Evidence map›Paper›PMID 26192328›Full record

Trial reportPloS one2015

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

Pleun C M van Poppel, Pauline Breedveld, Evertine J Abbink, Hennie Roelofs, Waander van Heerde, Paul Smits, Wenzhi Lin, Aaitje H Tan, Frans G Russel, Rogier Donders and 2 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01563770 (A Double Blind, Randomized Placebo-controlled Cross-over Study on the Cardiovascular Effects of Salvia Miltiorrhiza Extract), which is not on this map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
5.0field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01563770 naunknown statusnot on this map

A Double Blind, Randomized Placebo-controlled Cross-over Study on the Cardiovascular Effects of Salvia Miltiorrhiza Extract (Danshen) in Patients With Hypertension and Hyperlipidemia.

TypeinterventionalSponsorRadboud University Medical CenterRan2012 to 2013Enrolled20ConditionsDyslipidemias, Hypertension, Vasodilation, Oxidative StressArmsSalvia miltiorrhiza extract, Placebo
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Chinese patent medicine for atherosclerosis: a systematic review and Meta-analysis of randomized controlled trials.Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan · 2024
    Pooled it
  3. Trial
  4. Pharmaceuticals (Basel, Switzerland) · 2024
    Article
  5. Therapeutic effects ofExperimental and therapeutic medicine · 2018
    Article
  6. Article
  7. Article
  8. Review
  9. Article
  10. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 2 institutions in 1 country.

Pleun C M van PoppelDepartment of Internal Medicine, Radboud university medical center, Nijmegen, The Netherlands.
Pauline BreedveldDepartment of Pharmacology and Toxicology, Radboud university medical center, Nijmegen, The Netherlands.
Evertine J AbbinkClinical Research Centre Nijmegen, Radboud university medical center, Nijmegen, The Netherlands.
Hennie RoelofsDepartment of Gastro-Enterology, Radboud university medical center, Nijmegen, The Netherlands.
Waander van HeerdeDepartment of Clinical Chemistry, Radboud university medical center, Nijmegen, The Netherlands.
Paul SmitsDepartment of Pharmacology and Toxicology, Radboud university medical center, Nijmegen, The Netherlands.
Wenzhi LinMedical Center Balans, The Hague, The Netherlands.
Aaitje H TanPractice for acupuncture and member of the Dutch Association of Acupuncture Medicine, Amsterdam, The Netherlands.
Frans G RusselDepartment of Pharmacology and Toxicology, Radboud university medical center, Nijmegen, The Netherlands.
Rogier DondersDepartment for Health Evidence, Radboud university medical center, Nijmegen, The Netherlands.
Cees J TackDepartment of Internal Medicine, Radboud university medical center, Nijmegen, The Netherlands.
Gerard A RongenDepartment of Internal Medicine, Radboud university medical center, Nijmegen, The Netherlands; Department of Pharmacology and Toxicology, Radboud university medical center, Nijmegen, The Netherlands.
Radboud University Nijmegen · NLRadboud University Medical Center · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeDanshen 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.

methodsThis 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.

resultsLDL 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.

conclusionFour 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 registrationClinicalTrials.gov NCT01563770.

Indexed as

AcetylcholineAdultAgedBlood CoagulationBlood PressureCardiovascular DiseasesCross-Over StudiesDouble-Blind MethodDrugs, Chinese HerbalFemaleForearmHumansHyperlipidemiasHypertensionLipidsMaleAcetylcholineDrugs, Chinese HerbalLipidsNitroprussideWater

Identifiers

PMID26192328
PMCPMC4508048
OpenAlexW2220794253

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.