Efficacy of sinus irrigation versus sinus irrigation followed by functional endoscopic sinus surgery. Fluticasone propionate aqueous nasal spray does not influence the recurrence rate of chronic rhinosinusitis and nasal polyps 1 year after functional endoscopic sinus surgery. Effect of corticosteroids on wound healing after endoscopic sinus surgery. Treatment of nasal polyposis and chronic rhinosinusitis with fluticasone propionate nasal drops reduces need for sinus surgery. Optimizing the surgical field in pediatric functional endoscopic sinus surgery: a new evidence-based approach. Functional endoscopic sinus surgery improved asthma symptoms as well as PEFR and olfaction in patients with nasal polyposis. Functional endoscopic sinus surgery: 5 year follow up and results of a prospective, randomised, stratified, double-blind, placebo controlled study of postoperative fluticasone propionate aqueous nasal spray. Use of mometasone furoate to prevent polyp relapse after endoscopic sinus surgery. Postoperative care for Samter's triad patients undergoing endoscopic sinus surgery: a double-blinded, randomized controlled trial. Nasal irrigation for the alleviation of sinonasal symptoms. Efficacy of daily hypertonic saline nasal irrigation among patients with sinusitis: a randomized controlled trial.
Sinus irrigation is the traditional treatment for chronic maxillary sinusitis. Functional endoscopic sinus surgery (FESS) restores aeration and allows secretions to be removed from an infected sinus. This study compares the efficacy of sinus irrigation with that of sinus irrigation followed by FESS in 89 patients. We measured the effects by way of sinus radiographs, nasendoscopic findings, and patient complaints. When we analyzed the data in terms of intent to treat, we found significantly favorable results for sinus irrigation followed by FESS at the end point, though only for loss of smell and purulent rhinitis. Treatment consisting of sinus irrigation alone prevented surgery in 58% of all patients for 1 year. Both treatment methods were combined with a 10-day course of loracarbef, which might have contributed to the outcome. We conclude that a good option for treatment of chronic maxillary sinusitis seems to be sinus irrigation in combination with a broad-spectrum antibiotic followed by FESS. Local corticosteroids are widely used in the treatment of nasal polyps and chronic rhinosinusitis both before and after nasal surgery. Their efficacy after functional endoscopic sinus surgery (FESS) has not been fully established by placebo-controlled trials.
                This double-blind placebo-controlled randomized study was performed in order to investigate whether fluticasone propionate aqueous nasal spray (FPANS) reduces the recurrence rate of nasal polyps and chronic rhinosinusitis during the first year after FESS.
                The trial looked at 162 patients aged 18 years and older requiring FESS for chronic rhinosinusitis or nasal polyps. After FESS combined with peri-operative systemic corticosteroids, patients were randomized and given FPANS 400 microg b.i.d., FPANS 800 microg b.i.d. or placebo b.i.d. for the duration of 1 year. Patients were withdrawn from the trial (but still included in the study for statistical purposes) if there were recurrent or persistent diseases, defined as progressive regrowth of nasal polyps, recurrent signs and symptoms of chronic sinusitis combined with abnormalities on computed tomography scan and persistent complaints for at least 2 months after FESS.
                A significant reduction of symptoms was seen after FESS. After 1 year, 46 patients had been withdrawn from the trial because of recurrent diseases and 32 patients because of persistent symptoms. No differences in the number of patients withdrawn because of recurrent or persistent diseases were found between the patients treated with FPANS and patients treated with placebo. We were also unable to find a positive effect of FPANS compared with placebo in several subgroups such as patients with nasal polyps, high score at FESS or no previous sinus surgery.
                This placebo-controlled study does not show that treatment with FPANS up to 1 year after FESS had a positive effect compared with placebo. 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. Steroid treatment is the mainstay of therapy for nasal polyps and rhinosinusitis. Oral steroids have considerable systemic side effects, and nasal sprays do not sufficiently reach the middle meatus, where polyps originate. Nasal drops might be a more useful formula to deliver steroids into the middle meatus.
                We sought to investigate whether treatment with fluticasone propionate nasal drops (FPNDs) can reduce the need for surgery, as measured by signs and symptoms of nasal polyposis and chronic rhinosinusitis, in patients who are on the waiting list for functional endoscopic sinus surgery (FESS).
                Fifty-four patients (28 male) with severe nasal polyposis, chronic rhinosinusitis, or both indicated for FESS were included in a 12-week, double-blind, placebo-controlled study. Use of intranasal steroid spray was stopped at least 4 weeks before randomization. Signs and symptoms were recorded before, during, and at the end of the study period. At the end of the study, a computed tomographic scan was performed, and the need for operation was reassessed by using a standardized scoring method.
                FESS was no longer required in 13 of 27 patients treated with FPNDs versus 6 of 27 in the placebo group (P < .05). Six patients from the placebo group dropped out versus 1 from the FPND group. Symptoms of nasal obstruction, rhinorrhea, postnasal drip, and loss of smell were reduced in the FPND group (P < .05). Peak nasal inspiratory flow scores increased significantly (P < .01). Polyp volume decreased in the FPND group (P < .05), and computed tomographic scores improved in both groups (P < .05).
                Treatment with FPNDs in patients indicated for FESS can reduce the need for surgery. To conduct the first prospective randomized controlled study 1) evaluating the possibility of improving the quality of the operative field and to provide a bloodless functional endoscopic sinus surgery (FESS) in children through total intravenous anesthesia (TIVA) using remifentanil combined with propofol, and 2) testing the safety and efficacy of remifentanil in propofol-TIVA in inducing controlled hypotension in children at a target mean arterial blood pressure of 50 mm Hg.
                Randomized controlled trial.
                General hospital.
                Seventy children underwent FESS under hypotensive general anesthesia with equal randomization into two groups. Group I received TIVA with remifentanil, whereas group II had balanced anesthesia (BA) with esmolol. Heart rate, blood pressure, operative time, blood loss, and quality of the surgical conditions were recorded.
                Intraoperative blood loss in the TIVA group was less than in the BA group. The quality and dryness of the surgical field in both the visual analogue scale and the six-point scale was significantly better in the TIVA group than in the BA group. Hypotension was sustained at the target mean arterial blood pressure of 50 mm Hg in the two groups, without any significant difference.
                Improving the quality of the surgical field and providing a bloodless FESS in children is attainable with TIVA. TIVA using a combination of remifentanil and propofol is superior to BA, even with the use of additional potent hypotensive agents such as esmolol. Both techniques are safe and effective in inducing controlled hypotension in children at a target mean arterial blood pressure of 50 mm Hg. Nasal polyposis is a disease known to be associated with asthma. The management is anti-inflammatory, with topical and oral corticosteroids as the first-line treatment. The effect of surgical treatment on lower airway inflammation has not been sufficiently studied.
                The aim of this study is to investigate the effects of functional endoscopic sinus surgery (FESS) as well as fluticasone proprionate nasal drops (FPND) 400 microg b.i.d. on nasal and lower airway parameters in asthmatics with nasal polyposis.
                This was a prospective 21-week study of 68 patients with asthma and nasal polyposis, on the benefits of FESS on nasal '(butanol test, subjective olfaction, peak nasal inspiratory flow, congestion, rhinorrhoea, and polyp score)', and on the lower airway parameters (dyspnea, cough, mean daily peak expiratory flow rate (PEFR), and lung function tests). It also included a randomized, double-blind, placebo-controlled 14 weeks phase on FPND.
                Functional endoscopic sinus surgery significantly improved mean asthma symptom scores and daily PEFR and all nasal parameters including subjective and objective olfaction tests. This is the first study that shows the benefits of FESS on butanol tests in patients with nasal polyposis. We found no significant difference between topical treatment with FPND or placebo in the nasal or lower airway variables.
                Functional endoscopic sinus surgery improved nasal and asthma symptoms in patients with nasal polyposis. Functional endoscopic sinus surgery could be considered early in the natural course of nasal polyposis with concomitant asthma, as well as a second-line treatment in nasal polyposis patients with a reduced sense of smell. The potential benefits of FPND 400 microg b.i.d. were probably overshadowed by FESS. One hundred nine patients with chronic rhinosinusitis underwent functional endoscopic sinus surgery. Seventy seven patients had polyposis. The population was studied prospectively for 5 years postoperatively. Seventy two patients attended the 5 year follow-up visit. At 1, 2, 3, 4 and 5 years of follow-up all outcome measures except olfactory detection thresholds (visual analogue scores, endoscopic findings, nasal mucociliary clearance times, total nasal volumes) were significantly improved compared to preoperative baseline values. Olfactory detection thresholds were significantly improved at 1 and 2 years postoperation. Patient symptom scores were improved in a greater percentage of patients than more objective outcome measures. Thirty eight patients required a total of 88 postoperative rescue medication courses with prednisolone and antibiotic. Twelve patients failed the study as they required at least 1 rescue medication course a month for 2 consecutive months. We demonstrated an 89% 5 year "survival" rate with regards to the risk of failure. The patients were also entered into a randomised, stratified, prospective, double-blind, placebo controlled study of fluticasone propionate aqueous nasal spray 200 mcg twice daily, commencing 6 weeks after FESS, with a 5 year follow-up. The change in overall visual analogue score was significantly better in the FPANS group at 5 years. The changes in endoscopic oedema and polyp scores and in total nasal volumes were significantly better in the FPANS group at 4 years but not 5 years. Last value carried forward analysis demonstrated that changes in endoscopic polyp score and in total nasal volume was significantly better in the FPANS group at 5 years. Significantly more prednisolone rescue medication courses were prescribed in the placebo group. Of the 12 patients who failed the study, 10 were in the placebo group. This difference nearly achieved significance. To evaluate the effect of mometasone furoate on prevention or reduction of nasal polyp relapse and worsening of symptoms after functional endoscopic sinus surgery (FESS).
                Randomized, double-blind, placebo-controlled, multicenter study.
                Ten ear, nose, and throat clinics in Sweden.
                Adult subjects with bilateral nasal polyps fulfilling the criteria for surgery who underwent FESS.
                Two weeks after FESS, subjects were randomized to receive mometasone furoate nasal spray, 200 microg once daily, or placebo.
                Time to relapse, defined as an increase of 1 point or more on a 0- to 6-point endoscopic polyp scale.
                In the per-protocol population (n = 104), median time to relapse was 173 and 61 days for the mometasone and placebo groups, respectively (P = .007; hazard ratio [95% confidence interval], 0.72 [0.55-0.93]). In the intent-to-treat population (n = 159), median time to relapse was greater than 175 days in the mometasone group and 125 days in the placebo group (P = .049; hazard ratio, 0.79 [0.62-0.99]). The most common adverse event was epistaxis, with 6 cases reported in the mometasone group and 3 in the placebo group.
                Postoperative use of mometasone furoate, 200 microg once daily, provided a statistically significant longer time to relapse of nasal polyps than did placebo in subjects with bilateral nasal polyposis who had undergone FESS. The ability of mometasone to prevent or prolong the time to relapse among subjects undergoing FESS is important because this may prolong the time to subsequent surgery.
                clinicaltrials.gov Identifier: NCT00731185. 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. To determine the effect of nasal irrigation on sinonasal symptoms.
                A total of 150 adult subjects with chronic sinusitis symptoms were recruited from the community and assigned to 1 of 3 treatment groups: nasal irrigation with bulb syringe, nasal irrigation with nasal irrigation pot, or control treatment with reflexology massage. Groups 1 and 2 performed daily hypertonic saline irrigation with 1 device for 2 weeks and then with the other device for 2 weeks. Group 3 performed reflexology massage daily for 2 weeks. Prospective data collected included pretreatment Medical Outcomes Study Short Form, pretreatment and posttreatment Rhinosinusitis Outcomes Measure, daily medication use, subjective treatment efficacy, and preference of irrigation method.
                There was a significant and equivalent improvement in Rhinosinusitis Outcomes Measure 31 score after 2 weeks of intervention in each treatment group; 35% of subjects reported decreased use of sinus medication.
                Daily nasal irrigation using either a bulb syringe, nasal irrigation pot, and daily reflexology massage were equally efficacious and resulted in improvement in the symptoms of chronic sinusitis in over 70% of subjects. Medication usage was decreased in approximately one third of participants regardless of intervention. To test whether daily hypertonic saline nasal irrigation improves sinus symptoms and quality of life and decreases medication use in adult subjects with a history of sinusitis.
                Randomized controlled trial. Experimental subjects used nasal irrigation daily for 6 months.
                Seventy-six subjects from primary care (n=70) and otolaryngology (n=6) clinics with histories of frequent sinusitis were randomized to experimental (n=52) and control (n=24) groups.
                Primary outcome measures included the Medical Outcomes Survey Short Form (SF-12), the Rhinosinusitis Disability Index (RSDI), and a Single-Item Sinus-Symptom Severity Assessment (SIA); all 3 were completed at baseline, 1.5, 3, and 6 months. Secondary outcomes included daily assessment of compliance and biweekly assessment of symptoms and medication use. At 6 months, subjects reported on side effects, satisfaction with nasal irrigation, and the percentage of change in their sinus-related quality of life.
                No significant baseline differences existed between the 2 groups. Sixty-nine subjects (90.8%) completed the study. Compliance averaged 87%. Experimental group RSDI scores improved from 58.4 -/+ 2.0 to 72.8 -/+ 2.2 (P < or =.05) compared with those of the control group (from 59.6 -/+ 3.0 to 60.4 -/+ 1.1); experimental group SIA scores improved from 3.9 -/+ 0.1 to 2.4 -/+ 0.1 (P < or =.05) compared with those of the control group (from 4.08 -/+ 0.15 to 4.07 -/+ 0.27). The number needed to treat to achieve 10% improvement on RSDI at 6 months was 2.0. Experimental subjects reported fewer 2-week periods with sinus-related symptoms (P <.05), used less antibiotics (P <.05), and used less nasal spray (P =.06). On the exit questionnaire 93% of experimental subjects reported overall improvement of sinus-related quality of life, and none reported worsening (P <.001); on average, experimental subjects reported 57 -/+ 4.5% improvement. Side effects were minor and infrequent. Satisfaction was high. We found no statistically significant improvement on the SF-12.
                Daily hypertonic saline nasal irrigation improves sinus-related quality of life, decreases symptoms, and decreases medication use in patients with frequent sinusitis. Primary care physicians can feel comfortable recommending this therapy.
FESS as currently practised is a safe surgical procedure. The limited evidence available suggests that FESS as practised in the included trials has not been demonstrated to confer additional benefit to that obtained by medical treatment (+/- sinus irrigation) in chronic rhinosinusitis. More randomised controlled trials comparing FESS with medical and other treatments, with long-term follow up, are required.