Have the IHS Guidelines for controlled trials of acute treatment of migraine attacks been followed? Laying the ground for the 4th edition

Abstract

Background The International Headache Society (IHS) has published four editions of Guidelines for acute clinical trials in migraine in the past 28 years. This continuous update process has been driven by the increasing amount of scientific data in the field of migraine and by the need to continuously improve the quality of trials. Objectives To illustrate: i) the results of the analysis on the adherence of published trials to the 3rd edition published in 2012, in order to identify the critical areas that needed to be addressed in the 4th edition and ii) the changes introduced in this latter edition for improving adherence and methodology robustness. Methods We searched and reviewed all controlled trials on acute treatment of migraine published in the period 2012–2018 and we assessed their adherence to the 3rd edition of the IHS Guidelines using a score system based on the most important recommendations. Afterwards, we compared the two editions of the Guidelines and assessed the changes between them. Results We included data from 24 controlled clinical trials. Most trials had a randomized double-blind controlled (RDB) design, while a minority (16.7%) were non-randomized double-blind trials. Less than half (44.6%) of the RDB trials used the recommended “pain-free at 2 hours” endpoint as the primary efficacy measure. Trial design and evaluation of results were the areas that diverged the most from the recommendations. Conclusion Adherence to IHS guidelines for clinical trials has been suboptimal so far. The new edition has been adapted and optimized to facilitate uptake and strengthen the quality of evidence.

Parenteral NSAIDs for acute treatment of migraine: Adherence to the IHS guidelines for controlled trials

“…Similar scoring methods have been used in the past to examine trial adherence to specific IHS guidelines. [5][6][7] Although many of the recommendations outlined in the original IHS guideline have remained unchanged (double-blind, placebo-controlled, randomized, etc. ), some recommendations show discrepancies between editions.…”

“…5 Additionally, Alpuente et al reviewed the adherence of trials to the third edition of the Guidelines for acute treatment of migraine. 6 They identified migraine-specific and end-point-related recommendations that deserve special attention and found that some guideline recommendations were not thoroughly followed. Investigations such as these are valuable in providing a better understanding of study quality and important groundwork for developing future editions of the IHS Guidelines for controlled trials of acute treatment of migraine .…”

Outcomes in clinical trials for migraine: What should we measure and who should decide?

“…Given the centrality of endpoint choice, research consensus regarding outcome measures has been surprisingly difficult to achieve. Surveys of the literature consistently show that less than half of published clinical trials adhere to guidelines developed by the International Headache Society in 1991, updated in 2000, 2012, and again in the last 2 years 1–3 . This finding may suggest that the recommended outcomes and endpoints do not serve the needs of a substantial percentage of researchers.…”