Efficacy and Safety of the Two Ayurveda Drug Regimens in Uterine Fibroids: A Randomized Single-Blind Clinical Trial

Abstract

This study aims to assess the efficacy and safety of two Ayurveda drug regimens for the treatment of uterine fibroids (UF) in a randomized single-blind clinical trial. 120 participants with UF (volume\u2009≥\u20092\u2009cm3) were randomly allocated at a 1\u2009:\u20091\u2009:\u20091 ratio to 2 experimental groups and the control group. The 12-week intervention period was followed by 12-week follow-up. The primary efficacy endpoint was the change of the largest UF volume. The secondary efficacy endpoints were assessed by the pictorial bleeding assessment score (PBAC), UF symptoms, and quality of life score. The safety endpoints were changed in hepatic and renal safety parameters and patients experiencing adverse effects. Significant decrease was observed in the volume of UF in the arm II but not in arm I, while a significant increase was observed in the volume of the largest UF in the control group at 12th week. The PBAC score remained stable in all groups. Further mean value of the intervention arms symptom severity subscale (SSS) was significantly reduced compared to the control arm. Health-related quality of life (HRQL) value improved in 12th week of both experimental arms compared to baseline. Control arm HRQL value was reduced compared to baseline. The volume of the largest UF and both SSS and HRQL values remained stable within the follow-up period in the tested arms. The findings of this study demonstrated the safety and efficacy of selected two Ayurveda drug regimens in reducing the volume of UF and related symptoms and improving quality of life.