Hawthorn

Hawthorn (Crataegus spp.): A Comprehensive Reference

1. Identity and Botanical Classification

Taxonomy and Species

Crataegus sp., commonly known as hawthorn or hawberry, is a large genus of thorny shrubs and trees belonging to the family Rosaceae, comprising approximately 280 species, native to zones with a mild climate in Europe, East Asia, and North America. The genus is a member of the Rosaceae family and encompasses about 1,000 species worldwide, widely cultivated in many countries throughout the Northern Hemisphere, including China, the United States, France, Great Britain, and Mexico.

Several species are of primary medicinal and commercial importance:

• Crataegus pinnatifida, C. laevigata, C. monogyna, and C. oxyacantha represent the key medicinal species, found throughout Asia, Europe, and North America.
• The botanical name of the genus is Crataegus, belonging to the Rosaceae family of plants. Although there are hundreds of species of Crataegus, when people refer to the common hawthorn, they typically mean Crataegus monogyna.
• Countries such as China, Germany, and France have officially recorded some species in their pharmacopeias.

Plant Parts Used

Derived from the flower, leaves, and fruits of the plant, hawthorn is also known in Asia as Shan Zha. The leaf, flower, and fruit of hawthorn, due to the presence of bioactive compounds such as flavonoids, procyanidins, organic acids, and amines, show a wide range of effects on the cardiovascular system. The fruit is the main part of the plant used in Chinese medicine.

Common Preparations and Dosage Forms

Hawthorn preparations are widely available in various forms, from tinctures to extracts, as both prescription drugs and over-the-counter medications. Extracts are produced from the plant material using a predominantly hydroalcoholic solvent equivalent in strength to a minimum of 45% ethanol. The most studied and popular preparations are WS 1442 and LI 132, both derived from leaves and flowers of the plant.

Regarding the two principal standardized extracts:

• Crataegus special extract WS 1442 is a standardized aqueous alcoholic (45% ethanol) hawthorn extract containing 18.75% oligomeric procyanidins (OPC), which play a role as free-radical scavengers that protect the ischemic heart tissue from neutrophil elastase activity.
• Hawthorn extract WS 1442 is standardized to 18.75% oligomeric procyanidins. Hawthorn extract LI 132 is standardized to 2.2% flavonoids.

The hawthorn berry is also used as a food, prepared as jam or jelly, and made into a fruit drink. The fruit is sold whole (processed with sugar) and has been made into popular food products in the form of sugared strips eaten as a confection; hawthorn juice has also been manufactured into fruit drinks, soft drinks, and a vinegar product.

2. Traditional and Historical Use

Ancient China

In China, the bright red berries of hawthorn, also called Shanzha, have been extensively used to treat various ailments. It was first mentioned for "treating dysentery" in the Tang Materia Medica (Tang Ben Cao) dating back to 659 AD, the first known official pharmacopeia in the world. Hawthorn is particularly prevalent and extensively applied in China, where the fruits of some species have been consumed for almost a millennium. The medical text Compendium of Materia Medica (Ben Cao Gang Mu) documents its usage in traditional Chinese medicine, describing its efficacy in transforming food and drink, reducing meat accumulation, shrinking masses and lumps, healing phlegm-fluid retention, lessening distension, alleviating fullness, addressing acid regurgitation, dealing with blood stasis, easing pain, and decreasing swelling.

In traditional Chinese medicine, hawthorn is used to improve digestion, stimulate appetite, treat cardiovascular conditions and hyperlipidemia, and invigorate blood. Among the traditional Chinese herb formulas that include crataegus, the majority are digestive aids. The commonly used formula with crataegus as the dominant ingredient is Baohe Wan, first recorded in the book Danxi Xinfa (Essence of Teachings by Zhu Danxi) in 1481.

European Traditions

Hawthorn is one of the recognized medicinal plants in European medicine; Dioscorides primarily described its cardiovascular actions in the first century AD. Preparations from leaves and flowers of certain Crataegus species have been mentioned as remedies in the medical literature since the 1st century AD, mainly for treating cardiac diseases and for strengthening the aging heart. In 1896, 43 cases of patients suffering from various forms of heart disease and treated with Crataegus oxyacantha were reported, with promising results.

In European herbal traditions, the berries, flowers, and leaves are utilized for their astringent, antispasmodic, cardiotonic, diuretic, and hypotensive properties. The Swiss physician Paracelsus (1493–1541) may have been the first to mention hawthorn's action upon the heart. By the late 19th century (and probably even earlier), European homeopathic and medical doctors frequently used hawthorn for cardiovascular conditions.

Hawthorn berries, flowers, and leaves have been used traditionally throughout Europe to treat cardiovascular diseases including hypertension, myocardial dysfunction, angina, and tachycardia. In France, it is also used for insomnia and anxiety.

North America

At least 11 species of hawthorn were used by Native American tribes for back pain, bladder and digestive issues, circulatory support, and more. Tools were crafted out of the thorns and wood, and the berries were consumed as food by various coastal tribes. Also in North America, the Eclectic physicians of the late 19th and early 20th century administered hawthorn for various heart conditions.

3. Key Constituents and Active Compounds

Oligomeric procyanidins and flavone/flavonol types of flavonoids, which are considered to be the chief groups of active substances, are present in the plant along with phenolic acids, triterpenes, fatty acids, and sterols. The fruits, leaves, and seeds are rich in chemical constituents, including triterpenoid acids, phenolics, flavonoids, and polysaccharides.

Key individual compounds identified include:

• Oligomeric procyanidins (OPCs): The primary standardization marker for the WS 1442 extract, considered central to its cardioprotective activity.
• Flavonoids: Including vitexin, hyperoside (hyperin), isoorientin, and quercetin derivatives.
• Phenolic acids: One study identified the phenolic compounds in Crataegus pubescens fruit; the most abundant substances were (+)-catechin, (−)-epicatechin, and chlorogenic acid, which could be used as nutraceutical and functional foods.
• Triterpenic acids: Including ursolic acid (UA) and oleanolic acid (OA), which have been studied for cholesterol-lowering effects.

Hawthorn is rich in vitamins A, C, B1, and B2 as well as amino acids, calcium, and carotene and has more than 60 flavonoids. Hawthorn is rich in carbohydrates, organic acids, vitamins, and mineral elements, and also has a range of diverse biological functions including antioxidant, antibacterial effects, and pharmacological effects on digestive, cardiovascular, and endocrine systems, as well as neuroprotective functions and potential for preventing obesity.

4. Established Mechanisms of Action

Cardiovascular Mechanisms

Numerous experiments and clinical studies have underlined the cardiovascular efficacy of the plant through various mechanisms, including positive inotropic and negative chronotropic effects, escalation in coronary blood flow and exercise tolerance, inhibition of enzymes such as angiotensin-converting enzyme (ACE) and phosphodiesterase, anti-inflammatory and antihyperlipidemic effects, and improving the status of antioxidant enzymes.

More specifically, mechanistic research on WS 1442 has identified several pathways:

• Hawthorn extract WS 1442 increases contractility and positive muscle strength by inhibiting the Na⁺/K⁺-ATPase pump; WS 1442 acts at the serine 1177 site to phosphorylate eNOS and increase NO-mediated vasodilatation; it also effectively protects the vascular endothelium by inhibiting the Ca/PKC/RhoA pathway and activating the cAMP/Epac1/Rap1 pathway.
• Alcoholic extract of Crataegus oxyacantha (AEC) pretreatment maintained mitochondrial antioxidant status and prevented mitochondrial lipid peroxidative damage and decrease in Krebs cycle enzymes induced by isoproterenol in rat heart; AEC can act on myocardial tissue to reduce iNOS expression and downregulate COX-2 to exert anti-inflammatory effects.
• Hawthorn flavonoids exert hypolipidemic effects by acting on the PPARγ pathway to increase LDL expression in blood vessels.

Lipid-Lowering Mechanisms

Studies have shown that hawthorn constituents exhibit significant lipid-lowering effects. Hawthorn exerts its lipid-lowering effects by modulating the activity and expression of lipid metabolism-related enzymes, as well as through anti-inflammatory, antioxidant, and free radical-scavenging activities. These processes involve multiple signaling pathways, including the AMPK signaling pathway.

Broad Pharmacological Properties

Evidence from various in vivo and in vitro studies shows that hawthorn extracts exert a wide range of cardiovascular pharmacological properties, including antioxidant activity, positive inotropic effect, anti-inflammatory effect, anti-cardiac remodeling effect, antiplatelet aggregation effect, vasodilating effect, endothelial protective effect, reduction of smooth muscle cell migration and proliferation, protective effect against ischemia/reperfusion injury, antiarrhythmic effect, lipid-lowering effect, and decrease of arterial blood pressure.

5. Scientific Evidence by Area of Use

5.1 Chronic Heart Failure

Heart failure is the most extensively studied indication for hawthorn. The regulatory and clinical research landscape is substantial, though findings are not uniformly positive across all trial designs.

Regulatory Approvals

The German Commission E issued positive monographs for Crataegus leaves with flowers for the treatment of decreasing functional capacity of the heart corresponding to class II of the New York Heart Association (NYHA) Functional Classification, which is characterized by mild cardiac symptoms such as fatigue, palpitation, dyspnea, or anginal pain during ordinary activity. The leaf and flower also have a positive monograph in the EMA (European Medicines Agency), but only for traditional use.

Meta-Analyses and Systematic Reviews

Results of two meta-analyses, including a 2008 Cochrane systematic review, found that when used as an adjunct to conventional treatment in patients with chronic CHF (NYHA classes I through III), hawthorn substantially increased maximal workload tolerance, increased exercise tolerance, decreased the pressure–heart rate product (an index of cardiac oxygen consumption), and improved symptoms of fatigue and shortness of breath compared with placebo. The duration of the randomized controlled trials (RCTs) in these reviews ranged from three to 16 weeks, with most between six and eight weeks. The RCTs in these reviews used specific standardized leaf and flower extracts of hawthorn: LI 132 and WS 1442.

The Cochrane review concluded that there is a significant benefit in symptom control and physiologic outcomes from hawthorn extract as an adjunctive treatment for chronic heart failure. Importantly, the Cochrane reviewers noted methodological limitations: there are suggestions that positive findings may be overrepresented in complementary medicine journals, and that these journals favor positive conclusions at the expense of methodological quality. In addition, there is evidence that positive findings tend to be published in English-language journals, whereas some European journals are not indexed in major medical databases. Thus, treatment effects may be exaggerated, especially for herbal medicinal products because much of the evidence originates from European countries.

The SPICE Trial

The SPICE trial (Survival and Prognosis: Investigation of Crataegus Extract WS 1442 in Chronic Heart Failure) is a 24-month randomized controlled study involving 13 European countries and 2,681 patients, focused on patients with NYHA stage 2 and 3 heart failure. It utilized WS 1442, an extract standardized to contain 18.75% oligomeric procyanidins. WS 1442 was administered in a 900 mg/day dosage alongside standard drug therapy (which included diuretics in 85%, ACE inhibitors in 83%, beta-blockers in 64%, glycosides in 57%, and aldosterone blockers in 39% of patients).

In the SPICE trial, no difference was found for hawthorn in the primary measures of time to first cardiac event and no difference in trend for cardiac mortality reduction. In a subgroup analysis, patients with a left ventricular ejection fraction of at least 25% experienced a reduction in sudden cardiac death with hawthorn. The trial did support hawthorn extract's good safety record.

The HERB-CHF Trial

Both the HERB-CHF and SPICE trials evaluated the extract WS 1442 (Crataegutt forte) at 900 mg/day versus placebo over periods of 6 and 24 months, respectively, in patients with CHF class II or III (NYHA). In the HERB-CHF trial, no difference was found for the primary end point of a 6-minute walk distance or for quality of life and functional capacity measures for hawthorn over placebo.

The HERB-CHF study was too small to provide a reliable estimate of the effect of this hawthorn extract on mortality. The lack of an effect on the 6-minute walk test, peak VO₂, and the Heart Failure Survival Score — each a well-validated prognostic marker in chronic heart failure — suggests that a mortality benefit would not be expected.

Although most previous trials of hawthorn have reported modest improvements in exercise capacity, quality of life, and heart failure-related symptoms, these studies are limited by their short duration, lack of meaningful clinical outcomes for CHF, unclear severity of study patients, and frequent absence of conventional, evidence-based, concomitant medical therapy.

Overall strength of evidence for heart failure: There is conflicting evidence on the effects of hawthorn in people with heart failure. Older, shorter-term RCTs using standardized extracts showed symptomatic benefit, but larger, more rigorously designed trials (SPICE, HERB-CHF) using contemporary background therapies did not demonstrate benefit on meaningful clinical endpoints such as mortality or hospitalization. Clinical efficacy therefore remains unclear in CHF. Adverse events in clinical trials were similar to those of placebo, suggesting certain advantages for hawthorn over digoxin, including a wider therapeutic range and a lower risk in cases of toxicity.

5.2 Hypertension (High Blood Pressure)

A systematic review and meta-analysis was conducted, including six studies with a total of 428 participants. The trials focused on systolic (SBP) and diastolic blood pressure (DBP) changes over treatment periods of 10 weeks to 6 months. Hawthorn statistically significantly decreased SBP (MD: −6.65 mmHg; 95% CI [−11.72; 1.59]) and non-significantly reduced DBP (MD: −7.19 mmHg; 95% CI [−15.17; 0.79]) after 2–6 months of treatment.

One specific clinical trial in hypertensive patients with type 2 diabetes provided further data: hawthorn (Crataegus laevigata) leaves, flowers, and berries are used by herbal practitioners in the UK to treat hypertension in conjunction with prescribed drugs, and small-scale human studies support this approach. Although statistically significant, the difference between diastolic blood pressure of participants taking hawthorn and those taking placebo was modest. Furthermore, the study was not designed to yield information on the effects of hawthorn on longer-term clinical outcomes, such as ischemic heart disease and stroke.

Clinical investigations exploring the effects of Crataegus and its various preparations in hypertension have demonstrated somewhat contradictory results.

Overall strength of evidence for hypertension: Preliminary and modest. Several small RCTs and one meta-analysis suggest a statistically significant but clinically modest reduction in systolic blood pressure. Effect sizes are small, patient numbers are limited, and long-term outcomes have not been studied.

5.3 Lipid-Lowering Effects

During the last decades, hawthorn has received much attention because of its potential to reduce plasma cholesterol and triacylglycerol (TAG) concentrations and to treat heart arrhythmia. However, the scientific evidence for these beneficial effects of hawthorn still needs to be further substantiated, including identification of its bioactive compounds and the underlying mechanisms of action.

Hawthorn, particularly its bioactive compounds oleanolic acid (OA) and ursolic acid (UA), enhanced the cholesterol-lowering effect of plant sterols in preclinical hamster models. These findings are primarily from animal and in vitro studies; robust human RCT evidence for clinically meaningful lipid-lowering effects remains limited.

Overall strength of evidence for lipid lowering: Largely preclinical (animal/in vitro). Human data are insufficient to draw conclusions.

5.4 Anxiety

It is unclear whether hawthorn affects anxiety. A trend towards a reduction in anxiety was observed in those taking hawthorn compared with other groups in one study. Although hawthorn has been traditionally used in France as a mild sedative, no effect on anxiety, mood, or wellbeing was found in one randomized controlled trial in hypertensive diabetic patients.

Overall strength of evidence for anxiety: Insufficient and inconsistent. Available human data do not support a definitive anxiolytic effect.

5.5 Digestive Health

Extracts of the dried ripe berries and leaves were used in ancient traditional Chinese medicine to treat indigestion, chest pain, and hernia. According to the theory of Traditional Chinese Medicine, hawthorn has the functions of promoting digestion, invigorating the spleen, nourishing vitality, and removing blood stasis. Studies in the lab suggest a range of anti-inflammation, heart-protective, and digestion-improving properties. Modern clinical evidence for digestive indications in humans remains very limited.

5.6 Other Areas

There is not enough evidence to know whether hawthorn affects heart disease, angina (chest pain or discomfort from a lack of blood flow to the heart), abnormal heartbeat, or the buildup of plaque in arteries. There is no evidence to suggest that hawthorn affects weight loss.

Studies have shown that ingredients such as vitexin, isoorientin, ursolic acid, and maslinic acid, along with hawthorn extracts, can effectively modulate cancer-related signaling pathways and manifest anticancer properties via diverse mechanisms. These findings are from laboratory models; no human clinical evidence for anticancer effects is currently available.

6. Dosages Reported in Studies

Dosage ranges reported across clinical research vary by extract, indication, and study design:

• A total of 1,563 subjects were exposed to hawthorn products and received daily doses of up to 1,800 mg for treatment periods of up to 16 weeks in clinical trials and 2 years in post-marketing surveillance projects.
• Both the HERB-CHF and SPICE trials evaluated WS 1442 at 900 mg/day versus placebo, over periods of 6 and 24 months, respectively, in NYHA class II or III CHF patients.
• In the trials included in the 2008 Cochrane review, all used either WS 1442 or LI 132; dosages ranged widely across trials.
• One pharmacokinetic interaction study with digoxin used hawthorn (Crataegus special extract WS 1442, Schwabe Co.) at 450 mg twice daily (900 mg/day total).
• The typical pharmaceutical extract WS 1442 dose used in clinical studies for chronic heart failure was 900 mg/day (in divided doses); other clinical regimens used 160–600 mg/day depending on extract type and indication.

7. Safety Profile

General Tolerability

In several prospective clinical trials, hawthorn in conventional oral doses was typically described as having no serious drug-related adverse side effects. In most studies, adverse events with hawthorn occurred at rates similar to or less than those with placebo, and no instances of serum enzyme elevations or clinically apparent liver injury were mentioned. "Reported adverse events were infrequent, mild, and transient," according to the Cochrane reviewers.

Hawthorn is well tolerated; the most common adverse effects are vertigo and dizziness. Despite widespread use as a herbal supplement, hawthorn has not been implicated in cases of drug-induced liver injury.

Herb–Drug Interactions

Theoretical interactions exist with antiarrhythmics, antihypertensives, digoxin, and antihyperlipidemic agents.

The digoxin interaction has been specifically investigated. The flavonoid components of hawthorn may be responsible for hawthorn's beneficial effects in the treatment of heart failure. However, these components may also affect P-glycoprotein function and cause interactions with drugs that are P-glycoprotein substrates, such as digoxin, which is also used to treat heart failure.

Hawthorn interfered only with the Digoxin III immunoassay but had no effect on the Tina-Quant assay. Both hawthorn extracts increased intracellular calcium levels, but the lack of additive response with digoxin suggests both may bind to the same site of Na, K adenosine triphosphatase. Because of interference of hawthorn with a digoxin immunoassay and pharmacodynamic interaction with digoxin, a patient receiving digoxin should avoid hawthorn.

Based on knowledge of the multi-target mode of action of Crataegus-containing products, restraint from combining them with conventional cardiovascular medicines seems appropriate, as theoretically, interactions may occur, especially with digoxin and vasodilators.

Hawthorn and Heart Failure Progression

One study indicated hawthorn worsened heart failure in study participants. This may have been because hawthorn interacted with the drugs they were taking. The HERB-CHF retrospective analysis found an unexpected signal of early heart failure progression in the hawthorn group, though the retrospective nature of this analysis and the use of data not specifically designed to monitor progression rate complicates interpretation.

Hepatotoxicity

Oral forms of hawthorn extracts have not been linked to elevations in serum aminotransferase levels or to instances of clinically apparent liver injury with jaundice. One RCT provides further evidence for the safe use of hawthorn, a herb with no restrictions on its long-term use, with no significant change in liver or kidney parameters.

Adulteration Warning: Tejocote Root

The U.S. Food and Drug Administration (FDA) has warned the public about several hawthorn root dietary supplements labeled "tejocote root" (Mexican hawthorn, C. mexicana) because the products actually contain yellow oleander, a toxic plant. Five case reports were found to report severe cardiac problems after the consumption of tejocote (Crataegus mexicana root). In the United States, the root of Mexican hawthorn is contained in popular slimming supplements. Falsely positive digoxin levels were detected in the blood in three of the cases, which were ascribed to the cross-reactivity of tejocote with the digoxin immunoassay applied.

8. Regulatory Status

Hawthorn extract is advocated as an oral treatment option for chronic heart failure. The German Commission E approved the use of extracts of hawthorn leaf with flower in patients suffering from heart failure graded stage II according to the New York Heart Association. The Committee on Herbal Medicinal Products (HMPC) of the European Medicines Agency issued a European Union herbal monograph on Crataegus spp., folium cum flore, published in 2016.

References

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• NIH LiverTox — Hawthorn (NCBI Bookshelf)
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