A clinical trial of hydroxyethylrutosides in the treatment of haemorrhoids of pregnancy.
The safety and efficacy of 500 mg O-(beta-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 less than 0.001) improvement in patient-assessed subjective symptoms (pain, bleeding, exudation and pruritus) compared with placebo. There was also a significant (P less than 0.001) 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-(beta-hydroxyethyl)rutosides provide a safe and effective treatment for women with haemorrhoids of pregnancy.
Wijayanegara
H
H
Department of Obstetrics and Gynaecology, Hasan Sadikin Hospital, Bandung, Indonesia.
Mose
J C
JC
Achmad
L
L
Sobarna
R
R
Permadi
W
W
D000284:Administration, Oral; D000328:Adult; D004311:Double-Blind Method; D004361:Drug Tolerance; D005260:Female; D006484:Hemorrhoids / Q000150:complications* / Q000188:drug therapy*; D006801:Humans; D006896:Hydroxyethylrutoside / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011247:Pregnancy; D011249:Pregnancy Complications, Cardiovascular / Q000188:drug therapy*
D006896:Hydroxyethylrutoside