Danshen

*Salvia miltiorrhiza*

Evidence Rating

C Moderate

Confidence Level

Moderate

Traditions

TCM

Last Updated

2/12/2026

Summary

Danshen (Salvia miltiorrhiza) is one of the most important cardiovascular herbs in Traditional Chinese Medicine, used for millennia to "activate blood and resolve stasis." The root contains lipophilic tanshinones (tanshinone IIA, cryptotanshinone) and hydrophilic phenolic acids (salvianolic acid B, danshensu) with demonstrated antiplatelet, vasodilatory, antioxidant, and cardioprotective properties. Compound Danshen Dripping Pills (CDDP/T89) is one of the most widely used cardiovascular herbal preparations in China and has undergone FDA Phase III trials for chronic stable angina. Multiple Cochrane reviews cover danshen for acute ischemic stroke and angina, though they consistently note that included Chinese trials have significant methodological limitations. No European regulatory monographs exist. The evidence is moderate -- pharmacologically compelling with extensive Chinese clinical data, but limited by trial quality and the predominance of combination formulas.

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Drug Interactions

This herb has significant drug interactions. Do not use if you are taking medications without consulting a healthcare provider first. See detailed interaction information below.

Regulatory Status

Regulatory BodyStatus
Commission E (Germany)—
ESCOP (European)—
EMA/HMPC (EU)—

Metadata

FieldDetails
Common NamesDanshen, Red Sage, Chinese Sage, Dan Shen, Tanshinone Sage
Botanical NameSalvia miltiorrhiza Bunge
Plant FamilyLamiaceae (Labiatae)
Part UsedRoot and rhizome (Salviae miltiorrhizae radix et rhizoma), dried
Key ConstituentsLipophilic diterpenoids: Tanshinone IIA, Tanshinone I, Cryptotanshinone, Dihydrotanshinone I, Miltirone; Hydrophilic phenolic acids: Salvianolic acid B (lithospermic acid B), Danshensu (salvianic acid A, also known as 3-(3,4-dihydroxyphenyl)-2-hydroxypropanoic acid), Rosmarinic acid, Salvianolic acid A, Protocatechualdehyde
Evidence Quality RatingC — Moderate: extensive pharmacological data and Chinese clinical literature, but limited Western-standard RCTs; most clinical studies use combination formulas

Quality Markers (Chinese Pharmacopoeia 2020)

The Chinese Pharmacopoeia (2020 edition) specifies that the combined content of tanshinone IIA, cryptotanshinone, and tanshinone I must not be less than 0.25%, and the content of salvianolic acid B must not be less than 3.0%. These serve as minimum quality thresholds for raw material authentication and pharmaceutical manufacturing.


Approved Indications

Commission E (Germany)

  • No monograph. Danshen was not part of the German phytotherapy tradition at the time of Commission E evaluations. It has never been submitted for assessment.

ESCOP

  • No monograph. Salvia miltiorrhiza is not addressed in any ESCOP publication.

EMA/HMPC

  • No monograph or assessment report finalized. A draft EMA assessment report on Salvia miltiorrhiza Bunge, radix et rhizoma was initiated but has not resulted in an approved community herbal monograph. The regulatory challenges of bridging TCM clinical evidence into the EU framework remain a significant barrier. [Source: EMA draft assessment, ema.europa.eu]

Chinese Pharmacopoeia Status

  • Official drug. Listed in every edition of the Pharmacopoeia of the People’s Republic of China since its first modern compilation.
  • TCM indications: Promotes blood circulation and removes blood stasis (huo xue hua yu); clears heart heat and relieves restlessness; cools blood and removes carbuncle.
  • Therapeutic scope in Chinese regulation: Irregular menstruation, dysmenorrhea, amenorrhea, blood stasis-induced chest pain (angina), abdominal pain, rheumatic arthralgia, carbuncles, ulcers, palpitation, and insomnia.
  • Recommended decoction dose: 9-15 g/day.

Other Pharmacopoeias

  • Japanese Pharmacopoeia (JP): Listed as Tanjin (the Japanese reading of Dan Shen)
  • Korean Pharmacopoeia: Listed
  • United States Pharmacopeia (USP): Dietary ingredient monograph available through the Herbal Medicines Compendium [Source: hmc.usp.org]
  • WHO: Included in WHO monographs on selected medicinal plants

Agreement/Disagreement Between Bodies

  • Complete absence from European regulatory frameworks: Unlike hawthorn or ginkgo, danshen has zero regulatory recognition in Europe as a therapeutic agent. This reflects both the EU framework’s structural difficulty with non-European traditional medicines and the lack of pharmaceutical sponsors willing to fund the registration process.
  • Robust Chinese regulatory recognition: Danshen and its preparations (particularly Compound Danshen Dripping Pills and Compound Danshen Injection) are among the most widely prescribed cardiovascular herbal medicines in Chinese hospitals and pharmacies.
  • Growing international regulatory interest: The CDDP/T89 (Dantonic) FDA trials represent the most advanced attempt to bridge Chinese cardiovascular phytotherapy into Western regulatory frameworks.

Conditions Treated

Primary — Angina Pectoris and Coronary Heart Disease

Danshen is most extensively studied and prescribed for chronic stable angina and coronary heart disease (CHD). In China, injectable and oral danshen preparations are standard adjunctive therapy alongside conventional antianginal medications. The clinical evidence base, while vast in volume, is dominated by Chinese-language trials that often lack adequate blinding and allocation concealment.

  • Chronic stable angina: The predominant indication. Compound Danshen Dripping Pills (CDDP) are approved in over 26 countries outside the US and are one of the most widely used cardiovascular herbal products in the world. CDDP is composed of danshen extract, Panax notoginseng (Sanqi) extract, and borneol.
  • Unstable angina (adjunctive): Sodium tanshinone IIA sulfonate (STS) injection is used in Chinese hospitals as adjunctive therapy for acute coronary syndromes. A meta-analysis of 17 RCTs found STS injection improved clinical outcomes when added to standard therapy, though methodological quality of included trials was limited. [Source: PubMed 29181731]
  • Coronary heart disease (general): Meta-analyses suggest improvements in ECG findings, symptom relief, and nitroglycerin consumption when danshen preparations are added to standard care, but high risk of bias limits confidence. [Source: PubMed 28650203]

Secondary — Acute Ischemic Stroke (Adjunct) and Peripheral Vascular Disease

  • Acute ischemic stroke: Based on experimental data suggesting improvements to cerebral microcirculation, danshen injections are widely used in Chinese stroke units. The Cochrane review by Wu, Liu, and Zhang (2007) identified 6 randomized or quasi-randomized trials involving 494 patients. The review concluded that there was insufficient evidence to support or refute the routine use of danshen agents for acute ischemic stroke and called for further high-quality, large-scale RCTs. [Source: Cochrane Library, CD004295]
  • Peripheral vascular disease: Limited evidence from Chinese trials suggests potential benefit in improving blood flow parameters. Primarily used in TCM practice for conditions classified under “blood stasis” affecting the limbs.
  • Pulmonary heart disease: Sodium tanshinone IIA sulfonate injection has been studied as adjunctive therapy for pulmonary heart disease (cor pulmonale) in a systematic review and meta-analysis. [Source: PubMed 38580972]

Traditional — TCM “Blood Stasis” Indications

In Traditional Chinese Medicine theory, danshen is classified as a blood-activating, stasis-resolving herb (huo xue hua yu yao). Its traditional indications extend well beyond cardiovascular disease:

  • Gynecological disorders: Dysmenorrhea, irregular menstruation, amenorrhea from blood stasis, postpartum abdominal pain. Danshen is a key herb in many gynecological TCM formulas.
  • Chest bi syndrome (xiong bi): The TCM interpretation of angina pectoris — stabbing or fixed chest pain attributed to blood stasis obstructing the heart vessels.
  • Insomnia and restlessness: Danshen is said to “clear heart heat and calm the spirit,” making it a component in formulas for anxiety-related insomnia.
  • Carbuncles, sores, and skin conditions: Based on the traditional action of “cooling blood and removing carbuncle.”
  • Hepatitis and liver fibrosis: Increasingly studied for hepatoprotective effects, particularly salvianolic acid B’s antifibrotic activity. [NEEDS-RESEARCH — clinical evidence still preliminary]

Mechanism of Action

Danshen’s pharmacology is characterized by a dual-class system of bioactive compounds — lipophilic tanshinones (concentrated in the outer red-colored layer of the root) and hydrophilic salvianolic acids (distributed throughout the root). These two classes exert complementary cardiovascular effects through distinct molecular targets.

Tanshinone IIA — The Primary Lipophilic Bioactive

Tanshinone IIA is the most abundant and best-studied tanshinone. Its key mechanisms include:

Calcium channel modulation and vasodilation:

  • Blocks L-type Ca2+ channels, decreasing intracellular calcium concentration and ameliorating calcium overload in cardiomyocytes. [Source: PubMed 19542183; Frontiers in Pharmacology 2018]
  • Activates ATP-sensitive K+ channels, producing concentration-dependent vasorelaxation.
  • Inhibits store-operated calcium entry (SOCE) in pulmonary arterial smooth muscle cells via the PKG-PPAR-gamma signaling axis. [Source: PMC3547081]
  • Net effect: arterial vasodilation and reduced afterload, reduced myocardial oxygen demand.

Antiplatelet and antithrombotic activity:

  • Decreases expression of CD41 (GPIIb/IIIa complex) and CD62p (P-selectin) on platelet surfaces, inhibiting platelet aggregation and activation. [Source: PubMed 25038434]
  • Inhibits thrombus formation with more significant antiplatelet activity than anticoagulant activity.
  • Inhibits platelet aggregation via Erk-2 signaling pathway suppression.

Cardioprotective and anti-inflammatory actions:

  • Protects cardiomyocytes against ischemia-reperfusion injury through reduction of oxidative stress and suppression of NF-kB-mediated inflammatory cascades.
  • Inhibits cardiac hypertrophy in animal models of myocardial infarction.
  • Acts as a potent mixed-type inhibitor of soluble epoxide hydrolase (sEH) with an inhibition constant (Ki) of 0.87 micromolar, contributing to anti-inflammatory and cardioprotective effects. [Source: published sEH inhibition data]

Anti-atherosclerotic effects:

  • Inhibits oxidation of low-density lipoprotein (LDL).
  • Reduces foam cell formation in macrophages.
  • Suppresses vascular smooth muscle cell proliferation and migration.

Cryptotanshinone — Secondary Lipophilic Bioactive

  • Moderate mixed-type inhibitor of sEH (Ki = 6.7 micromolar).
  • Shares many of tanshinone IIA’s cardiovascular effects but with generally lower potency.
  • Both cryptotanshinone and tanshinone IIA activate human pregnane X receptor (PXR), which has implications for CYP3A4 induction and drug interactions (see Drug Interactions section). [Source: PMC2883758]

Salvianolic Acid B — The Primary Hydrophilic Bioactive

Salvianolic acid B (Sal B, also called lithospermic acid B) is the most abundant phenolic acid in danshen root. Its key mechanisms include:

Potent antioxidant activity:

  • Contains multiple phenolic hydroxyl groups conferring strong free radical scavenging ability.
  • Increases expression of antioxidant enzymes including superoxide dismutase (SOD), catalase (CAT), and glutathione (GSH).
  • Reduces expression of oxidative enzymes including cyclooxygenase-2 (COX-2), NADPH oxidase 4 (NOX-4), and inducible nitric oxide synthase (iNOS).
  • Inhibits generation of reactive oxygen species (ROS) and lipid peroxidation marker malondialdehyde (MDA). [Source: PMC7741185]

eNOS stimulation and endothelial protection:

  • Promotes endothelial nitric oxide synthase (eNOS) phosphorylation through the AMPK-PI3K-Akt signaling pathway.
  • Enhances L-arginine uptake into endothelial cells, increasing substrate availability for NO synthesis.
  • Nitric oxide (NO) production is considered a key factor through which salvianolic acid B reverses myocardial ischemia and hypoxia damage. [Source: PubMed 21282198; PMC3691933]
  • Delays endothelial cell senescence and maintains vascular integrity.

Antiplatelet activity:

  • Inhibits platelet activation and aggregation induced by thrombin, ADP, and collagen.
  • Specifically antagonizes the collagen receptor GPIa/IIa (alpha2-beta1 integrin), inhibiting platelet adhesion to collagen under flow conditions. [Source: PubMed 18625517]
  • Dose-dependently inhibits ADP- or thrombin-induced platelet aggregation in platelet-rich plasma (PRP).
  • Reduces soluble P-selectin release from agonist-stimulated washed platelets.
  • Pre-treatment with salvianolic acid B reduces adhesion of ADP-activated platelets to endothelial cells and inhibits NF-kB activation, suppressing pro-inflammatory mediators in a dose-dependent manner. [Source: PubMed 25466843]

Antifibrotic effects:

  • Inhibits TGF-beta1-induced proliferation in fibroblasts and downregulates alpha-SMA and COL1-alpha1 expression. [Source: PubMed 32645333]
  • Emerging interest in hepatic and myocardial antifibrotic applications.

Danshensu (Salvianic Acid A) — The Smallest Active Phenolic

  • Simplest phenolic acid in danshen; a metabolite of salvianolic acid B.
  • Inhibits platelet aggregation and adhesion.
  • Scavenges oxygen free radicals.
  • Protects endothelial cells against oxidative injury.
  • Contributes to the overall hemodynamic effects of whole danshen preparations.

Rosmarinic Acid

  • Shared with many Lamiaceae family members (rosemary, sage, lemon balm).
  • Antioxidant and anti-inflammatory activity.
  • Contributes to the overall phenolic acid fraction’s protective effects.

Synergy Between Compound Classes

A critical pharmacological concept: the lipophilic tanshinones and hydrophilic salvianolic acids act through complementary and partially overlapping pathways. Tanshinones provide calcium channel blockade and direct cardioprotection, while salvianolic acids provide endothelial protection through eNOS activation and potent antioxidant scavenging. Both classes contribute antiplatelet activity through different receptor targets (tanshinones via Erk-2/CD62p pathways; salvianolic acids via GPIa/IIa antagonism). This multi-target pharmacology is characteristic of complex herbal medicines and may explain the breadth of cardiovascular effects observed clinically.


Clinical Evidence Summary

Cochrane Reviews

Dan Shen Agents for Acute Ischaemic Stroke (Wu B, Liu M, Zhang S; Cochrane 2007, CD004295)

ParameterDetails
ScopeDan shen agents (any formulation) for acute ischemic stroke
Trials included6 randomized or quasi-randomized trials
Total patients494
Key findingNo reliable evidence that danshen agents improved or worsened outcomes after acute ischemic stroke
Conclusion”There is not enough evidence to recommend the routine use of Dan Shen agents in acute ischaemic stroke. Rigorously designed, randomized, double-blind, placebo-controlled trials are needed”
Quality assessmentIncluded trials had significant methodological limitations: unclear or inadequate randomization, lack of blinding, incomplete outcome reporting

[Source: Cochrane Library, CD004295; PubMed 15495099]

Angina Pectoris (Systematic Reviews and Meta-Analyses)

No standalone Cochrane review exists specifically for danshen in angina pectoris, but multiple systematic reviews employing Cochrane methodology have been published:

ReviewScopeTrials/PatientsKey Finding
Luo et al. 2017Danshen Dripping Pill (DSP) vs. isosorbide dinitrate for anginaMultiple RCTs, 1994-2016DSP appeared at least non-inferior to ISDN for angina symptom relief; risk of bias was high in most included trials
Network meta-analysis 20228 types of Salvia miltiorrhiza injections for unstable anginaMultiple RCTs via Cochrane Library searchAll 8 injection types showed efficacy for unstable angina when added to standard care; larger, higher-quality trials needed
Ma et al. (STS injection meta-analysis)Sodium tanshinone IIA sulfonate for unstable angina17 RCTsSTS injection combined with standard therapy reduced angina attacks and improved ECG findings; most trials had unclear or high risk of bias

[Sources: PubMed 28650203; PMC9574204; PubMed 29181731]

Compound Danshen Dripping Pills (CDDP/T89/Dantonic) — FDA Trials

CDDP represents the most important translational effort for danshen into Western medicine. The product is a three-component formula: danshen extract + Panax notoginseng extract + borneol. It has been approved in over 26 countries outside the US for chronic stable angina.

FDA Phase II Trial Results:

  • Conducted under FDA IND (Investigational New Drug application).
  • CDDP demonstrated significant improvements in exercise tolerance in patients with chronic stable angina pectoris.
  • Nitroglycerin use per week was reduced by approximately 25% compared to placebo.
  • Angina pectoris attacks every two weeks were reduced by approximately 27% compared to placebo.
  • No drug-related serious adverse events were reported.
  • Most adverse events were mild in intensity and unrelated to treatment.
  • No statistically significant difference in adverse event rates among treatment groups.

[Source: Tasly Pharmaceuticals clinical trial data; ScienceDirect review, S0753332218347863]

FDA Phase III Trial (NCT01659580):

ParameterDetails
SponsorTasly Pharmaceuticals (Tianjin, China)
DesignRandomized, double-blind, placebo-controlled, multicenter, international
IndicationChronic stable angina pectoris
Primary endpointTotal Exercise Duration (TED) via Bruce Protocol Treadmill Testing
Sites127 clinical centers across 9 countries
StatusPhase III completed; regulatory submission data under review
Product nameDantonic (T89) capsule

[Source: ClinicalTrials.gov NCT01659580; Tasly Pharmaceuticals announcement]

The CDDP/T89 program is historically significant: if approved, it would be the first traditional Chinese medicine to receive FDA approval as a prescription drug for a cardiovascular indication. However, final results and regulatory outcome have not been fully disclosed in the peer-reviewed literature as of early 2026.

INCODER Study (Chinese Multicenter RCT)

A multicenter, double-blind, randomized controlled superiority trial examining intensive versus standard dosing of CDDP in refractory angina patients with incomplete revascularization. The study protocol was published in Frontiers in Cardiovascular Medicine (2022), reflecting the ongoing investment in rigorous clinical evaluation of CDDP within China. [Source: Frontiers in Cardiovascular Medicine, 10.3389/fcvm.2022.860059]

Evidence Quality Assessment

The fundamental challenge in evaluating danshen’s clinical evidence is the quality gap:

  • Volume is vast: Thousands of Chinese-language clinical studies have been published on danshen and its preparations. PubMed alone indexes hundreds of clinical trials.
  • Quality is variable: Most Chinese trials included in systematic reviews have significant methodological limitations — unclear randomization methods, inadequate or absent blinding, small sample sizes (often n < 100), short duration, and frequent use of combination formulas making it impossible to isolate danshen’s contribution.
  • Combination formulas dominate: CDDP contains three active components; Compound Danshen Injection contains danshen and dalbergia wood extract. Attribution of effects to danshen alone versus the combination is difficult.
  • Publication bias: Chinese medical journals have historically had very high rates of positive results, raising concerns about selective reporting.
  • The T89 FDA trials represent a pivotal bridge: These are the only trials of a danshen-based product conducted to Western regulatory standards with adequate blinding, randomization, and international oversight.

Safety Profile

Contraindications

  • Concurrent anticoagulant/antiplatelet therapy (especially warfarin): The most clinically important safety concern. See Drug Interactions below.
  • Active bleeding disorders: Danshen’s antiplatelet and potential anticoagulant effects contraindicate use in patients with active hemorrhage, hemophilia, or severe thrombocytopenia.
  • Pre-surgical: Discontinue danshen preparations at least 7-14 days before elective surgery due to antiplatelet effects.
  • Hypersensitivity: Known allergy to Salvia miltiorrhiza or other Lamiaceae family members.

Drug Interactions

Warfarin (HIGH CLINICAL SIGNIFICANCE — CONTRAINDICATED COMBINATION)

The danshen-warfarin interaction is classified as “highly probable” based on clinical case reports and is the most important drug interaction for this herb.

Published case reports:

  • A 62-year-old male on warfarin 5 mg/day for mitral valve replacement, with previously stable INR, was admitted with pleural and pericardial effusion after taking danshen extract for 2 weeks. INR was greater than 8.4. [Source: PubMed 11302416]
  • A 48-year-old female on warfarin 4 mg/day developed an INR of 5.6 after taking danshen every other day for 4 weeks.
  • A 66-year-old male stabilized on warfarin 2.5 mg/day (INR 2.0) for one year was admitted with bleeding. INR upon admission was 5.5.

Mechanisms of the warfarin interaction:

  1. Pharmacokinetic: Danshen increases the absorption rate constants, AUC, maximum concentrations, and elimination half-lives of both R- and S-warfarin, while decreasing clearance and apparent volume of distribution.
  2. CYP enzyme effects: Tanshinones inhibit CYP1A2, CYP2C9, and CYP3A4 in vitro, all of which are involved in warfarin metabolism. Paradoxically, with multiple-dose administration, cryptotanshinone and tanshinone IIA may also induce CYP3A4 through PXR activation. The net clinical effect appears to be potentiation of warfarin’s anticoagulant action.
  3. Pharmacodynamic: Danshen has intrinsic anticoagulant-like properties including inhibition of platelet aggregation, antithrombin III-like activity, promotion of fibrinolytic activity, and interference with the extrinsic coagulation pathway. These effects are additive to warfarin’s anticoagulant mechanism.

[Sources: PubMed 11302416; PMC3976951; PMC2883758]

Digoxin (MODERATE CLINICAL SIGNIFICANCE)

  • Danshen may interfere with laboratory measurement of digoxin plasma levels (false readings with some immunoassays).
  • May increase the effects and toxicity of digoxin. Monitor digoxin levels closely in patients using both. [Source: WebMD; Medscape drug reference]

Antiplatelet agents (aspirin, clopidogrel) and anticoagulants (heparins, DOACs)

  • Theoretical additive risk of bleeding based on danshen’s antiplatelet mechanisms. Clinical case reports are limited to warfarin, but caution is warranted with all anticoagulant/antiplatelet agents.

CYP substrate drugs (MODERATE CONCERN)

  • Tanshinones inhibit CYP1A2, CYP2C8, CYP2C9, CYP2E1, and CYP3A4 in vitro. Multiple-dose administration may induce CYP3A4 in the gut. Clinical significance for most CYP substrates remains uncertain but warrants monitoring. [Source: PMC2883758; ScienceDirect S0009279718300103]

Antihypertensive agents

  • Theoretical additive hypotensive effects due to danshen’s vasodilatory properties. Monitor blood pressure.

Side Effects

Danshen preparations are generally well tolerated in clinical studies:

  • Common (mild): Gastrointestinal symptoms including abdominal distension, dyspepsia, nausea, and loose stools. Mild facial flushing and head fullness sensation observed occasionally with CDDP.
  • Uncommon: Dizziness, headache.
  • Rare: Allergic reactions, reversible thrombocytopenia.
  • Injection forms (STS injection, Compound Danshen Injection): Higher risk of adverse reactions including allergic responses, injection site reactions, and (very rarely) anaphylactoid reactions. Injection-related adverse events are more common than those seen with oral preparations and are a recognized concern in Chinese pharmacovigilance. These injection forms are not available outside of Chinese clinical settings.

In the FDA Phase II trial of CDDP/T89, there was no statistically significant difference in adverse events between treatment and placebo groups, and no drug-related serious adverse events were reported. [Source: Tasly clinical data]

Pregnancy and Lactation

  • Pregnancy Category C: Insufficient human data. Danshen’s blood-activating and stasis-resolving properties are traditionally considered contraindicated during pregnancy in TCM, as they may promote uterine bleeding. Some TCM practitioners specifically list danshen among herbs to avoid during pregnancy. There are no adequate human studies confirming safety. NOT recommended during pregnancy.
  • Lactation: Insufficient data. No adequate studies on excretion into breast milk. Avoid use during breastfeeding as a precautionary measure.

[Source: Drugs.com danshen monograph; RxList; Medscape]

Overdose and Toxicity

  • No well-documented cases of acute danshen overdose in the Western literature.
  • LD50 studies in animals indicate a wide safety margin for oral preparations.
  • Chronic toxicity in animal studies at doses far exceeding therapeutic ranges has not demonstrated significant organ toxicity.
  • The primary risk of “overdose” is excessive anticoagulation, particularly in the context of concurrent anticoagulant use.

Clinical Dosage

Traditional Decoction (TCM)

PreparationDosageNotes
Dried root decoction9-15 g/dayStandard dose per Chinese Pharmacopoeia (2020); simmered in water for 30-45 minutes
Higher dose decoctionUp to 20 g/dayUsed in some inflammatory conditions including viral hepatitis; should be under practitioner supervision

Standardized Preparations (Modern)

PreparationDosageNotes
Compound Danshen Dripping Pills (CDDP)10 pills (27 mg each), 3 times dailyMost widely used commercial preparation in China; sublingual or oral; contains danshen + Panax notoginseng + borneol
Dantonic (T89) capsuleAs studied in FDA trialsCapsule form of CDDP for Western markets; dosing per clinical trial protocol
Sodium Tanshinone IIA Sulfonate (STS) injection40-80 mg/day IVHospital use only in China; water-soluble derivative of tanshinone IIA; for acute coronary syndromes and pulmonary heart disease
Compound Danshen InjectionPer hospital protocolContains danshen and dalbergia wood extract; IV use in Chinese clinical settings
Danshen root extract capsules/tablets500-1500 mg/day standardized extractVarious commercial products; standardization varies

Duration

  • TCM tradition supports sustained use over weeks to months for cardiovascular indications.
  • Clinical trials of CDDP have studied durations ranging from 4 weeks to several months.
  • For chronic stable angina, long-term use is typical in Chinese clinical practice.
  • Minimum treatment duration of 4-8 weeks is suggested before assessing efficacy.

Important Considerations

  • The clinical evidence applies primarily to defined combination products (especially CDDP), not to crude danshen root alone. Single-herb danshen preparations may not replicate the effects seen in CDDP trials.
  • Standardization matters: Products should meet minimum quality thresholds for tanshinone and salvianolic acid content per pharmacopoeial standards.
  • Route of administration: Injectable forms (STS, Compound Danshen Injection) have different pharmacokinetic profiles and risk profiles compared to oral preparations. They are not interchangeable.

Sources

  • Wu B, Liu M, Zhang S. Dan Shen agents for acute ischaemic stroke. Cochrane Database Syst Rev. 2007;(2):CD004295. [PubMed: 15495099]
  • Luo J et al. How efficacious is danshen (Salvia miltiorrhiza) dripping pill in treating angina pectoris? Evidence assessment for meta-analysis of randomized controlled trials. Medicine (Baltimore). 2017;96(25). [PubMed: 28650203]
  • Jia Y et al. Efficacy and safety of eight types Salvia miltiorrhiza injections in the treatment of unstable angina pectoris: A network meta-analysis. Front Pharmacol. 2022;13:958013. [PMC: 9574204]
  • Chan TYK. Interaction between warfarin and danshen (Salvia miltiorrhiza). Ann Pharmacother. 2001;35(4):501-504. [PubMed: 11302416]
  • Ge B et al. Updates on the clinical evidenced herb-warfarin interactions. Evid Based Complement Alternat Med. 2014;2014:957362. [PMC: 3976951]
  • Shang Q et al. Tanshinone IIA: A promising natural cardioprotective agent. Evid Based Complement Alternat Med. 2012;2012:716459. [PMC: 3292221]
  • Xu S, Liu P. Tanshinone II-A: New perspectives for old remedies. Expert Opin Ther Pat. 2013;23(2):149-153.
  • Zhou L et al. Tanshinones, critical pharmacological components in Salvia miltiorrhiza. Front Pharmacol. 2019;10:202. [PMC: 6426754]
  • Shi MJ et al. Cardiovascular effects of salvianolic acid B. PMC3691933.
  • Xu H et al. Salvianolic acid B inhibits platelet adhesion under conditions of flow by a mechanism involving the collagen receptor alpha2beta1. Thromb Res. 2008;123(2):298-305. [PubMed: 18625517]
  • Cheng TO. Cardiovascular effects of danshen. Int J Cardiol. 2007;121(1):9-22.
  • Ho JH, Hong CY. Salvianolic acids: small compounds with multiple mechanisms for cardiovascular protection. J Biomed Sci. 2011;18:30. [PubMed: 21575191]
  • Ren J et al. Pharmacological effects of Salvia miltiorrhiza (Danshen) on cerebral infarction. Chin Med. 2010;5:22. [PMC: 2910010]
  • Wang BQ. Salvia miltiorrhiza: Chemical and pharmacological review of a medicinal plant. J Med Plants Res. 2010;4(25):2813-2820.
  • Xu H et al. Sodium tanshinone IIA sulfonate injection as adjuvant treatment for unstable angina pectoris: a meta-analysis of 17 RCTs. Heart. 2017;103(Suppl 5):A149. [PubMed: 29181731]
  • Fan HY et al. A review of the mechanism of action of Dantonic for the treatment of chronic stable angina. Biomed Pharmacother. 2019;109:2173-2178.
  • Su CY et al. Salvia miltiorrhiza: Traditional medicinal uses, chemistry, and pharmacology. Chin J Nat Med. 2015;13(3):163-182.
  • Chinese Pharmacopoeia Commission. Pharmacopoeia of the People’s Republic of China. 2020 ed. Beijing: China Medical Science Press.
  • FDA ClinicalTrials.gov. NCT01659580. Phase III Trial of Dantonic (T89) Capsule to Prevent and Treat Stable Angina.
  • Zhang Y et al. Effect of danshen extract on the activity of CYP3A4 in healthy volunteers. Br J Clin Pharmacol. 2010;69(6):656-661. [PMC: 2883758]
  • EMA. Draft Assessment Report on Salvia miltiorrhiza Bunge, radix et rhizoma. Available at: ema.europa.eu.

Connections

  • Hawthorn: The most comparable cardiovascular herb in the Western phytotherapy tradition. Hawthorn has full European regulatory recognition (Commission E, ESCOP, EMA) while danshen has none, despite both targeting heart failure and coronary artery disease through vasodilatory and cardioprotective mechanisms.
  • Ginkgo: Another herb with antiplatelet activity and cardiovascular/cerebrovascular indications. Both share concerns about bleeding risk and interactions with anticoagulants. Ginkgo has achieved Western regulatory recognition that danshen has not.
  • Garlic: Shares antiplatelet and anti-atherosclerotic properties. Like danshen, garlic interacts with warfarin, though the interaction is less potent.
  • Olive Leaf: Another cardiovascular herb with antihypertensive and antioxidant properties, though through different mechanisms (oleuropein vs. tanshinones/salvianolic acids).
  • Astragalus: A fellow TCM herb that shares the regulatory challenge of having extensive Chinese clinical literature but minimal Western regulatory recognition. Both illustrate the structural difficulty of integrating TCM evidence into EU frameworks.

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