Proteolytic enzyme therapy in evidence-based complementary oncology: fact or fiction? and Dr.Steve’s Bottom Line

Proteolytic enzyme therapy in evidence-based complementary oncology: fact or fiction?

Integr Cancer Ther. 2008 Dec;7(4):311-6

Authors: Beuth J

Systemic enzyme therapy was recently subjected to experimental investigations and to rigorous clinical studies in cancer patients. The designs of the relevant clinical cohort studies followed the guidelines of Good Epidemiological Practice and represent level IIB in evidence-based medicine (EBM). Scientifically sound experimental in vitro and in vivo investigations are far advanced and document promising immunological, anti-inflammatory, anti-infectious, and antitumor/antimetastatic activities of proteolytic enzyme mixtures (containing trypsin, chymotrypsin, and papain) or bromelain. EBM level II clinical studies, which are accepted by the European Union to show safety and efficacy of medical treatments, were performed to evaluate the benefit of complementary systemic enzyme therapy in cancer patients suffering from breast and colorectal cancers and plasmacytoma. These studies demonstrated that systemic enzyme therapy significantly decreased tumor-induced and therapy-induced side effects and complaints such as nausea, gastrointestinal complaints, fatigue, weight loss, and restlessness and obviously stabilized the quality of life. For plasmacytoma patients, complementary systemic enzyme therapy was shown to increase the response rates, the duration of remissions, and the overall survival times. These promising data resulted in an “orphan drug status” designation for a systemic enzyme product, which should motivate further studies on this complementary treatment.

Dr.Steve’s BOTTOM LINE: Evidence Based Medicine is a relatively new concept, and for those who did not go to medical school I would call it Evidence Based Health Information…..after the results are translated for you into non-medicalese.  That’s what this site is about and you can find more discussion about Evidence Based Health Information here.  Level IIB(or II-2) evidence means published articles  from well-designed epidemiologic (case control & cohort) analytic studies, preferably from more than one center or research group.  This means the evidence of proof is pretty good but not based on the gold standard of randomized controlled studies, which compare treatments head to head.  Usually, good Level II results means there is scientific plausibility and usually leads to Level I research.