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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 ≥ 2 cm3) were randomly allocated at a 1 : 1 : 1 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.
Highlights
Uterine fibroids are the most common reproductive tract tumor in the child-bearing age of women [1, 2]
The effectiveness and safety of selected two treatment regimens in uterine fibroid patients have not been explored by the scientific clinical trials. erefore, this research was designed as a randomized clinical trial which has been considered as a gold standard from the clinical research paradigm. e study aimed to compare the efficacy and safety of selected two Ayurveda drug regimens in the treatment of uterine fibroids
Study Design and Oversight. is study was a randomized single-blind clinical trial conducted in gynecology clinic of National Ayurveda Teaching Hospital, Borella, Sri Lanka during years 2018–2020. e ethics approval for this clinical trial was obtained from the Research Approval Committee of the Faculty of Graduate Studies in the University of Colombo and the Ethics Review Committee of Institute of Indigenous Medicine in University of Colombo, Sri Lanka. e trial was registered in ISRCTN registry. e study was conducted adhering to good clinical practice guidelines
Summary
Uterine fibroids are the most common reproductive tract tumor in the child-bearing age of women [1, 2]. Pharmacologic agents are used to provide relief for fibroid patients with mild symptoms, including combined oral contraceptives, progesterone (by oral, injection, or intrauterine device), and nonsteroidal anti-inflammatory drugs, antifibrinolytics, gonadotropinreleasing hormone agonists, selective estrogen or progesterone receptor modulator progestin, danazol, and aromatase inhibitors. Some of these medications are useful in reducing tumor growth [5]. The effectiveness and safety of selected two treatment regimens in uterine fibroid patients have not been explored by the scientific clinical trials. erefore, this research was designed as a randomized clinical trial which has been considered as a gold standard from the clinical research paradigm. e study aimed to compare the efficacy and safety of selected two Ayurveda drug regimens in the treatment of uterine fibroids
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