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 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.

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.

Effect of Aromatherapy with Essential oil of Lavandula Angustifolia Mill- Citrus Bergamia and Mindfulness-Based Intervention on Sexual Function, Anxiety, and Depression in Postmenopausal Women: A Randomized Controlled Trial with Factorial Design.

Background: Due to the importance of psychological support for women during menopause as a period with a high prevalence of mental health problems, this study aimed to evaluate the effect of the essential oil of lavender-Bergamot (La-Ber) and Mindfulness-Based Intervention (MBI) on sexual function, anxiety (primary outcome), and depression score (secondary outcome) in postmenopausal women with sexual dysfunction. Materials and Methods: This controlled randomized trial with a factorial design was performed on 132 postmenopausal women. Participants were randomly allocated into four equal groups: Aromatherapy-Routine Care (Aroma-RC), MBI-Placebo (MBI-P), Aromatherapy-MBI (Aroma-MBI), or Routine Care-Placebo (RC-P). Two to three drops of La-Ber or a similar placebo were inhaled three times a day for 8 weeks. Eight sessions of MBI intervention were conducted. At the end of the intervention and eight weeks afterward, the outcomes were assessed. Results: The sexual function score improved significantly in Aroma-MBI (adjusted Mean Difference [aMD]: 2.4, 95% CI: 0.01 to 4.80) and MBI-P (aMD: 2.6, 95% CI: 0.2 to 5.1) groups compared to the RC-P group. The anxiety score was reduced in the Aroma-RC group at the end of the intervention (aMD: -4.12, 95% CI: -7.41 to -0.72; p = 0.020) and eight weeks later as well as in the Aroma-MBI group. In terms of depression, the mean score of depression was significantly lower than the RC-P group in the Aroma-RC group at the end of the intervention (p = 0.011). Conclusions: MBI and aromatherapy seem effective on sexual function and menopausal anxiety. MBI improves sexual function, while aromatherapy ameliorated anxiety and depression.

The Effect of Selected Herbal Medicines on Bone Turnover Markers: A Systematic Review and Meta-Analysis.

Objective: To evaluate systematically the therapeutic effects of five herbal medicines (curcumin, black seed, ginger, cinnamon, and flaxseed oil) on bone turnover markers as a primary outcome. Materials and methods: A comprehensive systematic search of the literature was conducted in the electronic databases consisting of the Cochrane Library, MEDLINE, Web of Science, Scopus, Embase, ProQuest, and Google scholar, as well as SID, Magiran, and Irandoc for Persian literature up to December 2020. All Randomized controlled trials and quasi-experiments evaluated the impact of studied herbal medicines on bone turnovers of Bone Specific Alkaline Phosphatase (BSAP), osteocalcin, C-terminal Telopeptide type 1 Collagen (CTX-I), Deoxypyridinoline (DPD) were analyzed. Results: Sixteen interventional studies comprised 968 participants included in systematic review. Ten of eligible studies with 603 participants included in meta-analysis. Curcumin, black seed and flaxseed did not have a significant effect on BSAP (SMD=-1.76, 95%CI: -6.85 to 3.33, p=0.50, I2=0.99, 6 trials, 241 participants), CTx (SMD=-0.17ng/mL, 95%CI:-0.43 to 0.09, p=0.21, I2=1.000, 5 trials, 216 participants), DPD (MD=0.82nmol/mmol, 95%CI:-0.05 to 1.68, p=0.06, I2=0.000, 2 trials, 67 participants), osteocalcin (SMD=-2.02ng/mL, 95%CI:-4.49 to 0.45, p=0.11, I2=0.79, Six trials, 229 participants). As secondary outcomes, femoral neck Bone Mineral Density (BMD) increased significantly (p=0.03, I2=0.12) but lumbar spine BMD didn't differ (p=0.28, I2=0.97). Curcumin significantly increased total hip BMD (p<0.001, I2=0.12). QiangGuYin containing cinnamon as a combined Chinese medicine had significant effect on P1NP, ß-CTx, and BMD. Conclusion: Studied herbs except for QiangGuYin had no significant effects on bone turnover markers. Due to high heterogeneity between trials, further high-quality trials are suggested.

Clinical Efficacy of Curcumin and Vitamin E on Inflammatory-Oxidative Stress Biomarkers and Primary Symptoms of Menopause in Healthy Postmenopausal Women: A Triple-Blind Randomized Controlled Trial.

Aims of the Study. Reducing estrogen levels due to menopause activates oxidative and inflammatory processes, which causes symptoms of menopause, anxiety, and sexual dysfunction. As a suggestion, potential anti-inflammatory and antioxidant agents such as curcumin and vitamin E could be used as an effective alternative treatment due to parsimony, suitable access, and fewer side effects. Therefore, the present study was conducted to find out whether supplementation with curcumin and vitamin E affects inflammatory-oxidative stress biomarkers and primary symptoms of menopause in healthy postmenopausal women. Methods Used to Conduct the Study. The present study is a triple-blind parallel randomized controlled trial. Eighty-four eligible postmenopausal women aged 40 to 60 years old were randomly assigned into three groups using block randomization with an allocation ratio of 1 : 1 : 1. The curcumin group received one capsule containing 500 mg curcumin twice a day, the vitamin E group received one 500 mg capsule of vitamin E twice a day, and the placebo group took two placebo capsules containing 500 mg of microcrystalline cellulose (MCC) daily for eight weeks. Demographic and anthropometric characteristics, dietary intake, and early symptoms of menopause were collected at baseline. Serum levels of total antioxidant capacity (TAC), malondialdehyde (MDA), and high sensitivity C-reactive protein (hs-CRP) were measured at baseline and after the intervention. Intervention safety and satisfaction with the intervention were also evaluated. Results of the Study. Eighty-one participants completed the trial and were finally analyzed. There were no statistically significant differences in demographic characteristics and dietary intake of participants (except for vitamin C intake, P=0.023) between the groups at baseline. The mean ± standard deviation (SD) score of total menopause symptoms, depression, anxiety, psychological, vasomotor, and physical domains significantly decreased within all groups (P < 0.05). Between-group analyses indicated that decreasing the mean score of anxiety in the vitamin E group was significantly more than in the placebo group (P=0.026). The mean (SD) serum levels of MDA and hs-CRP significantly decreased only in the curcumin group (P=0.009 and P=0.025, respectively). Serum levels of TAC significantly increased in curcumin and vitamin E groups (P < 0.001 and P=0.006, respectively). Conclusions Drawn from the Study and Clinical Implications. Curcumin could improve the oxidative stress (MDA and TAC) and inflammatory (hs-CRP) biomarkers. Vitamin E may also improve the antioxidant status by increasing the TAC levels. The alleviation of anxiety in the vitamin E group was more than in the placebo group. Clinical Trial Registration. The trial was registered at the Iranian Registry of Clinical Trials (https://irct.ir/IRCT20131009014957N6).

The Relationship Between Usual Daily Physical Activity With Serum Markers Related to Bone Metabolism and Demographic Characteristics in Postmenopausal Women Aged 50-65 Years.

BACKGROUND: Bone turnover markers can predict subsequent changes in bone status. This study aimed to investigate the relationship between usual daily physical activity (PA) with bone markers. METHODS: This cross-sectional study was conducted on 500 postmenopausal women aged 50-65 years in Tabriz-Iran in 2018. The women were recruited by a simple random method. The International Physical Activity Questionnaire was used to assess PA. The laboratory tests of 25-Hydroxyvitamin D3, alkaline phosphatase, calcium, and phosphorus were also used to examine bone function. RESULTS: The education, income, employment status, sun exposure, and history of exercise were significantly correlated with PA. Among reproductive characteristics, only menopausal age showed a significant relationship with total PA levels (r = .285, P = .048). None of the anthropometric indices showed a statistically significant relationship with total PA. Serum calcium (r = -.242) and phosphorus (r = -.045) levels showed negative and inverse relationships with total PA. The intensity of this association was statistically significant only for the calcium (ß = -0.108, 95% confidence interval, -0.117 to 0.098; P = .023). 25-Hydroxyvitamin D3 (r = .007) and alkaline phosphatase (r = .046) were directly and positively but nonsignificantly correlated to the intensity of total PA. CONCLUSION: Usual daily physical activity with any levels has no effect on bone markers except for calcium. Despite of the beneficial effects of PA, our findings showed that usual daily physical activity without increasing total PA cannot affect bone health. For maximal effects of PA on bone health, it seems that a degree of intensity, continuity, and regularity of PA programs should be considered to stimulate bone formation.

Efficacy of nanomicelle curcumin, Nigella sativa oil, and their combination on bone turnover markers and their safety in postmenopausal women with primary osteoporosis and osteopenia: A triple-blind randomized controlled trial.

Literature supports the potential effects of nanomicelle curcumin and Nigella sativa on the amelioration of osteoporosis, a health concern of postmenopausal women. This study aimed to evaluate the impacts of nanomicelle curcumin (CUR), Nigella sativa oil (NS), and their combination on bone turnover biomarkers and assess their safety. This triple-blind randomized controlled trial was performed on 120 postmenopausal women aged 50-65 with primary osteoporosis or osteopenia. The subjects were randomly allocated to receive microcrystalline cellulose (placebo), 80 mg of CUR, 1000 mg of NS, or their combination (CUR-NS) for 6 months. All patients were also treated with alendronate (70 mg) and calcium (500 mg), vitamin D (400 IU) supplements. The serum levels of alkaline phosphatase (ALP), osteocalcin (OC), and osteopontin (OP) were measured at the baseline and after the intervention. For safety assessment, the hepatic enzyme levels of aspartate transaminase and alanine transaminase as well as serum urea and creatinine were evaluated. ALP levels were significantly reduced in the NS (p = .029) and CUR-NS (p = .015) groups compared with those in the placebo. After adjustment for the covariates, this effect was still significant in the CUR-NS group (p = .004). The OC levels were decreased in the placebo, CUR, and NS groups, and the OP concentration also was attenuated in all groups through the trial. However, the intergroup differences were not significant for both biomarkers. Evaluating the key renal metabolites and hepatic enzyme levels indicated no toxicity of the administered doses. This study reveals the beneficial effects of CUR-NS on the improvement of some bone turnover biomarkers. These compounds seem to be safe at the current dosage for supplementation in postmenopausal women.

Comparison of the effect of Ceratonia siliqua L. fruit oral capsule and vitamin E on semen parameters in men with idiopathic infertility: a triple-blind randomized controlled clinical trial.

OBJECTIVES: To compare the effect of oral Ceratonia siliqua (Carob) and vitamin E on sperm parameters in idiopathic infertile men. METHODS: In this triple-blind randomized controlled trial study, fifty 20-45-year-old infertile men with idiopathic abnormal sperm parameters were selected among men referring to the infertility clinic of Al Zahra-Iran Hospital, and randomly allocated into two groups. The first group received Carob capsules, 500 mg, and the second group received vitamin E capsules three times a day for 90 days. The primary outcomes of this study were the sperm parameters (count, motility, and morphology). RESULTS: After the intervention, the mean of sperm count increased from 49.08 to 60.22 million/mL in the carob vs. it increased from 47.64 to 58.88 million/mL in the vitamin E group (adjusted mean difference (aMD)=1.124 million/ml, 95% CI: -12.892 to 15.141). The mean sperm motility increased from 45.90 to 52.90% in the carob group but decreased from 55.23 to 38.10% in the vitamin E group (aMD=17.22%, 95% CI: 8.53 to 25.92). The mean sperms with normal morphology increased from 11.52 to 67.05% in the carob, and from 10.20 to 77.47% in the vitamin E group (aMD=-10.88%, 95% CI: -22.30 to 0.536). There was no serious side effect during the treatment course. CONCLUSIONS: Taking 1,500 mg oral dose of Carob capsule per day for 90 days improved sperm motility but had no significant effect for improving morphology and count comparing to vitamin E capsule.

The effect of nanomicelle curcumin supplementation and Nigella sativa oil on the expression level of miRNA-21, miRNA-422a, and miRNA-503 gene in postmenopausal women with low bone mass density: A randomized, triple-blind, placebo-controlled clinical trial with factorial design.

This study aimed to investigate the effect of nanomicelle curcumin (CUR), Nigella sativa oil (NS), and CUR and NS on the plasma levels of miR-21, miR-422a, and miR-503 expression in postmenopausal women with low bone mass density (BMD). This randomized, triple-blind, placebo-controlled clinical trial with a factorial design was conducted on 120 postmenopausal women from the integrated healthcare system, Tabriz-Iran. The BMD was determined using dual-energy X-ray absorptiometry (DEXA). Women were randomly divided into four groups of 30 participants: (a) CUR (80 mg) and placebo of NS, (b) NS (1,000 mg) and placebo of CUR, (c) CUR (80 mg) and NS (1,000 mg), and (d) both placebos (containing microcrystalline cellulose). The plasma level of miRNA-21, miRNA-422a, and miRNA-503 was determined by qRT-PCR. The expression level of miRNAs at the baseline was similar. At the end of the intervention, only the expression level of miRNA-21 changed statistically significantly between the four groups (p = .037) and between the NS and placebo groups (p = .005). Also, its expression in the two groups receiving NS (p = .037) and NS-CUR (p = .043) was significantly increased. NS and NS-CUR supplementation can increase the expression level of miRNA-21 in postmenopausal women with low bone density, and bring perspective to further studies of the target.

The effect of Nigella sativa on oxidative stress and inflammatory biomarkers: a systematic review and meta-analysis.

OBJECTIVES: The present systematic review of literature was conducted to study the effect of Nigella sativa (N.S) on oxidative stress and inflammatory biomarkers. CONTENT: Different online databases such as Cochrane Central Register of Controlled Trials, MEDLINE (PubMed), Scopus, Web of Sciences, EMBASE, and Clininaltrial.gov for English articles and national databases of SID, Magiran, Irandoc, and Iranmedex for Persian articles, which were published until March; 2019 were scrutinized. All Randomised Controlled Trials (RCTs) and quasi-experimental studies that aimed to compare the impact of N.S along, with placebo or without supplementation, on inflammatory factors and oxidative stress were entered in the present study. SUMMARY: Finally, 11 RCTs covering 710 women and men, in total, were participated in the present meta-analysis. Significant differences were observed in Tumor Necrosis Factor alpha (TNF-α) (Weighted Mean Difference (WMD) =-2.15 pg/mL, 95% Confidence Interval (CI) =-3.22--1.09, I2=32%; 5 trials with 262 participants) superoxide dismutase (WMD=63.79 µ/gHb, 95% CI=6.84-120.75, I2=0%; 2 trials, with 88 participants), and total antioxidant capacity (WMD=0.34 mmol/L, 95% CI=0.04 to 0.63, I2=94%; 5 trials with 232 participants). Nevertheless, there was no significant difference in high sensitivity C-reactive protein (WMD=-0.98 mg/L, 95% CI=-1.98-0.03, I2=78%; 5 trials with 267 participants), Interleukin 6 (IL-6) (WMD=-0.25 pg/mL, 95% CI=-0.65 to 0.16, I2=0%; 2 trials with 134 participants), and malondialdehyde (WMD=-0.95 nmol/mL, 95% CI=-1.97-0.08, I2=68%; 4 trials with 179 participants). OUTLOOK: Generally speaking, N.S probably results in the improvement of superoxide dismutase serum levels, TNF-α, and total antioxidant capacity. Thus, further studies are required to fully assess its impacts on all oxidative stress and inflammatory biomarkers.

The Effect of Panax ginseng on Genitourinary Syndrome in Postmenopausal Women: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

BACKGROUND: Menopause and estrogen deprivation cause a rise in the number of urogenital tract complaints. OBJECTIVE: This study was conducted to assess the effectiveness of ginseng on genitourinary syndrome. METHODS: This randomized trial was conducted on 60 postmenopausal women with genitourinary syndrome. The participants were randomly allocated to ginseng and placebo groups twice daily for 4 weeks. Vaginal maturation index and vaginal pH were evaluated before and 4 weeks after intervention as the primary outcomes. Also, the atrophic vaginitis and incontinence questionnaires were completed before and after intervention as the secondary outcomes. The safety of intervention was assessed by the side effects checklist. RESULTS: No significant differences were observed between the 2 groups in objective symptoms after the intervention, but the difference was statistically significant (p < 0.001) in terms of subjective symptoms of atrophic vaginitis. One case of insomnia and palpitation and 2 cases of hot flashes were reported in the intervention group, and 1 case of gastric discomfort and change in urine appearance was reported in the placebo group. CONCLUSION: Ginseng only improved the patient-assessed symptoms and had no significant effect on the clinician-assessed outcomes. Further studies are required to determine the precise pharmacological mechanisms of ginseng on genitourinary syndrome.

The effect of clomiphene citrate, herbal mixture, and herbal mixture along with clomiphene citrate on clinical and para-clinical parameters in infertile women with polycystic ovary syndrome: a randomized controlled clinical trial.

INTRODUCTION: To evaluate the effect of a herbal mixture (i.e., Mentha spicata, Zingiber officinale, Cinnamomum zeylanicum, and Citrus sinensis) alone and in combination with clomiphene citrate (CC) compared to CC on the treatment of polycystic ovary syndrome (PCOS). MATERIAL AND METHODS: This single-blind randomized clinical trial was conducted on 60 infertile participants with PCOS who were randomly divided into three groups. After spontaneous or progestin-induced withdrawal bleeding, group 1 (n = 20) received routine treatment with CC (50-150 mg) for three menstrual cycles from the 3rd to 5th day of menstruation for 5 days while group 2 (n = 20) and group 3 (n = 20) received herbal mixture capsules 700 mg/day and the herbal mixture along with CC for 3 months, respectively. Finally, several related parameters were measured, including the level of sex steroids, homeostatic model assessment for insulin resistance (HOMA-IR), lipid profile (primary outcomes), thyroid hormones, and clinical features. The analysis was based on intention-to-treat analysis. RESULTS: No statistically significant differences were observed between the groups in terms of socio-demographic characteristics. However, after adjustment for baseline, luteinizing hormone (aMD = 4.9; 95% CI: 3.7-6.2), luteinizing hormone/follicle-stimulating hormone (aMD = 0.9; 95% CI: 0.7-1.2), total testosterone (aMD = -0.12; 95% CI: -0.2 to -0.01) in group 2 and free testosterone (aMD = -6.0; 95% CI: -9.7 to -2.3) in group 3 revealed a significant difference compared to group 1. In addition, HOMA-IR in group 2 (aMD = -1.3; 95% CI: -2.4 to -0.2) decreased significantly compared to group 1. Further, total cholesterol, triglycerides, low-density lipoprotein cholesterol, and very low-density lipoprotein cholesterol decreased significantly in group 2 (aMD = -21.8; 95% CI: -31.5 to -12.1; aMD = -29.9; 95% CI: -47.9 to -12.0; aMD = -21.2; 95% CI: -31.3 to -11.1; aMD = -5.1; 95% CI: -7.5 to -2.7) and group 3 (aMD = -18.3; 95% CI: -27.4 to -9.2; aMD = -26.9; 95% CI: -43.8 to -9.9; aMD = -21.4; 95% CI: -31.1 to -11.7; aMD = -5.9; 95% CI: -8.3 to -3.6) compared to group 1, respectively. However, high-density lipoproteins cholesterol in group 2 (aMD = 6.8; 95% CI: 2.9-10.7) and group 3 (aMD = 10.7; 95% CI: 7.2-14.7) increased remarkably compared to group 1. Overall, clinical outcomes improved significantly in all groups (p < 0.05). CONCLUSIONS: In general, the herbal mixture along with CC was found to improve free testosterone, HOMA-IR, lipid profile, and clinical features of PCOS women.

Does aromatherapy with lavender affect physical and psychological symptoms of menopausal women? A systematic review and meta-analysis.

OBJECTIVES: The objective of this review was to evaluate systematically the effectiveness of Lavender aromatherapy on physical and psychological symptoms in menopausal women. METHODS: A comprehensive systematic literature search in the electronic databases including the Cochrane Library, MEDLINE (PubMed), Ovid, Embase, Scopus, ProQuest, Web of science, and Google scholar, as well as Magiran, SID, and Irandoc for Persian literature review up to January 2020. All Randomized controlled trials, and quasi-experimental studies that evaluated the impact of aromatherapy with lavender alone or in combination with other aromas on physical and psychological symptoms in menopausal women were included in this systematic review. RESULTS: Sixteen interventional studies consisted of 1092 postmenopausal women included in systematic review. Eight of eligible studies with 493 participants included in meta-analysis. There were significant between group differences in menopausal symptoms (standardized mean difference (SMD) = -1.39, 95% confidence interval (CI): 1.98 to -0.80, I2 = 76%; four trials, 236 participants); sleep quality score (SMD = -2.16, 95%CI: -3.77 to -0.54, I2 = 95%; three studies, 199 participants); systolic blood pressure (MD = -5.34 mmHg, 95% CI: -7.40 to -3.29, I2 = 10%; two study, 114 participants); diastolic blood (MD = -5.06 mmHg, 95% CI: -7.55 to -2.57, I2 = 0%; two study, 114 participants). Aromatherapy had positive effect on sexual function, self-esteem, anxiety, hot flash, but it had negative impact on triglyceride and high density lipoprotein compared to placebo (p < 0.05). CONCLUSIONS: Aromatherapy with Lavender in postmenopausal women may cause an improvement in most of physical and psychological symptoms. Further high quality studies especially with focus on the adverse events are suggested globally.

The effect of oral capsule of curcumin and vitamin E on the hot flashes and anxiety in postmenopausal women: A triple blind randomised controlled trial.

OBJECTIVE: The decline and eventual cessation of estrogen production cause a variety of symptoms during menopause, affecting each woman differently. Most women reported severe hot flashes and night sweats during menopause. The present study aimed to determine and compare the efficacy of curcumin and vitamin E on hot flashes and anxiety (primary objectives), sexual function, menopausal symptoms and adverse effects (secondary objectives). MATERIALS AND METHODS: This was a triple-blind randomized controlled clinical trial. The participants consisted of 93 postmenopausal women in Ahar city-Iran. They were assigned into three groups (two intervention groups and one control group). The first intervention group received oral capsule of curcumin (500 mg), the second intervention group was given oral tablets of vitamin E (200 IU/day), and the third group (control) received placebo twice a day for eight weeks. The participants completed the hot flash checklist one week before the intervention, and 4 weeks and 8 weeks after the intervention. They also filled out the Anxiety Scale, the Female Sexual Function Index (FSFI), the Greene Climacteric Scale before the intervention, and 4 weeks and 8 weeks after the intervention. One-way ANOVA, repeated measures ANOVA and ANCOVA tests were used for data analysis. RESULTS: There was no statistically significant difference between groups in terms of demographic characteristics, mean number of hot flashes, mean score of anxiety, sexual function index and menopausal symptoms before the intervention (p > 0.05). The mean age of participants was 51.7 years. Mean number of hot flashes in the curcumin group (adjusted mean difference = -10.7, 95%confidence interval = -3.6 to -17.9, P = 0.001) and in the vitamin E group (-8.7, -0.6 to -15.0, P = 0.029) was significantly lower than the placebo group after the intervention. The first significant effect of curcumin on hot flashes was observed after four weeks (P = 0.027). However, there was no significant difference between vitamin E group and placebo four weeks after intervention (P = 0.052) and the first significant effect of vitamin E on hot flashes was observed after eight weeks (P = 0.025). There was no statistically significant difference between the groups in terms of sexual function index, anxiety and menopausal symptoms (P > 0.05). CONCLUSION: The results of this study showed that oral intake of curcumin and vitamin E significantly reduced hot flashes in postmenopausal women but had no significant effect on anxiety, sexual function and menopausal symptoms.

The Effectiveness of Herbal Mixture Supplements with and without Clomiphene Citrate in Comparison to Clomiphene Citrate on Serum Antioxidants and Glycemic Biomarkers in Women with Polycystic Ovary Syndrome Willing to be Pregnant: A Randomized Clinical Trial.

This paper aimed to evaluate the effect of herbal mixture (Mentha spicata, Zingiberofficinale, Cinnamomumzeylanicum, and Citrussinensis) only and along with clomiphene citrate (CC) compared to CC on serum antioxidants, glycemic status, menstrual regulation, and rate of pregnancy. This single-blind randomized clinical trial was carried out on 60 infertile participants with polycystic ovary syndrome (PCOS) willing to be pregnant. They were randomly allocated into group 1 (n = 20) who received routine dose of CC pills (50-150 mg) for three menstrual cycles from the fifth day of menstruation for five days; group 2 (n = 20) who consumed herbal mixture daily (700 mg); and group 3 (n = 20) who used up herbal mixture along with CC for 3 months. Catalase (CAT), glutathione peroxidase (GPx), superoxide dismutase (SOD), malondialdehyde (MDA), fasting blood sugar (FBS), insulin, and homeostatic model assessment for insulin resistance (HOMA-IR) were measured in their blood samples. No statistically significant differences were observed between the three groups in terms of socio-demographic characteristics. After intervention, however, the levels of CAT in group 2 (adjusted mean difference (aMD): = 9.0; confidence interval (CI) 95% = 1.1-16.9) and group 3 (aMD = 12.2; CI 95% = 4.5-19.9), GPx in group 2 (aMD = 986.1; CI 95% = 141.1-1831.1) and group 3 (aMD = 1781.2; CI 95% = 960.7-2601.8), and SOD in group 2 (aMD = 55.1; CI 95% = 26.0-84.2) increased. While FBS in group 3 (aMD = -8.7; CI 95% = -14.7 to -2.7), insulin in group 2 (aMD = -5.6; CI 95% = -10.8 to -0.4), and HOMA-IR in group 2 (aMD = -1.3; CI 95% = -2.4 to -0.2) significantly decreased compared to the group 1. To summarize, herbal mixture supplements along with CC have beneficial effects on serum antioxidant levels, as well as glycemic biomarkers of infertile PCOS, menstrual regulation, and pregnancy rate.

Comparing the effectiveness of Salvia officinalis, clotrimazole and their combination on vulvovaginal candidiasis: A randomized, controlled clinical trial.

AIM: To determine the effect of vaginal tablet of Salvia officinalis, alone and in combination with Clotrimazole, on the recovery of Vulvovaginal candidiasis. METHODS: In this triple-blind randomized controlled trial, 111 participants were randomly assigned into three groups of 37 patients using block randomization with block sizes of 6 and 9, and allocation ratio of 1:1:1: 100 mg vaginal tablet of Clotrimazole and Placebo (CP), 400 mg vaginal tablet of S. officinalis and Placebo (SP), and vaginal tablet of S. officinalis and Clotrimazole (SC), once daily for 7 days. On the seventh day after the treatment was ended up, Vulvovaginal candidiasis were examined by vaginal symptoms and wet test, and if positive, they were examined by culture in chrome agar Candida medium. RESULTS: Socio-demographic characteristics was similar (P > 0.05). Thirty-six, 36 and 35 patients, respectively in CP, SC and SP groups recruited in the study. The frequency of a positive wet test confirmed by Sabrodextrose agar medium 7 days after treatment was significantly lower in SC group than the reference group of CP (adjusted odds ratio = 0.09, 95% confidence interval: 0.93-0.932, P = 0.043). There was no significant difference between SP and CP group (P = 0.071, 95% confidence interval: 0.032-1.151, adjusted odds ratio = 0.192). Also, there was no significant difference between the three groups in terms of vaginal symptoms at the baseline (P > 0.05), however the statistical differences were indicated after the intervention in cheesy discharge, pruritus and Vulvovaginal edema (P < 0.05.(. CONCLUSION: S. officinalis in the form of vaginal tablet, alone and when combined with Clotrimazole, can treat the Vulvovaginal Candidiasis.

Effect of Tribulus terrestris L. on sperm parameters in men with idiopathic infertility: A systematic review.

BACKGROUND AND OBJECTIVE(S): Tribulus terrestris L. is an herbal plant that has long been used as sex stimulant and to treat male infertility. This systematic review collected the clinical trials and/or quasi-experimental studies on the effect of T. terrestris on sperm parameters in idiopathic male infertility. MATERIALS AND METHODS: To search the related articles, Cochrane Library, EMBASE, ProQuest, Clinicaltrial.gov, WHO, Google Scholar, MEDLINE via Pubmed, Web of Science, SID, Magiran, Irandoc, and Iranmedex databases were used without any time limitation. Words used to search were T. terrestris L., Tribestan, male infertility and sperm parameters based on the MeSH glossary. To assess the eligibility of the articles, the views of the two authors and in cases where there was no agreement, the third person was used. RESULTS: Through searching of the databases, 5775 articles were identified, of which 3509 were entered after removing the duplicates. Afterward, 102 articles were screened for inclusion. Finally, 7 articles were included in this systematic review. Only one quasi-experimental without control arm article reported that the use of T. terrestris L. in the treatment of idiopathic male infertility was not effective, In the others, T. terrestris L. was reported to be effective in improving some or all parameters of the sperm, namely number, motility and morphology. CONCLUSION: The results of the present systematic review showed that the consumption of T terrestris L., in general, resulted in the improvement of sperm parameters. This result was obtained from 6 out of the 7 articles.