A Randomized, Double‐blind, Placebo‐controlled Study to Evaluate the Efficacy and Tolerability of Fufang Danshen (Salvia miltiorrhiza) as Add‐on Antihypertensive Therapy in Taiwanese Patients with Uncontrolled Hypertension

Abstract

Hypertension generally requires the use of a combination therapy to achieve the satisfactory control of blood pressure. A traditional Chinese herb, Danshen (Salvia miltiorrhiza), has been shown to have cardioprotective effects in animals and humans. The study investigated the add-on effect of Fufang Danshen extract capsule in Taiwanese hypertensive patients with uncontrolled blood pressure. This was a double-blind, placebo-controlled, randomized, single-center study clinical trial. Fifty-five patients with uncontrolled mild to moderate hypertension were enrolled under current conventional antihypertensive treatment, randomized equally to receive a Fufang Danshen capsule (formula mixture) 1000 mg twice-daily or a placebo capsule for 12 weeks. Primary endpoints were the control rate and the response rate. By ITT analysis at week 12, the control rates were 25.5% in the Fufang Danshen group and 7.3% in the control group (p = 0.016). The response rates were 45.6% in the Fufang Danshen group and 38.2% in the placebo group (p = 0.946). A significant reduction of systolic blood pressure at week 12 was noted in the Fufang Danshen group compared with the placebo group (13.8 vs 4.2 mmHg, p = 0.005). A decrease of pulse rate was also noted in the Fufang Danshen group (- 3.2 vs +2.7/min, p = 0.027). Adverse events were not statistically different between the two groups. It was concluded that Fufang Danshen (Salvia miltiorrhiza) extract reduced systolic blood pressure and pulse rate, and was well tolerated in patients with hypertension.

Herbal Medicine for Cardiovascular Diseases: Efficacy, Mechanisms, and Safety

“…In one clinical trial, Danshen capsules (1000 mg twice daily for 12 weeks) were able to significantly reduce SBP and pulse rate in patients with uncontrolled mild to moderate hypertension and under conventional antihypertensive treatment. It has also been found to be well-tolerated and considered to be safe in patients with hypertension (Yang et al, 2012).…”

Chinese Herbal Therapy and Western Drug Use, Belief and Adherence for Hypertension Management in the Rural Areas of Heilongjiang Province, China

“…The essence of Chinese herbal therapy is syndrome differentiation, diagnoses syndromes with clinical manifestations and treats patients using the holistic approach by adjusting the various aspects of the body to restore the order and harmony of the body. In TCM, hypertension is classified by syndromes, including Gan-fire flaming-up syndrome, Yin-deficiency and Yang-excess syndrome, phlegm-dampness accumulation syndrome, and yin-yang deficiency syndrome [ 9 – 10 ]. Based on TCM principles various Chinese herbal therapies have been invented [ 10 – 11 ], and clinical guidelines have been developed[ 11 – 12 ].…”

“…In TCM, hypertension is classified by syndromes, including Gan-fire flaming-up syndrome, Yin-deficiency and Yang-excess syndrome, phlegm-dampness accumulation syndrome, and yin-yang deficiency syndrome [ 9 – 10 ]. Based on TCM principles various Chinese herbal therapies have been invented [ 10 – 11 ], and clinical guidelines have been developed[ 11 – 12 ]. For example Tian-Ma-Gou-Teng-Yin (Chinese herbal formula) is commonly used as an antihypertensive therapy.…”

Potential Therapeutic Strategies for Hypertension‐Exacerbated Cardiotoxicity of Anticancer Drugs

“…The other compound is Danshen, a widely used traditional Chinese herbal medicine ( Salvia miltiorrhiza ) for treating cardiovascular disorders. Tanshinone IIA was identified as the main active chemical component of Danshen, which has been shown to alleviate both hypertension [94–96] and AIC [96–99]. Taken together, these promising new therapeutic remedies (i.e., beetroot juice, visnagin, and Danshen) deserve more in-depth investigations (Figure 1), particularly, well-controlled clinical trials in cancer patients.…”