RT Journal Article SR Electronic T1 Effects of a systemic enzyme therapy in healthy active adults after exhaustive eccentric exercise: a randomised, two-stage, double-blinded, placebo-controlled trial JF BMJ Open Sport & Exercise Medicine JO BMJ OPEN SP EX MED FD BMJ Publishing Group Ltd SP e000191 DO 10.1136/bmjsem-2016-000191 VO 2 IS 1 A1 Tobias Marzin A1 Gerhard Lorkowski A1 Claudia Reule A1 Stefanie Rau A1 Elisabeth Pabst A1 Johannes C Vester A1 Helmut Pabst YR 2017 UL http://bmjopensem.bmj.com/content/2/1/e000191.abstract AB Background Systemic enzyme therapy may improve symptoms of exhaustive eccentric exercise due to anti-inflammatory properties.Methods In a randomised, placebo-controlled, two-stage clinical trial, systemic enzyme therapy (Wobenzym) was administered for 72 hours before and 72 hours following a day on which subjects performed an exhaustive eccentric exercise (isokinetic loading of the quadriceps). Efficacy criteria (maximal strength and pain) and time points were selected to account for the multidimensional nature of exercise-induced muscle damage symptoms. Subjects were randomised in a crossover (stage I, n=28) and parallel group design (stage II, n=44).Results Analysis of stage I data demonstrated a significant superiority (Mann-Whitney=0.6153; p=0.0332; one sided) for systemic enzyme therapy compared with placebo. Stage II was designed as a randomised controlled parallel group comparison. Heterogeneity (I2>0.5) between stages led to separate analyses of stage I (endurance-trained subjects) and stage II (strength-trained subjects). Combined analysis resulted in no evidence for corresponding treatment effects. Analysis of pooled biomarker data, however, demonstrated significant favourable effects for systemic enzyme therapy in both stages.Conclusion Systemic enzyme therapy before and after exhaustive eccentric exercise resulted in higher maximal concentric strength in the less strength-trained subjects (stage I) and in significant favourable effects on biomarkers (inflammatory, metabolic and immune) in all subjects. The application of these findings needs further evaluation.