Influence of a complementary treatment with oral enzymes on patients with colorectal cancers - an epidemiological retrolective cohort study

Purpose: To evaluate the impact of postoperative treatment with an oral enz yme (OE) preparation given complementary to an antineoplastic therapy in pa tients with all stages of colorectal cancer. Methods: The design of this ep idemiological study was a retrolective cohort analysis with parallel groups . Design and conduct of the study were performed to current standards for p rospective, controlled clinical trials. Of a cohort of 1242 patients with c olorectal cancer (documented in 213 centres), 616 had received complementar y treatment with OE (182 OE only, 405 other complementary drugs, 29 protoco l violators) and 626 had not received OE (368 control only, 229 other compl ementary drugs, 29 protocol violators). Of 1162 patients who had undergone primary surgery, 526 received adjuvant chemotherapy and 218 radiotherapy. T he median follow-up time for the OE group was 9.2 months and for the contro l group 6.1 months. The primary test criterion of efficacy for OE treatment was the multivariate effect size of the changes from baseline of the disea se- and therapy-associated signs and symptoms (nausea, vomiting, changes in appetite, stomach pain or stomach disorder, tiredness, depression, memory or concentration disorder, sleep disturbance, dizziness, irritability, dysp noea at rest, dyspnoea during activity, headache, tumour pain, cachexia, sk in disorders and infections). Tumour-related events, e.g. death, were evalu ated by the number of events observed and time to event. Safety of treatmen t with OE was analysed in terms of number and severity of adverse events, t heir duration, treatment and outcome. Results: A significant reduction in d isease-associated signs and symptoms was observed in patients treated with OE alone, but not in those receiving OE in addition to other complementary treatments. Adverse reactions to chemo- and radiotherapy were diminished in all patients receiving OE. Analysis of survival did not demonstrate a redu ced number of deaths in the OE group. However, a trend to prolongation of s urvival was demonstrated, particularly in the patients with disease stage D ukes' D, in the subgroup receiving OE in addition to other complementary tr eatments. Similar but less-pronounced trends were observed for disease stag es Dukes' B and C. In the OE group, 21 of 616 patients (3.4%) experienced O E-associated adverse reactions, all of them mild to moderate gastrointestin al symptoms. Conclusion: Complementary treatment of colorectal cancer patie nts with OE improves their quality of life by reducing both the signs and s ymptoms of the disease and the adverse reactions associated with adjuvant a ntineoplastic therapies. This epidemiological retrolective cohort analysis provides evidence that patients may also benefit by a prolongation of survi val time. OE were generally well tolerated.