Intravenous Tranexamic Acid for Subdural and Epidural Intracranial Hemorrhage: Randomized, Double‐Blind, Placebo-Controlled Trial

2019 ◽  
Vol 14 (4) ◽  
pp. 286-291 ◽  
Author(s):  
Pouya Ebrahimi ◽  
Javad Mozafari ◽  
Reza Bahrami Ilkhchi ◽  
Mohammad Ghasem Hanafi ◽  
Maryam Mousavinejad
Keyword(s):  
Tranexamic Acid ◽  
Intracranial Hemorrhage ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Subdural Hemorrhage ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference ◽  
Epidural Hemorrhage ◽  
And Control

Background: Recovery of patients with traumatic brain injury largely depends on the reduction in secondary brain damage. The present study aims at investigating the effect of Tranexamic Acid (TXA) administration within the first hours of brain trauma in the emergency department (ED). Methods: This randomized, double-blind, placebo-controlled clinical trial was carried out in patients with subdural and epidural hemorrhage. Patients with any type of bleeding were assigned into two groups of TXA and 0.9% normal saline as placebo. The rate of intracranial hemorrhage after surgery was assessed by CT-scan and amount of hemoglobin (Hb) was measured immediately before surgery and after 6 hours of surgery. Results: A total of 80 participants were randomly assigned into four groups of 20 people. There was a significant difference in the mean of intraoperative bleeding during surgery in patients receiving TXA and placebo in both SDH (Subdural hematoma) and EDH (Epidural Hemorrhage) groups (P= 0.012). The Hb drop amount had no significant difference with placebo (P< 0.0001). No complications were observed in any of the intervention and control groups during the study as well. Conclusion: The use of TXA may reduce bleeding, however, based on the results of this study, such effect was not statistically significant in controlling the epidural and subdural hemorrhage, but clinical trials with a higher sample size are suggested for further investigation in this regard.

Homeopathic treatment of migraine: A double blind, placebo controlled trial of 68 patients

2000 ◽  
Vol 89 (01) ◽  
pp. 4-7 ◽  
Author(s):  
P Straumsheim ◽  
C Borchgrevink ◽  
P Mowinckel ◽  
H Kierulf ◽  
O Hafslund
Keyword(s):  
Pain Intensity ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Attack Frequency ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Homeopathic Treatment ◽  
Registration Period ◽  
Significant Difference ◽  
Accompanying Symptoms

AbstractTo evaluate the efficacy of homeopathy in preventing migraine attacks and accompanying symptoms, a randomised, double-blind, placebo-controlled clinical trial was conducted. There was a one-month registration period without treatment, followed by four months individualised homeopathic treatment or identical placebo. Patients were stratified for common or classical migraine.Seventy-three patients were randomised, 68 completed the trial. Baseline values were similar in the two groups. Both the homeopathy and placebo groups had reduction in attack frequency, pain intensity and drug consumption, with a statistically non-significant difference favouring homeopathy. Migraine diaries showed no difference between groups. The neurologists’ trial evaluation showed a statistically significant reduction in attack frequency in the homeopathy group (P=0.04) and non-statistically significant trends in favour of homeopathy for pain intensity and overall evaluation.Further research, with improved trial design, on the possible role of homeopathy in migraine prophylaxis is justified.

Efficacy of gabapentin mouthwash in managing oral mucositis pain in patients undergoing chemotherapy: a prospective, randomised, double-blind, controlled clinical trial

2020 ◽  
Vol 65 (1) ◽  
pp. 12-18
Author(s):  
Shahram Ala ◽  
Neda Zamani ◽  
Jafar Akbari ◽  
Ebrahim Salehifar ◽  
Ghasem Janbabai ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Pain Intensity ◽  
Oral Mucositis ◽  
Controlled Trial ◽  
Sufficient Evidence ◽  
Controlled Clinical Trial ◽  
Significant Activity ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference

Background and aims Gabapentin has been used for the management of radiotherapy and chemotherapy induced stomatitis in a number of studies. Due to lack of sufficient evidence, the present study was designed to evaluate the efficacy of gabapentin mouthwash in oral mucositis associated pain in patients undergoing cancer chemotherapy. Methods and results This study was a prospective, randomised, double-blind, placebo-controlled trial. The patients were randomly divided into two groups receiving either the gabapentin or placebo mouthwash. Patients were advised to rinse their mouth with 7 ml of solution for 30 s three times a day and were visited 10 days after initiation of the trial. The intensity of pain and severity of oral mucositis were assessed. Thirty-one patients received gabapentin mouthwash while 27 patients received placebo. Both gabapentin and placebo mouthwashes had decreased the pain intensity almost equally and did not show a significant difference between the two groups (P = 0.73). Also both gabapentin and placebo had reduced and improved swallowing, inflammation and erythema. But there was no noticeable difference between groups (P > 0.05). Conclusions These findings indicate that gabapentin mouthwash did not show a significant activity as a pain relieving agent in chemotherapy induced oral mucositis associated pain.

scholarly journals A Randomized, Double-blind, Placebo-controlled Trial of DL-3-n-butylphthalide in Amyotrophic Lateral Sclerosis Patients

2021 ◽  
Author(s):  
Mingsheng Liu ◽  
Xiaoli Yao ◽  
Xusheng Huang ◽  
Huifang Shang ◽  
Dongsheng Fan ◽  
...  
Keyword(s):  
Amyotrophic Lateral Sclerosis ◽  
Placebo Group ◽  
Clinical Global Impression ◽  
Rating Scale ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference ◽  
Lateral Sclerosis

Abstract Background: To determine the efficacy and safety of DL-3-n-butylphthalide (NBP) for the treatment of amyotrophic lateral sclerosis (ALS).Methods: A randomized, double-blind, placebo-controlled trial was performed at 19 ALS clinical centers of the Chinese ALS Association. Patients with definite or probable ALS were randomly treated with NBP or placebo for 12 months. The Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) score was the primary endpoint and was evaluated every 3 months. Secondary endpoints included survival and tracheotomy incidence, total Medical Research Council (MRC) score, percentage of predicted forced vital capacity (FVC), and clinical global impression scale score assessed using the visual analog scale. Results: Between November 23, 2015 and November 22, 2017, 312 ALS patients were enrolled and randomly allocated to either the NBP group (156 patients) or placebo group (156 patients). Ninety-three patients in the NBP group and 92 patients in the placebo group were included in the primary end point analysis. There was no significant difference in the ALSFRS-R score, total MRC score, or clinical global impression between the two groups after treatment. The NBP group exhibited a mild trend of less decrease in the percentage of predicted FVC between baseline and the 12-month visit than the placebo group (least-squares mean change from baseline ± standard error: -7.34±4.28, 95％CI(-15.24,0.56), p=0.0335). Adverse events were reported in 56.5% of patients in the placebo group and 68.8% of patients in the NBP group (χ2=2.99, P=0.0838). No serious adverse event related to treatment occurred.Conclusion: we found no evidence that NBP improved the ALSFRS-R score in patients with ALS. The results suggest a mild trend in the percentage of predicted FVC decreased slowly in the NBP treatment group than in the placebo group.Trial registration: A Multi-center, Randomized, Double Blinding, Placebo-Controlled Clinical Trial of Dl-3-Butylphthalide in the Treatment of Amyotrophic Lateral Sclerosis, ChiCTR-IPR-15007365, Registered 1 November 2015, http://www.chictr.org.cn/showproj.aspx?proj=12354

scholarly journals Efficacy and tolerance of early administration of tranexamic acid in patients with cirrhosis presenting with acute upper gastrointestinal bleeding: a study protocol for a multicentre, randomised, double-blind, placebo-controlled trial (the EXARHOSE study)

BMJ Open ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e021943 ◽  
Author(s):  
Matthieu Heidet ◽  
Roland Amathieu ◽  
Etienne Audureau ◽  
Oriane Augusto ◽  
Violaine Nicolazo de Barmon ◽  
...  
Keyword(s):  
Gastrointestinal Bleeding ◽  
Tranexamic Acid ◽  
Upper Gastrointestinal Bleeding ◽  
Controlled Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Intention To Treat ◽  
Acute Upper Gastrointestinal Bleeding ◽  
Shunt Procedure ◽  
Upper Gastrointestinal

IntroductionThe management of acute upper gastrointestinal bleeding (UGIB) is challenging in patients with cirrhosis, as it is responsible for severe complications and high mortality rates. Tranexamic acid (TXA) may help control the bleeding by counterbalancing cirrhosis-related hyperfibrinolysis. Still, there is a lack of unbiased data to conclude on its efficacy. The aim of this study is to evaluate the efficacy of TXA in the early treatment of acute UGIB in patients with cirrhosis.Methods and analysisThis study is a multicentre, randomised, double-blind, placebo-controlled trial, for adult patients with cirrhosis presenting with an acute UGIB and allocated to one of two arms: TXA or placebo (saline). Physicians from emergency mobile services, emergency departments (EDs) or intensive care units (ICUs) can include patients. Besides study intervention, standard care for UGIB will be performed as recommended. Intervention will consist an intravenous infusion of 10 mL of TXA (1 g) or saline, immediately followed by three identical intravenous infusions over 8 hours each (total dose of 4 g of TXA or 40 mL of placebo over 24 hours). Main analyses will be conducted in intention to treat on every patient included, then in modified intention to treat on patients with underlying lesion of portal hypertension visualised by endoscopy. The main objective is to show efficacy of TXA until day 5 on a composite criterion (bleeding control, rebleeding episodes and mortality). Secondary objectives aim at showing the efficacy of TXA on each individual component of the main outcome measure and others at 6 weeks and later (transjugular intrahepatic portosystemic shunt procedure, cirrhosis-specific complications, length of stay in ICU and in hospital, safety and tolerance of TXA, liver transplantation). Included patients will be followed up to 1 year after inclusion.500 patients will be necessary to show a reduction in the prevalence of the primary outcome from 30% to 18% with a bilateral alpha risk of 5% and a power of 80%.Ethics and disseminationEthical approval has been obtained from the Comité de Protection des Personnes Ile-de-France 1 (CPP-IDF1). Results will be disseminated via publications in peer-review medical journals and scientific forums.Protocol versionThis protocol is based on the latest version, as established on 11 October 2017 and validated by the IRB CPP Ile-de-France 1.Trial registration numberNCT03023189.

scholarly journals Faecal microbiota transplantation alters gut microbiota in patients with irritable bowel syndrome: results from a randomised, double-blind placebo-controlled study

Gut ◽  
2018 ◽  
Vol 67 (12) ◽  
pp. 2107-2115 ◽  
Author(s):  
Sofie Ingdam Halkjær ◽  
Alice Højer Christensen ◽  
Bobby Zhao Sheng Lo ◽  
Patrick Denis Browne ◽  
Stig Günther ◽  
...  
Keyword(s):  
Gut Microbiota ◽  
Controlled Trial ◽  
Symptom Relief ◽  
Controlled Study ◽  
Faecal Microbiota ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Faecal Microbiota Transplantation ◽  
Faecal Samples ◽  
Significant Difference

ObjectiveIBS is associated with an intestinal dysbiosis and faecal microbiota transplantation (FMT) has been hypothesised to have a positive effect in patients with IBS. We performed a randomised, double-blind placebo-controlled trial to investigate if FMT resulted in an altered gut microbiota and improvement in clinical outcome in patients with IBS.DesignWe performed this study in 52 adult patients with moderate-to-severe IBS. At the screening visit, clinical history and symptoms were assessed and faecal samples were collected. Patients were randomised to FMT or placebo capsules for 12 days and followed for 6 months. Study visits were performed at baseline, 1, 3 and 6 months, where patients were asked to register their symptoms using the IBS-severity scoring system (IBS-SSS) and IBS-specific quality of life (IBS-QoL). Prior to each visit, faecal samples were collected.ResultsA significant difference in improvement in IBS-SSS score was observed 3 months after treatment (p=0.012) favouring placebo. This was similar for IBS-QoL data after 3 months (p=0.003) favouring placebo. Patients receiving FMT capsules had an increase in faecal microbial biodiversity while placebos did not.ConclusionIn this randomised double-blinded placebo-controlled study, we found that FMT changed gut microbiota in patients with IBS. But patients in the placebo group experienced greater symptom relief compared with the FMT group after 3 months. Altering the gut microbiota is not enough to obtain clinical improvement in IBS. However, different study designs and larger studies are required to examine the role of FMT in IBS.Trial registration numberNCT02788071.

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