Table 3.

Clinical trials on Traumeel in acute musculoskeletal injury

Study design	Indication	Number of patientsa	Therapies	Main outcomes
Randomized, double-blind trials
Zell et al,53 Single center study in Germany 2-weeks duration	Ankle sprains	N = 73 n = 69	Traumeel ointment vs placebo ointment	More rapid and more frequent improvement in upper-ankle mobility in the Traumeel group vs placebo at 2 weeks.
Böhmer and Ambrus,54 Single center study in Germany 15-days duration	Varied musculoskeletal sport injuries	N = 68 n = 68	Traumeel ointment vs placebo ointment	Reduction in swelling and pain significantly greater in patients using Traumeel vs placebo after 15 days. No difference between the groups in skin temperature. Overall effectiveness of Traumeel was superior to placebo.
				Traumeel was well tolerated with all patients rating the treatment as “good” or “very good”.
Thiel and Borho,55 Single center study in Germany 8-days duration	Post traumatic hemarthrosis of the knee	N = 80 n = 73	Traumeel injections vs physiological saline injections	Greater degree of movement and greater reductions in pain and swelling with Traumeel vs saline after 3 injections over 8 days. No treatment-related adverse events.
Observational studies
Birnesser et al,58 Multicenter study in Germany; nonrandomized 2-week duration	Epicondylitis	N = 184 n = 163	Traumeel injections vs unspecified NSAID (mainly diclofenac)	Noninferior effects of Traumeel on three pain relief and two joint mobility variables. Global outcome rated as “good” and “very good” by 71% of Traumeel patients and 44% of NSAID patients.
				Tolerability assessed as “very good” by 88% of Traumeel patients and 45% NSAIDs patients.
Schneider et al,9 Multicenter study in Germany; nonrandomized 28-days duration	Tendinopathy of varying etiology (based on excessive tendon load rather than inflammation)	N = 457 n = 357	Traumeel ointment vs diclofenac 1% gel	Traumeel noninferior to diclofenac on all pain and mobility variables after 28 days. In the Traumeel and diclofenac groups, respectively, the mean (±standard deviation) reduction in summary score for pain-related variables was 5.3 ± 2.7 and 5.0 ± 2.7 units, and for mobility-related variables was 4.2 ± 3.8 and 3.7 ± 3.4 units. Global evaluation of therapies rated as “very good” or “good” by 88% of Traumeel cases and 82% of diclofenac cases.
Schneider et al,62 Multicenter study in Germany; prospective; nonrandomized Up to 3 months duration	Various musculoskeletal injuries	N = 133 n = 132	Traumeel (tablets and gel) vs conventional management	Rates of complete symptomatic resolution at the end of therapy were similar between treatment groups, occurring in 59.4% of Traumeel-treated patients and 57.8% of the conventionally treated group. No adverse events reported in the Traumeel group vs six (6.3%) mild-moderate events in the conventional group. Physician-rated tolerability was “very good” for 90% of Traumeel cases vs 50% of conventional cases (P = 001).
Surveillance studies
Zenner and Weiser,61 Multicenter study in Germany, Italy, and Portugal; prospective; randomized; standardized questionnaires	Variety of injuries (eg, sprains, post-traumatic edema), and degenerative and inflammatory conditions (arthrosis, and epicondylitis)	N = 1359	Traumeel tablet or drop forms (69% tablets, 29% drops, 2% both). One-third of patients were treated without other therapies (drug and nondrug)	Symptom improvement occurred in about half of all patients within the first week of treatment and an additional 34% of patients within 1 to 3 weeks. Treatment rated as “very good” or “good” by 83% of cases.
Zenner and Metelmann,59 Multicenter, drug monitoring trial	Variety of injuries, and degenerative and inflammatory conditions	N = 3241	Traumeel injection. Used exclusively by 17% of patients; adjuvant medications taken by 47% of patients; 65% received nonmedication therapies	Used most frequently in arthrosis (19%), particularly in inflammation of the knee and degenerative joint diseases, myogelosis (12%), sprains (12%), periarthropathia humeroscapularis (10%), epicodylitis (10%), and tendinovaginitis (8%). Traumeel, used exclusively, was highest for sprains (27%). Outcomes of Traumeel therapy was assessed as “very good” or “good” by 79% of patients.
Zenner and Metelmann,60 Multicenter, drug monitoring trial	Variety of injuries, and degenerative and inflammatory conditions	N = 3422	Traumeel ointment. Used exclusively by 38% of patients; adjuvant medications taken by 30% of patients; 52% received nonmedication therapies	Used most frequently for sprains (21%), hematomas (8%), myogelosis (8%), contusion (8%), tenosynovitis (8%), and arthrosis (9%). Traumeel was used exclusively by half or more of patients with hematomas, contusions and sprains. Outcomes of Traumeel therapy was assessed as “very good” or “good” by 87% of patients.

Notes:

^aN = recruited patient population, n = efficacy population.

Abbreviations: NSAID, nonsteroidal anti-inflammatory drugs.