Arnica Adverse Events; 3 things you should know

cearna - arnica-montanaThe Journal of the American Medical Association reported that arnica is the most common adjunct therapy used during septorhinoplasty surgery. Despite its widespread use, significant misunderstandings surround the regulation and safety of homeopathic arnica (1). This is the
beginning of a series of educational emails written by leading homeopath, Dr. Josephine Polich, aimed at educating aesthetic practitioners.

Regulation

Unlike herbals, homeopathic arnica is considered a drug by the FDA. Similar to other OTC drugs, there is an FDA monograph that defines the requirements including manufacturer, labeling, and use.

Safety

The foremost priority in practitioners’ minds is ensuring the safety of arnica. We reviewed 11 published studies on homeopathic arnica for a wide spectrum of treatments (2-12).

  • In general, Arnica was well-tolerated in all 11 clinical studies.
  • 2% of 789 patients showed adverse events due to arnica.
  • Patients should be told to discontinue topical applications if skin irritation is noticed.

6 out of the 11 studies reviewed had no adverse events reported, or adverse effects were less severe than patients who received the placebo (497 subjects studied).

4 out of the 11 studies reported adverse events (292 subjects studied). The only adverse event across the studies was skin irritation or rash with topical application, which occurred in about 5% of the population using gels. This is consistent with the American Society of Plastic Surgeons “Arnica Safety and Efficacy Report (13).” Consequently, patients should be informed that they should discontinue use if any skin irritation occurs with topical arnica gels.

adverseevents

  1. Widrig R, Suter A, Saller R, Melzer J. Choosing between NSAID and arnica for topical treatment of hand osteoarthritis in a randomized, double-blind study. Rheumatol Int 2007;27(6):585-91
  2. Brinkhaus B, Wilkens JM, Ludtke R, Hunger J, Witt CM, Willich SN. Homeopathic arnica therapy in patients receiving knee surgery: results of three randomised double-blind trials.Complement Ther Med. 2006 Dec;14(4):237-46
  3. Oberbaum M, Galoyan N, Lerner-Geva L, Singer SR, Grisaru S, Shashar D, Samueloff A. The effect of the homeopathic remedies Arnica montana and Bellis perennis on mild postpartum bleeding–a randomized, double-blind, placebo-controlled study–preliminary results.Complement Ther Med. 2005 Jun;13(2):87-90.PMID: 16036165
  4. Tveiten D, Bruseth S, Borchgrevink CF, Løhne K. Effect of arnica D 30 on hard physical exercise: A double-blind controlled trial during the Oslo Marathon 1990. Tidsskr Nor Loegeforen 1991;111(30):3630-1.
  5. Stevinson C, Devaraj VS, Fountain-Barber A, et al. Homeopathic arnica for prevention of pain and bruising: randomized placebo-controlled trial in hand surgery. J R Soc Med 2003;96(2):60-5.
  6. Jeffrey SL, Belcher HJ. Use of Arnica to relieve pain after carpal-tunnel release surgery. Altern Ther Health Med. 2002 Mar-Apr;8(2):66-8. PMID: 11892685
  7. Ramelet AA, Buchheim G, Lorenz P, Imfeld M. Homeopathic Arnica in postoperative haematomas: a double-blind study. Dermatology. 2000;201(4):347-8. PMID: 11146347
  8. Karow JH, Abt HP, Fröhling M, Ackermann H. Efficacy of Arnica montana D4 for healing of wounds after Hallux valgus surgery compared to diclofenac. Orthopaedic University Hospital Friedrichsheim, Frankfurt Medical School, Johann Wolfgang Goethe-Universität, Frankfurt, Germany.
  9. Knuesel O, Weber M, Suter A. Arnica Montana gel in osteoarthritis of the knee; an open, multicenter clinical trial. Avd Ther 2002;19(5):209-18
  10. Cornu C, Joseph P, Gaillard S, et al. No effect of a homoeopathic combination of Arnica montana and Bryonia alba on bleeding, inflammation, and ischaemia after aortic valve surgery. Br J Clin Pharmacol. 2010;69:136–142.
  11. Kotlus BS, Heringer DM, Dryden RM. Evaluation of homeopathic Arnica montana for ecchymosis after upper blepharoplasty: a placebo-controlled, randomized, double-blind study. Ophtal Plast Reconstr Surg 2010;26(6):395-7.
  12. Lawrence, W., Arnica Safety and Efficacy Report. American Society of Plastic Surgeons, Vol 112, No.4, 1164-1166.