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.

Effect of vitamin D supplementation on symptoms severity in vitamin D insufficient women with premenstrual syndrome: A randomized controlled trial.

BACKGROUND: Premenstrual syndrome (PMS) is one of the most prevalent disorders among reproductive women worldwide that negatively impact women's quality of life. This study aimed to investigate the effect of vitamin D supplementation on the severity of PMS symptoms in vitamin D insufficient women with PMS. METHODS: In this randomized, double-blind clinical trial, 44 vitamin D insufficient women with PMS received either 50,000 IU vitamin D or a placebo fortnightly for 16 weeks. Participants completed the PMS Daily Symptoms Rating form at beginning and during the last two months of the intervention, and their blood samples were collected to assess 25(OH)D serum levels. RESULTS: After the four months' intervention, the serum level of 25(OH)D in the vitamin D group raised from 21 ± 8 ng/ml to 40 ± 8 ng/ml (P < 0.001), while in the placebo group it raised from 21 ± 7 ng/ml to 23 ± 7 ng/ml (P = 0.03). Indeed, serum vitamin D levels in the placebo group could not reach a sufficient level. At the end of the intervention, the mean score of total PMS symptoms showed significant improvement in the vitamin supplemented group compared to the controls (p < 0.001). By grouping the PMS symptoms into five subgroups, the mean score of all five subgroups decreased post-supplementation compared to the baseline; however, the highest and lowest decrease were in depression (53 %) and water retention subgroups (28 %), respectively. This indicates a greater improvement in the mean scores of mood symptoms compared to physical symptoms in this study (p < 0.001). CONCLUSION: Results obtained in this clinical trial represent the helpful effects of vitamin D supplementation on total, physical and mood symptoms in vitamin D insufficient women with PMS. TRIAL REGISTRATION: This randomized controlled trial at IRCT.ir on 2018-06-20 with Registration No: IRCT20180525039822N1.

Vitex agnus castus effects on hyperprolactinaemia.

Background: Vitex agnus castus (VAC), also known as chaste tree, is a plant from the Mediterranean area, Crimea, and central Asia. Its fruit has been used for more than 2500 years as phytotherapic agent. In the last century, VAC has been mostly used for the treatment of premenstrual syndrome (PMS), menstrual irregularities, fertility disorders, and symptoms of menopause. Since some degree of hyperprolactinaemia may be observed in patients with such disorders, VAC effects on hyperprolactinaemia have been assessed in a small number of studies and in some patient series or single case reports. It has been postulated that the diterpenes contained in VAC extract may interact with dopamine D2 receptors (D2R) and inhibit prolactin release via dopamine D2R activation in the anterior pituitary. Most of the published papers focus on the use of VAC for the management of PMS or infertility. However, due to its action on D2R, VAC could have a role in the treatment of mild hyperprolactinaemia, including patients with idiopathic hyperprolactinaemia, microprolactinoma, drug-induced hyperprolactinaemia, or polycystic ovary syndrome. Methods: We have reviewed and analysed the data from the literature concerning the use of VAC extracts in patients with hyperprolactinaemia. Results: Some evidence suggests a possible role of VAC for the management of hyperprolactinaemia in selected patients, though in an inhomogeneous way. However, there are not any large randomized controlled trials supporting the same and the precise pharmacological aspects of VAC extract in such a clinical setting still remain obscure. Conclusion: It appears that VAC may represent a potentially useful and safe phytotherapic option for the management of selected patients with mild hyperprolactinaemia who wish to be treated with phytotherapy. However, larger studies of high quality are needed to corroborate it.

Phyto-progestins for the treatment of abnormal uterine bleeding without organic cause in women at high risk for breast cancer and breast cancer survivors: a prospective, pilot study.

OBJECTIVES: Some plants, such as Dioscorea Villosa (DV), Vitex Agnus Castus (VAC) and Turnera diffusa (D) have some 'progesterone-like' properties. We have investigated their simultaneous administration in breast cancer (BC) survivors or carriers of specific genetic mutations that can increase the risk of developing BC suffering from abnormal uterine bleeding without organic cause. METHODS: Women with irregular cycles in terms of length (interval between ≤ 24 or ≥ 38 days) without a uterine organic disease (polyps, adenomyosis, fibroids, hyperplasia/malignancy) were included. A daily diary of bleeding, questionnaires about health-related quality of life (Short Form 36) and menstrual psychophysical well-being (PGWB-1) and the Greene Climacteric Scale (GCS) (in women older than 40 years old) questionnaire were used. The presence of some premenstrual syndrome (PMS) symptoms was also evaluated. RESULTS: In the analyzed group of women (n = 15), all experienced a regularization of the menstrual cycles, with a mean duration in the three months of use of 27.1 ± 3.2 days, with a significant reduction of menstrual pain (p = 0.02) and flow (p = 0.02) intensity. Women with PMS (7/15) reported an impovement in depression, headache and abdominal pain scores (p < 0.05). No specific deterioration of different questionnaires evaluated during treatment were observed. General satisfaction with the treatment was 6.8 ± 0.3/10 on a 10 point. CONCLUSIONS: A combination of DV, VAC and D could be a promising candidate to treat menstrual irregularities without an organic cause, with a significant reduction of menstrual pain and flow intensity and possible additional benefits in PMS symptoms treatment in women at genetic risk for BC and BC survivors.

Limbic self-neuromodulation as a novel treatment option for emotional dysregulation in premenstrual dysphoric disorder (PMDD); a proof-of-concept study.

AIM: To assess the efficacy of a novel neurofeedback (NF) method, targeting limbic activity, to treat emotional dysregulation related to premenstrual dysphoric disorder (PMDD). METHODS: We applied a NF probe targeting limbic activity using a functional magnetic resonance imaging-inspired electroencephalogram model (termed Amyg-EFP-NF) in a double-blind randomized controlled trial. A frontal alpha asymmetry probe (AAS-NF), served as active control. Twenty-seven participants diagnosed with PMDD (mean age = 33.57 years, SD = 5.67) were randomly assigned to Amyg-EFP-NF or AAS-NF interventions with a 2:1 ratio, respectively. The treatment protocol consisted of 11 NF sessions through three menstrual cycles, and a follow-up assessment 3 months thereafter. The primary outcome measure was improvement in the Revised Observer Version of the Premenstrual Tension Syndrome Rating Scale (PMTS-OR). RESULTS: A significant group by time effect was observed for the core symptom subscale of the PMTS-OR, with significant improvement observed at follow-up for the Amyg-EFP group compared with the AAS group [F(1, 15)=4.968, P = 0.042]. This finding was specifically robust for reduction in anger [F(1, 15) = 22.254, P < 0.001]. A significant correlation was found between learning scores and overall improvement in core symptoms (r = 0.514, P = 0.042) suggesting an association between mechanism of change and clinical improvement. CONCLUSION: Our preliminary findings suggest that Amyg-EFP-NF may serve as an affordable and accessible non-invasive treatment option for emotional dysregulation in women suffering from PMDD. Our main limitations were the relatively small number of participants and the lack of a sham-NF placebo arm.

Effect of γ-tocopherol supplementation on premenstrual symptoms and natriuresis: a randomized, double-blind, placebo-controlled study.

BACKGROUND: This randomized, double-blind, placebo-controlled study aimed to investigate the effects of γ-tocopherol (Toc) supplementation on premenstrual symptoms and natriuresis. METHODS: We enrolled 51 Japanese women with premenstrual symptoms, particularly those who showed increased symptoms induced by water retention during the luteal phase compared with the follicular phase. Premenstrual symptoms were recorded in the first cycle's postmenstrual follicular phase; physical measurements and urine collection were conducted during the 48-h run-in period. The test supplement, which contained 180 mg of γ-Toc or placebo, was orally administered twice a day for 7 days during the luteal phase of the first and second cycles in a crossover manner. The same evaluation was conducted during the luteal phase, beginning in the morning of the sixth day of supplement administration. RESULTS: Compared with placebo intake, γ-Toc intake significantly reduced "fatigue" and "irritability/anger" symptoms. Furthermore, compared with placebo intake, γ-Toc intake significantly reduced the thigh circumference. Regarding the "swelling of the legs" and "heavy legs" symptoms and the thigh circumference, the biphasic trend of increasing and decreasing values in the daytime and morning, respectively, during the follicular phase was not observed at the luteal phase with placebo intake. Contrastingly, γ-Toc intake resulted in significantly lower values in the morning than placebo intake. The mean difference in 24-h urinary sodium excretion between γ-Toc and placebo intake was 10.6 mEq (95% confidence interval (CI): -0.1, 21.4, p = 0.05, power 55%). Plasma γ-Toc and its metabolite γ-carboxyethyl hydroxychroman (CEHC) levels were significantly higher with γ-Toc intake than with placebo intake. There were no significant between-supplement differences in serum electrolyte levels or cumulative urinary potassium excretion. CONCLUSION: γ-Toc intake could effectively alleviate certain premenstrual syndrome symptoms, particularly those related to water retention during the luteal phase. Furthermore, the underlying mechanism may involve the diuretic effect of γ-CEHC, which is a γ-Toc metabolite. TRIAL REGISTRATION: UMIN000047989; registration date: 10/06/2022, retrospectively registered.

Efficacy of Curcumin on Cognitive Function Scores in Women with Premenstrual Syndrome and Dysmenorrhea: A Triple-Blind, Placebo-Controlled Clinical Trial.

OBJECTIVE: To assess the efficacy of a curcumin supplementation on cognitive abilities in women suffering from premenstrual syndrome (PMS) and dysmenorrhea. METHODS: A randomized, triple-blind, placebo-controlled trial was conducted from December 2019 to March 2020. A total of 124 women who had both PMS and dysmenorrhea were enrolled, and were equally and randomly assigned to the curcumin group or placebo group, 62 cases in each. Each subject received either a capsule containing 500 mg of curcuminoid, or a placebo daily, for 10 days (7 days before and until 3 days after the onset of menstrual bleeding) over 3 menstrual cycles. The cognitive abilities questionnaire was used to measures cognitive functions in 7 specific areas. Adverse reactions were monitored during and after the trial in both groups. RESULTS: Administration of curcumin was associated with a significant increase in memory score (P=0.002), inhibitory control and selective attention (P=0.020), and total cognitive ability task (P=0.024). In addition, significant increments were found in scores of memory (3.5±3.1 vs. 0.4±3.8 in the curcumin and placebo groups, respectively; P=0.035), inhibitory control and selective attention (3.0±3.7 vs. 0.4±3.7; P=0.027) and total cognitive abilities (8.3±12.3 vs. 2.2±12.4; P=0.025) in the curcumin group versus placebo groups. Curcumin was safe and well-tolerable in current clinical trial. CONCLUSION: Curcumin has a beneficial efficacy on cognitive function scores in women with PMS and dysmenorrhea, with improvements in memory, inhibitory control and selective attention. (Registration No. IRCT20191112045424N1, available at: https://www.irct.ir ).

El alivio natural: Sauzgatillo (Vitex agnus-castus) para el síndrome premenstrual y la dismenorrea / The natural relief: Chasteberry (Vitex agnus-castus) for premenstrual syndrome and dysmenorrhea

El síndrome premenstrual es un trastorno común en mujeres en edad reproductiva y se caracteriza por al menos un síntoma físico, emocional o conductual, que aparece en la fase lútea del ciclo menstrual y se resuelve poco después del inicio de la menstruación. Los tratamientos convencionales para el dolor perimenstrual cíclico tienen inconvenientes que incluyen efectos secundarios, interferencia con la función reproductiva de las mujeres o escasa efectividad en el alivio de los síntomas. Muchas mujeres recurren a terapias naturales para tratar una gran variedad de síntomas menstruales. Esta revisión se centra en una de esas opciones naturales, el Sauzgatillo (Vitex agnus-castus). Se realizó una búsqueda e identificación de artículos publicados hasta mayo de 2022 recopilados por medio de sistemas de búsqueda electrónicos como Google Scholar, Medline, PubMed y Scopus. Las palabras de búsqueda fueron: “Premenstrual syndrome”, “dysmenorrhea” AND “Vitex agnus-castus”. Los estudios preclínicos señalan un mecanismo de acción en su implicación sobre el sistema serotoninérgico, así como su unión a los receptores de dopamina. Los estudios clínicos demuestran la seguridad y el efecto positivo sobre el síndrome premenstrual y la dismenorrea.

Premenstrual syndrome is a common disorder in women of reproductive age and is characterized by at least one physical, emotional, or behavioral symptom, which appears in the luteal phase of the menstrual cycle and resolves shortly after the onset of menstruation. Conventional treatments for cyclical perimenstrual pain have drawbacks that include side effects, interference with womens reproductive function, or limited effectiveness in relieving symptoms. Many women turn to natural therapies to treat a wide variety of menstrual symptoms. This review focuses on one of those natural options, Chasteberry (Vitex agnus-castus). The information available until May 2022 was collected via the library and electronic search systems such as Google Scholar, Medline, PubMed, and Scopus. The search words were: “Premenstrual syndrome”, “dysmenorrhea” AND “Vitex agnus-castus”. Preclinical studies point to a mechanism of action in its involvement in the serotoninergic system, as well as its binding to dopamine receptors. Clinical studies prove safety and positive effect on premenstrual syndrome and dysmenorrhea.

Current status and problems in the diagnosis and treatment of premenstrual syndrome and premenstrual dysphoric disorder from the perspective of obstetricians and gynecologists in Japan.

AIM: To investigate the current status and problems in the diagnosis and treatment of premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD) from the perspective of obstetricians and gynecologists (OB/GYNs) in Japan, the Japanese Society of Obstetrics and Gynecology (JSOG) conducted a national-wide survey. METHODS: An email survey was sent to all JSOG members (16 732) and a web-based survey was conducted using a Google form between September and November 2021. The current status and problems in PMS/PMDD diagnosis and treatment were surveyed in this cross-sectional study. RESULTS: In total, 1312 respondents (7.8% of all JSOG members) completed the questionnaire. In terms of diagnoses and treatment, OB/GYN was preferred over psychiatrist for PMS (91.4% vs. 45%); however, no differences were noted for PMDD (76.1% vs. 73.7%). A total of 1267 (96.6%) respondents engaged in routine PMS/PMDD treatment. Regarding the general diagnosis procedure, 84.4% respondents answered "only a vague medical interview," 8.4% kept a two-cycle symptom diary, and 10.3% used a screening questionnaire. The most commonly used medication was oral contraceptive pills (OCPs) (98.1%), followed by the Kampo, traditional Japanese herbal medicines, Kamishoyosan (73.6%). Concerning first-line drugs for treatment, OCPs were the most common (76.8%), followed by Kampo medicine (19.5%); selective serotonin reuptake inhibitors (SSRIs) were less frequently used (2.6%). Regarding first-line drugs among OCPs, 65.1% respondents reported drospirenone-ethinylestradriol use. CONCLUSIONS: This study indicates that only a few OB/GYNs practicing PMS/PMDD in Japan use a prospective diary, which is an essential diagnostic criterion for PMS/PMDD. Regarding treatment, SSRIs were used less frequently.

The Effect of Zinc Supplementation on the Improvement of Premenstrual Symptoms in Female University Students: a Randomized Clinical Trial Study.

Zinc is an essential microelement that plays many important functions in the body. It is crucial for the regulation of cell growth, hormone release, immunological response, and reproduction. Thus, this trial aimed to evaluate the effects of zinc supplementation in comparison with placebo on the improvement of premenstrual symptoms in female university students. This triple-masked, randomized, placebo-controlled, parallel trial was conducted among 69 female students aged 18-35 with premenstrual syndrome that living in dormitories of Hamadan University of Medical Sciences, in west of Iran. Participants were randomly assigned to two groups of equal number; one group received 220 mg of elemental zinc (n = 33) and the other group received placebo (n = 36) on a regular daily for 24 weeks. The premenstrual syndrome was assessed by Premenstrual Symptoms Screening Tool-Adolescent (PSST-A) questionnaire for all participants. Chi-square and t-student tests were used to compare the percentage or mean of parameters between two groups. All statistical analysis conducted by SPSS version 16. The mean age in the intervention group was 25.64 [Formula: see text] 0.53 years, and in the control group was 24.38 [Formula: see text] 0.51 years (P = 0.087). After 24 weeks of intervention, PMS physical and psychological symptoms such as anger, anxiety, depressed mood, overeating, breast tenderness, headaches, muscle pain, bloating, and weight gain significantly decreased in zinc group compared to placebo group (P < 0.001). We observed a significant increase in relationship with friends, classmates, and coworkers (p = 0.003) after 24 weeks of intervention with zinc compared to placebo. In conclusion, zinc, as a simple and inexpensive treatment, was associated with improvement of PMS symptoms. Given that this is among the first studies to evaluate the effect of zinc supplementation on PMS, additional studies are warranted to confirm these findings.

Effects of curcumin-piperine supplementation on systemic immunity in young women with premenstrual syndrome and dysmenorrhea: A randomized clinical trial.

INTRODUCTION: Premenstrual syndrome (PMS) and primary dysmenorrhea (PD) are common gynecological complications and there is evidence that inflammation may be an important factor in their etiology. There is a relationship between PMS and PD with susceptibility to allergic disorders. We aimed to assess the effect of curcumin co-administered with piperine on serum IL-10, IL-12 and IgE levels in patients with PD and PMS. MATERIALS AND METHODS: A sample of 80 patients were recruited to this triple-blind, placebo-controlled clinical trial. Participants were randomly allocated to curcumin (n = 40) and control groups (n = 40). Each participant received one capsule (500 mg of curcuminoid plus piperine, or placebo) daily, from 7 days before until 3 days after menstruation for three consecutive menstrual cycles. RESULTS: Serum IgE, IL-10 and IL-12 levels were quantified by using an ELISA kit. No significant differences were found between the two groups at baseline, including: age, BMI, and dietary intakes (P > 0.05). Curcumin + piperine treatment was associated with a significant reduction in the mean serum levels of IgE [from 223.6 ± 258.7 IU/mL to 161.3 ± 240.7; P = 0.001]; but there were no significant changes in the placebo group (P = 0.12). Serum concentrations of IL-10 and IL-12 before and after the trial period did not differ significantly between the two groups (P > 0.05). CONCLUSION: Curcumin plus piperine might be have positive effect on serum IgE levels with no significant changes on serum IL-10 and IL-12 in healthy young women with PMS and PD. Studies with higher doses and longer durations of treatment with curcumin are required to confirm these findings.

Role of Inflammation, Oxidative Stress, and Mitochondrial Changes in Premenstrual Psychosomatic Behavioral Symptoms with Anti-Inflammatory, Antioxidant Herbs, and Nutritional Supplements.

Premenstrual syndrome (PMS) significantly lowers the quality of life and impairs personal and social relationships in reproductive-age women. Some recommendations are that inappropriate oxidative stress and inflammatory response are involved in PMS. Various nutritional supplements and herbs showed neuro-psycho-pharmacological activity with antioxidant and anti-inflammatory properties. This study aims to determine the systematic review of randomized controlled trials (RCTs) of herbal medicine and nutritional supplements in PMS. We also comprehensively highlighted the role of oxidative stress, inflammation, and mitochondrial changes on PMS with the application of computational intelligence. We used PRISMA and research question-based techniques to collect the data for evaluation of our study on different databases such as Scopus, PubMed, and PROSPERO from 1990 to 2022. The methodological quality of the published study was assessed by the modified Jadad scale. In addition, we used network visualization and word cloud techniques to find the closest terms of the study based on previous publications. While we also used computational intelligence techniques to give the idea for the classification of experimental data from PMS. We found 25 randomized controlled studies with 1949 participants (mean ± SD: 77.96 ± 22.753) using the PRISMA technique, and all were high-quality studies. We also extracted the closest terms related to our study using network visualization techniques. This work has revealed the future direction and research gap on the role of oxidative stress and inflammation in PMS. In vitro and in vivo studies showed that bioactive molecules such as curcumin, allicin, anethole, thymoquinone, cyanidin 3-glucoside, gamma-linoleic acid, and various molecules not only have antioxidant and anti-inflammatory properties but also other various activities such as GABA-A receptor agonist, serotonergic, antidepressant, sedative, and analgesic. Traditional Unani Herbal medicine and nutritional supplements can effectively relieve PMS symptoms as they possess many bioactive molecules that are pharmacologically proven for the aforementioned properties. Hence, these biomolecules might influence a complex physical and psychological disease process like PMS. However, more rigorous research studies are recommended for in-depth knowledge of the efficacy of bioactive molecules on premenstrual syndrome in clinical trials.

Evaluation of the effectiveness of yoga in management of premenstrual syndrome: a systematic review and meta-analysis.

Aim: The management of Premenstrual Syndrome (PMS) is still evolving due to the modest effect sizes of the available treatment modalities. Yoga as therapeutic intervention in PMS has been gathering interest amongst researchers. The current manuscript reviews the evidence surrounding yoga in PMS.Methods: This manuscript was a systematic review and meta-analysis evaluating the effectiveness of yoga on the total scores and sub-domains of PMS after studies were identified using a pre-defined selection criterion after a search in PubMed, Google Scholar, Scopus and Web of Science. Both quantitative and qualitative analysis of the accumulated data was performed. Overall, 14 studies were identified for the review, 11 of which were used for the purpose of quantitative analysis.Results: The studies were heterogenous in terms of the design, yoga regimes, nature of interventions and tools used for outcome measures. It was found that yoga was beneficial in the management of PMS. This benefit was also seen when all the sub-domains of PMS were individually examined except physical sub-domain.Conclusion: Though there were certain limitations in our review like heterogeneity in studies, possibility of publication bias and restrictive selection criterion; it supported that yoga can be beneficial in patients with PMS.

Premenstrual syndrome and premenstrual dysphoric disorder in adolescents.

Premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD) represent two premenstrual disorders characterized by physical and psychological symptoms that occur in the luteal phase of the menstrual cycle, prior to the onset of menses, and have a negative impact on the psychosocial functioning of affected individuals. PMS, more common than PMDD, affects 20-40% of menstruating women, with common symptoms including fatigue, irritability, mood swings, depression, abdominal bloating, breast tenderness, acne, changes in appetite and food cravings. PMDD, affecting a smaller percentage of women, is characterized by more severe symptoms and is listed as a depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). While the pathophysiology of these premenstrual disorders remains unclear, it has been hypothesized that sensitivity to hormonal fluctuations during the luteal phase of the menstrual cycle, abnormal serotonergic activity, and aberrations in progesterone and the neurotransmitter gamma aminobutyric acid (GABA) may all play a role in these disorders. Treatment of PMS and PMDD is focused on alleviation of symptoms and improvement of functioning and quality of life for affected individuals. The treatment of severe PMS and PMDD typically requires pharmacologic therapy with selective serotonin reuptake inhibitors (SSRIs), oral contraceptive pills (OCPs), gonadotropin-releasing hormone (GnRH) agonists, and non-contraceptive estrogen formulations. Non-pharmacologic treatment with diet, exercise, cognitive behavioral therapy (CBT), certain vitamin and herbal supplements, and acupuncture may additionally be effective for some individuals.

The effect of a social network-based cognitive behavioral therapy intervention on the severity of premenstrual syndrome symptoms: a protocol of a randomized clinical trial study.

BACKGROUND: Premenstrual syndrome (PMS) is one of the most widespread menstrual disorders in women of reproductive age. This recurrent syndrome is a combination of physically, mentally, or behaviorally disturbing changes occurring during the secretory phase of the menstrual cycle. The aim of this study is to determine the effect of a cognitive-behavioral therapy-based educational intervention using social networks on PMS in female health center employees in Rudbar, Iran. METHODS/DESIGN: A randomized superiority controlled trial will be conducted involving 140 female employees of health centers affiliated with the Guilan University of Medical Sciences, Rudbar. The study involves a block size of 4 and 6 in a randomly varied order, 140 women who meet all the inclusion criteria will be randomly and equally divided into 2 groups: the intervention and the control groups. Those in the former group will receive a cognitive-behavioral therapy-based treatment for eight consecutive weeks on the social network platform WhatsApp; however, those in the control group will not be offered any treatment except usual care practices (unprotocolized usual care). The study's primary outcome is the severity of PMS symptoms, and the secondary outcomes include general self-efficacy, work-related quality of life, the impact of PMS on daily life, coping with the symptoms, and experiencing anxiety and depression at the beginning of the study to identify people with PMS. A daily record of the symptoms will be completed for two consecutive months by all female employees aged 20-45 years who wish to participate in the study. According to the initial screening, those with moderate to severe PMS will be included. We will use the MLwin software for the analyses. All questionnaires will be completed by both groups immediately and 8 weeks after the termination of the treatment. The data will be analyzed using linear mixed-effects modeling with random intercepts and slopes. DISCUSSION: It is anticipated that the findings of the present study may demonstrate the effectiveness of the cognitive behavioral therapy intervention on the severity of PMS symptoms that could guide healthcare providers in opting for suitable treatment alternatives for the syndrome. ETHICS AND DISSEMINATION: The research proposal is approved by the Human Ethics Committee of Qazvin University of Medical Sciences (IR.QUMS.REC.1399.252). The results of this intervention trial will be submitted for publication in a peer-reviewed research journal. TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT20180218038789N4 . Registered prospectively on October 28, 2020.

Effect of omega-3 fatty acids on premenstrual syndrome: A systematic review and meta-analysis.

INTRODUCTION: To date, no definitive results have been reported on the effect of omega-3 fatty acids on premenstrual syndrome (PMS). Therefore, this systematic review and meta-analysis aimed to determine the effect of omega-3 fatty acids on PMS. METHODS: In this systematic review and meta-analysis, the databases were searched. In this regard, randomized clinical trials investigating the effect of omega-3 fatty acids on PMS were included. The quality of the studies was assessed using the Cochrane Collaboration's Risk of Bias tool. Meta-analysis was done based on random effects model and calculation of standardized mean difference (SMDs). RESULTS: The results of meta-analysis showed that omega-3 fatty acids were efficient in reducing the severity of PMS in women (SMD = -0.968, 95% confidence interval [CI]: -1.471 to -0.464). In addition, the results showed that the studies were heterogeneous (I2  = 89.11%, p <0.001). Based on meta-regression analysis, aging (ß = -0.150, 95% CI -0.202 to -0.098, p <0.001) and increasing the duration of intervention (ß = -0.579, 95% CI -0.781 to -0.378, p <0.001) had a significant effect on the severity of PMS. We also found that omega-3 fatty acids could significantly reduce the somatic (SMD = -0.800, 95% CI: -1.126 to -0.474) and psychological (SMD = -0.373, 95% CI: -0.686 to -0.061) symptoms of PMS. CONCLUSION: Omega-3 fatty acids could reduce the severity of PMS. However, we should caution in the conclusion in affirming the beneficial effects of n-3 PUFAs on PMS, since the heterogeneity is evident in the analysis. The efficacy of the treatment was enhanced by increase of the treatment duration.

Effects of Auriculotherapy on treatment of women with premenstrual syndrome symptoms: A randomized, placebo-controlled clinical trial.

OBJECTIVE: This study aimed to investigate the effect of auriculotherapy on the intensity of physical and mood Premenstrual syndrome (PMS) symptoms. DESIGN: Single-blind randomized, placebo-controlled clinical trial. SETTING: Federal University of Parana, Curitiba, Brazil. INTERVENTION: Ninety-one women were randomly assigned to Auriculotherapy (AG), Placebo (PG), and Control (CG) groups. The intervention was 8 weeks long, done once per week. At each session in AG the microneedles were placed in seven points related to PMS symptoms (Anxiety; Endocrine; Muscle relaxation; Analgesia; Kidney; Shen Men; and Sympathetic). At PG the microneedles also were placed in seven points but unrelated to PMS symptoms (Tonsils; Vocal cords; Teeth; Eyes; Allergy; Mouth; and External nose). MAIN OUTCOME MEASURES: Assessments of PMS symptoms (Premenstrual Syndrome Screening Tool), musculoskeletal pain (Nordic Musculoskeletal Questionnaire), anxiety (Beck Anxiety Inventory), and quality of life (WHOQOL-Bref) were done at baseline, before the 5th session, after program completion, and a month follow-up. RESULTS: The AG and PG showed significantly lower scores of PMS symptoms, musculoskeletal pain, and anxiety. On the quality of life and follow-up analysis, the significance was observed only in PG. CONCLUSION: Auriculotherapy can be used as adjunctive therapy to reduce the physical and mood PMS symptoms.

Effects of curcumin supplementation on vitamin D levels in women with premenstrual syndrome and dysmenorrhea: a randomized controlled study.

BACKGROUND: Vitamin D has an established role in female reproduction. There is also evidence for an association between vitamin D levels and menstrual problems such as premenstrual syndrome (PMS) and dysmenorrhea. Curcumin, is a bioactive polyphenol constituent of turmeric, that can potentially interact with vitamin D receptors and its molecular targets. This study evaluated the effects of curcumin on vitamin D levels in young women with PMS and dysmenorrhea. METHODS: In this randomized, triple-blind, placebo-controlled trial, women with PMS and dysmenorrhea were divided randomly into experimental and control groups to receive one capsule (500 mg of curcuminoid+ 5 mg piperine, or placebo) daily, from approximately 7 days before until 3 days after menstruation for three consecutive menstrual cycles. Serum vitamin D levels, renal function, and liver enzymes were also measured before and after intervention. RESULTS: A total of 76 subjects (38 in each group) were recruited into the trial. Curcumin significantly increased the median (IQR) serum levels of vitamin D [from 12.8 ng/ml (7.0-24.6) to 16.2 ng/ml (6.4-28.8); P = 0.045], compared with placebo [from 18.6 ng/ml (2.2-26.8) to 21.3 ng/ml (5.2-27.1); P = 0.17]. Serum levels of aspartate aminotransferase and direct bilirubin were reduced by the end of trial in the curcumin group (p < 0.05), but did not change significantly in the control group (p > 0.05). Finally, no significant differences in levels of fasting blood glucose were detected between curcumin and placebo groups. CONCLUSION: Curcumin supplementation in women with PMS and dysmenorrhea led to a significant improvement of vitamin D, liver function enzyme test, but did not affect blood glucose. TRIAL REGISTRATION: The trial was registered on Iranian Registry of Clinical Trials registry (Trial ID: IRCT20191112045424N1 on 23 January 2020; available at https://www.irct.ir ).

Effects of PMS50 supplementation on psychological symptoms of students with premenstrual syndrome.

OBJECTIVE: To evaluate the effects of PMS50 supplementation on psychological symptoms in university students in Iran. METHODS: This double-blind clinical trial was conducted at Ahvaz Jundishapur University of Medical Sciences, between December 2018 and March 2019. Fifty female students with moderate to severe premenstrual syndrome (PMS) randomly received either 550 mg/day of PMS50 (n = 25) or placebo (n = 25), starting from 1 week before till the end of menstruation for three consecutive menstrual cycles. Anthropometric indices, dietary intake, physical activity level, and severity of PMS were assessed at baseline and post-intervention. Data were analyzed by SPSS (version 22). Independent t test was used to compare the results between groups. Paired t test was used to compare the results within groups before and after study. RESULTS: There was a significant improvement in psychological symptoms including depression, anger, feeling of hopelessness, desire to be alone, mood swings, irritability, anxiety, and poor concentration observed in the intervention group compared with the control group post-intervention. Restlessness was significantly reduced in both groups post-intervention. The mean scores of low self-esteem, change in appetite, and food cravings were decreased in both groups, but not significant between groups. CONCLUSION: PMS50 supplementation may be effective in improvement of psychological symptoms in PMS. Clinical Trial Registration No.: IRCT20181218042038 N1.

Herbal Products Used in Menopause and for Gynecological Disorders.

Herbal products are often used as an alternative to pharmacological therapy. Menopausal symptoms and gynecological disorders (such as premenstrual syndrome and dysmenorrhea) are the indications where pharmacological therapy may have serious adverse events, hence many women prefer to use herbal products to help with these symptoms. Here, we reviewed plants and derived products, which are commonly used for the abovementioned indications, focusing on clinical data, safely profile and whether or not their use is justified. We noted that limited data are available on the use of some plants for alleviating the symptoms of menopause and gynecological disorders. While black cohosh (Cimicifuga racemose) and red clover (Trifolium pretense) were consistently shown to help reduce menopausal symptoms in clinical studies, currently available data do not fully support the use of fenugreek (Trigonella foenum-graecum), hops (Humulus lupulus), valerian (Valeriana officinalis), and soybean (Glycine max and Glycine soja) for this indication. For premenstrual syndrome and premenstrual dysphoric disorder, chaste tree (Vitex agnus-castus) shows effectiveness, but more clinical studies are needed to confirm such effect upon the use of evening primrose (Oenothera biennis).