Jan 31, 2015  Abstract. Wobenzym is comparable to the NSAID diclofenac in relieving pain and increasing function in adults with moderate-to-severe painful knee OA and reduces reliance on analgesic medication. Wobenzym is associated with fewer adverse events and, therefore, may.

This randomized, double-blind, placebo-controlled, and comparator-controlled trial evaluated the safety and efficacy of an enzyme combination, as Wobenzym, in adults with moderate-to-severe osteoarthritis (OA) of the knee. Adults ( n = 150) received Wobenzym, diclofenac (a nonsteroidal anti-inflammatory drug, NSAID), or placebo for 12 weeks. Improvement in pain scores (Lequesne Functional Index) did not differ between subjects treated with Wobenzym or diclofenac, and both treatment groups improved compared to placebo ( P. Introduction Osteoarthritis (OA), known as degenerative joint disease, is characterized by gradual loss of joint cartilage and intermittent or persistent local inflammatory processes.

The hallmark signs of this progressive disorder are limitations in joint movement and pain. OA is the most common form of arthritis affecting nearly 14% of adults aged 25 to 65 and nearly 34% of adults over the age of 65 []. The most common site of osteoarthritis in individuals 40 years and older is the knee []. The signature pathologic feature of osteoarthritis is the progressive net loss of hyaline cartilage from within the joint, driven by the chondrocytic responses to aberrant loading of mechanical forces within the joint “mechanopathology,” with concomitant inflammatory responses to the degeneration of joint structures [–]. Nonsteroidal anti-inflammatory drugs (NSAIDs) are effective in reducing inflammation and pain but are associated with significant side effects that can interfere with therapeutic success, especially with long-term treatment []. Wobenzym is an orally administered combination of proteolytic enzymes and bioflavonoid. In combination, these active principles have produced beneficial outcomes in subjects with osteoarthritis of the knee and hip which were equivalent to those produced by the NSAID diclofenac [–].

However, these studies lacked a placebo control group. In this current randomized, double-blind clinical trial we compared the effectiveness of an enzyme combination, as Wobenzym, with the effectiveness of the NSAID diclofenac and placebo. Outcome measures included amelioration of pain, improvement of function, and type and frequency of side effects. Data Integrity The conduct of the experiment and the integrity of the collected data were monitored through oversight provided by Monitor Zentrale Deutschland (Sauerlach, Germany). The accuracy of the collected data was overseen by Clinical Research Facilities International (Schaijk, Netherlands).

The trial was reviewed and approved by an independent ethics committee and was performed according to the principles defined in the current edition of the Declaration of Helsinki, according to German Drug Law (AMG), and according to Good Clinical Practice (GCP). This trial was registered with ClinicalTrials.gov on March 13, 2014 (identifier ). Subjects Middle-aged and older adult volunteers with moderate-to-severe knee osteoarthritis were enrolled in the study after satisfying all inclusion and exclusion criteria. Briefly, inclusion required the age of 40–80, a score on Lequesne Functional Index of 10–14 (the maximum possible index score is 24), WOMAC-A pain subscale score of ≥25 (scores range from 0 to 100), and arthritis of the knee confirmed by conventional radiography or tomography and swelling of the affected knee upon physical examination.

Subjects were excluded based on a history of knee trauma, joint infection, joint surgery, or intra-articular injection (viscotherapy). Subjects with gastrointestinal diseases or with pharmacotherapy with corticosteroids, COX-II inhibitors, or glucosamine/chondroitin were excluded, as well as patients with known sensitivity to paracetamol, NSAIDs, or oral enzymes. Written informed consent was obtained from each patient prior to study enrollment following an oral and written explanation about the aim and the potential risks of the study.

Interventions Subjects were recruited, screened, evaluated for eligibility, and enrolled into the study at clinical centers located throughout Germany (Bensheim, Berlin, Essen, Hamburg, Luneburg, Munchen, Norderstedt, Siegen, Stockach, Wiesbaden, and Wolfratshausen) and 2 centers in the Netherlands (Oos, Zwoll). Subjects were assigned randomly to receive three times daily either 1 tablet of diclofenac sodium (50 mg; Merckle GmbH, Blaubeuren, Germany) and 2 tablets of an indistinguishable placebo, or 2 tablets of Wobenzym (Mucos Pharma GmbH & Co. KG, Berlin, Germany) and 1 tablet of placebo, or 3 tablets of placebo. The resultant doses of active treatments were, therefore, Wobenzym 6 tablets (2 tablets, 3 times daily) or diclofenac 150 mg (1 tablet, 3 times daily). All interventions were identical in the total number of tablets and appearance.

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