Chabot JA, et al. Pancreatic proteolytic enzyme therapy compared with gemcitabine-based chemotherapy for the treatment of pancreatic cancer. J Clin Oncol. 2010 Apr 20;28(12):2058-63.
This controlled, observational study evaluated PE therapy compared with gemcitabine-based chemotherapy in patients with inoperable pancreatic cancer. Of 55 enrolled patients, 23 chose chemotherapy and 32 elected enzyme treatment that consisted of pancreatic enzymes, nutritional supplements, detoxification, and an organic diet. The two groups had no statistically significant differences in quality of life or pathology at enrollment. At 1-year time point, researchers observed an increase in median overall survival (9.7 mo) and better quality of life (P<.01) in patients who chose gemcitabine-based chemotherapy compared with those in the PE group.
Dorr W, Herrmann T, Study G. Efficacy of Wobe-Mugos E for reduction of oral mucositis after radiotherapy: results of a prospective, randomized, placebo-controlled, triple-blind phase III multicenter study. Strahlenther Onkol. 2007;183:121-127.
This prospective, randomized, placebo-controlled, triple-blind phase III multicenter study evaluated the efficacy and safety of PEs (Wobe-Mugos® E containing papain 100 mg, trypsin 40 mg, and chymotrypsin 40 mg) to treat side effects associated with head-and-neck radiotherapy (RT) including oral mucositis. A total of 69 patients were enrolled, with 61 evaluable patients. The primary endpoint was the maximum mucositis score during weeks 1–6 of RT. Although the intervention was well tolerated, there were no between-group differences in the primary endpoint results. However, the intervention appeared to result in an earlier onset of mucositis, thus increasing the average scores over treatment duration. Investigators concluded the PE therapy did not confer any benefit for patients with RT-induced early oral mucositis.