Randomized Controlled Trials

Jan 022013
 
Adding tiotropium (Spiriva) helped some with uncontrolled asthma (RCT)

Spiriva (Tiotropium) for Uncontrolled Asthma Most people with asthma can achieve good control with inhaled corticosteroids (ICS) and a long-acting beta-agonist (LABA). Some people living with asthma, though, experience persistent symptoms despite maximum doses of these inhaled medications. Fairly or not, LABAs have also been sullied with an FDA black-box warning for worsening bronchospasm in a [… read more]

Jan 012013
 
Hydroxyethyl starch fries kidneys in another large trial (RCT)

Hydroxyethyl Starch (Voluven) Causes Kidney Failure In Large Trial Hydroxyethyl starch (HES) was already wearing a scarlet letter as an potentially dangerous volume resuscitation agent for patients in shock, after evidence emerged this year that hydroxyethyl starch kills people with severe sepsis. Now, another huge, convincing trial shows that hydroxyethyl starch (Voluven) damages kidneys and [… read more]

Dec 292012
 
Xigris' epitaph: "I Never Worked a Day in My Life" (PROWESS-SHOCK)

Recombinant human activated protein C or dotrecogin alfa — better known as Xigris, by Eli Lilly — seemed a godsend when it was first approved for treatment of severe sepsis in 2001. Xigris’ FDA approval (despite an evenly split 10-10 vote) was based solely on the Eli Lilly-funded PROWESS study, a phase 3 randomized trial [… read more]

Dec 292012
 
Oral rivaroxaban (Xarelto) noninferior to warfarin for PE (RCT)

(image: InPharm) Rivaroxaban (Xarelto) was noninferior to standard treatment (heparin and warfarin) in preventing recurrent VTE in patients with acute pulmonary embolism (PE), in the large EINSTEIN-PE randomized trial published in the April 5 New England Journal of Medicine. A once-daily oral factor Xa inhibitor that has already been demonstrated to be noninferior for treatment [… read more]

Dec 292012
 
An aspirin a day keeps recurrent DVT and PE away (RCT)

(image: Rex Parker) Among people with unprovoked deep venous thrombosis (DVT) or pulmonary embolism (PE), 1 in 5 will experience another DVT or PE within 2 years after stopping anticoagulation with warfarin (Coumadin). For this reason, the ACCP’s recommendations for treatment of unprovoked proximal DVT or PE suggest consideration of an “indefinite” period of anticoagulation [… read more]

Dec 262012
 
Pleural catheters equal to pleurodesis for dyspnea relief from malignant effusions (TIME2)

(image: Wikipedia) In the TIME2 randomized trial published in the June 13 2012 JAMA, indwelling pleural catheters and talc pleurodesis were equivalent at reducing dyspnea over the 6 weeks following the procedure among 106 patients with malignant pleural effusions. Most patients receiving pleural catheters required no hospital stays, and overall had fewer repeat procedures than those [… read more]

Dec 242012
 
Hydroxyethyl starches kill people with severe sepsis; use crystalloid instead (RCT)

Colloids are believed to be more effective expanders of plasma volume than crystalloids, making them a tempting therapy to use for patients in septic shock and other causes of hemodynamic instability. Problem is, some colloid solutions seem to kill people. The VISEP Trial using hydroxyethyl starch 200 kDa/0.5 demonstrated that this high molecular weight HES [… read more]

Dec 232012
 
Nicotine patches don't help in pregnancy, esp. if you don't wear them (RCT)

(image: Smokersworld.info) You never see pregnant women smoking in public, but surveys say 12-25% of pregnant women in developed countries smoke during pregnancy. Of course they know they shouldn’t — with smoking’s increased risks for miscarriage, low birth weight, premature birth, birth defects, and even sudden infant death after delivery. Most pregnant women want badly [… read more]

Dec 222012
 
Trophic feeding equal to full enteric feeding in acute lung injury (EDEN trial)

Where should we set the dial for caloric delivery to our patients with acute lung injury and acute respiratory distress syndrome (ARDS)? Weak observational trials suggest low caloric intake might be associated with poor outcomes [ref1, 2]. On the other hand, other observational data suggests just the opposite: restricting calories early on may reduce ventilator [… read more]

Dec 222012
 
Lansoprazole didn't help kids with uncontrolled asthma (RCT)

Proton Pump Inhibitors No Help for Kids’ Asthma Gastroesophageal reflux (GER) is a mysterious co-conspirator with asthma. Many people with uncontrolled asthma have reflux (either symptomatic by history, or asymptomatic and detected on esophageal pH studies). Randomized trials in adults suggest that treating symptomatic GERD (gastroesophageal reflux DISEASE) improves asthma, but treating asymptomatic GER does not [… read more]

Dec 202012
 
CPAP cures metabolic syndrome in obstructive sleep apnea (Retracted)

CPAP Improves Metabolic Syndrome in Obstructive Sleep Apnea This paper has been RETRACTED! Continuous positive airway pressure (CPAP) therapy reversed elements of the high cardiovascular risk profile known as metabolic syndrome in a substantial minority of Indians with treatment-naive obstructive sleep apnea, according to this article in the New England Journal of Medicine. More than [… read more]

Dec 182012
 
Enoxaparin prophylaxis: no effect on mortality or fatal pulmonary embolism (RCT)

Does Enoxaparin Prophylaxis Really Help Most Hospitalized Patients? A huge randomized trial (LIFENOX) stunned experts by showing no benefit of enoxaparin prophylaxis in preventing pulmonary embolism or all-cause mortality in acutely ill medical patients, compared to knee-length graduated compression stockings alone. Ajay Kakkar, Claudio Cimminiello, Jean-Francois Bergmann et al report their surprising results in the [… read more]

Dec 042012
 
Linezolid (Zyvox) good for MDR, XDR tuberculosis (RCT)

Linezolid (Zyvox) for XDR-TB: New Hope, New Caution Approved by the FDA in 2000 for drug-resistant gram positive bacterial infections, linezolid (Zyvox, Pfizer) has in clinical practice been mainly used for skin infections and the occasional pneumonia due to methicillin-resistant Staph aureus (MRSA). Now linezolid looks to be effective as an adjunct therapy for multi-drug resistant [… read more]

Nov 292012
 
Normal saline: toxic to kidneys? Chloride solutions may cause renal failure

Does Normal Saline Cause Acute Renal Failure? To internal medicine-trained physicians in the U.S., normal saline solution seems as harmless and healthy as mother’s milk. Intensivists trained in anesthesia or surgery might more often mention normal saline’s hypertonicity compared to blood, and its propensity to cause hyperchloremia, compared to lactated Ringer’s or similar solutions. But [… read more]

Nov 232012
 
Intensive glucose control in kids: no brain injury vs. standard care 3 yrs later (RCT)

Intensive Glucose Control: Safe for Critically Ill Kids’ Brains? After evangelizing globally for intensive glucose control (~100 mg/dL) to be the standard of care for virtually all critically ill adults for a decade, Greet van den Berghe might be disappointed that mounting evidence shows that a fanatical approach to maintenance of normoglycemia in critical illness [… read more]

Nov 062012
 
Lung volume reduction coils improve dyspnea, FEV1 in COPD (RCT)

(image: PneumRx) ATLANTA — In a small, open-label pilot study, bronchoscopically-placed metal coils that retract emphysematous lung, creating lung volume reduction without surgery, produced functional and airflow improvements in a majority of patients with severe COPD, the lead researcher reported at CHEST 2012. Investigators randomized 47 patients with severe emphysema type COPD to undergo either [… read more]

Oct 262012
 
Vitamin D is for "doesn't do diddly" for the common cold (RCT)

Extra Vitamin D Doesn’t Prevent Colds in Healthy Adults (JAMA) It looks like you can add Vitamin D to list of supplements (echinacea, vitamin C, etc.) who’ve gone up against the common cold and lost. (Scorekeepers will note that zinc held its own, though, in a Cochrane analysis.) Vitamin D plays an important role in immune responses, [… read more]

Oct 192012
 
"Practice ischemia" on an arm reduces contrast nephropathy after procedures (RCT)

Contrast-induced nephropathy (kidney damage) is a serious problem that can occur after many medical tests and procedures, but coronary angiography (cardiac catheterization) is the main culprit. People with pre-existing renal disease are most susceptible to contrast-induced nephropathy (CIN) — about 1 in 8 of them develop a “bump” in creatinine of >0.5 mg/dL after cardiac [… read more]

Oct 042012
 
Post-pyloric feeding no better than usual NG tube in vented patients (RCT)

Image: EIMJM.com Evidence-based practice guidelines adopted by critical care societies in Canada, Germany, Australia and New Zealand recommend starting enteral nutrition for critical illness shortly after admission to an ICU. In observational studies, critically ill adults get only about 50-70% their caloric goals from enteral feeding; reduced gastric motility is often responsible for the limited [… read more]