Investigators concluded that long-term data are needed regarding surgery, but confirmed it to be more efficacious than medical therapy alone.
A new investigation into the efficacy of endoscopic sinus surgery (ESS) for the treatment of chronic rhinosinusitis with nasal polyps confirmed that the operation was more efficacious than medical therapy alone.
However, the minimal clinically important difference between the 2 treatment methods was not met.
Marleen Vleming, PhD, Department of Otorhinolaryngology, Flevohospital, Almere, Netherlands, and fellow investigators noted that ESS had been a common operation for patients affected by chronic rhinosinusitis with nasal polyps in instances when medical therapy is deemed insufficient.
Despite this, no prior trials had confirmed the efficacy of the operation, which prompted Vleming and investigators to conduct an open-label, multi-center, randomized controlled trial to assess the efficacy of the procedure compared to medical therapy.
The trial was conducted in 3 tertiary care centers and 12 secondary care centers across 11 cities in the Netherlands and included adult patients 18 years and older with chronic rhinosinusitis with nasal polyps and an indication for endoscopic sinus surgery.
Between February 15, 2015, and August 27, 2019, a total of 371 affected patients were screened for eligibility, 238 of whom were deemed eligible before being randomly assigned to ESS plus medical therapy (121).
From there, 117 patients were assigned to the medical therapy group.
For patients in the ESS group, the procedure was performed according to local practice, with anterior ethmoidectomy being deemed mandatory. Medical therapy was prescribed at the patient’s otorhinolaryngologist’s discretion, and could include nasal corticosteroids, nasal rinsing, systemic corticosteroids, or systemic antibodies.
Investigators established the primary outcomes as disease-specific health-related quality of life (HRQoL) at 12 months of follow up, which was measured with the validated Sinonasal Outcome Test (SNOT-22). The minimal clinically important difference of the SNOT-22 was 9 points.
Lastly, primary and safety analyses were performed on an intention-to-treat (ITT) basis.
Overall baseline characteristics were similar between intervention groups, with the baseline mean SNOT-22 score being 51.2. Howecer, a lower proportion of patients in the ESS plus medical therapy group had exacerbation of chronic rhinosinusitis that were more severe than the medical therapy group.
At 12 months follow-up, investigators observed that the mean SNOT-22 score in the ESS plus medical therapy group was 27.9(SD 20·2; n=103). The mean score for the medical therapy group was 31·1 (20·4; n=103), with an adjusted mean difference of –4·9 (95% CI –9·4 to –0·4) that favored ESS plus medical therapy.
At the end of the trial, investigators reported that patients assigned to the ESS plus medical therapy group scored better than patients assigned to medical therapy on disease specific HRQoL using the SNOT-22, though the minimal clinically important difference was not met.
Despite this, Vleming and colleagues considered the main strength of their trial to be the first randomized controlled trial to gather evidence on the efficacy of ESS plus medical therapy, one that included measurement of disease-specific HRQoL with SNOT-22.
They added that most of their data on general nasal symptoms and control of chronic rhinosinusitis informed the benefits of surgery at 3 months, 6 months, and 12 months.
“The data from this trial provide a basis for further development of evidence-based guidelines on the treatment of CRSwNP,” the team wrote.
The study, "Endoscopic sinus surgery with medical therapy versus medical therapy for chronic rhinosinusitis with nasal polyps: a multicentre, randomised, controlled trial," was published online in The Lancet Respiratory Medicine.