Existing clinical data concerning the effectiveness of the Gonzalez regimen as a treatment for cancer are limited and inconclusive. To date, only one clinical study, a nonconsecutive case series involving 11 patients with pancreatic cancer, has been reported. Another clinical study involving patients with pancreatic cancer is currently under way, but no results have been reported. No data concerning the effectiveness of the Gonzalez regimen in patients with other types of cancer have been reported.

To assist readers in evaluating the results of human studies of complementary and alternative medicine (CAM) treatments for cancer, the strength of the evidence (i.e., the levels of evidence) associated with each type of treatment is provided whenever possible. To qualify for a level of evidence analysis, a study must:

• Be published in a peer-reviewed scientific journal.
• Report on a therapeutic outcome or outcomes, such as tumor response, improvement in survival, or measured improvement in quality of life.
• Describe clinical findings in sufficient detail that a meaningful evaluation can be made.

Separate levels of evidence scores are assigned to qualifying human studies on the basis of statistical strength of the study design and scientific strength of the treatment outcomes (i.e., endpoints) measured. The resulting two scores are then combined to produce an overall score. For an explanation of the scores and additional information about levels of evidence analysis of CAM treatments for cancer, refer to Levels of Evidence for Human Studies of Cancer Complementary and Alternative Medicine.

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