Journal Reading

Presented by:
 INTRODUCTION
undesirable effect of surgery, laser surgery therapy, injection, or trauma

eyelids  thinnest skin on the body  rich vascular supply

Ecchymosis

severe forms  hematoma, compartment syndrome  loss of vision. Facial ecchymosis 

disfigurement or embarrassment

Reduction of Ecchymosis Arnica montana (AM)

physiologic actions on vascular permeability
Homeopathy: through inhibition of inflammatory cascades and
alternative medicine that treats histamine modulation  Mixed Results
conditions using natural substances in
very dilute formulations
↓ Other naturally
commonly lower than 1 part in a million occurring agents
bromelain, vitamin K, Melilotus extract,
and Rhododendron tomentosum.
Bromelain Vitamin K
• Protease naturally present in pineapple stems • Hepatic biosynthesis of coagulation factors
• Anticytokine and antithrombotic activity  • Supplement to prevent and speed the clearing
reduce ecchymosis of bruising

Melilotus extract R. Tomentosum

• Coumarin  forestall edema and has been • Anti-inflammatory properties in animals and
used in the treatment of lymphedema • Reduce inflammation and ecchymosis in
• Antagonizes proinflammatory mediators humans
 Homeopathic Agents or Vitamins for Ecchymosis
Incomplete and inconclusive. Not specific for the oculofacial zone.

Leu et al
Accelerated resolution of laser surgery–induced ecchymosis of the upper inner arms with topical 20%
AM.

This Ophthalmic Technology Assessment

Reviews the literature on the efficacy and safety of various homeopathic agents or vitamins in
reducing ecchymosis after oculofacial surgery or laser surgery.
Question for Assessment

What is the efficacy and safety of homeopathic

agents or vitamins in the reduction of ecchymosis
for adults undergoing oculofacial surgery or laser
surgery?
Descriptio
n of
Evidence
 PubMed database initially in December 2019 and updated on February 28, 2020

limited to studies in Inclusion Search Strategy

the English  articles published after 1990
language
 assessed the use of homeopathic agents
or vitamins
 to reduce ecchymosis after oculofacial
surgery or laser surgery
 in human subjects
Arnica, Arnica montana, bromelain,
quercetin, Ledum, Ledum palustre,
Rhododendrum, tomentosum, vitamin K,
plant extracts, Melilotus,
nutritional support AND ecchymosis,
swelling, swell, bruise, bruising,
blepharoplasty, blepharoplastic,
oculofacial, and cosmetic surgery.
 124 initial citations, and 11 articles
panel’s methodologist (VKA)
assessed the quality of the methodologies
according
American Academy of Ophthalmology’s
guidelines
Rating
• Level I rating was assigned to well-designed and
well-conducted randomized clinical trials
• Level II rating was assigned to well-designed
case-control and cohort studies and lower-quality
randomized studies
• Level III rating was assigned to case series, case
reports, and lower-quality cohort and case-control
studies.
 9 studies met level I criteria
 2 studies met level III criteria.
 There were no level II studies.
Published
Results
 Level I
Study
Outcomes
 Arnica montana

Alonso topical AM gel for the prevention or resolution of bruising for patients with
et al facial telangiectasias treated with 585 nm pulsed dye laser surgery.

randomized, double-masked, placebo-controlled study

Vehicle/placebo (other
AM gel (one side)
side)
Neither group exhibited a
pretreatment group post-treatment group statistically significant
improvement with the
intervention in bruising score
(AM gel was applied for 2 weeks (AM gel was applied for 2 weeks
before the laser surgery after the laser surgery)

analog scale at postoperative days (PODs)

0, 3, 7, 10, 14, and 17.
Chaiet and
oral perioperative AM in reducing ecchymosis after rhinoplasty surger
Marcus

rhinoplasty surgery with nasal bone osteotomies 

prospectively randomized

perioperative oral AM 500 mg 12C capsules (next

(day of surgery) 3 days)/placebo Results demonstrated no
significant differences
photographs at 3 postoperative time points:
POD 2 or 3, 7, and 9 or 10
Kotlus et al effect of AM on ecchymosis after blepharoplasty

prospective, placebo-controlled, double-masked study

AM gel 3 times (operative day) 

Placebo
12-C capsule (3x/d for 3 days)

no statistically significant
Unilateral upper eyelid difference area of ecchymosis or
blepharoplasty
rank order of ecchymosis severity
for POD 3
contralateral blepharoplasty at least 1 month later
with the opposite regimen

evaluated at PODs 3 and 7 by rank order of severity and measurement

of surface area of observable ecchymosis
 homeopathic formulation of AM (SINECCH, Alpine Pharmaceuticals) in patients
Seeley et al
undergoing facelift surgery

face rhytidectomy patient

homeopathic oral AM Placebo no statistically significant

subjective differences between
patients given perioperative
evaluated at postoperative day 1, 5, 7, and 10 photographs homeopathic AM and patients
given placebo.
 effects of topical AM or mucopolysaccharide polysulfate or no treatment on the
Simsek
regression of postoperative edema and ecchymosis in patients undergoing open
et al
technique rhinoplasty

randomized  postoperative cream applied to the paranasal and periorbital

areas 4 times per day for 10 days or not

postoperative
No postoperative
AM Cream mucopolysaccharide
treatment
polysulfate cream

evaluated at interventions scored ecchymosis no significant difference between

AM and mucopolysaccharide
polysulfate

difference between AM cream and

with no cream
 Totonchi and effects of oral AM (SINECCH, Alpine Pharmaceuticals) in
Guyuron reducing ecchymosis after rhinoplasty with osteotomy

primary rhinoplasty  randomized

I.V dexa 10 mg  oral AM 3x/d orally for Neither agent but

6-day oral tap-off MP 4 days no placebo

rated the extent and intensity of ecchymosis AM does not provide any benefit
in extent or intensity of
ecchymosis
van Exsel effects of AM ointment 10% (Weleda AG) on ecchymosis after upper-eyelid
et al blepharoplasty

bilateral upper blepharoplasty  randomized

topical AM 10% Placebo

evaluated overall periorbital appearance based on light photography at

PODs 3, 7, and 42

no statistically significant
difference in ecchymosis between
AM and placebo
 VITAMIN K

Cohen and effects of topical vitamin K oxide gel (2% Auriderm Post-Op Gel, Biopelle Inc) in
Bhatia reducing purpura after pulsed dye laser surgery for facial telangiectases

randomized, double-masked, placebo-controlled

split-face study

vitamin K oxide gel Placebo

no statistically significant
evaluated photographs at PODs 0, 2, 4, 6, and 9 were scored difference between placebo and
vitamin K oxide gel
 topical 5% vitamin K in preventing and speeding the clearing of bruising in 22
Shah et al
patients undergoing 585-nm pulsed dye laser surgery for facial telangiectases

double-masked, randomized, placebo-controlled study

vitamin K cream Placebo

pretreatment with vitamin K did

evaluated at PODs 0, 3, 7, 10, 14, and 17 not prevent or reduce the severity
of bruising after laser surgery
Level III
Study
Outcomes
 Kang combination of topical AM and R. tomentosum in reducing postoperative ecchymosis
et al and edema in a select population of healthy volunteers after oculofacial surgery

Undergoing oculofacial procedures

topical hydrogel pads  AM 50 M 50%

Placebo
and R. tomentosum 50 M

subjective and retrospective

comparison with “expected healing” in patients not using AM metrics precluded any meaningful
and R. tomentosum statistical analysis and significant
conclusions
 effects of Melilotus extract in the management of postoperative ecchymosis after
Xu et al
simultaneous rhinoplasty and blepharoplasty

simultaneous rhinoplasty and blepharoplasty

6 mg oral dexamethasone
100 mg Melilotus
extract tablets orally
 tap-off until 1,5 mg day Neither agent
7

Melilotus extract statistically

significantly less ecchymosis in the
eyelids and paranasal ecchymosis
 Homeopathic agent type, dosing

Oculofacial procedures Different

Differed scoring
among the systems for
studies ecchymosis

Methodologies

Suggest that the but does not demonstrate effectiveness

These
homeopathic agents are at reducing ecchymosis after oculofacial
articles
safe plastic procedures
 CONCLUSIONS
This systematic review of the literature reveals that homeopathic AM, vitamin K
oxide, and Melilotus extract, although safe, failed to demonstrate any benefit
compared with placebo in reducing ecchymosis after oculofacial surgery or pulsed
dye laser surgery.
CRITICAL
APPRAIS
AL
 Are the results of the trial valid?
What question (PICO) did they address?
 P : Determine the efficacy and safety of homeopathic agents or vitamins in reducing ecchymosis after
oculofacial surgery or laser surgery
 I : literature search study

 C : assigned a level of evidence rating for each study

 O : Efficacy and safety of homeopathic agents or vitamins in reducing ecchymosis after oculofacial
surgery or laser surgery.
 V : Yes, a Reputated International Journal indexed Q1

 I : Yes, as evidence based that efficacy and safety of homeopathic agents or vitamins in reducing
ecchymosis after oculofacial surgery or laser surgery.
 A : Not sure, recommendations and suggestion are applicable in Indonesia because it’s only literature
search with limited English-based language study.

[√] Yes [ ] No [ ] Unclear

 Is it unlikely that important, relevant studies were missed?
• Yes, this study only included English article so there’s more studies in another language that
maybe have an important results that missed.

[√] Yes [ ] No [ ] Unclear

Were the criteria used to select articles for inclusion appropriate?

• Yes, inclusion criteria is used in this article selection  articles published after 1990,
assessed the use of homeopathic agents or vitamins to reduce ecchymosis after oculofacial
surgery or laser surgery in human subjects

[√ ] Yes [] No [] Unclear
 Were the included studies sufficiently valid for the
type of question asked?
• Yes, the included studies sufficiently valid for the type of question asked

[√] Yes [ ] No [ ] Unclear

Were the results similar from study to study?

• Yes, the results is similar from study to study

[√] Yes [] No [] Unclear

 What were the results?
The agents studied in the articles identified included oral or topical Arnica montana (AM), oral Melilotus extract,
topical vitamin K oxide, and topical AM combined with Rhododendron tomentosum. Metrics to describe
ecchymosis varied. In 7 controlled studies, perioperative AM provided no or negligible benefit versus placebo. In 2
studies, vitamin K cream was equivalent to placebo. One study of oral Melilotus extract had less ecchymosis
compared with controls in paranasal and eyelid ecchymosis at postoperative day (POD) 7, but not at PODs 1 and 4.
A lone cohort study of combined topical AM and R. tomentosum lacked objective metrics and adequate controls. No
serious side effects from administration of homeopathic agents or vitamins were identified.
The current literature does not support the use of
AM, vitamin K oxide, R. tomentosum, or Melilotus
extract for reducing ecchymosis after oculofacial
surgery or pulsed dye laser surgery.
THANK YOU