Written by Katja Boehm and the CAM-Cancer Consortium

Written by Katja Boehm and the CAM-Cancer Consortium

About
"CAM-Cancer" is the name of a project entitled "Concerted Action for Complementary and Alternative Medicine Assessment in the Cancer Field" (CAM-Cancer). Originally funded by the European Commission (EC) within the Framework 5 Programme, it is now hosted by the National Information Center for Complementary and Alternative Medicine (NIFAB) at the University of Tromsø, Norway.

Written by Katja Boehm and the CAM-Cancer Consortium.

Updated November 3rd, 2009

Carctol

Abstract and key points

Carctol is an Ayurvedic herbal mixture consisting of eight herbal extracts, which was recently developed in India and is available in Europe.

Its promoters claim that it cures cancer in many patients. This claim is not supported by evidence, as not a single controlled clinical trial has so far been carried out.

The safety of this product is uncertain. Its demonstrated benefits therefore do not outweigh its potential risks.

  • Carctol is a mixture of 8 herbs.
  • Neither pre-clinical studies nor controlled trials of Carctol for the treatment or palliation of cancer exist.
  • Its safety is uncertain.

What is Carctol?

Scientific name / brand name / common name
Carctol is a product made of a mixture of eight herbal remedies:

  • Chinese smilax (Smilax china L.) - roots
  • Blistering ammani (Ammani vesicatoria) - plant
  • Puncture vine (Tribulus terrestris L.) – seeds
  • Garden cress (Lepidium sativum L.) - seeds
  • Java pepper (Piper cubeba L.) - seeds
  • Himalayan rhubarb (Rheum emodi Wall.) – roots
  • Blepharis Edulis (Blepharis edulis Pers.) – seeds
  • Indian sarsaparilla (Hemidesmus indicus) – roots

Ingredients

Carctol contains a mixture of powdered Indian herbal extracts. Each 560 mg capsule contains 20 mg Indian sarsaparilla (Hemidesmus indicus), 20 mg Blistering ammani (Ammani vesicatoria), 20 mg Puncture vine (Tribulus terrestris L.), 80 mg Chinese smilax (Smilax China L.), 20 mg Garden cress (Lepidium sativum L.), 120 mg Java pepper (Piper cubeba L.), 20 mg Himalayan rhubarb (Rheum australe D. Don) and 200 mg Blepharis edulis (Blepharis edulis Pers.). No independent analyses of the product are available.

Application and dosage

A standard recommended daily dosage of Carctol for adults is between 4 and 8 capsules. Specific dosage instructions: Adult (Stage 1 or 2) 1 capsule 4 times a day, Adult (Chronic/Terminal Cases) 2 Capsules 4 times a day, Child 1/2 * 4 times a day, Infant 1/4 * 4 times a day. 13

Carctol is supposed to be taken in parallel with an acid-free, vegetarian diet and needs to be accompanied by digestion-assisting enzymes. Additionally, patients are advised to drink 3-5 litres of boiled and refrigerated water each day.

Advocates suggest that Carctol must be administered strictly, as per dosage schedule, for at least 60 days for the initial response and then to be continued as per physician’s advice 2. Supposedly, Carctol capsules are supposed to be continued for a further six months and the daily dosage is not to be interrupted.

One Website on Carctol suggests that a “two month trial is the minimum essential period, but more normally a six month period with follow-up periods is recommended”.11

History / providers

Carctol was developed by the Indian doctor Nandlan Tiwari (Rajasthan, India). Tiwari is an Ayurvedic medicine doctor who first started promoting Carctol in 1968 alongside dietary changes. He investigated the effect of indigenous herbs in the forest of Assam by gathering information provided by the tribes there, developed the herbal mixture and allegedly tested it on cancer patients for over 20 years. It is claimed that the remedy has also been tested in the UK. However, no publications exist in the medical literature. In Europe, Carctol is only available through specific UK doctors who prescribe the medicine as an Ayurvedic cancer treatment. However, “Ayurvedic medicine” implies it has a track record of traditional use, but this is not the case. A list of these doctors can be found on the official Carctol website.1 The doctor will ask the client to sign a consent form indicating s/he understands the status of the medicine in that it is an herbal dietary supplement. In Europe, Carctol cannot be bought from unauthorised sources.

Claims of efficacy / mechanisms of action / alleged indication

Carctol is advocated by its promoters as: an adjuvant treatment to prevent cancer, a means of providing protection for smokers, and a treatment of whooping cough, swallowing difficulties, appetite loss, menstrual disorders and alcohol-related liver damage. It is also recommended for a sole treatment of all types of cancer in cases where “the limits of conventional medicine have been reached” 1. According to the promoters, 30 to 40% of people using Carctol as a cancer treatment “will respond to it”. It is, however, not recommended as a substitute for conventional treatment.

The individual herbs do not have any known anti-carcinogenic properties. However, supporters of the remedy claim that it is the combination of herbs (through a synergistic effect) that causes the anti-carcinogenic activity of Carctol. Allegedly, laboratory-based toxicological testing of Carctol at the Indian Institute of Medical Sciences and in the UK, at the Lyne, Martin and Radford laboratories in London has shown it to be free of toxic bacteria, but no pre-clinical study assessing the toxicity of bacteria in Carctol has been published in the medical literature.

Dr Tiwari claims that Carctol works by helping to eliminate acids in the body. Carctol (in addition to other dietary changes) is claimed to work by changing the pH in the body from acid to alkaline by creating an alkaline environment within the body, in which acidic cancer cells cannot survive. This acidity theory dates back to the body humour theory of ancient Greek medicine. Carctol is claimed to be a detoxification method, which works by excreting toxins from the body, via the kidneys, liver and bowels. It is claimed to strengthen the immune system, neutralise toxicity from chemo- and radiotherapy, support kidney and liver function and improve digestion. It is also suggested that by administering Carctol during radio- and chemotherapy, patients are prevented from becoming neutropenic. None of these claims are supported by data nor are they physiologically plausible.

A search for 'carctol' on the electronic search engine “Google” achieved 66.300 hits (Google search on 3 November 2009). Websites promoting Carctol also advise patients to change their diet and drink large amounts of water to help cure the cancer. It is assumed that sour foods increase the acidity in the body, which could then stop Carctol from working.

Prevalence of use

No data exist to estimate the use of Carctol by cancer patients.

Legal issues

Carctol is imported into the UK by Cankut Herbs under medical supervision and is classified as an unlicensed medicine by the Medicines and Healthcare products Regulatory Agency (MHRA). Because five of the eight herbal ingredients are classified as medicines in the UK, the preparation cannot be advertised. In the UK, there is a list of doctors, which prescribe an unlicensed medicine if they believe it may be effective to the patient without it having to be trialed and licensed 1. The MHRA states that if a company places a manufactured herbal remedy on the market and supplies the product to herbalists, then in principle such a product would need to have either a marketing authorisation or traditional use registration ( This is in accordance with the new European Directives and Regulation of herbs.

Costs and expenditures

A month’s supply of Carctol costs between Euro 65 for the lowest dose and Euro 130 for the highest dose plus shipping and VAT and one tub contains 120 capsules 4. Four tubs will last around two months, the time span recommended for using the product initially. The digestive enzymes patients are recommended to take at the same time cost Euro 14 per month.

Does Carctol work?

Clinical trials

No controlled trials of Carctol for the treatment or palliation of cancer were found.

Pre-clinical studies

No pre-clinical trials of Carctol for the treatment or palliation of cancer were found.

Case reports/series

Between 1985 and 1989 websites claim that 1.900 terminal-stage cancer patients were treated with Carctol by Dr Tiwari 2. The findings are reported on the Internet by a graph plotting the total number of cases against the percentage of response rate, categorised by each type of cancer (including oesophageal, ear, nose and throat, brain, breast, bone, lymphoma, lungs, blood, kidney, cervical, stomach, colorectal, pancreatic and hepatobilliary cancer). On a scale of 0 to 100, patients had to self-score ‘how they were doing’.

The Indian cancer patients who followed the program reported a 75%-100% benefit in 2% of the patients, a 25%-75% benefit in 50% of the patients, and little or no benefit in the remaining 25%. Benefits include increased energy, weight gain, and increased well-being and tranquillity. In some cases it was claimed that the cancer disappeared.2, 16

In 2004, Dr Rosy Daniel from the UK claimed to have prescribed the herbal remedy to 860 cancer patients before and after chemotherapy 3. She stated that, in one fourth of those patients she still had contact with, the growth of the malignant tumour had stopped and in some cases the cancer went into recession or disappeared completely. Again, none of these claims are published in the medical literature. On her website, Dr Daniel claims that a non-acidic diet further aids the development of an alkaline environment.14 She recommends vegetables (except tomatoes), all pulses, nuts, seeds, grains, cereals, and non-acid fruits (melon, banana, papaya). The diet excludes acidic foods - even those that are alkaline-forming such as lemons. She claims that the body buffers the acid in lemons with alkali and as the alkaline buffers are used up, the tissues become more acidic. Meat, fish, and shellfish are also excluded in Dr Daniel's diet until the body's environment turns alkaline. However, Dr Daniel strongly recommends having medical supervision while using Carctol.

Only one publication in a scientifc journal could be located but the article only provides the personal view of its author.12

Is Carctol safe?

There is no literature regarding the safety of Carctol. The distributors of the remedy claim that Carctol has no adverse effects or herb-drug interactions, but one component contains coumarin, an anticoagulant. Also, two of the plants may lower blood sugar. Furthermore, the safety of Carctol has so far not been systematically assessed. Patients are advised to drink three to five litres of water each day and to follow a vegetarian diet. This could possibly lead to malnutrition and fluid congestion. Cancer patients should always consult a specialist before substantially changing their dietary habits.

The following information regarding safety, adverse effects and interactions is available for the individual plants Carctol contains. These relate to theoretical risks and do not necessarily refer to the dosages used in Carctol.

Sarsaparilla (Smilax febrifuga)
Sarsaparilla has Generally Recognised As Safe status (GRAS) for use in food in the US. It is possibly safe when used orally and appropriately for medicinal purposes (Natural Medicines Comprehensive Database). However, it is possibly unsafe when used in excessive amounts.

Cubebs (Piper cubeba)
Cubebs has Generally Recognised As Safe status (GRAS) for use in food in the US. It is possibly safe when used orally and appropriately for medicinal purposes 5. No adverse reactions have been reported.

Puncture vine (Tribulus terrestris)
Puncture vine may possibly be safe when used orally and appropriately, short-term. It has been safely used in studies for up to eight weeks but the long-term effect is unknown 67.

Himalayan rhubarb (Rheum emodi Wall.) The leaves of some members of this genus contain significant quantities of oxalic acid and should not be eaten in any quantity. Oxalic acid can lock up certain minerals in the body, especially calcium, leading to nutritional deficiency. The content of oxalic acid will be reduced if the plant is cooked. People with a tendency to rheumatism, arthritis, gout, kidney stones or hyperacidity should take especial caution if including this plant in their diet since it can aggravate their condition.15

Garden cress (Lepidium sativum L.)
There is insufficient reliable information available about the safety of garden cress.

Contraindications

None known.

Precautions/warnings

There is insufficient reliable information available about any of the ingredients. There is no data on the use of Carctol during pregnancy and lactation.

Adverse effects

No adverse effects of Carctol have been reported. One of the ingredients of Carctol, Himalayan rhubarb (Rheum acuminatum), has been linked with adverse effects such as bone loss and muscle weakness. Rhubarb can also cause anaphylaxis, diarrhoea, heart arrhythmias, depletion of potassium and other electrolytres 9. There is one report of a four-year old who ingested rhubarb leaves containing oxalic acid and died 10. Orally, rhubarb can cause cramp-like or spasmodic GI discomfort, watery diarrhoea and uterine contractions. When consuming sarsaparilla in excessive amounts, gastrointestinal (GI) irritation or temporary kidney impairment may occur due to it saponin constituents. Orally, ingesting large amounts of garden cress may cause GI irritations. Java pepper (Piper cubeba L.) and Puncture vine (Tribulus terrestris) can have psychoactive effects.

Interactions

Sarsaparilla can interact with digitalis by increasing the glycoside absorption. Theoretically, sarsaparilla may alter the absorption or elimination of simultaneously administered herbs. Sarsaparilla may interact with digoxin (Lanoxin) as it may increase digitalis glycoside absorption. 5

Theoretically, due to reports that cubebs increases stomach acid, cubebs might decrease the effectiveness of antacids and H2-blockers cimetidine (Tagamet), ranitidine (Zantac), nizatidine (Axid) and famotidine (Pepcid). Cubebs might also decrease the effectiveness of proton pump inhibitors including omeprazole (Prilosec), lansoprazole (Prevacid), rabeprazole (Aciphex), pantoprazole (Protonix) and esomeprazole (Nexium).

Theoretically, puncture vine might enhance the blood glucose-lowering effect of hypoglycaemic drugs, including glimepiride (Amaryl), glyburide (Diabeta, Glynase PresTabs, Micronase), insulin, metformin (Glucophage), pioglitazone (Actos), and rosiglitazone (Avanida).

Concurrent use of rhubarb might decrease mineral absorption. Overuse of rhubarb might cause potassium depletion, increasing the risk of cardio toxicity and digoxin toxicity. Overuse might compound corticosteroid-induced or diuretic-induced potassium loss (diuretics include chlorothiazide (Diuril), chlorthalidone (Thalitone), furosemide (Lasix), and hydrochlorothiazide (HCTZ, Hydrodiuril, Microzide).

No interactions of garden cress with herbs, supplements or other drugs are known.

Quality issues

There are no independent assessments of the quality of Carctol.

References

  1. Carctol home website accessed on 03 November 2009
  2. Anticancer herb website accessed on 03 November 2009
  3. Ebner S. Dr Daniel's 'miracle' cure. The Guardian, 21 September 2004, < (accessed on 03.11.09)
  4. Cancer research UK website accessed on 03 November 2009
  5. Natural Medicines Comprehensive Database accessed on 03 November 2009
  6. Brown GA, Vukovich MD, Reifenrath TA, et al. Effects of anabolic precursors on serum testosterone concentrations and adaptations to resistance training in young men. Int J Sport Nutr Exerc Metab 2000;10:340-59.
  7. Antonio J, Uelmen J, Rodriguez R, Earnest C. The effects of Tribulus terrestris on body composition and exercise performance in resistance-trained males. Int J Sport Nutr Exerc Metab 2000;10:208-15.
  8. Jiao DH, Ma YH, Chen SJ, et al. Resume of 400 cases of acute upper digestive tract bleeding treated by rhubarb alone. Pharmacology 1980;20 Suppl 1:128-30.
  9. McGuffin M, Hobbs C, Upton R, Goldberg A, eds. American Herbal Products Association's Botanical Safety Handbook. Boca Raton, FL: CRC Press, LLC 1997.
  10. Ellenhorn MJ, et al. Ellenhorn's Medical Toxicology: Diagnoses and Treatment of Human Poisoning. 2nd ed. Baltimore, MD: Williams & Wilkins, 1997.
  11. Anonymous: Carctol. accessed on 03 November 2009
  12. Ernst E. Carctol: profit before patients? Breast Care 2009;4:31-3.
  13. Anonymous: Carctol. accessed on 12 November 2009
  14. Anonymous: Carctol. accessed on 03 November 2009
  15. Bown D. Encyclopaedia of Herbs and their Uses. Dorling Kindersley, London. 1995.
  16. Klotter J. Carctol. Townsend Letter Feb/March 2005. accessed on 20 November 2009.

Legal notice
The present documentation has been compiled by the CAM-CANCER Project with all due care and expert knowledge. However, the CAM-CANCER Project provide no assurance, guarantee or promise with regard to the correctness, accuracy, up-to-date status or completeness of the information it contains. This information is designed for health professionals. Readers are strongly advised to discuss this information with their physician. Accordingly, the CAM-CANCER Project shall not be liable for damage or loss caused because anyone relies on the information it contains.