Reference: Lancet Respir Med. 2022 Jan 7 early online
Chronic rhinosinusitis plagues as many as 12% of adults, resulting in bothersome symptoms such as congestion and loss of smell. Medical therapy with intranasal corticosteroids, saline rinses, and intermittent oral antibiotic or steroid use has variable effectiveness. One in 5 individuals with chronic rhinosinusitis has nasal polyps (CRSwNP). For patients with ongoing symptoms, endoscopic sinus surgery (ESS) has become increasingly popular despite limited evidence of effectiveness from observational studies and a high rate of recurrence and revision.
Investigators in the Netherlands conducted an unblinded, randomized trial to compare ESS plus medical therapy to medical therapy alone in 234 adults with CRSwNP presenting to their otolaryngologist. Medical therapy was left to the discretion of the treating otolaryngologist and included typical intranasal therapy and intermittent systemic antibiotics and/or glucocorticoids. Disease-specific quality of life, as rated by the mean Sino-Nasal Outcome Test- 22 (SNOT-22) score (range 0-110, higher scores being worse) was similar at baseline (51.9 vs. 50.5 in ESS vs. medical group, respectively). In the ESS group, 90% of participants underwent ESS and were included in final analysis (n=109). In the medical therapy group, 21% (23/110) crossed over into the ESS arm of trial.
In an intention to treat analysis at 12 months of follow-up, there was a statistically significant improvement in mean SNOT-22 score in the ESS group compared with the medical therapy alone group (27.9 vs. 31.1, adjusted mean difference -4.9, 95% CI -9.4 to -0.4 favoring ESS). This did not meet the prespecified minimal clinically important difference of 9.0 points. Rates of most bothersome symptoms, including anosmia and postnasal drip, were similar at 12 months. In a safety analysis, there were three serious adverse events, including one stroke shortly after surgery, one cardiac arrest immediately postoperatively, and two orbital wall injuries in the ESS group. There was one myocardial infarction over the 12 months in the medical therapy group. Rates of antibiotic prescription were similar between groups, but fewer total systemic steroids were prescribed in the ESS group as compared with the medical therapy group (265.5 mg vs. 589 mg, respectively).
At first glance, this trial appears to demonstrate that endoscopic sinus surgery improves quality of life related to sinus disease at 12 months, but the magnitude of benefit for ESS appears very small relative to the potential risks. This includes the risk to the surgeon as ESS is the most common reason for malpractice claims against otolaryngologists. This trial highlights the importance of setting and sticking to a prespecified minimal clinically important difference. A 5-point difference on a 110-point scale often means very little. In an as-treated analysis to account for the relatively high rate of crossover, the difference in SNOT-22 scores was only 5.8 points in favor of ESS. Additionally, all surgeries represent a risk, as evidenced by the perioperative complications in the ESS arm of the trial. Based on the body of available evidence on this topic, it may be best to just keep rinsing.
For more information, see the topic Chronic Rhinosinusitis in DynaMed.
DynaMed EBM Focus Editorial Team
This EBM Focus was written by Carina Brown, MD, Assistant Professor at Cone Health Family Medicine Residency. Edited by Alan Ehrlich, MD, Executive Editor at DynaMed and Associate Professor in Family Medicine at the University of Massachusetts Medical School; Katharine DeGeorge, MD, MS, Deputy Editor at DynaMed and Associate Professor of Family Medicine at the University of Virginia; Dan Randall, MD, Deputy Editor at DynaMed; Nicole Jensen, MD, family physician at WholeHealth Medical; Vincent Lemaitre, PhD, Senior Medical Writer at DynaMed; and Sarah Hill, MSc, Associate Editor at DynaMed.