The coffee enema study: No cure, more pain, earlier death

A decade ago, the National Center for Complementary and Alternative Medicine helped fund a study with the National Cancer Institute of an arduous regimen for pancreatic cancer that is best known for frequent "detoxifying" coffee enemas.

The research design pitted standard chemotherapy against a regimen developed by Nicholas Gonzalez, a New York City physician. In the study, volunteers on the Gonzalez protocol got coffee enemas twice a day. They also took dozens of supplements each day, including 69 to 81 capsules of pancreatic enzymes; maintained a strict diet; and engage in other "detoxifying" activities, such as "skin brushing."

The hypothesis was that pancreatic enzymes are the body's primary defense against cancer and can be used to fight it. The idea originated in the early 1900s, but a century later there was little scientific evidence to suggest it would work. The best data were in a pilot study Gonzalez published in 1999 involving 11 pancreatic cancer patients. Five were reported to have lived at least two years, a long time for pancreatic cancer, which usually kills swiftly.

The protocol was not without risk — coffee enemas have been linked to infections and electrolyte imbalances that can be fatal.

But the taxpayer-funded study was approved. Investigators enrolled 55 volunteers with pancreatic cancer.

The results, published in 2010 in the Journal of Clinical Oncology, were dramatic. Patients who received standard chemotherapy lived an average of 14 more months, while those on the Gonzalez protocol lived on average for only four more months — and were in significantly more pain.

But some experts questioned the study's findings, saying it lacked a clear question and had a flawed design. For example, the volunteers were allowed to pick whether they received standard therapy or join the group that got coffee enemas. The initial plan was to make the assignments random, but few patients were willing to volunteer under those conditions.

Gonzalez himself is a critic of the project. He argues that the patients receiving his protocol were sicker than those receiving chemotherapy.

"It was a waste of taxpayers' money and 10 years of our lives," Gonzalez says. "It served no one and nothing."

Study leader Dr. John Chabot, professor of clinical surgery at Columbia University, says the trial was worthwhile. "Identifying treatments that don't work remains valuable."

Chabot says Gonzalez was strongly behind the study "until the data started to come through and begin to direct us toward a conclusion."

Dr. Josephine Briggs, NCCAM's director, declined to discuss the study. She called it "ancient history" and said the project would have little chance at receiving funding from her center today.

Today, patients continue to see Gonzalez about his cancer treatment. In the end, the study changed few minds and put volunteers at risk for little benefit to them or to the greater good — at a cost to taxpayers of $1.4 million, with $406,000 coming from NCCAM.

ttsouderos@tribune.com