The Efficacy of Dexamethasone Versus N-Acetylcysteine in Prevention of Post-Embolization Syndrome in Hepatocellular Carcinoma Patients: A Multicenter Randomized, Double-Blind, Double-Dummy, Non-Inferiority Trial.
Padungkeat Karasin, Kittithat Tantitanawat, Chanchai Charonpongsuntorn et al.
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In 30 seconds
This Phase 3, multicenter, randomized, double-blind, double-dummy non-inferiority trial compared a single intravenous 8 mg dose of dexamethasone (DEX) with N-acetylcysteine (NAC) to prevent post-embolization syndrome (PES) after transcatheter arterial chemoembolization in patients with early- to intermediate-stage hepatocellular carcinoma. Among 85 patients included in the outcome analysis, PES incidence was non-inferior between groups (difference proportion DEX-NAC 0.02, [95% CI: -0.13 to 0.17]). At 48 hours, DEX was associated with greater reductions in abdominal pain and fever, and less liver decompensation than NAC.
Key findings
- PES incidence was non-inferior between groups (difference proportion DEX-NAC 0.02, [95% CI: -0.13 to 0.17]).
- Abdominal pain reduction was greater with DEX than NAC (87.5% vs. 55.3%, p = 0.002), as was fever reduction (52.5% vs. 28.9%, p = 0.035).
- Liver decompensation reduction was greater with DEX than NAC (90% vs. 52.6%, p < 0.001).
- Anaphylactoid reactions (18.4%) occurred exclusively in the NAC group.
Why it matters
PES and related symptoms are common concerns after TACE. This trial suggests that, although overall PES incidence was comparable, the two preventive regimens may differ in symptom outcomes and liver decompensation at 48 hours. The findings add comparative evidence for periprocedural management, while the trial population and short assessment window limit how broadly the results can be applied.
What to keep in mind
The outcome analysis included 85 patients, and reported outcomes were assessed at 48 hours; longer-term effects are not provided in the abstract.