Treatment of Mild Hypertension Study (TOMHS)
Condition: Cardiovascular Diseases; Heart Diseases; Hypertension; Vascular Diseases
MeSH terms: Hypertension; Cardiovascular Diseases; Heart Diseases; Vascular Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the effects of nonpharmacologic therapy alone with those of one of five active
      drug regimens combined with non-pharmacologic therapy, for long- term management of patients
      with mild hypertension.
    

Detailed description: 
      BACKGROUND:

      Dietary sodium reduction has a mild effect on the reduction of hypertension. Weight loss,
      while achievable in the short-run with diet alone, may also have only mild effects on
      hypertension and is very difficult to maintain with diet and/or behavior modification.
      Alteration of patients' lifestyles to decrease excessive alcohol intake is somewhat
      controversial. Medications, on the other hand, have clear benefits in terms of blood pressure
      lowering, and in the case of diuretics and beta-blockers, reduction in cardiovascular
      morbidity and mortality. However, there is concern about their justified use in mild
      hypertension since each one has side effects, some of which may have long-term implications,
      such as alteration in serum lipids. Newer classes of drugs--calcium antagonists, angiotensin
      converting enzyme inhibitors, alpha blockers--had not previously been compared long-term with
      diuretics and beta-blockers.

      DESIGN NARRATIVE:

      TOMHS I enrolled 902 men and women to determine the feasibility of a larger trial.
      Participants were randomized in a double-blind manner to one of six treatment groups and
      within two strata. Stratum I was for participants not on antihypertensive drugs and Stratum
      II for those on antihypertensive drugs at initial screening. There were six treatment arms:
      placebo, a diuretic (chlorthalidone), a beta-adrenergic blocking agent (acebutolol), an alpha
      blocker (doxazosin mesylate), a calcium antagonist (amlodipine maleate), and an angiotensin
      converting enzyme inhibitor (enalapril maleate). All participants received a lifestyle
      intervention program that included reduction of sodium chloride and alcohol intake as well as
      weight reduction and increase in physical activity. All participants were followed for at
      least 48 months, with an average of 54 months. The primary endpoint was lowering of blood
      pressure. The treatments were also compared for effects on blood chemistries including
      lipoproteins, echocardiographic left ventricular mass, ventricular ectopic activity and ST-T
      changes of ischemia as measured by ambulatory ECG monitoring, side effects, and quality of
      life. Randomization took place between October 1986 and March 1988. Active follow-up ended in
      March-April 1992. Data analysis ended in May 1994.
    

Intervention name(s): diet, sodium-restricted; diet, reducing; exercise; alcohol restriction; chlorthalidone; acebutolol; doxazosin; amlodipine; enalapril
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Acebutolol; Amlodipine; Enalapril; Chlorthalidone; Doxazosin
Allocation: Randomized
Primary purpose: Treatment