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Does a placebo-effect exist in clinical trials on multiple sclerosis? Review of the literature

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Abstract

To verify whether the outcome in placebo-treated MS patients actually corresponds to that expected on the basis of the natural history and pretrial evolution of the disease, we here review the results of clinical trials conducted according to a placebo-controlled, randomized design, regardless of the experimental therapy used.

The frequency of relapse in remitting-relapsing patients decreases during follow-up, and disability in progressive cases increases more slowly than before enrollment. These data should be borne in mind when evaluating the impact of experimental drugs on the natural course of the disease.

Sommario

Sono stati rivisti i trials clinici condotti in pazienti affetti da SM secondo un disegno randomizzato e controllato con placebo, per verificare se i pazienti trattati con placebo evolvono meno rapidamente rispetto alla storia naturale e all'andamento pretrial. La maggioranza degli studi suggerisce che la frequenza di riaccensioni e l'accumulo di disabilità è inferiore rispetto alle condizioni pre-arruolamento. Questi dati vanno considerati nella valutazione dell'impatto di farmaci sperimentali sul decorso naturale della malattia.

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Authors and Affiliations

  1. Istituto Nazionale Neurologico “C. Besta”, via Celoria 11, 20133, Milano, Italy

    Mantia L. La, Eoli M. MD, Salmaggi A. & Milanese C.

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  1. Mantia L. La
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  2. Eoli M. MD
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  3. Salmaggi A.
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  4. Milanese C.
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La Mantia, L., Eoli, M., Salmaggi, A. et al. Does a placebo-effect exist in clinical trials on multiple sclerosis? Review of the literature. Ital J Neuro Sci 17, 135–139 (1996). https://doi.org/10.1007/BF02000844

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  • DOI: https://doi.org/10.1007/BF02000844

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