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. Treatment of nasal polyposis and chronic rhinosinusitis with fluticasone propionate nasal drops reduces need for sinus surgery. Postoperative care for Samter's triad patients undergoing endoscopic sinus surgery: a double-blinded, randomized controlled trial. Effect of corticosteroids on wound healing after endoscopic sinus surgery. Nasal irrigation for the alleviation of sinonasal symptoms. Evaluation of the medical and surgical treatment of chronic rhinosinusitis: a prospective, randomised, controlled trial. Effect of irrigation of the nose with isotonic salt solution on adult patients with chronic paranasal sinus disease. 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.
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. 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. 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. 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. 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 conduct the first prospective, randomized, controlled trial evaluating and comparing the medical and surgical treatment of polypoid and nonpolypoid chronic rhinosinusitis (CRS).
                Ninety patients with CRS were equally randomized either to medical or surgical therapy. All patients underwent pre- and posttreatment assessments of visual analogue score (VAS), the Sinonasal Outcome Test-20 (SNOT-20), the Short Form 36 Health Survey (SF-36), nitric oxide (NO), acoustic rhinometry, saccharine clearance time (SCT), and nasal endoscopy. Each patient had three assessments: before starting the treatment, after 6 months, and, finally, after 1 year.
                Both the medical and surgical treatment of CRS significantly improved almost all the subjective and objective parameters of CRS (P <.01), with no significant difference being found between the medical and surgical groups (P >.05), except for the total nasal volume in CRS (P <.01) and CRS without polyposis (P <.01) groups, in which the surgical treatment demonstrated greater changes.
                CRS should be initially targeted with maximal medical therapy (e.g., a 3 month course of a macrolide antibiotic, douche, and topical steroid), with surgical treatment being reserved for cases refractory to medical therapy. The presence of nasal polyps is not a poor prognostic factor for the efficacy of CRS therapy, either surgical or medical. In a prospective, randomized, controlled, double-blind trial we compared the effectiveness of endonasal irrigations with Ems salt solution to that with sodium chloride solution in the treatment of adult patients with chronic paranasal sinus disease. Subjects (n = 40) were randomly allocated to treatment either with isotonic Ems salt solution or with isotonic sodium chloride solution. The treatment consisted of endonasal irrigation twice daily and additional nasal spray as required. Nasal endoscopy, plain radiography of the paranasal sinuses, olfactometry, anterior rhinomanometry, and a saccharin-clearance test were carried out on days 1 and 7. Patients recorded rating scales of general discomfort, nasal airway obstruction, agreeableness of the irrigation, duration of improved nasal resistance after each irrigation, and the amount of additional nasal spray in a diary. Nasal air flow was not improved significantly. Subjective complaints, endonasal endoscopy, and radiography results revealed a significant improvement in both groups (P = 0.0001). In comparison, the two groups were not significantly different in outcome. Endonasal irrigations with salt solutions are effective in the treatment of chronic sinusitis, and a significant difference between Ems salt and sodium chloride was not observed. 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.
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.