Medical Treatment Group Research Articles

Factors affecting in-hospital clinical outcomes in patients with acute limb ischemia undergoing endovascular therapy or fogarty thrombectomy: a large-scale analysis based on the JROAD-DPC database

Abstract Background The etiology of acute limb ischemia (ALI) involves embolism as well as atherosclerotic thrombosis. Although endovascular therapy (EVT) or Fogarty thrombectomy (Fogarty TE) is the recommended revascularization method for ALI, treatment choice based on patient characteristics remains controversial. Purpose This study aimed to evaluate the differences in clinical outcomes between primary treatments and identify predictive factors affecting clinical outcomes in patients with ALI. Methods This retrospective study used data from the Japanese Registry of All Cardiac and Vascular Diseases-Diagnosis Procedure Combination (JROAD-DPC) database, from April 2012 to March 2020. We analyzed 18,701 patients with ALI and categorized them into medication and invasive treatment groups (EVT alone, Fogarty TE alone, bypass surgery alone, and hybrid treatment). The EVT-alone and Fogarty TE-alone groups were compared after propensity score matching, considering 19 clinically relevant covariates. The primary outcomes were in-hospital mortality, major amputation, and bleeding complications (anemia requiring transfusion or endoscopic hemostasis). The secondary outcomes were major adverse cardiovascular events (myocardial infarction, coronary intervention, heart failure, stroke, and cerebral hemorrhage), major amputation and/or death, hospitalization duration, and total cost during hospitalization. Results The EVT-alone group had more patients at a higher risk of atherosclerotic disease, including peripheral artery disease (PAD), chronic kidney disease (CKD), or hemodialysis. The Fogarty TE-alone group had more patients at a higher risk of embolism, including AF or AFL. After propensity score matching, in-hospital mortality (odds ratio [OR]: 1.58, 95% confidence interval [CI]: 1.29–1.92, p<.0001), bleeding complications (OR: 1.28, 95% CI: 1.12–1.46, p=0.0002), and major amputation rates (OR: 1.44, 95% CI: 1.17–1.76, p=0.0004) were significantly higher in the EVT-alone group than in the Fogarty TE-alone group. Major amputation and/or death rates and total hospitalization costs were higher in the EVT-alone group than in the Fogarty TE-alone group. In interaction analyses, EVT demonstrated a favorable trend of lower risks of death and/or major amputation in patients with PAD, CKD, and diabetes mellitus (all risk factors for atherosclerotic disease), especially in those with PAD and CKD. Conclusions Fogarty TE may be the preferred primary treatment for patients with ALI, particularly those without PAD or CKD.Study flowchartForest plot analyzing interaction effect

Endovascular thrombectomy for childhood stroke (Save ChildS Pro): an international, multicentre, prospective registry study.

Emerging evidence suggests that endovascular thrombectomy is beneficial for treatment of childhood stroke, but the safety and effectiveness of endovascular thrombectomy has not been compared with best medical treatment. We aimed to prospectively analyse functional outcomes of endovascular thrombectomy versus best medical treatment in children with intracranial arterial occlusion stroke. In this prospective registry study, 45 centres in 12 countries across Asia and Australia, Europe, North America, and South America reported functional outcomes for children aged between 28 days and 18 years presenting with arterial ischaemic stroke caused by a large-vessel or medium-vessel occlusion who received either endovascular thrombectomy plus best medical practice or best medical treatment alone. Intravenous thrombolysis was considered part of best medical treatment and therefore permitted in both groups. The primary outcome was the difference in median modified Rankin Scale (mRS) score between baseline (pre-stroke) and 90 days (±10 days) post-stroke, assessed by the Wilcoxon rank test (α=0·05). Efficacy outcomes in the endovascular thrombectomy and best medical treatment groups were compared in sensitivity analyses using propensity score matching. The Save ChildS Pro study is registered at the German Clinical Trials Registry, DRKS00018960. Between Jan 1, 2020, and Aug 31, 2023, of the 241 patients in the Save ChildS Pro registry, 208 were included in the analysis (115 [55%] boys and 93 [45%] girls). 117 patients underwent endovascular thrombectomy (median age 11 years [IQR 6-14]), and 91 patients received best medical treatment (6 years [3-12]; p<0·0001). The median Pediatric National Institutes of Health Stroke Scale (PedNIHSS) score on admission was 14 (IQR 10-19) in the endovascular thrombectomy group and 9 (5-13) in the best medical treatment group (p<0·0001). Both treatment groups had a median pre-stroke mRS score of 0 (IQR 0-0) at baseline. The change in median mRS score between baseline and 90 days was 1 (IQR 0-2) in the endovascular thrombectomy group and 2 (1-3) in the best medical treatment group (p=0·020). One (1%) patient developed a symptomatic intracranial haemorrhage (this patient was in the endovascular thrombectomy group). Six (5%) patients in the endovascular thrombectomy group and four (5%) patients in the best medical treatment group had died by day 90 (p=0·89). After propensity score matching for age, sex, and PedNIHSS score at hospital admission (n=79 from each group), the change in median mRS score between baseline and 90 days was 1 (IQR 0-2) in the endovascular thrombectomy group and 2 (1-3) in the best medical treatment group (p=0·029). Regarding the primary outcome for patients with suspected focal cerebral arteriopathy, endovascular thrombectomy (n=18) and best medical treatment (n=33) showed no difference in 90-day median mRS scores (2 [IQR 1-3] vs 2 [1-4]; p=0·074). Clinical centres tended to select children with more severe strokes (higher PedNIHSS score) for endovascular thrombectomy. Nevertheless, endovascular thrombectomy was associated with improved functional outcomes in paediatric patients with large-vessel or medium-vessel occlusions compared with best medical treatment. Future studies need to investigate whether the positive effect of endovascular thrombectomy is confined to older and more severely affected children. None.

Emergent endovascular treatment versus medical treatment for acute large vessel occlusions with nondisabling symptoms.

The aim of this study is to analyze the effectiveness and safety of medical treatment (MT) versus endovascular treatment (EVT) in acute large vessel occlusion patients with mild nondisabling stroke symptoms. This study is a multicenter observational study in which data from patients at three stroke centers were prospectively obtained and retrospectively analyzed. Patients were included if they arrived for treatment within 6 h of stroke onset or last known well time and had a baseline National Institutes of Health Stroke Scale (NIHSS) score of ≤5. Primary outcome was modified Rankin Scale (mRS) score 0-2 at 90 days. Secondary outcomes included symptomatic intracranial hemorrhage (sICH), discharge NIHSS score, 90-day all-cause mortality and length of stay. Clinical outcomes were compared through a multivariable logistic regression after adjusting for age, treatment type admission and discharge NIHSS score, admission Alberta Stroke Program Early CT (ASPECT) score and length of stay. Of the 82 patients included in the study, 42 were in the EVT group and 40 were in the MT group. The groups were similar in age (MT:66, EVT:64 age; p = .62), gender (MT:55%, EVT:54.8%; male) admission NIHSS score (MT:2, EVT:3 points; p = .26), ASPECT score (MT:10, EVT:9; p = .15). While discharge NIHSS score was found to be statistically significant between the groups (MT:1, EVT:2; p = .04). There was no difference between the two groups in terms of 90-day mRS scores (MT:1, EVT:1, p = .86) and mortality rates (MT:4, EVT:4; p = .94). In unadjusted analysis, sICH rates were similar between the MT and EVT groups (MT 5%, EVT 7.1%, p = .52). Neurological intensive care unit length of stay (MT:5 days, EVT:2 days p < .001), inpatient clinic length of stay (MT:3, EVT:2 days p = .041), and total length of stay (MT:9 days, EVT:4 days p < .001) were significantly longer in the MT group. Our multicenter study demonstrated that MT with blood pressure augmentation and anticoagulation at hyperacute stage is an alternative option for emergency large vessel occlusion patients with nondisabling mild stroke symptoms.

Subjective and objective evaluation of nasal obstruction in patients treated at the Hospital de Clínicas, Paraguay

Nasal obstruction is characterized by insufficient airflow and increased resistance in the nasal cavities, affecting patients’ quality of life and sleep. This study aims to compare the efficacy of medical and surgical treatment in patients with Nasal obstruction, using subjective evaluations (NOSE and VAS scales) and objective evaluations (active anterior rhinomanometry). This is an experimental and prospective longitudinal study conducted at the Hospital de Clínicas, Paraguay. Forty patients with Nasal obstruction were included, divided into medical treatment (nasal corticosteroids) and surgical treatment (turbinoplasty, septoplasty, or both) groups. Pre- and post-treatment evaluations were performed using the NOSE and VAS scales, and active anterior rhinomanometry. The sample included 52.5% men and 47.5% women, with an average age of 32.18±11.59 years. The main cause of Nasal obstruction was chronic rhinitis (62.5%). Treatments showed significant improvements in subjective and objective evaluations. In the medical group, VAS improved by 2.63 points in women and 2.00 in men, while the surgical group showed more pronounced improvements. The NOSE also showed significant reductions, especially in patients undergoing combined turbinoplasty and septoplasty. Active anterior rhinomanometry reflected an increase in overall nasal flow in all treated groups. Both medical and surgical treatments are effective in improving Nasal obstruction, with greater benefits observed in surgical treatments. Subjective and objective evaluations are valuable and complementary tools for assessing treatment in patients with Nasal obstruction. These results highlight the importance of a comprehensive evaluation in the management of Nasal obstruction.

Safety and Effectiveness Analysis of Endovascular Treatment versus Standard Medication Treatment in Patients with Progressive Acute Ischemic Stroke with Large Vessel Occlusion Stroke in the Ultra-Late Time Window: A Propensity Score Matched Cohort Study

The time from onset to symptom deterioration in ischemic stroke often exceeds 24hours, and this ultra-late time window is excluded from the endovascular treatment (EVT) guideline. This study aimed to explore the safety and efficacy of EVT in progressive acute ischemic stroke with large vessel occlusion stroke patients with onset to symptom deterioration times of 24 hours-7days. Progressive stroke patients with time window of 24 hours-7days treated at our hospital over the past 6years were retrospectively collected. Patients were categorized into EVT and standard medication treatment (SMT) groups based on the treatment approach. Patients were matched using propensity score matching. Safety outcomes primarily included 3-month mortality and symptomatic intracranial hemorrhage; efficacy outcome primarily included functional independence (3-month modified Rankin scale≤2). A total of 396 patients were included in the study, with 86 (21.7%) in EVT and 310 (78.3%) in SMT group. There were 140 remaining after propensity score matching, with 70 in each group (50%). Compared to SMT group, EVT group had higher functional independence (52.9% vs. 15.7%, odds ratio [OR]=7.504, 95% confidence interval [CI] 2.141-14.093, P < 0.001) and lower 3-month mortality (14.3% vs. 40.0%, OR=0.412, 95% CI 0.099-0.856, P < 0.001). EVT was also associated with higher symptomatic intracranial hemorrhage (25.7% vs. 5.7%, OR=9.926, 95% CI 1.874-36.547, P < 0.001). For patients with progressive acute ischemic stroke with large vessel occlusion in the ultra-late time window, EVT remains a viable treatment approach.

Randomised study for the Optimal Treatment of symptomatic patients with low-gradient severe Aortic valve Stenosis and preserved left ventricular ejection fraction (ROTAS trial)

BackgroundThe best management of symptomatic patients with low-gradient (LG) severe aortic stenosis (AS) and preserved left ventricular ejection fraction (LVEF) has not been established. The Randomised study for the Optimal...

Treatment of equine keratomycosis, part 2: reporting common systemic and ocular complications to enhance decision-making for equine clinicians and owners.

The primary aims were to provide descriptive data on systemic and ocular complications associated with the treatment of equine keratomycosis. The secondary aims were to determine if complication rates differ between treatment types or are related to surgical and anesthetic factors. The study was a retrospective evaluation of 126 cases between 2004 and 2020 with confirmed fungal infection and recorded incidence of complications during hospitalization and surgical intervention if pursued. Additional information recorded included the size of the donor graft if utilized, time under general anesthesia, and prescribed medications. Fisher exact and χ2 tests were used to evaluate complication frequency differences. Logistic regression models determined the effects of donor graft size, anesthesia time, and duration of hospitalization on complication rates. Hypercreatininemia followed by colic were the most frequent systemic complications in the medical treatment group. Colic and conjunctival graft dehiscence were the most frequent systemic and ocular complications in all surgery treatment groups, respectively. The frequency of systemic complications did not vary between treatment groups, although colic rates were significantly higher following general anesthesia. All colic cases were resolved with supportive care. Donor graft size, anesthesia time, and duration of hospitalization did not impact complication frequency. The mainstays of medical therapy included topical fluoroquinolones, topical voriconazole, topical atropine, oral NSAIDS, and oral gastroprotectants. Treatment of keratomycosis is associated with a range of complications. Colic remains a significant risk, with increased frequency reported following general anesthesia. Reporting common complications associated with treatment aids in decision-making for equine clinicians and owners.

The 'Prostate Embolisation AS first-line therapY compAred to meDication in treatment naïVe men with prostAte eNlargement, a randomised ControllEd trial' (P-EASY ADVANCE): a randomised controlled trial of prostate embolisation vs medication for BPH.

To compare prostate artery embolisation (PAE) to the combination of tamsulosin and dutasteride therapy as a potential first-line therapy for obstructive benign prostatic hyperplasia (BPH) in treatment-naïve patients in the 'Prostate Embolisation AS first-line therapY compAred to meDication in treatment naïVe men with prostAte eNlargement, a randomised ControllEd trial' (P-EASY ADVANCE). A total of 39 men with enlarged prostates, moderate-severe lower urinary tract symptoms (LUTS) and obstructed/equivocal urodynamic studies (UDS), and who had no prior treatment for BPH, were randomised to receive either combined medical therapy with tamsulosin and dutasteride (medication) or PAE. Follow-up UDS, International Prostate Symptom Score (IPSS), uroflowmetry and ultrasound were performed at short- to medium-term intervals following interventions and compared to baseline. The medication and PAE treatment groups had similar baseline characteristics, including prostate volumes (87.8 and 85.4 mL respectively), maximum urinary flow rate (Qmax; 6.5 and 6.6 mL/s, respectively), IPSS (19.5 and 21, respectively) and obstructed UDS (79% and 74%, respectively). Both interventions improved voiding and bladder outflow obstruction from baseline, with more patients unobstructed after PAE (63%) compared to medication (28%) (P = 0.03). PAE patients had significantly greater reductions in prostate size (P < 0.001), incomplete emptying (P = 0.002), total IPSS (P = 0.032), Qmax (P = 0.006) and quality of life (P = 0.001). Altered ejaculation, erectile dysfunction and nausea were more common in the medication group. Prostate artery embolisation was more effective than combined medical therapy at reducing urinary obstruction, decreasing prostate volume and improving LUTS in patients with BPH who had not previously been treated. This is the first randomised control study to compare PAE and combined medical therapy in exclusively treatment-naïve patients and raises the potential of PAE as an alternative early treatment option for BPH. Further randomised comparative trials are planned to further validate the role of PAE in mitigating obstructive BPH.

Influencing factors for surgical treatment in neonatal necrotizing enterocolitis: a systematic review and meta-analysis

BackgroundNecrotizing enterocolitis (NEC) is a complex disease characterized by gastrointestinal inflammation and is one of the most common gastrointestinal emergencies in neonates. Mild to moderate cases of NEC require medical treatment, whereas severe cases necessitate surgical intervention. However, evidence for surgical indications is limited and largely dependent on the surgeon’s experience, leading to variability in outcomes. The primary aim of this study is to identify the risk factors for surgical intervention in neonatal NEC, which will aid in predicting the optimal timing for surgical intervention.MethodsA literature search was conducted in PubMed, Embase, and Web of Science databases for case-control studies exploring risk factors for NEC requiring surgical intervention. The search was completed on June 16, 2024, and data analysis was performed using R Studio 4.3.2.Results18 studies were included, comprising 1,104 cases in the surgery group and 1,686 in the medical treatment group. The meta-analysis indicated that high C-reactive protein (CRP) levels [OR = 1.42, 95% CI (1.01, 1.99)], lower gestational age [OR = 0.52, 95% CI (0.3, 0.91)], sepsis [OR = 2.94, 95% CI (1.87, 4.60)], coagulation disorder [OR = 3.45, 95% CI (1.81, 6.58)], lack of enteral feeding [OR = 3.18, 95% CI (1.37, 7.35)], and hyponatremia [OR = 1.22, 95% CI (1.07, 1.39)] are significant risk factors for surgical treatment in neonatal NEC.ConclusionsHigh CRP levels, coagulation disorders, sepsis, lower gestational age, lack of enteral feeding, and hyponatremia are significant risk factors for surgical intervention in neonatal NEC. These findings have potential clinical significance for predicting surgical risk.

Pregnancies complicated with functioning adrenal adenomas causing severe obstetric outcomes: a 20-year experience at a tertiary center

BackgroundFunctioning adrenal adenoma during pregnancy is rare, and the diagnosis is challenging owing to unspecific symptoms and restricted investigations. The obstetric outcomes of patients who undergo surgery during pregnancy or who receive only medical treatment are poorly described.ObjectiveThe aim was to investigate the associations between functioning adrenal adenomas and obstetric outcomes.MethodsA retrospective study was performed in a tertiary center over 20 years. The clinical characteristics, management and obstetric outcomes of the diagnosed pregnant women were reviewed.ResultsA total of 12 women were diagnosed with functioning adrenal adenomas during pregnancy from January 2002 to September 2022. Eight women had cortisol-secreting adrenal adenomas, two had excessive catecholamine secretion, and two had primary aldosteronism. The initial symptoms of adrenal adenoma during pregnancy included hypertension or preeclampsia, gestational diabetes mellitus or prepregnancy diabetes mellitus, hypokalemia and ecchymosis. Four women underwent adrenalectomy during pregnancy, while 8 women received only medical therapy. Preterm birth occurred in all patients who received medicine, whereas 1 patient who underwent surgery experienced preterm birth. Among the 8 women in the medical treatment group, 3 had neonates who died.ConclusionsOnce hypertension, hyperglycemia and hypokalemia occur during the 1st or 2nd trimester, pregnant women with adrenal adenomas should be evaluated via laboratory and imaging examinations. The maternal and fetal outcomes were unpredictable owing to the severity of adrenal adenoma, particularly in patients who received only medical treatment. Adrenalectomy should be recommended during pregnancy.

Oral Ibuprofen versus Placebo for Management of Patent Ductus Arteriosus in Preterm infants: A Double Blinded, Randomized Controlled Trial

Abstract Background A consensus on the management of patent ductus arteriosus (PDA) in premature neonates remains indefinable. Conservative PDA treatment is based on the premise that in most preterms PDAs spontaneously close before discharge. Ibuprofen has been used for treating PDA, however, no clear guidelines for management have been suggested. Aim of Work The aim of this work is to compare the effect of oral ibuprofen versus placebo on PDA closure in preterm infants less than 34 weeks’ gestation. Methodology This study was conducted on 80 preterm neonates with gestational age ≤ 34 weeks with a hemodynamically significant PDA. They were randomized into a medical treatment group (n = 40) and a placebo group (n = 40). Both groups received conservative PDA therapy in the form of fluid restriction, positive end-expiratory pressure, and/or diuretics. The medical treatment group received oral ibuprofen (at an initial dose of 10 mg/kg/day, followed by 5 mg/kg/day for the next 2 days) and the placebo group received an oral placebo. The open-label option and an extended oral ibuprofen therapy (an offered or a repeated course with the same dose) were only offered if there are concerns over a poor patient condition that was attributed to persistent PDA and only after meeting certain criteria like signs of pulmonary hyperperfusion and/or systemic hypoperfusion. Echocardiography was done on day 1 of recruitment (48-72 hours of age) and was followed up till discharge. The patients were followed up for adverse effects of ibuprofen by serum creatinine and total serum bilirubin after the first course of treatment. Results There was no significant difference in PDA closure rate following the first ibuprofen course (62.5% in the ibuprofen treated group vs 65% in the placebo group, p &amp;gt; 0.05). At discharge time (mean 13.5 days in the ibuprofen group, 14 days in the placebo group), a closure rate of 75% was achieved in both groups, respectively. There was no significant difference in initial serum creatinine levels between the two groups either on day 1 of recruitment or after the first course of the intervention, p &amp;gt; 0.05, respectively. Meanwhile, serum creatinine significantly decreased in both groups after treatment (p-value &amp;lt;0.001, respectively). Also, there was no difference between the two groups in serum bilirubin either on day 1 of recruitment or after the first course of treatment, p &amp;gt; 0.05, respectively. Conclusion Conservative treatment is not inferior to oral ibuprofen therapy in the management of PDA. Oral ibuprofen does not elevate serum creatinine levels or cause hyperbilirubinemia.

Long-Term Outcomes of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention of Moderate Lesions in Patients with Chronic Coronary Syndrome

Background: Fractional flow reserve (FFR) is crucial to evaluating coronary artery stenosis in patients diagnosed with chronic coronary syndrome (CCS). By assessing the severity of stenosis, FFR assists in determining whether percutaneous coronary intervention (PCI) is necessary. Methods: Conducted at Tehran Heart Center from 2013 through 2017, this cohort study involved 52,248 CCS patients who underwent coronary angiography. Among them, 598 symptomatic individuals, despite receiving comprehensive medical treatment, underwent FFR assessment. Subsequently, 225 patients with positive FFR (≤0.80) underwent PCI, while 373 patients received solely medical treatment. The patients were monitored for 3 years to evaluate primary and secondary endpoints. Results: After 3 years, the PCI group demonstrated a lower incidence of the primary composite endpoint, consisting of all-cause mortality, nonfatal myocardial infarction, repeat target vessel/lesion revascularization (TVR/TLR), and coronary artery bypass graft surgery, than the medical treatment group (HR, 0.85; 95% CI, 0.74 to 0.98; P=0.012). Additionally, urgent TVR/TLR significantly decreased in the PCI group (HR, 0.56; 95% CI, 0.42 to 0.74; P&lt;0.001). Conclusion: FFR-guided PCI demonstrated effectiveness in reducing long-term major adverse cardiac events, primarily by lowering the incidence of TVR/TLR. The results emphasize the significance of FFR-guided PCI in addressing stenosis rather than alleviating ischemia.

Decompressive craniectomy plus best medical treatment versus best medical treatment alone for spontaneous severe deep supratentorial intracerebral haemorrhage: a randomised controlled clinical trial

It is unknown whether decompressive craniectomy improves clinical outcome for people with spontaneous severe deep intracerebral haemorrhage. The SWITCH trial aimed to assess whether decompressive craniectomy plus best medical treatment in these patients improves outcome at 6 months compared to best medical treatment alone. In this multicentre, randomised, open-label, assessor-blinded trial conducted in 42 stroke centres in Austria, Belgium, Finland, France, Germany, the Netherlands, Spain, Sweden, and Switzerland, adults (18-75 years) with a severe intracerebral haemorrhage involving the basal ganglia or thalamus were randomly assigned to receive either decompressive craniectomy plus best medical treatment or best medical treatment alone. The primary outcome was a score of 5-6 on the modified Rankin Scale (mRS) at 180 days, analysed in the intention-to-treat population. This trial is registered with ClincalTrials.gov, NCT02258919, and is completed. SWITCH had to be stopped early due to lack of funding. Between Oct 6, 2014, and April 4, 2023, 201 individuals were randomly assigned and 197 gave delayed informed consent (96 decompressive craniectomy plus best medical treatment, 101 best medical treatment). 63 (32%) were women and 134 (68%) men, the median age was 61 years (IQR 51-68), and the median haematoma volume 57 mL (IQR 44-74). 42 (44%) of 95 participants assigned to decompressive craniectomy plus best medical treatment and 55 (58%) assigned to best medical treatment alone had an mRS of 5-6 at 180 days (adjusted risk ratio [aRR] 0·77, 95% CI 0·59 to 1·01, adjusted risk difference [aRD] -13%, 95% CI -26 to 0, p=0·057). In the per-protocol analysis, 36 (47%) of 77 participants in the decompressive craniectomy plus best medical treatment group and 44 (60%) of 73 in the best medical treatment alone group had an mRS of 5-6 (aRR 0·76, 95% CI 0·58 to 1·00, aRD -15%, 95% CI -28 to 0). Severe adverse events occurred in 42 (41%) of 103 participants receiving decompressive craniectomy plus best medical treatment and 41 (44%) of 94 receiving best medical treatment. SWITCH provides weak evidence that decompressive craniectomy plus best medical treatment might be superior to best medical treatment alone in people with severe deep intracerebral haemorrhage. The results do not apply to intracerebral haemorrhage in other locations, and survival is associated with severe disability in both groups. Swiss National Science Foundation, Swiss Heart Foundation, Inselspital Stiftung, and Boehringer Ingelheim.

Effects and long-term outcomes of endurance versus resistance training as an adjunct to standard medication in patients with stable COPD: a multicenter randomized trial

BackgroundComparisons between endurance training (ET) and resistance training (RT) have produced equivocal findings in chronic obstructive pulmonary disease (COPD) patients. The purpose of our study is to investigate the effectiveness and long-term outcomes of adding ET and RT to conventional medical treatment in patients with COPD. A secondary objective is to investigate the clinical improvements resulting from exercise training in patients with different disease severities.MethodsThe study was a multicenter, prospective trial in people with stable COPD. The cohort was randomized to three groups: individualized medical treatment group (MT), MT + endurance training group (MT + ET) and MT + resistance training group (MT + RT). Exercise was performed 3 times weekly over a 12-week period. The endpoints of exercise capacity, health-related quality of life, COPD symptoms, lung function, and anxiety and depression questionnaires were re-evaluated at baseline, at the completion of the intervention and at 6 and 12-month follow-up. According to the COPD assessment tool offered by GOLD guidelines, patients were stratified into GOLD A and B groups and GOLD C and D groups for further subgroup analysis.ResultsThe intention-to-treat (ITT) population included 366 patients, 328 of them completed the study protocol over 12 months (the PP-population). There were no significant differences in the primary outcome, quality of life, between patients who underwent medical treatment (MT) alone, MT + endurance training (MT + ET), or MT + resistance training (MT + RT) at the completion of the intervention, 6-, or 12-month follow-up. Additionally, no significant differences were observed between MT, MT + RT, or MT + ET groups concerning the primary outcome, exercise capacity (3MWD), after initial 3 months of intervention. However, a small statistically significant difference was noted in favor of MT + ET compared to MT + RT at 12 months (ITT: Δ3MWD in ET vs RT = 5.53 m, 95% confidence interval: 0.87 to 13.84 m, P = 0.03) (PP: Δ3MWD in ET vs RT = 7.67 m, 95% confidence interval: 0.93 to 16.27 m, P = 0.04). For patients in the GOLD C and D groups, improvement in quality of life following ET or RT was significantly superior to medical intervention alone. Furthermore, upon completion of the exercise regimen, RT exhibited a greater improvement in anxiety compared to ET in these patients (ITT: ΔHAD-A at 3-month: RT = -1.63 ± 0.31 vs ET = -0.61 ± 0.33, p < 0.01) (PP: ΔHAD-A at 3-month: RT = -1.80 ± 0.36 vs ET = -0.75 ± 0.37, p < 0.01).ConclusionsOur study presents evidence of the beneficial effects of ET and RT in combination with standard medical treatment, as well as the long-term effects over time after the intervention. While the statistically significant effect favoring ET over RT in terms of exercise capacity was observed, it should be interpreted cautiously. Patients in severe stages of COPD may derive greater benefits from either ET or RT and should be encouraged accordingly. These findings have implications for exercise prescription in patients with COPD.Trial registrationChiCTR-INR-16009892 (17, Nov, 2016).

A low FODMAP diet plus traditional dietary advice versus a low-carbohydrate diet versus pharmacological treatment in irritable bowel syndrome (CARIBS): a single-centre, single-blind, randomised controlled trial

Dietary advice and medical treatments are recommended to patients with irritable bowel syndrome (IBS). Studies have not yet compared the efficacy of dietary treatment with pharmacological treatment targeting the predominant IBS symptom. We therefore aimed to compare the effects of two restrictive dietary treatment options versus optimised medical treatment in people with IBS. This single-centre, single-blind, randomised controlled trial was conducted in a specialised outpatient clinic at the Sahlgrenska University Hospital, Gothenburg, Sweden. Participants (aged ≥18 years) with moderate-to-severe IBS (Rome IV; IBS Severity Scoring System [IBS-SSS] ≥175) and no other serious diseases or food allergies were randomly assigned (1:1:1) by web-based randomisation to receive a diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) plus traditional IBS dietary advice recommended by the UK National Institute for Health and Care Excellence (hereafter the LFTD diet), a fibre-optimised diet low in total carbohydrates and high in protein and fat (hereafter the low-carbohydrate diet), or optimised medical treatment based on predominant IBS symptom. Participants were masked to the names of the diets, but the pharmacological treatment was open-label. The intervention lasted 4 weeks, after which time participants in the dietary interventions were unmasked to their diets and encouraged to continue during 6 months' follow-up, participants in the LFTD group were instructed on how to reintroduce FODMAPs, and participants receiving pharmacological treatment were offered diet counselling and to continue with their medication. The primary endpoint was the proportion of participants who responded to the 4-week intervention, defined as a reduction of 50 or more in IBS-SSS relative to baseline, and was analysed per modified intention-to-treat (ie, all participants who started the intervention). Safety was analysed in the modified intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT02970591, and is complete. Between Jan 24, 2017, and Sept 2, 2021, 1104 participants were assessed for eligibility and 304 were randomly assigned. Ten participants did not receive their intervention after randomisation and thus 294 participants were included in the modified intention-to-treat population (96 assigned to the LFTD diet, 97 to the low-carbohydrate diet, and 101 to optimised medical treatment). 241 (82%) of 294 participants were women and 53 (18%) were men and the mean age was 38 (SD 13). After 4 weeks, 73 (76%) of 96 participants in the LFTD diet group, 69 (71%) of 97 participants in the low-carbohydrate diet group, and 59 (58%) of 101 participants in the optimised medical treatment group had a reduction of 50 or more in IBS-SSS compared with baseline, with a significant difference between the groups (p=0·023). 91 (95%) of 96 participants completed 4 weeks in the LFTD group, 92 (95%) of 97 completed 4 weeks in the low-carbohydrate group, and 91 (90%) of 101 completed 4 weeks in the optimised medical treatment group. Two individuals in each of the intervention groups stated that adverse events were the reason for discontinuing the 4-week intervention. Five (5%) of 91 participants in the optimised medical treatment group stopped treatment prematurely due to side-effects. No serious adverse events or treatment-related deaths occurred. Two 4-week dietary interventions and optimised medical treatment reduced the severity of IBS symptoms, with a larger effect size in the diet groups. Dietary interventions might be considered as an initial treatment for patients with IBS. Research is needed to enable personalised treatment strategies. The Healthcare Board Region Västra Götaland, the Swedish Research Council, the Swedish Research Council for Health, Working Life and Welfare, AFA Insurance, grants from the Swedish state, the Wilhelm and Martina Lundgren Science Foundation, Skandia, the Dietary Science Foundation, and the Nanna Swartz Foundation.

Study protocol for a prospective, randomized, multicenter trial to investigate the influence of peripheral nerve stimulation on patients with chronic sacroiliac joint syndrome (SILENCING)

BackgroundThe prevalence of sacroiliac joint pain (SIJP) is estimated to be 10–30% in patients with chronic low back pain. Numerous conservative and surgical treatment modalities for SIJP have been described with limited evidence regarding long-term pain relief.Spinal cord stimulation (SCS) is a well-established technique to treat patients with chronic low back pain. However, the effect on patients with SIJP is not consistent. Therefore, peripheral nerve stimulation (PNS) for chronic SIJP was implemented in experimental trials. Clinical data on PNS for SIJP is still lacking. The authors present a case series and a protocol for a prospective, multicenter study to determine the effect of PNS in patients with chronic intractable SIJP.MethodA multicenter, prospective randomized controlled trial was designed. Patients with chronic intractable SIJP will be recruited and randomized in a 4:3 ratio to either the peripheral nerve stimulation group or to the best medical treatment group. A total of 90 patients are planned to be enrolled (52 in the PNS group and 38 in the BMT group). Patients in the intervention group receive a percutaneous implantation of a unilateral or bilateral lead which is externalized for a trial phase for 3–14 days. After trial phase only patients with at least 50% reduction of pain receive an impulse generator for permanent stimulation. Regular visits for participants are planned on day 0, after 3 months (± 30 days), 6 months (± 30 days), and 12 months (± 60 days). The primary outcome measurements is the difference in Numeric Pain Rating Scale (NRS) between baseline and after 6 months. Secondary outcomes is improvement of pain associated disability (ODI) and improvement of health-related quality of life after 6 and 12 months.DiscussionWe have described the protocol for a prospective, multicenter, randomized trial evaluating the influence of PNS on patients with chronic sacroiliac joint syndrome. We believe that PNS on patients with chronic sacroiliac joint syndrome will show promising results regarding pain relief and quality of life in comparison to BMT after 12 months. The design of this trial promises high evidence in comparison to the data to date.Trial registrationClinicalTrials.gov, NCT05357300. Registered on April 26, 2022.

Assessing the Potential Role of Artificial Intelligence in Medication-Related Osteonecrosis of the Jaw Information Sharing

BackgroundArtificial Intelligence, by answering questions about disease prevention strategies, can contribute to making diseases more treatable in their early stages. PurposeThis study aims to evaluate the quality of patient information by assessing the responses of the Chat Generative Pre-trained Transformer (ChatGPT, Open Al, USA) artificial intelligence model to questions related to medication-related osteonecrosis of the jaw (MRONJ). Study design, setting, sampleThe study was prospective cross-sectional design. The study was conducted within the Department of Oral and Maxillofacial Surgery. The study's questions were prepared by an experienced oral and maxillofacial surgeon and directed to the artificial intelligence platform. The responses were evaluated by oral and maxillofacial surgeons using the Global Quality Scale (GQS). Predictor variableThe predictor variable is question type. A total of 120 questions were categorized into six groups, which encompassed general information about MRONJ (Group 1), queries from patients about to initiate medication therapy (Group 2), questions from patients currently undergoing medication treatment (Group 3), inquiries from patients who had completed medication usage (Group 4), general treatment-related information (Group 5), and case scenarios (Group 6). Main Outcome VariablesThe main variable is the GQS score. The GQS rates the quality of information and its utility for the patients. The scores are as follows: Score 1: Poor quality, Score 2: Generally poor quality, Score 3: Moderate quality, Score 4: Good quality, Score 5: Excellent quality. CovariatesNot applicable. AnalysesKruskal-Wallis and Mann-Whitney-U tests were applied for intragroup and intergroup analyses. The statistical significance level was determined as p<0.05 and p<0.01. ResultsThe average score for all questions was calculated to be 3.9±0.8, which is above the "moderate quality" threshold. Group 1 had a mean score of 3.4±1.1; Group 2 had 4.1±0.7; Group 3 had 3.8±0.8; Group 4 had 4.3±0.6; Group 5 had 4.2±0.7; and Group 6 had 4.1±0.5. The variations in mean scores among these groups did not exhibit statistical significance (p>0.05). Conclusions and RelevanceThe artificial intelligence model has generated responses of moderate quality to questions about MRONJ. The use of the artificial intelligence platform may assist in patients gaining a fundamental understanding of MRONJ.

Ovarian reserve after dienogest therapy versus laparoscopic cystectomy for unilateral endometriomas: A randomized clinical trial

Objective: To assess the effect of Dienogest versus surgical management of endometriomas on ovarian reserve. Methods: This randomized clinical trial was conducted at Suez Canal university hospital from November 1st, 2020, to July 31st, 2022. We recruited patients with endometriomas according to particular inclusion and exclusion criteria. The study population was allocated into two groups: group one received Dienogest, and group two had laparoscopic cystectomy. Eligible patients were subjected to history and examination to evaluate pelvic pain using the Biberoglu and Behrman score and the visual analogue scale. Ultrasound examination was done to diagnose ovarian endometrioma and its diameter. Ovarian reserve was evaluated by the antral follicle count and serum anti-mullerian hormone. After 3 months, patients were reevaluated regarding cyst diameter, antral follicle count, pain scores, and the anti-mullerian hormone. The primary outcome measure was to evaluate the ovarian reserve before and after intervention in both groups. Results: The antral follicle count and anti-mullerian hormone increased significantly after Dienogest therapy and decreased significantly after surgical excision ( p &lt; 0.001). Only induration was significantly decreased in the medical treatment group ( p &lt; 0.001). Both management options resulted in a noticeable reduction in the visual analogue scale scores in each group individually. Conclusion: Dienogest rescued ovarian reserve in women with endometriomas.

Impact of short-peptide exclusive enteral nutrition therapy on physical growth and nutritional status in children with Crohn's disease

To evaluate the clinical efficacy of short-peptide exclusive enteral nutrition (EEN) therapy in inducing remission during active Crohn's disease (CD) in children, as well as changes in physical growth and nutritional indicators before and after treatment. A prospective study included 43 children with active CD who were admitted to the Department of Gastroenterology, Children's Hospital of Nanjing Medical University from January 2017 to January 2024. The participants were randomly divided into a medication treatment group (13 children) and a short-peptide + medication treatment group (30 children). The changes in the Pediatric Crohn's Disease Activity Index (PCDAI) scores, physical growth, and nutritional indicators before and after treatment were analyzed in both groups. The PCDAI scores in the short-peptide + medication treatment group were lower than those in the medication treatment group after treatment (P<0.05). The Z-scores for weight-for-age, body mass index, and albumin levels were higher in the short-peptide + medication treatment group compared to the medication treatment group (P<0.05). In the patients with moderate to severe CD, total protein levels in the short-peptide + medication treatment group were significantly higher than those in the medication treatment group (P<0.05). Short-peptide EEN therapy can induce clinical remission in children with active CD and promote their physical growth while improving their nutritional status.

Interventional embolisation for patients with cirrhosis and recurrent or persistent hepatic encephalopathy related to spontaneous portosystemic shunts: protocol for a prospective, non-randomised controlled study

IntroductionThe presence of spontaneous portosystemic shunts (SPSS) has been identified to be associated with hepatic encephalopathy (HE) in patients with cirrhosis. Nevertheless, the role of interventional embolisation in managing such...