TREATMENT OF MASKED HYPERTENSION WITH A CHINESE HERBAL FORMULA: A RANDOMIZED, PLACEBO‐CONTROLLED, SINGLE‐BLIND TRIAL

Abstract

Objective: Masked hypertension is associated with adverse cardiovascular outcomes. Nonetheless, no randomized controlled trials exist in the treatment of masked hypertension. The aim of this randomized, placebo-controlled trial was to investigate the efficacy and safety of blood pressure (BP) lowering treatment with a Chinese herbal formula, gastrodia-uncaria granules (GUG), in patients with masked hypertension. Design and method: Patients with an office BP of < 140/90 mmHg and daytime ambulatory BP of 135–150 mmHg systolic and/or 85–95 mmHg diastolic were randomized 1:1 to the treatment of GUG or placebo 5–10 grams twice daily for 4 weeks. The primary efficacy variable was the change in daytime ambulatory BP. Results: At baseline, office and daytime BP of the 251 participants (mean age 50.4 years, 53.4% men, mean body mass index 24.5 kg/m2, and 2.8%, 1.6%, and 30.7% with cardiovascular disease, diabetes mellitus, and smoking, respectively) averaged 129/82 and 135/89 mmHg, respectively. In the intention-to-treat analysis, daytime systolic/diastolic BP was reduced by 5.44 /3.39 and 2.91/1.60 mmHg in the GUG and placebo groups, respectively. The between-group difference in BP reductions was significant for the daytime (2.52/1.79 mmHg, P?0.025) and 24-h BP (2.33/1.49 mmHg, P?0.012), but not for the clinic and nighttime BPs (P?0.162). The per-protocol analysis in 229 patients produced similar results. Only one adverse event (sleepiness during the day) was reported and no serious adverse event occurred. Conclusions: BP lowering treatment with Chinese traditional medicine GUG is efficacious for patients with masked hypertension.