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The Cochrane Database of Systematic... Apr 2023Vestibular migraine is a form of migraine where one of the main features is recurrent attacks of vertigo. These episodes are often associated with other features of... (Review)
Review
BACKGROUND
Vestibular migraine is a form of migraine where one of the main features is recurrent attacks of vertigo. These episodes are often associated with other features of migraine, including headache and sensitivity to light or sound. The unpredictable and severe attacks of vertigo can lead to a considerable reduction in quality of life. The condition is estimated to affect just under 1% of the population, although many people remain undiagnosed. A number of pharmacological interventions have been used, or proposed to be used, at the time of a vestibular migraine attack to help reduce the severity or resolve the symptoms. These are predominantly based on treatments that are in use for headache migraine, with the belief that the underlying pathophysiology of these conditions is similar. OBJECTIVES: To assess the benefits and harms of pharmacological interventions used to relieve acute attacks of vestibular migraine.
SEARCH METHODS
The Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 23 September 2022.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) and quasi-RCTs in adults with definite or probable vestibular migraine comparing triptans, ergot alkaloids, dopamine antagonists, antihistamines, 5-HT3 receptor antagonists, gepants (CGRP receptor antagonists), magnesium, paracetamol or non-steroidal anti-inflammatory drugs (NSAIDs) with either placebo or no treatment. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were: 1) improvement in vertigo (assessed as a dichotomous outcome - improved or not improved), 2) change in vertigo (assessed as a continuous outcome, with a score on a numerical scale) and 3) serious adverse events. Our secondary outcomes were: 4) disease-specific health-related quality of life, 5) improvement in headache, 6) improvement in other migrainous symptoms and 7) other adverse effects. We considered outcomes reported at three time points: < 2 hours, 2 to 12 hours, > 12 to 72 hours. We used GRADE to assess the certainty of evidence for each outcome. MAIN RESULTS: We included two RCTs with a total of 133 participants, both of which compared the use of triptans to placebo for an acute attack of vestibular migraine. One study was a parallel-group RCT (of 114 participants, 75% female). This compared the use of 10 mg rizatriptan to placebo. The second study was a smaller, cross-over RCT (of 19 participants, 70% female). This compared the use of 2.5 mg zolmitriptan to placebo. Triptans may result in little or no difference in the proportion of people whose vertigo improves at up to two hours after taking the medication. However, the evidence was very uncertain (risk ratio 0.84, 95% confidence interval 0.66 to 1.07; 2 studies; based on 262 attacks of vestibular migraine treated in 124 participants; very low-certainty evidence). We did not identify any evidence on the change in vertigo using a continuous scale. Only one of the studies assessed serious adverse events. No events were noted in either group, but as the sample size was small we cannot be sure if there are risks associated with taking triptans for this condition (0/75 receiving triptans, 0/39 receiving placebo; 1 study; 114 participants; very low-certainty evidence). AUTHORS' CONCLUSIONS: The evidence for interventions used to treat acute attacks of vestibular migraine is very sparse. We identified only two studies, both of which assessed the use of triptans. We rated all the evidence as very low-certainty, meaning that we have little confidence in the effect estimates and cannot be sure if triptans have any effect on the symptoms of vestibular migraine. Although we identified sparse information on potential harms of treatment in this review, the use of triptans for other conditions (such as headache migraine) is known to be associated with some adverse effects. We did not identify any placebo-controlled randomised trials for other interventions that may be used for this condition. Further research is needed to identify whether any interventions help to improve the symptoms of vestibular migraine attacks and to determine if there are side effects associated with their use.
Topics: Adult; Female; Humans; Male; Migraine Disorders; Anti-Inflammatory Agents, Non-Steroidal; Vertigo; Headache; Tryptamines
PubMed: 37042545
DOI: 10.1002/14651858.CD015322.pub2 -
International Journal of Colorectal... Dec 2013A permanent stoma has a large impact on everyday life with several physical, mental, and social impairments for the individual. It seems obvious that if persons with... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
A permanent stoma has a large impact on everyday life with several physical, mental, and social impairments for the individual. It seems obvious that if persons with stomas are affected socially by the stoma creation, it is likely that the family and/or relatives will be affected as well. The objective of this systematic review was to explore how stoma creation may affect spouses of patients with stomas.
METHODS
A systematic review was undertaken based on database searches including studies published from 1950 to 2012. We applied a method of synthesis based on narrative summaries of both qualitative and quantitative results being assessed in parallel processes and finally included in a joint synthesis of results on a study level.
RESULTS
We identified 17 studies and included 6 studies. Spouses wanted to be more involved in the stoma education and specifically wanted more focus on the psychosocial aspects of stoma creation. Furthermore, spouses' sexual life was seriously affected, and their social life was restricted. In general, spouses wished for more support from the health care sector as well as from family and friends.
CONCLUSIONS
There is a need for further research focusing on spouses or relatives. Talking about worries and concerns regarding the new life situation may alleviate suffering and reduce uncertainty. Stoma nurses and other health professionals play an important role in the care of patients as well as spouses, and a greater insight into the worries and concerns affecting spouses is warranted to improve postoperative counseling and education.
Topics: Health Knowledge, Attitudes, Practice; Humans; Sexual Behavior; Social Support; Spouses; Surgical Stomas
PubMed: 23900653
DOI: 10.1007/s00384-013-1749-y -
The Cochrane Database of Systematic... Sep 2012Previous reports have shown that ion content in the air may have an effect on respiratory function. Results from studies which test the efficacy of air ionisers to... (Review)
Review
BACKGROUND
Previous reports have shown that ion content in the air may have an effect on respiratory function. Results from studies which test the efficacy of air ionisers to reduce asthma symptoms are often inconclusive and their use as a treatment for asthma remains debatable.
OBJECTIVES
We conducted a systematic review of the available evidence to determine the effectiveness of positive and negative ion generators in people with asthma.
SEARCH METHODS
We searched the Cochrane Airways Group Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL) as well as the alternative medicine database AMED. Searches were current as of June 2012.
SELECTION CRITERIA
Randomised controlled trials (parallel or crossover design studies) comparing ionisers with dummy ionisers (being negative or positive ion emitters), in children or adults with chronic asthma.
DATA COLLECTION AND ANALYSIS
Two reviewers independently assessed titles and abstracts of studies and assessed trial quality. Study quality was determined using two methods:The Cochrane approach to allocation concealment and the five point Jadad scale.
MAIN RESULTS
Six studies were selected for inclusion (106 participants). No results were combined as the studies were all of a crossover design.EFFECTS OF NEGATIVE ION GENERATORS (five studies) No study reported a significant difference in lung function between ionised and control air (morning Peak expiratory flow (PEF) - three studies; forced expiratory flow in one second (FEV1) - one study). There were no significant differences in symptoms or beta-2 agonist usage between ionised and control air in three studies.EFFECTS OF POSITIVE ION GENERATORS (one study) This study demonstrated that although positively ionised air was associated with a larger fall in FEV1 with exercise, this did not reach statistical significance. Baseline FEV1 was not demonstrated to be significantly different between treatment groups.
AUTHORS' CONCLUSIONS
Based on the evidence currently available from randomised controlled trials, a recommendation cannot be given for the use of room air ionisers to reduce symptoms in patients with chronic asthma.
Topics: Adolescent; Adult; Air Ionization; Anions; Asthma; Cations; Child; Child, Preschool; Cross-Over Studies; Humans; Infant; Ions; Randomized Controlled Trials as Topic; Young Adult
PubMed: 22972060
DOI: 10.1002/14651858.CD002986.pub2 -
Hematology, Transfusion and Cell Therapy 2021Hematopoietic stem cell transplantation (HSCT) is a treatment that requires long periods of hospitalization. The mobility restrictions result in physical, functional and... (Review)
Review
Hematopoietic stem cell transplantation (HSCT) is a treatment that requires long periods of hospitalization. The mobility restrictions result in physical, functional and psychological impairments. Physical exercise is a therapy that can restore physical and functional capacities; however, it is necessary to understand the effects of its practice in post-HSCT individuals. The purpose of this systematic review (SR) was to assess the impact of physical exercise in children and adolescents undergoing HSCT. The SR was conducted following the PRISMA guidelines through search in the electronic databases Embase, Lilacs, PEDro, PubMed and SCOPUS, without limitation of dates and languages. Randomized or non-randomized clinical trials with children and adolescents who underwent HSCT, aged between 3 to 19 years old, who participated in a regular physical activity program, were assessed. After removing duplicates and selecting studies according to the eligibility criteria, seven parallel studies incorporating hospitalized and discharged participants undertaking aerobic and strengthening exercises were included in this study. The main outcomes analyzed were exercise capacity, quality-of-life, body composition and freedom. Five studies comprised the meta-analysis regarding the effects of the distance walked in the 6-min walk test and quality-of-life. Physical exercise is considered to be safe, feasible and efficacious to prevent the decline of the quality-of-life in children and adolescents undergoing HCST, as well as a considerable improvement in physical capacity.
PubMed: 33288491
DOI: 10.1016/j.htct.2020.07.013 -
The Cochrane Database of Systematic... Aug 2016This is an updated version of the original Cochrane review published in Issue 6, 2012.Epilepsy is one of the most common chronic neurological disorders. Despite the... (Review)
Review
BACKGROUND
This is an updated version of the original Cochrane review published in Issue 6, 2012.Epilepsy is one of the most common chronic neurological disorders. Despite the plethora of antiepileptic drugs (AEDs) currently available, 30% of people continue having seizures. This group of people requires a more aggressive treatment, since monotherapy, the first choice scheme, fails to control seizures. Nevertheless, polytherapy often results in a number of unwanted effects, including neurological disturbances (somnolence, ataxia, dizziness), psychiatric and behavioural symptoms, and metabolic alteration (osteoporosis, inducement or inhibition of hepatic enzymes, etc.). The need for better tolerated AEDs is even more urgent in this group of people. Reports have suggested an antiepileptic role of melatonin with a good safety profile.
OBJECTIVES
To assess the efficacy and tolerability of melatonin as add-on treatment for epilepsy.
SEARCH METHODS
For the latest update, we searched the Cochrane Epilepsy Group's Specialized Register (12 January 2016), the Cochrane Central Register of Controlled Trials (CENTRAL) via the Cochrane Register of Studies Online (CRSO, 12 January 2016), and MEDLINE (Ovid, 11 January 2016). We searched the bibliographies of any identified study for further references. We handsearched selected journals and conference proceedings. We applied no language restrictions. In addition, we contacted melatonin manufacturers (i.e. Nathura) and original investigators to identify any unpublished studies.
SELECTION CRITERIA
Randomized controlled trials; double, single, or unblinded trials; parallel group or cross-over studies. People with epilepsy regardless of age and gender, including children and adults with disabilities. Administration of melatonin as add-on treatment to any AED(s) compared to add-on placebo or no add-on treatment.
DATA COLLECTION AND ANALYSIS
Review authors independently selected trials for inclusion according to pre-defined criteria, extracted relevant data, and evaluated the methodological quality of trials. We assessed the following outcomes: at least 50% seizure reduction, seizure freedom, adverse events, and quality of life.
MAIN RESULTS
We included six publications, with 125 participants (106 aged under 18 years). Two different comparisons were available: melatonin versus placebo and melatonin 5 mg versus melatonin 10 mg. Despite our primary intention, due to insufficient information on outcomes, we were unable to perform any meta-analyses, but summarized data narratively. Four studies were randomized, double-blind, cross-over, placebo-controlled trials and two were randomized, double-blind, parallel, placebo-controlled trials. Only two studies provided the exact number of seizures during the trial compared to the baseline: none of the participants with seizures during the trial had a change in seizure frequency compared with the baseline. Two studies systematically evaluated adverse effects (worsening of headache was reported in a child with migraine under melatonin treatment). Only one study systematically evaluated quality of life, showing no statistically significant improvement in quality of life in the add-on melatonin group.
AUTHORS' CONCLUSIONS
Included studies were of poor methodological quality, and did not systematically evaluate seizure frequency and adverse events, so that it was impossible to summarize data in a meta-analysis. It is not possible to draw any conclusion about the role of melatonin in reducing seizure frequency or improving quality of life in people with epilepsy.
Topics: Adolescent; Adult; Anticonvulsants; Child; Child, Preschool; Drug Therapy, Combination; Epilepsy; Humans; Infant; Melatonin; Randomized Controlled Trials as Topic; Young Adult
PubMed: 27513702
DOI: 10.1002/14651858.CD006967.pub4 -
The Cochrane Database of Systematic... Mar 2016This is an updated version of the original Cochrane review published in Issue 6, 2012.Epilepsy is one of the most common chronic neurological disorders. Despite the... (Review)
Review
BACKGROUND
This is an updated version of the original Cochrane review published in Issue 6, 2012.Epilepsy is one of the most common chronic neurological disorders. Despite the plethora of antiepileptic drugs (AEDs) currently available, 30% of people continue having seizures. This group of people requires a more aggressive treatment, since monotherapy, the first choice scheme, fails to control seizures. Nevertheless, polytherapy often results in a number of unwanted effects, including neurological disturbances (somnolence, ataxia, dizziness), psychiatric and behavioural symptoms, and metabolic alteration (osteoporosis, inducement or inhibition of hepatic enzymes, etc.). The need for better tolerated AEDs is even more urgent in this group of people. Reports have suggested an antiepileptic role of melatonin with a good safety profile.
OBJECTIVES
To assess the efficacy and tolerability of melatonin as add-on treatment for epilepsy.
SEARCH METHODS
For the latest update, we searched the Cochrane Epilepsy Group's Specialized Register (12 January 2016), the Cochrane Central Register of Controlled Trials (CENTRAL) via the Cochrane Register of Studies Online (CRSO, 12 January 2016), and MEDLINE (Ovid, 11 January 2016). We searched the bibliographies of any identified study for further references. We handsearched selected journals and conference proceedings. We applied no language restrictions. In addition, we contacted melatonin manufacturers (i.e. Nathura) and original investigators to identify any unpublished studies.
SELECTION CRITERIA
Randomized controlled trials; double, single, or unblinded trials; parallel group or cross-over studies. People with epilepsy regardless of age and gender, including children and adults with disabilities. Administration of melatonin as add-on treatment to any AED(s) compared to add-on placebo or no add-on treatment.
DATA COLLECTION AND ANALYSIS
Review authors independently selected trials for inclusion according to pre-defined criteria, extracted relevant data, and evaluated the methodological quality of trials. We assessed the following outcomes: at least 50% seizure reduction, seizure freedom, adverse events, and quality of life.
MAIN RESULTS
We included six publications, with 125 participants (106 aged under 18 years). Two different comparisons were available: melatonin versus placebo and melatonin 5 mg versus melatonin 10 mg. Despite our primary intention, due to insufficient information on outcomes, we were unable to perform any meta-analyses, but summarized data narratively. Four studies were randomized, double-blind, cross-over, placebo-controlled trials and two were randomized, double-blind, parallel, placebo-controlled trials. Only two studies provided the exact number of seizures during the trial compared to the baseline: none of the participants with seizures during the trial had a change in seizure frequency compared with the baseline. Two studies systematically evaluated adverse effects (worsening of headache was reported in a child with migraine under melatonin treatment). Only one study systematically evaluated quality of life, showing no statistically significant improvement in quality of life in the add-on melatonin group.
AUTHORS' CONCLUSIONS
Included studies were of poor methodological quality, and did not systematically evaluate seizure frequency and adverse events, so that it was impossible to summarize data in a meta-analysis. It is not possible to draw any conclusion about the role of melatonin in reducing seizure frequency or improving quality of life in people with epilepsy.
Topics: Adolescent; Adult; Anticonvulsants; Child; Child, Preschool; Drug Therapy, Combination; Epilepsy; Humans; Infant; Melatonin; Randomized Controlled Trials as Topic; Young Adult
PubMed: 26986179
DOI: 10.1002/14651858.CD006967.pub3 -
Current Pharmaceutical Design 2017Some trials on animals and human claim that melatonin can influence body weight. So we conducted a systematic review of controlled trials of melatonin effects on weight... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Some trials on animals and human claim that melatonin can influence body weight. So we conducted a systematic review of controlled trials of melatonin effects on weight of human subjects.
METHODS
First we performed a systematic and comprehensive search in June 2015 on MEDLINE/PubMed, Scopus, Google scholar, hand searching in key journals, the list of references of selected articles and gray literature.
RESULTS
We included 7 clinical trials with a total of 244 patients. All studies were parallel clinical trials conducted at the clinic. Evaluating standardized mean difference (SMD) using Cohen's method shows that none of the included studies have found a strong and significant effect of melatonin on body weight. However, some have reported decreasing or increasing effect of melatonin on body weight. We pooled SMDs using random effects (DerSimonian and Laird). Pooled SMD was still not significant SMD (95% CI) = 0.09(-0.17-0.34), with lack of heterogeneity I2=0.0%, p=0.66.
CONCLUSION
We concluded that once the standard treatment had increasing effect on body weight, melatonin could be able to slightly diminish this effect and vice versa. Subgroup analysis showed that melatonin was more effective in child and adolescents. According to the results hypothesis of the buffering role of melatonin on body weight fluctuations can be proposed.
Topics: Body Weight; Humans; Melatonin; Randomized Controlled Trials as Topic
PubMed: 27897121
DOI: 10.2174/1381612822666161129145618 -
PloS One 2009Although meta-analyses have shown that placebo responses are large in Major Depressive Disorder (MDD) trials; the placebo response of devices such as repetitive... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Although meta-analyses have shown that placebo responses are large in Major Depressive Disorder (MDD) trials; the placebo response of devices such as repetitive transcranial magnetic stimulation (rTMS) has not been systematically assessed. We proposed to assess placebo responses in two categories of MDD trials: pharmacological (antidepressant drugs) and non-pharmacological (device- rTMS) trials.
METHODOLOGY/PRINCIPAL FINDINGS
We performed a systematic review and meta-analysis of the literature from April 2002 to April 2008, searching MEDLINE, Cochrane, Scielo and CRISP electronic databases and reference lists from retrieved studies and conference abstracts. We used the keywords placebo and depression and escitalopram for pharmacological studies; and transcranial magnetic stimulation and depression and sham for non-pharmacological studies. All randomized, double-blinded, placebo-controlled, parallel articles on major depressive disorder were included. Forty-one studies met our inclusion criteria - 29 in the rTMS arm and 12 in the escitalopram arm. We extracted the mean and standard values of depression scores in the placebo group of each study. Then, we calculated the pooled effect size for escitalopram and rTMS arm separately, using Cohen's d as the measure of effect size. We found that placebo response are large for both escitalopram (Cohen's d - random-effects model - 1.48; 95%C.I. 1.26 to 1.6) and rTMS studies (0.82; 95%C.I. 0.63 to 1). Exploratory analyses show that sham response is associated with refractoriness and with the use of rTMS as an add-on therapy, but not with age, gender and sham method utilized.
CONCLUSIONS/SIGNIFICANCE
We confirmed that placebo response in MDD is large regardless of the intervention and is associated with depression refractoriness and treatment combination (add-on rTMS studies). The magnitude of the placebo response seems to be related with study population and study design rather than the intervention itself.
Topics: Antidepressive Agents, Second-Generation; Citalopram; Depressive Disorder, Major; Double-Blind Method; Humans; Placebos; Selective Serotonin Reuptake Inhibitors
PubMed: 19293925
DOI: 10.1371/journal.pone.0004824 -
Brain Research Bulletin Feb 2011Gustatory and olfactory functions are already present at birth, although the full development of both systems takes place postnatally. The existence of early postnatal... (Review)
Review
Gustatory and olfactory functions are already present at birth, although the full development of both systems takes place postnatally. The existence of early postnatal sensitive periods throughout the developmental course of sensory systems, including the taste and olfactory, has been well documented. The normal postnatal and later development of any sensory function parallels development of the central nervous system. This development is associated with development-related plastic changes that ensure the increasing efficiency of neural communication that takes place throughout development and correlates with signal changes acquired by means of neuroimaging techniques. In this paper, we review papers published in the last 10 years that have reported on the investigation of age-related changes in brain activation patterns in response to gustatory and olfactory processing with two related aims. We aim to ascertain the way in which developmental plastic changes within the taste and olfactory systems have been reflected in signals obtained through neuroimaging techniques. Furthermore, we aim to identify sensitive periods of gustatory and olfactory development by conducting a systematic review of research on brain activation patterns of the taste and olfactory systems that have been measured through neuroimaging techniques in developing populations. The main contribution of the present review is the identification of the need to conduct further research on developmental brain mapping of the taste and olfactory systems in newborns, children and adolescents, and on the association between developmental plastic changes and imaging signals. In addition, further developmental research based on longitudinal designs is required.
Topics: Age Factors; Brain; Brain Mapping; Humans; Olfactory Perception; Smell; Taste; Taste Perception
PubMed: 21184814
DOI: 10.1016/j.brainresbull.2010.12.010 -
The Cochrane Database of Systematic... Oct 2005Asthma is a chronic disease of the airways in which inflammation of the respiratory mucosa plays a crucial role. The mechanisms responsible for the maintaining of this... (Review)
Review
BACKGROUND
Asthma is a chronic disease of the airways in which inflammation of the respiratory mucosa plays a crucial role. The mechanisms responsible for the maintaining of this inflammatory response are only partially known and there is evidence that a role could be paid by chronic infection by intracellular pathogens (such as Chlamydia pneumoniae). Macrolides are antibiotics with both antimicrobic and antiinflammatory activities and thus their use in asthmatic patients could lead to reduction of the airways inflammation and therefore improvement of symptoms and pulmonary function.
OBJECTIVES
To determine whether macrolides are effective in the management of patients with chronic asthma.
SEARCH STRATEGY
We searched the Cochrane Airways Group Specialised Register of trials up to May 2005. This was also supplemented by manually searching bibliographies of previously published reviews, conference proceedings, and contacting study authors. All languages were included in the initial search.
SELECTION CRITERIA
Randomised, controlled clinical trials involving both children and adult patients with chronic asthma treated with macrolides for more than 4 weeks, versus placebo.
DATA COLLECTION AND ANALYSIS
Two reviewers independently examined all identified articles. The full text of any potentially relevant article was reviewed independently by two reviewers.
MAIN RESULTS
Seven studies recruiting a total of 416 participants met the inclusion criteria. The quality of reporting of study methodology was generally low. We assembled findings from studies comparing macrolide treatment for at least 4 weeks in adult and pediatric patients treated for chronic asthma. Four studies showed a positive effect on symptoms of macrolides in different types of asthmatic patients. There were limited data available for meta-analysis. There was no significant difference in FEV1 for either parallel or crossover trials. However, there were significant differences in eosinophilic inflammation and symptoms. One large parallel group trial reported significant differences in peak flow but these differences abated within six months of treatment.
AUTHORS' CONCLUSIONS
Considering the small number of patients studied, there is insufficient evidence to support or to refute the use of macrolides in patients with chronic asthma. Further studies are needed in particular to clarify the potential role of macrolides in some subgroups of asthmatics such as those with evidence of chronic bacterial infection.
Topics: Anti-Bacterial Agents; Anti-Inflammatory Agents; Asthma; Chronic Disease; Humans; Macrolides; Randomized Controlled Trials as Topic
PubMed: 16235309
DOI: 10.1002/14651858.CD002997.pub3