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In dogs with chronic enteropathy (idiopathic inflammatory bowel disease) is budesonide more effective than prednisolone or prednisone in resolving clinical signs?
Victoria Alice Coates Lumbry Park...
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PICO question
In dogs with chronic enteropathy (idiopathic inflammatory bowel disease) is budesonide more effective than prednisolone or prednisone in resolving clinical signs or improving the canine inflammatory bowel disease (IBD) activity index (CIBDAI) or the canine chronic enteropathy clinical activity index (CCECAI)?
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Appraisal, application and reflection
The literature search revealed one paper that was directly relevant to the PICO question outlined; this was a randomised double-blinded treatment control study (Dye et al., 2013). This study design method provides a high strength of evidence when assessing treatment efficacy due to the minimisation of bias. The study compared a population of dogs diagnosed with idiopathic inflammatory bowel disease (IBD) treated blindly with either budesonide or prednisone. Budesonide, a non-halogenated glucocorticoid, was developed to limit systemic side effects in human patients with IBD; whereas prednisone is a glucocorticoid prodrug metabolised by the liver to its active metabolite prednisolone, which results in systemic side effects when administered (Becker, 2013). The diagnostic procedures before entry into and upon completion of the trial, alongside treatment protocols, were standardised. Evaluations conducted throughout the study included weekly owner questionnaires regarding their dog’s clinical signs and attitude, alongside repeat physical examination by one of the study authors 3 weeks and 6 weeks after the initiation of treatment. Information gathered enabled the calculation of CIBDAI score both at enrolment and at 6 weeks, with clinical remission being defined as a 75% reduction in the pretreatment CIBDAI score. The study found that there was no significant difference (P = < .0001) in the effectiveness of budesonide compared to prednisone in improving the CIBDAI scores of the study population; both treatments had similar overall remission rates.
Despite providing statistically significant results, this study had multiple significant limitations that contributed to the weakness of the evidence. Firstly, the small size of the study population limited the power of the statistical analysis. Alongside this, management and trial therapies were non-standardised before entering the study, and medical records prior to referral were often incomplete; thus, assessing the true adequacy of the trial is difficult. Although randomised, the groups were not well matched at baseline as the dogs receiving prednisone therapy both had a greater proportion of eosinophilic inflammation, alongside higher white blood cell and neutrophil counts. Both these differences could have impacted on the study results; firstly, through the effect eosinophilic inflammation could have on response to treatment, and secondly through the indication of a greater disease severity in dogs in the prednisone group. Finally, the study was limited to a 6-week period; this unfortunately limits the findings of this study to be not representative of the long-term use of these immunomodulatory medications.
Based on the strength of the study analysed, there is only weak evidence comparing the efficacy of prednisone and budesonide when treating dogs with idiopathic IBD. Despite this, the non-inferiority of budesonide in comparison to prednisone is encouraging, particularly as this has previously been reported to have reduced systemic side effects observed in dogs (Pietra et al., 2013; Tumulty et al., 2004; and Stroup et al., 2006). However, our analysed study by Dye et al. (2013) is underpowered and did not identify any significant difference in observed side effects between budesonide and prednisone, indicating further research is needed in these areas.
Overall, a single study with moderate power of evidence of alongside some significant limitations, particularly population size, cannot be used as the sole provider of an answer to our PICO question. As such, further studies with greater power would be required before a definitive assessment of comparative treatment efficacy in reducing CIBDAI scores can be made.
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