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Clinical Therapeutics Jan 2016The objective of this meta-analysis was to systematically evaluate the efficacy of pramipexole for the treatment of primary moderate-to-severe restless leg syndrome... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
The objective of this meta-analysis was to systematically evaluate the efficacy of pramipexole for the treatment of primary moderate-to-severe restless leg syndrome (RLS).
METHODS
Databases of PubMed, OVID, ScienceDirect, SpringerLink, Thomson Reuters Web of Science, the Cochrane Library, the Wiley Online Library, ArticleFirst, CALIS, Study, CNKI, and WanFang were searched to identify randomized controlled trials (RCTs) investigating pramipexole for the treatment of primary moderate-to-severe RLS. A meta-analysis was then conducted to pool results.
FINDINGS
Twelve RCTs involving 3286 participants were included in this study. The mean (SD) treatment duration was 11.12 (5.72) weeks/person. The meta-analysis found that the post-treatment change in the International Restless Leg Syndrome Study Group Rating Scale (IRLS) score of the pramipexole group was significantly superior to that of the placebo group (weighted mean difference [WMD] = -4.64; 95% CI, -5.95 to -3.33; n = 8). More patients in the pramipexole group reported at least a 50% reduction in the IRLS score after treatment (risk ratio [RR] = 1.57; 95% CI, 1.43 to 1.73; n = 8). In terms of the scores for the Clinical Global Impression of Improvement scale (RR = 1.48; 95% CI, 1.31 to 1.66; n = 11) and the Patient Global Impression scale (RR = 1.54; 95% CI, 1.31 to 1.81; n = 9), treatment outcomes of the pramipexole group were significantly superior to those of the placebo group. In terms of the change in quality of life (WMD = 5.39; 95% CI, 2.28 to 8.50; n = 4), the change in daytime tiredness (WMD = -0.61; 95% CI, -1.21 to -0.01; n = 4), the change in the number of periodic limb movements per hour of sleep (WMD = -35.95; 95% CI, -56.42 to -15.48; n = 3), and the change in the quality of sleep (WMD = 3.60; 95% CI, 1.69 to 5.50; n = 6), the treatment outcomes of the pramipexole group were significantly superior to those of the placebo group.
IMPLICATIONS
This meta-analysis study indicated that pramipexole could effectively improve the symptoms of patients with primary moderate-to-severe RLS, although the quality of evidence was relatively low. Future clinical trials focusing on the medium-term and long-term treatment outcomes and using mainly objective indicators for evaluation are warranted. It is also necessary to pay close attention to augmentation during medication.
Topics: Benzothiazoles; Dopamine Agonists; Fatigue; Humans; Pramipexole; Quality of Life; Randomized Controlled Trials as Topic; Restless Legs Syndrome; Severity of Illness Index; Sleep; Treatment Outcome
PubMed: 26572941
DOI: 10.1016/j.clinthera.2015.10.010 -
Archives of Oral Biology Nov 2015The aim of this article was to systematically review the literature to identify papers dealing with risk factors associated with sleep bruxism (SB) in children. (Review)
Review
OBJECTIVE
The aim of this article was to systematically review the literature to identify papers dealing with risk factors associated with sleep bruxism (SB) in children.
DESIGN
A systematic search was carried out based on the following databases: PubMed, Embase, Scopus, Cochrane Oral Health Group's Trial Register and Cochrane Register of Controlled Trials, Web of Science, LILACs, SciELO. Studies investigating risk factors related to SB after multiple regression analysis and bruxism symptoms assessed with clinical diagnosis or specific questionnaires were searched. Six out of the 4546 initially identified studies were selected. This review was conducted according to the guidelines from the Cochrane Handbook for Systematic Reviews of Interventions, with reporting in agreement to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines.
RESULTS
Among the six analyzed articles, one randomized clinical trial (RCT) suggested the increase of SB in heavily exposed patients to second hand smoke (SHS) (OR=4.5, CI=2.2-9.4), two cross-sectional studies suggested neuroticism as determinant factor for the development of sleep bruxism (OR=1.9, CI=1.3-2.6), among children and three case-control studies suggested that children with sleep disturbances were more likely to have SB (OR=3.3, CI=1.6-6.6). Parafunctional behaviours (OR=2.3, CI=1.2-4.3) had a moderate association.
CONCLUSIONS
SHS and sleep disturbances presented the strongest association with SB. The most recurrent source of bias was the lack of blinding procedures. Furthermore, the use of reliable SB diagnostic procedures should be recommended to increase the quality of future studies. The evidence emerged from the considered studies was clinically relevant.
Topics: Case-Control Studies; Child; Humans; Prevalence; Randomized Controlled Trials as Topic; Risk Factors; Sleep Bruxism
PubMed: 26351743
DOI: 10.1016/j.archoralbio.2015.08.014 -
Dental Press Journal of Orthodontics 2014Prevalence of sleep bruxism (SB) in children is subject to discussions in the literature. (Review)
Review
INTRODUCTION
Prevalence of sleep bruxism (SB) in children is subject to discussions in the literature.
OBJECTIVE
This study is a systematic literature review aiming to critically assess the prevalence of SB in children.
METHODS
Survey using the following research databases: MEDLINE, Cochrane, EMBASE, PubMed, Lilacs and BBO, from January 2000 to February 2013, focusing on studies specifically assessing the prevalence of SB in children.
RESULTS
After applying the inclusion criteria, four studies were retrieved. Among the selected articles, the prevalence rates of SB ranged from 5.9% to 49.6%, and these variations showed possible associations with the diagnostic criteria used for SB.
CONCLUSION
There is a small number of studies with the primary objective of assessing SB in children. Additionally, there was a wide variation in the prevalence of SB in children. Thus, further, evidence-based studies with standardized and validated diagnostic criteria are necessary to assess the prevalence of SB in children more accurately.
Topics: Child; Child, Preschool; Humans; Prevalence; Sleep Bruxism
PubMed: 25628080
DOI: 10.1590/2176-9451.19.6.054-061.oar -
The Cochrane Database of Systematic... Oct 2014Sleep bruxism is an oral activity characterized by involuntary teeth grinding or clenching during sleep. Several forms of treatment have been proposed for this disorder,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Sleep bruxism is an oral activity characterized by involuntary teeth grinding or clenching during sleep. Several forms of treatment have been proposed for this disorder, including behavioural, dental and pharmacological strategies.
OBJECTIVES
To evaluate the effectiveness and safety of pharmacological therapy for the treatment of sleep bruxism compared with other drugs, no treatment or placebo.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 8, 2014), MEDLINE (1966 to August 2014), EMBASE (1980 to August 2013) and LILACS (1982 to August 2014). We identified additional reports from the reference lists of retrieved reports and from reviews on treatment of sleep bruxism. We applied no language restrictions.
SELECTION CRITERIA
We selected randomized controlled trials (RCTs) or quasi-RCTs that compared drugs with other drugs, no treatment or placebo in people with sleep bruxism.
DATA COLLECTION AND ANALYSIS
Review authors carried out data extraction and quality assessment of the included trials independently and in duplicate. We discussed discrepancies until we reached consensus. We consulted a third review author in cases of persistent disagreement. We contacted authors of primary studies when necessary.
MAIN RESULTS
We identified 18 potentially relevant RCTs, but only seven met the inclusion criteria. All studies had a small number of participants, ranging from seven to 16 people per study and had a cross-over design. Three studies were of low risk of bias, while four were of uncertain risk. Amitriptyline (three studies), bromocriptine (one study), clonidine (one study), propranolol (one study), levodopa (Prolopa®) (one study) and tryptophan (one study) were compared with placebo. Studies evaluating bromocriptine, clonidine, propranolol and levodopa reported our primary outcome of indices of bruxism motor activity.Results were imprecise and consistent with benefit, no difference or harm. These were the specific findings for each of the drugs according to specific outcomes: 1. Amitriptyline versus placebo for masseteric electromyography (EMG) activity per minute: standardized mean difference (SMD) -0.28 (95% confidence interval (CI) -0.91 to 0.34; P value = 0.37), 2. bromocriptine versus placebo for bruxism episodes per hour: mean difference (MD) 0.60 (95% CI -2.93 to 4.13), bruxism bursts per hour: MD -2.00 (95% CI -53.47 to 49.47), bruxism bursts per episode: MD 0.50 (95% CI -1.85 to 2.85) or number of episodes with grinding noise: MD 2.40 (95% CI -24.00 to 28.80), 3. clonidine versus placebo for number of bruxism episodes per hour: MD -2.41 (95% CI -4.84 to 0.02), 4. propranolol versus placebo for the number of bruxism episodes per hour: MD 1.16 (95% CI -1.89 to 4.21), 5. L-tryptophan versus placebo for masseteric EMG activity per second: SMD 0.08 (95% CI -0.90 to 1.06) and 6. levodopa versus placebo for bruxism episodes per hour of sleep: MD -1.47 (95% CI -3.64 to 0.70), for bruxism bursts per episode: MD 0.06 (95% CI -2.47 to 2.59).We combined several secondary outcomes (sleep duration, masseteric EMG activity per minute and pain intensity) in a meta-analysis for comparison of amitriptyline with placebo. The results for most comparisons were uncertain because of statistical imprecision. One study reported that clonidine reduced rapid eye movement (REM) sleep stage and increased the second stage of sleep. However, results for other sleep-related outcomes with clonidine were uncertain. Adverse effects were frequent in people who took amitriptyline (5/10 had drowsiness, difficulty awakening in the morning, insomnia or xerostomia compared with 0/10 in the placebo group), as well as in people who received propranolol (7/16 had moderate-to-severe xerostomia compare with 2/16 in the placebo group). Clonidine was associated with prolonged morning hypotension in three of 16 participants. The use of preventive medication avoided any adverse effects in people treated with levodopa and bromocriptine.
AUTHORS' CONCLUSIONS
There was insufficient evidence on the effectiveness of pharmacotherapy for the treatment of sleep bruxism. This systematic review points to the need for more, well-designed, RCTs with larger sample sizes and adequate methods of allocation, outcome assessment and duration of follow-up. Ideally, parallel RCTs should be used in future studies to avoid the bias associated with cross-over studies. There is a need to standardize the outcomes of RCTs on treatments for sleep bruxism.
Topics: Amitriptyline; Bromocriptine; Clonidine; Humans; Levodopa; Propranolol; Randomized Controlled Trials as Topic; Sleep Bruxism; Tryptophan
PubMed: 25338726
DOI: 10.1002/14651858.CD005578.pub2 -
Journal of Clinical Sleep Medicine :... Aug 2014To review systematically medical-legal cases of sleep-related violence (SRV) and sexual behavior in sleep (SBS). (Review)
Review
OBJECTIVE
To review systematically medical-legal cases of sleep-related violence (SRV) and sexual behavior in sleep (SBS).
SEARCH METHODS
We searched Pubmed and PsychINFO (from 1980 to 2012) with pre-specified terms. We also searched reference lists of relevant articles.
SELECTION CRITERIA
Case reports in which a sleep disorder was purported as the defense during a criminal trial and in which information about the forensic evaluation of the defendant was provided.
DATA EXTRACTION AND ANALYSIS
Information about legal issues, defendant and victim characteristics, circumstantial factors, and forensic evaluation was extracted from each case. A qualitative-comparative assessment of cases was performed.
RESULTS
Eighteen cases (9 SRV and 9 SBS) were included. The charge was murder or attempted murder in all SRV cases, while in SBS cases the charge ranged from sexual touching to rape. The defense was based on sleepwalking in 11 of 18 cases. The trial outcome was in favor of the defendant in 14 of 18 cases. Defendants were relatively young males in all cases. Victims were usually adult relatives of the defendants in SRV cases and unrelated young girls or adolescents in SBS cases. In most cases the criminal events occurred 1-2 hours after the defendant's sleep onset, and both proximity and other potential triggering factors were reported. The forensic evaluations widely differed from case to case.
CONCLUSION
SRV and SBS medical-legal cases did not show apparent differences, except for the severity of the charges and the victim characteristics. An international multidisciplinary consensus for the forensic evaluation of SRV and SBS should be developed as an urgent priority.
Topics: Adolescent; Adult; Criminal Law; Female; Forensic Medicine; Homicide; Humans; Male; Night Terrors; Rape; Sex Offenses; Sleep Wake Disorders; Somnambulism; Violence; Young Adult
PubMed: 25126042
DOI: 10.5664/jcsm.3976 -
Sleep Medicine Reviews Oct 2014Periodic limb movements of sleep (PLMS) are repetitive, stereotyped movements that can disrupt sleep and result in insomnia, non-restorative sleep, and/or daytime... (Meta-Analysis)
Meta-Analysis Review
Periodic limb movements of sleep (PLMS) are repetitive, stereotyped movements that can disrupt sleep and result in insomnia, non-restorative sleep, and/or daytime sleepiness. Currently, polysomnography is the gold standard and only clinically acceptable means of quantifying PLMS. Leg-worn actigraphy is an alternative method of measuring PLMS, which may circumvent many of the economic and technical limitations of polysomnography to quantify nocturnal leg movements. However, the use of leg actigraphy as a diagnostic means of assessing PLMS has not been systematically evaluated. In this review, the use of leg-worn actigraphy to measure PLMS is systematically evaluated, using both qualitative and quantitative assessment. Findings demonstrate significant heterogeneity among a limited number of studies in terms of type of actigraph utilized, position of the device on the lower extremity, and methods employed to count PLMS. In general, common accelerometers vary in their sensitivity and specificity to detect PLMS, which is likely related to the technical specifications of a given device. A current limitation in the ability to combine data from actigraphs placed on both legs is also a significant barrier to their use in clinical settings. Further research is required to determine the optimal methods to quantify PLMS using leg actigraphy, as well as specific clinical situations in which these devices may prove most useful.
Topics: Actigraphy; Humans; Leg; Nocturnal Myoclonus Syndrome; Polysomnography
PubMed: 24726711
DOI: 10.1016/j.smrv.2014.02.004