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Clinical Trial Results
Published September 3rd, 2006
This Article has
been peer reviewed.
Essiac® is an herbal formula that
has been used by North American cancer patients. Its recorded
history dates back to the 1920s when Canadian nurse Rene Caisse
blended a tea of burdock root, sheep sorrel, slippery elm bark, and
turkey rhubarb root, and offered it to her cancer patients. It is
believed she received the formulation from an Ojibwa Indian woman.
The name Essiac is Caisse spelled backwards.
Despite its relatively widespread use, there is little published
research about this herbal remedy in the scientific literature. As a
result, two teams of Canadian researchers launched research efforts.
The first group of researchers utilized a series of assays to
determine the validity of some of Essiac®'s purported activities in
vitro; the second group used an animal model to investigate the
effects of the mixture on the stomach, liver and immune system. Both
studies were funded by an educational grant from the manufacturer of
Essiac®. The company had no role in the collection or analysis of
the data.
Both research teams are presenting their findings at the 21st Annual
Meeting of the American Association of Naturopathic Physicians
(http://www.Naturopathic.org), being held August 9-12, 2006 at the
Oregon Convention Center, Portland, OR.
Study 1: In Vitro Analysis of Herbal Compound Essiac®
The first study entitled, An In Vitro Analysis of the Herbal Compound Essiac®,
was conducted by Deborah A. Kennedy, MBA, ND (Cand.), Division of Clinical
Epidemiology, The Canadian College of Naturopathic Medicine, Toronto, CN;
Stephen P. Myers, PhD, BMed, ND, Phillip A. Cheras, Ph.D., BAppSc., David
Lin, Ph.D., Rachel Li, PhD, Trudi Cattley, BAppSc., and Petta-Anne Paul
Brent, BSc., all of the Australian Centre for Complementary Medicine,
Southern Cross University, Lismore, NSW, AU; Dugald M.R. Seely, ND, MSc. (Cand.),
Division of Clinical Epidemiology, The Canadian College of Naturopathic
Medicine, Toronto, CN and the Institute of Medical Science, University of
Toronto, CN; and Blair J.N. Leonard, MD, Faculty of Medicine, University of
Toronto, Toronto, CN.
Methodology
The purpose of the study was to utilize a series of assays to determine
several of Essiac®'s purported activities in vitro. The activity of Essiac®
was measured using established in vitro assays to quantify: (1) antioxidant
activity; (2) platelet aggregation inhibition; (3) anti-microbial activity;
(4) arachidonic acid pathway inhibition; (5) cell-based immunomodulation;
(6) neoplastic cell specific cytotoxicity; (7) fibrinolytic activity; and
(8) inhibition of enzymes of the CYP450 pathway.
Results
Highlights of the findings showed:
-- there was significant antioxidant activity in the ABTS assay, with 1 ml
of Essiac® having the anti-oxidant activity of 3mm Troxol, a vitamin E
analogue;
-- Essiac® at 20-fold dilution showed significant immunomodulatory effects;
-- Essiac® showed significant cell specific cytotoxicity towards ovarian
epithelial carcinoma cells;
-- after hydrolysis with beta glucosidase, Essiac® showed increased
cytotoxicity towards prostate adenocarcinoma cells;
-- a 20-fold dilution of Essiac® showed significant inhibition of several
cytochrome P450 enzymes;
-- Essiac® demonstrated dose-dependant inhibition of clot fibrinolysis; and
-- Essiac® showed no specific activity in the platelet aggregation or
anti-microbial assays.
Conclusions
This analysis of Essiac® indicates significant antioxidant and
immunomodulatory properties, as well as neoplastic cell specific
cytotoxicity consistent with the historical properties ascribed to this
compound. Importantly, significant cytochrome P450 and fibrinolysis
inhibition was also observed. These data represent the first comprehensive
investigation of the in vitro effects of Essiac®.
Study 2: An In Vivo Analysis of the Herbal Compound Essiac®
The second study entitled, An In Vivo Analysis of the Herbal Compound Essiac®,
was conducted by Blair J.N. Leonard MD, Faculty of Medicine, University of
Toronto, Toronto, ON; Deborah A. Kennedy, MBA, ND (Cand.), Division of
Clinical Epidemiology, The Canadian College of Naturopathic Medicine,
Toronto, CN; Fong-Chi Cheng, MDS Pharma Services-Taiwan Ltd., Taipei, TW;
Keng-Kuang Chang, MDS Pharma Services-Taiwan Ltd., Taipei, TW; and Dugald
M.R. Seely, ND, MSc. (Cand.), Division of Clinical Epidemiology, The
Canadian College of Naturopathic Medicine, Toronto, CN and the Division of
Hematology/Oncology, Hospital for Sick Children, Toronto, CN.
Methodology
The study aimed to assess some of Essiac®'s purported effects on the liver,
stomach and immune system. To do so, the researchers administered Essiac®
liquid extract to Wistar rats under established rodent experimental models.
The rats received Essiac® 30-minutes prior to a physical challenge to the
liver, stomach or immune system. The rats were dosed again with the compound
at 4, 8 and 24 hours. Also at 24 hours they were sacrificed and specific
levels were measured, including body weight.
Results and Conclusions
Essiac® showed significant effects in gastric protection and non-significant
changes with other properties. Thus, the researchers concluded that Essiac®
administered in established in vivo experiments did not significantly
demonstrate the purported physiological modifying effects. These results are
significant as they represent the first published investigation on the in
vivo effects of Essiac® consumption.
The American Association of Naturopathic Physicians (AANP) was founded in
1985 to provide alternative methods for healing human diseases and disorders
than have been traditionally offered in the United States. Members of the
AANP must have graduated from one of North America's six accredited graduate
schools of naturopathic medicine.
http://www.Naturopathic.org
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