Double-blind randomized clinical trial in evaluating the efficacy and safety of rectum mucosa protector in the treatment of acute hemorrhoids

Objective To evaluate the clinical efficacy and safety of Titanoreine suppository containing rectum mucosa protector in the treatment of acute hemorrhoids. [WT5”HZ]Methods[WT5”BZ] Double blind, placebo controlled randomized study was made in patients with acute hemorrhoids (within 4 days). The duration of study was seven days, during which Titanoreine suppositories and suppositories without mucosa protector were used twice daily in the study group and control group respectively. [WT5”HZ]Results[WT5”BZ] 123 patients completed the 7 day treatment (60 patients in the study group and 63 in the control group). Patients in the two groups were comparable in age, sex, diagnosis, history of hemorrhoids, symptoms and signs before the enrollment. No major adverse event was observed in both groups. Score reduction on pain, bleeding, and itchiness was significantly different between the two groups after 2 day treatment ( P 0 05). After 7 day treatment, score reduction on pain, bleeding, edema, erosion, and itchiness was significantly higher in the study group than in the control group ( P 0 05). [WT5”HZ]Conclusions[WT5”BZ] Data from the study showed that Titanoreine suppository containing rectum protector is safe and effective in the treatment of acute hemorrhoids.