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The effects of nonpharmacologic interventions on blood pressure of persons with high normal levels. Results of the Trials of Hypertension Prevention, phase I |
The Trials of Hypertension Prevention Collaborative Research Group |
JAMA 1992 Mar 4;267(9):1213-1220 |
clinical trial |
8/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVE: To test the short-term feasibility and efficacy of seven nonpharmacologic interventions in persons with high normal diastolic blood pressure. DESIGN: Randomized control multicenter trials. SETTING: Volunteers recruited from the community, treated and followed up at special clinics. PARTICIPANTS: Of 16,821 screenees, 2182 men and women, aged 30 through 54 years, with diastolic blood pressure from 80 through 89 mmHg were selected. Of these, 50 did not return for follow-up blood pressure measurements. INTERVENTIONS: Three life-style change groups (weight reduction, sodium reduction, and stress management) were each compared with unmasked nonintervention controls over 18 months. Four nutritional supplement groups (calcium, magnesium, potassium, and fish oil) were each compared singly, in double-blind fashion, with placebo controls over 6 months. MAIN OUTCOME MEASURES: Primary: change in diastolic blood pressure from baseline to final follow-up, measured by blinded observers. Secondary: changes in systolic blood pressure and intervention compliance measures. RESULTS: Weight reduction intervention produced weight loss of 3.9 kg (p < 0.01), diastolic blood pressure change of -2.3 mmHg (p < 0.01), and systolic blood pressure change of -2.9 mmHg (p < 0.01). Sodium reduction interventions lowered urinary sodium excretion by 44 mmol/24 h (p < 0.01), diastolic blood pressure by 0.9 mmHg (p < 0.05), and systolic blood pressure by 1.7 mmHg (p < 0.01). Despite good compliance, neither stress management nor nutritional supplements reduced diastolic blood pressure or systolic blood pressure significantly (p > 0.05). CONCLUSIONS: Weight reduction is the most effective of the strategies tested for reducing blood pressure in normotensive persons. Sodium reduction is also effective. The long-term effects of weight reduction and sodium reduction, alone and in combination, require further evaluation.
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