Time to Align Coverage with Evidence for Treatment of Back Pain.

Despite improved knowledge about the benefits and harms of treatments for chronic back pain in the past several decades, there is a large and consequential mismatch between treatments found safe and effective and those routinely covered by health insurance. As a result, care for back pain has, if anything, deteriorated in recent decades-expenses are higher, harms are greater, and use of ineffective treatments is more common. Deficiencies in health care delivery processes and payment models are centrally involved in the failure to improve care for back pain.

Oral steroids for acute radiculopathy due to a herniated lumbar disk: a randomized clinical trial.

Importance: Oral steroids are commonly used to treat acute sciatica due to a herniated disk but have not been evaluated in an appropriately powered clinical trial.

Objective: To determine if oral prednisone is more effective than placebo in improving function and pain among patients with acute sciatica.

Design, Setting, And Participants: Randomized, double-blind, placebo-controlled clinical trial conducted from 2008 to 2013 in a large integrated health care delivery system in Northern California.

A randomized trial of epidural glucocorticoid injections for spinal stenosis.

Background: Epidural glucocorticoid injections are widely used to treat symptoms of lumbar spinal stenosis, a common cause of pain and disability in older adults. However, rigorous data are lacking regarding the effectiveness and safety of these injections.

Methods: In a double-blind, multisite trial, we randomly assigned 400 patients who had lumbar central spinal stenosis and moderate-to-severe leg pain and disability to receive epidural injections of glucocorticoids plus lidocaine or lidocaine alone.

An evidence-based systematic review of elderberry and elderflower (Sambucus nigra) by the Natural Standard Research Collaboration.

An evidence-based systematic review of elderberry and elderflower (Sambucus nigra) by the Natural Standard Research Collaboration consolidates the safety and efficacy data available in the scientific literature using a validated, reproducible grading rationale. This article includes written and statistical analysis of clinical trials, plus a compilation of expert opinion, folkloric precedent, history, pharmacology, kinetics/dynamics, interactions, adverse effects, toxicology, and dosing.

Should we reconsider the routine use of placebo controls in clinical research?

Background: Modern clinical-research practice favors placebo controls over usual-care controls whenever a credible placebo exists. An unrecognized consequence of this preference is that clinicians are more limited in their ability to provide the benefits of the non-specific healing effects of placebos in clinical practice.

Methods: We examined the issues in choosing between placebo and usual-care controls.

The prognosis of acute low back pain in primary care in the United States: a 2-year prospective cohort study.

Study Design: Prospective cohort study.

Objective: To assess the prognosis of patients presenting with acute low back pain (LBP) in a primary care setting in the United States.

Summary Of Background Data: Practice guidelines for acute LBP based on return-to-work outcomes underestimate the development of chronic pain in the primary care setting.

Acute low back pain and primary care: how to define recovery and chronification?

Study Design: A prospective cohort study.

Objective: To establish outcome measures for recovery and chronic pain for studies with patients who present with recent-onset acute low back pain (LBP) in primary care.

Summary Of Background Data: Among back pain researchers, no consensus exists about outcome definitions or how to identify primary-care patients as not-recovered from an episode of LBP.

Surgical versus nonoperative treatment for lumbar spinal stenosis four-year results of the Spine Patient Outcomes Research Trial.

Study Design: Randomized trial and concurrent observational cohort study.

Objective: To compare 4 year outcomes of surgery to nonoperative care for spinal stenosis.

Summary Of Background Data: Surgery for spinal stenosis has been shown to be more effective compared to nonoperative treatment over 2 years, but longer-term data have not been analyzed.

A detailed safety assessment of a saw palmetto extract.

Background: Saw palmetto is commonly used by men for lower-urinary tract symptoms. Despite its widespread use, very little is known about the potential toxicity of this dietary supplement.

Methods: The Saw palmetto for Treatment of Enlarged Prostates (STEP) study was a randomized clinical trial performed among 225 men with moderate-to-severe symptoms of benign prostatic hyperplasia, comparing a standardized extract of the saw palmetto berry (160 mg twice daily) with a placebo over a 1-year period.

Initial experience with a group presentation of study results to research participants.

Background: Despite ethical imperatives, informing research participants about the results of the studies in which they take part is not often performed. This is due, in part, to the costs and burdens of communicating with each participant after publication of the results.

Methods: Following the closeout and publication of a randomized clinical trial of saw palmetto for treatment of symptoms of benign prostatic hyperplasia, patients were invited back to the research center to participate in a group presentation of the study results.

Surgical versus nonsurgical therapy for lumbar spinal stenosis.

Background: Surgery for spinal stenosis is widely performed, but its effectiveness as compared with nonsurgical treatment has not been shown in controlled trials.

Methods: Surgical candidates with a history of at least 12 weeks of symptoms and spinal stenosis without spondylolisthesis (as confirmed on imaging) were enrolled in either a randomized cohort or an observational cohort at 13 U.S.

Creating a culture of research.

There is widespread concern about the ability of the current model of clinical research to keep pace with the growing need for testing new approaches to disease management and prevention. In response, important innovations are emerging in critical areas of research infrastructure and practice. However, success in fulfilling the promise of clinical research will also require a fundamental shift in the relationship between the clinical-research enterprise and all segments of society.

Saw palmetto for benign prostatic hyperplasia.

Background: Saw palmetto is used by over 2 million men in the United States for the treatment of benign prostatic hyperplasia and is commonly recommended as an alternative to drugs approved by the Food and Drug Administration.

Methods: In this double-blind trial, we randomly assigned 225 men over the age of 49 years who had moderate-to-severe symptoms of benign prostatic hyperplasia to one year of treatment with saw palmetto extract (160 mg twice a day) or placebo. The primary outcome measures were changes in the scores on the American Urological Association Symptom Index (AUASI) and the maximal urinary flow rate.

Spontaneous bleeding associated with ginkgo biloba: a case report and systematic review of the literature: a case report and systematic review of the literature.

Background: Ginkgo biloba (ginkgo) is a herbal remedy used by over 2% of the adult population in the United States. Several review articles have suggested that ginkgo may increase the risk of bleeding.

Objective: To report a case of bleeding associated with using ginkgo, to systematically review the literature for similar case reports, and to evaluate whether using ginkgo is causally related to bleeding.