scholarly journals Safety profile of sedative endoscopy including cognitive performance in liver cirrhosis: A double-blind randomized controlled trial

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Jeong-Ju Yoo ◽  
Hyeon Jeong Goong ◽  
Ji Eun Moon ◽  
Sang Gyune Kim ◽  
Young Seok Kim

AbstractThe indiscriminate use of sedative drugs during endoscopy can pose multiple risks including cognitive impairment in advanced liver cirrhosis. However, the data are scarce regarding which sedative drugs are safest in these populations. The aim of this study was to evaluate the safety profiles including cognitive performance among midazolam, propofol, and combination therapy in advanced cirrhotic patients. This double-blind randomized controlled study included 60 consecutive advanced cirrhotic patients who underwent upper gastrointestinal endoscopy. The Stroop application was used to screen for cognitive impairment. Patients were randomly assigned to one of 3 groups, midazolam, propofol, or the combination group, and underwent Stroop test before and two hours after the completion of endoscopy. Hemodynamic safety and the subjective satisfaction score were also evaluated. Patients did not show significant changes in on-time or off-time on the Stroop test before and two hours after sedatives, and there was no significant difference among the 3 treatment groups. Also, there were no significant vital sign changes after sedatives. Time-to-recovery was longest in midazolam group, and patient awakening and patient memory were highest in propofol group. However, all 3 groups showed no difference in patient satisfaction, but the combination group was more preferred in terms of subjective satisfaction by physicians. Factors affecting worsened Stroop speed after sedatives were older age, low education level and high MELD score. All sedative methods using midazolam, propofol, or combination therapy showed similar safety profile in advanced cirrhosis, and were not associated with increased risk of cognitive impairment.

2020 ◽  
Vol 46 (Supplement_1) ◽  
pp. S152-S152
Author(s):  
Katsuhiko Hagi ◽  
Tadashi Nosaka ◽  
Andrei Pikalov

Abstract Background Schizophrenia is associated with cognitive dysfunction as well as cardiovascular disease (CVD). A central risk factor for CVD is the metabolic syndrome (MetS), which is of special concern in schizophrenia. The prevalence of MetS in U.S. patients with schizophrenia is higher versus general population (32.5% versus 23%). The prevalence of MetS and diabetes mellitus (DM) in those with schizophrenia double that of the general population. Adverse events of some antipsychotics used to treat schizophrenia include weight gain, obesity and other MetS complications, particularly abnormal glucose and lipid metabolism. Patients with schizophrenia have low rates of treatment for MetS and its components. Furthermore, components of MetS are risk factors for cognitive impairment and dementia in the general population. Cognitive impairment is a hallmark feature of schizophrenia, and the level of community functioning is strongly correlated with the degree of cognitive impairment. Given the importance of cognitive impairment in schizophrenia, the potential role of MetS in contributing to cognitive dysfunction is important. The objective of this post-hoc analysis was to examine cross-sectional relationships between metabolic syndrome and cognitive performance in patients with schizophrenia treated with lurasidone or quetiapine XR for 6-weeks. Methods This post hoc analysis utilized data from 6-week, double-blind, placebo-controlled trial of patients with an acute exacerbation of schizophrenia who were randomized to fixed, once-daily oral doses of lurasidone 80 mg (LUR 80 n=125), lurasidone 160 mg (LUR 160, n=121), quetiapine XR 600 mg (QXR, n=120) and placebo (PBO, n=122). Patients with metabolic syndrome (MetS) at baseline were identified based on the National Cholesterol Education Program – Adult Treatment Panel III criteria (NCEP-ATP-III). Cognitive performance and functional capacity were assessed by the CogState computerized cognitive battery at baseline and 6 weeks. Results In the acute 6-week period, LUR160 was significantly superior on the cognitive composite score to PBO (p<0.05, d=0.37), while LUR 80 and QXR did not separate from PBO in the evaluable analysis sample (excluding subjects with non-evaluable composite Z-scores; n=267). A total of 45/267 (16.9%) patients met criteria for MetS. Treatment of patients with MetS group with LUR 160 (vs placebo) was associated with significantly greater week 6 improvement in the cognitive composite score (p<0.05, d=1.15), while LUR 80 and QXR did not separate from PBO. In the group without MetS, LUR dose groups and QXR did not differ from PBO in the CogState composite score. In the analysis of cognitive domain scores, LUR 80 was significantly superior to PBO on working memory in the group with MetS (p<0.05, d=1.01) and reasoning/problem solving in the group without MetS (p<0.05, d=0.46). LUR 160 was significantly superior to PBO on processing speed in the group with MetS (p<0.05, d=1.20), reasoning/problem solving (p<0.05, d=0.45) and social cognition (p<0.05, d=0.46) in the group without MetS. QXR was significantly superior to PBO on verbal learning and reasoning/problem solving in the group without MetS (p<0.05, d=0.38 and p<0.05, d=0.37, respectively). Discussion Patients with MetS responded to treatment with lurasidone with significantly improved CogState composite and domain scores. No improvement on cognition was seen in patients with MetS treated with QXR. Evaluation of potential for MetS and improvements in cognition should be important elements in the algorithm of optimization of treatment in patients with schizophrenia.


Nutrients ◽  
2020 ◽  
Vol 12 (7) ◽  
pp. 1978
Author(s):  
Chia-Yu Lai ◽  
Shao-Bin Cheng ◽  
Teng-Yu Lee ◽  
Yung-Fang Hsiao ◽  
Hsiao-Tien Liu ◽  
...  

Vitamin B-6 and glutathione (GSH) are antioxidant nutrients, and inadequate vitamin B-6 may indirectly limit glutathione synthesis and further affect the antioxidant capacities. Since liver cirrhosis is often associated with increased oxidative stress and decreased antioxidant capacities, we conducted a double-blind randomized controlled trial to assess the antioxidative effect of vitamin B-6, GSH, or vitamin B-6/GSH combined supplementation in cirrhotic patients. We followed patients after the end of supplementation to evaluate the association of vitamin B-6 and GSH with disease severity. In total, 61 liver cirrhosis patients were randomly assigned to placebo, vitamin B-6 (50 mg pyridoxine/d), GSH (500 mg/d), or B-6 + GSH groups for 12 weeks. After the end of supplementation, the condition of patient’s disease severity was followed until the end of the study. Neither vitamin B-6 nor GSH supplementation had significant effects on indicators of oxidative stress and antioxidant capacities. The median follow-up time was 984 d, and 21 patients were lost to follow-up. High levels of GSH, a high GSH/oxidized GSH ratio, and high GSH-St activity at baseline (Week 0) had a significant effect on low Child–Turcotte–Pugh scores at Week 0, the end of supplementation (Week 12), and the end of follow-up in all patients after adjusting for potential confounders. Although the decreased GSH and its related enzyme activity were associated with the severity of liver cirrhosis, vitamin B-6 and GSH supplementation had no significant effect on reducing oxidative stress and increasing antioxidant capacities.


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