| PDF (Download) | EssiacBreast Cancer | | Date: December 14, 2007 | HC# 020575-342 |
Re: Effect of Essiac on Women with Breast Cancer Examined
Zick S, Sen A, Feng Y, Green J, Olatunde S, Boon H. Trial of Essiac to ascertain its effect in women with breast cancer (TEA-BC) J Altern Complement Med. 2006;12(10):971-980.
Numerous surveys have assessed the use of complementary and alternative medicine (CAM) by women with breast cancer in the US, Britain, and Canada. According to the surveys, CAM use ranges from 16.5% to 84%. ESSIAC® (ESSIAC® CANADA INTERNATIONAL, Ottawa, Ontario), and Flor-Essence® (Flora Manufacturing and Distributing, Burnaby, British Columbia) are two herbal remedies that are commonly used. The original ESSIAC formula is made only in Canada by ESSIAC CANADA INTERNATIONAL and is distributed worldwide. ESSIAC has been used in Canada for more than 70 years. The formulation is comprised of four herbs: burdock root (Arctium lappa), Indian rhubarb (Rheum officinale), sheep sorrel (Rumex acetosella), and the inner bark of slippery elm (Ulmus rubra syn. U. fulva).
In the early 1920s, Nurse Rene M. Caisse began giving patients an Ojibwa herbal tea formulation which brought about the cure of stomach cancer of Rene's aunt (Mireza Potvin), who lived another 30 years cancer free. Rene Caisse and Dr. R.O. Fisher, her aunt's doctor, then conducted some animal studies with mice and shortened the formula to four herbs. Rene then named the formula 'ESSIAC' (Rene's last name spelled backwards). For a time, they began giving one herb, sheep sorrel, by injection (sheep sorrel was the herb that most powerfully killed the cancer cells in mice) along with the other three herbs taken as a tea specifically to help the body cleanse and eliminate the cancer cells and other toxins. Rene Caisse also used ESSIAC tea successfully without giving the injection (Demers 2000). According to Zick et al. 2006, the injection caused one death and one case of systemic toxicity, which led to its being deemed unsafe. However, according to Canadian researcher, Dr. Dennis Awang, no deaths or systemic toxicity have ever been clearly linked to such injections (Awang 2007, pers. comm.). In 1938, the death of a woman who was already very ill and had fainted previously that day from heart problems led to the discontinuance of sheep sorrel extract being given by injection. Based on autopsy, the cause of death was agreed upon as 'pulmonary embolism'. 'Both pathologists stressed emphatically that the embolism would have happened anyway whether this woman would have received treatment or not.' 'Death occurred as a result of an embolism in the pulmonary artery,' the report read, 'a condition brought about by a varicose condition. Pulmonary embolism had been evident for years' (Demers 2000).
According to Dr. Awang, the case of a patient's death that took place in the 1990s in Michigan several hours after an ESSIAC injection was also not clearly linked to the injection of ESSIAC. ESSIAC is often used by patients who are deathly ill so it is not surprising that deaths occur in patients using ESSIAC. However, it is important to note that ESSIAC preparations were traditionally prepared by boiling the coarsely cut herbs. Two herbs in ESSIAC, Indian rhubarb root and sheep sorrel herb, both contain oxalic acid which can be toxic if given intravenously in sufficient amounts. But the liquid extract made by boiling the herbs, as intravenous preparation are normally prepared normally destroys these compounds , even boiling for just a few minutes, and so this would not occur with properly prepared ESSIAC extracts.
ESSIAC tea was later reformulated to include an additional four herbs (watercress [Nasturtium officinale], blessed thistle [Cnicus benedictus], red clover [Trifolium pratense], and kelp [Laminaria digitata]). Today there are more than 40 different ESSIAC formulas available. Despite widespread use, there are no substantial clinical trials published and very little in vivo or in vitro research.
Health-related quality of life (HR-QOL) is becoming an important endpoint for assessing treatment and management of breast cancer. HR-QOL assesses the patient's physical, emotional, mental, and spiritual well-being. The purpose of this study was to assess efficacy of ESSIAC and HR-QOL of patients who are new ESSIAC users as compared to those who have never used ESSIAC. This was a retrospective study of women 18 years or older who had been diagnosed with primary breast cancer. A random computer-generated sample of women (n = 877) from the Ontario Cancer Registry were contacted and asked to fill-out five surveys.
A total of 541 packets of surveys were returned and 41 patients responded that they used ESSIAC. Only 32 (6.2%) reported using ESSIAC for breast cancer. The women who used ESSIAC were significantly younger (55 versus 62 years old, P = 0.005) and more likely to be married (P = 0.04). ESSIAC users were diagnosed with breast cancer at a later stage (P = 0.03) and were more likely to have received chemotherapy (P = 0.001). Reportedly, the three most common reasons to use ESSIAC were 'to boost my immune system,' 'to improve my chances of survival,' and 'to prevent a recurrence of cancer.' Most had a friend recommend ESSIAC. Most of the women (75%) purchased the ESSIAC brand with a four herb blend and 17% purchased Flor-Essence with an eight herb blend. The average daily dose was 43.6 mL ( 30.8 mL) and was used for 11.1 months (range 1-28 months). Only two women reported adverse events: nausea and unpleasant aftertaste. No women reported that ESSIAC interfered with their breast-cancer treatment.
According to the authors, ESSIAC had no effect on quality of life and mood state when comparing women who took ESSIAC (i.e. during or after chemotherapy for late stage cancer) and those who did not take ESSIAC (and who had not undergone chemotherapy and did not have late stage breast cancer). The Functional Assessment of Cancer Therapy Breast Cancer Version (FACT-B) HR-QOL survey revealed that ESSIAC users had significantly worse physical well-being than non-ESSIAC users (P < 0.05), most likely caused by their late stage breast cancer and the adverse effects of their chemotherapy treatments. The authors propose that ESSIAC is a marker of physical distress rather than a cause. The data indicate that younger women with more advanced disease and lacking a sufficient social support network are more likely to have worse physical well-being. This finding accords with other studies that show that CAM use is more popular in young women with more severe breast cancer.
While the authors conclude that ESSIAC does not improve HR-QOL or mood states, it is difficult to determine clinical value from a retrospective cohort, particularly in this case when comparing late stage breast cancer patients having undergone chemotherapy ('Treatment Group') versus early stage breast cancer patients not having had chemotherapy ('Control Group'). Clearly, the two groups being compared are not equivalent. A fair study of ESSIAC would be to compare a 'treatment' and 'control' group that is the same in all parameters except for the use of ESSIAC. Prospective, randomized, double-blind, placebo-controlled studies are needed. In addition, future studies are needed to determine whether ESSIAC alters clinical outcomes such as cancer reoccurrence rates.
—Heather S. Oliff, PhD
Comment by Suzanne M. Diamond, B.Sc., M.Sc.,
Consultant in Botanical Research,
Diamond Botanicals Research and Consulting
2656 Gulfstream Road,
Roberts Creek, British Columbia,
Canada
It is most important to note that the women who used ESSIAC reported many benefits from drinking ESSIAC tea. It may be more accurate to say from this retrospective study that chemotherapy does not improve HR-QOL or mood states (P = 0.001). 'ESSIAC users were diagnosed with breast cancer at a later stage (P = 0.03) and were more likely to have received chemotherapy (P = 0.001).'
The effects of ESSIAC on HR-QOL and mood states cannot be fairly assessed with a study of this design. A good study design to test the effects of ESSIAC against breast cancer would be to design a study similar to that done with flaxseed muffins at Toronto Hospitals which found significantly smaller tumors within 4 to 6 weeks for women eating flaxseed muffins versus controls – based on tumorectomies (Goss, P. et al. 2000) and other studies carried out with flaxseed lignans (Power and Thompson 2007; Thompson et al. 2005) and red clover isoflavones (Jarred et al. 2002; Stephens F 1997) that have documented powerful anticancer effects within a few days to weeks without any significant negative side effects.
Regarding the statement that 'The authors propose that ESSIAC is a marker of physical distress rather than a cause': These authors need to be clearer about their findings. For instance, the first thing that one MD who researches these teas said after reading this study was that it was 'very concerning that the ESSIAC users faired worse than the non-ESSIAC users – suggesting that ESSIAC may have caused an adverse effect.' Even though the authors state that they believe that ESSIAC is a marker of distress and not a cause – not everybody will understand this including medical doctors. This study is very misleading and causes an unfair bias against ESSIAC. The devastating effects of chemotherapy are well documented. Comparing women with early stage cancer who had not undergone chemotherapy with late stage cancer patients who were suffering the devastating effects of their late stage cancer compounded by their harsh chemotherapy cancer treatments and then noting that ESSIAC doesn't improve HR-QOL or mood states based on comparisons between these two disparate groups is very misleading.
Future studies are needed to give ESSIAC a fair chance to prove its anticancer effects without being overshadowed by the effects of chemotherapy. Chemotherapy drugs by definition are highly cytotoxic and cause death to cancer cells and normal cells alike. Chemotherapy typically causes nausea because it kills stomach cells. Chemotherapy drugs kill heart cells. Chemotherapy literally aims to kill all cancer cells before it kills the person – and it is known and accepted to have many terrible side effects.
Compare that with natural drugs based on isoflavones, anticancer compounds that are found in ESSIAC, that only kill cancer cells and do no harm whatsoever to normal cells. In my opinion, the Zick et al. 2006 study looks at the effects of chemotherapy, and it doesn't fairly assess the benefits of ESSIAC at all.
Conclusions: Numerous women reported beneficial effects of ESSIAC. Only 2 women reported minor adverse events. ESSIAC does not improve HR-QOL or mood states in women experiencing the devastating effects of chemotherapy for late stage cancer when compared (rather unfairly) with women who were recently diagnosed with early stage cancer and had not undergone chemotherapy. Future studies are needed to determine whether other clinical outcomes, such as cancer reoccurrence, are affected by ESSIAC.
References:
Goss, P. et al. 2000. Researchers Find Flaxseed Can Slow Tumour Growth in Breast Cancer Patients. Newspaper article – CP.
Jarred RA, Keikha M, Dowling C, McPherson SJ, Clare AM, Husband AJ, Pedersen JS, Frydenberg M, Risbridger GP. Induction of apoptosis in low to moderate-grade human prostate carcinoma by red clover-derived dietary isoflavones. Cancer Epidemiol Biomarkers Prev. 2002 Dec;11(12):1689-96. PMID: 12496063
Power KA, Thompson LU. 2007. Can the combination of flaxseed and its lignans with soy and its isoflavones reduce the growth stimulatory effect of soy and its isoflavones on established breast cancer? Mol Nutr Food Res. 2007 Jul;51(7):845-56. PMID: 17579892
Stephens FO. 1997. Phytoestrogens and prostate cancer: possible preventive role. Med J Aust. 1997 Aug 4;167(3):138-40. PMID: 9269268
Thompson LU, Chen JM, Li T, Strasser-Weippl K, Goss PE. 2005. Dietary flaxseed alters tumor biological markers in postmenopausal breast cancer. Clin Cancer Res. 2005 May 15; 11(10): 3828-35. PMID: 15897583 |