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Clinical Trials Update | July 28, 2015
Amy Thompson, MD
A recent trial was unable to demonstrate noninferiority of antibiotics relative to surgery for the treatment of computed tomography–confirmed uncomplicated acute appendicitis (Salminen P et al. JAMA. 2015;313:2340-2348).
The trial randomly assigned 530 patients to receive either antibiotics or an appendectomy, and tracked patient outcomes 1 year after intervention. Those in the antibiotic group received 3 days of intravenous ertapenem followed by 7 days of oral levofloxacin and metronidazole. Nearly all (99.6%) of the patients in the surgical group underwent successful appendectomy. Of those randomized to receive antibiotics, 27.3% underwent appendectomy within 1 year of their initial presentation. In an intention-to-treat analysis, the success rates between treatment groups differed by −27%, falling short of the prespecified minimal clinically important difference of 24% indicating noninferiority of the antibiotic intervention.
However, an accompanying editorial drew attention to the fact that 73% of patients who were randomized to the antibiotic group were successfully treated without surgery, and those in the antibiotic group who later underwent appendectomy did not experience major complications, suggesting it may be time to rethink appendectomy as the first-line treatment for uncomplicated acute appendicitis (Livingston E and Vons C. JAMA. 2015;313:2327-2328).