5OVERVIEW

1 OVERVIEW

Inflammation is associated with almost every major human disease and is a major player in musculoskeletal disorders (MSD). It is a crucial part of the healing process, and its primary physiological purpose is to restore tissue homeostasis.

If the normal process of inflammation resolution fails, it can lead to excessive or chronic inflammation, which is detrimental to recovery, giving rise to a plethora of chronic inflammatory diseases with eventual loss of organ function.

Traumeel® is a multitarget, multicomponent medication that supports inflammation resolution, accelerates the healing process, and provides sustained recovery from injury.

Traumeel® is used in treatment of various inflammatory conditions including injuries, especially of the musculoskeletal system, where a proresolution therapy is desirable, or when co-morbidities prohibit the use of a single-target approach. It is indicated as a first-line treatment for patients with traumatic injuries of all kinds such as sprains, dislocations, contusions, hemarthrosis and effusions into a joint. According to the research, Traumeel® regulates the inflammatory process in different organs and tissues, including acute, chronic, and degenerative disorders of the musculoskeletal system.

Traumeel® contains 14 components (plant extracts and minerals) combined to cover the different aspects of the inflammatory process. It has a different mode of action to conventional anti-inflammatory drugs, and a multitarget effect on chemical, cellular and tissue mediators which regulate inflammatory responses. The components of Traumeel® act synergistically to accelerate the process, which was shown in state-of- the-art next-generation sequencing technologies, genomics, and pre-clinical studies.

Traumeel® has a well-established efficacy and safety profile: Randomized controlled studies have shown that Traumeel® is significantly more

effective than placebo and at least as effective as diclofenac in the treatment of musculoskeletal injury.

Observational cohort studies have shown Traumeel® to be at least comparable with conventional therapies in terms of resolution of symptoms and time to symptomatic improvement.

Traumeel® ointment and gel is an effective alternative to topical diclofenac 1% gel in the treatment of ankle sprain. This has further added to the evidence-base for the use of Traumeel® in musculoskeletal injuries. A therapeutic algorithm has been developed to assist clinicians in the appropriate utilization of Traumeel® in clinical practice. Sporting institutions in Italy, Spain and Germany acknowledge Traumeel s efficacy and safety in their respective consensus guidelines or recommendations.

The MOZArT (Management of Osteoarthritis of the Knee with Zeel And Traumeel Injections) study is a large randomized controlled trial. It demonstrated that Traumeel® and Zeel® co-administered intra-articular injections are significantly superior to placebo in reducing knee pain in subjects with moderate-to-severe pain associated with knee osteoarthritis.