Rb. Anderson et al., Physical symptoms distress index - A sensitive tool to evaluate the impactof pharmacological agents on quality of life, ARCH IN MED, 159(7), 1999, pp. 693-700
Citations number
21
Categorie Soggetti
General & Internal Medicine","Medical Research General Topics
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.