1. Among patients with chronic aphasia post-stroke, right neurotomy of the seventh cervical nerve (C7) plus intensive speech and language therapy (SLT) was superior to intensive SLT alone in improving language function.
Evidence Rating Level: 1 (Excellent)
Aphasia is one of the most common conditions of cerebrovascular events. Chronic post-stroke aphasia refers to language impairment that persists for more than a year after stroke. Approximately 80% patients with aphasia following left hemispheric stroke also experience right spastic arm paralysis. Previous studies have reported that patients with left sided stroke, spastic arm paralysis, and aphasia showed improved language function after transfer surgery of the seventh cervical nerve (C7). It was hypothesized that C7 neurotomy combined with standard intensive speech and language therapy (SLT) for chronic post-stroke aphasia may have an additive effect on improving language function. This study thus examined whether right-sided C7 neurotomy combined with intensive SLT was more effective in improving language function in patients with chronic aphasia after a left hemispheric stroke compared to SLT alone. This was a multicenter, assessor-blinded, randomized controlled trial in four centers in Shanghai, China. Patients aged 40-65 with chronic post-stroke aphasia were included and randomized 1:1 to receive either right-sided C7 neurotomy plus three weeks of intensive SLT (neurotomy plus SLT group) or three weeks of intensive SLT only (control group). Out of the 50 included in the study, 25 were in the neurotomy plus SLT group (mean [SD] age, 53.0 [6.3], men [%], 20 [80.0]) and 25 were in the control group (mean [SD] age, 52.1 [7.5], men [%], 19 [76.0]). From baseline to one month, the mean increase in Boston naming test (BNT) score was 11.16 points in the neurotomy plus SLT group and 2.72 points in the control group (difference 8.51 points, 95% confidence interval (CI) 5.31 to 11.71, P<0.001). The between-group difference in BNT score remained stable at six months (group difference 8.26 points, 4.16 to 12.35, P<0.001). During this period, the neurotomy plus SLT group also showed greater improvement in the aphasia quotient compared to the control group (difference 7.06 points, 4.41 to 9.72, P<0.001). Similar results were found for patient-reported activities of daily living and post-stroke depression. There were no reports of treatment-related severe adverse events. Overall, this study found that C7 neurotomy plus intensive SLT was associated with a greater improvement in language function compared with intensive SLT alone, indicating that right-sided C7 neurotomy plus intensive SLT may be a promising intervention for patients with chronic post-stroke aphasia. Future studies should confirm these findings in other populations.
1. Time-restricted eating, regardless of timing of the eating window, did not result in significant changes in sleep, mood, or quality of life compared with usual care alone.
Evidence Rating Level: 2 (Good)
Although time-restricted eating (TRE) is a promising dietary approach for weight loss, it is unknown whether the timing of the eating window affects sleep, mood, and quality of life differently. This study thus examined whether three TRE schedule were associated with changes in sleep, mood, and quality of life compared with usual care (UC) alone in adults with overweight or obesity. This was a secondary analysis of adults aged 30 to 60 years with overweight or obesity from a parallel-group randomized clinical trial conducted in Granada (southern Spain) and Pamplona (northern Spain) between April 11, 2022, and March 6, 2023. Participants were randomized 1:1:1:1 to either the UC group (daily eating window of ≥12 hours & Mediterranean diet education program), early TRE group (8-hour eating window starting before 10 am), late TRE group (8-hour eating window starting after 1 pm), or self-selected TRE (chose own 8-hour eating window). Sleep, mood, and quality were assessed at baseline and after the 12-week intervention. In total, 197 participants were included (mean [SD] age, 46.1 [8.4] years; 98 women [49.7%]; mean [SD] body mass index, 32.8 [3.2] kg/m2), with 49 in the UC group, 49 in the early TRE group, 52 in the late TRE group, and 47 in the self-selected TRE group. Compared to the UC group, the early TRE group did not significantly differ in sleep (mean difference in total sleep time, 0.2 [95% CI, –0.2 to 0.6] hours), mood (mean difference in Beck Depression Inventory Fast Screen score, 0.2 [95% CI, –1.0 to 1.3] points; mean difference in state anxiety score on the State-Trait Anxiety Inventory, –1.2 [95% CI, –6.4 to 4.1] points; mean difference in Perceived Stress Scale score, 2.1 [95% CI, –1.8 to 5.9] points), and quality of life (mean difference in general health score on the Rand 36-Item Short Form Health Survey, 3.3 [95% CI, –4.4 to 10.9] points). There were also no significant differences when comparing late TRE and self-selected TRE groups to the UC group, as well as between TRE groups. Overall, this study found that in adults with overweight or obesity, including TRE into a UC intervention, regardless of the timing of the eating window, did not lead to significant changes in sleep, mood, or quality of life compared with UC alone. These findings suggest that TRE may be an effective weight management strategy without adversely affecting overall sleep health and psychological well-being. Future studies should confirm these results in larger populations and among those with specific sleep disturbances or mood disorders.
1. Oestrogen cream did not improve the continuation rate of ring pessary use and satisfaction among postmenopausal women with pelvic organ prolapse (POP) compared to placebo.
2. Participants who received oestrogen cream reported less common adverse events such as excessive discharge, vaginal erosion or ulcer, and vaginal bleeding.
Evidence Rating Level: 1 (Excellent)
Pelvic organ prolapse (POP) is a common condition among postmenopausal women, involving the descent of pelvic organs into or past the vaginal opening. Although pessary treatment is commonly recommended for managing symptomatic POP, 24-49% of women discontinued its use within 12-24 months due to adverse events such as excessive discharge, discomfort, and vaginal ulcers. As oestrogen can relieve genitourinary syndrome of menopause and help treat vaginal ulcers, its use may help optimize long-term pessary use. Given the limited research on the effects of oestrogen on long-term pessary use, this study examined the efficacy of intravaginal oestrogen cream vs placebo cream in the pessary treatment outcomes for POP. This was a multicenter, randomized, double blind, placebo-controlled trial conducted in 12 hospitals across China between May 2020-June 2023. Postmenopausal women with symptomatic POP (≥ stage 2) and successfully fitted with ring pessaries were included. Participants were randomly assigned 1:1 to receive vaginal conjugated oestrogen cream (0.625 mg/g) or placebo cream every night for the first two weeks after successful pessary fitting followed by twice weekly for 12 months. The composite primary outcome was pessary continuation (> five days a week) and a response of very much better or much better to the Patient Impression of Improvement (PGI-I) questionnaire at 12 months. Out of 420 postmenopausal women randomized, 411 participants were analyzed, of which 208 were in the vaginal oestrogen group (mean [SD] age, 66 [7.4] years; mean [SD] body mass index (BMI), 23.7 [2.7] kg/m2) and 203 were in the placebo group (mean [SD] age, 66 [7.4] years; mean [SD] body mass index (BMI), 24.1 [2.4] kg/m2). There was no significant difference in pessary continuation rate with satisfaction between the oestrogen group and the placebo group (181/208 (87.0%) vs 176/203 (86.7%); risk difference 0.3%, 95% confidence interval (CI) −6.2% to 6.9%; P=0.92). Compared to the placebo group, the oestrogen group had fewer reports of excessive discharge (34/208 (16.3%) vs 52/203 (25.6%); −9.3%, −17.1% to −1.4%), vaginal erosion or ulcer (4/208 (1.9%) vs 14/203 (6.9%); −5.0%, −8.9% to −1.0%), and vaginal bleeding (3/208 (1.4%) vs 13/203 (6.4%); −5.0%, −8.7% to −1.2%). Overall, this study found that oestrogen cream did not improve the continuation rate of ring pessary use and satisfaction, although it may be associated with lower risk of common adverse events. Future longer-term studies are needed to confirm study findings.
1. Administration of acetaminophen within 48h of intensive care unit admission was associated with reduced short- and long-term mortality in patients with sepsis-associated encephalopathy.
Evidence Rating Level: 2 (Good)
Sepsis-associated encephalopathy (SAE) is a common complication of sepsis that involves neuroinflammation and blood–brain barrier disruption and is associated with morbidity and mortality. Acetaminophen, a drug commonly used to reduce fever in sepsis, has been shown to have additional beneficial effects, including reducing inflammation, improving vascular function, and reducing the risk of sepsis-related multiple organ dysfunction syndrome. Although acetaminophen has been investigated in the context of sepsis, its effect on SAE prognosis remains unknown. This study thus examined the association between early acetaminophen use and survival rates in critically ill SAE patients. This was a retrospective study that used data from the MIMIC-IV database and included adults (>18 years) with SAE admitted to the intensive care unit (ICU) at the Beth Israel Deaconess Medical Center in Boston, Massachusetts, between 2008 and 2022. Patients were divided into the acetaminophen and nonacetaminophen groups. The acetaminophen group received acetaminophen (oral, nasal, or rectal) within the first 48 h of ICU admission. Propensity score matching (PSM) was used to balance baseline characteristics between groups. Out of the 4111 patients included in the study, 1689 were acetaminophen recipients (median [IQR] age, 70.9 [59.9, 81.1]; female, 698 [41.33%]) and 2422 were not (median [IQR] age, 71.3 [60.0, 81.0]; female, 1031 [42.57%]). After PSM, there were 3124 matched patients, with 1562 in each group. After PSM, the receipt of acetaminophen was associated with reduced 30-day, (HR = 0.78, 95%CI [0.65–0.94]), 60-day (HR = 0.71, 95%CI [0.60–0.83]), 90-day (HR = 0.70, 95%CI [0.60–0.81]), 180-day (HR = 0.70, 95%CI [0.60–0.80]) and 365-day (HR = 0.69, 95%CI [0.61–0.79]) mortality rate. Survival rates were higher in the acetaminophen group compared to the non-acetaminophen group, with a consistent trend at 30, 90, 180, and 365 days (log-rank p < 0.05). The protective effect was consistent across subgroups except for patients who received an acetaminophen dosage > 650 mg. Overall, this study found that early acetaminophen use was associated with reduced short- and long-term mortality in SAE patients. These findings suggest that acetaminophen may have a therapeutic role in SAE. Future studies are needed to confirm these findings and investigate underlying mechanisms.
Sodium-Glucose Cotransporter 2 Inhibitors and Serious Liver Events in Patients With Cirrhosis
1. Use of Sodium-Glucose Cotransporter 2 (SGLT-2) inhibitors among adults with cirrhosis receiving diuretic therapy was associated with lower incidence of serious liver events, defined as the incidence of ascites, variceal development, hyponatremia, or all-cause mortality.
Evidence Rating Level: 2 (Good)
Liver cirrhosis ranks as the 11th most common cause of mortality globally. Among patients with cirrhosis, 10% develop refractory ascites, defined as ascites that cannot be mobilized even with diuretic therapy. More effective therapies are thus needed to improve patient outcomes. Sodium-glucose cotransporter 2 (SGLT-2) inhibitors may offer additional liver-related benefits through their natriuretic and diuretic effects. Due to limited research on the efficacy of SGLT-2 inhibitors in patients with cirrhosis, this study evaluated the association between SGLT-2 inhibitor use and the risk of serious liver events in patients with cirrhosis on diuretic therapy. This retrospective cohort study used data from over 120 healthcare organizations within the TriNetX platform. Adult (>19 years) patients with cirrhosis receiving diuretic therapy (furosemide and spironolactone) from January 2013 to July 2021 were included and followed up for 3 years. 1:1 propensity score matching was used to balance baseline characteristics between patients receiving SGLT-2 inhibitors plus furosemide and spironolactone, and those receiving furosemide and spironolactone alone. The primary outcome was a composite variable of serious liver events, including the incidence of esophageal or gastric variceal development, ascites, hyponatremia, or all-cause mortality. Out of the 10 660 propensity-matched patients (mean [SD] age, 63.8 [10.7] years; 57.8% male), 5330 used SGLT-2 inhibitors and 5330 did not (control group). Patients receiving SGLT-2 inhibitors had a lower incidence of serious liver events (hazard ratio [HR], 0.68 [95% CI, 0.66-0.71) compared to control patients. Use of SGLT-2 inhibitors was also associated with reduced risk of hepatorenal syndrome (HR, 0.47 [95% CI, 0.40-0.56]), spontaneous bacterial peritonitis (HR, 0.55 [95% CI, 0.46-0.65]), paracentesis (HR, 0.54 [95% CI, 0.50-0.60]), variceal bleeding (HR, 0.79 [95% CI, 0.73-0.84]), hypoglycemia (HR, 0.75 [95% CI, 0.62-0.91]), and all-cause hospitalizations (HR, 0.67 [95% CI, 0.63-0.71]). Overall, this study found that use of SGLT-2 inhibitors was associated with a lower incidence of serious liver events among adults with cirrhosis receiving diuretic therapy compared to those receiving diuretic therapy alone. Future studies are needed to confirm study findings and compare different types and dosages of SGLT-2 inhibitors to optimize treatment for patients with cirrhosis.
Image: PD
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