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CHICAGO – Intranasal steroids were as good as saline alone as postoperative care in a randomized, double-blinded study of patients with chronic rhinosinusitis and Samter’s triad.
There was no difference in disease recurrence rate, complications, or quality of life at 6 months and 1-year postoperative using intranasal saline, saline plus budesonide, or saline and budesonide combined.
The surprising finding runs contrary to general practice and has several implications including how best to counsel patients for postoperative care, lead author Dr. Brian Rotenberg said at the Combined Otolaryngology Spring Meetings.
"If nasal steroids as done in this population don’t confer any additional benefit postoperatively, should we still prescribe them?" he asked. "Should we be prescribing something different or perhaps nothing at all? Is there a potential plus side here in terms of health-care cost savings?"
During a discussion of the study, an attendee expressed concern that insurers would interpret the results too broadly and deny coverage of postoperative nasal steroids for all patients with rhinosinusitis and polyposis, and not just those with Samter’s triad, a condition consisting of asthma, aspirin sensitivity, and nasal polyposis.
Another attendee agreed that nasal steroids are not potent enough in this population and said a pulse course of oral steroids 60 mg for 4 days can knock down symptoms in 80% of those with recurrence and be maintained with topical steroids. In the absence of a federally approved product for nasal use, he also suggested that dexamethasone eye drops can be effective.
Dr. Rotenberg replied that all patients received 3 weeks of postoperative oral prednisone, but that pulse-dosing of steroids was limited to one patient with early recurrence.
The 60 patients in the analysis had failed medical management for chronic rhinosinusitis with nasal polyposis and had a minimum preoperative Lund-Kennedy score of 8 out of 12. Nineteen patients were randomized to saline, 21 to saline plus budesonide, and 20 to saline/budesonide combination. Their mean Lund-Mackay scores were 20.6, 19.9, and 20.5, respectively.
Exclusion criteria included revision functional endoscopic sinus surgery, use of corticosteroids for other medical conditions, smoking, and concurrent disease with steroid contraindication.
At 6 months postoperatively, there were no significant differences between the saline, saline plus budesonide, and saline/budesonide combination groups with regard to Lund-Kennedy scores (1.5, 0.9, and 1.2, respectively), adrenocorticotropic hormone (ACTH) ranges (all normal), and intraocular pressure (12.4, 12.9, and 13.9 mm Hg, respectively), said Dr. Rotenberg of the University of Western Ontario in London, Ontario. Quality of life as assessed using the 21-item Sino-Nasal Outcome Test (SNOT-21) was also similar at a mean of 29.7, 27.4 and 28.2, respectively.
At 1 year of follow-up, once again there were no significant differences between the saline, saline plus budesonide, and saline/budesonide groups in Lund-Kennedy scores (3.7, 4.4, and 4.1, respectively), Lund-Mackay scores (11.8, 12.7, and 13.4, respectively), SNOT-21 scores (42.5, 47.9, and 42.2, respectively), intraocular pressure (13.1, 13.4,and 12.9 mm Hg, respectively). ACTH ranges were all normal.
A within-group analysis showed a significant improvement in all outcomes from baseline to 6 months, and a general worsening of outcomes at 1 year compared with the first 6 months, although they were still improved over baseline, Dr. Rotenberg said.
He pointed out that the literature is lacking in evidence guiding the postoperative management of patients with chronic rhinosinusitis with nasal polyps undergoing surgery. One study reported that steroid nasal spray did not influence polyp recurrence rate after surgery (Clin. Exp. Allergy. 2004;34:1395-400), while another showed that normal and buffered hypertonic saline nasal sprays had no beneficial effect on postoperative symptoms compared with no treatment (Am. J. Rhinol. 2006;20:191-6).
Dr. Rotenberg reported no relevant financial disclosures.
Session moderator Dr. Brent A. Senior said in an interview that the study was well designed and sufficiently powered, but would have been strengthened by the inclusion of a nontreatment group and more information on oral medications, as they can have a significant impact on disease. Follow-up to 18 months also would be useful, as the endoscopic appearance of the nasal cavity at 18 months has been shown to be predictive of how patients will do years after surgery.
"This is a good study, but not a game changer," he said, adding that additional work is needed to confirm the findings.
Dr. Senior is chief of rhinology, allergy and sinus surgery at the University of North Carolina at Chapel Hill.
rhinosinusitis and polyposis, dexamethasone eye drops,
Session moderator Dr. Brent A. Senior said in an interview that the study was well designed and sufficiently powered, but would have been strengthened by the inclusion of a nontreatment group and more information on oral medications, as they can have a significant impact on disease. Follow-up to 18 months also would be useful, as the endoscopic appearance of the nasal cavity at 18 months has been shown to be predictive of how patients will do years after surgery.
"This is a good study, but not a game changer," he said, adding that additional work is needed to confirm the findings.
Dr. Senior is chief of rhinology, allergy and sinus surgery at the University of North Carolina at Chapel Hill.
Session moderator Dr. Brent A. Senior said in an interview that the study was well designed and sufficiently powered, but would have been strengthened by the inclusion of a nontreatment group and more information on oral medications, as they can have a significant impact on disease. Follow-up to 18 months also would be useful, as the endoscopic appearance of the nasal cavity at 18 months has been shown to be predictive of how patients will do years after surgery.
"This is a good study, but not a game changer," he said, adding that additional work is needed to confirm the findings.
Dr. Senior is chief of rhinology, allergy and sinus surgery at the University of North Carolina at Chapel Hill.
CHICAGO – Intranasal steroids were as good as saline alone as postoperative care in a randomized, double-blinded study of patients with chronic rhinosinusitis and Samter’s triad.
There was no difference in disease recurrence rate, complications, or quality of life at 6 months and 1-year postoperative using intranasal saline, saline plus budesonide, or saline and budesonide combined.
The surprising finding runs contrary to general practice and has several implications including how best to counsel patients for postoperative care, lead author Dr. Brian Rotenberg said at the Combined Otolaryngology Spring Meetings.
"If nasal steroids as done in this population don’t confer any additional benefit postoperatively, should we still prescribe them?" he asked. "Should we be prescribing something different or perhaps nothing at all? Is there a potential plus side here in terms of health-care cost savings?"
During a discussion of the study, an attendee expressed concern that insurers would interpret the results too broadly and deny coverage of postoperative nasal steroids for all patients with rhinosinusitis and polyposis, and not just those with Samter’s triad, a condition consisting of asthma, aspirin sensitivity, and nasal polyposis.
Another attendee agreed that nasal steroids are not potent enough in this population and said a pulse course of oral steroids 60 mg for 4 days can knock down symptoms in 80% of those with recurrence and be maintained with topical steroids. In the absence of a federally approved product for nasal use, he also suggested that dexamethasone eye drops can be effective.
Dr. Rotenberg replied that all patients received 3 weeks of postoperative oral prednisone, but that pulse-dosing of steroids was limited to one patient with early recurrence.
The 60 patients in the analysis had failed medical management for chronic rhinosinusitis with nasal polyposis and had a minimum preoperative Lund-Kennedy score of 8 out of 12. Nineteen patients were randomized to saline, 21 to saline plus budesonide, and 20 to saline/budesonide combination. Their mean Lund-Mackay scores were 20.6, 19.9, and 20.5, respectively.
Exclusion criteria included revision functional endoscopic sinus surgery, use of corticosteroids for other medical conditions, smoking, and concurrent disease with steroid contraindication.
At 6 months postoperatively, there were no significant differences between the saline, saline plus budesonide, and saline/budesonide combination groups with regard to Lund-Kennedy scores (1.5, 0.9, and 1.2, respectively), adrenocorticotropic hormone (ACTH) ranges (all normal), and intraocular pressure (12.4, 12.9, and 13.9 mm Hg, respectively), said Dr. Rotenberg of the University of Western Ontario in London, Ontario. Quality of life as assessed using the 21-item Sino-Nasal Outcome Test (SNOT-21) was also similar at a mean of 29.7, 27.4 and 28.2, respectively.
At 1 year of follow-up, once again there were no significant differences between the saline, saline plus budesonide, and saline/budesonide groups in Lund-Kennedy scores (3.7, 4.4, and 4.1, respectively), Lund-Mackay scores (11.8, 12.7, and 13.4, respectively), SNOT-21 scores (42.5, 47.9, and 42.2, respectively), intraocular pressure (13.1, 13.4,and 12.9 mm Hg, respectively). ACTH ranges were all normal.
A within-group analysis showed a significant improvement in all outcomes from baseline to 6 months, and a general worsening of outcomes at 1 year compared with the first 6 months, although they were still improved over baseline, Dr. Rotenberg said.
He pointed out that the literature is lacking in evidence guiding the postoperative management of patients with chronic rhinosinusitis with nasal polyps undergoing surgery. One study reported that steroid nasal spray did not influence polyp recurrence rate after surgery (Clin. Exp. Allergy. 2004;34:1395-400), while another showed that normal and buffered hypertonic saline nasal sprays had no beneficial effect on postoperative symptoms compared with no treatment (Am. J. Rhinol. 2006;20:191-6).
Dr. Rotenberg reported no relevant financial disclosures.
CHICAGO – Intranasal steroids were as good as saline alone as postoperative care in a randomized, double-blinded study of patients with chronic rhinosinusitis and Samter’s triad.
There was no difference in disease recurrence rate, complications, or quality of life at 6 months and 1-year postoperative using intranasal saline, saline plus budesonide, or saline and budesonide combined.
The surprising finding runs contrary to general practice and has several implications including how best to counsel patients for postoperative care, lead author Dr. Brian Rotenberg said at the Combined Otolaryngology Spring Meetings.
"If nasal steroids as done in this population don’t confer any additional benefit postoperatively, should we still prescribe them?" he asked. "Should we be prescribing something different or perhaps nothing at all? Is there a potential plus side here in terms of health-care cost savings?"
During a discussion of the study, an attendee expressed concern that insurers would interpret the results too broadly and deny coverage of postoperative nasal steroids for all patients with rhinosinusitis and polyposis, and not just those with Samter’s triad, a condition consisting of asthma, aspirin sensitivity, and nasal polyposis.
Another attendee agreed that nasal steroids are not potent enough in this population and said a pulse course of oral steroids 60 mg for 4 days can knock down symptoms in 80% of those with recurrence and be maintained with topical steroids. In the absence of a federally approved product for nasal use, he also suggested that dexamethasone eye drops can be effective.
Dr. Rotenberg replied that all patients received 3 weeks of postoperative oral prednisone, but that pulse-dosing of steroids was limited to one patient with early recurrence.
The 60 patients in the analysis had failed medical management for chronic rhinosinusitis with nasal polyposis and had a minimum preoperative Lund-Kennedy score of 8 out of 12. Nineteen patients were randomized to saline, 21 to saline plus budesonide, and 20 to saline/budesonide combination. Their mean Lund-Mackay scores were 20.6, 19.9, and 20.5, respectively.
Exclusion criteria included revision functional endoscopic sinus surgery, use of corticosteroids for other medical conditions, smoking, and concurrent disease with steroid contraindication.
At 6 months postoperatively, there were no significant differences between the saline, saline plus budesonide, and saline/budesonide combination groups with regard to Lund-Kennedy scores (1.5, 0.9, and 1.2, respectively), adrenocorticotropic hormone (ACTH) ranges (all normal), and intraocular pressure (12.4, 12.9, and 13.9 mm Hg, respectively), said Dr. Rotenberg of the University of Western Ontario in London, Ontario. Quality of life as assessed using the 21-item Sino-Nasal Outcome Test (SNOT-21) was also similar at a mean of 29.7, 27.4 and 28.2, respectively.
At 1 year of follow-up, once again there were no significant differences between the saline, saline plus budesonide, and saline/budesonide groups in Lund-Kennedy scores (3.7, 4.4, and 4.1, respectively), Lund-Mackay scores (11.8, 12.7, and 13.4, respectively), SNOT-21 scores (42.5, 47.9, and 42.2, respectively), intraocular pressure (13.1, 13.4,and 12.9 mm Hg, respectively). ACTH ranges were all normal.
A within-group analysis showed a significant improvement in all outcomes from baseline to 6 months, and a general worsening of outcomes at 1 year compared with the first 6 months, although they were still improved over baseline, Dr. Rotenberg said.
He pointed out that the literature is lacking in evidence guiding the postoperative management of patients with chronic rhinosinusitis with nasal polyps undergoing surgery. One study reported that steroid nasal spray did not influence polyp recurrence rate after surgery (Clin. Exp. Allergy. 2004;34:1395-400), while another showed that normal and buffered hypertonic saline nasal sprays had no beneficial effect on postoperative symptoms compared with no treatment (Am. J. Rhinol. 2006;20:191-6).
Dr. Rotenberg reported no relevant financial disclosures.
rhinosinusitis and polyposis, dexamethasone eye drops,
rhinosinusitis and polyposis, dexamethasone eye drops,
FROM THE COMBINED OTOLARYNGOLOGY SPRING MEETINGS