PMCCPMCCPMCC

Search tips
Search criteria 

Advanced

 
Logo of bmjclinevidLink to Publisher's site
 
BMJ Clin Evid. 2008; 2008: 1301.
Published online 2008 March 14.
PMCID: PMC2907957

Burning mouth syndrome

John AG Buchanan, Hons BSc, BDS, MFDS RCPS Glasg, MB BS, MRCP(UK), Clinical Senior Lecturer/Honorary Consultant in Oral Medicine# and Joanna M Zakrzewska, BDS, MB, BChir, MD, FDSRCS, FFDRCSI, Consultant/ Honorary Professor, Facial pain lead#

Abstract

Introduction

Burning mouth syndrome mainly affects women, particularly after the menopause, when its prevalence may be 18-33%.

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 February 2007 (BMJ 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).

Results

We found 12 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.

Conclusions

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.

Key Points

Burning mouth syndrome is characterised by discomfort or pain of the mouth, with no known medical or dental cause. It may affect up to a third of postmenopausal women and up to 15% of adults overall.

  • Symptoms of burning mouth can also be caused by infections, allergies, vitamin deficiencies, and ill-fitting dentures, leading to problems identifying effective treatments.
  • Psychogenic factors may be involved in some people, such as anxiety, depression, or personality disorders.
  • People with burning mouth syndrome may show altered sensory and pain thresholds, or other signs of neuropathy.
  • Long-term outcomes are unknown, but half of people may have spontaneous resolution of their symptoms over 6-7 years.

CBT may improve symptom intensity compared with placebo, although no good-quality studies have been found.

Topical clonazepam may reduce pain compared with placebo, but may be absorbed systemically, with increased risk of dependence over time.

About this condition

Definition

Burning mouth syndrome is an idiopathic burning discomfort or pain affecting people with clinically normal oral mucosa, in whom a medical or dental cause has been excluded. Terms previously used to describe what is now called burning mouth syndrome include glossodynia, glossopyrosis, stomatodynia, stomatopyrosis, sore tongue, and oral dysaesthesia. A survey of 669 men and 758 women randomly selected from 48,500 people aged 20-69 years found that people with burning mouth also have subjective dryness (66%), take some form of medication (64%), report other systemic illnesses (57%), and have altered taste (11%). Many studies of people with symptoms of burning mouth do not distinguish those with burning mouth syndrome (i.e. idiopathic disease) from those with other conditions (such as vitamin B deficiency), making results unreliable. Local and systemic factors (such as infections, allergies, ill-fitting dentures, hypersensitivity reactions, and hormone and vitamin deficiencies ) may cause the symptom of burning mouth, and should be excluded before diagnosing burning mouth syndrome. This review deals only with idiopathic burning mouth syndrome.

Incidence/ Prevalence

Burning mouth syndrome mainly affects women, particularly after the menopause, when its prevalence may be 18-33%. One study in Sweden found a prevalence of 4% for the symptom of burning mouth without clinical abnormality of the oral mucosa (11/669 [2%] men, mean age 59 years; 42/758 [6%] women, mean age 57 years), with the highest prevalence (12%) in women aged 60-69 years. Reported prevalence in general populations varies from 1% to 15%. Incidence and prevalence vary according to diagnostic criteria, and many studies included people with the symptom of burning mouth, rather than with burning mouth syndrome as defined above.

Aetiology/ Risk factors

The cause is unknown, and we found no good aetiological studies. Possible causal factors include hormonal disturbances associated with the menopause, psychogenic factors (including anxiety, depression, stress, life events, personality disorders, and phobia of cancer), and neuropathy in so-called supertasters. Support for a neuropathic aetiology comes from studies that have shown altered sensory and pain thresholds in people with burning mouth syndrome. Two studies using blink reflex and thermal quantitative sensory tests have demonstrated signs of neuropathy in most people with burning mouth syndrome.

Prognosis

We found no prospective cohort studies describing the natural history of burning mouth syndrome. We found anecdotal reports of at least partial spontaneous remission in about 50% of people with burning mouth syndrome within 6-7 years. However, a recent retrospective study assessing 53 people with burning mouth syndrome (48 women and 5 men, mean duration of burning mouth syndrome 5.5 years, mean follow-up 56 months) found a complete spontaneous resolution of oral symptoms in 11% of people (2/19) who received no treatment. Overall, 30% of people (15/53) experienced a moderate improvement, with or without treatment.

Aims of intervention

To alleviate symptoms, with minimal adverse effects.

Outcomes

Self-reported relief of symptoms (burning mouth, altered taste, dry mouth); incidence and severity of anxiety and depression; quality of life using a validated ordinal scale.

Methods

BMJ Clinical Evidence search and appraisal February 2007. The following databases were used to identify studies for this review: Medline 1966 to February 2007, Embase 1980 to February 2007, and The Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Clinical Trials 2007, Issue 1. Additional searches were carried out using these websites: NHS Centre for Reviews and Dissemination (CRD) — for Database of Abstracts of Reviews of Effects (DARE) and Health Technology Assessment (HTA), Turning Research into Practice (TRIP), and NICE. Abstracts of the studies retrieved from the initial search were assessed by an information specialist. Selected studies were then sent to the author for additional assessment, using pre-determined criteria to identify relevant studies. Study design criteria for inclusion in this reveiw were: published systematic reviews and RCTs in any language, at least single blinded, and containing more than 20 individuals of whom more than 80% were followed up. There was no minimum length of follow-up required to include studies. We excluded all studies described as "open", "open label", or not blinded unless blinding was impossible. In addition, we use a regular surveillance protocol to capture harms alerts from organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA), which are added to the review as required. We have performed a GRADE evaluation of the quality of evidence for interventions included in this review (see table ).

Table
GRADE evaluation of interventions for burning mouth syndrome

Glossary

Moderate-quality evidence
Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Supertaster
People who have the highest density of fungiform papillae, which are responsible for taste, on the anterior tongue and taste 6-n-propylthiouracil as intensely bitter.
Very low-quality evidence
Any estimate of effect is very uncertain.

Notes

Disclaimer

The information contained in this publication is intended for medical professionals. Categories presented in Clinical Evidence indicate a judgement about the strength of the evidence available to our contributors prior to publication and the relevant importance of benefit and harms. We rely on our contributors to confirm the accuracy of the information presented and to adhere to describe accepted practices. Readers should be aware that professionals in the field may have different opinions. Because of this and regular advances in medical research we strongly recommend that readers' independently verify specified treatments and drugs including manufacturers' guidance. Also, the categories do not indicate whether a particular treatment is generally appropriate or whether it is suitable for a particular individual. Ultimately it is the readers' responsibility to make their own professional judgements, so to appropriately advise and treat their patients.To the fullest extent permitted by law, BMJ Publishing Group Limited and its editors are not responsible for any losses, injury or damage caused to any person or property (including under contract, by negligence, products liability or otherwise) whether they be direct or indirect, special, incidental or consequential, resulting from the application of the information in this publication.

Contributor Information

John AG Buchanan, Barts and The London School of Medicine and Dentistry, Dental Institute, Royal London Hospital, London, UK.

Joanna M Zakrzewska, Division of Diagnostic, Surgical and Medical Sciences, Eastman Dental Hospital, UCLH NHS Foundation, London, UK.

References

1. Fox H. Burning tongue glossodynia. N Y State J Med 1935;35:881–884.
2. Zakrzewska JM. The burning mouth syndrome remains an enigma. Pain 1995;62:253–257. [PubMed]
3. Van der Waal I. The burning mouth syndrome. 1st ed. Copenhagen: Munksgaard, 1990.
4. Merksey H, Bogduk N, eds. Classification of chronic pain. 2nd ed. Seattle: International Association for the Study of Pain Press, 1994.
5. Bergdahl M, Bergdahl J. Burning mouth syndrome: prevalence and associated factors. J Oral Pathol Med 1999;28:350–354. [PubMed]
6. Grushka M, Sessle BJ. Burning mouth syndrome. Dent Clin North Am 1991;35:171–184. [PubMed]
7. Bergdahl J, Anneroth G, Anneroth I. Clinical study of patients with burning mouth. Scand J Dent Res 1994;102:299–305. [PubMed]
8. Maragou P, Ivanyi L. Serum zinc levels in patients with burning mouth syndrome. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 1991;71:447–450. [PubMed]
9. Lamey PJ, Allam BF. Vitamin status of patients with burning mouth syndrome and the response to replacement therapy. Br Dent J 1986;168:81–84. [PubMed]
10. Hugoson A, Thorstensson B. Vitamin B status and response to replacement therapy in patients with burning mouth syndrome. Acta Odontol Scand 1991;49:367–375. [PubMed]
11. Tammiala-Salonen T, Hiidenkarii T, Parvinen T. Burning mouth in a Finnish adult population. Community Dent Oral Epidemiol 1993;21:67–71. [PubMed]
12. Basker RM, Sturdee DW, Davenport JC. Patients with burning mouths. A clinical investigation of causative factors, including the climacteric and diabetes. Br Dent J 1978;145:9–16. [PubMed]
13. Grushka M. Clinical features of burning mouth syndrome. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 1987;63:30–36. [PubMed]
14. Wardrop RW, Hailes J, Burger H, et al. Oral discomfort at the menopause. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 1989;67:535–540. [PubMed]
15. Rojo L, Silvestre FJ, Bagan JV, et al. Psychiatric morbidity in burning mouth syndrome. Psychiatric interview versus depression and anxiety scales. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 1993;75:308–311. [PubMed]
16. Lamey PJ, Lamb AB. The usefulness of the HAD scale in assessing anxiety in patients with burning mouth syndrome. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 1989;67:390–392. [PubMed]
17. Bartoshuk LM, Grushka M, Duffy VB, et al. Burning mouth syndrome: damage to CN VII and pain phantoms in CN V. Chem Senses 1999;24:609.
18. Svensson P, Bjerring P, Arendt-Nielsen L, et al. Sensory and pain thresholds to orofacial argon laser stimulation in patients with chronic burning mouth syndrome. Clin J Pain 1993;9:207–215. [PubMed]
19. Jaaskelainen SK, Forssell H, Tenovuo O. Abnormalities of the blink reflex in burning mouth syndrome. Pain 1997;73:455–460. [PubMed]
20. Forssell H, Jaaskelainen S, Tenovuo O, et al. Sensory dysfunction in burning mouth syndrome. Pain 2002;99:41–47. [PubMed]
21. Zakrzewska JM, Hamlyn PJ. Facial pain. In: Crombie IK, Croft PR, Linton SJ, et al, eds. Epidemiology of pain. Seattle: International Association for the Study of Pain Press, 1999:177–202.
22. Sardella A, Lodi G, Dermarosi F, et al. Burning mouth syndrome: a retrospective study investigating spontaneous remission and response to treatments. Oral Dis 2006;12:152–155. [PubMed]
23. Zakrzewska JM, Forsell H, Glenny AM. Interventions for the treatment of burning mouth syndrome. In: The Cochrane Library, Issue 1, 2007. Chichester, UK: John Wiley & Sons, Ltd. Search date 2004; primary sources Medline, Embase, Cochrane Library, and Cochrane Oral Health Group's Specialised Register. [PubMed]
24. Bergdahl J, Anneroth G, Perris H. Cognitive therapy in the treatment of patients with resistant burning mouth syndrome: a controlled study. J Oral Pathol Med 1995;24:213–215. [PubMed]
25. Gremeau-Richard C, Woda A, Navez ML, et al. Topical clonazepam in stomatodynia: a randomised placebo-controlled study. Pain 2004;108:51–57. [PubMed]
26. Joint Formulary Committee. British national formulary. 51st ed. London: British Medical Association and Royal Pharmaceutical Society of Great Britain, 2006.
27. Tammiala-Salonen T, Forssell H. Trazodone in burning mouth pain: a placebo-controlled, double-blind study. J Orofac Pain 1999;13:83–88. [PubMed]
28. Maina G, Vitalucci A, Gandolfo S, et al. Comparative efficacy of SSRIs and amisulpiride in burning mouth syndrome: a single-blind study. J Clin Psychiatry 2002;63:38–43. [PubMed]
29. McQuay HJ, Tramer M, Nye BA, et al. A systematic review of antidepressants in neuropathic pain. Pain 1996;68:217–227. [PubMed]
30. Bogetto F, Maina G, Ferro G, et al. Psychiatric comorbidity in patients with burning mouth syndrome. Psychosom Med 1998;60:378–385. [PubMed]
31. Femiano F, Gombos F, Scully C, et al. Burning mouth syndrome (BMS): controlled open trial of the efficacy of alpha-pipoic acid (thioctic acid) on symptomatology. Oral Dis 2000;6:274–277. [PubMed]
32. Femiano F, Scully C. Burning mouth syndrome (BMS): double blind controlled study of alpha-lipoic acid (thioctic acid) therapy. J Oral Pathol Med 2002;31:267–269. [PubMed]
33. Femiano F. Burning mouth syndrome (BMS): an open trial of comparative efficacy of alpha-lipoic acid (thioctic acid) with other therapies. Minerva Stomatol 2002;51:405–409. [PubMed]
34. Peng JY, Wu YF, Han WN. Clinical efficacy of burning mouth syndrome treated by livial. Hunan Yi Ke Da Xue Xue Bao 2001;26:157–158. [In Chinese] [PubMed]
35. Pisanty S, Rafaely B, Polshuk WZ. The effects of steroid hormones on buccal mucosa of menopausal women. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 1975;40:346–353. [PubMed]
36. Ferguson MM, Carter J, Boyle P, et al. Oral complaints related to climacteric symptoms in oophorectomized women. J R Soc Med 1981;74:492–497. [PMC free article] [PubMed]
37. Forabosco A, Crisculo M, Coukos G, et al. Efficacy of hormone replacement therapy in postmenopausal women with oral discomfort. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 1992;73:570–574. [PubMed]
2008; 2008: 1301.
Published online 2008 March 14.

CBT

Summary

SYMPTOM RELIEF Compared with control: CBT may be more effective at reducing the intensity of symptoms at six months in people with resistant burning mouth syndrome compared with control ( very low quality evidence ).

Benefits

We found one systematic review (search date 2004). The review identified one small RCT which compared CBT (12–15 sessions of 1 hour/week) versus a control group who received similar attention but without the CBT sessions (see comment below). The RCT found that CBT significantly reduced the intensity of symptoms at 6 months (30 people with resistant burning mouth syndrome; pain measured on a visual analogue scale ranging from 1 = endurable to 7 = unendurable; mean pretreatment score: 5.0 with CBT v 4.3 with placebo; mean score change at 6 months: –3.6 with CBT v +0.4 with placebo; P less than 0.001; AR for being symptom free at 6 months: 4/15 [27%] with CBT v 0/15 [0%] with placebo; significance not reported).

Harms

The RCT gave no information on adverse effects.

Comment

The trial was small, and individual characteristics of the two groups were not described; therefore, the groups may not have been comparable. The visual analogue scale for assessing oral burning was not validated.

Substantive changes

No new evidence

2008; 2008: 1301.
Published online 2008 March 14.

Benzodiazepines

Summary

SYMPTOM RELIEF Clonazepam compared with placebo: Topical clonazepam is more effective at reducing pain at 14 days in people with burning mouth syndrome compared with placebo ( moderate quality evidence ). ADVERSE EFFECTS Topical clonazepam may be absorbed systemically and could lead to benzodiazepine dependence if used in the long term.

Benefits

We found one systematic review, which identified one small, short-term RCT comparing topical clonazepam versus placebo (1 mg tablet of clonazepam or placebo sucked and held in the mouth for 3 minutes and then expectorated, 3 times/day) for 14 days. The RCT found that clonazepam decreased pain compared with placebo after 2 weeks' treatment (48 people; pain measured on a numerical scale of 0 = no pain to 10 = worst pain imaginable; mean decrease in pain score from baseline [intention to treat analysis]: 2.2 with clonazepam v 0.6 with placebo; P = 0.027).

Harms

The RCT found no significant difference between clonazepam and placebo in the frequency of adverse events (9/24 [38%] with clonazepam v 6/24 [25%] with placebo; P more than 0.05). The adverse events experienced included drowsiness (4/24 [17%] with clonazepam v 3/24 [13%] with placebo), increased burning sensation (2/24 [8%] in both groups), dry mouth (1/24 [4%] with clonazepam v 0/24 [0%] with placebo), spasmophilia (1/24 [4%] with clonazepam v 0/24 [0%] with placebo), and euphoria (1/24 [4%] with clonazepam v 0/24 [0%] with placebo; statistical assessments not performed for individual adverse effects). Two participants (2/24 [8%]) in the clonazepam group and one participant (1/24 [4%]) in the placebo group withdrew from the trial because of adverse events (statistical assessment not performed). Five participants using topical clonazepam were assessed for systemic absorption after the 14-week treatment period. While the blood concentration of clonazepam did not reach therapeutic ranges (defined as 20 µg/L or more), there was evidence of some systemic absorption, with blood concentrations of clonazepam reaching about 8 µg/L after sucking one tablet, and about 12 µg/L after swallowing one tablet. Systemic use of benzodiazepines such as clonazepam can lead to dependence.

Comment

In view of the possibility of systemic absorption and concerns about benzodiazepine dependence, the use of clonazepam in the management of burning mouth syndrome should be limited, and people should be made aware of the potential consequences of clonazepam use.

Substantive changes

No new evidence

2008; 2008: 1301.
Published online 2008 March 14.

Antidepressants

Summary

SYMPTOM RELIEF Trazodone compared with placebo: Trazodone is no more effective at reducing pain at eight weeks in people with burning mouth syndrome than placebo ( moderate quality evidence ). SSRIs compared with each other: The SSRIs sertraline, paroxetine, and amisulpride may all be equally effective at reducing pain at eight weeks in people with burning mouth syndrome ( very low quality evidence ).

Benefits

Antidepressants versus placebo:

We found one systematic review (search date 2004) which identified one RCT that met BMJ Clinical Evidence inclusion criteria. The double blind RCT compared trazodone 200 mg daily versus placebo. It found no significant difference in pain or related symptoms between trazodone and placebo measured on a visual analogue scale (0 mm = best score and 100 mm = worst score) at 8 weeks (37 women with burning mouth syndrome; mean difference in pain reduction between the groups at 8 weeks: –4.8 mm, 95% CI –20.3 mm to +10.7 mm).

SSRIs versus each other:

We found one small RCT, which found similar reduction in pain score (pain assessed by 10-point visual analogue scale, higher scores indicating more severe pain) with sertraline 50 mg daily, paroxetine 20 mg daily, and amisulpride 50 mg daily at 8 weeks (76 people; mean score reduction: 4.4 with sertraline v 3.7 with paroxetine v 4.0 with amisulpride; P values not reported). However, the study may have lacked power to detect clinically important differences among treatments, and lacked a placebo comparison.

Harms

The adverse effects of antidepressants in other populations are well documented, see review on depression in adults: drug and other physical treatments.

Antidepressants versus placebo:

The RCT identified by the review found that adverse effects caused 7/18 (39%) people taking trazodone to withdraw from the trial compared with 2/19 (10%) taking placebo. Significantly more people given trazodone experienced dizziness and drowsiness compared with placebo (dizziness: 11/18 [61%] with trazodone v 1/19 [5%] with placebo; P less than 0.001; drowsiness: 9/18 [50%] with trazodone v 2/19 [11%] with placebo; P less than 0.05).

SSRIs versus each other:

The RCT reported no serious adverse effects in any treatment group. In 2005, the US Food and Drug Administration and the UK Medicines and Healthcare Products Regulatory Agency issued warnings that recent observational studies have found that the use of paroxetine by women in the first trimester of pregnancy may increase the risk of congenital malformations. Antidepressants used in the treatment of burning mouth syndrome are used in relatively low doses, and women with burning mouth syndrome are usually over child-bearing age. People with clinical depression and burning mouth syndrome should be assessed by psychiatrists. Antidepressants should only be prescribed by suitably experienced and qualified practitioners who can assess the relative benefits and risks of antidepressant use for the individual.

Comment

Although the RCT comparing trazodone versus placebo was well conducted and used several pertinent outcome measures, including psychological ones, it was also too small and brief to detect clinically important effects. In the RCT comparing SSRIs versus each other, 34 people had a concurrent psychiatric diagnosis. The widespread use of antidepressants in burning mouth syndrome may be because of their effects on neuropathic pain, and the association of burning mouth syndrome with generalised anxiety disorder, depression, and adverse life events.

Substantive changes

No new evidence

2008; 2008: 1301.
Published online 2008 March 14.

Benzydamine hydrochloride

Summary

SYMPTOM RELIEF Compared with placebo: Benzydamine hydrochloride may be no more effective than placebo at reducing symptoms in people with burning mouth syndrome at four weeks ( very low quality evidence ).

Benefits

We found one systematic review (search date 2004). It found one small RCT comparing benzydamine hydrochloride oral rinse (15 mL of 0.15% for 1 minute 3 times daily for 4 weeks), placebo, and no treatment. It found no significant difference in symptoms among groups at 4 weeks (30 people with burning mouth syndrome; AR for improvement: 10% with benzydamine hydrochloride v 20% with placebo v 10% with no treatment; P value not reported). However, the trial was too small to detect a clinically important difference.

Harms

None of the participants in the RCT reported adverse effects.

Comment

Inclusion criteria were well defined. The trial was incompletely blinded because the third group received no treatment.

Substantive changes

No new evidence

2008; 2008: 1301.
Published online 2008 March 14.

Dietary supplements

Summary

SYMPTOM RELIEF Compared with placebo: The dietary supplement alphalioic acid may be more effective at improving symptoms in people with burning mouth syndrome compared with placebo ( very low quality evidence ). Compared with HRT: The dietary supplement oryzanol plus vitamin E may be less effective than tibolone at improving symptoms in postmenopausal women with burning mouth syndrome at six months ( very low quality evidence ).

Benefits

Dietary supplements versus placebo:

We found one systematic review (search date 2004, 3 RCTs). All three RCTs identified by the review evaluated outcomes on a 5-point scale (symptoms “worsening”, “unchanged”, “slight improvement”, “decided improvement”, or “resolution”). The first RCT included in the review compared alphalipoic acid (600 mg/day for 20 days, followed by 200 mg/day for 10 days) versus placebo. It found that alphalipoic acid significantly improved symptoms compared with placebo (42 people; AR for “slight improvement” or “decided improvement”: 16/21 [76%] with alphalipoic acid v 3/14 [21%] with placebo; RR 3.6, 95% CI 1.6 to 7.7; NNT 2, 95% CI 1 to 3; follow-up period unclear). The second RCT included in the review found that alphalipoic acid (200 mg 3 times/day) significantly improved symptoms after 2 months compared with placebo (60 people; AR for “slight improvement”, “decided improvement”, or “resolution”: 29/30 [97%] with alphalipoic acid v 12/30 [40%] with placebo; P less than 0.0001). The third RCT included in the review compared alphalipoic acid (200 mg 3 times/day), lactoperoxidase mouth rinse (5–6 times/day), bethanecol (5 mg 3 times/day), and placebo. It found that alphalipoic acid increased the proportion of people reporting improvement on the symptom scale at 60 days compared with the three other treatment options (80 people; 18/20 [90%] with alphalipoic acid v 0/20 [0%] with lactoperoxidase v 2/20 [10%] with bethanecol v 0/20 [0%] with placebo; it is unclear to what comparison the reported P less than 0.0001 refers).

Dietary supplements versus HRT:

See benefits of HRT in postmenopausal women.

Harms

Dietary supplements versus placebo:

In the third RCT identified by the review, four people in the alphalipoic acid arm reported heartburn, which settled with ranitidine. Four people taking bethanecol experienced adverse events, including nausea, dizziness, cold perspiration, or abdominal pain.

Dietary supplements versus HRT:

See harms of HRT in postmenopausal women.

Comment

Dietary supplements versus placebo:

The three RCTs of alphalipoic acid were performed by the same group at overlapping time periods. Therefore, it is possible that duplicate data may have been reported. Two of the trials were not clearly reported as being blinded. Unblinded assessment of subjective outcomes should be interpreted with caution.

Dietary supplements versus HRT:

See comment of HRT in postmenopausal women.

Substantive changes

No new evidence

2008; 2008: 1301.
Published online 2008 March 14.

HRT in postmenopausal women

Summary

SYMPTOM RELIEF Compared with dietary supplements: Tibolone may be more effective at improving symptoms in postmenopausal women with burning mouth syndrome at six months than the dietary supplement oryzanol plus vitamin E ( very low quality evidence ).

Benefits

We found one systematic review (search date 2004), which identified no RCTs of sufficient quality comparing HRT versus placebo. We found one additional RCT which compared oral tibolone 2.5 mg daily versus oryzanol (30 mg 3 times/day; see comment below) plus vitamin E (100 mg 3 times/day). The study had several flaws in its methods (see comment below). It found that tibolone significantly improved symptoms compared with oryzanol plus vitamin E at 3 and 6 months (56 postmenopausal women; AR for improvement at 3 months: 84.6% with tibolone v 13.3% with oryzanol plus vitamin E; P less than 0.005; AR for improvement at 6 months: 88.5% with tibolone v 16.7% with oryzanol plus vitamin E; P less than 0.005).

Harms

Adverse effects of HRT are well documented (See oestrogens under menopausal symptoms).

Drug safety alert

MHRA issues drug safety alert on the increased risk of breast cancer recurrence associated with tibolone (03 February 09).

A drug safety alert has been issued on the increased risk of breast cancer recurrence associated with tibolone (http://www.mhra.gov.uk).

Comment

We found three non-randomised intervention studies with no clear diagnostic criteria or outcome measures. The additional RCT (which was reported in Chinese) had several design weaknesses, which suggests that the results need to be interpreted with caution. The study gave no clear definition of burning mouth syndrome; it did not specify the method of randomisation; the study was not blinded; the scale used for assessing improvement of symptoms was not validated; and there were important differences between the groups at baseline. Oryzanol is a product mainly derived from rice bran oil and is used as a food supplement.

Substantive changes

No new evidence

2008; 2008: 1301.
Published online 2008 March 14.

Anaesthetics (local)

Summary

We found no direct information assessing the effects of local anaesthetics in the treatment of people with burning mouth syndrome.

Benefits

We found no systematic review or RCTs.

Harms

We found no RCTs.

Comment

None.

Substantive changes

No new evidence


Articles from BMJ Clinical Evidence are provided here courtesy of BMJ Publishing Group