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Epilepsia Dec 2015Topiramate (TPM) is an antiepileptic drug that is also used for other indications (e.g., migraine). Adverse event (AE) data from epilepsy trials could be supplemented by... (Review)
Review
OBJECTIVE
Topiramate (TPM) is an antiepileptic drug that is also used for other indications (e.g., migraine). Adverse event (AE) data from epilepsy trials could be supplemented by data from trials in other indications. Combining data across trials and indications is a novel method for evaluating AEs. We conducted a multiple-indications review by systematically reviewing randomized placebo-controlled trials of TPM, to compare the nervous system AEs of TPM in epilepsy with those in other indications.
METHODS
Randomized placebo-controlled trials of TPM including patients with any indication were included. We searched Cochrane Central Register of Controlled Trials (Issue 2, 2012) and MEDLINE (1966-February 2012). Two authors assessed eligibility and risk of bias, and extracted data. For each reported nervous system AE, we extracted event rates, applied random-effects inverse-variance meta-analysis (pooling within-indications then across-indications), and assessed within- and across-indication heterogeneity.
RESULTS
Ninety trials, including 16 epilepsy trials, were included. A difference was detected between TPM and placebo for three events (i.e., drooling, dysgeusia, and hypoesthesia) that were not reported in epilepsy trials but were reported by other trials. A difference between TPM and placebo was detected for speech disorder using epilepsy trials but not when combining all trials. For two events (i.e., cognitive disorder and "language problems"), no difference was detected between TPM and placebo when using epilepsy trials alone, but a difference was identified using all trials. A difference was detected between TPM and placebo for six events (i.e., ataxia, disturbance in attention, dizziness, memory impairment, paraesthesia, and somnolence) when using epilepsy trials alone, and using all trials.
SIGNIFICANCE
Including trials of any indication enabled detection of differences that would have been missed using epilepsy trials alone. Multiple-indications reviews can improve the synthesis of AEs for antiepileptic drugs.
Topics: Anticonvulsants; Epilepsy; Fructose; Humans; Randomized Controlled Trials as Topic; Topiramate
PubMed: 26662191
DOI: 10.1111/epi.13209 -
Movement Disorders : Official Journal... Apr 2009Upper and lower gastrointestinal dysautonomia symptoms (GIDS)--sialorrhea, dysphagia, and constipation are common in Parkinson's disease (PD) and often socially as well... (Review)
Review
Dysautonomia rating scales in Parkinson's disease: sialorrhea, dysphagia, and constipation--critique and recommendations by movement disorders task force on rating scales for Parkinson's disease.
Upper and lower gastrointestinal dysautonomia symptoms (GIDS)--sialorrhea, dysphagia, and constipation are common in Parkinson's disease (PD) and often socially as well as physically disabling for patients. Available invasive quantitative measures for assessing these symptoms and their response to therapy are time-consuming, require specialized equipment, can cause patient discomfort and present patients with risk. The Movement Disorders Society commissioned a task force to assess available clinical rating scales, critique their clinimetric properties, and make recommendations regarding their clinical utility. Six clinical researchers and a biostatistician systematically searched the literature for scales of sialorrhea, dysphagia, and constipation, evaluated the scales' previous use, performance parameters, and quality of validation data (if available). A scale was designated "Recommended" if the scale was used in clinical studies beyond the group that developed it, has been specifically used in PD reports, and clinimetric studies have established that it is a valid, reliable, and sensitive. "Suggested" scales met at least part of the above criteria, but fell short of meeting all. Based on the systematic review, scales for individual symptoms of sialorrhea, dysphagia, and constipation were identified along with three global scales that include these symptoms in the context of assessing dysautonomia or nonmotor symptoms. Three sialorrhea scales met criteria for Suggested: Drooling Severity and Frequency Scale (DSFS), Drooling Rating Scale, and Sialorrhea Clinical Scale for PD (SCS-PD). Two dysphagia scales, the Swallowing Disturbance Questionnaire (SDQ) and Dysphagia-Specific Quality of Life (SWAL-QOL), met criteria for Suggested. Although Rome III constipation module is widely accepted in the gastroenterology community, and the earlier version from the Rome II criteria has been used in a single study of PD patients, neither met criteria for Suggested or Recommended. Among the global scales, the Scales for Outcomes in PD-Autonomic (SCOPA-AUT) and Nonmotor Symptoms Questionnaire for PD (NMSQuest) both met criteria for Recommended, and the Nonmotor Symptoms Scale (NMSS) met criteria for Suggested; however, none specifically focuses on the target gastrointestinal symptoms (sialorrhea, dysphagia, and constipation) of this report. A very small number of rating scales have been applied to studies of gastrointestinal-related dysautonomia in PD. Only two scales met "Recommended" criteria and neither focuses specifically on the symptoms of sialorrhea, dysphagia, and constipation. Further scale testing in PD among the scales that focus on these symptoms is warranted, and no new scales are needed until the available scales are fully tested clinimetrically.
Topics: Constipation; Deglutition Disorders; Humans; Parkinson Disease; Primary Dysautonomias; PubMed; Reproducibility of Results; Severity of Illness Index; Sialorrhea
PubMed: 19205066
DOI: 10.1002/mds.22260 -
Developmental Medicine and Child... Nov 2010The aim of this unregistered evidence-based systematic review was to determine the state and quality of evidence on the effects of oral motor exercises (OME) on... (Review)
Review
AIM
The aim of this unregistered evidence-based systematic review was to determine the state and quality of evidence on the effects of oral motor exercises (OME) on swallowing physiology, pulmonary health, functional swallowing outcomes, and drooling management in children with swallowing disorders.
METHOD
A systematic search of 20 electronic databases was completed to identify relevant peer-reviewed literature published in English between 1960 and 2007. Experimental or quasi-experimental design studies examining OME as a treatment for children with swallowing disorders were appraised for methodological quality by two assessors and reviewed by a third.
RESULTS
Sixteen studies of varying methodological quality were included. No study examining the effects of OME on pulmonary health in children was identified. The included studies incorporated a wide variety of OME, and mixed findings were noted across all of the outcomes targeted in this review.
INTERPRETATION
Based on the results of this evidence-based systematic review, there is insufficient evidence to determine the effects of OME on children with oral sensorimotor deficits and swallowing problems. Well-designed studies are needed to provide clinicians with evidence that can be incorporated into the preferences of the client and the clinicians' knowledge of anatomy, physiology, and neurodevelopment in the management of this group of children.
Topics: Child; Child, Preschool; Databases, Factual; Deglutition; Deglutition Disorders; Evidence-Based Medicine; Humans; Motor Activity; Mouth; Musculoskeletal Manipulations; Retrospective Studies; Treatment Outcome
PubMed: 20497451
DOI: 10.1111/j.1469-8749.2010.03707.x -
Archives of Disease in Childhood Oct 2003Drooling frequently occurs in children with multiple handicaps; application of anticholinergic drugs is a potential strategy to treat drooling. A computer aided search... (Review)
Review
Drooling frequently occurs in children with multiple handicaps; application of anticholinergic drugs is a potential strategy to treat drooling. A computer aided search of original studies concerning the treatment of drooling was carried out. The methodological and statistical integrity of the identified studies were assessed with previously defined criteria. The articles were weighed for their separate contribution to the evidence. The search resulted in 64 reports, of which seven studies passed the screening and were subjected to further assessment and discussion by three referees. Because of the small number of reports and the methodological restriction within the studies, no meta-analysis could be performed. No general conclusion could be made about the efficacy of anticholinergic drugs in treatment of drooling in children with multiple handicaps. There was some evidence that three anticholinergic drugs (benztropine, glycopyrrolate, and benzhexol hydrochloride) are effective in the treatment of drooling, but it could not be concluded that one drug is preferable.
Topics: Child; Cholinergic Antagonists; Disabled Children; Humans; Randomized Controlled Trials as Topic; Research Design; Sialorrhea; Treatment Outcome
PubMed: 14500313
DOI: 10.1136/adc.88.10.911 -
Journal of Pain and Symptom Management Feb 2009Fifty percent of patients with amyotrophic lateral sclerosis (ALS) experience problems handling serous saliva and 20% fail to achieve adequate control of sialorrhea with... (Comparative Study)
Comparative Study Meta-Analysis Review
Fifty percent of patients with amyotrophic lateral sclerosis (ALS) experience problems handling serous saliva and 20% fail to achieve adequate control of sialorrhea with anticholinergic medications, or experience intolerable adverse effects from these drugs. Both botulinum and radiotherapy have been suggested in the literature as treatments for intractable sialorrhea. In this review, we assess the evidence for the effectiveness and toxicity of botulinum toxin and radiotherapy for sialorrhea in patients with ALS. Relevant studies were retrieved from Medline, Embase and Cochrane Databases. Handsearching of Neurology, Journal of Pain and Symptom Management, and Palliative Medicine and of reference lists, was carried out. Five studies (28 patients) were included in the analysis of botulinum. Of the four studies using an intraglandular method of injection, no adverse effects occurred. Two of these had positive findings of the effect of botulinum in salivary secretion rate and quality of life. In contrast, significant adverse effects were experienced by two patients in a study of retrograde injections into the salivary ducts. Two studies were included in the analysis of radiotherapy (27 patients). Both demonstrated a positive effect of radiotherapy on salivary secretion rate. Some patients experienced mild acute side effects. Because of the small numbers of studies, small sample sizes, and poor quality of reporting, it is not possible to draw firm conclusions. There is some evidence indicating that both botulinum and radiotherapy are well tolerated, effective treatments for persistent sialorrhea in patients with ALS and that the duration of action is up to three months with botulinum and six months with radiotherapy.
Topics: Amyotrophic Lateral Sclerosis; Botulinum Toxins; Clinical Trials as Topic; Comorbidity; Humans; Radiotherapy, Conformal; Sialorrhea; Treatment Outcome
PubMed: 18676117
DOI: 10.1016/j.jpainsymman.2008.02.006 -
Developmental Medicine and Child... Nov 2012The aim of this paper was to systematically review the efficacy and safety of botulinum toxin (BoNT) injections to the salivary glands to treat drooling in children with... (Review)
Review
AIM
The aim of this paper was to systematically review the efficacy and safety of botulinum toxin (BoNT) injections to the salivary glands to treat drooling in children with cerebral palsy and neurodevelopmental disability.
METHOD
A systematic search of The Cochrane Central Register of Controlled Trials, PubMed, CINAHL (Cumulative Index to Nursing and Allied Health Literature), EMBASE, and the Physiotherapy Evidence Database (PEDro) was conducted (up to 1 October 2011). Data sources included published randomized controlled trials (RCTs) and prospective studies.
RESULTS
Sixteen studies met inclusion criteria. Three outcome measures support the effectiveness of BoNT for drooling. One RCT found an almost 30% reduction in the impact of drooling on patients' lives, as measured by the Drooling Impact Scale (mean difference -27.45; 95% confidence interval [CI] -35.28 to -19.62). There were sufficient data to pool results on one outcome measure, the Drooling Frequency and Severity Scale, which supports this result (mean difference -2.71; 95% CI -4.82 to -0.60; p<0.001). There was a significant reduction in the observed number of bibs required per day. The incidence of adverse events ranged from 2 to 41%, but was inconsistently reported. One trial was terminated early because of adverse events.
INTERPRETATION
BoNT is an effective, temporary treatment for sialorrhoea in children with cerebral palsy. Benefits need to be weighed against the potential for serious adverse events. More studies are needed to address the safety of BoNT and to compare BoNT with other treatment options for drooling.
Topics: Botulinum Toxins; Cerebral Palsy; Child; Developmental Disabilities; Humans; Salivary Glands; Sialorrhea
PubMed: 22946706
DOI: 10.1111/j.1469-8749.2012.04370.x -
BMC Oral Health Feb 2024Human saliva as a bodily fluid-similar to blood-is utilized for diagnostic purposes. Unlike blood sampling, collecting saliva is non-invasive, inexpensive, and readily...
BACKGROUND
Human saliva as a bodily fluid-similar to blood-is utilized for diagnostic purposes. Unlike blood sampling, collecting saliva is non-invasive, inexpensive, and readily accessible. There are no previously published systematic reviews regarding different collection, transportation, preparation, and storage methods for human saliva.
DESIGN
This study has been prepared and organized according to the preferred reporting items for systematic reviews and meta-analyses (PRISMA) 2020 guidelines. This systematic review has been registered at PROSPERO (Registration ID: CRD42023415384). The study question according to the PICO format was as followed: Comparison of the performance (C) of different saliva sampling, handling, transportation, and storage techniques and methods (I) assessed for analyzing stimulated or unstimulated human saliva (P and O). An electronic search was executed in Scopus, Google Scholar, and PubMed.
RESULTS
Twenty-three descriptive human clinical studies published between 1995 and 2022 were included. Eight categories of salivary features and biomarkers were investigated (i.e., salivary flow rate, total saliva quantity, total protein, cortisol, testosterone, DNA quality and quantity, pH and buffering pH). Twenty-two saliva sampling methods/devices were utilized. Passive drooling, Salivette®, and spitting were the most utilized methods. Sampling times with optimum capabilities for cortisol, iodine, and oral cancer metabolites are suggested to be 7:30 AM to 9:00 AM, 10:30 AM to 11:00 AM, and 14:00 PM to 20:00 PM, respectively. There were 6 storage methods. Centrifuging samples and storing them at -70 °C to -80 °C was the most utilized storage method. For DNA quantity and quality, analyzing samples immediately after collection without centrifuging or storage, outperformed centrifuging samples and storing them at -70 °C to -80 °C. Non-coated Salivette® was the most successful method/device for analyzing salivary flow rate.
CONCLUSION
It is highly suggested that scientists take aid from the reported categorized outcomes, and design their study questions based on the current voids for each method/device.
Topics: Humans; Hydrocortisone; Saliva; Biomarkers; Specimen Handling; DNA
PubMed: 38308289
DOI: 10.1186/s12903-024-03902-w -
Children (Basel, Switzerland) Nov 2021We aimed to review and analyse the effectiveness and safety of botulinum toxin type A (BoNT-A) injections for drooling in children with cerebral palsy.
BACKGROUND
We aimed to review and analyse the effectiveness and safety of botulinum toxin type A (BoNT-A) injections for drooling in children with cerebral palsy.
DATA SOURCES
We searched the EMBASE, MEDLINE, Cochrane Database of Systematic Reviews, and Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library) databases from inception to January 2020.
METHODS
We included randomized controlled trials and observational studies which (1) involved children with cerebral palsy, (2) used BoNT-A for control of drooling, and (3) provided quantitative evaluations of drooling before and after intervention with BoNT-A.
RESULTS
Twenty-one trials met the inclusion criteria. Most studies showed that BoNT-A injections are safe and efficacious as a treatment for drooling in children with cerebral palsy. Four trials had sufficient data to pool the results for the meta-analysis. Both the drooling quotient ( = 0.002) and drooling Ffrequency and severity scale ( = 0.004) supported this conclusion.
CONCLUSION
BoNT-A injections are a safe, reversible, effective treatment for drooling control in children with cerebral palsy that can offer effectiveness for more than 3 months with few side effects. The dosage of BoNT-A should not exceed 4 units/kg. Further studies are required to determine the optimal dosage and target glands.
PubMed: 34943284
DOI: 10.3390/children8121089 -
International Journal of Environmental... May 2018The collection of salivary cortisol has been chosen as one of the least intrusive, easiest to collect, analyze, and store methods of obtaining information on...
The collection of salivary cortisol has been chosen as one of the least intrusive, easiest to collect, analyze, and store methods of obtaining information on physiological changes. It is, however, not clear what the best practice is when collecting salivary cortisol from children within the school setting. The aim of this systematic review is to evaluate the feasibility of cortisol collection in schools for future research and to make recommendations for best practice. The review included 25 peer-reviewed articles from seven databases. The hypotheses of the included studies vary, but they all use cortisol as a diurnal, baseline, or acute measure, or to measure the effect of an intervention. Two methods of salivary cortisol collection were preferred by most of the research, i.e., passive drool or cotton Salivettes. The review has concluded that cortisol is a physiological marker that can be successfully measured in school-based research. However, there are discrepancies across studies when evaluating the collection guidelines, protocols, and instructions to participants as well as transparency of the success rate of obtaining all samples. Recommendations are made for future research to address and avoid such discrepancies and improve cross-study comparisons by implementing standard protocol guidelines.
Topics: Child; Humans; Hydrocortisone; Saliva; Schools; Specimen Handling
PubMed: 29783677
DOI: 10.3390/ijerph15051025 -
Developmental Medicine and Child... Jan 2019To review the evidence for behavioural interventions to reduce drooling in children with neurodisability.
AIM
To review the evidence for behavioural interventions to reduce drooling in children with neurodisability.
METHOD
A detailed search in eight databases sought studies that: (1) included participants aged 0 to 18 years with neurodisability and drooling; (2) provided behavioural interventions targeting drooling or a drooling-related behaviour; and (3) used experimental designs. Two reviewers extracted data from full-text papers independently. Results were tabulated for comparison. The Risk of Bias assessment in N-of-1 Trials scale for single case experimental designs (SCEDs) and the Cochrane risk of bias assessment tool for randomized controlled trials (RCTs) were applied.
RESULTS
Of an initial yield of 763, seven SCEDs and one RCT were included. Behavioural interventions included the use of reinforcement, prompting, self-management, instruction, extinction, overcorrection, and fading. Each assessed body functions or structures' outcomes (drooling frequency and severity); three included activity outcomes (mouth drying, head control, eye contact, and vocalizations) and none assessed participation or quality of life. While each study reported positive effects of intervention, risk of bias was high.
INTERPRETATION
Low-level evidence suggests behavioural interventions may be useful for treatment of drooling in children with neurodisability. Well-designed intervention studies are urgently needed to determine effectiveness.
WHAT THIS PAPER ADDS
Behavioural interventions used to treat drooling included reinforcement, prompting, self-management, extinction, overcorrection, instruction, and fading. Interventions targeted body structures and function-level outcomes and activity-level outcomes. Low-level evidence supports the use of behavioural intervention to treat drooling.
Topics: Adolescent; Behavior Therapy; Child; Child, Preschool; Humans; Infant; Neurodevelopmental Disorders; Sialorrhea
PubMed: 30276810
DOI: 10.1111/dmcn.14048