A Randomized Trial Comparing Antibiotics with Appendectomy for Appendicitis.
The New England journal of medicine
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 ClinicalTrials.gov number, NCT02800785.).
Flum, David R; Davidson, Giana H; Monsell, Sarah E; Shapiro, Nathan I; Odom, Stephen R; Sanchez, Sabrina E; Drake, F Thurston; Fischkoff, Katherine; Johnson, Jeffrey; Patton, Joe H; Evans, Heather; Cuschieri, Joseph; Sabbatini, Amber K; Faine, Brett A; Skeete, Dionne A; Liang, Mike K; Sohn, Vance; McGrane, Karen; Kutcher, Matthew E; Chung, Bruce; Carter, Damien W; Ayoung-Chee, Patricia; Chiang, William; Rushing, Amy; Steinberg, Steven; Foster, Careen S; Schaetzel, Shaina M; Price, Thea P; Mandell, Katherine; Ferrigno, Lisa; Salzberg, Matthew; DeUgarte, Daniel A; Kaji, Amy H; Moran, Gregory J; Saltzman, Darin; Alam, Hasan B; Park, Pauline K; Kao, Lillian S; Thompson, Callie M; Self, Wesley H; Yu, Julianna T; Wiebusch, Abigail; Winchell, Robert J; Clark, Sunday; Krishnadasan, Anusha; Fannon, Erin; Lavallee, Danielle C; Comstock, Bryan A; Bizzell, Bonnie; Heagerty, Patrick J; Kessler, Larry G; and Talan, David A, "A Randomized Trial Comparing Antibiotics with Appendectomy for Appendicitis." (2020). Articles, Abstracts, and Reports. 3900.