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Combination of alpha lipoic acid and gabapentin, its efficacy in the treatment of Burning Mouth Syndrome: A randomized, double-blind, placebo controlled trial


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Burning Mouth Syndrome (BMS) is a disease that manifests as burning in the tongue or in any area of the oral mucosa, in the absence of clinically verifiable injuries. To verify the efficacy of alpha lipoic acid (ALA) and gabapentin (GABA), used individually and jointly, to reduce the burning in patients with burning mouth and establish a drug therapy for the BMS. During April and May 2008, we conducted a randomized, double-blind, placebo-controlled trial in the Department of Clinical Stomatology, Faculty of Dentistry, Rosario, Argentina. The gathering of patients was between those ones with BMS who were treated in our service between March 2003 and March 2008 without complying with the applied treatments. The 120 patients were randomly divided into 4 groups and were provided, by lot and in a blinded fashion, with four different treatment cycles consisting of the following drugs: Group A (n = 20) 600 mg / day of alpha lipoic acid for two months, Group B (n = 20) 300 mg / day of gabapentin for two months, Group C (n = 20) a combination of both drugs for two months and Group D (n = 60) 100 mg / day of cellulose starch for two months (control group). all 120 patients completed the treatment. The best response was obtained with the combination of ALA + GABA, with a 70% of the cases with reduced burning in this group and a 13.2 times greater chance of presenting positive changes for these patients than those taking placebo. The combined use of drugs that act at different levels of the nociceptive system can be useful for the treatment of this syndrome.
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Med Oral Patol Oral Cir Bucal. 2011 Aug 1;16 (5):e635-40. Dr ug therapy Bu rning Mouth Sy ndrome
Journal section: Oral Medicine and Pathology
Publication Types: Research
Combination of alpha lipoic acid and gabapentin, its efcacy in
the treatment of Burning Mouth Syndrome: A randomized,
double-blind, placebo controlled trial
Edgardo López-D’alessandro 1, Livia Escovich 2
1 Master of Oral Medicine, Teacher researcher. Oral Medicine and Pharmacology Chairs. Faculty of Dentistry. National Univer-
sity of Rosario. Argentina
2 Professor of Oral Medicine. Director of the Master of Oral Medicine, Faculty of Dentist ry. National University of Rosario.
San Luis 4303- Rosario,
Santa Fe, Argentina,
Post-code: 2000
Received : 06/03/2010
Accepte d: 31/05/2010
Burning Mouth Syndrome (BMS) is a disease that manifests as burning in the tongue or in any area of the oral
mucosa, in the absence of clinically veriable injuries.
Objectives: To verify the efcacy of alpha lipoic acid (ALA) and gabapentin (GABA), used individually and
jointly, to reduce the burning in patients with burning mouth and establish a drug therapy for the BMS.
Study Design: During April and May 2008, we conducted a randomized, double-blind, placebo-controlled trial
in the Department of Clinical Stomatology, Faculty of Dentistry, Rosario, Argentina. The gathering of patients
was between those ones with BMS who were treated in our service between March 2003 and March 2008 without
complying with the applied treatments. The 120 patients were randomly divided into 4 groups and were provided,
by lot and in a blinded fashion, with four different treatment cycles consisting of the following drugs: Group A
(n = 20) 600 mg / day of alpha lipoic acid for two months, Group B (n = 20) 300 mg / day of gabapentin for two
months, Group C (n = 20) a combination of both drugs for two months and Group D (n = 60) 100 mg / day of ce-
llulose starch for two months (control group).
Results and Conclusions: All 120 patients completed the treatment. The best response was obtained with the com-
bination of ALA + GABA, with a 70% of the cases with reduced burning in this group and a 13.2 times greater
chance of presenting positive changes for these patients than those taking placebo. The combined use of drugs that
act at different levels of the nociceptive system can be useful for the treatment of this syndrome.
Key words: Burning mouth syndrome, pharmacological treatment o� burning mouth, alpha lipoic acid, gabapen-urning mouth syndrome, pharmacological treatment o� burning mouth, alpha lipoic acid, gabapen-
tin, oral neuropathic pain.
López-D’alessand ro E, Escovich L. Combinat ion of alpha lipoic acid and
gabapentin, its efcacy in the t reatment of Burn ing Mout h Syndrome: A
randomized, double-blind, placebo controlled trial. Med Oral Patol Oral
Cir Bucal. 2011 Aug 1;16 (5):e635-40.
http://w ww.medicinaor ralfree01/v16i5/medor alv16i5p635.pdf
Article Number: 16942
© Medicina Oral S. L. C.I.F. B 96689336 - pISSN 1698-4447 - eISSN: 1698-6946
Indexed in:
Science Citation Index Expanded
Journal Citation Reports
Index Medicus, MEDLINE, PubMed
Scopus, Embase and Emcare
Indice Médico Español
Med Oral Patol Oral Cir Bucal. 2011 Aug 1;16 (5):e635-40. Dr ug therapy Bu rning Mouth Sy ndrome
Burning mouth syndrome (BMS) is a disease charac-
terized by the presence of burning mouth, taste distur-
bances and dry mouth sensation in the absence of in-
juries that justify it (1-3). The sensation of burning”
generally involves the tongue, at its tip and edges, and
can be extended to any area of the mouth. It often occurs
more frequently in women over 60 years in the peri-or
postmenopausal period; it is rarely found in men (1,2).
The etiology is unknown but it’s believed to be multifac-
torial; patients with BMS often have anxiety and clini-
cal depression (4,5). Among the important local factors
dental trauma, the presence of tartar, rough surfaces
prosthesis, allergic reactions to dental materials, chemi-
cal irritants of lipsticks, toothpastes and prolonged use
of mouthwashes may be included. Among the general
factors deciency states, deciencies of iron, folic acid
and vitamin B are important (6-9). Alpha Lipoic Acid is
a component produced in the body in very small quanti-
ties, being present in many foods such as spinach, broc-
coli and meats. This substance acts as a coenzyme in
various reactions, taking part in glycolysis - responsible
for the conversion of blood sugar into energy- and in
the regeneration of liver tissue damage. It also exerts
a neuro-regenerative action, because it crosses the he-
matoencephalic barrier and has a protective effect of
brain and nerve tissue (10,11). A systematic review of
the Cochrane Collaboration, noted that Alpha-Lipoic
Acid (ALA) may help in management of burning mouth
syndrome (12). Various studies have shown that the use
of ALA did not produce greater benets on the burning
mouth that the use of placebos (13,14). Gabapentin is an
anticonvulsant whose chemical structure consists of a
molecule of gamma-aminobutyric acid covalently linked
to a lipophilic cyclohexane ring. This drug was created
to act as an agonist of the inhibitory neurotransmitter
GABA of central activity since it is easily transferred to
the central nervous system (CNS) for having high lipid
solubility. The mechanism of action of this drug is still
unknown because it acts by increasing the discharge
promoted of GABA but without noting a steady reduce
in the potentials of action or affection of the calcium
channel current (15). The objective of this research was
to test the action of alpha lipoic acid and gabapentin
alone and jointly, on the symptoms of BMS.
Patients and Methods
We conducted a randomized clinical double-blind, pla-
cebo-controlled clinical trial among patients with BMS
seen at the Chair of Clinic Stomatology II of the Faculty
of Dentistry, Rosario, Argentina. The study was ap-
proved by the Bioethics Committee of the Institution.
Sample size was determined by considering a condence
level of 95% and an error rate of + / - 5%, determining the
need to include a number of 120 patients for our study.
The study was conducted during April and May 2008.
The 120 patients were selected among those patients
with BMS who have been treated at our service between
March 2003 and March 2008, without responding to the
applied treatments. A total of 120 patients with idiopathic
BMS of more than three months duration that wanted to
participate voluntarily were included. Polypharmacy pa-
tients using more than 3 systemically daily drugs, those
ones taking psychotropic and antihypertensives drugs as
well as patients with serious psychiatric conditions previ-
ously diagnosed were excluded. Patients with deciencies
of folic acid, vitamin B, carriers of anemias of any kind
and patients with Sjögren syndrome were also excluded.
Participants were warned of the possibility of access to
different drugs as well as the possibility of being treated
with placebo. An informed consent was signed where the
scope of the study and the freedom to leave treatment at
any time were specied, and also the provision of medi-
catio n following the com plet ion of the stud y was en sure d.
We performed an initial psychological diagnosis for all
patients through the application of the Hospital Anxiety
and Depression Scale (HAD) and the Hamilton Rating
Scale for Depression in order to meet the psychological
situation of our patients. Then we evaluated the presence
of burning through a numerical scale especially created
for this work, describing the burning from 0 to 4, where
the 0 value corresponded to the absence of burning, the
1 value to the presence of burning in a single area of the
tongue, the 2 value to two distinctive areas (tongue and
gums, tongue and lips or tongue and palate), the 3 value
to three areas and the 4 value corresponded to burning
spread throughout the mouth. This specic designed
scale, which considered the geographical distribution of
burning in dif fere nt are as of the mouth , allowed us to dis-
tinguish improvements or deteriorations of burning sen-
sation in the various assessments. The 120 patients were
randomly divided into 6 groups of 20 members each.
Once the groups were formed, our service attendants as-
signed a numerical order for each group being identied
as groups 1, 2, 3, 4, 5 and 6. On the other hand, six treat-
ment cycles were determined: cycles A, B, C, D, E and
F, so that cycle A (n = 20) corresponded to 600 mg / day
of ALA, the cycle B (n = 20) 300 mg / day of GABA, the
cycle C (n = 20) to the combination of both drugs and the
cycles D (n = 20), E (n = 20) and F (n = 20) were 100 mg
/ day of starch and cellulose (Placebo). The support staff
of our service made a draw with 6 balls to link the groups
with the cycles of treatment. After the draw, the three
groups were combined with cycles D, E and F to be treat-
ed with placebo, thus forming a single group for these
patients, Group D (n = 60) or control group proceeding to
medication delivery, allocation that was always masked
to both patients and researcher, through the use of cap-
sules of similar size and appearance so that just the sup-
port staff was the one who recorded the information until
Med Oral Patol Oral Cir Bucal. 2011 Aug 1;16 (5):e635-40. Dr ug therapy Bu rning Mouth Sy ndrome
the end of the treatment (blind). The beginning of the ad-
ministration of the different drugs was concomitant for
all patients, as well as the evaluation of the effects, which
was made monthly and also blinded (double blind), al-
ways by the same researcher using the protocol described
above, which was completed for the rst time the day be-
fore the start of treatment and thirty and sixty days, re-
spectively. To evaluate the changes that occurred with the
taking of the different drugs, it was established that the
improvements (positive changes) involved the passage of
a certain level or numerical category of burning to a low-
er one, the deteriorations (negative changes) involved an
increase of a certain level of burning to a higher one and
the total resolution indicated the total absence of burning,
that is to say the transition from any higher value to zero
value. In this way four categories were obtained for the
analysis of the results: Category 1: with negative changes
(deterioration), Category 2: no changes; Category 3: with
positive changes (improvements) and Category 4: with
total recovery. The Chi- square test was used for the anal-
ysis to an independent variable with a predictive value (P
<0.05) and the Odds ratios were calculated to determine
the relationship between treatment and its effect on the
intensit y of the burni ng with ( P <0.01). All subjects were
evaluated through an Intention-to-Treat Analysis which
would take into account all patients although they could
discontinue the treatment.
All patients included initially ended the study because
the duration of treatment lasted only 2 months and the
adverse effects that appeared were very mild. Of the
120 patients studied, 94 were females and 26 males with
a mean age of 14.1 ± 57.5 years, median: 57. The psy-
chological diagnosis showed 95 patients without pathol-
ogy (78%), 14 with anxiety (13%) and 11 with depres-
sion (9%). We assessed changes in levels of burning in
each group after one and two months of treatment. The
rst month of treatment, changes in levels of burning
were not dependent on the type of drug tested (p-value
= 0.293) (Fig. 1). After 2 months of treatment, we found
that the positive changes in the levels of burning, signif-
icantly depended on the type of drug assigned (p-value
<0.001) (Fig. 2). When relating the changes in patients
treated with ALA, GABA or the combination, and com-
paring them with changes in the group of patients who
received placebo, we observed the existence of a large
percentage of patients with negative changes within this
group (Fig. 3). When observing the patients who re-. 3). When observing the patients who re-3). When observing the patients who re-
ceived ALA, we found that 9/20 (45%) of these patients
did not presented changes, while the remaining 11/20
(55%) had positive changes or full recovery in the case.
Among the patients treated with GABA, 10/20 (50%)
remained unchanged while the rest manifested decrease
in the burning. Among those who were given the com-
bination of both drugs, only 6/20 (30%) remained un-
changed while 14/20 (70%) had positive changes. Final-
ly, and within the group of patients receiving placebo,
51/60 (85%) remained unchanged or worsened while
9/60 (15%) had positive changes. The calculation of odds
ratios determined that the possibility of presenting posi-
tive changes (or total resolution of the case) for patients
treated with ALA was 7 times higher than for those re-
ceiving placebo. For those patients who received GABA,
that possibility was 5.7 times higher than for the control
group and for the patients who received ALA and GABA
together, that possibility was 13.2 times higher than for
the control patients group (Table 1).
Fig. 1. Analysis of the changes after one month of treatment.
Med Oral Patol Oral Cir Bucal. 2011 Aug 1;16 (5):e635-40. Dr ug therapy Bu rning Mouth Sy ndrome
Fig. 2. Analysis of the changes af ter two months of treatment.
Fig. 3. Comparison of the changes caused by the different dr ugs after two months.
Treatment Percentage of
Favorable Cases #
Possibility of
Favorable Results *
Alpha lipoic Acid
(ALA) 55% 7 times better
(GABA) 50% 5.7 times better
(ALA+GABA) 70% 13.2 times better
Table 1. Favorable changes after two months of treat ment.
# Includes Pat ients wit h total case resolut ion.
* = ( p value< 0,001) compared with the placebo group.
Med Oral Patol Oral Cir Bucal. 2011 Aug 1;16 (5):e635-40. Dr ug therapy Bu rning Mouth Sy ndrome
Re�erences with link s to Crossre� - DOI
The communication of different therapeutic measures
to control the BMS is wide in the world literature (11-
20). The Gabapentin was used by White et al. (15) in
a case of a patient with BMS obtaining healing of the
case and it was subsequently used by Heckmann et al.
(16) who conducted a study with gabapentin in 15 pa-
tients, where the initial dose was 300 mg / day and then
grew at a rate of 300 mg every 48 hours to a maximum
of 2400 mg / day. Seven of the patients were treated
for two weeks, 6 patients for four weeks and another 2
patients for six weeks. Although 2 patients (13%) indi-
cated a decrease in pain of three points and another 2
patients (13%) showed a decrease of two points on the
VAS (visual analogue scale), the authors concluded that
gabapentin has little or no effect on the treatment of
BMS. In our study, we used GABA individually, with
xed doses of 300 mg daily for two months, getting no
major differences with the published studies, although
obtaining improvements when used it in combination
with ALA. Femiano et al. (17) used the ALA at a dose
of 600 mg / day and psychotherapy, in a parallel group
and placebo-controlled trial. This drug was chosen for
its neuroregenerative properties, demonstrated in the
treatment of diabetic neuropathy, another disease with
similar characteristics to the BMS that causes chronic
pain. In the group treated with a total of 48 patients, 5
patients (10%) experienced a slight improvement, 19 pa-
tients (40%) a clear improvement and 15 patients (31%)
recovered from the BMS. The 81% of patients treated
with the combination of ALA + Psychotherapy experi-
enced some improvement. In the placebo group only 6
patients (13%) experienced improvement, and this one
was classied as mild. At six months 19 patients (49%)
who had experienced improvement after two months
of treatment with ALA worsened. The same group has
published other studies with ALA under different con-
ditions but with similar results. Lopez Jornet et al. (20)
also used ALA in 30 patients but at a concentration of
800 mg daily for eight weeks with no statistically signif-
icant differences when comparing the treatment group
with the control group. Carbone et al. (12) conducted
a randomized, double-blind placebo-controlled study
among 54 women and 12 men who used 400 mg of ALA
daily together with vitamins, forming three groups ad-
ministered, for 16 weeks, with 400 mg / day of ALA,
400 mg / day of ALA + vitamins and Placebo, getting
similar effects in all three groups demonstrating a lack
of efcacy of ALA in BMS, as this did not produce bet-
ter effects than placebo. In a review of a series of 31
patients with BMS who took 600 mg / day in divided
doses of ALA, Steele et al. (13) determine that the drug
was benecial in only 11 patients of all patients sur-
veyed. Cavalcanti and da Silveira (14) performed a ran-
domized double-blind, placebo-controlled trial between
48 patients divided into two treatment cycles alternating
20-day 200 mg / day of ALA and 100 mg / day of cellu-
lose starch, but were not able to demonstrate the greater
efcacy of ALA over placebo. In our experience with
the administration of ALA in 20 patients, with a daily
dose of 600 mg for two months, we obtained similar
results to those of Femiano et al. (17), with a decrease of
the burning sensation in 55% of patients treated, being
the possibility of favorable changes 7 times higher for
patients who received ALA than for the control group.
Note that in our study we also indicated as a treatment
for one group the combination of ALA + GABA to try
to produce an action on both peripheral and central no-
ciceptive system, obtaining with this combination the
best results. Although effective treatments have been
exposed to particular cases, we are still looking for a
drug therapy that could be effective for most patients
with BMS.
Gabapentin and Alpha Lipoic Acid used both individu-
ally and jointly, were benecial for reducing the burn-
ing in patients with BMS. The most favorable results
were obtained with the administration of both drugs.
To establish specic therapies in the treatment of BMS,
further study of the pathophysiological mechanisms in-
volved in its pathogenesis would be required, as well
as determine the neurological changes involved in this
disease, focusing on this entity within the Central Sen-
sitization Syndromes. Given the limitations in time and
in the number of patients in our study, we recommend
conducting multicenter clinical trials in more prolonged
treatments, based on the combined use of drugs acting
at different levels of the nociceptive system, since that
could be the key to future advances in the treatment of
this disease.
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... The review authors produced a summary of the findings for the quality of evidence assessment using the [20] • Dx of BMS based on diagnostic criteria established by the IHS (sensation of burning or numbness in the oral mucosa thatoccurs for more than 2 h per day over more than 3 months in the absence of clinical alterations) [31] Carbone, et al. 2009 [5] • Presence of an isolated complaint of chronicpain in the oral mucosa with a normal clinical examination, and pain present for more than 4 months, which was continuous throughout all or part of the day, with no paroxysms and not following a nerve trajectory Cavalcanti & da Silveira, 2009 [24] • History of oral burning pain for more than 6 months and absence of oral finding Çinar, et al. 2018 [25] • Patients aged >18 years • BMS was diagnosed after ruling out all possible organic causes Femiano & Scully, 2002 [10] • Diagnosed with BMS from a history of constant burning discomfort in the anterior tongue, lower lip or hard palate, for more than two months, with no relevant drug or medical history López-D'alessandro & Escovich, 2011 [26] • Patients with BMS who have been treated at our service without responding to the applied treatment. ...
... A total of nine publications [5,[10][11][12]20,[24][25][26][27] comparing ALA to placebo or other active interventions (laser, vitamins, clonazepam, pregabalin, gabapentin, capsaicin, Biotène, ALA and vitamins, and ALA and gabapentin) used to treat BMS were eligible for qualitative analysis, as shown in Table 2. ...
... RCTs [5,[10][11][12]26], one single-blind open-label RCT [27], one crossover double-blind RCT [24], and two unblinded RCTs [20,25]. [11,24], with one study not being specific [25] (Table 3). ...
Burning mouth syndrome (BMS) is a chronic oral disorder of unknown etiology which presents therapeutic challenges. Alpha-lipoic acid (ALA) has been studied as a potential treatment for BMS. The objective of this systematic review and meta-analysis was to evaluate the effectiveness of ALA compared to that of placebo or other interventions in individuals with BMS. Randomized controlled trials (RCT) using ALA to treat BMS were identified from MEDLINE, Cochrane Library, EMBASE, and Web of Science up to February 3, 2021. The assessment of the risk of bias in the included studies was based on the Cochrane guidelines. The primary outcome evaluated was the visual analog scale (VAS) pain intensity. ALA was compared with placebo, clonazepam, gabapentin, pregabalin, ALA plus gabapentin, capsaicin, Biotène®, and laser therapy. Altogether, 137 records were scanned for inclusion/exclusion, and nine RCTs (two unclear and seven at high risk of bias) were included in the qualitative and quantitative analyses, with a total of 594 patients with BMS included in this review. All studies reported an improvement in VAS pain scores ranging from -0.72 to -2.77. Meta-analysis results showed a non-significant reduction in pain intensity for ALA (P = 0.616) compared to that of placebo on a VAS of 0-10. Patients taking ALA were 1.923 times more likely to show an improvement in self-reported BMS symptoms (P = 0.031) than those in the placebo group. Clonazepam and pregabalin showed a significant VAS pain reduction of 4.08 and 4.68 (P < 0.001), respectively, compared to that with ALA. Although ALA intervention provided a non-significant improvement in the pain score and was more likely to produce a reduction in BMS symptoms, the evidence was of low quality. Further research is needed to establish clear guidelines for the use of ALA for BMS treatment.
... 9 Among these trials involving 36 different systemic and topical drug combinations, 6 studies evaluated the combination of an opioid with a gabapentinoid (931 participants, with tapentadol being classified as an opioid) 5,8,15,25,36,72 ; 4 studies evaluated the combination of an opioid with an antidepressant (138 participants) 30,37,44,54 ; 3 studies evaluated the combination of a gabapentinoid with an antidepressant (472 participants) 24,41,68 ; 5 studies evaluated the combination of ketamine with an agent from a different drug class (152 participants) 3,17,58,61,69 ; 7 studies involved a combination with topical analgesics (1094 participants) 2,6,22,23,47,48,51 ; and 15 studies evaluated various other analgesic combinations (1954 participants). 4,10,13,20,31,32,34,45,46,50,52,60,63,64,71 Neuropathic pain conditions studied were peripheral neuropathic pain (diabetic neuropathy and postherpetic neuralgia), 30 low back pain with a neuropathic component, 5 HIV-associated polyneuropathy, 37 lumbar radiculopathy, 44 neuropathic cancer pain, 8,10,15,50,54 , chemotherapy-induced peripheral neuropathic pain, 6,23 diabetic neuropathy, 2,20,24,25,31,32,60,63,64,68,69,72 postherpetic neuralgia, 22,24,25,34,69,72 chronic/refractory neuropathic pain of mixed etiology, 47,48,52,58,61 multiple sclerosis, 71 lumbar spinal stenosis, 45 radiation-induced plexopathy, 13 Charcot-Marie-Tooth disease type 1A, 4 chronic phantom limb pain, 17 and spinal cord injury-related chronic neuropathic pain. 3 Copyright © 2022 by the International Association for the Study of Pain. ...
... 2,4,6,13,20,[23][24][25]36,37,41,44,47,48,50,58,68,71,72 Table 1 shows a summary of characteristics of all included studies. [2][3][4][5][6]8,10,13,15,17,20,[22][23][24][25][30][31][32]34,36,37,41,[44][45][46][47][48][50][51][52]54,58,60,61,63,64,68,69,71,72 Multiple comparable studies were included for opioid-gabapentinoid, opioid-antidepressant, and gabapentinoidantidepressant combinations that were combined in several metaanalyses. In many trials of these combinations, drug doses were lower during combination therapy compared with monotherapy, 24,25,30,41,68 likely due to the additive effects of sedative and other CNS depressant effects of these drugs thus precluding further dose increases. ...
... The remaining 15 studies (1954 participants), 9 new (1388 participants), 4,10,13,45,50,60,63,64,71 and 6 original (566 participants), 20,31,32,34,46,52 Table 1 did not fit into any of the drug combination categories predefined in the original review. 9 Six studies evaluated the combination of gabapentinoids with another analgesic from a different drug class: Kim et al. 45 combined pregabalin with limaprost, an oral prostaglandin E1 analogue, Matsuoka et al. ...
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Neuropathic pain causes substantial morbidity and healthcare utilization. Monotherapy with antidepressants or anticonvulsants often fails to provide relief. Combining different drugs sometimes provides improved analgesia and/or tolerability. Over half of patients receive 2 or more analgesics and combination trials continue to emerge. This review comprehensively searched CENTRAL, MEDLINE, and EMBASE for relevant trials. Included studies are double-blind RCTs evaluating combinations of two or more drugs versus placebo and/or at least one monotherapy in adults with neuropathic pain. Outcomes included measures of efficacy and adverse effects, and risk-of-bias was assessed. Meta-analyses compared combination to monotherapy wherever two or more similar studies were available. Forty studies (4,741 participants) were included. Studies were heterogenous with respect to various characteristics including dose titration methods and administration (i.e. simultaneous versus sequential) of the combination. Few combinations involved a non-sedating drug and several methodological problems were identified. For opioid-antidepressant, opioid-gabapentinoid and gabapentinoid-antidepressant combinations, meta-analyses failed to demonstrate superiority over both monotherapies. In general, adverse event profiles were not substantially different for combination therapy compared to monotherapy. Despite widespread use and a growing number of trials, convincing evidence has not yet emerged to suggest superiority of any combination over its respective monotherapies. Therefore, implementing combination therapy - as second- or third-line treatment - in situations where monotherapy is insufficient should involve closely monitored individual dosing trials to confirm safety and overall added benefit. Further research is needed, including trials of combinations involving non-sedating agents, and to identify clinical settings and specific combinations that safely provided added benefit.
... The results included the eleven studies 9,18,19,23,27,30,31,33,34,38,39 , which used the ALA (Alpha-lipoic acid) to treat the burning mouth syndrome. One study out of 10 used ALA without and with CPT (cognitive psychotherapy), one assessed the ALA effect with gabapentin, as well as without gabapentin and one study used ALA without vitamins and with vitamins 23,30,31 (Table I). ...
... The results included the eleven studies 9,18,19,23,27,30,31,33,34,38,39 , which used the ALA (Alpha-lipoic acid) to treat the burning mouth syndrome. One study out of 10 used ALA without and with CPT (cognitive psychotherapy), one assessed the ALA effect with gabapentin, as well as without gabapentin and one study used ALA without vitamins and with vitamins 23,30,31 (Table I). The regime of these studies 18,23,27,[31][32][33][34] generally contained 200 to 800 mg ALA on daily basis for two months. ...
... One study out of 10 used ALA without and with CPT (cognitive psychotherapy), one assessed the ALA effect with gabapentin, as well as without gabapentin and one study used ALA without vitamins and with vitamins 23,30,31 (Table I). The regime of these studies 18,23,27,[31][32][33][34] generally contained 200 to 800 mg ALA on daily basis for two months. The studies 23,27,34 which used the comparison of the change in pain between placebo and ALA showed no difference significantly. ...
Objective: Burning mouth syndrome (BMS) is generally characterized by oral mucosa burning in the absence of any medical and dental reasons. The findings of previous studies or reviews are generally ambiguous. Therefore, the aim of this study was to review the findings of previous studies of randomized controlled trials (RCTs) for pain as evaluated by Visual Analogue Scales (VAS). VAS is a validated, subjective measure for acute and chronic pain MATERIALS AND METHODS: A search of PubMed/MEDLINE/ScienceDirect and Embase up to 2020. Results: By following the criteria of exclusion and inclusion, the papers were examined and divided into two categories, one based on BMS and the other that used alpha-lipoic acid to treat BMS. The reviewed results were compared in terms of methodology, size of sample, outcomes, and results. Conclusions: Some studies showed positive results of using ALA to treat the BMS, but these findings need more improvements, and more investigations are required.
... After assessing 44 full-text articles for eligibility, 20 were excluded for other reasons. [27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][46] Consequently, 24 articles were included in the review. The search results are presented in Fig. 1. ...
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Burning mouth syndrome (BMS) is defined as an idiopathic orofacial pain with intraoral burning or dysesthesia. This systematic review aimed to analyze the scientific literature with regard to the effectiveness of placebo therapy in patients with BMS. A literature search was conducted through the PubMed-indexed journals within MEDLINE®, Scopus, Cochrane Central Register of Controlled Trials (CENTRAL), and Trip databases from their inception to May 31, 2022. The search terms were defined by combining (medical subject headings (MeSH) terms OR keywords) "burning mouth syndrome" AND (MeSH terms OR keywords) "placebo". Methodological quality assessments were performed utilizing the Joanna Briggs Institute (JBI) Critical Appraisal tool to attribute scores from 1 to 11 to the selected studies. The literature search, study selection and data extraction were carried out by 2 authors. Disagreements between the authors were resolved by the 3rd author, if necessary. A total of 44 articles met the inclusion criteria. After assessing full-text articles for eligibility, 20 articles were excluded. Consequently, 24 articles were retained. A total of 21 studies included in this systematic review had a low score of bias. In 13 studies, a positive response to placebo was noted. Among them, 7 showed a placebo response indistinguishable from active treatment. These changes were more pronounced in patients receiving placebo therapy compared to active treatment in 1 study. Placebo therapy may occasionally be beneficial and ethically acceptable for patients with BMS. To get stronger evidence for the use of a placebo, future studies with standardized methodology and outcomes are required.
... To establish specic therapies in the treatment of BMS, further study of the pathophysiological mechanisms involved in its pathogenesis would be required, as well as determine the neurological changes involved in this disease, focusing on this entity within the Central Sensitization Syndromes. [15] Non-pharmacological treatment Ÿ Low Level Laser Therapy The low intensity laser therapy (or biomodulation) is an alternative for the treatment of symptoms of BMS. The low intensity laser (LLLT) is the application of light with a low power laser or LED that promotes tissue regeneration, reduces inammation and relieves pain. ...
PURPOSE: The purpose of this review was to investigate the current and modern therapy approach of BMD (burning mouth disease) also referred as BMS (burning mouth syndrome), in order to have a better comprehension for the best and most successful way of treatment and management for this pathology. A literature research was carried outMATERIALS & METHODS: mainly using online sources, Pubmed database, and paper sources (specialized books). articles published over the last years have been rstly examined. Systematic reviews, narrative reviews, mini reviews and meta-analysis were primarily selected. If a subject matter appeared to have few or no such sources, articles based on case reports were also considered. Finally, 20 sources have been considered eligible for theRESULTS: purpose of the review, 19 scientic articles and 1 specialized book were selected. Clonazepam, capsaicin and Vortioxetine areCONCLUSIONS: currently the most widely used and known drugs even if further studies are needed especially in the case of Vortioxetine and selective serotonin reuptake inhibitors.
... Different pharmacological therapies for symptom relief have been reported including Duloxetine [10], Zinc supplementation [11], Milnacipran [12], Amisulpiride [13], Aripiprazole [14], Gabapentin [15], Pregabalin [16], Venlafaxine [17] and Lafutidine [18], but recent review studies have shown the effects of Alpha-lipoic Acid (ALA), Clonazepam, and Capsaicin, which will be discussed below. ...
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1. Abstract 1.1. Background and Objectives: Burning mouth syndrome (BMS) is defined as intraoral burning without evident etiology, which may be annoying for patient and may require treatment. This study aimed to review the treatments of BMS with special focus on novel treatments. 1.2. Materials and Methods: In this review article, key words related to BMS were searched in databases such as Pubmed, Sco-pus, Web of Science, Science Direct, Google Scholar and Persian databases such as SID and Magiran. Also the treatment methods which their effectiveness were confirmed by systematic reviews and meta-analysis were included.
Drug therapy for fibromyalgia is limited by incomplete efficacy and dose-limiting adverse effects (AEs). Combining agents with complementary analgesic mechanisms-and differing AE profiles-could provide added benefits. We assessed an alpha-lipoic acid (ALA)-pregabalin combination with a randomized, double-blind, 3-period crossover design. Participants received maximally tolerated doses of ALA, pregabalin, and ALA-pregabalin combination for 6 weeks. The primary outcome was daily pain (0-10); secondary outcomes included Fibromyalgia Impact Questionnaire, SF-36 survey, Medical Outcomes Study Sleep Scale, Beck Depression Inventory (BDI-II), adverse events, and other measures. The primary outcome of daily pain (0-10) during ALA (4.9), pregabalin (4.6), and combination (4.5) was not significantly different (P = 0.54). There were no significant differences between combination and each monotherapy for any secondary outcomes, although combination and pregabalin were both superior to ALA for measures of mood and sleep. Alpha-lipoic acid and pregabalin maximal tolerated doses were similar during combination and monotherapy, and AEs were not frequent with combination therapy. These results do not support any additive benefit of combining ALA with pregabalin for fibromyalgia. The observation of similarly reached maximal tolerated drug doses of these 2 agents (which have differing side-effect profiles) during combination and monotherapy-without increased side effects-provides support for future development of potentially more beneficial combinations with complementary mechanisms and nonoverlapping side effects.
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A síndrome da ardência bucal (SAB) é caracterizada por ser uma dor crônica, com sintomas de queimação, ardência ou dor sem nenhuma lesão visível na mucosa oral. Os sintomas ocorrem em mais de uma área da cavidade bucal, sendo a língua a região mais afetada. Objetivo: O objetivo deste trabalho foi apresentar, por meio de uma revisão de literatura, as principais características da SAB, relatar as teorias presentes quanto a fisiopatologia da SAB e identificar as principais opções de tratamento de acordo com os aspectos que o paciente pode apresentar. Materiais e métodos: Foi realizado uma busca, por artigos publicados nos últimos 15 anos, nas bases de dados: PUBMED, MEDLINE, SCIELO, DEDALUS e GOOGLE ACADÊMICO. Para seleção, foram usados os critérios de inclusão: artigos de revisão, relato de caso e pesquisa transversal. Resultados: A literatura propõe vários fatores associados relacionados a fisiopatologia da SAB, o que interfere diretamente no seu diagnóstico e na forma terapêutica. Isto torna a SAB uma condição patológica de difícil manejo. Considerações finais: A SAB é uma condição muito desafiadora para os cirurgiões-dentistas e também para outros profissionais da saúde. Por se tratar de uma patologia com etiologia multifatorial, o seu diagnóstico acaba se tornando difícil e desafiador o que afeta diretamente nos pacientes. O conhecimento sobre a SAB se faz importante na vida profissional dos cirurgiões-dentistas e nos profissionais de saúde em geral, para que, dessa forma, esses pacientes que são acometidos pela síndrome se sintam mais acolhidos e confortados.
Burning Mouth Syndrome (BMS) is a chronic debilitating oral pain disorder characterized by generalized burning sensations on the tongue and other oral mucosa, with no discernible medical or dental causes. Patients often suffer from anxiety, depression, and a significant impairment to their overall quality of life. Despite the prevalence of this condition spanning several centuries, BMS lacks definitive diagnostic criteria and appropriate treatments. Management of BMS is limited to symptomatic topical and systemic approaches. The aim of this paper is to summarize current literature in the etiopathogenesis, diagnosis, and therapeutics of BMS, with a focus on pharmacologic management. Mechanisms of action, drug interactions, adverse reactions, and dosing regimens are explored for potential pharmacotherapeutics used to manage BMS.
Burning mouth syndrome (BMS) is described by an intense burning sensation of the tongue or other oral areas without a clear etiopathology. The diagnosis of BMS is challenging due to variations of manifestations. The management of BMS is complicated due to the complex etiology of the disease. Many medications and treatment methods have been recommended for BMS management, but no one confirmed as the standard method. In this study, the therapeutic approaches of BMS were evaluated. The data of the article was obtained from PubMed/MEDLINE, Cochrane Library, and Web of Science. The following terms including “burning mouth syndrome”, “therapy”, and “treatment” were used for search in the databases. A wide range of articles about the therapeutic approach of BMS was searched and reviewed. Pharmacological and non-pharmacological approaches have been used for BMS management. Pharmacological treatments are including Capsaicin, Clonazepam, Low-dose aripiprazole, Alpha-lipoic acid, Duloxetine, Amitriptyline, Gabapentin, and Pregabalin, and ultra-micronized palmitoylethanolamide. Non-pharmacological therapies for BMS are cognitive therapy, Electroconvulsive therapy, Laser therapy, Acupuncture and auriculotherapy, Transcranial Magnetic Stimulation (rTMS), Salivary Mechanical Stimulation, and Botulinum Toxin. A detailed assessment of the etiology and pathophysiology of BMS, and having information about novel therapeutic interventions are essential for the management of BMS.
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Burning mouth syndrome mainly affects women, particularly after the menopause, when its prevalence may be 18% to 33%. METHODS AND OUTCOMES: We conducted a systematic review and aimed to answer the following clinical question: What are the effects of treatments for burning mouth syndrome? We searched: Medline, Embase, The Cochrane Library, and other important databases up to November 2009 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). We found 15 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. In this systematic review we present information relating to the effectiveness and safety of the following interventions: anaesthetics (local), antidepressants, benzodiazepines (topical clonazepam), benzydamine hydrochloride, cognitive behavioural therapy (CBT), dietary supplements, and hormone replacement therapy (HRT) in postmenopausal women.
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The burning mouth syndrome (BMS) is a chronic condition characterized by oral burning pain in the absence of clinical abnormalities and without established therapy. The purpose of this study was to evaluate the effectiveness of alpha lipoic acid (ALA) in the management of BMS symptoms through a randomized double-blind placebo-controlled trial. Thirty-eight patients (34 women and four men, median age 62.9 years, range 36-78) were included and 31 completed the study. The patients were randomized into two cycles of treatment: one with alpha lipoic acid and one with placebo both administered in identical capsules. These cycles were separated by a washout period of 20 days. The oral symptoms and the treatment response were assessed using a 100-mm visual analog scale before and after each cycle and the global perceived effect score, using a 5-point scale after each treatment cycle. The level of reduction on burning was significant for both treatments (paired t-test: P < 0.05; rp = 0.011; ral < 0.001). Considering the two cycles together, 22 patients reported at least some improvement after ALA use and 23 patients after placebo. Conclusions: Comparison of the oral assessment scores of the two cycles failed to demonstrate the effectiveness of ALA over placebo (t-test: P > 0.05; r = 0.75).
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Burning mouth syndrome (BMS) is a frequently seen pathology characterised by burning tongue and oral pain without macroscopic structural lesions to the mucose. BMS etiopathology isn't known and therapy is merely empirical and unsatisfactory. To evaluate the hypothesis that this syndrome would originate by a small diameter peripheral neuropathy combined to a mucosal trophic lesion, 37 patients, (7 male, 30 female, between 36 and 79 years, mean 54 years) affected by BMS, consecutively observed in our dispensary were submitted to a series of examinations and to therapeutical approach used in neuropathic painful syndromes. All patients were submitted to a complete stomatological exam and X-ray pantomography to exclude mucosal macroscopical lesions and dentistry illnesses. All patients executed sierological exams (glycemia, etc.), neurological exam, tongue and foot dorsum quantitative sensory examination, tongue and face telethermography. A few patients (3 male, 10 female; age 34 to 53, mean 49) were submitted to mucosal tongue biopsy, analyzed by optic microscopy and immunofluorescency following treatment with anticytoplasmatic neuronal proteins antibodies (protein gene product 9.5). These examinations showed subclinical polyneuropathy in 50% of patients. In particular, a loss of function in small diameter nervous fibres in about 50% of patients was observed. Histological examination of tongue mucose revealed a moderate atrophy in 70% patients. All patients were submitted to an antalgic therapy, with non-antiflammatory drugs used in neuropathic painful syndromes (quercetine, antiepileptic drugs benzodyazepinein and gabaergic, topical application of capsaicine solutions).
This paper reviews the clinical presentation and many causes of burning mouth condition. A diagnostic approach and some management procedures that include eliminating all oral irritants, correcting predisposing systemic disease, and most important of all, allaying anxiety that induces parafunctional mouth habits. The term “burning mouth condition” (BMC) is considered more appropriate than the word “syndrome” for this common and troublesome complaint
Burning mouth syndrome (BMS) is characterized by a burning sensation in the oral cavity although the oral mucosa is clinically normal. The syndrome mostly affects middle-aged women. Various local, systemic and psychological factors have been found to be associated with BMS, but its etiology is not fully understood. Oral complaints and salivary flow were surveyed in 669 men and 758 women randomly selected from 48,500 individuals between the ages 20 and 69 years. Fifty-three individuals (3.7%), 11 men (1.6%) and 42 women (5.5%), were classified as having BMS. In men, no BMS was found before the age group 40 to 49 years where the prevalence was 0.7%, which increased to 3.6% in the oldest age group. In women, no BMS was found in the youngest age group, but in the age group 30 to 39 years the prevalence was 0.6% and increased to 12.2% in the oldest age group. Subjective oral dryness, age, medication, taste disturbances, intake of L-thyroxines, illness, stimulated salivary flow rate, depression and anxiety were factors associated with BMS. In individuals with BMS, the most prevalent site with burning sensations was the tongue (67.9%). The intensity of the burning sensation was estimated to be 4.6 on a visual analogue scale. There were no increased levels of depression, anxiety or stress among individuals with more pain compared to those with less pain. It was concluded that BMS should be seen as a marker of illness and/or distress, and the complex etiology of BMS demands specialist treatment.
To study the efficacy of alpha lipoic acid (ALA) in a group of patients with burning mouth syndrome (BMS). Sixty BMS patients, 30 treated with ALA (Thioderm) 800 mg day(-1) for 8 weeks and 30 patients on the same protocol with a placebo. The symptomatology was measured on a Visual Analogue Scale (VAS). Sixty patients (54 females and 6 males, mean age 64.37 +/- 11.61 years) were included. Thirty-nine patients completed the treatment (23 with ALA and 16 with a placebo). Reviews were carried out at 0, 1 and 2 months. No statistically significant differences were found in the average pre- and post-treatment values for pain with the VAS scores, obtained in the placebo (6.6 +/- 2.5 - 2.8 +/- 25 = 3.8 +/- 3.7) versus ALA (6.3 +/- 2.8 - 4.0 +/- 2.7 = 2.2 +/- 2.6). Only one patient pertaining to the group treated with ALA abandoned because of adverse gastrointestinal side effects. The results showed no significant differences between the two groups.
A systematic review from the Cochrane Collaboration stated that alpha-lipoic acid (ALA) may help in the management of burning mouth syndrome (BMS). Because all of the data on ALA came from a single group, it has been stressed that its effectiveness should be reproduced in other populations. A double-blind, randomized, placebo-controlled study, including two test groups (Group A and Group B) and one control group (Group C), was carried out to evaluate the efficacy of systemic ALA (400 mg) and ALA (400 mg) plus vitamins in the treatment of BMS. Sixty-six patients (54 females and 12 males) were included in an 8-week trial. Symptoms were evaluated by using a visual analogue scale (VAS) and the McGill Pain Questionnaire (MPQ) at 0, 2, 4, 8 and 16 weeks. Fifty-two patients (43 females and 9 males, aged 67.3+/-11.9 years) completed the study. All three groups had significant reductions in the VAS score and in the mixed affective/evaluative subscale of the MPQ; the responders' rate (at least 50% improvement in the VAS score) was about 30%. No significant differences were observed among the groups either in the response rate or in the mean latency of the therapeutic effect. The fairly high placebo effect observed is very similar to data obtained from patients affected by atypical facial pain. This study failed to support a role for ALA in the treatment of BMS, and further investigations are needed to identify the cause of BMS in order to develop efficacious therapies.
The literature on burning mouth syndrome (BMS) is reviewed with particular reference to its prevalence, local and systemic etiologic factors, psychogenic background and treatment. Research requirements are discussed, which focus on different clinical and psychological parameters and the necessity to evaluate BMS. Finally, a treatment protocol including oral, medical and psychological investigations is presented.
Psychologic factors were studied in 10 patients with symptoms presumed to be caused by electricity (EG) and in 10 patients with symptoms presumed to be caused by visual display units (VG) and compared with a sex- and age-matched control group (CG). Psychologic differences between the EG and VG were also measured. The symptoms presumed to be caused by electricity or visual display units were registered, and the personality, psychologic functioning, and quality of life were determined by using the Karolinska Scales of Personality (KSP), an additional Personality Scale (PS), a Psychological Functioning Scale (PFS), and a quality of Life Scale (QLS). The results showed that the commonest general symptoms in the EG/VG were skin complaints, fatigue, pain, and dizziness, and the commonest oral symptoms were gustatory disturbance, burning mouth, and temporomandibular joint dysfunction. The patients in the EG described more different types of both general and oral symptoms than those in the VG. The result showed that the VG scored significantly higher only in the KSP Somatic Anxiety and Muscular Tension scales, and the EG scored significantly lower in the KSP Socialization scale and significantly higher in the Somatic Anxiety, Muscular Tension, and Psychasthenia scales. In addition, only the EG differed significantly on the PS, PFS, and QLS. The EG differed significantly in such psychologic aspects as being more fatigued in the PS, in having more difficulty in concentrating, in taking the initiative, and in getting on with people in the PFS and experiencing inactivity and visiting other people rarely in the QLS. The conclusion was that patients with symptoms presumed to be caused by electricity and visual display units differed from each other psychologically and, therefore, should be handled clinically in different ways. The need for an interdisciplinary approach to these patients is emphasized.
The goal of this study was to evaluate the prevalence and type of psychiatric disorders coexisting with burning mouth syndrome (BMS), to compare the clinical features of patients with BMS alone with patients with multiple diagnoses, and to investigate the number and severity of life events that occur before the onset of BMS. There were 102 patients with BMS, with no possible local or systemic causes, who were evaluated according to the diagnostic criteria of DSM-IV. All axis I diagnoses for which the patients met criteria at intake or lifetime were determined. Life events were evaluated for a period of 6 months before the onset of BMS. A statistical comparison between patients and a matched control group was performed first; moreover, patients with BMS alone were compared with patients with comorbid BMS. Although 29 (28.4%) BMS patients were not given any other lifetime psychiatric diagnosis, high rates of comorbid psychiatric diagnoses were found. The most prevalent concurrent diagnoses were depressive disorders and generalized anxiety disorder. No significant differences emerged in clinical features between patients with and without other current psychiatric disorders. The severity of life events, rather than in their number, was significantly associated with BMS. BMS has high psychiatric comorbidity but can occur in the absence of psychiatric diagnoses.