Menu | Welcome | Catalog | Search | Newsletter | Order | Glossary

Normal Healthy Human Studies

By Steven Wm. Fowkes

Judging by phone calls and letters to the Cognitive Enhancement Research Institute (CERI), anxiety is a common complaint in our modern society. Mild and "free floating" anxiety has become so pervasive that it has become an icon of modern times, a correlate of "techno-stress" which becomes increasingly endemic as the pace of technological change continues to accelerate.

Use of benzodiazepine anti-anxiety drugs (like Valium) reached epidemic proportions two decades ago, the use of which was enshrined in the Rolling Stones song "Mother's Little Helper." While long-term side effects have led to a significant decrease in use in recent times, modern benzodiazepine derivatives are still widely prescribed.

Drugs vs Nutrients
Although nutritional approaches to anxiety have not seen much use by the medical profession, consumers have obtained some degree of anxiolytic relief through the use of such over-the-counter items as B-complex vitamins, magnesium, GABA, and herbs like valerian. One of the more interesting of these nutritional products is Garum Armoricum (Stabilium), an historically ancient extract of fish viscera (internal organs) of certain deep-water fish species, the preparation of which dates back to ancient times.

Developed by neolithic inhabitants of the Armorican peninsula (westernmost France) and refined by Celtic Druids, Garum was adopted by the Romans as a broad-spectrum elixir that could be used to help the aged or infirm, or, more to their political purposes, to strength-en their soldiers prior to long marches or combat.

Stabilium is a dietary supplement composed of Garum Armoricum, sunflower oil and lecithin, manufactured in France by Yalacta Laboratories and distributed in the United States by Smart Basics. There have been two reports that Stabilium has anti-anxiety properties in asthenic (fatigue) patients dealing with severe anxiety [Crocq et al., 1978, 1980]. But the effect of Stabilium on normal, healthy people suffering mild or "free floating" anxiety remained untested until recently, when Dr. Thomas Dorman and colleagues studied college students at California Polytechnic State University ("CalPoly") at San Luis Obispo in a double-blind, placebo-control-led, cross-over study [Dorman, 1985].

College students were hypothesized to be an excellent test group because of the chronic nature of their academic stress and the high degree of homogeneity within the student population. Students with psychiatric conditions requiring medication were excluded. Anxiety was assessed with the Speilberger State-Trait Anxiety Inventory (STAI) which consists of 40 short questions [Speilberger, 1983]. Each question was rated on a scale of 1 to 4, with 4 indicating a higher level of anxiety. Subjects were tested (baseline) and randomly divided into two groups, one receiving Stabilium (30 students) and the other receiving an identical colored placebo filled with vegetable oil (24 students). Subjects were tested weekly.

After three weeks, both Stabilium and placebo were discontinued for a week (a washout period), after which the therapies were reversed; the Stabilium group received placebo and the placebo group got Stabilium. After three more weeks, treatment was again discontinued for a 1-week washout period before final testing.

The results show an obvious decrease in average anxiety scores during the initial weeks which is significantly greater in the Stabilium-first group. After the crossover, the placebo-first group also experienced an obvious decrease in average anxiety scores. However, the persistence of the anti-anxiety effect in the Stabilium-first group through the washout week and well into the second phase of the study seriously undercut the crossover design.

The ratio of the average anxiety scores of the Stabilium-first group to the placebo-first group would have been expected to reverse from less-than-one values in the first phase of the study to greater-than-one values in the second phase. But because of the lingering anti-anxiety effect of Stabilium, the ratio remains much closer to one. This indicates that future cross-over studies of Stabilium should be designed with a washout period of at least a month.

Despite the unanticipated inadequacy of the washout phase, the study clearly demonstrates a statistically significant decrease in anxiety (P.05) from Stabilium at weeks 2, 3 and 4 of the study. Although the lingering anti-anxiety effect of Stabilium was a liability in this study design, it should be considered an asset for real-life use of this product.

Through the initial randomization process, the Stabilium-first and placebo-first groups should have had approximately identical average anxiety scores. This did not turn out to be the case. After randomization, anxiety scores in the Stabilium-first group averaged more than two points higher than the placebo group. Although this discrepancy is notable, it did not undermine the conclusions of the study. >P? The lower-anxiety placebo-first group experienced a qualitatively identical decrease in anxiety during the second phase of the study when they received Stabilium as the higher-anxiety Stabilium-first group did during the first phase of the study.

One of the other assumptions of this study that needs questioning is the chronic nature of academic stress, as there was consider-able volatility in the individual anxiety test scores from week to week. `There were even dramatic increases in anxiety in subjects taking Stabilium and decreases in anxiety in those taking placebo.

"After using Stabilium for three years, I think that it is more useful than benzodiazepines, not only because of the complete lack of side effects, but the patients do not seem to get a sedating effect."

Although these observations do not negate the effect of Stabilium on anxiety they do put it in context. Stabilium has a mild, long-term anti-anxiety effect that is subjectively subtle compared to the weekly (and presumably daily) fluctuations in anxiety levels experienced by college students. Furthermore, it is quite different from the powerful, short-term anxiolytic effects of Valium-like drugs. This is probably due to a fundamental difference in mechanism of action. Unlike anxiolytic drugs, Stabilium presumably works through a nutritive mechanism. Due to this difference, Stabilium may be helpful in situations where Valium is not.

We asked Dr. Dorman (now in Kent, Washington) about his clinical evaluation of the merits of Stabilium vs Valium. He told us, "After using Stabilium for three years, I think that it is more useful than benzodiazepines, not only because of the complete lack of side effects, but the patients do not seem to get a sedating effect." He went on to add, "A lot of people on drugs report that their overall enthusiasm is in decline. The opposite occurs with Stabilium."

References: Crocq L, Bugard P and Viaud P. Fatigue Study Group inquiry into asthenia in general practice. Psychologie Medicale 10:1943-53, 1978. Crocq L, Bugard P et al., Treatment of astheno-depressive conditions by Minaprine-Multi-center study of 248 cases assessed by Fatigue Study Group Scale #4]. Psychologie Medicale 12(12) 643-61, 1980. Dorman T, Bemard L, Glaze P, Hogan J. Skinner R, Nelson D, Bowker L and Head D. The effectiveness of Garom Amoricum (Stabilium) on Reducing Anxiety in College Students. Journal of Advancement in Medicine 8(3): 193-200, Fall 1995.

Reprinted with permission of the Cognitive Enhancement Research Institute (CERI), publishers of Smart Drug News, a science oriented newsletter covering "smart drugs": what they are, what they do, how they do it, how to use them, how not to use them and where to get them. Also explores the latest research and treatment for Alzheimers's, Parkinson's, Down's syndrome and age-associated mental impairment in normal, healthy adults. To subscribe contact CERI at 415-321-CERI (2374).

Contact Us To Place Orders, Speak With Customer Service Or Receive Quotes For The Lowest World-Wide Shipping Rates:

Web Orders Toll-Free (USA/Canada) Customer Service Fax
Order Page 1-800-878-6520 1-415-749-3990 1-415-351-1348

Copyright© 1997,
Smart Basics, Inc.

Comments and
suggestions to:
SmartBasics Webmaster