Document Detail


Serenoa repens (saw palmetto): a systematic review of adverse events.
MedLine Citation:
PMID:  19591529     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Serenoa repens (W. Bartram) Small, also known as saw palmetto, is one of the most widely used herbal preparations for the treatment of lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH). Although a number of randomized controlled trials (RCTs) and systematic reviews of the efficacy of S. repens for the treatment of LUTS and BPH have been published, no systematic review on its drug interactions or adverse events currently exists. This review assesses all available human safety data of S. repens monopreparations. Systematic literature searches were conducted from date of inception to February 2008 in five electronic databases; reference lists and our departmental files were checked for further relevant publications. Information was requested from spontaneous reporting schemes of the WHO and national safety bodies. Twenty-four manufacturers/distributors of S. repens preparations and four herbalist organizations were contacted for additional information. No language restrictions were imposed. Only reports of adverse events in humans from monopreparations of S. repens were included. Data from all articles, regardless of study design, reporting adverse events or interactions were independently extracted by the first author and validated by the second. Forty articles (26 randomized controlled trials, 4 non-randomized controlled trials, 6 uncontrolled trials and 4 case reports/series) were included. They suggest that adverse events associated with the use of S. repens are mild and similar to those with placebo. The most frequently reported adverse events are abdominal pain, diarrhoea, nausea, fatigue, headache, decreased libido and rhinitis. More serious adverse events such as death and cerebral haemorrhage are reported in isolated case reports and data from spontaneous reporting schemes, but causality is questionable. No drug interactions were reported. Currently available data suggest that S. repens is well tolerated by most users and is not associated with serious adverse events. The majority of adverse events are mild, infrequent and reversible, and include abdominal pain, diarrhoea, nausea and fatigue, headache, decreased libido and rhinitis. We found no evidence for drug interactions with S. repens. However, higher quality reporting of adverse events is essential if safety assessments are to be improved in future.
Authors:
Taofikat B Agbabiaka; Max H Pittler; Barbara Wider; Edzard Ernst
Related Documents :
18034239 - Inter-observer reproducibility in reporting on renal drainage in children with hydronep...
18689579 - Statins and interstitial lung disease: a systematic review of the literature and of foo...
12714879 - Intrathoracic extravasation of antineoplastic agents: case report and systematic review.
25452989 - Unilateral multicystic dysplasia in a horseshoe kidney - a case report.
20689809 - Etiology of diarrhea in older children, adolescents and adults: a systematic review.
21103129 - In what circumstances is telemedicine appropriate in the developing world?
16028779 - Juvenile psammomatoid ossifying fibroma of the neurocranium. report of four cases.
24628839 - The role of psychosocial working conditions on burnout and its core component emotional...
10976189 - Medico-legal implications of hidden thyroid dysfunction: a study of two cases.
Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't; Review    
Journal Detail:
Title:  Drug safety     Volume:  32     ISSN:  0114-5916     ISO Abbreviation:  Drug Saf     Publication Date:  2009  
Date Detail:
Created Date:  2009-07-13     Completed Date:  2009-11-09     Revised Date:  2014-11-17    
Medline Journal Info:
Nlm Unique ID:  9002928     Medline TA:  Drug Saf     Country:  New Zealand    
Other Details:
Languages:  eng     Pagination:  637-47     Citation Subset:  IM    
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:
Clinical Trials as Topic
Drug Interactions
Humans
Male
Plant Extracts / adverse effects*,  therapeutic use
Prostatic Hyperplasia / drug therapy
Serenoa / adverse effects*,  chemistry
Urologic Diseases / drug therapy
Chemical
Reg. No./Substance:
0/Plant Extracts

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


Previous Document:  Do nanomedicines require novel safety assessments to ensure their safety for long-term human use?
Next Document:  Amyotrophic lateral sclerosis-like conditions in possible association with cholesterol-lowering drug...