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American Journal of Epidemiology Vol. 145, No. 9: 826-833
Copyright © 1997 by The Johns Hopkins University School of Hygiene and Public Health

other

Measurement Methods of Drug Consumption as a Secondary Judgment Criterion for Clinical Trials in Chronic Rheumatic Diseases

Florence Constant1,2,, Francis Guillemin2, Bernard Herbeth3, Jean François Collin2 and Michel Boulangé1

1Institute of Hydrology, University Henri Poincaré, Faculty of Medicine, Nancy, France
2School of Public Health, University Henri Poincaré, Faculty of Medicine, Nancy, France
3Center for Preventive Medicine, Nancy, France

Reprint requests to Dr. F. Constant, Service d'Hydrologie et de Climatologie Thérapeutiques, Faculté de Médecine, Université Henri Poincaré, B.P. 184, 54505 Vandoeuvre-les-Nancy, Cedex, France.

Drug consumption is sometimes used as a secondary judgment criterion for clinical trials. Many measurement methods are available to quantify drug consumption. Several methods were applied in a rheumatic disease trial involving 121 patients with chronic low back pain who lived around Saint-Nectaire, France, and who participated in the trial from April to November 1993 to determine an easily used and practical measurement method to detect a significant drug consumption change over time. Analgesic and nonsteroidal antiinflammatory drugs (NSAIDs) were classified according to the anatomical therapeutic chemical classification. Consumption was quantified on a weekly basis in number of tablets (method 1), unit of defined daily dose (method 2), milligrams of active principle (method 3), and NSAID equivalence score (method 4). These methods were applied in a randomized clinical trial of spa therapy on sufferers of chronic low back pain. An analysis of variance with repeated measures showed a significant difference in drug consumption between treatment and control groups detected by all methods, except for the NSAID consumption measured with method 3. The comparison of each method by the relative efficiency index indicated that method 1 had a greater sensitivity for detecting changes of drug consumption. Tablet count appears to be a more sensitive and more practical method for detecting a drug consumption change in clinical trials. Am J Epidemiol 1997; 145: 826–33.

clinical trials; drug therapy; evaluation studies; methods


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 Rheumatology (Oxford)Home page
M. H. Pittler, M. Z. Karagulle, M. Karagulle, and E. Ernst
Spa therapy and balneotherapy for treating low back pain: meta-analysis of randomized trials
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