Insulin potentiation therapy (IPT) uses insulin as an adjunctive agent to potentiate the effect of chemotherapy and other medications. It is claimed that insulin enhances the effect of the chemotherapy by "opening up" the receptors on cancer cells so that more of the pharmacological agent or chemotherapy can get in, thus lowering the chemotherapy dose. This document addresses IPT as an adjunctive agent to potentiate the effects of pharmacologic therapy in the treatment of cancer as well as infectious diseases, chronic degenerative disorders, fibromyalgia, chronic fatigue syndrome, arthritis, and many other conditions.

Investigational and Not Medically Necessary:

Insulin potentiation therapy (IPT) is considered investigational and not medically necessary for the treatment of cancer, infectious diseases, chronic degenerative disorders, and all other conditions.

Although proponents claim that IPT is effective, there is currently only one published randomized controlled trial on the effects of IPT in metastatic breast cancer (Lasalvia-Prisco, 2004). The trial studied 30 women with metastatic breast cancer and measurable lesions resistant to fluorouracil, adriamycin, cyclophosphamide, and also hormone therapy. Three groups each of ten women received two 21-day courses of the following treatments: insulin and methotrexate, methotrexate, and insulin, respectively. In each subject, the size of the target tumor was measured before and after treatment. The changes in the size of the target tumor in the three groups were compared statistically. The median increase in tumor size was significantly lower with insulin and methotrexate than with each drug used separately. The authors concluded that insulin enhanced the chemotherapy effect. While this small study may suggest insulin enhances a biochemical event with the administration of chemotherapy in the short term, it does not report any long-term effects or health outcomes. Therefore, further studies are warranted to provide more conclusive evidence of any improvement in health outcomes with the use of insulin potentiation therapy.

The American Cancer Society (ACS) (2008) describes IPT as the use of insulin along with lower doses of chemotherapy to treat cancer. The ACS also states:

Despite supporters' claims that insulin potentiation therapy has been well researched, no scientific studies that show safety and effectiveness have been published in available peer-reviewed journals. These claims cannot be verified.

There are also concerns about using lower doses of chemotherapy drugs. When chemotherapy drugs are tested in clinical trials, their effects are carefully monitored to learn which dose will best balance the need to kill cancer cells with the goal of keeping the side effects at a tolerable level. There is no evidence that chemotherapy at a fraction of the recommended and tested dose can produce the same effect as the full dose if used with insulin.

Most of the information about IPT comes from individuals (anecdotal reports). Even among these, however, there has been no evidence that those who reported being helped by IPT were followed long enough to verify if the treatment worked. IPT has also reportedly been used as treatment for fibromyalgia, chronic fatigue syndrome, arthritis, and some infections. The safety and efficacy of this therapy have not been confirmed with well designed clinical trials; in fact, no additional clinical trial data was found for any completed or ongoing clinical trials.

Insulin potentiation therapy (IPT) was developed in the 1930s in Mexico by Donato Perez Garcia, Sr, MD and has been explored by a few physician practices (Ayre, 2000). Specifically, the person reports to an IPT clinic after having had nothing to eat or drink (other than water) for 6 to 8 hours. Intravenous (IV) fluids are started, and the individual is given a dose of insulin based on his or her body weight. For those with cancer, low doses of chemotherapy drugs are given a few minutes later so they reach the bloodstream after the insulin has started to lower blood sugar. This is called the "therapeutic moment" by some IPT providers.

At this point, the individual usually has some symptoms of hypoglycemia, which can be quite severe, especially the first time, as responses may vary to a standard dose of insulin. The IV infusion is switched to a high-sugar solution to raise the blood sugar. After the symptoms of low blood sugar begin to improve, food may be given to raise the blood sugar further. At the next treatment, the insulin dose may be raised or lowered, depending on the individual's response to the first dose.

Between treatments, the individual may be given chemotherapy drugs by mouth, and also vitamins or other supplements. Treatment is usually provided twice weekly, generally for 12 to 18 sessions. After the first round of treatment is completed, some people are advised they need additional "maintenance" sessions (American Cancer Society, 2008).

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
For the following procedure and diagnosis codes, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Future ICD-10 coding (effective 10/01/2013)
A draft of ICD-10 Coding related to this document, as it might look today, is available for reference and comments at: Appendix 1: Future ICD-10 coding

Peer Reviewed Publications:

1. Ayre SG, Garcia y Bellon DP, Garcia DP Jr. Insulin, chemotherapy, and the mechanisms of malignancy: the design and the demise of cancer. Med Hypotheses. 2000; 55(4): 330-334.
2. Ayre SG, Perez Garcia y Bellon D, Perez Garcia D Jr. Insulin potentiation therapy: a new concept in the management of chronic degenerative disease Med Hypotheses. 1986; 20(2):199-210.
3. Lasalvia-Prisco E, Cucchi S, Vazquez J, et al. Insulin-induced enhancement of antitumoral response to methotrexate in breast cancer patients. Cancer Chemother Pharmacol. 2004; 53(3): 220-224.

1. American Cancer Society. Insulin Potentiation Therapy. Revised: 11/01/2008. Available at: http://www.cancer.org/docroot/ETO/content/ETO_5_3X_Insulin_Potentiation_Therapy.asp?sitearea=ETO Accessed on September 14, 2011.

Insulin Potentiation Therapy
IPT