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CNS Drugs Mar 2019Clozapine is the most effective medication for treatment-refractory schizophrenia. However, it has a high burden of adverse events, including common adverse events such... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Clozapine is the most effective medication for treatment-refractory schizophrenia. However, it has a high burden of adverse events, including common adverse events such as sialorrhea. Sialorrhea can lead to severe physical complications such as aspiration pneumonia, as well as psychological complications including embarrassment and low self-esteem. Compromised adherence and treatment discontinuation can occur due to intolerability. There have been no meta-analyses examining strategies to mitigate clozapine-induced sialorrhea.
METHODS
We systematically searched Chinese and Western research databases for randomised controlled trials examining agents for clozapine-induced sialorrhea. No limit to language or date were applied to the search. Where sufficient data for individual agents was available, pairwise meta-analyses were conducted. Results were provided as risk ratios and number needed to treat. Sensitivity analysis was conducted by study quality. Adverse events were provided as number needed to harm.
RESULTS
19 studies provided data for use in the meta-analysis. Improvement in clozapine-induced sialorrhea was seen in meta-analyses of propantheline (studies = 6, risk ratio [RR] 2.38, 95% confidence interval [CI] 1.52-3.73; number needed to treat [NNT] 3, 95% CI 1.9-2.7), diphenhydramine (studies = 5, RR 3.09, 95% CI 2.36-4.03; NNT 2, 95% CI 1.5-2.0), chlorpheniramine (studies = 2, RR 2.37, 95% CI 1.59-3.55; NNT 3, 95% CI 1.6-3.5), and benzamide derivatives (odds ratio [OR] 6.93, 95% CI 3.03-15.86). When meta-analyses were limited to high-quality studies, all these results remained significant. Single studies of benzhexol, cyproheptadine, doxepin and Kongyan Tang showed promise. Propantheline increased rates of constipation with a number needed to harm (NNH) of 9 (95% CI 4.2-204.1).
CONCLUSION
Clozapine-induced sialorrhea is a potentially serious adverse event. Included studies in this meta-analysis were limited by poor study quality. Diphenhydramine, chlorpheniramine and benzamide derivatives appear to have the best supporting evidence and lowest reported adverse events. Caution should be exercised when using propantheline given its increased risk of constipation.
Topics: Antidepressive Agents; Antipsychotic Agents; Clozapine; Histamine Antagonists; Humans; Medicine, Chinese Traditional; Muscarinic Antagonists; Randomized Controlled Trials as Topic; Salivation; Schizophrenia; Sialorrhea
PubMed: 30758782
DOI: 10.1007/s40263-019-00612-8 -
Dysphagia Aug 2014Difficulty in managing oral secretions is commonly experienced by patients with amyotrophic lateral sclerosis (ALS)/motor neurone disease (MND) and associated bulbar... (Review)
Review
Difficulty in managing oral secretions is commonly experienced by patients with amyotrophic lateral sclerosis (ALS)/motor neurone disease (MND) and associated bulbar weakness including dysphagia. There are no definitive evidence-based treatment guidelines to manage the distressing symptom of drooling. We reviewed the evidence for the effectiveness of botulinum toxin injections to reduce saliva in ALS/MND. The search strategy was conducted in four stages: (1) electronic search of relevant databases, (2) hand searches of all international ALS/MND symposium journals, (3) email request to MND care centres in the UK and Ireland, and (4) hand searching of reference lists. All studies were critically appraised and relevant data extracted. Botulinum toxin type A and type B were analysed separately. Due to heterogeneity, it was not possible to calculate a pooled estimate of effect. Twelve studies met the inclusion criteria (9 for type A and 3 for type B). Only two randomised controlled trials were identified. Study sample sizes were small with a mean of 12.5 subjects. The most frequently reported outcomes were weight of cotton rolls and number of tissues used. All studies claimed the intervention tested was effective, but only seven studies (4 for type A and 3 for type B) reported statistically significant differences. Although there is evidence to suggest that botulinum toxin B can reduce drooling, the evidence base is limited by a lack of randomized controlled trials. Evidence to support the use of botulinum toxin A is weaker. Larger trials will help remove the uncertainty practitioners face in treating this disabling symptom.
Topics: Amyotrophic Lateral Sclerosis; Botulinum Toxins, Type A; Humans; Injections; Neurotoxins; Sialorrhea; Treatment Outcome
PubMed: 24847964
DOI: 10.1007/s00455-014-9535-8 -
JAMA Otolaryngology-- Head & Neck... Aug 2018Complex head and neck cancer defects that require multiflap reconstructions are technically feasible, but the morbidity and patient outcomes of such large-scale head and...
IMPORTANCE
Complex head and neck cancer defects that require multiflap reconstructions are technically feasible, but the morbidity and patient outcomes of such large-scale head and neck operations have yet to be systematically reviewed.
OBJECTIVE
To systematically review existing literature to characterize the outcomes of large-scale head and neck resections that require multiple-flap reconstructions (defined as defects that require >1 flap [free, pedicled, or combinations thereof]).
EVIDENCE REVIEW
Two authors independently searched PubMed, Embase, and the Cochrane Review databases for English-only texts published on any date. Included studies examined patients who underwent complex head and neck surgical resections that required multiple simultaneous flaps for reconstruction. Included studies reported results on at least one of the following outcomes: functional and aesthetic, patient survival, or cost (estimated by operating room time, length of stay, and/or complications). Methodological Index for Non-Randomized Studies (MINORS) criteria for bias and modified Oxford Centre for Evidence-Based Medicine recommendations were used to assess study quality.
FINDINGS
Twenty-four studies published from November 1, 1992, through September 1, 2016, met the final inclusion criteria, with a total of 487 patients (370 male [79.4%]; mean [SD] weighted age, 55.1 [4.1] years). Sixty-two of 250 patients (24.8%) were partially or fully dependent on feeding tubes at follow-up. Twenty-two of 75 patients (29.3%) had poor postoperative oral competence, causing moderate to severe drooling. Nineteen of 108 patients (17.6%) had unintelligible speech. Nine of 64 patients (14.1%) were unsatisfied with their aesthetic outcome. The mean (SD) reported survival was 2.36 (1.39) years. The mean (SD) length of stay was 24.5 (12.2) days in 219 patients. Eighty-eight minor complications (eg, partial flap necrosis, donor site complications) and 185 major complications (eg, surgical reexplorations, flap loss, or cardiopulmonary complications) were reported in 380 patients. Mean (SD) MINORS scores were 16.0 (3.2) for comparison studies and 11.4 (1.8) for noncomparison studies.
CONCLUSIONS AND RELEVANCE
Because of limited patient life expectancies, modest functional and aesthetic outcomes, and significant associated costs, surgeons should weigh the curative potential and palliative benefits for individual patients with a comprehensive view of the overall outcomes of extensive head and neck resections and reconstructions. Realistic expectations should be emphasized during preoperative discussions with patients.
Topics: Head and Neck Neoplasms; Humans; Plastic Surgery Procedures; Surgical Flaps; Treatment Outcome
PubMed: 29978196
DOI: 10.1001/jamaoto.2018.0835 -
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 -
What sleep behaviors are associated with bruxism in children? A systematic review and meta-analysis.Sleep & Breathing = Schlaf & Atmung Dec 2017The aim of this article was to assess the sleep behaviors that serve as risk factors related to bruxism in children ages 0 to 12 years by performing a systematic review... (Meta-Analysis)
Meta-Analysis
PURPOSE
The aim of this article was to assess the sleep behaviors that serve as risk factors related to bruxism in children ages 0 to 12 years by performing a systematic review and meta-analysis of published studies.
METHODS
Seven databases were searched to identify all peer-reviewed articles potentially relevant to the review. Data were pooled for random-effects modeling. Sleep risk factors related to bruxism in this age group are summarized using pooled odds ratios (ORs), 95% confidence intervals (CIs), and P values.
RESULTS
Of 5637 initially identified articles, 14 met inclusion criteria. Study qualities of all case-control studies were high. Quality of cross-sectional studies was more variable. The pooled ORs, 95% CIs, and P values were as follows: snoring (2.86, 1.85-4.42, <0.0001), mouth breathing (1.51, 1.04-2.18, 0.029), restless sleep (2.31, 1.89-2.83, <0.0001), drooling (1.79, 1.07-2.97, 0.026), stomach position during sleep (1.70, 1.0-2.39, 0.003), and inadequate sleep time (2.56, 1.48-4.43, 0.001).
CONCLUSIONS
Snoring, mouth breathing, restless sleep, drooling, stomach position during sleep, and lack of sleep were the risk factors related to bruxism in children.
Topics: Case-Control Studies; Child; Cohort Studies; Cross-Sectional Studies; Humans; Sleep; Sleep Bruxism; Snoring
PubMed: 28396971
DOI: 10.1007/s11325-017-1496-3 -
Medicina Oral, Patologia Oral Y Cirugia... Mar 2021Drooling is a major morbidity in several neurological diseases. Intraglandular botulinum neurotoxin (BoNT) injections have been used to manage this condition. However,...
BACKGROUND
Drooling is a major morbidity in several neurological diseases. Intraglandular botulinum neurotoxin (BoNT) injections have been used to manage this condition. However, by decreasing salivary flow, BoNT injections may result in an increased risk of caries and other oral adverse effects. In this study, we aimed to assess whether, in patients with drooling, intraglandular BoNT injections are associated with increased dental caries development, modifications on salivary composition (oral pH, buffering capacity and osmolality) and cariogenic bacterial load.
MATERIAL AND METHODS
We performed a systematic review, searching PubMed, CENTRAL, Web of Science, and Scopus for all experimental and observational studies reporting on adverse effects of intraglandular BoNT injections in patients with drooling. Primary study selection, quality assessment, and data extraction were independently performed by two researchers. No studies were excluded based on their language, publication status or date of publication. Studies' quality was based on revised Cochrane Risk of Bias tools. Meta-analysis was not performed.
RESULTS
We retrieved 1025 studies, of which 5 were included. Two studies were two randomized controlled trials and three quasi-experimental studies. None of the included studies found BoNT injections to be associated with dental caries development or with significant reductions in oral pH. One of the included primary studies even observed an increase in salivary buffer capacity. One study found an increase in Lactobacilli counts. As for the risk of bias, two studies were classified as having a critical risk, two as high risk and one as having some concerns.
CONCLUSIONS
Currently, there is no evidence that, in patients with drooling, BoNT injections associate with increased risk of dental caries or disturbances in oral pH or salivary buffering capacity. However, the included primary studies had important limitations and differences in their methodologies.
Topics: Botulinum Toxins, Type A; Cerebral Palsy; Dental Caries; Humans; Neuromuscular Agents; Oral Health; Sialorrhea
PubMed: 33340083
DOI: 10.4317/medoral.24101 -
American Journal of Otolaryngology 2024Sialorrhea or drooling can result in physical and psychosocial complications, such as aspiration and social isolation. Treatment options include botulinum toxin into the...
INTRODUCTION
Sialorrhea or drooling can result in physical and psychosocial complications, such as aspiration and social isolation. Treatment options include botulinum toxin into the salivary glands and 4-duct ligation (i.e., simultaneous ligation of the bilateral parotid and submandibular ducts). This systematic review aimed to compare the efficacy and complication rates of botulinum toxin and 4-duct ligation for the treatment of drooling in children.
METHODS
Following PRISMA guidelines, PubMed, Embase, Web of Science, and Cochrane Library were searched from inception through June 17, 2021 for studies examining the efficacy of botulinum toxin or 4-duct ligation for drooling in children. Data were summarized by pooled counts, percentages, and means. Complication rates were compared by a chi-squared test.
RESULTS
A total of 22 studies (n = 606) examining botulinum toxin and 5 studies (n = 124) examining 4-duct ligation were included. From 12 botulinum toxin studies (n = 211), mean drooling frequency and severity scores was 7.5 at baseline. Mean difference from baseline was -2.6 (n = 92) at 4 weeks follow-up, -2.1 at 8 weeks (n = 41), -2.1 at 12 weeks (n = 56), and - 2.1 at 16 weeks (n = 58). From 4 4-duct ligation studies (n = 103), mean baseline drooling frequency and severity score was 8.4. Mean difference was -3.7 at mean follow-up of 35.6 months (n = 103). Eighteen botulinum studies (n = 343) recorded 53 (15.5 %) complications, including thickened saliva (n = 9), dysphagia (n = 4), and cheek abscesses (n = 4). Four 4-duct ligation studies (n = 108) recorded 25 (23.1 %) complications, including parotid gland swelling (n = 4), aspiration pneumonia (n = 3), and oxygen desaturation (n = 3). There was no statistically significant difference in complication rates between botulinum toxin and four-duct ligation (p = 0.065).
CONCLUSION
Botulinum toxin injection and 4-duct ligation are both effective in improving sialorrhea in children and have comparable complication rates.
Topics: Child; Humans; Sialorrhea; Botulinum Toxins, Type A; Parotid Gland; Saliva; Salivary Ducts; Treatment Outcome; Submandibular Gland
PubMed: 38043299
DOI: 10.1016/j.amjoto.2023.104119 -
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 -
Saudi Medical Journal Jan 2022To evaluate the diagnostic utility of self-collected saliva in coronavirus desease-19 (COVID-19) screening procedures. (Meta-Analysis)
Meta-Analysis
OBJECTIVES
To evaluate the diagnostic utility of self-collected saliva in coronavirus desease-19 (COVID-19) screening procedures.
METHODS
A total of 6 databases were reviewed from their inception until August 2021. Sensitivity and specificity were measured by extracting items (true-positive, true-negative, false-positive and false-negative) from each paper. We evaluated the diagnostic accuracy based on Quality Assessment of Diagnostic Accuracy Studies, version 2.
RESULTS
A total of 41 studies were included in the final analysis. The diagnostic odds ratio (OR) of self-collected saliva was 196.2022 (95% confidence interval [CI]: 117.8833-326.5546). The area under the summary receiver operating characteristic curve was 0.955. For detecting COVID-19, self-collected saliva had a moderate sensitivity of 0.8476 [0.8045-0.8826] and positive predictive value of 0.9404 [0.9122-0.9599] but high specificity of 0.9817 [0.9707-0.9887] and negative predictive value of 0.9467 [0.9130-0.9678]. In a subgroup analysis, the diagnostic accuracy of self-collected saliva tended to be higher for symptomatic (vs. asymptomatic) examinees.
CONCLUSION
Although naso/oropharyngeal swab tests are the most accurate and important diagnostic tools, the saliva-based testing method can be used as a suitable alternative test, with the advantages of increased patient convenience, efficient testing, and the need for fewer medical staff and resources. In particular, simple collecting method such as drooling or spitting without coughing would be effective in evaluating the symptomatic patients.PROSPERO no.: CRD42021279287.
Topics: COVID-19; Humans; Nasopharynx; Reverse Transcriptase Polymerase Chain Reaction; SARS-CoV-2; Saliva; Sensitivity and Specificity; Specimen Handling
PubMed: 35022280
DOI: 10.15537/smj.2022.43.1.20210743