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Giornale Italiano Di Dermatologia E... Jun 2018Psoriasis is a chronic-relapsing skin disorder which requires long-term treatments. Therapeutic options for psoriasis include topical treatments, phototherapy and... (Review)
Review
Psoriasis is a chronic-relapsing skin disorder which requires long-term treatments. Therapeutic options for psoriasis include topical treatments, phototherapy and systemic therapy. However, those treatments, and particularly the topical drug therapies, may present some limitations, including poor efficacy/tolerability ratio and lack of adherence. Recently, the supersaturated aerosol foam formulation of the fixed combination calcipotriene plus betamethasone dipropionate (Cal/BD) has gained major attention because it overcomes some of the limitations associated with other topical treatments. This fixed-combination has increased efficacy compared with its individual components. Moreover, the alcohol-free aerosol foam formulation allows a higher penetration of the active ingredients into the skin, resulting in enhanced bioavailability and, consequently, in better clinical outcomes than other products with the same components. Given the short duration of therapy course and the fast onset of action, a reduced amount of Cal/BD foam formulation would be required for the treatment of psoriasis patients, resulting also in cost saving. Therefore this novel formulation could represent an alternative to other topical agents and a first-line therapy in the treatment of mild and mild-to-moderate psoriasis.
Topics: Administration, Cutaneous; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Humans; Phototherapy; Psoriasis; Severity of Illness Index; Skin Absorption; Treatment Outcome
PubMed: 27982547
DOI: 10.23736/S0392-0488.16.05516-4 -
American Journal of Physiology. Lung... May 2016Surfactant, synthesized by type II pneumocytes (PN-II), mainly comprises phosphatidylcholine (PC) and is essential to prevent neonatal respiratory distress. Furthermore,...
Surfactant, synthesized by type II pneumocytes (PN-II), mainly comprises phosphatidylcholine (PC) and is essential to prevent neonatal respiratory distress. Furthermore, PC is essential to lung tissue growth and maintenance as a membrane component. Recent findings suggest that the lung contributes to systemic lipid homeostasis via PC export through ABC-A1 transporter expression. Hence it is important to consider pharmacological interventions in neonatal lung PC metabolism with respect to such export. Five-day-old rats were treated with carrier (control), intraperitoneal betamethasone, subcutaneous recombinant human keratinocyte growth factor (rhuKGF), or their combination for 48 h. Animals were intraperitoneally injected with 50 mg/kg [D9-methyl]choline chloride 1.5, 3.0, and 6.0 h before death at day 7, and lung lavage fluid (LLF) and tissue were harvested. Endogenous PC, D9-labeled PC species, and their water-soluble precursors (D9-)choline and (D9-)phosphocholine were determined by tandem mass spectrometry. Treatment increased secreted and tissue PC pools but did not change equilibrium composition of PC species in LLF. However, all treatments increased specific surfactant components in tissue. In control rats, peak D9-PC in lavaged lung was reached after 3 h and was decreased at 6 h. Only 13% of this net loss in lavaged lung was found in LLF. Such decrease was not present in lungs treated with betamethasone and/or with rhuKGF. D9-PC loss at 3-6 h and PC synthesis calculated from D9 enrichment of phosphocholine indicated that daily synthesis rate is higher than total pool size. We conclude that lung tissue contributes to systemic PC homeostasis in neonatal rats, which is altered by glucocorticoid and rhuKGF treatment.
Topics: Animals; Betamethasone; Drug Evaluation, Preclinical; Fibroblast Growth Factor 7; Glucocorticoids; Kinetics; Lung; Phosphatidylcholines; Pulmonary Surfactants; Rats, Sprague-Dawley
PubMed: 26944086
DOI: 10.1152/ajplung.00010.2016 -
Pediatric Research Nov 2019The use of antenatal corticosteroids (ACS) in low-resource environments is sporadic. Further, drug choice, dose, and route of ACS are not optimized. We report the...
BACKGROUND
The use of antenatal corticosteroids (ACS) in low-resource environments is sporadic. Further, drug choice, dose, and route of ACS are not optimized. We report the pharmacokinetics and pharmacodynamics of oral dosing of ACS using a preterm sheep model.
METHODS
We measured pharmacokinetics of oral betamethasone-phosphate (Beta-P) and dexamethasone-phosphate (Dex-P) using catheterized pregnant sheep. We compared fetal lung maturation responses of oral Beta-P and Dex-P to the standard treatment with 2 doses of the i.m. mixture of Beta-P and betamethasone-acetate at 2, 5, and 7 days after initiation of ACS.
RESULTS
Oral Dex-P had lower bioavailability than Beta-P, giving a lower maximum maternal and fetal concentration. A single oral dose of 0.33 mg/kg of Beta-P was equivalent to the standard clinical treatment assessed at 2 days; 2 doses of 0.16 mg/kg of oral Beta-P were equivalent to the standard clinical treatment at 7 days as assessed by lung mechanics and gas exchange after preterm delivery and ventilation. In contrast, oral Dex-P was ineffective because of its decreased bioavailability.
CONCLUSION
Using a sheep model, we demonstrate the use of pharmacokinetics to develop oral dosing strategies for ACS. Oral dosing is feasible and may facilitate access to ACS in low-resource environments.
Topics: Administration, Oral; Animals; Betamethasone; Biological Availability; Dexamethasone; Female; Glucocorticoids; Lung; Pregnancy; Sheep
PubMed: 31365919
DOI: 10.1038/s41390-019-0519-0 -
The Cochrane Database of Systematic... Oct 2009Idiopathic thrombocytopenic purpura (ITP) is a common hematologic disorder caused by immune-mediated thrombocytopenia. The magnitude of the maternal-fetal risk of ITP... (Review)
Review
BACKGROUND
Idiopathic thrombocytopenic purpura (ITP) is a common hematologic disorder caused by immune-mediated thrombocytopenia. The magnitude of the maternal-fetal risk of ITP during pregnancy is controversial. Labour management of pregnant women with ITP remains controversial. Management of ITP during pregnancy is complex because of the disparity between maternal and fetal platelet counts.
OBJECTIVES
To assess the effectiveness and safety of corticosteroids, intravenous immunoglobulin, vinca alkaloids, danazol, dapsone, and any other types of pharmacological treatments for the treatment of idiopathic thrombocytopenic purpura during pregnancy.
SEARCH STRATEGY
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (February 2009), LILACS (1982 to 8 February 2009), ClinicalTrials.gov (8 February 2009), Current Controlled Trials (16 February 2009), Google Scholar (16 February 2009) and ongoing and unpublished trials cited in the reference lists of relevant articles.
SELECTION CRITERIA
Randomised controlled trials (RCTs) on any medical treatments for idiopathic thrombocytopenia purpura during pregnancy.
DATA COLLECTION AND ANALYSIS
Two review authors independently evaluated methodological quality and extracted trial data. Any disagreement was resolved by discussion or by consulting a third review author.
MAIN RESULTS
This review included one RCT in which 38 women (41 pregnancies) were randomised, with only 26 women (28 pregnancies) being analysed.This RCT comparing the effect of betamethasone (1.5 mg/day) with no medication found no statistically significant difference in neonatal thrombocytopenia (risk ratio (RR) 1.12, 95% confidence interval (CI) 0.62 to 2.05) and neonatal bleeding (RR 1.00, 95% CI 0.24 to 4.13). Review authors conducted an intention-to-treat analysis which showed similar findings: RR 1.18, 95% CI 0.57 to 2.45 and RR 1.05, 95% CI 0.24 to 4.61, respectively. Maternal death, perinatal mortality, postpartum haemorrhage and neonatal intracranial haemorrhage were not studied by this RCT.
AUTHORS' CONCLUSIONS
Current evidence indicates that compared to no medication, betamethasone did not reduce the risk of neonatal thrombocytopenia and neonatal bleeding in ITP during pregnancy. There is insufficient evidence to support the use of betamethasone for treating ITP. This Cohrane review does not provide evidence about other medical treatments for ITP during pregnancy. This systematic review also identifies the need for well-designed, adequately powered randomised clinical trials for this medical condition during pregnancy. Unless randomised clinical trials provide evidence of a treatment effect and the trade off between potential benefits and harms are established, policy-makers, clinicians, and academics should not use betamethasone for ITP in pregnant women. Any future trials on medical treatments for treating ITP during pregnancy should test a variety of important maternal, neonatal or both outcome measures, including maternal death, perinatal mortality, postpartum haemorrhage and neonatal intracranial haemorrhage.
Topics: Betamethasone; Female; Humans; Infant, Newborn; Pregnancy; Pregnancy Complications, Hematologic; Purpura, Thrombocytopenic, Idiopathic; Thrombocytopenia, Neonatal Alloimmune
PubMed: 19821437
DOI: 10.1002/14651858.CD007722.pub2 -
Journal of Pharmacy & Pharmaceutical... 2023Our previous study has demonstrated that tetracycline exerts excellent bactericidal activity against strains isolated from patients with atopic dermatitis (AD) while...
Our previous study has demonstrated that tetracycline exerts excellent bactericidal activity against strains isolated from patients with atopic dermatitis (AD) while simultaneously inhibiting the development of T helper (Th) type 2 (Th2) cells. The present study was designed to evaluate the effectiveness of dual therapy with betamethasone and tetracycline for AD. Betametasone (0.1%) and tetracycline (3%) were topically administered to NC/Nga mice with AD-like skin lesions. Skin severity scores, histological changes to the lesioned skin, and serum IgE levels were assessed as indicators of therapeutic effectiveness. Topical treatment with both drugs reduced the skin severity score more significantly than was the case with betamethasone alone or tetracycline alone. This was associated with a reduction in the degree of epidermal thickening, the density of cellular infiltration into the dermis, the mast cell count in the dermis and the serum IgE concentration. Furthermore, the degree of Th1/Th2 cell development in auricular lymph nodes and the count on the lesioned skin were synergistically suppressed by simultaneous application of both drugs. The present results show that simultaneous topical application of betamethasone and tetracycline synergistically ameliorates AD-like skin lesions in NC/Nga mice. This suggests that dual therapy with betamethasone and tetracycline for AD lesions colonized by might be one of the best options for inhibiting the development of both Th1 and Th2 cells and acting on superficially located
Topics: Mice; Animals; Dermatitis, Atopic; Betamethasone; Staphylococcus aureus; Immunoglobulin E; Anti-Bacterial Agents; Skin; Tetracycline; Disease Models, Animal
PubMed: 36942298
DOI: 10.3389/jpps.2023.11182 -
American Journal of Obstetrics and... Jan 2018Antenatal steroids are standard of care for women who are at risk of preterm delivery; however, antenatal steroid dosing and formulation have not been evaluated...
BACKGROUND
Antenatal steroids are standard of care for women who are at risk of preterm delivery; however, antenatal steroid dosing and formulation have not been evaluated adequately. The standard clinical 2-dose treatment with betamethasone-acetate+betamethasone-phosphate is more effective than 2 doses of betamethasone-phosphate for the induction of lung maturation in preterm fetal sheep. We hypothesized that the slowly released betamethasone-acetate component induces similar lung maturation to betamethasone-phosphate+betamethasone-acetate with decreased dose and fetal exposure.
OBJECTIVE
The purpose of this study was to investigate pharmacokinetics and fetal lung maturation of antenatal betamethasone-acetate in preterm fetal sheep.
STUDY DESIGN
Groups of 10 singleton-pregnant ewes received 1 or 2 intramuscular doses 24 hours apart of 0.25 mg/kg/dose of betamethasone-phosphate+betamethasone-acetate (the standard of care dose) or 1 intramuscular dose of 0.5 mg/kg, 0.25 mg/kg, or 0.125 mg/kg of betamethasone-acetate. Fetuses were delivered 48 hours after the first injection at 122 days of gestation (80% of term) and ventilated for 30 minutes, with ventilator settings, compliance, vital signs, and blood gas measurements recorded every 10 minutes. After ventilation, we measured static lung pressure-volume curves and sampled the lungs for messenger RNA measurements. Other groups of pregnant ewes and fetuses were catheterized and treated with intramuscular injections of betamethasone-phosphate 0.125 mg/kg, betamethasone-acetate 0.125 mg/kg, or betamethasone-acetate 0.5 mg/kg. Maternal and fetal betamethasone concentrations in plasma were measured for 24 hours.
RESULTS
All betamethasone-treated groups had increased messenger RNA expression of surfactant proteins A, B, and C, ATP-binding cassette subfamily A member 3, and aquaporin-5 compared with control animals. Treatment with 1 dose of intramuscular betamethasone-acetate 0.125mg/kg improved dynamic and static lung compliance, gas exchange, and ventilation efficiency similarly to the standard treatment of 2 doses of 0.25 m/kg of betamethasone-acetate+betamethasone-phosphate. Betamethasone-acetate 0.125 mg/kg resulted in lower maternal and fetal peak plasma concentrations and decreased fetal exposure to betamethasone compared with betamethasone-phosphate 0.125 mg/kg.
CONCLUSION
A single dose of betamethasone-acetate results in similar fetal lung maturation as the 2-dose clinical formulation of betamethasone-phosphate+betamethasone-acetate with decreased fetal exposure to betamethasone. A lower dose of betamethasone-acetate may be an effective alternative to induce fetal lung maturation with less risk to the fetus.
Topics: ATP Binding Cassette Transporter, Subfamily A; Animals; Aquaporin 5; Betamethasone; Dose-Response Relationship, Drug; Female; Fetal Organ Maturity; Glucocorticoids; Lung; Models, Animal; Pregnancy; Pulmonary Surfactant-Associated Proteins; RNA, Messenger; Sheep
PubMed: 29138038
DOI: 10.1016/j.ajog.2017.11.560 -
The Cochrane Database of Systematic... Oct 2014Respiratory distress syndrome (RDS) is caused by a deficiency of pulmonary surfactant (an active agent that keeps pulmonary alveoli open and facilitates the entry of air... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Respiratory distress syndrome (RDS) is caused by a deficiency of pulmonary surfactant (an active agent that keeps pulmonary alveoli open and facilitates the entry of air to the lungs, thus improving the oxygenation of the newborn).A number of interventions such as pulmonary surfactant and prenatal corticosteroids are used to prevent RDS. Ambroxol has been studied as a potential agent to prevent RDS, but effectiveness and safety has yet to be evaluated.
OBJECTIVES
To evaluate the efficacy and safety of giving ambroxol to pregnant women who are at risk of preterm birth, for preventing neonatal RDS.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (29 November 2013), CENTRAL (The Cochrane Library 2013, Issue 11),Embase (1988 to November 2013), MEDLINE (PubMed 1970 to November 2013), LILACS (1982 to November 2013), the WHO International Clinical Trials Registry Platform (ICTRP) (November 2013) and reference lists of retrieved studies.
SELECTION CRITERIA
Randomised controlled trials (RCTs) comparing the administration of ambroxol given to pregnant women at risk of preterm birth versus placebo, antenatal corticosteroids (betamethasone or dexamethasone), or no treatment.We did not identify any trials comparing ambroxol with dexamethasone (corticosteroid) in this review. Nor did we identify any trials comparing ambroxol combined with corticosteroid versus corticosteroid alone, or placebo/no treatment.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion and trial quality. Two review authors independently extracted data. Data were checked for accuracy.
MAIN RESULTS
We included 14 studies (in 18 trial reports), involving 1047 pregnant women at risk of preterm birth with 1077 newborns. However, three of the included studies did not report on this review's outcomes of interest. We carried out two main comparisons: ambroxol versus antenatal corticosteroids (betamethasone); and ambroxol versus placebo or no treatment. Seven RCTs provided data for our comparison of ambroxol versus corticosteroid (betamethasone) and two trials contributed data to our comparison of ambroxol compared to placebo or no treatment.The included studies were generally judged as having either 'low' risk of bias or 'unclear' risk of bias (because the trial reports provided insufficient details about methods of sequence generation, allocation concealment and blinding). Primary outcomesThere was no clear evidence of a difference in the incidence of RDS among newborns born to women who received ambroxol when compared to newborns of women who were given the corticosteroid, betamethasone (risk ratio (RR) 0.79, 95% confidence interval (CI) 0.59 to 1.07, seven RCTs, 728 women/758 newborns, moderate quality evidence) or placebo/no treatment (average RR 0.74; 95% CI 0.46 to 1.20, two studies, 204 women/204 newborns,T2= 0.07; I(2)= 53%, low-quality evidence). Results were imprecise and consistent with appreciable benefit as well as negligible effect.Similarly, there was no clear evidence of a difference in the rates of perinatal mortality between the group of women who received ambroxol and women in the corticosteroid (betamethasone) group (RR 0.51, 95% CI 0.23 to 1.12, six studies, 648 women/657 newborns, moderate quality evidence) or the placebo/no treatment group (RR 0.61; 95% CI 0.19 to 1.98, one study, 116 women/116 newborns, low-quality evidence).In terms of maternal adverse effects, there was no clear differences (in nausea or vomiting) between those women who received ambroxol compared to either those women who received corticosteroids (betamethasone) (average RR 3.45; 95% CI 0.34 to 35.51, three studies, 305 women, T(2)= 2.82; I(2)= 67%, very low-quality evidence), or women who received placebo or no treatment (RR 1.79; 95% CI 0.45 to 7.13, one study, 116 women, low-quality evidence). No other adverse effects (e.g. diarrhoea, gastric irritation and headache) were reported in the included studies. Secondary outcomesFor the review's secondary outcomes, none of the included studies reported on the incidence of bronchopulmonary dysplasia, periventricular haemorrhage, necrotising enterocolitis or rate of maternal mortality.One small trial (involving 88 women) comparing ambroxol with placebo or no treatment, reported no difference between groups in terms of the need for mechanical ventilation in the neonate (RR 0.94; 95% CI 0.73 to 1.21, 88 women/88 babies, low-quality evidence) or the administration of pulmonary surfactant (RR 1.19; 95% CI 0.61 to 2.30, one RCT, 88 women/88 babies, low-quality evidence).
AUTHORS' CONCLUSIONS
This review is based on very low to moderate quality evidence from 14 small trials (many are published in the form of conference abstracts with minimal methodological details provided). There is insufficient evidence to support or refute the practice of giving ambroxol to women at risk of preterm birth for preventing neonatal RDS, perinatal mortality and adverse effects. More research is needed in order to fully evaluate the benefits and risks of this intervention.
Topics: Adrenal Cortex Hormones; Ambroxol; Betamethasone; Expectorants; Female; Humans; Infant, Newborn; Pregnancy; Premature Birth; Randomized Controlled Trials as Topic; Respiratory Distress Syndrome, Newborn
PubMed: 25361381
DOI: 10.1002/14651858.CD009708.pub2 -
The Cochrane Database of Systematic... Jul 2009Hemolysis, elevated liver enzymes and low platelets (HELLP) syndrome is a severe form of pre-eclampsia. Pre-eclampsia is a multi-system disease of pregnancy associated... (Review)
Review
BACKGROUND
Hemolysis, elevated liver enzymes and low platelets (HELLP) syndrome is a severe form of pre-eclampsia. Pre-eclampsia is a multi-system disease of pregnancy associated with an increase in blood pressure and increased perinatal and maternal morbidity and mortality. Eighty per cent of women with HELLP syndrome present before term. There are suggestions from observational studies that steroid treatment in HELLP syndrome may improve disordered maternal hematological and biochemical features and perhaps perinatal mortality and morbidity.
OBJECTIVES
To summarise the evidence on the effects of corticosteroids on maternal and neonatal mortality and morbidity in women with HELLP syndrome.
SEARCH STRATEGY
We searched the Cochrane Pregnancy and Childbirth Group trials register (October 2003). We scanned lists of references from review articles and primary studies.
SELECTION CRITERIA
Randomised and quasi-randomised trials evaluating the effects of adjunctive corticosteroids in patients diagnosed with HELLP syndrome were sought.
DATA COLLECTION AND ANALYSIS
The two authors independently applied inclusion criteria, assessed trial quality and extracted relevant data.
MAIN RESULTS
Of the five studies reviewed (n = 170), three were conducted antepartum and two postpartum. Four of the studies randomised participants to standard therapy or dexamethasone. One study compared dexamethasone with betamethasone. Dexamethasone versus control There were no significant differences in the primary outcomes of maternal mortality and morbidity due to placental abruption, pulmonary oedema and liver hematoma or rupture. Of the secondary maternal outcomes, there was a tendency to a greater platelet count increase over 48 hours, statistically significantly less mean number of hospital stay days (weighted mean difference (WMD) -4.50, 95% confidence interval (CI) -7.13 to -1.87), mean interval (hours) to delivery (41 +/- 15) versus (15 +/- 4.5) (p = 0.0068) in favour of women allocated to dexamethasone.There were no significant differences in perinatal mortality or morbidity due to respiratory distress syndrome, need for ventilatory support, intracerebral hemorrhage, necrotizing enterocolitis and a five minute Apgar less than seven. The mean birthweight was significantly greater in the group allocated to dexamethasone (WMD 247.00, 95% CI 65.41 to 428.59).Dexamethasone versus betamethasone There were no significant differences in all the maternal and perinatal mortality and in primary morbidity outcomes.Women randomised to dexamethasone fared significantly better for: oliguria, mean arterial pressure, mean increase in platelet count, mean increase in urinary output and liver enzyme elevations.
AUTHORS' CONCLUSIONS
There is insufficient evidence to determine whether adjunctive steroid use in HELLP syndrome decreases maternal and perinatal mortality, major maternal and perinatal morbidity.
Topics: Adrenal Cortex Hormones; Betamethasone; Dexamethasone; Female; HELLP Syndrome; Humans; Pregnancy; Randomized Controlled Trials as Topic
PubMed: 19588331
DOI: 10.1002/14651858.CD002076.pub3 -
The Journal of Maternal-fetal &... Jun 2020To evaluate whether administration of antenatal late-preterm betamethasone is cost-effective in the immediate neonatal period. Cost-effectiveness analysis of...
To evaluate whether administration of antenatal late-preterm betamethasone is cost-effective in the immediate neonatal period. Cost-effectiveness analysis of late-preterm betamethasone administration with a time horizon of 7.5 days was conducted using a health-system perspective. Data for neonatal outcomes, including respiratory distress syndrome (RDS), transient tachypnea of the newborn (TTN), and hypoglycemia, were from the Antenatal Betamethasone for Women at Risk for Late-Preterm Delivery trial. Cost data were derived from the Healthcare Cost and Utilization Project from the Agency for Health Care Research and Quality, and utilities of neonatal outcomes were from the literature. Outcomes were total costs in 2017 United States dollars and quality-adjusted life years (QALYs) for each individual infant as well as for a theoretical cohort of the 270 000 late-preterm infants born in 2015 in the USA. For an individual patient, compared to withholding betamethasone, administering betamethasone incurred a higher total cost ($6592 versus $6265) and marginally lower QALYs (0.02002 QALYS versus 0.02006 QALYs) within the studied time horizon. For the theoretical cohort of 270 000 patients, administration of betamethasone was $88 million more expensive ($1780 million versus $1692 million) with lower QALYs (5402 QALYs versus 5416 QALYs), compared to withholding betamethasone. For administration of betamethasone to be cost-effective, the rate of hypoglycemia, RDS, or TTN among late-preterm infants receiving betamethasone would need to be less than 20.0, 4.5, and 2.4%, respectively. Administration of betamethasone in the late-preterm period is likely not cost-effective in the short-term.
Topics: Betamethasone; Case-Control Studies; Cost-Benefit Analysis; Female; Glucocorticoids; Humans; Hypoglycemia; Infant, Premature; Pregnancy; Quality-Adjusted Life Years; Respiratory Distress Syndrome, Newborn
PubMed: 30353764
DOI: 10.1080/14767058.2018.1540582 -
The Cochrane Database of Systematic... Jun 2015Nasal polyps frequently occur in people with cystic fibrosis. Sinus infections have been shown to be a factor in the development of serious chest complications in these... (Review)
Review
BACKGROUND
Nasal polyps frequently occur in people with cystic fibrosis. Sinus infections have been shown to be a factor in the development of serious chest complications in these people. Nasal polyps have been linked to a higher risk of lower respiratory tract infections with Pseudomonas aeruginosa . Topical nasal steroids are of proven efficacy for treating nasal polyposis in the non-cystic fibrosis population. There is no clear current evidence for the efficacy of topical steroids for nasal polyps in people with cystic fibrosis. This is an updated version of a previously published review.
OBJECTIVES
To assess the effectiveness of topical nasal steroids for treating symptomatic nasal polyps in people with cystic fibrosis.
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.Latest search: 10 June 2015.
SELECTION CRITERIA
Randomised and quasi-randomised controlled comparing the effects of topical nasal steroids to placebo in people with nasal polyps with cystic fibrosis.
DATA COLLECTION AND ANALYSIS
Two authors independently assessed risk of bias in the included trial and extracted data.
MAIN RESULTS
One single-centred trial (46 participants) was identified comparing a topical steroid (betamethasone) given as nasal drops to placebo. Treatment was given twice daily for six weeks; 22 participants received the active drug.Subjective symptom scores, change in polyp size, and side effects were assessed. There was no difference in nasal symptom scores between the treatment and placebo groups. Betamethasone was effective in reducing the size of polyps, but was associated with increased reports of mild side effects, nasal bleeding and discomfort.Risk of bias was high since over 50% of people enrolled did not complete the study. Follow-up of participants was short (six weeks) also reducing the significance of the results for clinical practice.
AUTHORS' CONCLUSIONS
This review suggests topical steroids for nasal polyposis in people with cystic fibrosis have no demonstrable effect on subjective nasal symptom scores. They have some effect in reducing the size of the polyps, but due to the small sample size, poor completion rates and lack of follow-up, the trial is at high risk of bias and evidence for efficacy is limited. Overall there is no clear evidence for using topical steroids in people with cystic fibrosis and nasal polyposis.A well-designed randomised controlled trial of adequate power and long-term follow-up is needed. Validated measures of symptoms and physical findings should be performed and quality of life issues addressed.
Topics: Administration, Intranasal; Adult; Betamethasone; Cystic Fibrosis; Glucocorticoids; Humans; Nasal Polyps
PubMed: 26098667
DOI: 10.1002/14651858.CD008253.pub4