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A Randomized Controlled Trial

Kenneth A. Holroyd, PhD; Francis J. O'Donnell, DO; Michael Stensland, MS; Gay L. Lipchik, PhD; Gary E. Cordingley, MD, PhD; Bruce W. Carlson, PhD

JAMA. 2001;285:2208-2215.

Context  Chronic tension-type headaches are characterized by near-daily headaches and often are difficult to manage in primary practice. Behavioral and pharmacological therapies each appear modestly effective, but data are lacking on their separate and combined effects.

Objective  To evaluate the clinical efficacy of behavioral and pharmacological therapies, singly and combined, for chronic tension-type headaches.

Design and Setting  Randomized placebo-controlled trial conducted from August 1995 to January 1998 at 2 outpatient sites in Ohio.

Participants  Two hundred three adults (mean age, 37 years; 76% women) with diagnosis of chronic tension-type headaches (mean, 26 headache d/mo).

Interventions  Participants were randomly assigned to receive tricyclic antidepressant (amitriptyline hydrochloride, up to 100 mg/d, or nortriptyline hydrochloride, up to 75 mg/d) medication (n = 53), placebo (n = 48), stress management (eg, relaxation, cognitive coping) therapy (3 sessions and 2 telephone contacts) plus placebo (n = 49), or stress management therapy plus antidepressant medication (n = 53).

Main Outcome Measures  Monthly headache index scores calculated as the mean of pain ratings (0-10 scale) recorded by participants in a daily diary 4 times per day; number of days per month with at least moderate pain (pain rating 5), analgesic medication use, and Headache Disability Inventory scores, compared by intervention group.

Results  Tricyclic antidepressant medication and stress management therapy each produced larger reductions in headache activity, analgesic medication use, and headache-related disability than placebo, but antidepressant medication yielded more rapid improvements in headache activity. Combined therapy was more likely to produce clinically significant (50%) reductions in headache index scores (64% of participants) than antidepressant medication (38% of participants; P = .006), stress management therapy (35%; P = .003), or placebo (29%; P = .001). On other measures the combined therapy and its 2 component therapies produced similar outcomes.

Conclusions  Our results indicate that antidepressant medication and stress management therapy are each modestly effective in treating chronic tension-type headaches. Combined therapy may improve outcome relative to monotherapy.

Author Affiliations: Department of Psychology (Drs Holroyd, Lipchik, and Carlson and Mr Stensland) and College of Osteopathic Medicine (Dr Cordingley), Ohio University, Athens; and Headache Treatment and Research (Drs Holroyd, O'Donnell, and Lipchik) and OrthoNeuro (Dr O'Donnell), Westerville, Ohio. Dr Lipchik is now with St Vincent Health Center, Erie, Pa.

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