Evidence map›Paper›PMID 18788838›Full record

Trial reportCNS drugs2008

Oral zolmitriptan in the short-term prevention of menstrual migraine: a randomized, placebo-controlled study.

Michael M Tuchman, Angela Hee, Ugochi Emeribe, Stephen Silberstein

Abstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in CNS drugs, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 3 pooled it
2.3field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 3 syntheses or guidelines pooled it, 53 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Article
  5. Review
  6. Management of Menstrual Migraine.Current neurology and neuroscience reports · 2020
    Review
  7. Article
  8. Preventive treatment in migraine and the new US guidelines.Neuropsychiatric disease and treatment · 2013
    Article
  9. Treatment of perimenstrual migraine with triptans: an update.Current pain and headache reports · 2012
    Review
  10. Article
  11. Review
  12. Review
  13. Review
  14. Menstrual migraine: therapeutic approaches.Therapeutic advances in neurological disorders · 2009
    Article
  15. Clinical aspects of perimenstrual headaches.Current pain and headache reports · 2009
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 3 institutions in 1 country.

Michael M TuchmanPalm Beach Neurological Center, Palm Beach Gardens, Florida 33418, USA. mmtuchman@aol.com
Angela Hee
Ugochi Emeribe
Stephen Silberstein
AstraZeneca (United States) · USPalm Beach Neurological Center · USThomas Jefferson University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the efficacy and tolerability of oral zolmitriptan as a short-term preventative therapy for menstrual migraine.

methodsThis was a randomized, double-blind, parallel group, placebo-controlled, multicentre, two-phase study. The results of the second phase are reported here (the first phase evaluated zolmitriptan in the acute treatment of menstrual migraine and is reported elsewhere). Women who successfully completed phase I (with either a positive or negative outcome, and who still fulfilled the inclusion criteria) were randomized to zolmitriptan 2.5 mg oral tablet three times daily, zolmitriptan 2.5 mg twice daily or placebo three times daily. Patients were treated for three consecutive menstrual cycles, starting 2 days prior to the expected onset of menses, for 7 days in total.

resultsTwo hundred and fifty-three patients completed phase I and were eligible for phase II. The intention-to-treat population comprised 244 patients (zolmitriptan three times daily [n = 83]; zolmitriptan twice daily [n = 80]; placebo [n = 81]). Both zolmitriptan regimens demonstrated superior efficacy versus placebo, as measured by the proportion of patients with a >or=50% reduction in the frequency of menstrual migraine attacks (zolmitriptan three times daily [58.6%], p = 0.0007 vs placebo; zolmitriptan twice daily [54.7%], p = 0.002 vs placebo; placebo three times daily [37.8%]). The mean frequency of breakthrough migraine attacks per menstrual cycle was reduced accordingly. Fewer breakthrough attacks were treated with escape medication in the zolmitriptan three times daily (61.6% of attacks; p = 0.0004 vs placebo) and twice daily (60.7%; p = 0.0055 vs placebo) treatment groups than in the placebo group (74.4%). Short-term preventative therapy with zolmitriptan was well tolerated.

conclusionZolmitriptan 2.5 mg oral tablet is effective and well tolerated as a short-term preventative therapy for menstrual migraine attacks.

Indexed as

Administration, OralAdultDouble-Blind MethodFemaleHumansMenstruation DisturbancesMiddle AgedMigraine DisordersOxazolidinonesRetrospective StudiesSerotonin Receptor AgonistsTime FactorsTryptaminesOxazolidinonesSerotonin Receptor AgonistsTryptamineszolmitriptan

Identifiers

PMID18788838
OpenAlexW1965399275

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.