Efficacy and safety of Shaobei injection in treatment of grade I-III internal hemorrhoids: A multicenter, single-arm clinical study

Hemorrhoids are a common anorectal disorder that significantly affects quality of life. Sclerotherapy is a minimally invasive treatment, with outcomes influenced by the used sclerosant. Shaobei Injection, a traditional Chinese medicine extract, shows therapeutic potential but requires further validation. A prospective, open-label, single-arm, multi-center study evaluated the efficacy and safety of Shaobei injection in treating Grade I–III internal hemorrhoids. Patients received endoscopic administration with Shaobei injection, with clinical cure and overall effectiveness assessed within 4 weeks. Recurrence and adverse events were monitored over one year. Among 273 patients, the 4-week clinical cure rate was 72.5% (95% CI: 66.8%–77.7%), and the overall effective rate was 100% (95% CI: 98.7%–100%). Seven patients (2.5 %) reported moderate, manageable adverse events. One patient (0.4%) experienced drug-related anal discomfort. The 1-year recurrence rate was 10.6%. Shaobei Injection demonstrated high short-term efficacy, favorable safety, and promising long-term potential for treating Grade I–III internal hemorrhoids. ChiCTR1900023461(date of 1st registration, May 29, 2019)