About Traumeel
Traumeel is a homeopathic medication containing 12 botanical substances and 2 mineral substances. It has been sold in the United States since 1986 and in Germany since 1937, and it is available worldwide for use as an anti-inflammatory, analgesic, antiedematous, antiexudative drug. The indications for its use include temporary relief of symptoms associated with inflammatory, exudative, and degenerative processes due to acute trauma, repetitive or overuse injuries, and minor pain from osteoarthritis, rheumatoid arthritis, gouty arthritis, and ankylosing spondylitis.
Objective: To evaluate the clinical safety of Traumeel oral tablets by measuring changes from baseline to posttreatment in the following: complete blood cell count, liver profile, serum chemistry, bleeding time, coagulation time, and the gastrointestinal system (presence of occult blood in the stool).
Methods: The four week study was performed with one group of 20 volunteers. Baseline measures included case history, physical examination, vital signs, hematology, urinalysis, and a clinical chemistry. Volunteers received the study drug, two Traumeel tablets sublingually three times per day. Selected laboratory tests were performed once a week. Each subject was required to keep a daily log of study drug intake and report any adverse symptoms following drug ingestion. A final examination of each study participant was performed during the fourth week of the study.
Results: Statistical evaluation of the laboratory data revealed no significant (P>.05) differences from baseline to posttreatment in this study. All adverse events experienced by the subjects were mild to moderate in severity, transient, and subsequently resolved without intervention despite continued use of Traumeel. Some examples reported by subjects were stomach discomfort, headache, diarrhea, dizziness, nausea, insomnia, and arm/leg pain.
Conclusion: Traumeel is well tolerated and safe in healthy subjects. There was no significant gastrointestinal toxicity in the form of symptoms or gastrointestinal blood loss. Conventional nonsteroidal anti-inflammatory drugs cause gastrointestinal ulceration and bleeding in some patients and are especially hazardous for patients with diseases or taking medications that interfere with normal coagulation. It has anti-inflammatory and analgesic effects and does not inhibit the arachidonic acid pathway of prostaglandin synthesis. It deserves consideration as a safer alternative for patients at high risk for gastrointestinal bleeding with conventional NSAIDS.
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