Approximately 75,000-150,000 patients each year in the United States undergo intensive
cardiac evaluations for symptoms of angina-like chest pain that produce no positive
findings. These patients often have high levels of disability and suffering and account for
$250,000,000-$500,000,000 in estimated health care costs each year. There is some evidence
from randomized, controlled trials that a pharmacologic agent, imipramine, and a program of
training in pain coping skills and cognitive-behavioral therapy (CBT) both produce
short-term reductions in pain intensity. However, no studies have compared the effects of
these two treatments on measures of pain, suffering, and disability at post-treatment and
over a one-year follow-up period.
Our investigation is a 16-week, randomized controlled outcome study of these interventions
and their respective placebo control procedures. One hundred and sixty patients are being
recruited for this study. We will assess the effects of our interventions on patients' pain
levels, quality of life, and health care resource usage at baseline, post-treatment, 6-month
follow-up, and at 12-month follow-up. We will evaluate the clinical significance of our
treatment effects as well as their statistical significance.
- Substernal chest pain at least 2X per week for at least 3 months;
- Angiographic evidence of normal or non-obstructive (<50% luminal diameter narrowing)
coronary arteries among subjects > 40 years of age; OR Normal exercise stress tests,
normal echocardiogram, and cardiologist evaluation that symptoms are not cardiac in
origin among subjects < 40 years of age;
- Gastroesophageal reflux disease ruled out by 24-hour pH monitoring, endoscopy, or
1-month trial of anti-reflux therapy with omeprazole 20 mg bid;
- Pain threshold levels for esophageal balloon distention must be 12 ml.
- Mitral valve prolapse