To compare quality of life in elderly patients with isolated systolic hypertension allocated randomly to groups to receive placebo or active treatment in the Systolic Hypertension in the Elderly Trial.Design
Double-blind randomized controlled trial.Methods
Patients aged 60 years were allocated randomly to groups to receive first-line treatment with nitrendipine (with second- and third-line enalapril and hydrochlorothiazide) or placebo. Trained interviewers administered trail-making tests (Trail A and B), Brief Assessment Index (a measure of depressed mood) and four subscales from the Sickness Impact Profile (Ambulation, Social Interaction, Sleep and Rest, and Home work).Results
Six hundred and ten patients completed a baseline and at least one follow-up questionnaire. Trail-making scores were slower in actively treated patients, especially in the first 6 months of follow-up when the between-group effect sizes were 0.25 [95% confidence interval (CI) 0.07 to 0.43] for Trail-making A and 0.13 (95% CI −0.05 to 0.31) for Trail-making B. Across the 4 years of follow-up, patients receiving active treatment were more likely to report problems on the Social Interaction scale than were placebo-treated patients (odds ratio 1.32, 95% CI 1.02 to 1.69), equivalent to a 7% difference. There were no significant differences between active and placebo treatment in the other Sickness Impact Profile dimensions or in the measure of depression.Conclusions
Active treatment in the Systolic Hypertension in Europe trial was associated with some small adverse impacts on quality of life.