The effect of ursodeoxycholic acid on indirect hyperbilirubinemia in neonates treated with phototherapy: a randomized clinical trial.

OBJECTIVES: Indirect hyperbilirubinemia during neonatal period is a common problem, and most preterm and more than half of the term neonates find this problem. Ursodeoxycholic acid (UDCA) protects the liver against oxidative stresses and prevents cellular apoptosis. In addition, it causes stimulation of bile flow, is well tolerated by the patient, and has limited side effects. Thus, the aim of this study was to investigate the effect of UDCA in treating neonates with unconjugated hyperbilirubinemia undergoing phototherapy. METHODS: In this randomized clinical trial, 220 neonates with unconjugated hyperbilirubinemia who referred to Amir-Kabir Hospital, Arak, Iran in 2017-2018, were randomly assigned to phototherapy group (Control group) and phototherapy plus UDCA group (Intervention group) as 10 mg/kg/day. The level of total bilirubin was measured at the baseline, and after 12, and 24 h using spectrophotometric, and the duration of receiving phototherapy was also measured in both groups. RESULTS: The mean age of included neonates in the control and intervention group was 5.3 and 4.9 days, respectively. The results revealed that after 12 h of treatment, the total bilirubin level in the control group had diminished by 2.70 mg/dL on average while, in the intervention group, the reduction was 3.7 md/dL (p = .001) and after 24 h of treatment, the total bilirubin level in the control group had diminished by 5.22 mg/dL on average and in the intervention group, the reduction was 6.54 md/dL (p = .001). It was also observed that there is no significant difference between groups in terms of the mean of the duration required for phototherapy (p = .63). CONCLUSIONS: UDCA combined with phototherapy enhances TSB decrease, but this effect is not relevant from a clinical point of view because it does not decrease phototherapy and hospital stay duration. Thus, this study does not support the UDCA use in the clinical practice. TRIAL REGISTRATION: IRCT, IRCT2017071515511N2. Registered 21 Aug 2017 - Retrospectively registered, https://en.irct.ir/trial/14763.

Comparison of the effect of ferrous sulfate and ferrous gluconate on prophylaxis of iron deficiency in toddlers 6-24 months old: A randomized clinical trial.

BACKGROUND: Iron deficiency anemia (IDA) is one of the most common anemias, especially in children 4-23 months. Therefore, prophylaxis is necessary to improve iron status as well as reduce IDA in Toddlers. The aim of this study was to compare the efficacy of daily supplementation with ferrous gluconate (FG) and ferrous sulfate (FS) on iron status in toddlers. MATERIALS AND METHODS: A total of 120 healthy toddlers were divided randomly into 2 groups at the Amir-Kabir Hospital, Arak, Iran and received FS and FG from March 2020 to December 2020. Iron status was evaluated at baseline and after 6 months of supplementation. The statistical significance of the differences in iron status between FS and FG groups was calculated using Student's t-test and the Pearson' s Chi-square test for qualitative variables. SPSS software (version 16, Chicago, IL, USA) was used for statistical analysis. RESULTS: Comparison of iron status of FS and FG groups toddlers at baseline and after 6 months of supplementation showed that there was a significant difference in hemoglobin (Hb) (10.46 vs. 12.45, P = 0.001) and ferritin level (28.08 vs. 59.63, P = 0.001). CONCLUSIONS: Although prophylaxis with FG led to a higher Hb and ferritin levels, our study recommended that both FG and FS supplements were effective for prophylactic use in the prevention of IDA. However, FG was more effective than FS because FG group that received FG supplementation indicated a higher Hb and ferritin levels in comparison to the FS group that received FS supplementation.

Effects of Helichrysum Psudoplicatum supplementation on pruritus intensity, fatigue, quality of life and anorexia in hemodialysis patients: a randomized, double-blind placebo-controlled trial.

OBJECTIVES: Anorexia, fatigue and pruritus are common complications of hemodialysis (HD) patients. Today, the use of medicinal plants is more than synthetic drugs due to their safety. Therefore, we designed a randomized controlled clinical trial to evaluate the effects of Helichrysum psudoplicatum (H. psudoplicatum) supplementation on biochemical parameters, pruritus intensity, fatigue, quality of life and anorexia in HD patients. METHODS: This randomized, double-blind, placebo-controlled trial was performed on 50 subjects with, aged 55-65 years old. HD patients were randomly divided into two groups. Intervention group received 250 mg/day of H. psudoplicatum supplement capsule for 6 weeks (n=25), and the placebo group was given placebo capsule for the same time duration and dosage (n=25). The serum concentrations of urea, creatinine, albumin and hemoglobin were measured enzymatically methods. Anorexia, pruritus intensity, quality of life the dialysis patients with pruritus and fatigue score was measured using a Simplified Nutritional Appetite Questionnaire (SNAQ), Numerical rating scale (NRS), Fatigue severity scale (FSS) and ItchyQoL questionnaire, respectively. Shapiro-Wilk and independent-samples t-test or Mann-Whitney test were used for the analysis of the data. RESULTS: The results showed that the H. psudoplicatum supplementation significantly improved the pruritus intensity, quality of life the dialysis patients with pruritus and fatigue in HD patients, for 6 weeks (p<0.001). However, it did not significantly effect on the anorexia, albumin, hemoglobin, urea, creatinine, arm circumference, and body mass index (p>0.05). CONCLUSIONS: According to the results of this study, H. psudoplicatum supplementation can be effective as an adjunct therapy to improve pruritus intensity, quality of life, fatigue and relative improvement of anorexia in HD patients.

The Effect of a Persian Herbal Medicine Compound on the Lipid Profiles of Patients with Dyslipidemia: A Randomized Double-Blind Placebo-Controlled Clinical Trial.

INTRODUCTION: It has been well established in the world that lipid disorders promote the development of atherosclerosis and its clinical consequences. This study aimed to assess the impacts of a Persian medicinal (PM) compound on lipid profile. MATERIALS AND METHODS: From June 21 to October 21, 2020, a randomized double-blind controlled clinical trial was conducted with 74 dyslipidemic patients, who were randomly divided into two equally populated groups: one prescribed with a Persian medicinal herbal compound (n = 37) and a placebo group (n = 37). A Persian herbal medicine including fenugreek, sumac, and purslane is introduced. Biochemical parameters including 12-hour fasting serum levels of total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), very-low-density lipoprotein (VLDL), and triglyceride (TG) were measured before the initiation and after the completion of study protocol. RESULTS: Percent changes of biochemical parameters include the following: intervention group = cholesterol: 35.22, Tg: 45.91, LDL: 24.81, HDL: 2.05, VLDL: 8.94 and placebo group = cholesterol: 6.94, Tg: -7.3, LDL: 7.37, HDL: 2.88, VLDL: -0.14. The serum levels of total cholesterol (p=0.01) and LDL (p=0.01) significantly decreased and no increase was recorded in HDL (p=0.03) levels over time in the intervention group. Furthermore, between-group analysis showed a statistically significant difference between the intervention and placebo groups in this regard. VLDL (p=0.2) and TG (p=0.2) levels also decreased, however not significantly. CONCLUSION: This study showed that a Persian medicinal herbal compound could be safe and beneficial to decrease the levels of serum cholesterol and LDL in dyslipidemic patients. However, larger long-term studies are recommended to clarify this effect.

Effects of Artemisia supplementation on anorexia in hemodialysis patients: a randomized, double-blind placebo-controlled trial.

OBJECTIVES: One of the most important problems of hemodialysis (HD) patients is anorexia due to the lack of proper treatment for it and on the other hand kidney disease is increasing. We designed a randomized controlled clinical trial to investigate the effects of Artemisia supplementation on anorexia in HD patients. MATERIALS AND METHODS: This randomized, double-blind, placebo-controlled trial was carried out on 58 subjects with HD, aged 55-65 years old. Participants were randomly divided into two groups. One group received 250 mg/day of Artemisia supplement capsule for six weeks (n=26), and the other group was given placebo for the same time duration and dosage (n=32). The serum concentrations of urea, creatinine, albumin and hemoglobin were measured enzymatically using commercial kits. Anorexia score was measured using a Simplified Nutritional Appetite Questionnaire (SNAQ). Independent t-test analysis were applied to evaluate the data. RESULTS: The results showed that the Artemisia supplementation significantly improved the anorexia in HD patients, for six weeks (p<0.05). However, it did not significantly effect on the albumin, hemoglobin, urea, creatinine, arm circumference, and body mass index (p>0.05). CONCLUSION: According to the outcomes of this study, Artemisia supplementation can be effective as an adjunct therapy for improve anorexia in HD patients.

Effect of omega-3 fatty acid plus vitamin E Co-Supplementation on lipid profile: A systematic review and meta-analysis.

BACKGROUND: Dyslipidemia is linked to chronic inflammation, which in return leads to a set of chronic disorders. Omega-3 fatty acids have been reported to reduce inflammation. Furthermore, Vitamin E is a fat-soluble vitamin which has antioxidant and anti-inflammatory effects. Vitamin E and omega-3 fatty acids co-supplementations may be more effective than the single supplementation in control dyslipidemia. Therefore, we designed and conducted the current systematic review and meta-analysis to investigate the effect of co-supplementation of vitamin E and omega-3 fatty acids on the lipid profile. METHODS: A comprehensive search for studies published between January 1990 and July 2018 was performed. The initial search extracted 3015 potentially relevant articles. After studying these publications, 9 RCTs were potentially eligible and retrieved in full text. RESULTS: The meta-analysis indicate that on total cholesterol, HDL, LDL and triglyceride individually did not show any significant difference between intervention and control groups, but vitamin E an omega-3 fatty acids co-supplementations significantly reduce VLDL levels. CONCLUSIONS: Based on the available evidence, omega-3 fatty acid and vitamin E co-supplementation can reduce VLDL, although its effect on other lipid profile parameters requires more well-designed studies.

The effect of vitamin D supplementation on oxidative stress parameters: A systematic review and meta-analysis of clinical trials.

Recent studies have shown that vitamin D supplementation beneficially decreases oxidative stress (OS) parameters; however, there is no consensus on this subject. In this systematic review and meta-analysis we aimed to investigate the effect of vitamin D supplementation on OS parameters. We searched electronic databases including Medline, Embase, Scopus, Web of Science and Cochrane Library up to July 2018 without any language restriction. Trials were reviewed using preferred reporting items for systematic reviews and meta-analyses (PRISMA) and Cochrane handbook. To compare the effects of vitamin D with placebo, standardized mean difference (SMD) with 95% confidence intervals (CI) were pooled using random effects model. Across thirteen clinical trials, we found that vitamin D supplementation increased serum levels of total antioxidant capacity (TAC) (SMD: 0.54 mmol/L, 95% CI: 0.29 to 0.79; I2 = 65.4%, P = 0.001) and glutathione (GSH) (SMD: 0.33; 95% CI: 0.11 to 0.54, P = 0.003; I2 = 61.2%, P = 0.001). Besides, malondialdehyde (MDA) concentration decreased significantly (SMD: -0.40 mmol/L, 95% CI: -0.60 to -0.21, P < 0.001) following vitamin D supplementation compared to placebo. However, its effects on nitric oxide (NO) was not significant (0.17, 95% CI: -0.10 to 0.45, I2 = 71.1%, P = 0.21). Finally, we showed that vitamin D supplementation can improve OS parameters; however, this finding may not be clinically significant. Further large prospective clinical trials are needed to confirm the effect of vitamin D supplement on other OS parameters.

Assessing staff-oriented care with developmental support approach in Iranian NICUs.

BACKGROUND: Regarding improvements in preterm infants' survival rates, it is necessary the improvement of Neonatal Intensive Care Unit (NICUs) status in order to provide comprehensive care. The aim of this study was to assess the aspects of staffing-oriented neonatal care in NICUs affiliated to Universities of Medical Sciences in Iran. METHODS: This survey is a cross-sectional study which was conducted in 23 NICUs of nine type-1 Universities of Medical Sciences across country. The study checklist contained 39 items in four domains, including "Composition, Philosophy, Training, and Support", "Management", "Resources", and "Transition Systems". Data were gathered through observation and analyzed using Stata software, version 13. RESULTS: In this study, the mean score of staffing-oriented care was 43.5 of 100. In none of the studied domains, the mean score obtained was not above 50. Among the four domains studied, the highest score was related to "Management", (the mean score of 50 of 100) and the lowest score related to "Resources" (the mean score of 35 of 100). CONCLUSIONS: Considering the importance of the role of health professionals in the neonatal comprehensive care, and also the low mean score of staffing-oriented care (43.51 out of 100) and also its items in NICUs in this study, it is concluded that more attention is needed for staff-oriented care as well as the strengthening of this dimension of developmental care along with other dimensions, through designing of appropriate interventions to improve the health outcomes of preterm infants.