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Antibiotics prove noninferior to surgery for appendicitis in large trial

New England Journal of Medicine
Reuters Health - 05/10/2020 - A 10-day course of antibiotics is as effective against appendicitis as traditional surgery, although less effective in patients with appendicolith, according to a new noninferiority trial.

With 1,552 randomized participants treated at 25 U.S. medical centers, the study is the largest appendicitis trial ever conducted.

At 30 days, quality-of-life scores were essentially identical whether a volunteer was placed in the antibiotics or appendectomy group, while patients in the antibiotic group missed less time at work and school.

When antibiotics were given, 29% of the patients ended up receiving surgery within 90 days anyway.

"But many of our patients were quick to point out there's a 7 in 10 chance of avoiding surgery," coauthor Dr. David Flum of the University of Washington School of Medicine, in Seattle, told Reuters Health by phone. "Some are going to say, get it over with, I don't want to have the risk. But a lot of others have to worry about copays, travel, work schedule or caregiver burdens" and will prefer the antibiotic option.

"We just can't assume it's for everybody," he said.

In addition, "47% of the patients treated with antibiotics were not hospitalized as part of their initial treatment, which is a pretty big deal for trying to avoid hospitals in the COVID era," said Dr. Flum.

The study was released Monday at the American College of Surgeons Clinical Congress annual meeting and online in The New England Journal of Medicine.

More than one in 20 Americans will develop appendicitis at some point in their lives, according to the National Institute of Diabetes and Digestive and Kidney Diseases. About 11.6 million cases occur worldwide each year, with about 50,000 deaths.

The outcomes in the new study, known as CODA, differed depending on whether patients had appendicolith.

The cumulative 90-day incidence of appendectomy among patients treated with antibiotics was 25% when appendicolith were absent and 41% in the group where stones were present.

"About 1 in 4 patients with appendicitis have appendicolith. We have never really understood the role those little stones in the base of the appendix play in treatment. We know people with them tend to have more severe forms of appendicitis," said Dr. Flum.

The six prior studies of antibiotic therapy "have excluded these patients. They wanted to see how antibiotics work in the patients most likely to benefit. We wanted to include them to help the average doctor and average patient make good decisions about care," he said.

Based on 30-day scores on the European Quality of Life-5 Dimensions questionnaire, the primary outcome, antibiotics were noninferior to appendectomy (mean difference, 0.01 points).

The likelihood that an appendectomy would eventually be required continued to grow over the 90 days of the study among patients who received antibiotic therapy. The trial will be following patients for three years.

Dr. Flum said the Finnish APPAC study published two years ago in JAMA showed that the cumulative need for appendectomy seems to level out to about 39% by the five-year mark.

The mean number of missed days at work was 5.26 with antibiotics and 8.73 with appendectomy, according to the new results.

The complication rate was twice as high with antibiotics, but nearly all of that increase was caused by patients with appendicolith receiving antibiotics instead of surgery. Drainage procedures were five times more common in the antibiotic group.

One thing that might surprise doctors: Only half of surgery patients reported being free of symptoms a week after surgery.

Symptoms were resolved within seven day for 46% of surgery patients when appendicolith were present versus 38% of patients treated with antibiotics. When appendicolith were absent, the rates were 51% and 53% respectively.

"There were three components to the question: Do you have right-side abdominal pain, do you have tenderness when you press on the right side of your belly, and do you have fever? If the patient said no to all those things they got a checkmark," Dr. Flum explained. "It only happened about half the time at a week and 70% at four weeks. We've never really asked this question of patients getting surgical care before. That's new information for surgeons. Frankly, we were surprised to find that after about a week it was the same in both groups."

"After surgery, there's still inflammation around the area where the appendix was. It's not unusual to have pain or tenderness after surgery," he said.

Ninety-six percent of appendectomies were done laparoscopically.

Based on the new findings, "I see a lot more antibiotic treatment in the future," said Dr. Flum. "But appendectomy is not going anywhere as a treatment option."

By Gene Emery

SOURCE: https://bit.ly/2EWq25I and https://bit.ly/3jBunKE The New England Journal of Medicine, online Oct. 5, 2020

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