EXPRESS: DECOMPRESSIVE SURGERY IN PATIENTS WITH MALIGNANT MIDDLE CEREBRAL ARTERY INFARCTION: A RANDOMIZED, CONTROLLED TRIAL IN A TURKISH POPULATION (DEMITUR TRIAL)

2021 ◽  
pp. 174749302110076
Author(s):  
Emre Kumral ◽  
Hadiye Åžirin ◽  
Ayse Sagduyu ◽  
AyÅŸe Güler ◽  
Nurcan Özdamar ◽  
...  
Keyword(s):  
Treatment Group ◽  
Medical Treatment ◽  
Medical Therapy ◽  
Decompressive Surgery ◽  
Controlled Clinical Trial ◽  
Hemispheric Stroke ◽  
Risk Of Death ◽  
Randomized Controlled ◽  
Surgery Group ◽  
Hemispheric Infarction

Background - Decompressive surgery (hemicraniectomy) for large hemispheric stroke reduces the risk of death and increases the chance of a favorable outcome. We aim to evaluate the outcome in patients up to 80 years of age with space-occupying hemispheric infarction treated with surgical decompression compared to medical therapy alone. Methods - This trial is a prospective, randomized, controlled, clinical trial based on a stroke center. The primary end point was survival with slight or moderate disability 12 months after randomization (defined by a score of 0 to 3 on the modified Rankin scale (mRS), which ranges from 0 [no symptoms] to 6 [death]). Secondary outcomes included death, Barthel Index, National Institute of Health Stroke Scale, and Stroke Impact Scale 2.0 (SIS) at 6 months and 1-year after randomization. The variables for subgroup analysis were age, sex, presence of aphasia and neglect. Results - We randomly allocated 151 patients aged 41 years or older (median, 65 years; range, 41 to 79) with large hemispheric stroke to either conservative medical treatment or hemicraniectomy; the assignment was made within 12 to 38 hours after the onset of symptoms. A statistically significant reduction in mortality was achieved after 30 days in the surgery group compared to the medical treatment group. Fifty-five of 70 (79%) patients randomized to surgery versus 26 of 81 (32%) patients randomized to medical treatment survived (P=0.001). Of 151 patients randomized, the proportion of patients with a mRS score ≤3 at the 6-months and 1-year follow-up was 48% and 64%, respectively, in the surgery group compared to medical treatment group, 14% and 20%, respectively (P=0.001 and P=0.001, respectively). There was a 47% absolute risk reduction of death after surgery compared to medical treatment at 1-year after stroke (P=0.001). Activities of daily living (58.8+16.1 vs 50.9+15.2; P=0.04), strength (20.2+9.2 vs 15.3+7.2; P=0.020), hand function (1.2+0.7 vs 0.8+0.6; P=0.022), memory (71.9+14.9 vs 59.2+18.5; P=0.001), and communication (62+17.7 vs 51.9+17.6; P=0.019) assessed by the SIS, were better in the surgical group than in the medical treatment group 1-year after stroke. Conclusions - This study showed that surgery in 48 hours increased survival and reduced mortality in life-threatening massive cerebral infarction. Early hemicraniectomy is a beneficial procedure in patients with large hemispheric infarction up to 80 years of age regardless of hemisphere dominance and improves daily life/ instrumental activities compared to medical therapy.

scholarly journals Music Medicine as a Component of Acute Migraine Attack Management in The Emergency Room: A Randomized Controlled Open-Label Trial

2020 ◽  
Author(s):  
Pearl Angeli B. Diamante
Keyword(s):  
Medical Treatment ◽  
Emergency Room ◽  
Medical Therapy ◽  
Controlled Trial ◽  
The Philippines ◽  
Acute Migraine ◽  
Open Label ◽  
Randomized Controlled ◽  
Music Medicine ◽  
Severe Migraine

Background: Acute severe migraine requiring Emergency Room (ER) visit is managed by giving analgesics for pain relief. Since music medicine has been beneficial in other pain syndromes, the study of its effect as a noninvasive add-on to current management is worth pursuing. Objective: To identify if music medicine in addition to medical therapy will reduce the severity and duration of an acute attack of moderate to severe migraine compared to medical management alone. Methods: An open label randomized controlled trial was conducted at the ER of a tertiary hospital in the Philippines from July 2017 to June 2018. Patients who presented at the ER with acute moderate to severe headache fulfilling the ICH-3 criteria for migraine were included. They were randomized to medical therapy or to medical therapy with music medicine. A decrease in the severity of the headache after one hour of medical treatment was the primary outcome. Results: One hundred eighty-three adult migraneurs were included without difference between group in age, gender, and occupation. There was a statistically significant reduction (p=0.037) in pain severity after one hour in 82 of 87 patients given medical treatment with music medicine (94%) compared to 73 of 86 in the medical therapy alone (85%). There were more headache-free patients at one hour in the music group (55% versus 42%, p=0.05). Conclusion: There is decreased duration and severity of pain when music medicine is added to conventional medical therapy in treating patients with an acute migraine. This is the first randomized trial done in the acute ER setting.

scholarly journals Efficacy and Safety of Dahuang Zhechong Pill in Silicosis: A Randomized Controlled Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Wu-Yi-Nuo Tang ◽  
Jing-Tao Liang ◽  
Ju Wu ◽  
Li Liu ◽  
Ming-Zhang Lu ◽  
...  
Keyword(s):  
Treatment Group ◽  
Pulmonary Function ◽  
Conventional Treatment ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Conventional Treatment Group ◽  
Randomized Controlled ◽  
Safety Outcomes ◽  
Medicine Prescription

Background. There is no effective therapy for silicosis, and Dahuang Zhechong pill (DHZCP), an ancient Chinese medicine prescription, may have a therapeutic effect on silicosis. This study aims to verify the efficacy and safety of DHZCP in silicosis. Methods. This is a randomized controlled clinical trial done at Panzhihua Second People’s Hospital (Panzhihua City, Sichuan Province, China). Participants diagnosed with silicosis were recruited and randomized to the conventional treatment group (CG) or DHZCP combined with the conventional treatment group (DG). Forced vital capacity % predicted (FVC%), diffusing capacity of the lung for carbon monoxide % predicted (DLCO%), six-minute walk distance (6MWD), peripheral oxygen (SpO2), King’s Brief Interstitial Lung Disease Questionnaire (K-BILD), and safety outcomes were measured at baseline and 9 weeks. Results. Fifty-six participants (28 in each group) completed the study, and 53 of them (26 in DG and 27 in CG) completed pulmonary function. At 9 weeks, compared with no DHZCP, DHZCP treatment was associated with significant improvements in FVC% (mean ± SD, 95%CI) (8.2 ± 3.9, 0.3 to 16.0), DLCO% (8.6 ± 3.5, 1.5 to 15.7), SpO2 (3.8 ± 0.7, 2.3 to 5.2), and K-BILD total score (6.0 ± 2.3, 1.4 to 10.7). And, there were no statistical differences of safety outcomes between the two groups. Eight patients accepting DHZCP developed mild diarrhea during the first week, which subsequently resolved on its own. Conclusion. DHZCP could improve the pulmonary function, the quality of life, and the exercise capacity of silicosis patients.

scholarly journals Managing Nonagenarians with Acute Myocardial Infarction: Invasive versus Conservative Treatment

2020 ◽  
Vol 2020 ◽  
pp. 1-6
Author(s):  
Jooho Lee ◽  
Kyoung-Woo Seo ◽  
Jin-Sun Park ◽  
Hyoung-Mo Yang ◽  
Hong-Seok Lim ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Treatment Group ◽  
Medical Treatment ◽  
Treatment Strategy ◽  
St Segment Elevation ◽  
Risk Of Death ◽  
St Segment ◽  
Significant Difference ◽  
One Year

Background. Limited data are available to support an invasive treatment strategy in nonagenarians with acute myocardial infarction (AMI). We aimed to investigate whether percutaneous coronary intervention (PCI) is beneficial in this frail population. Methods. We retrospectively analyzed 41 nonagenarians with AMI (both ST-segment-elevation and non-ST-segment-elevation MI) between 2006 and 2015 in a single center. We assessed 30-day and one-year mortality rates according to the treatment strategy. Results. Among study subjects, 24 (59%) were treated with PCI (PCI group) and 17 (41%) were treated with conservative management (medical treatment group) per the clinician’s discretion. The median follow-up duration was 30 months (0–74 months). Thirty-day mortality was lower in the PCI group than in the medical treatment group (17% vs. 65%; P < 0.001 ). One-year mortality was also lower in the PCI group than in the medical treatment group (21% vs. 76%; P < 0.001 ). The PCI group presented a 73% decreased risk of death (adjusted hazard ratio: 0.269; 95% confidence interval: 0.126–0.571; P < 0.001 ). In the Killip class 1 through 3 subgroups (n = 36), 30-day and one-year mortality were still higher among those in the medical treatment group (13% vs. 54% at 30 days; P < 0.001 and 17% vs. 69% at one year; P < 0.001 ). Landmark analysis after 30 days revealed no significant difference in the cumulative mortality rate between the two groups, indicating that the mortality difference was mainly determined within the first 30 days after AMI. Conclusion. Mortality after AMI was decreased in correlation with the invasive strategy relative to the conservative strategy, even in nonagenarians. Regardless of age, PCI should be considered in AMI patients. However, large-scale randomized controlled trials are needed to support our conclusion.

Percutaneous patent foramen ovale closure for secondary stroke prevention

Neurology ◽  
2018 ◽  
Vol 91 (1) ◽  
pp. e8-e18 ◽  
Author(s):  
Georgios Tsivgoulis ◽  
Aristeidis H. Katsanos ◽  
Dimitris Mavridis ◽  
Alexandra Frogoudaki ◽  
Agathi-Rosa Vrettou ◽  
...  
Keyword(s):  
Medical Treatment ◽  
Medical Therapy ◽  
Lower Risk ◽  
Patent Foramen Ovale ◽  
Foramen Ovale ◽  
Randomized Controlled ◽  
Increased Risk ◽  
Reduced Risk ◽  
Pfo Closure ◽  
New Onset

ObjectiveCurrent guidelines report no benefit for patent foramen ovale (PFO) closure compared to medical treatment in patients with cryptogenic ischemic stroke (IS) or TIA. Two recent randomized controlled clinical trials have challenged these recommendations.MethodsWe performed a systematic review and network meta-analysis of randomized controlled trials to estimate the safety and efficacy of closure compared to medical treatment, and to compare available devices. We conducted pairwise meta-analyses for closure vs medical therapy, irrespective of the device used, and for each device vs medical therapy.ResultsOur literature search highlighted 6 studies. PFO occlusion was associated with reduced risk of recurrent IS (risk ratio [RR] 0.42, 95% confidence interval [CI] 0.20–0.91) and IS/TIA (RR 0.65, 95% CI 0.48–0.88) but with increased risk of new-onset atrial fibrillation (AF) (RR 4.59, 95% CI 2.01–10.45) compared to medical treatment. In indirect analyses, both Amplatzer (AMP) and GORE devices were found to be associated with a lower risk of new-onset AF compared to STARFlex (SFX) (RR 0.25, 95% CI 0.10–0.65 and RR 0.28, 95% CI 0.08–0.95). Moreover, AMP was found to be associated with a lower risk of recurrent IS/TIA events compared to the SFX device (RR 0.35, 95% CI 0.14–0.91). In the clustered ranking plot on the risk of IS against new-onset AF, GORE was comparable to AMP; however, on the risk of IS/TIA against new-onset AF, AMP appeared to be superior to the GORE device. In both ranking plots, SFX was highlighted as the worst option.ConclusionPFO closure is associated with reduced risk of recurrent IS or IS/TIA and with increased risk of new-onset AF.

Efficacy of docosahexaenoic acid–choline–vitamin E in paediatric NASH: a randomized controlled clinical trial

2017 ◽  
Vol 42 (9) ◽  
pp. 948-954 ◽  
Author(s):  
Evelyn Zöhrer ◽  
Anna Alisi ◽  
Jörg Jahnel ◽  
Antonella Mosca ◽  
Claudia Della Corte ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Vitamin E ◽  
Treatment Group ◽  
Docosahexaenoic Acid ◽  
Lifestyle Modification ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Glucose Levels ◽  
Randomized Controlled ◽  
The Impact

Nonalcoholic steatohepatitis (NASH), a progressive form of nonalcoholic fatty liver disease, is one of the most common hepatic diseases in children. We conducted a randomized controlled clinical trial on children with biopsy-proven NASH based on a combinatorial nutritional approach compared with placebo. Participants were assigned to lifestyle modification plus placebo or lifestyle modification plus a mix containing docosahexaenoic acid, choline, and vitamin E (DHA–CHO–VE). Forty children and adolescents participated in the entire trial. The primary outcome was the improvement of liver hyperechogenicity. Secondary outcomes included alterations of alanine aminotransferase (ALT) and other metabolic parameters. Furthermore, changes of serum bile acids (BA) and plasma fibroblast growth factor 19 (FGF19) levels were evaluated as inverse biomarkers of disease severity. At the end of the study, we observed a significant decrease in severe steatosis in the treatment group (50% to 5%, p = 0.001). Furthermore, although the anthropometric and biochemical measurements in the placebo and DHA–CHO–VE groups were comparable at baseline, at the end of the study ALT and fasting glucose levels improved only in the treatment group. Finally, we found that BA levels were not influenced whereas FGF19 levels were significantly increased by DHA–CHO–VE. The results suggest that a combination of DHA, VE, and CHO could improve steatosis and reduce ALT and glucose levels in children with NASH. However, further studies are needed to assess the impact of a DHA and VE combination on repair of liver damage in paediatric NASH.

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