| Symptomatic relief of migraine: multicenter comparison of Cafergot P-B, Cafergot, and placebo. | |
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MedLine Citation:
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PMID: 2497984 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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A multicenter, randomized, double-blind trial was conducted to compare the efficacy of Cafergot P-B with that of its components, Cafergot, pentobarbital, and Bellafoline, and with placebo for the treatment of migraine. Patients with vascular headaches of the migraine type who regularly experienced nervous tension and some form of gastrointestinal distress with their headaches were randomized to one of five treatment groups. They were given treatment packets containing their assigned drug for use during two separate migraine attacks. Patients made pretreatment evaluations of the following symptoms: head pain, nervous tension, nausea, vomiting, anorexia, abdominal cramps, and photophobia. They made posttreatment evaluations of these symptoms 0.5, 1.0, 1.5, 2.0, and 3.0 hours after ingesting their assigned drug. Improvement scores were calculated from the differences between the pretreatment and the posttreatment ratings. Patients also made a final global assessment of their drug's efficacy. All patients who took at least one dose of the study medication and completed a baseline evaluation and at least one postdose evaluation of severity of pain were included in the analysis (n = 254). The comparisons of particular interest were those between Cafergot P-B and Cafergot and between Cafergot P-B and placebo. Cafergot P-B was significantly more effective than Cafergot in relieving head pain at hours 2 and 3, nervous tension, nausea, vomiting, anorexia, and photophobia. Cafergot P-B was significantly more effective than placebo in relieving head pain, nervous tension, nausea (second headache only), vomiting, and photphobia. The incidence of reported adverse effects was no greater with Cafergot P-B than with Cafergot; however, patients given Cafergot P-B reported less vomiting than did patients given Cafergot. The results of this study show that addition of pentobarbital and Bellafoline to Cafergot provides greater relief of pain, vomiting, nervous tension, photophobia, and other symptoms associated with migraine, while reducing the severity of the nausea that may accompany a migraine headache or Cafergot therapy. |
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Authors:
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A P Friedman; F J Di Serio; D S Hwang |
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Publication Detail:
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Type: Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial |
Journal Detail:
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Title: Clinical therapeutics Volume: 11 ISSN: 0149-2918 ISO Abbreviation: Clin Ther Publication Date: 1989 |
Date Detail:
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Created Date: 1989-06-27 Completed Date: 1989-06-27 Revised Date: 2007-11-15 |
Medline Journal Info:
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Nlm Unique ID: 7706726 Medline TA: Clin Ther Country: UNITED STATES |
Other Details:
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Languages: eng Pagination: 170-82 Citation Subset: IM |
Affiliation:
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Sandoz Research Instittue, East Hanover, New Jersey. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adult Aged Anorexia / drug therapy Clinical Trials as Topic Colic / drug therapy Double-Blind Method Ergotamine Ergotamines / adverse effects, therapeutic use* Female Humans Light Male Middle Aged Migraine Disorders / complications, drug therapy* Pain / drug therapy Phobic Disorders / drug therapy Random Allocation Vomiting / drug therapy |
| Chemical | |
Reg. No./Substance:
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0/Ergotamines; 113-15-5/Ergotamine |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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