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At least 289 records · Page 16Linked to original sources
PubMed1987

5-Aminosalicylic acid enema in the treatment of distal ulcerative colitis, proctosigmoiditis, and proctitis.

The efficacy and safety of 4-g 5-aminosalicylic acid enemas were assessed in 153 patients with ulcerative colitis involving up to 50 cm of distal colon. Seventy-six patients received active medication and 77 received a placebo. There were 20 dropouts (6 in the active group and 14 in the placebo group) during the study because of insufficient efficacy. After 6 wk of therapy, 48 of the 76 patients (63%) receiving 5-aminosalicylic acid were considered to be "much improved" by the study physician compared to 22 of the 77 patients (29%) on placebo (p = 0.001). A disease activity index based on patient symptoms and sigmoidoscopic appearance was used to assess efficacy. Mean disease activity index declined 55% for patients on 5-aminosalicylic acid and 24% for patients on placebo (p = 0.0001). Analysis of subgroups indicated that patients most likely to respond were those with disease confined to the 20-40 cm from the anus. Response was not affected by concurrent sulfasalazine, but patients requiring concurrent oral steroids had a diminished response. Rapid onset of efficacy was shown by a significant reduction in rectal bleeding within 3 days of treatment initiation. 5-Aminosalicylic acid enemas are well tolerated and are of benefit in the treatment of ulcerative colitis confined to the distal colon.

Adult↗
PubMed2005

Sucralfate does not ameliorate acute radiation proctitis: randomised study and meta-analysis.

AIMS: During pelvic radiotherapy, many patients develop radiation-induced gastrointestinal symptoms, which may interfere with treatment. Prophylaxis during radiotherapy should ideally prevent acute reaction and the development of delayed injury. Sucralfate, an aluminium sucrose octasulphate, has been used for acute and delayed radiation side-effects. However, conflicting results have been published. We report here a prospective, randomised, placebo-controlled study of prophylactic sucralfate during pelvic radiotherapy. In addition, a meta-analysis of available data from the literature has been carried out. MATERIALS AND METHODS: Fifty-one patients with localised pelvic tumours scheduled for curative conformal pelvic radiotherapy (total dose 64-70 Gy over 6.5-7 weeks in 2 Gy daily fractions) were included. Peroral sucralfate 2 g three times daily, or identically appearing placebo tablets, was given during the course of radiotherapy. Symptom registration, endoscopy and biopsies were carried out immediately before radiotherapy, 2 weeks and 6 weeks into the treatment course, and 2 weeks after completing radiotherapy. Mucosal cup forceps biopsies were obtained through a rigid proctoscope. Graded endoscopic appearance and quantitative histology were registered. RESULTS: On the basis of previously published negative reports, an unplanned interim analysis of 44 evaluable patients showed significantly increased diarrhoea in the sucralfate group and the trial was stopped. No difference was seen in other symptoms, endoscopic appearance or histology. A meta-analysis comprising five published studies showed no statistically significant beneficial effect of sucralfate on acute symptoms. CONCLUSION: Sucralfate cannot be recommended for prophylaxis of acute radiation proctopathy and may even worsen the symptoms.

Acute Disease↗
PubMed2007

Proctitis after external-beam radiotherapy for prostate cancer classified by Vienna Rectoscopy Score and correlated with EORTC/RTOG score for late rectal toxicity: results of a prospective multicenter study of 166 patients.

PURPOSE: To evaluate the Vienna Rectoscopy Score (VRS) as a feasible and effective tool for detecting and classifying pathologic changes in the rectal mucosa after radiotherapy (RT) for prostate cancer, and, also, to correlate its findings with the European Organization for Research and Treatment of Cancer (EORTC)/Radiation Therapy Oncology Group (RTOG) score for late rectal toxicity. METHODS AND MATERIALS: A total of 486 patients with localized prostate cancer underwent external-beam RT up to 70 or 74 Gy within an Austrian-German prospective multicenter trial. In 166 patients, voluntary rectal sigmoidoscopy was performed before and at 12 and/or 24 months after RT. Pathologic findings such as telangiectasia, congested mucosa, and ulcers were graded (Grades 0-3) and summarized according to the VRS. Late rectal side effects (EORTC/RTOG) were documented and correlated with the corresponding VRS. RESULTS: Before RT, 99% had a VRS score of 0. The median follow-up was 40 months. Overall, a late rectal side effects grade or score 1-3 was detected in 43% by EORTC/RTOG compared with 68% by VRS (p < 0.05). Grades 0, 1, 2, and 3 late rectal side effects were found using EORTC/RTOG in 57%, 11%, 28%, and 3%, respectively; the corresponding percentages were 32%, 22%, 32%, and 14% for a VRS of 0, 1, 2, and 3, respectively. A significant coherence between the VRS and EORTC/RTOG was found (p < 0.01). CONCLUSIONS: The VRS is a feasible and effective tool for describing and classifying pathologic findings in the rectal mucosa after RT within a multicenter trial. The VRS and EORTC/RTOG showed a high coherence. However the VRS was significantly more sensitive.

Aged↗
PubMed1998

Budesonide enema for the treatment of active, distal ulcerative colitis and proctitis: a dose-ranging study. U.S. Budesonide enema study group.

BACKGROUND & AIMS: Budesonide is a highly potent topical glucocorticosteroid that is characterized by low systemic availability as a result of high first-pass hepatic metabolism. The aim of this study was to evaluate the efficacy and safety of three doses of an enema preparation of budesonide in patients with active distal ulcerative colitis/proctitis. METHODS: In a double-blind multicenter trial, 233 patients were randomized to receive either a placebo enema or budesonide enema at a dose of 0.5 mg/100 mL, 2.0 mg/100 mL, or 8.0 mg/100 mL. The primary efficacy variables were an improvement of sigmoidoscopic inflammation grade, total histopathology score, and remission rates. Effects on cortisol concentrations were also assessed. RESULTS: After 6 weeks of treatment, there was significant improvement in sigmoidoscopy and histopathology scores in the budesonide 2.0-mg and 8.0-mg dose groups compared with placebo. Remission was achieved in 19% of patients in the 2.0-mg budesonide group (P </= 0.050) and 27% of patients in the 8.0-mg budesonide group (P </= 0.001) compared with 4% in the placebo group. More than 90% of all budesonide patients had a normal adrenocorticotropin (ACTH)-stimulated cortisol response at the last visit. The budesonide enemas were well tolerated. CONCLUSIONS: Budesonide enema is both effective and safe for the treatment of active distal ulcerative colitis/proctitis. A dose of 2. 0 mg/100 mL budesonide is the lowest effective dose.

Adult↗