To Study the Efficacy and Safety of Diosmin with Tranexamic Acid and Mefenamic Acid Versus only Tranexamic Acid and Mefenamic Acid in Medical Management of Abnormal Uterine Bleeding: A Randomized Controlled Trial

Abstract

Background: Abnormal uterine bleeding (AUB) is a common problem in reproductive age group and perimenopausal age group being responsible for many outpatient visits. Traditional management of AUB consists of giving mefenamic acid, tranexamic acid, or their combination with progestogens or hormonal intrauterine deviced levonorgestrel intrauterine system (LNG-IUS) for severe or nonresponsive cases. The objective of the current study was to study the efficacy and safety of adding diosmin along with tranexamic acid and mefenamic acid in reducing menstrual blood loss in AUB patients. Materials and Methods: It was a prospective double-blind randomized controlled trial in which 900 mg of diosmin was given once daily along with 500 mg tranexamic acid and 250 mg mefenamic acid during menstruation (Group I-92 patients), or only tranexamic acid and mefenamic acid during menstruation (Group II-92 patients). Results: Mean age, parity, body mass index, and socioeconomic status were similar in the two groups. It was 35.68 years versus 36.78 years, 2.2 versus 2.3, 23.68 kg/m 2 versus 24.62 kg/m 2 respectively. Mean days of bleeding before this treatment were 6.8 versus 6.6 ( P = 0.33) and were 3.5 versus 5.2 ( P = 0.02) after treatment. There was a significant reduction in both groups as compared to before treatment ( P = 0.021 in Group I, 0.027 in Group II) but the reduction was greater in Group I ( P = 0.02). The amount of blood loss was 385 ml versus 390 ml ( P = 0.7) before treatment which was significantly reduced in both groups to 68 ml versus 112 ml ( P = 0.02 in Group I, 0.03 in Group II) with more decrease in Group I than in Group II ( P = 0.01). Mean hemoglobin at beginning of the study was 8.4 versus 8.5 g/dl in Group I and Group II ( P = 0.02) and significantly increased in both groups posttreatment to 10.9 and 9.8 g/dl in Group I and Group II ( P = 0.012 in Group I, 0.011 in Group II) with increase being more in Group I than Group II ( P = 0.03). Pictorial blood assessment chart score was 398 versus 406 ( P = 0.35) before treatment and decreased significantly to 86.5 and 110.5 ( P = 0.001 in Group I, 0.001 in Group II) with more decrease being in Group I than II ( P = 0.01). There was significant decrease in dysmenorrhea with both treatments with no difference in the two groups. Various adverse effects such as nausea, vomiting, abdominal pain, diarrhea, constipation, and headache were equal in the two groups. Conclusion: Both the group’s diosmin with tranexamic acid and mefenamic acid (Group I) and tranexamic acid and mefenamic acid (Group II) were efficacious in reducing menstrual blood loss, number of menstrual days and dysmenorrhea with effect being more by addition of diosmin. Adverse effects were equal in both the two groups.