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Epilepsy & Behavior : E&B Mar 2023Levetiracetam (LVT), while an effective treatment for multiple seizure types, is associated with a high incidence of neuropsychiatric adverse events (NPAEs). In... (Review)
Review
BACKGROUND
Levetiracetam (LVT), while an effective treatment for multiple seizure types, is associated with a high incidence of neuropsychiatric adverse events (NPAEs). In predominantly retrospective studies, supplementation with pyridoxine/vitamin B (PN) was associated with improvement in NPAEs in some people. A previous review highlighted a lack of double-blind, controlled trials of PN for the treatment of NPAEs in individuals treated with LVT. The current paper updates the findings from the previous review to include evidence from studies published since June 2019.
METHODS
An updated systematic review of the published literature was performed in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. PubMed, Embase, the Cochrane Library, and Google Scholar were searched to identify studies published between June 2019 and 2nd November 2022 in which supplementary PN was initiated for the treatment of LVT-associated NPAEs. All study types were eligible. The risk of bias in randomized trials was assessed using the Cochrane risk-of-bias tool.
RESULTS
Seven additional studies were identified: two double-blind, randomized controlled trials (RCTs), four retrospective studies, and one retrospective case series. One RCT reported significant improvements from baseline in behavioral adverse events (BAEs) in both the intervention (PN) group and the low-dose control group (both p < 0.05), with a significantly greater improvement in the intervention group (p < 0.001). In the second RCT, differences in BAE severity between PN and placebo groups at the endpoint were not statistically significant. In one retrospective study, subjective irritability was reported to have improved from baseline in 9/20 individuals (45%) treated with supplementary PN. Data for systematic assessments (PHQ-9 and GAD-7) were available for 10 individuals. Assessment by PHQ-9 showed that six individuals improved, two worsened and two had no change. Based on the GAD-7, three people improved, two worsened and five had no change. In the second retrospective study, 18/41 individuals (44%) who commenced PN following the emergence of BAEs showed "significant" improvement. In a separate group of individuals with pre-existing behavioral problems in whom PN treatment was initiated at the same time as commencing LVT, 3/18 (16.7%) developed BAEs. This compared with 79/458 people (17.2%) who were initially treated only with LVT. The third retrospective study compared treatment-related irritability in individuals who had been treated with both LVT and perampanel, either sequentially or concomitantly. Two people who developed irritability while receiving LVT monotherapy were able to continue treatment with the addition of PN. The fourth study reported a significantly lower LVT discontinuation rate in individuals taking PN and a higher rate of improved behavior in those who were able to continue LVT. The case series reported improvements in behavioral symptoms in six people within two to three weeks of commencing supplementary PN.
CONCLUSION
Data published within the last three years add to earlier evidence suggesting that PN might be effective in the treatment of NPAEs associated with LVT. However, the quality of evidence remains poor and only a few prospective trials have been published. Data from placebo-controlled trials are still largely lacking. Currently, there is insufficient evidence to justify any firm recommendation for PN supplementation to treat NPAEs associated with LVT. Further well-designed, prospective trials are warranted.
Topics: Humans; Levetiracetam; Pyridoxine; Vitamin B 6; Treatment Outcome; Drug-Related Side Effects and Adverse Reactions; Randomized Controlled Trials as Topic
PubMed: 36791631
DOI: 10.1016/j.yebeh.2022.109065 -
Obesity Surgery Mar 2022Bariatric surgery, although an effective method, still has complications, like nutritional deficiencies. Our aim was to summarize the evidence on the frequency of... (Meta-Analysis)
Meta-Analysis Review
Bariatric surgery, although an effective method, still has complications, like nutritional deficiencies. Our aim was to summarize the evidence on the frequency of complex B vitamin deficiencies in studies comparing Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG). We included 25 studies for qualitative synthesis and 21 studies for quantitative synthesis. Relevant data was extracted, including proportion of patients with deficiency and mean serum vitamin values in 3 different timeframes. B12 and folate were the most prevalent deficiencies. B12 deficiency was more common after RYGB and folate serum mean levels were higher after RYGB. SG causes less nutrient deficiency and is therefore a better technique from this point of view. More studies are needed on B2, B3, and B6 vitamins to draw better conclusions.
Topics: Folic Acid; Gastrectomy; Gastric Bypass; Humans; Obesity, Morbid; Vitamin B Complex; Vitamin B Deficiency
PubMed: 34982396
DOI: 10.1007/s11695-021-05783-2 -
The Cochrane Database of Systematic... Oct 2015Epilepsy is a common neurological condition characterised by recurrent seizures. Most patients respond to conventional antiepileptic drugs, however, around 30% will... (Review)
Review
BACKGROUND
Epilepsy is a common neurological condition characterised by recurrent seizures. Most patients respond to conventional antiepileptic drugs, however, around 30% will continue to experience seizures despite multiple antiepileptic drugs. Sulthiame, also known as sultiame, is a widely used antiepileptic drug in Europe and Israel. We present a summary of the evidence for the use of sulthiame as add-on therapy in epilepsy.
OBJECTIVES
To compare the efficacy and side-effect profile of sulthiame as add-on therapy compared with placebo or another antiepileptic drug.
SEARCH METHODS
We searched the Cochrane Epilepsy Group's Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, ClinicalTrials.gov and the WHO ICTRP Search Portal on 11 August 2015. No language restrictions were imposed. We contacted the manufacturers of sulthiame and researchers in the field to seek any ongoing or unpublished studies.
SELECTION CRITERIA
Randomised controlled add-on trials of sulthiame in people of any age with epilepsy of any aetiology.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected trials for inclusion and extracted relevant data. The following outcomes were assessed: 1) reduction in seizure frequency of 50% or greater between baseline and end of follow-up; 2) complete cessation of seizures during follow-up; 3) mean seizure frequency; 4) time to treatment withdrawal; 5) adverse drug effects; and 6) quality of life scoring. Primary analyses were intention-to-treat. We present a narrative analysis.
MAIN RESULTS
We included one trial with 37 participants with a new diagnosis of West syndrome. Sulthiame was given as an add-on therapy to pyridoxine. No data were reported for outcomes 1), 3) or 6). Overall risk ratio with 95% confidence intervals (CI) for complete cessation of seizures during a nine-day follow-up period versus placebo was 0.71 (95% CI 0.53 to 0.96). Meaningful analysis of time to treatment withdrawal and adverse drug effects was not possible due to incomplete data.
AUTHORS' CONCLUSIONS
Sulthiame may lead to a cessation of seizures when used as an add-on therapy to pyridoxine in patients with West syndrome. The included study was small and had a significant risk of bias which limits the impact of the evidence. No conclusions can be drawn about the occurrence of adverse drug effects, change in quality of life or mean reduction in seizure frequency. No evidence exists for the use of sulthiame as an add-on therapy in patients with epilepsy outside West syndrome. Large, multi-centre randomized controlled trials are necessary to inform clinical practice if sulthiame is to be used as an add-on therapy for epilepsy.
Topics: Anticonvulsants; Epilepsy; Female; Humans; Infant; Male; Pyridoxine; Randomized Controlled Trials as Topic; Spasms, Infantile; Thiazines
PubMed: 26510094
DOI: 10.1002/14651858.CD009472.pub3 -
The Cochrane Database of Systematic... May 2016People with end-stage kidney disease (ESKD) have high rates of cardiovascular events. Randomised controlled trials (RCTs) of homocysteine-lowering therapies have not... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
People with end-stage kidney disease (ESKD) have high rates of cardiovascular events. Randomised controlled trials (RCTs) of homocysteine-lowering therapies have not shown reductions in cardiovascular event rates in the general population. However, people with kidney disease have higher levels of homocysteine and may have different mechanisms of cardiovascular disease. We performed a systematic review of the effect of homocysteine-lowering therapies in people with ESKD.
OBJECTIVES
To evaluate the benefits and harms of established homocysteine lowering therapy (folic acid, vitamin B6, vitamin B12) on all-cause mortality and cardiovascular event rates in patients with ESKD.
SEARCH METHODS
We searched Cochrane Kidney and Transplant's Specialised Register to 25 January 2016 through contact with the Information Specialist using search terms relevant to this review.
SELECTION CRITERIA
Studies conducted in people with ESKD that reported at least 100 patient-years of follow-up and assessed the effect of therapies that are known to have homocysteine-lowering properties were included.
DATA COLLECTION AND ANALYSIS
Two authors independently extracted data using a standardised form. The primary outcome was cardiovascular mortality. Secondary outcomes included all-cause mortality, incident cardiovascular disease (fatal and nonfatal myocardial infarction and coronary revascularisation), cerebrovascular disease (stroke and cerebrovascular revascularisation), peripheral vascular disease (lower limb amputation), venous thromboembolic disease (deep vein thrombosis and pulmonary embolism), thrombosis of dialysis access, and adverse events. The effects of homocysteine-lowering therapies on outcomes were assessed with meta-analyses using random-effects models. Prespecified subgroup and sensitivity analyses were conducted.
MAIN RESULTS
We included six studies that reported data on 2452 participants with ESKD. Interventions investigated were folic acid with or without other vitamins (vitamin B6, vitamin B12). Participants' mean age was 48 to 65 years, and proportions of male participants ranged from 50% to 98%.Homocysteine-lowering therapy probably leads to little or no effect on cardiovascular mortality (4 studies, 1186 participants: RR 0.93, 95% CI 0.70 to 1.22). There was no evidence of heterogeneity among the included studies (I² = 0%). Homocysteine-lowering therapy had little or no effect on all-cause mortality or any other of this review's secondary outcomes. All prespecified subgroup and sensitivity analyses demonstrated little or no difference. Reported adverse events were mild and there was no increase in the incidence of adverse events from homocysteine-lowering therapies (3 studies, 1248 participants: RR 1.12, 95% CI 0.51 to 2.47; I(2) = 0%). Overall, studies were assessed as being at low risk of bias and there was no evidence of publication bias.
AUTHORS' CONCLUSIONS
Homocysteine-lowering therapies were not found to reduce mortality (cardiovascular and all-cause) or cardiovascular events among people with ESKD.
Topics: Aged; Cardiovascular Diseases; Cause of Death; Female; Folic Acid; Homocysteine; Humans; Hyperhomocysteinemia; Kidney Failure, Chronic; Male; Middle Aged; Myocardial Infarction; Renal Dialysis; Stroke; Venous Thrombosis; Vitamin B 12; Vitamin B 6; Vitamin B Complex
PubMed: 27243372
DOI: 10.1002/14651858.CD004683.pub4 -
Nutrients Jun 2017Although vitamins play a major role in health, and their deficiency may be linked to symptoms of optic-nerve dysfunction, the association between serum vitamin levels... (Meta-Analysis)
Meta-Analysis Review
Although vitamins play a major role in health, and their deficiency may be linked to symptoms of optic-nerve dysfunction, the association between serum vitamin levels and glaucoma in humans remains controversial. In this study, articles in the PubMed, Web of Science, and EMBASE databases were searched up to 25March 2017. Nine studies on primary open-angle glaucoma (POAG), four studies on normal tension glaucoma (NTG), and six studies on exfoliative glaucoma (EXG) were retrieved. The combined results showed no differences in the levels of serum vitamin B₆ between POAG ( = 0.406) and EXG ( = 0.139) patients and controls. The weighted mean differences (WMDs) with 95% confidence intervals (CIs) were 2.792 ng/mL (-3.793 to 9.377) and 1.342 ng/mL (-3.120 to 0.436), respectively. There was no difference between POAG ( = 0.952), NTG ( = 0.757), or EXG ( = 0.064) patients and controls in terms of serum vitamin B. The WMDs with 95% CIs were 0.933 pg/mL (-31.116 to 29.249), 6.652 pg/mL (-35.473 to 48.777), and 49.946 pg/mL (-102.892 to 3.001), respectively. The serum vitamin D levels exhibited no differences ( = 0.064) between POAG patients and controls; the WMD with 95% CI was 2.488 ng/mL (-5.120 to 0.145). In conclusion, there was no association found between serum vitamin B₆, vitamin B, or vitamin D levels and the different types of glaucoma.
Topics: Glaucoma; Glaucoma, Open-Angle; Humans; Sensitivity and Specificity; Vitamin B 12; Vitamin B 6; Vitamin D
PubMed: 28635642
DOI: 10.3390/nu9060636 -
Urology Journal Dec 2017This review systematically discusses and summarizes the effect of vitamin B6 on semen quality.
PURPOSE
This review systematically discusses and summarizes the effect of vitamin B6 on semen quality.
MATERIAL AND METHOD
To achieve this contribution, we searched the PubMed, Scopus, and Web of Science databases for English language papers from 1984 through 2017 using the key words "sperm" versus "Vitamin B6", "pyridoxine", and "pyridoxal". Also, the references from selected published papers were included, only if relevant.
RESULT
To date, as revealed by rodent studies, high doses of vitamin B6 impair semen quality and sperm parameters. While in humans, it is suggested, but not yet directly approved, that seminal vitamin B6 levels may alter sperm quality (i.e., sperm quantity and quality), and that vitamin B6 deficiency may trigger the chemical toxicity to sperm (i.e., hyperhomocysteinemia, oxidative injury).
CONCLUSION
The adverse effect of vitamin B6, when used at high doses, has been revealed in experimental animals, but not yet directly approved in humans. Consequently, in vitro studies on human ejaculate as well as clinical studies that investigate the direct effect of vitamin B6 on semen quality seem very significant.
PubMed: 29290084
DOI: 10.22037/uj.v0i0.3808 -
Nutrition and Cancer 2023Inconsistent findings have emerged from epidemiological research investigating the association between vitamin B and the risk of gastric cancer. To obtain a more precise... (Meta-Analysis)
Meta-Analysis Review
Inconsistent findings have emerged from epidemiological research investigating the association between vitamin B and the risk of gastric cancer. To obtain a more precise assessment, we conducted a comprehensive search of published data and performed a meta-analysis. PubMed, Web of Science, EMBASE and Cochrane Library databases were systematically searched. A total of 12 studies (5 prospective cohort and 7 case-control studies) involving 5,692 cases and 814,157 participants were included in the meta-analysis. The results showed that high intake of vitamin B may reduce the odds of gastric cancer (OR = 0.83, 95% CI: 0.73-0.95, = 0.006). However, this association was only observed in the case-control studies (OR = 0.68, 95% CI: 0.51-0.89, = 0.006) but not in the cohort studies (RR = 1.01, 95% CI: 0.94-1.08, = 0.819). Additionally, the negative association between vitamin B intake and gastric cancer risk was found in the United States of America (OR = 0.71, 95% CI: 0.62-0.82, = 10), but not in Europe (OR = 0.88, 95% CI: 0.74-1.05, = 0.169) or the other regions (OR = 0.86, 95% CI: 0.66-1.13, = 0.280). In conclusion, there is not sufficient evidence to assume that vitamin B intake is associated with gastric cancer risk, which needs further confirmation.
Topics: Humans; United States; Vitamin B 6; Stomach Neoplasms; Prospective Studies; Risk; Vitamins; Vitamin B 12
PubMed: 37904520
DOI: 10.1080/01635581.2023.2274134 -
Frontiers in Medicine 2023Many eye diseases, such as diabetic retinopathy (DR), age-related macular degeneration (AMD), and cataracts are preventable and treatable with lifestyle. The objective...
Many eye diseases, such as diabetic retinopathy (DR), age-related macular degeneration (AMD), and cataracts are preventable and treatable with lifestyle. The objective of this review is to assess the most recent research on the ideal dietary approach to prevent or support the treatment of DR, AMD, and cataracts, as well as to construct a food pyramid that makes it simple for people who are at risk of developing these pathologies to decide what to eat. The food pyramid presented here proposes what should be consumed every day: 3 portions of low glycemic index (GI) grains (for fiber and zinc content), 5 portions (each portion: ≥200 g/day) of fruits and vegetables (spinach, broccoli, zucchini cooked, green leafy vegetables, orange, kiwi, grapefruit for folic acid, vitamin C, and lutein/zeaxanthin content, at least ≥42 μg/day, are to be preferred), extra virgin olive (EVO) oil (almost 20 mg/day for vitamin E and polyphenols content), nuts or oil seeds (20-30 g/day, for zinc content, at least ≥15.8 mg/day); weekly: fish (4 portions, for omega-3 content and eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) 0.35-1.4 g/day), white meat (3 portions for vitamin B12 content), legumes (2 portions for vegetal proteins), eggs (2 portions for lutein/zeaxanthin content), light cheeses (2 portions for vitamin B6 content), and almost 3-4 times/week microgreen and spices (saffron and curcumin). At the top of the pyramid, there are two pennants: one green, which indicates the need for personalized supplementation (if daily requirements cannot be met through diet, omega-3, and L-methylfolate supplementation), and one red, which indicates that certain foods are prohibited (salt and sugar). Finally, 3-4 times per week, 30-40 min of aerobic and resistance exercises are required.
PubMed: 37324128
DOI: 10.3389/fmed.2023.1168560 -
The American Journal of Clinical... Mar 2024The optimal dosage range for B-vitamin supplementation for stroke prevention has not received sufficient attention. (Meta-Analysis)
Meta-Analysis
BACKGROUND
The optimal dosage range for B-vitamin supplementation for stroke prevention has not received sufficient attention.
OBJECTIVE
Our aim was to determine the optimal dosage range of a combination of folic acid, vitamin B12, and vitamin B6 supplementation in stroke prevention.
METHODS
We searched PubMed, the Cochrane Central Register of Controlled Trials, and Embase database for randomized controlled trials published between January 1966 and April 2023, whose participants received B-vitamin supplementation and that reported the number of stroke cases. Relative risk (RR) was used to measure the effect of combined supplementation on risk of stroke using a fixed-effects model. Risk of bias was assessed with the Cochrane risk-of-bias algorithm.
RESULTS
The search identified 14 randomized controlled trials of folic acid combined with vitamin B12 and vitamin B6 supplementation for stroke prevention that included 76,664 participants with 2720 stroke cases. In areas without and with partial folic acid fortification, combined B-vitamin supplementation significantly reduced the risk of stroke by 34% [RR: 0.66; 95% confidence interval (CI): 0.50, 0.86] and 11% (RR: 0.89; 95% CI: 0.79, 1.00), respectively. Further analysis showed that a dosage of folic acid ≤0.8 mg/d and vitamin B12 ≤0.4 mg/d was best for stroke prevention (RR: 0.65; 95% CI: 0.48, 0.86) in these areas. In contrast, no benefit of combined supplementation was found in fortified areas (RR: 1.04; 95% CI: 0.94, 1.16).
CONCLUSIONS
Our meta-analysis found that the folic acid combined with vitamin B12 and vitamin B6 supplementation strategy significantly reduced the risk of stroke in areas without and with partial folic acid fortification. Combined dosages not exceeding 0.8 mg/d for folic acid and 0.4 mg/d for vitamin B12 supplementation may be more effective for populations within these areas. This trial was registered at PROSPERO asCRD42022355077.
Topics: Humans; Vitamins; Vitamin B 12; Folic Acid; Vitamin B 6; Stroke; Dietary Supplements
PubMed: 38432716
DOI: 10.1016/j.ajcnut.2023.12.021 -
Journal of Alzheimer's Disease : JAD 2020Previous studies have indicated that B vitamin deficiencies are an essential cause of neurological pathology. There is a need to provide evidence of the benefit of B... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Previous studies have indicated that B vitamin deficiencies are an essential cause of neurological pathology. There is a need to provide evidence of the benefit of B vitamins for the prevention of cognitive decline in community-dwelling older adults.
OBJECTIVE
To examine the association between intake and plasma levels of vitamins B12, B6, and folate and cognitive function in older populations through a systematic review and meta-analysis.
METHODS
Medline (PubMed), EMBASE, and Cochrane databases were used to search the literature though August 8, 2019. We included observational population-based studies evaluating the association between concentrations or intake levels of vitamins B6, B12, or folate and cognition in older adults aged ≥45 years. The quality of all studies was assessed by the modified Newcastle-Ottawa Scale. Odds ratios (ORs) and hazard ratios (HRs) were analyzed by the random-effects model. Sensitivity analyses were conducted by excluding the studies with significant heterogeneity.
RESULTS
Twenty-one observational studies with sample sizes ranging from 155-7030 were included in the meta-analysis. Higher levels of vitamin B12 (OR = 0.77, 95% CI = 0.61-0.97) and folate concentration (OR = 0.68, 95% CI = 0.51-0.90) were associated with better cognition in cross-sectional studies, but not in sensitivity analyses or prospective studies. High vitamin B6 concentrations showed no significant benefit on cognition and dementia risk. Prospective studies did not provide substantial evidence for the relationship.
CONCLUSION
The results from our meta-analysis suggest that vitamins B12, B6, and folate may not be modifiable risk factors for slowing cognitive decline among community-dwelling older individuals.
Topics: Cognition; Cognitive Dysfunction; Cross-Sectional Studies; Folic Acid; Humans; Independent Living; Observational Studies as Topic; Vitamin B 12; Vitamin B 6
PubMed: 32773392
DOI: 10.3233/JAD-200534