[Efficacy of Arnica in varicose vein surgery: results of a randomized, double-blind, placebo-controlled pilot study].
BACKGROUND
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.


METHODS
Prospective, randomized, double-blind, placebo-controlled pilot trial according to ICH GCP guidelines.


METHODS
The study was conducted by a surgeon at the Angiosurgical Clinic, Berlin- Buch.


METHODS
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 cm(2) 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.


CONCLUSIONS
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.
Wolf
M
M
Praxis für Homöopathie, Berlin-Karow, Deutschland. manfred.wolf@berlin.de
Tamaschke
C
C
Mayer
W
W
Heger
M
M
D018650:Arnica; D004311:Double-Blind Method; D005260:Female; D006406:Hematoma / Q000188:drug therapy*; D006705:Homeopathy; D006801:Humans; D008297:Male; D008875:Middle Aged; D010149:Postoperative Pain / Q000517:prevention & control; D008517:Phytotherapy; D010865:Pilot Projects; D010919:Placebos; D010936:Plant Extracts / Q000627:therapeutic use; D011183:Postoperative Complications / Q000517:prevention & control; D012449:Safety; D016896:Treatment Outcome; D014648:Varicose Veins / Q000601:surgery; D014945:Wound Healing / Q000187:drug effects*
D010919:Placebos; D010936:Plant Extracts