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Pharmacologic treatment of migraine

Comparison of guidelines

A. Schuurmans, MD C. van Weel, FRCGP

ABSTRACT

OBJECTIVE To compare guidelines (not the primary studies) for pharmacologic treatment of migraine as to methods of

guideline development; recommendations, particularly on triptans; and quality of supporting evidence (with emphasis on comparative studies of triptans versus ergot alkaloids and nonsteroidal anti-infl ammatory drugs [NSAIDs]).

DATA SOURCES

We searched MEDLINE via PubMed for guidelines on migraine management published since 1990 in any language; in addition, we browsed the Internet for information.

STUDY SELECTION We found nine clinical guidelines on migraine; one guideline, not supported by references, was excluded.

SYNTHESIS Preference for triptans is not well founded and is largely based on comparisons with placebo. Too few studies

compared new drugs with established ones (NSAIDs or dihydroergotamine). Guidelines that propose a hierarchy for selection of drugs are opinion-based rather than evidence-based.

CONCLUSION The current lack of evidence from comparative studies seriously limits development of evidence-based clinical

practice guidelines for pharmacologic treatment of migraine.

RÉSUMÉ

OBJECTIF Comparer les directives (et non les études primaires) concernant le traitement pharmacologique de la migraine, sous

l’aspect particulier des méthodes de développement de ces directives, des recommandations émises, notamment pour les triptans, et de la qualité des preuves à l’appui (notamment pour les études comparant les triptans aux alcaloïdes de l’ergot et aux anti-infl ammatoires non stéroïdiens [AINS]).

SOURCES DES DONNÉES On a utilisé PubMed pour identifi er dans MEDLINE les directives publiées dans toutes les langues

depuis 1990 sur le traitement de la migraine; on a également consulté Internet.

CHOIX DES ÉTUDES Neuf lignes directrices de pratique sur la migraine ont été repérées; une directive sans support

bibliographique a été exclue.

SYNTHÈSE La préférence pour les triptans n’est pas bien fondée, reposant principalement sur des comparaisons avec placebo.

Trop peu d’études ont comparé les nouveaux médicaments aux médicaments traditionnels (AINS ou dihydroergotamine). Les directives préconisant un ordre de préférence pour les médicaments reposent sur des opinions plutôt que sur des preuves.

CONCLUSION À l’heure actuelle, il n’y a pas assez d’études comparatives sur le traitement pharmacologique de la migraine

pour permettre l’émission de lignes directrices de pratique fondées sur des preuves.

This article has been peer reviewed.

Cet article a fait l’objet d’une révision par des pairs.

Can Fam Physician 2005;51:838-843.

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everal guidelines on diagnosis and treatment of migraine headache have been developed since the introduction of sumatriptan, the fi rst drug in its class, around 1990. Until that time, ergot alka- loids were known to be eff ective against migraine, and nonsteroidal anti-infl ammatory drugs (NSAIDs) and acetaminophen were often prescribed.

Sumatriptan seemed to mark the beginning of a new period in migraine treatment. Th e effi cacy of sumatriptan was self-evident, but by the time it was introduced, the essential question was whether the much more expensive sumatriptan was cost- eff ective compared with “simple” analgesics, such as acetaminophen, NSAIDs, or ergot alkaloids.

Another issue was sumatriptan’s safety for chronic use. Th is required studies that compared sumatrip- tan with available (reference) medications, a general problem1 in introducing new drugs. In compar- ing migraine treatment guidelines published since 1990, we were particularly interested in the role these guidelines defi ned for triptans and the evi- dence to support this role (particularly in compar- ing triptans with reference medications).

One problem for family physicians is that dif- ferent guidelines deal with the same clinical topic.

Th is can lead to information overload or even con- fl icting guidance. Th is is why we decided to com- pare guidelines on migraine management.

Sources of information

In our systematic search for published guidelines on migraine treatment, we used MEDLINE through PubMed. Th e point of departure for the search was the occurrence of the word “migraine” in the title.

In keeping with this, we specifi ed that publications should include the key terms guideline, guidelines, or consensus and that the key terms pharmaco- therapy or drug therapy had to occur. In view of the small number of publications, no limitations were

applied with regard to the target group (fi rst line) of the guidelines. As we were particularly inter- ested in the position of triptans, we restricted the search to guidelines published after 1990.

In addition, we browsed the Internet via AltaVista using the terms “clinical guidelines,” “prac- tice guidelines,” and “medical guidelines.” Th e web- sites of institutes known to participate in guideline development were also searched. We also looked in a few relevant and recent reviews for references to other guidelines.

We summarized and subdivided recommenda- tions found in the guidelines into fi rst-, second-, and third-choice medications according to the guide- lines or to our best judgment. Special emphasis was placed on the role of triptans and their posi- tion in comparison with acetaminophen, NSAIDs, and ergot alkaloids.

Results

The search produced 32 articles; nine were clin- ical guidelines for migraine management.2-10 We could not use one guideline because the recom- mendations were not supported by references.2 A summary of recommendations from the guidelines investigated is shown in Table 1.2-10 Some guide- lines3,4,6,9 recommend a stepwise approach: acute attacks are treated initially with the safest, least expensive therapies with a switch to migraine- specifi c medication only if initial treatment fails.

Stratifi ed management, on the other hand, speci- fi es migraine severity and recommends migraine- specifi c agents for severe attacks.7

Th e remaining guidelines,5,7,10 which do not make recommendations in order of preference, give each investigated drug a place based on all references.

Table 12-10 shows medications in order of preference, partly as stated by the guidelines,3,4,6,7,9 and partly (a somewhat arbitrary arrangement) according to our best judgment.5,8,10 Table 22-4,6-22 summarizes the position of triptans and (dihydro-)ergotamine in relation to NSAIDs and ergot alkaloids (only key studies are presented). Th ere are few comparative studies; most recommendations mention the eff ec- tiveness of sumatriptan among other triptans. Most Dr Schuurmans is a clinical pharmacologist at the

Dutch Institute for Eff ective Use of Medicine in Utrecht, Th e Netherlands. Professor van Weel teaches in the Department of Family Medicine at the University Medical Centre in Nijmegen, Th e Netherlands.

everal guidelines on diagnosis and treatment of migraine headache have been developed since the introduction of sumatriptan, the fi rst drug in its class, around 1990. Until that time, ergot alka-

S

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guidelines, however, emphasize the lack of research on ergotamine and, to a lesser degree, dihydroer- gotamine.

Discussion

The guidelines we investigated differ greatly in thoroughness and content. The AGREE instru- ment23 is an internationally accepted tool for assessing guidelines, but unfortunately it does

not enable users to grade the quality of guide- lines. Th e guidelines we studied ranged from the American guideline, which gives each investigated drug a place based on all published studies, to the German guideline, which recommends a stepwise approach with conventional medication but has only weak support for this recommendation. Use of levels of evidence is relatively common. The guidelines that make no use of them3,9,10 mostly discuss and evaluate the references they cite.3,10 Table 1. Summary of recommendations from investigated guidelines: Where no evidence is listed in the Table, none had been presented in the guideline.

GUIDELINE

FIRST-CHOICE TREATMENT (LEVEL OF EVIDENCE)

SECOND-CHOICE TREATMENT (LEVEL OF EVIDENCE)

THIRD-CHOICE TREATMENT (LEVEL OF EVIDENCE)

The Netherlands. NHG.3 (1999) Stepwise approach

Antiemetic combined with acetaminophen or ASA

Antiemetic combined with NSAID Sumatriptan, ergotamine The Netherlands. Quality-control

committee of the Netherlands Society for Neurology.4 (1997)

Stepwise approach

Acetaminophen, ASA, or NSAID combined with an antiemetic if necessary

(I-III)

Sumatriptan (I) Ergotamine (I, III)

United States. American Academy of Family Physicians and American College of Physicians–American Society of Internal Medicine.6 (2002) Stepwise approach

NSAIDs (ASA, ibuprofen, naproxen, tolfenamic acid, or a combination) (I, II)

Intranasal DHE (I) eg, naratriptan, sumatriptan,

rizatriptan, zolmitriptan

Intranasal opiate (I) or intravenous antiemetic (II)

Germany. German Migraine and Headache Society.9 (1998) Stepwise approach

Antiemetic combined with ASA, acetaminophen, or NSAID

Ergotamine, DHE

Sumatriptan

Canada. Canadian Headache Society.7 (1997)

Stratifi ed approach

ASA (I), acetaminophen (III); NSAID (ibuprofen, naproxen) (I);

antiemetic (III)

NSAID (ibuprofen, naproxen, mefenamic acid) (I), sumatriptan (I), DHE (I), ergotamine (II)

Intravenous antiemetic (I), NSAID (ketorolac) (I), intravenous phenothiazine (I),* sumatriptan (I), DHE (I), intranasal opiate (I), corticosteroid (II)

United States. US Headache Consortium.5 (2000) Without ranking

Intravenous antiemetic (II), acetaminophen (II), NSAID (I, II) (ASA, ibuprofen, naproxen, tolfenamic acid), phenothiazine (II),* intranasal or subcutaneous DHE (I, II), sumatriptan (I), naratriptan (I), rizatriptan (I), zolmitriptan (I)

Ergotamine (II), NSAID (intramuscular ketorolac) (II)

Barbiturate (II, III), opiate (I), corticosteroid (III)

Canada. Canadian Association of Emergency Physicians.8 (1999) (Only serious migraine emergency) Without ranking

Intravenous antiemetic (I),

intravenous phenothiazine (I),* NSAID (I), sumatriptan (I), DHE (II)

Haloperidol (III), intranasal lidocaine (I), intranasal opiate (I), corticosteroid (II)

Canada. Therapeutics Initiative.10 (1997)

Without ranking

Acetaminophen, ASA, NSAID (ibuprofen, naproxen, diclofenac) combined with an antiemetic, oral sumatriptan

Intravenous antiemetic, phenothiazine,* DHE, NSAID (ketorolac), subcutaneous sumatriptan, opiate

DHE, opiate, intranasal sumatriptan

ASA—acetylsalicylic acid, DHE—dihydroergotamine, NHG—Netherlands College of General Practitioners, NSAID—nonsteroidal anti-infl ammatory drug.

Levels of evidence: I—At least one properly conducted randomized controlled trial, systematic review, or meta-analysis; II—Other comparison trials or non-randomized cohort, case-control, or epidemiologic studies, preferably with more than one study; III—Expert opinion or consensus statements.

* Not as an antiemetic.

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Orders of preference in guidelines3,4,9 are opinion- based, but this is not always mentioned.3,9 One guideline7 classifies migraine headache on the basis of its severity without mentioning that this classifi cation is not based on the reference stud- ies. Another guideline6 mentions that the question

of which approach is best (stepwise or stratifi ed management) is still unresolved.24,25

The place of triptans varies enormously (Table 12-10). Th is is at least remarkable, given the sparse international literature and the fact that all guidelines were based on (systematic) searches of Table 2. Role of triptans: Comparative studies with NSAIDs and ergot alkaloids, and the role of (dihydro-)ergotamine.

GUIDELINE RESULTS OF TRIALS (LEVEL OF EVIDENCE, WHERE GIVEN)

The Netherlands. NHG.3 (1999)

Stepwise approach

Sumatriptan compared with:

• NSAIDs: equally eff ective11,12

• Ergotamine: sumatriptan more eff ective, but headaches recurred sooner13

• DHE: sumatriptan works somewhat faster, but headaches recurred sooner14 Ergotamine: eff ectiveness demonstrated15,16

The Netherlands. Quality- control committee of the Netherlands Society for Neurology.4 (1997) Stepwise approach

Sumatriptan compared with other medications: records the small number of studies, not the conclusions12,13 (I) Ergotamine and DHE: conclusions based mainly on clinical experience16,17 (II)

United States. American Academy of Family Physicians and American College of Physicians–

American Society of Internal Medicine.6 (2002) Stepwise approach

Oral sumatriptan compared with:

• NSAIDs: equally eff ective11,12,18 (I)

• Ergot or caff eine: sumatriptan more eff ective13 (I)

Subcutaneous sumatriptan compared with subcutaneous and intranasal DHE: sumatriptan more eff ective, but headaches recurred sooner14,19 (I) Intramuscular sumatriptan compared with intravenous chlorpromazine: equally eff ective20 (III)

Ergotamine: inconsistent results17 (III)

• Subcutaneous, intravenous, and intramuscular DHE: no studies demonstrate eff ectiveness as monotherapy21 (III)

• Intranasal DHE: less eff ective than subcutaneous sumatriptan19 (II)

• Subcutaneous DHE: after 3 hours equally eff ective as subcutaneous sumatriptan14 (I) Germany. German Migraine

and Headache Society.9 (1998) Stepwise approach

Oral sumatriptan compared with NSAIDs: not reviewed12 Ergotamine and DHE: eff ectiveness mentioned but not supported22

Canada. Canadian Headache Society.7 (1997)

Stratifi ed approach

Oral and subcutaneous sumatriptan compared with:

• NSAID: equally eff ective11 (I)

• DHE: sumatriptan more eff ective14 (I)

Ergotamine: eff ectiveness not demonstrated17,22 (I)

Subcutaneous, intravenous, intramuscular, and intranasal DHE: eff ective14 (I) Canada. Canadian

Association of Emergency Physicians.8 (1999) (Only serious migraine emergency) Without ranking

Oral sumatriptan compared with ergotamine and caff eine: eff ective13 (I) Subcutaneous sumatriptan compared with:

• Subcutaneous DHE: sumatriptan faster, but more recurrence of headaches14 (I)

• Intranasal DHE: sumatriptan more eff ective, but shorter acting19 (II) DHE: few studies, no conclusions21 (III)

Intranasal DHE: eff ective19 (II) Canada. Therapeutics

Initiative.10 (1997) Without ranking

Oral sumatriptan compared with ergotamine with caff eine and ASA: no visible diff erence11-13 Subcutaneous sumatriptan compared with:

• Subcutaneous DHE: equally eff ective14

• Intranasal DHE: sumatriptan more eff ective19 Ergotamine: eff ectiveness not demonstrated22 Intranasal DHE: eff ective19

ASA—acetylsalicylic acid, DHE—dihydroergotamine, NHG—Netherlands College of General Practitioners, NSAID—nonsteroidal anti-infl ammatory drug.

Levels of evidence: I—At least one properly conducted randomized controlled trial, systematic review, or meta-analysis; II—Other comparison trials or non-randomized cohort, case-control, or epidemiologic studies, preferably with more than one study; III—Expert opinion or consensus statements.

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this literature. National medicopolitical diff erences might have a role here, as only a few guidelines consider costs in their recommendations.3,9 Given the many assumptions in the articles focusing on costs, it seems that cost-eff ectiveness calculations are somewhat theoretical.26,27

A factor that hampers development of high- quality guidelines for migraine treatment is that recently developed drugs, such as the triptans, have been the subject of more studies and more pub- lications than old ones. Consequently, all guide- lines list sumatriptan with supporting evidence.

Th is, however, is evidence against placebo because there are only few comparisons with other eff ective drugs (Table 22-4,6-22). Recommendations on ergot alkaloids are, to a large extent, based on opinion or consensus.

Although the side eff ects of ergotamine (particu- larly vasoconstriction, nausea, and vomiting) are well known,16 triptans also have side eff ects (such as chest pain).28,29 Lack of data on the relative long- term safety of triptans has led to the conclusion that they are equal to the older drugs in terms of side eff ects. Again this is opinion, rather than evi- dence-based information.

Limitations

Th is study was limited by the time frame chosen for selecting guidelines, but more information from recent reviews28-32 and results of studies compar- ing sumatriptan and NSAIDs33,34 do not essentially change the fi ndings of this study.

Conclusion

Guidelines should support medical practitioners in pursuing the highest quality of care for their patients.

But family physicians who turn to the guidelines on migraine for support for pharmacotherapy will prob- ably not fi nd much help. Diff erent guidelines recom- mend diff erent approaches, even when they are written for the same clinical care setting, such as primary care.

Actual guideline-prescribed care will depend to a large extent on which guideline has been used. Th is intro- duces an unsatisfactory element of chance.

A comparison of the effectiveness and safety of all available migraine drugs, over all stages of migraine severity, would benefi t family physicians.

As long as these data are unavailable, guidelines will have little to off er. As long as new drugs are not tested before they are introduced in studies that compare their therapeutic value in the prac- tical settings in which patients are usually treated, important information is unavailable to those who have to design guidelines. We would welcome a policy in which new medicines are accepted only when they have an evidence-based value over exist- ing standard therapy.

Competing interests None declared

Correspondence to:A. Schuurmans, MD, clinical pharmacologist, Tijinkweg 6, 7421 ED Deventer, The Netherlands; or Professor C. van Weel, Department of Family Medicine, University Medical Centre Nijmegen, PO Box 9101, 6500 HB Nijmegen, The Netherlands

EDITOR’S KEY POINTS

• Family doctors frequently treat migraine headache, and there are numerous guidelines with recommendations for best care. The intro- duction of triptans added a new but expensive alternative.

• Some guidelines are based on an evaluation of the evidence, but ranking of treatments is somewhat arbitrary and based on con- sensus. This is because there are few trials comparing older treat- ments with triptans.

• Family doctors need to be aware of the lack of convincing evidence that triptans are more eff ective than older treatments.

POINTS DE REPÈRE DU RÉDACTEUR

• Le médecin de famille doit souvent traiter des céphalées migraineuses et il existe du nombreuses directives préconi- sant un traitement de préférence à un autre. L’introduction des triptans représente une option nouvelle, quoique dispendieuse.

• Certaines directives reposent sur une évaluation des preuves, mais l’établissement d’un ordre de préférence pour les traite- ments est plutôt arbitraire et relève du consensus. La raison en est qu’il y a peu d’études comparant les agents tradition- nels aux triptans.

• Le médecin de famille doit savoir qu’il y a peu de preuves convain- cantes que les triptans sont supérieurs aux traitements traditionnels.

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