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. 2016 Apr 25;2016(4):CD003455. doi: 10.1002/14651858.CD003455.pub2

Kochhar 1991.

Methods Double‐blind RCT. Duration of study: 4 weeks
Follow‐up: at 4 weeks
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