Document Detail


Adverse-event profile of Crataegus spp.: a systematic review.
MedLine Citation:
PMID:  16752934     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Crataegus spp. (hawthorn) monopreparations are predominantly used for treating congestive heart failure. The effectiveness of hawthorn preparations (flowers with leaves; berries) is documented in a number of clinical studies, reviews and meta-analyses. The aim of this article is to assess the safety data of all available human studies on hawthorn monopreparations. Systematic searches were conducted on MEDLINE, EMBASE, AMED, The Cochrane Library, the UK National Research Register and the US ClinicalTrials.gov (up to January 2005). Data were requested from the spontaneous reporting scheme of the WHO. Hand searches were also conducted in a sample of relevant medical journals, conference proceedings, reference lists of identified articles and our own files. Eight manufacturers of hawthorn-containing preparations were contacted and asked to supply any information on adverse events or drug interactions. Data from all clinical studies and reports were assessed. Only human studies on monopreparations were included. Data from hawthorn-containing combination preparations and homeopathic preparations were excluded. All studies were read and evaluated by one reviewer and independently verified by at least one additional reviewer.Twenty-nine clinical studies were identified, of which 24 met our inclusion criteria. A total of 7311 patients were enrolled, and data from 5,577 patients were available for analysis. The daily dose and duration of treatment with hawthorn monopreparations ranged from 160 to 1,800 mg and from 3 to 24 weeks, respectively. The extracts most used in the clinical trials were WS 1,442 (extract of hawthorn standardised to 18.75% oligomeric procyanidins) and LI 132 (extract of hawthorn standardised to 2.25% flavonoids). Overall, 166 adverse events were reported. Most of these adverse events were, in general, mild to moderate; eight severe adverse events have been reported with the LI 132 extract. The most frequent adverse events were dizziness/vertigo (n = 15), gastrointestinal complaints (n = 24), headache (n = 9), migraine (n = 8) and palpitation (n = 11). The WHO spontaneous reporting scheme received 18 case reports. In the identified trials, the most frequent adverse events were dizziness (n = 6), nausea (n = 5), fall (n = 2), gastrointestinal haemorrhage (n = 2), circulation failure (n = 2) and erythematous rash (n = 2). There were no reports of drug interactions. In conclusion, all data reviewed in this article seem to indicate that hawthorn is well tolerated even if some severe adverse events were reported; this suggests that further studies are needed to better assess the safety of hawthorn-containing preparations. Moreover, the unsupervised use of this drug can be associated with problems, especially if given with concomitant medications.
Authors:
Claudia Daniele; Gabriela Mazzanti; Max H Pittler; Edzard Ernst
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Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  Drug safety     Volume:  29     ISSN:  0114-5916     ISO Abbreviation:  Drug Saf     Publication Date:  2006  
Date Detail:
Created Date:  2006-06-06     Completed Date:  2006-11-03     Revised Date:  2014-11-17    
Medline Journal Info:
Nlm Unique ID:  9002928     Medline TA:  Drug Saf     Country:  New Zealand    
Other Details:
Languages:  eng     Pagination:  523-35     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Crataegus / adverse effects,  chemistry*
Heart Failure / drug therapy*
Humans
Phytotherapy / adverse effects*
Plant Extracts / adverse effects*,  therapeutic use
Randomized Controlled Trials as Topic
Treatment Outcome
Chemical
Reg. No./Substance:
0/Plant Extracts; 8057-51-0/crataegus extract

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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