Purpose: To compare the effects of a multimodal nonpharmacologic intervention to digoxin and to placebo in patients with congestive heart failure receiving background therapy with angiotensin-converting enzyme inhibitors.
Design: Randomized, parallel assignment to three treatment groups of 20 patients with congestive heart failure (New York Heart Association Class II and III).
Intervention: Nonpharmacologic treatment program included the following: (1) graduated exercise training, three to five times per week; (2) structured cognitive theraphy and stress management; and (3) dietary intervention aimed at salt reduction and weight reduction in the overweight. Digoxin was titrated to achieve a blood level between 0.8 and 2.0 ng/ml. Placebo and digoxin were administered in a randomized, double-blind fashion.
Results: Echocardiographic ejection fraction improved (p<0.05) in the digitalis group (change=+4.4±6.5) compared with both placebo (change=−1.2±3.9) and nonpharmacologic therapy (change=−3.2±3.9). The nonpharmacologic treatment program was well tolerated by all patients and resulted in significant improvement (p<0.05) in exercise tolerance (digoxin=+51±50 s, placebo=+91±76, nonpharmacologic therapy=+182±139), as well as Beck Depression Inventory score (digoxin=+1.2±4.4, placebo=+2.0±4.2, nonpharmacologic therapy=−5.0±4.2), Hamilton Scale scores of anxiety (digoxin=+3.0±6.8, placebo=+6.0±2.6, nondrug therapy=−5.2±5.4), and depression (digoxin=+l.0±4.9, placebo=+5.0±5.0, nonpharmacologic therapy=−6.6±10.1). In addition, weight loss was significantly greater with nonpharmacologic therapy (digoxin=+0.32±1.76 kg; placebo=−1.35±1.44 kg; nonpharmacologic therapy=−4.37±4.50 kg) compared with both digoxin and placebo.
Conclusions: Nonpharmacologic therapy improved functional capacity, body weight, and mood state in patients with congestive heart failure. In contrast, digoxin improved ejection fraction without corresponding changes in exercise tolerance or quality of life.