The efficacy of oral Lavandula angustifolia Mill. essential oil on menopausal symptoms, serum lipid profile, and cortisol concentration in postmenopausal women: A triple-blind, randomized, controlled trial.

OBJECTIVE: To determine the effect of oral Lavandula angustifolia Mill. essential oil (LEO) on menopausal symptoms, serum cortisol level, and lipid profile in postmenopausal women. METHODS: This was a triple-blind parallel-armed randomized trial. Seventy-two postmenopausal women aged 50-65 years referring to healthcare centers in Tabriz, Iran with a score of 15-42 on the Green scale were included from May 10, 2022 to May 22, 2023. The participants were randomly assigned to two groups with a 1:1 ratio and using four and six blocks. One group received LEO soft gel 80 mg per day, and another group received a similar placebo for 60 days. A demographic questionnaire and a Greene menopause symptom scale were used for data collection. The lipid profile (total cholesterol, triglyceride, LDL, HDL) and the serum levels of cortisol were measured using biochemical methods. Chi-square, Fisher's exact tests, Independent samples t-test, Analysis of Covariance (ANCOVA), Repeated measure ANOVA, and Paired sample t-test were utilized for analyses. A p-value less than 0.05 was considered statistically significant. RESULTS: The demographic and personal characteristics of the participants were similar. After two months of intervention, all symptoms in psychological, physical, vasomotor, anxiety, depression, and sexual dysfunction domains were significantly relieved (decreased) among both groups (p < 0.003), except for sexual dysfunction, the reduction of which was not significant in the placebo group (p = 0.317). The mean (SD) total score of menopausal symptoms reduced from 27.4 (6.3) at baseline to 17.7 (4.9) at the end of the study in the LEO group (p < 0.001). It also decreased from 27.4 (7.1) to 17.6 (5.1) in the placebo group (p < 0.001). However, between-group analyses revealed that this reduction was significantly greater in the LEO group compared to the placebo group only in the sexual dysfunction (Mean (SD): 1.3 (0.6) vs. 1.0 (0.5); adjusted mean difference (95% confidence interval); p: - 0.35 (-0.67 to -0.02); 0.039). No significant within-group changes or between-group differences were observed (p > 0.05) in terms of studied serum markers. CONCLUSION: The oral LEO exhibited a significant enhancement in sexual dysfunction among postmenopausal women. Therefore, it can be used alongside other therapies to improve sexual dysfunction during menopause. LEO did not affect lipid profile and serum cortisol level in this study.

Phoenix dactylifera L. pollen versus pentoxifylline on improvement of sperm parameters in idiopathic male infertility: A randomized clinical trial.

ETHNOPHARMACOLOGICAL RELEVANCE: Phoenix dactylifera L. pollen is the male reproductive dust of palm flowers known as a natural product that is considered a strong stimulant of sexual potency and fertility in Iranian traditional medicine (ITM). In this regard, no evidence-based medications are empirically prescribed to treat IMI. However, applying traditional medicine for the treatment of male infertility has attracted more attention in recent years. AIM OF THE STUDY: Phoenix dactylifera L. pollen was compared with pentoxifylline (PTX) to evaluate its efficacy on sperm parameters. MATERIALS AND METHODS: During this parallel randomized controlled trial, 80 adult men with asthenozoospermia, oligozoospermia, or teratozoospermia (age 20-35 years) were enrolled. In two separate groups of participants with a 1:1 ratio, participants received either 6 g of Phoenix dactylifera L. pollen powder daily or 400 mg of PTX tablets daily for 90 days. We measured the sperm parameters as well as the serum sex hormones in the sample. ANCOVA and t-tests were used to compare groups. RESULTS: There was no significant difference between the study groups in terms of baseline characteristics or demographic characteristics. According to the results, participants who took Phoenix dactylifera L. pollen powder had significantly improved sperm concentration (p = 0.016), morphology (p = 0.029), sperm counts (p = 0.012), progressive motility (p = 0.016), total motility (p = 0.018), and reduced immotile sperms (p = 0.014) compared to those who took PTX. CONCLUSIONS: In light of these results, Phoenix dactylifera L. pollen is recommended as a treatment factor for ameliorating IMI by enhancing sperm functional capacity and semen parameters.

The effect of lavender on mood disorders associated with the use of combined oral contraceptives (COCs): a triple-blinded randomized controlled trial.

BACKGROUND: The use of contraceptive methods is influenced by their effectiveness, availability, and minimal side effects. OCPs are one of the most effective and widely used methods of pregnancy prevention worldwide. This method not only prevents pregnancy but also helps prevent and treat other diseases. One of the main reasons for discontinuing this method is the emotional disturbances associated with its use. Lavender is an evergreen, fragrant plant that has gained significant attention for its anti-anxiety effects. This study was conducted to investigate the effect of lavender essential oil capsules on mood disorders during the use of COCs. METHODS: This triple-blinded clinical trial was conducted on 60 married women (aged 15-49 years old) who were consumers of COCs, referring to 26 health centers in Tabriz, Iran. The participants were randomly assigned to either the intervention (consuming one gelatin capsule containing 80 mg LEO daily) or control (consuming one placebo capsule daily) group. The intervention continued for 56 days. Scores for positive and negative were determined using the Positive and Negative Affect Schedule (PANAS) questionnaire; and for stress, depression, and anxiety were measured using the DASS-21 questionnaire on day's 28th and 56th post-intervention. Data analysis was conducted using the t-test and ANOVA with repeated measures, and a p-value of < 0.05 was considered significant for all analyses. RESULTS: A statistically significant difference was observed in mood disorders, stress, and depression between women receiving LEO or placebo. The consumption of LEO increased the positive mood on day 28 [MD (95% CI): 4.5 (2.1 to 7.0), p = 0.001] and day 56 [5.9 (3.4 to 8.3), p < 0.001] while decreased the negative mood on day 28 [MD (95% CI): -3.5 (-5.3 to -1.3), p < 0.001] and day 56 [-4.3 (-6.3 to -2.2), p < 0.001], stress on day 28 [MD (95% CI): -4.9 (-7.1 to -2.8), p = 0.001] and day 56 [-5.3 (-7.6 to -3.1), p < 0. 001], and depression on day 28 [MD (95% CI): -3.0 (-4.9 to 1.1), p = 0.003] and day 56 [-3.1 (-5.0 to 1.2), p = 0.002]. There was no statistically significant difference between the two groups in terms of anxiety. CONCLUSIONS: The consumption of LEO with COCs improved mood disorders and reduced stress and depression. The use of hormonal contraceptives and mood changes should be considered by providers. Therefore, regarding the possibility of mood changes, it is expected that appropriate counseling and education will be provided to women who consume COC., providing appropriate solutions, including the simultaneous use of LEO.

The efficacy of topical sodium pentaborate formulation on hemorrhoid disease: A randomized, double-blind, placebo-controlled trial.

Background: The topical application of boron has been significantly associated with intensifying wound healing. Using 3% boric acid in deep wounds significantly contributes to wound healing and reduces the duration of hospitalization in the intensive care. The objective of this study was to assess the therapeutic impact of a topical gel containing sodium pentaborate pentahydrate on the management of wounds resulting from grade 1 to 3 hemorrhoids. Methods: In this randomized double-blind placebo-controlled trial, we applied a topical gel consisting of sodium pentaborate pentahydrate 3% on 206 eligible patients with the diagnosis of grade 1, 2, and 3 hemorrhoid diseases. Then patients were randomly allocated to two groups of sodium pentaborate pentahydrate or placebo gel with a ratio of 1:1 and received the allocated gel for four weeks. Patient hemorrhoid symptoms severity, hemorrhoid degree, and anoscopy findings were compared before and after the trial. Results: Before the intervention, symptom severity (p > 0.05) and anoscopy findings (p = 0.815) were similar between the two groups. Subsequent to the intervention, a majority of patients in the intervention group experienced a reduction in anal itching compared to the placebo group [adjusted mean difference (aMD) 95% CI: -1.98 (-2.2 to -1.8), p = 0.007]. Moreover, resting pain [aMD (95% CI): -1.37 (-1.6 to -1.1), p = 0.015], pain during defecation [aMD (95% CI): -2.19 (-2.4 to -2.0), p = 0.005], feeling a lump in the anus (aMD (95% CI): -0.71 (-1.2 to -0.2), p = 0.011), bleeding during defecation (41.7% vs. 66.9%, p = 0.027), and hemorrhoid degree (p < 0.001) in the intervention group was less than the placebo group. Conclusion: Our findings indicate the effectiveness of the study gel on hemorrhoid symptoms and anoscopy findings in patients.

The effects of synbiotic supplementation on blood pressure and other maternal outcomes in pregnant mothers with mild preeclampsia: a triple-blinded randomized controlled trial.

INTRODUCTION: Preeclampsia affects a significant percentage of pregnancies which is a leading cause of premature birth. Probiotics have the potential to affect inflammatory factors, and oxidative stress, which are linked to the development of preeclampsia. The study aimed to compare the effect of synbiotic and placebo on blood pressure and pregnancy duration as primary outcomes, and other pregnancy outcomes. METHODS: This study comprised 128 pregnant women with mild preeclampsia and gestational ages exceeding 24 weeks who were referred to the high-risk pregnancy clinic. It was a randomized, controlled, phase III, triple-blinded clinical experiment. The intervention and control groups were distributed to the participants at random. Intervention group received one oral synbiotic capsule, and control group received placebo daily until delivery. Based on gestational age at the time of diagnosis, preeclampsia was stratificated as early (< 34 weeks) or late (≥ 34 weeks). Data obtained from questionnaires, and biochemical serum factors were analyzed using SPSS software version 23 software. RESULTS: With the exception of the history of taking vitamin D3, there were no statistically significant variations in socio-demographic variables between the research groups. After the intervention, the means of systolic blood pressure (adjusted mean difference: -13.54, 95% CI: -5.01 to -22.07), and diastolic blood pressure (adjusted mean difference: -10.30, 95% CI: -4.70 to -15.90) were significantly lower in the synbiotic-supplemented group than in the placebo group. Compared to the placebo group, the incidence of severe PE (p < 0.001), proteinuria (p = 0.044), and mean serum creatinine level (p = 0.005) significantly declined in the synbiotic-supplemented group after the intervention. However, our analysis found no significant association for other outcomes. CONCLUSION: Based on our results, synbiotic had beneficial effects on some pregnancy outcomes. Further studies with larger samples are needed to verify the advantages of synbiotic supplementation for high-risk pregnancies, particularly with regards to higher doses, and longer intervention periods. TRIAL REGISTRATION: IRCT20110606006709N20.

The Effectiveness of Perinatal Omega-3 Supplements in Neurodevelopment and Physical Growth of 9- and 12-month-old Infants: A Follow-up of a Clinical Trial.

BACKGROUND: Omega-3 fatty acids (FAs) are essential long-chain polyunsaturated fatty acids (LCPUFAs) that are essential for optimal health and development. OBJECTIVE: The present study aimed to evaluate the effectiveness of maternal fish oil (containing omega-3 LCPUFA) intake from 21th week of pregnancy to 30 days postpartum for neurodevelopment and growth of infants at 9 and 12 months. METHODS: This was a follow-up study of a triple-blinded clinical trial. The study population was 9-- month-old infants. Their mothers were randomly divided into two groups of 75 people with a 1:1 ratio to take one fish oil supplement or a placebo daily. The anthropometric indicators of infants at months 9 and 12 and neurodevelopment at month 12 by the ASQ questionnaire were measured. In the fish oil and placebo groups, respectively, 73 and 71 infants at nine months, as well as 71 and 69 at 12 months, were analyzed. RESULTS: No statistically significant impact was observed following consuming omega-3 capsules on the neurodevelopmental domains, growth parameters, and the profile of maternal serum FAs (p > 0.05) except DHA. Neurodevelopmental problems were illustrated in one case in the intervention group and two cases in the placebo group. CONCLUSION: Perinatal relatively low-dose omega-3 LCPUFAs supplements indicated no statistically significant impacts on the growth and neurodevelopment of 9- and 12-month-old infants in a population with low consumption of marine products. Further studies investigating the effect of higher doses of omega-3 LCPUFAs are suggested.

Harnessing tumor-derived exosomes: A promising approach for the expansion of clinical diagnosis, prognosis, and therapeutic outcome of prostate cancer.

Prostate cancer is the second leading cause of men's death worldwide. Although early diagnosis and therapy for localized prostate cancer have improved, the majority of men with metastatic disease die from prostate cancer annually. Therefore, identification of the cellular-molecular mechanisms underlying the progression of prostate cancer is essential for overcoming controlled proliferation, invasion, and metastasis. Exosomes are small extracellular vesicles that mediate most cells' interactions and contain membrane proteins, cytosolic and nuclear proteins, extracellular matrix proteins, lipids, metabolites, and nucleic acids. Exosomes play an essential role in paracrine pathways, potentially influencing Prostate cancer progression through a wide variety of mechanisms. In the present review, we outline and discuss recent progress in our understanding of the role of exosomes in the Prostate cancer microenvironment, like their involvement in prostate cancer occurrence, progression, angiogenesis, epithelial-mesenchymal transition, metastasis, and drug resistance. We also present the latest findings regarding the function of exosomes as biomarkers, direct therapeutic targets in prostate cancer, and the challenges and advantages associated with using exosomes as natural carriers and in exosome-based immunotherapy. These findings are a promising avenue for the expansion of potential clinical approaches.

The efficacy of Nigella sativa L. oil on serum biomarkers of inflammation and oxidative stress and quality of life in patients with knee osteoarthritis: A parallel triple-arm double-blind randomized controlled trial.

The aim of this double-blind clinical trial was to investigate the effects of Nigella sativa oil on serum inflammatory and oxidative stress biomarkers and quality of life in patients with knee osteoarthritis (OA). Forty-five patients who met the eligibility criteria were randomly divided into three groups with a ratio of 1:1:1. The first group received 2.5 mL oral N. sativa oil twice/day plus placebo topical oil, the second group received 2.5 mL topical N. sativa oil three times/day plus placebo oral oil, and the third group received oral and topical oil placebos. There were no intergroup differences in baseline characteristics. After 6 weeks of supplementation, oral N. sativa caused a significant improvement in the serum levels of hs-CRP (p = .003), MDA (p = .003), and TAC (p = .001). Oral N. sativa oil compared to placebo (aMD (95% CI): -0.81 (-1.45 to -0.19); p = .012) and topical N. sativa oil [aMD (95% CI): -0.76 (-1.38 to -0.15); p = .016] significantly reduced hs-CRP serum levels. Significant improvements were observed in the general, physical, and mental health subscales in the oral and topical N. sativa oil compared to the placebo group (p < .05). The six-week oral N. sativa oil supplementation was effective in improving inflammatory biomarkers in knee OA. Both oral and topical N. sativa oil increased the quality of life.

The Efficacy of Nigella sativa L. and Curcumin Nanomicelle Alone or Together on Lipid Profile, Glycemic Control Indices, and Serum 17-Β Estradiol in Postmenopausal Women.

Introduction: Menopause is a condition for metabolic disorders. This study aimed to evaluate the effect of Nigella sativa (NS), curcumin nanomicelle (CN), lipid profile, glycemic status and 17-ß estradiol (ES) levels in postmenopausal women. Methods: Triple-blind randomized clinical trial was conducted on 120 postmenopausal women. Participants were randomly assigned to four groups: 1) NS capsule 1000 mg and CN placebo, 2) 80 mg CN capsule and NS placebo, 3) both NS and CN capsules and 4) NS and CN placebo. Participants received a single dose daily for 6 months. The serum lipid profile, glycemic control biomarkers, and ES were measured pre-and post-intervention using biochemical methods. Results: Total cholesterol (TC), triglyceride (TG), high-density lipoprotein (HDL) and low-density lipoprotein (LDL) cholesterol, fasting blood sugar (FBS), fasting insulin (FI), insulin resistance (IR), and ES showed significant improvement in NS group. CN significantly reduced TC, FI, and IR, and significantly increased ES. The combination of NS-CN significantly decreased TC, LDL, FI, and IR, and increased HDL and ES. The comparison of the studied with the placebo groups showed that these changes were significant in glycemic indices and NS significantly increased estrogen. Conclusion: NS, CN and NS-CN improved lipid profiles, blood sugar, and hormone levels. However, this improvement was significant in glycemic indices and estrogen levels compared to the placebo group. No superiority of combined NS-CN over NS or CN was found in this trial.

Up-regulation of plasma miRNA-21 and miRNA-422a in postmenopausal osteoporosis.

BACKGROUND: Many researchers focused on diverse miRNAs in the progression of osteoporosis in postmenopausal women. This study aimed to evaluate the association between plasma miRNA-21-5p and miRNA-422a with osteoporosis in postmenopausal women. METHODS: This cross-sectional comparative study was performed on 126 randomly selected postmenopausal women aged 50-65, including 65 osteoporotic and 61 normal-bone mineral density (BMD) women. miRNA-21 and miRNA-422a were identified using qRT-PCR in these women. BMD was evaluated by the dual-energy X-ray absorptiometry method. A binary logistic regression model adjusted for confounders was used to evaluate the associations between plasma miRNAs' expression levels and osteoporosis. The Area Under Curve (AUC) was calculated to differentiate low BMD in the postmenopausal period using Receiver-Operator Characteristic (ROC) curves. RESULTS: miRNA-21 and miRNA-422a were significantly up-regulated in osteoporotic compared to non-osteoporotic postmenopausal women. The expression levels of miRNA-21 and miRNA-422a indicated a significant reverse correlation with both lumbar spine and femoral neck density. After adjusting the confounders, the likelihood of osteoporosis in the postmenopausal women with under the median plasma levels of miRNA-21 (OR = 0.025; 95% CI: 0.003 to 0.198, p<0.001) and miRNA-422a (OR = 0.037; 95% CI: 0.007 to 0.211, p<0.001) was significantly less than the women with the levels above the median. There were significant inverse correlations between miRNA-21 (p<0.001, r = -0.511) and miRNA-422a (p<0.001, r = -0.682) with BMD-lumbar spine as well as an inverse correlation between miRNA-21(p<0.001, r = -0.374) and miRNA-422a (p<0.001, r = -0.602) with BMD-femoral neck. The AUC (95%CI) for miRNA-21 and miRNA-422a was 0.84 (0.77 to 0.91) and 0.98 (0.96 to 0.99), respectively. ROC analysis illustrated that sensitivity and specificity values were 83.1% and 74%, respectively, for miRNA-21 at the cut-off point of 3.38. Also, at the cut-off point of 2.86, a sensitivity of 94% as well as a specificity of 89% was determined for miRNA-422a. CONCLUSIONS: This study indicated that the odds of osteoporosis in postmenopausal women increased with the higher expression of plasma miRNA-21 and miRNA-422a.

Anticancer Effect of Enterococcus faecium, Isolated from Vaginal Fluid, on Ovarian Cancer Cells

Background: Given the association between cervicovaginal microbiota and OVC, we investigated the effect of Enterococcus faecium conditioned medium (CM) on OVC (Caov-4) cells. Methods: CM was obtained from the bacterium E. faecium isolated from the vagina of healthy women. The Caov-4 cells were treated with varying concentrations of CM that comprised co-cultured bacteria with 0.2, 0.5, 1, 1.5, and 2 OD for 12, 24, and 48 h. The apoptosis and growth of cancer cells were evaluated by 4',6-diamidino-2-phenylindole (DAPI) staining, flow cytometry, and DNA laddering assay. Moreover, the expression of PTEN, BAX, BCL2, and AKT1 genes were analyzed using real-time PCR. Results: The CM at a concentration of 0.5 OD from the cultured bacteria and incubation time of 48 h showed the highest negative effect on the viability of cancer cells. The CM treatment increased DNA fragmentation and also induced apoptosis in Caov-4 cells. Interestingly, CM could decrease the expression of proapoptotic genes were less, while antiapoptotic genes were more than fluorouracil in the presence of CM. Conclusion: CM of human-derived E. faecium could have an anticancer effect on OVC cells in a concentration- and time-dependent manner. This study demonstrated that E. faecium secretes anticancer substances into the CM, which could directly affect the viability and apoptosis of cancer cells.

The self-care behaviors and health literacy can play important preventive roles in older female osteoporosis.

BACKGROUND: Osteoporosis is a common complication of aging and menopause. Self-care and health literacy are among the factors affecting health status. The purpose of this research was to determine the preventive roles of self-care behaviors and health literacy in older women with osteoporosis. METHODS: This cross­sectional analytical research was conducted on 250 postmenopausal women consisting of 125 osteoporotic and 125 healthy people aged 60-70. They were selected by purposive sampling in Tabriz Sina Hospital from September 2021 to December 2021. Data collection instruments were a demographic questionnaire, a Menopausal Self­Care Questionnaire, and a European Health Literacy Survey Questionnaire. Data were analyzed using SPSS 23 software. RESULTS: The mean (SD) total score of self-care in healthy women was 118.97 (19.92) and in women with osteoporosis was 84.7 (14.98) (p < 0.001). Also, healthy women all had sufficient health literacy (100%), but 52.8% of women with osteoporosis had insufficient health literacy. The odds of osteoporosis decreased significantly with the rise in the total score of self-care behaviors [Odds ratio 95% confidence interval (95% CI); p: 0.909 (0.880 to 0.939); p < 0.001] and its subdomains as well as with increasing health literacy level [OR (95% CI); p: 0.322 (0.266 to 0.383); p < 0.001]. There was a significant positive correlation between self-care behaviors and health literacy (r = 0.616, p < 0.001). CONCLUSIONS: Self-care in aged women is particularly important in reducing the risk of osteoporosis, and empowering women in the field of health literacy is an important factor in improving self-care behaviors and ultimately the health of these people.

Cosmetic Breast Implants and the Risk of Suicide: A Systematic Review and Meta-Analysis.

Objective: Having cosmetic breast implants increases a woman's chance of suicide, which is now a global challenge. This systematic review evaluated the possible risk of suicide among women who undergo cosmetic breast implants. Method : This meta-analysis was done based on Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA). In the current systematic review and meta-analysis, we systematically searched for all articles written in both English or Persian that estimated the prevalence of suicidal ideation in women who had cosmetic breast implants. We systematically searched different databases, including MEDLINE (PubMed), Web of Science, Embase, Cochrane, Library ProQuest, Scopus, and Google Scholar, from inception to March 2021. There was also a search for references. Suicidal ideation, a suicide plan, or suicide attempts were the outcomes. In order to determine the total pooled prevalence of suicidal ideation, we utilized a random-effects model. To examine the risks of bias in each study, we applied the Joanna Briggs Institute Critical Appraisal method. Results: We identified 218 citations in our initial search. After omitting duplicated citations and excluding irrelevant studies according to the title and abstract selection, 42 studies were chosen for the full text analysis. Finally, 11 research, examining a total of 324,332 women were incorporated into the systematic review and critical appraisal assessment. Eight of these studies were found to be eligible for meta-analysis. The frequency of suicide in women with cosmetic breast implant was 0.2% (95% CI: 0.1% to 0.4%; P < 0.001) (Q-value: 168.143, I2:95.83). Most of the included studies had moderate quality. Conclusion: There might be a correlation between cosmetic breast implants and suicide risk, which could be stronger in the presence of a history of mental illnesses. The evidence about the possible effects of breast implants on the risk of suicide is still inconclusive, and there is a need for future well-designed studies on this topic.

The effectiveness of omega-3 fatty acids on health outcomes in women with breast cancer: A systematic review.

This study aimed to systematically evaluate the impact of omega-3 fatty acids on the health outcomes of women with breast cancer in electronic databases (PubMed, Scopus, ProQuest, Web of Science, and Cochrane Library) for interventional studies. The risk of bias and the quality of the included articles were assessed by Cochrane Collaboration Handbook guidance. The statistical analyses were not conducted because of the heterogeneity of the included studies. Of 3676 identified articles, 11 articles were included in this study. The majority of the included studies were not of high quality. Median progression time and overall survival significantly improved. Additionally, surgical site healing complications and infection rates decreased. There was a significant decrease in perceived stress, sleep disturbance, depression, pain, joint stiffness, and fatigue throughout the intervention. Moreover, omega-3 fatty acids consumption significantly increased the total serum omega-3, EPA, and DHA, and decreased the omega-6: omega-3 ratio, total leukocytes, lymphocytes, leptin, and CRP, accordingly. Mild gastrointestinal symptoms were reported in only two studies without clinically relevant adverse events. Omega-3 fatty acids may cause improvement in physical, mental, and some inflammatory and metabolic indices during treatment or posttreatment course of breast cancer patients. Due to the possibility of free radical formation, omega-3 FAs supplementation and consumption must be done very carefully.

The role of bone turnover markers in screening low bone mineral density and their relationship with fracture risk in the postmenopausal period.

Background: Using bone turnover marker (BTM) monitoring to identify "quick losers" who may develop osteoporosis in the coming years is one of the main challenges in clinical practice. This study was implemented to examine the association of BTMs with bone mineral density (BMD) as well as to determine their relationship with the fracture risk assessment tool (FRAX) in women in the postmenopausal period. Materials and Methods: This study was observational cross-sectional research that was done on women between the ages of 50 and 65 who were in the postmenopausal period. A dual-energy X-ray absorptiometry was applied to select 120 eligible women with normal BMD and 120 women without normal BMD. BTMs were assessed using enzyme-linked immunosorbent assay. Osteoporosis's Odds Ratio (OR) was estimated using a confounder-adjusted logistic regression model. The area under curve was calculated for the differentiation of low BMD in the postmenopausal period through receiver-operator characteristic (ROC) curves. To assess the probability of major osteoporotic fracture and hip fracture for the future 10 years, FRAX was applied. Results: Higher serum osteocalcin (OC) (OR: 1.134, 95% confidence interval [CI]: 1.086-1.184), osteopontin (OP) (OR: 1.180; 95%CI: 1.105-1.261), and alkaline phosphatase (ALP) (OR: 1.007; 95%CI: 1.001-1.144) concentrations were potential risk factors for developing low BMD in women after menopause. The area under curve (AUC) (95%CI) for OC, OP, and ALP was 0.75 (0.668-0.8130), 0.75 (0.685-0.812), and 0.602 (0.524-0.670), respectively. ROC analysis indicated that at the cut-off point of 16.28 ng/mL, sensitivity and specificity were 70.3% and 70.9%, respectively, for OC. Furthermore, at the cut-off point of 28.85 ng/mL, the sensitivity of 70.3% and specificity of 66.6% were obtained for OP. The serum OC and OP were significantly related to hip and major osteoporotic fractures (P < 0.05). Conclusion: The higher serum concentration of OC, OP, and ALP had significant associations with lower BMD. These BTMs can be complementary tools and helpful in the postmenopausal period as measures for screening of bone loss and possible bone fracture.

The effect of the boron-based gel on the treatment of diabetic foot ulcers: A prospective, randomized controlled trial.

BACKGROUND: Chronic ulcers represent impaired healing capacity with high mortality in the elderly or patients with systemic disorders such as diabetes. Boron is an effective agent in wound healing by promoting cell migration and proliferation and reducing inflammation in the wound area. This study aimed to evaluate the therapeutic effect of a sodium pentaborate-based topical formulation compared to control on the treatment of diabetic foot ulcers. METHODS: A prospective, double-blind, randomized controlled trial was conducted to apply randomly the topical sodium pentaborate 3% gel or topical conventional remedy (control) by patients diagnosed with diabetic foot ulcers. The 171 eligible participants aged 18-75 years received the allocated medicines twice a day for a month with an allocation ratio of 3:1. Twenty-five days and two months after the end of the trial, participants were reinvestigated for their ulcer condition and any recurrence. Wagner's classification of diabetic foot ulcers was applied to this purpose (0-5). RESULTS: 161 participants (57 females, 104 males; mean age: 59.37) completed this study. After the intervention, most participants in the intervention group had a lower ulcer grade than the control group (adjusted mean difference (95% CI): - 0.91 (-1.1 to -0.73); p < 0.001). Moreover, most participants in the intervention group (n = 109 (90.8%)) were treated at a higher rate than the control group (n = 5 (12.2%)) after intervention (adjusted odds ratio (95% CI): 0.008 (0.002-0.029); p < 0.001). There was no case of recurrence in the intervention group while its rate was (n = 2 (40%)) in the control group (p < 0.001). CONCLUSION: The present study suggests that topical sodium pentaborate gel may help treat and decrease the grade of diabetic foot ulcers and prevent the recurrence of diabetic foot ulcers.

Is hyperemesis gravidarum associated with transient hyperthyroidism? A systematic review and meta-analysis.

Emerging evidence suggests an association of hyperemesis gravidarum (HG) with transient hyperthyroidism and high HCG levels. For synthesizing the current evidence to determine the association between HG with hormones related to thyroid function, a comprehensive systematic search was performed in the electronic databases comprised Medline, Web of Science, Scopus, Embase, ProQuest, and Cochrane Library up to December 2021. All published observational studies that evaluated the association of hyperemesis gravidarum with transient hyperthyroidism were investigated considering the PICO method. The standardized Joanna Briggs Institute Meta-Analysis of Statistics, Assessment, and Review Instrument were applied to appraise the included studies. Twenty-nine studies consisted of 6525 women included in the systematic review. Among them, 28 studies with 2446 participants were included in the meta-analysis. There were significant associations of HG with fT3 (MD: 1.31 pg/mL, 95% CI: 0.61 to 2.01), fT4 (MD: 1.95 ng/dL, 95% CI: 1.17 to 2.73), TSH (MD: -1.22µIU/mL, 95% CI: -1.75 to -0.68), TT4 (MD: 0.56 nmol/L, 95% CI:-0.43 to 1.24), and HCG (MD: 1.90IU/L, 95% CI: 0.497 to 3.301). In conclusion, the serum levels of fT3, fT4, and TT4 increased but TSH decreased significantly in women with compared without HG, indicating the significant association of HG with GTT.

The Associations between Bone Mineral Density and Oxidative Stress Biomarkers in Postmenopausal Women.

BACKGROUND: Oxidative stress plays an essential role in bone health among postmenopausal women. This study aimed to compare the oxidative stress biomarkers among postmenopausal women aged 50-65 years with normal bone mineral density, osteopenia, and osteoporosis. METHODS: In this observational study, 120 women with normal bone mineral density, 82 with osteopenia, and 86 with osteoporosis were selected based on the densitometry data obtained from the dual-energy X-ray absorptiometry method. The serum total antioxidant capacity (TAC), superoxide dismutase (SOD) activity, and malondialdehyde (MDA) levels were measured using biochemical methods. A binary logistic regression model adjusted for confounders was used to estimate the risk of osteopenia and osteoporosis. The P-value of <0.05 was considered statistically significant. RESULTS: There were significant differences between the three groups in age, menopausal age, body mass index, and education (P<0.05). According to the binary logistic regression model, higher SOD activity and serum TAC levels were associated with a lower risk of osteoporosis (adjusted odds ratio [aOR], 0.991; 95% confidence intervals [CI], 0.986 to 0.996; and aOR, 0.373; 95% CI, 0.141 to 0.986, respectively). MDA was a significant risk factor for osteopenia in postmenopausal women (aOR, 1.702; 95% CI, 1.125 to 2.576). CONCLUSION: Higher SOD activity and serum TAC levels in the studied postmenopausal women were associated with a significantly lower risk of osteoporosis. Moreover, the risk of osteopenia increased significantly with higher serum MDA levels.

Dietary acid load is associated with primary osteoporosis in postmenopausal women aged 50-65 years: A cross-sectional study.

This study aimed to investigate the association between dietary acid load (DAL) and primary osteoporosis. This was a cross-sectional study. Among 850 randomly selected postmenopausal women aged 50-65 years, 232 women consisted of 124 women with normal bone mineral density (BMD) and 108 with primary osteoporosis were selected after examining the eligibility criteria. Demographic characteristics, anthropometric indices, and physical activity were collected through questionnaires. Osteoporosis was diagnosed using the dual-energy X-ray absorptiometry method. DAL was assessed by a valid and reliable semiquantitative food frequency questionnaire during the last year. Independent t-test, Mann-Whitney, Chi-square, and adjusted binary logistic regression were used for data analysis through SPSS/24. There were significant differences between the two groups in terms of age, body mass index (BMI), number of deliveries, and years after menopause (p < .05). The mean (standard deviation (SD)) potential renal acid load (PRAL) and net endogenous acid production (NEAP) were higher in postmenopausal women with osteoporosis than those with normal BMD (PRAL: -13.1 ± 11.1 mEq/day vs. -10.8 ± 12.7 mEq/day; NEAP: 29.5 ± 8.5 mEq/day vs. 31.2 ± 9.2 mEq/day). The mean consumption of potassium, magnesium, and calcium in the osteoporosis group was significantly lower than in the other group (p < .05). There were significant associations between osteoporosis with PRAL (odds ratio (OR) = 1.030; 95% confidence interval (CI): 1.001 to 1.060, p = .027) and NEAP scores (OR = 1.041; 95% CI: 1.003 to 1.081, p = .037). The odds of osteoporosis increased by 3% following one unit increase in PRAL score. Similarly, it increased by 4% with increasing NEAP score up to one unit. Therefore, dietary patterns that produce high DAL can have a detrimental effect on bone health.

The effect of an anti-inflammatory in comparison with a low caloric diet on physical and mental health in overweight and obese women with knee osteoarthritis: a randomized clinical trial.

PURPOSE: To evaluate the effect of an anti-inflammatory compared to a low-calorie diet on the physical and mental health of patients with knee OA. METHODS: In this randomized parallel clinical trial, participants were selected among overweight and obese women aged 40 years or older with mild to moderate OA. Sixty women with a ratio of 1:1 were randomly assigned to receive either low-calorie or anti-inflammatory accompanied by a low-calorie diet for two months. The dietary intake and weight of participants were measured. Study variables were assessed using the Western Ontario and McMaster Index (WOMAC), visual analog pain scale (VAS), Beck Depression Inventory (BDI-II), Beck Anxiety Inventory (BAI-I), and the Short Form 36 Health Survey Questionnaire (SF-36) to indicate the quality of life (QoL). RESULTS: There was no statistically significant difference between the two groups in demographic and baseline variables except for the emotional well-being subscale of QoL. There was significant difference in anti-inflammatory compared to low-calorie diet in terms of weight (MD (95% CI): - 4.02 kg (- 6.77 to - 1.28); p = 0.005), VAS (MD (95% CI): - 0.97 (- 1.53 to - 0.41); p = 0.001), WOMAC-total score (MD (95% CI): - 9.91 (- 15.05 to - 4.78); p < 0.001), WOMAC-pain subscale (MD (95% CI): - 3.30 (- 5.30 to - 1.29); p = 0.002), WOMAC-physical function (MD(95% CI): - 5.48 (- 9.41 to - 1.53); p = 0.007), depression (p = 0.003), anxiety (p = 0.011), QoL-physical functioning (0.041), and QoL-pain (0.010) after the intervention. CONCLUSION: An anti-inflammatory accompanied by a low-calorie diet resulted in greater weight loss and greater improvement in pain intensity, functional status, depression, anxiety, and some dimension of QoL in overweight and obese women with knee OA compared to the low-calorie diet. Trial registration number and date of registration: IRCT201610220030424N2; 2018-04-23.