title: Radiation-induced proctosigmoiditis. Prospective, randomized, double-blind controlled trial of oral sulfasalazine plus rectal steroids versus rectal sucralfate.
abstract: In a prospective study, 37 consecutive patients with radiation-induced proctosigmoiditis were randomized to receive a four-week course of either 3.0 g oral sulfasalazine plus 20 mg twice daily rectal prednisolone enemas (group I, N = 18) or 2.0 g twice daily rectal sucralfate enemas plus oral placebo (group II, N = 19). The two groups were comparable with respect to demographic features, duration of symptoms, and clinical and endoscopic staging of the disease. Fifteen patients in group I and 17 in group II completed the trial. At four weeks, both groups showed significant clinical improvement (P less than 0.01 for group I and P less than 0.001 for group II) and endoscopic healing (P less than 0.01 for group I and P less than 0.001 for group II). When the two groups were compared, sucralfate enemas showed a significantly better response as assessed clinically (P less than 0.05), although endoscopically the response was not statistically different (P greater than 0.05). We conclude that both treatment regimens are effective in the management of radiation proctitis. Sucralfate enemas give a better clinical response, are tolerated better, and because of the lower cost should be the preferred mode of short-term treatment.
authors.affiliation: Department of Gastroenterology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
authors.forename: R
authors.initials: R
authors.lastname: Kochhar
authors.forename: F
authors.initials: F
authors.lastname: Patel
authors.forename: A
authors.initials: A
authors.lastname: Dhar
authors.forename: S C
authors.initials: SC
authors.lastname: Sharma
authors.forename: S
authors.initials: S
authors.lastname: Ayyagari
authors.forename: R
authors.initials: R
authors.lastname: Aggarwal
authors.forename: M K
authors.initials: MK
authors.lastname: Goenka
authors.forename: B D
authors.initials: BD
authors.lastname: Gupta
authors.forename: S K
authors.initials: SK
authors.lastname: Mehta
mesh_terms: D000284:Administration, Oral; D000285:Administration, Rectal; D000328:Adult; D000368:Aged; D003113:Colonoscopy; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011239:Prednisolone / Q000627:therapeutic use*; D011350:Proctocolitis / Q000188:drug therapy* / Q000209:etiology; D011446:Prospective Studies; D011832:Radiation Injuries / Q000188:drug therapy*; D013392:Sucralfate / Q000627:therapeutic use*; D012460:Sulfasalazine / Q000627:therapeutic use*
chemical_list: D012460:Sulfasalazine; D013392:Sucralfate; D011239:Prednisolone