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Journal of Family Medicine and Primary... Oct 2023The term post-tubal sterilization syndrome has been used variously to include abnormal menstrual bleeding, pre-menstrual dysmenorrhea distress, hysterectomy, and...
BACKGROUND
The term post-tubal sterilization syndrome has been used variously to include abnormal menstrual bleeding, pre-menstrual dysmenorrhea distress, hysterectomy, and miscellaneous other conditions like the need for recanalization, the feeling of regret, and menopausal syndrome.
OBJECTIVES
To compare the menstrual disorders in post-tubal ligated and non-ligated women and also to compare the histopathology of endometrium in both post-tubal ligated and non-ligated groups in order to compare the menstrual disorders.
MATERIALS AND METHODS
It is a comparative cross-sectional study on 200 women between 30 and 50 years, divided into two groups and further into two sub-groups in each group. Group 1 includes cases (post-tubal ligated), and group 2 includes controls (non-tubal ligated); sub-group I includes patients with abnormal uterine bleeding (AUB), and sub-group II includes patients without AUB. Data were recorded using standard performa along with investigations and detailed examination.
RESULTS
In the case group (post-tubal ligated), maximum patients of 39.22% were having polymenorrhea and 29.41% patients had menorrhagia, whereas in the control group (non-tubal ligated), maximum patients of 38.78% had polymenorrhea and 30.61% had menorrhagia, respectively. However, the difference is statistically non-significant ( value = 1.00).
CONCLUSION
Our study suggests that the incidence of menstrual disorders did not differ significantly with tubal ligation. The patients worried about the effects of tubal ligation on their future life that must be counseled and that tubal ligation has no adverse effect on their life including their menstrual pattern. The findings of the study help family physicians in educating the clientele. We also recommend large studies with multiple centers so as to give statistically significant findings of associations.
PubMed: 38074221
DOI: 10.4103/jfmpc.jfmpc_880_23 -
Natural Product Research May 2024The genus , a group of perennial ornamental herbs in the family Orchidaceae, is widely distributed in tropical and subtropical regions. Many species of the genus have... (Review)
Review
The genus , a group of perennial ornamental herbs in the family Orchidaceae, is widely distributed in tropical and subtropical regions. Many species of the genus have been commonly used as traditional herbal medicines for the treatment of menorrhagia, haemoptysis, traumatic bleeding, snake bites, and pneumonia. This review describes the ornamental value of plants of the genus and summarises the chemical constituents and pharmacological activities reported during the last decade. The main chemical constituents of this genus are phenolic acids, alkaloids, flavonoids, etc. Most phenolic acids and alkaloids have a nervogenic acid skeleton, and most alkaloids also have a pyrrolizidine skeleton. Extracts from the genus plants showed significant haemostatic, antitumor, anti-inflammatory, hypolipidemic, antioxidant, and antibacterial activities. This paper proposed ideas and research directions for the future study of plants in the genus , providing valuable information for the development of new drugs and promoting their utilisation.
PubMed: 38693725
DOI: 10.1080/14786419.2024.2347460 -
Journal of Comparative Effectiveness... Aug 2023What is this summary about? This is a summary of a research study (known as a clinical trial) called the LIBERTY extension study. The LIBERTY extension study is a... (Review)
Review
What is this summary about? This is a summary of a research study (known as a clinical trial) called the LIBERTY extension study. The LIBERTY extension study is a long-term study looking at how well a medicine called relugolix combination therapy worked in reducing blood loss during menstrual periods in women with uterine fibroids with heavy menstrual periods. Women were included in the extension study if they finished the 24-week LIBERTY 1 or LIBERTY 2 studies. Heavy menstrual periods were considered to be menstrual blood loss of about one-third of a cup of blood (80 ml) per cycle for two cycles or about two-thirds of a cup of blood (160 ml) during one cycle. The LIBERTY extension study also looked at whether relugolix combination therapy was safe to take for up to 1 year. What were the results? Out of 770 total women with uterine fibroids with heavy menstrual bleeding who took part in the LIBERTY 1 and LIBERTY 2 studies, 476 took part in the LIBERTY extension study. From the start of the LIBERTY 1 and LIBERTY 2 studies through the end of the LIBERTY extension: 163 women took relugolix combination therapy for 52 weeks 149 women took relugolix alone for 12 weeks followed by relugolix combination therapy for 40 weeks 164 women took placebo for 24 weeks followed by relugolix combination therapy for 28 weeks The LIBERTY extension study showed that most women in all three treatment groups responded to relugolix combination therapy by having less bleeding during their menstrual periods, having improved anemia symptoms, and having stable bone mineral loss. Side effects were similar across treatment groups, and the most common side effects were headaches and hot flushes. What do the results mean? Women with uterine fibroids with heavy menstrual bleeding taking relugolix combination therapy may have fewer uterine fibroid bleeding symptoms for up to 1 year of treatment. NCT03049735 (ClinicalTrials.gov) (LIBERTY 1) NCT03103087 (ClinicalTrials.gov) (LIBERTY 2) NCT03412890 (ClinicalTrials.gov) (LIBERTY extension study).
Topics: Female; Humans; Leiomyoma; Menorrhagia; Pyrimidinones; Uterine Neoplasms; Clinical Trials as Topic
PubMed: 37477173
DOI: 10.57264/cer-2023-0069 -
Advances in Therapy Nov 2023Intravenous (IV) administration of iron is considered a safe and efficacious treatment for iron deficiency anemia (IDA), recommended in patients requiring rapid...
INTRODUCTION
Intravenous (IV) administration of iron is considered a safe and efficacious treatment for iron deficiency anemia (IDA), recommended in patients requiring rapid replenishment of iron, or intolerant or unresponsive to oral administration of iron. Recent randomized controlled trials (RCTs) have shown high incidence of hypophosphatemia after administration of two IV iron preparations: saccharated ferric oxide (SFO) and ferric carboxymaltose (FCM). The present study aimed to conduct matching-adjusted indirect comparison (MAIC) of hypophosphatemia incidence with these iron formulations and ferric derisomaltose (FDI) based on data from head-to-head RCTs conducted in Japan.
METHODS
A MAIC of hypophosphatemia incidence was conducted on the basis of data from two head-to-head RCTs. The relative odds of hypophosphatemia with FDI versus SFO were obtained from patient-level data from a recent RCT and adjusted for cumulative iron dose, while parametric models of serum phosphate levels from a separate RCT were used to estimate the relative odds of hypophosphatemia with FCM with SFO. An anchored MAIC was then conducted comparing FDI with FCM.
RESULTS
The adjusted odds of experiencing hypophosphatemia were significantly lower with FDI than SFO [odds ratio (OR) of 0.02; 95% confidence interval (CI) 0.01-0.05]. The parametric models of serum phosphate from the RCT comparing FCM with SFO provided an estimated OR of 1.17 for the incidence of hypophosphatemia with FCM versus SFO. Combining the two estimates in the MAIC showed that the odds of experiencing hypophosphatemia would be 52.5 (95% CI 27.7-99.4) times higher with FCM than FDI in patients with IDA associated with heavy menstrual bleeding in Japan.
CONCLUSIONS
Direct comparison of patient-level data and a MAIC from two RCTs in Japanese patients with heavy menstrual bleeding indicated that hypophosphatemia is less frequent in patients treated with FDI than those with FCM or SFO. Results are in agreement with RCTs comparing FDI and FCM in patients with various etiologies conducted in the USA and Europe.
Topics: Female; Humans; Iron; Incidence; Menorrhagia; East Asian People; Randomized Controlled Trials as Topic; Administration, Intravenous; Hypophosphatemia; Ferric Oxide, Saccharated; Anemia, Iron-Deficiency; Phosphates
PubMed: 37702931
DOI: 10.1007/s12325-023-02591-1 -
Journal of Pediatric Endocrinology &... Aug 2023We sought to study factors predictive of achieving menstrual suppression with norethindrone vs. norethindrone acetate in adolescents, as optimal dosing is unknown....
OBJECTIVES
We sought to study factors predictive of achieving menstrual suppression with norethindrone vs. norethindrone acetate in adolescents, as optimal dosing is unknown. Secondary outcomes included analyzing prescriber practices and patient satisfaction.
METHODS
We performed a retrospective chart review of adolescents ages <18 years presenting to an academic medical center from 2010 to 2022. Data collected included demographics, menstrual history, and norethindrone and norethindrone acetate use. Follow-up was measured at one, three, and 12 months. Main outcome measures were starting norethindrone 0.35 mg, continuing norethindrone 0.35 mg, achieving menstrual suppression, and patient satisfaction. Analysis included Chi-square and multivariate logistic regression.
RESULTS
Of 262 adolescents initiating norethindrone or norethindrone acetate, 219 completed ≥1 follow-up. Providers less often started norethindrone 0.35 mg for patients with body mass index ≥25 kg/m, prolonged bleeding, or younger age at menarche, but more often for patients who were younger, had migraines with aura, or were at risk of venous thromboembolism. Those with prolonged bleeding or older age at menarche were less likely to continue norethindrone 0.35 mg. Obesity, heavy menstrual bleeding, and younger age were negatively associated with achieving menstrual suppression. Patients with disabilities reported greater satisfaction.
CONCLUSIONS
While younger patients more often received norethindrone 0.35 mg vs. norethindrone acetate, they were less likely to achieve menstrual suppression. Patients with obesity or heavy menstrual bleeding may achieve suppression with higher doses of norethindrone acetate. These results reveal opportunities to improve norethindrone and norethindrone acetate prescribing practices for adolescent menstrual suppression.
Topics: Female; Adolescent; Humans; Norethindrone; Menorrhagia; Norethindrone Acetate; Retrospective Studies; Obesity
PubMed: 37279406
DOI: 10.1515/jpem-2023-0133 -
American Journal of Obstetrics and... Dec 2023In the pivotal LIBERTY 1 and 2 trials and long-term extension study, once-daily relugolix combination therapy (40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
In the pivotal LIBERTY 1 and 2 trials and long-term extension study, once-daily relugolix combination therapy (40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate) reduced menstrual blood loss volume and pain among women with uterine fibroids. Relugolix combination therapy was well tolerated with preservation of bone mineral density through 52 weeks.
OBJECTIVE
This study aimed to report the 2-year relugolix combination therapy efficacy and safety results of the phase 3 LIBERTY randomized withdrawal study.
STUDY DESIGN
Women with uterine fibroid-associated heavy menstrual bleeding who completed the 24-week LIBERTY 1 or 2 trials, followed by the 28-week long-term extension study (up to 52 weeks total treatment), and who met the responder criteria (menstrual blood loss volume <80 mL and ≥50% reduction from pivotal study baseline at week 48 [week 24 of long-term extension]) were randomized in a 1:1 ratio to either blinded treatment with relugolix combination therapy or placebo for 52 weeks (total treatment period, 104 weeks). For women who had a relapse of heavy menstrual bleeding during the study (menstrual blood loss volume ≥80 mL), open-label relugolix combination therapy was offered. The primary endpoint was the proportion of women who maintained menstrual blood loss volume <80 mL through week 76 (week 24 of randomized withdrawal study). Secondary endpoints included time to menstrual blood loss volume ≥80 mL, proportion of women who maintained a menstrual blood loss volume of <80 mL through week 104 (over the 52-week randomized treatment period), the proportion of women who achieved or maintained amenorrhea at week 76 at the end of treatment, and the change in Uterine Fibroid Symptom-Quality of Life Bleeding and Pelvic Discomfort Scale and symptom severity scores. Analyses were performed for the modified intent-to-treat population, including all randomized women who received ≥1 dose of the study drug.
RESULTS
Of the 229 randomized women (relugolix combination therapy, n=115; placebo, n=114), 228 received the study drug and 175 (76.7%) completed the randomized withdrawal study. Through week 76, 78.4% of women on relugolix combination therapy maintained menstrual blood loss volume <80 mL vs 15.1% in the placebo group (difference, 63.4%; 95% confidence interval, 52.9%-73.9%; P<.0001). At week 104, 69.8% of women on relugolix combination therapy maintained menstrual blood loss volume <80 mL vs 11.8% in the placebo group (difference, 58.0%; 95% confidence interval, 47.0%-69.1%; P<.0001). Through week 104, 88.3% of women on placebo relapsed with heavy menstrual bleeding (median time to relapse, 5.9 weeks). Among the 89 women in the placebo group who relapsed and received open-label rescue treatment, 87 women responded to relugolix combination therapy with a menstrual blood loss volume <80 mL. The proportion of women who achieved or maintained amenorrhea were 57.4% vs 13.3% at week 76 (difference, 44.1%; 95% confidence interval, 33.10%-55.1%; P<.0001) and 58.3% vs 10.6% at week 104 (difference, 47.6%; 95% confidence interval, 37.0%-58.3%; nominal P<.0001) for relugolix combination therapy and the placebo group, respectively. Relugolix combination therapy was generally well tolerated; no new safety signals were identified, and the adverse event profile over the second year was consistent with that reported through the first year of treatment. Bone mineral density remained stable in women who received relugolix combination therapy from week 52 to week 104. In women continuously treated with relugolix combination therapy up to 2 years, bone mineral density was generally preserved.
CONCLUSION
After 2 years of treatment with relugolix combination therapy, there was evidence of durability of the effect in maintaining low menstrual blood loss volume in women with symptomatic uterine fibroids. Most women had return of heavy menstrual bleeding and associated symptoms after treatment cessation, which improved upon retreatment with relugolix combination therapy. Relugolix combination therapy was well tolerated, the adverse event profile remained consistent, and the mean bone mineral density was generally preserved through 2 years of treatment.
Topics: Female; Humans; Menorrhagia; Uterine Neoplasms; Amenorrhea; Quality of Life; Neoplasm Recurrence, Local; Leiomyoma; Uterine Hemorrhage; Recurrence
PubMed: 37666383
DOI: 10.1016/j.ajog.2023.08.030 -
International Journal of Gynaecology... Aug 2023
Topics: Female; Humans; Iron Deficiencies; Uterine Diseases; Uterine Hemorrhage; Anemia, Iron-Deficiency; Menorrhagia
PubMed: 37538012
DOI: 10.1002/ijgo.14942 -
Clinical Cancer Research : An Official... Mar 2024Bintrafusp alfa, a first-in-class bifunctional fusion protein composed of the extracellular domain of TGFβ receptor II (a TGFβ "trap") fused to a human IgG1 mAb...
PURPOSE
Bintrafusp alfa, a first-in-class bifunctional fusion protein composed of the extracellular domain of TGFβ receptor II (a TGFβ "trap") fused to a human IgG1 mAb blocking programmed death-ligand 1 (PD-L1), was evaluated as treatment in patients with locally advanced or persistent, recurrent, or metastatic (P/R/M) cervical cancer.
PATIENTS AND METHODS
In this multicenter, open-label, phase Ib trial (NCT04551950), patients with P/R/M cervical cancer received bintrafusp alfa 2,400 mg once every 3 weeks plus cisplatin or carboplatin plus paclitaxel with (Cohort 1A; n = 8) or without (Cohort 1B; n = 9) bevacizumab; patients with locally advanced cervical cancer received bintrafusp alfa 2,400 mg every 3 weeks plus cisplatin plus radiation, followed by bintrafusp alfa monotherapy maintenance (Cohort 2; n = 8). The primary endpoint was safety; secondary endpoints included efficacy (including objective response rate) and pharmacokinetics.
RESULTS
At the data cutoff of April 27, 2022, patients in Cohorts 1A, 1B, and 2 had received bintrafusp alfa for a median duration of 37.9, 31.1, and 16.7 weeks, respectively. Two dose-limiting toxicities (grade 4 amylase elevation and grade 3 menorrhagia) unrelated to bintrafusp alfa were observed in Cohort 1B and none in other cohorts. Most treatment-emergent adverse events of special interest were grades 1-2 in severity, most commonly anemia (62.5%-77.8%) and bleeding events (62.5%-77.8%). Objective response rate was 75.0% [95% confidence interval (CI), 34.9-96.8], 44.4% (95% CI, 13.7-78.8), and 62.5% (95% CI, 24.5-91.5) in Cohorts 1A, 1B, and 2, respectively.
CONCLUSIONS
Bintrafusp alfa had manageable safety and demonstrated clinical activity, further supporting the investigation of TGFβ/PD-L1 inhibition in human papillomavirus-associated cancers, including cervical cancer.
Topics: Female; Humans; Uterine Cervical Neoplasms; B7-H1 Antigen; Cisplatin; Neoplasm Recurrence, Local; Immunologic Factors; Paclitaxel; Transforming Growth Factor beta
PubMed: 38165683
DOI: 10.1158/1078-0432.CCR-23-1829 -
BMC Women's Health Feb 2024Adolescent heavy menstrual bleeding(HMB), menorrhagia or abnormal uterine bleeding commonly occur in adolescent women. The differential diagnosis can be challenging. The... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Adolescent heavy menstrual bleeding(HMB), menorrhagia or abnormal uterine bleeding commonly occur in adolescent women. The differential diagnosis can be challenging. The pneumonic: PALM-COEIN (polyp, adenomyosis, leiomyoma, malignancy and hyperplasia, coagulopathy, ovulatory dysfunction, endometrial, iatrogenic, and not yet classified), is commonly used but it does not stratify as to the likelihood of a disorder. We have sought to develop a probability-based differential diagnosis for Adolescent HMB, menorrhagia or abnormal uterine bleeding.
METHODS
A comprehensive literature search was conducted using PubMed, EMBASE, and SCOPUS databases. Case series describing adolescents from 10-19 years of age with HMB, menorrhagia or abnormal uterine bleeding was acceptable if: more than 10 patients were included; editorials, case reports, and secondary sources such as review articles, or book chapters were excluded. No language filter was used, but an English abstract was required. The etiology of HMB, menorrhagia or abnormal uterine bleeding, and the country of origin was extracted from articles that met inclusion criteria. Cumulative rate estimates were determined by Bayesian probability modeling.
RESULTS
Seventeen full text articles were reviewed in detail; 2,770 patients were included. The most frequent causes of HMB were Ovarian Uterine Disorders (23.7%; 95% CredI 22-25.5%), Coagulation Disorders (19.4%; 95% CredI 17.8-21.1%), and Platelet Disorders (6.23%; 95% CredI 5.27-7.27%) with 45.9% (95% CredI 43.8-47.%9) of the cases of indeterminate origin.
CONCLUSIONS
The leading causes of HMB in healthy adolescent females were varied. The sub-analysis identified distinct etiologies, suggesting that multiple factors must be considered in the evaluation of HMB. While PALM-COEIN (polyp, adenomyosis, leiomyoma, malignancy and hyperplasia, coagulopathy, ovulatory dysfunction, endometrial, iatrogenic, and not yet classified) provides us with a comprehensive picture of the possible causes of HMB in females, this systematic review assigns probabilities to the etiologies of HMB in adolescent females, providing physicians with a more focused and efficient pathway to diagnosis.
Topics: Female; Adolescent; Humans; Menorrhagia; Adenomyosis; Bayes Theorem; Hyperplasia; Leiomyoma; Polyps; Iatrogenic Disease
PubMed: 38378571
DOI: 10.1186/s12905-024-02921-7 -
Cureus Apr 2024Adolescence is a crucial phase in a woman's life, as it signifies the beginning of her reproductive journey. During this time, there are notable variations in sexual...
BACKGROUND AND OBJECTIVES
Adolescence is a crucial phase in a woman's life, as it signifies the beginning of her reproductive journey. During this time, there are notable variations in sexual development and a sense of caution that can present challenges for healthcare providers. The rationale for studying adolescent gynecological problems lies in the need to understand and address the unique reproductive health challenges faced by young girls. By investigating these issues, researchers and healthcare professionals can develop effective strategies for prevention, early detection, and treatment of gynecological conditions in adolescents. This knowledge is crucial for promoting the overall well-being and reproductive health of young girls, ensuring they receive appropriate care and support during this critical stage of development. This study focuses on identifying the most common gynecological issues in teenagers, exploring the root causes, examining the available treatment options, and understanding how they are managed at a tertiary care facility. Methods: This cross-sectional observational study took place at a tertiary care center and focused on gynecological issues in adolescent females who sought care at the gynecology department from January 2016 to December 2022. The study participants were categorized into three groups: early adolescence (10-13 years), middle adolescence (14-16 years), and late adolescence (17-19 years) for analysis. Ethical approval was obtained for this hospital-based research, which involved examining, investigating, and treating the study participants.
RESULTS
Out of the 49,700 new female patients, 2000 (4.02%) fell within the specified age range. The average age of the participants was 16.87±2.16, and the majority of them sought help for menstrual issues (63.45%), followed by abdominal discomfort (15.6%) and vaginal discharge (7.2%). Menstrual disorders were the most common concern, with dysmenorrhea and puberty menorrhagia being prevalent issues. Abdominal pain was caused by various factors, such as urinary tract infections, ovarian tumors, pelvic inflammatory disease, endometriosis, and endometrial tuberculosis. The majority of cases were treated conservatively, with only a small percentage requiring surgical intervention.
CONCLUSION
The significance of early detection and intervention in addressing gynecological issues among adolescents is highlighted in the findings of this research, underscoring the necessity for specialized healthcare services that cater to the specific needs of this demographic. Adolescent gynecology plays a crucial role in safeguarding the reproductive health and overall well-being of young women, emphasizing the importance of seeking assistance proactively.
PubMed: 38711716
DOI: 10.7759/cureus.57713