Mahdis Naafe1, Nourossadat Kariman2, Zohreh Keshavarz2, Nasim Khademi3, Faraz Mojab4, Abolfazl Mohammadbeigi5. 1. 1 Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences , Tehran, Iran . 2. 2 Midwifery and Reproductive Health Research Center, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences , Tehran, Iran . 3. 3 Department of Midwifery, Faculty Member, Development of Nursing & Midwifery sciences Research, Najafabad Branch, Islamic Azad University , Najafabad, Iran . 4. 4 Department of Pharmacognosy, School of Pharmacy, Shahid Beheshti University of Medical Sciences , Tehran, Iran . 5. 5 Research Center for Environmental Pollutants, Qom University of Medical Sciences , Qom, Iran .
Abstract
OBJECTIVES:Heavy menstrual bleeding (HMB) is one of the leading causes of low quality of life and iron deficiency anemia in women. This study aimed to determine the effect of hydroalcoholic extracts of Capsella bursa-pastoris on HMB. DESIGN: This study is a triple-blinded, randomized clinical trial. SETTING: The study was conducted in gynecology clinics affiliated to Shahid Beheshti University of Medical Sciences, Tehran, Iran. SUBJECTS: Our patients affected to a complaint of HMB. After obtaining a complete medical history of the women and filling out the demographic forms, the participants were assigned randomly into the experimental (n = 42) and control groups (n = 42). INTERVENTION: The eligible participants were given a pictorial blood loss assessment chart (PBLAC) to confirm HMB during the menstrual cycle. The experimental group received two capsules of mefenamic acid (500 mg) every 8 h and two Capsella bursa-pastoris capsules every 12 h. The intervention started from the first day of menstruation to the end of this period up to 7 days for two consecutive cycles. In the control group, the patients received mefenamic acid and placebo instead of Capsella bursa-pastoris capsules. OUTCOME MEASUREMENTS: The PBLAC score and number of bleeding days, incidence of any possible problems, as well as participant satisfaction were measured. The data were analyzed using t-test, Chi-square, repeated-measures ANOVA, and ANCOVA tests in PASW Statistics ver. 18. RESULTS: After the intervention, there was observed significant decrease in the amount of menstrual bleeding in both groups. However, the mean decrease in the amount of bleeding was significantly more in the Capsella bursa-pastoris group (p < 0/001). CONCLUSION: Compared with control group, hydroalcoholic extracts of Capsella bursa-pastoris capsule appeared to be effective in reducing menstrual bleeding in this study. Further research regarding the efficacy and safety of Capsella bursa-pastoris is required.
RCT Entities:
OBJECTIVES: Heavy menstrual bleeding (HMB) is one of the leading causes of low quality of life and iron deficiency anemia in women. This study aimed to determine the effect of hydroalcoholic extracts of Capsella bursa-pastoris on HMB. DESIGN: This study is a triple-blinded, randomized clinical trial. SETTING: The study was conducted in gynecology clinics affiliated to Shahid Beheshti University of Medical Sciences, Tehran, Iran. SUBJECTS: Our patients affected to a complaint of HMB. After obtaining a complete medical history of the women and filling out the demographic forms, the participants were assigned randomly into the experimental (n = 42) and control groups (n = 42). INTERVENTION: The eligible participants were given a pictorial blood loss assessment chart (PBLAC) to confirm HMB during the menstrual cycle. The experimental group received two capsules of mefenamic acid (500 mg) every 8 h and two Capsella bursa-pastoris capsules every 12 h. The intervention started from the first day of menstruation to the end of this period up to 7 days for two consecutive cycles. In the control group, the patients received mefenamic acid and placebo instead of Capsella bursa-pastoris capsules. OUTCOME MEASUREMENTS: The PBLAC score and number of bleeding days, incidence of any possible problems, as well as participant satisfaction were measured. The data were analyzed using t-test, Chi-square, repeated-measures ANOVA, and ANCOVA tests in PASW Statistics ver. 18. RESULTS: After the intervention, there was observed significant decrease in the amount of menstrual bleeding in both groups. However, the mean decrease in the amount of bleeding was significantly more in the Capsella bursa-pastoris group (p < 0/001). CONCLUSION: Compared with control group, hydroalcoholic extracts of Capsella bursa-pastoris capsule appeared to be effective in reducing menstrual bleeding in this study. Further research regarding the efficacy and safety of Capsella bursa-pastoris is required.
Entities:
Keywords:
Capsella bursa-pastoris; PBLAC chart; heavy menstrual bleeding; mefenamic acid
Authors: Annie R A McDougall; Maya Goldstein; Andrew Tuttle; Anne Ammerdorffer; Sara Rushwan; Roxanne Hastie; A Metin Gülmezoglu; Joshua P Vogel Journal: Int J Gynaecol Obstet Date: 2022-06 Impact factor: 4.447