Oral Enzyme Research Articles

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

To evaluate the impact of postoperative treatment with an oral enzyme (OE) preparation given complementary to an antineoplastic therapy in patients with all stages of colorectal cancer. The design of this epidemiological study was a retrolective cohort analysis with parallel groups. Design and conduct of the study were performed to current standards for prospective, controlled clinical trials. Of a cohort of 1,242 patients with colorectal cancer (documented in 213 centres), 616 had received complementary treatment with OE (182 OE only, 405 other complementary drugs, 29 protocol violators) and 626 had not received OE (368 control only, 229 other complementary drugs, 29 protocol violators). Of 1,162 patients who had undergone primary surgery, 526 received adjuvant chemotherapy and 218 radiotherapy. The median follow-up time for the OE group was 9.2 months and for the control 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 disease- 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, dyspnoea at rest, dyspnoea during activity, headache, tumour pain, cachexia, skin disorders and infections). Tumour-related events, e.g. death, were evaluated by the number of events observed and time to event. Safety of treatment with OE was analysed in terms of number and severity of adverse events, their duration, treatment and outcome. A significant reduction in disease-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 reduced number of deaths in the OE group. However, a trend to prolongation of survival was demonstrated, particularly in the patients with disease stage Dukes' D, in the subgroup receiving OE in addition to other complementary treatments. Similar but less-pronounced trends were observed for disease stages Dukes' B and C. In the OE group, 21 of 616 patients (3.4%) experienced OE-associated adverse reactions, all of them mild to moderate gastrointestinal symptoms. Complementary treatment of colorectal cancer patients with OE improves their quality of life by reducing both the signs and symptoms of the disease and the adverse reactions associated with adjuvant antineoplastic therapies. This epidemiological retrolective cohort analysis provides evidence that patients may also benefit by a prolongation of survival time. OE were generally well tolerated.

Impact of complementary oral enzyme application on the postoperative treatment results of breast cancer patients--results of an epidemiological multicentre retrolective cohort study.

[corrected] To evaluate the impact of postoperative treatment with an oral enzyme (OE) preparation given complementary to an antineoplastic therapy in patients with breast cancer. The design of this epidemiological study was a retrolective cohort analysis with parallel groups. Design and conduct of the study were performed to current standards for prospective, controlled clinical trials. A cohort of 2,339 breast cancer patients undergoing surgical intervention and radio-, chemo- or hormonal therapy were studied in 216 centres. Of the 2,339 patients, 1,283 received complementary treatment with OE and 1,056 did not receive OE. Patients with other complementary medications were excluded and the final analysis was performed with the data from 649 patients, of whom 239 (37%) were additionally treated with OE (test group) and 410 (63%) without OE (control group). The median follow-up time for the test group was 485 days and for the control group 213 days. The primary endpoint of the study was to determine whether complementary treatment with OE can reduce typical disease- or therapy-associated signs and symptoms (gastrointestinal symptoms, mental symptoms, dyspnoea, headache, tumour pain, cachexia, skin disorders, infections, and side effects associated with the antineoplastic therapy) in patients with breast cancer. Imbalances for causal effects (covariates) were adjusted for by means of the propensity score. Outcome analysis was performed by estimating the linear regression between change in symptom score and propensity score with all data and using this regression line to calculate the change in symptom score which would be expected for each patient. Tumour-associated events (recurrence, metastasis, and death) were evaluated in terms of the number of events observed and time to event. The safety of treatment with OE was analysed in terms of the number and severity of adverse events, their duration, treatment and outcome. For all symptoms except tumour pain, the adjusted mean improvement in symptom scores was larger in the test group than in the control group. The adjusted difference was statistically significant for all symptoms, except tumour pain and infections. The results show that the typical disease- and therapy-associated signs and symptoms in patients on complementary therapy with OE during postoperative treatment were significantly less. For 75% of the test group and 55% of the control group the physician recorded "no signs and symptoms". A clear reduction in the side effects of radiotherapy and chemotherapy was documented in 74% of the test group and 55% of the control group. Analysis of survival, recurrence, and metastasis demonstrated a reduced number of events in the test group. There was evidence of a beneficial influence of OE on time to event, although the median observation time was too short in these breast cancer patients to draw definite conclusions. The safety component was judged in 98% of the test group and 76% of the control group as "very good" or "good". In the total sample of 2,339 patients, the rate of OE-associated adverse reactions was 3.2%. All side effects were mild to moderate gastrointestinal symptoms. Complementary treatment of breast cancer patients with OE improves the quality of life by reducing signs and symptoms of the disease and the side effects of adjuvant antineoplastic therapies. This epidemiological retrolective cohort analysis provides evidence that the patients may also gain benefit by a prolongation of the time to event for cancer recurrence, metastasis and survival. OE was generally well tolerated.

Retrolective cohort study of an additive therapy with an oral enzyme preparation in patients with multiple myeloma.

To evaluate the impact of an additive therapy with an oral enzyme (OE) preparation given for more than 6 months additionally to standard combination chemotherapy (vincristine/melphalan/cyclophosphamide/prednisone (VMCP)- or methylprednisolone/ vincristine/CCNU/cyclophosphamide/melphalan (MOCCA)-regimen) in the primary treatment of patients with multiple myeloma stages I-III. A cohort of 265 patients with multiple myeloma stages I-III was consecutively treated at our institution in two parallel groups (control group (n = 99): chemotherapy +/-OE for less than 6 months; OE-group (n = 166): chemotherapy + OE for more than 6 months). The median follow-up time in the stages I, II, and III for the OE-group was 61, 37, and 46.5 months, respectively; for the control group the respective values were 33, 51.5, and 31.5 months. The primary endpoint of the study was disease-specific survival. Secondary endpoints were response to therapy, duration of first response and side effects. The chosen method for evaluation was the technique of a retrolective cohort analysis with a concurrent control group. Survival analysis was performed by the Kaplan-Meier method and multivariate analysis was done with the Cox proportional hazards model. Significantly higher overall response rates and longer duration of remissions were observed in the OE-group. Primary responders showed a longer mean survival time than non-responders. Additive therapy with OE given for more than 6 months decreased the hazard of death for patients at all stages of disease by approximately 60%. Observation time was not long enough to estimate the median survival for patients at stages I and II; for stage III patients it was 47 months in the control group versus 83 months for the patients treated with OE (P = 0.0014) which means a 3-year gain of survival time. Significant prognostic factors for survival, in the Cox regression analysis, were stage of disease and therapy with OE. The OE-therapy was generally well tolerated (3.6% of patients with mild to moderate gastrointestinal symptoms). OEs represent a promising new additive therapy in multiple myeloma which will be further evaluated in a randomized phase III trial in the USA.