The effect of propolis supplementation on cardiovascular risk factors in women with rheumatoid arthritis: A double-blind, placebo, controlled randomized clinical trial.

Propolis has gained popularity in recent years because of its beneficial properties, which make it a possible preventative and therapeutic agent as well as a valuable food and cosmetic ingredient. The objective of this study was to evaluate the effects of propolis supplementation on cardiovascular risk factors in women with rheumatoid arthritis. This randomized, double-blind, placebo-controlled clinical trial was performed among 48 patients diagnosed with rheumatoid arthritis. Subjects were randomly assigned to placebo and intervention groups, supplemented with 1000 mg/day of propolis for 12 weeks. Cardiovascular risk factors including, high-sensitivity C-reactive protein (hs-CRP), monocyte chemoattractant protein (MCP-1), Nitric oxide, blood pressure, and lipid profile were assessed pre-and post-intervention. The atherogenic index of plasma value, as well as total cholesterol/high-density lipoprotein cholesterol (HDL-C), triglyceride/HDL-C, and non-HDL-C/HDL-C ratios, were significantly reduced in the intervention group, compared with the placebo group post-intervention (p < 0.05). Moreover, there was a significant reduction in the serum level of hs-CRP in the intervention group when compared with the placebo group (p = 0.001). Furthermore, propolis supplementation could marginally reduce MCP-1 (p = 0.051). These data indicate that propolis supplementation may be a promising treatment strategy for cardiovascular complications among rheumatoid arthritis patients.

Effect of beetroot or beetroot plus vitamin C supplementation on cardiovascular function in patients with coronary artery disease: protocol for a double-blind, placebo-controlled, randomised trial.

INTRODUCTION: Coronary artery disease (CAD), classified into the atherosclerosis category, is a prevalent cardiovascular disease worldwide that is associated with serious comorbidities and death. The purpose of this study was to evaluate the effect of beetroot/beetroot plus vitamin C on cardiovascular health status and function in patients with CAD. METHOD AND ANALYSIS: A randomised, placebo-controlled, double-blind clinical trial to recruit 90 patients with CAD at the cardiac outpatient clinic and Imam Reza Hospital, Mashhad, Iran. Participants will be divided into three groups: (1) Those who receive 500 mg three times a day of beetroot capsules, (2) Those who receive 500 mg three times a day of beetroot plus vitamin C capsules, and (3) Those who receive placebo capsules three times a day for 4 weeks. Pulse wave velocity, Augmentation Index, heart rate, volume of oxygen (VO2) max/VO2 peak, peak heart rate, blood pressure, interleukin 6 (IL-6), high sensitivity C reactive protein, intercellular adhesion molecule, vascular cell adhesion molecule, lipid profile and anthropometry will be measured at the beginning and end of the intervention. ETHICS AND DISSEMINATION: This study was approved by the Ethics Committee of Mashhad University of Medical Sciences (IR.MUMS.MEDICAL.REC.1399.717). All participants will be asked to complete the consent form at the beginning of the study. The results will be actively disseminated through peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: Iranian Registry of Clinical Trials, IRCT20210217050393N1 (registered 16 May 2021).

Effects of Melatonin and Propolis Supplementation on Inflammation, Oxidative Stress, and Clinical Outcomes in Patients with Primary Pneumosepsis: A Randomized Controlled Clinical Trial.

BACKGROUND AND OBJECTIVE: The present study aimed to investigate the effects of propolis and melatonin supplementation on inflammation, clinical outcomes, and oxidative stress markers in patients with primary pneumosepsis. MATERIALS AND METHODS: This pilot randomized controlled trial was conducted on 55 patients with primary pneumosepsis who were randomly assigned to the intervention and control groups. In the three intervention groups, the patients received propolis alone (1,000 mg/day), propolis (1,000 mg/day) plus melatonin (20 mg/day), and melatonin alone (20 mg/day). The control group received placebo. The inflammatory and oxidative stress markers as well as clinical outcomes were evaluated before and after the intervention, and the 28-day survival rate was also recorded. RESULTS: After the intervention, the combination of propolis and melatonin significantly reduced interleukin-6 (-55.282 pg/mL) and C-reactive protein (-21.656 mg/L) levels, while increasing gavage intake (326.680 mL/day) and improving some clinical outcomes (APACHE II, SOFA, and NUTRIC scores) compared to the control group. However, no significant difference was observed between the groups in terms of oxidative stress and hematological indices. In addition, there was no significant difference in the 28-day survival rate between the groups (p = 0.07). CONCLUSION: Supplementation with propolis and melatonin may improve clinical outcomes by reducing inflammation. Further investigations are required to confirm these findings.

Efficacy of high-dose versus low-dose vitamin D supplementation on serum levels of inflammatory factors and mortality rate in severe traumatic brain injury patients: study protocol for a randomized placebo-controlled trial.

BACKGROUND: Traumatic brain injury (TBI) is the most common trauma worldwide and is a leading cause of injury-related death and disability. Inflammation is initiated as a result of the TBI, which is in association with severity of illness and mortality in brain trauma patients, especially in subdural hemorrhage and epidural hemorrhage cases. A high percentage of adults admitted to the intensive care unit with TBI are diagnosed with vitamin D deficiency; this deficiency may induce impaired immune responses and increase the risk of infections. Vitamin D intervention has been shown to modulate pro- and anti-inflammatory cytokines in non-critically ill patients, but to date, there is no substantial data on the effectiveness of vitamin D for the improvement of immune function in traumatic brain injury patients. METHODS/DESIGN: A randomized clinical trial (RCT) will be performed on 74 Iranian adults 18-65 years old with brain trauma and will be treated daily with vitamin D supplements (100,000 IU oral drop) or a similar placebo (1000 IU) for 5 days. DISCUSSION: If this randomized clinical trial demonstrates reductions in inflammatory cytokines, it would provide evidence for a multicenter clinical trial to evaluate the efficacy of vitamin D supplementation in neurocritically ill patients. Since vitamin D supplements are inexpensive and safe, this clinical trial could have the potential to improve clinical outcomes in traumatic brain injury patients through reduction of inflammation and infection-associated morbidity and mortality rates. TRIAL REGISTRATION: Iranian Registry of Clinical Trials, IRCT20180619040151N3 . Registered on 10 August 2019.

The effect of face-to-face with telephone-based counseling on sexual satisfaction among reproductive aged women in Iran.

This study was designed to investigate and compare the effect of face-to-face with telephone-based counseling on sexual satisfaction in women of reproductive age in Iran. This study was a randomized controlled trial in which 46 married women who got married 1-5 years ago were randomly selected and assigned to 1 of 2 groups (face-to-face and telephone-based counseling). Two groups received counseling by a trained midwife once a week for 4 weeks. The sexual satisfaction (using the Sexual Satisfaction Index) score was calculated in the beginning of the study and after 4 weeks. An independent t test, chi-square test, likelihood ratio test, Fisher's exact test, and linear-by-linear test were used for analyzing data. The mean score of sexual satisfaction in the face-to-face group was 93.6 (SD = 7.1) and improved significantly to 108.08 (SD = 5.44) after intervention (p =.001). The mean score of sexual satisfaction in the telephone-based counseling was 93.52 (SD = 5) and increased to 113 (SD = 6.07) after 4 weeks (p =.001). Telephone-based counseling could increase the sexual satisfaction better than face-to-face counseling (mean difference: 20.34 [SD = 7.38] vs. 14.47 [SD = 5.32], p =.003). The telephone-based counseling is an effective and affordable method to solve the sexual problems and could increase the sexual satisfaction. Using this method in public health centers is recommended.