Bonderup 2003.
Methods | Randomized, double‐blind, placebo‐controlled. Duration of study was 8 weeks. Stool frequency and stool weight was recorded pre‐ and immediately after stopping treatment. All patients underwent sigmoidoscopy with standardized biopsy protocol pre‐ and post‐treatment. Randomization was performed by the drug company. Medication and placebo were delivered prepackaged with consecutive randomized numbers | |
Participants | Patients (n = 20, 16 females) aged > 18 years with clinically and histologically confirmed active collagenous colitis Clinical: > 4 stools/day and/or stool weight > 200 g/day averaged over 3 days pre‐treatment. Negative stool samples for pathogens, parasites, and ova. Histological: collagen layer > 10 um Inflammation was graded on a scale (0 to 3) independently by 2 pathologists Patients with other chronic gastrointestinal diseases were excluded, as were those with clinically significant renal or hepatic disease, those who had been treated with anti‐inflammatory drugs (aminosalicylates, corticosteroids, azathioprine) in the previous 3 months or were pregnant or breast feeding |
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Interventions | Budesonide (9 mg/day for 4 weeks, 6 mg for 2 weeks and 3 mg for 2 weeks) versus placebo for 8 weeks | |
Outcomes | Primary outcome was the proportion of patients that achieved a clinical or histological response Clinical: reduction of stool frequency and/or stool weight by > 50% Histological: decrease in inflammation grade or reduction in thickness of the collagen layer |
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Notes | No antiinflammatory drug treatment was allowed during the study period or for 3 months prior to inclusion. During the study antidiarrheal medications were allowed except during the periods of stool sampling. During these periods no other treatments with effects on the GI tract were allowed. NSAIDS were not permitted, but other chronic medications (e.g. ‐ antihypertensives) were allowed | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described in published study |
Allocation concealment (selection bias) | Low risk | Randomization was performed centrally by the drug company Medication and placebo were delivered prepackaged with consecutive randomized numbers |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "double‐blind" Quote: "The placebo medication was identical in appearance" Quote: "Histopathological evaluation was performed blindly by the two pathologists" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No description of dropouts or withdrawals |
Selective reporting (reporting bias) | Low risk | The primary outcome of clinical remission was reported Histopathological changes were also described |
Other bias | Low risk | Study appeared to be free of other forms of bias |