HEALTH SERVICE RESEARCH POSTER PRESENTATION ABSTRACTS
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THURSDAY, 10:15-11:00 AM
Daniel C, Mazzanti G, Pittler MH*, Ernst E.
Adverse events profile of Crataegus spp (hawthorn): systematic
review.
Complementary Medicine, Peninsula Medical School,
Universities of Exeter and Plymouth m.h.pittler@exeter.ac.uk
*Presenting author
PURPOSE: To assess the adverse events profile
of Crataegus spp (hawthorn) mono-preparations.
METHODS: Systematic searches were conducted
in Medline, Embase, Amed, Cochrane Library, the UK National Research
Register, ClincalTrials.gov US and the WHO spontaneous reporting scheme
(all until January 2005). Hand-searches were conducted in a sample of
relevant medical journals, proceedings, reference lists of identified
articles and our own files. Eight manufacturers of hawthorn preparations
were contacted and asked to supply further information on adverse events
or drug interactions. Data from all clinical studies and case reports
were assessed. Only human studies on mono-preparations were included.
Data of hawthorn containing combination preparations and homeopathic
preparations were excluded. Hard copies were obtained, read and evaluated
by one reviewer and independently verified by a second reviewer.
RESULTS: 29 clinical studies were identified
of which 24 could be included. A total of 7311 patients were enrolled,
and data from 5580 patients were available for analysis. The daily dose
and duration ranged between 160 mg to 1800 mg and 3 to 24 weeks respectively.
Overall, 226 (4%) adverse events were reported. Only one case of acute
eczema was reported as serious. This, however, also occurred in the
placebo group. In placebo-controlled trials, the most frequent adverse
events were dizziness/vertigo (hawthorn 8 / placebo 9), gastrointestinal
complaints (hawthorn 9 / placebo 5) and headache/migraine (hawthorn
3 / placebo 3). The WHO spontaneous reporting scheme received 18 case
reports. The most frequent adverse events were dizziness (6), nausea
(5) and fall (2). There were no reports of interactions.
CONCLUSIONS: Although further studies are needed
to assess the safety of hawthorn preparations, all data reviewed here
indicate that hawthorn is not associated with serious adverse events.
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