Original Article · Originalarbeit
Wirksamkeit von Arnica bei Varizenoperation: Ergebnisse einer randomisierten, doppelblinden, Placebo-kontrollierten Pilot-StudieWolf M.a · Tamaschke C.b · Mayer W.c · Heger M.d
aPraxis für Homöopathie, Berlin-Karow; bPraxis für Gefässerkrankungen, Berlin-Buch; cClinical Study Monitoring, Walldorf-Heidelberg; dForschungszentrum HomInt, Karlsruhe, Deutschland
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Efficacy of Arnica in Varicose Vein Surgery: Results of a Randomized, Double-Blind, Placebo-Controlled Pilot Trial Introduction: In homeopathy Arnica is widely used as a woundhealing medication and for the treatment of hematomas. Objective: In this pilot study the efficacy and safety of Arnica D12 in patients following varicose vein surgery were investigated. Design: Prospective, randomized, double-blind, placebo-controlled pilot trial according to ICH GCP guidelines. Setting: The study was conducted by a surgeon at the Angiosurgical Clinic, Berlin- Buch. Intervention: After randomized allocation, 60 patients received either Arnica D12 or placebo. Start of medication occurred the evening before operation with 5 globules. On the operation day one preoperative and hourly postoperative dosages after awakening were given. On days 2–14 of the study 5 globules 3 times a day were given. Outcome Criteria: Surface (in cm² and using a three-point verbal rating scale) and intensity of hematomas induced by operation, complications of wound healing, and intensity of pain (five-point verbal rating scale) as well as efficacy and safety of the study medication were assessed. Results: Hematoma surface was reduced (from day 7 to day 14) under Arnica by 75.5% and under placebo by 71.5% (p = 0.4726). The comparison of hematoma surface (small, medium, large) using the verbal rating scale yielded a value of p = 0.1260. Pain score decreased by 1.0 ± 2.2 points under Arnica and 0.3 ± 0.8 points under placebo (p = 0.1977). Remission or improvement of pain was observed in 43.3% of patients in the Arnica group and in 27.6% of patients in the placebo group. Tolerability was rated as very good in all cases. Conclusion: The results of this pilot study showed a trend towards a beneficial effect of Arnica D12 with regard to reduction of hematoma and pain during the postoperative course. For a statistically significant proof of efficacy of Arnica D12 in patients following varicose vein surgery a larger sample size is necessary.
© 2003 S. Karger GmbH, Freiburg
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