NIA Public Information
Office: (301) 496-1752
The Trial of Nonpharmacologic Interventions in the Elderly (TONE) is the first multi-center clinical trial of sufficient size and duration to show that lifestyle modifications can be used to control high blood pressure in older people. TONE was co-funded by the National Heart, Lung, and Blood Institute (NHLBI) and the National Institute on Aging (NIA), both of the National Institutes of Health. The TONE findings appear in the March 18, 1998, issue of the Journal of the American Medical Association.
"This is good news for older Americans with hypertension who may be unaware of the impact of modest lifestyle changes," said NHLBI Director Dr. Claude Lenfant. "TONE proves that lifestyle modifications are an essential component in the treatment of high blood pressure."
"By modifying their own behavior, older Americans can play an important role in the treatment and management of their high blood pressure," added NIA Director Dr. Richard Hodes. "They can become less dependent on drug therapy -- and improve their quality of life -- by reducing dietary intake of salt, and, if overweight, losing some weight through diet and exercise."
The patients selected to participate in TONE were 975 hypertensive men and women between the ages of 60 and 80 who were being treated with a single antihypertensive medication. TONE was conducted at four academic health centers with 585 overweight patients and 390 normal weight patients. The overweight patients were randomized to four groups: sodium reduction, weight loss, combined weight loss and sodium reduction, or usual care. The normal weight patients were assigned to either a sodium reduction or usual care group.
At the end of the study, 328 of the original 975 participants, or 30%, were off their blood pressure medications. The study demonstrated that both weight loss and sodium reduction produced the best result as far as reducing the need for blood pressure medicine. Sodium reduction lowered the need for antihypertensive medications by 31 percent, weight loss by 36 percent, and the combination by 53 percent when compared to usual care. Although TONE was not designed to look separately for effects on heart disease or stroke, the lowest rates of cardiovascular problems were seen in the groups receiving TONE interventions.
"With more than two out of every three older Americans having hypertension, our findings have great relevance for the general public and for health-care providers. They underscore the importance of sodium reduction and weight loss in the management of hypertension," said Dr. Paul Whelton, MD, National Chair of the TONE study and Dean of the Tulane University School of Public Health and Tropical Medicine in New Orleans.
The goal for the TONE participants was to cut sodium intake to 1,800 mg per day and lose at least 10 pounds. Patients in the weight-loss group lost the most weight, an average of 8 to 10 pounds. At the end of 30 months, 38 percent of those in the sodium-reduction group succeeded in reducing sodium to the goal of 1,800 mg per day. The average American consumes about 4,000 mg of sodium daily.
Nutritionists and exercise counselors were instrumental in both monitoring and encouraging the TONE participants. They helped participants adapt the lifestyle recommendations to their individual circumstances. There was very little indication of nutrition-related side effects among the participants, including excess weight loss. After a four-month intensive intervention period where participants were given the knowledge and behavior skills needed to stay with a low-salt and/or weight-loss regimen, the process of weaning patients off their blood pressure drugs was initiated under physician supervision. Antihypertensive medications were restarted if a participant had high blood pressure at one or more TONE study follow-up visits.
About 50 million Americans have high blood pressure, which is defined as a systolic pressure above 140 mmHg and a diastolic pressure above 90 mmHg. Hypertension is one of the most important risk factors for cardiovascular disease and is extremely common in the elderly, especially older minority populations.
Nearly three-fourths of Americans with high blood pressure do not have the condition controlled, according to NHLBI's recently released Sixth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Older women in particular have trouble controlling their high blood pressure. Some of the reasons for not taking blood pressure medicine include the cost of the drugs and their side effects.
The TONE study has important implications for physicians and public health professionals because it shows that older people with hypertension are able to make and sustain lifestyle changes. These changes are possible even after decades of physical inactivity and unhealthy eating habits.
In an accompanying editorial, Dr. Jeremiah Stamler of Northwestern University's School of Medicine notes that the TONE results bolster previous studies showing the favorable effects lifestyle modifications can have on lowering blood pressure. Scientific evidence further demonstrates that high blood pressure may be prevented altogether by improving American lifestyles with healthier diets and increased physical activity, Stamler says.
TONE was conducted at Johns Hopkins University School of Medicine, Baltimore, Maryland (Principal investigator: Lawrence J. Appel); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Principal investigators: Mark A. Espeland and Walter H. Ettinger); University of Medicine and Dentistry of New Jersey -- Robert Wood Johnson Medical School, New Brunswick, New Jersey (Principal investigator: John B. Kostis); and the University of Tennessee, Memphis, Tennessee (Principal investigator: William B. Applegate).
To contact Dr. Whelton, please call Cyndy Moore of the Tulane University Medical School's press office at (504) 588-5221. Co-author Dr. Jeffrey Cutler at NHLBI can be reached by calling the NHLBI Communications Office at (301) 496-4236. To reach Dr. Andre J. Premen of NIA's Geriatrics Program, please call the NIA Public Information Office at (301) 496-1752.
Note to editors: If your readers would like more information on high blood pressure, they can check the Cardiovascular Information page on the NHLBI Web site.