Efficacy of Arnica montana D4 for healing of wounds after Hallux valgus surgery compared to diclofenac.
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.
Karow
Jens-Hagen
JH
Orthopaedic University Hospital Friedrichsheim, Frankfurt Medical School, Johann Wolfgang Goethe-Universität, Frankfurt, Germany. karow@bias-online.de
Abt
Hans-Peter
HP
Fröhling
Markus
M
Ackermann
Hanns
H
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D018650:Arnica; D004008:Diclofenac / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006215:Hallux Valgus / Q000601:surgery*; D006801:Humans; D008297:Male; D010147:Pain Measurement / Q000187:drug effects; D010149:Postoperative Pain / Q000188:drug therapy; D010865:Pilot Projects; D010936:Plant Extracts / Q000627:therapeutic use; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D010936:Plant Extracts; D004008:Diclofenac