference in the number of dogs in remission between the two treatments (p=0.70).
  • There were no significant changes in the bodyweight of dogs in either group.
Study Weaknesses:
  • The primary outcome of the paper is not directly reflective of the primary outcome of interest of this BET. 
  • Small sample size with no power calculation
  • Outcomes incompletely reported
  • Changes in individual CIBDAI parameters from baseline not stated
  • Different dosing regimes used for different treatments (prednisone dosed per kg, budesonide dosed in four weight categories)
  • Prednisone dose decreased at week 3, budesonide dose maintained at a constant rate
  • No statement regarding ethical approval for the study
  • Assessment of adverse reactions was subjective and not validated
Attachment:
Evidence appraisalEvidence appraisal

Comments

There was no significant difference in the type or severity of side effects seen by owners in dogs treated with prednisone versus budesonide. However, as a sample size calculation was not performed, it is difficult to interpret the significance of any of the findings.

This paper does not directly report the outcome of interest in the BET but the CIBDAI is a recognised composite scoring scheme for IBD severity which includes stool consistency and frequency. 

The study used prednisone, as opposed to prednisolone which is commercially available in the UK. There are subtle pharmacokinetic differences between the two drugs but these are not considered to be clinically significant.  Budesonide is not currently licensed for the treatment of inflammatory bowel disease in dogs in the UK. Clinicians should consider licensing regulations and follow the cascade.

Bottom line

Budesonide and prednisone are similarly effective in reducing the clinical signs associated with inflammatory bowel disease.

Disclaimer

The BETs on this website are a summary of the evidence found on a topic and are not clinical guidelines. It is the responsibility of the individual veterinary surgeon to ensure appropriate decisions are made based on the specific circumstances of patients under their care, taking into account other factors such as local licensing regulations. Read small print

References

Dye, TL, Diehl, KJ, Wheeler, SL, Westfall, DS, (2013). Randomized, controlled trial of budesonide and prednisone for the treatment of idiopathic inflammatory bowel disease in dogs. Journal of Veterinary Internal Medicine, 27: 1385-91.

About this BET

First author:
Daisy Jones
Second author:
Zoe Belshaw
Institution:

University of Nottingham

Search last performed:
2017-04-05 08:16:54
Original publication date:
2017-05-31 08:16:54
Last updated:
2017-05-31 08:16:54
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