Outlook: Clinical Trials

JANUARY 09, 2012
Michele Reed, PharmD

Start Back: Primary Care Management for Low Back Pain

A recent clinical trial compared the clinical and cost-effectiveness of stratified primary care for low back pain—the intervention group—with nonstratified current best practice—the control group.1

Study subjects (n = 1573) were stratified according to their prognosis of low, medium, or high risk and randomly assigned by use of computer-generated stratified blocks with a 2:1 ratio to the intervention or the control group.

The primary end point was the effect of treatment on the Roland Morris Disability Questionnaire (RMDQ) score at 12 months. In an economic analysis, incremental quality-adjusted life-years (QALYs) and health care costs related to back pain were estimated.

Results showed that overall, adjusted mean changes in RMDQ scores were significantly higher in the intervention group than in the control group at 4 months (4.7 [standard deviation 5.9] vs 3.0 [5.9]), between-group difference 1.81 [95% confidence interval (CI), 1.06-2.57]) and at 12 months (4.3 [6.4] vs 3.3 [6.2], 1.06 [0.25-1.86]). Additionally, stratified care was associated with a mean increase in generic health benefit at 12 months, with an increase of 0.039 QALYs and a cost savings of £240.01 vs £274.40 compared with the control group.

The study authors concluded that the use of a stratified approach, one with prognostic screening and matched pathways, will have important implications for the future management of back pain in primary care.


Celecoxib as an Adjunct in the Treatment of Obsessive-Compulsive Disorder

A recent clinical study assessed the efficacy of celecoxib as an adjuvant agent in the treatment of obsessivecompulsive disorder (OCD).2 This 8-week, double-blind, placebo-controlled trial assigned subjects to either a study group or a control group.

The study group (n = 25) received fluoxetine 20 mg/day plus celecoxib 400 mg/day (200 mg twice a day), and the control group (n = 25) received fluoxetine 20 mg/day plus placebo. The primary end point was change in scores on the Yale-Brown Obsessive- Compulsive Scale over 8 weeks.

Results showed that the combination of fluoxetine and celecoxib decreased the symptoms of obsessions and compulsions significantly more than fluoxetine plus placebo. The authors concluded that celecoxib can be an effective adjuvant agent in the management of patients with OCD; therefore, anti-inflammatory therapies should be further investigated for use with this indication.


Education, Income, and Incident Heart Failure in Postmenopausal Women

In a recent study, investigators used data from the Women’s Health Initiative Hormone Trials to examine the association between socioeconomic status levels and incident heart failure (HF) hospitalization among postmenopausal women.3 The study included healthy post-menopausal women (n = 26,160), and education and income were self-reported. The analysis was adjusted for demographics, comorbid conditions, behavioral factors, and hormone and dietary modification assignments.

Results showed that women with household incomes less than $20,000 per year had higher HF hospitalization incidence (57.3/10,000 person-years) than women with household incomes greater than $50,000 per year (16.7/10,000 person-years; P <.01). Additionally, women with less than a high school education had higher HF hospitalization incidence (51.2/10,000 person-years) than those with degrees from college and above (25.5/10,000 personyears; P <.01).

Using multivariable analyses, results demonstrated that women with the lowest income levels had 56% higher risk (hazard ratio [HR], 1.56; 95% CI, 1.19-2.04) than the highest income women, and women with the least amount of education had 21% higher risk for incident HF hospitalization (HR, 1.21; 95% CI, 0.90-1.62) than the most educated women.

The authors concluded that lower income is associated with an increased incidence of HF hospitalization among healthy, post-menopausal women, whereas multivariable adjustment attenuated the association of education with incident HF.

Dr. Reed received her doctor of pharmacy degree from the University of the Sciences in Philadelphia, Pennsylvania, and currently works as a medical editor in the greater Philadelphia area.


1. Hill JC, Whitehurst DG, Lewis M, et al. Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial. Lancet. 2011;378(9802):1560-1571.

2. Sayyah M, Boostani H, Pakseresht S, Malayeri A. A preliminary randomized double-blind clinical trial on the efficacy of celecoxib as an adjunct in the treatment of obsessive-compulsive disorder. Psychiatry Res. 2011;189(3):403-406.

3. Shah RU, Winkleby MA, Van Horn L, et al. Education, income, and incident heart failure in post-menopausal women: the Women’s Health Initiative Hormone Therapy Trials. J Am Coll Cardiol. 2011;58(14):1457-1464.

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