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.

Evaluation of Curcumin-Piperine Supplementation in COVID-19 Patients Admitted to the Intensive Care: A Double-Blind, Randomized Controlled Trial.

BACKGROUND: Curcumin is a traditional remedy for diseases associated with hyper-inflammatory responses and immune system impairment. Piperine, a bioactive compound in black pepper, has the potential to enhance curcumin bioavailability. 0This study aims to examine the effect of the curcumin-piperine co-supplementation in patients infected with SARS-CoV-2 and admitted to the intensive care unit (ICU). MATERIAL AND METHODS: In this parallel randomized, double-blind, placebo-controlled trial, 40 patients with COVID-19 admitted to ICU were randomized to receive three capsules of curcumin (500 mg)-piperine (5 mg) or placebo for 7 days. RESULTS: After 1 week of the intervention, serum aspartate aminotransferase (AST) (p = 0.02) and C-reactive protein (CRP) (p = 0.03) were significantly decreased, and hemoglobin was increased (p = 0.03) in the curcumin-piperine compared to the placebo group. However, compared with the placebo, curcumin-piperine had no significant effects on the other biochemical, hematological, and arterial blood gas and 28-day mortality rate was three patients in each group (p = 0.99). CONCLUSION: The study results showed that short-term curcumin-piperine supplementation significantly decreased CRP, AST, and increased hemoglobin in COVID-19 patients admitted to the ICU. Based on these promising findings, curcumin appears to be a complementary treatment option for COVID-19 patients, although some parameters were not affected by the intervention.

Association of omega-6 polyunsaturated fatty acids with blood pressure: A systematic review and meta-analysis of observational studies.

OBJECTIVES: This systematic review and meta-analysis aimed at summarizing earlier findings on the association of n-6 PUFAs levels in diets or blood with blood pressure. METHODS: PubMed/Medline, Scopus, and Web of Science were searched for observational studies. Publications with data on the risk of hypertension, or the correlation between n-6 PUFAs or mean values of serum n-6 PUFAs levels in normotensive and hypertensive were included. RESULTS: Twenty-two studies (16 cross-sectional studies, 5 cohorts and one case-control) were eligible. Combining 14 extracted effect sizes showed that higher circulatory/dietary n-6 PUFAs tended to be associated with 10% lower risk of HTN (95% CI: 0.81, 1.00), whereas combining 23 effect sizes illustrated no difference in circulatory/dietary n-6 PUFAs mean levels between normotensive and hypertensive subjects. According to subgroup analysis based on fatty acid types, total n-6 PUFAs (OR = 0.82, 95% CI: 0.70, 0.97) and linoleic acid (OR = 0.56, 95% CI: 0.39, 0.82) were inversely related to the risk of HTN. Circulatory/dietary n-6 PUFAs were correlated neither with systolic nor with diastolic blood pressure. CONCLUSIONS: Higher circulatory/dietary n-6 PUFAs tend to be associated with lower odds of HTN. Particularly, total n-6 PUFAs and linoleic acid were associated with lower risk of HTN.

The Therapeutic Impact of Garlic (Allium Sativum) on Oxidative Stress Markers among Polycystic Ovary Syndrome Patients: A Randomized, Double-Blinded Clinical Trial.

Background: The present study aimed to investigate the effect of garlic supplementation on oxidative stress markers in patients with polycystic ovary syndrome (PCOS). Methods: Eighty patients with PCOS were randomized and instructed to consume either garlic supplementation (800 mg/day) or a placebo (starch) for 8 weeks. They were also asked to avoid intake of any other supplement during the study. Oxidative stress-related markers including total antioxidant capacity, catalase, glutathione, malondialdehyde concentrations, and anthropometric measures were assessed at baseline and end of the trial. Results: Garlic supplementation resulted in significant improvement in catalase concentration (1.82 ± 9.28 vs. -1.55 ± 8.66; P value: 0.03), glutathione levels (29.15 ± 57.53 vs. 2.42 ± 77.51; P value: 0.048) as well as weight (-0.64 ± 1.94 vs. 0.11 ± 0.82; P value: 0.04), body mass index (BMI; -0.25 ± 0.75 vs. 0.05 ± 0.61; P value: 0.04), and waist circumference (-0.21 ± 0.77 vs. 0.02 ± 0.65; P value: 0.01). However, we failed to detect any significant change in hip circumference, waist to hip circumference ratio, total antioxidant capacity, and malondialdehyde levels between the two groups. Conclusions: The present study indicates that garlic supplementation could be beneficial in improving oxidative stress and weight loss among PCOS women.

The effects of adjunctive treatment with L-carnitine on monitoring laboratory variables in ICU patients: a double-blinded randomized controlled clinical trial.

BACKGROUND: Critically ill patients must be monitored constantly in intensive care units (ICUs). Among many laboratory variables, nutritional status indicators are a key role in the prognosis of diseases. We investigated the effects of L-carnitine adjunctive therapy on monitoring variables in critical illness. METHOD: A prospective, double-blind, randomized controlled trial was implemented in a medical ICU. Participants were 54 patients, aged > 18 years, with multiple conditions, randomly assigned to receive 3 g L-carnitine per day or placebo, along with enteral feeding, for 1 week. Primary outcomes included monitoring variables related to nutritional status. RESULT: Of 54 patients randomly assigned, 51 completed the trial. Serum albumin (Alb) (P-value: 0.001), total protein (P-value: 0.003), and calcium (Ca) (0.044) significantly increased in the intervention vs. control group. Alanine transaminase (ALT) (0.022), lactate (<0.001), creatinine (Cr) (0.005), and international normalized ratio (INR) (0.049) decreased meaningfully in the intervention vs. control group. CONCLUSION: L-Carnitine supplementation in critically ill patients can improve several parameters including INR, Cr, ALT, lactate, Ca, Alb, and total protein. TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT 20151108024938N2. This trial was approved by the Research Ethics Committee of Mashhad University of Medical Sciences (registration code: IR.MUMS.fm.REC.1396.671) (available at https://en.irct.ir/trial/30748 , May 2018).

The first semi-quantitative toddler's food frequency questionnaire (T-FFQ) in Iran.

Background: Only few food frequency questionnaires (FFQs) have been specifically designed and validated for toddlers. There is no valid instrument to assess usual intakes of Iranian toddlers. The present study was designed to develop a FFQ, and to examine its validity and reliability among toddlers. Material and methods: This cross-sectional study was conducted in 2019 in Iran. Mothers of 100 toddlers completed a semi-quantitative FFQ with 99 items as well as three non-consecutive dietary records. Data on maternal age, education, toddler gender, birth order, birth weight, current weight and height, and the age of beginning complementary foods were collected. By comparing the results obtained from dietary records and the FFQ, we assessed the relative validity. Reliability was evaluated by intra-class correlation coefficients between results of two FFQs administered with four weeks intervals to the same participants (n=20), as well as weighted kappa. The Bland-Altman plots were used to assess the level of agreement between two FFQs. Results: Mean and standard deviation (SD) of age was 32.71 (4.76) years and 22.42 (3.52) months, for mothers and toddlers, respectively. The FFQ showed acceptable validity and reliability. The correlation coefficients for the first FFQ were 0.82 (energy), 0.81 (fats), 0.60 (carbohydrate), 0.96 (calcium), 0.39 (iron) and 0.24 (vitamin C), all P-values were <0.001, except for vitamin C (P: 0.02). Reliability coefficients were between 0.77 (vitamin C) and 0.99 (calcium, potassium, phosphorus, zinc, riboflavin, vitamin B12, vitamin E and D). The Cronbach's Alpha was 0.91, showing high reliability. Conclusion: The present study provided a thorough assessment of both validity and reliability of T-FFQ, and indicated acceptable validity as compared with three-day dietary records and good reliability. Therefore, this FFQ could be a useful tool to evaluate usual dietary intake of toddlers.

The effect of oral zinc on hemoglobin and dose of erythropoietin in hemodialysis patients.

Background: In hemodialysis (HD) patients, low serum zinc level could cause hyporesponsivity to erythropoiesis-stimulating agents and lead to anemia. This study investigated the effects of oral zinc supplements on the required dose of erythropoietin in patients undergoing HD. Materials and Methods: In a double-blinded randomized trial, 76 HD patients were assigned to 2 groups of 38. One group (intervention) was treated with oral zinc supplements of 210 mg, daily for 6 months, and the other group (control) used placebo capsules for 6 months. The serum zinc level, hemoglobin level, and required dose of erythropoietin, albumin, ferritin, ferrous, and total iron-binding capacity were evaluated 3 and 6 months after intervention. Results: Repeated measures ANOVA did not show a significant increase in Hb level after 6 months of intervention (P = 0.28). However, the required dose of erythropoietin was decreased, but the changes were not statistically significant (P > 0.05). The changes in the other variables were not statistically significant. Conclusion: Oral zinc supplementation in HD patients could not increase hemoglobin level irrespective of their serum zinc level.

Effect of oral magnesium supplement on cardiometabolic markers in people with prediabetes: a double blind randomized controlled clinical trial.

To evaluate the effect of magnesium supplementation on insulin resistance and cardiovascular markers in people with prediabetes. A 12 week double-blind placebo-controlled randomized clinical trial was conducted at Isfahan Endocrine and Metabolism Research Center, Iran, on people with prediabetes (n = 86) to compare the effects of magnesium oxide 250 mg/day versus a placebo on anthropometric indices, blood pressure, fasting glucose, insulin, HOMA-IR index, C-reactive protein, uric acid and lipid profile. Both groups had similar distributions of anthropometric and biochemical variables at baseline. Those who received magnesium supplementation had significantly higher levels of HDL-cholesterol compared to the placebo group at the end of the study (49.7 ± 10.9 vs 43.6 ± 7.2 mg/dL, P = 0.003). The mean changes of HOMA-IR index, total cholesterol, LDL-cholesterol, triglyceride, uric acid and C-reactive protein levels as well as anthropometric indices and blood pressure in supplemented and placebo groups did not differ significantly. Magnesium supplementation increased HDL-cholesterol levels in people with prediabetes. However, other cardiometabolic markers were not improved by magnesium supplementation at the above dosage and duration.

Novel Drug Design for Treatment of COVID-19: A Systematic Review of Preclinical Studies.

Background: Since the beginning of the novel coronavirus (SARS-CoV-2) disease outbreak, there has been an increasing interest in discovering potential therapeutic agents for this disease. In this regard, we conducted a systematic review through an overview of drug development (in silico, in vitro, and in vivo) for treating COVID-19. Methods: A systematic search was carried out in major databases including PubMed, Web of Science, Scopus, EMBASE, and Google Scholar from December 2019 to March 2021. A combination of the following terms was used: coronavirus, COVID-19, SARS-CoV-2, drug design, drug development, In silico, In vitro, and In vivo. A narrative synthesis was performed as a qualitative method for the data synthesis of each outcome measure. Results: A total of 2168 articles were identified through searching databases. Finally, 315 studies (266 in silico, 34 in vitro, and 15 in vivo) were included. In studies with in silico approach, 98 article study repurposed drug and 91 studies evaluated herbal medicine on COVID-19. Among 260 drugs repurposed by the computational method, the best results were observed with saquinavir (n = 9), ritonavir (n = 8), and lopinavir (n = 6). Main protease (n = 154) following spike glycoprotein (n = 62) and other nonstructural protein of virus (n = 45) was among the most studied targets. Doxycycline, chlorpromazine, azithromycin, heparin, bepridil, and glycyrrhizic acid showed both in silico and in vitro inhibitory effects against SARS-CoV-2. Conclusion: The preclinical studies of novel drug design for COVID-19 focused on main protease and spike glycoprotein as targets for antiviral development. From evaluated structures, saquinavir, ritonavir, eucalyptus, Tinospora cordifolia, aloe, green tea, curcumin, pyrazole, and triazole derivatives in in silico studies and doxycycline, chlorpromazine, and heparin from in vitro and human monoclonal antibodies from in vivo studies showed promised results regarding efficacy. It seems that due to the nature of COVID-19 disease, finding some drugs with multitarget antiviral actions and anti-inflammatory potential is valuable and some herbal medicines have this potential.

The effects of l-Carnitine supplementation on inflammatory markers, clinical status, and 28 days mortality in critically ill patients: A double-blind, randomized, placebo-controlled trial.

AIM: Critical ill patients experience catabolic stress, which results in a systemic inflammatory response. The inflammatory response is associated with increased complications, including infection, multi-organ dysfunction, increased length of ICU stays, and mortality. l-Carnitine supplementation may play an important role in these patients by regulating inflammatory cell function. The purpose of the present study was to investigate the effect of l-Carnitine supplementation on clinical status, inflammatory markers, and mortality rate in critically ill patients admitted to the intensive care unit (ICU). METHODS: This randomized, double-blind, placebo-controlled trial was performed on critically ill patients. Subjects were randomly assigned into placebo (n = 27) and l-Carnitine (n = 27) groups. l-Carnitine (3000 mg/day) was administered via nasogastric tube for the intervention group for 7 days, while the other group received a placebo for the same duration. Serum levels of inflammatory markers, including C-reactive protein (CRP) and interleukin-6 (IL-6) were measured. Nutritional status and the acute physiology and chronic health evaluation (APACHE) score, sequential organ failure assessment (SOFA) score, and 28-day mortality were also recorded. RESULTS: Fifty-one critically ill patients completed the study. l-Carnitine supplementation significantly reduced the levels of CRP (mean change ± SE: -34.9 ± 6.5) and IL-6 (mean change ± SE: -10.64 ± 2.16) compared to the baseline, which is both statistically significant compared with the control group (p < 0.05). The SOFA and APACHE scores were significantly reduced in the l-Carnitine group compared with the placebo group (p = 0.02 and p < 0.001, respectively). CONCLUSIONS: l-Carnitine supplementation showed beneficial effects on inflammatory and clinical outcomes of critically ill patients. TRIAL REGISTRATION DETAILS: Trial registration: IRCT, Registered 30 May 2018, https://www.irct.ir/trial/30748.

The effect of garlic (Allium sativum) supplementation on the lipid parameters and blood pressure levels in women with polycystic ovary syndrome: A randomized controlled trial.

Polycystic ovary syndrome (PCOS) is the most prevalent female endocrine-related disorder in reproductive ages. The aim of the study was to investigate the effect of garlic on the lipid parameters and blood pressure levels in women with PCOS. The present study was a randomized, double-blinded control trial, conducted on 80 PCOS patients. Participants were taught to intake either a total 800 mg/day garlic supplement or an identical placebo (starch) after lunch for 8 weeks. Physical activity, diet intake, anthropometric measures, and blood pressure were evaluated at baseline and end of the study. The blood sample was also taken to assess the change in outcomes of interest at the pre- and post-intervention. Garlic supplementation significantly reduced serum total cholesterol (change mean difference: -8.05, 95% CI: -15.47, -0.62) and LDL-C (change mean difference: -7.67, 95%CI: -14.64, -0.70) levels in comparison to the control group. In addition, a trend to a significant decrease was found in serum triglyceride levels and Systolic blood pressure; however, no significant difference was observed between two groups in HDL-C and diastolic blood pressure levels. The present study suggested that garlic supplementation might be effective on lipid markers improvement. Further studies are needed to confirm our findings.

The Illness Belief Network Questionnaire: Development and Evaluation of a Psychosomatic Assessment Tool.

Objective: Patients' beliefs and emotions toward an illness can influence their coping responses, illness behaviors, adherence to treatment, quality of life, and even the psychoneuroimmune responses. The aim of present study was to develop and validate a novel questionnaire assessing both rational and irrational beliefs of patients regarding their illness. Method : In a cross sectional methodological study, the items of the Illness Belief Network (IBN) were developed regarding patients and clients' opinions about and attribution of their disease extracted from 400 clinical interviews and were coded based on Leventhal's self-regulation model. An expert panel coded the items. A total of 400 patients with different medical conditions completed the questionnaire. Participants additionally rated the Illness Perceptions Questionnaire in its revised form (IPQ-R) to assess convergent validity. Construct validity was examined by conducting exploratory and confirmatory factor analysis. The Cronbach alpha and Intracluster Correlation Coefficient (ICC) were used for examining Internal consistency and test-retest reliability of the IBN. Results: The IBN questionnaire was finalized with 84 items, and the results of factor analysis revealed 5 factors: psychosocial causes, environmental causes, control, meaning, and consequence/timeline; extracted factors were confirmed by confirmatory factor analysis. Cronbach's α coefficient for scale was 0.92 and it ranged from 0.79 to 0.89 for the subscales. IBN indicated excellent test-retest reliability results based on ICC 0.842(95%CI: 0.798-0.846). The correlation coefficients of all items exceeded the prespecified acceptable value of 0.40, indicating satisfactory item discriminant validity, and correlation between IBN and IPQ-R subscales were statistically significant (all p values < 0.01), indicating acceptable convergent validity. Conclusion: The IBN questionnaire is a valid and reliable phenomenological, non-judging, and clinical tool to assess patient's rational and irrational or faith-based beliefs about the illness. This tool can be used to improve doctor-patient communication by exploring the complex nature of human thinking.

Effect of curcumin-pipeine supplementation on clinical status, mortality rate, oxidative stress, and inflammatory markers in critically ill ICU patients with COVID-19: a structured summary of a study protocol for a randomized controlled trial.

OBJECTIVES: This study aims to investigate the efficacy of curcumin-piperine co-supplementation on oxidative stress factors, clinical symptoms, and mortality rate in patients with coronavirus (COVID-19) admitted to the intensive care unit (ICU). TRIAL DESIGN: This study is a randomized, placebo-controlled, double-blind, parallel-arm clinical trial. PARTICIPANTS: The study participants will be recruited from patients admitted to the ICU of Al-Zahra hospital with a definitive diagnosis of COVID-19. The inclusion criteria are aged between 20 and 75 years, confirmation of COVID-19 based on the PCR test, and admitted to the ICU. The exclusion criteria include the present use of parenteral nutrition support, a history of underlying diseases such as congenital disorders, immune diseases, renal and hepatic insufficiency, and pancreatitis, a history of sensitivity to herbal remedies such as turmeric and pepper, and regular use of anticoagulant drugs such as warfarin. This study will be performed in the Al-Zahra hospital, an academic hospital affiliated with Isfahan University of Medical Sciences, Isfahan, Iran. INTERVENTION AND COMPARATOR: Sixty eligible patients will be randomly assigned, in a 1:1 ratio, to receive curcumin-piperine capsules (three capsules/day; each capsules containing 500 mg curcumin plus 5 mg piperine; in total 1500 mg curcumin and 15 mg piperine/daily) for seven days (n=30) or matching placebo capsules (three capsules/day; each capsules containing 505 mg maltodextrin; totally 1515 mg, maltodextrin/ daily) for same duration (n=30). Capsules will be administered after oral or enteral feeding at 9, 15 and 21 o'clock. MAIN OUTCOMES: The primary outcome is the time from initiation of supplementation (curcumin-piperine or placebo) to normalization of fever, respiratory rate, and blood oxygen saturation. The secondary outcomes are the mortality rate, length of stay in ICU, temperature, levels of blood oxygen saturation, ventilator dependency, respiratory rate, levels of C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), levels of liver markers (ALT, AST, LDH), and levels of kidney function markers (BUN, Creatinine). FOLLOW UP: All of the parameters will be assessed at baseline and end of the study (7 days intervention). In addition, the rate of mortality will be collected after 4 weeks (28 days' mortality in the ICU, 4 weeks follow up). RANDOMISATION: Eligible patients will be randomly assigned to either the intervention group (Curcumin-piperine) or the control group (Placebo). Randomization sequences will be generated using an electronic table of random numbers to allocate the included participants into either control or intervention groups (in a 1:1 ratio) using the stratified block randomization method. Stratification was conducted according to sex (male and female), with a block size of four. The allocation sequences will be prepared by an independent statistician and will be kept inside sealed, opaque, and consecutively numbered envelopes. Participants, investigators, nurses, and physicians will be unaware of the trial-group assignment. BLINDING (MASKING): This study is a double-blind clinical trial (participants, investigators, nurses, and physicians). The curcumin-piperine and placebo supplements will be similar in the terms of texture, taste, color, odor, and weight. Both tablets will be provided in containers that are completely identical in weight, shape, labeling, and packaging. All participants, investigators, nurses, and physicians will be unaware of the trial-group assignment. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): The sample size is estimated at 60 participants, including 30 patients in the intervention group and 30 patients in the placebo group. TRIAL STATUS: The protocol is Version 2, registered on May 13, 2021. Recruitment began May 20, 2021, and is anticipated to be completed by September 20, 2021. TRIAL REGISTRATION: This trial has been registered in Iranian Registry of Clinical Trials (IRCT) with the title of "Evaluation of the effect of curcumin-piperine supplementation in patients with coronavirus admitted to the intensive care unit (ICU): a double-blind clinical trial study". IRCT registration number is IRCT20121216011763N52 . The registration date was May 13, 2021. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (File 1). In the interest of expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

The effects of spirulina (Arthrospira platensis) supplementation on anthropometric indices, blood pressure, sleep quality, mental health, fatigue status and quality of life in patients with ulcerative colitis: A randomised, double-blinded, placebo-controlled trial.

BACKGROUND: An emerging body of evidence has highlighted the protective role of spirulina in human health. Thus, we conducted a randomised controlled trial to discern the effects of spirulina supplementation on anthropometric indices, blood pressure, sleep quality, mood, fatigue status and quality of life among ulcerative colitis patients. METHODS: Eighty participants with ulcerative colitis were randomly allocated to receive, either, 1 g/day (two 500 mg capsules) spirulina (n = 40) or placebo (n = 40), in a clinical trial for eight weeks. Dietary intake, physical activity, sleep quality, mental health, fatigue status and quality of life were assessed for each participant at baseline and trial cessation. Anthropometric indices and blood pressure were also assessed. RESULTS: Seventy-three participants completed the intervention. Our results revealed that spirulina supplementation significantly reduced sleep disturbances (P = .03), while no significant changes occurred in the sleep quality score or other sleep parameters, vs the placebo group (P > .05). Furthermore, a significant reduction in stress score (P = .04) and increase in quality of life (P = .03) was detected; but not anxiety, depression or fatigue scores (P > .05). Additionally, anthropometric indices and blood pressure did not significantly change (P > .05). CONCLUSION: An improved quality of life was observed among ulcerative colitis patients following spirulina supplementation, which could be attributed to improved sleep disturbance and stress status. Further clinical studies, with longer duration interventions and suitably powered sample sizes, are necessary to elucidate the veracity of our findings.

Efficacy of Sesame (Sesamum indicum L.) in the Management of Incomplete Abortion: An Open-Label Randomized Controlled Clinical Trial.

BACKGROUND: Incomplete abortion is a common complication of pregnancy. Sesamum indicum L. is a widely used emmenagogue herb. OBJECTIVES: We designed a clinical trial to evaluate the efficacy of sesame for the removal of retained products of conception (RPOC). METHODS: In this randomized, open-label, and controlled trial, 45 patients received sesame powder as an intervention group and 45 patients received expectant management as a control group for 5 days. The primary outcome measure was complete resolution of RPOC assessed by sonography. Secondary outcome measures were severity of patients' vaginal bleeding and pain. RESULTS: 84.1% had complete resolution of RPOC in the sesame group, while 26.2% had complete resolution of RPOC in the control group, which was statistically significant (p < 0.001). Moreover, patients in the sesame group showed a significantly more decreasing trend in pain and vaginal bleeding compared to the control group (p < 0.001). CONCLUSION: Sesame had a significant effect on the removal of RPOC and the reduction of pain and vaginal bleeding.

The antidepressant effects of lavender (Lavandula angustifolia Mill.): A systematic review and meta-analysis of randomized controlled clinical trials.

BACKGROUND AND AIMS: Antidepressant drugs are accompanied with high rate of adverse effects. Lavender is one of the most common herbal drugs mentioned in Traditional Persian literature with potential efficacy on mental disorders and less serious side effects. Thus, the aim of this study was to determine the efficacy of lavender on depression severity by preforming a systematic review and meta-analysis. METHODS: Databases including PubMed, Scopus, Cochrane library, Embase and Web of science were searched for relevant articles till December 2020. Quality of studies were evaluated by Jadad scale and the Cochrane collaboration tool. Depression as endpoint measure or as a subscale of any valid assessment tool was subjected to quantitative data analyses. Both fixed and random effects meta-analysis were conducted for data synthesis. RESULTS: Out of 342 screened studies, 17 articles were included in the meta-analysis. Results showed significant efficacy of lavender in decreasing depression scores compared to the control group (pooled Standardized Mean Difference (SMD)= -0.66, 95 % CI: -0.85 to -0.46;P < 0.001, I2 = 68.2 %;). Subgroup analysis proved that the effect of lavender was marginally more pronounced in participants with diagnosed depression (pooled SMD= -0.62, 95 % CI: -1.26 to 0.01, P = 0.055; I2 = 88.1 %) while its effect was statistically significant in patients having other diseases with concomitant depressive symptoms (pooled SMD= -0.65, 95 % CI: -1.84 to -0.46, P < 0.001; I2 = 52.1 %), and the oral route (pooled SMD= -0.56, 95 % CI: -1.07 to -0.05, P = 0.032; I2 = 85.2 %;) was the most effective route of administration. CONCLUSIONS: This systematic review and meta-analysis concluded that lavender has significant antidepressant effects. However, due to some limitations, further large clinical trials are recommended with more homogeneous populations and rigorous designs.

Association of Maternal Dietary Components During Pregnancy and/or Lactation with Insulin-Dependent Diabetes Mellitus.

CONTEXT: Considering the increasing trend in the incidence of type 1 diabetes mellitus (T1DM), the identification of its environmental determinants, especially those related to the prenatal and lactation period, might ultimately result in primary prevention of the disease. We aimed to review the evidence of the association between mothers' dietary components during pregnancy and/or lactation with T1DM. EVIDENCE ACQUISITION: An electronic and comprehensive literature search was performed until August 2019 in the international databases, including Web of Science (ISI), PubMed, and Scopus, using the following keywords: type 1 diabetes mellitus, autoimmunity, mother, maternal, diet and lactation in different combinations. Papers related to the objectives of the study were selected. RESULTS: Based on our review, the maternal consumption of meat, especially processed meat, was associated with increased risk of T1DM, whereas the maternal use of vegetables, potato, low-fat margarine, and berries showed protective effects against the development of T1DM in offspring. There was no significant association between the use of multivitamins and mineral supplements with T1DM, according to the available data. The results of the reviewed studies regarding the association between the maternal use of vitamin D, fatty acids, and coffee during pregnancy with T1DM were not consistent and conclusive. CONCLUSIONS: Findings of this review indicate that the maternal consumption of some foods is associated with increased or decreased risk of T1DM. However, for some foods or dietary components, including coffee, vitamin D, and fatty acids, the results are not conclusive. We conclude that although maternal diet could influence the development of insulin autoantibodies (IA) and T1DM in offspring, there is no sufficient evidence for most nutrients, and available data are controversial, which should be dealt with in future cohort or interventional studies.

The Effectiveness of Acceptance and Commitment Therapy on Quality of Life in a Patient with Myocardial Infarction: A Randomized Control Trial.

Objective: Acceptance and commitment therapy (ACT) interventions increase psychological flexibility and improve mental health and quality of life in patients with myocardial infarction. Study design: A controlled clinical trial study was conducted to evaluate the efficacy of an ACT intervention in improving the quality of life in patients with MI in Isfahan, Iran. Method : The present controlled clinical trial with a pre and post-test design was conducted on a statistical population consisting of patients with MI admitted to hospitals in Isfahan (n = 60) who were selected through sequential sampling based on the study inclusion criteria and were randomly divided into an intervention and a control group (n1 = n2 = 30). The case group received 8 weekly 90-minute sessions of ACT and the control group received no interventions. The pretest-posttest design was administered in both groups using a demographic questionnaire and the Minnesota Living with Heart Failure Questionnaire (MLHFQ) designed to assess the health status of patients with heart failure in terms of quality of life. The data obtained were analyzed in SPSS-20 using descriptive statistics and the ANCOVA. Results: In this study, 2 general areas of quality of life, including physical and mental health, were examined in the patients. There was a significant increase in the quality of life and subscales of mental and physical health in the experimental group (p < 0.001). Conclusion: Considering the effectiveness of ACT in improving quality of life in these patients, this method of intervention can be used as a complementary therapy in health care centers to reduce the side-effects experienced by these patients.

Effects of synbiotic supplementation on microbiota-derived protein-bound uremic toxins, systemic inflammation, and biochemical parameters in patients on hemodialysis: A double-blind, placebo-controlled, randomized clinical trial.

OBJECTIVES: The generation of key nephrovascular protein-bound uremic toxins, indoxyl sulfate and phenol, in hemodialysis (HD) patients is attributed to the dysbiotic gut microbiota. The aim of this study was to investigate the effects of synbiotic supplementation on serum levels of indoxyl sulfate, phenol, inflammation, and biochemical parameters in HD patients. METHODS: Forty-two HD patients (synbiotic group: n = 21; placebo group: n = 21) were analyzed in this randomized, double-blind, placebo-controlled study. During a 2-mo intervention, the synbiotic group received two synbiotic capsules daily, between the main meals, whereas the placebo group received maltodextrin as the placebo. Blood pressure, uremic factors, and biochemical parameters were assessed before the start and after the end of the study. RESULTS: After adjustment for potential confounders, there was no significant effect of synbiotic on serum levels of urea, creatinine, liver enzymes, high-sensitivity C-reactive protein, sodium, potassium, phosphorus, blood pressure, or albumin in the treatment group compared with the placebo group. A significant increase in indoxyl sulfate and parathyroid hormone levels were observed only in the treatment group. However, between-group analyses were not significant. Compared with baseline values, phenol levels were decreased in both groups (P≤001), with no significant between-group difference. CONCLUSIONS: Synbiotic supplementation might increase indoxyl sulfate and parathyroid hormone levels in HD patients.

The Effect of Omega-3 Supplementation on Serum Levels of Inflammatory Biomarkers and Albumin in Hemodialysis Patients: A Systematic Review and Meta-analysis.

This systematic review and meta-analysis were performed to evaluate the effect of omega-3 supplementation on serum levels of inflammatory biomarkers (C-reactive protein [CRP], high-sensitivity CRP [hs-CRP], tumor necrosis factor-alpha, interleukin-6) and albumin in patients on hemodialysis. A literature search was performed in MEDLINE, Cochrane Central Register of Controlled Trials, PubMed, EMBASE, Web of Science, and Google Scholar. Randomized controlled trials that evaluated the effect of omega-3 supplementation versus placebo were selected. Eight randomized controlled trials comprising 371 patients on hemodialysis were included. According to our results, omega-3 supplementation significantly decreased serum levels of CRP (standardized mean difference [SMD]: -1.95 mg/Dl; 95% confidence interval [CI]: -3.09, -0.80) and hs-CRP (SMD: -2.09; 95% CI: -3.62, -0.56) but did not significantly improve albumin (SMD: 0.91; 95% CI: -0.78, 2.59), tumor necrosis factor-alpha (SMD: -1.51; 95% CI: -3.24, 0.22), and interleukin-6 (SMD: 0.72, 95% CI: -0.56, 1.99). We concluded that omega-3 supplementation leads to a significant decrease in serum levels of CRP and hs-CRP.