“TOMHS,” Treatment of Mild Hypertension Study   Sponsor     National Heart, Lung and Blood Institute (NHLBI), U.S. National Institutes of Health (NIH); Pfizer, Merck, Sharpe, and Dohme.   Berman Center Site Principal Investigator     John Flack, MD, MPH   Description     This randomized, controlled, double-blind trial was conducted at four clinical sites in the U.S. between 1986 and February 1992. The study compared the combined effects of diet treatment and 1 of 5 active drug regimens with diet treatment alone for the four-year management of 902 middle-aged adults with "mild" hypertension (diastolic BP 85-99 mmHg).   Role of the Berman Center     The Berman Center enrolled 296 participants of whom all but two completed the trial. Participants were seen for study visits every three months for four years.   Abstract     This study compared the relative efficacy and safety of a combination of pharmacologic and nutritional-hygienic intervention to nutritional-hygienic intervention alone for controlling mild hypertension. Nine hundred two men and women with average blood pressure 140/91 mmHg received vigorous sustained nutritional counseling to reduce obesity, moderate sodium intake and avoid heavy use of alcohol. Participants randomized to active drugs additionally received either diuretic (chlorthalidone); beta-blocker (acebutolol); alpha 1-antagonist (doxazosin mesylate); calcium antagonist (amlodipine maleate); or angiotensin-converting enzyme inhibitor (enalapril maleate).     Blood pressure reductions were sizable in all six groups, and were significantly greater for participants assigned to drug treatment than placebo (-15.9 versus -9.1 mm Hg for systolic blood pressure and -12.3 versus -8.6 mm Hg for diastolic blood pressure; p < 0.0001). After 4 years, 59% of participants assigned to placebo and 72% of participants given drug treatment continued on their initial medication as monotherapy. Rates of death, major and minor nonfatal cardiovascular, and other clinical events were lower in the drug compared to placebo groups (11.1% versus 16.2%, p=0.03). Incidence rates of most resting electrocardiographic abnormalities were lower and quality of life was improved more for those assigned to drug-treatment groups rather than for the placebo group.     As an initial regimen, drug treatment in combination with nutritional-hygienic intervention was more effective in preventing cardiovascular and other clinical events than was nutritional-hygienic treatment alone. Drug-treatment group differences were minimal. The TOMHS results were used to plan for the larger NHLBI trial, Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT).