scholarly journals Impact of Glutathione and Vitamin B-6 in Cirrhosis Patients: A Randomized Controlled Trial and Follow-Up Study

Nutrients ◽  
2020 ◽  
Vol 12 (7) ◽  
pp. 1978
Author(s):  
Chia-Yu Lai ◽  
Shao-Bin Cheng ◽  
Teng-Yu Lee ◽  
Yung-Fang Hsiao ◽  
Hsiao-Tien Liu ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Randomized Controlled Trial ◽  
Liver Cirrhosis ◽  
Disease Severity ◽  
Controlled Trial ◽  
Vitamin B ◽  
Double Blind ◽  
Randomized Controlled ◽  
Antioxidant Capacities

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.

scholarly journals Glutathione and Related Antioxidant Capacities But Not Vitamin B-6 Had Significant Association with Severity of Liver Dysfunction in Liver Cirrhotic Patients

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 1128-1128
Author(s):  
Yi-Chia Huang ◽  
Chia-Yu Lai ◽  
Shao-Bin Cheng ◽  
Hsiao-Tien Liu ◽  
Shih-Chien Huang
Keyword(s):  
Oxidative Stress ◽  
Liver Cirrhosis ◽  
Liver Dysfunction ◽  
Trolox Equivalent Antioxidant Capacity ◽  
Vitamin B ◽  
Double Blind ◽  
Antioxidant Capacities ◽  
Trolox Equivalent ◽  
Cirrhotic Patients

Abstract Objectives Liver cirrhosis is often associated with increased oxidative stress and decreased antioxidant capacities. Vitamin B-6 and glutathione (GSH) are antioxidant nutrients. Inadequate vitamin B-6 status may indirectly limit GSH synthesis and further affect the antioxidant capacities. The purpose of this study was to assess whether individual or the combination of vitamin B-6 and GSH supplementation had effects on antioxidant capacities and clinical outcomes in patients with liver cirrhosis. Methods This was a double-blind randomized clinical trial and a follow-up study. 61 liver cirrhotic 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, 61 patients were followed until the end of the study. Baseline and 12 weeks of fasting blood samples were drawn to measure levels of plasma GSH, oxidized GSH (GSSG), trolox equivalent antioxidant capacity (TEAC), activities of glutathione S-transferase (GSH-St), glutathione peroxidase (GSH-Px), glutathione reductase (GSH-Rd), superoxide dismutase (SOD) and catalase. The severity of liver dysfunction (Child-Turcotte-Pugh score) was evaluated at baseline, 12 weeks after baseline, and the end of the follow-up time. Results The median follow-up time was 984 d, 21 patients were lost of follow-up during follow-up period. After 12 weeks of supplementation, neither vitamin B-6 nor GSH supplementation had effects on indicators of oxidative stress and antioxidant capacities. However, high levels of GSH, GSH/GSSG ratio, and GSH-St activity at baseline (week 0) but not at week 12 had significant effect on low Child-Turcotte-Pugh scores at week 0, week12 and the end of follow-up in all patients after adjusting for potential confounders. Conclusions Although GSH supplementation had no significant effect on reducing oxidative stress and increase antioxidant capacities, the decreased glutathione and its related enzyme activity should be considered by clinicians in the treatment of liver cirrhotic patients. Funding Sources This study was funded by a grant from the Ministry of Science and Technology, Taiwan (MOST 104–2320-B-040–009-MY3) and Taichung Veterans General Hospital, Taiwan (TCVGH-1084601C).

The SNAP Trial: 2-Year Results of a Double-Blind Multicenter Randomized Controlled Trial of a Silicon Nitride Versus a PEEK Cage in Patients After Lumbar Fusion Surgery

2021 ◽  
pp. 219256822098547
Author(s):  
R. F. M. R. Kersten ◽  
F. C. Öner ◽  
M. P. Arts ◽  
M. Mitroiu ◽  
K. C. B. Roes ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Silicon Nitride ◽  
Interbody Fusion ◽  
Controlled Trial ◽  
Segmental Motion ◽  
Lumbar Interbody Fusion ◽  
Double Blind ◽  
Randomized Controlled ◽  
Disability Questionnaire

Study Design: Randomized controlled trial. Objectives: Lumbar interbody fusion with cages is performed to provide vertebral stability, restore alignment, and maintain disc and foraminal height. Polyetheretherketone (PEEK) is commonly used. Silicon nitride (Si3N4) is an alternative material with good osteointegrative properties. This study was designed to assess if Si3N4 cages perform similar to PEEK. Methods: A non-inferiority double-blind multicenter RCT was designed. Patients presenting with chronic low-back pain with or without leg pain were included. Single- or double-level instrumented transforaminal lumbar interbody fusion (TLIF) using an oblique PEEK or Si3N4 cage was performed. The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ). The non-inferiority margin for the RMDQ was 2.6 points on a scale of 24. Secondary outcomes included the Oswestry Disability Questionnaire (ODI), Visual Analogue Scales (VAS), SF-36 Physical Function, patient and surgeon Likert scores, radiographic evaluations for subsidence, segmental motion, and fusion. Follow-up was planned at 3, 6, 12, and 24-months. Results: Ninety-two patients were randomized ( i.e. 48 to PEEK and 44 to Si3N4). Both groups showed good clinical improvements on the RMDQ scores of up to 5-8 points during follow-up. No statistically significant differences were observed in clinical and radiographic outcomes. Mean operative time and blood loss were statistically significantly higher for the Si3N4 cohort. Although not statistically significant, there was a higher incidence of complications and revisions associated with the Si3N4 cage. Conclusions: There was insufficient evidence to conclude that Si3N4 was non-inferior to PEEK.

scholarly journals The Influence of Prenatal DHA Supplementation on Individual Domains of Behavioral Functioning in School-Aged Children: Follow-Up of a Randomized Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (9) ◽  
pp. 2996
Author(s):  
Jacqueline F. Gould ◽  
Peter J. Anderson ◽  
Lisa N. Yelland ◽  
Robert A. Gibson ◽  
Maria Makrides
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Fetal Brain ◽  
Executive Dysfunction ◽  
Behavioral Functioning ◽  
Singleton Pregnancy ◽  
Double Blind ◽  
Randomized Controlled ◽  
Trial Entry

Docosahexaenoic acid (DHA) accumulates in the fetal brain during pregnancy and is thought to have a role in supporting neurodevelopment. We conducted a multicenter, double-blind, randomized controlled trial in women with a singleton pregnancy who were <21 weeks’ gestation at trial entry. Women were provided with 800 mg DHA/day or a placebo supplement from trial entry until birth. When children reached seven years of age, we invited parents to complete the Strengths and Difficulties Questionnaire (SDQ), the Behavior Rating Inventory of Executive Function (BRIEF), and the Conners 3rd Edition Attention-Deficit Hyperactivity Disorder (ADHD) Index to assess child behavior and behavioral manifestations of executive dysfunction. There were 543 parent–child pairs (85% of those eligible) that participated in the follow-up. Scores were worse in the DHA group than the placebo group for the BRIEF Global Executive, Behavioral Regulation and Metacognition Indexes, and the Shift, Inhibit, Monitor, Working Memory, and Organization of Materials scales, as well as for the Conners 3 ADHD index, and the SDQ Total Difficulties score, Hyperactivity/Inattention score, and Peer Relationship Problems score. In this healthy, largely term-born sample of children, prenatal DHA supplementation conferred no advantage to childhood behavior, and instead appeared to have an adverse effect on behavioral functioning, as assessed by standardized parental report scales.

Effect of curcumin supplementation on disease severity in patients with liver cirrhosis: A randomized controlled trial

2020 ◽  
Vol 34 (6) ◽  
pp. 1446-1454 ◽  
Author(s):  
Masoud Nouri‐Vaskeh ◽  
Aida Malek Mahdavi ◽  
Hossein Afshan ◽  
Leila Alizadeh ◽  
Mohammad Zarei
Keyword(s):  
Randomized Controlled Trial ◽  
Liver Cirrhosis ◽  
Disease Severity ◽  
Controlled Trial ◽  
Randomized Controlled
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