Dong Quai

Metadata

Approved Indications

Commission E (Germany)

• No Commission E monograph exists for Angelica sinensis

ESCOP

• No ESCOP monograph exists for Angelica sinensis

EMA/HMPC

• Status: MONOGRAPH REJECTED (2013)
• Assessment report: EMA/HMPC/614586/2012 (July 2013)
• Reasons for rejection:
  1. Inadequate evidence of at least 30 years of medicinal use, including at least 15 years within the European Union
  2. Preliminary evidence of toxicological concerns in relation to phytochemistry
  3. Use requiring supervision of a medical practitioner (incompatible with traditional use registration)
• Current EU status: Available only as food/dietary supplement under Directive 2002/46/EC

Health Canada

• Has issued a monograph with indications: traditionally used in herbal medicine as a blood tonic and to promote blood circulation; to relieve dysmenorrhea, irregular menstruation, and menopausal symptoms

Agreement/Disagreement Between Bodies

• Unanimous European rejection: No major European regulatory body has adopted Dong Quai
• Contrast with TCM: In TCM pharmacopeias, Dong Quai is a first-tier gynecological herb
• Health Canada: More permissive, acknowledging traditional use
• This divergence between TCM tradition and European regulatory assessment is the defining feature of Dong Quai’s profile

Conditions Treated

Traditional (TCM Framework)

• Blood deficiency syndromes: Amenorrhea, dysmenorrhea, irregular menstruation
• Blood stasis: Trauma, pain, abscesses
• Intestinal dryness: Constipation
• Used in combination: Almost always combined with other herbs in TCM formulas (Dang Gui Bu Xue Tang, Si Wu Tang, etc.)
• Not typically used as single herb in TCM

Marketed Uses in Western Context

• Menstrual cramps / dysmenorrhea
• Menstrual irregularities
• Menopausal symptoms
• General “female tonic”
• Anemia (traditional claim)

Evidence Assessment

• Menopausal symptoms (monotherapy): Negative — single RCT showed no benefit
• Dysmenorrhea: No controlled trials as monotherapy [NEEDS-RESEARCH]
• Menstrual irregularities: Anecdotal and traditional only; no controlled evidence
• In combination formulas: Some positive evidence from TCM formula studies, but effects cannot be attributed to Dong Quai alone

Mechanism of Action

Specific Compounds

Proposed Mechanisms

1. Uterine smooth muscle effects: Ligustilide and butylidenephthalide may have antispasmodic effects on uterine muscle — could explain traditional use for dysmenorrhea
2. Estrogenic activity: Disputed. Some in vitro studies suggest weak estrogenic binding; the Hirata 1997 RCT found no estrogenic effects (no change in endometrial thickness, vaginal maturation, FSH, estradiol)
3. Hematopoietic effects: Polysaccharides may stimulate blood cell production — this aligns with TCM “blood tonic” concept
4. Anticoagulant activity: Coumarins and ferulic acid inhibit platelet aggregation
5. Antioxidant: Ferulic acid and related compounds

Critical Assessment of Mechanism

• No clearly established mechanism for menopausal symptom relief
• Estrogenic hypothesis not confirmed in the only adequate clinical trial
• Antispasmodic mechanism for dysmenorrhea is plausible but untested in humans
• Most evidence is from in vitro or animal studies, with very limited clinical translation

Clinical Evidence Summary

The Key Trial: Hirata et al. 1997

Other Evidence

Evidence Assessment

• Single adequate RCT: Negative for the primary marketed indication (menopause)
• No adequate RCTs for dysmenorrhea as monotherapy
• Combination formula evidence cannot be attributed to Dong Quai alone
• Represents the weakest evidence base among the seven herbs reviewed

European vs. US/Anglophone Consensus

The TCM vs. Evidence-Based Phytotherapy Tension

• In TCM, Dong Quai is almost never used alone; it is part of complex multi-herb formulas
• European evidence-based phytotherapy evaluates single-herb efficacy
• This methodological mismatch may partly explain the negative clinical trial result
• However, even within TCM, the evidence for formula-level efficacy is limited by modern standards

Safety Profile

Contraindications

• Known hypersensitivity to Angelica sinensis or Apiaceae
• Anticoagulant therapy: Absolute contraindication — documented potentiation of warfarin
• Bleeding disorders: Anticoagulant and antiplatelet activity
• Planned surgery: Discontinue at least 2 weeks before surgical procedures
• Hormone-sensitive conditions: Precautionary avoidance (unconfirmed estrogenic activity)

Drug Interactions — SIGNIFICANT

Side Effects

• Gastrointestinal: burping, gas, bloating
• Photosensitivity: Furanocoumarins (psoralen, bergapten) can cause phototoxic reactions; increased UV sensitivity
• Elevated blood pressure (reported but uncommon)
• Skin rash (rare)
• Heavy menstrual bleeding (if used in menstruating women — consistent with anticoagulant effect)

Pregnancy and Lactation

• Pregnancy: Contraindicated — uterotonic potential, anticoagulant activity, furanocoumarin content
• Lactation: Not recommended — insufficient safety data
• Fertility: No established benefit; safety in preconception period uncertain

Toxicological Concerns (Cited in EMA Rejection)

• Furanocoumarins: Photosensitizing and potentially photocarcinogenic with UV exposure
• Coumarins: Anticoagulant activity at pharmacologically relevant doses
• Safrole: Trace amounts of safrole (a known hepatocarcinogen) have been detected in some Angelica species [NEEDS-RESEARCH for A. sinensis specifically]

Clinical Dosage

Traditional Dosage Forms

Important Notes on Dosage

• No standardized extract with clinical validation exists (unlike Remifemin for Black Cohosh or Ze 440 for Vitex)
• TCM dosing is formula-dependent and prescribed by practitioners, not self-administered
• Western supplement dosing is empirical, not evidence-based
• Maximum duration: 6 months suggested for supplement use (though this is arbitrary)

Connections

• Represents the polar opposite of Black Cohosh and Vitex Chasteberry in terms of European regulatory validation
• Anticoagulant interactions are the most clinically important safety finding; compare with the milder anticoagulant concerns for Evening Primrose Oil and Red Clover
• For menstrual disorder indications, Vitex Chasteberry has far superior evidence