title: Sucralfate or placebo following argon plasma coagulation for chronic radiation proctitis: a randomized double blind trial.
abstract: OBJECTIVE
  Chronic radiation proctitis is a long-term complication of radiation therapy for pelvic malignancy. The aim of this study was to compare the efficacy and safety of two treatment regimens, sucralfate or placebo, following argon plasma coagulation (APC) for chronic haemorrhagic radiation proctitis.
  
  
  METHODS
  A single-centre, randomized, placebo-controlled, double-blind study was performed on patients with haemorrhagic chronic radiation proctitis after irradiation for prostate, uterine, cervical, rectal or vaginal cancer. All patients received APC, and were then randomized to oral sucralfate (6 g twice a day) or placebo treatment for 4 weeks. APC was repeated every 8 weeks if necessary after the first session. Patients were graded clinically and endoscopically according to the Chutkan and Gilinski scales before and at 8 and 16 weeks after initial APC treatment (1.5-2 l/min, 25-40 W) and after 52 weeks (clinical only).
  
  
  RESULTS
  Of 122 patients, 117 completed the entire protocol, with 57/60 in the sucralfate group and 60/62 in the placebo group. At baseline there were no significant differences between the sucralfate and placebo groups. At 1 year, a significant improvement in the clinical scale in both groups occurred compared with baseline. After 16 weeks, the median overall clinical severity scores fell from 4 to 2 points and the median bleeding score from 2 to 0 in both groups.
  
  
  CONCLUSIONS
  APC is safe and effective for the management of chronic radiation proctitis. Additional sucralfate treatment did not influence the clinical or endoscopic outcome.
authors.affiliation: Department of Gastroenterology and Hepatology, Medical Centre for Postgraduate Education Department of Gastroenterology, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland. mchrusc@mp.pl
authors.forename: M R
authors.initials: MR
authors.lastname: Chruscielewska-Kiliszek
authors.forename: J
authors.initials: J
authors.lastname: Regula
authors.forename: M
authors.initials: M
authors.lastname: Polkowski
authors.forename: M
authors.initials: M
authors.lastname: Rupinski
authors.forename: E
authors.initials: E
authors.lastname: Kraszewska
authors.forename: J
authors.initials: J
authors.lastname: Pachlewski
authors.forename: E
authors.initials: E
authors.lastname: Czaczkowska-Kurek
authors.forename: E
authors.initials: E
authors.lastname: Butruk
mesh_terms: D000368:Aged; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D057908:Argon Plasma Coagulation; D002908:Chronic Disease; D004311:Double-Blind Method; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000209:etiology / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011349:Proctitis / Q000209:etiology / Q000628:therapy*; D011832:Radiation Injuries / Q000209:etiology / Q000628:therapy*; D011878:Radiotherapy / Q000009:adverse effects; D012720:Severity of Illness Index; D013392:Sucralfate / Q000627:therapeutic use*
chemical_list: D000897:Anti-Ulcer Agents; D013392:Sucralfate