Treatment of acute intracerebral haemorrhage with a Chinese herbal formula (Shengdi Dahuang Decoction): a multicentre, double-blind, randomised, placebo-controlled trial.

Importance: Per preliminary studies, Shengdi Dahuang Decoction (SDD) is potentially effective for acute intracerebral haemorrhage (ICH); however, its effectiveness has not been rigorously assessed in extensive randomised clinical trials.

Objective: To evaluate whether SDD can improve 90-day functional outcomes in patients with ICH.

Design: Randomised, double-blind, placebo-controlled clinical trial included patients with acute ICH within 4 hours of symptom onset at five hospitals in Shanghai, China.

Interventions: Patients were randomised 1:1 to receive either SDD granules (each sachet contained 15 g of raw Rehmannia glutinosa and 5 g of raw rhubarb) or placebo granules orally or via a nasogastric tube (as soon as possible within 12 hours of onset, two times daily for 7 days), in addition to ICH guideline-directed treatments. Per our preclinical study, SDD reduces inflammatory injury after ICH in rats.

Main outcomes: The primary outcome measure was the proportion of patients with a score ranging 0-1 on the modified Rankin Scale (mRS) on the 90th day.

Results: Of the total 1211 participants with cerebral haemorrhage assessed for eligibility, 483 were enrolled. Of this, 242 participants were randomly assigned to receive SDD granules and 241 to receive placebo granules (mean age, 62.7 years; 72.9% male). Among these, 112 (46.3%) and 84 (34.9%) patients in the SDD and placebo groups, respectively, had an mRS score of 0-1 on the 90th day (adjusted relative risk 1.20, 95% CI 1.00 to 1.43; p=0.046) . The proportion of patients with poor clinical outcomes (mRS score of 5 or 6 at 90 days) was higher in the placebo group (11.2%) than in the SDD group (5.4%) (p=0.021). The 90-day mortality rate (p=0.299), 7-day National Institute of Health Stroke Scale score (p=0.583), 7-day Glasgow Coma Scale score (p=0.577), 24-hour haematoma enlargement rate (p=0.675) or 7-day relative perihaematomal oedema did not significantly differ (p=0.343) between the groups. The incidence of adverse events between the two groups did not differ significantly (p>0.05).

Conclusions: In patients with acute ICH, incorporating SDD as a supplementary intervention alongside guideline-directed treatments may help enhance 90-day functional outcomes; however, more clinical trials are required to further prove its efficacy.

Trial registration number: NCT04200781.