Review article Annals and Essences of Dentistry

10.5368/aedj.2017.9.2.3.2
A POTENT REGIMEN FOR ORAL LICHEN PLANUS: A REVIEW

1 1
Tejaswi Katne Post graduate student
2 2
Anantha Venkata Srikar Muppirala Post graduate student
3 3
Rama Raju Devaraju Professor and Head
4 4
Ramlal Gantala Professor

1-4
Department of Oral Medicine and Radiology S.V.S Institute of Dental Sciences Telangana India

ABSTRACT: Background:Oral lichen planus (OLP) is a chronic inflammatory disease that affects oral mucosa. Substantial fluctuation is
seen between the patients in response to various treatments posing difficulty for the physician in management of the disease.
Aim: To assess efficacy of any form of intervention used to manage oral lichen planus.
Materials and methods: All the published randomised control trials from 2000 to 2016 in the management of OLP, comparing active
interventions with or without placebo irrespective of age, gender were selected from Cochrane central register of controlled trials,
CENTRAL, EMBASE and MEDLINE were included in the study, and SWOT analysis was performed.
Results and conclusion: Thirty two randomised control trials using different drug interventions were included in this systematic review.
The superiority of corticosteroids in remission of clinical signs of OLP is evident, though with few side effects. Future research with
consistent parameters and newer formulations, directed towards personalised medicine are required in a quest of the potent regime to treat
this condition.

KEYWORDS: Lichen planus, drug therapy, topical steroids.

INTRODUCTION

Oral lichen planus is a chronic inflammatory T-cell
1
mediated autoimmune disease with unclear aetiology.
The conception in pathogenesis of Oral lichen planus has
been continuously changing from earlier era to recent
times from initial concept of inflammation to immunological
mediated reaction then followed by the idea of
autoimmune mediated reaction to present genetic concept.
Accordingly the treatment strategies have been
2
continuously kept on changing to the present day.
Various treatment regimens have been tried to improve
the lesions and to reduce the pain but a cure for OLP has
not been found because of lack of an apparent cause and
its recalcitrant nature. Purpose of the present systematic
review was to evaluate the efficacy and safety of
interventions in the treatment of OLP.
per study. All the studies included were performed in a
secondary care except for one (yoke 2006), which was a
multi-centre study. Diagnosis of oral lichen planus was
confirmed clinically and histopathologically in all except in
one study (Malhotra 2008).
Results and discussion
A randomised cross over study on 48 subjects was
done by Buajeeb (2000) to compare the efficacy of
Flucinolone acetonide gel 0.1% in two base forms (
carbopol 1% and 0.5%) and Flucinolone acetonide in oral
base 0.5% for 4 weeks and concluded that both drugs
provided similar efficacy in the treatment but there was no
3
statistical significance.

Materials and methods Study on 48 subjects using fluticasone propionate

All the published randomised control trials from 2000 to
2016 in the management of lichen planus comparing
active interventions with or without placebo, irrespective
of age, gender having symptomatic OLP and
histopathological confirmation were included and selected
from Cochrane central register of controlled trials
CENTRAL, EMBASE, MEDLINE, Cochrane oral health
trials register using key words lichen planus, oral lichen
planus, randomised control trials oral lichen planus,
steroids oral lichen planus, drug therapy oral lichen planus
and SWOT analysis was performed.
Study characteristics
All the included studies in this systematic review were
randomised control trials. The total number of participants
included in the trials was 2073, with a mean of 65 subjects
Vol. IX Issue 2 AprJun 2017 7c
spray (50g aqueous solution) and beta methasone
sodium phosphate mouth rinse (0.5 mg tab in 10 ml of
water) for 6 weeks with intervening washout with 0.15%
benzydamine hydrochloride was carried out by Hegarty
(2002) and concluded that both are effective in the
management but fluticasone spray is easily accepted by
the patients and recurrence is noticed in 4 subjects within
4
the treatment period.
Efficacy and compliance of new lipid microspheres
loaded with 0.025% of Clobetasol propionate (Formulation
A) with commonly used formulation (a sort of dispersion of
a lipophilic ointment in a hydrophilic phase) with the same
amount of drug. (Formulation B) on 50 subjects for 2
months was evaluated by Campisi (2004) and concluded
that Formulation A was effective and superior in terms of
Review article
symptom remission and compliance and recurrence was
5 14
noticed in five patients receiving Formulation B.
Effectiveness of Clobetasol (0.025%) and cyclosporine
(1.5%) was compared on 40 subjects by Conrotto (2006)
in terms of long term remission of symptoms and cost
effectiveness for 2 months and stated that Clobetasol is
more effective than cyclosporine in inducing clinical
improvement and gives less stable results with higher
incidence of side effects in a follow up of 2 months.
Cyclosporine is cost effective (five times higher than that
6
of Clobetasol).
A study on 139 subjects was done by Yoke (2006) to
compare the effectiveness of cyclosporine solution with
triamcinolone acetonide in oral base for 8 weeks. Pain,
burning sensation, area of reticulation erythema, ulceration
were all worse in patients receiving cyclosporine by the
th
end of 4 week and concluded that topical cyclosporine is
7
no more effective than steroid.
Topical tacrolimus (0.1%) was compared with
triamcinolone acetonide (0.1%)in hypromellose 20%
ointment by Laeijendecker(2006) on 40 subjects (20 in
each group) for 6 weeks and results were in favour of
topical tacrolimus(0.1%) which induced a better initial
therapeutic response than triamcinolone but relapses
8 18
occurred within 3-9 weeks of cessation of treatment.
Effectiveness of isotretinoin 0.18% with most frequently
used isotretinoin 0.05% concentration was evaluated on
70 subjects for 3 months by Scardina (2006) and
concluded that isotretinoin 0.18% was superior and
effective in disappearance of dysplastic phenomena than
9
0.05%.
Study was conducted on 13 subjects by Thongprasom
(2007) to compare the effectiveness of cyclosporine
solution with triamcinolone acetonide 0.1% in orabase for
8 weeks and concluded that topical cyclosporine was not
effective than triamcinolone acetonide and more side
10
effects were noticed in patients receiving cyclosporine.
Efficacy of curcuminoids capsules (2000mg/day) for 7
st
weeks and prednisone 60mg/day for 1 week on 33
subjects were evaluated by Chainani Wu (2007) which
stated that curcuminoids at this dose were well tolerated
11
but this study ended early for futility.
Efficacy of 1% pimecrolimus for 4 weeks on 12
subjects was done by Passeron (2007) and concluded that
pimecrolimus seems to be effective and well tolerated
treatment but with minimal side effects and relapse of the
12
treatment was seen in 1 month follow up.
Forty subjects were evaluated to compare the efficacy
and safety of pimecrolimus 1% cream with triamcinolone
acetonide 0.1% for 2 months by Gorouhi (2007) drawing to
a conclusion that both the drugs were effective in the
management but with minimal side effects noticed with
13
pimecrolimus in 2 months of follow up.
Effect of Clobetasol propionate with and without topical
anti-fungal drug for 6 weeks on 35 subjects was carried by
Lodi (2007) which stated that addition of miconazole
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Annals and Essences of Dentistry
significantly have not affected the signs and symptoms
except in preventing iatrogenic candidiasis.
Study on 49 subjects was done to evaluate the efficacy
and safety of betamethasone (5 mg) oral mini pulse
therapy with triamcinolone acetonide 0.1% paste for 6
months by Malhotra (2008) and concluded that both are
equally effective but response is earlier with
betamethasone oral mini pulse therapy and relapse of the
treatment was seen in half of the patients with more side
15
effects.
In a study conducted by Radfar (2008), the
effectiveness of Clobetasol (0.05%) and tacrolimus (0.1%)
was evaluated. Regimen was used for 6 weeks on 30
subjects divided in 2 groups and summarized that the
16
latter is superior and is more effective than Clobetasol.
Thirty two subjects were evaluated by Corrocher (2008) to
compare the efficacy of tacrolimus 0.1% and Clobetasol
0.05% for 4 weeks and result was in favour of tacrolimus
with low symptom scores and is more effective than
17
Clobetasol.
Efficacy of Aloe Vera with placebo for 8 weeks on 54
subjects was carried out by Choonhakaran (2008) which
stated that Aloe Vera is more effective than placebo and
can be considered as a safe alternative treatment with no
side effects.
Efficacy of pimecrolimus 1% cream (Elidel) with vehicle
for 30 days on 20 subjects was evaluated by Volz (2008)
drawing to a conclusion that pimecrolimus is more
effective and no severe adverse reactions were reported in
19
one month follow up.
Thirty subjects were evaluated to know the efficacy of
Ignatia with placebo for 4 months by Mousavi (2009) which
20
stated that Ignatia has beneficial effects.
One hundred and twenty four subjects were included
in a study by Nolan (2009) to evaluate the efficacy of 0.2%
hyaluronic acid and placebo for 28 days and concluded
that 0.2% hyaluronic acid was effective in reducing size of
the lesion and providing efficacy for up to 4 hrs after
administration and can be useful addition to the treatment
21
option for oral lichen planus.
Carbone (2009) conducted a randomized, double-
blind, placebo-controlled trial to compare the efficacy and
safety of two different formulations of Clobetasol, in the
topical management of OLP and to evaluate the remission
from signs and symptoms. Thirty-five patients were divided
into two groups: the first received clobetasol propionate
0.025% and the second was given clobetasol propionate
0.05%. In all, 14 of the 15 clobetasol 0.025% patients
(93%) and 13 of the 15 clobetasol 0.05% patients (87%),
had symptoms improvement after 2 months of therapy (P
= 0.001 in both groups). Also, 13 of the 15 clobetasol
0.025% patients (87%) and 11 of the 15 clobetasol 0.05%
patients (73%) had clinical improvement after 2 months of
therapy (P < 0.05 in both groups). No statistical
differences were found in comparing the two different
22
formulations.
8c
Review article
The efficacy of intralesional injection of 0.5ml BCG-PSN
and 10mg triamcinolone acetonide was evaluated by
Xiong (2009), in 56 patients for 2 weeks. The intralesional
BCG-PSN injection is equally effective and can be a
promising therapeutic alternative for erosive OLP,
especially for those insensitive, or even resistant, to
23
glucocorticoids.
Wu (2010) conducted a study on 69 subjects to
evaluate short term efficacy and safety of thalidomide (1%)
and dexamethasone (0.043%) for 3 weeks. In conclusion,
thalidomide appears as effective as dexamethasone with
recurrence seen in 3 month follow up and adverse effects
24
at 1 year.
The efficacy of aloe vera was evaluated by Salazar-
Sanchez (2010) in a study on 64 subjects, in comparison
with placebo for 12 weeks and concluded that aloe vera
improves total quality of life scores with no adverse
25
effects.
In a 4 week study on 46 subjects by Mansourian (2011),
compared the therapeutic effects of aloe vera mouth wash
with triamcinolone acetonide (0.1%) for and concluded that
aloe vera mouth wash is an effective substitute for
26
triamcinolone acetonide. Sawaarn (2011) assessed in 30
subjects, the efficacy of systemic lycopene 8mg/day
against placebo for 8 weeks. The study concluded that
lycopene is very effective in reducing the oxidative stress,
27
which may have a role in the disease pathogenesis.
Mc Caughey (2011) conducted a study on 21 subjects
to assess the efficacy of topical pimecrolimus 1% with
placebo for 6 weeks. Pimecrolimus 1% was found superior
28
to vehicle in reducing symptoms but with no side effects.
Fu (2012) in a study on 38 subjects evaluated the efficacy
of amlexanox paste with dexamethasone paste for 7 days.
Here, the topical application of amlexanox appeared as
29
effective as dexamethasone with no serious side effects.
Sonthalia (2012) piloted an 8 week study on 40 subjects,
to relate the efficacy of clobetasol propionate 0.05% with
tacrolimus 0.1%. The results disclosed that the latter is
effective and can be considered as first line of therapy with
30
no adverse effects.
An 8 week study on 40 subjects was conducted by
Lee (2013), to compare the efficacy between intralesional
injection (0.5 ml) and mouth rinse of triamcinolone
acetonide (0.4%). It concluded that efficacies of both the
treatments were similar but rate of adverse effects was
significantly lower for intralesional injection of
31
triamcinolone acetonide than mouth rinse.
Mu guard (5ml) was found effective in reducing pain
and ulceration associated with oral mucositis in
comparison to saline bicarbonate, in a study by Velez
32
(2014), conducted on 20 subjects.
Efficacy of topical curcumin and triamcinolone was
evaluated in 50 subjects by Sied Javad Kia (2015). The 4
week study concluded that curcumin is effective because
of its desirable anti-inflammatory effects and insignificant
33
side effects.
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Annals and Essences of Dentistry
Siva Raman (2016) compare the effectiveness of
topical triamcinolone acetonide (0.1%), clobetasol (0.05%)
and tacrolimus Orabase (0.03%) in the management. thirty
subjects were included in this study which concluded that
clobetasol propionate has higher efficacy when compared
to triamcinolone acetonide and tacrolimus with no side
effects. It was also inferred that triamcinolone acetonide
34
0.1% has better effects than tacrolimus 0.03%.
Numerous therapies have been considered. All the
above included trials have used different interventions,
comparisons, dosages, vehicles, time of application and
different ways of measuring the common outcomes such
as pain and clinical symptoms. Of the 32 included trials
eleven trials compared an active intervention with placebo.
Two active treatments were compared in thirteen trials and
in eight studies same intervention was compared in
different concentrations. Seven studies same intervention
was compared at different concentrations.
Twelve trials out of 32 have compared eight different
active treatments with placebo. Not all the trials using
steroids showed evidence that these treatments were
better than placebo in reducing pain and lesional size of
oral lichen planus. Studies conducted by Choonhakaran
18 25
(2008) and Salazar-Sanchez (2010) have shown that
aloe Vera gel may be associated with a reducing pain in
OLP patients. Three trials of pimecrolimus have shown
that it is better than placebo. Of them, the study by Volz
19
(2008) had a very short period of follow up and another
28
study by McCaughy (2011) had no post treatment follow
21
up. Nolan (2009) has shown weak evidence of trials
20
using hyaluronic acid and Mousavi (2009) using Ignatia.
These both trials may be effective in reducing pain and
27
clinical signs of OLP. Sawaarn (2011) have conducted
trial on lycopene which showed significant reduction in
32
pain compared to placebo. Velez (2014) saw significant
reductions in MuGuard treated group despite of several
limitations of the trial such as short span of study, head to
head comparisons with steroids and Calcineurin inhibitors
in management of OLP which makes it debatable.
Six trials out of 32 have compared with different steroid
5
treatments. Study by Campisi (2004) showed
15
microspheres while another trial by Malhotra (2008)
showed betamethasone to be effective in reducing pain.
4
Study by Hegarty (2002) has shown lesional surface area
reduction favouring spray. However all the three trials
were at high risk and no statistical difference was seen in
other three studies.
Seven trials out of 32 have compared steroids with
Calcineurin inhibitors, each evaluating a different pair of
17
intervention. Study by Corrocher (2008) and Sonthalia
30
(2012) favoured tacrolimus in terms of pain reduction.
17
Corrocher (2008) was the only study with significant
8
difference. Study by Laeijendecker (2006) favoured
Calcineurin in terms of clinical improvement. However
10 16 13
studies conducted by Thongprasom , Radfar , Gorouhi ,
30
Sonthalia have found no statistical difference in clinical
response between steroid and Calcineurin inhibitor.
Seven trials comparing two active interventions
(excluding steroids and Calcineurin inhibitors) didnt show
evidence that any of these interventions may be effective
9c
Review article
in reducing pain and clinical signs of OLP, except for two
3 9
trials i.e. Buajeeb (2000) and Scardina (2006) .
Although several trials have been conducted with
various medicaments, studies on personalised medicine
are scarce. Future research should be focussed on
identifying the defective protein and treatment is directed
towards it. We are identifying the single nucleotide
polymorphism (SNP) thus providing the matching
medication. SNPs like rs1042173, rs1045642, rs6323,
rs9923231 etc were identified in few cases of OLP. The
efficacy of Clobetasol propionate, cyclosporine, curcumin
and tretinoin drugs were evaluated against these protiens.
Cyclosporine in these samples showed poor efficacy,
while other were superior which is backing with the
literature. Further insilico studies with phase are needed
to direct management further competently.
CONCLUSION
OLP is an autoimmune mucocutaneous disorder, where
the management is still empirical. With this systematic
review, an attempt was made to establish various
therapeutic modalities in OLP, taking into consideration
only randomized control trials, using evidence based
medicine analysis. Literature confirms the frequent use of
topical corticosteroids, which remains the main stay in this
condition, few indicated use of calcineurin inhibitors for
treatment & symptomatic relief. The evidence of the trials
suggests the superiority of corticosteroids in alleviating
pain and remission of clinical signs of OLP with few side
effects. Further studies on large scale, future research with
consistent parameters and newer formulations, also the
research directed towards personalised medicine are
required in a quest of the potent regime to treat this
condition.
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Surg Oral Med Oral Pathol Oral Radiol Endod. S.V.S Institute of Dental sciences
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Ph No-+91 95810 31028
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