Selected Abstracts [*].

ANTIDEPRESSANT MEDICATIONS AND STRESS MANAGEMENT THERAPY ARE MODESTLY EFFECTIVE IN TREATING CHRONIC TENSION-TYPE HEADACHES

Holroyd KA, O'Donnell FJ, Stensland M, et al: Management of chronic tension--type headache with tricyclic antidepressant medication, stress management therapy, and their combination. JAMA 2001; 285:22082215

This randomized, placebo-controlled trial was conducted from August 1995 to January 1998 at two outpatient sites in Ohio and included 203 adults (mean age, 37 years; 76% women) with chronic tension-type headaches (mean, 26 headache days/mo). Individuals randomly received a tricyclic antidepressant (amitriptyline hydrochloride, up to 100 mg/day, or nortriptyline hydrochloride, up to 75 mg/day) medication (n = 53), a placebo (n = 48), stress management (eg, relaxation, cognitive coping) therapy (three sessions and two telephone contacts) plus a placebo (n = 49), or stress management therapy plus an antidepressant medication (n = 53). Monthly headache index scores were calculated as the mean of pain ratings (on a scale of 0 to 10) recorded by the individuals in a diary four times daily, number of days per month with at least moderate pain (pain rating 5), analgesic medication use, and Headache Disability Inventory scores, compared with an intervention group. Tricyclic antidepressant medication and stress manage ment therapy each produced larger reductions in headaches, analgesic medication use, and headache-related disability than did the placebo. However, antidepressant medications improved headaches more rapidly. 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 a placebo (29%; P= .001).

MEDIAN SURVIVAL AFTER THE ONSET OF DEMENTIA IS MUCH SHORTER THAN PREVIOUSLY ESTIMATED

Wolfson C, Wolfson DB, Asgharian M, et al: A reevaluation of the duration of survival after the onset of dementia. N Engl J Med 2001; 344:1111-1116

Data were collected from the Canadian Study of Health and Aging to estimate survival from the onset of symptoms of dementia. The estimate was adjusted for length bias. The study included a random sample of 821 individuals aged 65 years and older from Canada who were screened for cognitive impairment (396 had probable Alzheimer's disease, 252 had possible Alzheimer's disease, and 173 had vascular dementia). The unadjusted median survival was 6.6 years (95% confidence interval [CI], 6.2-7.1). After adjusting for length bias, the estimated median survival was 3.3 years (95% CI, 2.7-4.0). The median survival was 3.1 years for individuals with probable Alzheimer's disease, 3.5 years for individuals with possible Alzheimer's disease, and 3.3 years for those with vascular dementia. (An editorial, "Aging and the Public Health Effects of Dementia," appears in the same issue, pp 1160-1161.)

COGNITIVE BEHAVIORAL THERAPY IS A VIABLE INTERVENTION FOR CHRONIC PRIMARY SLEEP-MAINTENANCE INSOMNIA

Edinger JD, Wohlgemuth WK, Radtke RA, et al: Cognitive behavioral therapy for treatment of chronic primary insomnia. JAMA 2001; 285:1856-1864

This randomized, double-blind, placebo-controlled clinical trial was conducted at an academic medical center from January 1995 to July 1997 and included 75 adults (35 women; mean age, 55.3 years) with chronic primary sleep-maintenance insomnia (duration of symptoms, 13.6 years). The patients were randomly assigned to cognitive behavioral therapy (CBT) (sleep education, stimulus control, and time-in-bed restrictions; n = 25); progressive muscle relaxation training (RT; n = 25), or a quasi-desensitization (placebo) treatment (n = 25). The 6-week outpatient treatment was followed up at 6 months. Cognitive behavioral therapy produced greater improvements across the majority of outcome measures than did RT or placebo treatment. Sleep logs showed that CBT-treated patients achieved an average 54% reduction in their wake time after sleep onset (WASO), whereas RT-treated and placebo-treated patients achieved only 16% and 12% reductions, respectively. Those who received CBT also showed a greater normalization of sleep and subjective symptoms than did the other groups, with an average sleep time of more than 6 hours, middle WASO of 26.6 minutes, a nd sleep efficiency of 85.1%. In contrast, those patients treated with RT continued to report a middle WASO of 43.4 minutes and sleep efficiency of 78.8%.

ADJUVANT ADENOIDECTOMIES OR ADENOTONSILLECTOMIES SUBSTANTIALLY REDUCE THE LIKELIHOOD OF FURTHER HOSPITALIZATIONS AND OPERATIONS RELATED TO OTITIS MEDIA IN CHILDREN [less than or equal to]2 YEARS OLD

Coyte PC, Croxford R, McIssac W, et al: The role of adjuvant adenoidectomy and tonsillectomy in the outcome of the insertion of tympanotomy tubes. N Engl J Med 2001; 344:1188-1195

Hospital discharge records from 1995 through 1997 were examined for surgery results for 37,316 children (aged 19 years or younger) in Ontario, Canada, who received tympanotomy tubes as their first surgical treatment for otitis media. When compared with treatment involving the insertion of tympanotomy tubes alone, adjuvant adenoidectomy was associated with a reduction in the likelihood of reinsertion of tympanotomy tubes (relative risk [KR], 0.5; 95% confidence interval [CI], 0.5-0.6; P [less than] .001) and the likelihood of readmission for conditions related to otitis media (KR, 0.5; 95% CI, 0.5-0.6; P [less than] .001). The risk of these outcomes was reduced even further when an adjuvant adenotonsillectomy was done. Children as young as 1 year old appeared to benefit from adjuvant adenotonsillectomy, while 2-year-olds benefited from an adjuvant adenoidectomy. Children 3 years old and older benefited the most from an adjuvant adenoidectomy. (A related article, "Effect of Early or Delayed Insertion of Tympan otomy Tubes for Persistent Otitis Media on Developmental Outcomes at the Age of Three Years," appears in the same issue, pp 1179-1187.)

BENZODIAZEPINES (EXCEPT FOR LORAZEPAM) DO NOT INCREASE THE RISK OF HIP FRACTURES

Pierfitte C, Macouillard G, Thicoipe M, et al: Benzodiazepines and hip fractures in elderly people: case-control study. BMJ 2001; 322:704-708

This case-control study included 245 incident cases of hip fractures unrelated to traffic accidents or cancer in patients over 65 years of age from January 1996 to July 1997. The use of benzodiazepines, as determined from questionnaires, medical records, or plasma samples at the time of hospital admission, was not associated with an increased risk of hip fractures (odds ratio [OR], 0.9; 95% confidence interval [CI], 0.5-1.5). Hip fractures were associated with the use of two or more benzodiazepines, also determined from questionnaires or medical records, but not from plasma samples. Of the individual drugs, only lorazepam was significantly associated with an increased risk of hip fractures (OR, 1.8; CI, 1.1-3.1).

RALOXIFENE, A SELECTIVE ESTROGEN- RECEPTOR MODULATOR, DOES NOT AFFECT OVERALL COGNITIVE SCORES IN POST- MENOPAUSAL WOMEN WITH OSTEOPOROSIS OVER A 3-YEAR TREATMENT PERIOD

Yaffe K, Krueger K, Sarkar S, et al: Cognitive function in postmenopausal women treated with raloxifene. N Engl J Med 2001; 344:1207-1213

The study included 7,478 postmenopausal women with osteoporosis (mean age, 66 years), who were enrolled in the Multiple Outcomes of Raloxifene Evaluation trial at 178 sites in 25 countries. The women were randomly treated with raloxifene (60 or 120 mg) or a placebo daily for 3 years. The mean scores of the groups on six tests of cognitive function, which were administered at baseline, at 6 months, and at 1, 2, and 3 years, were compared. A decline in cognitive function was defined as a score in the worst 10% at 3 years. The mean cognitive scores in the three groups of women were comparable at baseline. The scores improved slightly in all of the groups during the 3-year study with no significant differences. The risk of decline in cognitive function, measured by four of the six tests, did not differ significantly between the two raloxifene groups combined and the placebo group. However, there was a trend toward less decline in the combined raloxifene group on the two tests of verbal memory (relative risk [RR ], 0.77) and attention (RR, 0.87). (An editorial, "Can Estrogen or Selective Estrogen-Receptor Modulators Preserve Cognitive Function in Elderly Women?" appears in the same issue, pp 1242-1244.)

FLUVOXAMINE IS EFFECTIVE IN TREATING SOCIAL PHOBIAS, SEPARATION ANXIETY DISORDERS, OR GENERALIZED ANXIETY DISORDERS IN CHILDREN AND ADOLESCENTS

Research Unit on Pediatric Psychopharmacology Anxiety Study Group: Fluvoxamine for the treatment of anxiety disorders in children and adolescents. N Engl J Med 2001;344:1279-1285

This study included 128 children aged 6 to 17 years who met criteria for social phobia, separation anxiety disorder, or generalized anxiety disorder and who had received psychological treatment for 3 weeks without improvement. The children were randomly treated with fluvoxamine (at a maximum of 300 mg/day) or a placebo for 8 weeks and evaluated with rating scales designed to assess the degree of anxiety and impairment. Children treated with fluvoxamine had a mean ([+ or -]SD) decrease of 9.7 [+ or -] 6.9 points in symptoms of anxiety on the Pediatric Anxiety Rating Scale (range of possible scores, 0-25, with higher scores indicating greater anxiety), as compared with a decrease of 3.1 [+ or -] 4.8 points among children in the placebo group (P [less than].001). Forty-eight of the 63 children in the fluvoxamine group (76%) had a score of less than 4 on the Clinical Global Impressions-Improvement scale compared with 19 of the 65 children in the placebo group (29%, P [less than].001).

STATINS DO NOT REDUCE THE RISK OF FRACTURES

Van Staa T, Wegman S, de Vries F, et al: Use of statins and risk of fractures. JAMA 2001; 285:1850-1855

This case-control study of data from the General Practice Research Database (GPRD) included 683 general clinical practices in the United Kingdom. The study included 81,880 patients aged 50 years or older who had a fracture of the vertebrae, clavicle, humerus, radius/ulna, carpus, hip, ankle, or foot occurring between the enrollment date into the GPRD and July 1999. Women comprised 75.6% of the group and the mean age was 70 years. The main outcome measure was the risk of fracture in current users of statins compared with that of nonusers. The adjusted odds ratio (OR) for current use of statins compared with nonuse was 1.01 (95% confidence interval [CI], 0.88-1.16). For forearm, hip, and vertebral fractures, the ORs were 1.01 (95% CI, 0.80-1.27), 0.59 (95% CI, 0.31-1.13), and 1.15 (95% CI, 0.62-2.14), respectively. Relative to nonuse, a statin dose of less than 20 mg/day was associated with an adjusted OR of fracture of 1.13 (95% CI, 0.96-1.33); this OR was 1.07 (95% CI, 0.82-1.38) at doses of 20.0 to 39.9 mg and 0.85 (95% CI, 0.47-1.53) at doses of 40.0 mg/day or more. The adjusted OR was 0.71 (95% CI, 0.50-1.01) for statin use durations of 0 to 3 months, 1.31 (95% CI, 0.87-1.95) for durations of 3 to 6 months, 1.14 (95% CI, 0.82-1.58) for durations of 6 to 12 months, and 1.17 (95% CI, 0.99-1.40) for periods of more than 12 months. (An editorial, "Statins and Fracture Risk," appears in the same issue, pp 1888-1889.)

(*.) Originally prepared for presentation on Southern Medical Association's web site (http://www.sma.org) by Elaine McClellan-Holm.