Schroeder 1987.
| Methods | Placebo‐controlled, double‐blind, and randomised study (N = 87) | |
| Participants | Patients, age 15‐70 years, with mild‐to‐moderate UC (defined by symptomatic, radiographic, endoscopic criteria) Patients receiving corticosteroids or SASP were required to stop such therapy at least 1 week prior to start of study Pre‐entry evaluations included history, physical, blood count, chemistry screening, urinalysis, stool sample (had to be negative for ova, parasites, enteric pathogens) |
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| Interventions | Group 1: 4.8 g/day Asacol (400 mg of 5‐ASA, coated with pH‐sensitive polymer Eudragit‐S which dissolves at pH 7 or higher) (n = 38) Group 2: 1.6 g/day Asacol (400 mg of 5‐ASA, coated with pH‐sensitive polymer Eudragit‐S which dissolves at pH 7 or higher) (n = 11) Group 3: matched placebo (500 mg microcellulose with identical pH‐sensitive coating (n = 38) Patients received 12 tablets daily for 6 weeks |
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| Outcomes | Primary outcome: clinical response, described as 'complete', 'partial', or 'no response', was determined on the basis of stool frequency, amount of rectal bleeding, and physician's global assessment (which included sigmoidoscopic appearance) on 4‐point scales, compared to baseline data Secondary outcomes: complete response' indicated resolution of all symptoms, adverse events |
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| Notes | Early termination of treatment for any reason was deemed to constitute treatment failure | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation sequence was developed by the Section of Medical Research Statistics, Rochester Methodist Hospital |
| Allocation concealment (selection bias) | Low risk | Centralized randomisation by pharmacist |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind: matching placebo |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | More placebo patients (n= 16) did not complete the study than 5‐ASA patients (n = 5) Placebo patients were more likely to drop out do to flare of UC or no improvement |
| Selective reporting (reporting bias) | Low risk | All expected outcomes were reported |
| Other bias | Low risk | The study appears to be free of other sources of bias |