Sara Saei1, Adeleh Sahebnasagh2, Arash Ghasemi3, Jafar Akbari4, Abbas Alipour5, Hossein Lashkardoost6, Ali Yaghobi Joybari4, Farid Nejad Dadgar4, Shahram Ala4, Ebrahim Salehifar7. 1. Student Research Committee, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran. 2. Clinical Research Center, Department of Internal Medicine, Faculty of Medicine, North Khorasan University of Medical Sciences, Bojnurd, Iran. 3. Emam Khomeini Hospital, Mazandaran University of Medical Sciences, Sari, Iran. 4. Pharmaceutical Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran. 5. Department of Epidemiology, Faculty of Medicine, Community Medicine Department, Mazandaran University of Medical Sciences, Sari, Iran. 6. School of Public Health, North Khorasan University of Medical Sciences, Bojnurd, Iran. 7. Gastrointestinal Cancer Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.
Abstract
BACKGROUND: Acute radiation proctitis (ARP) is a usual adverse effect in patients undergoing pelvic radiotherapy. The symptoms include diarrhea, rectal blood or mucus discharge, fecal urgency and tenesmus with pain. Sucralfate, an aluminum-based salt of sucrose octasulfate, is a cytoprotective agent that forms a coating barrier at injured sites by adhering to mucoproteins. It has been used in topical management of a wide variety of local lesion. This study was designed to evaluate the preventive effect of rectal sucralfate on acute radiotherapy induced proctitis. METHODS: Seven percent sucralfate ointment was prepared for topical use. Drug quantification, chemical stability and microbial limit tests were performed carefully. In this randomized double blind placebo controlled trial, fifty-seven patients with pelvic malignancies undergoing radiotherapy were allocated to receive either 1 g of sucralfate or 1 g of placebo, given as a twice daily ointment, one day before and during radiotherapy for six weeks. The eligible patients were evaluated based on RTOG acute toxicity criteria and the following ARP symptoms weekly: rectal hemorrhage, diarrhea, rectal pain, and fecal urgency. The influence of symptoms on lifestyle was also recorded weekly. RESULTS: Acute proctitis was significantly less prevalent in patients in the sucralfate group. The incidence of rectal bleeding (P=0.003), diarrhea (P=0.002), rectal pain (P=<0.001) and fecal urgency (P=0.002) was significantly less common in the sucralfate group. No statistical significant difference was observed for radiotherapy induced cystitis in the placebo and sucralfate groups (P=0.27). CONCLUSION: This study suggests that sucralfate7% ointment reduces the incidence of symptoms associated with acute radiation proctitis.
BACKGROUND: Acute radiation proctitis (ARP) is a usual adverse effect in patients undergoing pelvic radiotherapy. The symptoms include diarrhea, rectal blood or mucus discharge, fecal urgency and tenesmus with pain. Sucralfate, an aluminum-based salt of sucrose octasulfate, is a cytoprotective agent that forms a coating barrier at injured sites by adhering to mucoproteins. It has been used in topical management of a wide variety of local lesion. This study was designed to evaluate the preventive effect of rectal sucralfate on acute radiotherapy induced proctitis. METHODS: Seven percent sucralfate ointment was prepared for topical use. Drug quantification, chemical stability and microbial limit tests were performed carefully. In this randomized double blind placebo controlled trial, fifty-seven patients with pelvic malignancies undergoing radiotherapy were allocated to receive either 1 g of sucralfate or 1 g of placebo, given as a twice daily ointment, one day before and during radiotherapy for six weeks. The eligible patients were evaluated based on RTOG acute toxicity criteria and the following ARP symptoms weekly: rectal hemorrhage, diarrhea, rectal pain, and fecal urgency. The influence of symptoms on lifestyle was also recorded weekly. RESULTS: Acute proctitis was significantly less prevalent in patients in the sucralfate group. The incidence of rectal bleeding (P=0.003), diarrhea (P=0.002), rectal pain (P=<0.001) and fecal urgency (P=0.002) was significantly less common in the sucralfate group. No statistical significant difference was observed for radiotherapy induced cystitis in the placebo and sucralfate groups (P=0.27). CONCLUSION: This study suggests that sucralfate7% ointment reduces the incidence of symptoms associated with acute radiation proctitis.
Authors: D E Kyrmizakis; C E Papadakis; J G Bizakis; G A Velegrakis; N M Siafakas; E S Helidonis Journal: Am J Otolaryngol Date: 2001 Jan-Feb Impact factor: 1.808