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Experience with a multi crossover model in dyspepsia.

T Johannessen1, D Fosstvedt, H Petersen

  • 1Department of Community Medicine and General Practice, University of Trondheim, Norway.

Scandinavian Journal of Gastroenterology. Supplement
|January 1, 1988
PubMed
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The multi cross over model (MCOM) offers a partly randomized approach for single case studies, evaluating drug efficacy by comparing active treatment to placebo periods. This method, demonstrated with cimetidine for dyspepsia, shows reasonable results despite statistical considerations.

Area of Science:

  • Clinical research methodology
  • Pharmacological studies
  • Statistical modeling in medicine

Background:

  • Single case studies provide valuable individual-level data.
  • Partially randomized designs can balance rigor and feasibility.
  • Evaluating drug efficacy requires robust statistical methods.

Purpose of the Study:

  • To introduce and evaluate a novel Multi Cross Over Model (MCOM) for single case studies.
  • To assess the efficacy of cimetidine in non-ulcer dyspepsia using the MCOM.
  • To explore the statistical properties and practical advantages of the MCOM.

Main Methods:

  • The MCOM involves regular alternations between active drug and placebo periods.
  • Individual patient evaluation uses an X-score based on symptom reduction compared to placebo.

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  • Group effects are analyzed using X-score distribution and paired t-tests.

    • Main Results:

    • The MCOM was applied to a study of cimetidine for non-ulcer dyspepsia.
    • Results indicated a reasonable demonstration of cimetidine's effect.
    • The model showed a small degree of violation of statistical preassumptions.

    Conclusions:

    • The MCOM is a viable, partly randomized approach for single case studies.
    • The model effectively illustrates the advantages of single case analysis in clinical trials.
    • Despite statistical objections, the MCOM provides reasonable and interpretable results for drug efficacy studies.