The objective of this review is to describe psychiatric adverse events occurring after ingestion of dietary supplements containing herbal ephedra and to assess the possible relationship between supplement use and the events. The authors reviewed all adverse event reports related to dietary supplements containing herbal ephedra from US FDA MedWatch files as of 30 September, 2001. Psychosis, mania or severe agitation, severe depression, hallucinations, delusions, suicide attempts, paranoia and violent behaviour were classified as serious psychiatric events. Events were categorised based on the amount of information supporting a causal relationship. Out of almost 1800 total adverse events, 57 were classified as both psychiatric in nature and serious. Two-thirds of these psychiatric cases involved patients with pre-existing psychological/psychiatric conditions and/or use of other mood-altering medications or illicit substances. The majority of case reports were insufficiently documented to make an informed judgment about a relationship between the use of ephedra and the adverse event in question. The case reports evaluated do not prove a definitive causal link between ephedra and psychiatric complications. However, they do raise concern that such a relationship may exist.
"Causality between SJW and psychosis was not definitive, as positive re-challenges were not undertaken . Psychotic events have also been documented in Ephedra sinica use, although in most cases a preexisting psychiatric condition and/or concomitant medication/drug use was apparent (Maglione et al., 2005) "
[Show abstract][Hide abstract] ABSTRACT: This paper reports a critical review of 27 herbal medicines and formulas in treating a broad range of psychiatric disorders (in addition to anxiety and depression), including obsessive-compulsive, seasonal affective, bipolar depressive, psychotic, phobic and somatoform disorders. Ovid Medline, Pubmed and the Cochrane Library were searched for pharmacological and clinical evidence of herbal medicines with psychotropic activity. A forward search of later citations was also conducted. Whilst substantial high-quality evidence exists for the use of kava and St John's wort in the treatment of anxiety and depression respectively, currently there is insufficient robust clinical evidence for the use of many other herbal medicines in psychiatric disorders. Phytotherapies which potentially have significant use in psychiatry, and urgently require more research are Rhodiola rosea (roseroot) and Crocus sativus (saffron) for depression; Passiflora incarnata (passionflower), Scutellaria lateriflora (scullcap) and Zizyphus jujuba (sour date) for anxiety disorders; and Piper methysticum (kava) for phobic, panic and obsessive-compulsive disorders. While depression and anxiety are commonly researched, the efficacy of herbal medicines in other mental disorders requires attention. The review addresses current issues in herbal psychotherapy: herbal safety, future areas of application, the relationship of herbal medicine with pharmaceuticals and the potential prescriptive integration of phytomedicines with synthetic psychotropic medicines. Particular attention is given to clinical and safety issues with St John's wort and kava.
Phytotherapy Research 08/2007; 21(8):703-16. DOI:10.1002/ptr.2187 · 2.66 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Concerns have been raised about the sufficiency of dietary botanical supplement (DBS) surveillance in the US. The Food and Drug Administration's Center for Food Safety and Applied Nutrition's Adverse Event Reporting System (CAERS) represents one of the few existing surveillance mechanisms, but it has not been well characterized with respect to DBS adverse effects.
To characterize data on DBSs associated with adverse event reports submitted to CAERS.
We requested and obtained CAERS data from 1999 to 2003 involving adverse effects associated with the 6 most frequently used DBSs: Echinacea, ginseng, garlic, Ginkgo biloba, St. John's wort, and peppermint. We summarized and characterized the adverse event reports received, focusing on the composition of the DBSs and the nature of associated adverse events. We also cross-referenced reported single-ingredient DBSs with corresponding available product information. A sample of CAERS cases associated with signal DBSs was also characterized in detail.
CAERS reports involving ginseng DBSs were most frequently reported during the study period, whereas reports involving St. John's wort were the least frequently reported. Most CAERS reports involved multiple-ingredient DBSs, and 3-13% of reports involved multiple DBSs. Gastrointestinal and neurologic problems were the most common clinical outcomes among single-ingredient DBS-associated adverse events.
CAERS surveillance of DBS adverse effects is potentially as effective as other passive surveillance methods, but the number of reports is relatively small, validation is incomplete, and some inconsistencies within reports were found. Reports in CAERS may underrepresent DBS adverse events associated with DBS consumption.
Annals of Pharmacotherapy 06/2008; 42(5):653-60. DOI:10.1345/aph.1K611 · 2.06 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Four popular ephedra-free dietary supplements were evaluated for their effects on heart rate (HR), blood pressure (BP), and electrocardiographic (ECG) parameters. Twelve healthy men participated in a study randomized for product sequence, with a 21-day washout period between supplement-administration phases. Throughout the study, Holter monitors were used to assess ECG and HR activity. BP was assessed automatically on multiple occasions. The supplements were ingested three times daily for 3 days. Caffeine content, microbial load, and serum caffeine concentrations were determined. Mean systolic (SBP) and diastolic BP (DBP) readings showed significant increases relative to baseline (10.8 ± 2.5 and 5.3 ± 3.1 mm Hg, respectively; P < 0.05). All supplements significantly increased HR and decreased bradycardia runs; abnormal atrial/ventricular events were frequently noted. Gastrointestinal and sympathomimetic symptoms were also common. Two supplements were heavily contaminated with Bacillus species. In light of these findings, the use of ephedra-free dietary supplements should be discouraged in individuals with hypertension, diabetes, or other cardiovascular diseases.Clinical Pharmacology & Therapeutics (2013); advance online publication 30 January 2013. doi:10.1038/clpt.2012.241.
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