Lakshmi V Srivaths1, Jennifer E Dietrich2, Donald L Yee3, Haleh Sangi-Haghpeykar4, Donald Mahoney3. 1. Department of Pediatrics, Section of Hematology/Oncology, Texas Children's Hospital/Baylor College of Medicine, Houston, Texas. Electronic address: lvsrivat@txch.org. 2. Department of Pediatric and Adolescent Gynecology, Texas Children's Hospital, Department of Obstetrics and Gynecology, Baylor College of Medicine, Houston, Texas. 3. Department of Pediatrics, Section of Hematology/Oncology, Texas Children's Hospital/Baylor College of Medicine, Houston, Texas. 4. Department of Obstetrics and Gynecology, Baylor College of Medicine, Houston, Texas.
Abstract
STUDY OBJECTIVE: To compare the efficacy of oral tranexamic acid (TA) with combined oral contraceptives (COC) in reducing menstrual blood loss (MBL) and improving quality of life in adolescent heavy menstrual bleeding (HMB). DESIGN, SETTING, AND PARTICIPANTS: A prospective randomized crossover trial with 17 postmenarchal girls aged 21 years and younger with HMB who were seen at our institution. INTERVENTIONS: Patients were randomized to group A (TA arm) or group B (COC arm), each for 3 cycles, with crossover to the second arm after 1-month washout. MAIN OUTCOME MEASURES: The primary end points were difference in improvement in MBL and QOL, from baseline to end of each therapy. RESULTS:Seventeen patients were enrolled (mean age 14.2 years, range 11.7 to 16.8 years). Nine patients completed both arms; 8 patients withdrew from the study due to adverse events or noncompliance. Compared with baseline, significant improvement (P < .05) was demonstrated by TA and COC in MBL (mean Pictorial Blood Assessment Chart score decrease: TA, 536.4; COC, 430.6) and quality of life (mean Pediatric Quality of Life Inventory(TM) version 4.0 Generic Scales score increase: TA, 15.6; COC, 16.75), but no significant difference was noted between TA and COC (P > .05). There was statistically significant reduction in the length of menstrual cycle for COC only (mean reduction 5.3 days; P = .04) and not for TA (P = .18). Ten patients (58%) experienced adverse events that were possibly drug related (TA: n = 3, 30%; COCP: n = 7, 64%). CONCLUSION: In this pilot study, oral TA appeared as efficacious as COC in the management of adolescent HMB by reducing MBL and improving quality of life.
RCT Entities:
STUDY OBJECTIVE: To compare the efficacy of oral tranexamic acid (TA) with combined oral contraceptives (COC) in reducing menstrual blood loss (MBL) and improving quality of life in adolescent heavy menstrual bleeding (HMB). DESIGN, SETTING, AND PARTICIPANTS: A prospective randomized crossover trial with 17 postmenarchal girls aged 21 years and younger with HMB who were seen at our institution. INTERVENTIONS:Patients were randomized to group A (TA arm) or group B (COC arm), each for 3 cycles, with crossover to the second arm after 1-month washout. MAIN OUTCOME MEASURES: The primary end points were difference in improvement in MBL and QOL, from baseline to end of each therapy. RESULTS: Seventeen patients were enrolled (mean age 14.2 years, range 11.7 to 16.8 years). Nine patients completed both arms; 8 patients withdrew from the study due to adverse events or noncompliance. Compared with baseline, significant improvement (P < .05) was demonstrated by TA and COC in MBL (mean Pictorial Blood Assessment Chart score decrease: TA, 536.4; COC, 430.6) and quality of life (mean Pediatric Quality of Life Inventory(TM) version 4.0 Generic Scales score increase: TA, 15.6; COC, 16.75), but no significant difference was noted between TA and COC (P > .05). There was statistically significant reduction in the length of menstrual cycle for COC only (mean reduction 5.3 days; P = .04) and not for TA (P = .18). Ten patients (58%) experienced adverse events that were possibly drug related (TA: n = 3, 30%; COCP: n = 7, 64%). CONCLUSION: In this pilot study, oral TA appeared as efficacious as COC in the management of adolescent HMB by reducing MBL and improving quality of life.
Authors: L V Srivaths; Q C Zhang; V R Byams; J E Dietrich; A H James; P A Kouides; R Kulkarni Journal: Haemophilia Date: 2017-09-05 Impact factor: 4.287
Authors: Anne Lethaby; Michelle R Wise; Maria Aj Weterings; Magdalena Bofill Rodriguez; Julie Brown Journal: Cochrane Database Syst Rev Date: 2019-02-11