|Date: June 15, 2005||HC# 050251-282|
Re: Toxicology Testing of Catuama - a Brazilian Herbal Energy Product - in Healthy Adults
Oliveira C, Moraes MEA, Moraes MO, Bezerra F, Abib E, De Nucci G. Clinical toxicology study of an herbal medicinal extract of Paullinia cupana, Trichilia catigua, Ptychopetalum olacoides and Zingiber officinale (Catuama) in healthy volunteers. Phytother Res. 2005;19:54-57.
Interest in natural stimulant and sexual enhancement products continues to grow worldwide. Of course, one of the primary concerns with products in these categories is their short- and long-term safety.
Cuatuama®* is a patented herbal extract containing three South American herbs - guarana (Paullinia cupana), catuaba (Erythroxylum catuaba)**, muira puama (Ptychopetalum olacoides), - plus ginger (Zingiber officinale) is available commercially in Brazil and is used as a stimulant, tonic, and aphrodisiac. Extracts from the catuaba tree and the guarana plant have long been used as central nervous system stimulants and aphrodisiacs in South America. Muira puama, also known locally as "potency wood" – an indicator of its ethnobotanical use, is commonly used in Brazil as a sexual stimulant, as a tonic, and to treat gastrointestinal and nervous system disorders. Ginger root is used as an alternative medicine for hyperemesis and vertigo.
Although there have been some previous toxicological studies on Catuama in animals, no toxicological testing of Catuama had been conducted in humans; therefore, the authors of the present study investigated whether the chronic administration of Catuama in healthy human subjects would have any measurable serious adverse effects.
Forty-eight healthy men and women, aged 19–45 years, received an oral dose of Catuama extract (25 mL) twice a day (morning and afternoon) for 28 days at the Miguel Servet Clinical Pharmacology Unit, Campinas, Brazil. The Catuama formulation contained 125 mL fluid extract of guarana, 0.875 mL fluid extract of catuaba and of muira puama, and 0.2 mL alcohol extract of ginger. All subjects were requested to record any adverse effects of treatment. Blood and urine samples were collected weekly and at the end of the study for clinical laboratory screening, and electrocardiograms were performed at the same intervals.
Compliance was good, and only 1 subject (male) did not complete the study. No serious adverse reactions were reported; however, some minor side effects related to treatment were reported: 3 women reported a change in feces color, 1 woman reported a stomachache, 1 woman reported insomnia for 1 day, and 1 woman reported an increase in evacuation frequency. The results of all hematological and biochemical tests were normal throughout the 28-day treatment period for all subjects.
The authors conclude that chronic (28 days) administration of 25 mL Catuama® to healthy men and women resulted in no serious adverse effects or hematological or biochemical changes.
—Brenda Milot, ELS
*Catuama® is the registered trademark for a proprietary, patented product produced by Laboratorios Catariensis in Brazil, imported into the U.S. and marketed by ABKIT, Inc., New York, NY.
**The common name "catuaba" is also used for the herb Erythroxylum catuaba, but this taxon is not employed in this product.