Randomized Controlled Trials

Jul 072012
 
GM-CSF (Leukine) for acute lung injury & ARDS (RCT)

Human recombinant granulocyte macrophage colony stimulating factor (GM-CSF or Leukine) did not reduce ventilator-days in patients with acute lung injury / ARDS in a randomized trial published in the January 2012 Critical Care Medicine. Why would it have? Interestingly, patients with ARDS with higher levels of GM-CSF in their BAL fluid are more likely to survive. GM-CSF maintains [… read more]

Jun 232012
 
Acupuncture improved COPD in a "real" randomized trial

Acupuncture has danced on the fringes of mainstream Western medical therapy for decades. Acupuncture has been shown to improve numerous conditions –for example, reducing dyspnea in patients with cancer, asthma and chronic obstructive pulmonary disease (COPD) in a few randomized trials. But — unsurprisingly, given complementary medicine’s lack of funding and acceptance among traditional academics — [… read more]

Jun 142012
 
Most clinical trials are too small, often underpowered

The past decade has seen an explosion in the number of clinical trials; there are now more than 10,000 new trials registered each year. Although clinical trials’ quality is improving somewhat, most are still small and single-center and a large proportion do not adhere with reporting requirements, raising serious questions as to what we are [… read more]

Jun 092012
 
COPD self-care program fail; unexplained deaths at VA hospitals (RCT)

Chronic diseases like chronic obstructive pulmonary disease (COPD) account for at least 2/3 of medical care spending in the U.S. Policy makers, payers, and many physicians recognize that the outpatient clinic-based model is poorly suited to provide support in between physician visits, when most complications or exacerbations occur. Many hospitalizations and decline in function could [… read more]

Jun 072012
 
Inhaled hypertonic saline for young kids with cystic fibrosis: no benefit? (RCT)

(image: Bennett Gamel blog) Inhaled hypertonic saline (7% NaCl) increases clearance of mucus by airway cilia, making it an attractive treatment for cystic fibrosis. Hypertonic saline has been a cornerstone of daily therapy for CF ever since a 2006 NEJM randomized trial showed that ~80 adults and kids older than 6 using hypertonic saline for [… read more]

May 252012
 
Fever reduction improves early mortality in septic shock? Take a closer look

by Scott Aberegg, MD, MPH It is rare occasion that one article allows me to review so many aspects of the epistemology of medical evidence, but alas Schortgen et al afforded me that opportunity in the May 15th issue of AJRCCM. The issues raised by this article are so numerous that I shall make subsections for each one. [… read more]

May 132012
 
Chantix: no excess cardiovascular risk in new meta-analysis

(image: People’s Pharmacy) Sure to re-light controversy around Pfizer’s varenicline (Chantix): a new study concludes the smoking cessation drug likely carries no increased risk for cardiovascular events.  Judith Prochaska and Joan Hilton (University of California – San Francisco) report the results in the May 4 BMJ. Sonal Singh (Johns Hopkins) et al’s previous meta-analysis, reported in CMAJ [… read more]

Apr 122012
 
Release the data on Relenza and Tamiflu, Cochrane implores Pharma (NYT)

Antiviral drugs oseltamivir (Tamiflu) and zanamivir (Relenza) made big bucks for Roche and GSK respectively during the H1N1 influenza pandemic: Roche reportedly sold  about $3 billion of Tamiflu in 2009. Although sales have dropped off precipitously, the drugs are still recommended by CDC for serious cases of seasonal influenza. But do Relenza and Tamiflu even [… read more]

Apr 062012
 

The 5-year results of the Danish Lung Cancer Screening Trial (DLCST) were reported in the April 2012 Thorax, and they show no mortality benefit from annual screening for lung cancer with chest CT. Rather, it appeared that more harmless early stage cancers were identified through screening — “overdiagnosis” of cancers that would never have advanced [… read more]

Mar 042012
 

It wasn’t such a crazy idea, injecting beta-agonists continuously into the veins of people with acute respiratory distress syndrome (ARDS) for a week. After all, if you spray some albuterol on alveolar epithelial cells in a dish, it upregulates their cAMP production and doubles the rate at which they clear fluid across their basement membranes. [… read more]

Feb 282012
 

For unclear reasons, people receiving chemotherapy for solid tumors are at particularly increased risk for deep venous thrombosis and pulmonary embolism (DVT/PE). Semuloparin is an ultra-low-molecular weight heparin with a long half life of 16-20 hours that (like enoxaparin) is renally excreted. Sanofi, makers of Lovenox, report in the February 16 New England Journal of [… read more]

Feb 232012
 

GlaxoSmithKline has a new once-daily inhaled corticosteroid called fluticasone furoate; it has enhanced affinity for glucocorticoid receptors and a longer duration of action compared to the commonly-used fluticasone propionate, which must be taken twice daily to achieve a steady bioavailable concentration. In the January Thorax, William Busse et al report the findings of a Phase [… read more]

Feb 222012
 
Restrictive blood transfusion was fine for high-CV-risk patients after hip fracture repair (RCT, NEJM)

There’s not much data to guide the transfusion of red blood cells. In 1999, there was the beautifully executed and practice-changing Transfusion Requirements in Critical Care (TRICC) trial, which showed that a restrictive transfusion strategy (hemoglobin trigger of 7 g/dL) in ICU patients resulted in a non-stat.significantly lower mortality (19% vs. 23%) compared to a [… read more]

Feb 212012
 
Amoxicillin speeds resolution of acute sinus infections, but imperceptibly? (RCT, JAMA)

Amoxicillin may hasten the recovery from acute sinusitis (sinus infections), with more patients feeling just a tiny bit better after a week of amoxicillin compared to placebo, according to a clinical trial published in the February 15 JAMA. After 10 days, those taking placebo felt as well as those taking antibiotics. You may have heard [… read more]

Feb 192012
 

Traditional bronchoscopy with transbronchial biopsy (TBBx) has only a 34% sensitivity at diagnosing peripheral pulmonary nodules < 2 cm in size. Transthoracic needle aspiration (TTNA)’s superior sensitivity of 90% for diagnosing peripheral lesions makes it the standard of care for peripheral lesions, but TTNA carries a considerable risk for pneumothorax. A huge proportion of patients experience [… read more]

Feb 182012
 

Please also see the newer post describing the final results of PANTHER-IPF, published in NEJM 2012. PANTHER-IPF, a landmark clinical trial testing commonly used therapies for idiopathic pulmonary fibrosis, was stopped in October 2011 for apparent harm caused to patients by prednisone and azathioprine. This news was released back then, but maybe you missed it, as [… read more]

Feb 082012
 

One-third of smokers try to quit each year, but few stay quit. Even with varenicline (Chantix), the most effective smoking cessation aid to date, only 10% are abstinent at one year. Anne Joseph, Steven Fu, Dorothy Hatsukami et al wonder if that’s partly because our (fee-for-service-driven) intermittent-visit model of patient care and counseling leaves craving [… read more]

Jan 282012
 
Apixaban for thromboprophylaxis post-discharge causes bleeding (ADOPT Trial, NEJM)

For years, Pharma have been itching to prove a benefit of extended chemoprophylaxis against DVT / PE in medically ill patients after hospital discharge. Three weeks or more of enoxaparin after surgical knee or hip replacement is standard care, since it reduces the high risk of serious venous thromboembolism with a relatively low risk of [… read more]

Jan 142012
 

When given to people with acute exacerbations of chronic obstructive pulmonary disease, corticosteroids aren’t proven to reduce mortality, but they improve FEV1, reduce hospitalization by ~1 day, and increase 30-day treatment success, according to a 2009 Cochrane review of 10 randomized trials. Patients in ICUs were excluded from the analyzed studies, and it’s unclear whether steroids are [… read more]

Jan 112012
 
13 doses rifapentine + isoniazid as good as 9 months INH for latent TB (RCT, NEJM)

Nine months is a long time to take daily isoniazid — and an even longer time to go without beer. If you have latent tuberculosis infection (LTBI) diagnosed by a positive tuberculin skin test, and you make it through a year or 2 without developing active TB, your lifetime risk of reactivation TB (given a healthy [… read more]