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The Cochrane Database of Systematic... Dec 2018Vitamins and minerals play multiple functions within the central nervous system which may help to maintain brain health and optimal cognitive functioning.... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Vitamins and minerals play multiple functions within the central nervous system which may help to maintain brain health and optimal cognitive functioning. Supplementation of the diet with various vitamins and minerals has been suggested as a means of maintaining cognitive function, or even of preventing dementia, in later life.
OBJECTIVES
To evaluate the effects of vitamin and mineral supplementation on cognitive function in cognitively healthy people aged 40 years or more.
SEARCH METHODS
We searched ALOIS, the Cochrane Dementia and Cognitive Improvement Group's (CDCIG) specialised register, as well as MEDLINE, Embase, PsycINFO, CINAHL, ClinicalTrials.gov and the WHO Portal/ICTRP from inception to 26th January 2018.
SELECTION CRITERIA
We included randomised controlled trials that evaluated the cognitive effects on people aged 40 years or more of any vitamin or mineral supplements taken by mouth for at least three months.
DATA COLLECTION AND ANALYSIS
Study selection, data extraction, and quality assessments were done in duplicate. Vitamins were considered broadly in the categories of B vitamins, antioxidant vitamins, and combinations of both. Minerals were considered separately, where possible. If interventions and outcomes were considered sufficiently similar, then data were pooled. In order to separate short-term cognitive effects from possible longer-term effects on the trajectory of cognitive decline, data were pooled for various treatment durations from 3 months to 12 months and up to 10 years or more.
MAIN RESULTS
In total, we included 28 studies with more than 83,000 participants. There were some general limitations of the evidence. Most participants were enrolled in studies which were not designed primarily to assess cognition. These studies often had no baseline cognitive assessment and used only brief cognitive assessments at follow-up. Very few studies assessed the incidence of dementia. Most study reports did not mention adverse events or made only very general statements about them. Only 10 studies had a mean follow-up > 5 years. Only two studies had participants whose mean age was < 60 years at baseline. The risk of bias in the included studies was generally low, other than a risk of attrition bias for longer-term outcomes. We considered the certainty of the evidence behind almost all results to be moderate or low.We included 14 studies with 27,882 participants which compared folic acid, vitamin B12, vitamin B6, or a combination of these to placebo. The majority of participants were aged over 60 years and had a history of cardio- or cerebrovascular disease. We found that giving B vitamin supplements to cognitively healthy adults, mainly in their 60s and 70s, probably has little or no effect on global cognitive function at any time point up to 5 years (SMD values from -0.03 to 0.06) and may also have no effect at 5-10 years (SMD -0.01). There were very sparse data on adverse effects or on incidence of cognitive impairment or dementia.We included 8 studies with 47,840 participants in which the active intervention was one or more of the antioxidant vitamins: ß-carotene, vitamin C or vitamin E. Results were mixed. For overall cognitive function, there was low-certainty evidence of benefit associated with ß-carotene after a mean of 18 years of treatment (MD 0.18 TICS points, 95% CI 0.01 to 0.35) and of vitamin C after 5 years to 10 years (MD 0.46 TICS points, 95% CI 0.14 to 0.78), but not at earlier time points. From two studies which reported on dementia incidence, there was low-certainty evidence of no effect of an antioxidant vitamin combination or of vitamin E, either alone or combined with selenium. One of the included studies had been designed to look for effects on the incidence of prostate cancer; it found a statistically significant increase in prostate cancer diagnoses among men taking vitamin E.One trial with 4143 participants compared vitamin D3 (400 IU/day) and calcium supplements to placebo. We found low- to moderate-certainty evidence of no effect of vitamin D3 and calcium supplements at any time-point up to 10 years on overall cognitive function (MD after a mean of 7.8 years -0.1 MMSE points, 95% CI -0.81 to 0.61) or the incidence of dementia (HR 0.94, 95% CI 0.72 to 1.24). A pilot study with 60 participants used a higher dose of vitamin D3 (4000 IU on alternate days) and found preliminary evidence that this dose probably has no effect on cognitive function over six months.We included data from one trial of zinc and copper supplementation with 1072 participants. There was moderate-certainty evidence of little or no effect on overall cognitive function (MD 0.6 MMSE points, 95% CI -0.19 to 1.39) or on the incidence of cognitive impairment after 5 years to 10 years. A second smaller trial provided no usable data, but reported no cognitive effects of six months of supplementation with zinc gluconate.From one study with 3711 participants, there was low-certainty evidence of no effect of approximately five years of selenium supplementation on the incidence of dementia (HR 0.83, 95% CI 0.61 to 1.13).Finally, we included three trials of complex supplements (combinations of B vitamins, antioxidant vitamins, and minerals) with 6306 participants. From the one trial which assessed overall cognitive function, there was low-certainty evidence of little or no effect on the TICS (MD after a mean of 8.5 years 0.12, 95% CI -0.14 to 0.38).
AUTHORS' CONCLUSIONS
We did not find evidence that any vitamin or mineral supplementation strategy for cognitively healthy adults in mid or late life has a meaningful effect on cognitive decline or dementia, although the evidence does not permit definitive conclusions. There were very few data on supplementation starting in midlife (< 60 years); studies designed to assess cognitive outcomes tended to be too short to assess maintenance of cognitive function; longer studies often had other primary outcomes and used cognitive measures which may have lacked sensitivity. The only positive signals of effect came from studies of long-term supplementation with antioxidant vitamins. These may be the most promising for further research.
Topics: Adult; Aged; Antioxidants; Ascorbic Acid; Calcium; Cholecalciferol; Cognition; Cognitive Dysfunction; Copper; Dementia; Dietary Supplements; Folic Acid; Humans; Middle Aged; Minerals; Randomized Controlled Trials as Topic; Selenium; Vitamin A; Vitamin B 12; Vitamin B 6; Vitamin E; Vitamins; Zinc; beta Carotene
PubMed: 30556597
DOI: 10.1002/14651858.CD011906.pub2 -
JMIR MHealth and UHealth Jul 2021Telemedicine, including video-, web-, and telephone-based interventions, is used in adult and pediatric populations to deliver health care and communicate with patients.... (Review)
Review
BACKGROUND
Telemedicine, including video-, web-, and telephone-based interventions, is used in adult and pediatric populations to deliver health care and communicate with patients. In the realm of hematology, telemedicine has recently been used to safely and efficiently monitor treatment side-effects, perform consultations, and broaden the reach of subspecialty care.
OBJECTIVE
We aimed to synthesize and analyze information regarding the feasibility, acceptability, and potential benefits of telemedicine interventions in malignant and nonmalignant hematology, as well as assess the recognized limitations of these interventions.
METHODS
Studies were identified through a comprehensive Medical Subject Headings (MeSH) search on the PubMed MEDLINE, Controlled Register of Clinical Trials (Cochrane CENTRAL from Wiley), Embase, and CINAHL (EBSCO) databases on February 7, 2018. A second search, utilizing the same search strategy, was performed on October 1, 2020. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines in the reporting of included evidence. Included studies were original articles researching the feasibility, acceptability, and clinical outcomes of telemedicine or telehealth interventions in pediatric or adult populations with malignant or nonmalignant hematological conditions. Data items in the extraction form included first author name, publication year, country, malignant or nonmalignant hematological condition or disease focus of the study, participant age, participant age subgroup (pediatric or adult), study design and setting, telemedicine intervention type and description, study purpose, and main study outcomes.
RESULTS
A total of 32 articles met the preset criteria and were included in this study. Most (25/32) studies were conducted in adults, and the remaining (7/32) were conducted in the pediatric population. Of the 32 studies, 12 studied malignant hematological conditions, 18 studied nonmalignant conditions, and two studied both malignant and nonmalignant conditions. Study types included pilot study (11/32), retrospective study (9/32), randomized controlled trial (6/32), cross-sectional study (2/32), case study (1/32), pre-post study (1/32), noncomparative prospective study (1/32), and prospective cohort study (1/32). The three main types of telemedicine interventions utilized across all studies were video-based (9/32), telephone-based (9/32), and web-based interventions (14/32). Study results showed comparable outcomes between telemedicine and traditional patient encounter groups across both pediatric and adult populations for malignant and nonmalignant hematological conditions.
CONCLUSIONS
Evidence from this review suggests that telemedicine use in nonmalignant and malignant hematology provides similar or improved health care compared to face-to-face encounters in both pediatric and adult populations. Telemedicine interventions utilized in the included studies were well received in both pediatric and adult settings. However, more research is needed to determine the efficacy of implementing more widespread use of telemedicine for hematological conditions.
Topics: Adult; Child; Cross-Sectional Studies; Hematology; Humans; Pilot Projects; Prospective Studies; Retrospective Studies; Telemedicine
PubMed: 34255706
DOI: 10.2196/29619 -
BMJ Open Nov 2017To systematically review the quality of reporting of pilot and feasibility of cluster randomised trials (CRTs). In particular, to assess (1) the number of pilot CRTs... (Review)
Review
OBJECTIVES
To systematically review the quality of reporting of pilot and feasibility of cluster randomised trials (CRTs). In particular, to assess (1) the number of pilot CRTs conducted between 1 January 2011 and 31 December 2014, (2) whether objectives and methods are appropriate and (3) reporting quality.
METHODS
We searched PubMed (2011-2014) for CRTs with 'pilot' or 'feasibility' in the title or abstract; that were assessing some element of feasibility and showing evidence the study was in preparation for a main effectiveness/efficacy trial. Quality assessment criteria were based on the Consolidated Standards of Reporting Trials (CONSORT) extensions for pilot trials and CRTs.
RESULTS
Eighteen pilot CRTs were identified. Forty-four per cent did not have feasibility as their primary objective, and many (50%) performed formal hypothesis testing for effectiveness/efficacy despite being underpowered. Most (83%) included 'pilot' or 'feasibility' in the title, and discussed implications for progression from the pilot to the future definitive trial (89%), but fewer reported reasons for the randomised pilot trial (39%), sample size rationale (44%) or progression criteria (17%). Most defined the cluster (100%), and number of clusters randomised (94%), but few reported how the cluster design affected sample size (17%), whether consent was sought from clusters (11%), or who enrolled clusters (17%).
CONCLUSIONS
That only 18 pilot CRTs were identified necessitates increased awareness of the importance of conducting and publishing pilot CRTs and improved reporting. Pilot CRTs should primarily be assessing feasibility, avoiding formal hypothesis testing for effectiveness/efficacy and reporting reasons for the pilot, sample size rationale and progression criteria, as well as enrolment of clusters, and how the cluster design affects design aspects. We recommend adherence to the CONSORT extensions for pilot trials and CRTs.
Topics: Bias; Cluster Analysis; Feasibility Studies; Humans; Models, Statistical; Pilot Projects; Randomized Controlled Trials as Topic; Research Report; Sample Size
PubMed: 29122791
DOI: 10.1136/bmjopen-2017-016970 -
Reproductive Sciences (Thousand Oaks,... Apr 2023Uterine fibroids are the most common tumor of reproductive-age women worldwide and cause significant morbidity in affected women. Vitamin D has emerged as a potential... (Review)
Review
Uterine fibroids are the most common tumor of reproductive-age women worldwide and cause significant morbidity in affected women. Vitamin D has emerged as a potential therapy for uterine fibroids based on experimental and epidemiologic evidence. The objective of this systematic review was to evaluate the role of vitamin D in the pathophysiology of uterine fibroids and its efficacy for prevention and treatment of fibroids. A comprehensive search was conducted of Cochrane Library, Embase, PubMed, Scopus, and Web of Science from inception to March 2022. English-language publications that evaluated vitamin D and uterine fibroids in humans, whether experimental or clinical, were considered. The search yielded 960 publications, and 89 publications met inclusion criteria: 23 preclinical studies, 25 clinical studies, and 41 review articles. Preclinical studies indicated that the vitamin D receptor was decreased in fibroid cells. Vitamin D treatment of fibroid cells decreased proliferation, extracellular matrix protein expression, and Wnt/β-catenin signaling. Fourteen clinical studies (n = 3535 participants) assessed serum vitamin D level in women with ultrasound-proven fibroids, and all found an inverse correlation between serum vitamin D level and presence of fibroids. Five clinical studies (n = 472 patients) evaluated treatment of fibroids with vitamin D. Four of five studies showed vitamin D significantly inhibited fibroid growth. One pilot study (n = 109 patients) of vitamin D for secondary prevention of fibroids demonstrated smaller recurrent fibroids in the treated group. These studies provide evidence for vitamin D as a therapy for uterine fibroids and underscore the need for well-designed, randomized, placebo-controlled clinical trials.
Topics: Humans; Female; Vitamin D; Uterine Neoplasms; Pilot Projects; Leiomyoma
PubMed: 35960442
DOI: 10.1007/s43032-022-01011-z -
The American Journal of Cardiology May 2023Neuroendocrine tumors (NETs) are a rare group of malignancies which are aggressive and widely metastatic. Cardiac metastases (CMs) are rarely reported because of NET. We... (Meta-Analysis)
Meta-Analysis
Neuroendocrine tumors (NETs) are a rare group of malignancies which are aggressive and widely metastatic. Cardiac metastases (CMs) are rarely reported because of NET. We aim to analyze the available literature to study the proportional prevalence of CM because of NET and its location and effect on the ejection fraction (EF) and survival rate. Our search strategy and meta-analysis are in line with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) AMSTAR-2 (Assessing the methodological quality of systematic Reviews-2) Guidelines. A literature search was conducted on MEDLINE (EMBASE and PubMed) for randomized clinical trials, pilot trials, and retrospective and prospective studies. Statistical analysis was performed using the CRAN-R software (https://CRAN.R-project.org/doc/FAQ/R-FAQ.html). The quality assessment of the included articles was performed using the Cochrane Risk of Bias and Newcastle-Ottawa Scale. A total of 16,685 patients were included in the study. The mean age of patients included in the study was 61.28 ± SD 9.89 years. Of these, 257 patients had a total of 283 CM. Metastasis was mainly located in the left ventricle with a pooled proportion of 0.48, 95% confidence interval (CI) 0.4 to 0.56, pericardium: 0.34, 95% CI 0.19 to 0.53, right ventricle 0.28, 95% CI 0.16 to 0.44, interventricular septum 0.25, 95% CI 0.16 to 0.37, left atrium 0.1, 95% CI 0.03 to 0.26 and right atrium 0.05, 95% CI 0.01 to 0.20. Decrease in EF at the time of CM diagnosis was the effect most consistently reported in patients with CM. Pooled mean survival was 35.89, 95% CI 8.27 to 155.68 months after the diagnosis of CM. CM due to NET was <2% and the left ventricle is the most common metastatic location, followed by the pericardium. Decreased EF was the most common clinical picture observed. Further studies are needed to analyze the clinical impact of NET CM.
Topics: Humans; Middle Aged; Prospective Studies; Prevalence; Retrospective Studies; Melanoma; Melanoma, Cutaneous Malignant
PubMed: 36996525
DOI: 10.1016/j.amjcard.2023.02.011 -
Journal of Cancer Research and Clinical... Apr 2018Physical activity has positive effects on cancer patients. Dancing addresses diverse bio-psycho-social aspects. Our aim was to assess the evidence on ballroom dancing... (Review)
Review
BACKGROUND
Physical activity has positive effects on cancer patients. Dancing addresses diverse bio-psycho-social aspects. Our aim was to assess the evidence on ballroom dancing and to develop the setting for a pilot project.
METHODS
We performed a systematic review, extracted the data and designed a pilot training based on standard curricula. We included cancer patients during or after therapy. Training duration was 90 min with one regular pause and individual pauses as needed.
RESULTS
We retrieved two systematic reviews and six controlled studies. Types of dancing varied. Only one study used ballroom dancing. Dance training might improve well-being, physical fitness, fatigue and coping during and after therapy. Yet, evidence is scarce and data to derive the effect size are lacking; 27 patients and their partners took part in the pilot training. Patients and partners needed more time to learn the steps than is planned in regular ballroom classes. Participants were very satisfied with the adaptation of the training to their physical strength and estimated the training in a sheltered group. No side effects occurred. In spite of a high rate of participants reporting fatigue, 90 min of physical activity with only a few minutes of rest were manageable for all participants.
CONCLUSION
Ballroom dancing may offer benefits for patients with respect to quality of life. Cancer patients prefer sheltered training setting and curricula of regular ballroom classes must be adapted for cancer patients. Strict curricula might reduce motivation and adherence and exclude patients with lower or variable fitness.
Topics: Adult; Aged; Dancing; Female; Humans; Male; Middle Aged; Neoplasms; Pilot Projects; Randomized Controlled Trials as Topic
PubMed: 29423728
DOI: 10.1007/s00432-018-2606-8 -
Advances in Experimental Medicine and... 2023Higher education's expectations place demands on students' attainment, leading them to experience stress and anxiety, which negatively affect their academic improvement...
Higher education's expectations place demands on students' attainment, leading them to experience stress and anxiety, which negatively affect their academic improvement and life satisfaction. The aim of this systematic review was to investigate (a) if mindfulness as an inner ability is related to academic attainment, through dependent variables, including compassion, engagement, stress or anxiety state, depression, self-efficacy, mindfulness's facets (non-reactivity, acting with awareness) and (b) if mindfulness-based interventions positively affect the academic performance of college and university students. The systematic review was conducted in accordance with the PRISMA statement. PubMed, Web of Science, and Cochrane Library Wiley were screened to identify studies published relevant to the topic. In total, 568 papers were retrieved in the initial search. Five papers met the eligibility criteria and were included in the systematic review: a randomized controlled trial, a non-randomized controlled trial, a quasi-experimental study, a quantitative exploratory pilot study, and a longitudinal randomized controlled study. Most interventional studies revealed a non-significant direct effect of practicing mindfulness technique on academic attainment. Further research, especially randomized controlled trials are necessary to clarify the effect of mindfulness on academic performance of college and university students.
Topics: Humans; Academic Performance; Depression; Mindfulness; Pilot Projects; Randomized Controlled Trials as Topic; Stress, Psychological; Students; Universities
PubMed: 37581795
DOI: 10.1007/978-3-031-31986-0_20 -
The Cochrane Database of Systematic... Dec 2014Manual rotation is commonly performed to increase the chances of normal vaginal delivery and is perceived to be safe. Manual rotation has the potential to prevent... (Review)
Review
BACKGROUND
Manual rotation is commonly performed to increase the chances of normal vaginal delivery and is perceived to be safe. Manual rotation has the potential to prevent operative delivery and caesarean section, and reduce obstetric and neonatal complications.
OBJECTIVES
To assess the effect of prophylactic manual rotation for women with malposition in labour on mode of delivery, and maternal and neonatal outcomes.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 October 2014), the Australian and New Zealand Clinical Trials Registry (ANZCTR), ClinicalTrials.gov, Current Controlled Trials and the WHO International Clinical Trials Registry Platform (ICTRP) (all searched 23 February 2014), previous reviews and, references of retrieved studies.
SELECTION CRITERIA
Randomised, quasi-randomised or cluster-randomised clinical trials comparing prophylactic manual rotation in labour for fetal malposition versus expectant management, augmentation of labour or operative delivery. We defined prophylactic manual rotation as rotation performed without immediate assisted delivery.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed study eligibility and quality, and extracted data.
MAIN RESULTS
We included only one small pilot study (involving 30 women). The study, which we considered to be at low risk of bias, was conducted in a tertiary referral hospital in Australia, and involved women with cephalic, singleton pregnancies. The primary outcome was operative delivery (instrumental delivery or caesarean section).In the manual rotation group, 13/15 women went on to have an instrumental delivery or caesarean section, whereas in the control group, 12/15 women had an operative delivery. The estimated risk ratio was 1.08 (95% confidence interval 0.79 to 1.49). There were no maternal or fetal mortalities in either groupThere were no clear differences for any of the secondary maternal or neonatal outcomes reported (e.g. perineal trauma, analgesia use duration of labour).In terms of adverse events, there were no reported cases of umbilical cord prolapse or cervical laceration and a single case of a non-reassuring or pathological cardiotocograph during the procedure.
AUTHORS' CONCLUSIONS
Currently, there is insufficient evidence to determine the efficacy of prophylactic manual rotation early in the second stage of labour for prevention of operative delivery. One additional study is ongoing. Further appropriately designed trials are required to determine the efficacy of manual rotation.
Topics: Adult; Analgesia, Obstetrical; Cesarean Section; Extraction, Obstetrical; Female; Humans; Labor Presentation; Obstetric Labor Complications; Perineum; Pilot Projects; Pregnancy; Version, Fetal
PubMed: 25532081
DOI: 10.1002/14651858.CD009298.pub2 -
Evidence-based Dentistry Jun 2022Data sources PubMed, Scopus, Web of Science, Latin American and Caribbean Health Sciences Literature, Brazilian Bibliography in Dentistry and Cochrane Library. The grey... (Meta-Analysis)
Meta-Analysis Review
Data sources PubMed, Scopus, Web of Science, Latin American and Caribbean Health Sciences Literature, Brazilian Bibliography in Dentistry and Cochrane Library. The grey literature was searched using the System for Information on Grey Literature in Europe database. Abstracts from the Annual Session of the International Association for Dental Research and its regional subgroups (1990-2020) were searched. Theses and dissertations (full texts) were searched in the ProQuest and Capes databases. Unpublished and ongoing studies were searched in clinical trial databases (Current Controlled Trials, International Clinical Trials Registry Platform, ClinicalTrials.gov, Registro Brasileiro de Ensaios Clínicos and EU Clinical Trials Register).Study selection In total, 14 randomised clinical trials comparing the clinical performance of composite resin restorations in posterior teeth placed with the incremental or the bulk-filling techniques were evaluated.Data extraction and synthesis Relevant information on the research project, participants, interventions and outcomes was collected using extraction forms by three study authors. Data extraction was pilot-tested using a sample of four studies to ensure that the data were consistent with the specific research question. To avoid overlapping, multiple reports of the same study with different follow-ups were extracted into a single form.Results Considering the primary and secondary outcomes (retention/fracture rate, anatomical form, surface texture, colour match, marginal adaption, marginal discoloration, caries and postoperative sensitivity), it is possible to state that there was no difference between incremental or bulk fill resin composite techniques in Class II and I cavities.Conclusions A systematic review and meta-analysis with moderated quality of evidence bulk fill and incremental techniques showed similar clinical performance on posterior resin composite restorations.
Topics: Brazil; Caribbean Region; Composite Resins; Databases, Factual; Dental Caries; Dental Restoration, Permanent; Humans
PubMed: 35750739
DOI: 10.1038/s41432-022-0264-9 -
Undersea & Hyperbaric Medicine :... 2016Traumatic brain injury (TBI) affects 3.2 to 5.3 million persons in the United States (U.S.), and the impact in the U.S. military is proportionally higher. Consensus is... (Review)
Review
Traumatic brain injury (TBI) affects 3.2 to 5.3 million persons in the United States (U.S.), and the impact in the U.S. military is proportionally higher. Consensus is lacking regarding an accepted outcome to measure the effectiveness of interventions to improve the symptoms associated with TBI, and no standard-of-care treatment exists for mild TBI (mTBI). A recent literature review evaluated hyperbaric oxygen therapy (HBO₂) interventions, and findings were mixed. We conducted a systematic review of non-HBO₂ mTBI interventional trials published in 2005-2015 in military and civilian populations. A total of 154 abstracts, seven randomized controlled trials (RCTs) and five pilot studies were reviewed. RCTs were evaluated using Consolidated Standards of Reporting Trials criteria. Results indicated that studies published within the period of review were small pilot studies for rehabilitation therapy and motion capture or virtual reality gaming interventions. Neuropsychological assessments were commonly specified outcomes, and most studies included a combination of symptom and neuropsychological assessments. Findings indicated a lack of large-scale, well-controlled trials to address the symptoms and sequelae of this condition, but results of small exploratory studies show evidence of potentially promising interventions.
Topics: Brain Concussion; Humans; Military Personnel; Neuropsychological Tests; Outcome Assessment, Health Care; Pilot Projects; Quality of Life; Randomized Controlled Trials as Topic; Stress Disorders, Post-Traumatic
PubMed: 28768077
DOI: No ID Found