Intranasal budesonide spray as an adjunct to oral antibiotic therapy for acute sinusitis in children. Effect of corticosteroids on wound healing after endoscopic sinus surgery. Influence of topical steroid treatment on maxillary sinusitis. The end of antibiotic treatment in adults with acute sinusitis-like complaints in general practice? A placebo-controlled double-blind randomized doxycycline trial. Postoperative care for Samter's triad patients undergoing endoscopic sinus surgery: a double-blinded, randomized controlled trial. Short therapy with amoxicillin-clavulanate and corticosteroids in acute sinusitis: results of a multicentre study in adults. Antibiotics and topical nasal steroid for treatment of acute maxillary sinusitis: a randomized controlled trial. Treatment of acute rhinosinusitis diagnosed by clinical criteria or ultrasound in primary care. A placebo-controlled randomised trial. Topical corticosteroids in chronic rhinosinusitis: a randomized, double-blind, placebo-controlled trial using fluticasone propionate aqueous nasal spray.
The role of topical corticosteroids in the treatment of acute sinusitis has not been established in children.
                An attempt was made to determine the impact of topical corticosteroids as an adjunct to antibiotic treatment in the management of childhood sinusitis.
                In a double-blind, placebo-controlled study, 151 children with sinusitis were recruited from a general pediatric outpatient clinic and 89 completed a 3-week trial. Treatment consisted of amoxicillin-clavulanate potassium, 40 mg/kg/d tid, combined with bid nasal spray of either budesonide, 50 micrograms, to each nostril (n = 43) or placebo )n = 46_ for 3 weeks. Patients maintained daily symptom cards throughout the study and were examined by the same physician each week.
                Clinical symptoms and signs decreased significantly in both treatment groups in comparison to baseline (P < .01). We detected a significant improvement in the scores of the cough and nasal discharge at the end of second week in the budesonide group when compared with placebo (P < .05). Friedman nonparametric repeated measures ANOVA test revealed a significant decrease in the total weekly scores of cough during the second week of budesonide treatment (P < .001) in contrast to continuous decline during the second and third weeks in the placebo group (P < .001 and P < .05, respectively). While the nasal discharge score decreased significantly during the second week in the budesonide group (P < .01), no significant effect on the nasal discharge score was observed in the placebo group.
                These data suggest that topical corticosteroids may be a useful ancillary treatment to antibiotics in childhood sinusitis and effective in reducing the cough and nasal discharge earlier in the course of acute sinusitis. Approximately 20% patients with chronic rhinosinusitis undergoing Functional Endoscopic Sinus Surgery (FESS) experience impaired wound healing, leading to recurrences of sinusitis and polyps.
                We investigated the efficacy of oral+ local steroids in wound healing, following FESS in subjects with a chronic rhinosinusitis with/without nasal polyps. Ninety-nine subjects were randomised to receive 6 months' treatment with mometasone furoate nasal spray (MFNS) 200 microg bid or placebo in double-blind manner approximately 2 weeks after FESS. Postoperative mean total score for several endoscopic parameters scores assessed at 6 months was calculated as the primary efficacy end-point. An endoscopic combination score (for inflammation, oedema, and polyps), a total symptoms score, and percent subjects requiring rescue medication, were assessed as secondary end-points.
                MFNS led to greater, although not significant, reductions in total endoscopic scores in all subjects, compared with placebo. The combination scores, however, indicated significantly improved healing with MFNS than with placebo for all subjects (median scores: 0.0 vs 2.0, p = 0.02), and particularly for subjects with nasal polyps (median scores: 2.0 vs 4.0, p = 0.03). The total symptom scores and percent subjects requiring rescue medication were similar in the two groups. MFNS was well tolerated.
                These results suggest that treatment with MFNS following sinus surgery may improve wound healing, particularly in subjects with nasal polyps. The clinical efficacy and adverse effects of budesonide administered as a nasal aerosol in addition to sinus washings and erythromycin therapy was assessed by comparison with placebo in a randomized, double-blind study of 40 patients with chronic or recurrent maxillary sinusitis. Most of the patients had been referred for operative treatment. Corticosteroid therapy, 400 micrograms daily, or placebo was continued for 3 months. Budesonide and antral irrigations reduced nasal symptoms more effectively than placebo, and there was a significantly greater reduction in facial pain and sensitivity in the budesonide group than in the placebo group. During the treatment period, mucosal thickening as evaluated by radiology decreased more clearly in the budesonide group than in the placebo group, but the difference did not reach statistical significance. The most frequently isolated bacteria were Staphylococcus aureus, Staphylococcus epidermidis and Haemophilus influenzae. Only 2 of 20 Haemophilus strains were beta-lactamase producers. The cellular picture was dominated by neutrophils in all secretions. There was no significant difference in clinical outcome between the two groups. Topical steroid therapy did not cause any adverse effects. Acute sinusitis-like complaints are very common and are usually treated with antibiotics in spite of the lack of evidence for the effectiveness of antibiotic therapy and the increasing number of resistant strains.
                To assess the effectiveness of doxycycline in adults with acute sinusitis-like complaints in general practice.
                The effects of doxycycline in a placebo-controlled, double-blind, randomized trial were assessed in adults consulting their general practitioner (GP) with complaints after a common cold or influenza, pain in the head when bending forward, purulent nasal discharge, predominantly unilateral maxillary pain, toothache, or pain when chewing. Primary outcome events were the resolution of facial pain and the resumption of daily activities. Treatment differences were assessed by means of Kaplan-Meier curves and hazard ratios. The follow-up period was 42 days.
                No significant difference was found in time to recover between the doxycycline-treated group and the placebo-treated group. However, the adjusted hazard ratio for the group receiving doxycycline was 1.17 (95% CI = 0.87-1.57) for the resolution of pain and 1.31 (95% CI = 0.96-1.78) for the resumption of daily activities. After 10 days, 85% of all patients reported improvement and 60% were completely cured. Side effects were reported by 17% of the doxycycline-treated group, with two patients withdrawing because of side effects.
                Data from this study indicate that doxycycline does not add to the effectiveness of decongestive nose drops and steam inhalation in treating acute sinusitis-like complaints in general practice adults. Evidence is lacking to guide the postoperative management of Samter's triad patients with chronic rhinosinusitis with polyposis (CRSwP) undergoing endoscopic sinus surgery (ESS). The purpose of this study was to compare three different standardized medication regimens prescribed to these patients after ESS.
                Three-arm, randomized, double-blinded, controlled trial.
                Patients with Samter's triad undergoing ESS were postoperatively randomized into three medication regimens, those being saline irrigation alone (control group A), saline irrigation plus separate budesonide nasal spray (group B), and saline irrigation mixed with budesonide nasal spray (group C). Outcome measures were Sino-Nasal Outcome Test scores, Lund-Mackay computed tomography scores, and Lund-Kennedy endoscopic scores taken at preoperative baseline, and then at 6 months and 1 year postoperatively. Side effect profiles were also measured (adrenocorticotropic hormone blood level ranges and intraocular pressure at the same interval points). Analysis of variance and χ(2) analyses were conducted using a Bonferroni correction method and routine descriptive statistics. Inter- and intragroup comparisons were made.
                Sixty subjects were recruited. All groups were equivalent at baseline in all outcomes. All intragroup analyses showed statistically and clinically significant improvement in disease status as compared to baseline (P < .0167), with a sustained but lessened improvement at 1 year. However, no statistically or clinically significant differences were observed between groups at any time point (P > .05). There was no treatment effect noted.
                In this study, nasal steroids did not confer any additional benefit over saline alone as post-ESS care for the Samter's triad CRSwP patient population.
                Copyright © 2011 The American Laryngological, Rhinological, and Otological Society, Inc. Evolution of bacterial resistance shortens antibiotic treatment in ENT infections. The efficacy and tolerance of amoxicillin-clavulanate (ACA), with and without associated short steroid therapy, was evaluated in acute sinusitis of adults at a dosage of 1.5 g/d for 5 d vs. 10 d. This multicentre, randomized, double-blind, placebo-controlled study included 433 patients, 417 of whom were suitable for intent-to-treat (ITT) analysis. The therapeutic success rate in the ITT population, assessed according to strict clinical and radiological criteria, was respectively, 80% and 85% in the 5-d and 10-d treatment groups. Due to the statistical risks that were evidenced, the 2 durations of treatment could not be considered equivalent. The analysis of medical history shows that some risk factors (recurrence of sinusitis, previous surgical sinus drainage) seem to promote therapeutic failure and that 5-d treatment is inappropriate in these patients. The persistence of therapeutic success on day 30 was not influenced by the initial duration of treatment. The efficacy and good tolerance of ACA in acute sinusitis in adults were confirmed. Further studies will be needed to define the indications of short treatments better, which seem to be indicated in the absence of specific risk factors. Acute sinusitis is a common clinical problem that usually results in a prescription for antibiotics but the role of antibiotics is debated. Anti-inflammatory drugs such as topical steroids may be beneficial but are underresearched.
                To determine the effectiveness of amoxicillin and topical budesonide in acute maxillary sinusitis.
                A double-blind, randomized, placebo-controlled factorial trial of 240 adults (aged > or =16 years) with acute nonrecurrent sinusitis (had > or =2 diagnostic criteria: purulent rhinorrhea with unilateral predominance, local pain with unilateral predominance, purulent rhinorrhea bilateral, presence of pus in the nasal cavity) at 58 family practices (74 family physicians) between November 2001 and November 2005. Patients were randomized to 1 of 4 treatment groups: antibiotic and nasal steroid; placebo antibiotic and nasal steroid; antibiotic and placebo nasal steroid; placebo antibiotic and placebo nasal steroid.
                A dose of 500 mg of amoxicillin 3 times per day for 7 days and 200 mug of budesonide in each nostril once per day for 10 days.
                Proportion clinically cured at day 10 using patient symptom diaries and the duration and severity of symptoms.
                The proportions of patients with symptoms lasting 10 or more days were 29 of 100 (29%) for amoxicillin vs 36 of 107 (33.6%) for no amoxicillin (adjusted odds ratio, 0.99; 95% confidence interval, 0.57-1.73). The proportions of patients with symptoms lasting 10 or more days were 32 of 102 (31.4%) for topical budesonide vs 33 of 105 (31.4%) for no budesonide (adjusted odds ratio, 0.93; 95% confidence interval, 0.54-1.62). Secondary analysis suggested that nasal steroids were significantly more effective in patients with less severe symptoms at baseline.
                Neither an antibiotic nor a topical steroid alone or in combination was effective as a treatment for acute sinusitis in the primary care setting.
                isrctn.org Identifier: ISRCTN60825437. To compare antibiotics and placebo in patients with clinically diagnosed acute maxillary sinusitis (AMS). To study whether sinus ultrasound examination would help to detect those patients who benefit from antibiotic therapy.
                A double-blind, randomised, placebo-controlled multicentre trial.
                Nine primary care sites in Finland.
                150 adult patients (mean age 39.7 years) with a clinical diagnosis of sinusitis.
                Antibiotics (amoxicillin 750 mg x 2, doxycycline 100 mg x 2 or penicillin V 1500 mg x 2) or placebo twice daily for 7 days; all patients were examined with sinus ultrasound after randomisation.
                Clinical success (patients' report of recovery) in telephone interview at 2 weeks.
                A total of 146 patients completed the 2-week follow-up. Patients receiving antibiotics achieved a slightly higher rate of clinical success than patients receiving placebo (80% vs 66%; p = 0.068).
                Antibiotics hasten symptom relief in AMS. Yet many patients recover in 2 weeks without antimicrobial treatment. Only half of patients with a clinical diagnosis of AMS have sinusitis in ultrasound examination. Chronic rhinosinusitis (CRS) is a recalcitrant inflammatory process which has a marked detrimental impact on quality of life. At the present there is no cure for this condition, measures are taken to stop progression, and provide symptomatic relief. Topical corticosteroids are commonly prescribed in the management of CRS, but few trials show effectiveness in clinical settings. We set up a randomized, double-blind, placebo-controlled trial to study the effectiveness of a topical corticosteroid agent--fluticasone propionate aqueous nasal spray (FPANS) in patients with CRS. We measured symptoms, diary card, and rigid endoscopy scores, acoustic rhinometry, middle meatal swabs, blood tests--CRP, ESR, WBC, and eosinophil count. Measurements were done at the start of the trial, at 8 weeks, and 16 weeks where possible. Twenty-two patients completed the trial, 9 received FPANS, and 13 had placebo. There was no difference between the 2 groups on all counts. When patients were considered as one group, there was an improvement in the diary card scores (p = 0.054), comparing baseline to 8 or 16 weeks. There was no evidence that the regular use of topical corticosteroid increased the risk of developing an infection. An important observation was that the topical corticosteroid did not precipitate acute sinusitis. There is compelling evidence that topical corticosteroids down-regulate cytokine expression, and it is likely that a larger, and longer multi-centre trial may prove their efficacy in CRS.
Current evidence is limited for acute sinusitis confirmed by radiology or nasal endoscopy, 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.