Abstract
Objectives: Heavy Menstrual Bleeding (HMB) is the most important problems of Uterine Leiomyoma (UL). This study aimed to assess the effect of the extract of the Capsella bursa-pastoris (CBP) on the control of HMB and quality of life in patients with uterine leiomyoma.
 Design: In a double-blind randomized, clinical trial 54 women with uterine leiomyoma were randomly assigned to the intervention/control groups by block randomization.
 Setting: Gynecology outpatient clinics.
 Intervention: The intervention group received 350 mg of alcoholic extract of Capsella bursa-pastoris and the control group received placebo twice daily for three months.
 Main Outcome Measures: Amount of bleeding by Pictorial blood loss assessment chart (PBAC), quality of life by menstrual quality of life questionnaires (MQ) and bleeding duration by calendar were evaluated.
 Results: The mean of PBAC decreased from 464.00± 283.61 at baseline to 323.82±207.66 in the intervention group and decreased from 445.92±362.64 to 214.36±137.68 in control group in the third month. The improvement trend was significant in the two groups, but there was no significant difference between groups. The mean of bleeding duration and menstrual quality of life showed improvement in patients of two groups without significant difference between the two groups.
 Conclusion: Despite the effectiveness of CBP in the intervention group in decreasing of PBAC score and menstrual bleeding duration and improvement of menstrual quality of life in patients who suffered from UL, it did not show a significant effect compared to the control group. Future studies with a larger sample size in one specific type of UL suggested.
Highlights
Leiomyoma is smooth muscle tumours that occur in various parts of the body with soft tissues and most frequently occur in the uterus
Inclusion criteria consisted of women within the age range of 18 to 45 years, menstrual bleeding with a score more than 100 in Pictorial Blood Assessment chart (PBAC), uterine leiomyoma proven by ultrasound, not use of any effective medication on menstrual bleeding (OCP, ASA, anti-coagulant), not regular herbal using during the 2 weeks before the study, no abnormal pap smear, no pregnancy, no breastfeeding and absence of systemic disease
140 women with heavy menstrual bleeding and uterine leiomyoma were evaluated for their eligibility to study.81 patients did not meet the inclusion criteria, 4 of them did not accept to participate and one of them did not follow the steps
Summary
Leiomyoma is smooth muscle tumours that occur in various parts of the body with soft tissues and most frequently occur in the uterus. HMB is the most significant symptom of leiomyoma, often occurs in one-third of the symptomatic patients, and generally reflects the need for treatment [5]. HMB in patients with uterine leiomyoma is one of the critical health problems and one of the most crucial indications of hysterectomy. Nonsteroidal anti-inflammatory drugs are more effective than placebo in functional uterine bleeding, there is no clinical evidence in favour of their positive impact on leiomyoma-related bleeding [4,5]. The oral medications including anti-fibrinolytic drugs (e.g., tranexamic acid), hormonal contraceptives, GnRH agonists, selective progesterone receptor modulators, aromatase inhibitors, and estrogen receptor antagonists, are effective on leiomyoma-related bleeding, but have specific complications or contraindication [6,7,9]
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