Effectiveness of Persian Golnar on Excessive Menstrual Bleeding in Women with Abnormal Uterine Bleeding, Compared to Tranexamic Acid: A Triple-Blind, Randomized Equivalence Trial.

Abstract

Abnormal uterine bleeding (AUB) is a major healthcare problem in females of reproductive age and impacts women's health and quality of life (QoL). This study aimed to test the equivalence of Persian Golnar (PG) and tranexamic acid (TA) for the treatment of excessive menstrual bleeding. A triple-blind randomized equivalence trial with parallel design and block randomization technique was performed. A total of 80 patients with AUB were randomly allocated to receive either PG or TA for three consecutive menstrual cycles. Blood loss was measured by the Pictorial Blood Loss Assessment Chart (PBAC). Hematological evaluations were done before the intervention and after treatment. QoL and premenstrual dysphoric disorder (PMDD) as secondary outcomes were assessed using the menorrhagia questionnaire (MQ) and Premenstrual Symptoms Screening Tool (PSST). Statistical analysis was performed using an independent t-test, paired t-test, χ2 test, Mann-Whitney test, and Wilcoxon signed-rank test. Seventy-six women completed the 12-week follow-up. Both PG and TA groups experienced a significant reduction in blood loss. Furthermore, the serum level of hemoglobin in the PG group enhanced significantly (P < 0.001). QoL and PMDD scores were significantly improved in both groups (P< 0.001). The findings of the current trial supposed that the Golnar product is as effective as tranexamic acid in controlling bleeding and enhancing the quality of life and premenstrual symptoms.