Comparative Effectiveness of Anti-TNF in Combination with Low Dose Methotrexate vs Anti-TNF Monotherapy in Pediatric Crohn’s Disease: a Pragmatic Randomized Trial

Tumor Necrosis Factor inhibitors (TNFi), including infliximab and adalimumab, are a mainstay of pediatric Crohn’s disease (PCD) therapy; however, non-response and loss of response is common. As combination therapy with methotrexate may improve response, we performed a multi-center, randomized, double-blind, placebo-controlled pragmatic trial to compare TNFi with oral methotrexate to TNFi monotherapy.

Leggi
Marzo 2023

Spinal Cord Burst vs Placebo Stimulation for Chronic Radicular Pain After Lumbar Spine Surgery

To the Editor In a recent randomized clinical trial that included patients with chronic radicular pain after spine surgery, Dr Hara and colleagues found no significant difference in back pain–related disability with burst spinal cord stimulation vs placebo. We commend the authors for their avoidance of industry sponsorship, which can introduce bias into interventional pain research. However, we would like to highlight important aspects of this study.

Leggi
Marzo 2023

Spinal Cord Burst vs Placebo Stimulation for Chronic Radicular Pain After Lumbar Spine Surgery

To the Editor As leaders of the American Society of Anesthesiologists, the American Association of Neurological Surgeons, the American Academy of Pain Medicine, the American Society of Pain and Neuroscience, the Congress of Neurological Surgeons, the International Neuromodulation Society, and the North American Neuromodulation Society, we are writing to express our serious concerns about the randomized clinical trial by Dr Hara and colleagues.

Leggi
Marzo 2023

Spinal Cord Burst vs Placebo Stimulation for Chronic Radicular Pain After Lumbar Spine Surgery

To the Editor We believe there are several methodological problems that limit interpretation of the findings of the crossover randomized clinical trial by Dr Hara and colleagues. A fundamental flaw is that patient selection was based on a minimal 2-point reduction in leg pain using a paresthesia trial; a 50% pain reduction from baseline is the commonly used threshold for spinal cord stimulation implantation. This trial considered leg pain intensity, but the primary outcome was disability for back pain. The authors assumed that all patients who responded to paresthesia spinal cord stimulation would respond to burst spinal cord stimulation. Although some of these patients may have met these criteria, the majority may not have, creating heterogeneity. Moreover, the authors did not evaluate the response to the burst trial prior to the crossover period. In the PROCO trial, a positive response to paresthesia spinal cord stimulation led to implantation, but only those responding to 10 kHz were randomized to variable-kilohertz stimulation.

Leggi
Marzo 2023

Spinal Cord Burst vs Placebo Stimulation for Chronic Radicular Pain After Lumbar Spine Surgery—Reply

In Reply In our quadruple-blinded, crossover, randomized clinical trial of 50 patients with chronic radicular pain after spine surgery, spinal cord burst stimulation resulted in no significant differences in core outcome measures, including functional disability measured by the Oswestry Disability Index, the Numerical Rating Scale for leg and back pain, quality of life, and physical activity levels, compared with placebo.

Leggi
Marzo 2023

The efficacy of peroral endoscopic myotomy vs. pneumatic dilation as treatment for patients with achalasia suffering from persistent or recurrent symptoms after laparoscopic Heller myotomy. A RANDOMIZED CLINICAL TRIAL

For achalasia patients with persistent or recurrent symptoms after laparoscopic Heller myotomy (LHM), pneumatic dilation (PD) is the most frequently used treatment. Per-oral endoscopic myotomy (POEM) is increasingly being investigated as rescue therapy. This study aimed to determine the efficacy of POEM versus PD for patients with persistent or recurrent symptoms after LHM.

Leggi
Marzo 2023