Dr. Brett Kotlus and co-authors evaluated the efficacy of homeopathic arnica montana for ecchymosis (bruising) in conjunction with upper eyelid surgery.

1. ORIGINAL ARTICLE
Evaluation of Homeopathic Arnica montana for Ecchymosis
After Upper Blepharoplasty: A Placebo-Controlled,
Randomized, Double-Blind Study
Brett 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 upper
eyelid blepharoplasty. The use of homeopathic preparations of
Arnica montana, a flowering herb, has been advocated by
physicians, patients, and manufacturers for reduction of postsurgical ecchymosis. The authors evaluate its efficacy after
upper eyelid blepharoplasty.
Methods: A prospective, placebo-controlled, double-blind
study was performed in which patients were randomly assigned
to the administration of homeopathic A. montana or placebo
concurrent with unilateral upper eyelid blepharoplasty followed
by contralateral treatment at least 1 month later. Ecchymosis
was evaluated at days 3 and 7 by rank order of severity and
measurement of surface area of observable ecchymosis.
Results: There was no statistically significant difference in
area of ecchymosis or rank order of ecchymosis severity for
days 3 and 7 after treatment with A. montana versus placebo.
Additionally, there was no difference in ease of recovery per
patient report, and there was no difference in the rate of
ecchymosis resolution.
Conclusions: The authors find no evidence that homeopathic
A. montana, as used in this study, is beneficial in the reduction or
the resolution of ecchymosis after upper eyelid blepharoplasty.
(Ophthal Plast Reconstr Surg 2010;0:000–000)
A
rnica montana is a flowering herb also known as wolf’s
bane, leopard’s bane, and mountain tobacco. The physiologic actions of A. montana are not fully understood, but it has
been purported to affect vascular permeability by way of
histamine modulation,1 and it may modify inflammatory cascades via selective inhibition of transcription factors.2 Many
widely available A. montana preparations are formulated according to homeopathic principles, which dictate that multiple
dilution factors of a substance can render it more potent in
treating specific disorders.3,4 There are inadequate data to
support the safety of nonhomeopathic preparations of A. montana extract,5 but no serious adverse effects have been reported
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
in conjunction with the use of homeopathic A. montana. By
anecdotal and published reports, homeopathic forms of this
herb are used by patients and recommended by surgeons to
alleviate postoperative ecchymosis, edema, and pain.6
The eyelids are unique anatomical structures because
they contain the body’s thinnest skin while having a rich
vascular supply. For this reason, the undesirable appearance of
ecchymosis is common after upper blepharoplasty. We evaluated the efficacy of homeopathic A. montana in the modification of ecchymosis after upper eyelid blepharoplasty with a
prospective, placebo-controlled, randomized, double-blind
clinical trial.
METHODS
Thirty 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 consent was obtained for all patients prior to study enrollment. The study
protocol conformed to the guidelines of the Helsinki Declaration and
was compliant with Health Insurance Portability and Accountability
Act of 1996 (HIPAA) standards. Exclusion criteria included active
infection, current anticoagulant or antiplatelet use (for at least 14 days
prior to blepharoplasty), known bleeding disorders, and contraindications to upper blepharoplasty.
Patient participation consisted of 3 visits for each upper eyelid,
including the blepharoplasty procedure, and follow-up visits 3 days and
7 days after the procedure. Standard view photographs were taken at
each visit, including a frontal view with the eyes closed. A metric ruler
was taped to the forehead for calibration purposes. Blepharoplasty was
performed separately for the right and left upper eyelids, with at least
1 month between procedures to avoid a crossover effect. For each
procedure, 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 dosage
regimen for A. montana consisted of a single 1-M capsule (500 mg
substrate) taken orally 3 times for the operative day, followed by a 12-C
capsule (500 mg substrate) taken 3 times daily for the next 3 days. The
homeopathic potency designation “C” refers to a 100-fold serial dilution and “M” refers to a 1,000-fold serial dilution. Placebos were
formulated with the same sucrose/lactose pellets that were used to
make the A. montana 1-M and 12-C capsules. The capsules were
prepared by Alpine Pharmaceuticals (San Rafael, CA, U.S.A.) according to the standards of the Homeopathic Pharmacopeia of the United
States (Fig. 1).
Upper blepharoplasties were performed by 2 of the authors
using a standard skin-only excision technique. Anesthesia was achieved
with 1% lidocaine with epinephrine (1:200,000). A high-temperature
surgical cautery pen was used for meticulous intraoperative hemostasis.
On the final follow-up visit, subjects were queried in regard to
the recovery period for each upper eyelid with the question, “Which
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2. B. S. Kotlus et al.
Ophthal Plast Reconstr Surg, Vol. 0, No. 0, 2010
FIG. 2. Change in area of ecchymosis from day 3 to day 7 for
A. montana versus placebo.
FIG. 1.
Arnica montana and placebo capsules.
side was easier?” and the responses were recorded. A chi-square test
was performed to determine whether the easier laterality corresponded
with administration of the active ingredient.
The area (cm2) of detectable upper eyelid ecchymosis as seen
in digital photographs was measured for days 3 and 7 using the
measurement and calibration tools in Adobe Photoshop CS3, Version 10.0 (Adobe Systems Inc., San Jose, CA, U.S.A.). An independent sample t test was conducted to assess whether mean
differences existed in square centimeters of ecchymosis by treatment
group for days 3 and 7 separately. A one-sample KS test was conducted
to evaluate the assumption of normality for square centimeters of
ecchymosis for each group.
An independent observer decided on a rank order of all subject
photographs from least ecchymotic to most ecchymotic for days 3 and
7 separately. A Mann-Whitney U signed-rank test was conducted to
assess whether mean rank differences existed in square centimeters of
bruising for days 3 and 7 by treatment group (active vs. placebo). An
independent sample t test was conducted to assess whether mean
differences existed in the difference in square centimeters of ecchymosis 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.).
RESULTS
Thirty patients were enrolled in the study, and blepharoplasty
was performed on 57 eyelids (3 patients did not follow-up for the
second eyelid). No adverse effects or events were noted during the
course of the study.
A preliminary one-sample Kolmogorov-Smirnov (KS) test was
conducted to evaluate the assumption of normality for square centimeters of ecchymosis for day 3 for each group. The results of the KS tests
were not significant for either group: active, z (28) ϭ 0.79, p ϭ 0.561
and placebo, z (29) ϭ 1.05, p ϭ 0.217, suggesting the assumption of
normality was met. Levene test of equal error variances was not
significant, suggesting the assumption of homogeneity was met. The
results of the t test were not significant (t (55) ϭ 0.19, p ϭ 0.854),
suggesting that statistically there was no mean difference in ecchymosis on day 3 for the active group (mean ϭ 3.46, standard deviation [SD]
ϭ 2.43) compared with placebo (mean ϭ 3.58, SD ϭ 2.60).
An independent sample t test was conducted to assess whether
mean differences existed for square centimeters of ecchymosis for day
7 by treatment group (active vs. placebo). A preliminary one-sample
KS test was conducted to evaluate the assumption of normality for
square centimeters of ecchymosis for day 7 for each group. The results
of the KS tests were not significant for either group: active, z (28) ϭ
1.12, p ϭ 0.160 and placebo, z (29) ϭ 1.18, p ϭ 0.125. Levene test of
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equal error variances was not significant. The results of the t test were
not significant, t (55) ϭ 0.81, p ϭ 0.419, suggesting that statistically
there was no mean difference in ecchymosis on day 7 for the active
group (mean ϭ 0.87, SD ϭ0.84) compared with placebo (mean ϭ 1.09,
SD ϭ 1.18).
A chi-square test of independence was conducted to determine
which eye was easiest (active vs. placebo). The chi-square test was not
statistically significant: ␹2 (1) ϭ 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 during
placebo administration was easiest.
A Mann-Whitney U signed-rank test was conducted to assess
whether mean rank differences existed for square centimeters of ecchymosis by treatment group (active vs. placebo). For day 3, the results
were not significant, U (57) ϭ 403.00, p ϭ 0.926, suggesting there was
no mean rank difference in ecchymosis on day 3 for the active group
(mean rank [MR] ϭ 28.89, sum of ranks [SR] ϭ 809.00) compared
with placebo (mean ϭ 29.10, SD ϭ 844.00). For day 7, the results of
the Mann-Whitney U signed-rank test were not significant, U (57) ϭ
336.50, p ϭ 0.267, indicating there was no mean rank difference in
ecchymosis on day 7 for the active group (MR ϭ 26.52, SR ϭ 742.50)
compared with placebo (mean ϭ 31.40, SD ϭ 910.50).
A preliminary one-sample KS test was conducted to evaluate
the assumption of normality in square centimeters of ecchymosis
change from days 3 to 7 for each group. The results of the KS tests were
not significant for either group: active, z (28) ϭ 0.67, p ϭ 0.753 and
placebo, z (29) ϭ 1.07, p ϭ 0.203. Levene test of equal error variances
was not significant. The results of the t test were not significant, t
(55) ϭ 0.19, p ϭ 0.850, indicating that statistically there was no mean
difference in change in ecchymosis for the active group (mean ϭ 2.59,
SD ϭ 1.98) compared with placebo (mean ϭ 2.49, SD ϭ 1.94) (Fig. 2).
DISCUSSION
Presently, few limited studies examine the efficacy of
homeopathic A. montana in the perioperative period, and none
address its effects after surgery of the ocular adnexa. Previously
published trials have investigated A. montana’s influence on
postsurgical complications after tooth extraction,7 soreness in
runners,8 ecchymosis after hand surgery,9 incidence of hematomas after saphenous vein stripping,10 and postpartum bleeding.11 Ernst and Pittler’s6 systematic review of trials published
prior to 1998 did not find strong evidence to support that A.
montana is clinically effective beyond a placebo effect. They
cited design weaknesses of the reviewed placebo-controlled
trials, including small sample size, lack of randomization, and
lack of statistical analysis.
Seeley et al.12 published a trial comparing 29 patients
who underwent rhytidectomy and received homeopathic A.
© 2010 The American Society of Ophthalmic Plastic and Reconstructive Surgery, Inc.

3. Arnica montana After Blepharoplasty
Ophthal Plast Reconstr Surg, Vol. 0, No. 0, 2010
Montana versus placebo. No statistically significant difference
in subjective examiner assessment of ecchymosis or ecchymotic intensity (measured by computer analysis of skin color)
was found, nor was there a difference in patient report of
comfort level between the 2 groups. There was a statistically
significant reduction in area of ecchymosis for the A. montana
group on postoperative days 1 and 7 but not for days 5 and 10,
an observation not easily explained.
Totonchi and Guyuron observed that when compared
with a placebo group, patients receiving homeopathic A. montana experienced no difference in extent or intensity of ecchymosis after rhinoplasty. However, in the early postoperative
period, the patient receiving A. montana had significantly less
edema per blinded panelist ratings.13 The current study did not
specifically examine the influence of A. montana on eyelid
edema, although edema does influence comfort, which was
subjectively assessed with a patient questionnaire.
Practitioners of allopathic medicine (a term reportedly
coined by Hahnemann, the founder of homeopathy) have been
largely skeptical of homeopathic remedies3 and have faced
challenges when attempting to integrate these with more “conventional” practices.14 Nevertheless, homeopathic A. montana
has been widely endorsed by surgeons for perioperative use.
The manufacturer of SinEcch (Alpine Pharmaceuticals, San
Rafael, CA, U.S.A.), a popular homeopathic A. montana preparation and regimen (identical to the formulation used in this
study), claims to have sold more than 250,000 units over the
last 10 years (M. Quinn, Alpine Pharmaceuticals, personal
communication, 2006).
We did not find that 1-M/12-C A. montana decreased
ecchymosis or improved ease of recovery after upper blepharoplasty as compared with placebo. Neither subjective (rank
order analysis) nor objective (ecchymotic area comparison)
measures suggested a difference between active treatment and
homeopathic A. montana in this study. The contralateral upper
eyelid was used as a control for each patient to correct for the
wide range of interpatient variation in ecchymosis seen after
upper blepharoplasty. The reason for this commonly seen
variation may be related to both intrinsic and extrinsic factors,
such as anatomical variances and dietary differences. It may
also be true that different subjects may have varied responses to
pharmacologic agents and herbs due to genotypic differences.
The present study only included male patients with an age
range of 43 to 78 years because of the characteristics of the
patient population in the clinic in which the study was performed. It is not known whether there is an age or gender
influence on response to homeopathic A. montana.
The concept of a pill that lessens ecchymosis after
surgery is appealing. An assortment of agents and techniques
has been attempted for reduction of ecchymosis after blepharoplasty with minimally proven benefit.15,16 It is certain that
surgeons will continue to seek methods of controlling the
corporeal response to trauma, especially when of an iatrogenic
nature. Patients will similarly continue to pursue an active role
in easing the undesirable aspects of postsurgical healing. Homeopathic A. montana, as investigated in this study, was not
found to be a beneficial means of accomplishing these aims in
regard to postsurgical upper eyelid ecchymosis.
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© 2010 The American Society of Ophthalmic Plastic and Reconstructive Surgery, Inc.
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