Latin Name: Crataegus monogyna
Pharmacopeial Name: Crataegi folium cum flore
Other Names: whitethorn herb, hawthorn tops, haw, mayhaw
There are approximately 280 known species of hawthorns in the genus Crataegus. The species referred to in this monograph is a spiny shrub native to the northern wooded temperate zones of Europe, from England to Latvia and from the Pyrenees Mountains (southern France) to northern Italy (Leung and Foster, 1996). It has become naturalized in parts of North America as a garden escape (Budavari, 1996; Leung and Foster, 1996). The material of commerce for the phytomedicine industry is obtained from the United Kingdom and other European countries (BHP, 1996), including Albania, Bulgaria, Romania, the former Yugoslavia, and Poland (Wichtl and Bisset, 1994).
Hawthorn has a long history of use, confirmed safety, and clinical evidence to support its cardiovascular benefits, especially cardiotonic activity. There is significant evidence to support its use in clinical cardiology and by the general public. The fruits (berries) of various species, long used in traditional European herbal medicine, are edible (Hedrick, 1972). Hawthorn is one of the oldest known medicinal plants used in European medicine; its cordial actions on the heart were first reported by first century Greek herbalist Dioscorides and later by Swiss physician Paracelsus (14931541) (Weihmayr and Ernst, 1996). Other sources state that its clinical use for heart disease and cardiovascular disorders did not begin in Europe until the nineteenth century (Anschutz, 1900; Hobbs and Foster, 1990).
In phytomedicine, hawthorn refers to the fruit, leaf, and/or flower of the genus Crataegus (usually C. laevigata, syn. C. oxyacantha) and C. monogyna. Commission E in 1984 published one monograph on hawthorn (often commonly referred to as crataegus, based on the Latin name of the genus) that included all of its aerial parts and was based on historical experience, many pharmacological studies on various preparations on the three different plant parts, about 20 open clinical studies, and many patient case reports (Schilcher, 1997). The original indications were for functional Stages I to II of the New York Heart Association (NYHA) assessment of the four stages of heart disease. Other indications included sensation of pressure in the chest, cardiac degeneration not yet requiring digitalis, and slight forms of bradycardic arrhythmias (Steinhoff, 1997).
In 1994, however, the original monograph was replaced by four: an approved monograph for hawthorn leaf with flower and three unapproved monographs for hawthorn fruit (berry), leaf, and flower, respectively. There was good reason for this change. When the first monograph had been produced, none of the scientific data on hawthorn included studies carried out according to good clinical practices (GCP). Both experimental and clinical studies that have been conducted since around 1991 have confirmed activity of hawthorn leaf with flower preparations. A subsequent review of clinical literature revealed the availability of pharmacodynamics (the effects of a substance on the physiological processes) of a 45% ethanol extract, or 70% methanol extract of flowering leaf tops with defined content of flavonoids and proanthocyanidins. The other three hawthorn components were re-evaluated and "the flowers, leaves, and fruits as single compounds received a negative assessment because there no longer seemed to be sufficient scientific evidence to justify their inclusion" (Steinhoff, 19931994). This also brought the monographs in line with the tenth edition of the French pharmacopeia, which specifies "dried flowering tops" of C. monogyna. The approval of the one hawthorn preparation based on the extract of leaf with flower is an example of the trend later adopted by the Commission to rely on new scientific data for evaluations and to re-assess and approve specific, well-defined extract preparations that are often proprietary commercial products. A recent monograph on hawthorn berry (fruit) acknowledges the lack of research on the cardioactivity of the berry (Upton et al., 1999a).
The literature review also resulted in a more precise indication for the approved monograph: "decreasing cardiac output according to functional Stage II of the NYHA." According to NYHA, Stage II is defined as "Patients with cardiac disease but without resulting limitations of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain" (NYHA, 1994). The use of hawthorn appears to be extremely safe; Commission E noted no contraindications or adverse side effects, nor have more recent reviews (e.g., Upton et al., 1999a, 1999b).
Hawthorn has been extensively studied in Germany. A review on hawthorn preparations used in cardiology found that hawthorn can be employed for indications for which digitalis is not yet indicated (Blesken, 1992). In a later review of its therapeutic effectiveness, the authors found that recent research supported its usefulness in congestive heart failure (CHF) (Weihmayr and Ernst, 1996). Rigorous clinical trials showed benefit concerning objective signs and subjective symptoms of Stage II NYHA congestive heart failure. No adverse drug reactions had been reported. The authors concluded that hawthorn is an effective and safe therapeutic alternative for CHF.
One placebo-controlled, randomized, double-blind study on 30 patients for eight weeks was performed with hawthorn leaf with flower extract WS 1442 (Crataegutt® forte; W. Schwabe, Germany) at a dose of 160 mg per day (Leuchtgens, 1993). The hawthorn group showed a statistically significant advantage over placebo in all parameters: Alteration in the pressure-x-rate product under standardized stationary bicycle endurance test, a score of subjective improvement of complaints elicited by a questionnaire, exercise tolerance, and changes in heart and arterial blood pressure (systolic and diastolic blood pressure was mildly reduced in both groups). No adverse reactions occurred.
Studies with early-stage CHF patients, using daily doses of leaf with flower extract ranging from 160 to 900 mg, showed improved heart function and exercise tolerance, and a lessening in shortness of breath and postexercise fatigue (Reuter, 1994; Zapfe et al., 1993). Schulz and co-authors cite 14 clinical studies published from 1981 to 1994 on the therapeutic efficacy of hawthorn preparations on a total of 808 patients (Schulz et al., 1998). A recent monograph on hawthorn leaf with flower extract cites 10 clinical studies on standardized preparations (3 open studies, 7 controlled) (Upton et al., 1999b). Reuter discussed 15 clinical trials on 872 patients given single preparations of Crataegus extracts (160900 mg) standardized to 5% oligomeric proanthocyanidins (OPC), 19% OPC, and 2.2% flavonoids. Tolerability was generally very good, with higher dosages resulting in occasional mild side effects. Significant improvements in stress tolerance and anaerobic threshold occurred with daily doses of 300900 mg over a four-week period, and to a greater extent after eight weeks. Subjective complaints, however, improved with much lower doses of 160180 mg (Reuter, 1994).
An eight-week multicenter, placebo-controlled, double-blind trial using WS 1442 in 136 patients with Stage II NYHA cardiac insufficiency focused on changes in the blood pressure and heart rate output measured at the beginning and end of treatment (Weikl et al., 1996). A clear improvement in the performance of the heart in the treatment group was seen, while the placebo group progressively worsened. The therapeutic difference between the groups was statistically significant. Patient assessment of improvement in the main symptoms (reduced performance, shortness of breath, ankle edema, etc.) confirmed the superiority of hawthorn, with better quality of life and mental well-being reported. Tolerability was very good, with overall results confirming the extract to be an effective and low-risk phytotherapeutic form of treatment for patients with Stage II NYHA cardiac insufficiency.
Another study provided evidence that hawthorn extract can improve heart function in patients with chronic heart disease (Schmidt et al., 1994). This eight-week, multicenter, double-blind, placebo-controlled study tested the effects of 600 mg/day of Faros® 300, (LI 132, an extract manufactured by Lichtwer Pharma, Berlin). Seventy-eight patients with Stage II heart disease taking hawthorn had significant gains in their stamina and endurance (as measured by a stationary bicycle), had lower blood pressure and lower heart rates while exercising, and pumped more blood at lower pressure. Also, patients taking hawthorn had fewer overall symptoms, felt less fatigue, and experienced less shortness of breath.
Hawthorn extract (LI 132) at a dose of 900 mg daily was shown to compare favorably with the cardiac drug Captopril (37.5 mg daily) in the treatment of 132 Stage II cardiac insufficiency patients (Tauchert et al., 1994). Captopril is used to reduce resistance to blood flow in peripheral arteries. Hawthorn performed equally well, with the added benefit of working on the heart. Exercise tolerance significantly increased in both test groups, and the incidence and severity of symptoms decreased by 50%. There was no placebo control.
Another report evaluated the efficacy of high doses of hawthorn leaf with flower extract (900 mg daily of Faros® 300) in 1,476 patients with Stage I and Stage II cardiac insufficiency, with therapy lasting four and eight weeks (Loew et al., 1996). Treatment-related changes were evaluated for the typical symptoms of heart failure. The symptom score decreased by a mean of 66% at the conclusion of therapy, with the Stage I NYHA patients largely symptom-free. A subgroup of patients with symptoms including borderline hypertension showed decreases in systolic and diastolic pressure. This group also showed a drop in heart rate from 89 to 79 beats per minute, and arrhythmias were significantly reduced independently of heart failure.
Although the Commission E no longer recognizes this use, hawthorn berry preparations have been shown to combat angina, a condition resulting from insufficient blood flow to the heart muscle. In one study demonstrating the usefulness of a combined extract of hawthorn berry, leaf, and flower in the treatment of patients with stable angina pectoris (Hanack and Br ckel, 1983), 60 angina patients were given either 180 mg of hawthorn berry-leaf-flower extract (Crataegutt® novo, W. Schwabe, Germany) or placebo for three weeks. The ECG measures improved in the hawthorn patients, and blood flow and oxygen delivery to the heart muscle rose. Hawthorn patients also exercised for longer periods of time without an angina attack.
A double-blind crossover study tested the effects of Crataegutt® novo hawthorn berry-leaf-flower extract in 36 patients, averaging 74 years in age, with Stage I or Stage II cardiac insufficiency (O'Connolly et al., 1986; O'Connolly et al., 1987). The study found that patients treated with this preparation had a decreased heart rate and improved cardiac output under resting and exercise conditions, which was not evidenced in the control group. Treated patients also had significant improvement in psychological assessment ratings and sleep behavior.
In Germany, hawthorn leaf with flower is official in the German Pharmacopeia (DAB, 1997), approved in the Commission E monographs, and the tea infusion dosage form is official in the German Standard License monographs (Braun et al., 1997). The alcoholic fluidextract dosage form is official in the German Pharmacopeia, tenth edition, third supplement (DAB 10, 1993). Hawthorn is used as a component in over 100 drug preparations, especially cardiotonics, coronary remedies, and antihypertensives, in various dosage forms, including the hydro-alcoholic native dry extract in drages (coated tablets), fluidextract (drops) (Wichtl and Bisset, 1994), and aqueous infusion (Braun et al., 1997; Meyer-Buchtela, 1999).
German pharmacopeial grade hawthorn leaf with flower consists of the whole or cut, dried flower-bearing tips, up to about 7 cm long, of C. monogyna Jaquin emend. Lindman or C. laevigata (Poiret) de Candolle (syn: C. oxyacantha L.p.p. et auct.), and rarely some other European species such as C. pentagyna Waldstein et Kitaibel ex Willdenow, C. nigra Waldstein et Kitaibel, and/or C. azarolus L. It must contain not less than 0.7% flavonoids calculated as hyperoside. Botanical identity must be confirmed by a thin-layer chromatography (TLC) test, macroscopic and microscopic examinations, and organoleptic evaluations (DAB, 1997). Under proper storage conditions, the raw material shelf life is three years (Braun et al., 1997). It is interesting to note that the only form of hawthorn that is official in the 1998 European Pharmacopoeia is the dried false-fruit, which is an unapproved herb in the Commission E monographs. It must contain not less than 1.0% procyanidins, calculated as cyanidin chloride, based on the dried material (Ph.Eur.3, 1998).
Hawthorn leaf with flower, consisting of dried flowering twig tips of Crataegus monogyna Jaquin emend. Lindman or C. laevigata (Poiret) de Candolle [Fam. Rosaceae], or other members of the Crataegus genus cited in a valid pharmacopeia and preparations from them in an effective dosage. The preparation contains flavonoids (flavones, flavonols), including hyperoside, vitexinrhamnose, rutin, and vitexin and oligomeric procyanidins (n=2 to n=8 catechins and/or epicatechins).
Chemistry and Pharmacology
Hawthorn leaf with flower contains 13% oligomeric procyanidins; 12% flavonoids, including flavonols and flavone derivatives such as hyperoside, vitexinrhamnose, rutin, and vitexin; amines (choline, acetylcholine, trimethylamine); catechins; phenol carboxylic acids (e.g., chlorogenic acid); purines; sterols; and approximately 0.6% triterpene acids (oleanolic, ursolic, and crataegolic acids) (Budavari, 1996; Meyer-Buchtela, 1999; Wichtl and Bisset, 1994).
The following pharmacodynamic effects have been established in isolated organs or in animal experimentation with preparations from hawthorn leaf with flower (hydroalcoholic extract with defined content of oligomeric procyanidins and/or flavonoids: macerates, fresh plant extract) and with individual fractions (oligomeric procyanidins, biogenic amines): positive inotropic effect, positive dromotropic effect, negative bathmotropic effect, increased coronary and myocardial circulatory perfusion, and reduction in peripheral vascular resistance.
Pharmacological investigations have shown that the most important components in terms of improving the peripheral vascular system are flavonoids, flavonglycosides (quercetin, rutin, hyperoside, and vitexin), procyanidine derived from catechin or epicatechin (oligomeric procyanidines), pentacyclical triterpenes, and aromatic carbon dioxides (Reuter, 1994). As long as a specific effectiveness can't be assigned to a single substance, the entire Crataegus extract must be viewed as the effective treatment (Reuter, 1994).
In cases of cardiac insufficiency according to Stage II NYHA, an improvement of subjective findings as well as an increase in cardiac work tolerance, a decrease in pressure/heart rate product, an increase in the ejection fraction, and a rise in the anaerobic threshold have been established in human pharmacological studies following the administration of 160 to 900 mg aqueous-alcoholic extract per day (adjusted to oligomeric procyanidins and/or flavonoids) over periods lasting up to 56 days.
The pharmacokinetics of the preparation have been investigated only in animal studies, and no scientific results are available in the context of human pharmacokinetics. Investigations of acute toxicity using a hydroalcoholic dry extract (drug/extract ratio 5:1, standardized for oligomeric procyanidins) are available, according to which no fatal events occurred after oral or peritoneal administration in mice or rats in doses of up to 3 g per kg of body weight.
Symptoms of acute toxicity in rats and mice with an intraperitoneal administration of 3 g per kg body weight include sedation, piloerection, dyspnea, and tremor. The oral administration of powdered herb at individual doses of 3 g per kg body weight in rats and 5 g per kg body weight in mice produced no fatal reactions. No toxic effects were observed after oral administration of 30, 90, and 300 mg aqueous/ethanolic dry extract per kg body weight in rats and dogs over a period of 26 weeks. For this extract, the "no effect" dose was 300 mg per kg body weight. No fatal events and no toxic effects were observed after the oral administration of 300 and 600 mg preparation powder per kg body weight over a period of four weeks. No experimental data are available concerning embryonic and fetal toxicity, fertility, and post-natal development.
Although they have indeed produced different results, more recent studies are now available in regards to testing the mutagenicity of Crataegus preparations. It is assumed that the mutagenic activity demonstrated on Salmonella is based on the quercetin content, and the induction of SCE, particularly on the presence of flavone-C-glycosides as well as of flavone aglycones. By comparison with the quantity of quercetin ingested with the food, however, the content of quercetin in the preparation is so low that a risk for humans may be practically excluded.
No experimental data are available regarding carcinogenicity. The findings regarding gene toxicity and mutagenicity give no indication of carcinogenic risk of the preparation in human use.
Animal studies have found that hawthorn shows positive inotropic and negative chronotropic effects of the alcoholic extract (IV), as well as hypotensive activity (Bruneton, 1995). Isolated human artery studies have concluded that Crataegus extract dilates the coronary arteries to cause a more effective flow of blood to the heart. Animal studies have proven clear hemodynamic effects along with this vasodilatatory effect (Reuter, 1994). Observations in human subjects confirm the experimental results: improvement of symptoms and of the ECG in patients with mild cardiac insufficiency (with long term treatment of aqueous extract, orally), decrease in rhythm, and improvement of systolic contraction (Bruneton, 1995).
The Commission E approved the use of hawthorn leaf with flower for decreasing cardiac output as described in functional Stage II of NYHA.
Hawthorn has been used in cases of mild bradyarrhythmia, paroxymsmal tachycardia, hypertension, arteriosclerosis, Buerger's disease, and for relief of the feeling of pressure and tightness in the cardiac region (Wichtl and Bisset, 1994). Hawthorn is often combined with conventional cardiovascular medications (such as digitalis and oubain) to speed up cardiac compensation and prevent the indigestion and nausea associated with said treatments. It is additionally used as a sedative, antispasmodic, and as a general source of flavonoids (Upton et al., 1999b).
Note: A physician must be consulted in cases where symptoms continue unchanged for longer than six weeks or in case of swelling of the legs. Medical diagnosis is absolutely necessary when pains occur in the region of the heart, spreading out to the arms, upper abdomen or the area around the neck, or in cases of respiratory distress (dyspnea).
Use During Pregnancy and Lactation
No restrictions known.
Interactions with Other Drugs
Dosage and Administration
Unless otherwise prescribed:
Take orally following liquid or dry pharmaceutical forms for a minimum of six weeks: 160-900 mg native, water-ethanol extract (ethanol 45% v/v or methanol 70% v/v, drug-extract ratio = 4-7:1, with defined flavonoid or procyanidin content), corresponding to 30-168.7 mg procyanidins, calculated as epicatechin, or 3.5-19.8 mg flavonoids, calculated as hyperoside in accordance with DAB 10, in two or three individual doses.
Hawthorn fluidextract DAB 10: Equivalent individual or daily dosage must be confirmed by clinical-pharmacological experiment or clinical study.
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This material was adapted from The Complete German Commission E MonographsTherapeutic Guide to Herbal Medicines. M. Blumenthal, W.R. Busse, A. Goldberg, J. Gruenwald, T. Hall, C.W. Riggins, R.S. Rister (eds.) S. Klein and R.S. Rister (trans.). 1998. Austin: American Botanical Council; Boston: Integrative Medicine Communications.
1) The Overview section is new information.
2) Description, Chemistry and Pharmacology, Uses, Contraindications, Side Effects, Interactions with Other Drugs, and Dosage sections have been drawn from the original work. Additional information has been added in some or all of these sections, as noted with references.
3) The dosage for equivalent preparations (tea infusion, fluidextract, and tincture) have been provided based on the following example:
- Unless otherwise prescribed: 2 g per day of [powdered, crushed, cut or whole] [plant part]
- Infusion: 2 g in 150 ml of water
- Fluidextract 1:1 (g/ml): 2 ml
- Tincture 1:5 (g/ml): 10 ml
4) The References and Additional Resources sections are new sections. Additional Resources are not cited in the monograph but are included for research purposes.
This monograph, published by the Commission E in 1994, was modified based on new scientific research. It contains more extensive pharmacological and therapeutic information taken directly from the Commission E.
Excerpt from Herbal Medicine: Expanded Commission E Monographs
Copyright 2000 American Botanical Council
Published by Integrative Medicine Communications
Available from the American Botanical Council.
This monograph, published by the Commission E in 1994, was modified based on new scientific research. It contains more extensive pharmacological and therapeutic information taken directly from the Commission E.