ADVERSE NONDRUG REACTIONS - AN UPDATE

Objective: Healthy volunteers are involved in stage I of clinical inve stigations. It appears to be necessary to characterize such subjects m ore closely. Representing an essential aspect are symptoms giving rise to complaints that are typical side effects of drugs but that often a lso occur as adverse nondrug reactions. Correlations are supposed to e xist between personality, motivation, and emotion of subjects and the incidence of their complaints. Methods: One hundred thirty medical stu dents answered the ''Questionnaire for Side Effects of Drugs'' (Reiden berg and Lowenthal, 1968), and they were studied with regard to their personality (Freiburg Personality Inventory), motivation (Motivation Q -Sort) and emotion (State-Trait-Anxiety Inventory). Results: The most frequent complaints noted in young healthy volunteers who did not take any drugs were fatigue (65%), headache (25%), and nasal congestions ( 30%). Only 11% of the medical students were free of symptoms, 50% stat ed that they had one or two symptoms, and 3% had more than six symptom s. Statistically significant, even though weak, correlations existed b etween the number of symptoms and the personality traits of nervousnes s and neuroticism, motivation, and trait-anxiety. However, cluster ana lysis was adopted to form two groups: One subgroup (not nervous, emoti onally stable, success-motivated, and not very anxious) that stated le ss adverse nondrug reactions, and another contrasting subgroup that co mplained about symptoms more frequently. Conclusion: It appears that t he distribution of the incidence of complaints in a nonselected group of healthy volunteers is not of a random character. The relevance of t his finding to stage I clinical trials is evident.