Ninety-two middle-aged and elderly patients with disabling
tinnitus participated in a double-blind randomized clinical trial comparing
nortriptyline (a
tricyclic antidepressant) to placebo. The study was stratified for presence (n = 38) or absence (n = 54) of current major depression (by DSM-III criteria). Both active
drug and placebo were given for 6 weeks following a dose adjustment phase; the median nightly dose of
nortriptyline was 100 mg. The two primary outcome variables were global satisfaction questions: "Has the medication helped you in any way?" and "Has your
tinnitus improved?" Sixty-seven percent of
nortriptyline patients stated the
drug had helped them, versus 40 percent of placebo patients (chi-square = 7.14, p = 0.008). However,
tinnitus severity was not significantly affected by
nortriptyline (active: 43%; placebo: 30%; chi-square = 1.567, p = N/S). Benefit was more likely to be reported by depressed patients, by patients with
insomnia, by women, and by patients without cervical
musculoskeletal disease.
Nortriptyline is useful in some patients with disabling
tinnitus, but has not been shown to directly affect
tinnitus sensation. Placebo effects were strongly significant and must be considered important in
tinnitus therapy. It is difficult to specify the most appropriate outcome measures for
tinnitus therapeutic trials.