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The Laryngoscope Aug 2023A number of patient-reported outcome measures (PROMs) assess quality of life and symptom severity in patients with salivary gland dysfunction, but many vary in the... (Review)
Review
OBJECTIVE
A number of patient-reported outcome measures (PROMs) assess quality of life and symptom severity in patients with salivary gland dysfunction, but many vary in the extent of validation and domain types addressed. We identified PROMs validated to measure salivary gland function and analyzed key properties.
DATA SOURCES
PubMed, Web of Science, Embase, PsycInfo, and CINAHL.
REVIEW METHODS
A systematic review was performed using Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Validated instruments with >1 item to assess salivary gland-related symptoms were included. PROMs were evaluated for developmental methodology, structure, validity, and reliability using Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) criteria.
RESULTS
A total of 2059 abstracts were retrieved, and 133 full-text articles were reviewed. Sixteen PROMs assessing xerostomia (n = 7), sialadenitis (n = 4), Sjogren's syndrome (n = 2), Parkinson's-associated sialorrhea (n = 2), and oral systemic sclerosis (n = 1) were identified. Most (n = 15) were developed de novo, one was adapted from a pre-existing questionnaire. Eleven PROMs demonstrated "very good" analysis of internal consistency per COSMIN criteria, and 10 included test-retest data. Regarding content validity, four PROMs were developed with both patient and physician input, but none were rated as "adequate." All included comparisons against other questionnaires (n = 7), salivary flow rate (n = 9), and/or healthy controls (n = 3). The most rigorously developed PROM, the Xerostomia Inventory, was rated adequate in 6 out of 7 domains.
CONCLUSIONS
Several PROMs evaluate salivary function. The abilties of these PROMs to meet design and validation standards were variable, with notable limitations in content validity for all tools. New and updated PROMs assessing obstructive and inflammatory salivary symptoms should utilize patient and provider input.
LEVEL OF EVIDENCE
N/A Laryngoscope, 133:1796-1805, 2023.
Topics: Humans; Quality of Life; Reproducibility of Results; Patient Reported Outcome Measures; Surveys and Questionnaires; Consensus
PubMed: 36606658
DOI: 10.1002/lary.30550 -
European Journal of Neurology Jan 2022Sialorrhea often happens in patients with neurologic disorders, and botulinum toxin (BoNT), which inhibits acetylcholine activation, may be an effective treatment for... (Meta-Analysis)
Meta-Analysis
BACKGROUND AND PURPOSE
Sialorrhea often happens in patients with neurologic disorders, and botulinum toxin (BoNT), which inhibits acetylcholine activation, may be an effective treatment for drooling. This systematic review and meta-analysis of randomized control trials aims to evaluate the efficacy and safety of BoNT in adults and children with sialorrhea due to neurological disorders.
METHODS
The PubMed, Embase, and Cochrane databases were searched for relevant studies published before August 2021. The pooled estimate of outcomes was calculated using a random effect model.
RESULTS
The review included 17 studies involving 981 patients. Compared with placebo, both BoNT type A (BoNT-A) and BoNT type B (BoNT-B) alleviated drooling frequency and severity (mean difference, 95% CI; BoNT-A: -1.20, -1.89 to -0.51; BoNT-B: -1.62, -2.07 to -1.17), reduced saliva weight (BoNT-A: -1.70, -2.30 to -1.10; BoNT-B: -1.12, -1.97 to -0.27), and improved global impression of change (BoNT-A: -1.30, -1.73 to -0.86; BoNT-B: -1.58, -1.95 to -1.21) in adults 4 weeks postinjection. BoNT-B remained effective at 12 weeks. In children, BoNT-A and BoNT-B alleviated sialorrhea symptoms (BoNT-A: -1.63, -2.42 to -0.85; BoNT-B: -5.20, -6.03 to -4.37) and BoNT-A reduced saliva weight (-0.77, -1.54 to 0.00) at 4 weeks postinjection. After 12 weeks, BoNT-B remained efficacious. Most adverse effects (AEs) were mild to moderate and self-limited.
CONCLUSIONS
There is moderate certainty of evidence (COE) that either BoNT-A or BoNT-B could relieve sialorrhea after 4 and 12 weeks of follow-up without significantly more severe AEs in adults. However, the COE is very low to low in children.
Topics: Botulinum Toxins, Type A; Child; Humans; Neuromuscular Agents; Sialorrhea; Treatment Outcome
PubMed: 34449931
DOI: 10.1111/ene.15083 -
Otolaryngology--head and Neck Surgery :... Oct 2021Chronic sialorrhea commonly occurs in patients with neurodevelopmental disorders. While conservative management can provide sufficient symptom control, surgical... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
Chronic sialorrhea commonly occurs in patients with neurodevelopmental disorders. While conservative management can provide sufficient symptom control, surgical intervention is often required. One of the most common procedures utilized is submandibular gland excision (SMGE), with or without parotid duct ligation or rerouting (PDL or PDR). This study aims to compare these surgical approaches and their outcomes.
DATA SOURCES
PubMed, Web of Science, and Embase.
REVIEW METHODS
This systematic review includes studies of patients with chronic sialorrhea treated with SMGE alone or SMGE plus PDR or PDL and reports on postintervention outcomes and complications. Two independent investigators assessed study eligibility, rated quality, and extracted data for analysis. A random effects model was used for meta-analysis of pooled data.
RESULTS
Of 3186 studies identified, 21 met inclusion criteria, with 708 patients: 103 underwent SMGE alone (15%); 299 (42%), SMGE and PDL; and 306 (43%), SMGE plus PDR. Overall, a majority of patients had significant improvement, with very good to excellent control of symptoms after surgery: SMGE, 82% (95% CI, 73%-89%); SMGE and PDL, 79% (95% CI, 73%-85%); and SMGE and PDR, 85% (95% CI, 75%-92%). Importantly, there was no significant difference in outcomes with the addition of PDL or PDR. Reported complications included sialocele, parotitis, dental caries, and dry mouth.
CONCLUSION
Our systematic review identified consistent positive outcomes with SMGE for patients with chronic sialorrhea but no additional benefit when PDR or PDL was performed as a concurrent procedure.
Topics: Chronic Disease; Humans; Ligation; Sialorrhea; Submandibular Gland
PubMed: 33494642
DOI: 10.1177/0194599820985165 -
Journal of Pain and Symptom Management Apr 2022Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative motor neuron disease (MND), and sialorrhea is a known symptom in patients with ALS, which may cause a... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND AND OBJECTIVES
Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative motor neuron disease (MND), and sialorrhea is a known symptom in patients with ALS, which may cause a social embarrassment and discomfort. However, people do not pay attention to sialorrhea up to now. This study is aimed at conducting a systematic review and meta-analysis of the pooled prevalence of sialorrhea in ALS patients all around the world and raising awareness of salivation.
METHODS
We searched PubMed and EMBASE databases to obtain the comprehensive literatures which reported the prevalence of sialorrhea. We used AHRQ and NOS to evaluate the literature quality. Subgroup analyses were performed based on screening instruments and severity of sialorrhea. At the meantime, sensitivity analyses was also conducted to identify the source of heterogeneity.
RESULTS
A total of 17 eligible studies which included 21 groups of data reported prevalence of sialorrhea. The pooled prevalence of sialorrhea among ALS patients was 30.8% (95% CI: 20.0%-44.2%). For studies using ALSFRS-R, direct questioning, postal survey, and ALSSoL average and ALSFRS-R, the pooled prevalence of sialorrhea was 22.7%, 25.8%, 29.8% and 52.0% respectively. According to the severity of sialorrhea, the prevalence of mild, moderate, and severe sialorrhea were 25.1%, 11.2%, and 10.5%, respectively. And none of the studies alone had a significant effect on the overall prevalence of sialorrhea after we eliminated each study separately in sensitivity analyses.
CONCLUSIONS
Sialorrhea is a relatively common symptom in ALS patients with a comparatively high prevalence. In our study, we found that the prevalence of sialorrhea in ALS patients is relatively higher than the results based on direct questioning or postal survey. Therefore, we deduced that sialorrhea should be evaluated by more complex professional assessment scales to improve the quality of life and improve early prognosis of disease.
Topics: Amyotrophic Lateral Sclerosis; Humans; Prevalence; Quality of Life; Salivation; Sialorrhea
PubMed: 34920148
DOI: 10.1016/j.jpainsymman.2021.12.005 -
Clinical Oral Investigations Jun 2023The present systematic review and network meta-analysis of randomized control trials (RCTs) aimed to establish whether there are evidence-based differences in the... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
The present systematic review and network meta-analysis of randomized control trials (RCTs) aimed to establish whether there are evidence-based differences in the pharmacological agents used to manage sialorrhea in patients with Parkinson's disease (PD).
MATERIAL AND METHODS
The authors searched the databases: MEDLINE via PubMed, EMBASE, Scopus, Web of Science, and Cochrane Library for clinical trials. Unpublished trials were searched on clinicaltrials.gov and the Brazilian Clinical Trials Registry. Means and standard deviations of changes in the salivary flow or drooling reported by participants due to the interventions were recorded.
RESULTS
The authors analyzed 13 RCTs. Compared to the placebo, types A and B of the botulinum toxin effectively reduced the salivary flow and the severity or frequency of drooling. However, the network meta-analysis did not differentiate between the botulinum toxin types. Ipratropium bromide and glycopyrrolate did not differ from the placebo. Indirect evidence showed that ipratropium had similar results to those obtained with both types of botulinum toxin. The CINeMA approach estimated the quality of the evidence as very low for all comparisons.
CONCLUSION
The best treatment for sialorrhea in patients with PD is not fully elucidated yet. Therefore, more well-conducted randomized clinical trials are required to increase the level of evidence.
CLINICAL RELEVANCE
There needs to be more evidence defining the best intervention to treat sialorrhea in patients with PD. However, botulinum toxin types A and B seem to reduce sialorrhea in patients effectively.
Topics: Humans; Sialorrhea; Parkinson Disease; Network Meta-Analysis; Botulinum Toxins, Type A; Glycopyrrolate
PubMed: 37036514
DOI: 10.1007/s00784-023-04981-9 -
Frontiers in Neurology 2022The prevalence and associated factors of dysphagia in Parkinson's disease (PD) are different in studies conducted in different countries. The purpose of our systematic...
BACKGROUND
The prevalence and associated factors of dysphagia in Parkinson's disease (PD) are different in studies conducted in different countries. The purpose of our systematic review and meta-analysis was to evaluate the prevalence of dysphagia in PD and to clarify its associated factors.
METHODS
Two researchers systematically searched PubMed, Embase, Web of Science, Cochrane Library, CNKI, Wanfang Database, SinoMed and VIP databases and manually searched references in the retrieved articles to identify potential research subjects. The last search was conducted on June 28, 2022. Finally, a total of 58 studies including 60 observations with 20,530 PD patients were included in our meta-analysis.
RESULTS
The meta-analysis estimated that the pooled prevalence rate of dysphagia in PD was 36.9% (95% CI: 30.7-43.6%) and instrumental examination showed a higher prevalence (57.3%, 95% CI: 44.3-69.1%). Oceania showed the highest prevalence of dysphagia in PD (56.3%) compared to Africa (39.5%), Asia (38.6%), Europe (36.1%) and America (28.9%). Dysphagia in PD was associated with older age, lower body mass index, longer disease duration, higher Hoehn and Yahr stage and levodopa equivalent daily dose, PIGD subtype, severe motor symptoms, drooling and higher levels of depression, and lower quality of life.
CONCLUSIONS
In conclusion, our meta-analysis showed that dysphagia occurs in more than one-third of PD patients and was associated with several demographic characteristics and PD-related characteristics, motor symptoms, non-motor symptoms, as well as decreased quality of life. It deserves early screening, diagnosis, and treatment in clinical practice to prevent serious complications from dysphagia.
PubMed: 36277913
DOI: 10.3389/fneur.2022.1000527 -
Bipolar Disorders May 2015To evaluate the efficacy and safety of clozapine for treatment-resistant bipolar disorder (TRBD). (Review)
Review
OBJECTIVE
To evaluate the efficacy and safety of clozapine for treatment-resistant bipolar disorder (TRBD).
METHODS
A systematic review of randomized controlled studies, open-label prospective studies, and retrospective studies of patients with TRBD was carried out. Interventions included clozapine monotherapy or clozapine combined with other medications. Outcome measures were efficacy and adverse drug reactions (ADRs).
RESULTS
Fifteen clinical trials with a total sample of 1,044 patients met the inclusion criteria. Clozapine monotherapy or clozapine combined with other treatments for TRBD was associated with improvement in: (i) symptoms of mania, depression, rapid cycling, and psychotic symptoms, with many patients with TRBD achieving a remission or response; (ii) the number and duration of hospitalizations, the number of psychotropic co-medications, and the number of hospital visits for somatic reasons for intentional self-harm/overdose; (iii) suicidal ideation and aggressive behavior; and (iv) social functioning. In addition, patients with TRBD showed greater clinical improvement in long-term follow-up when compared with published schizophrenia data. Sedation (12%), constipation (5.0%), sialorrhea (5.2%), weight gain (4%), and body ache/pain (2%) were the commonly reported ADRs; however, these symptoms but did not usually require drug discontinuation. The percentage of severe ADRs reported, such as leukopenia (2%), agranulocytosis (0.3%), and seizure (0.5%), appeared to be lower than those reported in the published schizophrenia literature.
CONCLUSION
The limited current evidence supports the concept that clozapine may be both an effective and a relatively safe medication for TRBD.
Topics: Antipsychotic Agents; Bipolar Disorder; Clozapine; Humans
PubMed: 25346322
DOI: 10.1111/bdi.12272 -
The Cochrane Database of Systematic... Jun 2016Autism spectrum disorders (ASD) include autistic disorder, Asperger's disorder and pervasive developmental disorder - not otherwise specified (PDD-NOS). Antipsychotics... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Autism spectrum disorders (ASD) include autistic disorder, Asperger's disorder and pervasive developmental disorder - not otherwise specified (PDD-NOS). Antipsychotics have been used as a medication intervention for irritability related to ASD. Aripiprazole, a third-generation, atypical antipsychotic, is a relatively new drug that has a unique mechanism of action different from that of other antipsychotics. This review updates a previous Cochrane review on the safety and efficacy of aripiprazole for individuals with ASD, published in 2011 (Ching 2011).
OBJECTIVES
To assess the safety and efficacy of aripiprazole as medication treatment for individuals with ASD.
SEARCH METHODS
In October 2015, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL) and seven other databases as well as two trial registers. We searched for records published in 1990 or later, as this was the year aripiprazole became available.
SELECTION CRITERIA
Randomised controlled trials (RCTs) of aripiprazole (administered orally and at any dosage) versus placebo for treatment of individuals with a diagnosis of ASD.
DATA COLLECTION AND ANALYSIS
Two review authors independently collected, evaluated and analysed data. We performed meta-analysis for primary and secondary outcomes, when possible. We used the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach to rate the overall quality of the evidence.
MAIN RESULTS
We included three trials in this review. Two were included in the previous published review, and the results of one, placebo-controlled discontinuation study were added to this review. Although we searched for studies across age groups, we found only studies conducted in children and youth. Included trials had low risk of bias across most domains. High risk of bias was seen in only one trial with incomplete outcome data. We judged the overall quality of the evidence for most outcomes to be moderate.Two RCTs with similar methods evaluated use of aripiprazole for a duration of eight weeks in 316 children/adolescents with ASD. Meta-analysis of study results revealed a mean improvement of -6.17 points on the Aberrant Behavior Checklist (ABC) - Irritability subscale (95% confidence intervals (CIs) -9.07 to -3.26, two studies, 308 children/adolescents, moderate-quality evidence), -7.93 points on the ABC - Hyperactivity subscale (95% CI -10.98 to -4.88, two studies, 308 children/adolescents, moderate-quality evidence) and -2.66 points on the ABC - Stereotypy subscale (95% CI -3.55 to -1.77, two studies, 308 children/adolescents, moderate-quality evidence) in children/adolescents taking aripiprazole relative to children/adolescents taking placebo. In terms of side effects, children/adolescents taking aripiprazole had a greater increase in weight, with a mean increase of 1.13 kg relative to placebo (95% CI 0.71 to 1.54, two studies, 308 children/adolescents, moderate-quality evidence), and had a higher risk ratio (RR) for sedation (RR 4.28, 95% CI 1.58 to 11.60, two studies, 313 children/adolescents, moderate-quality evidence) and tremor (RR 10.26, 95% CI 1.37 to 76.63, two studies, 313 children/adolescents, moderate-quality evidence). A randomised, placebo-controlled discontinuation study found that 35% of children/adolescents randomised to continue intervention with aripiprazole relapsed with respect to their symptoms of irritability, compared with 52% of children/adolescents randomised to placebo, for a hazard ratio of 0.57 (95% CI 0.28 to 1.12, 85 children/adolescents, low-quality evidence).All three included trials were supported by Bristol-Myers Squibb (Princeton, NJ) and Otsuka Pharmaceutical Company, Ltd. (Tokyo, Japan), with editorial support provided by Ogilvy Healthworld Medical Education and Bristol-Myers Squibb.
AUTHORS' CONCLUSIONS
Evidence from two RCTs suggests that aripiprazole can be effective as a short-term medication intervention for some behavioural aspects of ASD in children/adolescents. After a short-term medication intervention with aripiprazole, children/adolescents showed less irritability and hyperactivity and fewer stereotypies (repetitive, purposeless actions). However, notable side effects, such as weight gain, sedation, drooling and tremor, must be considered. One long-term, placebo discontinuation study found that relapse rates did not differ between children/adolescents randomised to continue aripiprazole versus children/adolescents randomised to receive placebo, suggesting that re-evaluation of aripiprazole use after a period of stabilisation in irritability symptoms is warranted. Studies included in this review used criteria from the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) (APA 2000) for ASD diagnosis; however, the diagnostic criteria for ASD changed significantly with release of the fifth edition of the DSM (DSM-5) in 2013 (APA 2013).
Topics: Adolescent; Antipsychotic Agents; Aripiprazole; Child; Child Development Disorders, Pervasive; Female; Humans; Hyperkinesis; Irritable Mood; Male; Randomized Controlled Trials as Topic
PubMed: 27344135
DOI: 10.1002/14651858.CD009043.pub3 -
Cureus Jan 2024Parkinson's disease (PD) is a terminal, debilitating neurodegenerative disorder typically affecting individuals over 60. It is associated with various conditions that... (Review)
Review
Parkinson's disease (PD) is a terminal, debilitating neurodegenerative disorder typically affecting individuals over 60. It is associated with various conditions that drastically affect the patient's quality of life (QoL). Although there is no cure for PD, its symptoms can be significantly improved and even resolved through different treatments. Mainstay treatments for PD include levodopa combined with carbidopa, dopamine agonists, and even deep brain stimulation (DBS) of the subthalamic nucleus. New treatment methods have emerged, such as botulinum toxin (BoNT), which further improve symptoms and, thus, the QoL of patients with PD. Botulinum toxin is a potent neurotoxin produced by that typically causes descending paralysis by suppressing acetylcholine secretion. Serotypes used to treat various disorders include serotype A (BoNT-A) and serotype B (BoNT-B). This paper aims to evaluate the outcomes of BoNT injection on different symptoms associated with PD. An extensive review using PubMed, ScienceDirect, and ProQuest articles concerning 'botulinum toxin and Parkinson's disease' was done per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, resulting in 23,803 articles. After applying strict inclusion and exclusion criteria, the total number of articles was finally 41. The results showed that movement disorders were a common occurrence in PD, consisting of tremors, dystonia, and freezing of gait (FOG), with tremors being the most common symptom. Tremors and dystonia were significantly improved following BoNT-A, correlating with significant improvements in various scales subjectively and objectively evaluating the symptoms and QoL. In contrast, FOG was not significantly improved by either BoNT-A or BoNT-B. Pain is associated with movement disorders such as PD and was the primary indication for the administration of BoNT; studies found pain and QoL were significantly improved following BoNT injection. Quality of life can also be affected by sialorrhea and overactive bladder, which often occur as the disease progresses. Injections of BoNT-A and BoNT-B were shown to significantly improve saliva production, flow rate, drooling frequency, voiding frequency, and urinary urge incontinence. Across all studies analyzed, it is evident that BoNT may have a significant effect on improving the QoL of patients suffering from PD. While research continues to find a cure or stop the progression of PD, it remains critical to continue focusing on improving patients' QoL. Future research should evaluate whether BoNT can be used to successfully treat other symptoms of PD, such as epiphora or constipation.
PubMed: 38435899
DOI: 10.7759/cureus.53309 -
The Annals of Otology, Rhinology, and... Feb 2023Botulinum toxin A is known to be effective and safe in managing sialorrhea in pediatric patients; however, there is no consensus on a protocol for optimal injection... (Review)
Review
OBJECTIVE
Botulinum toxin A is known to be effective and safe in managing sialorrhea in pediatric patients; however, there is no consensus on a protocol for optimal injection sites and appropriate dosing for injection.
METHODS
This review was performed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol. PubMed, EMBASE, and other databases were queried to identify articles that evaluated botulinum toxin type A for the treatment of sialorrhea in the pediatric population. A total of 405 studies were identified. After applying inclusion and exclusion criteria, 31 articles were included for review.
RESULTS
A total of 14 studies evaluated 2-gland injections, and 17 studies evaluated 4-gland injections. Of the 31 studies included, one study assessed incobotulinumtoxinA (Xeomin) the remaining all used onabotulinumtoxinA (Botox). For 2-gland injection studies, a combined total of 899 participants were reviewed, where 602 participants received 50 units into their submandibular glands, while 262 participants received 30 to 50 units. Among 4-gland injection studies, there was a combined total of 388 participants, with the most prevalent dosage utilized being 60 to 100 units in 230 participants, followed by 100 units total in 77 participants. The most common adverse event was dysphagia which resolved in nearly all cases. Three studies aimed to examine 2-gland versus 4-gland injections, with 2 of the studies concluding 4-gland injection was superior.
CONCLUSIONS
The strength of evidence suggests that the dosing of 50 units total of onabotulinumtoxinA to the submandibular glands is safe and effective in the pediatric population. For 4-gland injections, bilateral submandibular and parotid gland injections of 60 to 100 units total is the safe and effective dosage. There is no substantial evidence comparing 4-gland injections to 2-gland injections, but research thus far suggests 4-gland injections to be superior. Future study is needed to evaluate incobotulinumtoxinA and abobotulinumtoxinA dosages in the pediatric population.
Topics: Humans; Child; Botulinum Toxins, Type A; Sialorrhea; Parotid Gland; Submandibular Gland; Injections; Treatment Outcome
PubMed: 35176902
DOI: 10.1177/00034894221078365