Shengdi Dahuang Decoction Improves Functional Outcomes in Acute Intracerebral Hemorrhage

This randomized, double-blind, placebo-controlled clinical trial evaluated the efficacy and safety of Shengdi Dahuang Decoction (SDD), a traditional Chinese herbal formula containing rhubarb, in patients with acute intracerebral hemorrhage (ICH). The study was conducted across five hospitals in Shanghai, China, and enrolled 483 patients (242 in the SDD group, 241 in the placebo group) who presented within 4 hours of symptom onset. Patients received either SDD granules (15 g raw and 5 g raw rhubarb per sachet) or matching placebo granules, administered orally or via nasogastric tube twice daily for 7 days, in addition to standard guideline-directed care. Follow-up continued for 90 days.

The primary outcome was the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-1 at 90 days, indicating functional independence. In the SDD group, 112 of 242 patients (46.3%) achieved this endpoint compared to 84 of 241 patients (34.9%) in the placebo group, yielding an adjusted relative risk of 1.20 (95% CI 1.00 to 1.43; p=0.046). This result was statistically significant, though the lower bound of the confidence interval approached 1.00, indicating marginal significance.

Key secondary outcomes included the proportion of patients with poor clinical outcomes (mRS 5 or 6 at 90 days), which was significantly lower in the SDD group (5.4% vs 11.2%; p=0.021). However, no significant differences were observed for 90-day mortality (p=0.299), 7-day NIH Stroke Scale score (p=0.583), 7-day Glasgow Coma Scale score (p=0.577), 24-hour hematoma enlargement rate (p=0.675), or 7-day relative perihaematomal oedema (p=0.343). The incidence of adverse events did not differ significantly between groups (p>0.05), but serious adverse events and discontinuation rates were not reported.

Compared to prior landmark studies in acute ICH, such as those evaluating intensive blood pressure lowering or surgical evacuation, this trial explores a novel adjunctive therapy. The observed improvement in functional outcomes without significant effects on mortality or hematoma expansion suggests a potential neuroprotective or anti-inflammatory mechanism, though the study was not designed to elucidate mechanisms. The marginal p-value and confidence interval for the primary outcome warrant cautious interpretation.

Methodological limitations include the lack of reporting on study phase, funding sources, and conflicts of interest. The trial was conducted at five hospitals in a single city in China, which may limit generalizability to other populations and healthcare settings. Additionally, the study did not report on blinding integrity, allocation concealment details, or whether the analysis followed intention-to-treat principles. The authors note that more clinical trials are required to further prove its efficacy, indicating the preliminary nature of these findings.

Clinically, these results suggest that incorporating SDD as a supplementary intervention alongside guideline-directed treatments may help enhance 90-day functional outcomes in patients with acute ICH. However, given the marginal statistical significance and the absence of effect on mortality or other key secondary endpoints, clinicians should interpret these findings as hypothesis-generating rather than practice-changing. The safety profile appears acceptable based on reported adverse events, but the lack of detailed safety data limits firm conclusions.

Several questions remain unanswered. The optimal dosing regimen, duration of therapy, and patient subgroups most likely to benefit have not been established. The mechanism of action of SDD in ICH is unclear, and whether the effect is driven by rhubarb or other components is unknown. Future trials should include larger, more diverse populations, longer follow-up, and standardized outcome assessments to confirm these findings and clarify the role of SDD in acute ICH management.