Flowers of the bloodroot plant, Sanguinaria canadensis.  You're welcome, I could have used a very different image (warning: gross bordering on horrifying).

Flowers of the bloodroot plant, Sanguinaria canadensis. You’re welcome, I could have used a very different image (warning: gross bordering on horrifying; click on image to see it).

Cervical dysplasia is a precancerous condition picked up by Pap smears. It is most often caused by human papillomavirus (HPV) infection. Mild cases may resolve spontaneously and can be followed by observation with frequent Pap smears, but cervical dysplasia can progress to cancer. The standard treatment is to remove the abnormal cells with a cone biopsy (using a knife) or a Loop Electrosurgical Excision Procedure (LEEP) using a wire loop heated by electricity. Those procedures not only treat the disease, but they provide a pathology specimen that can be examined to rule out more serious or invasive disease. Both LEEP and cone biopsy are 85-90% effective in removing all the abnormal cells. If cancer is suspected, a cone biopsy is preferable because LEEP may damage the edges of the specimen and make it more difficult to interpret. Otherwise, LEEP is often preferred because it is less expensive and doesn’t require anesthesia or an operating room. I have discussed misguided attempts by alternative medicine practitioners to treat cervical dysplasia before.

Surgery is often perceived as scary and not “natural,” so it’s not surprising that a “natural” treatment has been devised to replace surgery. Escharotics are corrosive salves that get their name from the thick dry scab that they can produce called an eschar. The “natural” escharotic treatment alternative for cervical dysplasia involves applying a solution of bloodroot (Sanguinaria canadensis) and zinc chloride. They claim that the solution selectively kills abnormal cells of the cervix while leaving healthy cells unaffected. That claim is almost certainly false, and the efficacy and safety of escharotic treatment has not been properly tested or compared to conventional treatment.

Who is using escharotic treatments?

Not mainstream doctors. Neither the American Congress of Obstetricians and Gynecologists (ACOG) nor the American Cancer Society (ACS) even mention escharotic treatments on their websites. The only proponents I could find were naturopaths and chiropractors.

Dr. Nicholas LeRoy bills himself as a “holistic medicine physician” but he is actually a chiropractor who is also trained in acupuncture and oriental medicine. His website says he “designs unique therapies” for the treatment of cervical dysplasia and other conditions, and he integrates chiropractic, diet, nutrition, acupuncture, and herbal supplementation. He also offers breast thermography and makes misleading claims for it, and he spreads misinformation about “90 deaths and thousands of injuries” from HPV vaccines. He has a book coming out on HPV and cervical dysplasia. It is ironic that someone who is putting himself forward as an expert on cervical dysplasia is discouraging the HPV vaccine, the one thing that offers an effective way to prevent the disease.

Naturopathic treatment of cervical dysplasia

A naturopathic review of cervical dysplasia recommends this approach to treatment:

  • A comprehensive nutritional intake and dietary counseling
  • Education on safe sex
  • Smoking cessation
  • Dietary supplements: folic acid, indole-3-carbinol, antioxidants like CoQ10 and vitamins C and E, green tea extract, and Coriolus versicolor (a mushroom)
  • Escharotic treatment with bromelain or zinc/sanguinaria
  • Vaginal suppositories with magnesium sulfate, glycerin complex, Hydrastis tincture, thuja oil, tea tree oil, bitter orange oil, vitamin A, ferric sulfate, and ferrous sulfate.
  • Vaginal green tea suppositories

They admit that critics of natural medicine say there is no published evidence that these options work or are backed by science, but they say several recently published articles explain the science and patient outcomes. They don’t list those “several” articles; they only cite a single published case report of one patient who was treated with 10 escharotic treatments along with an oral vitamin and botanical protocol.

Another naturopathic website makes similar recommendations and adds detoxification, exercise, stress management, homeopathy, and flower essences. It never ceases to amaze me how naturopaths will throw everything but the kitchen sink at a disease hoping something will stick. If the treatment works, they have no way of knowing what part of the treatment worked; so they convince themselves that the whole schmear was necessary and that they have some kind of holistic wisdom that guided them to know what particular mix of treatments would work.

Their reasons to prefer escharotic treatment

They claim escharotic treatment is superior to LEEP because it is natural, doesn’t damage normal cells or leave a scar, doesn’t cause complications like infection or reduced fertility, stimulates regrowth of normal tissue, is preferred by most women, and is less expensive. Every one of those claims is questionable. They only admit one drawback: escharotic treatment requires more visits (ten versus one). They don’t mention that the tissue removed in LEEP can be examined for invasive cancer, which is not possible with escharotic treatment. They also don’t mention that LEEP is covered by medical insurance, while escharotic treatment is not.

What is the evidence?

A PubMed search produced only the same single case report mentioned above. The only other evidence I could find anywhere online consisted of references to two studies reportedly published in an obscure, unobtainable naturopathy journal. A 2003 review article on cervical dysplasia in the Alternative Medicine Review describes those two studies. The references for those studies list the same author, Hudson TS, and a journal called J Naturopathic Med. That journal is not listed in PubMed and I have been unable to even find any reference to such a journal on the Internet except in a very few citations on naturopathic websites. I even tried to locate it by asking one of the proponents of the therapy for help, but my query went unanswered. Note: I did find an International Journal of Naturopathic Medicine, but it was founded in 2004, long after the 1991 and 1993 dates of the studies in question.

So I can’t evaluate the studies for myself; I can only copy the description of the two studies provided in the review article:

First study:

A small study using local escharotic treatment was conducted on seven women with carcinoma in situ of the cervix. Three levels of treatment were employed: local treatment to the cervix, systemic treatment, and constitutional treatment. Local escharotic treatment utilized preparations of ZnCl, bloodroot, bromelain, and Calendula succus. Local treatment was repeated twice weekly for five weeks with treatments 2-3 days apart. Topical vitamin A was applied following each local treatment. Systemic treatment was comprised of ascorbic acid 6-10 g per day, beta carotene 120,000-180,000 IU per day, and selenium 400 mcg per day. Patients were also prescribed a vegan diet to eliminate animal fats and two botanical compounds to enhance immune function – Taraxacum officinalis and Arctium lappa. Systemic treatment was continued for not less than three months. Constitutional treatment consisted of a homeopathic remedy prescribed on an individual basis.

All seven patients received one year of follow-up. Four of the women remained disease free after the one-year period. One woman improved to atypia and then reverted to mild dysplasia. One woman had resolution of the cells of the endocervix and not the ectocervix, and one woman had resolution of the cells of the ectocervix and not the endocervix. The latter patients appeared to be non-compliant with regard to diet and lifestyle changes, suggesting the influence of synergistic effects of this multi-modality approach.

Comment: That dose of beta carotene is 60 times the RDA, and The Medical Letter says no one should take high-dose beta carotene. The addition of homeopathic remedies to the protocol speaks volumes about the author; it does not inspire confidence. This was a very small uncontrolled preliminary study with only 7 subjects, and the results were not promising. The success rate of 4 out of 7 is far inferior to the 85-90% success rate with conventional treatment. And then they have the gall to blame the treatment failures on the patients for non-compliance with peripheral recommendations that were highly unlikely to have affected the study results. They say it suggests the influence of synergistic effects of their multi-modality approach. No, it doesn’t. It suggests that the escharotic treatment is less effective than LEEP or cone biopsy.

Second study:

A follow-up study was performed by the same group on 43 cases, including cervical atypia (n=7), cervical dysplasia (n=26), and carcinoma in situ (n=10) during the following two years. A similar protocol was used, with the addition of 10 mg folic acid daily. The results of the study were encouraging as 38 of the women had complete regression to normal, while three of the women had partial regression and two had persistent lesions. The two women with persistent lesions had lowgrade dysplasia. These studies yield promising results, suggesting the need for a multi-faceted approach to preventing cervical cancer. Table 3 summarizes the escharotic treatment.

You can read the details of Table 3 here. It describes the protocol for applying bromelain and washing it off with a solution of Calendula succus, then applying a zinc/bloodroot mixture, and washing that off. Finally, two vaginal suppositories of vitamin A are left in the vagina for 24 hours.

Comment: This study mixed in cases of atypia, dysplasia, and carcinoma in situ, and without access to the study, we can’t determine the success rate for the various diagnoses. What if the seven cases of atypia were all in the group that had complete regression to normal? What if they were all mild cases of atypia that would have resolved spontaneously without any treatment? While larger than the first study, it is still small and preliminary, and there is no control group, so we have no way of knowing if it is less, more, or as effective as conventional treatments like LEEP. I am left wondering why they chose to add folic acid, and why they used such a large dose, a whopping 25,000 times the RDA, a level that has been shown to increase the risk of cancer and heart problems. One of the instructions, “avoid contact of the zinc/sanguinaria mixture with the vaginal wall,” is a tacit acknowledgement that it does damage normal cells, contradicting their claim that it only affects the abnormal cells.

I found the same description of these two studies almost exactly word-for-word on a naturopath’s website, making me wonder whether the naturopath had read the studies herself or merely copied the description from the review article.

Bloodroot and black salve

Bloodroot is one of the main ingredients in black salve, a dangerous topical quack treatment for cancer. In the form of Cansema, black salve containing zinc chloride, bloodroot and other ingredients has been banned by the FDA for use as a cancer cure. But it is still readily available online.

Steven Barrett says “The idea that bloodroot kills only cancer cells and spares normal ones is preposterous.” There is good evidence that bloodroot does damage normal cells. A woman who used it for skin blemishes developed a large eschar on her neck and was left with a scar. Black salve products containing bloodroot are known to cause necrosis of normal tissue along with scarring, granulomatous inflammation, implanted foreign material, reactive stromal atypia, suppuration, and residual cancer. A 2012 review of bloodroot pointed out that it can cause significant tissue destruction, scars, and keloid formation.

Quackwatch warns against using escharotics, and shows a picture of a woman whose naturopath treated her with a black herbal salve for a bump on her nose. It ate away a large part of her face and her nose sloughed off. It took 3 years and 17 plastic surgeries to reconstruct her face. The picture is not pretty; click on the link only if you don’t mind being grossed out.

Andrew Weil used a bloodroot paste to treat skin lesions on his dog and on a friend (neither had biopsies to establish a diagnosis) and thought the results were satisfactory, so he started recommending it. According to Quackwatch, his advice persuaded a woman to use it and it destroyed her nose.

In 2014, a letter in The Medical Journal of Australia reported the case of a 55-year-old man who used a bloodroot-containing black salve on a lesion he suspected might be cancerous. It left an inch-wide hole in his head. There is a picture of the resulting hole here. Viewer discretion advised.

What about bromelain?

The only reference to bromelain and cervical dysplasia in PubMed is that same single case report. Bromelain is a mixture of proteolytic enzymes derived from pineapple; it is used as a meat tenderizer in cooking. It is approved in Europe for the removal of dead and damaged tissue in severe burn wounds. It is not harmless to normal cells: the healthy surrounding skin has to be protected with a sterile paraffin ointment.

Conclusion

The escharotic treatment of cervical dysplasia is not evidence-based, is not approved by any professional organization, and is used only by a few chiropractors and naturopaths. The claim that it doesn’t harm normal tissue is false: there is clear evidence that both bromelain and bloodroot damage normal cells. Sure, they can kill cancer cells, but as Rose Shapiro pointed out in her book Suckers: How Alternative Medicine Makes Fools of Us All, you can destroy cancer cells in a petri dish with a flamethrower or bleach. I suppose that anything that destroys tissue ought to be effective for cervical dysplasia (sulfuric acid? a cigarette lighter?). I suspect that they have used escharotics very cautiously and have been lucky to avoid adverse effects so far. The effectiveness and safety of escharotic treatment has not been established, and until it has, I think it is irresponsible to offer it as an alternative to evidence-based conventional treatments. There is reason to think it may be less effective than conventional treatments and there is reason to think it may be dangerous.

 

 

Posted by Harriet Hall

Harriet Hall, MD also known as The SkepDoc, is a retired family physician who writes about pseudoscience and questionable medical practices. She received her BA and MD from the University of Washington, did her internship in the Air Force (the second female ever to do so),  and was the first female graduate of the Air Force family practice residency at Eglin Air Force Base. During a long career as an Air Force physician, she held various positions from flight surgeon to DBMS (Director of Base Medical Services) and did everything from delivering babies to taking the controls of a B-52. She retired with the rank of Colonel.  In 2008 she published her memoirs, Women Aren't Supposed to Fly.

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