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Report of the Quality Standards Subcommittee of the American Academy of Neurology and the European Federation of Neurological Societies

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Report of the Quality Standards Subcommittee of the American Academy of Neurology and the European Federation of Neurological Societies

G. Gronseth, MD, FAAN; G. Cruccu, MD; J. Alksne, MD; C. Argoff, MD; M. Brainin, MD, FESO; K. Burchiel, MD; T. Nurmikko, MD, PhD; J. M. Zakrzewska, MD, FDSRCS, FFDRCSI

Practice Parameter: The diagnostic evaluation and treatment of trigeminal neuralgia(an evidence-based review)
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If you have questions, comments, or feedback regarding this slide presentation, or would like to modify the contents to present this in a lecture, please contact [email protected]
presentation objectives
Presentation Objectives
  • To perform an evidence-based review of the diagnosis and treatment of trigeminal neuralgia
  • To make evidence-based recommendations
overview
Overview
  • Background
  • Gaps in care
  • AAN guideline process
  • Analysis of evidence, conclusions, recommendations
  • Recommendations for future research
background
Background
  • Trigeminal neuralgia (TN) is sudden, usually unilateral, severe, brief, stabbing, recurrent episodes of pain in the distribution of one or more branches of the trigeminal nerve.1
  • The annual incidence of TN is 4 to 5 in 100,000.2
  • Classic TN (CTN) includes cases without an established etiology, and symptomatic TN (STN) is diagnosed when investigations identify a structural abnormality (e.g., MS plaques, tumors, etc.).
aan guideline process
AAN Guideline Process
  • Clinical Question
  • Evidence
  • Conclusions
  • Recommendations
clinical questions
Clinical Questions
  • The first step of developing guidelines is to clearly formulate questions to be answered.
  • Questions address areas of controversy, confusion, or variation in practice.
  • Questions must be answerable with data from the literature.
  • Answering the question must have the potential to improve care/patient outcomes.
slide8
Literature Search/Review

Complete

Search

Review abstracts

Review full text

Select articles

Relevant

Rigorous, Comprehensive, Transparent

aan classification of evidence
AAN Classification of Evidence
  • All studies rated Class I, II, III, or IV
  • Five different classification systems:
    • Therapeutic
      • Randomization, control, blinding
    • Diagnostic
      • Comparison to gold standard
    • Prognostic
    • Screening
    • Causation
aan level of recommendations
AAN Level of Recommendations
  • A = Established as effective, ineffective, or harmful for the given condition in the specified population.
  • B = Probably effective, ineffective, or harmful for the given condition in the specified population.
  • C = Possibly effective, ineffective, or harmful for the given condition in the specified population.
  • U = Data is inadequate or conflicting; given current knowledge, treatment is unproven.
  • Note that recommendations can be positive or negative.
translating class to recommendations
Translating Class to Recommendations
  • A = Requires two consistent Class I studies.
  • B = Requires one Class I study or two consistent Class II studies.
  • C = Requires one Class II study or two consistent Class III studies.
  • U = Studies not meeting criteria for Class I through Class III.
applying this process to the issue
Applying This Processto the Issue

We will now turn our attention to the guidelines.

clinical questions13
Clinical Questions

Diagnostic questions

  • How often does routine neuroimaging (CT, MRI) identify a structural cause of TN (excluding vascular contact with compression of the fifth cranial nerve?
  • Which clinical or laboratory features accurately identify patients with STN?
  • For patients with CTN, does high-resolution MRI accurately identify patients with neurovascular compression?
clinical questions14
Clinical Questions

Pharmacologic questions

Which drugs effectively treat CTN?

Which drugs effectively treat STN?

3. Is there evidence of efficacy of intravenous drugs in acute exacerbations of TN?

clinical questions15
Clinical Questions

Surgical questions

When should surgery be offered?

Which surgical technique gives the longest pain-free period with the fewest complications and good quality of life?

Which surgical techniques should be used in patients with MS?

methods
Methods
  • Medline, EMBASE and Cochrane Library:
    • Database creation to December 2007
    • Relevant, fully published, peer-reviewed articles
    • Supplemented through manual searches by panel members
  • Search terms:
    • Trigeminal neuralgia, tic douloureux, facial pain, or trigeminal neuropathy
methods17
Methods
  • At least two panelists reviewed each article for inclusion. A third panelist was added for arbitrating disagreements
  • Risk of bias determined using the classification of evidence for each study (Class I–IV).
  • Strength of practice recommendations linked directly to level of evidence (Level A–U).
  • Conflicts of interest disclosed.
literature review
> 500 abstracts

47 articles

Literature Review
  • Inclusion criteria:
  • - Relevant to the clinical questions
  • - Limited to human subjects
  • RCT, case control, cohort studies, case series > 6, meta-analysis
  • Exclusion criteria:
  • -Abstracts, reviews, and undocumented or unstated mention of improvement
aan classification of evidence for therapeutic intervention
AAN Classification of Evidencefor Therapeutic Intervention
  • Class I: Randomized, controlled clinical trial with masked or objective outcome assessment in a representative population. Relevant baseline characteristics are presented and substantially equivalent among treatment groups or there is appropriate statistical adjustment for differences. The following are required:

a) concealed allocation

b) primary outcome(s) clearly defined

c) exclusion/inclusion criteria clearly defined, and

d) adequate accounting for drop-outs (with at least 80% of enrolled subjects completing the study) and cross-overs with numbers sufficiently low to have minimal potential for bias.

aan classification of evidence for therapeutic intervention20
AAN Classification of Evidencefor Therapeutic Intervention
  • Class II: Prospective matched group cohort study in a representative population with masked outcome assessment that meets b-d above OR a randomized controlled trial in a representative population that lacks one criteria a-d.
aan classification of evidence for therapeutic intervention21
AAN Classification of Evidencefor Therapeutic Intervention
  • Class III: All other controlled trials (including well-defined natural history controls or patients serving as own controls) in a representative population, where outcome is independently assessed, or independently derived by objective outcome measurement.*
  • Class IV: Studies not meeting Class I, II, or III criteria including consensus, expert opinion, or a case report.

*Objective outcome measurement: an outcome measure that is unlikely to be affected by an observer’s (patient, treating physician, investigator) expectation or bias (e.g., blood tests, administrative outcome data).

aan classification of evidence for screening
Class I: A statistical, population-based sample of patients studied at a uniform point in time (usually early) during the course of the condition. All patients undergo the intervention of interest. The outcome, if not objective, is determined in an evaluation that is masked to the patients’ clinical presentations.AAN Classification of Evidencefor Screening
aan classification of evidence for screening23
AAN Classification of Evidencefor Screening
  • Class II: A statistical, non-referral-clinic-based sample of patients studied at a uniform point in time (usually early) during the course of the condition. Most patients undergo the intervention of interest. The outcome, if not objective, is determined in an evaluation that is masked to the patients’ clinical presentations.
aan classification of evidence for screening24
AAN Classification of Evidencefor Screening
  • Class III: A sample of patients studied during the course of the condition. Some patients undergo the intervention of interest. The outcome, if not objective, is determined in an evaluation by someone other than the treating physician.
  • Class IV: Studies not meeting Class I, II, or III criteria including consensus, expert opinion, or a case report.
aan classification of evidence for diagnosis
Class I:A cohort study with prospective data collection of a broad spectrum of persons with the suspected condition, using an acceptable reference standard for case definition. The diagnostic test is objective or performed and interpreted without knowledge of the patient’s clinical status. Study results allow calculation of measures of diagnostic accuracy. AAN Classification of Evidencefor Diagnosis
aan classification of evidence for diagnosis26
AAN Classification of Evidencefor Diagnosis
  • Class II:A case control study of a broad spectrum of persons with the condition established by an acceptable reference standard compared to a broad spectrum of controls or a cohort study where a broad spectrum of persons with the suspected condition where the data was collected retrospectively. The diagnostic test is objective or performed and interpreted without knowledge of disease status. Study results allow calculation of measures of diagnostic accuracy.
aan classification of evidence for diagnosis27
AAN Classification of Evidencefor Diagnosis
  • Class III:A case control study or cohort study where either persons with the condition or controls are of a narrow spectrum. The condition is established by an acceptable reference standard. The reference standard and diagnostic test are objective or performed and interpreted by different observers. Study results allow calculation of measures of diagnostic accuracy.
  • Class IV:Studies not meeting Class I, II, or III criteria including consensus, expert opinion, or a case report.
analysis of evidence
Analysis of Evidence

Question 1: How often does routine neuroimaging (CT, MRI) identify a structural cause (excluding vascular contact with compression of the fifth cranial nerve)?

conclusion recommendation
Conclusion/Recommendation

Conclusion: For patients with TN, routine neuroimaging may identify a cause in up to 15% of patients (four Class III studies). These reported yields are most representative of those expected from referral centers.

Recommendation: Weak evidence indicates that for patients with TN, routine imaging may be considered to identify a cause in up to 15 percent of patients with STN (Level C).

clinical context
Clinical Context
  • The initial diagnostic evaluation of a patient with TN naturally focuses on those clinical characteristics known to identify patients with symptomatic trigeminal neuralgia (STN). Those characteristics include the presence of trigeminal sensory deficits and bilateral involvement.
analysis of evidence31
Analysis of Evidence

Question 2: Which clinical or laboratory features accurately identify patients with STN?

conclusion recommendation32
Conclusion/Recommendation

Conclusion: For patients with TN, younger age (one Class I and three Class II studies) and abnormal trigeminal nerve evoked potentials (two Class II and two Class III studies) are probably associated with an increased risk of STN. However, there is too much overlap in patients with CTN and STN for these predictors to be considered clinically useful.

Recommendation: Good evidence indicates that measuring trigeminal reflexes in a qualified electrophysiogical laboratory should be considered useful for distinguishing STN from classic trigeminal neuralgia (CTN) (Level B).

clinical context33
Clinical Context
  • If after the initial evaluation the clinician remains suspicious of STN, further testing is desirable. Based upon cost, local expertise and availability, and patient preferences, obtaining trigeminal reflex testing or head imaging are both reasonable next steps.
analysis of evidence34
Analysis of Evidence

Question 3: Does high-resolution MRI accurately identify patients with neurovascular compression?

conclusion recommendation35
Conclusion/Recommendation

Conclusion: Because of inconsistency of results, there is insufficient evidence to support or refute the usefulness of MRI to identify vascular contact in CTN or to indicate the most reliable MRI technique.

Recommendation: There is insufficient evidence to support or refute the usefulness of MRI to identify vascular contact in CTN or to indicate the most reliable MRI technique (Level U).

clinical context36
Clinical Context
  • Because of a high diagnostic accuracy, MRI might reasonably be foregone in a patient with normal trigeminal reflexes.
analysis of evidence37
Analysis of Evidence

Question 4: Which drugs effectively treat CTN pain?

conclusion recommendation38
Conclusion/Recommendation

Conclusion: Carbamazepine is established as effective for controlling pain in patients with CTN (multiple Class I and II studies). Oxcarbazepine is probably effective for treating pain in CTN (three Class II studies). Baclofen, lamotrigine, and pimozide are possibly effective for controlling pain in patients with CTN (single Class II study for each drug). Topical ophthalmic anesthesia is probably ineffective for controlling pain in patients with CTN (single Class I study). There is insufficient evidence to support or refute the efficacy of clonazepam, gabapentin, phenytoin, tizanidine, topical capsaicin, and valproate for controlling pain in patients with CTN.

Recommendation:

Strong evidence supports that carbamazepine should be offered to treat CTN pain (Level A).

Good evidence supports that oxcarbazepine should be considered to treat CTN pain (Level B).

Weak evidence supports that baclofen, lamotrigine, and pimozide may be considered to treat CTN pain (Level C).

Good evidence supports that topical ophthalmic anesthesia should not be considered to treat CTN pain (Level B).

clinical context39
Clinical Context
  • The two drugs to consider as first-line therapy in TN are CBZ (200-1200 mg/day) and OXC (600-1800 mg/day). Although the evidence for CBZ is stronger than for OXC, the latter may pose fewer safety concerns.
  • There is little evidence to guide the clinician on the treatment of TN patients that who fail first-line therapy. Some evidence supports add-on therapy with lamotrigine or a switch to baclofen (pimozide being no longer in use).
analysis of evidence40
Analysis of Evidence

Question 5. Which drugs effectively treat STN pain?

conclusion recommendation41
Conclusion/Recommendation

Conclusion: There is insufficient evidence to support or refute the effectiveness of any medication in treating pain in STN (Class IV studies).

Recommendation: There is insufficient evidence to support or refute the effectiveness of any medication in treating pain in STN (Level U).

clinical context42
Clinical Context
  • The effect of other drugs commonly used in neuropathic pain is unknown. There are no published studies directly comparing polytherapy with monotherapy.
analysis of evidence43
Analysis of Evidence

Question 6: Is there evidence of efficacy of intravenous administration of drugs in acute exacerbations of TN?

conclusion recommendation44
Conclusion/Recommendation

Conclusion: There is insufficient evidence to support or refute the efficacy of IV medications for the treatment of pain from TN (Class IV study).

Recommendation: There is insufficient evidence to support or refute the efficacy of intravenous medications for the treatment of pain from TN (Level U).

analysis of evidence45
Analysis of Evidence

Question 7: When should surgery be considered?

conclusion recommendation46
Conclusion/Recommendation

Conclusion: There is insufficient evidence to allow conclusions as to when surgery should be offered (two Class IV studies).

Recommendation: There is insufficient evidence to allow conclusions as to when surgery should be offered (Level U).

clinical context47
Clinical Context
  • Referral for a surgical consultation seems reasonable in TN patients refractory to medical therapy. Some TN experts believe TN patients failing to respond to first-line therapy are unlikely to respond to alternative medications and suggest early surgical referral.
analysis of evidence48
Analysis of Evidence

Question 8: Which surgical technique gives the longest pain-free period with the fewest complications and good quality of life?

conclusion recommendation49
Conclusion/Recommendation

Conclusion: Percutaneous procedures on the Gasserian ganglion, gamma knife, and microvascular decompression are possibly effective in the treatment of TN (multiple Class III studies). The evidence about peripheral techniques is either negative (two Class I studies about streptomycin/lidocaine) or insufficient (Class IV studies for all the other peripheral techniques).

Recommendation: There is weak evidence to support that early surgical therapy may be considered for patients with TN refractory medical therapy (Level C). There is weak evidence to support percutaneous procedures on the Gasserian ganglion, gamma knife, and microvascular decompression may be considered (Level C).

analysis of evidence50
Analysis of Evidence

Question 9. Which surgical techniques should be used in patients with multiple sclerosis?

conclusion recommendation51
Conclusion/Recommendation

Conclusion: There is insufficient evidence to support or refute the effectiveness of the surgical management of TN in patients with MS.

Recommendation: There is insufficient evidence to support or refute the effectiveness of the surgical management of TN in patients with MS (Level U).

future research
Future Research
  • To establish a better estimate of the yield of routine brain imaging in identifying patients with STN, we need a population-based study of consecutive, newly diagnosed patients with TN all undergoing head imaging.
  • To improve our knowledge of the diagnostic accuracy of clinical characteristics and electrophysiologic studies to distinguish STN from CTN, we need prospective cohort surveys of large populations of patients with TN all undergoing standardized diagnostic assessments reported using STARD criteria.3
future research53
Future research
  • It would also be useful to determine if finding a neurovascular contact on high-resolution MRI accurately identifies patients who will respond to microvascular decompression. This question could be answered with a prospective study comparing longterm outcomes in patients with TN undergoing microvascular decompression with and without neurovascular contact identified on preoperative high-resolution MRI.
future research54
Future research
  • The efficacy of new drugs and, in particular, surgical interventions, needs to be determined in well-designed RCTs. Although double-blinded studies are impractical for surgical trials, randomized treatment allocation and independent outcome assessment would go a long way to establish the efficacy of the surgical techniques.
  • The optimal timing of surgical referral remains a crucial question. How many different drugs should be tried before referring a patient for surgery? What is the likelihood that a patient with TN failing OXC or CBZ will respond to alternative drugs? These are questions that could be answered by a large prospective cohort survey of patients with TN treated in a standardized, stepwise fashion.
references
References
  • Merskey H, Bogduk N. Classification of Chronic Pain: Descriptions of Chronic Pain Syndromes and Definitions of Pain Terms. Seattle: IASP Press; 1994;59–71.
  • Katusic S, Williams DB, Beard CM, et al. Epidemiology and clinical features of idiopathic trigeminal neuralgia and glossopharyngeal neuralgia: similarities and differences, Rochester, Minnesota, 1945–1984. Neuroepidemiology 1991;10:276–281.
  • Bossuyt P, Reitsma J, Bruns D, et al. Towards complete assessment and accurate reporting studies of diagnostic accuracy: the STARD initiative. Clin Radiol 2003;58:575-580.

For a complete list of references, please access the full guideline at www.aan.com/guidelines

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