Hirano, K., Tada, M., Isayama, H., Sasahira, N., Umefune, G., & Akiyama, D. et al. (2016). Outcome of Long-term Maintenance Steroid Therapy Cessation in Patients With Autoimmune Pancreatitis. Journal Of Clinical Gastroenterology, 50(4), 331-337
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/26565969
| Methods | Study design: Single group intervention study
Number of groups: 1 |
| Participants | Number of participants: 21
Age: 67 ± 10 (range 44-79) Sex: 3 female (14.2%) Participants with dementia: 0 Inclusion criteria: ≥20 years old Autoimmune pancreatitis according to Asian diagnostic criteria Undergoing steroid therapy ≥3 years Current maintenance therapy: prednisolone 5mg or less IgG level maintained <1600mg/dL over past year No imaging results suggesting active IgG4-related lesions Pancreatic amylase and lipase not exceeding normal values Krebs Von den Lungen in normal range TSH between 0.3 – 10 uIU/mL Exclusion criteria: Patients who relapsed clinically while on steroid therapy Concomitant medicines: 7 (33%) on anti-diabetic medications Country: Japan Setting: Outpatient clinic |
| Interventions | Medicine: Prednisolone
Withdrawal schedule: Tapered by 1mg every 8-10 weeks until complete cessation |
| Outcomes | Rate of successful deprescription of prednisolone without serological/clinical relapse
Change in HbA1c Number of anti-diabetic medicines required Serological (IgG/IgG4) and clinical (abnormal imaging) relapse |
| Dates | Dates: June 2010- June 2014
Follow-up duration: 36 months (planned) |
| Funding sources | Japanese Ministry of Health, Labor and Welfare Research Program of Intractable Disease |
| Notes | Trial terminated in December 2013 due to high rates of relapse (38%).
All participants informed/offered option of resuming prednisolone, and followed until June 2014. |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | High | Hand-selected patients |
| Allocation concealment (selection bias) | Low | Single arm study |
| Blinding of participants and personnel (performance bias) | High | Unblinded, single arm study |
| Blinding of outcome assessment (detection bias) | High | Outcome assessors not described |
| Incomplete outcome data (attrition bias) | High | Significant missing data in results without explanation |
| Selective reporting (reporting bias) | Low | A clinical trial protocol is referred to, but not referenced/available |
| Confounding (non-randomized) | High | No control group |
| Other bias | ||
| Selection bias | Representativeness of the exposed cohort | Selected group of patients |
| Selection of the non-exposed cohort | N/A | |
| Ascertainment of exposure | Secure record | |
| Demonstration that outcome of interest was not present at start of study | Yes | |
| Comparability bias | Comparability of cohorts on the basis of the design or analysis | N/A no second cohort |
| Outcome bias | Assessment of outcome | Record linkage |
| Was follow-up long enough for outcomes to occur | Yes | |
| Adequacy of follow-up of cohorts | No statement | |
Leave a Reply