Lancet study finds FYTF-919 has no overall effect on hemorrhage recovery

A clinical trial published in The Lancet on November 12, 2024, evaluated the traditional Chinese medicine herbal remedy FYTF-919 against a placebo for patients with acute intracerebral hemorrhage, finding no overall improvement in functional recovery while identifying potential benefits in specific patient subgroups. This publication was the first in its 200-year history to feature a multicenter clinical trial on Chinese herbal medicine led by Chinese teams, supplying data on traditional remedies for acute neurological emergencies.

CHAIN Study Tests Herbal Treatment Across 26 Hospitals

The trial, designated as the CHAIN study, operated under the joint leadership of Guo Jianwen from the Guangdong Provincial Hospital of Chinese Medicine alongside Song Lili and Craig Anderson from Fudan University. Researchers employed a multicenter, placebo-controlled design to assess the herbal treatment, also known as Zhongfeng Xingnao, across 26 hospitals spanning 12 provinces in China. The study enrolled 1,641 patients who had suffered spontaneous intracerebral hemorrhage and could begin treatment within a 48-hour window following the event. Participants received either FYTF-919 or a placebo administered orally or nasally for a duration of 28 days, with structured follow-up assessments scheduled at 90 and 180 days.

FYTF-919 Shows No Significant Effect on Functional Recovery

Across the entire cohort of 1,641 participants, the evaluation revealed that FYTF-919 did not produce a statistically significant effect on functional recovery. The analysis detected no measurable improvements in survival rates or health-related quality of life among the treated individuals compared to the control group. Regarding safety, the trial established that the frequency and types of adverse events showed no significant differences between the herbal treatment arm and the placebo group, demonstrating comparable tolerability over the 28-day administration period.

Subgroup Results for Larger Hemorrhages

Despite the absence of an overall therapeutic effect, a detailed subgroup analysis uncovered distinct signals in specific patient categories. A potential treatment benefit emerged among patients presenting with a hemorrhage volume exceeding 15 milliliters, as well as among individuals with lobar hemorrhages. Within these specific subsets, the intervention demonstrated a positive influence on the functional independence of affected patients at the 90-day mark.

Modern Clinical Standards Evaluate Traditional Healing Methods

Within evidence-based medicine, the scientific review of traditional healing methods using modern clinical standards is regarded as a central step for their worldwide evaluation.