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The Cochrane Database of Systematic... 2001Spinal immobilisation involves the use of a number of devices and strategies to stabilise the spinal column after injury and thus prevent spinal cord damage. The... (Review)
Review
BACKGROUND
Spinal immobilisation involves the use of a number of devices and strategies to stabilise the spinal column after injury and thus prevent spinal cord damage. The practice is widely recommended and widely used in trauma patients with suspected spinal cord injury in the pre-hospital setting.
OBJECTIVES
To quantify the effect of different methods of spinal immobilisation (including immobilisation versus no immobilisation) on mortality, neurological disability, spinal stability and adverse effects in trauma patients.
SEARCH STRATEGY
We searched the Cochrane Controlled Trial Register (CCTR), the specialised register of the Cochrane Injuries Group, MEDLINE, EMBASE, CINAHL, PubMed and the National Research Register. We checked reference lists of all articles and contacted experts in the field to identify eligible trials. Manufacturers of spinal immobilisation devices were also contacted for information.
SELECTION CRITERIA
Randomised controlled trials comparing spinal immobilisation strategies in trauma patients with suspected spinal cord injury. Trials in healthy volunteers were excluded.
DATA COLLECTION AND ANALYSIS
Two reviewers independently applied eligibility criteria to trial reports and extracted data.
MAIN RESULTS
We found no randomised controlled trials of spinal immobilisation strategies in trauma patients.
REVIEWER'S CONCLUSIONS
We did not find any randomised controlled trials that met the inclusion criteria. The effect of spinal immobilisation on mortality, neurological injury, spinal stability and adverse effects in trauma patients remains uncertain. Because airway obstruction is a major cause of preventable death in trauma patients, and spinal immobilisation, particularly of the cervical spine, can contribute to airway compromise, the possibility that immobilisation may increase mortality and morbidity cannot be excluded. Large prospective studies are needed to validate the decision criteria for spinal immobilisation in trauma patients with high risk of spinal injury. Randomised controlled trials in trauma patients are required to establish the relative effectiveness of alternative strategies for spinal immobilisation.
Topics: Humans; Immobilization; Spinal Cord Injuries; Spinal Injuries
PubMed: 11406043
DOI: 10.1002/14651858.CD002803 -
Facial Plastic Surgery : FPS Jun 2024Corrective septal surgery for children with nasal obstruction has historically been avoided due to concern about the impact on the growing nose, with disruption of...
Corrective septal surgery for children with nasal obstruction has historically been avoided due to concern about the impact on the growing nose, with disruption of midfacial growth. However, there is a paucity of data evaluating complication and revision rates post-nasal septal surgery in the pediatric population. In addition, there is evidence to suggest that failure to treat nasal obstruction in children may itself result in facial deformity and/or developmental delay. The aim of this systematic review is to evaluate the efficacy and safety of septal surgery in pediatric patients with nasal obstruction. A systematic review was conducted in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines. MEDLINE, Embase, and the Cochrane Library were searched. Original studies in pediatric patients (<18 years of age) with nasal obstruction were eligible for inclusion. Patients with cleft lip or palate as their primary diagnosis were excluded. Our primary outcomes were patient-reported outcome measures (PROMs), postsurgical complications, and revision rates. Secondary outcomes included surgical technique, anatomical considerations, and anthropometric measurements. Eighteen studies were included (1,080 patients). Patients underwent septoplasty, septorhinoplasty, rhinoplasty, or a combination of procedures for nasal obstruction. Obstruction was commonly reported secondary to trauma, nasal septal deviation, or congenital deformity. The mean age of the patients was 13.04 years with an average follow-up of 41.8 months. In all, 5.6% patients required revision surgery and there was an overall complication rate of 7.8%. Septal surgery for nasal obstruction in children has low revision and complication rates. However, a pediatric-specific outcome measure is yet to be determined. Larger prospective studies with long-term follow-up periods are needed to determine the optimal timing of nasal surgery for nasal obstruction in the pediatric population.
Topics: Humans; Nasal Obstruction; Rhinoplasty; Child; Nasal Septum; Postoperative Complications; Reoperation; Adolescent; Patient Reported Outcome Measures
PubMed: 38035612
DOI: 10.1055/a-2219-9266 -
Sleep and Biological Rhythms Jul 2023Obstructive Sleep Apnea (OSA) corresponds to episodes of complete or partial upper airway obstruction during sleep. The gold standard for diagnosing OSA is... (Review)
Review
Obstructive Sleep Apnea (OSA) corresponds to episodes of complete or partial upper airway obstruction during sleep. The gold standard for diagnosing OSA is polysomnography; however, metabolomics is an innovative and highly sensitive method that seeks to identify and quantify small molecules in biological systems. Identify the metabolites most frequently associated with obstructive sleep apnea in adults. The search for articles was conducted between October 2020 and August 2021, in electronic databases, such as MEDLINE/PubMed, Scielo, Embase, and Cochrane, through the combination of descriptors: obstructive sleep apnea, metabolomic, adult. This systematic review included all cross-sectional studies published, including human patients aged 18 years or older, of both genders who underwent type I or II polysomnography and metabolomics study. The search strategy selected 3697 surveys, and 4 of them were selected to be a part of this systematic review. Based on the analyzed surveys, it was found that all of them were able to diagnose OSA, reaching a sensitivity of 75-97%, and specificity that ranged from 72 to 100%; besides differentiating patients with OSA (severe, moderate, and mild) from simple snorers with a mean sensitivity of 77.2% and specificity of 66.25%. These findings suggest that, in addition to being used as a screening and diagnostic strategy for OSA, metabolomics has the potential to be used for severity stratification and to monitor the disease's progression.
PubMed: 38469078
DOI: 10.1007/s41105-023-00445-5 -
The Cochrane Database of Systematic... Dec 2021Cystic fibrosis (CF) is the most common, life-limiting, genetically inherited disease. It affects multiple organs, particularly the respiratory system. However,... (Review)
Review
BACKGROUND
Cystic fibrosis (CF) is the most common, life-limiting, genetically inherited disease. It affects multiple organs, particularly the respiratory system. However, gastrointestinal problems such as constipation and distal intestinal obstruction syndrome (DIOS) are also important and well-recognised complications in CF. They share similar symptoms e.g. bloating, abdominal pain, but are distinct conditions. Constipation occurs when there is gradual faecal impaction of the colon, but DIOS occurs when there is an accumulation of faeces and sticky mucus, forming a mass in the distal part of the small intestine. The mass may partially block the intestine (incomplete DIOS) or completely block the intestine (complete DIOS). Symptoms of DIOS can affect quality of life and other aspects of CF health, such as airway clearance, exercise, sleep and nutritional status. Treatment of constipation and prevention of complete bowel obstruction are required for gastrointestinal management in CF. However, many different strategies are used in clinical practice and there is a lack of consensus. The importance of this topic was highlighted in a recent research priority setting exercise by the James Lind Alliance.
OBJECTIVES
To evaluate the effectiveness and safety of laxative agents of differing types for preventing DIOS (complete and incomplete) in children and adults with CF.
SEARCH METHODS
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. Date of search: 09 September 2021. We also searched online trial registries. Date of last search: 12 October 2021.
SELECTION CRITERIA
Randomised and quasi-randomised controlled parallel trials comparing laxative therapy for preventing DIOS (including osmotic agents, stimulants, mucolytics and substances with more than one action) at any dose to placebo, no treatment or an alternative laxative therapy, in people of any age with pancreatic sufficient or insufficient CF and any stage of lung disease. Randomised cross-over trials were judged on an individual basis.
DATA COLLECTION AND ANALYSIS
Two authors independently assessed trials for inclusion, extracted outcome data and performed a risk of bias assessment for the included data. We judged the certainty of the evidence using GRADE criteria.
MAIN RESULTS
We included one cross-over trial (17 participants) with a duration of 12 months, in which participants were randomly allocated to either cisapride (a gastro-prokinetic agent) or placebo for six months each. The trial had an unclear risk of bias for most domains but had a high risk of reporting bias. Radiograph scores revealed no difference in occurrence of DIOS between cisapride and placebo (narrative report, no data provided). There were no adverse effects. Symptom scores were the only secondary outcome within the review that were reported. Total gastrointestinal symptom scores favoured cisapride with a statistically significant mean difference (MD) of -7.60 (95% confidence interval (CI) -14.73 to -0.47). There was no significant difference at six months between cisapride and placebo for abdominal distension, MD -0.90 (95% CI -2.39 to 0.59) or abdominal pain, MD -0.4 (95% CI -2.05 to 1.25). The global symptom scores (whether individuals felt better or worse) were reported in the paper to favour cisapride and be statistically significant (P < 0.05). We assessed the available data to be very low certainty. There was a great deal of missing data from the included trial and the investigators failed to report numerical data for many outcomes. The overall risk of bias of the trial was unclear and it had a high risk for reporting bias. There was also indirectness; the trial drug (cisapride) has since been removed from the market in several countries due to adverse effects, thus it has no current applicability for preventing DIOS. The included trial also had very few participants, which downgraded the certainty a further level for precision.
AUTHORS' CONCLUSIONS
There is an absence of evidence for interventions for the prevention of DIOS. As there was only one included trial, we could not perform a meta-analysis of the data. Furthermore, the included trial compared a prokinetic agent (cisapride) that is no longer licensed for use in a number of countries due to the risk of serious cardiac events, a finding that came to light after the trial was conducted. Therefore, the limited findings from the trial are not applicable in current clinical practice. Overall, a great deal more research needs to be undertaken on gastrointestinal complications in CF, as this is a very poorly studied area compared to respiratory complications in CF.
Topics: Cisapride; Constipation; Cystic Fibrosis; Humans; Intestinal Obstruction; Quality of Life; Randomized Controlled Trials as Topic
PubMed: 34936085
DOI: 10.1002/14651858.CD012619.pub3 -
Brain Sciences Oct 2022Nasal obstruction is believed to play a significant role in the pathophysiology and management of obstructive sleep apnea (OSA). However, controversy remains about the... (Review)
Review
Nasal obstruction is believed to play a significant role in the pathophysiology and management of obstructive sleep apnea (OSA). However, controversy remains about the ability of isolated nasal surgery to improve OSA. The objective of this systematic review is to give an updated overview of the literature on whether isolated nasal surgery can improve OSA subjectively (Epworth Sleepiness Scale (ESS)) and/or objectively (polysomnography (PSG)). A systematic review was performed searching the electronic databases PubMed, Embase.com (accessed on 20 June 2022) Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials (CENTRAL) up to 20 June 2022. Eligible studies were reviewed for methodological quality using the NIH Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies. Twenty-one studies met the inclusion criteria. The majority of the included studies reported no significant reduction in the apnea-hypopnea index (AHI) after isolated nasal surgery in patients with OSA. The meta-analysis suggests that the AHI slightly decreases after nasal surgery. The ESS was significantly lower after nasal surgery in eighteen studies. Based on the present analysis of objective outcomes, isolated nasal surgery did not improve the AHI significantly in the majority of the studies. The meta-analysis suggests a slight decrease in AHI after nasal surgery, but this reduction is not clinically relevant in terms of treatment success. Isolated nasal surgery should therefore not be recommended as a first-line treatment for OSA. Because of high study heterogeneity, these results should be interpreted with caution. Isolated nasal surgery can possibly improve OSA subjectively. Perhaps only OSA patients with complaints of nasal obstruction or OSA patients experiencing difficulty with continuous positive airway pressure (CPAP) compliance would benefit from isolated nasal surgery.
PubMed: 36358372
DOI: 10.3390/brainsci12111446 -
Archives of Internal Medicine Feb 2007The relationship between marijuana smoking and pulmonary function or respiratory complications is poorly understood; therefore, we conducted a systematic review of the... (Review)
Review
BACKGROUND
The relationship between marijuana smoking and pulmonary function or respiratory complications is poorly understood; therefore, we conducted a systematic review of the impact of marijuana smoking on pulmonary function and respiratory complications.
METHODS
Studies that evaluated the effect of marijuana smoking on pulmonary function and respiratory complications were selected from the MEDLINE, PsychINFO, and EMBASE databases according to predefined criteria from January 1, 1966, to October 28, 2005. Two independent reviewers extracted data and evaluated study quality based on established criteria. Study results were critically appraised for clinical applicability and research methods.
RESULTS
Thirty-four publications met selection criteria. Reports were classified as challenge studies if they examined the association between short-term marijuana use and airway response; other reports were classified as studies of long-term marijuana smoking and pulmonary function or respiratory complications. Eleven of 12 challenge studies found an association between short-term marijuana administration and bronchodilation (eg, increases of 0.15-0.25 L in forced expiratory volume in 1 second). No consistent association was found between long-term marijuana smoking and airflow obstruction measures. All 14 studies that assessed long-term marijuana smoking and respiratory complications noted an association with increased respiratory symptoms, including cough, phlegm, and wheeze (eg, odds ratio, 2.00; 95% confidence interval, 1.32-3.01, for the association between marijuana smoking and cough). Studies were variable in their overall quality (eg, controlling for confounders, including tobacco smoking).
CONCLUSIONS
Short-term exposure to marijuana is associated with bronchodilation. Physiologic data were inconclusive regarding an association between long-term marijuana smoking and airflow obstruction measures. Long-term marijuana smoking is associated with increased respiratory symptoms suggestive of obstructive lung disease.
Topics: Airway Resistance; Humans; Marijuana Smoking; Pulmonary Ventilation; Respiratory Function Tests; Respiratory Tract Diseases
PubMed: 17296876
DOI: 10.1001/archinte.167.3.221 -
Brazilian Journal of Otorhinolaryngology 2021Allergic rhinitis is a chronic inflammatory disease of the nasal mucosa, mediated by immunoglobulin E, affecting 1 in 6 individuals. The treatment aims at attaining... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
Allergic rhinitis is a chronic inflammatory disease of the nasal mucosa, mediated by immunoglobulin E, affecting 1 in 6 individuals. The treatment aims at attaining symptomatic control with minimal side effects, a requirement for new alternative therapies, including phototherapy, as it has an immunosuppressive and immunomodulatory effect.
OBJECTIVE
To identify the effectiveness of phototherapy in the treatment of allergic rhinitis through a meta-analysis.
METHODS
We searched Web of Science, Scielo, PubMed, SCOPUS, PEDro, and LILACS databases, using the terms: "intranasal irradiation", "phototherapy" and "allergic rhinitis". The R software Metafor package was used for the meta-analysis and the effect size was calculated for each symptom individually.
RESULTS
All symptoms decreased considerably after phototherapy: rhinorrhea (ES• = -1.35; p < 0.0001; I = 91.84%), sneezing (ES• = -1.24; p < 0.0001; I = 91.43%), nasal pruritus (ES• = -1.10; p < 0.0001; I = 91.43%); nasal obstruction (ES• = -1.11; p < 0.0001; I = 91.88%). The effects were more significant in perennial allergic rhinitis than in the seasonal type.
CONCLUSION
Considering the effect size and the statistical significance attained in our study, rhinophototherapy showed to be an effective treatment for reducing the nasal symptom scores triggered by AR.
Topics: Humans; Nasal Mucosa; Nasal Obstruction; Phototherapy; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
PubMed: 33663975
DOI: 10.1016/j.bjorl.2020.12.016 -
The Cochrane Database of Systematic... Feb 2020This living systematic review is one of several Cochrane Reviews evaluating the medical management of patients with chronic rhinosinusitis. Chronic rhinosinusitis is... (Meta-Analysis)
Meta-Analysis
BACKGROUND
This living systematic review is one of several Cochrane Reviews evaluating the medical management of patients with chronic rhinosinusitis. Chronic rhinosinusitis is common. It is characterised by inflammation of the nasal and sinus linings, nasal blockage, rhinorrhoea, facial pressure/pain and loss of sense of smell. It occurs with or without nasal polyps. 'Biologics' are medicinal products produced by a biological process. Monoclonal antibodies are one type, already evaluated in related inflammatory conditions (e.g. asthma and atopic dermatitis).
OBJECTIVES
To assess the effects of biologics for the treatment of chronic rhinosinusitis.
SEARCH METHODS
The Cochrane ENT Information Specialist searched the Cochrane ENT Register; CENTRAL (2019, Issue 9); Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 16 September 2019.
SELECTION CRITERIA
Randomised controlled trials (RCTs) with at least three months follow-up comparing biologics (currently, monoclonal antibodies) against placebo/no treatment in patients with chronic rhinosinusitis.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methodological procedures. Our primary outcomes were disease-specific health-related quality of life (HRQL), disease severity and serious adverse events (SAEs). The secondary outcomes were avoidance of surgery, extent of disease (measured by endoscopic or computerised tomography (CT) score), generic HRQL and adverse events (nasopharyngitis, including sore throat). We used GRADE to assess the certainty of the evidence for each outcome.
MAIN RESULTS
We included eight RCTs. Of 986 adult participants, 984 had severe chronic rhinosinusitis with nasal polyps; 43% to 100% of participants also had asthma. Three biologics, with different targets, were evaluated: dupilumab, mepolizumab and omalizumab. All the studies were sponsored or supported by industry. Anti-IL-4Rα mAb (dupilumab) versusplacebo/no treatment (all receiving intranasal steroids) Three studies (784 participants) evaluated dupilumab. Disease-specific HRQL was measured with the SNOT-22 (score 0 to 110; minimal clinically important difference (MCID) 8.9 points). At 24 weeks, the SNOT-22 score was 19.61 points lower (better) in participants receiving dupilumab (mean difference (MD) -19.61, 95% confidence interval (CI) -22.54 to -16.69; 3 studies; 784 participants; high certainty). Symptom severity measured on a 0- to 10-point visual analogue scale (VAS) was 3.00 lower in those receiving dupilumab (95% CI -3.47 to -2.53; 3 studies; 784 participants; moderate certainty). The risk of serious adverse events may be lower in the dupilumab group (risk ratio (RR) 0.45, 95% CI 0.28 to 0.75; 3 studies; 782 participants; low certainty). The number of participants requiring nasal polyp surgery (actual or planned) during the treatment period is probably lower in those receiving dupilumab (RR 0.17, 95% CI 0.05 to 0.52; 2 studies; 725 participants; moderate certainty). Change in the extent of disease using the Lund Mackay computerised tomography (CT) score (0 to 24, higher = worse) was -7.00 (95% CI -9.61 to -4.39; 3 studies; 784 participants; high certainty), a large effect favouring the dupilumab group. The EQ-5D visual analogue scale (0 to 100, higher = better; MCID 8 points) was used to measure change in generic quality of life. The mean difference favouring dupilumab was 8.59 (95% CI 5.31 to 11.86; 2 studies; 706 participants; moderate certainty). There may be little or no difference in the risk of nasopharyngitis (RR 0.95, 95% CI 0.72 to 1.25; 3 studies; 783 participants; low certainty). Anti-IL-5 mAb (mepolizumab) versusplacebo/no treatment (all receiving intranasal steroids) Two studies (137 participants) evaluated mepolizumab. Disease-specific HRQL measured with the SNOT-22 at 25 weeks was 13.26 points lower (better) in participants receiving mepolizumab (95% CI -22.08 to -4.44; 1 study; 105 participants; low certainty; MCID 8.9). It is very uncertain whether there is a difference in s ymptom severity: on a 0- to 10-point VAS symptom severity was -2.03 lower in those receiving mepolizumab (95% CI -3.65 to -0.41; 1 study; 72 participants; very low certainty). It is very uncertain if there is difference in the risk of serious adverse events (RR 1.57, 95% CI 0.07 to 35.46; 2 studies; 135 participants, very low certainty). It is very uncertain whether or not the overall risk that patients still need surgery at trial end is lower in the mepolizumab group (RR 0.78, 95% CI 0.64 to 0.94; 2 studies; 135 participants; very low certainty). It is very uncertain whether mepolizumab reduces the extent of disease as measured by endoscopic nasal polyps score (scale range 0 to 8). The mean difference was 1.23 points lower in the mepolizumab group (MD -1.23, 95% -1.79 to -0.68; 2 studies; 137 participants; very low certainty). The difference in generic quality of life (EQ-5D) was 5.68 (95% CI -1.18 to 12.54; 1 study; 105 participants; low certainty), favouring the mepolizumab group. This difference is smaller than the MCID of 8 points. There may be little or no difference in the risk of nasopharyngitis (RR 0.73, 95% 0.36 to 1.47; 2 studies; 135 participants; low certainty). Anti-IgE mAb (omalizumab) versus placebo/no treatment (all receiving intranasal steroids) Three very small studies (65 participants) evaluated omalizumab. We are very uncertain about the effect of omalizumab on disease-specific HRQL, severe adverse events, extent of disease (CT scan scores), generic HRQL and adverse effects.
AUTHORS' CONCLUSIONS
In adults with severe chronic rhinosinusitis and nasal polyps, using regular topical nasal steroids, dupilumab improves disease-specific HRQL compared to placebo, and reduces the extent of the disease as measured on a CT scan. It probably also improves symptoms and generic HRQL and there is no evidence of an increased risk of serious adverse events. It may reduce the need for further surgery. There may be little or no difference in the risk of nasopharyngitis. In similar patients, mepolizumab may improve both disease-specific and generic HRQL. It is uncertain whether it reduces the need for surgery or improves nasal polyp scores. There may be little or no difference in the risk of nasopharyngitis. It is uncertain if there is a difference in symptom severity and the risk of serious adverse events. We are uncertain about the effects of omalizumab.
Topics: Biological Products; Chronic Disease; Humans; Nasal Obstruction; Nasal Polyps; Quality of Life; Randomized Controlled Trials as Topic; Rhinitis; Sinusitis; Treatment Outcome
PubMed: 32102112
DOI: 10.1002/14651858.CD013513.pub2 -
The Cochrane Database of Systematic... Jun 2018Cystic fibrosis (CF) is the most common, life-limiting, genetically inherited disease. It affects multiple organs, particularly the respiratory system. However,... (Review)
Review
BACKGROUND
Cystic fibrosis (CF) is the most common, life-limiting, genetically inherited disease. It affects multiple organs, particularly the respiratory system. However, gastrointestinal problems such as constipation and distal intestinal obstruction syndrome (DIOS) are also important and well-recognised complications in CF. They share similar symptoms e.g. bloating, abdominal pain, but are distinct conditions. Constipation occurs when there is gradual faecal impaction of the colon, but DIOS occurs when there is an accumulation of faeces and sticky mucus, forming a mass in the distal part of the small intestine. The mass may partially block the intestine (incomplete DIOS) or completely block the intestine (complete DIOS). Symptoms of DIOS can affect quality of life and other aspects of CF health, such as airway clearance, exercise, sleep and nutritional status. Treatment of constipation and prevention of complete bowel obstruction are required for gastrointestinal management in CF. However, many different strategies are used in clinical practice and there is a lack of consensus. The importance of this topic was highlighted in a recent research priority setting exercise by the James Lind Alliance.
OBJECTIVES
To evaluate the effectiveness and safety of laxative agents of differing types for preventing DIOS (complete and incomplete) in children and adults with CF.
SEARCH METHODS
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. Date of search: 22 May 2018.We also searched online trial registries. Date of last search: 10 June 2018.
SELECTION CRITERIA
Randomised and quasi-randomised controlled parallel trials comparing laxative therapy for preventing DIOS (including osmotic agents, stimulants, mucolytics and substances with more than one action) at any dose to placebo, no treatment or an alternative laxative therapy, in people of any age with pancreatic sufficient or insufficient CF and any stage of lung disease. Randomised cross-over trials were judged on an individual basis.
DATA COLLECTION AND ANALYSIS
Two authors independently assessed trials for inclusion, extracted outcome data and performed a risk of bias assessment for the included data. We judged the quality of the evidence using GRADE criteria.
MAIN RESULTS
We included one cross-over trial (17 participants) with a duration of 12 months, in which participants were randomly allocated to either cisapride (a gastro-prokinetic agent) or placebo for six months each. The trial had an unclear risk of bias for most domains but had a high risk of reporting bias.Radiograph scores revealed no difference in occurrence of DIOS between cisapride and placebo (narrative report, no data provided). There were no adverse effects. Symptom scores were the only secondary outcome within the review that were reported. Total gastrointestinal symptom scores favoured cisapride with a statistically significant mean difference (MD) of -7.60 (95% confidence interval (CI) -14.73 to -0.47). There was no significant difference at six months between cisapride and placebo for abdominal distension, MD -0.90 (95% CI -2.39 to 0.59) or abdominal pain, MD -0.4 (95% CI -2.05 to 1.25). The global symptom scores (whether individuals felt better or worse) were reported in the paper to favour cisapride and be statistically significant (P < 0.05).We assessed the available data to be very low quality. There was a great deal of missing data from the included trial and the investigators failed to report numerical data for many outcomes. The overall risk of bias of the trial was unclear and it had a high risk for reporting bias. There was also indirectness; the trial drug (cisapride) has since been removed from the market in several countries due to adverse effects, thus it has no current applicability for preventing DIOS. The included trial also had very few participants, which downgraded the quality a further level for precision.
AUTHORS' CONCLUSIONS
There is an absence of evidence for interventions for the prevention of DIOS. As there was only one included trial, we could not perform a meta-analysis of the data. Furthermore, the included trial compared a prokinetic agent (cisapride) that is no longer licensed for use in a number of countries due to the risk of serious cardiac events, a finding that came to light after the trial was conducted. Therefore, the limited findings from the trial are not applicable in current clinical practice.Overall, a great deal more research needs to be undertaken on gastrointestinal complications in CF, as this is a very poorly studied area compared to respiratory complications in CF.
Topics: Adolescent; Adult; Cisapride; Cystic Fibrosis; Gastrointestinal Agents; Humans; Intestinal Obstruction; Syndrome
PubMed: 29894558
DOI: 10.1002/14651858.CD012619.pub2 -
The Cochrane Database of Systematic... Jan 2006Obstructive sleep apnoea-hypopnoea (OSAH) is a syndrome characterised by recurrent episodes of partial or complete upper airway obstruction during sleep that are usually... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Obstructive sleep apnoea-hypopnoea (OSAH) is a syndrome characterised by recurrent episodes of partial or complete upper airway obstruction during sleep that are usually terminated by an arousal. Nasal continuous positive airway pressure (CPAP) is the primary treatment for OSAH , but many patients are unable or unwilling to comply with this treatment. Oral appliances (OA) are an alternative treatment for OSAH.
OBJECTIVES
The objective was to review the effects of OA in the treatment of OSAH in adults.
SEARCH STRATEGY
We searched the Cochrane Airways Group Specialised Register. Searches were current as of June 2005. Reference lists of articles were also searched.
SELECTION CRITERIA
Randomised trials comparing OA with control or other treatments in adults with OSAH .
DATA COLLECTION AND ANALYSIS
Two authors independently extracted data and assessed trial quality. Study authors were contacted for missing information.
MAIN RESULTS
Sixteen studies (745 participants) met the inclusion criteria. All the studies had some shortcomings, such as small sample size, under-reporting of methods and data, and lack of blinding. OA versus control appliances (six studies): OA reduced daytime sleepiness in two crossover trials (WMD -1.81;95%CI -2.72 to -0.90), and improved apnoea-hypopnoea index (AHI) (-10.78; 95% CI-15.53 to -6.03 parallel group data - five studies). OA versus CPAP (nine studies): OA were less effective than CPAP in reducing apnoea-hypopnoea index (parallel group studies: WMD 13 (95% CI 7.63 to 18.36), two trials; crossover studies: WMD 7.97; (95% CI 6.38 to 9.56, seven trials). However, no significant difference was observed on symptom scores. CPAP was more effective at improving minimum arterial oxygen saturation during sleep compared with OA. In two small crossover studies, participants preferred OA therapy to CPAP. OA versus corrective upper airway surgery (one study): Symptoms of daytime sleepiness were initially lower with surgery, but this difference disappeared at 12 months. AHI did not differ significantly initially, but did so after 12 months in favour of OA.
AUTHORS' CONCLUSIONS
There is increasing evidence suggesting that OA improves subjective sleepiness and sleep disordered breathing compared with a control. CPAP appears to be more effective in improving sleep disordered breathing than OA. The difference in symptomatic response between these two treatments is not significant, although it is not possible to exclude an effect in favour of either therapy. Until there is more definitive evidence on the effectiveness of OA in relation to CPAP, with regard to symptoms and long-term complications, it would appear to be appropriate to recommend OA therapy to patients with mild symptomatic OSAH, and those patients who are unwilling or unable to tolerate CPAP therapy. Future research should recruit patients with more severe symptoms of sleepiness, to establish whether the response to therapy differs between subgroups in terms of quality of life, symptoms and persistence with usage. Long-term data on cardiovascular health are required.
Topics: Adult; Continuous Positive Airway Pressure; Female; Humans; Male; Orthodontic Appliances; Randomized Controlled Trials as Topic; Sleep Apnea, Obstructive
PubMed: 16437488
DOI: 10.1002/14651858.CD004435.pub3