OBJECTIVE: To investigate efficacy and side effects of Cissus quadrangularis L. and micronised purified flavanoid fraction (MPFF) in treatment of hemorrhoids. MATERIAL AND METHOD: A prospective double blind randomized study was designed in acute hemorrhoidal patients from three hospitals. In each hospital, eighty patients received the flavanoid mixture, C. quadrangularis, or placebo (3 x 2 p.c. for 4 days and then 2 x 2 p.c. for 3 days). Patients were evaluated on bleeding, pain, discharge, pruritis, erythema, and direct patient interviews. Each symptom was scored on a graded severity scale from 0 to 3 on the first day and the seventh day. Blood tests and monitoring of treatment-related side effects were conducted. RESULTS:Five hundred seventy patients (299 females, 271 males) were enrolled. No significant difference regarding age, gender, occupation, and history of disease was recorded. Mostly acute bleeding ceased at the second day in all groups. Analysis on all groups revealed improvement in all symptoms with non-significant difference. No adverse events, no blood chemistry changes were reported. CONCLUSION: The therapeutic efficacy of flavanoid mixture, C. quadrangularis L. and placebo are not different indicating that they play no role in improving early hemorrhoidal symptoms. Long-term studies should be conducted for effects in preventive and curative action.
RCT Entities:
OBJECTIVE: To investigate efficacy and side effects of Cissus quadrangularis L. and micronised purified flavanoid fraction (MPFF) in treatment of hemorrhoids. MATERIAL AND METHOD: A prospective double blind randomized study was designed in acute hemorrhoidalpatients from three hospitals. In each hospital, eighty patients received the flavanoid mixture, C. quadrangularis, or placebo (3 x 2 p.c. for 4 days and then 2 x 2 p.c. for 3 days). Patients were evaluated on bleeding, pain, discharge, pruritis, erythema, and direct patient interviews. Each symptom was scored on a graded severity scale from 0 to 3 on the first day and the seventh day. Blood tests and monitoring of treatment-related side effects were conducted. RESULTS: Five hundred seventy patients (299 females, 271 males) were enrolled. No significant difference regarding age, gender, occupation, and history of disease was recorded. Mostly acute bleeding ceased at the second day in all groups. Analysis on all groups revealed improvement in all symptoms with non-significant difference. No adverse events, no blood chemistry changes were reported. CONCLUSION: The therapeutic efficacy of flavanoid mixture, C. quadrangularis L. and placebo are not different indicating that they play no role in improving early hemorrhoidal symptoms. Long-term studies should be conducted for effects in preventive and curative action.