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Shengdi Dahuang Decoction Improves Functional Outcomes in Acute Intracerebral HemorrhageNew herbal formula may help stroke patients recover better function

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Key Takeaway
Consider SDD as a potential adjunct to standard care for acute ICH, but await confirmatory trials before changing practice.

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.

Imagine waking up after a stroke and feeling like your body has become a stranger. You try to walk, but your leg drags. You try to speak, but words get stuck. This is the reality for thousands of people who suffer a brain bleed, known as an intracerebral haemorrhage.

For decades, doctors have focused on stopping the bleeding and controlling blood pressure. While these steps save lives, they do not always fix the damage done to the brain tissue. Many patients are left with lasting weakness or confusion.

But there is hope on the horizon. A new study looks at a traditional Chinese herbal formula called Shengdi Dahuang Decoction. Early signs suggest it might help the brain heal better after a bleed.

The Old Way vs. A New Hope

Current treatments are excellent at saving lives. However, they often leave patients with significant disability. The brain needs more than just a stop to the bleeding; it needs protection from the swelling and inflammation that follow.

Think of the brain like a busy city after a major accident. The roads are blocked, and the emergency crews are busy clearing debris. Inflammation is like a chaotic crowd trying to help but accidentally causing more damage. The goal is to calm that crowd down so the city can rebuild.

Researchers believe this herbal mix acts like a skilled traffic controller. It does not stop the bleeding directly. Instead, it reduces the harmful swelling and inflammation that occur after the injury.

Imagine a factory where workers are stressed and making mistakes. The herbal formula acts like a supervisor who calms the workers down. This allows the factory to run smoothly again. In the brain, this means less swelling and a better environment for nerve cells to repair themselves.

What The Study Tested

Scientists conducted a large, rigorous test to see if this idea held true in real people. They gathered 242 patients who had just suffered a brain bleed. These patients were split into two groups.

One group received the herbal granules mixed with their standard medical care. The other group received a fake treatment, or placebo, mixed with the same standard care. Neither the patients nor the doctors knew who got which treatment until the end.

The patients took the granules twice a day for seven days. They started taking them within 12 hours of the stroke symptoms appearing. This timing was crucial because the brain is most vulnerable to swelling in the first few days.

The Surprising Results

The main question was simple: Who could walk and function better after 90 days? The results were promising for the herbal group.

More patients in the herbal group achieved a high level of independence. Specifically, 46.3% of those taking the herbs could care for themselves without help. In the placebo group, only 34.9% reached that same level of function.

This difference was not a fluke. The math shows a clear advantage for the herbal treatment. Patients taking the herbs were less likely to end up in a severe state of disability.

But There's A Catch

This doesn't mean this treatment is available yet.

While the numbers look good, there are important details to understand. The study did not find that the herbal mix stopped the bleeding or killed patients faster. The death rates were similar in both groups.

The real benefit was in recovery. Patients who took the herbs were less likely to end up with severe disability. They were more likely to return to their homes and daily routines. This is a huge deal for families waiting for a loved one to wake up and recognize them.

What Experts Say

Doctors involved in the study noted that this fits with what they already know about brain healing. Reducing inflammation is a key part of recovery. This herbal mix seems to do exactly that without causing side effects.

The safety profile was excellent. There were no major differences in bad side effects between the two groups. Patients could take the herbs alongside their regular blood pressure and clotting medications without issues.

If you or a loved one has had a brain bleed, talk to your doctor about recovery options. This study suggests that adding this herbal mix to standard care could improve your chances of walking again.

However, do not start taking it on your own. You must discuss it with your medical team first. They need to check if it fits your specific situation and current medications.

This is a strong step forward, but it is not the final word. The study authors say more trials are needed. Scientists want to see if this works in different types of brain bleeds and for different ages of patients.

It will take time for this treatment to be approved for everyone. Regulatory bodies need to review the full data before adding it to official treatment guidelines. Until then, it remains a promising option for doctors to consider in specific cases.

The journey to better stroke recovery is long. But every new piece of research brings us closer to a future where more patients can walk out of the hospital and back into their lives.

Study Details

Study typeRct
Sample sizen = 1,211
EvidenceLevel 2
Follow-up752.4 mo
PublishedApr 2026
View Original Abstract ↓
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 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.
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