Insulin Potentiation Therapy

Our assessments of evidence for each medical benefit fall into one of these categories:

• Strong evidence: consistent, significant effects in several large (or at least one very large) well designed clinical studies or at least two meta-analysesa statistical analysis that combines the results of two or more research studies; the results of smaller research studies addressing the same or similar questions can be analyzed as though they are one bigger, more powerful study of clinical studies of moderate or better quality (or one large meta-analysis) finding similar results
• Good evidence: significant effects in one large or several mid-sized and well-designed clinical studies ( randomized controlled trialsa study design in which people are randomly assigned to either an experimental group or a control group to compare the outcomes from different treatments; an RCT is considered a strong design for determining a therapy’s effects with an appropriate placebo or other strong comparison control or observational studies that control for confounds)
• Modest evidence: significant effects in at least three small but well-designed randomized controlled trials (RCTs), or one or more well-designed, mid-sized clinical studies of reasonably good quality (RCTs or observationala type of study in which individuals are observed or certain outcomes are measured, but no attempt is made to affect the outcome (for example, no treatment is given); an example is a study that records people’s diets, but doesn’t try to alter their diets, and looks for patterns of disease or other outcomes related to different foods studies), or several small studies aggregated into a meta-analysis
• Preliminary evidence: significant effects in small or poorly designed clinical studies OR conflicting results in adequate studies but a preponderance of evidence of an effect
• Weak evidence: one or more case studies, supported by animal evidence OR small treatment effects of limited clinical significance OR studies with no controls OR weak trends of effects
• Insufficient evidence: preclinical evidence only OR clinical studies with such poor or unclear methodology that no conclusion can be drawn OR conflicting findings across clinical studies with no preponderance of evidence in one direction; conflicting evidence occurs when studies find conflicting effects (positive effect vs no effect or negative effect) with the same treatment and the same general study population (same cancer type, for example)

Learn more about how we research and rate therapies and practices in How We Rate Therapies ›

Preliminary evidencesignificant effects in small or poorly designed clinical studies OR conflicting results in adequate studies but a preponderance of evidence of an effect (this is the CancerChoices definition; other researchers and studies may define this differently) of tumor response and less progression among people with metastatic breast cancer with progressive disease after chemotherapy treated with intravenous human recombinant insulin and intravenous methotrexate

Also see preclinical evidence of increased toxicity of methotrexate from IPT in Safety and precautions ›

• Higher incidence of stable disease and lower incidence of progressive disease, plus a smaller increase in the size of lesions among people with metastatic breast cancer with progressive disease after chemotherapy with fluorouracil + Adriamycin + cyclophosphamide treated with intravenous human recombinant insulin (0.3 U/kg body weight every other day) followed 20 minutes later by a 15-minute intravenous infusion of methotrexate, for 2 courses of 21 days each separated by a 7-day interval without treatment compared to either methotrexate alone or insulin alone in a small RCTrandomized controlled trial, a study design in which people are randomly assigned to either an experimental group or a control group to compare the outcomes from different treatments; an RCT is considered a strong design for determining a therapy’s effects¹Lasalvia-Prisco E, Cucchi S et al. Insulin-induced enhancement of antitumoral response to methotrexate in breast cancer patients. Cancer Chemotherapy and Pharmacology. 2004 Mar;53(3):220-4.

Weak evidenceone or more case studies, supported by animal evidence OR small treatment effects of limited clinical significance OR studies with no controls OR weak trends of effects (this is the CancerChoices definition; other researchers and studies may define this differently) of tumor response or an effect on progression but no evidence of an effectoverall, one or more studies did not demonstrate that a treatment or intervention led to an expected outcome; this does not always mean that there is no effect in clinical practice, but that the studies may have been underpowered (too few participants) or poorly designed. Larger, well-designed studies provide more confidence in making assessments. on survival among people with progressive metastatic prostate tumors following previous treatment then treated with intravenous insulin and chemotherapy

• Complete objective responses in 33%, partial response in 11%, stable disease in 22%, and disease progression in 33% after disease progression following previous treatment with hormone therapy, bilateral castration, and/or androgenic blockade among people with metastatic prostate tumors treated with 10 treatments of 0.4 UI intravenous insulin per kilogram added either to cyclophosphamide/epirubicin and vinblastine or to docetaxel in a small uncontrolled triala study in which a therapy is used, but without a comparison group against which to judge outcomes; an uncontrolled trial is considered a weak study design;²Damyanov C, Gerasimova D, Maslev I, Gavrilov V. Low-dose chemotherapy with insulin (insulin potentiation therapy) in combination with hormone therapy for treatment of castration-resistant prostate cancer. ISRN Urology. 2012;2012:140182. another review³Sissung TM, Schmidt KT, Figg WD. Insulin potentiation therapy for cancer? Lancet Oncology. 2019 Feb;20(2):191-192. pointed out that the median survival in this study was 11.7 months compared to 18.9 months in a similar group treated with docetaxel plus prednisone in a separate study⁴Tannock IF, de Wit R et al; TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. New England Journal of Medicine. 2004 Oct 7;351(15):1502-12.

Weak evidenceone or more case studies, supported by animal evidence OR small treatment effects of limited clinical significance OR studies with no controls OR weak trends of effects (this is the CancerChoices definition; other researchers and studies may define this differently) of better quality of life among people with metastatic prostate tumors treated with intravenous insulin added to chemotherapy

• Better quality of life among people with metastatic prostate tumors treated with 10 treatments of 0.4 UI intravenous insulin per kilogram added either to cyclophosphamide/epirubicin and vinblastine or to docetaxel in a small uncontrolled triala study in which a therapy is used, but without a comparison group against which to judge outcomes; an uncontrolled trial is considered a weak study design⁵Damyanov C, Gerasimova D, Maslev I, Gavrilov V. Low-dose chemotherapy with insulin (insulin potentiation therapy) in combination with hormone therapy for treatment of castration-resistant prostate cancer. ISRN Urology. 2012;2012:140182.