Kochhar 1991.
Methods | Double‐blind RCT. Duration of study: 4 weeks Follow‐up: at 4 weeks |
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Participants | 37 people with CRP, 36 cervix and 1 prostate Dx confirmed on symptoms (graded) and mucosal appearance (graded). Cumulative score | |
Interventions | Intervention (group 1): oral sulfasalzine 1 g tds + prednisolone enemas 20 mg bd for 4 weeks 18 people entered, 1 dropped out (unclear why), and 2 did not tolerate the drug Comparator (group 2): oral placebo + rectal sucralfate 2 g bd for 4 weeks 19 entered, with 2 dropouts (unclear why) | |
Outcomes | Groups' responses: 1. Clin improvement 8/15, P < 0.01; endoscopic changes 7/15, P < 0.01 2. Clin improvement 16/17, P < 0.001 (clin response better P < 0.05); endoscopic changes 12/17, P < 0.001 | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised, but methods of sequence generation not described |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
Blinding (performance bias and detection bias) | Low risk | Both the participants and the physician were blinded to the type of therapy |
Blinding of outcome assessment subjective | Low risk | Participants were blinded, and filled out their own diary |
Blinding of outcome assessment objective | Unclear risk | Not described |
Incomplete outcome data: subjective outcomes | Unclear risk | Group 1: 1 drop out, reasons not discussed. 2 others dropped out because they did not tolerate the drug. Group 2: 2 drop outs, reasons not discussed |
Incomplete outcome data: objective outcomes | Unclear risk | Group 1: 1 drop out, reasons not discussed. 2 others dropped out because they did not tolerate the drug. Group 2: 2 drop outs, reasons not discussed |
Selective reporting (reporting bias) | Unclear risk | Study was published in 1991, so no study protocol available. However, all outcomes prespecified in the methods section were reported in the results section |
Other bias | Low risk | No indications of other bias |