Ulcerative colitis Appendix G: Evidence tables tables G: Evidence Appendix NationalClinical Guideline Centre, 2013.
Table 49: FERRY1993 Outcome Author Patients Intervention measures Effect size Comments
G. D. Ferry et al. All patients: Group 1: Olsalazine (up Outcome 1: Clinical At 1 month Funding: to 2g) remission Supported in part by the Olsalazine Versus Sulfasalazine N=59crandomised (Asymptomatic -free Group1:4/28 Food and Drug in Mild to Moderate Childhood N=28 randomised from all symptoms, Administration Grant, Ulcerative Colitis: Results of the N=56 (for analysis as 3 patients had micro colitis and so were formed bowel Group 2:6/28 Pharmacia, Inc., the Bob Pediatric Gastroenterology excluded) N=26 (completers) movements, no visible and Vivian Smith Collaborative Research Group blood (all of the above At 2 months Foundation and the Kelsey- Clinical Trial. Journal of Drop-outs (don’t complete the study): 30mg/kg/day of for at least 7 days)) Seybold Foundation. Pediatric Gastroenterology and Olsalazine (maximum Group1:5/28 d Nutrition; 17: 32-38. 1993. N=6 (10%) 2g/day) Group 2:8/28
78 Limitations: REF ID: FERRY1993 Inclusion criteria: Medication was started at one dose per day or At 3 months Unclear method of Study design and quality: Children 2-17 years old 25% of the calculated randomisation and daily dose and Group1:4/28 allocation concealment Double blind RCT Severity: Mild to moderate (see below for criteria) increased by one dose every 3 days until four Group 2:9/28 Multicentre, 13 centres, United Newly diagnosed or relapse while off all medications (patients who doses per day were Outcome 2: Endoscopic States, Canada had relapsed had been off all medications for at least 1 week prior to achieved. remission (normal At 2 months Additional outcomes: trial start) mucosa) 12 week trial All medications were Group1:5/17 Mean change in Diagnosis confirmed histologically after colonoscopy, or barium enema stopped in those with a colonoscopic score Randomisation: Patients were and limited colonoscopy relapse 1 week prior to Group stratified by new diagnosis and the trial. 2:11/24 Colonoscopy improvement relapse. Randomisation Exclusion: schedule by centre. No further Group 2: Time to remission information Severe UC Sulphasalazine (up to Outcome 2: Clinical and 4g) endoscopic remission At 2 months Allocation concealment: Significant abdominal distension or tenderness associated with (normal mucosa and Group1:2/17
cOnly one third of the expected patients were enrolled in the trial. It was decided that it would take too long to complete the trial waiting for further patients so enrolment was then stopped. dOlsalazine group: Two patients were non compliant. In the Sulfasalazine group four patients discontinued the drug due to adverse drug reactions.
Appendix G: Evidence tables tables G: Evidence Appendix Ulcerative colitis NationalClinical Guideline Centre, 2013 Outcome Author Patients Intervention measures Effect size Comments Unclear guarding or rebound asymptomatic) e N=28 randomised Blinding: Double blind. Identical Localized proctitis Group capsules. Drugs were dispensed N=24 (completers) 2: 3/24 f
in a double blind fashion. History of allergy to salicylates or sulfa-containing drugs Standard paediatric Outcome assessment: Previous intolerance to olsalazine or sulfasalazine dose of sulfasalazine, Outcome 3: Adverse Colonoscopy score was 60mg/kg/day events Group1: 11/2 modified by Roth, score from 0- Significant glucose-6- phosphate dehydrogenase deficiency (maximum 4g/day) 8
3 for 5 characteristics. Severity based on temperature and If judged to be non compliant or if the patients refused Medication was started Olsalazine: headache, Group stool frequency. at one dose per day or nauseas, vomiting rash, 2: 13/28 Group 1: Olsalazine (up to 2g) 25% of the calculated increased diarrhoea, Sample size calculation: 90 Mean age (SD): 10.5 (4.1), range 2.1-17.9 years daily dose and fever, pruritus) patients per arm based on 80% Extent: rectosigmoid n=9, left colon n=5, beyond splenic flexure n=14 increased by one dose Sulphasalazine: all of power, p=0.05 for a 25% Mean colonoscopy score: 1.3 (0.5) every 3 days until four the above apart from . difference in adverse events Drop outs: 2 (non compliant) doses per day were pruritus plus achieved. neutropenia and Type of analysis: ITT Group 2: Sulphasalazine (up to 4g) anorexia. Mean age (SD): 10.9 (4.2), range 3.1-17.5 years All medications were 79 Compliance rates: >85% of the Extent: rectosigmoid n=6, left colon n=8, beyond splenic flexure n=14 stopped in those with a
Two patients on each prescribed dose taken was Mean colonoscopy score: 1.2 (0.6) relapse 1 week prior to drug reported considered compliant. This was Drop outs: 4 (Adverse events) the trial. increased diarrhoea verified by tablet counts. which was thought to Unclear if 2 patients were non Concomitant therapy: be drug related. compliant in the olsalazine group. No antibiotics, anticholinergic or Also reports clinical improvement but no N=4 dropout/ withdrawal due antidiarrheal drugs definition was given so this has not been to AEs in the sulphasalazine were permitted during included in the analysis. group (they were thought to be the study. 10 of 28 patients on olsalazine had possibly drug related Starting prednisone or received prednisone, 8 for worsening of (neutropenia, 3 for rash and/or enemas was left to the symptoms and two for lack of headache) discretion of the response.1 patient in the sulphasalazine attending group was put on prednisone. gastroenterologist at each centre.
e 17 patients on olsalazine did not have a repeat colonoscopy at 2 months (concurrent medication or did not return for the procedure) f 4 patients on sulphasalazine did not have a repeat colonoscopy (concurrent medication, adverse reactions to sulphasalazine, did not return for the procedure)