Pictorial Blood Loss Assessment Chart Research Articles

Vascular effect of levonorgestrel intrauterine system on heavy menstrual bleeding: is it associated with hemodynamic changes in uterine, radial, and spiral arteries?

The aim of this study was to evaluate the clinical and blood flow changes associated with the use of a levonorgestrel-releasing intrauterine device (LNG-IUD) in patients with idiopathic heavy menstrual bleeding (HMB). LNG-IUD was inserted into a total of 91 patients (39.5 ± 5.4 years) who were diagnosed with HMB. Uterine volume, ovarian volume, uterine, radial and spiral artery blood flow, Pictorial Blood Loss Assessment Chart (PBAC) scores, and other clinical and laboratory parameters were evaluated before and 12 months after insertion of LNG-IUD. Compared to pre-insertion values, LNG-IUD dramatically improved haemoglobin, PBAC scores, and endometrial thickness. Mean resistance indices of radial and spiral arteries significantly increased 12 months after insertion. Our study results suggest that a significant increase in the resistance indices of the intra-myometrial arteries in LNG-IUD users one year after insertion may be due to its local progestational effects, indicating a possible mechanism of LNG-IUD in reducing menstrual blood flow. Impact Statements What is already known on this subject? The mechanisms of action of LNG-IUD on heavy menstrual bleeding include atrophy, decidualization and vascular changes of in the endometrium, resulting endometrial suppression. However, the exact mechanism to stop bleeding is not clear. What do the results of this study add? The present study suggests that one of the effects of the LNG-IUD on heavy menstrual bleeding is its ability to increase the resistance indexes of the intra-myometrial arteries. What are the implications of these findings for clinical practice and/or further research? These results will foster further studies on the effects of LNG-IUD on intra-myometrial arteries and will further assure clinicians on the vascular effect of LNG-IUD during management of heavy menstrual bleeding which includes hysterectomy as a final step.

Use of a levonorgestrel 52-mg intrauterine system in the control of abnormal uterine bleeding in women with inherited bleeding disorders

ObjectiveTo evaluate the efficacy of a levonorgestrel 52-mg intrauterine system (LNG 52-mg IUS) in controlling abnormal uterine bleeding and improving quality of life in women with inherited bleeding disorders. Study designWe assessed 20 participants laboratory diagnosed with inherited bleeding disorders, who presented with abnormal uterine bleeding and were registered in a Central Blood Center. The primary outcomes were menstrual bleeding volume and quality of life before and after LNG 52-mg IUS placement. We used the Pictorial Blood Loss Assessment Chart (PBAC) score for measuring menstrual bleeding and the Short Form-36 Health Survey to assess quality of life before and after LNG 52-mg IUS placement. We also conducted blood tests to evaluate the hematimetric level. Follow-up visits were conducted at 1, 3, 6, and 12 months after LNG 52-mg IUS placement. Statistical analyses were performed using the Friedman non-parametric test. ResultsThe use of LNG 52-mg IUS reduced uterine bleeding in women with inherited bleeding disorders. The median PBAC score was higher before LNG 52-mg IUS placement than at 3, 6, and 12 months after placement (p < 0.001). The amenorrhea rate was 70% after 12 months. There was an improvement in all eight parameters of quality of life (p < 0.001). The mean hemoglobin, ferritin, and serum iron levels were also higher at 12 months than before LNG 52-mg IUS placement. ConclusionLNG 52-mg IUS placement can effectively control abnormal uterine bleeding in women with inherited bleeding disorders and consequently improve their quality of life. ImplicationsThe results from our study suggest that women with inherited bleeding disorders who present with heavy menstrual bleeding can benefit from the use of a levonorgestrel-releasing intrauterine system similar to women without bleeding disorders.

Relapse after conservative surgery combined with triptorelin acetate versus conservative surgery only in women with focal adenomyosis: study protocol for a multicenter, prospective, randomized controlled trial

BackgroundThe preservation of fertility and integrity of the reproductive organs has increasingly been of concern to most women with adenomyosis. Adenomyomectomy is conservative surgery that is now widely applied; however, relapse is a serious problem after the operation. Postoperative treatment, such as gonadotropin-releasing hormone agonist (GnRHa) has been suggested to result in reducing the rate of disease recurrence. However, there is still a lack of evidence from randomized clinical trials examining the efficacy of GnRHa in decreasing the postoperative recurrence rate.Method/designRelapse after conservative surgery combined with triptorelin acetate versus conservative surgery only in women with focal adenomyosis is a multicenter, prospective, randomized controlled trial. The primary outcome is relapse assessed using a visual analogue scale (VRS) and numeric rating scale (NRS), pictorial blood loss assessment chart (PBAC) score, and the size of the uterus and the lesion as measured by two/three-dimensional color doppler ultrasonography (2D/3D-CDUS) or magnetic resonance imaging (MRI). The secondary outcomes include quality of life, clinical pregnancy, ovarian reserve, adverse events, assessment by the Short Form (36) Health Survey and Female Sexual Function index, serum follicle-stimulating hormone, estradiol levels, and anti-Muellerian hormone and so on. All these indexes are measured at 3, 6, 12, 18, 24, 30, and 36 months after conservative surgery.DiscussionThe result of this large, multicenter randomized trial will provide evidence for one of the strategies of long-term management in focal adenomyosis after conservative operation.Trial registrationChinese Clinical Trial Registry: ChiCTR1800014340. Registered on 6 January 2018.

Prevalence and knowledge of heavy menstrual bleeding among gynecology outpatients by scanning a WeChat QR Code.

The aim of this study was to assess menstrual blood loss (MBL) and knowledge of heavy menstrual bleeding (HMB) among the gynecology outpatients at Peking University People’s Hospital, by scanning a WeChat (a social media application software developed by Tencent) QR Code using a mobile phone or tablet. This survey was conducted among outpatients who were treated at the Gynecology Department of Peking University People’s Hospital between September 2016 and November 2016. All participants filled up the questionnaires and scales through WeChat: general information questionnaire, Pictorial Blood Loss Assessment Chart (PBAC), Menorrhagia Multi-Attribute Quality-of-Life Scale (MMAS), and HMB knowledge questionnaire. Menstrual blood volume was assessed by the PBAC and self-assessment. Among the 1152 patients who filled out the survey, 77.4% (892/1152) had normal menstrual cycle (assessed by the patients), 15.6% (180/1152) patients described themselves as HMB, whereas the results from PBAC showed that 58.0% (668/1152) had HMB (PBAC ≥100). Among patients with PBAC ≥100, only 26.8% (179/668) patients reported HMB through self-assessment. Regarding its impact on daily life, the MMAS scores of HMB patients (PBAC ≥100) were significantly lower compared to those with normal blood loss (P<0.001). Regarding the awareness to HMB, 63.2% (728/1152) of the patients were not familiar with HMB. HMB is a common abnormal uterine bleeding and is frequently found among Chinese gynecology outpatients. HMB has major impacts on a woman’s quality of life, affecting both physical and emotional health domains. Since women generally have low levels of awareness and understanding of HMB, they could assess their blood loss using the PBAC, which they can forward to their health care provider using a mobile phone or tablet and the WeChat platform. This tool may be effortlessly used by the health care providers and patients to easily share HMB-related data.

Comparison between Golnar product and placebo in heavy menstrual bleeding: A double-blind randomized clinical trial.

Golnar product is a poly herbal formulation advised by Persian medicine to control heavy menstrual bleeding (HMB). This study was conducted to compare the efficacy of this product with placebo in patients with HMB. In this double-blind randomized clinical trial, 100 women with HMB were randomly assigned into two groups. The patients in the Golnar group (n=50) took Golnar capsules 500 mg three times a day for the first 7 days of menstrual cycle for three cycles. The placebo group (n=50), took placebo capsules in the same manner. The duration and volume of bleeding (using Pictorial Blood Loss Assessment Chart: PBAC), quality of life (using Menorrhagia Questionnaire: MQ), and hemoglobin level (Hb) were measured 3 months after initiation of the intervention. Eighty-two patients (43 in the Golnar and 39 in the placebo groups) completed the 3-month intervention period. In the Golnar group, PBAC score decreased from 201.62 (144.11) to 109.44 (69.57) (p<0.001) and MQ score improved significantly from 0.58 (0.27) to 0.39 (0.31) (p<0.001), while changes in placebo group were not significant. Hb increased in the Golnar group from 12.78±0.98 to 12.97±0.95 mg/dl (p=0.048) and decreased in the placebo group from 12.94±1.08 to 12.44±1.01mg/dl (p<0.001). No significant adverse effects were found in the Golnar group. The Golnar product can be considered an effective intervention for patients with HMB. Assessment of side-effects is suggested to be performed in a larger sample. In addition, a comparison between the Golnar product and nonsteroidal anti-inflammatory drugs could be valuable.

Alleviation of Symptoms and Improvement of Endometrial Receptivity Following Laparoscopic Adenomyoma Excision and Secondary Therapy with the Levonorgestrel-releasing Intrauterine System.

To assess the treatment efficacy of adenomyoma and improvement in implantation receptivity associated with the levonorgestrel-releasing intrauterine system (LNG-IUS) combined with adenomyoma resection. Fifty subjects (control group) underwent laparoscopic adenomyoma excision and received gonadotropin-releasing hormone (GnRH) agonists, and 201 subjects (experimental group) underwent laparoscopic adenomyoma resection and received GnRH agonists combined with the LNG-IUS. Pipelle endometrial biopsies were obtained in the mid-luteal phase, before the operation, and 19months after the operation. Menstrual blood loss was measured using a pictorial blood loss assessment chart. Pain intensity during menstruation was evaluated on a 10-point visual analog scale (VAS). The volume of uterus was measured through ultrasound. Quantification of HOXA10 promoter methylation was performed through bisulfite sequencing polymerase chain reaction (BSP). Real-time polymerase chain reaction analyzed the expression levels of endometrial HOXA10-mRNA and leukemia inhibitory factor (LIF)-mRNA. After surgery, the scores for dysmenorrhea and menorrhagia were significantly improved, and the volume of the uterus was obviously reduced (all p < 0.01). The mean number of methylated CpG sites, level of endometrial HOXA10-mRNA, and level of endometrial LIF-mRNA were 5.6 ± 1.7 versus 3.9 ± 1.3, 0.8 ± 0.2 versus 0.9 ± 0.3, and 0.8 ± 0.2 versus 1.0 ± 0.2, respectively, in the control group versus the experimental group at 19months after surgery, and significant improvements were observed in the experimental group (p < 0.001, p = 0.034, p < 0.001). Laparoscopic adenomyoma excision and GnRH agonists can alleviate the symptoms, reduce the number of methylated CpG sites in HOXA10, and improve endometrial HOXA10-mRNA and endometrial LIF-mRNA levels. When combined with subsequent use of the LNG-IUS, better efficacy can be achieved.

Effectiveness and safety of ormeloxifene and medroxyprogesterone acetate in dysfunctional uterine bleeding - A prospective interventional quasi-randomized interval clinical study

Background: Progestogens and selective estrogen receptor modulators are used in treating dysfunctional uterine bleeding (DUB). There is a lack of consensus regarding the best agent. Aim and Objective: To compare the effectiveness and safety of ormeloxifene and medroxyprogesterone acetate (MPA) in DUB. Materials and Methods: A comparative evaluation of gynecology outpatients with DUB at a tertiary care teaching hospital by a prospective interventional quasi-random design. Patients having DUB were allocated into two groups based on treatment with ormeloxifene (n = 20) and MPA (n = 20). Each patient was followed up for 3 months and evaluated for: (a) Menstrual blood loss assessed using pictorial blood loss assessment chart (PBAC) score and presence of clots, (b) endometrial thickness, (c) hemoglobin (Hb) level, (d) assessment of symptoms, and (e) adverse effects. Mann–Whitney U test and Chi-square test were used to compare both groups. Results: There was a significant reduction in PBAC score and passage of clots compared to baseline in both groups. An increase in Hb was statistically significant in MPA group. Decrease in PBAC score, increase in Hb, and decrease in endometrial thickness after treatment was not significant between groups. In ormeloxifene group, symptoms significantly improved after 1 month and 75% patients had amenorrhea. Conclusion: Ormeloxifene, with less frequent administration and higher tolerability, can be used as an effective alternative to MPA for controlling menstrual blood loss.

Uterine Fibroid Symptom and Health-related Quality of Life Questionnaire: a Chinese translation and validation study.

The Uterine Fibroid Symptom and Health-related Quality of Life (UFS-QOL) questionnaire is a validated tool in English language to assess treatment outcomes for women with fibroids. We performed a Chinese (traditional) translation and cultural adaptation of it and evaluated its reliability, validity, and responsiveness. Overall, 223 Chinese women aged ≥18 years with uterine fibroids self-administered the UFS-QOL, Short-Form Health Survey-12, pictorial blood loss assessment chart (PBAC), and a visual analogue scale (VAS) on fibroid-related symptom severity. Demographics and haemoglobin levels were recorded; physical examination and ultrasound for size of fibroids were performed. Half of the women were followed up 6 months later for responsiveness. Cronbach's alpha coefficients ranged from 0.706 to 0.937, demonstrating high internal reliability. The intra-class correlation coefficients to measure test-retest reliability implied excellent stability of symptom scores (0.819, P<0.001), health-related quality of life scores (0.897, P<0.001), and all subscales (range 0.721-0.870, P<0.001). Convergent validity was demonstrated by positive correlations between the findings of various symptom severity assessment tools (PBAC, VAS on fibroid-related symptoms severity) and the symptom severity domain of Chinese UFS-QOL. In addition, there were positive correlations between health-related quality of life scores of Chinese UFS-QOL and the corresponding subscales of the Short-Form Health Survey-12. Responsiveness was shown by reduction of symptom severity scores and improvement of health-related quality of life scores after treatment. The Chinese version of the UFS-QOL is valid, reliable, and responsive to changes after treatment.

Heavy Menstrual Bleeding Under-Recognized in Menstruating Women Treated with Oral Anticoagulants

Background: Reproductive-age women are at increased risk of venous thromboembolism (VTE) due to increased estrogen states, such as pregnancy and the use of estrogen-based medications. The use of oral anticoagulants (OACs), the standard of care for VTE, is associated with increased rates of heavy menstrual bleeding (HMB), defined as &amp;gt;80 mL loss of blood per cycle, in this patient population. In addition to a need for interventions, ranging from initiation of hormonal therapy to surgical management of bleeding, HMB is a deterrent for adherence to OAC. Decreased adherence, such as temporary discontinuation, is associated with an increased risk of recurrent VTE. This is particularly true for women treated with rivaroxaban, for whom the literature suggests the risk of HMB and other forms of abnormal uterine bleeding is increased two-fold, as compared to warfarin. Methods: We performed a retrospective cohort study of reproductive-aged (18-50 years) women receiving oral anticoagulant therapy at a single tertiary care center between January 1, 2012 and December 31, 2018. Female subjects within the appropriate age range were identified using a Cohort Discovery Tool, a web-based interface which allows investigators to query an underlying research data warehouse that contains electronic health record data for the Oregon Health &amp; Science University healthcare system. Medical record review was performed on all identified records to confirm inclusion criteria, including a documented visit with a primary care provider within 6 months following initial prescription. Exclusions included surgical menopause, pregnancy within 6 months of initial prescription, and lactation within 3 months. We abstracted demographic information, initial anticoagulant prescription and indication, menstrual bleeding history, hormonal therapy and HMB specific medical or surgical treatment within 6 months of initial prescription. Results: A total of 236 eligible subjects were identified. The majority (40.6%) were prescribed rivaroxaban as compared to apixaban (25.2%) or warfarin (34.2%). Most (67.1%) were receiving anticoagulation for the treatment of VTE although 20.1% were anticoagulated for 'other' reasons, including superficial thrombophlebitis and prophylaxis in the post-operative setting or for travel. For the majority of subjects (59.8%), no discussion of menstrual history was documented prior to or at the time of initial prescription. Twenty-nine percent of women received medical (including hormonal) or surgical therapy for HMB, including 32.6% of women treated with rivaroxaban, 23.7% of women treated with apixaban and 28.8% of women treated with warfarin (p &amp;lt;0.001). Discussion: Our study confirms prior reports of increased prevalence of HMB and other abnormal uterine bleeding in women prescribed rivaroxaban as compared to apixaban or warfarin. Our overall numbers, however, are lower than those previously reported in the literature, where HMB, defined as blood loss of &amp;gt;80mL/cycle or a pictorial blood loss assessment chart score of &amp;gt;100, is reported in 66% of warfarin users. We used a different definition of HMB, which was any menstrual bleeding severe enough to require an intervention, including hormonal therapy, surgery or iron replacement, which may explain this difference. Not all women with standardly defined HMB may require such therapies. However, since the vast majority of providers did not assess for menstrual bleeding at the time of drug initiation, it is possible that HMB was unrecognized. Our next step will be to survey women who received an initial prescription in 2017 or 2018 regarding symptoms of HMB, in order to assess the proportion of subjects whose diagnosis of HMB went undetected. Our findings underscore the importance of addressing and discussing menstrual bleeding with menstruating women using oral anticoagulants. Disclosures No relevant conflicts of interest to declare.

The Effect of Capsella bursa-pastoris Extract on Heavy Menstrual Bleeding and Quality of Life in Patients with Uterine Leiomyoma: A Double-blind Randomized Clinical Trial

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.&#x0D; Design: In a double-blind randomized, clinical trial 54 women with uterine leiomyoma were randomly assigned to the intervention/control groups by block randomization.&#x0D; Setting: Gynecology outpatient clinics.&#x0D; 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.&#x0D; 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.&#x0D; 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.&#x0D; 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.

Comparative evaluation of the efficacy and safety of Ormeloxifene and combined oral contraceptives in dysfunctional uterine bleeding

Introduction: Dysfunctional Uterine Bleeding (DUB) is an abnormal uterine bleeding, in the absence of any organic, systemic or iatrogenic cause. Pharmacological treatment options available are combined oral contraceptive pills, progestogens, danazol, gonadotrophin releasing hormone (GnRH) agonists, SERMs, prostaglandin synthetase inhibitor, anti-fibrinolytics and ethamsylate. The purpose of the study was to evaluate the efficacy and safety of Ormeloxifene and compare it to combined oral contraceptive pills (OCPs) in dysfunctional uterine bleeding. Method: Hundred women aged 20-50 years presenting with DUB were randomly allocated to two groups of 50 each. Group A were given Ormeloxifene tablet 60 mg twice a week for 12 weeks, followed by 60 mg once a week for 12 weeks. Group B were given OCPs containing 30 microgram Ethinyloestradiol and 150 microgram Levonorgestrel from day 1 to day 21st of the menstrual cycle for 6 cycles. The outcome was studied by assessment of menstrual blood loss by Pictorial Blood loss Assessment Chart (PBAC) score, Hb level in g/dl, endometrial thickness in mm, patient’s level of satisfaction and any drug side effects at the end of 6 months. Results: The reduction in mean PBAC score with Ormeloxifene (330 to 2.8) was significantly more than with oral contraceptive pills (317 to 74) at 6 months (P&lt;0.001). In both the groups mean hemoglobin level increased but rise in Hb in group A (1.5 g/dl) was more as compared to the rise in Hb in group B (1.2 g/dl). The mean endometrial thickness decreased in both the groups but the decrease in group A (9.6 mm to 8.4 mm) was not statistically significant as compared to the decrease in group B (9.8 mm to 6.4 mm). The side effects were minimal in both the groups. 22% patients with Ormeloxifene and 10% with oral contraceptive pills were highly satisfied with their treatment. Conclusion: Ormeloxifene is effective in control of DUB and can be used as an alternative to OCP for treatment of DUB with possibly minimal side effects and better dosage compliance.

Pregnancy and symptomatic relief following ultrasound-guided transvaginal radiofrequency ablation in patients with adenomyosis.

To report the reproductive results and symptomatic relief of patients with adenomyosis who attempted to conceive after ultrasound-guided radiofrequency ablation (RFA). Of 182 consecutive patients with adenomyosis who had undergone RFA, only 81 patients were eligible for this study. Pregnancy outcomes, postoperative complications, preoperative and postoperative pictorial blood loss assessment chart scores, and pain scores were evaluated. Of these 81 patients, 74 were infertile and seven were single at the time of RFA. The mean age at the time of operation was 35.8 years. The mean duration from the time of RFA to conception was 18.9 months (range, 2-72 months). Fifty-nine patients tried natural conception, while 22 patients attempted conception with assisted reproductive techniques. Twenty-nine (35.8%) patients achieved 39 pregnancies. Except for the 23 patients who did not actively try to conceive and who inevitably or arbitrarily discontinued pregnancy attempts, the pregnancy success rate reached 50%. Twenty-two (84.6%) of the 29 patients delivered 24 (66.7%) live babies (nine vaginal deliveries and 15 cesarean sections). Twelve (33.3%) pregnancies ended in spontaneous abortions. No uterine ruptures occurred. Paired sample t-tests revealed that preoperative pictorial blood loss assessment chart and pain scores were significantly (P < 0.05) different from the postoperative scores at 1-, 3- and 6-months. RFA could be considered a minimally-invasive treatment option for patients with adenomyosis who desire to maintain fertility and alleviate symptoms.

A Clinical Study to Evaluate the Safety and Effectiveness of the Cerene Device to Treat Heavy Menstrual Bleeding (Clarity Study)

Study Objective To evaluate the safety and effectiveness of a novel cryoablation device (Cerene Cryotherapy Device, Channel Medsystems, Emeryville, CA) in premenopausal women with heavy menstrual bleeding due to benign causes. Design A prospective, multi-center, single-arm, open-label, non-randomized study Setting At 11 academic and private practices in North America: 8 clinic sites in the US, and 3 outpatient hospital sites (1 in Mexico and 2 in Canada). Patients or Participants 242 subjects comprise the Intent-to-Treat (ITT) population. Subject demographics were similar to other published endometrial ablation studies performed. Interventions Subjects were treated with the Cerene Device, a single-use disposable device requiring no capital equipment, which delivers a 2.5-minute cryoablation of the endometrium. Analgesia and local anesthesia were administered per investigator discretion; IV sedation was used in only 3% of subjects and no general anesthesia was used. Measurements and Main Results There were no device- or procedure-related serious adverse events, nor unanticipated adverse device effects. The Cerene Device was effective in reducing menstrual blood loss measured by pictorial blood loss assessment chart (PBLAC) score. Mean score dropped from 360.6 pretreatment (± 332.1; range 150-4506) to 51 at 12 months post treatment (±64.1), with 81% of 230 evaluable subjects reporting a PBLAC score of ≤ 75 and 85% of evaluable subjects reporting a PBLAC score of ≤ 100. The median pain rating was ≤ 2 (mild) throughout the treatment. Of 223 subjects that underwent hysteroscopic evaluation at 12 months, the uterine cavity was accessible and visualized in 220 subjects. Quality of life improved with 90% of reporting subjects indicating satisfied or very satisfied at Month 12. Conclusion The study demonstrated that the Cerene Device is safe and effective and provides the benefits of reduced menstrual blood loss, limited use of pain medication, high patient tolerability, quality of life improvement, and preserved access to the uterine cavity.

Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding.

Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding.

Treatment of symptomatic adenomyosis with the levonorgestrel-releasing intrauterine system.

To determine the long-term effects of using the levonorgestrel-releasing intrauterine system (LNG-IUS) to treat symptomatic adenomyosis. A prospective longitudinal study was conducted among 1100 women who received the LNG-IUS at a tertiary teaching hospital in China between December 10, 2006, and December 24, 2014. All participants had symptomatic adenomyosis (visual analogue scale [VAS] ≥7 and/or pictorial blood loss assessment chart [PBAC] score >100) diagnosed by transvaginal sonography. Follow-up was at 3, 6, 12, 24, 36, 48, and 60months after LNG-IUS placement. The primary outcome was symptom relief. Secondary outcomes included LNG-IUS retention status; changes in uterine volume; serum levels of cancer antigen 125 (CA125); menstruation pattern; and adverse events. In all, 374 (33.7%) participants completed 60months of LNG-IUS treatment. The VAS, verbal rating scale, PBAC score, hemoglobin level, uterine volume, and serum CA125 level all showed marked improvements at this time point when compared with baseline (P<0.05 for all comparisons). The cumulative retention rate of LNG-IUS was 56.2%. Changes in menstruation pattern at 60months included amenorrhea (n=97, 25.9%) and shortened periods (n=82, 21.9%). The incidence of adverse events was <10% and not considered notable. Long-term use of LNG-IUS was effective and acceptable for the treatment of symptomatic adenomyosis. Registered at clinicaltrials.gov (NCT03027648).

Vaginal bromocriptine improves pain, menstrual bleeding and quality of life in women with adenomyosis: A pilot study.

Adenomyosis is a benign uterine disease where endometrial glands and stroma are found within the myometrium surrounded by an area of hypertrophic myometrium. Symptomatology includes heavy menstrual bleeding and pelvic pain. The pathogenesis of adenomyosis is not known; however, animal models have shown increased uterine concentration of prolactin as a risk factor. Prolactin acts as a smooth muscle cell mitogen. If prolactin is central to adenomyosis pathogenesis, reducing uterine prolactin could be a possible medical treatment option. In this pilot study, we aim to evaluate the effect of bromocriptine, a prolactin inhibitor, on menstrual bleeding and pain in women with adenomyosis. 23 women with diffuse adenomyosis were enrolled from a university hospital in Sweden and a tertiary care center in the USA. Nineteen patients completed 6months of treatment with vaginal bromocriptine at a dose of 5mg daily. Participants completed validated measures at baseline, 3 and 6months of treatment, and at 9months (3 months after cessation of bromocriptine). Validated measures utilized included Pictorial Blood Loss Assessment Chart (PBLAC), Aberdeen Menorrhagia Clinical Outcomes Questionnaire (AMCOQ), Visual Analog Scale for pain (VAS), McGill Pain Questionnaire (MPQ), Endometriosis Health Profile (EHP-30), Female Sexual Function Index (FSFI) and the Fibroid Symptom Quality of Life (UFS-QOL) symptom severity and health-related quality of life (HRQL) subscores. Scores were compared between baseline and 9months using the Wilcoxon signed rank test. Mean age of participants was 44.8years. About 77.8% reported PBLAC scores>250 and 68.4% reported moderate to severe pain at baseline. Compared with baseline, women had lower 9-month scores (median [interquartile range] for all) on PBLAC (baseline 349 [292-645] vs 9-month 233 [149-515], P=0.003), VAS (5.0 [4-8.3] vs 2.5 [0-4.5], P<0.001), EHP Core Pain (15.9 [9.1-50.0] vs 3.4 [2.3-34.1], P=0.029), EHP Core Self-image (41.7 [16.7-58.3] vs 25 [0-5], P=0.048) and Symptom Severity Score (60 [44-72] vs 44 [25-56], P<0.001) and higher HRQL scores (57 [37-63] vs 72 [51-85], P<0.001) following bromocriptine treatment. Other EHP core parameters and FSFI were not significantly different. Significant improvement in menstrual bleeding, pain and quality of life after vaginal bromocriptine treatment suggests a novel therapeutic agent for adenomyosis.

Efficacy of Ormeloxifene vs Norethisterone in the Management of Perimenopausal DUB

Background: Disorders of menstruation are the most common reason for a gynaecological consultation among women of reproductive age group. Dysfunctional Uterine Bleeding is defined as abnormal uterine bleeding in the absence of organic, systemic or iatrogenic causes. It can be managed both medically and surgically. In medical management, several drugs have been used. However there is lack of studies suggesting the most appropriate drug. The objective of our study is to compare the treatment efficacy of Norethisterone acetate (a progesterone derivative) versus Ormeloxifene (selective estrogen receptor modulator) in the treatment of DUB. Methodology: Total of 100 perimenopausal women with DUB were enrolled in our prospective study. They were randomly assigned into group A and group B. Group A was treated with 60mg Ormeloxifene two times a week for 3 months followed by once a week for another 3months. Group B was treated with Norethisterone 5 mg two times a day from Day5 to Day26 for 6 months. Primary outcome parameters noted were reduction in menstrual blood loss that was measured by fall in Pictorial Blood Loss Assessment Chart (PBAC) score, increase in haemoglobin, and decrease in endometrial thickness at the end of study. Results: In our study, the reduction in mean PBAC score with Ormeloxifene was significantly more than that seen with norethisterone after 6 months of therapy. There was a significant increase in hemoglobin level and reduction in endometrial thickness with Ormeloxifene compared to norethisterone. Patients were more compliant to Ormeloxifene because of better tolerance and convenient dosage schedule. Conclusion: In our study Ormeloxifene was found to be more effective than Norethisterone in reducing blood loss, improving haemoglobin level and reducing endometrial thickness in DUB patients.

Quality of life after laparoscopic removal of Essure® sterilization devices.

Objective(s)To assess changes in quality of life after laparoscopic removal of Essure® sterilization devices (Bayer AG, Leverkusen, Germany).Study DesignIn this prospective observational study in an academic research hospital, 80 women with new or worsening symptoms since placement of Essure® sterilization devices undergoing subsequent surgical removal were included. Laparoscopic removal of Essure® devices and salpingectomy with or without cornual excision were performed. Concomitant uterine procedures could be associated where indicated for gynaecological complaints. Comparison using the T student test for coupled series was done in this before-and-after study.ResultsHealth related quality of life (HRQL) was the primary outcome measured by the Short Form 12 (SF-12) questionnaire and a global 10 cm visual analogue scale (VAS). Secondary outcomes included assessment of pain, using continuous (VAS) and ordinal scales (Modified McGill Pain Questionnaire), menstrual bleeding (pictorial blood loss assessment chart (PBAC) score) and surgical feasibility and safety. There was a significant improvement in quality of life in both mental and physical health aspects of the SF-12 (34.02 (+/−1.19) vs. 49.61 (+/−1.42, P < .0001) and 36.55 (+/−0.99) vs. 43.32 (+/−1.18, P < .0001 respectively) as well as global VAS assessment (+2.91 (SD +/−0.27)) at the end of the first post-operative month. These improvements were maintained at three and six months. Mean pain decreased at one month following surgery compared to baseline (VAS 3.6 (+/−0.36) to 1.4 (+/−0.25), P < .0001 and McGill pain score 18.70 (+/−1.88) to 4.73 (+/−0.90), P < .0001). Improvements of a similar magnitude were observed when analysis was restricted to the 47 women without concomitant uterine surgery. No significant changes in bleeding were seen following of Essure® device removal. Planned procedures were all successfully completed.ConclusionLaparoscopic removal of Essure® devices in symptomatic women is technically successful and associated with short and medium-term improvement in quality of life as well as reduction in pelvic pain.

“Evaluation of the effect of roasted lentil flour (lentil savigh) as a functional food in menstrual bleeding reduction”

BackgroundMenorrhagia is a regular menstrual cycle lasting more than seven days and/or blood loss over 80 mL per cycle. One of the herbs recommended in Iranian traditional medicine for menorrhagia treatment is lentil savigh, which is the flour made from roasted lentil (Lens culinaris medic). MethodsThe current randomized clinical trial was conducted on 54 patients within the age range of 18 to 50 years randomly divided into two groups. The treatment group took three 10-gram lentil savigh sachets in the morning. The control group was treated with 500 mg tranexamic acid capsule every eight hours, both from the first day of menstruation for seven days. Patient's bleeding was evaluated by the pictorial blood loss assessment chart (PBAC), before and in each of the three treatment cycles. Quality of life was evaluated by the menorrhagia questionnaire (MQ) at the beginning and the end of the study for each patient. ResultsThe mean (SD) of PBAC scores significantly decreased before and after three cycles from 383.5(163) to 222.1(128.6) in the lentil savigh group (P < 0.0001), and from 333.8(141.3) to 239.1(132.6) in the tranexamic acid group (P < 0.0001). There was no significant difference between the two groups (P < 0.6).Quality of life significantly improved in the lentil savigh group from 61.5(12.3) to 34.4(14.6) in comparison with that of the tranexamic acid group changing from 56.3(11.1) to 46.8(12.7) (P < 0.004). ConclusionBoth products were effective in menstrual bleeding reduction, but lentil savigh improved the quality of life more effectively. Therefore, lentil savigh, as a functional food, could be introduced as a good initial choice for menorrhagia treatment.

Oral Gonadotropin-Releasing Hormone Antagonist Relugolix Compared With Leuprorelin Injections for Uterine Leiomyomas

To investigate the noninferiority of relugolix compared with leuprorelin acetate in reducing heavy menstrual bleeding associated with uterine leiomyomas. In a double-blind, double-dummy trial, premenopausal women with uterine leiomyomas and heavy menstrual bleeding defined as a pictorial blood loss assessment chart score of at least 120 were randomized in a 1:1 ratio to relugolix (40 mg, oral, once daily) or leuprorelin acetate (1.88 mg or 3.75 mg, monthly injection) for 24 weeks. The primary endpoint was the proportion of patients with a total pictorial blood loss assessment chart score of less than 10 for weeks 6-12. Secondary endpoints included myoma and uterine volumes, and hemoglobin levels. A sample size of 144 patients per group (n=288) was estimated to provide at least 90% power to demonstrate noninferiority (prespecified noninferiority margin -15%; one-sided 0.025 level of significance). From March 2016 to September 2017, 281 patients were randomized (relugolix, n=139, leuprorelin n=142). Demographic and baseline characteristics were well balanced; mean pictorial blood loss assessment chart score was 254.3 in the relugolix group and 263.7 in the leuprorelin group. The proportion of patients with total pictorial blood loss assessment chart score of less than 10 for weeks 6-12 was 82.2% in the relugolix group and 83.1% in the leuprorelin group, demonstrating noninferiority of relugolix compared with leuprorelin (relugolix-leuprorelin difference -0.9%; 95% CI: -10.10 to 8.35; prespecified noninferiority margin -15%; P=.001). Reductions in myoma and uterine volumes and increases in hemoglobin levels were comparable in the two groups. Relugolix was associated with an earlier effect on menstrual bleeding than leuprorelin (pictorial blood loss assessment chart score of less than 10, 64.2% vs 31.7% [relugolix-leuprorelin difference 32.5%; 95% CI: 20.95-44.13%] for weeks 2-6 and pictorial blood loss assessment chart score of 0, 52.6% vs 21.8% [30.7%; 95% CI: 19.45-42.00%] for weeks 2-6) and faster recovery of menses after treatment discontinuation (relugolix median [Q1, Q3], 37 days [32.0, 46.0]; leuprorelin median, 65 days [54.0, 77.0]). Adverse events and bone mineral density loss were similar between relugolix and leuprorelin treatment groups. In women with uterine leiomyomas, once-daily treatment with relugolix, an oral gonadotropin-releasing hormone antagonist, demonstrated noninferiority to monthly leuprorelin for improvement of heavy menstrual bleeding at 6-12 weeks of treatment, had a more rapid effect on menstrual bleeding, and was generally well tolerated. ClinicalTrials.gov, NCT02655237; JAPIC Clinical Trial Information, JapicCTI-163128. Takeda Pharmaceutical Company Limited and an affiliate of NovaQuest Capital Management LLC.