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Structured Abstract
Objectives:
This systematic review (SR) evaluates the literature on pharmacologic and nonpharmacologic interventions to prevent or treat attacks of primary headaches (migraine, tension headache, cluster headache, and other trigeminal autonomic cephalgias) in women who are pregnant (or attempting to become pregnant), postpartum, or breastfeeding.
Data sources:
We searched Medline®, Embase®, Cochrane CENTRAL, CINAHL®, and ClinicalTrials.gov to identify primary studies (comparative studies and single-group studies) in women who are pregnant (or attempting to become pregnant), postpartum, or breastfeeding with primary headache (direct evidence). We searched Medline, the Cochrane Database of Systematic Reviews, and Epistemonikos for existing SRs of harms of interventions in pregnant women regardless of indication (indirect evidence).
Review methods:
We extracted study data into the Systematic Review Data Repository. We assessed the risk of bias and evaluated the strength of evidence (SoE) using standard methods. The PROSPERO protocol registration number is CRD42020158310.
Results:
Our searches for direct and indirect evidence yielded 8,549 citations and 2,788 citations, respectively. Sixteen primary studies comprising 14,185 patients in total and 26 SRs met criteria. Risk of bias was high for most primary studies. We found no evidence addressing effectiveness of any intervention for prevention of primary headaches. We found one single-group study (of topiramate) and 11 SRs reporting potential harms of various interventions used for primary headache prevention during pregnancy. Antiepileptics (except lamotrigine), venlafaxine, tricyclic antidepressants, benzodiazepines, beta blockers, prednisolone, and oral magnesium may be associated with increased risk of fetal/child adverse effects, but calcium channel blockers and antihistamines may have low risk of adverse effects (indirect evidence; low to moderate SoE). For treatment of acute attacks of primary headache, we found three randomized controlled trials (RCTs), eight nonrandomized comparative studies (NRCSs), and four single-group studies. Combination metoclopramide and diphenhydramine may be more effective than codeine in reducing severity of migraine or tension headache; adverse effect profiles were similar (1 RCT; low SoE). Triptans used for migraine during pregnancy were not associated with spontaneous abortions or congenital anomalies (8 NRCSs; low SoE). Acetaminophen, prednisolone, indomethacin, ondansetron, antipsychotics, and intravenous magnesium may be associated with increased risk of fetal/child adverse effects, but low-dose aspirin (either during pregnancy or postpartum) may not be associated with increased risk (indirect evidence; low to moderate SoE). There is insufficient evidence to make conclusions about the benefits or harms of nonpharmacologic treatments used during pregnancy, including acupuncture (1 RCT); biofeedback, relaxation therapy, and physical therapy (1 RCT and 2 single-group studies); nerve blocks (1 single-group study); and transcranial magnetic stimulation (1 single-group study).
Conclusions:
Evidence regarding the benefits and harms of all interventions in women who are pregnant (or attempting to become pregnant), postpartum, or breastfeeding is insufficient, or at best of low strength of evidence. Future research is needed to identify the most effective and safe interventions for preventing or treating primary headaches in these populations of women.
Contents
Suggested citation:
Saldanha IJ, Roth JL, Chen KK, Zullo AR, Adam GP, Konnyu KJ, Cao W, Bhuma MR, Kimmel HJ, Mehta S, Riester MR, Sorial MN, Balk EM. Management of Primary Headaches in Pregnancy. Comparative Effectiveness Review No. 234. (Prepared by the Brown Evidence-based Practice Center under Contract No. 290-2015-00002-I.) AHRQ Publication No. 20(21)-EHC026. Rockville, MD: Agency for Healthcare Research and Quality; November 2020. DOI: https://doi.org/10.23970/AHRQEPCCER234. Posted final reports are located on the Effective Health Care Program search page.
This report is based on research conducted by the Brown Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2015-00002-I). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.
None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.
The information in this report is intended to help healthcare decision makers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of healthcare services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.
This report is made available to the public under the terms of a licensing agreement between the author and the Agency for Healthcare Research and Quality. This report may be used and reprinted without permission except those copyrighted materials that are clearly noted in the report. Further reproduction of those copyrighted materials is prohibited without the express permission of copyright holders.
AHRQ or U.S. Department of Health and Human Services endorsement of any derivative products that may be developed from this report, such as clinical practice guidelines, other quality enhancement tools, or reimbursement or coverage policies, may not be stated or implied.
AHRQ appreciates appropriate acknowledgment and citation of its work. Suggested language for acknowledgment: This work was based on an evidence report, Management of Primary Headaches in Pregnancy, by the Evidence-based Practice Center Program at the Agency for Healthcare Research and Quality (AHRQ).
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