Abstract Details

Title Adherence to the IHS Guidelines for Controlled Trials of Acute Treatment of Migraine Attacks with Parenteral NSAIDs

Topic Headache

Presentation(s) P1 - Poster Session 1 (9:00 AM-5:00 PM)

Poster/Presentation
Number 203

Objective To assess the adherence to International Headache Society (IHS) controlled trial guidelines for acute treatment of migraine with parenteral non-steroidal anti-inflammatory drugs (NSAIDs).

Background Parenteral NSAIDs are important alternatives to oral NSAIDs, especially in patients with severe migraine who have emesis or gastroparesis. As published research has increased on using parenteral NSAIDs for acute migraine treatment, it is important to examine the adherence of these studies to the IHS controlled trial guidelines.

Design/Methods PubMed was queried for clinical trials investigating NSAIDs for acute migraine treatment in adult patients. We developed a 15-point scoring system based on the essential components in the IHS guidelines. Since the first guidelines for controlled trials of drugs in migraine developed in 1991, three updated editions have been published. Each trial, based on their published date, was evaluated with the appropriate edition of the trial guidelines.

Results We evaluated data from 19 controlled clinical trials. The median score was 8 (interquartile range 3). All trials followed the IHS migraine diagnosis criteria, but only four (21.1%) reported predefined headache frequency. Almost all trials were randomized (94.7%), but less were double-blinded (78.9%) or placebo-controlled (52.6%). Every trial included a clear explanation of the pain scale used to measure the treatment response. However, only three (15.8%) used pain freedom at 2-hour as the primary endpoint. Twelve (63.1%) assessed the headache associated symptoms.

Conclusions Most clinical trials on parenteral NSAIDs for acute migraine treatment did not fully adhere to the IHS recommendations. Future studies should pay special attention to IHS guideline adherence in order to improve the quality of clinical trials for the acute treatment of migraine.

Authors/Disclosures
John Waters PRESENTER	Mr. Waters has nothing to disclose.
John Curran	Mr. Curran has nothing to disclose.
Hsiangkuo Yuan, MD, PhD (Jefferson Headache Center)	An immediate family member of Dr. Yuan has received personal compensation for serving as an employee of Merck. Dr. Yuan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Yuan has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Yuan has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pfizer. Dr. Yuan has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Salvia. Dr. Yuan has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Cerenovous. Dr. Yuan has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Regional Anesthesia and Pain Medicine. Dr. Yuan has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Current Headache and Pain Reports. Dr. Yuan has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for MedLink Neurology. Dr. Yuan has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Cephalalgia. The institution of Dr. Yuan has received research support from NIH. The institution of Dr. Yuan has received research support from American Headache Society. The institution of Dr. Yuan has received research support from Pfizer. Dr. Yuan has received publishing royalties from a publication relating to health care. Dr. Yuan has received publishing royalties from a publication relating to health care. Dr. Yuan has received personal compensation in the range of $500-$4,999 for serving as a Grant reviewer with NIH. Dr. Yuan has received personal compensation in the range of $10,000-$49,999 for serving as a Invited speaker with Chinese Stroke Association.

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