Effects of Dan Shen (Salvia miltiorrhiza) on blood pressure management in hypertensive patients: a randomized controlled trial.

Objective: This randomised, double-blind, placebo-controlled trial aimed to evaluate the efficacy and safety of Salvia miltiorrhiza (Dan Shen) in the management of primary hypertension.

Methods: From April 2023 to September 2024, 320 patients aged 30-75 years with diagnosed primary hypertension were enrolled at Ganzhou Hospital of Southern Medical University (Ganzhou People's Hospital). Patients were randomised to receive either intravenous Salvia miltiorrhiza (20 mL diluted in 200 mL of 5% glucose daily for 12 weeks) or a placebo with identical appearance and administration. Primary outcomes included changes in blood pressure measured by 24-h ambulatory blood pressure monitoring (ABPM). Secondary outcomes included symptom scores, lipid and glucose profiles and health-related quality of life (QoL) assessed using validated laboratory measures and the SF-36 questionnaire.

Results: A significant reduction in systolic and diastolic blood pressure (DBP) was observed in the intervention group from week 4, reaching 136.78 ± 10.28 and 85.36 ± 8.37 mmHg by week 12, respectively - both significantly lower than in the control group (p < 0.01). Symptom scores for headache, dizziness and fatigue decreased by 1.2, 1.1 and 1.2 points (p < 0.01), with no significant changes in the control group. Lipid profiles improved notably: total cholesterol (TC), LDL-C and triglycerides (TGs) declined by 9.8%, 10.7% and 17.1%, respectively, while HDL-C increased by 17.0% (all p < 0.05). Fasting glucose levels fell by 4.3% (p < 0.05). QoL, assessed via SF-36, improved significantly, particularly in vitality (+20.9) and physical functioning (+18.6). Adverse events (AEs) were mild to moderate, mainly gastrointestinal discomfort and dizziness, and did not result in dropout. Treatment adherence was high, with 94.2% of participants completing at least 80% of the protocol.

Conclusion: Dan Shen significantly reduced both systolic and DBP, alleviated hypertension-related symptoms, improved lipid and glucose metabolism, and enhanced QoL in patients with primary hypertension.