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Effects of a systemic enzyme therapy in healthy active adults after exhaustive eccentric exercise: a randomised, two-stage, double-blinded, placebo-controlled trial
  1. Tobias Marzin1,
  2. Gerhard Lorkowski2,
  3. Claudia Reule3,
  4. Stefanie Rau4,
  5. Elisabeth Pabst5,
  6. Johannes C Vester6,
  7. Helmut Pabst5
  1. 1 Zentrum für Leistungsdiagnostik, Sportschule Fuerstenfeldbruck-Puch Gmbh, Fuerstenfeldbruck, Germany
  2. 2 GL Pharma Consulting Research & Development, Gauting, Germany
  3. 3 BioTeSys GmbH, Esslingen, Germany
  4. 4 Mucos Pharma GmbH & Co. KG, Unterhaching, Germany
  5. 5 Sportmedizin, Gilching, Germany
  6. 6 IDV Data Analysis and Study Planning, Krailling, Germany
  1. Correspondence to Tobias Marzin; tobias{at}sportschule-ffb.de

Abstract

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.

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Footnotes

  • Acknowledgements The authors would like to thank the coaches of the Sportschule Puch Fuerstenfeldbruck, and in particular Lorenz Westner for their assistance in conducting this trial.

  • Contributors TM: study conception and design, aquisition of data, analysis and interpretation of data. GL: analysis and interpretation of data, drafting of manuscript. CR: study conception and design, analysis and interpretation of data, drafting of manuscript. SR: study conception and design, analysis and interpretation of data. JCV: statistical analysis and interpretation of data. EP: acquisition of data. HP: main investigator, study conception and design, aquisition of data, analysis and interpretation of data. Every contributing author has reviewed the paper and had the final authority over the content.

  • Competing interests GL works among several others as consultant for Mucos Pharma GmbH & Co. KG. Mucos Pharma GmbH & Co. KG has contributed the product needed for intervention and funded the trial with SR as company representative.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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