Some non-parametric and categorical data analyses for a change-over design study and discussion of apparent carry-over effects.

This paper addresses the statistical analysis of data from a pair of two period change-over design studies from two centres. These studies compared an active treatment with placebo for the relief of heartburn. The principal response variable was whether or not the patient experienced relief for heartburn from a symptom-provoking meal within 15 minutes of the initial dose of treatment. Other response variables were an ordinal response classification for the pattern of relief for up to two doses and a composite measure for time to relief. Categorical data methods and non-parametric rank methods for the analysis of such responses are described. A result of interest is the significance of (treatment X period) interaction (i.e. carry-over effects). It is interpreted as a tendency for less effective placebo treatment in the period following the active period compared with the first period; in contrast, the active treatment was equally effective in both periods. Discussion centres on the implications of this finding for conclusions concerning the comparison of the active treatment with placebo.

Clinical experience with diltiazem in Japan.

In a cooperative postmarketing study, 3,913 Japanese patients received diltiazem, an orally administered calcium channel blocking agent, for 30 to over 360 days. Drug safety was assessed by monthly evaluations of subjective symptoms, electrocardiographic recordings, adverse experiences, vital signs, and biochemical profiles. Original case report forms were processed and analyzed in the United States. None of the observed adverse experiences were serious or life threatening. They occurred in 1.8% of the patients and primarily involved the gastrointestinal system; anorexia and nausea were the most common adverse effects. The majority of the other adverse experiences were extensions of the drug's pharmacologic effects. Diltiazem appears to cause relatively minor clinical toxicity at a low frequency.

Does basic aluminum sucrose sulfate affect blood coagulability?

Basic aluminum sucrose sulfate (sucralfate) is a sulfated disaccharide similar in structure to heparin that has been shown not to possess anticoagulant effects in vitro or in animal models. As an adjunct to a study of the efficacy of sucralfate in the treatment of duodenal ulcer disease, we evaluated the drug's anticoagulant effects. Twenty-eight patients were randimized to treatment with sucralfate. Evaluations of prothrombin time and activated partial thromboplastin time, prestudy and after two and/or four weeks of treatment with sucralfate, demonstrated no evidence of anticoagulant activity.