title: Salvia Miltiorrhiza Root Water-Extract (Danshen) Has No Beneficial Effect on Cardiovascular Risk Factors. A Randomized Double-Blind Cross-Over Trial.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01563770.
authors.affiliation: Department of Internal Medicine, Radboud university medical center, Nijmegen, The Netherlands.
authors.forename: Pleun C M
authors.initials: PC
authors.lastname: van Poppel
authors.affiliation: Department of Pharmacology and Toxicology, Radboud university medical center, Nijmegen, The Netherlands.
authors.forename: Pauline
authors.initials: P
authors.lastname: Breedveld
authors.affiliation: Clinical Research Centre Nijmegen, Radboud university medical center, Nijmegen, The Netherlands.
authors.forename: Evertine J
authors.initials: EJ
authors.lastname: Abbink
authors.affiliation: Department of Gastro-Enterology, Radboud university medical center, Nijmegen, The Netherlands.
authors.forename: Hennie
authors.initials: H
authors.lastname: Roelofs
authors.affiliation: Department of Clinical Chemistry, Radboud university medical center, Nijmegen, The Netherlands.
authors.forename: Waander
authors.initials: W
authors.lastname: van Heerde
authors.affiliation: Department of Pharmacology and Toxicology, Radboud university medical center, Nijmegen, The Netherlands.
authors.forename: Paul
authors.initials: P
authors.lastname: Smits
authors.affiliation: Medical Center Balans, The Hague, The Netherlands.
authors.forename: Wenzhi
authors.initials: W
authors.lastname: Lin
authors.affiliation: Practice for acupuncture and member of the Dutch Association of Acupuncture Medicine, Amsterdam, The Netherlands.
authors.forename: Aaitje H
authors.initials: AH
authors.lastname: Tan
authors.affiliation: Department of Pharmacology and Toxicology, Radboud university medical center, Nijmegen, The Netherlands.
authors.forename: Frans G
authors.initials: FG
authors.lastname: Russel
authors.affiliation: Department for Health Evidence, Radboud university medical center, Nijmegen, The Netherlands.
authors.forename: Rogier
authors.initials: R
authors.lastname: Donders
authors.affiliation: Department of Internal Medicine, Radboud university medical center, Nijmegen, The Netherlands.
authors.forename: Cees J
authors.initials: CJ
authors.lastname: Tack
authors.affiliation: Department of Internal Medicine, Radboud university medical center, Nijmegen, The Netherlands; Department of Pharmacology and Toxicology, Radboud university medical center, Nijmegen, The Netherlands.
authors.forename: Gerard A
authors.initials: GA
authors.lastname: Rongen
mesh_terms: D000109:Acetylcholine / Q000494:pharmacology; D000328:Adult; D000368:Aged; D001777:Blood Coagulation / Q000187:drug effects; D001794:Blood Pressure / Q000187:drug effects; D002318:Cardiovascular Diseases / Q000150:complications*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000494:pharmacology*; D005260:Female; D005542:Forearm / Q000098:blood supply; D006801:Humans; D006949:Hyperlipidemias / Q000150:complications / Q000378:metabolism / Q000503:physiopathology / Q000517:prevention & control*; D006973:Hypertension / Q000150:complications / Q000378:metabolism / Q000503:physiopathology / Q000517:prevention & control*; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D009599:Nitroprusside / Q000494:pharmacology; D018517:Plant Roots / Q000737:chemistry*; D012307:Risk Factors; D012449:Safety; D027561:Salvia miltiorrhiza / Q000737:chemistry*; D014867:Water / Q000737:chemistry*
chemical_list: D004365:Drugs, Chinese Herbal; D008055:Lipids; D014867:Water; D009599:Nitroprusside; D000109:Acetylcholine