Research Article

The design of clinical trials for treatment of diabetic neuropathy

  1. Dan Ziegler*

Article first published online: 8 JAN 1999

DOI: 10.1002/(SICI)1520-6769(199707)21:1<83::AID-NRC211>3.0.CO;2-N

Issue

Neuroscience Research Communications

Neuroscience Research Communications

Special Issue: Proceedings of the Fourth International Symposium on Diabetic Neuropathy, and Neurodiab VII. July 15-19, 1997, Noordwijkerhout, The Netherlands

Volume 21, Issue 1, pages 83–91, July 1997

Additional Information

How to Cite

Ziegler, D. (1997), The design of clinical trials for treatment of diabetic neuropathy. Neuroscience Research Communications, 21: 83–91. doi: 10.1002/(SICI)1520-6769(199707)21:1<83::AID-NRC211>3.0.CO;2-N

Author Information

  1. Diabetes Research Institute at the Heinrich Heine University, Auf'm Hennekamp 65, 40225 Düsseldorf, Germany

*Diabetes Research Institute at the Heinrich Heine University, Auf'm Hennekamp 65, 40225 Düsseldorf, Germany

Publication History

  1. Issue published online: 8 JAN 1999
  2. Article first published online: 8 JAN 1999
  3. Manuscript Accepted: 21 MAY 1996

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Keywords:

  • diabetic polyneuropathy;
  • clinical trials;
  • pharmacological treatment;
  • placebo;
  • efficacy measures

Abstract

Randomized clinical trials (RCTs) are a widely accepted means of applying experimental methods to a clinical setting and have been advocated as the gold standard for comparing and evaluating different treatments. However, the quality of the RCTs published between 1981–1992 that evaluated the effects of medical treatment in diabetic polyneuropathy was poor. Adequate designs for RCTs in diabetic neuropathy have to consider the following aspects: type and stage of neuropathy, homogeneity of the study population, outcome measures (neurophysiological markers, intermediate clinical end points, ultimate clinical outcomes, quality of life), natural history, sample size, study duration, reproducibility of neurophysiological and intermediate end points, regression to the mean, true and perceived placebo effects, measures of treatment effect, generalisability of the overall trial result to individual patients, and the reporting of the RCTs. © 1997 John Wiley & Sons, Ltd.

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