Dataset Information

Oral Corticosteroids Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis Without Nasal Polyposis: A Randomized Clinical Trial.

ABSTRACT:

Importance

Although oral corticosteroids are commonly prescribed following endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) without nasal polyposis, there are little data to suggest that this is a beneficial practice.

Objective

To assess the efficacy of oral corticosteroids following ESS in CRS without polyps.

Design, setting, and participants

This prospective double-blinded, placebo-controlled, randomized noninferiority clinical trial conducted in a single academic tertiary rhinology practice included adults with CRS without polyps undergoing ESS. Of 81 patients recruited, 72 completed the study.

Interventions

Patients were randomized into 2 treatment groups: a 12-day postoperative taper of oral prednisone vs matched placebo tablets. All study patients also received a uniform 2-week postoperative regimen of oral antibiotics, fluticasone nasal spray, and saline rinses.

Main outcomes and measures

The primary outcome measures were Sinonasal Outcome Test-22 (SNOT-22) scores and Lund-Kennedy endoscopy scores, collected preoperatively and postoperatively at 1 week, 1 month, 3 months, and 6 months. Scores were compared between treatment groups at each time point using longitudinal difference between treatment groups and analyzed using 2-way, repeated measures analysis of variance. Secondary outcome measures included treatment-related adverse effects.

Results

Overall, 72 patients (mean [SD] age, 49.4 [14.9] years; 36 men, 36 women) completed the study, with 33 in the prednisone arm and 39 in the placebo arm. When comparing longitudinal differences between treatment groups, there was no clinically meaningful difference observed in SNOT-22 total (F[4254] = 1.71, η2 = 0.01 [95% CI, 0.00-0.05]) or Lund-Kennedy scores (F[4247] = 1.23, η2 = 0.02 [95% CI, 0.00-0.50]). In SNOT-22 subdomain analyses, there was no clinically meaningful difference between treatment groups for rhinologic, extranasal rhinologic, ear/facial, or sleep subdomains. However, the prednisone group had worse longitudinal scores for psychological dysfunction compared with the placebo group (F[4254] = 3.18, η2 = 0.05 [95% CI, 0.02-0.09]). Reported adverse effects were similar between the 2 treatment groups.

Conclusions and relevance

In this randomized clinical trial of patients with CRS without polyps, oral prednisone following ESS conferred no additional benefit over placebo in terms of SNOT-22 total scores, SNOT-22 rhinologic subscores, or Lund-Kennedy endoscopy scores up to 6 months after surgery. Patients receiving prednisone, however, did demonstrate worse SNOT-22 psychologic subdomain scores. These results suggest that the risks of oral corticosteroids may outweigh the benefits; thus use of oral corticosteroids after ESS for CRS without polyps should be carefully considered.

Trial registration

ClinicalTrials.gov Identifier: NCT02748070.

SUBMITTER: Chang MT

PROVIDER: S-EPMC7934078 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Oral Corticosteroids Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis Without Nasal Polyposis: A Randomized Clinical Trial.

Chang Michael T MT Noel Julia J Ayoub Noel F NF Qian Zhen Jason ZJ Dholakia Sachi S Nayak Jayakar V JV Patel Zara M ZM Hwang Peter H PH

JAMA otolaryngology-- head & neck surgery 20210501 5

<h4>Importance</h4>Although oral corticosteroids are commonly prescribed following endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) without nasal polyposis, there are little data to suggest that this is a beneficial practice.<h4>Objective</h4>To assess the efficacy of oral corticosteroids following ESS in CRS without polyps.<h4>Design, setting, and participants</h4>This prospective double-blinded, placebo-controlled, randomized noninferiority clinical trial conducted in a single a ...[more]

PMID: 33662124

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Project description:BackgroundComparative effectiveness research between endoscopic sinus surgery (ESS) and biologic therapy for severe chronic rhinosinusitis with nasal polyposis (CRSwNP) is a nascent field as new therapeutic modalities become clinically available.MethodsA prospective, multicenter cohort of CRSwNP patients, undergoing ESS between 2011 and 2019, were compared to phase-3 biologic trial data. Patients undergoing ESS received baseline nasal endoscopy quantified via Lund-Kennedy (LK) grading. Patients meeting inclusion criteria, modified from Dupilumab-LIBERTY-NP-24&52, omalizumab-POLYP-1&2, and Mepolizumab-SYNAPSE clinical trials, were included in this study. Baseline characteristics and outcome measures were compared between these cohorts at 24 weeks and 52 weeks, when possible.ResultsA total of 111 CRSwNP patients met modified inclusion criteria. There were no statistically significant differences in baseline age, sex, asthma status, aspirin-exacerbated respiratory disease status, smell identification, LK-polyp score, and Lund-Mackay computed tomography (CT) scores between ESS and biologic groups. At 24 weeks, ESS demonstrated significantly greater improvements in 22-item Sino-Nasal Outcome Test (SNOT-22) compared to one (of two) dupilumab trials (p < 0.05) and both omalizumab trials (p < 0.001). ESS associated with significantly lower nasal polyp scores (NPS) compared to dupilumab (p < 0.001) and omalizumab (p < 0.001), despite comparable improvements in smell identification (p > 0.05). At 52 weeks, ESS resulted in statistically similar improvement in SNOT-22 scores compared to dupilumab (p = 0.21), but NPS remained significantly lower in the ESS group compared to dupilumab (p < 0.001) and mepolizumab (p < 0.001).ConclusionAt 24 weeks and 52 weeks, ESS offers comparable SNOT-22 improvements compared to dupilumab. ESS and dupilumab offer comparable improvement in smell identification at 24 weeks. Compared to omalizumab, ESS offers superior SNOT-22 improvements. ESS offers significantly greater reductions in polyp size compared to omalizumab, dupilumab, and mepolizumab therapies.

Project description:Objectives/hypothesisWe sought to evaluate preoperative and postoperative productivity losses and quality of life (QOL) impairment reported by patients with recurrent acute rhinosinusitis (RARS) as compared to patients with chronic rhinosinusitis without nasal polyposis (CRSsNP).Study designProspective, multi-institutional, nested case-control.MethodsParticipants with RARS (n = 20) and CRSsNP (n = 20) undergoing endoscopic sinus surgery (ESS) were enrolled as part of a prospective cohort study. For comparison, participants diagnosed with RARS cases were age/gender-matched to control participants diagnosed with CRSsNP using a 1:1 ratio.ResultsRARS and CRSsNP participants were followed for ∼14 months postoperatively. Productivity losses were reported as the number of days missed from normal productive activities out of the previous 90 days. RARS participants reported similar baseline productivity losses (12.6 ± 27.1 [standard deviation]) as participants with CRSsNP (11.7 ± 20.9; P = .314). Postoperatively, improvement in productivity losses was similar between RARS participants and CRSsNP controls (-6.7 ± 20.0 vs. -9.8 ± 19.1; P = .253). Preoperative and postoperative disease-specific QOL measures (Sino-Nasal Outcomes Test-22 and Rhinosinusitis Disability Index) were similar between the two groups. RARS participants reported a significant decrease in days of previous antibiotic (P = .009) and nasal decongestant (P = .004) use following ESS, whereas participants with CRSsNP reported a significant decrease in antibiotic (P = .002) and oral corticosteroid use (P = .002).ConclusionsRARS patients report baseline productivity losses and disease-specific QOL impairment to levels that parallel those with CRSsNP. Patients with RARS report improvement in QOL following ESS in all disease-specific QOL measures and in several medication measures. Productivity losses and postoperative improvements are similar between patients with RARS and CRSsNP.Level of evidence3b Laryngoscope, 126:1046-1053, 2016.

Project description:IntroductionChronic rhinosinusitis with polyposis (CRSwNP) is a multifactorial naso-sinusal inflammatory disease that affects 2-4% of the adult population. It highly affects the patient quality of life (QoL) in many levels making it a public health issue. The management of CRSwNP is based on a detailed clinical history, a complete endoscopic examination and a precise computed tomographic (CT) analysis. The aim of this study is to evaluate the prevalence and severity of the various CRS clinical manifestations as well as to highlight the potential relationship between symptom scores, asthma and ESS outcomes.Patients and methodsA retrospective cohort study was performed in the 20 August hospital, between January 2017 and December 2018, on patients diagnosed with CRS according to guidelines recommendations, and were beforehand refractory to initial medical therapy and elected to FESS. The patients were divided into two groups, the first group (G1) of patients with asthma and the second (G2) without asthma in order to expose an eventual significant difference in the improvement of symptoms after surgery. The Sino Nasal Outcome Test-22 (SNOT-22) was used to evaluate QOL.ResultsA total of 100 patients participated in the study with an average age of 44.53 years. The sex ratio was 1.04 (51% men). Asthma was present in 48% of patients while 20% of patients were intolerant to aspirin with a significant difference between the asthmatic and non-asthmatic group (p < 0.05). It appears that asthma was not objectively correlated with a higher Lund Mackay radiological score (p > 0.05). A higher significant improvement was observed between preoperative and postoperative SNOT-22 scores in group with asthma [42.7 ± 16.3 versus 11.8 ± 9.1] and in group without asthma [38.3 ± 15.1 versus 10.5 ± 14.2].ConclusionAsthma in CRS is an additional symptom in these patients, mainly reflected in the subset of nasal symptoms in SNOT-22. However, it did not significantly affect the quality of life of the CRSwNP population.

Project description:BackgroundAlthough patients with chronic rhinosinusitis with nasal polyps (CRSwNP) may benefit from endoscopic sinus surgery (ESS), some patients will experience polyp recurrence, adding to the overall disease burden of CRSwNP. We aimed to investigate predictors of revision ESS in patients with CRSwNP.MethodsA nationwide population-based study including all adults diagnosed with CRSwNP who had surgical procedure codes for ESS (N = 3506), followed up between January 2012 and December 2019. Logistic regression models provided adjusted odds ratios (OR) with 95% confidence intervals (CIs) for the odds of revision surgery within one and 3 years post-index surgery.Results559 (15.9%) of the patients had at least one revision surgery during the follow-up. Median time to revision of ESS was 425 days (interquartile range: 213-898). Baseline asthma (OR = 1.58, 95% CI 1.17-2.12) and antibiotic use (OR = 1.61, 95% CI 1.27-2.04) were associated with higher odds of revision ESS, particularly within 3 years post-index surgery, whereas Increasing age was inversely associated with the odds of ESS revision (OR = 0.82, 95% CI 0.76-0.88). The highest odds of revision ESS were observed within 3 years post-index surgery in patients who had undergone extensive surgery at index (OR = 14.13, 95% CI 3.41-95.64) compared with those who had undergone limited surgery. OCS use was frequent among CRSwNP patients, with a higher cumulative dose in patients undergoing multiple ESS revisions (63%, n = 97, median daily dose 3.29 mg, IQR: 1.64-3.70) compared with patients without revisions (49%, n = 1361 and 1.64 mg, IQR: 1.64-3.29, respectively. p-value <0.001).ConclusionsA small proportion of CRSwNP patients require revision ESS with associated high cumulative OCS doses, highlighting the need for additional therapies to achieve disease control and reduce the corticosteroid burden. A few simple baseline characteristics can predict the need for recurrent surgery among the patients with CRSwNP.

Project description:BACKGROUND:Chronic rhinosinusitis (CRS) is one of the commonest chronic health problems among adults in the UK. Around 15% of CRS patients undergo functional endoscopic sinus surgery (FESS) annually after failing medical treatment. However, as incomplete resolution of symptoms or complications post-operatively is common, the post-operative management is considered to be as important as the surgery itself. A bioabsorbable corticosteroid-eluting sinus implant (CESI) (Propel®, mometasone furoate 370 µg) has been used as an alternative post-FESS treatment. OBJECTIVE:The objective of this study was to assess the cost effectiveness of the corticosteroid-eluting implant versus non-corticosteroid-eluting spacer following FESS for treatment of patients with CRS. METHODS:A decision tree model was developed to estimate the cost and effectiveness in each strategy. Costs and effects were estimated from a UK National Health Service (NHS) and personal social services perspective over a 6-month time horizon. Model pathways and parameters were informed by existing clinical guidelines and literature and sensitivity analyses were conducted to explore uncertainties in base-case assumptions. RESULTS:Over a 6-month time horizon, inserting CESI at the end of FESS is less costly (£4646 vs. £4655 per patient) and is the more effective intervention [total quality-adjusted life-years (QALYs) over 6 months 0.443 vs. 0.444] than non-corticosteroid-eluting spacers; hence, it is a dominant strategy. The probabilistic analysis results indicate that CESI following FESS has a 62% probability of being cost effective at the £20,000/per QALY willingness-to-pay threshold and 56% probability of being a cost-saving intervention. CONCLUSIONS:The use of CESI after FESS results in fewer post-operative complications than non-corticosteroid-eluting implants and may be a cost-saving technology over a 6-month time horizon. Although the cost of initial treatment with the CESI is greater, cost savings are made due to a reduction in the number of complications experienced.

Project description:BackgroundChronic rhinosinusitis (CRS) is a common source of ill health; 11% of UK adults reported CRS symptoms in a worldwide population study. Guidelines are conflicting regarding whether antibiotics should be included in primary medical management, reflecting the lack of evidence in systematic reviews. Insufficient evidence to inform the role of surgery contributes to a fivefold variation in UK intervention rates. The objective of this trial is to establish the comparative effectiveness of endoscopic sinus surgery (ESS) or a prolonged course of antibiotics (clarithromycin) in adult patients with CRS in terms of symptomatic improvement and costs to the National Health Service compared with standard medical care (intranasal medication) at 6 months.Methods/designA three-arm parallel-group trial will be conducted with patients who remain symptomatic after receiving appropriate medical therapy (either in primary or secondary care). They will be randomised to receive: (1) intranasal medication plus ESS, (2) intranasal medication plus clarithromycin (250 mg) or (3) intranasal medication plus a placebo. Intranasal medication (current standard medical care) is defined as a spray or drops of intranasal corticosteroids and saline irrigations. The primary outcome measure is the SNOT-22 questionnaire, which assesses disease-specific health-related quality of life. The study sample size is 600. Principal analyses will be according to the randomised groups irrespective of compliance. The trial will be conducted in at least 16 secondary or tertiary care centres with an internal pilot at six sites for 6 months.DiscussionThe potential cardiovascular side effects of macrolide antibiotics have been recently highlighted. The effectiveness of antibiotics will be established through this trial, which may help to reduce unnecessary usage and potential morbidity. If ESS is shown to be clinically effective and cost-effective, the trial may encourage earlier intervention. In contrast, if it is shown to be ineffective, then there should be a significant reduction in surgery rates. The trial results will feed into the other components of the MACRO research programme to establish best practice for the management of adults with CRS and design the ideal patient pathway across primary and secondary care.Trial registrationISRCTN36962030 . Registered on 17 October 2018.

Dataset Information

Oral Corticosteroids Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis Without Nasal Polyposis: A Randomized Clinical Trial.

Importance

Objective

Design, setting, and participants

Interventions

Main outcomes and measures

Results

Conclusions and relevance

Trial registration

Publications

Oral Corticosteroids Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis Without Nasal Polyposis: A Randomized Clinical Trial.

Similar Datasets

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