The Effect of plantago major VAGINAL SUPP on Heavy Menstrual Bleeding Patients with Uterine Leiomyoma: A Double-blind Randomized Clinical Trial

Background: One major symptom associated with leiomyomas is heavy menstrual bleeding (HMB). This study aimed to assess the effects of plantain leaf extract vaginal suppositories (p. major supp) on the control of HMB in patients with uterine leiomyoma. Methods: In a double-blind randomized, clinical trial 60 women with uterine leiomyoma and HMB were randomly assigned to the intervention/placebo groups by Stratified block randomization. The intervention group received p. major vaginal supp and mefenamic acid capsule, whereas the control group received placebo vaginal supp and mefenamic acid capsule every 8 hours in the first 3 days of menstruation for 3 menstruation cycles. The amount and duration of bleeding were evaluated using the pictorial blood loss assessment chart (PBAC) and calendar, respectively. Results: The mean of PBAC decreased from 652.6 +/- 189 baseline to 175.6 +/- 139 in the intervention group and Increased from 775.3 +/- 192 to 825 +/- 247 in control group in third month. A trend of improvement was significant in the intervention group, and there was a significant difference between the groups. The mean of bleeding duration showed improvement in patients of the intervention group without a significant difference between the two groups. Conclusion: P. major vaginal supp were effective in decreasing PBAC scores in the intervention group; despite its effectiveness in decreasing the duration of menstrual bleeding in the intervention group, the effect was not significant compared to the control group in patients who suffered from uterine leiomyoma (UL). Clinically, however, the difference was significant; patients in the placebo group experienced more days of bleeding than the intervention group. P. major vaginal supp could be suggested as a complementary treatment for controlling HMB in patients suffering from UL, but further studies are required.