Qingre Huatan Formula vs placebo for early neurological deterioration in acute ischemic stroke

This randomized double-blind placebo-controlled pilot study evaluated the Qingre Huatan Formula (QHF) in patients with acute ischemic stroke. The population consisted of 72 eligible patients who presented within 48 hours of symptom onset. The intervention involved initiating QHF within 48 hours of stroke onset and continuing treatment for 10 days. The comparator was a placebo treatment administered for the same 10-day duration.

The primary outcome measured was the proportion of early neurological deterioration (END) within 7 days of stroke onset, defined as an increase of ≥2 points in the National Institutes of Health Stroke Scale (NIHSS). Secondary outcomes included changes in NIHSS scores from baseline to 10 days and the proportion of patients achieving a good functional outcome, defined as a modified Rankin Scale score ≤2. The follow-up period extended to 90 days.

Specific numerical results for the primary and secondary outcomes were not reported in the available evidence. Safety and tolerability data, including adverse events, serious adverse events, discontinuations, and overall tolerability, were not reported. The study was published as a guideline, though the specific phase was not reported. Funding sources and conflicts of interest were not reported.

Key limitations include the small sample size of 72 patients and the pilot study design, which may limit generalizability. The absence of reported outcome data prevents a definitive assessment of efficacy or safety. Practice relevance is noted as potentially providing valuable evidence for traditional Chinese medicine in acute ischemic stroke, but current data is insufficient to support specific clinical recommendations.