Annals of internal medicine
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Review Meta Analysis
Effect of Weight Loss Interventions on the Symptomatic Burden and Biomarkers of Polycystic Ovary Syndrome : A Systematic Review of Randomized Controlled Trials.
Polycystic ovary syndrome (PCOS) is common in women of reproductive age and is associated with obesity. Clinical guidelines recommend weight loss, but the impact on the clinical manifestations of PCOS is unclear. ⋯ National Institute for Health and Care Research School for Primary Care Research. (PROSPERO: CRD42022367488).
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Randomized Controlled Trial Multicenter Study
In acute ischemic stroke and a large infarct, adding EVT to medical treatment improved functional outcome at 12 mo.
Thomalla G, Fiehler J, Subtil F, et al; TENSION Investigators. Endovascular thrombectomy for acute ischaemic stroke with established large infarct (TENSION): 12-month outcomes of a multicentre, open-label, randomised trial. Lancet Neurol. 2024;23:883-892. 39074480.
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Although medical devices are widely used in clinical practice, clinicians and the public have limited access to information on how devices are tested, regulated, and used, posing challenges to patient safety. This article uses Cook Medical's Celect inferior vena cava (IVC) filter, a medical device used for prevention of pulmonary embolism, as a case study of the transparency gap in medical device regulation. Recently unsealed court documents from litigation related to Celect reveal that the device's clinical study protocol did not follow U. ⋯ Food and Drug Administration (FDA) guidance for IVC filter testing and that study outcome definitions for IVC perforation had lower sensitivity for detecting adverse events than those recommended by professional societies. Furthermore, a comparison of court documents and the public record indicates that adverse events and patient deaths were misreported to FDA reviewers and were inaccurately reported in the published literature and on the device label, providing patients and clinicians with inaccurate information about the device's safety. The Celect IVC filter case demonstrates the need for regulatory reforms to ensure that critical safety data are accessible to the FDA, clinicians, and patients to inform decision making.
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Practice Guideline
2023 U.S. Department of Veterans Affairs and U.S. Department of Defense Clinical Practice Guideline for the Management of Headache.
Headache medicine and therapeutics evidence have been rapidly expanding and evolving since the 2020 U.S. Department of Veterans Affairs (VA) and U.S. Department of Defense (DoD) clinical practice guideline (CPG) for the management of headache. Therefore, the CPG was revised in 2023, earlier than the standard 5-year cycle. This article reviews the 2023 CPG recommendations relevant to primary care clinicians for treatment and prevention of migraine and tension-type headache (TTH). ⋯ The revised CPG includes 52 recommendations on evaluation, pharmacotherapy, invasive interventions, and nonpharmacologic interventions for selected primary and secondary headache disorders. In addition to triptans and aspirin-acetaminophen-caffeine, newer calcitonin gene-related peptide (CGRP) inhibitors (gepants) are options for treatment of acute migraine. Medications to prevent episodic migraine (EM) include angiotensin-receptor blockers, lisinopril, magnesium, topiramate, valproate, memantine, the newer CGRP monoclonal antibodies, and atogepant. AbobotulinumtoxinA can be used for prevention of chronic migraine but not EM. Gabapentin is not recommended for prevention of EM. Ibuprofen (400 mg) and acetaminophen (1000 mg) can be used for treatment of TTH, and amitriptyline for prevention of chronic TTH. Physical therapy or aerobic exercise can be used in management of TTH and migraines.