Hawthorn
Crataegus spp.
Evidence Rating
C Moderate
Confidence Level
High
Traditions
Western
Last Updated
2/9/2026
Summary
Hawthorn extract WS 1442 is the most rigorously studied herbal cardiac medicine. It has Commission E approval for NYHA II heart failure, ESCOP and EMA/HMPC monograph support, and was tested in a 2,681-patient mortality trial (SPICE). While the SPICE trial did not meet its primary endpoint, it demonstrated excellent safety alongside optimal heart failure medication and showed a significant reduction in sudden cardiac death in the NYHA III subgroup. The mechanism involves positive inotropy without increased myocardial oxygen demand -- a unique pharmacological profile among cardiac agents.
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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 Body | Status |
|---|---|
| Commission E (Germany) | âś“ Approved |
| ESCOP (European) | âś“ Approved |
| EMA/HMPC (EU) | âś“ Approved |
Metadata
| Field | Details |
|---|---|
| Common Names | Hawthorn, Weissdorn (German), Aubepine (French), Biancospino (Italian) |
| Botanical Name | Crataegus monogyna Jacq., C. laevigata (Poir.) DC. (syn. C. oxyacantha), and their hybrids |
| Plant Family | Rosaceae |
| Part Used | Leaf with flower (Crataegi folium cum flore) — this is the Commission E-approved part; berry preparations have a separate, weaker evidence base |
| Evidence Quality Rating | HIGH — Large RCT (n=2,681), Cochrane review, multiple meta-analyses, regulatory monographs |
Approved Indications
Commission E (Germany, 1994)
- Approved: Decreasing cardiac output as described in functional stage II of the NYHA classification
- The original 1984 monograph was revised in 1994 to upgrade the indication
- Specifically for finished medicinal products containing defined alcoholic extracts
ESCOP Monograph
- Approved: Declining cardiac performance corresponding to NYHA functional class II
- For finished medicinal products with alcoholic extracts as active ingredient
- Tea preparations: “nervous heart complaints and support of cardiovascular function”
EMA/HMPC (2016, Report No. EMA/HMPC/159076/2014)
- Well-established use: Certain defined extracts of Crataegus fulfill requirements for well-established use status based on Cochrane review evidence
- Traditional use indications:
- Symptomatic treatment of temporary nervous cardiac complaints (palpitations), after exclusion of serious conditions by a physician
- Relief of mild stress symptoms and as a sleep aid
- Note: The HMPC distinguished between well-established use (stronger evidence extracts) and traditional use (general preparations)
Agreement/Disagreement Between Bodies
- Strong agreement across Commission E, ESCOP, and EMA/HMPC on the core indication of heart failure NYHA II
- EMA/HMPC added nuance by creating a two-tier system (well-established vs. traditional use) not present in the older Commission E monograph
- No US FDA recognition — hawthorn is sold as an unregulated dietary supplement in the US
- The WHO also includes hawthorn in its monograph series with similar indications
Conditions Treated
Primary (evidence-based)
- Heart failure NYHA class II (reduced exercise tolerance, fatigue, dyspnea on exertion)
- Heart failure NYHA class III (adjunctive, based on SPICE trial subgroup data)
- Nervous cardiac complaints (palpitations without organic cause, “Herzneurose” in German tradition)
Secondary/Traditional
- Mild hypertension (supportive)
- Age-related cardiovascular decline
- Cardiac arrhythmias (limited evidence)
Mechanism of Action
Hawthorn’s pharmacology is multi-targeted and distinct from conventional cardiac drugs:
Positive Inotropy (cAMP-independent)
- WS 1442 increases force of myocardial contraction independently of the cAMP pathway [Source: Holubarsch et al., link.springer.com/article/10.1007/s40256-017-0249-9]
- This distinguishes it from beta-agonists and phosphodiesterase inhibitors, which increase oxygen demand
- Positive inotropy without increased myocardial oxygen consumption — a unique and clinically valuable profile
Endothelial Nitric Oxide (eNOS) Activation
- Induces endothelium-dependent, NO-mediated vasorelaxation
- Mechanism: eNOS phosphorylation at serine 1177
- Improves endothelial function and NO synthesis
- Delays endothelial senescence [Source: ScienceDirect, Crataegus overview]
Phosphodiesterase Inhibition
- Flavonoids and oligomeric procyanidins inhibit phosphodiesterase
- Contributes to vasodilatory and cardiotonic effects
- Complementary to the cAMP-independent inotropic mechanism
Antiarrhythmic Properties
- Protects myocardium from ischemic damage and reperfusion injury
- Protective against hypertension-related hypertrophy
Antioxidant and Anti-inflammatory
- Oligomeric procyanidins (OPCs) possess potent radical scavenging activity
- Inhibit human neutrophil elastase
- Target cAMP/Rap1 pathway to prevent endothelial hyperpermeability
Key Active Constituents
- Oligomeric procyanidins (OPCs): 17.3-20.1% in WS 1442 — primary bioactive fraction
- Flavonoids: Hyperoside, vitexin, vitexin-2-rhamnoside
- Triterpene acids: Ursolic acid, oleanolic acid
Clinical Evidence Summary
The SPICE Trial (Survival and Prognosis: Investigation of Crataegus Extract WS 1442 in CHF)
| Parameter | Details |
|---|---|
| Design | Randomized, double-blind, placebo-controlled, multicenter, international |
| Population | NYHA class II-III heart failure, LVEF <=35% |
| Sample Size | n=2,681 (WS 1442: 1,338; Placebo: 1,343) |
| Intervention | WS 1442 900 mg/day vs placebo, on top of optimal medical therapy |
| Duration | 24 months |
| Primary Endpoint | Time to first cardiac event |
| Result | Average time to first cardiac event: 620 days (WS 1442) vs 606 days (placebo). HR 0.95, 95% CI [0.82-1.10], p=0.476. Not significant. |
| Event Rates | 27.9% (WS 1442) vs 28.9% (placebo) |
| Key Secondary Finding | Significant reduction in sudden cardiac death in the NYHA III subgroup (post-hoc) |
| Safety | WS 1442 was safe to use in patients receiving optimal heart failure medication. No significant herb-drug interactions detected |
| Publication | Holubarsch et al., European Journal of Heart Failure, 2008 |
[Source: pubmed.ncbi.nlm.nih.gov/19019730/]
Other Key Trials
Tauchert 1999 (NYHA II, n=209)
- WS 1442 (900 mg/day) vs placebo, 16 weeks
- Significant improvement in exercise tolerance (bicycle ergometry)
- Significant improvement in heart failure symptoms score [Source: pubmed.ncbi.nlm.nih.gov/10546150/]
Zapfe 2001 (NYHA III, n=40)
- WS 1442 (1800 mg/day) vs placebo
- Significant improvement in exercise tolerance and symptoms
- First evidence supporting use in NYHA III [Source: pubmed.ncbi.nlm.nih.gov/12040357/]
Tauchert 1994 (NYHA II, n=132)
- WS 1442 vs placebo, 8 weeks
- Significant improvement in pressure-heart-rate product during exercise [Source: pubmed.ncbi.nlm.nih.gov/8375791/]
Cochrane Review (Guo et al., 2008)
- Included 14 RCTs (n=855 total in earlier version)
- Concluded: significant benefit in maximal workload, exercise tolerance, pressure-heart-rate product, and symptom scores (dyspnea, fatigue)
- Evidence supports use as adjunctive treatment for heart failure
HEpEF Trial (Exercise + WS 1442 in HFpEF)
- Examined WS 1442 combined with endurance exercise in heart failure with preserved ejection fraction (HFpEF)
- Showed positive effects on quality of life measures [Source: mdpi.com/2075-4418/2/3/59]
European vs US/Anglophone Consensus
| Aspect | European Position | US/Anglophone Position |
|---|---|---|
| Regulatory status | Registered phytopharmaceutical; physician-prescribed in Germany | Unregulated dietary supplement |
| Clinical guidelines | Referenced in some European heart failure guidelines as adjunctive option | Not mentioned in AHA/ACC guidelines |
| Insurance coverage | Historically covered by German statutory health insurance (Gesetzliche Krankenversicherung); coverage reduced since 2004 reforms | Not covered |
| Medical education | Taught in German pharmacy and medical curricula | Barely mentioned in US medical education |
| Clinical perception | Respected evidence-based phytomedicine | Often dismissed as “alternative medicine” |
| Key disconnect | SPICE trial (n=2,681) is larger than many pivotal trials for approved cardiovascular drugs, yet hawthorn remains invisible in US practice |
Safety Profile
Contraindications
- Known hypersensitivity to Crataegus or other Rosaceae members
- No absolute contraindications identified by Commission E
- Should not replace guideline-directed medical therapy for heart failure
Drug Interactions
- No clinically significant herb-drug interactions detected in clinical trials, including the SPICE trial where patients received standard heart failure medications (ACE inhibitors, beta-blockers, diuretics, digoxin)
- Theoretical concern: avoid co-administration with drugs known to prolong QT interval (increased ECG monitoring recommended)
- Does not appear to interact with digoxin, warfarin, or standard heart failure medications based on clinical data
Side Effects
- Generally very well tolerated
- Mild GI complaints (nausea, dizziness) reported rarely
- Allergic reactions reported very rarely
- No toxicity observed even at doses up to 1800 mg/day in clinical trials
Pregnancy and Lactation
- Insufficient data — not recommended during pregnancy or lactation
- No teratogenicity signals in preclinical data, but human data lacking
- Commission E and ESCOP: contraindicated or “not recommended” in pregnancy/lactation as precaution
Long-term Safety
- Evidence supports safety of long-term use (SPICE trial: 24 months)
- No accumulation concerns even in patients with renal dysfunction
- Post-marketing surveillance data from decades of German pharmaceutical use is reassuring
Clinical Dosage
| Preparation | Dosage | Notes |
|---|---|---|
| WS 1442 extract (standardized to 17.3-20.1% OPCs) | 900 mg/day (divided into 2-3 doses) | Most studied dose; used in SPICE trial |
| WS 1442 high-dose | 1800 mg/day | Used in NYHA III trial (Zapfe 2001) |
| General standardized extract | 160-900 mg/day | Commission E range |
| Extract standardized to 2.2% flavonoids | 240-480 mg/day | Alternative standardization used in some products |
| Dried drug (tea) | 1-1.5 g per cup, 3-4 times daily | Traditional use only; not for heart failure indication |
| Duration | Minimum 6 weeks for clinical effect | Longer-term use (months to years) supported by evidence |
Key point: The clinical evidence applies specifically to defined extracts (particularly WS 1442). Generic hawthorn supplements with uncharacterized phytochemical profiles should not be assumed equivalent.
Sources
- Holubarsch CJF et al. The efficacy and safety of Crataegus extract WS 1442 in patients with heart failure: The SPICE trial. Eur J Heart Fail. 2008;10(12):1255-1263. [PubMed: 19019730]
- Tauchert M. Efficacy and safety of crataegus extract WS 1442 in comparison with placebo in patients with chronic stable NYHA class-III heart failure. Am Heart J. 2002;143(5):910-915. [PubMed: 12040357]
- Holubarsch CJF et al. Benefit-Risk Assessment of Crataegus Extract WS 1442: An Evidence-Based Review. Am J Cardiovasc Drugs. 2018;18:25-36.
- EMA/HMPC Assessment Report on Crataegus spp., folium cum flore (EMA/HMPC/159076/2014), 2016
- German Commission E Monograph: Crataegi folium cum flore (1994 revision)
- ESCOP Monograph: Crataegi folium cum flore
- Guo R et al. Hawthorn extract for treating chronic heart failure. Cochrane Database Syst Rev. 2008.
Connections
- Compare with Ginkgo for another phytomedicine with large-trial evidence
- Compare with Horse Chestnut for another herb with Cochrane-level evidence