- How It Works
- Purported Uses
- Research Evidence
- Patient Warnings
- Side Effects
- Dosage (Inside MSKCC Only)
Common Name
Hoxsey herbs, Hoxsey formula, Hoxsey method
Clinical Summary
Alternative therapy comprised of herbal tonics and restrictive diet promoted as a cure for cancer. The Hoxsey treatment, illegal in the United States, is available at the Bio-Medical Center and other clinics in Tijuana, Mexico. According to inventor Harry Hoxsey, the principal “brown” tonic contains potassium iodide, licorice, red clover, burdock root, stillingia root, barberry, cascara, pokeroot, prickly ash bark, and buckthorn bark. The diet involves eliminating pork, vinegar, tomatoes, pickles, carbonated drinks, alcohol, bleached flour, sugar and salt, and emphasizes iron, calcium, vitamin C, yeast supplements and grape juice. Hoxsey claimed the treatment detoxifies the body, strengthens the immune system, balances body chemistry, and allows the body to digest and excrete tumors. Superoxide dismutase (SOD), vitamin B12, Gerovital (a mixture of procaine hydrochloride and vitamins), “Prolobin liver,” TST-100, rosette cactus, Koch Antitoxins, BCG vaccine, and Shulte’s medications sometimes are included in the regimen.
Hoxsey was convicted many times for practicing medicine without a license; the U.S. government reported that the 400 patients Hoxsey claimed to have cured never had cancer, were cured before receiving his treatment, still had cancer, or had died from the disease (2). The National Cancer Institute evaluated 77 case reports submitted by Hoxsey and concluded that none showed efficacy (5). No clinical data support the value of this therapy.
Purported Uses
- Cancer treatment
Constituents
Formulae have varied with time and by clinic.
“Brown tonic” (per 5 cc)
External Powder
Topical Liquid
“Brown tonic” (per 5 cc)
- Potassium iodide, 150 mg
- Licorice (Glycyrrhiza glabra), 20 mg
- Red clover (Trifolium pratense), 20 mg
- Burdock root (Arctium lappa), 10 mg
- Stillingia root (Stillingia sylvatica), 10 mg
- Barberry (Berberis vulgaris), 10 mg
- Cascara (Cascara sagrada), 5 mg
- Prickly ash bark (Zanthoxylum americanum), 5 mg
- Buckthorn bark (Rhamnus catharticus), 20 mg
- Pokeroot (Phytolacca americana), 10 mg
- Potassium iodide
- Elixir lactate of pepsin
- Antimony trisulfide
- Zinc chloride
- Bloodroot
External Powder
- Arsenic sulfide
- Sulfur
- Talc
Topical Liquid
Mechanism of Action
Hoxsey claimed that the internal formulation “stimulates the elimination of toxins that poison the system, thereby correcting the abnormal blood chemistry and normalizing cell metabolism.” His head nurse added that it restores acid/base balance, normal metabolism, and immune function, and “deals with the DNA.” None of these claims is substantiated by scientific data. The herbal tonic was developed by Hoxsey’s great grandfather, whose horse was reportedly cured of a leg tumor after eating wild herbs. Hoxsey combined these herbs with home remedies to create the “brown” tonic. In vitro and animal studies conducted with individual components (e.g., licorice, red clover, burdock, pokeroot, stillingia, barberry - see individual monographs) indicate possible anti-tumor and immunostimulant properties, but their concentrations and activity in the tonic have not been determined (1) (2).
Pharmacokinetics
No formal pharmacokinetics studies have been conducted.
Warnings
The American Cancer Society strongly urges cancer patients not to use the Hoxsey treatment, as no objective evidence exists to support its efficacy.
(2)
Adverse Reactions
External paste and powder: Severe burns, scars, and disfigurement can occur with use of the external treatments.
Iodine toxicity: “Iodisms” can result from intake as low as 60 mg/day or long-term use, causing pimples, excessive secretion of the eyes or nose, impotence, and inflammation of salivary glands.
Buckthorn: A violent laxative, causing abdominal pain, dehydration, anxiety, decreased respirations, diarrhea, nausea, trembling, vomiting.
Cascara: Only approved for short-term use. Laxative effects can cause abdominal pain, cramping, diarrhea, discoloration of urine, fluid and electrolyte imbalance, osteomalacia, steatorrhea, vitamin and mineral deficiencies, vomiting.
Licorice: Hypertension, lethargy, muscle pain, cardiac arrhythmias, sodium retention, hypokalemia, hyper-mineralcorticoidism, pseudo-hyperaldosteronism, decreased libido in men, and suppression of scalp sebum secretion
Pokeweed: Nausea, vomiting, diarrhea, abdominal cramps. Ingestion has been associated with illnesses requiring hospitalization, and has caused deaths in children and heart block.
(2) (5)
Herb-Drug Interactions
Potassium iodide has been found to interact with the following medications:
Lithium: Concomitant use has been found to cause hyperthyroidism.
Anticoagulants: Decreased effectiveness.
(4)
Literature Summary and Critique
No clinical trials, only retrospective reviews, have evaluated the Hoxsey treatment. In the 1940s and 50s, the NCI examined 137 case reports of patients Hoxsey claimed to cure with his internal herbal tonic. The NCI found no evidence that the tonic is effective. Researchers from the University of British Columbia followed up on 71 of Hoxsey’s patients in 1957, also finding inadequate evidence for the treatment’s effectiveness. Subsequent reviews of the available literature and cases by the American Cancer Society have reached the same conclusion.
(1) (2)
Austin S, Dale EB, DeKadt S. Long term follow-up of cancer patients using Contreras, Hoxsey and Gerson therapies. J Naturopathic Medicine 1994;5:74-6.
A small, prospective evaluation of patient survival at three Tijuana clinics, including the Biomedical Center. Patients were interviewed at the clinic regarding location of primary tumor, presence of metastasis, and whether it was biopsy-confirmed. Most patients were unaware of the stage of their cancer, and medical records were not available for review. Patients receiving Hoxsey treatment (n=39) were queried by mail yearly for 4-5 years or until death; the 23 who did not reply were excluded. Of the 16 evaluable patients, 10 died with an average survival from beginning of study of 15.4 months. The six remaining claimed to be disease-free with an average follow-up of 58 months. Meaningful statistical analysis and comparison to historical control could not be performed due to the small sample size for each cancer site. Due to the obvious flaws of this study - the majority of patients lost to follow-up, lack of access to detailed medical records, and reliance upon patients for disease stage information - the authors claim their results are uncertain, but should provoke interest in further investigation of the Hoxsey treatment.
Richardson MA, et al. Assessment of outcomes at alternative medicine cancer clinics: a feasibility study. J Altern Complement Med 2001;7:19-32.
A recent evaluation of record keeping the Bio-Medical Center found that only 43.6% of patients treated for cancer had pathological confirmation, data needed for follow-up on outcomes was not available, and 60-90% of patients have received prior conventional therapy. The authors concluded that a retrospective study of survival to evaluate the efficacy of this clinic’s treatment is not feasible.
References
- American Cancer Society. Questionable methods of cancer management: ‘nutritional’ therapies. Ca: Cancer J Clin 1993;43:309-19.
- American Cancer Society. Hoxsey Method/Bio-Medical Center. Ca: Cancer J Clin 1990;40:51-5.
- Smith M, Boon HS. Counseling cancer patients about herbal medicine. Patient Education Counseling 1999;38:109-20.
- Fetrow CW, et al. Professional’s Handbook of Complementary and Alternative Medicines. Philadelphia: Springhouse; 1999.
- Hoxsey Herbal Treatment. American Cancer Society’s Guide to Complementary and Alternative Methods. American Cancer Society: 2000.
http://documents.cancer.org/6516.00/. Accessed April 6, 2011. - Richardson MA, et al. Assessment of outcomes at alternative medicine cancer clinics: a feasibility study. J Altern Complement Med 2001;7:19-32.
- Janssen WF. Cancer quackery: past and present. FDA Consumer 1977;11:27-32.
- Austin S, Dale EB, DeKadt S. Long term follow-up of cancer patients using Contreras, Hoxsey and Gerson therapies. J Naturopathic Medicine 1994;5:74-6.
How It Works
Bottom Line: The Hoxsey Herbal Therapy is not a cancer cure and some of its components may be dangerous.
The Hoxsey herbal tonic was developed by Harry Hoxsey’s great grandfatherafter when his horse was cured of a leg tumor after eating wild herbs. Hoxsey combined these herbs with home cancer remedies popular at the time to create a tonic to be taken by mouth, as well as a preparation for topical application. Hoxsey’s remedies were promoted in newspapers and through his clinic through the first half of the 20th century, but eventually the U.S. government forced Hoxsey to stop selling medicines without a medical license.
According to Hoxsey, the tonic stimulates detoxification of the body while normalizing cell metabolism. However there is no proof for this. His tonic has never been tested in the laboratory, in animals, or in humans, and there is no scientific evidence to support the claim that it has anticancer effects in the human body. Hoxsey also claimed that his topical medicine would selectively kill cancer cells, however the caustic ingredients contained in the ointment are known to burn healthy tissue as well.
Purported Uses
- To treat cancer
No scientific evidence supports this use. Although some researchers have attempted to follow patients who used the Hoxsey herbal therapy at clinics in Mexico, the record keeping at these clinics is so poor that the studies could not be done.
Research Evidence
Cancer treatment:
Hoxsey made many claims of curing patients with his tonic, but when the National Cancer Institute (N.C.I.) tried to verify his claims by inspecting the medical records of 137 “cured” patients, it found NO evidence that the tonic is more effective than no treatment at all. Since then, several groups of researchers (University of British Columbia, American Cancer Society) have followed up on Hoxsey’s patients and come to the same conclusions.
One group of researchers followed 39 patients with cancer who were being treated at the Bio-Medical Center in Tijuana, Mexico, where Hoxsey Herbal Therapy is offered. Because medical records were not available, the researchers had to get all of the information about the patient’s medical condition directly from the patient, and most patients were not aware of the stage of their cancer. After four to five years of follow-up, ten patients had died with an average survival of 15.4 months; six patients were still alive. The problems with this study include: 1) Most of the patients were lost to follow-up, so we do not know what happened to the remaining 23 patients. 2) This study included many different types of cancers with many different types of previous cancer treatments. 3) Without access to patients’ records, the researchers had no idea what stage cancer the patients had, or if their cancer had been accurately diagnosed. This study does not provide enough evidence to support the use of Hoxsey Therapy.
A separate evaluation of the quality of record keeping the Bio-Medical Center found it to be severely lacking. Without adequate record keeping, it is not possible for quality clinical trials to truly determine if the Hoxsey Herbal Therapy is safe or effective.
Patient Warnings
- The American Cancer Society strongly urges cancer patients not to use the Hoxsey treatment. No sound scientific evidence exists to support its safety or effectiveness.
- Because it is not regulated by the F.D.A., products used in this treatment may be contaminated with other botanicals and/or the concentration listed on the label may be inaccurate.
Side Effects
- The topical paste and powder have caused severe burns, scars, and disfigurement.
- High levels of iodine from the potassium iodide can cause pimples, excessive secretion of the eyes or nose, impotence, and inflammation of salivary glands.
- Buckthorn, one of the ingredients in the herbal tonic, is a violent laxative, and can cause abdominal pain, dehydration, anxiety, decreased respirations, diarrhea, nausea, trembling, and vomiting.
- Cascara, one of the ingredients in the herbal tonic, is a laxative and can cause abdominal pain, cramping, diarrhea, discoloration of urine, fluid and electrolyte imbalance, osteomalacia (softening of the bones), steatorrhea (fat in the feces), vitamin and mineral deficiencies, and vomiting.
- Licorice, one of the ingredients in the herbal tonic, can cause interact with the body’s hormones and lead to imbalances in water, sodium, and potassium retention. High blood pressure, fatigue, muscle pain, cardiac arrhythmias, hypokalemia (low levels of potassium in the blood), and decreased libido can result.
- Pokeweed, one of the ingredients in the herbal tonic, causes nausea, vomiting, diarrhea, and abdominal cramps. Ingestion has been associated with illnesses requiring hospitalization, and has caused deaths in children.
Dosage (Inside MSKCC Only)
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