Salvia Miltiorrhiza Root Water-Extract (Danshen) Has No Beneficial Effect on Cardiovascular Risk Factors. A Randomized Double-Blind Cross-Over Trial

PLoS One. 2015 Jul 20;10(7):e0128695. doi: 10.1371/journal.pone.0128695. eCollection 2015.

Abstract

Purpose: Danshen is the dried root extract of the plant Salvia Miltiorrhiza and it is used as traditional Chinese medicinal herbal product to prevent and treat atherosclerosis. However, its efficacy has not been thoroughly investigated. This study evaluates the effect of Danshen on hyperlipidemia and hypertension, two well known risk factors for the development of atherosclerosis.

Methods: This was a randomized, placebo-controlled, double-blind crossover study performed at a tertiary referral center. Participants were recruited by newspaper advertisement and randomized to treatment with Danshen (water-extract of the Salvia Miltiorrhiza root) or placebo for 4 consecutive weeks. There was a wash out period of 4 weeks. Of the 20 analysed participants, 11 received placebo first. Inclusion criteria were: age 40-70 years, hyperlipidemia and hypertension. At the end of each treatment period, plasma lipids were determined (primary outcome), 24 hours ambulant blood pressure measurement (ABPM) was performed, and vasodilator endothelial function was assessed in the forearm.

Results: LDL cholesterol levels were 3.82±0.14 mmol/l after Danshen and 3.52±0.16 mmol/l after placebo treatment (mean±SE; p<0.05 for treatment effect corrected for baseline). Danshen treatment had no effect on blood pressure (ABPM 138/84 after Danshen and 136/87 after placebo treatment). These results were further substantiated by the observation that Danshen had neither an effect on endothelial function nor on markers of inflammation, oxidative stress, glucose metabolism, hemostasis and blood viscosity.

Conclusion: Four weeks of treatment with Danshen (water-extract) slightly increased LDL-cholesterol without affecting a wide variety of other risk markers. These observations do not support the use of Danshen to prevent or treat atherosclerosis.

Trial registration: ClinicalTrials.gov NCT01563770.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acetylcholine / pharmacology
  • Adult
  • Aged
  • Blood Coagulation / drug effects
  • Blood Pressure / drug effects
  • Cardiovascular Diseases / complications*
  • Cross-Over Studies
  • Double-Blind Method
  • Drugs, Chinese Herbal / adverse effects
  • Drugs, Chinese Herbal / pharmacology*
  • Female
  • Forearm / blood supply
  • Humans
  • Hyperlipidemias / complications
  • Hyperlipidemias / metabolism
  • Hyperlipidemias / physiopathology
  • Hyperlipidemias / prevention & control*
  • Hypertension / complications
  • Hypertension / metabolism
  • Hypertension / physiopathology
  • Hypertension / prevention & control*
  • Lipids / blood
  • Male
  • Middle Aged
  • Nitroprusside / pharmacology
  • Plant Roots / chemistry*
  • Risk Factors
  • Safety
  • Salvia miltiorrhiza / chemistry*
  • Water / chemistry*

Substances

  • Drugs, Chinese Herbal
  • Lipids
  • Water
  • Nitroprusside
  • Acetylcholine

Associated data

  • ClinicalTrials.gov/NCT01563770

Grant support

This study was financed by Cinmar Pharma BV, ‘s Hertogenbosch, the Netherlands, Department of Pharmacology-Toxicology, Radboud university medical centre, Nijmegen, the Netherlands, and the Dutch Association of Acupuncture Medicine (NAAV, Amsterdam, the Netherlands). Cinmar Pharma had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. AHT is a representative of NAAV and was involved in preparation of the manuscript. He nor NAAV have any financial interest in Danshen.