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.
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Spinal Cord Burst vs Placebo Stimulation for Chronic Radicular Pain After Lumbar Spine Surgery
To the Editor We have several concerns regarding the recent randomized clinical trial about the role of burst stimulation in patients with chronic pain after back surgery.
Augmentation vs. Switching Drugs for Late-Life Treatment-Resistant Depression
Augmentation with aripiprazole or bupropion produced higher remission rates than switching to bupropion.
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.
In adults with acute HF, high-intensity care vs. usual care reduced a composite of death or HF readmission at 180 d
Annals of Internal Medicine, Ahead of Print.
In symptomatic AF, cryoballoon ablation reduced progression to persistent AF vs. antiarrhythmic therapy at 3 y
Annals of Internal Medicine, Ahead of Print.
In acute HF in the ED, a risk-based management algorithm vs. usual care reduced a composite clinical outcome at 30 d
Annals of Internal Medicine, Ahead of Print.
Antihypertensive therapy reduced incident dementia vs. placebo at a median 4.3 y
Annals of Internal Medicine, Ahead of Print.
Effect of Intrapartum Azithromycin vs Placebo on Neonatal Sepsis and Death
This randomized trial compares the efficacy of intrapartum azithromycin vs placebo to reduce neonatal sepsis or mortality, as well as neonatal and maternal infections, among birthing parents and their infants in West Africa.
Lower vs Higher Oxygen Saturation Targets and Survival to Hospital Discharge Among Patients Resuscitated After Out-of-Hospital Cardiac Arrest—Reply
In Reply Regarding our recent study, Drs Wetsch and Böttiger are concerned that a target oxygen saturation of 90% to 94% in the EXACT trial should be considered hypoxia. This target oxygen saturation was justified by a meta-analysis of previous phase 2 trials testing a lower oxygen target in patients with out-of-hospital cardiac arrest. In that meta-analysis, there was a range of different “low” oxygen targets. The largest study was by Young et al, which randomized 166 patients with suspected hypoxic-ischemic encephalopathy to receive an oxygen saturation of 90% to 97% compared with standard care. A total of 37 of 86 patients (43%) assigned to the lower oxygen target and 46 of 78 (59%) assigned to standard oxygen target died by day 180 (odds ratio, 0.53 [95% CI, 0.28-0.98]; P = .04). These data were suggestive that a target oxygen saturation as low as 90% was safe, but required a larger trial to prove benefit. It is acknowledged that current guidelines recommend a target oxygen saturation of 94% to 98% and that an oxygen saturation less than 90% should be avoided. Given the results of the EXACT trial, we agree that there are now compelling data supporting a minimum target oxygen saturation of 94% during prehospital and emergency department care in these patients.
Induction Therapy With Olamkicept vs Placebo for Active Ulcerative Colitis
This randomized clinical trial compares clinical response at 12 weeks with olamkicept vs placebo in treating adult patients with active ulcerative colitis.
Lower vs Higher Oxygen Saturation Targets and Survival to Hospital Discharge Among Patients Resuscitated After Out-of-Hospital Cardiac Arrest
To the Editor A recent study compared the effect of 2 oxygen saturation targets on survival after out-of-hospital cardiac arrest. The authors have focused on an important area of postresuscitation care, because hyperoxia (defined as Pao2 >300 mm Hg) has shown to be associated with worse outcomes. In contrast to a 2022 study, the study by Dr Bernard and colleagues did not report any benefit for low oxygen targets, although the oxygen target for the intervention group (peripheral oxygen saturation of 90%-94%) was far below international recommendations. Thus, this trial compared hypoxia with normoxia rather than normoxia with hyperoxia and, not surprisingly, the intervention group experienced more episodes of hypoxemia and rearrest. Although this study was stopped early without having reached the required number of patients due to the COVID-19 pandemic and thus had insufficient statistical power, the study results nearly showed statistical significance (P = .05), with worse survival in the lower oxygen saturation target intervention group (38.3%) vs the standard group (47.9%). Therefore, we are concerned that the wording of the conclusion “…targeting an oxygen saturation of 90%-94%…did not significantly improve survival…” was misleading and did not represent the most important findings of this study. Furthermore, as shown in Table 2 in the article, the first Paco2 measurement in the emergency department was 60 mm Hg in both groups, revealing severe hypoventilation in the out-of-hospital setting that may have influenced the results of the study.
Effectiveness and Safety of SGLT2 Inhibitors vs DPP-4 Inhibitors in Patients With Type 2 Diabetes
This comparative effectiveness study evaluates cardiovascular effectiveness and safety of SGLT2 inhibitors vs DPP-4 inhibitors in adults with type 2 diabetes overall and at varying baseline HbA1c levels.
MRI-Guided vs CT-Guided Stereotactic Body Radiotherapy for Patients With Prostate Cancer
This randomized clinical trial assesses genitourinary toxic effects after magnetic resonance imaging (MRI)–guided vs computed tomography (CT)–guided stereotactic body radiotherapy for prostate cancer.
Cefepime/Enmetazobactam vs Piperacillin/Tazobactam and Complicated Urinary Tract Infection or Acute Pyelonephritis—Reply
In Reply In response to the insightful questions by Dr Hsu and colleagues, the ALLIUM phase 3 study was completed prior to the change in the CLSI piperacillin/tazobactam breakpoints in 2022 and the EUCAST breakpoints in 2021. However, a post hoc outcomes analysis was performed on the primary analysis set, which excluded patients with baseline urinary pathogens with a piperacillin/tazobactam MIC of greater than 16 μg/mL and/or if the pathogen encoded an extended-spectrum β-lactamase. In this analysis, improved outcomes in patients receiving cefepime/enmetazobactam compared with piperacillin/tazobactam were still observed. Although not presented in our article, we performed another post hoc analysis that excluded patients with a baseline pathogen piperacillin/tazobactam MIC of greater than 8 μg/mL, accounting for the new piperacillin/tazobactam breakpoints (susceptible, ≤8 μg/mL). In this analysis, improved outcomes in the cefepime/enmetazobactam group (79.1% [250/316]) compared with the piperacillin/tazobactam group (60.3% [182/302]) were again observed (treatment difference, 18.8% [95% CI, 11.6%-25.7%]; P
Cefepime/Enmetazobactam vs Piperacillin/Tazobactam and Complicated Urinary Tract Infection or Acute Pyelonephritis
To the Editor A recent trial comparing the effect of cefepime/enmetazobactam vs piperacillin/tazobactam on complicated urinary tract infection or acute pyelonephritis found that patients receiving cefepime/enmetazobactam had a better primary outcome. We have some concerns about this study.