European Academy of Neurology guideline on trigeminal neuralgia.

BACKGROUND AND PURPOSE: Trigeminal neuralgia (TN) is an extremely painful condition which can be difficult to diagnose and treat. In Europe, TN patients are managed by many different specialities. Therefore, there is a great need for comprehensive European guidelines for the management of TN. The European Academy of Neurology asked an expert panel to develop recommendations for a series of questions that are essential for daily clinical management of patients with TN. METHODS: A systematic review of the literature was performed and recommendations was developed based on GRADE, where feasible; if not, a good practice statement was given. RESULTS: The use of the most recent classification system is recommended, which diagnoses TN as primary TN, either classical or idiopathic depending on the degree of neurovascular contact, or as secondary TN caused by pathology other than neurovascular contact. Magnetic resonance imaging (MRI), using a combination of three high-resolution sequences, should be performed as part of the work-up in TN patients, because no clinical characteristics can exclude secondary TN. If MRI is not possible, trigeminal reflexes can be used. Neurovascular contact plays an important role in primary TN, but demonstration of a neurovascular contact should not be used to confirm the diagnosis of TN. Rather, it may help to decide if and when a patient should be referred for microvascular decompression. In acute exacerbations of pain, intravenous infusion of fosphenytoin or lidocaine can be used. For long-term treatment, carbamazepine or oxcarbazepine are recommended as drugs of first choice. Lamotrigine, gabapentin, botulinum toxin type A, pregabalin, baclofen and phenytoin may be used either alone or as add-on therapy. It is recommended that patients should be offered surgery if pain is not sufficiently controlled medically or if medical treatment is poorly tolerated. Microvascular decompression is recommended as first-line surgery in patients with classical TN. No recommendation can be given for choice between any neuroablative treatments or between them and microvascular decompression in patients with idiopathic TN. Neuroablative treatments should be the preferred choice if MRI does not demonstrate any neurovascular contact. Treatment for patients with secondary TN should in general follow the same principles as for primary TN. In addition to medical and surgical management, it is recommended that patients are offered psychological and nursing support. CONCLUSIONS: Compared with previous TN guidelines, there are important changes regarding diagnosis and imaging. These allow better characterization of patients and help in decision making regarding the planning of medical and surgical management. Recommendations on pharmacological and surgical management have been updated. There is a great need for future research on all aspects of TN, including pathophysiology and management.

A systematic review of rescue analgesic strategies in acute exacerbations of primary trigeminal neuralgia.

BACKGROUND: Trigeminal neuralgia (TN) can have a significant impact on wellbeing and quality of life. Limited data exist for treatments that improve TN pain acutely, within 24 h of administration. This systematic review aims to identify effective treatments that acutely relieve TN exacerbations. METHODS: We searched Medline and Cochrane Central Register of Controlled Trials (CENTRAL) for relevant English language publications. The reference list for all articles was searched for other relevant publications. All studies that satisfied the following PICO criteria were included: (i) Population-adults with acute exacerbation of primary TN symptoms; (ii) Intervention-any medication or intervention with the primary goal of pain relief within 24 h; (iii) Comparator-usual medical care, placebo, sham or active treatment; (iv) Outcome-more than 50% reduction in pain intensity within 24 h of administration. RESULTS: Of 431 studies, 17 studies were identified that reported immediate results of acute treatment in TN. The evidence suggests that the following interventions may be beneficial: local anaesthetic, mainly lidocaine (ophthalmic, nasal or oral mucosa, trigger point injection, i.v. infusion, nerve block); anticonvulsant, phenytoin or fosphenytoin (i.v. infusion); serotonin agonist, sumatriptan (s.c. injection, nasal). Other referenced interventions with very limited evidence include N-methyl-d-aspartate receptor antagonist (magnesium sulphate infusion) and botulinum toxin (trigger point injection). CONCLUSIONS: Several treatment options exist that may provide fast and safe relief of TN. Future studies should report on outcomes within 24 h to improve knowledge of the acute analgesic TN treatments.

Adverse effects of anti-epileptics in trigeminal neuralgiform pain.

BACKGROUND: Side effects of anti-epileptic drugs (AEDs) have not been adequately documented in trigeminal neuralgia and its variants. The aim of this observational cross-sectional study was to compare the A-B Neuropsychological Assessment Schedule (ABNAS), which measures cognitive side effects to the Adverse Events Profile (AEP), which looks at a broader range of side effects, and to investigate drug/dosage relationships with questionnaire scores to help determine a point at which a drug change would be indicated. METHODS: One hundred five patients were recruited from a facial pain clinic, over a 10-month period. Self-complete questionnaire scores were compared between patients using different AEDs. RESULTS: A-B Neuropsychological Assessment Schedule score correlated well with AEP indicating that cognitive side effects were a significant burden. Toxic range on the ABNAS was estimated to occur when scores were >43/72 (95% CI: 37.4-48.6). Polytherapy is weakly associated with the higher scores. Oxcarbazepine dosage was found to linearly correlate with AEP and ABNAS scores, better than carbamazepine dosage. Memory alteration was least common with lamotrigine and oxcarbazepine, and there was less association between fatigues with oxcarbazepine/pregabalin. CONCLUSION: Anti-epileptic drugs have significant side effects. The ABNAS questionnaire is a useful tool along with the AEP to recognize and monitor AEDs' side effects and to help to adjust medications to optimal dosage.

Comparison of tolerability and adverse symptoms in oxcarbazepine and carbamazepine in the treatment of trigeminal neuralgia and neuralgiform headaches using the Liverpool Adverse Events Profile (AEP).

BACKGROUND: Adverse effects of drugs are poorly reported in the literature . The aim of this study was to examine the frequency of the adverse events of antiepileptic drugs (AEDs), in particular carbamazepine (CBZ) and oxcarbazepine (OXC) in patients with neuralgiform pain using the psychometrically tested Liverpool Adverse Events Profile (AEP) and provide clinicians with guidance as to when to change management. METHODS: The study was conducted as a clinical prospective observational exploratory survey of 161 patients with idiopathic trigeminal neuralgia and its variants of whom 79 were on montherapy who attended a specialist clinic in a London teaching hospital over a period of 2 years. At each consultation they completed the AEP questionnaire which provides scores of 19-76 with toxic levels being considered as scores >45. RESULTS: The most common significant side effects were: tiredness 31.3 %, sleepiness 18.2 %, memory problems 22.7 %, disturbed sleep 14.1 %, difficulty concentrating and unsteadiness 11.6 %. Females reported significantly more side effects than males. Potential toxic dose for females is approximately 1200 mg of OXC and 800 mg of CBZ and1800mg of OXC and 1200 mg of CBZ for males. CONCLUSIONS: CBZ and OXC are associated with cognitive impairment. Pharmacokinetic and pharmacodynamic differences are likely to be the reason for gender differences in reporting side effects. Potentially, females need to be prescribed lower dosages in view of their tendency to reach toxic levels at lower dosages. Side effects associated with AED could be a major reason for changing drugs or to consider a referral for surgical management.

Differential diagnosis of facial pain and guidelines for management.

The diagnosis and management of facial pain below the eye can be very different dependant on whether the patient visits a dentist or medical practitioner. A structure for accurate diagnosis is proposed beginning with a very careful history. The commonest acute causes of pain are dental and these are well managed by dentists. Chronic facial pain can be unilateral or bilateral and continuous or episodic. The commonest non-dental pains are temporomandibular disorders (TMDs), especially musculoskeletal involving the muscles of mastication either unilaterally or bilaterally; they may be associated with other chronic pains. A very wide range of treatments are used but early diagnosis, reassurance and some simple physiotherapy is often effective in those with good coping strategies. Dentists will often make splints to wear at night. Neuropathic pain is usually unilateral and of the episodic type; the most easily recognized is trigeminal neuralgia. This severe electric shock like pain, provoked by light touch, responds best to carbamazepine, and neurosurgery in poorly controlled patients. Trauma, either major or because of dental procedures, results in neuropathic pain and these are then managed as for any other neuropathic pain. Red flags include giant cell arteritis which much be distinguished from temporomandibular disorders (TMD), especially in >50 yr olds, and cancer which can present as a progressive neuropathic pain. Burning mouth syndrome is rarely recognized as a neuropathic pain as it occurs principally in peri-menopausal women and is thought to be psychological. Chronic facial pain patients are best managed by a multidisciplinary team.

A systematic review of screening diagnostic tools for trigeminal neuralgia.

Background and objective: Trigeminal neuralgia (TN) is a rare chronic neuropathic pain condition of sudden and severe pain, often described as an electric shock. Diagnosis is challenging for non-expert clinicians, particularly in primary care settings. We wanted to identify and assess the diagnostic accuracy of existing screening tools for TN and orofacial pain that could be used to support the diagnosis of TN in primary care. Databases and data treatment: We searched key databases (MEDLINE, ASSIA, Embase, and Web of Knowledge and PsycINFO) supplemented by citation tracking from January 1988 to 2021. We used an adapted version of the Quality of Diagnostic Accuracy Studies (QUADAS-2) to assess the methodological quality of each study. Results: Searches identified five studies, from the UK, USA and Canada; three validated self-report questionnaires; and two artificial neural networks. All screened for multiple orofacial pain diagnoses, including dentoalveolar pain, musculoskeletal pain (temporomandibular disorders) and neurological pain (trigeminal neuralgia, headache, atypical facial pain and postherpetic neuralgia). The overall quality assessment was low for one study. Conclusions: Diagnosis of TN can be challenging for non-expert clinicians. Our review found few existing screening tools to diagnose TN, and none is currently suitable to be used in primary care settings. This evidence supports the need to adapt an existing tools or to create a new tool for this purpose. The development of an appropriate screening questionnaire could assist non-expert dental and medical clinicians to identify TN more effectively and empower them to manage or refer patients for treatment more effectively.

Classifying orofacial pains: a new proposal of taxonomy based on ontology.

We propose a new taxonomy model based on ontological principles for disorders that manifest themselves through the symptom of persistent orofacial pain and are commonly seen in clinical practice and difficult to manage. Consensus meeting of eight experts from various geographic areas representing different perspectives (orofacial pain, headache, oral medicine and ontology) as an initial step towards improving the taxonomy. Ontological principles were introduced, reviewed and applied during the consensus building process. Diagnostic criteria for persistent dento-alveolar pain disorder (PDAP) were formulated as an example to be used to model the taxonomical structure of all orofacial pain conditions. These criteria have the advantage of being (i) anatomically defined, (ii) in accordance with other classification systems for the provision of clinical care, (iii) descriptive and succinct, (iv) easy to adapt for applications in varying settings, (v) scalable and (vi) transferable for the description of pain disorders in other orofacial regions of interest. Limitations are that the criteria introduce new terminology, do not have widespread acceptance and have yet to be tested. These results were presented to the greater conference membership and were unanimously accepted. Consensus for the diagnostic criteria of PDAP was established within this working group. This is an initial first step towards developing a coherent taxonomy for orofacial pain disorders, which is needed to improve clinical research and care.

Persistent orofacial muscle pain.

The pathophysiology of persistent orofacial myalgia has been the centre of much controversy. In this article we suggest a novel descriptive term; 'persistent orofacial muscle pain' (POMP) and review current evidence that supports the hypothesis that the induction of POMP involves the interplay between a peripheral nociceptive source in muscle, a faulty central nervous system component and decreased coping ability. In this context it is widely accepted that a complex interaction of variable intrinsic and extrinsic factors act to induce POMP and dysfunction.

Pilot study to evaluate the efficacy and tolerability of levetiracetam (Keppra) in treatment of patients with trigeminal neuralgia.

BACKGROUND AND PURPOSE: The objective of this study was to determine whether levetiracetam (LEV) is an effective drug for treatment of trigeminal neuralgia (TN). METHODS: Ten patients with TN were enrolled in a 10-week, prospective, open-label pilot study. The primary outcome measure was the visual analogue scale on daily pain diary and side effects. Serum levels of LEV were measured to assess correlation between drug levels and pain control. RESULTS: There was a significant tendency towards improvement in pain severity compared with baseline in four patients with higher doses of 4,000 mg/day. The four treatment responders had less pain compared with baseline (50-90% improvement) and three subjects continued the drug after study completion. All patients rated themselves on the global evaluation scale as much improved (n = 2), minimally improved (n = 3), no change (n = 1), minimally worse (n = 2), much worse (n = 1) and very much worse (n = 1). LEV was very well tolerated and there was no difference in side effects between the low and high doses of LEV evaluations. CONCLUSION: Given its established safety profile, a randomized, placebo-controlled, double-blind trial of LEV using enhancement enrollment design is needed to confirm these open-labelled findings using a wide variety of outcome measures.

Alternative respiration of fungus Phycomyces blakesleeanus.

Respiratory characteristics of germinating spores, developing mycelium and mitochondria of the fungus Phycomyces blakesleeanus were investigated by means of oxygen Clark-type electrode. The effects of respiratory inhibitors and metabolic compounds on oxygen consumption were tested. It was demonstrated that P. blakesleeanus apart of cyanide-sensitive respiration, CSR, possess alternative respiration, (cyanide-resistant respiration, CRR) which is constitutive and whose capacity decreases during development. Maximum is observed for activated spores where CRR capacity is significantly greater than CSR. After treatment with antimycin A, a third type of respiration insensitive to antimycin A and low concentration of SHAM (sufficient for inhibition of CRR), but sensitive to cyanide and high concentration of SHAM, has been expressed.

The specialist management of non-temporomandibular orofacial pain: maxillofacial surgery's known unknown?

The management of orofacial pain is considered to be within the remit of oral and maxillofacial surgery (OMFS). In this study we aimed to provide an overview of the healthcare "journey" of a group of patients referred to a specialist unit with "complex" non-temporomandibular orofacial pain. We retrospectively reviewed all those who were referred over a six-month period and followed for up to three years. A total of 133 were included, 69% were female, and the mean (SD) duration of symptoms before assessment was 66.4 (88.8) months. Patients were treated for seven different conditions by a mean (SD) of 2.6 (1.2) specialties, and 3.2 (2.5) medications had been tried before assessment at the unit. A mean (SD) of 3.9 (3.3) appointments were attended over the three years, and 80% of patients were prescribed at least one medication. Patients were under the care of the unit for a mean (SD) of 11.9 (14.0) months, and 38% were still being seen at three years. Those with trigeminal neuralgia were most likely to remain in care at three years (p=<0.001), and those with burning mouth syndrome (p=<0.001) or persistent idiopathic facial pain (p=0.005) were most likely to be discharged. In the current NHS climate, the lack of resources to treat facial pain and the focus on a mix of skills, mean that OMF surgeons are likely to have an increasing role in the treatment of these patients. This paper provides an important insight into these conditions.

AAN-EFNS guidelines on trigeminal neuralgia management.

Several issues regarding diagnosis, pharmacological treatment, and surgical treatment of trigeminal neuralgia (TN) are still unsettled. The American Academy of Neurology and the European Federation of Neurological Societies launched a joint Task Force to prepare general guidelines for the management of this condition. After systematic review of the literature the Task Force came to a series of evidence-based recommendations. In patients with TN MRI may be considered to identify patients with structural causes. The presence of trigeminal sensory deficits, bilateral involvement, and abnormal trigeminal reflexes should be considered useful to disclose symptomatic TN, whereas younger age of onset, involvement of the first division, unresponsiveness to treatment and abnormal trigeminal evoked potentials are not useful in distinguishing symptomatic from classic TN. Carbamazepine (stronger evidence) or oxcarbazepine (better tolerability) should be offered as first-line treatment for pain control. For patients with TN refractory to medical therapy early surgical therapy may be considered. Gasserian ganglion percutaneous techniques, gamma knife and microvascular decompression may be considered. Microvascular decompression may be considered over other surgical techniques to provide the longest duration of pain freedom. The role of surgery versus pharmacotherapy in the management of TN in patients with multiple sclerosis remains uncertain.

Burning mouth syndrome as a trigeminal small fibre neuropathy: Increased heat and capsaicin receptor TRPV1 in nerve fibres correlates with pain score.

Burning mouth syndrome (BMS) is often an idiopathic chronic and intractable pain condition, affecting 1.5-5.5% of middle-aged and elderly women. We have studied the heat and capsaicin receptor TRPV1, and its regulator nerve growth factor (NGF), in BMS. Patients with BMS (n=10) and controls (n=10) were assessed for baseline and post-topical capsaicin pain scores, and their tongue biopsies immunostained for TRPV1, NGF, and structural nerve markers neurofilament and peripherin. Nerve fibres penetrating the epithelium were less abundant in BMS (p<0.0001), indicating a small fibre neuropathy. TRPV1-positive fibres were overall significantly increased in BMS (p=0.0011), as were NGF fibres (p<0.0001) and basal epithelial cell NGF staining (p<0.0147). There was a significant correlation between the baseline pain score and TRPV1 (p=0.0143) and NGF fibres (p=0.0252). A significant correlation was observed between baseline and post-capsaicin pain (p=0.0006). Selective TRPV1 and NGF blockers may provide a new therapy for BMS.

A study of the discomalleolar ligament in the adult human.

The discomalleolar ligament (Pinto's ligament) is not described in the anatomy textbooks but was demonstrated by Pinto and others. This is a ligamentous structure connecting the malleus in the tympanic cavity and the articular disc and capsule of the temporomandibular joint. This anatomical relationship between the middle ear and the temporomandibular joint is supposed to be one of the explanations for the aural symptoms associated with temporomandibular joint dysfunction. The objectives of our study were to determine: (1) the frequency of occurrence and morphology of the discomalleolar ligament, (2) its attachments, (3) the morphology of Pinto's ligament in endoscopic visualisation, and (4) whether tension applied to the discomalleolar ligament could elicit movement of the malleus. Fourteen adult human temporomandibular joint and tympanic cavity specimens were examined with the use of an endoscope and then by gross dissection with the superior approach and with the use of the operating microscope. Endoscopic visualisation showed in four cases a band of tissue in the upper temporomandibular joint compartment, known as Pinto's ligament. The dissections exposed a discomalleolar ligament in 11 specimens. We were able to identify two main types of this ligament on the basis of its shape. The discomalleolar ligament was either triangular in shape, as in the first group of seven specimens, or longitudinal in shape, as in the second group of four specimens. We observed that tension applied to the discomalleolar ligament resulted in movement of the malleus in three specimens.

Referrals to a facial pain service.

AIM: To assess the quality of referral letters to a facial pain service and highlight the key requirements of such letters. METHOD: The source of all referral letters to the service for five years was established. For one year the information provided in 94 referrals was assessed. Using a predetermined checklist of essential information the referral letters were compared to these set criteria. RESULTS: The service received 7,001 referrals and, on average, general dental practitioners (GDPs) referred 303 more patients per year than general medical practitioners (GMPs). Seventy-one percent of all referrals were from primary care practitioners, the rest were from specialists. Over 70% of GMP and 52% of GDP letters included a past medical history, with GMPs more likely to suggest a possible diagnosis and include previous secondary care referrals. The mean score for GMP referrals compared to the standard proforma (maximum of 12) was 5.6 and for GDP referrals 5.0. A relevant drug history was included by 75.6% GMP compared to 38.7% of GDPs. GMPs were more likely to include any relevant mental health history. CONCLUSIONS: The overall quality of referral letters is low which makes it difficult for the specialists to provide robust treatment plans.

Interventions for the treatment of burning mouth syndrome.

BACKGROUND: The complaint of a burning sensation in the mouth can be said to be a symptom of other disease or a syndrome in its own right of unknown aetiology. In patients where no underlying dental or medical causes are identified and no oral signs are found, the term burning mouth syndrome (BMS) should be used. The prominent feature is the symptom of burning pain which can be localised just to the tongue and/or lips but can be more widespread and involve the whole of the oral cavity. Reported prevalence rates in general populations vary from 0.7% to 15%. Many of these patients show evidence of anxiety, depression and personality disorders. OBJECTIVES: The objectives of this review are to determine the effectiveness and safety of any intervention versus placebo for relief of symptoms and improvement in quality of life and to assess the quality of the studies. SEARCH STRATEGY: We searched the Cochrane Oral Health Group Trials Register (20 October 2004), the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 4, 2004), MEDLINE (January 1966 to October 2004), EMBASE (January 1980 to October). Clinical Evidence Issue No. 10 2004, conference proceedings and bibliographies of identified publications were searched to identify the relevant literature, irrespective of language of publication. SELECTION CRITERIA: Studies were selected if they met the following criteria: study design - randomised controlled trials (RCTs) and controlled clinical trials (CCTs) which compared a placebo against one or more treatments; participants - patients with burning mouth syndrome, that is, oral mucosal pain with no dental or medical cause for such symptoms; interventions - all treatments that were evaluated in placebo-controlled trials; primary outcome - relief of burning/discomfort. DATA COLLECTION AND ANALYSIS: Articles were screened independently by two reviewers to confirm eligibility and extract data. The reviewers were not blinded to the identity of the studies. The quality of the included trials was assessed independently by two reviewers, with particular attention given to allocation concealment, blinding and the handling of withdrawals and drop outs. Due to both clinical and statistical heterogeneity statistical pooling of the data was inappropriate. MAIN RESULTS: Nine trials were included in the review. The interventions examined were antidepressants (two trials), cognitive behavioural therapy (one trial), analgesics (one trial), hormone replacement therapy (one trial), alpha-lipoic acid (three trials) and anticonvulsants (one trial). Diagnostic criteria were not always clearly reported. Out of the nine trials included in the review, only three interventions demonstrated a reduction in BMS symptoms: alpha-lipoic acid (three trials), the anticonvulsant clonazepam (one trial) and cognitive behavioural therapy (one trial). Only two of these studies reported using blind outcome assessment. Although none of the other treatments examined in the included studies demonstrated a significant reduction in BMS symptoms, this may be due to methodological flaws in the trial design, or small sample size, rather than a true lack of effect. AUTHORS' CONCLUSIONS: Given the chronic nature of BMS, the need to identify an effective mode of treatment for sufferers is vital. However, there is little research evidence that provides clear guidance for those treating patients with BMS. Further trials, of high methodological quality, need to be undertaken in order to establish effective forms of treatment for patients suffering from BMS.

Satisfaction with care of patients attending a dedicated dental clinic: comparisons between 1989 and 1994.

This investigation aimed to audit patient satisfaction with care at a dedicated dental clinic, using previously developed standards and criteria. A self-complete questionnaire was administered to a group of 161 patients assessing the dimensions of care availability, affective behaviour and technical competence. Comparisons with baseline showed a high but slightly decreased level of satisfaction with technical competence, a significantly higher level of satisfaction with the affective behaviour of the clinic staff but a continuing level of dissatisfaction with the availability of care. Respondents with AIDS reported higher levels of satisfaction for all 3 dimensions. Women were less satisfied with the availability of care. The results indicate the inter-related nature of the dimensions of technical competence and care availability. Satisfaction with care availability will only improve if initiatives beyond the clinic are introduced to increase the overall supply of dental services available to this population.

Interventions for the treatment of burning mouth syndrome.

BACKGROUND: The complaint of a burning sensation in the mouth can be said to be a symptom of other disease or a syndrome in its own right of unknown aetiology. In patients where no underlying dental or medical causes are identified and no oral signs are found, the term burning mouth syndrome (BMS) should be used. The prominent feature is the symptom of burning pain which can be localised just to the tongue and/or lips but can be more widespread and involve the whole of the oral cavity. Reported prevalence rates in general populations vary from 0.7% to 15%. Many of these patients show evidence of anxiety, depression and personality disorders. OBJECTIVES: The objectives of this review are to determine the effectiveness and safety of any intervention versus placebo for relief of symptoms and improvement in quality of life and to assess the quality of the studies. SEARCH STRATEGY: Electronic databases (The Cochrane Library, the Cochrane Oral Health Group's Specialised Register, MEDLINE, EMBASE), Clinical Evidence Issue No. 3, conference proceedings and bibliographies of identified publications were searched to identify the relevant literature, irrespective of language of publication. SELECTION CRITERIA: Studies were selected if they met the following criteria: study design - randomised controlled trials (RCTs) and controlled clinical trials (CCTs) which compared a placebo against one or more treatments; participants - patients with burning mouth syndrome, that is, oral mucosal pain with no dental or medical cause for such symptoms; interventions - all treatments that were evaluated in placebo-controlled trials; primary outcome - relief of burning/discomfort DATA COLLECTION AND ANALYSIS: Articles were screened independently by two reviewers to confirm eligibility and extract data. The reviewers were not blinded to the identity of the studies. The quality of the included trials was assessed independently by two reviewers, with particular attention given to allocation concealment, blinding and the handling of withdrawals and drop-outs. Due to differences in patient type, treatment and outcome measures, statistical pooling of the data was inappropriate. MAIN RESULTS: Six trials were included in the review. The interventions examined were antidepressants (two trials), cognitive behavioural therapy (one trial), analgesics (one trial), hormone replacement therapy (one trial) and vitamin complexes (one trial). The participants included in the six identified trials reported suffering from BMS from six months to 20 years. Diagnostic criteria were not always clearly reported. Out of the six trials included in the review, only two interventions demonstrated a reduction in BMS symptoms; vitamin complexes and cognitive behavioural therapy. Neither of these studies reported using blind outcome assessment. Although none of the other treatments examined in the included studies demonstrated a significant reduction in BMS symptoms, this may be due to methodological flaws in the trial design, or small sample size, rather than a true lack of effect. REVIEWER'S CONCLUSIONS: Given the chronic nature of BMS, the need to identify an effective mode of treatment for sufferers is vital. However, there is little research evidence that provides clear guidance for those treating patients with BMS. Further trials, of high methodological quality, need to be undertaken in order to establish effective forms of treatment for patients suffering from BMS.

Interventions for treating oral lichen planus.

BACKGROUND: Oral lichen planus is a chronic autoimmune disease of unknown aetiology that affects the inner surface of the mouth. The symptomatic forms are painful,tend to worsen with age and with remissions being rare. Current treatment is palliative and not curative, many topical and systemic agents have been tried with little hard evidence for efficacy. OBJECTIVES: To assess the effectiveness and safety of any form of palliative therapy against placebo for the treatment of symptomatic oral lichen planus. SEARCH STRATEGY: Electronic databases, handsearching of conference proceedings and specific journals, researchers in the field, drug manufacturers. SELECTION CRITERIA: Any placebo-controlled trial of palliative therapy for symptomatic oral lichen planus, using a randomised or quasi-randomised design that measured changes in symptoms and/or clinical signs. DATA COLLECTION AND ANALYSIS: Change in symptoms (pain, discomfort) and clinical signs (visual impression, lesion measurements) at the end of therapy. Odds ratio of improvement vs no improvement for each trial outcome and pooling where appropriate. MAIN RESULTS: A total of nine RCTs were identified. The nine interventions were grouped into four separate classes (cyclosporines, retinoids, steroids and phototherapy) for comparison. No therapy was replicated exactly, the closest replication involved two trials using high and low dose cyclosporine mouthwash. Only trials recording the same outcomes in each therapeutic class were pooled. The largest number of pooled trials was three. Large odds ratios with very wide confidence intervals indicating a statistically significant treatment benefit were seen in all trials. However this has to be tempered by considerations of the small study sizes, the lack of replication, the difficulty in measuring outcome changes and the very high likelihood of publication bias. Only systemic agents were associated with treatment toxicities, all other side-effects were mild and mainly limited to local mucosal reactions. REVIEWER'S CONCLUSIONS: The review provides only weak evidence for the superiority of the assessed interventions over placebo for palliation of symptomatic OLP. The results highlight the need for larger placebo-controlled RCTs with more carefully selected and standardised outcome measures before between-treatment comparisons can be properly interpreted.