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The Cochrane Database of Systematic... Sep 2010Nausea, retching and vomiting are very commonly experienced by women in early pregnancy. There are considerable physical and psychological effects on women who... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Nausea, retching and vomiting are very commonly experienced by women in early pregnancy. There are considerable physical and psychological effects on women who experience these symptoms. This is an update of a review of interventions for nausea and vomiting in early pregnancy previously published in 2003.
OBJECTIVES
To assess the effectiveness and safety of all interventions for nausea, vomiting and retching in early pregnancy, up to 20 weeks' gestation.
SEARCH STRATEGY
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (28 May 2010).
SELECTION CRITERIA
All randomised controlled trials of any intervention for nausea, vomiting and retching in early pregnancy. We excluded trials of interventions for hyperemesis gravidarum which are covered by another review. We also excluded quasi-randomised trials and trials using a crossover design.
DATA COLLECTION AND ANALYSIS
Four review authors, in pairs, reviewed the eligibility of trials and independently evaluated the risk of bias and extracted the data for included trials.
MAIN RESULTS
Twenty-seven trials, with 4041 women, met the inclusion criteria. These trials covered many interventions, including acupressure, acustimulation, acupuncture, ginger, vitamin B6 and several antiemetic drugs. We identified no studies of dietary or other lifestyle interventions. Evidence regarding the effectiveness of P6 acupressure, auricular (ear) acupressure and acustimulation of the P6 point was limited. Acupuncture (P6 or traditional) showed no significant benefit to women in pregnancy. The use of ginger products may be helpful to women, but the evidence of effectiveness was limited and not consistent. There was only limited evidence from trials to support the use of pharmacological agents including vitamin B6, and anti-emetic drugs to relieve mild or moderate nausea and vomiting. There was little information on maternal and fetal adverse outcomes and on psychological, social or economic outcomes. We were unable to pool findings from studies for most outcomes due to heterogeneity in study participants, interventions, comparison groups, and outcomes measured or reported. The methodological quality of the included studies was mixed.
AUTHORS' CONCLUSIONS
Given the high prevalence of nausea and vomiting in early pregnancy, health professionals need to provide clear guidance to women, based on systematically reviewed evidence. There is a lack of high-quality evidence to support that advice. The difficulties in interpreting the results of the studies included in this review highlight the need for specific, consistent and clearly justified outcomes and approaches to measurement in research studies.
Topics: Acupuncture Therapy; Antiemetics; Female; Zingiber officinale; Humans; Morning Sickness; Nausea; Phytotherapy; Pregnancy; Pregnancy Complications; Randomized Controlled Trials as Topic; Treatment Outcome; Vitamin B 6; Vitamin B Complex; Vomiting
PubMed: 20824863
DOI: 10.1002/14651858.CD007575.pub2 -
The Cochrane Database of Systematic... Sep 2010Nausea and vomiting are the most common symptoms experienced in early pregnancy, with nausea affecting between 70 and 85% of women. About half of pregnant women... (Review)
Review
BACKGROUND
Nausea and vomiting are the most common symptoms experienced in early pregnancy, with nausea affecting between 70 and 85% of women. About half of pregnant women experience vomiting.
OBJECTIVES
To assess the effects of different methods of treating nausea and vomiting in early pregnancy.
SEARCH STRATEGY
We searched the Cochrane Pregnancy and Childbirth Group trials register (December 2002) and the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 4, 2002).
SELECTION CRITERIA
Randomised trials of any treatment for nausea and/or vomiting in early pregnancy.
DATA COLLECTION AND ANALYSIS
Two reviewers assessed the trial quality and extracted the data independently.
MAIN RESULTS
Twenty-eight trials met the inclusion criteria. For milder degrees of nausea and vomiting, 21 trials were included. These trials were of variable quality. Nausea treatments were: different antihistamine medications, vitamin B6 (pyridoxine), the combination tablet Debendox (Bendectin), P6 acupressure and ginger. For hyperemesis gravidarum, seven trials were identified testing treatments with oral ginger root extract, oral or injected corticosteroids or injected adrenocorticotropic hormone (ACTH), intravenous diazepam and acupuncture. Based on 12 trials, there was an overall reduction in nausea from anti-emetic medication (odds ratio 0.16, 95% confidence interval 0.08 to 0.33).
AUTHORS' CONCLUSIONS
Anti-emetic medication appears to reduce the frequency of nausea in early pregnancy. There is some evidence of adverse effects, but there is very little information on effects on fetal outcomes from randomised controlled trials. Of newer treatments, pyridoxine (vitamin B6) appears to be more effective in reducing the severity of nausea. The results from trials of P6 acupressure are equivocal. No trials of treatments for hyperemesis gravidarum show any evidence of benefit. Evidence from observational studies suggests no evidence of teratogenicity from any of these treatments.
Topics: Antiemetics; Female; Humans; Hyperemesis Gravidarum; Nausea; Pregnancy; Pregnancy Complications; Pregnancy Trimester, First; Pregnancy Trimester, Second; Randomized Controlled Trials as Topic; Vomiting
PubMed: 20824826
DOI: 10.1002/14651858.CD000145.pub2 -
BMJ Clinical Evidence Jan 2010Evidence for the efficacy of treatments for autism has improved in recent years. In this systematic review the evidence for both drug and non-drug treatments is... (Review)
Review
INTRODUCTION
Evidence for the efficacy of treatments for autism has improved in recent years. In this systematic review the evidence for both drug and non-drug treatments is appraised and clinical guidance is provided for their use.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of early intensive multidisciplinary intervention programmes in children with autism? What are the effects of dietary interventions in children with autism? What are the effects of drug treatments in children with autism? What are the effects of non-drug treatments in children with autism? We searched: Medline, Embase, The Cochrane Library, and other important databases up to May 2009 (Clinical evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 30 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: applied behavioural analysis; auditory integration training; Autism Preschool Programme; casein-free diet; chelation; Child's Talk programme; cognitive behavioural therapy; digestive enzymes; EarlyBird programme; facilitated communication; Floortime therapy; gluten-free diet; immunoglobulins; melatonin; memantine; methylphenidate; More Than Words programme; music therapy; olanzapine; omega-3 fish oil; picture exchange communication system; Portage scheme; probiotics; relationship development interventions; risperidone; secretin; selective serotonin reuptake inhibitors (SSRIs); sensory integration training; social stories; social skills training; Son-Rise programme; TEACCH; vitamin A; vitamin B6 (pyridoxine) plus magnesium; and vitamin C.
Topics: Antipsychotic Agents; Autistic Disorder; Caseins; Double-Blind Method; Humans; Infant; Language Disorders; Magnesium; Memantine; Secretin
PubMed: 21729335
DOI: No ID Found -
The Cochrane Database of Systematic... Oct 2009Cardiovascular disease such as coronary artery disease, stroke and congestive heart failure, is a leading cause of death worldwide. A postulated risk factor is elevated... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Cardiovascular disease such as coronary artery disease, stroke and congestive heart failure, is a leading cause of death worldwide. A postulated risk factor is elevated circulating total homocysteine (tHcy) levels which is influenced mainly by blood levels of cyanocobalamin (vitamin B12), folic acid (vitamin B9) and pyridoxine (vitamin B6). There is uncertainty regarding the strength of association between tHcy and the risk of cardiovascular disease.
OBJECTIVES
To assess the clinical effectiveness of homocysteine-lowering interventions (HLI) in people with or without pre-existing cardiovascular disease.
SEARCH STRATEGY
We searched The Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library (issue 3 2008), MEDLINE (1950 to August 2008), EMBASE (1988 to August 2008), and LILACS (1982 to September 2, 2008). We also searched in Allied and Complementary Medicine (AMED; 1985 to August 2008), ISI Web of Science (1993 to August 2008), and the Cochrane Stroke Group Specialised Register (April 2007). We hand searched pertinent journals and the reference lists of included papers. We also contacted researchers in the field. There was no language restriction in the search.
SELECTION CRITERIA
We included randomised clinical trials (RCTs) assessing the effects of HLI for preventing cardiovascular events with a follow-up period of 1 year or longer. We considered myocardial infarction and stroke as the primary outcomes. We excluded studies in patients with end-stage renal disease.
DATA COLLECTION AND ANALYSIS
We independently performed study selection, risk of bias assessment and data extraction. We estimated relative risks (RR) for dichotomous outcomes. We measured statistical heterogeneity using I(2). We used a random-effects model to synthesise the findings.
MAIN RESULTS
We included eight RCTs involving 24,210 participants with a low risk of bias in general terms. HLI did not reduce the risk of non-fatal or fatal myocardial infarction, stroke, or death by any cause (pooled RR 1.03, 95% CI 0.94 to 1.13, I(2) = 0%; pooled RR 0.89, 95% CI 0.73 to 1.08, I(2) = 15%); and pooled RR 1.00 (95% CI 0.92 to 1.09, I(2): 0%), respectively.
AUTHORS' CONCLUSIONS
Results from available published trials suggest that there is no evidence to support the use of HLI to prevent cardiovascular events.
Topics: Angina Pectoris; Cardiovascular Diseases; Humans; Hyperhomocysteinemia; Myocardial Infarction; Randomized Controlled Trials as Topic; Stroke; Vitamin B Complex
PubMed: 19821378
DOI: 10.1002/14651858.CD006612.pub2 -
BMJ Clinical Evidence Jun 2009More than half of pregnant women suffer from nausea and vomiting, which typically begins by the 4th week and disappears by the 16th week of pregnancy. The cause of... (Review)
Review
INTRODUCTION
More than half of pregnant women suffer from nausea and vomiting, which typically begins by the 4th week and disappears by the 16th week of pregnancy. The cause of nausea and vomiting in pregnancy is unknown, but may be due to the rise in human chorionic gonadotrophin concentration. In 1 in 200 women, the condition progresses to hyperemesis gravidarum, which is characterised by prolonged and severe nausea and vomiting, dehydration, and weight loss.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of treatment for nausea and vomiting in early pregnancy? What are the effects of treatments for hyperemesis gravidarum? We searched: Medline, Embase, The Cochrane Library, and other important databases up to May 2008 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 30 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: acupressure; acupuncture; antihistamines; corticosteroids; corticotrophins; diazepam; dietary interventions other than ginger; domperidone; ginger; metoclopramide; ondansetron; phenothiazines; and pyridoxine (vitamin B6).
Topics: Acupressure; Administration, Oral; Domperidone; Female; Humans; Metoclopramide; Nausea; Phytotherapy; Pregnancy; Single-Blind Method; United States Food and Drug Administration; Vomiting
PubMed: 21726485
DOI: No ID Found -
BMC Cardiovascular Disorders Sep 2008Experimental and epidemiological evidence suggests that homocysteine (tHcy) may be a causal risk factor for atherosclerosis. B-vitamin supplements reduce tHcy and... (Meta-Analysis)
Meta-Analysis Randomized Controlled Trial Review
The effect of long-term homocysteine-lowering on carotid intima-media thickness and flow-mediated vasodilation in stroke patients: a randomized controlled trial and meta-analysis.
BACKGROUND
Experimental and epidemiological evidence suggests that homocysteine (tHcy) may be a causal risk factor for atherosclerosis. B-vitamin supplements reduce tHcy and improve endothelial function in short term trials, but the long-term effects of the treatment on vascular structure and function are unknown.
METHODS
We conducted a sub-study of VITATOPS, a randomised, double-blind, placebo-controlled intervention trial designed to test the efficacy of long term B-vitamin supplementation (folic acid 2 mg, vitamin B6 25 mg and vitamin B12 0.5 mg) in the prevention of vascular events in patients with a history of stroke. We measured carotid intima-medial thickness (CIMT) and flow-mediated dilation (FMD) at least two years after randomisation in 162 VITATOPS participants. We also conducted a systematic review and meta-analysis of studies designed to test the effect of B-vitamin treatment on CIMT and FMD.
RESULTS
After a mean treatment period of 3.9 +/- 0.9 years, the vitamin-treated group had a significantly lower mean plasma homocysteine concentration than the placebo-treated group (7.9 micromol/L, 95% CI 7.5 to 8.4 versus 11.8 micromol/L, 95% CI 10.9 to 12.8, p < 0.001). Post-treatment CIMT (0.84 +/- 0.17 mm vitamins versus 0.83 +/- 0.18 mm placebo, p = 0.74) and FMD (median of 4.0%, IQR 0.9 to 7.2 vitamins versus 3.0%, IQR 0.6 to 6.6 placebo, p = 0.48) did not differ significantly between groups. A meta-analysis of published randomised data, including those from the current study, suggested that B-vitamin supplements should reduce CIMT (-0.10 mm, 95% CI -0.20 to -0.01 mm) and increase FMD (1.4%, 95% CI 0.7 to 2.1%). However, the improvement in endothelial function associated with homocysteine-lowering treatment was significant in short-term studies but not in longer trials.
CONCLUSION
Although short-term treatment with B-vitamins is associated with increased FMD, long-term homocysteine-lowering did not significantly improve FMD or CIMT in people with a history of stroke.
Topics: Aged; Carotid Arteries; Dietary Supplements; Double-Blind Method; Down-Regulation; Drug Combinations; Female; Folic Acid; Homocysteine; Humans; Male; Middle Aged; Regional Blood Flow; Stroke; Time Factors; Treatment Outcome; Tunica Intima; Tunica Media; Vasodilation; Vitamin B 12; Vitamin B 6; Vitamin B Complex
PubMed: 18803866
DOI: 10.1186/1471-2261-8-24 -
Acta Myologica : Myopathies and... Jul 2007A systematic review of evidence for randomised controlled trials using pharmacologic and nutritional therapies in McArdle disease was undertaken. Primary outcome... (Review)
Review
A systematic review of evidence for randomised controlled trials using pharmacologic and nutritional therapies in McArdle disease was undertaken. Primary outcome measures included any objective assessment of exercise endurance. Secondary outcome measures included changes in metabolic parameters, subjective measures such as quality of life scores and adverse outcomes. Ten randomised controlled trials were identified. Two trials low dose creatine (60 mg/kg/day) and oral sucrose 75 g prior to exercise demonstrated a positive effect.
Topics: Creatine; Double-Blind Method; Glycogen Phosphorylase, Muscle Form; Glycogen Storage Disease Type V; Humans; Mutation; Randomized Controlled Trials as Topic; Ribose; Sucrose; Treatment Outcome; Vitamin B 6
PubMed: 17915572
DOI: No ID Found -
The Journal of Nutrition Jul 2007We conducted a systematic review to evaluate the association between folate, vitamin B-6, vitamin B-12, and cognitive function in the elderly. Our search was conducted... (Review)
Review
We conducted a systematic review to evaluate the association between folate, vitamin B-6, vitamin B-12, and cognitive function in the elderly. Our search was conducted in Medline for English-language publications of human subjects from 1966 through November 2006; we supplemented these results with information from article reviews and domain experts. We included longitudinal cohort and case-control studies of B vitamins and analyses of cognitive tests or Alzheimer's disease. We evaluated the quality and heterogeneity of study outcomes and assessed 30 different cognitive function tests. Of 24 studies that met eligibility criteria, 16 were determined to be of fair quality. A majority of the studies reviewed 2 or more B vitamins. Considerable heterogeneity was found among B-vitamin-level thresholds, comparisons, and data analyses. Six of 10 folate studies reported a significant association between low baseline blood folate concentrations and subsequent poor test performance in the global cognitive domain, and 4 of 9 folate studies found associations between low blood folate concentrations and increased prevalence of Alzheimer's disease. Studies did not reveal an association of vitamin B-6 and vitamin B-12 blood concentrations with cognitive-test performance or Alzheimer's disease, nor was B-vitamin dietary intake associated with cognitive function. Higher plasma homocysteine concentrations were associated with poorer cognitive function. Although the majority of studies indicated that low blood folate concentrations predicted poorer cognitive function, data supporting this association were limited because of the heterogeneity in cognition-assessment methodology, and scarcity of good quality studies and standardized threshold levels for categorizing low B-vitamin status.
Topics: Aged; Cognition Disorders; Folic Acid; Humans; Vitamin B 12; Vitamin B 6
PubMed: 17585032
DOI: 10.1093/jn/137.7.1789 -
The Cochrane Database of Systematic... Oct 2005The use of mega-vitamin intervention began in the 1950s with the treatment of schizophrenic patients. Pyroxidine (vitamin B6) was first used with children diagnosed with... (Review)
Review
BACKGROUND
The use of mega-vitamin intervention began in the 1950s with the treatment of schizophrenic patients. Pyroxidine (vitamin B6) was first used with children diagnosed with "autism syndrome" when speech and language improvement was observed in some children as a result of large doses of B6. A number of studies attempted to assess the effects of vitamin B6-Magnesium (Mg) was found to reduce undesirable side effects from B6) on characteristics such as verbal communication, non-verbal communication, interpersonal skills, and physiological function, in individuals with autism.
OBJECTIVES
To determine the efficacy of vitamin B6 and magnesium (B6-Mg) for treating social, communication, and behavioural responses of children and adults with autism.
SEARCH STRATEGY
We searched the Cochrane Controlled Trials Register (Cochrane Library, Issue 2, 2002), MEDLINE (1966 to January 2002), EMBASE (1980 to January 2002), PsycINFO (1887 to January 2002), Dissertation Abstracts International (1861 to January 2002). The search engine FirstSearch was also used (January 2002). All searches were updated in April 2005. Reference lists for all the obtained studies and other review articles were examined for additional studies.
SELECTION CRITERIA
All studies in which the participants had been diagnosed with autistic spectrum disorder were randomly allocated prior to intervention and in which outcomes were compared to either a placebo or non-treated group were included.
DATA COLLECTION AND ANALYSIS
Two reviewers independently evaluated and extracted data from all potential studies identified for inclusion.
MAIN RESULTS
This update includes a new trial (Kuriyama 2002) to bring the total of included studies to three (total n=33). One study, which used a cross-over design (Tolbert 1993) provided insufficient data to conduct an analysis. Another crossover study (Findling 1997) yielded no significant differences between treatment and placebo group performances following the B6 intervention on measures of social interaction, communication, compulsivity, impulsivity, or hyperactivity. The latest study (Kuriyama 2002) was motivated by evidence from epilepsy research and was focussed on a subgroup of children with pervasive developmental disorders (PDDs) who exhibited clinical features similar to those with pyroxidine-dependent epilepsy. This small study (n=8) only measured IQ and 'Social Quotient' and found a statistically significant benefit for IQ (5.2, 95% CI = [0.2 to 10.3]) when in the treated group, by using change scores.
AUTHORS' CONCLUSIONS
Due to the small number of studies, the methodological quality of studies, and small sample sizes, no recommendation can be advanced regarding the use of B6-Mg as a treatment for autism.
Topics: Adult; Autistic Disorder; Child; Drug Therapy, Combination; Humans; Magnesium; Randomized Controlled Trials as Topic; Vitamin B 6; Vitamin B Complex
PubMed: 16235322
DOI: 10.1002/14651858.CD003497.pub2 -
Annals of Family Medicine 2004We undertook a literature review to produce evidence-based recommendations for nonsurgical family physician management of carpal tunnel syndrome (CTS). (Review)
Review
BACKGROUND
We undertook a literature review to produce evidence-based recommendations for nonsurgical family physician management of carpal tunnel syndrome (CTS).
METHODS
Study design was systematic review of randomized controlled trials (RCTs) on CTS treatment. Data sources were English publications from all relevant databases, hand searches, and guidelines. Outcomes measured were nonsurgical management options for CTS.
RESULTS
We assessed 2 systematic reviews, 16 RCTs, and 1 before-and-after study using historical controls. A considerable percentage of CTS resolves spontaneously. There is strong evidence that local corticosteroid injections, and to a lesser extent oral corticosteroids, give short-term relief for CTS sufferers. There is limited evidence to indicate that splinting, laser-acupuncture, yoga, and therapeutic ultrasound may be effective in the short to medium term (up to 6 months). The evidence for nerve and tendon gliding exercises is even more tentative. The evidence does not support the use of nonsteroidal anti-inflammatory drugs, diuretics, pyridoxine (vitamin B6), chiropractic treatment, or magnet treatment.
CONCLUSIONS
For those who are not able to get surgery or for those who do not want surgery, there are some conservative modalities that can be tried. These modalities include ones for which there is good evidence. It would be reasonable to try some of the techniques with less evidence if the better ones are not successful. Reconsideration of surgery must always be kept in mind to avoid permanent nerve damage.
Topics: Adult; Aged; Carpal Tunnel Syndrome; Family Practice; Female; Humans; Male; Middle Aged
PubMed: 15209206
DOI: 10.1370/afm.21