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Wednesday, June 17, 2015

Trial Compares Antibiotics vs Appendectomy for Treatment of Appendicitis

JAMA: Among patients with uncomplicated appendicitis, antibiotic treatment did not meet a prespecified level of effectiveness compared with appendectomy, although most patients who received antibiotic therapy did not require an appendectomy, and for those who did, they did not experience significant complications, according to a study in the June 16 issue of JAMA.

Appendectomy has been the standard treatment for acute appendicitis for over a century. More than 300,000 of these procedures are performed annually in the United States. Although appendectomy is generally well tolerated, it is a major surgical intervention and can be associated with postoperative complications. An increasing amount of evidence supports the use of antibiotics instead of surgery for treating patients with uncomplicated acute appendicitis, according to background information in the article.

Paulina Salminen, M.D., Ph.D., of Turku University Hospital, Turku, Finland, and colleagues randomly assigned 530 patients with uncomplicated acute appendicitis (confirmed by a computed tomography [CT] scan) to receive antibiotic therapy for 10 days or a standard appendectomy. The researchers tested the hypothesis that antibiotic treatment was noninferior (not worse than) to appendectomy, and assumed that there would be sufficient benefits from avoiding surgery and that a 24 percent failure rate in the antibiotic group would be acceptable.

Of the 273 patients randomized to the surgical group, all but 1 underwent successful appendectomy, resulting in a success rate of 99.6 percent. Of the 256 patients available for 1-year follow-up in the antibiotic group, 186 (72.7 percent) did not require appendectomy. Seventy patients (27.3 percent) in the antibiotic group underwent surgical intervention within 1 year of initial presentation for appendicitis. The intention-to-treat analysis yielded a difference in treatment efficacy between groups of -27.0 percent. Given the prespecified noninferiority margin of 24 percent, the researchers were unable to demonstrate noninferiority of antibiotic treatment relative to surgery.

There were no intra-abdominal abscesses or other major complications associated with delayed appendectomy inpatients assigned to antibiotic treatment.

“Antibiotic treatment of patients with uncomplicated acute appendicitis was not shown to be noninferior to appendectomy for uncomplicated appendicitis within the first year of observation following initial presentation of appendicitis. Nevertheless, the majority (73 percent) of patients with uncomplicated acute appendicitis were successfully treated with antibiotics,” the authors write. “These results suggest that patients with CT-proven uncomplicated acute appendicitis should be able to make an informed decision between antibiotic treatment and appendectomy. Future studies should focus both on early identification of complicated acute appendicitis patients needing surgery and to prospectively evaluate the optimal use of antibiotic treatment in patients with uncomplicated acute appendicitis.”
(doi:10.1001/jama.2015.6154; Available pre-embargo to the media at http://media.jamanetwork.com)