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French Guidelines for the Diagnosis and Management of in Adults and Children

Gilles Gkraud, MD,l Michel Lank-i-Minet, MD,’ Christian Lucas, MD,3 and Dominique Valade, MD,4 on behalf of the French Society for the Study of Migraine Headache (SFEMC) lDepartment of Neurology, Rangueil Hospital, Toulouse, 2Pain Centel; Pasteur Hospital, Nice, 3Depurtment of Neurology, Sulengro Hospital, Lille, and 4Heuduche Emergency Centel; Lur-iboisi&e Hospital, Paris, France

ABSTRACT

Background: The French Recommendations for Clinical Practice: Diagnosis and Therapy of Migraine are guidelines concerning the overall management of patients with migraine, including diagnostic and therapeutic strategies and assessment of disability Objective: This article summarizes the guidelines as they apply to adults and children, and proposes future direction for steps toward optimal treatment of migraine in patients in France. Methods: The recommendations were categorized into 3 levels of proof (A-C) according to the National Agency for Accreditation and Evaluation in Health (ANAES) methodology and were based on a professional consensus reached among members of the Working Group and the Guidelines Review Group of the ANAES. Results: The International Headache Society diagnostic criteria for migraine should be used in routine clinical practice. Recommended agents for the treatment of migraine in adults include nonsteroidal anti-inflammatory drugs, acetylsalicylic acid (ASA) monotherapy or in combination with , acetaminophen monotherapy, , tartrate, and mesylate. Patients should use the medication as early as possible after the onset of migraine headache. For migraine prophylaxis in adults, the following can be used: , , , or as first-line treatment, and , , sodium, or as second-line treatment. Migraine in children can be distinguished from that in adults by shorter duration (2-48 hours in children aged ~15 years), more frequent bilateral localization, fre- quent predominant gastrointestinal disturbances, and frequent pallor hailing the onset of the attack. The follow- ing drugs are recommended in children and adolescents: ibuprofen in children aged >6 months, diclofenac in children weighing >16 kg, naproxen in children aged >6 years or weighing >25 kg, ASA alone or in combina- tion with metoclopramide, acetaminophen alone or in combination with metoclopramide, and ergotamine tar- trate in children aged >10 years. Conclusions: These guidelines are intended to help general practitioners to manage migraine patients according to the rules of evidence-based medicine. (Clin Ther: 2004;26: 1305-13 18) Copyright 0 2004 Excerpta Medica, Inc. Key words: guidelines, migraine, diagnosis, treatment, adults, children.

Accepted for publicationJuly 22, 2004. Printed in the USA. Reproduction in whole or part IS not permitted. 0149-2918/04/$19.00

Copyright@ 2004 Excerpta MedicaJnc. 1305 CLINICAL THERAPEUTICS®

INTRODUCTION Level A recommendations are based on established The French Recommendations for Clinical Practice: scientific evidence with the highest level of proof. Diagnosis and Therapy of Migraine 1 are guidelines These include randomized, comparative, controlled concerning the overall management of patients with trials with high statistical power and without major migraine, including diagnostic and therapeutic strate- bias; and/or meta-analyses of randomized, comparative gies and the assessment of disability caused by controlled trials; or combinations of well-conducted migraine. The guidelines were designed for health studies. care professionals involved in the care of patients Level B recommendations are based on scientific with migraine (eg, general practitioners, specialists, evidence provided by studies with an intermediate and pharmacists). This article summarizes the guide- level of proof, such as randomized, comparative trials lines as they apply to adults and children. The com- with lower statistical power; well-conducted, nonran- plete text, with full argumentation and references, is domized trials; or cohort studies. available (in French) elsewhere. Level C recommendations are based on evidence These guidelines were developed at the request of with a lower level of proof, such as that provided by the French Society for the Study of Migraine and case-control studies or case series. Headache (Soci t fran aise d' tude des et Unless specified otherwise, the recommendations des c phal es) by the National Agency for Accred- proposed were based on a professional consensus itation and Evaluation in Health (ANAES). The reached among members of the Working Group and ANAES is an official national agency that uses precise the Guidelines Review Group of the ANAES. The methodology to constitute Working and Review absence of evidence with a high level of proof does Groups, including specialists, general practitioners, not mean that the recommendations are not pertinent members of the national drug agency, and others. or useful; rather, it should be an incentive for addi- Pharmaceutical companies are not represented in the tional studies when possible. ANAES, and everyone in the Working and Review Groups must sign a form indicating no conflicts of MIGRAINE IN ADULTS interest before participating. Prevalence Headaches other than migraine are not covered in According to the diagnostic criteria described later, these guidelines except as part of the differential diag- the estimated prevalence of migraine in adults aged nosis. Other associated topics (ie, conditions associat- 18 to 65 years is 12 to 17 in 100, with a female pre- ed with migraine [apart from associated psychiatric dominance (female-male ratio, 3:1) .3# disorders], predisposing migraine factors, migraine in pregnancy, menstrual migraine, migraine and oral contraception, migraine and smoking, transformed Table I. International Headache Society classification of migraine, and rare and complicated forms of migraine migraine.* headache [International Headache Society (IHS) Codes 1.2.2-1.5, Table 12]) are not discussed in this article. Code Description In addition, a complete comparison of these guide- I.I Migraine without aurar lines with those of other national and international 1.2 Migraine with aura guidelines is beyond the scope of this article, because 1.2.1 Typical aura with migraine headache~ habits, drugs, and behaviors are different between 1.2.2 1.2.6 Other types of auras§ countries. However, as shown in the reference list, these 1.3 1.5 Rare and complicated forms of migrainell guidelines were based on evidence-based medicine and 1.6. I Probable migraine without aura, fulfilling all the diagnostic criteria~ except one used data largely from the international literature. ~Adapted with permission. 2 GRADING OF RECOMMENDATIONS ~SeeTable II2 for diagnostic criteria of migraine without aura. INTHE GUIDELINES ¢SeeTable III2 for diagnostic criteria of typical aura with migraine headache. §Includes familial and sporadic hemiplegic migraine, basilar-type migraine. The recommendations are categorized into 3 levels IIIncludes retinal migraine, chronic migraine, status migrainous, persi~ent (A-C), as follows. aura, migrainous infarction.

]306 G. G@raud et al.

Clinical Diagnosis Table III. Diagnostic criteria of typical aura with migraine The recommended diagnostic criteria for migraine headache.* were established in 1988 by the IHS, based on an expert consensus} These criteria are summarized in A. >2 Attacks Fulfilling criteria B D Tables 112 and 111.2 B. Aura consisting of > I of the Following, but not motor weaknesst: Only the diagnoses of migraine without aura (Code Fully reversible visual symptoms, including positive Features (eg, 1.1), typical aura with migraine headache (Code flickering lights, spots, or lines) and/or negative Features (eg, 1.2.1), and probable migraine without aura, fulfilling loss orvision) Fully reversible sensory symptoms, including positive Features all the diagnostic criteria except one (Code 1.6.1) are (eg,"pins and needles") and/or negative Features (eg, numbness) covered in this article because the other types of Fully reversible dysphasic speech disturbance migraine (Codes 1.2.2-1.5) are rarely encountered. C. >2 of the Following: The diagnosis of migraine is based on a clinical Homonymous visual symptoms and/or unilateral sensory triad (professional consensus): symptoms _>1 Aura symptom developing gradually over _>5 minutes • Recurrent attacks separated by totally pain-free and/or different aura symptoms occurring in succession over intervals _>5 minutes • Characteristic migraine symptoms Each symptom lasts 5 60 minutes • Unremarkable clinical examination D. Headache Fulfilling criteria B D for IHS migraine classification The IHS diagnostic criteria for migraine without I. I (migraine without auraS) begins during the aura or Follows aura and for typical aura with migraine headache aura within 60 minutes E. Physical examination between attacks is unremarkable. In case of are presented in Tables 112 and 111,2 respectively. doubt, organic diseases should be ruled out using appropriate These criteria are easy to use and enable the clini- investigations cian to ask essential questions in a logical and structured manner. It is recommended to use the IHS = International HeadacheSociety. ~Adapted with permission.2 The term migraine with aura has replaced the former term, classic or accompanied migraine. tFor more details, see reference 5. $See Table II2 for diagnostic criteria of migraine without aura. Table II. Diagnostic criteria of migraine without aura.*

A. _>5 Attacks Fulfilling criteria B D B. Migraine attacks lasting 4-72 hours (untreated or unsucces> IHS criteria in routine clinical practice (professional fully treated) consensus). C. Headache with _>2 of the following characteristics: Critical analysis of these diagnostic criteriademon- Unilateral localization strates an acceptable level of interobserver variability6 Pulsating quality Moderate or severe pain intensityt and good specificity,but unsatisfactory sensitivity.7,s Aggravation by or causing avoidance of routine physical Therefore, Lhe criteriaare restrictiveand cannot provide activity (eg, walking, climbing stairs) the diagnosis in all pauents with migraine. To avoid this D. The presence o[_>l of the Following symptoms occurs during problem in roudne practice and thus avoid depriving the headache: certain patients of appropriate management, it is rec- and/or Photosensitivity and phonosensitivity ommended to use Code 1.6.] (probable migraine with- E. Physical examination between attacks is unremarkable. In case out aura, fulfilling all diagnostic criteria except one). of doubt, organic diseases should be ruled out using appropriate Migraine must be distinguished from tension investigations headache, a more diffuse headache that is nonpulsat- ing, not aggravated by exercise, and less intense (mild *Adapted with permission.2 The term migraine without aura has replaced the former term, common migraine. The presence of criteria AE fulfills the or moderate pain) than migraine, with no accompa- strict diagnostic definition of migraine without aura (International Headache nying gastrointestinal (GI) symptoms but sometimes Society [IHS] classification code I. I [Table 12]). If one of the criteria AD is with phonosensitivity and/or photosensitivity (IHS not fulfilled, the diagnosis is probable migraine without aura (IHS code 1.6. I criteria of tension headache2). Migraine and tension [Table 12]). tAs measured using a 4qtem painqntensity scale (0 = none, I = mild, 2 = headache are often associated or intertwined in the moderate, and 3 = severe). same patient. 9

1307 CLINICAL THERAPEUTICS®

Role of Additional DiagnosticTesting This diary can be used by the physician to better Computed Tomography and Magnetic Resonance determine the severity of the migraine, to take into Imaging account the impact of the disease on ADLs, and to There is no indication for cerebral computed assist in the choice of treatment and type of follow-up tomography (CT) or magnetic resonance (MR) im- measures required. aging (professional consensus) in patients with and/or depressive disorders concurrent migraine defined by IHS diagnostic criteria for with migraine further aggravate disability. 1~-16 migraine with or without aura or to differentiate Careful history taking is recommended to look for migraine from tension headache. 1° In patients with signs of depression or anxiety, and to focus therapy known migraine, cerebral CT scanning or MR imag- not only on the pain but also on any associated ing is recommended (professional consensus) in cases depression and anxiety. of sudden-onset headache (so-called "thunderclap" Several scales have been developed to measure the headache) and recent (past 3 months) headache dif- quality of life and productivity of migraineurs. 17-~9 ferent from the usual migraine. In cases of acute, Two scales--the Short-Form Headache Impact Test2° severe, intense headache that develops in <1 minute and the Migraine Disability and Assessment and lasts >1 hour, emergency noncontrast cerebral (MIDAS)X~--have been translated into French but CT scanning or MR imaging is recommended. M have not been assessed in migraine management in France. Among the migraine population, it would be Electroencephalography important to identify those patients who require reg- Electroencephalography (EEG) is not indicated in ular medical care. Further research should be per- patients with migraine as defined by the IHS diagnos- formed in this area. tic criteria ~2 (professional consensus). EEG is not recommended to rule out secondary headaches; CT Pharmacologic Treatment scanning and MR imaging are indicated for this (pro- Migraine is a largely underdiagnosed condition. In fessional consensus). French studies, 3,~ 30% to 45% of migraineurs have never consulted a physician for migraine, and are Sinus and Cervical Spine Radiography, unaware that they have migraine and that appro- Ophthalmic and Orthoptic Examination, priate treatment is available. This situation leads and Abdominal Sonography to widespread self-medication for attacks; -50% of There is no indication for radiography of the sinus- migraineurs use over-the-counter drugs to treat their es or the cervical spine, ophthalmic examination, attacks. orthoptic examination, or abdominal sonography for Study of the treatment patterns of migraineurs has the diagnosis of migraine (professional consensus). revealed overconsumption of nonspecific , with several doses being taken during the same Assessment of Disability to Optimize Management attack and with half of patients having no significant Migraine has a serious impact on patients' lives migraine relief 2 hours after dosing. = It also reveals because of the frequency of the attacks (>2 attacks/ underuse of migraine-specific treatments by patients month in 42%-50% of patients); their duration (>24 who would benefit from them, such as those with hours in 39% of patients); their intensity (severe or severe attacks, those whose migraine is disabling, very severe in 48%-74% of patients); the presence of and/or those who do not attain relief with nonspecific associated GI symptoms; and the disruption of activ- drugs. ities of daily living (ADLs), including those in occu- pational, social, and family life. 3,<~3 Acute Treatment To achieve optimal management of migraine, it is Acute treatments for migraine attacks can be classi- recommended (professional consensus) to advise fied into 2 categories: nonspecific agents (analgesics patients to keep a diary Patients should note the date, and nonsteroidal anti-inflammatory drugs [NSAIDs]) duration, intensity, and triggering factors of the and migraine-specific agents ( derivatives and attack, as well as any medications used to treat it. triptans), which, by their effect on (5-HT~B/~>)

1308 G. G@raud et al.

receptors, inhibit neurogenic inflammation and activities? vasodilatation considered to be the cause of migraine If the patient says yes to all 4 of these questions, his headache. 23 or her treatment regimen should not be changed. If the patient says no to at least 1 of these 4 ques- Nonspecific Agents tions, the physician should prescribe an NSAID and a Recommended nonspecific agents include NSAIDs together. The patient should be instructed to (naproxen sodium, 2<25 ibuprofen, 2<2r ketoprofen, 28 start with the NSAID and use the triptan only if relief or diclofenac potassium > [level A]); acetylsalicylic is not obtained 2 hours after receiving the NSAID. If acid (ASA) monotherapy3° (level A) or in combina- the NSAID is ineffective or poorly tolerated, a triptan tion with metoclopramide31,32 (level A); and aceta- should be prescribed as the first-line drug. minophen monotherapy33 (level C). Combining There are various medicaP r and economic38 argu- metoclopramide hydrochloride with ASA improves ments for using triptans as the first-line treatment in the risk for GI symptoms but does not potentiate the patients with severe attacks and/or patients who are effect of ASA (professional consensus). No greatly disabled by migraine. However, due to the clinical evidence shows that combining with lack of validated scales in French for routine clinical acetaminophen or ASA potentiates the effect of these practice, no professional consensus exists there. drugs. Adjunctive use of caffeine cannot be recom- mended because it may induce drug abuse or Patients PreviouslyTreated with Migraine-SpecificAgents dependence/addiction (professional consensus). If a patient treats with ergotamine tartrate, his or Opiate analgesics (eg, codeine sulfate, propoxy- her treatment regimen should not be changed if he or phene hydrochloride, hydrochloride, mor- she has effective migraine relief (no pain or mild phine sulfate) should not be used alone or in combi- pain) 2 hours after receiving ergotamine, has no con- nation for migraine because of the risk for abuse or traindications to its use, and is not requiring increas- dependence/addiction (professional consensus). 2~ ingly higher doses 3. (professional consensus). Each triptan has efficacy and tolerability profiles Migraine-Specific Agents different from the others, but these differences are Triptans 23 (level A) are effective for migraine minimal 23 (level A). A patient who does not respond headache, associated GI symptoms, and phono-/ to 1 triptan may respond to another. > A patient who photosensitivity. Ergotamine tartrate 3. (level B) and does not respond to a particular triptan during an ini- dihydroergotamine mesylate nasal spray 35 (level A) or tial migraine attack may respond to it in subsequent injection36 (level B) are recommended. attacks (level A). Before concluding that a particular Only the compounds listed in Table IV are licensed triptan is ineffective in a patient, it should be tried for in France (Autorisation de mise sur le march [AMM]) _>3 attacks, unless it is poorly tolerated (professional for the indication of the acute treatment of migraine. consensus).

Therapeutic Strategy Method of Use Patients PreviouslyTreated with NonspecificAgents Irrespective of the type of treatment, the patient During a patient's initial consultation, it is recom- should take the medication as early as possible after mended to ask the patient about his or her usual the onset of migraine headache. Delaying administra- migraine medication practices and the relief obtained tion of an oral triptan after the onset of a migraine with it (professional consensus), using the following headache might reduce the likelihood of complete questions: relief, increase the risk for headache recurrence and • Do you have significant relief <2 hours after tak- adverse effects, and prolong suffering*°#1 (level A). If ing the medication? an ergot derivative or triptan is being used, the patient • Is the medication well tolerated? should wait until a headache develops before treating • Do you take only 1 dose? an attack preceded by aura (professional consensus). • Two hours after taking the medication, can you For all patients with migraine, the total number resume normal occupational, social, and family of doses taken per month should be counted, using

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Z

C Table IV. Drugs licensed in France (Autorisation de mise sur le march~ [AMM]) for the indication of the acute treatment of migraine. %

Ages Treatment Type/ Approved Active Substance for; y Dose Adverse Effects Contraindications

Symptomatic treatments for migraine headache and associated GI disturbances Carbaspirin calcium + metoclopramide HCI >10 900 mg, given at attack onset Related to metoclopramide: Related to metoclopramide: neuropsychiatric disorders, tar-dive pheochromocytoma, GI bleeding, dyskinesia, extrapyramidal symptoms, stenosis or perforation of the GI tract, endocrine disorders history of drug-induced tar-dive dyskinesia

Lysine acetylsalicylate + metoclopramide > I 0 900 mg, given at attack onset Related to salicylate: GI disturbances, Related to salicylate: active hemorrhagic syndrome, gastroduodenal ulcer, hypersenZiv~ hypersensitivity reactions, to salicylates,risk for- hemordsage Reye's syndrome M igraine-specific treatments Ergot derivatives Hypersensitivity to ergot derivatives, peripheral vascular disease,coronary artery disease,shock, hypertension, severe infection, severe liver-failure Ergotamine taFLrate > I 0 Adults: 2 mg/d, max 6 mg/d and Ergotism, nausea, vomiting 10 mg/wk Children > I 0 years: half dose Dihydroergotamine mesylate >16 and Intranasal solution: I spray in each Intranasal solution: transient local <65 nostril at attack onset; injectable reactions, nasal obstruction, solution: I ampule, may be repeated rhinorrhea. once 30-60 min later- (max 2 mg/d Injectable solution: ergotism, and 8 mg/wk) precordial pain

(continued) Table IV. (Continued)

Ages Treatment Type/ Approved Active Substance for, y Dose Adverse Effects Contraindications

SSRAs 8 65 Vascular- flushing; veFLigo; asthenia; Hypersensitivity to SSRAs; history of ; nausea; vomiting; coronary myocardial infarction or ischemic spasm (< I% of attacks); moderate heart disease, coronary vasospasm or- severe hypeFLension; paresthesia; (Prinzmetal's angina), or- peripheral sensations of weakness, tingling, heat, vascular- disease, stroke, or- transient pressure, or- tightness ischemic attack; severe liver- failure; moderate or- severe hypeFLension or uncontrolled mild hypertension; combination with monoamine oxidase inhibitor- malate Tablet: 12.5 mg/d, max 25 mg/d Tablet: 40 mg/d, max 80 mg/d succinate Tablet: 2.5 mg/d, max 5 mg/d HCI Tablet: 2.5 mg/d, max 5 mg/d benzoate Tablet, lyophilisate: 10 20 mg/attack succinate Tablet: 50 100 mg/d, max 300 mg/d; subcutaneous injection: 6 mg/attack, may be repeated once; suppository: 25 mg, max 50 mg/d; nasal spray: 10 20 mg/attack Tablet: 2.5 mg/d max 10 mg/d; nasal spray: 5 mg/0.1 mL

GI = ga~rointe~inal; HCI = hydrochloride; max = maximum; SSRAs = selecLive serotonin receptor . CLINICAL THERAPEUTICS®

a diary, to identify excessive use of medication shown to be effective in the prophylactic treatment of (>10 d/mo for >3 months). Excessive use occurs fre- migraine ~2 (level B) and can be considered in some quently in patients with migraine and can lead to the patients, depending on their psychological profile. development of chronic daily headache related to Data ~3-~5 in the literature are insufficient to draw con- medication overuse 21 (professional consensus). This clusions about the efficacy of acupuncture, homeop- is true of all the migraine medications. ath> and cervical manipulation for the prevention of migraine. Migraine Prophylaxis Nonpharmacologic Prophylactic Treatments Pharmacologic Prophylaxis Relaxation, biofeedback, and cognitive and behav- Drugs prescribed for prophylactic treatment of ioral therapies for stress management have been migraine are listed in Table V. ~6#r The following drugs

TableV. Drugs* used in France for the prophylaxis of migraine in adults. 46,47

Active Substance Daily Dosage Adverse Effects Contraindications

Propranolol HCI 40 240 mg Common: asthenia, poor exercise tolerance; Asthma, heart failure, atrioventricular rare (<1% of attacks): insomnia, nightmares, block, bradycardia (note: possible impotence, depression, hypoglycemia aggravation of migraine with aura) Hetoprolol succinate I 0(~200 mg maleatet I 0~0 mg Atenololt 100 mg 80~40 mg Oxetorone fumarate 60 180 mg (I 3 tablets) Common: somnolence; rare (< I% of attacks): diarrhea requiring discontinuation Amitriptyline HCI 1030 mg in the evening Dry mouth, somnolence, weight gain Glaucoma, prostatic adenoma Pizotifen maleate Progressive dosage to Common: sedation, weight gain; rare (< 1% of Glaucoma, urethroprostatic disorders 3 tablets/d attacks): digestive disorders, vertigo, muscle (0.5 1.5 mg) pain, asthenia Valproate sodiumt 50(~ 1000 mg Nausea, weight gain, somnolence, tremor, Liver disease alopecia, abnormal liver function test results Hethysergide maleate 2 6 mg (I 3 tablets); Common: nausea, vertigo, insomnia; rare Hypertension, coronary insuf- discontinuation required (< I% of attacks): retroperitoneal fibrosis ficiency, arteriopathy, gastric u Icer, for I moq6mo liver and/or kidney failure Flunarizine HCI 10 mg (I tablet in the Common: somnolence, weight gain; rare Depression, extrapyramidal syndrome evening); <6 mo (<1% of attacks): depression, extrapyramidal consecutively syndrome Gabapentint 1200 2400 mg Nausea, vomiting, convulsion, somnolence, Hypersensitivity to gabapentin ataxia, vertigo 50 mg Somnolence, nasal congestion, dry mouth, Hypersensitivity to one of the active ejaculation disorders compounds; Parkinson's disease; severe heart, liver, and/or kidney failure Topiramate 50 200 mg Vertigo, ataxia, somnolence, dysarthria, Hypersensitivity to one of the active paresthesia, irritabili~ asthenia, weight loss compounds and/or to sulfamides

HCI = hydrochloride. *All of these drugs are given in tablet form. tThis drug has not been approved for the prophylaxis of migraine.

1312 G. G6raud et al. have been approved for this indication in France~6#7: reserved for patients with severe migraine resistant to flunarizine hydrochloride, maleate, other treatments. ~6 Dihydroergotamine (10-20 mg) is metoprolol succinate, oxetorone fumarate, pizotifen, widely used for first-line prophylaxis in France and is and propranolol hydrochloride (all level A); and dihy- well tolerated. ~6 However, its efficacy remains to be droergotamine and indoramin hydrochloride (both confirmed. level B). Amitriptyline hydrochloride is approved for the indication of refractory pain (level A). Starting Treatment The following drugs are approved for indications Prophylaxis should begin with a single drug, at a other than prophylactic treatment of migraine but are low dose. The dose should be increased progressive- also effective for this indication: , divalproate, ly until the optimal dose is achieved, with adverse valproate sodium, gabapentin, nadolol, naproxen sodi- effects taken into account. um, timolol maleate, and topiramate (all level A)28 There is no evidence that ASA, hydro- Evaluation of E~cacy chloride, cyclandelate, or is The efficacy of migraine prophylaxis should be effective in prophylaxis of migraine. assessed after >3 months of treatment. Treatment is considered to be effective if the frequency of migraine Therapeutic Strategy (Professional Consensus) attacks is reduced by >50%. It is also important to When to Use Pharmacologic Prophylaxis take into account the reduction in the consumption It is recommended to start prophylactic treatment of acute-treatment medications and the intensity and in 2 situations: (1) as a function not only of the fre- duration of the attacks as measured using the diary. quency and the intensity of the attacks but also of the ADL disability caused by them; and (2) when a Alternative Prophylaxis patient has taken 6 to 8 doses of acute migraine med- If prophylactic treatment is unsuccessful, and the ication per month for _>3 consecutive months, even if patient has not experienced any adverse effects, the the medication is effective, to avoid medication over- dose can be increased. Or, a different prophylactic use (this applies to migraine-specific and/or nonspe- drug can be used. After each prophylactic monother- cific agents). apy has been tried, 2 drugs may be combined, each at The introduction of preventive treatment should be a low dose to reduce the risk for adverse effects with combined with patient education. The patient should either drug. be advised that preventive treatment does not elimi- nate migraine attacks but does limit their frequency Discontinuation and intensity. Keeping an attack diary is helpful for If successful, prophylactic treatment should be assessing the efficacy of the prophylactic treatment. continued for 6 months to 1 year. The dose should then be decreased slowly (over 3-6 months) prior to Drugs to Use in Prophylaxis discontinuation. The same treatment can be restarted No compound has been shown to be more effica- if the frequency of the attacks increases again. cious in migraine prophylaxis compared with the others (level A). Thus, the choice of drug depends MIGRAINE IN CHILDREN on the risk-benefit ratio, including adverse effects, Prevalence contraindications, drug-drug interactions, and any The prevalence of migraine in children (aged 5 to comorbidities the patient may have. "+9 Taking into 15 years) is estimated to be between 3% and 10% in account the risk-benefit ratio, the following drugs France. 5o can be used: propranolol, metoprolol, oxetorone, or amitriptyline as first-line treatment; pizotifen, flunar- Clinical Diagnosis izine, valproate sodium, gabapentin, or topiramate as Migraine in children can be distinguished from that second-line treatment. Methysergide is effective for in adults by shorter duration (2-48 hours in children third-line prophylaxis, but its use is associated with a aged <15 years2), more frequent bilateral localization, risk for retroperitoneal fibrosis; thus, it should be frequent predominant GI disturbances, and frequent

1313 CLINICAL THERAPEUTICS®

pallor hailing the onset of the attack. 5° instruct patients and their families to use/administer As in adults, it is recommended to use IHS Code acute medications as early as possible after the onset 1.6.1 (probable migraine without aura, fulfilling all of migraine headache. The rectal route should be used the diagnostic criteria but one) to avoid depriving in cases of nausea or vomiting. The intranasal route some children of appropriate management. The lack should be used in children aged >12 years and in chil- of sensitivity of the IHS diagnostic criteria for dren weighing >35 kg. If acetaminophen, ASA, and migraine without aura is more pronounced in chil- other NSAID treatments are unsuccessful, sumatrip- dren than in adults. 51,52 tan nasal spray should be the next line of treatment. If aura develops preceding a migraine attack, the child Role of Additional DiagnosticTesting should wait for the development of headache before The role of additional diagnostic testing is the same treating with triptans or ergot derivatives. for children as in adults, except that indications for neu- roimaging should be expanded because of the difficul- Migraine Prophylaxis ty in establishing the cause of headache in children. 53 Nonpharmacologic Prophylaxis Relaxation, biofeedback, and cognitive and behav- Assessment of Disability to Optimize ioral therapies for stress management are recom- Management mended for migraine prophylaxis in children, as in As in adults, no quality-of-life scale has been vali- adults 58 (level B). These treatments have been shown dated in French. Instead, it is recommended to keep to be more effective than beta-blockers 59 (level B). a diary of the attacks to help the child and his or her family identify precipitating factors, evaluate treat- Pharmacologic Prophylaxis ment efficacy, and enable the physician to assess the Physicians should prescribe drugs as prophylactic characteristics of migraine (attack frequency, intensi- treatment only after failure of nonpharmacologic ty, and associated GI symptoms) and its impact on treatments (professional consensus). There is a lack of daily life (eg, missed school days). established scientific evidence about the efficacy of prophylactic treatments in children, but the following Pharmacologic Treatment drugs can be recommended if nonpharmacologic Acute Treatment treatments are unsuccessful or if migraine attacks are Nonspecific/Migraine-SpecificAgents particularly frequent or severe, with a significant The following drugs are recommended for children handicap in ADLs (professional consensus): flunar- and adolescents in acute first-line treatment of izine 5 mg/d in children aged >10 years, dihydroer- migraine (professional consensus): ibuprofen in chil- gotamine 5 to 10 mg/d, pizotifen 1 mg/d in children dren aged >6 months, 5~ diclofenac in children weigh- aged >12 years, propranolol 2 to 4 mg/kg.d, meto- ing >16 kg, naproxen in children aged >6 years or prolol 25 to 30 mg/d, oxetorone 15 to 30 mg/d, and weighing >25 kg, ASA alone or in combination with amitriptyline 3 to 10 mg/d. These compounds should metoclopramide, acetaminophen alone or in combi- be used at low doses to reduce the occurrence of nation with metoclopramide, and ergotamine tartrate adverse effects, particularly sedation. in children aged >10 years. Sumatriptan succinate nasal spray (10-20 mg) is effective55,56 (level A) for PROPOSITIONS FOR FUTURE ACTION the treatment of moderate to severe migraine attacks To optimize the treatment of migraine in patients in in adolescents aged 12 to 17 years. France, the MIDAS21 must be validated in studies of Data 57 in the literature are insufficient to draw con- migraine. The MIDAS also must be tested as an evalua- clusions about the efficacy of oral or injectable suma- tion tool for deciding when to initiate--and to test the triptan in children and adolescents, and sumatriptan effect of long-term treatment. Patients requiring regu- nasal spray in children aged 5 to 12 years. lar medical care should be identified. Migraine recom- mendations should be adapted for individual patients. Therapeutic Strategy Regarding prophylaxis, the efficacy of migraine It is recommended (professional consensus) to prophylaxis with dihydroergotamine must be evalu-

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ated using the methodology defined by the IHS. leurbanne), Olivier Joyeux (Valence), Catherine For children, valid and reliable diagnostic criteria Jung (Strasbourg), Lucette Lacomblez (Paris), Jacques must be developed. Also, the efficacy of acute treat- Lagarde (I2Isle-Jourdain), Pierre Landrieu (LeKremlin- ment and prophylactic treatment should be evaluated Bic tre), Claire Lejeune (Paris), Pierrette Lhez in this patient population. (Bordeaux), Claudie Locquet (Paris), Jacques Finally, due to rapid evolution of migraine treat- Maillecourt (Dreux), Alain Masclet (Thiers), H 1 ne ments, the recommendations established by the Work- Massiou (Paris), Jean Maupetit (Libourne), Jean- ing Group should be revised in 5 years. Fran ois Meder (Paris), Samuel Merran (Paris), G rard Mick (Voiron), Philippe Pariser (Paris), Jean ACKNOWLEDGMENTS Parrot (Paris), Andr Pradalier (Colombes), Robert These guidelines were drawn up at the request of Pujol (Saint-B at), Daniel Reizine (Paris), Catherine the French Society for the Study of Migraine Head- Rummens (Bayonne), Jean-Michel S nard (Toulouse), ache (Soci t fran aise d' tude des migraines et des Carole Sereni (Paris), Alain Serrie (Paris), Christine c phal es) by the ANAES. Tommasi-Davenas (V nisieux), Christophe Tzourio Members of the Working Group included: (Paris), Martine Veyri-Courtade (Toulouse), and Chairman: Gilles G raud (Toulouse); Project Francis Vuillemet (Colmar). Managers: Marie-Christine Mignon (ANAES, Paris) and Nathalie Preaubert (ANAES, Paris); Members: REFERENCES Gilles Baudesson (Saint-Ouen-Iiaum ne), Jacques 1. Guidelines for the diagnosis and therapeutic manage- Birge (Boulay), Fr d rique Brudon (Villeurbanne), ment of migraine headache m adults and children: Mayer Cikurel (Le Cheznay), Catherine Denis (Saint Clinical and economic aspects [m French]. Rev Neurol Denis), Elsa Diarte (Saint-Denis), Nathalie Dumarcet (Paris). 2003;159:451-45118. (Saint-Denis), Mohammed E1 Amrani (Paris), Louis- 2. Headache Classification Committee of the Inter- Pierre Jenoudet (Bron), Michel Lanteri-Minet national Headache Society The International Classi- (Nice), Christian Lucas (Lille), Jean-Fran ois Maurin fication of Headache Disorders, 2nd ed. Cephalalgia. (Arm es), Philippe Michel (Bordeaux), Naji Mimassi 2004;24(Suppl 1): 1-160. (Brest), Jean-Claude Mselati (Orsay), Philippe Nicot 3. Lant ri-Minet M, Lucas C, Leroy L. Framig 99. Lettre (Panazol), Clara Pelissier (Paris), Patrick Pochet Neurol. 2000;4(Suppl 5):5-19. (Clermont-Ferrand), Fran oise Radat (Bordeaux), 4. Henry P, Auray JP, Gaudm AF, et al. Prevalence and Jacques Robert (Melun), and Dominique Valade clinical characteristics of migraine disorders. GRIM2000: (Paris). A nationwide survey in France. Neurology. 2002;59: Members of the Guidelines Review Group includ- 232-237. ed: Daniel Annequin (Paris), Sylvie Aulanier (Le 5. Russell MB, Olesen J. A nosographic analysis of the Havre), Alain Autret (Tours), Laurent Barl (Lons- migraine aura in a general population. Brain. 1996; Le-Saunier), Patrick Bastien (ANAES), G rard 119:355-361. Mer (ANAES), Henri Becker (Cannes), Claude Belmas 6. Leone M, Filippini G, D'Amico D, et al. Assessment of (Perpignan), Fran ois Boureau (Paris), Philippe International Headache Society diagnostic criteria: A Bourrier (Le Mans), Jean-Claude Bourrin (Draguig- reliability study. Cephalalgia. 1994;14:280-284. nan), Nathalie Brion (Versailles), H 1 ne Chapoulart 7. Rasmussen BK,Jensen R, OlesenJ. A population-based (Bordeaux), Christelle Creac'h (Saint-Etienne), Anne analysis of the diagnostic criteria of the International Donnet (Marseille), Virgine Dousset (Bordeaux), Headache Society Cephalalgia. 1991;11:129-134. Alain Eschalier (Clermont-Ferrand), Nelly Fabre 8. Michel P, Dartigues JF, Henry P, et al, for the (Toulouse), Jean Feullet (Sorbiers), Fran ois Fr t Groupe de Recherche Interdisciplinaire sur la (Chaulnes), Jean-Yves Gauvrit (Lille), Bernard Gay Migraine (GRIM; Interdisciplinary Research Group on (Rions), Philippe Giffard (V nisieux), Patrick Ginies Migraine). Validity of the International Headache (Montpellier), Pierre Giraud (Annecy), Evelyne Society criteria for migraine. Neuroepidemiology. 1993; Guegan-Massardier (Rouen), Michel Hamon (Paris), 12:51-57. Philippe Holfliger (Nice), Michel Huguet (Vii- 9. Rasmussen BK, Jensen R, Schroll M, Olesen J.

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Address correspondence to: Gilles G raud, MD, Department of Neurology, H pital de Rangueil, TSA 50032, Toulouse 31059, France. E-mail: [email protected]

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