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Source: Holroyd KA, et al. Management of chronic tension-type headache with tricyclic antidepressant medication, stress management therapy, and their combination: A randomized controlled trial. JAMA 2001;285: 2208-2215.
Chronic tension-type headaches are characterized by near-daily headaches and often are difficult to manage in primary practice. Behavioral and pharmacological therapies appear modestly effective, but data are lacking on their separate and combined effects.
To evaluate the clinical efficacy of behavioral and pharmacological therapies, singly and combined, for chronic tension-type headaches, Holroyd et al conducted a randomized, placebo-controlled trial from August 1995 to January 1998 at two outpatient sites in Ohio.
Two hundred three adults (mean age, 37 years; 76% women) with a diagnosis of chronic tension-type headaches (mean, 26 headache days/mo) were randomly assigned to receive tricyclic antidepressant medication (AM, amitriptyline hydrochloride, up to 100 mg/d, or nortriptyline hydrochloride, up to 75 mg/d) (n = 53); placebo (n = 48); stress management therapy (SMT, e.g., relaxation, cognitive coping; three sessions and two telephone contacts) plus placebo (n = 49); or SMT plus AM (n = 53).
Monthly index scores were calculated as the mean of pain ratings (0-10 scale) recorded by participants in a daily diary four 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.
Tricyclic AM and SMT each produced larger reductions in headache activity, analgesic medication use, and headache-related disability than placebo, but AM 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 = 0.006), stress management therapy (35%; P = 0.003), or placebo (29%; P = 0.001). On other measures, the combined therapy and its two component therapies produced similar outcomes.
The authors conclude that AM and SMT are modestly effective in treating chronic tension-type headaches. Combined therapy may result in improved outcome relative to monotherapy.
This is the first published placebo-controlled trial to examine the separate and combined effects of behavioral and drug therapies for a chronic headache disorder. It is useful because it briefly describes SMT, and makes it potentially accessible to practitioners. There are methodological flaws, including a substantial number of exclusions, which make the results difficult to generalize to patients with chronic headache who have a comorbid disorder, such as a pain syndrome, or concomitant headache disorder:
"There were 206 excluded participants: Fifty-four chose not to be evaluated for the study or did not complete the pretreatment evaluation; 53 did not receive a primary diagnosis of chronic tension-type headache or received a diagnosis of analgesic-abuse headaches at the baseline evaluation; 26 experienced migraines more than one day a month; 19 were using AM, other prophylactic headache medication, or anxiolytics regularly (15 days/mo); 31 presented with a medical or psychiatric disorder that required referral; 10 were currently receiving psychotherapy; six were pregnant or planned a pregnancy; six had a pain disorder other than headache as their primary pain problem; and one had a medical contraindication to amitriptyline."
The investigators used a psychologist or counselor to administer SMT in three one-hour sessions, all at the same time as visits for medication dose adjustments. Instruction manuals and audiotapes were given, and deep muscle relaxation training of 16 muscle groups was introduced. Active cognitive coping or problem solving techniques were introduced. These skills were applied to pain management, and a review of progress to date was held.
Meds helped more quickly than SMT, but at six months both methods were significantly better than placebo. Eighty percent of the participants who received meds and 30% of participants who received placebo reported adverse effects (P = 0.001). Of nine reported adverse effects caused by AM (dry mouth, drowsiness, weight gain, dizziness, sweating, constipation, abdominal pains, nervousness, increased appetite), only dry mouth and drowsiness were reported by more than 10% of participants in either treatment group; 51 participants (53%) in the AM group reported dry mouth vs. 12 (13%) in the placebo group (P = 0.001) and 43 participants (44%) in the AM group reported drowsiness vs. 10 (11%) in the placebo group (P = 0.001).
Adverse effects from SMT were not reported.
The treatment of chronic tension headache is difficult and taxing, and often frustrating. Patient involvement, with identification of triggers and home-learning of problem solving and coping skills, puts the responsibility for treatment where it needs to be—helping the patient help herself. Recommend stress management therapy along with pharmacological therapy.