danshen

Danshen (Salvia miltiorrhiza Bunge): A Comprehensive Reference

1. Identity, Botanical Description, and Common Names

Danshen is the dried root and rhizome of Salvia miltiorrhiza Bunge, a perennial plant belonging to the genus Salvia of the family Lamiaceae. Its official pharmacopoeial designation is Salviae Miltiorrhizae Radix et Rhizoma. It is also known as red sage or Danshen (Chinese Pinyin name), and is a perennial plant in the genus Salvia of the mint family, Lamiaceae.

Common English-language synonyms include Chinese red sage, Chinese sage, red root sage, and red sage. It should be noted that more than 20 Salvia species have been used under the name of Danshen; however, according to the Chinese Pharmacopoeia (PPRC-2010), only Salvia miltiorrhiza meets the requirements to be ascribed as the formal Danshen. At least 19 other Salvia species have been used traditionally as Danshen in some local areas, and of these, S. bowleyana Dunn. and S. przewalskii Maxim. are the most common substitutes; both have a chemical composition similar to S. miltiorrhiza, including salvianolic acids and tanshinones.

Danshen is the dried root of S. miltiorrhiza (Labiatae) and is one of the most versatile Chinese herbal drugs, sometimes described as Chinese sage or red sage root. The consumption of Danshen in the world exceeds 20 million kilograms per year. Danshen is commonly used in Asia, including China, Japan, and Korea, with markets in America and Europe growing substantially; it is included in multiple pharmacopeias, with salvianolic acid B and tanshinone IIA used as quality markers.

2. Traditional and Historical Use

2.1 China

Its roots are highly valued as a "super grade herb (herbs lacking observable toxicity)" in the Shennong's Herbal Classic of Materia Medica (Shennong Bencao Jing) written during the reign of the Qin and Han dynasties (221 BC to 220 AD), and it has been clinically used for more than 2,000 years. Classified as a top-grade herb in that canon, it is characterized by a bitter taste, slightly cold properties, and is associated with the heart and liver meridians.

Traditional applications include removing blood stasis, relieving pain, promoting blood circulation, dredging meridians, clearing the heart, alleviating vexation, cooling the blood, and eliminating carbuncles. Following this first record, S. miltiorrhiza was well described in classical TCM works such as the Compendium of Materia Medica (Bencao Gangmu, Ming Dynasty, 1596 AD).

It was classified as a top-grade medication in the Shennong Bencao Jing for the treatment of heart and spleen disease, to clear the blood circulation system, relieve irritation, and replenish the Qi. Danshen has also been recommended for the treatment of angina pectoris in the Yi Xue Xiao Jin Zhen (Medical Golden Needle, published in China, 1916).

Danshen is classified within the heart and liver meridians and is renowned for its ability to activate collaterals and blood vessels, facilitate the removal of blood stasis without compromising vital Qi. It plays a pivotal role in promoting blood circulation and alleviating blood stasis. Clinically, it was commonly used to treat uterine bleeding, irregular menstruation, blood stasis, and abdominal pain, among other symptoms.

Danshen was used infrequently in ancient Chinese medicine, yet it has become an important herb in modern Chinese clinical practice. In clinical practice, Danshen has been developed into more than thirty pharmaceutical dosage forms for the therapy of cardiovascular disease, hepatic injury, pneumonia, chronic nephritis, and arthrophlogosis.

2.2 Korea and Japan

According to the original Korean text of the Donguibogam (written in the 17th century), Dansam (the Korean name) effectively removes blood stasis and enriches the blood. The dried roots have been used as folk or traditional medicine in Japan, Korea, and China for hundreds of years to treat a variety of diseases, such as cancers, cardiovascular diseases, liver diseases, and nervous system diseases.

2.3 Traditional Preparations

In Chinese traditional medicine there were two primary types of S. miltiorrhiza preparations used by patients: directly prepared herbal raw materials (decoctions, extracts, tinctures) and Chinese patent medicines (water pills, honey pills). The use of other products such as injection and ultrafine granular powder has been increasing significantly.

Danshen tea is widely used as a healthy food to prevent coronary heart disease. The daily dose in traditional use is given as 9–15 g, with the duration of use unspecified in many classical sources. A prominent traditional compound formula, the Danshen Decoction (Danshen Yin), combined danshen with other herbs for the treatment of epigastric pain and blood stasis. The Danshen-Shanzha formula, pairing danshen root with hawthorn fruit (Crataegus pinnatifida), was originally used in folk medicine since the Han Dynasty. It was used clinically by Dr. Jin-Mo Shi in the late Qing Dynasty, who believed this combination had the effect of promoting Qi and blood circulation, removing blood stasis, and relieving pain. This prescription was officially recorded in the book "Shi Jin-Mo's Clinical Experience on Medicine" in 1982.

3. Key Constituents and Active Compounds

More than 200 compounds have been identified from Salvia miltiorrhiza. Up to now, more than 50 compounds from aqueous extracts and over 80 lipophilic compounds have been isolated from Danshen. These constituents are conventionally divided into two major chemical families based on their polarity.

3.1 Lipophilic (Fat-Soluble) Constituents: Tanshinones

The main active components of S. miltiorrhiza can be divided into two parts, water-soluble salvianolic acids and lipid-soluble tanshinones. The lipid-soluble components mainly include tanshinone I, tanshinone IIA (Tan-IIA), dihydrotanshinone I, and cryptotanshinone.

Tanshinone IIA (Tan-IIA) is the main fat-soluble component of Salvia miltiorrhiza. Chemically, tanshinones are abietane-type diterpenoid quinones. Tan-IIA modulates multiple targets including Nrf2, AMPK, GSK-3β, EGFR, CD36, HO-1, NOX4, Beclin-1, TLR4, TNF-α, STAT3, Caspase-3, and Bcl-2 proteins, and multiple pathways including NF-κB, SIRT1/PGC1α, MAPK, SREBP-2/Pcsk9, Wnt, PI3K/Akt/mTOR, TGF-β/Smad, and Hippo/YAP pathways.

The most commercially available preparations from Danshen extract are primarily formulated with ethanol extract, in which the diterpenoid tanshinones—including cryptotanshinone, tanshinone IIA, and tanshinone I—are the major components, accounting for approximately 95% of the total amount.

3.2 Hydrophilic (Water-Soluble) Constituents: Phenolic Acids

The water-soluble components include Danshensu (3,4-dihydroxyphenyllactic acid), salvianolic acid B, and protocatechualdehyde. The identified active compounds include Danshensu, salvianolic acid B, protocatechuic acid, catechin, protocatechualdehyde, tanshinone, tanshinone IIA, tanshinone VI, lithospermate B, cryptotanshinone, and polysaccharides.

Both salvianolic acid A and B are active components of Salvia miltiorrhiza that have various pharmacological activities. A large number of pharmacological studies have shown that Danshen and its main components—including fat-soluble tanshinones (tanshinone IIA, tanshinone I, cryptotanshinone, and dihydrotanshinone I) and water-soluble salvianolic acids (salvianolic acid A, salvianolic acid B, and rosmarinic acid)—exhibit pharmacological activities including anti-inflammatory, antioxidant, anti-tumor, and anti-fibrosis activity, as well as modulation of immune response.

3.3 Other Identified Constituents

A variety of chemical constituents including tanshinones, salvianolic acids, polysaccharides, flavonoids, and volatile oils have been isolated and identified from Danshen using traditional extraction methods (decoction, infusion, maceration, continuous reflux extraction) and newer technologies (semi-bionic extraction, ultrasonic extraction, and supercritical fluid extraction).

4. Mechanisms of Action

4.1 Cardiovascular and Vascular Mechanisms

Accumulating evidence suggests that Danshen and its components prevent vascular diseases, in particular atherosclerosis and cardiac diseases, including myocardial infarction, myocardial ischemia/reperfusion injury, arrhythmia, cardiac hypertrophy, and cardiac fibrosis. Both lipophilic constituents (tanshinone I, tanshinone IIa, tanshinone IIb, cryptotanshinone, dihydrotanshinone) and hydrophilic constituents (danshensu, salvianolic acid A and B, protocatechuic aldehyde) contribute to cardiovascular protective actions, suggesting a potential synergism among these constituents.

Pharmacological examinations showed that the plant and its active ingredients—tanshinones and salvianolic acids—have anticoagulant, vasodilatory, increased blood flow, anti-inflammatory, free radical scavenging, mitochondrial protective, and other activities.

Tan-IIA induces remarkable cardioprotective effects via enhancing angiogenesis, which may serve as an effective treatment against cardiovascular diseases. Salvianolic acid A and B have been shown to increase capillary density by promoting the expression of VEGF, VEGFR-2, and MMP-9.

4.2 Antioxidant Mechanisms

Danshen may enhance endogenous anti-oxidative enzyme activities such as the expression of endothelial nitric oxide synthase and may scavenge oxygen free radicals. Substantial evidence has shown that Danshen extracts can suppress oxidative stress by increasing the activity of superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), and catalase (CAT), as well as reducing reactive oxygen species (ROS) and malondialdehyde (MDA) levels in diabetic renal tissue and paracetamol-induced liver injury models.

4.3 Anti-inflammatory and Immunomodulatory Mechanisms

Tanshinones and salvianolic acids isolated from Danshen are considered to be the main components of its biological activity and pharmacology, playing important roles in increasing the index of immune organs, regulating the number and function of immune cells, and releasing immunoreactive substances. Especially tanshinone IIA, cryptotanshinone, salvianolic acid B, and rosmarinic acid show good biological activity in treating rheumatoid arthritis, some immune-mediated inflammatory diseases, psoriasis, and inflammatory bowel disease.

4.4 Antiplatelet and Anticoagulant Mechanisms

Danshen and its active ingredient rosmarinic acid exhibit antiplatelet effects through the inhibition of ERp57, a member of the protein disulfide isomerase (PDI) family with potential roles in platelet aggregation. Danshen extract exhibited potent inhibitory effects on platelet aggregation induced by arachidonic acid.

Prevention and treatment of cerebral infarction by Danshen involves multiple pathways, including anti-atherosclerosis, anti-hypertension, anti-platelet aggregation, anti-inflammatory, and anti-oxidative effects.

4.5 Hepatoprotective Mechanisms

Network pharmacology analysis revealed that six potential active ingredients—including tanshinone IIA, salvianolic acid B, and Danshensu—may contribute to the hepatoprotective effects of Danshen on alcoholic liver disease (ALD) and non-alcoholic fatty liver disease (NAFLD). The mechanism of action may relate to regulating intracellular molecular targets such as PPARα, CYP1A2, and MMP2 for regulation of lipid metabolism, antioxidant effects, and anti-fibrogenesis.

5. Scientific Evidence by Area of Use

5.1 Cardiovascular Disease

Since 2000, 39 clinical trials have been identified that used S. miltiorrhiza in TCM prescriptions, alone or with other herbs, for the treatment of patients with cardiovascular disease (CVD).

A meta-analysis of sixty randomized clinical trials indicated that Danshen Dripping Pill—consisting of S. miltiorrhiza, Panax notoginseng, and Dryobalanops camphora—showed much more apparent efficacy compared to isosorbide dinitrate. However, the overall evidence base for Danshen-only preparations in cardiovascular outcomes is more limited. Limited clinical studies have shown efficacy in coronary artery disease, but the quality of methodology limits the validity and extrapolation of these findings.

One randomized, placebo-controlled, double-blind crossover trial enrolled patients aged 40–70 years with hyperlipidemia and hypertension, randomizing 20 analyzed participants to treatment with Danshen (water-extract of the Salvia miltiorrhiza root) or placebo for 4 consecutive weeks, with a 4-week washout period. This study found no significant beneficial effect on the assessed cardiovascular risk factors, illustrating that evidence for some commonly ascribed indications remains mixed.

A placebo-controlled, prospective, randomized study examined biochemical indices in coronary heart disease (CHD) patients. Patients received 10 Danshen pills (27 mg/pill) in the Danshen group, while control patients received placebo pills, three times daily; the duration of follow-up was three months. Several clinical trials showed improvement of the lipid patterns of hyperlipidemic patients and protective properties in patients with liver or renal injury.

Compound Danshen Dripping Pills (CDDP), a compound TCM preparation composed of Salvia miltiorrhiza, Panax notoginseng, and borneol, was approved in China in 1994 as a drug for the treatment of coronary heart disease and angina pectoris. In China, CDDP is the most prevalent herbal medicine used against cardiovascular diseases. It was first launched by the China Food and Drug Administration in 1995, and has been approved by the Australian Therapeutic Goods Administration. It has also been undergoing a phase-III clinical trial overseen by the US Food and Drug Administration.

Evidence strength: Evidence from Chinese clinical trials suggests benefit in coronary artery disease and angina when Danshen is used in combination formulas, but Western-standard systematic reviews consistently note that most individual trials are of low methodological quality, lack adequate blinding, and do not report all-cause mortality or long-term follow-up. The evidence for Danshen as a standalone intervention for cardiovascular outcomes in Western-standard RCTs is limited.

5.2 Cerebrovascular Disease and Stroke

Limited clinical studies have shown efficacy in acute ischemic stroke, but the quality of methodology limits the validity and extrapolation of these findings. One meta-analysis included 11 trials in which danshen was compared with other medicines, and another included 6 trials in which danshen was compared with placebo. A third meta-analysis included trials examining many traditional Chinese medicines, including danshen. Although improvement in neurological deficit was reported with danshen use, quality of life was not assessed, and deaths from any cause were not reported. Long-term follow-up was not reported, and few trials reported adverse reactions. The authors of all three meta-analyses questioned the quality of trials and ultimately were not able to make definitive statements about the role of danshen in therapy.

A meta-analysis showed the effectiveness of tanshinone IIA in brain protection in animal models of cerebral ischemic injury. This, however, represents preclinical rather than clinical evidence.

Evidence strength: Preliminary and insufficient for definitive conclusions. Meta-analyses are limited by poor methodology of constituent trials.

5.3 Liver Disease

Radix salviae miltiorrhizae (Danshen), a classic TCM herb, has been used for centuries to treat liver diseases. In vivo results indicated that Danshen could alleviate hepatic inflammation, fatty degeneration, and hepatic fibrogenesis in ALD and NAFLD animal models. A significant reduction in MDA levels in both ALD and NAFLD models implies decreased levels of oxidative stress. The hepatoprotective effects of Danshen have been proved by several clinical trials in NAFLD and hepatocarcinoma patients in recent years. The total extracts of Danshen and its components such as tanshinol A, tanshinone I, tanshinone IIA, dihydrotanshinone I, neotanshinone A, cryptotanshinone, salvianolic acid A, and salvianolic acid B were found to exhibit hepatoprotective effects in various hepatic cell lines and animal models against viral hepatitis, paracetamol-induced hepatitis, hepatic fibrosis, and hepatocarcinoma.

Evidence strength: Supported by substantial preclinical (in vitro and animal) data and some clinical trial evidence, but large, well-controlled Western-standard RCTs are limited.

5.4 Metabolic Conditions (Lipids, Diabetes)

Salvia miltiorrhiza, also known as Danshen, is a highly frequented Chinese traditional medicinal herb and a health-promoting food used extensively against diabetes, cardiovascular, and cerebrovascular ailments. Crude extracts and pure compounds isolated from Danshen exhibit a wide range of pharmacological effects, including anti-atherosclerotic, anti-arrhythmic, anti-thrombotic, anti-hypertensive, anti-myocardial ischemia-reperfusion injury, endothelial dysfunction protection, sedative and analgesic, neuroprotective, anti-depressive, anti-hepatic fibrosis, anti-pulmonary fibrosis, anti-renal fibrosis, anti-inflammatory, anti-oxidative, anti-tumor, and anti-diabetic effects. Most of this evidence, however, derives from cell and animal studies; controlled clinical evidence for anti-diabetic effects is limited.

Evidence strength: Largely preclinical (in vitro and animal). Human evidence for metabolic outcomes requires more robust trials.

5.5 Oncology (Adjunctive Use)

A systematic review and meta-analysis of high-quality RCTs using Chinese formulas including Danshen for cancer treatment found that Danshen formulae combined with chemotherapy were better than a conventional drug treatment plan alone. Tan-IIA shows multiple pharmacological effects, including anticarcinogenic, cardiovascular, nervous, respiratory, urinary, digestive, and motor system activities. Much of the oncological research on Danshen components remains at the in vitro or animal stage.

Evidence strength: Preliminary. Anti-cancer activity is well-documented in cell and animal models; human clinical evidence is limited and is primarily in the context of adjunctive use with conventional chemotherapy.

5.6 Bone and Skeletal Health

Red sage (Salvia miltiorrhiza Bunge), also known as Danshen, has been used historically and is currently exploited in combination with other herbs to treat skeletal diseases in traditional Chinese medicine. The promise of Salvia miltiorrhiza may not only lay in the pharmacological efficacy of herbal extracts but also as a source of highly potent osteogenic, anti-osteoclastogenic, and anti-cathepsin K modulators, which could be superior to the traditional Western approach that primarily relies on a single drug against a single anti-osteoporotic target.

Evidence strength: Preliminary; predominantly in vitro and animal research, with very limited human trial data for skeletal indications.

5.7 Immune-Mediated Inflammatory Diseases

Especially tanshinone IIA, cryptotanshinone, salvianolic acid B, and rosmarinic acid show good biological activity in treating rheumatoid arthritis, some immune-mediated inflammatory diseases, psoriasis, and inflammatory bowel disease. These findings are largely from preclinical models.

Evidence strength: Preclinical. Robust human clinical trials specifically for rheumatoid arthritis and IBD are lacking.

6. Dosage Forms and Reported Dosages

There are several types of Danshen preparations for clinical application, including injections, capsules, tablets, granules, medicinal granules, and dripping pills. In China, commercially available forms include tablets, capsules, granules, injectables, oral liquids, sprays, and dripping pills (which are made by blending herbal extract with excipients under thermal conditions, followed by dripping the mixture into an insoluble cooling liquid in which the droplets are solidified to form the "dripping pill").

Specific dosages reported in published studies include:

• Danshen root extract 5 g twice daily for 60 days has been used in diabetic patients with coronary heart disease.
• Ten Danshen pills (27 mg/pill) three times daily were administered in a placebo-controlled study of CHD patients, with a three-month follow-up period.
• In traditional Chinese medicine, the daily dose from the root is given as 9–15 g, with the duration of use unspecified in many sources.
• Doses of danshen 20 mg/kg in capsule form have been used in studies.
• In a pharmacokinetic interaction study, 7 days of Danshen capsule administration was given to twenty healthy male volunteers.

Active components in commercially available preparations of danshen vary greatly. Results of quality control studies show that processing causes huge quality variation among market samples, especially in tanshinones, resulting in significant variation of biological activity.

7. Body Systems and Health Areas

Based on the scientific literature, Danshen has been studied in relation to the following body systems:

• Cardiovascular system: Danshen is an eminent medicinal herb that possesses broad cardiovascular and cerebrovascular protective actions and has been used in Asian countries for many centuries. Research covers coronary artery disease, angina pectoris, myocardial ischemia/reperfusion injury, arrhythmia, cardiac hypertrophy, cardiac fibrosis, and atherosclerosis.
• Cerebrovascular system: Danshen, the dried root of Salvia miltiorrhiza, is used in Chinese medicine to treat vascular disease. According to Chinese medicine theory, Danshen promotes blood flow and resolves blood stasis. Research covers ischemic stroke and cerebral infarction.
• Hepatic system: It is widely indicated for liver disorders caused by blood stasis accumulation and obstruction. The hepatoprotective effects of Danshen have been proven by several clinical trials in NAFLD and hepatocarcinoma patients in recent years.
• Immune system: Most studies on Danshen focus on the treatment of cardiovascular and cerebrovascular diseases; however, the pharmacological effects of Danshen and its main constituents on regulating the immune response and immune-related diseases have been systematically reviewed. Tanshinones and salvianolic acids play roles in the treatment of autoimmune diseases and common immune-mediated inflammatory diseases.
• Musculoskeletal system: Danshen constituents have been studied for osteogenic and anti-osteoclastogenic activity, as well as in models of osteoarthritis.
• Oncology: Tan-IIA shows pharmacological effects including anticarcinogenic activity across multiple organ systems.
• Endocrine/Metabolic system: Anti-diabetic and lipid-modulating activities have been reported in preclinical studies.
• Reproductive system: Danshen had been used to treat irregular menstruation, cold hernia, and abdominal pain within the framework of TCM theory.

8. Safety Considerations and Drug Interactions

8.1 General Tolerability

When taken by mouth, Danshen is possibly safe and is usually well-tolerated. Side effects might include upset stomach, itching, and reduced appetite. Adverse reactions reported include allergy, dizziness, headache, mild GI symptoms, and reversible thrombocytopenia. S. miltiorrhiza has very low acute toxicity, with an LD50 by injection of 40–80 g/kg in animal studies.

8.2 Interaction with Warfarin (Well-Documented)

The interaction between Danshen and warfarin is among the most clinically significant and best-documented herb–drug interactions. Because of both pharmacokinetic and pharmacodynamic interactions, danshen should be avoided in patients taking warfarin.

In vitro studies have found that tanshinones in danshen inhibit CYP1A1, 2C6, and 2C11-mediated warfarin metabolism, and that sodium tanshinone IIA sulfonate replaces warfarin from the binding site on the human serum albumin–warfarin complex, increasing free warfarin concentration. A controlled clinical trial (n = 40) concluded that concomitant administration of two weeks of danshen with warfarin significantly prolonged prothrombin time (PT) and INR compared to those in the control group.

Danshen can increase the international normalized ratio of coagulation time and the risk of bleeding in patients administered warfarin, through decreasing the elimination of warfarin.

8.3 Interaction with Digoxin

Danshen may interfere with laboratory digoxin plasma levels and increase the anticoagulant effect of warfarin. Digoxin helps the heart beat more strongly; danshen also seems to affect the heart. Taking danshen along with digoxin can increase the effects of digoxin and increase the risk of side effects.

8.4 Interaction with Other Antiplatelet/Anticoagulant Drugs

Co-administration of multiple doses of Danshen capsules caused increases in apparent oral clearance of clopidogrel and its metabolite by 96.5% and 73.7%, respectively, and corresponding declines in Cmax and AUC in human volunteers. This demonstrates a clinically relevant pharmacokinetic interaction with clopidogrel.

Danshen tablet potently inhibited the metabolism of rivaroxaban in rat and human liver microsomes. This inhibition may be because its lipid-soluble components such as dihydrotanshinone I strongly inhibit the activities of CYP enzymes, especially CYP3A and CYP2J. When Danshen tablet and rivaroxaban are used simultaneously in the clinic, it is necessary to strengthen drug monitoring of rivaroxaban and adjust the dosage.

8.5 CYP450 and P-glycoprotein Interactions

The major components of danshen—tanshinones—are regarded as the substance basis for danshen–drug interaction. Influence on P-glycoprotein (P-gp) and cytochrome P450 (CYP) by these tanshinones is considered a potential reason for danshen–drug interactions. Danshen has been shown to induce intestinal CYP3A4. Using human liver microsomes and recombinant CYP isozymes, different inhibitory potency against various CYPs has been observed for Danshen extract and its individual constituents. Water-soluble constituents from Danshen tend to exert little or weak inhibitory effect on CYPs, except for tanshinol and salvianolic acid B.

8.6 Quality and Adulteration Concerns

Reports state that substitute species and the increase of new cultivars exacerbate quality problems with Danshen. At least 19 other Salvia species have been used traditionally as Danshen in some local areas. Quality control studies show that processing causes huge quality variation among market samples, especially in tanshinones, resulting in significant variation of biological activity.

8.7 Traditional Contraindications

S. miltiorrhiza is not suitable for patients who have deficiency but not stasis, or deficiency accompanied by cold, or with a tendency to bleed, according to TCM categorization.

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