ORIGINAL ARTICLE

Evaluation of Homeopathic Arnica montana for EcchymosisAfter Upper Blepharoplasty: A Placebo-Controlled,

Randomized, Double-Blind StudyBrett S. Kotlus, M.D., M.S.*†‡, Dustin M. Heringer, M.D.*†, and Robert M. Dryden, M.D.*†

*Division of Oculoplastic Surgery, Department of Ophthalmology, University of Arizona Health Science Center;†Arizona Centre Plastic Surgery, Tucson, Arizona; and ‡Allure Medical Spa, Shelby Township, Michigan, U.S.A.

Purpose: Ecchymosis is commonly encountered after uppereyelid blepharoplasty. The use of homeopathic preparations ofArnica montana, a flowering herb, has been advocated byphysicians, patients, and manufacturers for reduction of post-surgical ecchymosis. The authors evaluate its efficacy afterupper eyelid blepharoplasty.

Methods: A prospective, placebo-controlled, double-blindstudy was performed in which patients were randomly assignedto the administration of homeopathic A. montana or placeboconcurrent with unilateral upper eyelid blepharoplasty followedby contralateral treatment at least 1 month later. Ecchymosiswas evaluated at days 3 and 7 by rank order of severity andmeasurement of surface area of observable ecchymosis.

Results: There was no statistically significant difference inarea of ecchymosis or rank order of ecchymosis severity fordays 3 and 7 after treatment with A. montana versus placebo.Additionally, there was no difference in ease of recovery perpatient report, and there was no difference in the rate ofecchymosis resolution.

Conclusions: The authors find no evidence that homeopathicA. montana, as used in this study, is beneficial in the reduction orthe resolution of ecchymosis after upper eyelid blepharoplasty.

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Arnica montana is a flowering herb also known as wolf’sbane, leopard’s bane, and mountain tobacco. The physio-

logic actions of A. montana are not fully understood, but it hasbeen purported to affect vascular permeability by way ofhistamine modulation,1 and it may modify inflammatory cas-cades via selective inhibition of transcription factors.2 Manywidely available A. montana preparations are formulated ac-cording to homeopathic principles, which dictate that multipledilution factors of a substance can render it more potent intreating specific disorders.3,4 There are inadequate data tosupport the safety of nonhomeopathic preparations of A. mon-tana extract,5 but no serious adverse effects have been reported

in conjunction with the use of homeopathic A. montana. Byanecdotal and published reports, homeopathic forms of thisherb are used by patients and recommended by surgeons toalleviate postoperative ecchymosis, edema, and pain.6

The eyelids are unique anatomical structures becausethey contain the body’s thinnest skin while having a richvascular supply. For this reason, the undesirable appearance ofecchymosis is common after upper blepharoplasty. We evalu-ated the efficacy of homeopathic A. montana in the modifica-tion of ecchymosis after upper eyelid blepharoplasty with aprospective, placebo-controlled, randomized, double-blindclinical trial.

METHODSThirty consecutive male patients with visually significant upper

eyelid dermatochalasis at a single center were enrolled in the study,which was approved by the institutional review board. Informed con-sent was obtained for all patients prior to study enrollment. The studyprotocol conformed to the guidelines of the Helsinki Declaration andwas compliant with Health Insurance Portability and AccountabilityAct of 1996 (HIPAA) standards. Exclusion criteria included activeinfection, current anticoagulant or antiplatelet use (for at least 14 daysprior to blepharoplasty), known bleeding disorders, and contraindica-tions to upper blepharoplasty.

Patient participation consisted of 3 visits for each upper eyelid,including the blepharoplasty procedure, and follow-up visits 3 days and7 days after the procedure. Standard view photographs were taken ateach visit, including a frontal view with the eyes closed. A metric rulerwas taped to the forehead for calibration purposes. Blepharoplasty wasperformed separately for the right and left upper eyelids, with at least1 month between procedures to avoid a crossover effect. For eachprocedure, a 4-day course of oral capsules was dispensed. Order of eyes(left vs. right) and order of administration of capsules (A. montana vs.placebo) was randomized using a computer-generated list. The dosageregimen for A. montana consisted of a single 1-M capsule (500 mgsubstrate) taken orally 3 times for the operative day, followed by a 12-Ccapsule (500 mg substrate) taken 3 times daily for the next 3 days. Thehomeopathic potency designation “C” refers to a 100-fold serial dilu-tion and “M” refers to a 1,000-fold serial dilution. Placebos wereformulated with the same sucrose/lactose pellets that were used tomake the A. montana 1-M and 12-C capsules. The capsules wereprepared by Alpine Pharmaceuticals (San Rafael, CA, U.S.A.) accord-ing to the standards of the Homeopathic Pharmacopeia of the UnitedStates (Fig. 1).

Upper blepharoplasties were performed by 2 of the authorsusing a standard skin-only excision technique. Anesthesia was achievedwith 1% lidocaine with epinephrine (1:200,000). A high-temperaturesurgical cautery pen was used for meticulous intraoperative hemostasis.

On the final follow-up visit, subjects were queried in regard tothe recovery period for each upper eyelid with the question, “Which

Accepted for publication November 11, 2009.This study was performed under approval of the institutional review

board.This study was conducted as a thesis for ASOPRS Membership.The authors have no conflicts of interest.Supported in part by an Individual Research Grant from the Cosmetic

Surgery Foundation.Address correspondence and reprint requests to Brett S. Kotlus, M.D.,

M.S., 8180 26 Mile Road, Shelby Twp, MI 48316, U.S.A. E-mail:kotlus@gmail.com

DOI: 10.1097/IOP.0b013e3181cd93be

Ophthal Plast Reconstr Surg, Vol. 0, No. 0, 2010 1

side was easier?” and the responses were recorded. A chi-square testwas performed to determine whether the easier laterality correspondedwith administration of the active ingredient.

The area (cm2) of detectable upper eyelid ecchymosis as seenin digital photographs was measured for days 3 and 7 using themeasurement and calibration tools in Adobe Photoshop CS3, Ver-sion 10.0 (Adobe Systems Inc., San Jose, CA, U.S.A.). An inde-pendent sample t test was conducted to assess whether meandifferences existed in square centimeters of ecchymosis by treatmentgroup for days 3 and 7 separately. A one-sample KS test was conductedto evaluate the assumption of normality for square centimeters ofecchymosis for each group.

An independent observer decided on a rank order of all subjectphotographs from least ecchymotic to most ecchymotic for days 3 and7 separately. A Mann-Whitney U signed-rank test was conducted toassess whether mean rank differences existed in square centimeters ofbruising for days 3 and 7 by treatment group (active vs. placebo). Anindependent sample t test was conducted to assess whether meandifferences existed in the difference in square centimeters of ecchymo-sis from days 3 to 7 by treatment group (active vs. placebo).

Statistical analyses were performed with SPSS Statistics 17.0(SPSS Inc., Chicago, IL, U.S.A.).

RESULTSThirty patients were enrolled in the study, and blepharoplasty

was performed on 57 eyelids (3 patients did not follow-up for thesecond eyelid). No adverse effects or events were noted during thecourse of the study.

A preliminary one-sample Kolmogorov-Smirnov (KS) test wasconducted to evaluate the assumption of normality for square centime-ters of ecchymosis for day 3 for each group. The results of the KS testswere not significant for either group: active, z (28) � 0.79, p � 0.561and placebo, z (29) � 1.05, p � 0.217, suggesting the assumption ofnormality was met. Levene test of equal error variances was notsignificant, suggesting the assumption of homogeneity was met. Theresults of the t test were not significant (t (55) � 0.19, p � 0.854),suggesting that statistically there was no mean difference in ecchymo-sis on day 3 for the active group (mean � 3.46, standard deviation [SD]� 2.43) compared with placebo (mean � 3.58, SD � 2.60).

An independent sample t test was conducted to assess whethermean differences existed for square centimeters of ecchymosis for day7 by treatment group (active vs. placebo). A preliminary one-sampleKS test was conducted to evaluate the assumption of normality forsquare centimeters of ecchymosis for day 7 for each group. The resultsof the KS tests were not significant for either group: active, z (28) �1.12, p � 0.160 and placebo, z (29) � 1.18, p � 0.125. Levene test of

equal error variances was not significant. The results of the t test werenot significant, t (55) � 0.81, p � 0.419, suggesting that statisticallythere was no mean difference in ecchymosis on day 7 for the activegroup (mean � 0.87, SD �0.84) compared with placebo (mean � 1.09,SD � 1.18).

A chi-square test of independence was conducted to determinewhich eye was easiest (active vs. placebo). The chi-square test was notstatistically significant: �2 (1) � 0.04. Twelve participants (48.0%)endorsed that the eye treated during arnica administration was easiest,and 13 participants (52.0%) endorsed that the eye treated duringplacebo administration was easiest.

A Mann-Whitney U signed-rank test was conducted to assesswhether mean rank differences existed for square centimeters of ec-chymosis by treatment group (active vs. placebo). For day 3, the resultswere not significant, U (57) � 403.00, p � 0.926, suggesting there wasno mean rank difference in ecchymosis on day 3 for the active group(mean rank [MR] � 28.89, sum of ranks [SR] � 809.00) comparedwith placebo (mean � 29.10, SD � 844.00). For day 7, the results ofthe Mann-Whitney U signed-rank test were not significant, U (57) �336.50, p � 0.267, indicating there was no mean rank difference inecchymosis on day 7 for the active group (MR � 26.52, SR � 742.50)compared with placebo (mean � 31.40, SD � 910.50).

A preliminary one-sample KS test was conducted to evaluatethe assumption of normality in square centimeters of ecchymosischange from days 3 to 7 for each group. The results of the KS tests werenot significant for either group: active, z (28) � 0.67, p � 0.753 andplacebo, z (29) � 1.07, p � 0.203. Levene test of equal error varianceswas not significant. The results of the t test were not significant, t(55) � 0.19, p � 0.850, indicating that statistically there was no meandifference in change in ecchymosis for the active group (mean � 2.59,SD � 1.98) compared with placebo (mean � 2.49, SD � 1.94) (Fig. 2).

DISCUSSIONPresently, few limited studies examine the efficacy of

homeopathic A. montana in the perioperative period, and noneaddress its effects after surgery of the ocular adnexa. Previouslypublished trials have investigated A. montana’s influence onpostsurgical complications after tooth extraction,7 soreness inrunners,8 ecchymosis after hand surgery,9 incidence of hema-tomas after saphenous vein stripping,10 and postpartum bleed-ing.11 Ernst and Pittler’s6 systematic review of trials publishedprior to 1998 did not find strong evidence to support that A.montana is clinically effective beyond a placebo effect. Theycited design weaknesses of the reviewed placebo-controlledtrials, including small sample size, lack of randomization, andlack of statistical analysis.

Seeley et al.12 published a trial comparing 29 patientswho underwent rhytidectomy and received homeopathic A.

FIG. 1. Arnica montana and placebo capsules.

FIG. 2. Change in area of ecchymosis from day 3 to day 7 forA. montana versus placebo.

B. S. Kotlus et al. Ophthal Plast Reconstr Surg, Vol. 0, No. 0, 2010

2 © 2010 The American Society of Ophthalmic Plastic and Reconstructive Surgery, Inc.

Montana versus placebo. No statistically significant differencein subjective examiner assessment of ecchymosis or ecchy-motic intensity (measured by computer analysis of skin color)was found, nor was there a difference in patient report ofcomfort level between the 2 groups. There was a statisticallysignificant reduction in area of ecchymosis for the A. montanagroup on postoperative days 1 and 7 but not for days 5 and 10,an observation not easily explained.

Totonchi and Guyuron observed that when comparedwith a placebo group, patients receiving homeopathic A. mon-tana experienced no difference in extent or intensity of ecchy-mosis after rhinoplasty. However, in the early postoperativeperiod, the patient receiving A. montana had significantly lessedema per blinded panelist ratings.13 The current study did notspecifically examine the influence of A. montana on eyelidedema, although edema does influence comfort, which wassubjectively assessed with a patient questionnaire.

Practitioners of allopathic medicine (a term reportedlycoined by Hahnemann, the founder of homeopathy) have beenlargely skeptical of homeopathic remedies3 and have facedchallenges when attempting to integrate these with more “con-ventional” practices.14 Nevertheless, homeopathic A. montanahas been widely endorsed by surgeons for perioperative use.The manufacturer of SinEcch (Alpine Pharmaceuticals, SanRafael, CA, U.S.A.), a popular homeopathic A. montana prep-aration and regimen (identical to the formulation used in thisstudy), claims to have sold more than 250,000 units over thelast 10 years (M. Quinn, Alpine Pharmaceuticals, personalcommunication, 2006).

We did not find that 1-M/12-C A. montana decreasedecchymosis or improved ease of recovery after upper blepha-roplasty as compared with placebo. Neither subjective (rankorder analysis) nor objective (ecchymotic area comparison)measures suggested a difference between active treatment andhomeopathic A. montana in this study. The contralateral uppereyelid was used as a control for each patient to correct for thewide range of interpatient variation in ecchymosis seen afterupper blepharoplasty. The reason for this commonly seenvariation may be related to both intrinsic and extrinsic factors,such as anatomical variances and dietary differences. It mayalso be true that different subjects may have varied responses topharmacologic agents and herbs due to genotypic differences.The present study only included male patients with an agerange of 43 to 78 years because of the characteristics of thepatient population in the clinic in which the study was per-formed. It is not known whether there is an age or genderinfluence on response to homeopathic A. montana.

The concept of a pill that lessens ecchymosis aftersurgery is appealing. An assortment of agents and techniqueshas been attempted for reduction of ecchymosis after blepha-roplasty with minimally proven benefit.15,16 It is certain thatsurgeons will continue to seek methods of controlling thecorporeal response to trauma, especially when of an iatrogenic

nature. Patients will similarly continue to pursue an active rolein easing the undesirable aspects of postsurgical healing. Ho-meopathic A. montana, as investigated in this study, was notfound to be a beneficial means of accomplishing these aims inregard to postsurgical upper eyelid ecchymosis.

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Ophthal Plast Reconstr Surg, Vol. 0, No. 0, 2010 Arnica montana After Blepharoplasty

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