Abstract:
Uterine fibroids are the most common genital tract tumor in
reproductive age women. The main treatment option for fibroid is surgical
intervention. Options for medical therapy are currently limited to preoperative
reduction of symptoms related to uterine bleeding and fibroid size. Ayurveda
treatment for this condition is widely practiced in Sri Lanka. We aimed to
evaluate the efficacy of two Ayurveda treatment regimes in patients with uterine
fibroids. The study is designed as a randomized, single blind, three arm clinical
study with 30 participants in each arm. Participants diagnosed with uterine
fibroids size 2 cm or more and meet the inclusion criteria are enrolled to this
study. Arm I and Arm II undergo two Ayurveda treatment regimens and Arm III
is the control group. Endpoint will be calculated from baseline in volume of the
largest fibroid by two dimension ultrasound scan after 12 weeks of treatment
intervention and repeat in four weeks follow up. Clinical improvements and
quality of life is assessed by Uterine Fibroid Symptom and Health-Related
Quality of Life Questionnaire (UFS-QOL). Effect of therapy on each arm is
assessed based on the Ayurveda body constitution (Prakriti). Haematological
investigations are conducted before and after the treatment as safety parameters.
Statistical analysis will be done using SPSS version 16. All statistical tests will
be performed, two-tailed with significance determined by reference to the 5%
level. Outcome of this study will be to developed evidence-based effective
alternative to standard methods of treating uterine fibroids
