Patients with chronic rhinosinusitis with nasal polyps were found to benefit more from the combination of endoscopic sinus surgery plus medical therapy vs medical therapy alone, although the minimal clinically important difference was not met.
Endoscopic sinus surgery (ESS) plus medical therapy may be more effective vs medical therapy alone in the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP), according to study findings published in The Lancet Respiratory Medicine.
Typically performed when patients with CRSwNP are unresponsive to medical therapy alone, ESS has been shown in prior research to significantly improve symptoms and health-related quality of life (HRQOL). However, more than 1 in 5 patients (20%–30%) have been indicated to require revision ESS after 5 to 10 years.
“Large variations in the management of CRSwNP exist both between and within countries and among individual specialists, which can lead to inefficient and inappropriate care,” said the study authors. “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 of the most important knowledge gaps in otorhinolaryngology.”
With no randomized controlled trials having explored the efficacy of ESS, they conducted an open-label, multi-center, pragmatic, randomized, controlled trial to compare treatment outcomes of ESS plus medical therapy vs 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 February 15, 2015 and August 27, 2019. Participants were randomly assigned at a 1:1 ratio to receive either ESS plus medical therapy or medical therapy alone, such as nasal corticosteroids, nasal rinsing, systemic corticosteroids, or systemic antibiotics.
“ESS was performed according to local practice, although anterior ethmoidectomy was mandatory,” they noted. “Primary and safety analyses were performed on an intention-to-treat (ITT) basis.”
The primary outcome assessed was disease-specific HRQOL at 12 months of 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 minimal clinically important difference of the 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 were given medical therapy alone, with 234 included in the baseline ITT population (ESS plus medical therapy, n = 118; medical therapy, n = 116).
After 12 months, 103 patients given ESS plus medical therapy and 103 treated with medical therapy alone were analyzed for the primary outcome. Findings of the 12-month follow-up showed that the mean (SD) SNOT-22 score was 27.9 (20.2) in the ESS plus medical therapy group and 31.1 (20.4) in the medical therapy group, with an adjusted mean difference of –4.9 (95% CI, –9.4 to –0.4) favoring ESS plus medical therapy.
“ESS plus medical therapy is more efficacious than medical therapy alone in patients with CRSwNP, although the minimal clinically important difference was not met.”
Regarding safety, adverse events were similar between the groups, with the most common adverse events cited as minor epistaxis or gastrointestinal problems.
“Long-term follow-up data are needed to determine whether the effect persists. The current results are a basis for 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 multicentre, randomised, controlled trial. Lancet Respir Med. Published online January 7, 2022. doi:10.1016/S2213-2600(21)00457-4