TRAUMEEL® PRODUCT MONOGRAPH56

7 CLINICAL SAFETY

IN VITRO STUDIES

When the possible effects of Traumeel® on the functions of neutrophil cells were tested in vitro, it was observed that Traumeel® did not affect functions of neutrophils such as superoxide anion production and adhesion.[Conforti 1997] The lack of any affect on neutrophil functions indicates that Traumeel® is unlikely to interfere with antimicrobial first defenses. At least one of these neutrophil functions are inhibited by many conventional anti-inflammatory and analgesic compounds.

Furthermore, when investigating the adhesion of human platelets to fibrinogen coated surfaces, Traumeel® did not affect platelet adhesion stimulated by two natural agonists (ADP and thrombin).[Conforti 1997] As inflammatory and homeostatic events are interlinked and platelets are involved in inflammatory reactions, the lack of any impact of Traumeel® on platelet function is of interest. Importantly, the normal homeostatic process is unlikely to be affected by Traumeel®, which suggests it could be used in patients at risk of hemorrhagic events.

CLINICAL STUDIES IN ADULTS

Safety In a four-week study, 20 healthy volunteers (aged 18 75 years) received two Traumeel® oral tablets sublingually, three times a day.[Arora 2000] Laboratory tests were performed once a week to assess the effect of Traumeel® on complete blood count, liver profile, serum chemistry, bleeding time, coagulation time and the gastrointestinal system.

The results showed that there was no significant effect from baseline to study completion on any measured laboratory parameter. All subjects vital signs remained stable throughout the study. No significant changes in hematological parameters, including hematocrit, and platelet and neutrophil counts were observed. Laboratory indicators of kidney and liver function remained unchanged, and no significant differences in prothrombin time or partial thromboplastin time were detected from baseline to post treatment. When stool samples were analyzed for occult blood, as an indicator of gastrointestinal toxicity, all results were negative for all subjects throughout the study.[Arora 2000]

A total of 11 subjects reported 36 adverse events after taking Traumeel®:[Arora 2000]

Headache was the most commonly reported adverse event (n=15) Other common events included diarrhea and stomach discomfort/bloating (n=6),

and feelings of nausea (n=2) All events were considered to be mild (n=30; 83.3%) or moderate (n=6;16.7%) in

severity No events required Traumeel® to be stopped; all were transient and resolved

despite continuation of the study drug