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A Randomized Controlled Trial of Nonpharmacologic Interventions in the Elderly (TONE)

Paul K. Whelton, MD, MSc; Lawrence J. Appel, MD, MPH; Mark A. Espeland, PhD; William B. Applegate, MD; Walter H. Ettinger, Jr, MD; John B. Kostis, MD; Shiriki Kumanyika, PhD; Clifton R. Lacy, MD; Karen C. Johnson, MD, MPH; Steven Folmar, PhD; Jeffrey A. Cutler, MD, MPH; for the TONE Collaborative Research Group

JAMA. 1998;279:839-846.

Context.— Nonpharmacologic interventions are frequently recommended for treatment of hypertension in the elderly, but there is a paucity of evidence from randomized controlled trials in support of this recommendation.

Objective.— To determine whether weight loss or reduced sodium intake is effective in the treatment of older persons with hypertension.

Design.— Randomized controlled trial.

Participants.— A total of 875 men and women aged 60 to 80 years with systolic blood pressure lower than 145 mm Hg and diastolic blood pressure lower than 85 mm Hg while receiving treatment with a single antihypertensive medication.

Setting.— Four academic health centers.

Intervention.— The 585 obese participants were randomized to reduced sodium intake, weight loss, both, or usual care, and the 390 nonobese participants were randomized to reduced sodium intake or usual care. Withdrawal of antihypertensive medication was attempted after 3 months of intervention.

Main Outcome Measure.— Diagnosis of high blood pressure at 1 or more follow-up visits, or treatment with antihypertensive medication, or a cardiovascular event during follow-up (range, 15-36 months; median, 29 months).

Results.— The combined outcome measure was less frequent among those assigned vs not assigned to reduced sodium intake (relative hazard ratio, 0.69; 95% confidence interval [CI], 0.59-0.81; P<.001) and, in obese participants, among those assigned vs not assigned to weight loss (relative hazard ratio, 0.70; 95% CI, 0.57-0.87; P<.001). Relative to usual care, hazard ratios among the obese participants were 0.60 (95% CI, 0.45-0.80; P<.001) for reduced sodium intake alone, 0.64 (95% CI, 0.49-0.85; P=.002) for weight loss alone, and 0.47 (95% CI, 0.35-0.64; P<.001) for reduced sodium intake and weight loss combined. The frequency of cardiovascular events during follow-up was similar in each of the 6 treatment groups.

Conclusion.— Reduced sodium intake and weight loss constitute a feasible, effective, and safe nonpharmacologic therapy of hypertension in older persons.

From the Department of Biostatistics and Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, La (Dr Whelton); Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins University School of Medicine, Baltimore, Md (Dr Appel); Departments of Public Health Sciences (Dr Espeland) and Internal Medicine (Drs Ettinger and Folmar), Wake Forest University School of Medicine, Winston-Salem, NC; Department of Preventive Medicine, University of Tennessee, Memphis (Drs Applegate and Johnson); Division of Cardiovascular Diseases and Hypertension, University of Medicine and Dentistry of New Jersey–Robert Wood Johnson Medical School, New Brunswick (Drs Kostis and Lacy); Center for Biostatistics and Epidemiology, Pennsylvania State University College of Medicine, Hershey (Dr Kumanyika); and Clinical Applications and Prevention Program, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Md (Dr Cutler). Dr Kumanyika is now with the Department of Nutrition and Dietetics, University of Illinois at Chicago.

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