Effectiveness and safety of 3% polidocanol foam sclerotherapy in hemorrhoidal disease: a multicenter, prospective study

AIM: To evaluate the effectiveness and safety of 3% polidocanol foam sclerotherapy (PFS) injection under anoscopy in the treatment of hemorrhoidal disease (HD) compared with rubber band ligation (RBL). METHOD: This was a multicenter, open-label, prospective, observational study that enrolled 222 patients with Goligher grade I, II, or III HD (internal or mixed), who were treated with 3% PFS or RBL, which depended on the physician's assessment and the patient's willingness. The primary endpoint was the clinical cure rate under anoscopy and clinical symptoms assessment at 4 weeks post-treatment. RESULTS: A total of 222 patients from 14 centers participated in the study, with 127 patients receiving PFS and 95 patients receiving RBL. Among the effectiveness analysis set (EAS), the clinical cure rate was 74.19% (69/93) in the PFS group and 83.13% (69/83) in the RBL group (P > 0.05). The PFS group showed quicker and better improvement in hemorrhage score post-treatment than the RBL group, with the mean (SD) changes from baseline in hemorrhage score of the two groups (P < 0.001) at 1, 4, and 12 weeks being -3.44 (1.99) vs. -1.70 (2.19), -3.85 (1.80) vs. -2.75 (2.02), and -3.81 (1.84) vs. -2.89 (2.10), respectively. The incidences of adverse events (AEs) were 2.36% (3/127) in the PFS group and 3.16% (3/95) in the RBL group, respectively, and no serious adverse events (SAEs) occurred in both groups. CONCLUSION: Patients treated with PFS showed similar effectiveness and safety as those treated with RBL under anoscopy, and a quick improvement trend in hemorrhage score post-treatment was observed in patients treated with PFS, but it needs further verification. TRIAL REGISTRATION: This study has been registered on the website of Chinese Clinical Trial Registry ( https://www.chictr.org.cn/ ), registration number: ChiCTR2200060325.