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Essiac/Flor•Essence (PDQ®)     
Last Modified: 03/20/2008
Health Professional Version
Human/Clinical Studies

Essiac
Flor•Essence



Essiac

No report of a clinical study of Essiac has been published in the peer-reviewed scientific literature. Brief descriptions of one incomplete clinical study and one retrospective evaluation of Essiac as a treatment for cancer have been published. Reviewed in [1-6] It is not clear whether the described patient populations consisted entirely of adults or whether they included children.

As noted previously (refer to the History 1 section of this summary for more information), the developer provided a four-herb recipe for Essiac to a Canadian corporation in 1977. Reviewed in [2,6] In 1978, the corporation filed a preclinical new drug submission with the Canadian Department of National Health and Welfare (Health Protection Branch) and was given permission to conduct studies on the safety and the efficacy of Essiac in cancer patients. Reviewed in [2,4-8] In 1982, the Department withdrew its permission after determining the research was not being conducted as planned (refer to the History 1 section of this summary for more information). Reviewed in [2,4-8] At that time, the available incomplete data were reviewed, and no clear evidence of improved survival could be demonstrated for treated patients. Reviewed in [1,2,5,6] Pain control and quality of life were not assessed in these studies. The review of the data indicated, however, that Essiac was not toxic. Reviewed in [5,6] Because no evidence of harm was found, the Canadian government allowed the corporation to distribute Essiac to cancer patients through their physicians under Canada’s Emergency Drug Release Program. Nonetheless, restrictions were imposed on the promotion of Essiac as a treatment for cancer. Reviewed in [2] Access to Essiac under Canada’s Emergency Drug Release Program has since been discontinued.

In the early 1980s, the Canadian Department of National Health and Welfare (Bureau of Human Prescription Drugs) conducted a retrospective review of data voluntarily submitted by physicians for 86 cancer patients who had gained access to Essiac under Canada’s Emergency Drug Release Program during the period between 1978 and 1982. Reviewed in [1,2,4] (Note: [2] states that data from 87 patients were reviewed.) The Bureau’s evaluation was based on written summaries submitted by the physicians and not on a review of the original patient records. Reviewed in [4] The Bureau found 47 patients did not benefit from Essiac, one had subjective improvement, five required fewer analgesics, four had an objective response, and four were in stable condition. Reviewed in [1,4] Among the remaining 25 patients, 17 had died, and the reports for 8 were considered unevaluable. The Bureau solicited additional information about the four patients who had an objective response and the four patients who were in stable condition. This additional information revealed that, among these eight patients, two had died, three had progressive disease, and three remained in stable condition. Reviewed in [1,4] The three patients in stable condition had received previous conventional therapy. Therefore, the benefits of treatment for these patients, if any, could not be clearly ascribed to Essiac. Reviewed in [4]

Flor•Essence

No results of human studies of Flor•Essence have been reported anecdotally or in the peer-reviewed scientific literature.

References

  1. Tamayo C: Essiac for cancer. Alternative Therapies in Women's Health 2 (3): 19-23, 2000. 

  2. Kaegi E: Unconventional therapies for cancer: 1. Essiac. The Task Force on Alternative Therapies of the Canadian Breast Cancer Research Initiative. CMAJ 158 (7): 897-902, 1998.  [PUBMED Abstract]

  3. Locock RA: Essiac. Can Pharm J 130: 18-9, 1997. 

  4. Herbal treatments. In: US Congress, Office of Technology Assessment.: Unconventional Cancer Treatments. Washington, DC: U.S. Government Printing Office, 1990. OTA-H-405, pp 71-5. Also available online. 2 Last accessed March 07, 2008. 

  5. Essiac. Toronto, Canada: Canadian Breast Cancer Research Alliance, 1996. 

  6. LeMoine L: Essiac: an historical perspective. Can Oncol Nurs J 7 (4): 216-21, 1997.  [PUBMED Abstract]

  7. Reviews of Therapies: Herbal/plant therapies: Essiac. Houston, Tex: M.D. Anderson Cancer Center, 2002. Available online. 3 Last accessed March 07, 2008. 

  8. Campbell MJ, Hamilton B, Shoemaker M, et al.: Antiproliferative activity of Chinese medicinal herbs on breast cancer cells in vitro. Anticancer Res 22 (6C): 3843-52, 2002 Nov-Dec.  [PUBMED Abstract]



Glossary Terms

analgesic
A drug that reduces pain. Analgesics include aspirin, acetaminophen, and ibuprofen.
anecdotal report
An incomplete description of the medical and treatment history of one or more patients. Anecdotal reports may be published in places other than peer-reviewed, scientific journals.
cancer (KAN-ser)
A term for diseases in which abnormal cells divide without control and can invade nearby tissues. Cancer cells can also spread to other parts of the body through the blood and lymph systems. There are several main types of cancer. Carcinoma is a cancer that begins in the skin or in tissues that line or cover internal organs. Sarcoma is a cancer that begins in bone, cartilage, fat, muscle, blood vessels, or other connective or supportive tissue. Leukemia is a cancer that starts in blood-forming tissue such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the blood. Lymphoma and multiple myeloma are cancers that begin in the cells of the immune system. Central nervous system cancers are cancers that begin in the tissues of the brain and spinal cord. Also called malignancy.
clinical study (KLIH-nih-kul STUH-dee)
A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Also called clinical trial.
conventional therapy (kun-VEN-shuh-nul THAYR-uh-pee)
A currently accepted and widely used treatment for a certain type of disease, based on the results of past research. Also called conventional treatment.
efficacy
Effectiveness. In medicine, the ability of an intervention (for example, a drug or surgery) to produce the desired beneficial effect.
Essiac
An herbal tea mixture that contains burdock root, Indian rhubarb root, sheep sorrel, and slippery elm bark. It has been claimed to remove toxins from the body, make the immune system stronger, relieve pain, control diabetes, treat AIDS, reduce tumor size, increase cancer survival, and improve quality of life. No clinical trial using Essiac in humans has been reported in a peer-reviewed, scientific journal, and the FDA has not approved the use of Essiac for the treatment of any medical conditions.
objective response (ub-JEK-tiv reh-SPONTS)
A measurable response.
progressive disease
Cancer that is growing, spreading, or getting worse.
quality of life
The overall enjoyment of life. Many clinical trials assess the effects of cancer and its treatment on the quality of life. These studies measure aspects of an individual’s sense of well-being and ability to carry out various activities.
retrospective (REH-troh-SPEK-tiv)
Looking back at events that have already taken place.
subjective improvement
An improvement that is reported by the patient, but cannot be measured by the healthcare provider (for example, "I feel better").
toxic (TOK-sik)
Having to do with poison or something harmful to the body. Toxic substances usually cause unwanted side effects.


Table of Links

1http://www.cancer.gov/cancertopics/pdq/cam/essiac/HealthProfessional/9.cdr#Sect
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2http://www.princeton.edu/~ota/disk2/1990/9044_n.html
3http://www.mdanderson.org/departments/CIMER/display.cfm?id=641EA504-ED43-11D4-8
10200508B603A14&method=displayFull&pn=6EB86A59-EBD9-11D4-810100508B603A
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