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The Cochrane Database of Systematic... Jun 2022Acute respiratory distress syndrome (ARDS) is a significant cause of hospitalisation and death in young children. Positioning and mechanical ventilation have been... (Review)
Review
BACKGROUND
Acute respiratory distress syndrome (ARDS) is a significant cause of hospitalisation and death in young children. Positioning and mechanical ventilation have been regularly used to reduce respiratory distress and improve oxygenation in hospitalised patients. Due to the association of prone positioning (lying on the abdomen) with sudden infant death syndrome (SIDS) within the first six months, it is recommended that young infants be placed on their back (supine). However, prone positioning may be a non-invasive way of increasing oxygenation in individuals with acute respiratory distress, and offers a more significant survival advantage in those who are mechanically ventilated. There are substantial differences in respiratory mechanics between adults and infants. While the respiratory tract undergoes significant development within the first two years of life, differences in airway physiology between adults and children become less prominent by six to eight years old. However, there is a reduced risk of SIDS during artificial ventilation in hospitalised infants. Thus, an updated review focusing on positioning for infants and young children with ARDS is warranted. This is an update of a review published in 2005, 2009, and 2012.
OBJECTIVES
To compare the effects of different body positions in hospitalised infants and children with acute respiratory distress syndrome aged between four weeks and 16 years.
SEARCH METHODS
We searched CENTRAL, which contains the Acute Respiratory Infections Group's Specialised Register, MEDLINE, Embase, and CINAHL from January 2004 to July 2021.
SELECTION CRITERIA
Randomised controlled trials (RCTs) or quasi-RCTs comparing two or more positions for the management of infants and children hospitalised with ARDS.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted data from each study. We resolved differences by consensus, or referred to a third contributor to arbitrate. We analysed bivariate outcomes using an odds ratio (OR) and 95% confidence interval (CI). We analysed continuous outcomes using a mean difference (MD) and 95% CI. We used a fixed-effect model, unless heterogeneity was significant (I statistic > 50%), when we used a random-effects model.
MAIN RESULTS
We included six trials: four cross-over trials, and two parallel randomised trials, with 198 participants aged between 4 weeks and 16 years, all but 15 of whom were mechanically ventilated. Four trials compared prone to supine positions. One trial compared the prone position to good-lung dependent (where the person lies on the side of the healthy lung, e.g. if the right lung was healthy, they were made to lie on the right side), and independent (or non-good-lung independent, where the person lies on the opposite side to the healthy lung, e.g. if the right lung was healthy, they were made to lie on the left side) position. One trial compared good-lung independent to good-lung dependent positions. When the prone (with ventilators) and supine positions were compared, there was no information on episodes of apnoea or mortality due to respiratory events. There was no conclusive result in oxygen saturation (SaO MD 0.40 mmHg, 95% CI -1.22 to 2.66; 1 trial, 30 participants; very low certainty evidence); blood gases, PCO (MD 3.0 mmHg, 95% CI -1.93 to 7.93; 1 trial, 99 participants; low certainty evidence), or PO (MD 2 mmHg, 95% CI -5.29 to 9.29; 1 trial, 99 participants; low certainty evidence); or lung function (PaO/FiO ratio; MD 28.16 mmHg, 95% CI -9.92 to 66.24; 2 trials, 121 participants; very low certainty evidence). However, there was an improvement in oxygenation index (FiO% X M/ PaO) with prone positioning in both the parallel trials (MD -2.42, 95% CI -3.60 to -1.25; 2 trials, 121 participants; very low certainty evidence), and the cross-over study (MD -8.13, 95% CI -15.01 to -1.25; 1 study, 20 participants). Derived indices of respiratory mechanics, such as tidal volume, respiratory rate, and positive end-expiratory pressure (PEEP) were reported. There was an apparent decrease in tidal volume between prone and supine groups in a parallel study (MD -0.60, 95% CI -1.05 to -0.15; 1 study, 84 participants; very low certainty evidence). When prone and supine positions were compared in a cross-over study, there were no conclusive results in respiratory compliance (MD 0.07, 95% CI -0.10 to 0.24; 1 study, 10 participants); changes in PEEP (MD -0.70 cm HO, 95% CI -2.72 to 1.32; 1 study, 10 participants); or resistance (MD -0.00, 95% CI -0.05 to 0.04; 1 study, 10 participants). One study reported adverse events. There were no conclusive results for potential harm between groups in extubation (OR 0.57, 95% CI 0.13 to 2.54; 1 trial, 102 participants; very low certainty evidence); obstructions of the endotracheal tube (OR 5.20, 95% CI 0.24 to 111.09; 1 trial, 102 participants; very low certainty evidence); pressure ulcers (OR 1.00, 95% CI 0.41 to 2.44; 1 trial, 102 participants; very low certainty evidence); and hypercapnia (high levels of arterial carbon dioxide; OR 3.06, 95% CI 0.12 to 76.88; 1 trial, 102 participants; very low certainty evidence). One study (50 participants) compared supine positions to good-lung dependent and independent positions. There was no conclusive evidence that PaO was different between supine and good-lung dependent positioning (MD 3.44 mm Hg, 95% CI -23.12 to 30.00; 1 trial, 25 participants; very low certainty evidence). There was also no conclusive evidence for supine position and good-lung independent positioning (MD -2.78 mmHg, 95% CI -28.84, 23.28; 25 participants; very low certainty evidence); or between good-lung dependent and independent positioning (MD 6.22, 95% CI -21.25 to 33.69; 1 trial, 25 participants; very low certainty evidence). As most trials did not describe how possible biases were addressed, the potential for bias in these findings is unclear.
AUTHORS' CONCLUSIONS
Although included studies suggest that prone positioning may offer some advantage, there was little evidence to make definitive recommendations. There appears to be low certainty evidence that positioning improves oxygenation in mechanically ventilated children with ARDS. Due to the increased risk of SIDS with prone positioning and lung injury with artificial ventilation, it is recommended that hospitalised infants and children should only be placed in this position while under continuous cardiorespiratory monitoring.
Topics: Adult; Child; Child, Preschool; Humans; Infant; Infant, Newborn; Patient Positioning; Positive-Pressure Respiration; Respiration, Artificial; Respiratory Distress Syndrome; Sudden Infant Death
PubMed: 35661343
DOI: 10.1002/14651858.CD003645.pub4 -
Minerva Medica Oct 2021Asthma is a complex disorder characterized by expiratory airflow limitation, wheeze, shortness of breath, chest tightness and cough, which can vary over time and in...
INTRODUCTION
Asthma is a complex disorder characterized by expiratory airflow limitation, wheeze, shortness of breath, chest tightness and cough, which can vary over time and in intensity. Being highly heterogeneous, asthma was characterized and classified in several asthma phenotypes and endotypes from 1947 until today. The present systematic review aims to summarize and describe evidence that was published in the last ten years in the field of asthma phenotyping and endotyping.
EVIDENCE ACQUISITION
The systematic review resumed high-quality evidence (clinical trials and randomized control trials) retrieved on MEDLINE and EMBASE databanks and involving adult asthmatic populations. Analyses of literature were conducted according to PRISMA and CASP guidelines.
EVIDENCE SYNTHESIS
Querying MEDLINE and EMBASE databanks, 5019 and 12261 entries were retrieved, respectively. Applying limitations for year of publication, age of participants, and type of publication, the search results were reduced to 98 and 132 articles, respectively. After data abstraction and resolution of duplications, only 50 articles were further evaluated. The research products were then classified first in macro-areas of interest (phenotypes or endotypes) and then in detailed micro-areas.
CONCLUSIONS
This systematic review overviews the principal findings available from high-quality literature in the last decade concerning asthma phenotypes and endotypes. Asthma has been described from different points of view, characterizing symptoms, microbiota composition, comorbidities, viral infections, and airway and/or systemic inflammatory status. The comprehension of precise mechanisms underlying asthma pathogenesis is thereby the basis for the development of novel therapeutic strategies, likely essential to the development of precision medicine.
Topics: Adult; Age Factors; Asthma; Biological Products; Clinical Trials as Topic; Comorbidity; Cough; Disease Progression; Drug Resistance; Humans; Microbiota; Obesity; Phenotype; Randomized Controlled Trials as Topic; Respiratory Sounds; Sputum; Steroids; Treatment Outcome
PubMed: 33969960
DOI: 10.23736/S0026-4806.21.07498-X -
Sleep Medicine Oct 2019Obstructive sleep apnea/hypopnea syndrome (OSAHS) is a very common, yet undiagnosed, breathing disorder that has many more implications besides disrupted sleep. Its role... (Meta-Analysis)
Meta-Analysis
Efficacy of continuous positive airway pressure (CPAP) preventing type 2 diabetes mellitus in patients with obstructive sleep apnea hypopnea syndrome (OSAHS) and insulin resistance: a systematic review and meta-analysis.
BACKGROUND
Obstructive sleep apnea/hypopnea syndrome (OSAHS) is a very common, yet undiagnosed, breathing disorder that has many more implications besides disrupted sleep. Its role as an independent risk factor for metabolic abnormalities such as insulin resistance (IR) and impaired glucose tolerance is becoming increasingly recognized. The main treatment for OSAHS is continuous positive airway pressure (CPAP), however the impact of CPAP on IR and glucose metabolism is still debated.
OBJECTIVES
Compile all available evidence regarding the effect of CPAP on IR in non-diabetic OSA patients.
METHODS
A literature search in Medline, Epistemonikos and the Cochrane Controlled Trial Register were searched through March 2018. We included Randomized Controlled Trials (RCTs) comparing CPAP treatment with sham CPAP, placebo or no treatment in non-diabetic adults with OSAHS. Risk of Bias was evaluated using Cochrane tool and a meta-analysis evaluating the efficacy of CPAP in both HOMA index and fasting glucose was done. Certain of evidence was rated using GRADE approach.
RESULTS
Nine studies consisting of 443 participants were included. CPAP treatment significantly improved HOMA index (Mean difference = -0.39 Ui (CI, -0.69 to -0.08), p < 0.05. I2 = 57% (GRADE = LOW). However, CPAP showed no significant changes in fasting glucose (GRADE = LOW).
CONCLUSION
This systematic review and meta-analysis shows evidence that metabolic disturbances could be halted and regressed with CPAP treatment in patients with insulin resistance and OSAHS. In conclusion, treatment with CPAP could improve HOMA IR index.
Topics: Adult; Case-Control Studies; Continuous Positive Airway Pressure; Diabetes Mellitus, Type 2; Female; Glucose Intolerance; Humans; Insulin Resistance; Male; Middle Aged; Placebo Effect; Randomized Controlled Trials as Topic; Risk Factors; Sleep Apnea, Obstructive; Treatment Outcome
PubMed: 31518943
DOI: 10.1016/j.sleep.2018.12.017 -
Archivos de Bronconeumologia Jun 2023Continuous Positive Airway Pressure (CPAP) is the most effective therapy for symptomatic obstructive sleep apnoea (OSA). However, uncertainty remains about the... (Meta-Analysis)
Meta-Analysis
Effect of Continuous Positive Airway Pressure on Glucose and Lipid Profiles in Patients With Obstructive Sleep Apnoea: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
BACKGROUND AND AIM
Continuous Positive Airway Pressure (CPAP) is the most effective therapy for symptomatic obstructive sleep apnoea (OSA). However, uncertainty remains about the effectiveness of CPAP in improving OSA-related metabolic dysregulation. This meta-analysis of randomized controlled trials (RCTs) aimed to investigate whether CPAP, compared to other control treatments, could improve glucose or lipid metabolism in OSA patients.
METHODS
Relevant articles were searched in three different databases (MEDLINE, EMBASE and Web of Science) from inception to 6th Feb 2022 through specific search terms and selection criteria.
RESULTS
From a total of 5553 articles, 31 RCTs were included. CPAP modestly improved insulin sensitivity as determined by mean fasting plasma insulin and Homeostasis Model Assessment of Insulin Resistance reduction of 1.33mU/L and 0.287, respectively. In subgroup analyses pre-diabetic/type 2 diabetic patients as well as those with sleepy OSA showed a greater response to CPAP. Regarding lipid metabolism, CPAP was associated with a mean total cholesterol reduction of 0.064mmol/L. In subgroup analyses, the benefit was higher in patients that showed more severe OSA and oxygen desaturations at the baseline sleep study as well as in younger and obese subjects. Neither glycated haemoglobin nor triglycerides, HDL- and LDL-cholesterol were reduced by CPAP.
CONCLUSION
CPAP treatment may improve insulin sensitivity and total cholesterol levels in OSA patients but with low effect size. Our results suggest that CPAP does not substantially improve metabolic derangements in an unselected OSA population, but the effect may be higher in specific subgroups of OSA patients.
Topics: Humans; Insulin Resistance; Glucose; Continuous Positive Airway Pressure; Randomized Controlled Trials as Topic; Triglycerides; Sleep Apnea, Obstructive; Cholesterol
PubMed: 37024342
DOI: 10.1016/j.arbres.2023.03.012 -
The Cochrane Database of Systematic... Jun 2018Bronchiectasis is a chronic airway disease characterised by a destructive cycle of recurrent airway infection, inflammation and tissue damage. Antibiotics are a main... (Review)
Review
BACKGROUND
Bronchiectasis is a chronic airway disease characterised by a destructive cycle of recurrent airway infection, inflammation and tissue damage. Antibiotics are a main treatment for bronchiectasis. The aim of continuous therapy with prophylactic antibiotics is to suppress bacterial load, but bacteria may become resistant to the antibiotic, leading to a loss of effectiveness. On the other hand, intermittent prophylactic antibiotics, given over a predefined duration and interval, may reduce antibiotic selection pressure and reduce or prevent the development of resistance. This systematic review aimed to evaluate the current evidence for studies comparing continuous versus intermittent administration of antibiotic treatment in bronchiectasis in terms of clinical efficacy, the emergence of resistance and serious adverse events.
OBJECTIVES
To evaluate the effectiveness of continuous versus intermittent antibiotics in the treatment of adults and children with bronchiectasis, using the primary outcomes of exacerbations, antibiotic resistance and serious adverse events.
SEARCH METHODS
On 1 August 2017 and 4 May 2018 we searched the Cochrane Airways Review Group Specialised Register (CAGR), CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, and AMED. On 25 September 2017 and 4 May 2018 we also searched www.clinicaltrials.gov, the World Health Organization (WHO) trials portal, conference proceedings and the reference lists of existing systematic reviews.
SELECTION CRITERIA
We planned to include randomised controlled trials (RCTs) of adults or children with bronchiectasis that compared continuous versus intermittent administration of long-term prophylactic antibiotics of at least three months' duration. We considered eligible studies reported as full-text articles, as abstracts only and unpublished data.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened the search results and full-text reports.
MAIN RESULTS
We identified 268 unique records. Of these we retrieved and examined 126 full-text reports, representing 114 studies, but none of these studies met our inclusion criteria.
AUTHORS' CONCLUSIONS
No randomised controlled trials have compared the effectiveness and risks of continuous antibiotic therapy versus intermittent antibiotic therapy for bronchiectasis. High-quality clinical trials are needed to establish which of these interventions is more effective for reducing the frequency and duration of exacerbations, antibiotic resistance and the occurrence of serious adverse events.
Topics: Adult; Anti-Bacterial Agents; Bronchiectasis; Child; Humans
PubMed: 29860722
DOI: 10.1002/14651858.CD012733.pub2 -
Clinical Otolaryngology : Official... Dec 2009There is no consensus about the value of objective measurements of nasal patency. (Review)
Review
BACKGROUND
There is no consensus about the value of objective measurements of nasal patency.
OBJECTIVE
To assess the correlation between the subjective sense of nasal patency and the outcomes found with rhinomanometry and acoustic rhinometry.
TYPE OF REVIEW
Structured literature search. SEARCH STRATEGY AND EVALUATION METHOD: Review of English-language articles in which correlations were sought between subjective nasal patency symptoms and objective scores as found with rhinomanometry [nasal airway resistance (NAR)] and acoustic rhinometry [minimal cross-sectional area (MCA)]. Correlations were related to unilateral or combined assessment of nasal passages and to symptomatic nasal obstruction or unobstructed nasal breathing.
RESULTS
Sixteen studies with a level of evidence II-a or II-b fit the inclusion criteria and were further analysed. Almost every possible combination of correlations or lack thereof in relation to the variables included was found. However, when obstructive symptoms were present, a correlation between the patency symptoms with nasal airway resistance and minimal cross-sectional area was found more often than in the absence of symptoms. In cases of bilateral assessment a correlation was found almost as often as it was not between patency symptoms and total nasal airway resistance or combined minimal cross-sectional areas, while in the limited amount of studies in which unilateral assessment was done a correlation was found each time between patency symptoms and nasal airway resistance.
CONCLUSIONS
The correlation between the outcomes found with rhinomanometry and acoustic rhinometry and an individual's subjective sensation of nasal patency remains uncertain. Based on this review, it seems that the chance of a correlation is greater when each nasal passage is assessed individually and when obstructive symptoms are present. There still seems to be only a limited argument for the use of rhinomanometry or acoustic rhinometry in routine rhinologic practice or for quantifying surgical results.
Topics: Humans; Nasal Obstruction; Rhinomanometry; Rhinometry, Acoustic; Severity of Illness Index
PubMed: 20070760
DOI: 10.1111/j.1749-4486.2009.02042.x -
The Journal of Asthma : Official... Sep 2013Airway inflammation that occurs in asthma is mainly distributed in the small airways. Leukotriene receptor antagonists (LTRAs) are systemically active drugs that may act... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Airway inflammation that occurs in asthma is mainly distributed in the small airways. Leukotriene receptor antagonists (LTRAs) are systemically active drugs that may act on the small airways.
OBJECTIVES
The aim of our study was to assess the efficacy of LTRAs for small-airway abnormalities in asthmatics.
METHODS
We searched the databases of Cochrane Central, MEDLINE, and EMBASE from the time of the establishment of the databases to December 2012. The data were extracted using a pooled mean difference (MD) or standardized mean difference (SMD) with a 95% confidence interval (CI).
RESULTS
Eight studies were included. The outcomes were the conventional parameters for the detection of small-airway abnormalities. Eight studies were included. The outcomes were the conventional parameters for the detection of small-airway abnormalities. LTRAs compared to placebo improved small-airway abnormalities, as indicated by a number of radiological and physiological parameters, such as lung attenuation (MD, 61.00; 95% CI, 26.32 to 95.68) and residual volume (SMD, -0.85; 95% CI, -1.29 to -0.42). Conventional inhaled corticosteroids (ICSs) compared to LTRAs improved small-airway abnormalities, as indicated by the reactance area (p = 0.028). Compared with conventional treatment alone, a combination of LTRAs and conventional treatment improved small-airway abnormalities, as indicated by a number of radiological and physiological parameters, such as airway wall thickness (p < 0.05), alveolar nitric oxide concentration (p = 0.04), a decrease in resistance from 5 to 20 hertz (p = 0.032), reactance area (p = 0.014), eosinophil cationic protein levels (p = 0.045) and number of eosinophils (p = 0.035) in the late-phase induced sputum. However, there was no significant improvement in forced expiratory flow between 25% and 75% of forced vital capacity in any of the comparisons.
CONCLUSIONS
LTRAs may improve most of the conventional parameters for the detection of small-airway abnormalities in asthmatics. However, there is no evidence of the superiority of LTRAs over ICSs in improving functional parameters related to the small airways.
Topics: Asthma; Humans; Leukotriene Antagonists; Randomized Controlled Trials as Topic; Respiratory Function Tests
PubMed: 23713591
DOI: 10.3109/02770903.2013.806543 -
NPJ Primary Care Respiratory Medicine Feb 2015Evidence suggests that 15-30% of individuals with obstructive sleep apnoea (OSA) have type 2 diabetes mellitus (T2DM), and that OSA is an independent risk factor for... (Meta-Analysis)
Meta-Analysis Review
Effects of continuous positive airway pressure therapy on glycaemic control, insulin sensitivity and body mass index in patients with obstructive sleep apnoea and type 2 diabetes: a systematic review and meta-analysis.
BACKGROUND
Evidence suggests that 15-30% of individuals with obstructive sleep apnoea (OSA) have type 2 diabetes mellitus (T2DM), and that OSA is an independent risk factor for T2DM. There is considerable interest in ascertaining whether OSA treatment improves glycaemic control and insulin sensitivity in patients with OSA and T2DM.
AIMS
To assess the effects of continuous positive airway pressure (CPAP) therapy on glycosylated haemoglobin (HbA1c) level, insulin sensitivity and body mass index (BMI) in patients with OSA and T2DM.
METHODS
MEDLINE, EMBASE and the Cochrane Library were searched to identify prospective studies involving patients with OSA and T2DM who had received CPAP, and data on primary outcome (change in HbA1c) and/or secondary outcomes (changes in insulin sensitivity and BMI) were reported. All relevant studies published before 31 January 2014 were included.
RESULTS
Six studies were included in the systematic review and meta-analysis. The numbers of patients ranged from 9 to 44 (total=128), and mean age ranged from 50.7 to 66.1 years. For the change in HbA1c (six studies, 128 patients), the combined standardised paired difference revealed no significant effect of CPAP (-0.071, 95% confidence interval (CI)=-0.245, 0.103; P=0.421). Similarly, there was no significant effect of CPAP on the change in BMI (-0.102, 95% CI=-0.296, 0.092; P=0.302; five studies, 103 patients). In contrast, there was a significant effect of CPAP on the change (improvement) in insulin sensitivity (0.330, 95% CI=0.001, 0.658; P=0.049; three studies, 39 patients).
CONCLUSION
The limited available evidence from randomised controlled trials and prospective observational studies suggests that CPAP does not decrease HbA1c level or BMI in patients with OSA and T2DM but may improve insulin sensitivity.
Topics: Adolescent; Adult; Body Mass Index; Child; Comorbidity; Continuous Positive Airway Pressure; Diabetes Mellitus, Type 2; Female; Glycated Hemoglobin; Humans; Insulin Resistance; Male; Sleep Apnea, Obstructive; Young Adult
PubMed: 25719929
DOI: 10.1038/npjpcrm.2015.5 -
International Orthodontics Mar 2021This systematic review assessed the effects of tooth-borne (TB), tooth-bone-borne (TBB) and bone-borne (BB) micro-implant assisted rapid maxillary expansion (RPE) on... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
This systematic review assessed the effects of tooth-borne (TB), tooth-bone-borne (TBB) and bone-borne (BB) micro-implant assisted rapid maxillary expansion (RPE) on airway dimensions and function in young children and adolescents (10- to 17-years-old).
MATERIALS AND METHODS
Unrestricted search in 5 electronic databases until June 6th, 2020 was undertaken. This was supplemented with search in 6 additional resources for published, unpublished and ongoing trials up. Randomized (RCT) and non-randomized (Non-RCT) prospective studies that assessed the influence of the mini-screw-assisted rapid palatal expansion (MARPE) approach on airway and breathing in young children and adolescents were included. Two reviewers performed the study selection and data extraction blindly and in duplicate by two authors while disagreements. A random-effects model with a 95% confidence interval (CI), I2 and Chi tests were done. ROBINS-I, Cochrane Risk of Bias and GRADE tools were used. Reporting of this review was based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.
RESULTS
Overall, 518 articles were retrieved; only 3 studies (2 RCT and one non-RCT) met the inclusion criteria. Both TB RPE and BB RPE improved on a short-term basis the dimensions of the airway, though the difference was not significant (P>0.05). TBB RPE significantly improved nasal airflow [(Mean difference (MD) 52.7 cm/s, 95% confidence interval (95% CI) 9.0-96.4), P=0.020)], reduced nasal resistance (MD -0.20Pa/cm, 95% (-0.38)-(-0.02), P=0.028), and changed respiratory muscle strength variables (P>0.05). No correlation was found between the anatomical dimensions of the airway and the functional airway parameters (P>0.05).
CONCLUSIONS
The short-term airway volumetric changes secondary to MARPE were not significant. The influence of MARPE appliances on breathing is still not clear. Registration PROSPERO database (CRD42020183340).
Topics: Adolescent; Bone Screws; Child; Databases, Factual; Humans; Maxilla; Middle Aged; Palatal Expansion Technique; Palate; Respiration
PubMed: 33516650
DOI: 10.1016/j.ortho.2021.01.004 -
The Annals of Pharmacotherapy Mar 2007Oral phenylephrine is used as a decongestant, yet there has been no previously published systematic review supporting its efficacy and safety. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Oral phenylephrine is used as a decongestant, yet there has been no previously published systematic review supporting its efficacy and safety.
OBJECTIVE
To assess the efficacy and safety of oral phenylephrine as a nonprescription decongestant.
METHODS
MEDLINE, the Cochrane Central Registry of Controlled Trials, EMBASE, International Pharmaceutical Abstracts, and the Federal Register were searched for English and non-English-language studies published through January 2007 that measured the effects of oral phenylephrine on nasal airway resistance (NAR) in patients with nasal congestion. The retrieved studies were supplemented with information from our personal files and by hand searches of the references in any of the studies. Additionally, a Web of Science Search was conducted using the Cited Reference function for all published clinical trials identified. Studies included in the analysis were randomized, placebo-controlled trials; studies of combination products were excluded. Two investigators independently extracted data on NAR, self-reported decongestant effects, and cardiovascular effects (ie, heart rate, blood pressure) from each of the included studies. Meta-analyses were performed for NAR and cardiovascular effects using a random effects model. Subjective decongestant effects were summarized.
RESULTS
Based on 8 unpublished studies that included 138 patients, phenylephrine 10 mg did not affect NAR more than placebo; the mean maximal difference in relative change from baseline between phenylephrine and placebo was 10.1% (95% CI -3.8% to 23.9%). Eight unpublished studies on phenylephrine 25 mg showed a significant reduction of maximal NAR compared with placebo of 27.6% (95% CI 17.5% to 37.7%). There was significant heterogeneity among the studies included in this analysis, which was partially attributable to different laboratories and methods used. Patient-reported decongestion was not consistently better for any phenylephrine dose compared with placebo, and NAR was a more sensitive measurement of efficacy. Phenylephrine showed no consistent effect on heart rate or blood pressure for doses of 25 mg or less.
CONCLUSIONS
There is insufficient evidence that oral phenylephrine is effective for nonprescription use as a decongestant. The Food and Drug Administration should require additional studies to show the safety and efficacy of phenylephrine.
Topics: Airway Resistance; Humans; Nasal Decongestants; Nasal Obstruction; Phenylephrine; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 17264159
DOI: 10.1345/aph.1H679