16 September, 2009

A Study the Champions of Woo Rue

I'm sure most of you have heard the news about Patrick Swayze, who succumbed to pancreatic cancer on Monday. He survived 20 months, which is actually pretty amazing for this disease. You don't have to be a Swayze fan to miss him, or to respect the grace and strength with which he faced a horrific disease.

A few hours before he died, Orac posted a review of a major study that pitted woo-based medicine against science-based medicine in treating pancreatic cancer. This is a study that you will not hear the woo-meisters trumpeting, because the results are devastating for them:

In words:

At enrollment, the treatment groups had no statistically significant differences in patient characteristics, pathology, quality of life, or clinically meaningful laboratory values. Kaplan-Meier analysis found a 9.7-month difference in median survival between the chemotherapy group (median survival, 14 months) and enzyme treatment groups (median survival, 4.3 months) and found an adjusted-mortality hazard ratio of the enzyme group compared with the chemotherapy group of 6.96 (P<.001). At 1 year, 56% of chemotherapy-group patients were alive, and 16% of enzyme-therapy patients were alive. The quality of life ratings were better in the chemotherapy group than in the enzyme-treated group (P <.01).

Moreover, the quality of life, as measured by standardized surveys, was actually worse for the Gonzalez therapy group:

Patients in the two groups responded similarly to the questionnaires on quality of life before initiation of therapy, but the overall FACT-PA scores during 12 months decreased more in the enzyme group than in the gemcitabine group (Fig 3). Twenty-four percent of total measurements were missing. Quality of life scores of both groups were significantly different (P.01). During the first 6 months of the study, pain scores increased in the enzyme group, but they decreased in the chemotherapy group (P.05); however, few patients reported on use of analgesics. (Table 2).
In all my years in medicine, surgery, and surgical oncology, I have never seen a study with such a striking difference in outcome between the two groups.


Not only was the median survival of patients in the Gonzalez therapy group worse than it was for the standard chemotherapy group, it was three times worse. At one year, 56% of the chemotherapy patients were alive; only 16% of the Gonzalez protocol patients were. But it's still even worse than that for the Gonzalez therapy. Not only did Gonzalez therapy patients do worse than those receiving standard therapy, but they did worse than the "average" pancreatic cancer patient as determined by the survival curve derived from data from the SEER Database. The most likely reason to explain such a result is that the Gonzalez therapy is not just inferior to gemcitabine but is probably completely biologically inactive against pancreatic cancer. What we are looking when we examine the survival curve for the Gonzalez protocol group is, most likely, indistinguishable from a survival curve of untreated pancreatic cancer versus treated.
Remember that when the woo-meisters start piling on Swayze's death with the claim that if only he'd followed their regimen of woo, he'd be alive today.

If he hadn't kicked them to the curb, we would have lost him long ago.

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