Essiac 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 1 incomplete clinical study and 1 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 (History), the developer provided a 4-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 of 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 (see History). 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, 1 had “subjective improvement,” 5 required fewer analgesics, 4 had an “objective response,” and 4 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 4 patients who had an objective response and the 4 patients who were in stable condition. This additional information revealed that, among these 8 patients, 2 had died, 3 had progressive disease, and 3 remained in stable condition. Reviewed in [1,4] The 3 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 Tamayo C: Essiac for cancer. Alternative Therapies in Women's Health 2 (3): 19-23, 2000. 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] Locock RA: Essiac. Can Pharm J 130: 18-9, 1997. 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. Last accessed June 16, 2004. Essiac. Toronto, Canada: Canadian Breast Cancer Research Alliance, 1996. Available online. Last accessed June 16, 2004. LeMoine L: Essiac: an historical perspective. Can Oncol Nurs J 7 (4): 216-21, 1997. [PUBMED Abstract] Reviews of Therapies: Herbal/plant therapies: Essiac. Houston, Tex: M.D. Anderson Cancer Center, 2002. Available online. Last accessed June 16, 2004. 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] Read More On This Subject

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