Levine 2002.
Study characteristics | ||
Methods | Multicenter, randomized, double‐blind, double‐dummy, dose‐response, parallel‐group study | |
Participants | Adults (aged 18 to 80 years) with mild to moderately‐active ulcerative colitis confirmed by flexible sigmoidoscopy (N = 154) | |
Interventions | Balsalazide 6.75 g/day (n = 35), Balsalazide 2.25 g/day (n = 35) or Asacol 2.4 g/day (n = 36) for 8 weeks | |
Outcomes | Primary outcome: Difference between treatment groups in rectal bleeding and in at least one other symptom. Improvement was defined as improvement in at least one category of the disease activity scale (i.e. normal, mild, moderate, severe) Secondary outcomes: Remission status (normal stool frequency and no blood in stool for 48 hours before visit, physician’s global assessment score of quiescent and a sigmoidoscopy score of mild or normal), rectal biopsy score, and IBDQ score |
|
Notes | For the purposes of this review we used only the comparison between Balsalazide 6.75 g and Asacol 2.4 g (i.e. equimolar doses) Funding support and conflicts of interest were not reported |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blind, double‐dummy: Placebos were identical in appearance to the Balsalazide capsules and mesalamine (Asacol) tablets |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 31% dropout rate. Dropouts appear to be balanced across intervention groups. More participants withdrew from the low‐dose Balsalazide and mesalamine groups due to lack of therapeutic effect than the high‐dose Balsalazide group |
Selective reporting (reporting bias) | Low risk | Expected outcomes were reported |
Other bias | Low risk | The study appears to be free of other sources of bias |