A Clinical Trial of Hydroxyethylrutosides in the Treatment of Haemorrhoids of Pregnancy

Abstract

The safety and efficacy of 500 mg O-( β-hydroxyethyl)rutosides given orally twice daily in the treatment of 97 patients with first-, second-, or third-degree haemorrhoids were investigated in a double-blind, randomized placebo-controlled trial. The rutosides produced a significant ( P < 0.001) improvement in patient-assessed subjective symptoms (pain, bleeding, exudation and pruritus) compared with placebo. There was also a significant ( P < 0.0001) improvement in clinician-assessed subjective and objective signs (bleeding, inflammation and dilatation of the haemorrhoidal plexus) after 2 and 4 weeks' treatment compared with placebo. There were three mild, transient side-effects reported in the active treatment group and no drug-related problems in the pregnancy or delivery were observed. The results suggest that O-( β-hydroxyethyl)rutosides provide a safe and effective treatment for women with haemorrhoids of pregnancy.