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

[Article in German]

Author information

1
Praxis für Homöopathie, Berlin-Karow, Deutschland. manfred.wolf@berlin.de

Abstract

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 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.

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.

PMID:
14605480
DOI:
74778
[Indexed for MEDLINE]
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