Standardized Acupuncture Plus Modified Xiaoxuming Decoction for Acute Ischemic Stroke: A Randomized Controlled Trial.
Zhiqiang Huang, Bo Wang, Zhen Chen et al.
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In 30 seconds
This single-center, assessor-blinded randomized controlled trial enrolled adults with imaging-confirmed acute ischemic stroke within 72 hours and compared standard care with or without standardized acupuncture plus modified Xiaoxuming Decoction for 28 days. In the 128 participants, the intervention group had a lower adjusted day-28 NIHSS score (adjusted difference: -1.30 points; 95% confidence interval: -2.36 to -0.24; P = 0.017). Day-28 Barthel Index and selected inflammatory and gut biomarkers also differed, but day-90 clinical outcomes did not differ significantly. The biomarker findings were exploratory and did not establish a causal brain-gut pathway.
Key findings
- Adjusted day-28 NIHSS was lower with the combined intervention (adjusted difference: -1.30 points; 95% confidence interval: -2.36 to -0.24; P = 0.017).
- Day-28 Barthel Index was higher in the intervention group, while day-90 NIHSS, Barthel Index, and observed mRS 0-2 did not differ significantly.
- At day 28, the intervention group had higher Shannon diversity and fecal butyrate, and lower interleukin-6 and LPS.
- No intervention-related serious adverse event was identified; participant-level biomarker changes were not significantly associated with NIHSS change.
Why it matters
The trial reports a modest early neurological difference when acupuncture and modified Xiaoxuming Decoction were added to standard care, alongside changes in selected gut and inflammatory measures. The lack of significant differences in reported day-90 clinical outcomes and the absence of an association between biomarker changes and NIHSS change temper interpretation. These results help distinguish an early clinical signal from evidence of durable benefit or a demonstrated biological mechanism.
What to keep in mind
The trial was single-center, and the biomarker findings were exploratory. Day-90 clinical outcomes did not differ significantly, and biomarker changes were not significantly associated with NIHSS change.