Randomised controlled trialindependent cross-checkabstract only checked★ key study I-ORG-07 in-depth review
Antibiotics instead of surgery for appendicitis
A Randomized Trial Comparing Antibiotics with Appendectomy for Appendicitis.
Overview
CODA Collaborative; Flum DR et al.. N Engl J Med 2020 · PMID 33017106 · DOI 10.1056/NEJMoa2014320
Antibiotics worked about as well for overall health at 30 days, but 29% still needed surgery within 90 days.
Does the study support the specific claim? Partly · Methodological quality: high
Plain-language summary
Study explained simply
- What did the researchers want to find out?
Appendicitis treatment
- How was the study done?
RCT
- How many people, animals or samples were studied?
1552
- What was actually found?
Antibiotics noninferior; many later surgeries
- How large was the observed effect?
29% appendectomy by 90 d
- What do the results mean in everyday life?
Surgery is not the only option, but appendicitis must be treated
- What are the study's limitations?
Unblinded
- What does it say about Elawady's specific claim?
Partly supports 'not always remove'
- Do the results apply to Germany and Europe?
Applicable
- What can explicitly not be concluded from this study?
Diet-based treatment
Scientific in-depth review
1. Full reference
- Authors
- CODA Collaborative; Flum DR et al.
- Journal
- N Engl J Med
- Year
- 2020
- Identifier
- PMID 33017106 DOI 10.1056/NEJMoa2014320
- Verification
- verified – PubMed efetch 2026-10-25
- Retracted
- no
- Corrections
- none
- Extent checked
- abstract only
- Conflicts of interest and funding
Funded by PCORI.
2. Research question
Antibiotics vs appendectomy for appendicitis
3. Study design and population
- Study design
- Randomised controlled trial – Pragmatic noninferiority RCT
- Country
USA
- Sample size
1552 adults (414 with appendicolith)
4. Methods and endpoints
- Exposure / intervention
10-day antibiotics
- Comparator
Appendectomy
- Endpoints
30-day EQ-5D; appendectomy and complications to 90 days
5. Actual results
- Results
Noninferior (difference 0.01). 29% of antibiotic group had appendectomy by 90 days (41% with appendicolith, 25% without). Complications 8.1 vs 3.5 per 100 (RR 2.28), driven by appendicolith (20.2 vs 3.6). Serious adverse events 4.0 vs 3.0 per 100.
- Absolute risks
not reported
- Authors' conclusion
Antibiotics noninferior on health status; nearly 3 in 10 had appendectomy by 90 days; appendicolith increases risk.
6. Strengths
- Large pragmatic RCT
7. Weaknesses
- Unblinded
- Short primary endpoint
8. Risk of bias
- Orienting tool
- RoB 2
- Type of assessment
- simplified assessment (abstract only)
- Full formal assessment
- no
- Overall risk of bias
- some concerns
9. Assessment of the statistical interpretation
10. Relevance to the specific claim
Shows that appendicitis can sometimes be treated without removal (antibiotics), but treatment is still required; relevant to C-ORG-17.
11. Independent contrary findings
12. Transferability to Germany and Europe
Applicable.
13. Overall methodological judgement
Supports non-operative option in selected patients.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | high |
| Risk of bias | some concerns |
| Precision of results | high |
| Directness | direct |
| Reproducibility | replicated |
| Consistency with the overall evidence | consistent |
| Regional transferability | high |
| Adequacy of the interpretation (by the archive) | not applicable |
14. Open questions
15. Linked fact checks
- No working organ should be removed (e.g., a thyroid with nodules that still functions); one should stay away from the scalpel, and Elawady is 'against any operation, including caesarean section'. – Studies contradicting or limiting the claim
- The appendix (like tonsils and adenoids) is removed far too readily from early childhood onward. – Studies supporting the claim