The story gets generally good marks from us with a couple of provisos. We liked the balanced discussion of the results and the physician comments in the story. Unfortunately, the headline is overly enthusiastic in its description of the study results. There was an important omission: the story did not report that the study actually failed in its primary objective to demonstrate that antibiotic therapy was as good as appendectomy.
The gold standard treatment for appendicitis has been appendectomy. In recent years, the laparoscopic (minimally invasive) approach has largely replaced the open surgery. As a result, most patients leave the hospital the day after laparoscopic surgery and have a brief recuperation period. The surgery itself has been shown to be very safe with few complications. Having said that, it is still surgery. CT diagnosis has renewed interest in the use of antibiotics to treat appendicitis, because the images allow doctors to more confidently diagnose uncomplicated appendicitis. At the moment, the American College of Surgeons, Society for Surgery of the Alimentary Tract and the World Society of Emergency Surgery all consider appendectomy to be the treatment of choice for appendectomy. Although the story does provide a reasonably balanced review of the study results, we are troubled by the enthusiasm portrayed in the headline. As noted by Dr. Wray,”The high failure rate of antibiotic therapy suggests that it is not ready for the clinic. I think we need to determine who are really the candidates for this type of nonoperative therapy.”
While the story does mention cost, it passes along a claim that isn’t necessarily true. The only mention of costs was the potential for cost savings, but there was no mention of the costs associated with 27% of the subjects having to undergo surgery in addition to the antibiotic therapy. Nor was there any consideration of additional monitoring or complications from antibiotic treatment (which can include serious antibiotic resistant infections requiring hospitalization).
The story provided the reader with an insightful discussion of the benefits of antibiotics only for uncomplicated appendicitis, pointing out that 73% of the participants who received antibiotics did not undergo subsequent appendectomy, and thus avoided pain and recovery time. It also included comments about the 27% of those patients who failed antibiotic treatment and underwent an appendectomy. We would have liked to have seen the actual numbers provided rather than simply the percentages. The 73% was 186 of 256, and the 27% was 70 of 256.
Having said that there are some important provisos to the story. It never mentions that the study did not meet the researcher’s cutoff line for comparing the two treatment, so according to their protocol actually the study failed to demonstrate that antibiotics were as good as surgery. As the authors concluded: “Among patients with CT-proven, uncomplicated appendicitis, antibiotic treatment did not meet the prespecified criterion for noninferiority compared with appendectomy.” This statement hardly matches the headline of the CNN story, “Surgery-free option for appendicitis could become the norm.”
The harms were appropriately explained, especially by the study’s author who mentioned antibiotic resistance, which is a significant concern of the public. As noted above, the story does report the percentage of patients originally treated with antibiotics who had to have surgery anyway within one year. The comments from Dr. Wray and those of the senior author Dr. Salminen point to the downside of antibiotics in this context. We appreciate the article concluding with the caveats of the antibiotic treatment, so the reader is aware that more studies will be needed before the procedure is implemented in practice.
This story gives readers a good summary of the study design and results. However, until the eighth paragraph the story makes it seem as though antibiotics are on the verge of replacing appendectomies for many cases. Only deep in the story are readers told that what this study really calls for is a serious re-examination of standard practice – which will require many years and many, many more patients, as well as a study design that captures all the costs and problems associated with antibiotics. The headline and lead paragraph should have alerted readers that this study is a first step only.
No disease mongering here.
The story provides comments from the senior author of the paper as well as the balanced comments of Dr. Wray.
But the story doesn’t mention that the senior author (Dr. Salminen) disclosed speaking fees from Merck and Roche. Readers should have been told about this relationship and that Merck sells the IV antibiotic (ertapenem, brand name Invanz) that was the primary drug in this study.
We believe that such potential conflicts of interest should be reported by journalists. And it’s especially difficult to understand why they aren’t in a case like this where the financial relationship was disclosed by the author.
The story clearly reports that the study directly compared antibiotic treatment to standard appendectomy… and that with a laparoscopic (minimally invasive) procedure, patients typically go home the same day. The story could have been better if it had pointed out that all the surgery patients in the study underwent the older, open procedure, so it did not include the minimally invasive procedure that is common in the US.
The story indirectly provides the reader with the notion that both approaches are generally available. However, the story would have been clearer if it pointed out the antibiotics used in the study are currently available, meaning that a doctor and patient could choose to use antibiotic treatment for appendicitis now, although it is not considered standard therapy.
So often, stories like this attempt to place a research protocol into its own unique position. We liked the fact that earlier research was mentioned and the issue of antibiotic or appendectomy has been looked at many times over the years. While this study is not groundbreaking, it does add to the growing body of information on the topic and makes it clear that additional research is needed to better define which patients might be best suited for an approach.
Given the comments of Dr. Wray and Dr. Salimen, it is clear that the story was not based solely on a press release.