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The Cochrane Database of Systematic... Oct 2009Acute sinusitis is a common reason for primary care visits. It causes significant symptoms and often results in time off work and school. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Acute sinusitis is a common reason for primary care visits. It causes significant symptoms and often results in time off work and school.
OBJECTIVES
We examined whether intranasal corticosteroids (INCS) are effective in relieving symptoms of acute sinusitis.
SEARCH STRATEGY
We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library, 2008, issue 4) which contains the Acute Respiratory Infections Group's Specialized Register, MEDLINE (January 1966 to October 2008), EMBASE (1990 to October 2008) and bibliographies of included studies.
SELECTION CRITERIA
Randomized controlled trials (RCTs) were considered eligible if they compared INCS treatment to placebo treatment of a control group for acute sinusitis; acute sinusitis was defined by clinical diagnosis and confirmed by radiological evidence or by nasal endoscopy. The primary outcome was the proportion of participants with either resolution or improvement of symptoms. Secondary outcomes were any adverse events that required discontinuation of treatment, drop-outs before the end of the study, rates of relapse, complications and return to school or work.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted the data, assessed trial quality and resolved discrepancies by consensus.
MAIN RESULTS
Four studies with 1943 participants met the inclusion criteria. The trials were well designed, double-blind, placebo controlled in which the included participants had acute sinusitis. The treatment assigned was INCS versus control treatment for 15 or 21 days. The rates of loss to follow up in the studies were 7%, 11%, 41% and 10%. When the results from the three trials included in the meta-analysis were combined, participants receiving INCS were more likely to have resolution or improvement of symptoms than those receiving placebo (73% versus 66.4%; risk ratio (RR) 1.11; 95% CI 1.04 to 1.18). Higher doses of INCS had a stronger effect on improvement or complete relief of symptoms: for mometasone furoate (MFNS) 400 mcg versus 200 mcg, (RR 1.10; 95% CI 1.02 to 1.18 versus RR 1.04; 95% CI 0.98 to 1.11). No significant adverse events were reported and there was no significant difference in the drop-out and recurrence rate for the two treatment groups and for groups receiving higher doses of INCS.
AUTHORS' CONCLUSIONS
For acute sinusitis confirmed by radiology or nasal endoscopy, current evidence is limited, but supports the use of INCS as a monotherapy or as an adjuvant therapy to antibiotics. Clinicians should weigh the modest but clinically important benefits against possible minor adverse events when prescribing therapy.
Topics: Acute Disease; Administration, Intranasal; Adrenal Cortex Hormones; Humans; Randomized Controlled Trials as Topic; Sinusitis
PubMed: 19821340
DOI: 10.1002/14651858.CD005149.pub3 -
The Cochrane Database of Systematic... Apr 2007Acute sinusitis is a common reason for primary care visits. It causes significant symptoms and often results in time off work and school. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Acute sinusitis is a common reason for primary care visits. It causes significant symptoms and often results in time off work and school.
OBJECTIVES
We examined whether intranasal corticosteroids (INCS) are effective in relieving symptoms of acute sinusitis.
SEARCH STRATEGY
We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 4, 2006), MEDLINE (January 1966 to December 2006), EMBASE (1990 to June 2006) and bibliographies of included studies.
SELECTION CRITERIA
Randomized controlled trials (RCTs) were considered eligible if they compared INCS treatment to placebo treatment of a control group for acute sinusitis; acute sinusitis was defined by clinical diagnosis and confirmed by radiological evidence or by nasal endoscopy. The primary outcome was the proportion of participants with either resolution or improvement of symptoms. Secondary outcomes were any adverse events that required discontinuation of treatment, drop-outs before the end of the study, rates of relapse, complications and return to school or work.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted the data, assessed trial quality and resolved discrepancies by consensus.
MAIN RESULTS
Four studies with 1943 participants met the inclusion criteria. The trials were well designed, double-blind, placebo controlled in which the included participants had acute sinusitis. The treatment assigned was INCS versus control treatment for 15 or 21 days. The rates of loss to follow up in the studies were 7%, 11%, 41% and 10%. When the results from the three trials included in the meta-analysis were combined, participants receiving INCS were more likely to have resolution or improvement of symptoms than those receiving placebo (73% versus 66.4%; RR 1.11; 95% CI 1.04 to 1.18). Higher doses of INCS had a stronger effect on improvement or complete relief of symptoms: for mometasone furoate (MFNS) 400 mcg versus 200 mcg, (RR 1.10; 95% CI 1.02 to 1.18 versus RR 1.04; 95% CI 0.98 to 1.11). No significant adverse events were reported and there was no significant difference in the drop-out and recurrence rate for the two treatment groups and for groups receiving higher doses of INCS.
AUTHORS' CONCLUSIONS
For acute sinusitis confirmed by radiology or nasal endoscopy, current evidence is limited, but supports the use of INCS as a monotherapy or as an adjuvant therapy to antibiotics. Clinicians should weigh the modest but clinically important benefits against possible minor adverse events when prescribing therapy.
Topics: Acute Disease; Administration, Intranasal; Adrenal Cortex Hormones; Humans; Randomized Controlled Trials as Topic; Sinusitis
PubMed: 17443574
DOI: 10.1002/14651858.CD005149.pub2 -
Health Technology Assessment... Nov 2004To assess the clinical and cost-effectiveness of once-daily use of topical corticosteroids versus more frequent use of same-potency topical corticosteroids in the... (Review)
Review
Clinical and cost-effectiveness of once-daily versus more frequent use of same potency topical corticosteroids for atopic eczema: a systematic review and economic evaluation.
OBJECTIVES
To assess the clinical and cost-effectiveness of once-daily use of topical corticosteroids versus more frequent use of same-potency topical corticosteroids in the treatment of people with atopic eczema.
DATA SOURCES
Electronic databases. Bibliographies of included studies and related papers. Experts in the field. Manufacturer submissions to the National Institute for Clinical Excellence.
REVIEW METHODS
Studies were assessed for inclusion according to predefined criteria by two reviewers. Data extraction and quality assessment were undertaken by one reviewer and checked by a second reviewer. Clinical effectiveness data were synthesised through a narrative review with full tabulation of results.
RESULTS
One RCT comparing moderately potent corticosteroids, eight RCTs comparing potent corticosteroids and one RCT comparing very potent corticosteroids were included. No RCTs or CCTs of mild corticosteroids were eligible. Most RCTs were of poor methodological quality, although two were judged to be of good quality. The only study that compared moderately potent corticosteroids found no significant difference between once- and twice-daily application. For potent corticosteroids, some statistically significant differences in numbers of patients responding to treatment were identified favouring twice-daily treatment, but these were inconsistent between physician and patient assessment and outcomes selected for analysis. Two studies found a significant improvement in some symptoms with once-daily mometasone furoate compared with twice-daily application of a different active compound, while a third study found no significant differences. One good-quality study favoured twice-daily application of fluticasone propionate ointment, while other studies found no significant difference or an improvement in one symptom but not others. The only study comparing very potent corticosteroids found a statistically significant difference in comparative clinical response in favour of three-times daily treatment, but no difference in number of patients with at least a good response. There appears to be little difference in the frequency or severity of short-term events, however data are limited. No published economic evaluations were identified. Given findings on clinical effectiveness, where outcomes from the comparators are similar, the relative cost-effectiveness of once-daily versus more frequent application of topical corticosteroids becomes a case of cost-minimisation, where the least-cost alternative should be favoured, all else being equal. Topical corticosteroid products included in this review have a wide variation in price; the cost per 30 g/30 ml varies between GBP0.60 and GBP4.88. Specific decisions on the least-cost alternative, between once-daily and more frequent application of products, will be determined by the relative price of the products being compared. Where patients can be appropriately prescribed once-daily treatment of a similarly priced product, a reduction in the quantity of topical corticosteroid used will be expected. However, issues related to pack size for prescribed products and subsequent waste (unused product) could easily erode any potential saving. The potential cost-savings on prescribed products are very small at a patient level; although given the large numbers of patients with atopic eczema, cost savings in theory could be substantial. The presence of specifically marketed 'once-daily' topical corticosteroids, which are relatively expensive (per unit price), may result in additional costs should there be a general recommendation in favour of once-daily use of topical corticosteroids, compared to more frequent use.
CONCLUSIONS
The literature is very limited; that available indicates the clinical effectiveness of once-daily and more frequent application of potent topical corticosteroids is very similar, but it does not offer a basis for favouring either option. The cost-effectiveness of once-daily versus more frequent use will depend on the generalisability of the findings to the specific treatment decision and the relative product prices. The trials included in this review generally refer to moderate to severe atopic eczema, whereas most patients have mild disease, and furthermore most of the included trials report on potent topical corticosteroids (eight of 10 RCTs); therefore the generalisability of the findings is limited. Further research is required on the clinical and cost-effectiveness of once-daily versus more frequent use of same potency corticosteroids, specifically on mild potency products for mild to moderate atopic eczema. Outcomes should include quality of life and compliance.
Topics: Administration, Topical; Adolescent; Adrenal Cortex Hormones; Adult; Child; Child, Preschool; Cost-Benefit Analysis; Dermatitis, Atopic; Drug Administration Schedule; Humans; Infant; Prevalence; Randomized Controlled Trials as Topic; Severity of Illness Index; Treatment Outcome; United Kingdom
PubMed: 15527669
DOI: 10.3310/hta8470 -
Clinical Therapeutics Sep 2001Fluticasone propionate is an established corticosteroid administered intranasally for the treatment of rhinitis or by oral inhalation for the treatment of asthma.... (Review)
Review
BACKGROUND
Fluticasone propionate is an established corticosteroid administered intranasally for the treatment of rhinitis or by oral inhalation for the treatment of asthma. Mometasone furoate, a closely related corticosteroid currently available in an intranasal formulation, is being investigated in an oral inhalation formulation for the treatment of asthma.
OBJECTIVE
This article reviews available data on the comparative structure-activity relationships, chemistry, pharmacology, pharmacokinetics, and systemic bioavailability of fluticasone propionate and mometasone furoate to assess whether claims of differences in the absolute systemic bioavailability of the 2 compounds are supported by the published literature.
METHODS
Information for this review was identified through a MEDLINE search of the literature from 1966 to the present that contained the term mometasone or fluticasone. The resulting list was narrowed by excluding articles dealing with dermatologic applications. A systematic review was conducted of the identified literature pertaining to the molecular structure, topical potency, lipophilicity, pharmacokinetics, and bioavailability of the 2 agents. Additionally, the pharmacology of the 2 moieties was assessed by a review of the available literature on receptor binding affinity, transactivation and transrepression potency, and inhibition of inflammatory-cell cytokine expression.
RESULTS
Based on the available data, fluticasone propionate and mometasone furoate have similar physicochemical properties and structure-activity relationships. When administered intranasally, mometasone furoate is reported to have comparable relative systemic bioavailability to that of fluticasone propionate (mean plasma area under the curve, 123 pmol x h/L vs 112 pmol x h/L, respectively). When administered as a single dose by dry powder inhaler, orally inhaled fluticasone propionate is reported to have a total systemic bioavailability of approximately 17%, whereas that of mometasone furoate is reported to be < 1%. However, the mometasone furoate bioavailability study that reported the latter value used lower drug doses and a less sensitive assay than the fluticasone propionate bioavailability study. When multiple-dose data were used, mometasone furoate had an estimated 11% systemic bioavailability, similar to that of fluticasone propionate.
CONCLUSIONS
Inhaled fluticasone propionate and mometasone furoate appear to have comparable potential systemic absorption and, based on the total systemic bioavailabilities of the parent compounds, have a low potential for systemic side effects at the recommended clinical doses. However, in the case of mometasone furoate, the contribution of the active metabolites to systemic effects has not been adequately assessed.
Topics: Administration, Intranasal; Androstadienes; Biological Availability; Cytokines; Fluticasone; Humans; Mometasone Furoate; Pregnadienediols; Receptors, Glucocorticoid; Rhinitis, Allergic, Perennial; Time Factors
PubMed: 11589253
DOI: 10.1016/s0149-2918(01)80113-2