Patients with chronic rhinosinusitis with nasal polyps were found to benefit more from the combination of endoscopic sinus surgery and medical treatment compared to medical treatment alone, although the minimal clinically important difference was not reached.
According to the results of a study published in Respiratory Medicine The Lancet.
Typically performed when patients with CRSwNP fail to respond to medical treatment alone, ESS has been shown in previous research to significantly improve symptoms and health-related quality of life (HRQOL). However, more than 1 in 5 patients (20% to 30%) were indicated to require an ESS revision after 5 to 10 years.
“Wide variations in the management of CRSwNP exist both between and within countries and between individual specialists, which can lead to ineffective and inappropriate care,” the study authors said. “The positioning of ESS plus medical therapy in patients with CRSwNP has been identified by the UK National Institute of Health and Care Excellence, the European Rhinologic Society and the Dutch Society of Otorhinolaryngology and Head and Neck Surgery as one major knowledge gaps. in otolaryngology.
In the absence of randomized controlled trials that explored the effectiveness of ESS, they conducted an open-label, multicenter, pragmatic, randomized, controlled trial to compare the outcomes of ESS treatment plus medical therapy versus medical therapy alone in patients with CRSwNP.
In the study, adults aged 18 years and older with CRSwNP and an indication for ESS were recruited from 3 tertiary care centers and 12 secondary care centers in 11 cities in the Netherlands between 15 February 2015 and August 27, 2019. Participants were randomly assigned. in a 1:1 ratio to receive either ESS plus medical therapy or medical therapy alone, such as nasal corticosteroids, nasal rinse, systemic corticosteroids, or systemic antibiotics.
“ESS was performed according to local practice, although anterior ethmoidectomy was mandatory,” they noted. “Primary and safety analyzes were performed on an intention-to-treat (ITT) basis.”
The primary outcome assessed was disease-specific HRQoL at 12 months follow-up, measured with the validated Sinonasal Outcome Test 22 (SNOT-22), in which each item is scored from 0 to 5 based on severity with a total score of 0 to 110 points. The minimum clinically important difference in SNOT-22 was identified at 9.0 points.
Of the 238 patients eligible for analysis, 121 were randomly assigned to ESS plus medical therapy and 117 received medical therapy alone, with 234 included in the baseline ITT population (ESS plus medical therapy, n = 118; medical treatment, n = 116).
After 12 months, 103 patients who received ESS plus medical treatment and 103 treated with medical treatment alone were analyzed for the primary outcome. The 12-month follow-up results showed that the mean (SD) SNOT-22 score was 27.9 (20.2) in the ESS plus medical treatment group and 31.1 (20.4) in the treatment group. medical, with an adjusted mean difference of -4.9 (95% CI, -9.4 to -0.4) in favor of ESS plus medical treatment.
“ESS plus medical therapy is more effective than medical therapy alone in patients with CRSwNP, although the minimal clinically important difference was not reached.”
Regarding safety, adverse events were similar between the groups, with the most common adverse events being cited as minor nosebleeds or gastrointestinal issues.
“Long-term follow-up data is needed to determine if the effect persists. The current results provide a basis for the further development of evidence-based guidelines.
Lourijsen ES, Reitsma S, Vleming M, et al. Endoscopic sinus surgery with medical therapy versus medical therapy for chronic rhinosinusitis with nasal polyps: a multicenter, randomized, controlled trial. Respir Med Lancet. Published online January 7, 2022. doi:10.1016/S2213-2600(21)00457-4