TRAUMEEL® PRODUCT MONOGRAPH48

Study design 378 physicians completed surveys for patients in their care receiving

Traumeel® ointment. 3,422 patients: 47.7% male, 51.8% female; mean age 39.9 years.

The most frequent complaint was sprains, followed in descending order of frequency by degenerative joint disease, hematoma, tenosynovitis, myogelosis, and contusion. Edema, epicondylitis, periarthritis of the shoulder and bursitis were also treated.

Duration of symptoms was <1 week for 55% of patients, between 1 week and 1 month for 27%, and over 1 month for 18%.

Traumeel® was the only treatment for 37.7% of patients: 31.3% received non- medical therapy (e.g. application of heat or cold, massage), 9.8% received additional medical therapy (half other preparations of Traumeel®), and 20.3% combined additional medical and non-medical therapy.

Frequency of application: once daily 14.9%, twice daily 47.5%, three times daily 34.3%, every other day 1.9%.

Mode of application: alone 48.1%, with dressing 45.0%, with iontophoresis 4.3%. Duration of treatment: <1 week 22.4%, 1 week to 1 month 63.6%, 1 3 months

9.8%, 3 6 months 1.6%, >6 months 1.4%.

Outcome measures Physician-rated therapy outcome: very good, good, satisfactory,

unsuccessful, worsened.

SURVEILLANCE STUDIES

Drug surveillance for Traumeel® ointment

Zenner S, Metelmann H. Therapy experience with a homeopathic ointment: results of drug surveillance conducted on 3,422 patients. Biol Ther. 1994;XII(3):204 211.

STUDY DESIGN FORMULATION INDICATION(S) Multi-centric, post- marketing drug surveillance.

Traumeel® ointment. Various traumatic, inflammatory, and degenerative disorders.