CorticosteroidThe purpose of the study is to investigate the relationship between inhaled or intranasal adrenergic corticosteroide nasal and corticosteroids and the development of central serous chorioretinopathy Corticosteroide nasal. The medical records of three patients with CSC who were found to use inhaled adrenergic agents or corticosteroids or both were identified prospectively. Six patients with CSC were found to be chronic users of corticosteroid four patients or both beta adrenergic agonist and corticosteroid two patients metered dose inhalers or nasal sprays. In three cases, there was a close temporal correlation between the use of a corticosteroid nasal spray and the development of CSC. These findings suggest that, corticosteroide nasal patients who are susceptible, the periocular or systemic absorption of corticosteroide nasal corticosteroids may be cirticosteroide to produce CSC in humans, supporting previous hypotheses regarding the pathogenesis of the disorder.
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Acute sinusitis is a common condition in ambulatory care, where it is frequently treated with antibiotics, despite little evidence of their benefit. Intranasal corticosteroids might relieve symptoms; however, evidence for this benefit is currently unclear. We performed a systematic review and meta-analysis of the effects of intranasal corticosteroids on the symptoms of acute sinusitis.
We included 6 studies having a total of 2, patients. In 5 studies, antibiotics were prescribed in addition to corticosteroids or placebo. Analysis of individual symptom scores revealed most consistently significant benefits for facial pain and congestion. Acute sinusitis is a common condition, affecting an estimated 31 million Americans annually. Currently, it is not clear whether corticosteroids offer significant benefits for patients with acute sinusitis.
In particular, there have been no good-quality double-blind randomized controlled trials RCTs examining oral corticosteroids in acute sinusitis, even though the oral route is favored for other upper respiratory tract infections. In terms of intranasal steroids, a Cochrane review of 4 RCTs showed a small beneficial effect on improvement of symptoms at 15 to 21 days; however, interpretation was limited by both high heterogeneity and differing outcome measures used in the primary studies.
Given the conflicting evidence, there is a pressing clinical need to clarify whether intranasal corticosteroids should be prescribed for patients with acute sinusitis. Accordingly, we undertook a systematic review of the most recent evidence to attempt to resolve this question.
We included in our meta-analysis RCTs that compared intranasal corticosteroids with placebo in children or adults who had clinical symptoms and signs of acute sinusitis or rhinosinusitis, in outpatient ambulatory settings. Two authors independently reviewed the titles and abstracts of electronic searches, obtaining full-text articles to assess for relevance where necessary. Disagreements were resolved by discussion with a third author.
We performed citation searches of all full-text papers retrieved. Two authors independently assessed the methodologic quality of studies.
Quality was assessed using the criteria of allocation concealment, randomization, comparability of groups at baseline, blinding, treatment adherence, and percentage participation. Two authors independently extracted data using an extraction template. In both data extraction and quality assessment, disagreements were documented and resolved by discussion with a third author. Primary outcomes included the proportion of participants with improvement or complete resolution of symptoms.
We tested dose response by undertaking a post hoc subgroup analysis according to intranasal corticosteroid dosage. We used meta-regression in Stata StataCorp, LP to test subgroup interactions on the outcomes and the I 2 statistic to measure the proportion of statistical heterogeneity for each outcome.
Where substantial heterogeneity was detected, we looked for the direction of effect and considered the reasons for this heterogeneity. Where applicable, we used a random-effects analysis or considered not pooling the outcomes and reporting the reasons for this.
We excluded 15 of these studies for the following reasons: The characteristics of included studies are presented in Table 1. The 6 included studies randomized 2, patients recruited from outpatient otorhinolaryngology, emergency medicine, and general practice settings in 3 countries: The age range of participants varied: The corticosteroids used were budesonide 2 studies , fluticasone propionate 1 , and mometasone furoate 3.
Two trials compared 2 different doses of mometasone furoate. In addition to intranasal corticosteroids, 5 trials 14 , 18 — 21 prescribed antibiotics amoxicillin, co-amoxiclav, or cefuroxime to patients in both groups. One of these trials 19 prescribed intranasal xylometazoline hydrochloride to all participants before administration of the study spray for the first 3 days.
Two trials reported outcomes based on computed tomography scans of sinuses. All 6 included studies demonstrated adequate allocation concealment, blinding, percentage participation, and comparability of groups both at baseline and in provision of care apart from the intervention; however, 3 studies did not report the method of randomization Table 2. We therefore performed a sensitivity analysis excluding these studies. In 5 RCTs 14 , 17 , 18 , 20 , 21 that assessed resolution or improvement of symptoms at days 14 to 21, intranasal steroids had a modest clinical beneficial effect, with an RD of 0.
This overall result was similar even with the removal of the 2 trials of lower quality, 18 , 21 with an RD of 0. Given that both analyses showed heterogeneity, however, we performed subgroup analyses on outcome timing and on dosage. Combining the 3 studies reporting this outcome at 14 to 15 days 14 , 17 , 20 showed no significant effect of intranasal corticosteroids, with an RD of 0.
In contrast, combining the 3 studies that reported resolution or improvement at 21 days 18 , 20 , 21 showed that intranasal corticosteroids had a significant beneficial effect with no heterogeneity, with an RD of 0. Effect of intranasal steroids on resolution of symptoms of acute sinusitis at A 14 to 15 days and B 21 days. In the 2 trials 14 , 20 that reported the proportion of participants with persistent symptoms at 10 days after onset of treatment, there was no benefit of intranasal corticosteroids, with an RD of 0.
Three trials using mometasone furoate nasal spray 17 , 18 , 21 showed a significant effect on symptom resolution or improvement at 15 to 21 days, with an RD of 0. We therefore investigated the high heterogeneity by performing subgroup analysis by dose. Dose-response relationship of mometasone furoate and likelihood of symptom resolution. Three RCTs reported individual symptom scores in 5 groups of patients who received different doses of mometasone furoate compared with placebo 17 , 18 , 21 For each group, the symptoms of facial pain, nasal congestion, headache, rhinorrhea, postnasal drip, and cough were reported on a scale of 0 none to 3 severe at baseline and averaged across the first 15 days of therapy see the Supplemental Appendix at http: One trial reported that no adverse events occurred with steroid therapy 19 ; 2 trials reported no serious adverse events in either group 14 , 20 ; and the remaining trials reported that adverse events were mainly mild or moderate in severity.
Meta-analysis of the rate of occurrence of these outcomes revealed no significant differences between steroid and placebo groups. Three trials 17 , 19 , 20 reported the rate of relapse or recurrence of acute sinusitis up to 2 months after initiation of treatment. This systematic review demonstrates that intranasal corticosteroids offer a small but significant symptomatic benefit in acute sinusitis. This effect is most marked when patients are given longer durations of treatment 21 days and higher doses of the medication.
Our analysis of individual symptom scores suggests that facial pain and nasal congestion may be most responsive to intranasal corticosteroids. Our included trials reported no serious adverse events associated with intranasal corticosteroid use and no increase in frequency of nonserious adverse events compared with placebo.
Other potential harms might include effects from systemic absorption; however, the single included trial addressing this outcome found no clinically relevant changes in the hypothalamic-pituitary-adrenal axis, 20 and 2 recent reviews found no evidence of suppression of this axis or of growth suppression with intranasal corticosteroids. Only 1 included trial assessed the potential benefit of intranasal corticosteroids for work and quality of life outcomes in acute sinusitis.
This may be an acceptable trade-off for some patients. The therapeutic benefit at the population level is currently unclear. Our subgroup analysis suggests the benefit of intranasal corticosteroids is most marked at 21 days, with an additional 11 patients experiencing symptom resolution for every treated. In contrast, this effect was not significant at 15 days.
Our subgroup analysis had only a small number of trials, however, and further research is needed to clarify the clinical benefit at 15 days or less as discussed below. Clearly, patients are likely to experience pronounced symptoms in the first 7 to 14 days of their illness and may be less willing to consider a therapy that does not offer an increased likelihood of improvement in this earlier time period.
We found evidence of a dose-response relationship for mometasone furoate nasal spray: We had insufficient data to assess whether other types of intranasal corticosteroids showed a similar effect, or whether this higher dose was associated with an increase in adverse events. The small benefit of intranasal corticosteroids for the broad measure of symptom resolution or improvement at 14 to 21 days was similar in direction and size to that found in a recent Cochrane review.
We have demonstrated that this heterogeneity arises from both the variation in the timing of the outcome measure and the dose of intranasal corticosteroids used. We found larger effect sizes in subgroup analyses by dose and timing of outcome measure. The recent Cochrane review may therefore have underestimated the benefit of intranasal corticosteroids. Williamson et al 14 acknowledged that their RCT was underpowered to detect clinically useful effects, and the study may have used an inappropriately low dose of budesonide.
Important limitations of this systematic review include first, that 5 of the studies prescribed antibiotics to both steroid and placebo groups.
Williamson et al 14 found no interaction between antibiotic therapy and steroid therapy using a factorial design, which argues against a synergistic effect of these drug classes.
Second, included studies varied in the types and doses of steroids, duration of therapy, and outcome measures reported. Particularly, the definition of resolution of symptoms varied among the studies, and all measures of resolution involved subjective assessment. These factors prevented pooling of all outcomes and are likely to have contributed to the heterogeneity of the data.
Third, included studies were underpowered to detect rare adverse effects of corticosteroid, as well as relapse rates and days missed from work or school. Fourth, the limited number of trials meant we were unable to assess publication bias using funnel plots or place undue weight on the findings from small subgroup analyses.
Finally, in 4 of the 6 included trials, radiologic or endoscopic evidence of acute sinusitis was an inclusion criterion. In ambulatory care, it is impractical and inappropriate to perform radiologic investigations on patients with symptoms of sinusitis. This review highlights the need for adequately powered RCTs comparing intranasal corticosteroids with placebo in the absence of antibiotics for symptom relief in acute sinusitis.
We recommend that trials should use at least 21 days of therapy with high-dose mometasone furoate nasal spray. Inclusion criteria should be based on a clinical scoring system rather than radiologic evidence. Self-report and telephone follow-up should be used to assess the time to complete resolution of symptoms and also the time to onset of symptom resolution, which will be particularly important in clarifying whether there is benefit at time points earlier than 21 days.
Recording the duration of symptoms at baseline will also improve our understanding of patterns of symptom resolution. As acute sinusitis is diagnosed in an estimated 31 million Americans annually, 1 a full assessment of economic implications is important. Antibiotics are widely prescribed for acute sinusitis despite limited evidence of beneficial effect; thus, measuring the extent to which intranasal corticosteroids reduce antibiotic prescribing will be highly relevant to clinical practice and policy.
A systematic review using individual patient data may improve our ability to combine the data from existing research. Finally, a double-blind, placebo-controlled trial of the benefit of oral steroids in acute sinusitis has not yet been performed. Since delivery of intranasal corticosteroids to the nasal mucosa may be reduced by nasal congestion, and this may be a factor responsible for our finding of a nonsignificant benefit at 15 days, oral drug delivery might offer earlier and greater symptomatic relief.
In summary, on the basis of the current evidence, we believe that intranasal corticosteroids offer a small therapeutic benefit in acute sinusitis and may be most helpful for symptoms of facial pain and nasal congestion.
This benefit may be greater with courses of 21 days in duration and with high-dose mometasone furoate. We would like to acknowledge the input of Professors Paul Glasziou and Chris Del Mar into the initial stages of this project. Neither the British Society for Antimicrobial Chemotherapy nor the National Institute of Health Research had any role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript.
National Center for Biotechnology Information , U. Journal List Ann Fam Med v. This article has been cited by other articles in PMC. Abstract PURPOSE Acute sinusitis is a common condition in ambulatory care, where it is frequently treated with antibiotics, despite little evidence of their benefit. METHODS Search Strategy and Selection We included in our meta-analysis RCTs that compared intranasal corticosteroids with placebo in children or adults who had clinical symptoms and signs of acute sinusitis or rhinosinusitis, in outpatient ambulatory settings.
Data Extraction and Quality Assessment Two authors independently assessed the methodologic quality of studies. Open in a separate window.