Efficacy of Arnica montana D4 for healing of wounds after Hallux valgus surgery compared to diclofenac.

Abstract

OBJECTIVE:

This study was undertaken to answer the question: "Is Arnica D4 as efficacious as diclofenac in relation to symptoms and wound healing after foot surgery?"

METHODS:

In this randomized double-blinded, parallel-group study (GCP-standard), the efficacy of Arnica D4 10 pillules (taken orally, 3 times per day) and diclofenac sodium, 50 mg (taken orally, 3 times per day) were investigated for equivalence in 88 patients 4 days after hallux valgus surgery. Outcome parameters were (1) postoperative irritation, (2) patient mobility, (3) rated pain, and (4) use of analgesics. The hierarchic equivalence test based on one-sided Wilcoxon-Mann-Whitney-U confidence intervals (CIs) was used. Equivalence was perceived, when the lower margin of the 95% CI was > 0.36 corresponding to a range of equivalence of 1/2 standard deviation.

RESULTS:

Arnica D4 and diclofenac were equivalent for wound irritation (lower margin of the 95% CI on day 4: 0.4729 for rubor; 0.3674 for swelling; 0.4106 for calor) and patient mobility (0.4726). A descriptive analysis showed the superiority of Arnica D4 with respect to patient mobility (p = 0.045). With respect to pain, Arnica D4 was inferior to diclofenac (lower margin of the 95% CI 0.026). No significant differences were found regarding the use of additional analgesics during the 4 postoperative days (Dipidolor, Janssen-Cilag, Neuss, Germany; p = 0.54; Tramal, Grünenthal, Aachen, Germany; p = 0.1; and Novalgin, AVENTIS-Pharma, Bad Soden, Germany; p = 0.1). Arnica D4 was significantly better tolerated than diclofenac (p = 0.049). Nine (9) patients (20.45%) of the diclofenac group and 2 (4.5%) of the Arnica D4 group reported intolerance. There was no disturbance in wound healing in any of the patients. Arnica D4 is 60% cheaper than diclofenac.

CONCLUSIONS:

After foot operations, Arnica D4 can be used instead of diclofenac to reduce wound irritation.

• Authors: Jens-Hagen Karow, Hans-Peter Abt, Markus Fröhling, Hanns Ackermann
• Journal: Journal of alternative and complementary medicine (New York, N.Y.) (J Altern Complement Med) 2008 Jan-Feb Vol. 14 Issue 1 Pg. 17-25 ISSN: 1075-5535 [Print] United States
• PMID: 18199022 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• Plant Extracts
• Diclofenac

Topics

• Anti-Inflammatory Agents, Non-Steroidal (therapeutic use)
• Arnica
• Diclofenac (therapeutic use)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Female
• Hallux Valgus (surgery)
• Humans
• Male
• Pain Measurement (drug effects)
• Pain, Postoperative (drug therapy)
• Pilot Projects
• Plant Extracts (therapeutic use)
• Treatment Outcome
• Wound Healing (drug effects)