Zinberg 1990.
Study characteristics | ||
Methods | Double‐blind, placebo‐controlled trial | |
Participants | Men and women, 18 to 75 years of age, with mild‐to‐moderate ulcerative colitis ‐ visible blood in the stool and disease involvement of 15 cm or more above the anal verge as defined by flexible sigmoidoscopy or colonoscopy (N = 15). The exacerbation could be a first instance or relapse of established disease. At least 3 days prior to participation, SASP, antidiarrheal agents, antispasmodics, and anticholinergics were discontinued. Oral or rectal steroids were not permitted within 1 week of study entry and other immunosuppressants were not permitted within 1 month of study. Concomitant medications not permitted during the study included NSAIDs, salicylates, digitalis derivatives, tranquilizers, and anti‐depressants At initial patient interview, history and physical exam were performed including baseline laboratory studies. Urine analysis for enteric pathogens was also performed |
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Interventions | Olsalazine (Pharmacia) in opaque gelatin capsules, each of 250 mg (n = 7) or indistinguishable placebo capsules (n = 8) in identical containers, 12 capsules/day (3 with each meal and 3 at bedtime) for 28 days Compliance was assessed by interview as well as by pill count | |
Outcomes | Evaluations were performed at the end of the 2nd and 4th weeks. Endoscopic evaluation was performed at entry and after 4 weeks Clinical evaluation included participant recordings of number of daily bowel movements, stool consistency, presence of blood and mucus, urgency, and incontinence. Endoscopic evaluation assessed the severity of ulceration, friability, erythema, and exudate, each on a 3‐point scale. The sum of these 3 scores gave a total endoscopic score. Improvement was assessed in terms of the changes in both clinical and endoscopic evaluations | |
Notes | 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) | Low risk | Centralized randomization Randomization was on an alternate basis between drug and placebo and allocated by pharmaceutical manufacturer |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blind: physically‐indistinguishable placebo capsules were provided in identical containers |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Dropouts balanced across intervention groups with similar reasons for withdrawal |
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 |
AE: adverse event; CAI: clinical activity index; CFT: contact friability test; EI: endoscopy index; ESR: erythrocyte sedimentation rate; IBD: inflammatory bowel disease; LOCF: last observation carried forward; MMDAI: modified Mayo disease activity index; PFA: patient functional assessment; PGA: physician global assessment; QOL: quality of life; SASP: sulfasalazine; UCCS: ulcerative colitis clinical score; UC‐DAI: ulcerative colitis disease activity index;