Randomised controlled trialindependent cross-checkfull text checked★ key study I-INS-113 in-depth review
A small Chinese trial of dexamethasone in ketoacidosis with pancreatitis
Clinical efficacy of dexamethasone on diabetic ketoacidosis complicated with acute pancreatitis: A randomized controlled study.
Overview
Zhang J et al.. Medicine (Baltimore) 2023 · PMID 37832092 · DOI 10.1097/MD.0000000000035320
The trial reported better results with dexamethasone, but its numbers are physiologically implausible and it did not replace insulin and fluids.
Does the study support the specific claim? No · Methodological quality: very low
Plain-language summary
Study explained simply
- What did the researchers want to find out?
Test dexamethasone in DKA with acute pancreatitis.
- How was the study done?
Single-centre randomised trial.
- How many people, animals or samples were studied?
106 patients.
- What was actually found?
Reported better labs and fewer adverse events with dexamethasone.
- How large was the observed effect?
Glucose 9.5 vs 14.6 mmol/L (reported).
- What do the results mean in everyday life?
This does not show that cortisone can treat ketoacidosis.
- What are the study's limitations?
Implausible pH data; unclear methods; no registration.
- What does it say about Elawady's specific claim?
Cannot support steroid-only treatment of DKA.
- Do the results apply to Germany and Europe?
Not applicable.
- What can explicitly not be concluded from this study?
Cannot be used to change DKA treatment.
Scientific in-depth review
1. Full reference
- Authors
- Zhang J et al.
- Journal
- Medicine (Baltimore)
- Year
- 2023
- Identifier
- PMID 37832092 DOI 10.1097/MD.0000000000035320
- Verification
- verified – PubMed efetch 2026-10-26; Crossref 2026-10-26
- Retracted
- no
- Corrections
- none
- Extent checked
- full text
- Conflicts of interest and funding
No conflicts declared; funding not stated.
2. Research question
Does dexamethasone improve DKA complicated by acute pancreatitis?
3. Study design and population
- Study design
- Randomised controlled trial – Single-centre randomised placebo-controlled trial (random number table)
- Population
Adults with DKA plus acute pancreatitis (55 T1D, 51 T2D)
- Country
China (Wuxi)
- Period
2020-2022
- Sample size
106 (53 per group)
- Inclusion and exclusion criteria
pH <7.32 or HCO3 <15, glucose >=16.7 mmol/L, ketone >=5 mmol/L, imaging-confirmed severe pancreatitis
4. Methods and endpoints
- Exposure / intervention
Dexamethasone 5 mg IV daily for 7 days plus 'symptomatic treatment such as fluid replacement and maintaining acid-base balance'
- Comparator
Placebo (normal saline) plus the same symptomatic treatment
- Endpoints
Laboratory values, symptoms, adverse events
- Statistical methods
t-tests and chi-square; sample-size formula given
5. Actual results
- Results
After treatment glucose 9.52 vs 14.62 mmol/L, pH 7.43 vs 7.00, adverse events 17.0% vs 58.5% (dexamethasone vs placebo). Baseline venous pH reported as 6.49 +/- 0.52 and 6.45 +/- 0.48, and serum sodium 153 mmol/L; insulin use is not described in the methods. Retraction/correction: none found (PubMed, Crossref).
- Absolute risks
not reported
- Authors' conclusion
Dexamethasone has a good clinical effect on DKA patients complicated with acute pancreatitis.
6. Strengths
- Randomised design stated
- Full text available
7. Weaknesses
- Single centre, two authors, no trial registration reported
- Blinding and allocation concealment not described
- Physiologically implausible data: mean baseline pH 6.45-6.49 with SD about 0.5 (implies about half of patients below pH 6.5), post-treatment SD 0.58
- Baseline inclusion required pH <7.32, yet the reported distribution implies values above 7.45 in some patients
- Glucose fell more with dexamethasone, contrary to the well-established hyperglycaemic effect of glucocorticoids
- Co-treatment (insulin) not described
8. Risk of bias
- Orienting tool
- RoB 2
- Type of assessment
- simplified assessment (abstract only)
- Full formal assessment
- no
- Overall risk of bias
- high
- Rationale
Unclear randomisation/concealment, no blinding description, no registration, implausible data; results cannot be relied on.
9. Assessment of the statistical interpretation
Recalculation (stats/C-INS-08_zhang2023_plausibility.py): with the reported mean and SD, about 51-54% of patients would have pH <6.5 and about 17% <6.0, which is far outside reported DKA series; the data are not credible as reported.
10. Relevance to the specific claim
The only randomised study found in an honest search for steroid benefit in DKA. It concerns DKA with pancreatitis, gave dexamethasone on top of standard treatment, and has implausible data; it does not support steroids instead of insulin and fluids.
11. Independent contrary findings
2024 hyperglycaemic crises consensus (I-INS-07) and ADA 2026 (I-INS-130): glucocorticoids raise glucose and can precipitate crises.
12. Transferability to Germany and Europe
Not transferable; not reflected in any guideline.
13. Overall methodological judgement
Very low-quality, implausible trial; does not support the claim.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | very low |
| Risk of bias | high |
| Precision of results | low |
| Directness | indirect |
| Reproducibility | not replicated |
| Consistency with the overall evidence | inconsistent |
| Regional transferability | low |
| Adequacy of the interpretation (by the archive) | not applicable |