Safety and efficacy of memantine for multiple sclerosis-related fatigue: A pilot randomized, double-blind placebo-controlled trial.

BACKGROUND: Fatigue is one of the most common symptoms in patients with multiple sclerosis (MS). Currently, there is no approved medication for MS-related fatigue. OBJECTIVE: In this study, we aim to evaluate the safety and efficacy of memantine for improving fatigue in patients with MS. METHODS: This was a pilot randomized, double-blind, placebo-controlled clinical trial. Eligible patients with relapsing-remitting MS (RRMS) according to the McDonald criteria were randomized to receive either memantine (20 mg/day) or placebo and were assessed at baseline and three months after treatment. The change in the severity of fatigue was determined by the Modified Fatigue Impact Scale (MFIS). RESULTS: Sixty-four patients were randomly allocated to the memantine (n = 32) and placebo (n = 32) groups. Sixteen patients in the memantine group and 24 patients in the placebo group completed the study. The mean [95% CI] absolute change in MFIS scores from baseline did not differ significantly between the memantine (-5.8 [-12.7 to 1.0]) and placebo (-4.0 [-10.6 to 2.7]) groups (between-group difference: -1.9 [-11.7 to 7.8], P = .702). No serious adverse events were reported, except for dizziness and sedation in four patients in the experimental arm, which resulted in discontinuation. CONCLUSION: This trial failed to prove any clinical efficacy of memantine for the management of MS-related fatigue. Although memantine was generally well-tolerated, adverse events were among the major causes of dropout in this study.

Trace elements in schizophrenia: a systematic review and meta-analysis of 39 studies (N†=†5151 participants).

CONTEXT: The pathogenesis of schizophrenia appears to be multifaceted. OBJECTIVE: The aim of this meta-analysis of studies that investigated blood and hair concentrations of trace elements in people diagnosed with schizophrenia was to determine whether levels of trace elements in patients with schizophrenia differ from those in healthy individuals. DATA SOURCES: The PubMed, Scopus, and Web of Science databases were searched to January 2018. STUDY SELECTION: Studies that compared concentrations of trace elements in patients with schizophrenia with those in healthy controls, in patients with schizophrenia under different treatment regimens, or in patients with schizophrenia at different stages of disease were included. DATA EXTRACTION: Data on study and sample characteristics and measures of trace elements were extracted. RESULTS: Thirty-nine studies with a total of 5151 participants were included. Meta-analysis of combined plasma and serum data showed higher levels of copper, lower levels of iron, and lower levels of zinc among patients with schizophrenia vs controls without schizophrenia. Subgroup analyses confirmed the following: higher levels of copper in plasma, in users of typical antipsychotic drugs, and in males; lower levels of zinc in serum, in patients in Asia, in drug-naive/drug-free patients, and in inpatients; lower levels of iron in serum, in patients in Asia, in drug-naive/drug-free patients, in patients on antipsychotic drugs, in inpatients, in patients with acute or newly diagnosed schizophrenia, in patients with chronic or previously diagnosed schizophrenia, and in males; and lower levels of manganese in plasma and in patients with chronic or previously diagnosed schizophrenia. CONCLUSIONS: This meta-analysis provides evidence of an excess of copper, along with deficiencies of zinc, iron, and manganese, in patients with schizophrenia.

Effects of adopting a smoke-free policy in state psychiatric hospitals.

OBJECTIVE: The aim of this study was to investigate how adopting a smoke-free policy in state psychiatric hospitals affected key factors, including adverse events, smoking cessation treatment options, and specialty training for clinical staff about smoking-related issues. METHODS: Hospitals were surveyed in 2006 and 2008 about their smoking policies, smoking cessation aids, milieu management, smoking cessation treatment options, and aftercare planning and referrals for smoking education. Comparisons were made between hospitals that went smoke-free between the two time periods (N=28) and those that did not (N=42). RESULTS: Among hospitals that changed to a smoke-free policy, the proportion that reported adverse events decreased by 75% or more in three areas: smoking or tobacco use as a precursor to incidents that led to seclusion or restraint, smoking-related health conditions, and coercion or threats among patients and staff. Hospitals that did not adopt a smoke-free policy cited several barriers, including resistance from staff, patients, and advocates. CONCLUSIONS: Although staff were concerned that implementing a smoke-free policy would have negative effects, this was not borne out. Findings indicated that adopting a smoke-free policy was associated with a positive impact on hospitals, as evidenced by a reduction in negative events related to smoking. After adoption of a smoke-free policy, fewer hospitals reported seclusion or restraint related to smoking, coercion, and smoking-related health conditions, and there was no increase in reported elopements or fires. For hospitals adopting a smoke-free policy in 2008, there was no significant difference between 2006 and 2008 in the number offering nicotine replacement therapies or clinical staff specialty training. Results suggest that smoking cessation practices are not changing in the hospital as a result of a change in policy.

Automated surveillance for adverse drug events at a community hospital and an academic medical center.

OBJECTIVES: To compare the rates and nature of ADEs at an academic medical center and a community hospital using a single computerized ADE surveillance system. DESIGN: Prospective cohort study of patients admitted to two tertiary care hospitals. Outcome Measure Adverse drug events identified by automated surveillance and voluntary reporting. METHODS: We implemented an automated surveillance system across an academic medical center and a community hospital. Potential events identified by the computer were reviewed in detail by medication safety pharmacists and scored for causality and severity. Findings were compared between the two hospitals, and with voluntary reports from nurses and pharmacists. RESULTS: Over the 8 month study period, 25,177 patients were admitted to the university hospital and 8,029 to the community hospital. There were 1,116 ADEs in 900 patients at the university hospital for an overall rate of 4.4 ADEs per 100 admissions. At the community hospital, 399 patients experienced 501 ADEs for a rate of 6.2 events per 100 admissions. Rates of antibiotic-associated colitis, drug-induced hypoglycemia, and anticoagulation-related ADEs were significantly higher at the community hospital compared with the university hospital. Computerized surveillance detected ADEs at a rate 3.6 times that of voluntary reporting at the university hospital and 12.3 times that at the community hospital. CONCLUSIONS: Operation of a common automated ADE surveillance system across hospitals permits meaningful comparison of ADE rates in different inpatient settings. Automated surveillance detects ADEs at rates far higher than voluntary reporting, and the difference may be greater in the community hospital setting. Community hospitals may experience higher rates of certain types of ADEs compared with academic medical centers.