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Results of a Randomized, Double-blind, Placebo-Controlled Clinical Trial

Brook M. Seeley, MD; Andrew B. Denton, MD; Min S. Ahn, MD; Corey S. Maas, MD

Arch Facial Plast Surg. 2006;8:54-59.

Objectives  To design a model for performing reproducible, objective analyses of skin color changes and to apply this model to evaluate the efficacy of homeopathic Arnica montana as an antiecchymotic agent when taken perioperatively.

Methods  Twenty-nine patients undergoing rhytidectomy at a tertiary care center were treated perioperatively with either homeopathic A montana or placebo in a double-blind fashion. Postoperative photographs were analyzed using a novel computer model for color changes, and subjective assessments of postoperative ecchymosis were obtained.

Results  No subjective differences were noted between the treatment group and the control group, either by the patients or by the professional staff. No objective difference in the degree of color change was found. Patients receiving homeopathic A montana were found to have a smaller area of ecchymosis on postoperative days 1, 5, 7, and 10. These differences were statistically significant (P<.05) only on postoperative days 1 (P<.005) and 7 (P<.001).

Conclusions  This computer model provides an efficient, objective, and reproducible means with which to assess perioperative color changes, both in terms of area and degree. Patients taking perioperative homeopathic A montana exhibited less ecchymosis, and that difference was statistically significant (P<.05) on 2 of the 4 postoperative data points evaluated.

Author Affiliations: Connecticut Facial Plastic Surgery, Farmington, Conn (Dr Seeley); Department of Facial Plastic Surgery, Vancouver General Hospital, Vancouver, British Columbia (Dr Denton); Aesthetic Wellness Center, Worcester, Mass (Dr Ahn); and The Maas Clinic, San Francisco, Calif (Dr Maas).

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