2025 ACP临床指南：门诊急性发作性偏头痛的药物治疗

指南神经内科· 头痛与疼痛 · 2025

Applicability

These recommendations apply to nonpregnant and nonlactating adults with acute, episodic, moderate to severe migraine headache in outpatient settings. Most participants in the included studies were females Outpatient Pharmacologic Treatment of Acute Episodic Migraine Headache CLINICAL GUIDELINE of reproductive age with a history of 1 to 8 acute, episodic, moderate to severe migraine headaches per month, with or without aura, and with or without concomitant use of medication to prevent migraine. No eligible studies included participants with mild migraine headaches, and studies in nonoutpatient settings were excluded.

# CLINICAL CONSIDERATIONS

CLINICAL CONSIDERATIONS

• This guideline assessed the comparative effectiveness of medications that are beneficial to treat acute, episodic, moderate to severe migraine to help clinicians select which medication treatment or treatments to initiate (Figure 1 ). • Ask patients if they used an NSAID, acetaminophen, or the combination of an NSAID and acetaminophen to treat episodic migraine headache and ensure that they are using the appropriate dosage. Consider increasing the dosage of an NSAID or acetaminophen without exceeding the recommended maximum daily dose in patients who do not achieve sufficient pain relief but may not be receiving an adequate or acceptable dose. • If patients use an adequate dose of an NSAID or acetaminophen and still do not have sufficient pain relief, then add a triptan to an NSAID, or to acetaminophen when NSAIDs are contraindicated or not tolerated. • Be aware that patients who do not tolerate or have inadequate response to a recommended migraine treatment may respond to another within the same drug class. Choice of a specific NSAID (aspirin, celecoxib, diclofenac, ibuprofen, or naproxen) or triptan (almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, or zolmitriptan) should be based on individualized decision making, taking into consideration patient preferences on such factors as route of administration and cost. • Consider treating mild episodic migraine headache with an NSAID, acetaminophen, or the combination of an NSAID and acetaminophen. • Although available comparative effectiveness data were uncertain, there is evidence supporting efficacy for CGRP antagonists-gepants (rimegepant, ubrogepant, or zavegepant) or ergot alkaloid (dihydroergotamine). Consider using these options to treat moderate to severe acute episodic migraine headache in nonpregnant outpatient adults who do not tolerate or have inadequate response to combination therapy of a triptan and an NSAID or acetaminophen. • Consider using the ditan lasmiditan to treat moderate to severe acute episodic migraine headache in nonpregnant outpatient adults who do not tolerate or have inadequate response to all other pharmacologic treatments included in this guideline. • Do not use opioids or butalbital for the treatment of acute episodic migraine. • Consider using a nonoral triptan and an antiemetic in people having severe nausea or vomiting.

• In people of childbearing potential and in those who are pregnant or breastfeeding, discuss the AEs of pharmacologic treatments during pregnancy and lactation. • Counsel patients to begin treatment of migraine headache as soon as possible after its onset, using combination therapy (such as a triptan with an NSAID or acetaminophen) to improve efficacy. • If the episodic migraine occurs frequently or treatment does not provide an adequate response, the addition of preventive medications may be warranted ( 16 ). • Patients should be aware of medication overuse headache, which is a potential complication of migraine treatment. Medication overuse headache is defined as headache occurring on 15 or more days per month for at least 3 months in people with a preexisting headache disorder that develops because of overuse of acute medication. Also, be aware that the threshold for medication overuse headache varies by treatment (for example, ≥15 days per month with NSAIDs; ≥10 days per month with triptans). • Highlight the importance of lifestyle modifications with patients, including staying well hydrated, maintaining regular meals, securing sufficient and consistent sleep, engaging in regular physical activity (preferably moderate to intense aerobic exercise), managing stress with relaxation techniques or mindfulness practices, and, where applicable, pursuing weight loss for those who are overweight or obese. Also, explore modifiable migraine triggers or contributing factors during a detailed history.

• Prescribe less costly recommended medications (17) .

# TREATMENTS WITH NO RECOMMENDATIONS

TREATMENTS WITH NO RECOMMENDATIONS

The CGC determined that comparative evidence was inconclusive to inform recommendations for monotherapy with a CGRP antagonist-gepant, the ergot alkaloid dihydroergotamine, or the ditan lasmiditan but addressed these pharmacologic treatments in the Clinical Considerations section. The CGC determined that these 3 treatment options compared with placebo were efficacious for the acute treatment of episodic migraine. However, CGRP antagonists-gepants and dihydroergotamine had very little comparative evidence for prioritized outcomes. For lasmiditan, there was either insufficient-certainty evidence for any comparative effectiveness findings or no data on prioritized health outcomes.

The CGC developed this guideline according to ACP's guideline development process (10) and policy on disclosure of interests and management of conflicts of interest (11) . ACP is a GRADE (Grading of Recommendations, Assessment, Development and Evaluation) Center, and the CGC used GRADE methods to develop this guideline, including Evidence-to-Decision tables when reporting the evidence (Figure 2 ; Supplement, available at Annals.org) (12) . The Appendix (available at Annals.org) lists the key questions (Appendix Table 1 , available at Annals.org) for the supporting systematic review (8) and details the methods for the guideline and systematic review. ACP completes the Guidelines International Network (GIN) Standards for Reporting form (13) for each guideline it publishes; the form can be found in GIN's International Guidelines Library or on ACP's website (www.acponline.org/clinicalinformation/guidelines/guideline-process).

# SYSTEMATIC REVIEW OF BENEFITS AND HARMS AND SUMMARY OF THE EVIDENCE

SYSTEMATIC REVIEW OF BENEFITS AND HARMS AND SUMMARY OF THE EVIDENCE

This guideline is based on an accompanying systematic review and network meta-analysis (8) completed by the ACP Center for Evidence Reviews (CER) at Cochrane Austria. The accompanying systematic review (8) and Evidence-to-Decision tables (Supplement) provide a detailed summary of findings.

OUTCOMES OF INTEREST

Benefits and Harms

The CGC and CGC Public Panel independently rated the importance of clinical outcomes as critical, important, or less important for decision making

CLINICAL GUIDELINE

Outpatient Pharmacologic Treatment of Acute Episodic Migraine Headache (Appendix Table 2 , available at Annals.org). The prioritized outcomes used in the Summary of Findings tables and appraised for certainty of evidence were pain freedom and pain relief at 2 hours; sustained pain freedom and sustained pain relief up to 48 hours; need for rescue medication within 24 hours; nausea, vomiting, and restored physical function at 2 hours; and overall and serious adverse events (AEs). In addition, information on AEs was captured through U.S. Food and Drug Administration medication labels. The CGC considered the directionality, magnitude of effects, confidence intervals, and GRADE ratings to interpret the effects of individual prioritized outcomes and made judgments across all outcomes for each comparison to develop the recommendations.

Public and Patient Values and Preferences

The CGC incorporated public and patient values and preferences for eligible interventions when developing this clinical guideline. The CGC considered evidence about the values and preferences of the public and patients from 2 sources, the accompanying rapid review regarding patients' values and preferences (9) and consultation with the CGC Public Panel. The CGC Public Panel participated in the outcome rating exercise, provided preferences for interventions based on the systematic review's findings on benefits and harms (8) , and provided feedback on the draft guideline recommendations.

Economic Evidence

The CGC considered economic evidence from cost-effectiveness analyses (CEAs) and resource utilization (intervention cost) data when developing this clinical guideline. The accompanying rapid review (8) summarizes the evidence on the economic value of pharmacologic interventions for acute episodic migraine headache based on willingness-to-pay thresholds reported in high-quality CEAs that are applicable to the United States (Appendix Table 3 , available at Annals.org). The CGC also considered resource utilization (intervention cost) data from annualized wholesale acquisition cost (WAC) (Supplement) for each pharmacologic treatment of interest (14) . Outpatient Pharmacologic Treatment of Acute Episodic Migraine Headache CLINICAL GUIDELINE

RECOMMENDATIONS

A visual clinical guideline for this topic displaying a visual summary of the recommendations, rationales, and clinical considerations, alongside an interactive data visualization, is available at Annals.org (15).

Recommendation 1: ACP recommends that clinicians add a triptan to a nonsteroidal anti-inflammatory drug to treat moderate to severe acute episodic migraine headache in outpatient settings for nonpregnant adults who do not respond adequately to a nonsteroidal anti-inflammatory drug (strong recommendation; moderate-certainty evidence).

EN_PAPER

Pharmacologic Treatments of Acute Episodic Migraine Headache in Outpatient Settings: A Clinical Guideline From the American College of Physicians

Authors

Abstract

The American College of Physicians (ACP) developed this guideline based on the best available evidence on the comparative benefits and harms of pharmacologic treatments of acute episodic migraine headache, patients' values and preferences, and economic evidence about these pharmacologic treatments.

Methods: This guideline is based on a systematic review and network meta-analysis of the comparative benefits and harms of pharmacologic treatments of acute episodic migraine headaches, as well as systematic reviews of patients' values and preferences and comparative cost-effectiveness analyses. The Clinical Guidelines Committee evaluated the following clinical outcomes using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach: pain freedom and pain relief at 2 hours; sustained pain freedom and sustained pain relief up to 48 hours; need for rescue medication within 24 hours; nausea, vomiting, and restored physical function at 2 hours; and overall and serious adverse events (AEs). Additional data on AEs were captured through U.S. Food and Drug Administration medication labels.

Audience and Population: The audience for this clinical guideline is physicians and other clinicians. The population is adults with acute episodic migraine headache (defined as 1 to 14 headache days per month) managed in outpatient settings.

Recommendation 1: ACP recommends that clinicians add a triptan to a nonsteroidal anti-inflammatory drug to treat moderate to severe acute episodic migraine headache in outpatient settings for nonpregnant adults who do not respond adequately to a nonsteroidal antiinflammatory drug (strong recommendation; moderatecertainty evidence).

Recommendation 2: ACP suggests that clinicians add a triptan to acetaminophen to treat moderate to severe acute episodic migraine headache in outpatient settings for nonpregnant adults who do not respond adequately to acetaminophen (conditional recommendation; low-certainty evidence).

M igraine is a prevalent and disabling condition, ranking as the second leading cause of global disability (expressed as years lived with disability) in all adults and the top cause in females aged 15 to 49 years (1, 2) . In the United States, migraine affects approximately 16% of people, and females are more affected than males (21% of females and 11% of males) (3) . Migraine is disproportionately prevalent in adults aged 18 to 44 years (18%), people who are unemployed (21%), and those with a household income less than $35 000 per year (20%) (4) . Migraine-related disability has increased in the United States despite the prevalence of migraine remaining relatively consistent for the past 30 years (5) . Migraine accounts for about 4 million emergency department visits and more than 4.3 million office visits per year (3), representing an important health problem and a substantial economic burden of more than $78 billion annually CLINICAL GUIDELINE in medical expenses and lost productivity in the United States (6) .

Migraine is characterized by recurrent episodes of headache of usually moderate to severe intensity lasting 4 to 72 hours with or without aura (sensory disturbances); generally pulsating; and often accompanied by nausea, vomiting, photophobia, or phonophobia. Disabling episodes can interfere with daily living and affect quality of life.

Migraine remains underdiagnosed and undertreated (7) . Many pharmacologic options are available to adults with migraine headache, including nonspecific over-thecounter pain pharmacotherapies (such as nonsteroidal anti-inflammatory drugs [NSAIDs]) and migraine-specific drugs (such as triptans and dihydroergotamine). Newer, more costly therapeutic classes (that is, calcitonin gene-related peptide antagonists [CGRP antagonists-gepants] and selective 5-hydroxytryptamine 1F [5-HT 1F ] agonists [ditans]) have emerged as potential alternative treatments.

PURPOSE AND SCOPE

The purpose of this clinical guideline from the American College of Physicians (ACP) is to present clinical recommendations to prioritize among effective pharmacologic treatments of acute episodic migraine headaches, based on the best available evidence on the comparative benefits and harms of these treatments (8) , consideration of patients' values and preferences (9) , and economic evidence (8) .

Pharmacologic treatments considered in this guideline for the treatment of acute episodic migraine headache were initially identified through scoping of the scientific literature for drugs previously shown to be effective compared with placebo and through clinical input from the topic expert panel and the Clinical Guidelines Committee (CGC). The pharmacologic treatments included in the final list were selected through a stepwise approach based on the following criteria: availability in the United States, evidence supporting efficacy of pharmacologic treatments (compared with placebo) in published systematic reviews, and alignment with eligibility criteria defined in the comparative effectiveness systematic review used to inform this ACP clinical guideline (8) . Additional details on the selection of treatments are available in Figure 1 .

The comparative effectiveness review included the following pharmacologic treatments:

• Analgesic: acetaminophen

POPULATION

The population is adults with acute episodic migraine headache (defined as 1 to 14 headache days per month) managed in outpatient settings. This guideline does not address adults who have chronic migraine (defined as ≥15 headache days per month), status migrainosus (a migraine that lasts > 3 days), or other primary or secondary headache disorders or adults with probable migraine (those with migrainelike headaches missing one of the features required to fulfill all diagnostic criteria for a type or subtype of migraine).

INTENDED AUDIENCE

The intended audience is physicians and other clinicians caring for adults with acute episodic migraine headache in outpatient settings.

CLINICAL GUIDELINE DEVELOPMENT PROCESS

Comparative effectiveness evidence showed that the combination of a triptan (sumatriptan) and an NSAID (naproxen) had the greatest net benefit, with a larger net benefit than monotherapy with a triptan (moderate-certainty evidence), an NSAID (aspirin, celecoxib, diclofenac, ibuprofen, or naproxen; high-certainty evidence), acetaminophen (low-certainty evidence), or a CGRP antagonist-gepant (low-certainty evidence). The combination of a triptan (rizatriptan) and acetaminophen had a similar net benefit to triptan monotherapy (lowcertainty evidence), but all prioritized benefit outcomes with data showed a directionally favorable relationship for the combination of a triptan and acetaminophen. This combination also showed a greater net benefit than acetaminophen (low-certainty evidence) (Supplement). On the basis of these data, the CGC determined that the combination therapy of a triptan and an NSAID had the largest net benefit, followed by the combination of a triptan and acetaminophen.

The CGC considered that some participants in the included studies had tried over-the-counter medications, such as NSAIDs, acetaminophen, or both, before enrolling in trials, and that the use of these medications is common in nonpregnant adults with moderate to severe episodic migraine before additional care is sought. The CGC determined that triptans are associated with more AEs than NSAIDs and acetaminophen. Although these AEs are generally mild (for example, fatigue, dizziness, and nausea) (Supplement), it is important to consider that they could still affect daily activities and quality of life in some people. When formulating the recommendations, the CGC also considered the evidence of patients' values and preferences showing that they probably prioritize effectiveness for pain relief over accompanying symptoms and harms (moderate-certainty evidence) and that "some pain relief" may be more important than "absence of pain" (low-certainty evidence) (Supplement) (9) .

Combination therapy of a triptan (sumatriptan) and an NSAID (naproxen), compared with triptan monotherapy, resulted in a higher likelihood of sustained pain relief up to 48 hours after initial treatment (130 more events per 1000 treated people) and lower likelihood of using rescue medication at 24 hours (130 fewer events

Grading Certainty of Evidence

High

Moderate

Low

Confident that the true effect lies close to the estimate of the effect (the intervention "results in" the effect).

Moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a sizable possibility that it is substantially different (the intervention "probably results in" the effect).

Confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect (the intervention "may result in" the effect).

Grading Strength of Recommendations

Strength

Balance

Outpatient Pharmacologic Treatment of Acute Episodic Migraine Headache per 1000 treated people) (high-certainty evidence).

Monotherapy with a CGRP antagonist-gepant may have a lower likelihood of pain freedom and relief at 2 hours, as well as sustained pain freedom up to 48 hours after initiating medication treatment, than the combination of a triptan and an NSAID (lowcertainty evidence) (Supplement). Compared with triptan monotherapy, the ergot alkaloid dihydroergotamine may not differ in pain relief at 2 hours (low-certainty evidence), but triptan monotherapy probably had a higher likelihood of freedom from nausea and vomiting at 2 hours (200 and 40 more events per 1000 people,

Outpatient Pharmacologic Treatment of Acute Episodic Migraine Headache respectively; moderate-certainty evidence) and may result in a lower likelihood of rescue medication use within 24 hours of treating an acute migraine (140 fewer events per 1000 treated people; low-certainty evidence) (Supplement). Overall, the net benefit of these treatments was worse, and costs were meaningfully higher than those of recommended treatments. Annualized WAC of CGRP antagonists-gepants ranged from $4959 to $5994 for the oral formulations and was $8800 for the intranasal spray formulation. Annualized WAC for intranasal spray and injectable formulations of dihydroergotamine was $1320 and $4042, respectively (Supplement).

EVIDENCE GAPS AND RESEARCH NEEDS

There is a critical need for funding agencies, such as the Patient-Centered Outcomes Research Institute or National Institute of Neurological Disorders and Stroke, to support well-designed, comparative effectiveness trials of newer medications to treat moderate to severe episodic migraine compared with the combination of a triptan and an NSAID or acetaminophen. These trials should focus on the combination therapies as initial treatment options and in patients who did not achieve adequate relief with an initial pharmacologic treatment attempt for a moderate to severe acute episodic migraine. The trials should also be long enough to provide efficacy data across multiple migraine headaches rather than focusing on the effects of a single migraine headache. Further, longer trial periods will increase the likelihood that enrolled participants will have a migraine during the trial and be analyzed, as opposed to being excluded from analyses as was the case for several included studies in the systematic review used to inform this clinical guideline (8) .

AREAS OF INSUFFICIENT EVIDENCE

Most of the studies analyzed in this report compared an intervention of interest versus a placebo (the common comparator in the network meta-analysis); only some were direct head-to-head comparison studies. The comparative evidence among acetaminophen, combination therapy of an NSAID (aspirin) and acetaminophen, lasmiditan, dihydroergotamine, and CGRP antagonistsgepants (rimegepant, ubrogepant, and zavegepant) was very limited. Evidence is insufficient to draw firm conclusions about the comparative benefits and harms of triptans compared with lasmiditan and CGRP antagonistsgepants. These head-to-head comparisons are listed in bullet points in the Supplement. The systematic review identified only 1 CEA comparing 3 drug classes (triptans, CGRP antagonists-gepants, and the ditan lasmiditan). No CEAs were identified assessing other pharmacologic treatments of interest included in this guideline.

AREAS OF NO EVIDENCE

Included studies focused on a single migraine headache, with an absence of efficacy data across multiple migraine headaches. The accompanying systematic review (8) did not identify head-to-head comparative studies for lasmiditan, celecoxib, eletriptan, frovatriptan, or naratriptan. In addition, it did not find comparative effectiveness evidence eligible for this clinical guideline to evaluate the efficacy of switching pharmacologic treatments in patients who did not achieve adequate relief with an initial pharmacologic treatment attempt for an acute migraine headache. Note: Clinical guidelines are meant to guide care based on the best available evidence and may not apply to all patients or individual clinical situations. They should not be used as a replacement for a clinician's judgment. Any reference to a product or process contained in a guideline is not intended as an endorsement of any specific commercial product. All ACP clinical guidelines are considered automatically withdrawn or invalid 5 years after publication or once an update has been issued.

Financial Support: Financial support for the development of this guideline comes exclusively from the ACP operating budget.

Disclosures: Disclosure forms are available with the article online. All financial and intellectual disclosures of interest were declared, and potential conflicts were discussed and managed. No other committee members were recused from participation due to a conflict interest. A record of disclosures of interest and management of conflicts is kept for each Clinical Guidelines Committee meeting and conference call and can be viewed at www. acponline.org/clinical_information/guidelines/guidelines/ conflicts_cgc.htm.

Corresponding Author: Amir Qaseem, MD, PhD, MHA, American College of Physicians, 190 N. Independence Mall West, Philadelphia, PA 19106; e-mail, aqaseem@acponline.org.

Outpatient Pharmacologic Treatment of Acute Episodic Migraine Headache CLINICAL GUIDELINE medications. Then, in a second step they performed a coherent search strategy in databases (Ovid Medline ALL, Embase [Elsevier], and CENTRAL [Cochrane Library/ Wiley] ) in May 2023 to identify randomized controlled trials published in English applying date limits based on the search dates of the original systematic reviews. Those searches were updated in October 2024. The CER and the CGC used the GRADE approach to summarize the review findings and to rate the certainty of evidence for clinical outcomes.

Rationale

The CGC determined that triptans, NSAIDs (aspirin, celecoxib, diclofenac, ibuprofen, and naproxen), acetaminophen, and the combination of a triptan with an NSAID or acetaminophen were efficacious compared with placebo for the acute treatment of moderate to severe episodic migraine (Figure 1 ) (8) .

The CGC recommends combination therapy of a triptan and an NSAID or acetaminophen in nonpregnant adults seeking acute treatment of an episodic migraine who have an inadequate response to NSAIDs and acetaminophen monotherapies. Further, the CGC recognizes that triptan monotherapy is an effective treatment with evidence supporting its comparative benefits for treating episodic migraine (Supplement). However, the CGC determined that combination therapy of a triptan (sumatriptan or rizatriptan) and an NSAID (naproxen) or acetaminophen had a greater net benefit than triptan monotherapy (Supplement). The evidence was uncertain for combination therapy of an NSAID (aspirin) and acetaminophen (Supplement).

The evidence on patients' values and preferences (9) showed that they probably prioritize the effectiveness on pain outcomes over accompanying symptoms, potential harms, or other treatment attributes (such as convenience or route of administration, consistency of effect, ability to function normally, numbers of doses required, and cost) (moderate-certainty evidence). In addition, they may consider some pain relief more important than absence of pain and prefer oral medication over other routes of administration (suppository, nasal spray, subcutaneous injection, intramuscular injection, or intravenous injection) (lowcertainty evidence) (Supplement). When asked to prioritize treatment options considered in this guideline, the CGC Public Panel showed a preference for using acetaminophen, an NSAID, triptan monotherapy, or combination therapies of a triptan and an NSAID or acetaminophen (Supplement). None of the panel reported a preference for using dihydroergotamine or CGRP antagonists-gepants. The CGC Public Panel noted that factors supporting their preferences were benefits, harms, and costs, with costs and benefits being the most frequently identified important factors for decision making. The Public Panel also reported a general preference for oral treatments, which is consistent with the accompanying systematic review on values and preferences (low-certainty evidence) (9) .

ith resource utilization (cost of interventions) (Supplement).

||Recommendations| |---|---|

|Analgesic|Combination therapies|

|Acetaminophen|Triptan and NSAID|

|CGRP antagonists-gepants|Triptan and acetaminophen|

|Rimegepant||

|Ubrogepant||

|Zavegepant||

|Ditan||

|Lasmiditan||

|Ergot alkaloid||

|Dihydroergotamine||

|NSAIDs||

|Aspirin|Clinical Considerations|

|Celecoxib Diclofenac potassium Ibuprofen Naproxen Triptans Almotriptan Eletriptan Frovatriptan Naratriptan Rizatriptan Sumatriptan|Efficacious treatments with no or insufficient comparative evidence CGRP antagonists-gepants Rimegepant Ubrogepant Zavegepant Ditan Lasmiditan Ergot alkaloid Dihydroergotamine|

|Zolmitriptan||

|Combinations||

|Acetaminophen, NSAID (aspirin),||

|and caffeine||

|Triptan (||

|Analgesic|| |---|---|

|Acetaminophen||

|CGRP antagonists-gepants||

|Ubrogepant Zavegepant Selective 5-HT 1F agonist (ditan)|Published SRs: efficacy (vs. placebo)|

|Ergot alkaloids Dihydroergotamine (mesylate) Ergotamine (tartrate)|ACP SR eligibility criteria|

|Ergotamine (tartrate) +|Interventions without data|

|caffeine|supporting efficacy|

|NSAIDs|compared with placebo:|

|Aspirin|Tolfenamic acid|

|Celecoxib|Indomethacin|

|Diclofenac potassium||

|Ibuprofen||

|Indomethacin||

|Ketorolac||

|Naproxen||

|Tolfenamic acid||

|Serotonin-1B and||

|serotonin-1D||

|receptor agonists (triptans)||

|Almotriptan||

|Eletriptan||

|Frovatriptan||

|Naratriptan||

|Rizatriptan||

|Sumatriptan||

|Combinations of any of the||

|listed treatments||

|5-HT||

The CER conducted the supporting systematic review and network meta-analysis on benefits and harms (8) , which was funded by ACP. The systematic reviewers followed a 2-step approach for the literature searches. First, they conducted literature searches in MEDLINE (Ovid) in February 2023 to detect relevant systematic reviews of placebo-controlled and head-to-head trials of migraine Appendix Table 1 . Key Questions for the Systematic and Rapid Reviews Key Question 1a: What are the comparative benefits and harms of initial pharmacologic treatments in adult patients with acute attacks of episodic migraine? Do treatment benefits and harms vary by: Demographic characteristics (age, sex, gender, race/ethnicity)?

The presence of menstrual migraine? Key Question 1b: What are the comparative benefits and harms of second-step pharmacologic treatments in adult patients who did not achieve adequate relief with an initial pharmacologic treatment attempt for an acute migraine attack? Do treatment benefits and harms vary by: Demographic characteristics (age, sex, gender, race/ethnicity)?

The presence of menstrual (cyclical) migraine? Key Question 2a: What are patients' values and preferences regarding initial pharmacologic treatments of acute attacks of episodic migraine? Key Question 2b: What are patients' values and preferences regarding second-step pharmacologic treatments of acute attacks of episodic migraine? Key Question 3a: What is the cost-effectiveness of initial pharmacologic treatments in adult patients with acute attacks of episodic migraine? Do treatment outcomes vary by: Demographic characteristics (age, sex, gender, race/ethnicity)?

The presence of menstrual (cyclical) migraine? Key Question 3b: What is the cost-effectiveness of second-step pharmacologic treatments in adult patients who did not achieve adequate relief with an initial pharmacologic treatment attempt for an acute attack of episodic migraine? Do treatment outcomes vary by: Demographic characteristics (age, sex, gender, race/ethnicity)?

The presence of menstrual (cyclical) migraine?

Peer Review

The supporting systematic review and clinical guideline each had a peer-review process through the journal. The guideline was posted online for comments from ACP Regents and Governors, who represent internal medicine and its subspecialty physician members at the national and international level. The CGC considered any feedback before finalizing the guideline.

Guideline Expiration or Living Guideline Process

All ACP clinical guidelines are considered automatically withdrawn or invalid 5 years after publication or once an update has been issued. † The intervention is dominated by strict dominance (the intervention is less effective and more costly than an alternative) or extended dominance (there is an alternative that is more effective and more cost-effective).

References

Disclosures of Interests and Management of Conflicts of Interest

All financial and intellectual disclosures of interest were declared, and potential conflicts were discussed and managed in accordance with CGC policy (11) . Disclosure of interests and management of any conflicts can be found on ACP's website (www.acponline.org/about-acp/whowe-are/leadership/boards-committees-councils/clinicalguidelines-committee/disclosure-of-interests-and-conflictof-interest-management-summary-for-clinical-guidelines).

Key Questions and Clinical Outcomes of Interest

The CGC identified the key questions (Appendix Table 1 ). The ACP CER at Cochrane Austria assessed the efficacy of potentially eligible interventions when compared with placebo and included only efficacious interventions. Members of the CGC (clinicians and nonclinician public members), CGC Public Panel, and topic expert panel independently rate the importance of evaluated outcomes a priori (Appendix Table 2 ). The CGC prioritized outcomes for decision making on the basis of the ratings.

Authors of the accompanying systematic review (9) searched databases (Ovid Medline ALL and EBSCO CINAHL), used relevant studies as seed references for backward citation searching in Scopus (Elsevier) and citationchaser (https://estech.shinyapps.io/citationchaser), and manually searched the reference lists of pertinent systematic reviews for any quantitative study that reported patients' values and preferences about pharmacologic treatment of acute episodic migraine published in English from inception to October 2024. The CER and the CGC used the GRADE approach to summarize review findings and rate the certainty of evidence about values and preferences 19) . The CGC Public Panel participated in the outcome rating exercise, provided its views on the findings from the systematic review about the benefits and harms of interventions, shared preferences about treatment options, and provided feedback on the draft recommendations.

The accompanying rapid review included studies addressing CEAs of eligible interventions (8) Registry) for any peer-reviewed and non-industry-conducted CEA or trial-based or model-based economic evaluation that reported outcomes with units of health (such as quality-adjusted life-years) in U.S. settings, included upto-date reference cases, and was published in English from January 2013 to October 2024. The CER used the Drummond checklist (20) to assess the methodological quality of eligible CEAs and used a scale developed by Doran (21) to assess the overall risk of bias. The CER graded the certainty of evidence in accordance with GRADE guidance (22, 23) . The CGC applied a predefined set of value thresholds, derived through informal consensus, to categorize interventions as high, intermediate, low, or no value (Appendix Table 3 ).

The CGC estimated annualized WAC (14) for each eligible pharmacologic treatment; it was calculated by estimating 4 migraine headache days per month, which was the median frequency reported in studies included in the systematic review used to inform this clinical guideline. The CGC judged if there were meaningful differences based on the distribution of costs associated with resource utilization (cost of interventions) (Supplement).

Author contributions are available at Annals.org.

Author Contributions: Conception and design: A. Qaseem, I. Etxeandia-Ikobaltzeta, T.J. Wilt, C.S. Harrod, T.G. Cooney, C.J. Crandall, E. Balk, D.K. Owens, P.G. Shekelle. Analysis and interpretation of the data: A. Qaseem, J.A. Tice, I. Etxeandia-Ikobaltzeta, T.J. Wilt, C.S. Harrod, T.G. Cooney, E. Balk, A.M. Linsky, A.J. Obley, D.K. Owens, J. Yost. Drafting of the article: A. Qaseem, I. Etxeandia-Ikobaltzeta, C.S. Harrod, J. Lewis, M.C. Miller, T. Shamliyan, J. Yost. Critical revision for important intellectual content: A. Qaseem

APPENDIX. DETAILED METHODS

Detailed Methods of the Systematic Review and Guideline

Details of the ACP guideline development process can be found in ACP's methods articles (10, 11) .

Committee Composition and Stakeholder Involvement

The CGC is a multidisciplinary group of 14 to 15 members: 12 to 13 are internal medicine physicians representing various clinical areas of expertise across hospital and ambulatory medicine, including internal medicine subspecialties, and 2 are nonphysician public members. The CGC Public Panel, involving 6 members from the public, provided input at various points in the guideline development process (see Public and Patient Values and Preferences). The CGC convened a topic expert panel made up of clinical topic experts, clinicians, and epidemiologists to inform the systematic review and assist in refining the scope and key questions (see acknowledgments of individual members in the accompanying systematic review [8] ).

Systematic Review on Benefits and Harms

引用 / 出处

2025 ACP临床指南：门诊急性发作性偏头痛的药物治疗. 2025.