Chinese medicine herbal compound of no benefit in intracerebral haemorrhage

In the treatment of patients with moderate to severe intracerebral haemorrhage, the traditional Chinese medicine herbal compound FYTF-919 has no significant effect on functional recovery, survival, and health-related quality of life, as shown in a study.

Researchers conducted a pragmatic, multicentre, randomised, double-blind, placebo-controlled trial. They enrolled adults with symptomatic spontaneous intracerebral haemorrhage within 48 hours after the onset of symptoms, which led to moderate to severe neurological impairment (National Institute of Health Stroke Scale scores of at least 8 or Glasgow Coma Scale score of between 7 and 14).

A total of 1,648 patients were randomly assigned to receive 33 mL (or 25 mL via a nasogastric tube if a participant’s swallowing was impaired) of either oral liquid FYTF-919 (n=817) or matching placebo (n=831), administered at least 30 minutes after a meal every 8 hours (or 6 hours via nasogastric tube) over 24 hours. Treatment lasted for 28 days. The primary efficacy outcome was the utility weighted modified Rankin Scale (higher scores indicating a better outcome according to the participants’ perspective) at 90 days.

The intention-to-treat population comprised 1,641 patients, including 815 in the FYTF-919 group and 826 in the placebo group. Three-fourths of the population (75.7 percent) consumed at least 80 percent of the study medication, and 60.6 percent consumed all of it within 28 days.

Mean utility weighted modified Rankin Scale scores at 90 days did not significantly differ between the FYTF-919 and the placebo group (difference, 0.01, 95 percent confidence interval, −0.02 to 0.04; p=0.63). The null association persisted in adjusted and sensitivity analyses.

The incidence of serious adverse events was similar between the two treatment groups.