A Randomized Trial Comparing Antibiotics with Appendectomy for Appendicitis

David R Flum, Giana H Davidson, Sarah E Monsell, Nathan I Shapiro, Stephen R Odom, Sabrina E Sanchez, F Thurston Drake, Katherine Fischkoff, Jeffrey Johnson, Joe H Patton, Heather Evans, Joseph Cuschieri, Amber K Sabbatini, Brett A Faine, Dionne A Skeete, Mike K Liang, Vance Sohn, Karen McGrane, Matthew E Kutcher, Bruce Chung, Damien W Carter, Patricia Ayoung-Chee, William Chiang, Amy Rushing, Steven Steinberg, Careen S Foster, Shaina M Schaetzel, Thea P Price, Katherine A Mandell, Lisa Ferrigno, Matthew Salzberg, Daniel A DeUgarte, Amy H Kaji, Gregory J Moran, Darin Saltzman, Hasan B Alam, Pauline K Park, Lillian S Kao, Callie M Thompson, Wesley H Self, Julianna T Yu, Abigail Wiebusch, Robert J Winchell, Sunday Clark, Anusha Krishnadasan, Erin Fannon, Danielle C Lavallee, Bryan A Comstock, Bonnie Bizzell, Patrick J Heagerty, Larry G Kessler, David A Talan
New England Journal of Medicine 2020 October 5

BACKGROUND: Antibiotic therapy has been proposed as an alternative to surgery for the treatment of appendicitis.

METHODS: We conducted a pragmatic, nonblinded, noninferiority, randomized trial comparing antibiotic therapy (10-day course) with appendectomy in patients with appendicitis at 25 U.S. centers. The primary outcome was 30-day health status, as assessed with the European Quality of Life-5 Dimensions (EQ-5D) questionnaire (scores range from 0 to 1, with higher scores indicating better health status; noninferiority margin, 0.05 points). Secondary outcomes included appendectomy in the antibiotics group and complications through 90 days; analyses were prespecified in subgroups defined according to the presence or absence of an appendicolith.

RESULTS: In total, 1552 adults (414 with an appendicolith) underwent randomization; 776 were assigned to receive antibiotics (47% of whom were not hospitalized for the index treatment) and 776 to undergo appendectomy (96% of whom underwent a laparoscopic procedure). Antibiotics were noninferior to appendectomy on the basis of 30-day EQ-5D scores (mean difference, 0.01 points; 95% confidence interval [CI], -0.001 to 0.03). In the antibiotics group, 29% had undergone appendectomy by 90 days, including 41% of those with an appendicolith and 25% of those without an appendicolith. Complications were more common in the antibiotics group than in the appendectomy group (8.1 vs. 3.5 per 100 participants; rate ratio, 2.28; 95% CI, 1.30 to 3.98); the higher rate in the antibiotics group could be attributed to those with an appendicolith (20.2 vs. 3.6 per 100 participants; rate ratio, 5.69; 95% CI, 2.11 to 15.38) and not to those without an appendicolith (3.7 vs. 3.5 per 100 participants; rate ratio, 1.05; 95% CI, 0.45 to 2.43). The rate of serious adverse events was 4.0 per 100 participants in the antibiotics group and 3.0 per 100 participants in the appendectomy group (rate ratio, 1.29; 95% CI, 0.67 to 2.50).

CONCLUSIONS: For the treatment of appendicitis, antibiotics were noninferior to appendectomy on the basis of results of a standard health-status measure. In the antibiotics group, nearly 3 in 10 participants had undergone appendectomy by 90 days. Participants with an appendicolith were at a higher risk for appendectomy and for complications than those without an appendicolith. (Funded by the Patient-Centered Outcomes Research Institute; CODA number, NCT02800785.).


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