A prospective randomized placebo-controlled double-blinded pilot study of misoprostol rectal suppositories in the prevention of acute and chronic radiation proctitis symptoms in prostate cancer patients

OBJECTIVE: Radiation proctitis is a known complication of radiation therapy for prostate cancer. Available medical treatment is usually ineffective an d has focused on relieving symptoms after damage has occurred. Our study ai med at evaluating the use of misoprostol rectal suppositories in the preven tion of acute as well as chronic radiation proctitis symptoms. METHODS: A prospective, randomized, placebo-controlled, double-blinded tria l was conducted in patients with recently diagnosed stages B and C prostate cancer who underwent external beam irradiation. Patients received either a misoprostol or a placebo suppository 1 h before each radiation session. Mi soprostol suppositories were made from two 200-mu g tablets (Cytotec, Searl e Pharmaceuticals, Skokie, IL), whereas the placebo was made from cocoa but ter. A 12-point radiation proctitis symptom score was obtained from each pa tient at 4, 8, 12, and 36 wk after radiation therapy. RESULTS: A total of 16 patients were enrolled. Seven patients received plac ebo, and nine patients received misoprostol. Mean radiation proctitis sympt om scores in the placebo group were 4.86, 5.86, 5.71, and 3.83 at 4, 8, 12, and 36 wk, respectively. The mean scores in the misoprostol group were 0.7 8, 0.67, 0.33, and 0.37 at 4, 8, 12, and 36 wk, respectively. The differenc e between the two groups was statistically significant (p < 0.05) at 4, 8, 12, and 36 wk. CONCLUSION: Misoprostol rectal suppositories significantly reduce acute and chronic radiation proctitis symptoms in patients receiving radiation thera py for prostate cancer. (C) 2000 by Am. Cell. of Gastroenterology.