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A meta-analysis of the placebo response in acute migraine and how this response may be influenced by some of the characteristics of clinical trials

  • Clinical Trials
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Abstract

Migraine is the most common cause of vascular headache and a highly prevalent illness. In the last 20 years, the discovery of new agents has increased clinical research on migraine. In most of clinical trials that have been conducted, the efficacy was established using a placebo as a control treatment. The objective of the study reported here was to analyse the response rate in patients who received a placebo as well as to determine how a number of the methodological factors may affect the effect of the placebo in clinical trials of acute migraine. Computer-based information searches were conducted on the Medline database. Data analysis included the outcomes ‘pain relief’, ‘pain-free’, ‘associated symptoms’, ‘recurrence’, ‘patients’ opinion’ about pain relief and ‘adverse events’. Administration route, study design and country in which the study was carried out were the methodological factors that were analyzed. Meta-analysis was computed using Mantel-Haenszel, and a total of 98 papers were considered in the final analysis. After 2 h, 28.6% of the patients of the placebo group improved and 8.8% were pain-free. The percentage of pain-free patients was the highest in the placebo and active drug groups in which the placebo or drug had been administered subcutaneously, in parallel design studies (vs. cross-over trials) and in studies performed in Europe (vs. North America). Adverse events in the placebo group were significantly higher in studies performed in North America. These data reinforce the need for knowing the magnitude of the placebo response in each specific situation during the planning of clinical trials on acute migraine.

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Notes

  1. Reports two clinical studies.

  2. Reports two clinical studies.

  3. The paper reports results from more than one clinical trial.

  4. The paper reports results from more than one clinical trial.

  5. Reports two clinical studies.

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Author information

Authors and Affiliations

  1. Department of Pharmacology, Therapeutics and Toxicology, Universitat Autònoma de Barcelona, Bellaterra, Spain

    Ana Macedo & Magí Farré

  2. Unit of Pharmacology, Institut Municipal d’Investigació Mèdica, Barcelona, Spain

    Magí Farré

  3. Department of Experimental and Health Sciences, Universitat Pompeu Fabra, 08003, Barcelona, Spain

    Josep-E. Baños

Authors
  1. Ana Macedo
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  2. Magí Farré
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  3. Josep-E. Baños
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Corresponding author

Correspondence to Josep-E. Baños.

Appendix

Appendix

Articles included in the meta-analysis

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Macedo, A., Farré, M. & Baños, JE. A meta-analysis of the placebo response in acute migraine and how this response may be influenced by some of the characteristics of clinical trials. Eur J Clin Pharmacol 62, 161–172 (2006). https://doi.org/10.1007/s00228-005-0088-5

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