Benzodiazepines for restless legs syndrome.

BACKGROUND: Restless legs syndrome (RLS) is a common disease affecting about 5% to 15% of the population. Symptoms of RLS can be severe in a minority of and can have a major impact on sleep, mostly sleep initiation, and quality of life. Benzodiazepines are drugs that can induce and maintain sleep and, hence, intuitively are thought to be beneficial to people with RLS. Altough benzodiazepines, particularly clonazepam, are used to treat RLS symptoms, a systematic review done by the American Academy of Sleep Medicine stated that benzodiazepines should not be used as a first-line treatment, although could be used as a coadjuvant therapy. OBJECTIVES: To evaluate the efficacy and safety of benzodiazepine compared to placebo or other treatment for idiopathic RLS, including unconfounded trials comparing benzodiazepines versus open control. SEARCH METHODS: In March 2016 we searched CENTRAL, MEDLINE, Embase and LILACS We checked the references of each study and contacted study authors to identify any additional studies. We considered studies published in any language. SELECTION CRITERIA: Randomised clinical trials of benzodiazepine treatment in idiopathic RLS. DATA COLLECTION AND ANALYSIS: We did not perform data collection and analysis, since we did not include any studies, MAIN RESULTS: We did not identify any studies that met the inclusion criteria of the review. Two cross-over studies are awaiting classification because the cross-over trials did not give data at the end of the first cross-over period. AUTHORS' CONCLUSIONS: The effectiveness of benzodiazepines for RLS treatment is currently unknown.

Oral appliances and functional orthopaedic appliances for obstructive sleep apnoea in children.

BACKGROUND: Apnoea is a breathing disorder marked by the absence of airflow at the nose or mouth. In children, risk factors include adenotonsillar hypertrophy, obesity, neuromuscular disorders and craniofacial anomalies. The most common treatment for obstructive sleep apnoea syndrome (OSAS) in childhood is adeno-tonsillectomy. This approach is limited by its surgical risks, mostly in children with comorbidities and, in some patients, by recurrence that can be associated with craniofacial problems. Oral appliances and functional orthopaedic appliances have been used for patients who have OSAS and craniofacial anomalies because they hold the lower jaw (mandible) forwards which potentially enlarges the upper airway and increases the upper airspace, improving the respiratory function. OBJECTIVES: To assess the effects of oral appliances or functional orthopaedic appliances for obstructive sleep apnoea in children. SEARCH METHODS: We searched the following electronic databases: Cochrane Oral Health's Trials Register (to 7 April 2016); Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 3) in the Cochrane Library (searched 7 April 2016); MEDLINE Ovid (1946 to 7 April 2016); Embase Ovid (1980 to 7 April 2016); LILACS BIREME (from 1982 to 7 April 2016); BBO BIREME (from 1986 to 7 April 2016) and SciELO Web of Science (from 1997 to 7 April 2016). We searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform for ongoing trials on 7 April 2016. We placed no restrictions on the language or date of publication when searching the electronic databases. SELECTION CRITERIA: All randomised or quasi-randomised controlled trials comparing all types of oral and functional orthopaedic appliances with placebo or no treatment, in children 15 years old or younger. PRIMARY OUTCOME: reduction of apnoea to less than one episode per hour. SECONDARY OUTCOMES: dental and skeletal relationship, sleep parameters improvement, cognitive and phonoaudiological function, behavioural problems, quality of life, side effects (tolerability) and economic evaluation. DATA COLLECTION AND ANALYSIS: Two review authors screened studies and extracted data independently. Authors were contacted for additional information. We calculated risk ratios with 95% confidence intervals for all important dichotomous outcomes. We assessed the quality of the evidence of included studies using GRADEpro software. MAIN RESULTS: The initial search identified 686 trials. Only one trial, reporting the results from a total of 23 children and comparing an oral appliance to no treatment, was suitable for inclusion in the review. The trial assessed apnoea-hypopnoea, daytime symptoms (sleepiness, irritability, tiredness, school problems, morning headache, thirstiness in the morning, oral breathing and nasal stuffiness) and night-time symptoms (habitual snoring, restless sleep and nightmares measured by questionnaire). Results were inconsistent across outcomes measures and time points. The evidence was considered very low quality. AUTHORS' CONCLUSIONS: There is insufficient evidence to support or refute the effectiveness of oral appliances and functional orthopaedic appliances for the treatment of obstructive sleep apnoea in children. Oral appliances or functional orthopaedic appliances may be considered in specified cases as an auxiliary in the treatment of children who have craniofacial anomalies which are risk factors for apnoea.

Opioids for restless legs syndrome.

BACKGROUND: Restless legs syndrome (RLS) is a distressing and common neurological disorder that may have a huge impact in the quality of life of those with frequent and intense symptoms. Patients complain of unpleasant sensations in the legs, at or before bedtime, and feel an urge to move the legs, which improves with movement, such as walking. Symptoms start with the patient at rest (e.g. sitting or lying down), and follow a circadian pattern, increasing during the evening or at night. Many pharmacological intervention are available for RLS, including drugs used to treat Parkinson's disease (L-Dopa and dopaminergic agonists), epilepsy (anticonvulsants), anxiety (benzodiazepines), and pain (opioids). Dopaminergic drugs are those most frequently used for treatment of RLS, but some patients do not respond effectively and require other medication. Opioids, a class of medications used to treat severe pain, seem to be effective in treating RLS symptoms, and are recommended for patients with severe symptoms, because RLS and pain appear to share the same mechanism in the central nervous system. All available drugs are associated to some degree with side effects, which can impede treatment. Opioids are associated with adverse events such as constipation, tolerance, and dependence. This justifies the conduct of a systematic review to ascertain whether opioids are safe and effective for treatment of RLS. OBJECTIVES: To asses the effects of opioids compared to placebo treatment for restless legs syndrome in adults. SEARCH METHODS: We searched the Cochrane Central Register of Controlled trials, CENTRAL 2016, issue 4 and MEDLINE, EMBASE, and LILACS up to April 2016, using a search strategy adapted by Cochraneto identify randomised clinical trials. We checked the references of each study and established personal communication with other authors to identify any additional studies. We considered publications in all languages. SELECTION CRITERIA: Randomised controlled clinical trials of opioid treatment in adults with idiopathic RLS. DATA COLLECTION AND ANALYSIS: Two review authors independently screened articles, independently extracted data into a standard form, and assessed for risk of bias. If necessary, they discussed discrepancies with a third researcher to resolve any doubts. MAIN RESULTS: We included one randomised clinical trial (N = 304 randomised; 204 completed; 276 analysed) that evaluated opioids (prolonged release oxycodone/naloxone) versus placebo. After 12 weeks, RSL symptoms had improved more in the drug group than in the placebo group (using the IRLSSS: MD -7.0; 95% CI -9.69 to -4.31 and the CGI: MD -1.11; 95% CI -1.49 to -0.73). More patients in the drug group than in the placebo group were drug responders (using the IRLSSS: RR 1.82; 95% CI 1.37 to 2.42 and the CGI: RR1.92; 95% ICI 1.49 to 2.48). The proportion of remitters was greater in the drug group than in the placebo group (using the IRLSSS: RR 2.14; 95% CI 1.45 to 3.16). Quality of life scores also improved more in the drug group than in the placebo group (MD -0.73; 95% CI -1.1 to -0.36). Quality of sleep was improved more in the drug group measured by sleep adequacy (MD -0.74; 95% CI -1.15 to -0.33), and sleep quantity (MD 0.89; 95% CI 0.52 to 1.26).There was no difference between groups for daytime somnolence, trouble staying awake during the day, or naps during the day. More adverse events were reported in the drug group (RR 1.22; 95% CI 1.07 to 1.39). The major adverse events were gastrointestinal problems, fatigue, and headache. AUTHORS' CONCLUSIONS: Opioids seem to be effective for treating RLS symptoms, but there are no definitive data regarding the important problem of safety. This conclusion is based on only one study with a high dropout rate (moderate quality evidence).