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"Natural" Remedies

by Jay Tarnow, M.D.

The popularity of herbal remedies and "natural" medications has increased dramatically in the United States over the past few years. More patients are asking their physicians whether they may benefit from natural treatments, and many already employ the services of herbalists, naturopaths, and other healers. Many patients choose to self-medicate with herbal remedies that are available over the counter. The National Institutes of Health (NIH) has recognized that as many as 25% of people in the U.S. seek and obtain nontraditional treatments. Unfortunately medical schools and residency training programs have largely ignored the topic of natural remedies; thus leaving physicians poorly equipped to advise their patients regarding these treatment options. Furthermore, medical research has, until recently (I am aware of several federal and foundation funded clinical trials of omega 3 fatty acids), overlooked this area, and pharmaceutical companies do not typically fund studies on these medications.

One common public misperception is that because something is "natural," it is automatically safe. Don't forget that marijuana, opium, and arsenic are "natural". The US Food and Drug Administration (FDA) does not regulate herbal remedies, though recently it has begun looking into claims made by various herbal manufacturers in an effort to limit unsubstantiated claims of efficacy. Subsequently, the FDA does not regulate the manufacturing or potential substitution of ingredient contents in herbal remedies. Due to the lack of federal regulation and lagging medical research, mainly anecdotal data are available regarding safety, efficacy, and appropriate indications for natural treatments, and little to no data are available regarding potential drug interactions. The one commonly cited natural remedy for the treatment of ADHD is Pycnogenol. Other commonly used herbal products include St. John's Wart, Gingko Biloba, Ginseng, and Kava Kava.

Pycnogenol is derived from the bark of the European coastal pine. It consists of a mixture of bioflavonoids that are felt to be free radical scavengers, and thus helpful in protecting blood vessels, improving circulation, reducing inflammation, and protecting collagen from natural degradation. There is no indication that pycnogenol affects catecholamines, which are the neurotransmitters most consistently implicated in ADHD. To date there are no controlled studies of this compound in ADHD, though anecdotal reports abound. The only reference I was able to find in the scientific literature regarding pycnogenol use in ADHD were two letters written to the editors of the Journal of the American Academy of Child and Adolescent Psychiatry.

St. John's Wort received much media attention a few years ago as a potential treatment for depression. Hypericum is the extract of the flower of St. John's Wort that is believed to provide its therapeutic effects. It is believed to either cause inhibition of serotonin reuptake by presynaptic receptors, and/or to inhibit the enzyme monoamine oxidase (MAO), which are known mechanisms of action for current pharmaceutical antidepressants. To date St. John's Wort has been shown to be effective in controlled trials of mild to moderate depression, however, a meta-analysis suggested that it may not be effective for the acute treatment of severely depressed patients. The suggested dosage is 300mg taken three times daily, with possible side effects of gastrointestinal symptoms and fatigue. Of concern is the potential for drug interactions with other antidepressants, in particular selective serotonin reuptake inhibitors (SSRI's). There are no published trials comparing St. John's Wort to SSRI's though the NIH has sponsored a multi-center, randomized, controlled study comparing 50-150mg/day of sertraline (Zoloft), 900-1800mg/day of St. John's Wort, and placebo in over 300 patients. I am not aware of any systematic research into the possible uses of St. John's Wort for ADHD.

Ginkgo Biloba is believed to have cognitive enhancing effects and has been studied in Alzheimer's and vascular dementia. Ginkgo Biloba is produced from the seed of the ginkgo tree and consists of various amino acids and bioflavonoids. Its mechanism of action may involve membrane stabilization, inhibition of platelet-activating factor, and free radical scavenging. A recent double-blind placebo-controlled study (1997) of ginkgo for dementia revealed 27% of patients on ginkgo versus 14% on placebo improved. The changes were modest but objectively measurable. Currently there are no published trials comparing ginkgo to pharmacological agents such as tacrine or donepezil. The suggested dose range is 120-240 mg per day, divided in two to three dosages, with potential side effects including gastrointestinal symptoms, headaches, dizziness, and irritability.

Ginseng is commonly advertised to improve mood, enhance energy, and reduce stress. The active component of ginseng is believed to consist of ginsenosides, which are steroid like compounds. A number of small and poorly designed studies have reported a variety of beneficial effects such as reducing plasma glucose levels and increasing the level of high density cholesterol.

Kava Kava is the dried rhizome and roots of Piper methysticum, a large shrub commonly found in Polynesian islands. It is believed to be helpful in treating anxiety, which may be secondary to mild muscle relaxant effects of kavapyrones. Several placebo-controlled studies have shown it to be effective in reducing symptoms in patients with various anxiety diagnoses including agoraphobia, generalized anxiety disorder, and specific phobia. The suggested dosage range is 60-120mg/day with potential side effects including gastrointestinal symptoms, headaches, allergic skin reaction, and dizziness. To date there are no controlled trials comparing kava to anxiolytics such as benzodiazepines, buspirone, and SSRI's.

It is clear that herbal remedies and natural medications represent a growing field in the pharmacology of mental disorders. Some of the agents above may in fact have a very useful role in the treatment of various patients. However, the questions remain for which patients and for which conditions. A problem that is faced with vitamins and nutritional supplements is their absorption in adequate quantities. The body is wired to protect the brain allowing only a limited type and amount of substances that can cross the blood brain barrier. Therefore, finding the therapeutic dosage can be challenging.

Fortunately academic scientists have begun to recognize that these compounds may have a beneficial role, and have begun large, multi-center studies to answer some of these important questions. In the interim these compounds remain unproven both with regards to their efficacy and safety, let alone the potential for drug interactions. At the same time they are easily available and can appear quite attractive based on anecdotal reports and popular press articles. In the absence of more conclusive data, these agents should be used cautiously and should not be combined with prescribed medications without informing your physician. In cases where patients have wished to try some of these remedies, I have recommended that they pursue them as "trials." Namely, one should have a list of target symptoms that one hopes to improve and a timeline (usually 8-12 weeks) in which to look for change. If no improvement occurs then terminating the trial is prudent.