TRAUMEEL® PRODUCT MONOGRAPH62

Drugs diclofenac can interact with: Lithium, anticoagulants, antidiabetic agents, ciclosporin, tacrolimus, methotrexate, quinolone antimicrobials, other NSAIDs including COX-2 selective inhibitors, corticosteroids, antiplatelet agents, selective serotonin reuptake inhibitors (SSRIs), diuretics, antihypertensives, cardiac glycosides, mifepristone, baclofen, drospirenone, ketorolac, penicillamine, erlotinib, iloprost, pentoxifylline, sibutramine, venlafaxine, phenytoin, ritonavir, zidovudine.[FDA MedWatch]

Results of the large scale randomized study, TAASS, confirm that topical Traumeel®, in ointment or gel form, is an effective alternative to topical diclofenac 1% gel for reducing pain and improving function for the treatment of acute ankle sprain.[González de Vega 2013]

In addition, the MOZArT study investigated patients with moderate-to-severe chronic knee osteoarthritis (OA) randomized to 3 weekly intra-articular co- administration of both Traumeel® and Zeel® T (n=119) or saline (n=113).[Lozada 2017] The significant reduction in pain observed with Traumeel® and Zeel® T versus placebo could provide a safer alternative to the use of long-term NSAIDs for the relief of pain in this chronic condition. The pain reduction of Traumeel® and Zeel® T in the MOZArT study is comparable to other intra-articular injection therapies and higher than for oral therapies.[Lozada 2017]

In observational cohort studies Traumeel® has shown significantly better tolerance compared with NSAIDs.[Birnesser 2004, Schneider 2008] Post-marketing drug surveillance has shown that adverse reactions to Traumeel® are uncommon and largely limited to mild local reactions at the site of administration.[Zenner 1992, 1994, 1997]

Therapeutic algorithm management of musculoskeletal injury In view of the results from TAASS, the established evidence base, and new data on inflammation resolution, the authors of a recent publications by Wolfarth et al. suggest a revised therapeutic algorithm in primary care for acute, sub-acute or acute on chronic pain/swelling of presumed musculoskeletal origin.[Wolfarth 2022] The algorithm is particularly relevant in patients with mild-to-moderate symptoms where there is a desire to avoid or complement the effects of NSAIDs. Traumeel®, a multitarget agent, is considered part of the general armamentarium to manage these conditions.[Wolfarth 2022]

GUIDELINE RECOMMENDATIONS IN SPORTS MEDICINE

The growing evidence base for the use of Traumeel® is leading to increasing recognition among the medical community and inclusion in consensus statements and guidelines.[Bisciotti 2018, Fernandes Jaen 2016, Del Valle Soto 2013]