Phytomedicine : international journal of phytotherapy and phytopharmacology · 2025
Songling Xuemaikang capsule for grade 1 hypertension at low-to-moderate risk: a multicenter randomized placebo-controlled trial.
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Jiang Yuerong, Qu Hua, Guo Haiyan, Guo Ming, Liang Jiaqi, Niu Yichu, Chen Luying, Wang Xin, Li Yafei, Jiang Hongyan, Ma Jinhui, Wang Zhipeng, Luan Sasa, Lu Chunru, Shi Dazhuo
Аннотация
BACKGROUND: Songling Xuemaikang Capsule (SXC), a Chinese herbal medicine, has shown promise in decreasing blood pressure (BP), but its efficacy in grade 1 hypertension patients at low-to-moderate cardiovascular (CV) risk remains uncertain.
PURPOSE: This study investigated the efficacy of SXC in grade 1 hypertension patients at low-to-moderate CV risk.
STUDY DESIGN: This study was designed as a multicenter, randomized, double-blind, placebo-controlled clinical trial.
METHODS: Eligible patients from 9 centers were randomized to receive SXC or placebo for consecutive 8 weeks. The primary outcome was the changes of 24-h ambulatory BP. The secondary outcomes were the changes of daytime/nighttime BP, office BP, and control rate of hypertension. The adverse events were reported.
RESULTS: Of 508 patients who underwent screening, 393 were randomized after a 2-week run-in phase, and 356 were included in final analysis. Intention-to-treat analysis revealed a greater reduction in 24-h systolic/diastolic blood pressure (SBP/DBP) in SXC group compared to placebo group (-5.91±11.32/-4.66±9.33 mm Hg vs -2.26±10.47/-2.56±8.76 mm Hg, p < 0.001/p < 0.001). The patients in SXC group also showed a greater reduction in daytime SBP/DBP, nighttime SBP/DBP and office SBP/DBP than placebo group (p = 0.002/p = 0.004, p = 0.005/p = 0.046 and p < 0.001/p = 0.001, respectively). The control rate of 24-h BP (defined as SBP/DBP <130/80 mm Hg) was higher in SXC group than in placebo group (38.04 % vs 24.42 %, p = 0.002). There was no statistical difference in adverse events between two groups.
CONCLUSION: Treatment with SXC for 8-week demonstrated a superiority in reducing 24-h average SBP/DBP over placebo, without increasing adverse events. The confirmed net efficacy suggested that SXC may provide an alternative therapy for grade 1 hypertension patients at low-to-moderate CV risk.
PURPOSE: This study investigated the efficacy of SXC in grade 1 hypertension patients at low-to-moderate CV risk.
STUDY DESIGN: This study was designed as a multicenter, randomized, double-blind, placebo-controlled clinical trial.
METHODS: Eligible patients from 9 centers were randomized to receive SXC or placebo for consecutive 8 weeks. The primary outcome was the changes of 24-h ambulatory BP. The secondary outcomes were the changes of daytime/nighttime BP, office BP, and control rate of hypertension. The adverse events were reported.
RESULTS: Of 508 patients who underwent screening, 393 were randomized after a 2-week run-in phase, and 356 were included in final analysis. Intention-to-treat analysis revealed a greater reduction in 24-h systolic/diastolic blood pressure (SBP/DBP) in SXC group compared to placebo group (-5.91±11.32/-4.66±9.33 mm Hg vs -2.26±10.47/-2.56±8.76 mm Hg, p < 0.001/p < 0.001). The patients in SXC group also showed a greater reduction in daytime SBP/DBP, nighttime SBP/DBP and office SBP/DBP than placebo group (p = 0.002/p = 0.004, p = 0.005/p = 0.046 and p < 0.001/p = 0.001, respectively). The control rate of 24-h BP (defined as SBP/DBP <130/80 mm Hg) was higher in SXC group than in placebo group (38.04 % vs 24.42 %, p = 0.002). There was no statistical difference in adverse events between two groups.
CONCLUSION: Treatment with SXC for 8-week demonstrated a superiority in reducing 24-h average SBP/DBP over placebo, without increasing adverse events. The confirmed net efficacy suggested that SXC may provide an alternative therapy for grade 1 hypertension patients at low-to-moderate CV risk.