COMPARISON OF A LIFE-STYLE MODIFICATION PROGRAM WITH PROPRANOLOL USE IN THE MANAGEMENT OF DIASTOLIC HYPERTENSION

OBJECTIVE: To compare the management of mild diastolic hypertension (9 0 to 104 mm Hg) using a nonpharmacologic intervention with that using propranolol or placebo. DESIGN: Randomized, placebo-controlled trial w ith a 2 x 2 factorial design. SETTING: University-based ambulatory car e center. PARTICIPANTS: Two hundred seven men and 105 women, 22 to 59 years of age, 73% white, who had mild diastolic hypertension untreated for at least eight weeks.INTERVENTIONS: 1) a multicomponent lifestyle modification intervention (lifestyle focus group, or LFG) administere d in eight weekly meetings + placebo, 2) LFG + propranolol, 3) propran olol alone, and 4) placebo alone, followed for 12 months. MEASUREMENTS : Systolic blood pressure (SEP), diastolic blood pressure (DBP), and s elf-reported adverse effects at each of nine follow-up visits; fasting total cholesterol, triglycerides, and glucose at baseline and 12 mont hs; 24-hour urine sodium (Na+) and potassium (K+), three-day food reco rds and physical activity questionnaire at three and 12 months; and a quality of life questionnaire at 12 months. MAIN RESULTS: The mean dec reases in DBP at 12 months were: 8.5 mm Hg in the LFG + propranolol gr oup; 7.7 mm Hg in the propranolol-only group; 5.9 mm Hg in the placebo only group; and 5.4 mm Hg in the LFG + placebo group. Repeated-measure s analysis of covariance showed that level of baseline DBP (p < 0.0001 ), time of follow-up (p < 0.0001), and propranolol use (p < 0.0001) we re significantly associated with a decrease in DBP at 12 months. Despi te reductions in urinary Na+ (-35 mEq; 95% CI = -50, -19), dietary Na (-521 mg; 95% CI = -710, -332), total calories ingested (-238; 95% Cl = -335, -140), and weight (-1.4 Ib; 95% CI = -3.7, +0.8), and signifi cant increases in dietary K+ (+294 mg; 95% CI = +107, +480) and in met s-minutes of exercise (+43; 95% CI = +20, +67) at three months, assign ment to the LFG intervention had no effect on DBP at three or 12 month s. The subjects assigned to take propranolol more frequently reported fatigue during ordinary activities, sleep disturbance, decrease in sex ual activity, and depressed feelings, when compared with the subjects taking placebo, but the numbers of study withdrawals did not differ by drug assignment, No significant difference in total cholesterol and g lucose levels was observed by group assignment. Triglycerides increase d significantly in the subjects assigned to propranolol (mean differen ce = +20 mg/dL; 95% CI of difference +1.5, +39). There was no differen ce in the responses to 21 quality of life items between the subjects a ssigned to propranolol and those assigned to placebo. CONCLUSIONS: Thi s multicomponent lifestyle modification intervention was unable to pro mote persistent behavior changes and thus was inferior to propranolol therapy for the treatment for mild diastolic hypertension. Future rese arch should focus on single modifiable factors to lower blood pressure .