Curcumin Gel in the Treatment of Minor Aphthous Ulcer: a
Randomized, Placebo- Controlled Trial
Manifar S (DDS), Obwaller A (Ph.D.), Gharehgozloo A (M.D.), Boorboor Shirazi Kordi HR
(M.D.), Akhondzadeh S (Ph.D.)
1- Oral Medicine Clinic, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran
2- Orphanidis Pharma Research GmbH, Vienna, Austria 3- Psychiatric Research Center, Tehran University of Medical Sciences, Tehran, Iran *Corresponding author: Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, South Kargar Street, Tehran 13337, Iran, Tel: +98-21-55412222, Fax: +98-21-55419113 Email: email@example.com
26 Dec 2011
1 Feb. 2012
Background: It has been reported that curcumin has anti inflammatory, antibacterial, anti
tumor and analgesic properties.
Objective: The purpose of this study was to investigate the efficacy of curcumin in the treatment
of minor aphthous stomatitis.
Methods: The study was a two week, randomized, double blind, placebo controlled of patients
with minor aphthous. Patients between 18 and 65 years old were included if they presented with
1–5 aphthous ulcers of less than 24 h duration. Twenty-eight patients were randomly allocated to
curcumin gel containing (2% curcumin) and 29 patients were allocated to placebo gel for a two
week, double-blind, placebo-controlled study. The patients used the medication using a swap
twice per day. After enrolment, the size of ulcers were measured by the investigator, and pain was
evaluated by the patients based on Perceived Pain Rating Scale before drug application (day 0)
and at days 4, 7, and 14. Patients overall satisfaction were assessed at the end of treatment.
Results: Curcimin gel significantly reduced pain intensity and size of aphthous ulcer compare to
placebo. Significant group differences appeared at the end of the trial regarding overall
satisfaction of the patients.
Conclusion: The results of present study provide evidence that curcumin gel is a well tolerated
effective treatment modality for minor aphthous stomatitis.
Keywords: Curcumin, Minor aphthous stomatitis, Pain
Volume 11, No. 41, Winter 2012
also occur as widespread lesions in association
with systemic diseases including Behcet’s
Stomatitis (RAS), commonly referred to as
syndrome, and gastrointestinal mal absorption
canker sores, are inflammatory lesions of the
disorders like Crohn's and Celiac diseases [1,
2, 5]. It is unclear whether these presentations
involve the cheeks, gums, tongue, lips, and
are manifestations of the underlying disease or
roof or floor of the mouth. It is usually painful
represent a separate oral disorder. Treatment
and associated with redness, swelling, and
for RAS is symptomatic; the goals being to
occasional bleeding from the affected area (s)
decrease pain, healing time, number and size
[1, 2]. Manifestation of the disease can range
of the ulcer, and to increase disease-free
from mild to severe and, in extreme cases,
periods. Current treatment options include
even hinder a person’s ability to ingest foods,
topical agents, systemic and topical steroids,
thereby making the person susceptible to
corticosteroids, cauterization and antibiotics,
mouth rinses containing active enzymes, laser
suspected including genetics, stress, nutritional
The lack of predictability of the efficacy of
deficiencies, diet, hormonal changes, and
a particular treatment mirrors the mystery
surrounding the etiology of the condition .
indeterminate etiology of the disease, it is
Over the last decade evidence based herbal
difficult to find a definitive cure and current
medicine in the treatment of psychiatric
treatments are aimed towards ameliorating the
disorders and dermatological disease, has been
symptoms [1, 3]. The less severe form of the
considered [6-15]. There are some natural
disease is often known as minor aphthous
remedies that are being explored for the
stomatitis while the less common but more
treatment of aphthae [16, 17]. Herbal medicine
severe type is major aphthous stomatitis [2, 4].
will relieve pain, reduce inflammation and
Minor aphthous stomatitis is a very common
prevent infection in the treatment of aphthae
self-limiting, recurrent disease of unknown
. It has been reported that curcumin has
cause. One or several painful ulcers appear on
anti inflammatory, antibacterial, anti tumor
the lining mucosa of the mouth . The ulcers
and analgesic properties [18-21]. Therefore,
heal in 7-10 days with or without treatment.
the objective of this study was to investigate
Major aphthous stomatitis are larger recurrent
the efficacy of curcumin in the treatment of
ulcers of unknown cause appearing as deep,
painful areas in the mouth that leave scars on
healing. They last longer than minor aphthae [1 - 4].
The study was a randomized, double blind,
common form of oral ulcerative diseases and
placebo controlled of patients with minor
affects an estimated 15-20% of the population
aphthous ulcer referred to Oral Medicine
prevalence has been documented as being as
University of Medical Sciences, Tehran, Iran)
high as 50-66%5 and it is especially common
in North America [1 – 4]. These aphthae can
Journal of Medicinal Plants, Volume 11,
No. 41, Winter 2012
Patients between 18 and 65 years old were
patients were advised not to eat or drink for 1
included if they presented with 1–5 aphthous
ulcers of less than 24 h duration. The ulcers
diameter was not greater than 6 mm and they
did not suffer from acute or chronic diseases of
After enrolment, the size of ulcers were
the oral mucosa. Patients were excluded from
measured by the investigator, and pain was
the study if they had concurrent clinical
evaluated by the subjects based on Perceived
conditions including serious liver, kidney, and
Pain Rating Scale before drug application (day
heart dysfunctions or if they had ulcers as a
0) and at days 4, 7, and 14 as well as subject
manifestation of a systemic disease process
overall satisfaction score at the end of
such as ulcerative colitis, Crohn’s disease,
treatment on four-point description scale
excellent=4) [22). Ulcer size was measured
using a sterile calibrated dental probe with
component of the study, the patients could not
millimeter marking and the longest diameter
have a history of alcohol or drug abuse nor
was used as measurement. In addition, all
could they be taking any narcotic analgesics.
subjects were requested to immediately inform
Patients were excluded if they had a history of
investigators at any time for any side effect.
Pregnant or lactating women and those of
deviation (SD) for quantitative variables with
contraception were also excluded. The trial
descriptive statistics. To evaluate the efficacy
the Mann-Whitney U
test was used.
committee at Tehran University of Medical
All patients completed the study protocol.
No adverse drug reaction to a treatment was
entering into the study. This trial is registered
reported as a reason for leaving the study. No
with the Iranian Clinical Trials Registry
significant difference was identified between
patients randomly assigned to the group 1 or 2
condition with regard to basic demographic
data including age, gender, level of education
Efficacy based on Perceived Pain Rating
allocated to placebo gel for a two week,
double-blind, placebo-controlled study. The
At the study entry, the mean ulcer pain of
patients used the medication using a swap
the 2 groups matched well (ns), but it was later
twice per day and the surface of lesions were
significantly relieved in the turmeric group at
covered by a thin layer of medications. The
Table 1- Characteristics of the patients
mean±SD Number of ulcers, median (range)
Efficacy based on global satisfaction:
antibiotics, mouth rinses containing active
Significant group differences appeared at
enzymes, laser treatments and combination
satisfaction of the patients (P≤
0.01; Table 2)
Our findings suggest that curcimin gel can
reduce pain intensity and size of aphthous
Efficacy based on size of the ulcers:
ulcer. To our knowledge this is the first
Although the ulcer size of the treatment
group and the placebo group matched well at
the study entry (p>0.05), significant group
characteristics of the patients, such as sex, age
differences appeared at the later visits (day 4
and type of aphthouse, did not differ between
groups and cannot explain differences in the
therapeutic outcome. So far, several studies
have shown positive effects of curcumin as
anti inflammatory, anti tumor, antibacterial
effective treatment for RAS that can efficiently
and analgesic agent. Therefore, the results of
reduce the signs and symptoms of the disease
our study are in line with these studies [18-21].
at a low daily dose and with minimal effects
In conclusion, the results of this study
[1-4]. Treatment for RAS is symptomatic; the
provide evidence that curcumin gel is a well
goals being to decrease pain, healing time,
tolerated and effective treatment modality for
number and size of the ulcer, and to increase
RAS. Additional studies with higher number
disease-free periods. Current treatment options
of patients and in the prevention of ulcer
include topical agents, systemic and topical
development if treatment is commenced at the
prodromal stage may be needed to examine the
Journal of Medicinal Plants, Volume 11,
No. 41, Winter 2012
role of curcumin in the treatment of RAS.
This study was supported by a grant from
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