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.

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 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.

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.

The effect of early enteral nutrition supplemented with synbiotics on lipid and glucose homeostasis in critically ill patients: A randomized controlled trial.

BACKGROUND AND AIMS: The aim of the present study was to investigate the effects of gut microbiota modulation through synbiotic supplementation on lipid and glucose homeostasis in tube-fed critically-ill adult patients. METHODS: This study is placebo-controlled, parallel, single-center, double-blind clinical trial. 42 patients were randomly distributed in placebo and synbiotic groups to receive intervention for a maximum of 14 days. Serum levels of fasting glucose, total cholesterol, and triglycerides, insulin, and free fatty acids were obtained from blood sampling at baseline and the end of the study. Also, insulin resistance was determined by homeostasis model assessment of insulin resistance (HOMA-IR). RESULT: Fasting glucose level (Day0 = 87.84 ±â€¯15.51, Day14 = 83.76 ±â€¯8.71 mg/dl, P = 0.51), fasting insulin level (Day0 = 9.46 ±â€¯7.31, Day14 = 7.97 ±â€¯5.19 mIU/L, P = 1.00), and HOMA index (Day0 = 1.89 ±â€¯1.48, Day14 = 1.72 ±â€¯1.17, P = 0.75) during the study were decreasing in both groups, but the decreases were not significant. Serum levels of total cholesterol, triglyceride, and free fatty acidsat the beginning of the study were 114.18 ±â€¯43.43 mg/dl, 146.59 ±â€¯53.99 mg/dl, 0.83 ±â€¯0.57 mmol/L, and at the end of the study were 129.10 ±â€¯39.05 mg/dl, 127.40 ±â€¯91.88 mg/dl, 0.88 ±â€¯0.77 mmol/L, respectively. None of these changes were significant either (P = 0.99, P = 0.38, P = 0.90, respectively). CONCLUSIONS: According to our findings, synbiotics supplementation in critically ill patients has no significant effect on lipid and glucose profile.

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.

Effects of synbiotic supplementation on energy and macronutrients homeostasis and muscle wasting of critical care patients: study protocol and a review of previous studies.

BACKGROUND: An extreme and persistent dysbiosis occurs among critically ill patients, regardless of the heterogeneity of disease. Dysbiosis in critically ill patients may make them prone to hospital-acquired infections, sepsis, multi-organ failure (MOF), energy homeostasis disturbance, muscle wasting, and cachexia. Modulation of gut microbiota through synbiotics can be considered as a potential treatment for muscle wasting and macronutrient homeostasis disturbances. METHODS: This is a prospective, single-center, double-blind, parallel randomized controlled trial with the aim to evaluate the effects of synbiotic supplementation on energy and macronutrient homeostasis and muscle wasting in critically ill patients. A total of 40 hemodynamically stable, adult, critically ill patients who receive enteral nutrition via a nasogasteric tube (NGT) in the 24-48 h after admission to critical care will be included in this study. Eligible patients will be randomly assigned to receive Lactocare (ZistTakhmir) capsules 500 mg every 12 h or a placebo capsule, which contains only the sterile maize starch and is similar to synbiotic capsules for 14 days. The synbiotic and placebo capsules will be given through the nasogastric tube, separately from gavage, after feeding. DISCUSSION: Gut microbiota modulation through synbiotics is proposed to improve clinical prognosis and reduce infectious complications, ventilator dependency, and length of ICU stay by improving energy and macronutrient homeostasis and reducing muscle protein catabolism. TRIAL REGISTRATION: Iranian Registry of Clinical Trials, IRCT20190227042857N1. Registered on 17 March 2019.

Herbal medicines for suppressing appetite: A systematic review of randomized clinical trials.

The suppression of appetite with herbal medicines has become very popular in recent years. We conducted this systematic review to evaluate the recent scientific evidence regarding herbal medicines that are used to suppress appetite. We retrieved clinical trials from PubMed, Cochrane Central Register of Controlled Trials, Web of Science, Scientific Information Database, and IranMedex from January 1, 2013 to April 24, 2018. English and Persian language randomized clinical trials that used herbal medicines to suppress appetite in healthy or obese or overweight individuals were included. Risk of bias was assessed using Cochrane methodology. Out of 591 articles, 22 trials with 973 participants were included. One study on the Meratrim formulation which contained the Sphaeranthus indicus flower heads extract and Garcinia mangostana fruit, revealed longer-term evidence; while 6 studies on Ilex paraguariensis, Spinacia oleracea, Phaseolus vulgaris, Secale cereale, Sorghum bicolor and Plantago showed short-term evidence for suppressing appetite. No serious adverse events were reported. Despite some methodological concerns in the included studies, there is promising evidence for suppressing appetite with herbal medicines that needs to be confirmed in long-term clinical trials with adequate sample size and higher methodological quality with more attention to safety, effective dose and side effects.

Auricular or body acupuncture: which one is more effective in reducing abdominal fat mass in Iranian men with obesity: a randomized clinical trial.

BACKGROUND: The prevalence of abdominal obesity is on the rise worldwide. Previous studies have indicated the higher diagnostic value of body fat distribution pattern compared with general body in abdominal obesity assessments. Several non-pharmacological methods have been suggested for obesity management, of which acupuncture has gained a great deal of research interest with promising results. This study aimed to comparatively evaluate the effects of conventional auricular and body electroacupuncture on abdominal fat mass in obese men. METHODS: The volunteers were randomly divided into four groups, including 2 interventions and 2 controls. This study was conducted on 80 obese volunteer men with Body Mass Index (BMI) range of 30-40 kg/m2.The intervention groups including real body electroacupuncture (A), real auricular acupuncture (C) and the control groups containing sham body electroacupuncture (B), and sham auricular acupuncture (D). All groups were in combination with a low-calorie diet for 6 weeks. BMI, Trunk Fat Mass (TFM), Waist Circumference (WC), and Hip Circumference (HC) were measured pre- and post-intervention. RESULTS: In group A, respectively a significant reduction was shown in BMI (P < 0.005), TFM (P < 0.005), WC (P < 0.05, P < 0.005) and HC (P < 0.005) when compared with controls (Groups B and D). Interestingly, group C had significant decreases in BMI (P < 0.005), TFM (P < 0.01, P < 0.005), WC (P < 0.005) and HC (P < 0.001) after comparison with the sham. Likewise, WC (P < 0.05) and HC (P < 0.05) were significantly reduced post- intervention when compared with two treatment groups. CONCLUSIONS: In our study, acupuncture treatment (body or auricular) seemed to have an effect on reducing BMI, TFM, WC and HC. Comparison of the two types of treatment (body and auricular acupuncture) suggests that the two types of acupuncture had similar effects on reducing BMI and TFM, but body electroacupuncture is more effective in reducing WC and auricular in HC. It seems that both auricular and body electro-acupuncture combined with a low-calorie diet are efficient, simple and painless methods to reduce respectively the HC and WC fat in obese men, compared with conventional techniques. TRIAL REGISTRATION: IRCT201201127117N2.

Comparison of intensive insulin therapy versus conventional glucose control in traumatic brain injury patients on parenteral nutrition: A pilot randomized clinical trial.

BACKGROUND: Parenteral nutrition (PN) is a valuable life saving intervention, which can improve the nutritional status of hospitalized malnourished patients. PN is associated with complications including hyperglycemia. This study was conducted to compare two methods of blood glucose control in traumatic brain injury patients on PN. MATERIALS AND METHODS: A randomized, open-label, controlled trial with blinded end point assessment was designed. Traumatic brain injury patients (GCS = 4-9) on PN, without diabetes, pancreatitis, liver disease, kidney complication, were participated. Patients were randomly assigned to receive continuous insulin infusion to maintain glucose levels between 4.4 mmol/l (80 mg/dl) and 6.6 mmol/l (120 mg/dl) (n = 13) or conventional treatment (n = 13). Patients in the conventional group were not received insulin unless glucose levels were greater than 10 mmol/l (>180 mg/dl). These methods were done to maintain normoglycemia in ICU. The primary outcome was hypo/hyperglycemic episodes. Other factors such as C-reactive protein, blood electrolytes, liver function tests, lipid profile and mid-arm circumference were compared. RESULTS: Mean glucose concentration were significantly lower in IIT group (118 ± 28 mg/dl) vs conventional group (210 ± 31 mg/dl) (P < 0.01). No hypoglycemic episode occurred in two groups. Triglyceride (P = 0.02) and C-reactive protein (P = 0.001) was decreased in the IIT group, significantly. There were also significant differences in the electrolytes, with magnesium and phosphorus being lower in the IIT group (P = 0.05). CONCLUSION: In this pilot study, blood glucose level, CRP and TG were lower in IIT group. Further data collection is warranted to reach definitive conclusions.

Effects of body electroacupuncture on plasma leptin concentrations in obese and overweight people in Iran: a randomized controlled trial.

BACKGROUND: The prevalence of obesity, a major public health problem, is increasing in many countries, including Iran. Leptin, a peptide hormone that is released from adipocytes, is a major factor in appetite regulation. Levels of plasma leptin increase with increased body fat mass (BFM). Research has found acupuncture to be effective both in weight loss and suppression of appetite. Although a few studies have reported the effect of body and ear acupuncture on leptin levels, researchers have performed few studies on the effect of body electroacupuncture in humans. OBJECTIVE: The research team examined the effects of body electroacupuncture and a low-calorie diet on plasma leptin in obese and overweight individuals with an excess (phlegm-dampness or phlegm-heat) or deficiency (spleen/stomach qi deficiency or primary qi deficiency) pattern according to Chinese medicine. DESIGN: The research team randomly assigned participants to one of two groups, intervention or control. SETTING: This study occurred in the nutritional clinic at Ghaem Hospital in Mashhad, Iran. PARTICIPANTS: Participants were individuals (N = 86) between 18 and 65 years of age with body mass indexes (BMI) between 25 and 45 kg/m2. INTERVENTION: The intervention group (n = 47) received actual electroacupuncture, and the control group (n = 47) received sham acupuncture. Both groups consumed a low-calorie diet for 6 weeks. OUTCOME MEASURES: The research team measured plasma leptin, BFM, body weight (BW), and BMI before and after treatment. RESULTS: For participants in the intervention group with both the excess and the deficiency patterns, the research team found a significant reduction in plasma leptin (24.96%, P = .001) and BFM (8.29%, P = .001). In the control group, the team found a less significant reduction in leptin and BFM. The difference between the two groups was significant for leptin (P = .03) but not for BFM (P = .8). CONCLUSIONS: While body electroacupuncture with a low-calorie diet can reduce plasma leptin concentration, the mechanism will require further clarification.

Serum selenium concentration in Mashhad prisoners, Iran.

OBJECTIVES: To determine the serum selenium concentration among prisoners in the central jail of Mashhad, Northeast of Iran. METHODS: In a cross-section study, a sample of 435 prisoners (387 men [34.5±10 years] and 48 women [36.4±11 years]) recruited during May 2008 to June 2008 from Mashhad Central Prison, Mashhad, Iran, using multistage sampling method, proportionate to gender, age groups and kind of crime. Serum level of selenium was assessed using atomic absorption spectrophotometer. RESULTS: The mean of serum selenium concentration was 121±20 ug/l. Prevalence of selenium deficiency was 9.7% in selected sample. The selenium deficiency was more prevalent in women than men (25.5% versus 7.8%, p=0.00). Age distribution of serum selenium level had a different pattern among men and women. While in men serum selenium level on average was least in those aged 50 and over, in women, serum selenium did not change with age. Body mass index (BMI) and weight change had no relations. CONCLUSION: Results of this study suggest that selenium status of the prisoners in Mashhad central prison is of concern. Women may be at higher risk for selenium deficiency. These results have implications for officials in charge with prisoners and health policy makers.

Effects of auricular acupressure combined with low-calorie diet on the leptin hormone in obese and overweight Iranian individuals.

BACKGROUND: Human leptin is a peptide hormone that is released from white adipocytes. The absence of leptin or its receptor leads to uncontrolled food intake, leading to obesity. In the present work, the effects of auricular acupressure combined with low-calorie diet on the leptin hormone level were investigated. METHODS: Volunteers (n=86) with body mass indices (BMI) between 25 and 45 kg/m² were randomised into a case (n=43) or a control (n=43) group. Participants in each group received a low-calorie diet for 6 weeks. The case group was treated with auricular acupressure and the control group received a sham procedure. Plasma leptin levels, body fat mass, body weight and BMI were measured before and after treatment. RESULTS: Participants who received auricular acupressure showed significant reductions in their plasma leptin levels (18.57%, p<0.01) as well as in their body fat mass (4%, p<0.05). These changes were not observed in the control group. The reduction in leptin was significantly greater in the acupressure group than the controls. CONCLUSIONS: Auricular acupressure combined with a low-calorie diet significantly reduced plasma levels of leptin. However, the mechanism of this reduction is not clear.