Premenstrual syndrome is associated with differences in heart rate variability and attentional control throughout the menstrual cycle: A pilot study.

INTRODUCTION: Most persons with an active menstrual cycle suffer from a range of aversive symptoms (e.g. reduced ability to concentrate) in the days before their menstruation - the premenstrual syndrome (PMS). Biological and cognitive mechanisms of PMS are poorly understood. It has been shown that vagally mediated heart rate variability (vmHRV), a physiological marker of self-regulation, decreases during the PMS-affected cycle phase (luteal phase) only in individuals with high PMS symptomology. This study investigates the specific associations between vmHRV, PMS symptomology and cognitive self-regulation (attentional control). METHODS: In this between-subject study, participants completed an vmHRV baseline measurement through electrocardiography, a reaction time paradigm to measure attentional control (modified attention network test revised, ANT-R) and filled out a questionnaire regarding impact of PMS as well as current menstrual phase. RESULTS: Mixed Model analysis showed interactions effects in the hypothesized direction. VmHRV was decreased during the luteal phase only in individuals with higher PMS. Analogously, performance in the Executive Functioning of the ANT-R task was reduced in the luteal compared to the follicular phase only in individuals with increased PMS symptoms. No effects were found in the Orienting Network Score. DISCUSSION: The results point in the direction of associations between vmHRV, PMS and self-regulation. This could hint at common underlying mechanisms. Further research, however, must be conducted to examine causal pathways to confirm these associations.

Management of Premenstrual Dysphoric Disorder: A Scoping Review.

Premenstrual dysphoric disorder (PMDD) and premenstrual syndrome (PMS) refer to physical, cognitive, or affective symptoms that arise in the late luteal phase and remit with menses. The present work is a clinically focused scoping review of the last twenty years of research on treatment for these disorders. A search of key terms using the PubMed/Medline, the Cochrane Library, Embase, and Web of Science databases was performed, and 194 studies of adult women met initial inclusion criteria for review. Research studies concerning medications, pharmacological and non-pharmacological complementary and alternative medicine treatments, and surgical interventions with the most available evidence were appraised and summarized. The most high-quality evidence can be found for the use of selective serotonin reuptake inhibitors (SSRIs) and combined oral contraceptives (COCs), with gonadotropin releasing hormone (GnRH) agonists and surgical interventions showing efficacy for refractory cases. While there is some evidence of the efficacy of alternative and complementary medicine treatments such as nutraceuticals, acupuncture, and yoga, variability in quality and methods of studies must be taken into account. Reprinted from Int J Womens Health 2022; 14:1783-1801, with permission from Dove Medical Press Ltd. Copyright © 2022.

Saffron extract as an emerging novel therapeutic option in reproduction and sexual health: recent advances and future prospectives.

Saffron, derived from Crocus sativus, is gaining research attention for potential therapeutic applications. Its diverse clinical applications extend to cardiovascular health, diabetes management, sleep quality, psychiatric illnesses, and rheumatoid arthritis. Saffron's positive effects on blood pressure, glucose levels, cognitive function, and inflammatory markers contribute to its versatility. Additionally, carotenoids like crocin and crocetin suggest anti-cancer potential. In terms of reproductive health, saffron's impact on male reproductive health shows conflicting findings on semen parameters. However, in female reproductive health, saffron appears promising for managing dysmenorrhoea, reducing menstrual pain, regulating hormonal fluctuations, and improving overall menstrual health. Safety considerations highlight the importance of adhering to specified dosages, as excessive intake may lead to toxicity. Yet, within the therapeutic range, saffron is considered safe, relieving symptoms without serious side effects, according to clinical research. Future trials in 2023 will explore saffron's potential in cancer therapy, diabetes management, mental health, stress response, cardiovascular health, postmenopausal women's well-being, and chronic obstructive pulmonary disease (COPD). This ongoing research underscores saffron's adaptability and promise as a natural treatment across various medical applications, emphasizing its efficacy. The current review, therefore, aims to provide up-to-date insights on saffron's role particularly in the realm of reproductive health, contributing to a growing body of evidence supporting its diverse therapeutic benefits.

Efficacy of the Flo App in Improving Health Literacy, Menstrual and General Health, and Well-Being in Women: Pilot Randomized Controlled Trial.

BACKGROUND: Reproductive health literacy and menstrual health awareness play a crucial role in ensuring the health and well-being of women and people who menstruate. Further, awareness of one's own menstrual cycle patterns and associated symptoms can help individuals identify and manage conditions of the menstrual cycle such as premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD). Digital health products, and specifically menstrual health apps, have the potential to effect positive change due to their scalability and ease of access. OBJECTIVE: The primary aim of this study was to measure the efficacy of a menstrual and reproductive health app, Flo, in improving health literacy and health and well-being outcomes in menstruating individuals with and without PMS and PMDD. Further, we explored the possibility that the use of the Flo app could positively influence feelings around reproductive health management and communication about health, menstrual cycle stigma, unplanned pregnancies, quality of life, work productivity, absenteeism, and body image. METHODS: We conducted 2 pilot, 3-month, unblinded, 2-armed, remote randomized controlled trials on the effects of using the Flo app in a sample of US-based (1) individuals who track their cycles (n=321) or (2) individuals who track their cycles and are affected by PMS or PMDD (n=117). RESULTS: The findings revealed significant improvements at the end of the study period compared to baseline for our primary outcomes of health literacy (cycle tracking: D̄=1.11; t311=5.73, P<.001; PMS or PMDD: D̄=1.20; t115=3.76, P<.001) and menstrual health awareness (D̄=3.97; t311=7.71, P<.001), health and well-being (D̄=3.44; t311=5.94, P<.001), and PMS or PMDD symptoms burden (D̄=-7.08; t115=-5.44, P<.001). Improvements were also observed for our secondary outcomes of feelings of control and management over health (D̄=1.01; t311=5.08, P<.001), communication about health (D̄=0.93; t311=2.41, P=.002), menstrual cycle stigma (D̄=-0.61; t311=-2.73, P=.007), and fear of unplanned pregnancies (D̄=-0.22; t311=-2.11, P=.04) for those who track their cycles, as well as absenteeism from work and education due to PMS or PMDD (D̄=-1.67; t144=-2.49, P=.01). CONCLUSIONS: These pilot randomized controlled trials demonstrate that the use of the Flo app improves menstrual health literacy and awareness, general health and well-being, and PMS or PMDD symptom burden. Considering the widespread use and affordability of the Flo app, these findings show promise for filling important gaps in current health care provisioning such as improving menstrual knowledge and health. TRIAL REGISTRATION: OSF Registries osf.io/pcgw7; https://osf.io/pcgw7 ; OSF Registries osf.io/ry8vq; https://osf.io/ry8vq.

Association between physical activity and risk of premenstrual syndrome among female college students: a systematic review and meta-analysis.

BACKGROUND: This study aimed to analyze the relationship between physical activity and the risk of premenstrual syndrome among college students. METHODS: Eligible studies were searched from the PubMed, Web of Science, and Embase databases. The link between physical activity and the risk of premenstrual syndrome was evaluated using odds ratio (OR) and 95% confidence interval (CI). The heterogeneity of the included studies was tested and their sources were explored by subgroup analysis. A sensitivity analysis was performed to assess the effect of a single study on the pooled results. The included studies were evaluated for publication bias. Five moderate-quality studies were included in this meta-analysis. RESULTS: Physical activity levels were negatively associated with risk of premenstrual syndrome among college students (OR [95%CI] = 1.46 [1.09, 1.96], P = .011). The pooled results were not influenced after being stratified by the study region and whether multi-factor correction was performed or not. Publication bias was not observed in the included studies. CONCLUSION: A high level of physical activity is dramatically associated with a reduced risk of premenstrual syndrome among female college students.

Prevalence of premenstrual syndrome and its associations with dietary and other lifestyle factors among university female students in Dubai: A cross-sectional study.

BACKGROUND: Premenstrual syndrome is a relatively prevalent condition that affects a significant number of menstruating women worldwide. It can range from mild to severe and may interfere with daily activities. OBJECTIVE: This study aims to investigate the prevalence of premenstrual syndrome and its associated factors among female university students in Dubai. DESIGN: This study was designed as a cross-sectional study. METHODS: The analysis for this study involved 217 female university students (aged ⩾18 years old) who completed a self-reported online questionnaire. Participants were recruited through simple random sampling, and the study received ethical approval from the Zayed University Ethical Committee. RESULTS: All participants reported that they experienced at least one premenstrual syndrome symptom with different levels of severity. The prevalence rate of psychological, physical, and behavioral symptoms was 83.0%, 79.4%, and 76.6%, respectively. The most frequently reported premenstrual psychological symptoms were loss of control (69.6%). Most reported physical premenstrual symptoms included lethargy/fatigue/decreased energy (56.7%); premenstrual syndrome symptoms interfered with participants' daily routines (45.2%). Normal body mass index, no smoking, milk consumption, cruciferous vegetables, fruits, animal foods, fish oil supplements, and no fast-food consumption were all significant factors associated with decreasing premenstrual syndrome. CONCLUSIONS: Premenstrual syndrome is a common menstrual disorder among university students that interferes with their daily routines. Dietary habits and other lifestyle factors were highly related to premenstrual syndrome. Therefore, health promotion programs are highly recommended to encourage healthy diets and lifestyles for females as early as adolescence at the school level.

Global, regional, and national burden of premenstrual syndrome, 1990-2019: an analysis based on the Global Burden of Disease Study 2019.

STUDY QUESTION: What is the burden of premenstrual syndrome (PMS) at the global, regional, and national levels across 21 regions and 204 countries and territories? SUMMARY ANSWER: Over the past few decades, the global prevalent cases of PMS have grown significantly from 652.5 million in 1990 to 956.0 million in 2019, representing a 46.5% increase. WHAT IS KNOWN ALREADY: PMS, which affects almost half of reproductive women worldwide, has substantial social, occupational, academic, and psychological effects on women's lives. However, no comprehensive and detailed epidemiological estimates of PMS by age and socio-demographic index (SDI) at global, regional, and national levels have been reported. STUDY DESIGN, SIZE, DURATION: An age- and SDI-stratified systematic analysis of the prevalence and years lived with disability (YLD) of PMS by age and SDI across 21 regions and 204 countries and territories has been performed. PARTICIPANTS/MATERIALS, SETTING, METHODS: The prevalence and YLD of PMS from 1990 to 2019 were retrieved directly from the Global Burden of Diseases (GBD) 2019 study. The number, rates per 100 000 persons, and average annual percentage changes (AAPCs) of prevalence and YLD were estimated at the global, regional, and national levels. MAIN RESULTS AND THE ROLE OF CHANCE: Globally, the prevalent cases of PMS increased by 46.5% from 652.5 million in 1990 to 956.0 million in 2019; in contrast, however, the age-standardized prevalence rate was approximately stable at 24 431.15/100 000 persons in 1990 and 24 406.51/100 000 persons in 2019 (AAPC, 0[95% CI: -0.01 to 0.01]). Globally, the YLD was 8.0 million in 2019 and 5.4 million in 1990, with a sizable increase over the past 30 years. The age-standardized YLD rate was stable (AAPC 0.01, P = 0.182), at 203.45/100 000 persons in 1990 and 203.76/100 000 persons in 2019. The age-standardized burden estimates were the highest in the low-middle SDI regions and the lowest in the high SDI regions. Peaks in burden rate estimates were all observed in the 40-44 years age group. Regional age-standardized burden estimates were the highest in South Asia and the lowest in Western Sub-Saharan Africa. The national age-standardized burden estimates were the highest in Pakistan and the lowest in Niger. LIMITATIONS, REASONS FOR CAUTION: The accuracy of the results depended on the quality and quantity of the GBD 2019 data. Fortunately, the GBD study endeavoured to retrieve data globally and applied multiple models to optimize the completeness, accuracy, and reliability of the data. In addition, the GBD study took the country as its basic unit and neglected the influence of race. Further study is warranted to compare differences in PMS burden associated with race. Finally, no data are available on the aetiology and risk information related to PMS, which might help us to better understand the trends and age distribution of PMS and help local governments formulate more detailed policies and comprehensive interventions. WIDER IMPLICATIONS OF THE FINDINGS: Although the age-standardized prevalence/YLD rate has been stable over the past 30 years, the absolute number of prevalent cases and YLD grew significantly worldwide from 1990 to 2019. Public health-related policies should be implemented to reduce the prevalence and alleviate the symptoms of PMS. Lifestyle changes and cognitive-behavioral therapy are critical in helping to reduce the burden of PMS. STUDY FUNDING/COMPETING INTEREST(S): This study was supported by the National Key Research and Development Program of China (grant number 2022YFC2704100) and the National Natural Science Foundation of China (No. 82001498, No. 82371648). The authors declare no conflict of interest. TRIAL REGISTRATION NUMBER: N/A.

Translation and Validation of the Premenstrual Assessment Form-Short Form Questionnaire in Hungarian.

Introduction: Premenstrual symptoms, including premenstrual syndrome and its more severe form premenstrual dysphoric disorder, are a set of somatic and psychological symptoms that occur during the luteal phase of the menstrual cycle. Our research aimed to adapt the Hungarian version of the Premenstrual Assessment Form-Short Form (PAF-SF), a questionnaire suitable for assessing premenstrual symptoms, and to examine its reliability, validity, and applicability. Methods: The questionnaire was validated according to Beaton's six-step guidelines. Our sample consisted of 198 menstruating women, 50 of whom completed the instrument for a second time to assess reliability. Descriptive statistics were calculated presenting mean (standard deviation), the internal consistency was measured by Cronbach's alpha value, the test-retest reliability using intraclass correlation coefficients, Spearman rank correlation was applied to test the criterion validity of the questionnaire, and discriminant validity was examined using the independent-sample t test using IBM SPSS 28.0 software. The structural validity was evaluated by confirmatory factor analysis (CFA) using IBM AMOS 29.0 software. The level of significance was set at p < 0.05. Results: Our sample (average age 25.37 ± 4.80 years) scored 28.08 ± 9.49 points out of the maximum 60 points when filling out the PAF-SF questionnaire. The result of Cronbach's alpha calculation, which supports the reliability of the questionnaire, was 0.845. During the CFA, the three-factor structure (Affect, Water Retention, and Pain) was supported (root mean-square error approximation [RMSEA] = 0.054; Tucker-Lewis Index = 0.965; Comparative Fit Index = 0.976; χ2 = 48.642; df = 31; p = 0.023; χ2/df = 1.569). Discussion: The PAF-SF questionnaire proved to be a reliable measuring tool for assessing premenstrual symptoms among women of reproductive age.

The impact of premenstrual disorders on work disruptions among working women: A cross-sectional study.

Background: Physical and emotional manifestations of premenstrual disorder cause increased absenteeism, decreased productivity, and decreased work-related quality of life. Objective: Due to the relatively high prevalence of premenstrual disorders in Iran and limited studies on its work-related problems, this study investigated the relationship between premenstrual disorders and work performance in working women. Materials and Methods: This cross-sectional study was conducted on 358 working women (teachers and industrial workers) in Yazd, Iran, from July 2019 to January 2020. Data were collected using premenstrual symptom screening tool, the work productivity and activity impairment (a modified version), and functional work capacity questionnaires. Women were classified into 2 groups: women with and without premenstrual disorders. Productivity, functional capacity, and ability to perform activities of daily living were compared between groups. Results: Among 358 participants, 121 women (33.8%) had premenstrual disorders. The prevalence of premenstrual disorders was significantly higher in teachers than workers (0.41% vs. 24.7%, respectively) (p = 0.002). The work results showed a worse score in the group with premenstrual disorder than the other group and teachers compared to workers (p < 0.001). Conclusion: This study showed a significant association between premenstrual disorders and worse work productivity, functional work capacity, and ability to perform activities of daily living. Teachers had a higher prevalence of premenstrual disorders and worse work performance than workers, which can be due to higher education levels, work stress, more complex tasks, and increased work responsibility in teachers.

Changes in menstrual symptoms and work productivity after checklist-based education for premenstrual syndrome: an 8-month follow-up of a single-arm study in Japan.

BACKGROUND: Premenstrual syndrome (PMS) is prevalent among women of reproductive age, but most do not seek medical advice. We hypothesized that building PMS awareness could promote medical help-seeking for PMS and thus reduce menstrual symptoms and improve work productivity. METHODS: In January 2020, women aged between 25 and 44 years, having paid work, and not currently consulting with an obstetrics and gynecology doctor (n = 3090) responded to the Menstrual Distress Questionnaire (MDQ), the Premenstrual Symptoms screening tool, and the World Health Organisation Health and Work Performance Questionnaire. In addition, they received checklist-based online education for PMS. Of 3090 participants, 2487 (80.5%) participated in a follow-up survey in September 2020. We conducted multiple logistic regression analyses and text analyses to explore factors that encouraged and discouraged medical help-seeking. We also evaluated changes in menstrual symptoms and work productivity, using generalized estimating equations with interactions between the severity of PMS, help-seeking, and time. RESULTS: During the follow-up period, 4.9% of the participants (121/2487) sought medical help. Those having high annual income (adjusted odds ratio [aOR] = 2.07, 95% confidence interval [CI]: 1.21-3.53) and moderate-to-severe PMS (aOR = 2.27, 95% CI: 1.49-3.46) were more likely to have sought medical help. Those who did not seek medical help despite their moderate-to-severe PMS reported normalization of their symptoms (36%), time constraints (33%), and other reasons for not seeking medical help. Participants with moderate-to-severe PMS who had sought medical help showed a significant improvement of - 8.44 points (95% CI: - 14.73 to - 2.15 points) in intermenstrual MDQ scores during the follow-up period. However, there were no significant improvements in premenstrual and menstrual MDQ scores or absolute presenteeism. CONCLUSION: Medical help-seeking alleviated intermenstrual symptoms in women with moderate-to-severe PMS, but only a small proportion of them sought medical help after PMS education. Further research should be conducted to benefit the majority of women who are reluctant to seek medical help, including the provision of self-care information. TRIAL REGISTRATION: UMIN Clinical Trials Registry number: UMIN000038917.

The effect of perceived stress on menstrual complaints in university students.

Studies have examined the effect of stress on dysmenorrhea and premenstrual syndrome. For this reason in this study, it was aimed to determine the impact of stress on menstrual symptoms (adverse effects, abdominal pain, and coping methods). This descriptive and correlational study was conducted with 351 university students in Turkey by sharing the link to the questionnaire on online social media platforms. It was determined that those whose income was equal to their expenses had lower menstrual symptoms, having a chronic disease and smoking increased menstrual symptoms (F = 3.19/p = .04; t = 2.33/p = .02; t = 3.96/p = .00). The study identified that there was a positive low-level correlation (r: 0.25, p < .01) between the Perceived Stress Scale-14 and the Menstruation Symptom Questionnaire, and the 6.5 percent change in menstrual symptoms was explained by perceived stress. In the study, it is thought that stress affects the experience of menstrual symptoms. Therefore, it is believed that by providing training on stress and effective coping methods by midwives and nurses, menstrual symptoms can be reduced, contributing to women's health. For future studies, it is recommended to examine the effects of stress coping methods training on stress and menstrual complaints.

Effect of nutritional interventions on the psychological symptoms of premenstrual syndrome in women of reproductive age: a systematic review of randomized controlled trials.

CONTEXT: Premenstrual syndrome (PMS) affects approximately 48% of women of reproductive age worldwide. It can lead to functional impairment, lower quality of life, and decreased work productivity. Despite the availability of medical treatment options, women are seeking alternative interventions because of concerns of harmful side effects and limited evidence of efficacy associated with pharmacological treatments. To date, high-quality research investigating the effects of dietary and nutrient intervention on PMS is limited. OBJECTIVE: This systematic review investigated the effect of nutritional interventions on the psychological symptoms of PMS. DATA SOURCES: Five electronic databases were searched for randomized controlled trials (RCTs) published in English from inception to October 2022. Trials eligible for inclusion were nutritional intervention studies involving women of reproductive age that measured PMS-associated psychological outcomes. DATA EXTRACTION: Articles were selected using prespecified inclusion criteria. Data screening and extraction and risk-of-bias assessments were conducted by 3 independent reviewers using article screening software and the Cochrane Risk of Bias 2 tool. DATA ANALYSIS: Thirty-two articles reporting on 31 RCTs involving 3254 participants, ranging in age from 15 to 50 years were included and narratively reviewed. Only 1 of the included studies had a low risk of bias. Treatment with vitamin B6, calcium, and zinc consistently had significant positive effects on the psychological symptoms of PMS. There was insufficient evidence to support the effects of vitamin B1, vitamin D, whole-grain carbohydrates, soy isoflavones, dietary fatty acids, magnesium, multivitamin supplementation, or PMS-specific diets. CONCLUSIONS: There is some evidence to support the use of nutritional interventions for improving psychological symptoms of PMS. However, more research using consistent protocols, procedures to minimize risk of bias, intention-to-treat analysis, and clearer reporting is required to provide conclusive nutritional recommendations for improving PMS-related psychological outcomes. PROSPERO REGISTRATION NO: CRD42022369999.

Premenstrual Syndrome: Awareness and Oral Manifestations in Patients Attending Dental Hospital in Pune.

Fluctuations in androgenic hormonal levels are noticeable through women's menstrual cycle. Changes in estrogen and progesterone have been shown to affect periodontium. Many women report an increase in gingival inflammation and discomfort associated with their menstrual cycle, most commonly before the menstrual period. Approximately 80% of women experience complaints of premenstrual syndrome (PMS) 7 to 10 days before menstruation. Therefore, the present study was carried out to check prevalence of PMS and its oral and periodontal manifestations in patients attending dental hospital. For the study, 100 systemically healthy women of reproductive age attending dental hospital were selected. Thorough recording of oral discomfort and associated symptoms during late luteal phase was done. Clinical parameters such as plaque index and gingival index were recorded. Thirty-seven females reported complaints suggestive of PMS. Oral changes during PMS were experienced by 59 females. Halitosis and oral ulcers were more frequent. Findings of the present study showed the possibility of influence of sex hormones on oral manifestations during premenstrual period.

Emerging Perspectives on the Impact of Diabetes Mellitus and Anti-Diabetic Drugs on Premenstrual Syndrome. A Narrative Review.

Diabetes mellitus (DM) and premenstrual syndrome (PMS) are global health challenges. Both disorders are often linked to a range of physical and psychological symptoms that significantly impact the quality of life of many women. Yet, the exact relation between DM and PMS is not clear, and the management of both conditions poses a considerable challenge. In this review, we aimed to investigate the interplay between DM, anti-diabetic drugs, and the different theories and symptoms of PMS. Female sex hormones are implicated in the pathophysiology of PMS and can also impair blood glucose control. In addition, patients with diabetes face a higher susceptibility to anxiety and depression disorders, with a significant number of patients experiencing symptoms such as fatigue and difficulty concentrating, which are reported in patients with PMS as well. Complications related to diabetic medications, such as hypoglycemia (with sulfonylurea) and fluid retention (with thiazolidinediones) may also mediate PMS-like symptoms. DM can, in addition, disturb the normal gut microbiota (GM), with a consequent loss of beneficial GM metabolites that guard against PMS, particularly the short-chain fatty acids and serotonin. Among the several available anti-diabetic drugs, those (1) with an anti-inflammatory potential, (2) that can preserve the beneficial GM, and (3) possessing a lower risk for hypoglycemia, might have a favorable outcome in PMS women. Yet, well-designed clinical trials are needed to investigate the anti-diabetic drug(s) of choice for patients with diabetes and PMS.

Laparoscopic sleeve gastrectomy for premenstrual syndrome symptoms in patients with obesity.

BACKGROUND: Premenstrual syndrome (PMS) is a pathological condition characterized by a series of abnormal physical, psychological, and behavioral symptoms. We evaluated the effectiveness of laparoscopic sleeve gastrectomy (LSG) in the treatment of patients with obesity and PMS. METHODS: In this case-control study, 131 patients with obesity (BMI ≥ 27.5 kg/cm2) diagnosed with moderate-to-severe PMS from March 2018 to March 2022 were prospectively selected to undergo LSG or not at their own discretion. Participants self-reported their PMS severity using the Premenstrual Syndrome Screening Tool. Among them, 68 patients chose LSG surgery, and 63 control group patients were followed up without surgery. Data were recorded at baseline and at 3 months post-treatment. We used a multivariate analysis to assess the improvement in PMS symptoms and associated factors. RESULTS: Of the 131 patients with obesity and PMS, the improvement rate of PMS in the LSG group was 57.35% (n = 39), while the improvement rate of PMS in the control group was 25.40% (n = 16). Furthermore, our study revealed that surgery is an independent factor affecting the improvement of patients with PMS. Additionally, there was a correlation between alcohol use, T2DM and obesity-related metabolic diseases, and BMI with PMS. The changes in BMI, testosterone, and estradiol(E2) levels may also contribute to the improvement of patients with obesity and PMS. CONCLUSION: LSG can improve the management of obesity in patients with PMS to some extent. Changes in BMI, testosterone, and E2 may be indicative of improvement in patients with obesity and PMS.

Feasibility Study on Menstrual Cycles With Fitbit Device (FEMFIT): Prospective Observational Cohort Study.

BACKGROUND: Despite its importance to women's reproductive health and its impact on women's daily lives, the menstrual cycle, its regulation, and its impact on health remain poorly understood. As conventional clinical trials rely on infrequent in-person assessments, digital studies with wearable devices enable the collection of longitudinal subjective and objective measures. OBJECTIVE: The study aims to explore the technical feasibility of collecting combined wearable and digital questionnaire data and its potential for gaining biological insights into the menstrual cycle. METHODS: This prospective observational cohort study was conducted online over 12 weeks. A total of 42 cisgender women were recruited by their local gynecologist in Berlin, Germany, and given a Fitbit Inspire 2 device and access to a study app with digital questionnaires. Statistical analysis included descriptive statistics on user behavior and retention, as well as a comparative analysis of symptoms from the digital questionnaires with metrics from the sensor devices at different phases of the menstrual cycle. RESULTS: The average time spent in the study was 63.3 (SD 33.0) days with 9 of the 42 individuals dropping out within 2 weeks of the start of the study. We collected partial data from 114 ovulatory cycles, encompassing 33 participants, and obtained complete data from a total of 50 cycles. Participants reported a total of 2468 symptoms in the daily questionnaires administered during the luteal phase and menses. Despite difficulties with data completeness, the combined questionnaire and sensor data collection was technically feasible and provided interesting biological insights. We observed an increased heart rate in the mid and end luteal phase compared with menses and participants with severe premenstrual syndrome walked substantially fewer steps (average daily steps 10,283, SD 6277) during the luteal phase and menses compared with participants with no or low premenstrual syndrome (mean 11,694, SD 6458). CONCLUSIONS: We demonstrate the feasibility of using an app-based approach to collect combined wearable device and questionnaire data on menstrual cycles. Dropouts in the early weeks of the study indicated that engagement efforts would need to be improved for larger studies. Despite the challenges of collecting wearable data on consecutive days, the data collected provided valuable biological insights, suggesting that the use of questionnaires in conjunction with wearable data may provide a more complete understanding of the menstrual cycle and its impact on daily life. The biological findings should motivate further research into understanding the relationship between the menstrual cycle and objective physiological measurements from sensor devices.

Effectiveness and safety of Jiawei Xiaoyao pill in the treatment of premenstrual syndrome (liver depression, spleen deficiency, and blood-heat syndrome): a multi-center, randomized, placebo-controlled trial.

OBJECTIVE: To investigate the effectiveness and safety of Jiawei Xiaoyao pill (，JXP) in the treatment of symptoms associated with premenstrual syndrome (PMS). METHODS: A total of 144 regularly menstruating women with PMS were recruited at 8 sites in China from August 2017 to December 2018, and randomized to receive either a JXP or a matching placebo (12 g/d, 6 g twice a day) for 3 menstrual cycles. The primary indicator was the reduced Daily Record of Severity of Problems (DRSP) scores in the luteal phase after 3 months of treatment. The safety outcomes included clinical adverse events (AEs), adverse reactions (ARs), changes in vital signs, and laboratory tests. RESULTS: JXP surpassed the placebo in reducing DRSP scores (psychological/somatic dysfunction) in the luteal phase over 3 menstrual cycles of treatment (PFAS = 0.002, PPPS = 0.001). Additionally, there were no significant differences in the incidence of AEs, severe AEs, withdrawal due to AEs and ARs between the two groups (all P > 0.05), and no clinically significant adverse medical events related to the test drug observed. CONCLUSIONS: JXP was superior to the placebo in relieving the symptoms associated with PMS, which signified that JXP may be effective, safe, and well-tolerated as an alternative therapy.

Network structure of complex interactions of premenstrual syndrome and influencing factors in young adult women.

BACKGROUND: In the transition phase from adolescence to adulthood, premenstrual syndrome (PMS) occurs more commonly, with a variety of symptoms. The occurrence of PMS may be the result of a combination of demographic, physiological, psychological and sociological factors. This study aimed to identify the central symptoms of PMS, and explored the complex influencing factors especially the one-to-one inter-relationships factors with specific symptoms. METHOD: This is a cross-sectional study conducted in mainland China. 3458 young adult women were assessed. Using the Premenstrual Syndrome Scale (PSS) to assess the PMS, and PSS score was over 6 divided into PMS group, and vice versa. Influencing factors were assessed by a set of self-reported questionnaire. Network analysis was used to examined the interplay of PMS, whilst also considering the influencing factors of PMS. RESULTS: In summary, 1479 participants were in PMS group. Anxiety had the highest strength centrality (1.12/1.09), shown higher centrality in the both network. Swelling of the hands or feet also shown higher strength centrality (0.89) in PMS group. PMS is associated with a higher history of dysmenorrhea, and neurotic personality. Neurotic personality - depressed mood/nervousness (0.27/0.23), history of dysmenorrhea - abdominal distension (0.21), had significantly higher weight than other edges in PMS group. CONCLUSION: Anxiety was the most central symptom in the network, and was closely associated with other symptoms like depressed mood, which provided additional evidence for the centrality of emotional features in PMS. Moreover, the influencing factors of PMS combined demographic, physiological, psychological, and sociological factors. According to the central symptoms and factors affecting the specific PMS symptoms in young adult women, targeted intervention is helpful to prevent and alleviate PMS. LIMITATION: Cross-sectional design cannot infer the directionality of the associations between variables. All data is self-reported with recall bias and the edge weights across the constructs of influencing factors and PMS were fairly small.

Translation and validation of the Chinese version of the menstrual distress questionnaire.

BACKGROUND: The Menstrual Distress Questionnaire (MDQ) is a commonly used questionnaire that assesses various symptoms and distress associated with the menstrual cycle in women. However, the questionnaire has not been completely translated into Chinese with rigorous reliability and validity testing. METHODS: This study translated the Menstrual Distress Questionnaire Form Cycle (MDQC) from English into Chinese: MDQCC in two stages. First, it was translated forward and backward using Jones' model; second, to test the validity and reliability, 210 Chinese-speaking women were recruited through online announcements and posters posted between June 2019 and May 2020. Expert validity, construct validity, convergent validity, and factorial validity were determined using content validity index (CVI), intraclass correlation coefficient (ICC), composite reliability (CR), and exploratory factor analysis, respectively. For concurrent criterion validity, MDQCC score was compared with three existing pain scales. Reliability was evaluated using internal consistency across items and two-week test-retest reliability over time. RESULTS: The CVI for content validity was .92. Item-CVI for expert validities among the 46 items ranged from .50 - 1; scale-CVI for the eight subscales, from .87 - 1; ICC, from .650 - .897; and CRs, from .303 - .881. Pearson correlation coefficients between MDQCC and short-form McGill pain questionnaire, present pain intensity, and visual analog scale scores were .640, .519, and .575, respectively. Cronbach's α for internal consistency was satisfactory (.932). ICC for test-retest reliability was .852 for the entire MDQCC. CONCLUSION: MDQCC was valid and reliable for Mandarin Chinese-speaking women. It can be used to evaluate female psychiatric symptoms related to the menstrual cycle in future work.

The Menstrual Distress Questionnaire has been used to evaluate menstrual distress, including dysmenorrhoea and premenstrual syndrome. This questionnaire has been translated into Persian, Korean, Japanese, and Cantonese, rendering it to be used more and more widely all over the world. The study translated all 46 items of the Menstrual Distress Questionnaire from English to Mandarin Chinese using a two-stage strategy. The Chinese version of this questionnaire developed by the present study was found to be a valid and reliable tool in Chinese Mandarin-speaking female populations. It could be used to evaluate women's physical and psychiatric symptoms related to the menstrual cycle in future works.

Preparation of Transdermal Gel Containing l-Theanine for the Potential Treatment of Premenstrual Syndrome: A Preclinical Study.

Background: Premenstrual syndrome (PMS) is experienced by many women who suffer from either its psychological or physical symptoms. Current treatment is limited to symptomatic therapy or oral contraceptives. On the other hand, l-theanine, which has a relaxant effect, has been reported to be useful for PMS, but its short half-life when administered orally makes it less effective. Permeability and properties of transdermal gel containing l-theanine were evaluated as a preclinical study of PMS symptoms relief formulation. Materials and Methods: Lyogel composed of stearic acid, stearyl alcohol, and propylene glycol was selected. The ratio of these components and the preparation method were investigated. Permeation of Strat-M membranes was evaluated by using Franz cells (in vitro). Moreover, lyogel was applied to institute of cancer research mice's backs for 10 days to examine the permeability of l-theanine. Results: l-Theanine solution did not permeate the Strat-M membrane at all in the permeation study, but lyogel allowed l-theanine to permeate. When the composition of lyogel was 4.4:11.1:296 (mmol) for stearic acid, stearyl alcohol, and propylene glycol, l-theanine absorption through Strat-M membrane was better. In skin permeation study using mice, l-theanine was detected in the serum, that is, it was proven that l-theanine penetrated the skin. Conclusion: The preparation of transdermal gels contained l-theanine was investigated as a preclinical study. The skin permeability of semisolid formulations of hydrophobic ointments, hydrophilic ointments, oily creams, creams, and lyogel containing theanine was compared and found that lyogel was the best. The composition of lyogel was also studied to obtain a formulation with good application comfort. Although it is suggested that this lyogel could be tested in clinical studies to determine whether it is effective for relief of PMS symptoms, lyogel may be suitable as an easy-to-use l-theanine-containing formulation for women that can relieve PMS symptoms.