Benefit-Risk Assessment of Crataegus Extract WS 1442: An Evidence-Based Review

Abstract

Preparations from Crataegus (hawthorn) have a long history in the treatment of heart failure. WS 1442 is a dry extract from hawthorn leaves with flowers (4–6.6:1), extraction solvent of ethanol 45% (w/w), adjusted to 17.3–20.1% of oligomeric procyanidins. Nonclinical studies show that WS 1442 has positive inotropic and antiarrhythmic properties and protects the myocardium from ischemic damage, reperfusion injury, and hypertension-related hypertrophy, improves endothelial functions such as NO synthesis, and delays endothelial senescence. Randomized, controlled trials in patients with heart failure have demonstrated that the herbal medicinal product increases functional capacity, alleviates disabling symptoms, and improves health-related quality of life, all of which have become important targets of heart failure therapy according to current disease management guidelines. Clinical trials (including a 2-year mortality study with polypharmacy and > 1300 patients exposed) and post-marketing surveillance studies have shown that WS 1442 has a very favorable safety profile both as monotherapy and as add-on therapy, where no drug interactions have been observed. No specific adverse reactions to WS 1442 are known to date. WS 1442 may thus help to close the therapeutic gap between systolic and diastolic heart failure for which evidence of efficacy for other cardioactive drugs is sparse. Scientific evidence shows that WS 1442 is safe and has a beneficial effect in patients with heart failure corresponding to New York Heart Association classes II or III. The benefit-risk assessment for WS 1442 is therefore positive.

Water-Based Extraction of Bioactive Principles from Blackcurrant Leaves and Chrysanthellum americanum: A Comparative Study

“…HAW extracts demonstrated strong ACE inhibition (81–92%). HAW extracts have been described as an effective treatment of mild hypertension [ 64 ] and moderate heart failure [ 65 , 66 , 67 , 68 , 69 , 70 , 71 ]. The extracts of leaves and flowers (flowering tops) were shown to induce cardiovascular effects such as vasodilation and endothelial protection [ 64 , 72 ].…”

Phytochemical composition and bioactivities of hawthorn (Crataegus spp.): review of recent research advances

“…Hawthorn extract WS 1442 containing a range of pharmacologically active substances including oligomeric proanthocyanidins and flavonoids is, possibly, the most famous Crataegus fruit-based drug with 89 and 14 records in WoS since 1980 and 2015, respectively. Moreover, two most recent articles reviewed WS 1442 in terms of experimental and clinical experiences (Zorniak et al, 2017) and benefit-risk assessment (Holubarsch et al, 2018). Therefore, only those studies, which were not reviewed in these publications, will be covered briefly.…”

Advantageous Extraction, Cleanup, and UHPLC-MS/MS Detection of Patulin Mycotoxin in Dietary Supplements and Herbal Blends Containing Hawberry from Crataegus spp.

“…Numerous studies have confirmed that standardized Crataegus spp. extract WS® 1442 obtained from carefully planted, harvested, and stored hawberry is healthy and safe and has highly beneficial effects in various groups of patients [6]. The review by Zorniak et al [7] suggested that standardized extract WS® 1442 can be successfully used as an addition to optimal treatment of chronic heart failure in clinical conditions.…”