Trial Files Throwback Thursday: Opioids vs Non-Opioids for Chronic Pain, IV Albumin For Spontaneous Bacterial Peritonitis, and PPI for GI Bleed

Jun 5, 2025

Are non-opioids effective for chronic back pain or hip or knee osteoarthritic pain?

Effect of Opioid vs Nonopioid Medications on Pain-Related Function in Patients With Chronic Back Pain or Hip or Knee Osteoarthritis Pain (SPACE)

Krebs EE et al. JAMA (March 2018)

Bottom Line: This pragmatic, 12-month randomized trial with masked outcome assessment evaluated the long-term outcomes of opioid versus nonopioid medications in patients with moderate to severe chronic back pain or hip or knee osteoarthritis. A total of 240 patients were randomized, with intervention involving opioids (immediate-release morphine, oxycodone, hydrocodone/acetaminophen) and comparator being nonopioids (acetaminophen or NSAIDs). The primary outcome was pain-related function, measured by the Brief Pain Inventory interference scale (range, 0–10; higher scores indicate worse function). Mean 12-month scores were 3.4 in the opioid group and 3.3 in the nonopioid group (difference, 0.1 [95% CI, −0.5 to 0.7]; P = .58) Adverse medication-related symptoms were significantly higher in the opioid group (overall P = .03). Results do not support the initiation of opioid therapy for moderate to severe chronic back pain or hip or knee osteoarthritis pain.

LINK TO ARTICLE (SPACE)


Does IV albumin reduce renal impairment and mortality in patients with cirrhosis and spontaneous bacterial peritonitis?

Effect of Intravenous Albumin on Renal Impairment and Mortality in Patients with Cirrhosis and Spontaneous Bacterial Peritonitis

Sort P et al. NEJM (August 1999)

Bottom line: This randomized clinical trial involved 126 patients with cirrhosis and spontaneous bacterial peritonitis, assessing the efficacy of cefotaxime plus intravenous albumin versus cefotaxime alone. The primary outcome was renal impairment defined as nonreversible deterioration of renal function during hospitalization. Results showed 6 patients (10%) in the intervention group experienced renal impairment compared to 21 patients (33%) in the comparator group (P=0.002). Additionally, 22% of patients in the intervention group died at three months compared to 41% in the comparator group (P=0.03). The study concluded that intravenous albumin in addition to an antibioitic reduces renal impairment and mortality in this patient population.

LINK TO ARTICLE (Sort et al.)


What is the effect of omeprazole before endoscopy in patients with GI bleeding?

Omeprazole before Endoscopy in Patients with Gastrointestinal Bleeding

Lau JY et al. NEJM (April 2017)

Bottom Line: This randomized controlled trial investigated the effects of preemptive infusion of high-dose omeprazole on the need for endoscopic therapy in patients with upper gastrointestinal bleeding over a 17-month period. A total of 638 patients were enrolled, receiving either omeprazole or placebo (each an 80 mg IV bolus followed by 8 mg infusion per hour). The primary outcome was the need for endoscopic treatment, with results showing 19.1% in the omeprazole group compared to 28.4% in the placebo group (P=0.007). Safety outcomes showed no significant differences in transfusion rates (1.54 and 1.88 units, respectively; P=0.12), recurrent bleeding (11 and 8, P=0.49), emergency surgery (3 and 4, P=1.00), or 30-day mortality (8 and 7, P=0.78). On endoscopy, fewer patients in the omeprazole group had actively bleeding ulcers (12 of 187, vs. 28 of 190 in the placebo group; P=0.01). The study concluded that omeprazole infusion effectively reduced the need for endoscopic intervention and accelerated the resolution of signs of bleeding in ulcers.

LINK TO ARTICLE (Lau et al.)


Trial Files Issue #2025-12