Physical symptoms distress index - A sensitive tool to evaluate the impactof pharmacological agents on quality of life

Objectives: To examine whether the degree of stress associated with adverse physical side effects correlates with overall, quality of life (QOL) and c ompliance rates. To determine if instruments used to assess QOL can detect differences between treatments that have no known central nervous system ef fects. Patients and Methods: This randomized, double-blind, parallel group study e valuated 180 to 480 mg of controlled onset, extended release (COER)-verapam il (n = 259) or 30 to 120 mg/d of nifedipine gastrointestinal therapeutic s ystem (GITS) (n = 269) in men and women between 21 and 80 years of age with stages 1 to 3 hypertension. A battery of questions evaluating psychologica l well-being and a physical symptom distress index was administered after a 4-week placebo washout (baseline) and after 10 weeks of treatment or at dr opout. Results: Both treatments effectively lowered blood pressure, and there were no significant between-group differences in psychosocial QOL. A difference in the level of physical symptom distress was detected between treatments (P = .002; multivariate analysis of variance), with 7 significant univariat e treatment effects, all favoring COER-verapamil, being noted-pedal edema, polyuria, rapid heart beat or palpitations, hives, muscle cramps, abdominal , cramps, and headaches. Constipation-related distress increased significan tly (P = .001) but to a similar extent with both treatments. The difference in symptom distress tended to predict compliance as there were more withdr awals in the nifedipine GITS group (n = 85) vs COER-verapamil group (n = 64 ) (P = .08). Conclusions: Patient-assessed physical symptom distress is a sensitive, sim ple technique to evaluate the effect of antihypertensive medications on QOL and tolerability, as shown by its ability to detect the improvement associ ated with COER-verapamil. Depending on the agents involved; the Physical Sy mptom Distress Index may more closely predict dropout rates than the tradit ional psychosocial instruments, as suggested by the lower dropout rate in t he COER-verapamil group. Thus, in studying treatment effects on QOL, both t he distress of physical symptoms and the impact of psychosocial factors sho uld be evaluated.