Double-blind, randomized crossover study of intravenous infusion of magnesium sulfate versus 5% dextrose on depressive symptoms in adults with treatment-resistant depression.

AIM: Treatment-resistant depression patients are more likely to suffer from comorbid physical and mental disorders, experience marked and protracted functional impairment, and incur higher health-care costs than non-affected individuals. Magnesium sulfate is a treatment option that may offer great potential for patients with treatment-resistant depression based on prior work in animals and humans. METHODS: Twelve subjects with mild or moderate treatment-resistant depression were randomized into a double-blind crossover trial to receive an infusion of 4 g of magnesium sulfate in 5% dextrose or placebo infusion of 5% dextrose with a 5-day washout in between the 8-day intervention period. Subjects were assessed before and after the intervention for serum and urine magnesium, lipid panel, the Hamilton Rating Scale for Depression, and the Patient Health Questionnaire-9. RESULTS: We found a difference in serum magnesium from day 2 to 8 (pre-infusion) (P < 0.002) and from baseline to day 8 (P < 0.02). No changes were noted on the Hamilton Rating Scale for Depression or the Patient Health Questionnaire-9 24 h post-treatment, but as serum magnesium increased from baseline to day 7, the Patient Health Questionnaire-9 decreased from baseline to day 7 (P = 0.02). CONCLUSION: Magnesium sulfate did not significantly affect depression 24 h post-infusion, but other results were consistent with the literature. The association between changes in serum magnesium and the Patient Health Questionnaire-9 supports the idea that magnesium sulfate may be used to address treatment-resistant depression, an ongoing medical challenge.

RETRACTED ARTICLE: The Novel Effects of a Hydrolyzed Polysaccharide Dietary Supplement on Immune, Hepatic, and Renal Function in Adults with HIV in a Randomized, Double-Blind Placebo-Control Trial.

The primary objective of the study was to evaluate the effects of a hydrolyzed polysaccharide, rice bran arabinoxylan compound (RBAC), on immune, hepatic, and renal function in HIV + individuals. A six-month randomized double-blind placebo-controlled trial was utilized to conduct the intervention. Forty-seven HIV + participants on stable antiretroviral therapy were enrolled and randomly assigned to one of the two study conditions (n = 22 RBAC and n = 25 placebo) and consumed 3 gram/day of either compound for six months. Participants were assessed at baseline and 3 and 6 months follow-up for CD4+ and CD8+, liver enzymes, and kidney function. No side effects were reported, and liver and kidney markers nearly remained completely within normal limits. The percentage change in CD4+ was similar for the placebo (+2.2%) and RBAC (+3.1%) groups at 6 months follow-up. The percentage change in CD8+ count significantly decreased from baseline to 6 months in the RBAC group (-5.2%), whereas it increased in the placebo group (+57.8%; p = 0.04). The CD4+/CD8+ ratio improved clinically in the RBAC group from 0.95 (SD =0.62) at baseline to 1.07 (SD =0.11) at 6 months, whereas it declined in the placebo group from 0.96 (SD =0.80) at baseline to 0.72 (SD =0.59) at 6 months. Our results showed a statistically significant decrease in CD8+ count and a clinically significant increase in CD4+/CD8+ ratio for the RBAC group compared to the placebo group. Thus, the results of this study suggest that the immunomodulatory and antisenescent activities of RBAC are promising for the HIV population.

The Novel Effects of a Hydrolyzed Polysaccharide Dietary Supplement on Immune, Hepatic, and Renal Function in Adults with HIV in a Randomized, Double-Blind, Placebo-Control Trial.

The primary objective of the study was to evaluate the effects of a hydrolyzed polysaccharide, rice bran arabinoxylan compound (RBAC), on immune, hepatic, and renal function in HIV + individuals. A 6-month randomized double-blind placebo-controlled trial was utilized to conduct the intervention. Forty-seven HIV + individuals on stable antiretroviral therapy were enrolled and randomly assigned to one of the 2 study conditions (n = 22 RBAC and n = 25 placebo) and consumed 3 gram/day of either compound for 6 months. Participants were assessed at baseline and 3 and 6 months follow-up for CD4+ and CD8+, liver enzymes, and kidney function. No side effects were reported, and liver and kidney markers remained nearly completely within normal limits. The percentage change in CD4+ was similar for the placebo (+2.2%) and RBAC (+3.1%) groups at 6 months follow-up. The percentage change in CD8+ count significantly decreased from baseline to 6 months in the RBAC group (-5.2%), whereas it increased in the placebo group (+57.8%; p = 0.04). The CD4+/CD8+ ratio improved clinically in the RBAC group from 0.95 (SD = 0.62) at baseline to 1.07 (SD = 0.11) at 6 months, whereas it declined in the placebo group from 0.96 (SD = 0.80) at baseline to 0.72 (SD = 0.59) at 6 months. Our results showed a statistically significant decrease in CD8+ count and a clinically significant increase in CD4+/CD8+ ratio for the RBAC group compared to the placebo group. Thus, the results of this study suggest that the immunomodulatory and antisenescent activities of RBAC are promising for the HIV population.

Cardiovascular, endothelial function, and immune markers in response to treatment with a polysaccharide in HIV+ adults in a randomized, double-blind placebo-controlled trial.

BACKGROUND AND AIM: Given the ongoing problems of hypertension and endothelial dysfunction in the HIV population, the primary objective of the study was to assess the cardiovascular, endothelial function, and immune markers in response to rice bran arabinoxylan compound (RBAC) treatment in a sample of HIV+ adults on antiretroviral therapy (ART). STUDY DESIGN: A randomized, double-blind placebo-controlled trial of 6 months was used to execute the study. MATERIALS AND METHODS: Forty-seven subjects were enrolled and randomly assigned to one of two study conditions (n=22 RBAC and n=25 placebo) for 6 months with assessments at baseline and 3 and 6 months. A multivariate repeated measures analysis of variance model was used to assess the differences between RBAC and placebo groups in cardiovascular (systolic blood pressure), endothelial function (skin blood flow in response to nitric oxide), and immune (CD4+ cell count) markers from baseline to 6 months. RESULTS: The effect of treatment (RBAC versus placebo) was significant (Wilks' λ=0.92, F[3, 102]=3.07, P=0.03). The effect of time was significant (Wilks' λ=0.10, F[2, 103]=474.6, P<0.001). The overall interaction between treatment and time was significant (Wilks' λ=0.92, F[2, 103]=4.58, P=0.01). Time contrasts showed that a difference in the overall dependent variable did not occur from baseline to 3 months (F[1, 104]=2.7, P=0.10), marginally occurred from baseline to 6 months (F[1, 104]=3.2, P=0.08), and was significant from 3 to 6 months (F[1, 104]=6.43, P=0.01). CONCLUSIONS: The overall significant interaction suggests varying responses in the dependent variables between RBAC and placebo over time, which is being driven by systolic blood pressure, as it decreased in the RBAC group, but increased in the placebo group. In addition, CD4+ manifested a non-significant increase from baseline to 3 months then decreased from 3 to 6 months in the RBAC group, whereas it decreased at 3 months followed by a slight increase at 6 months in the placebo group. Skin blood flow in response to nitric oxide improved non-significantly overall in both groups, but worsened from 3 to 6 months in the placebo group. Thus, RBAC treatment may contribute to modest short-term improvements in systolic blood pressure, endothelial function, and CD4+ cell count, which could help improve the overall health profile of HIV+ adults. RELEVANCE FOR PATIENTS: Persons with HIV on ART suffer disproportionately from hypertension and endothelial dysfunction compared to the non-infected population, and conventional medical therapy does not alleviate these issues. RBAC is a safe, low-risk alternative that may help to improve the overall quality of life of these patients through modest improvements in these biomarkers plus CD4+ cell count.

Intravenous infusion of magnesium sulfate is not associated with cardiovascular, liver, kidney, and metabolic toxicity in adults.

BACKGROUND: Magnesium (Mg) deficiency contributes to the pathophysiology of numerous diseases. The therapeutic use of Mg has steadily increased over time. The increased in-hospital use of intravenous (IV) magnesium sulfate (MgSO4) warrants more extensive investigation regarding the safety of the therapy. The aim of this study was to determine the safety of IV MgSO4 infusion on cardiovascular, liver, kidney, and metabolic markers in adults. METHODS: Twelve volunteers were randomized to one of two cross-over conditions: (a) IV infusion of MgSO4 in 5% dextrose followed by IV infusion of 5% dextrose 1 week later or (b) IV infusion of 5% dextrose followed by IV infusion of MgSO4 in 5% dextrose 1 week later. An electrocardiogram was recorded continuously during the infusions. Blood was drawn pre- and post-infusion for blood count (high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and triglycerides). Results: Serum Mg increased from pre- to post-infusion in the MgSO4 + 5% dextrose group (p < 0.0001). The QRS interval length increased from pre- to post-infusion in the MgSO4 + 5% dextrose group (p < 0.04). Additionally, serum glucose concentration increased in the MgSO4 + 5% dextrose group (p = 0.04). These significant findings were modeled with gender and age as covariates. No other significant differences were found. CONCLUSIONS: The administration of IV infusion of MgSO4 (4 g/100 mL) in 5% dextrose over a 4-hour treatment period poses no significant deleterious effects on cardiovascular, liver, kidney, or metabolic function. RELEVANCE FOR PATIENTS: IV infusion of MgSO4 may be used for certain treatment indications without significant concern for systemic or organ toxicity.

Admission levels of serum amyloid a and procalcitonin are more predictive of the diagnosis of acute appendicitis compared with C-reactive protein.

BACKGROUND: Acute appendicitis is the commonest surgical emergency, but its diagnosis can be elusive with a negative appendicectomy rate of 20%. The aims of this study were to investigate the potential value of the markers of acute inflammation, serum amyloid A (SAA), and serum procalcitonin (ProCT), in the diagnosis of acute appendicitis in adults and to compare that with the commonly used serum C-reactive protein (CRP). METHODS: Adult patients presenting with acute right lower abdominal pain and a clinical suspicion of acute appendicitis were included. Blood samples were obtained within 6 hours of admission for rapid serum CRP assay and for end-of-recruitment batch analysis of SAA and serum ProCT concentrations. RESULTS: A total of 147 patients (81 males) with a mean (±SD) age of 36 (±17) years were recruited. Appendicitis was confirmed histologically in 61 of 72 patients (84.7%) who underwent appendicectomy. A post hoc analysis revealed a diagnostic sensitivity and specificity for SAA of 92% and 72%, ProCT of 85% and 74%, and CRP of 75% and 72%, respectively. The receiver operator characteristics for the area under the curves showed that SAA (P=0.011) and ProCT (P=0.037) significantly exceeded CRP in the prediction of acute appendicitis on admission. CONCLUSIONS: The measurement of SAA and serum ProCT on admission in patients with clinically suspected acute appendicitis seems to outperform serum CRP in aiding that diagnosis.