Chinese Herbal Medicine in Patients With Acute Intracerebral Hemorrhage - CHAIN

Nov 25, 2024
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
Key-Area Research and Development Program of Guangdong Province
Date Published:
11/12/2024
Original Posted Date:
11/25/2024
References

Contribution To Literature:

The CHAIN trial failed to show that a traditional Chinese medicine is beneficial in patients with acute intracerebral hemorrhage.

Description:

The goal of the trial was to evaluate a traditional Chinese medicine (FYTF-919) compared with placebo among patients with acute intracerebral hemorrhage.

Study Design

  • Randomized
  • Parallel
  • Placebo
  • Double-blind

Patients with acute intracerebral hemorrhage were randomized to receive FYTF-919 every 8 hours (n = 817) vs. placebo (n = 831) for 28 days.

  • Total number of enrollees: 1,648
  • Duration of follow-up: 6 months
  • Mean patient age: 62 years
  • Percentage female: 35%
  • Percentage with diabetes: 8.5%

Inclusion criteria:

  • Patients ≥18 years of age
  • Acute intracerebral hemorrhage
  • Within 48 hours of symptom onset

Exclusion criteria:

  • Advanced dementia
  • Poor prognosis
  • Significant pre-stroke disability
  • Advanced cancer

Principal Findings:

The primary outcome, mean utility weighted modified Rankin Scale score at 90 days, was: 0.44 in the FYTF-919 group vs. 0.44 in the placebo group (difference 0.01, 95% confidence interval -0.02 to 0.04; p = 0.63).

Interpretation:

Among patients with acute intracerebral hemorrhage, a traditional Chinese medicine (FYTF-919) failed to provide benefit. FYTF-919 did not improve functional status compared with placebo. Outcomes were the same in various tested subgroups.

References:

Guo J, Chen X, Wu M, et al., for the CHAIN Investigators. Traditional Chinese Medicine FYTF-919 (Zhongfeng Xingnao Oral Prescription) for the Treatment of Acute Intracerebral Hemorrhage: A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Clinical Trial. Lancet 2024;Nov 12:[Epub ahead of print].

Clinical Topics: Prevention

Keywords: Cerebral Hemorrhage, Herbal Medicine, Drugs, Chinese Herbal, Secondary Prevention


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