RESUMO
The safety and efficacy of Trihydroxyethylrutosides (HR) in the treatment of 53 patients with 1st-2nd degree hemorrhoids of pregnancy (16th-34th week) was investigated in a double-blind randomised, placebo controlled trial. The dosage of Trihydroxyethylrutosides was 1 tablet of 300 milligrams twice daily for the first 2 weeks. If the treatment was successful, the treatment was stopped. If the clinical signs or symptoms still persisted, the treatment was continued for another two weeks using the same dosage and re-evaluated at the end of the fourth week after initial treatment. The parameters for efficacy were symptoms (pain, bleeding, exudation and pruritus) and the objective signs on proctoscopy (bleeding, inflammation and dilatation of the hemorrhoidal venous plexus). The study revealed improvement of symptoms in the study group which was better than in the control group after 2 weeks of treatment but the clinical signs were not different. After a further 2 weeks of treatment, the result showed improvement of both clinical signs and symptoms in this study. Only one mild transient side effect was reported in the HR group and there were no drug-related problems in the pregnancies, delivery or the babies.