St. John's Wort supplement and Gaba

 

 

 

St. John's wort (Hypericum perforatum), used most commonly for depression, is one of the top selling and best researched herbs used in the USA It is also popular in Canada and many countries in Europe – including Germany, where it is used more frequently than selective serotonin reuptake inhibitors (SSRIs). In addition to St. John's wort's (SJW) primary use in depression, there is increasing interest in research for it in related mental conditions such as obsessive compulsive disorders and social phobia.
While conflicting evidence exists about its efficacy, SJW has demonstrated its most positive results in mild-to-moderate depression with some success seen in treating major depression. Hypericin and hyperforin are the components of SJW to which its antidepressant activity is most commonly ascribed. However, most clinical trials have used SJW extracts standardized to 0.3% hypericin content with a dose of 300 mg three times a day, although other dosing regimens have been used. SJW is believed to exert its antidepressant action by activating the serotonergic, noradrenergic, and dopaminergic systems and by activating gamma-aminobutyric acid (GABA) and glutamic acid receptors in the brain. Since SJW is a pharmacologically active agent, it also is responsible for adverse reactions and has been associated with multiple potentially serious and clinically relevant drug interactions.

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Concurrent use of St. John's Wort has been implicated in decreasing plasma levels of cyclosporine A resulting in organ rejection in transplant patients. In HIV patients, it has decreased plasma levels of indinavir resulting in failure of antiretroviral therapy. Women taking SJW and oral contraceptives could experience a decrease in efficacy resulting in an increased number of breakthrough bleeding events and unplanned pregnancies. Concomitant use of SJW with warfarin has been associated with decreased anticoagulation properties resulting in unstable or decreased International Normalized Ratio (INR) values and is reportedly responsible for decreased plasma levels of digoxin.

Use of SJW is also associated with the induction of mania or hypomania in patients suffering with bipolar disorder. It has been postulated that the drug interactions observed with the co-administration of SJW and prescription medication such as those described above are mediated by different mechanisms. Most of these interactions are consistent with the induction of cytochrome P450 3A4 enzyme. Further studies indicate that other likely mechanisms of SJW drug-herb interactions exist, including enhanced expression and drug efflux activity of P-glycoprotein/MDR1 and activation of pregnane X. Additionally, use of SJW has been associated with reversible photosensitivity causing erythematous skin lesions after sun exposure.

Despite a fairly well-defined literature and an increase in educational initiatives, there is still a considerable lack of knowledge about clinically relevant safety issues associated with herbs such as St. John's wort among healthcare professionals (HCPs) and employees at health food stores where these products are often purchased. Moreover, many consumers still mistakenly perceive that the use of herbal supplements, also called "natural remedies", carry little to no risk. In addition to general evaluations of herbal knowledge among HCPs, knowledge specific to SJW has also been assessed. One study of physicians revealed that those surveyed were unaware of interactions involving SJW including: SJW-warfarin (56%), SJW-digoxin (68%), and SJW-OCP (68%). Similarly, a study of community pharmacists found that 48% were unaware of the interaction between SJW and cyclosporine, and 32% had not heard of the SJW-OCP interaction.

Since 1994, dietary supplements (i.e. herbs, nutraceuticals, botanicals) have been regulated under the Dietary Supplement Health and Education Act (DSHEA) in the USA. Under DSHEA, manufacturers are not required to provide data demonstrating safety and efficacy of a dietary product as long as it was present in the marketplace prior to the introduction of the legislation. As such, the Food and Drug Administration (FDA) can only intervene if a dietary supplement is proven unsafe after it has already reached consumers. Even then, the onus is on the FDA to demonstrate that the product is unsafe, rather than on the manufacturer to produce evidence of its safety.

Dietary supplement manufacturers in the USA also include or omit safety information on product labels at their own discretion. The lack of clinically pertinent information displayed on the label of natural health products has recently been addressed in countries such as Canada where 71% of the population reports using natural products. The new Canadian regulatory measures now require more specific information to be included on labels for natural health products including potential drug interactions and adverse effects.

The benefits of including clinically relevant safety information on dietary supplement product labels was demonstrated in a recent study by Sarino et al. Inclusion of drug interaction information on product labels was associated with a lower incidence of inappropriate advice dispensed about SJW products by both pharmacists and health store clerks. Based on these findings, more comprehensive safety warnings on the labeling of SJW products may be positively associated with improved quality of counseling by pharmacists and advice from health store clerks. This would help improve patient safety by increasing the likelihood of an intervention before an adverse event occurs. The purpose of this study was to evaluate clinically relevant safety information included on labeling in a nationally representative sample of SJW products in the USA.

 

 

 

 

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