The use of Prophylactic Flucloxacillin in Treatment of Open Fractures of the Distal Phalanx within an Accident and Emergency Department: A Double-Blind Randomized Placebo-Controlled Trial

2003 ◽  
Vol 28 (5) ◽  
pp. 388-394 ◽  
Author(s):  
J. STEVENSON ◽  
G. MCNAUGHTON ◽  
J. RILEY
Keyword(s):  
Emergency Department ◽  
Open Fracture ◽  
Controlled Trial ◽  
Distal Phalanx ◽  
Open Fractures ◽  
Controlled Study ◽  
Double Blind ◽  
Accident And Emergency ◽  
Significant Difference ◽  
Accident And Emergency Department

Open fractures of the distal phalanx commonly present to the Accident and Emergency Department. Controversy surrounds the use of prophylactic antibiotics in treating this injury. A double-blind, prospective, randomized placebo-controlled study was undertaken comparing the use of prophylactic flucloxacillin to placebo in addition to meticulous wound toilet. One hundred and ninety-three adult patients with an open fracture of the distal phalanx were studied. Seven patients developed superficial infections, an overall infection rate of 4%. No patient developed osteitis or a deep wound infection. There were three cases of infection in the 98 patients (3%) in the antibiotic group and four cases of infection in the 95 patients (4%) in the placebo group. A difference of proportion test confirmed no significant difference. It is concluded that the addition of prophylactic flucloxacillin to thorough wound toilet and careful soft-tissue repair of open fracture of the distal phalanx confers no benefit.

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.

Dexamethasone (DM) for cancer-related fatigue: A double-blinded, randomized, placebo-controlled trial.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9002-9002 ◽  
Author(s):  
Sriram Yennurajalingam ◽  
Susan Frisbee-Hume ◽  
Marvin Omar Delgado-Guay ◽  
Janet Bull ◽  
Alexandria T. Phan ◽  
...  
Keyword(s):  
Advanced Cancer ◽  
Controlled Trial ◽  
Symptom Assessment ◽  
Primary Objective ◽  
Controlled Study ◽  
Advanced Cancer Patients ◽  
Double Blind ◽  
Cancer Related Fatigue ◽  
Significant Difference ◽  
Edmonton Symptom Assessment Scale

9002 Background: Cancer-related-fatigue (CRF) is the most common and distressing symptoms in patients with advanced cancer. Currently, there is no standard treatment for CRF. Although corticosteroids have been used in the treatment of CRF, there are no well-powered placebo-controlled trials that used a validated CRF outcome measure. The primary objective of this prospective, randomized, double-blind, placebo-controlled study is to compare the effect of DM versus placebo on CRF. Methods: Advanced cancer patients with fatigue ≥ 4/10 on the Edmonton Symptom Assessment Scale (ESAS) and at least 2 other CRF-related symptoms (pain, nausea, appetite, depression, anxiety or sleep disturbance ≥ 4/10), normal cognition, no infections and hemoglobin ≥ 9 g/L were eligible for enrollment. Patients were randomized to either receive dexamethasone 4 mg orally twice a day for 15 days (primary end point) or matching placebo. The primary outcome was the day 15 change in Functional Assessment of Chronic Illness-Fatigue (FACIT-F) subscale scores. Differences in the group means (normal distribution) were analyzed using the two-sample t-test. Results: In 83 evaluable patients (43 DM and 40 placebo), median age was 60 years, 61% were white, and 53% were female. There was no difference in the demographics and fatigue (FACIT-F subscale) between DM and placebo groups except for sex (p=0.02). The mean (SD) FACIT-F subscores at baseline and at day 15 for DM were 18 (11) and 27 (11) (p<0.001) and for placebo were 21 (9) and 24 (12) (p=0.06), respectively. Mean improvement in FACIT-F subscale was significantly higher in the DM group compared to placebo (9.6 (11) vs. 3.1 (9.7), p=0.005). We found a significant difference in ESAS physical distress (p=0.02), but no differences in ESAS overall symptom distress (p=0.11) and ESAS psychological distress (P=0.88) between DM and placebo. There were insignificantly higher numbers of grade ≥3 toxicities in patients who received DM than in patients who received placebo (20/42 vs. 18/47, p=0.37). Conclusions: Dexamethasone was more effective than placebo in reducing CRF in patients with advanced cancer. Long-term safety studies are needed.

scholarly journals Periarticular Injection with Bupivacaine for Postoperative Pain Control in Total Knee Replacement: A Prospective Randomized Double-Blind Controlled Trial

2012 ◽  
Vol 2012 ◽  
pp. 1-6 ◽  
Author(s):  
Varah Yuenyongviwat ◽  
Chaturong Pornrattanamaneewong ◽  
Thitima Chinachoti ◽  
Keerati Chareancholvanich
Keyword(s):  
Pain Control ◽  
Controlled Trial ◽  
Ease Of Use ◽  
Morphine Consumption ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Periarticular Injection ◽  
Post Operative Pain ◽  
Significant Difference

Background. Local periarticular injection with bupivacaine alone in TKA has not been studied. Thus, we aimed to examine the effectiveness of local periarticular injection with bupivacaine for post-operative pain control in TKA.Method. Sixty patients undergoing TKA by a single surgeon were randomly assigned into two groups in a double-blind, placebo-controlled study. In the injection group, patients received periarticular injections with 0.25% bupivacaine before wound closure; in the control group, patients received a 0.9% normal saline injection. Both groups received the same anesthetic procedure, post-operative pain control, and rehabilitation protocol.Results. There was a significant reduction in post-operative morphine consumption in the first six hours after the operation (mean 0.9 mg and 2.43 mg,P=0.01), but there was no significant difference in post-operative morphine consumption between six hours and ninety-six hours after the operation, visual analogue scale (VAS) score, morphine side effects during the first 96 hours, length of hospital stay, or complications from morphine consumption.Conclusion. Local periarticular injection with bupivacaine alone before wound closer was shown to be an effective method to improve pain control after TKA with a few complications and ease of use.

Donepezil for cancer-related fatigue: A double-blind, randomized, placebo-controlled study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9003-9003
Author(s):  
E. Bruera ◽  
B. El Osta ◽  
V. Valero ◽  
L. Driver ◽  
J. Palmer ◽  
...  
Keyword(s):  
Advanced Cancer ◽  
Controlled Trial ◽  
Subscale Score ◽  
Assessment System ◽  
Phone Call ◽  
Controlled Study ◽  
Fatigue Improvement ◽  
Open Label ◽  
Double Blind ◽  
Significant Difference

9003 Background: Fatigue is the most frequent symptom in advanced cancer. No standard treatment is available. We previously found that open-label donepezil significantly improved fatigue by day 3 and 7 in patients (pts) on opioids for cancer pain (Fisch et al, ASCO 2003). The purpose of this study was to compare donepezil (D) with placebo (P) for fatigue in pts with advanced cancer. Methods: In this randomized, double-blind, placebo-controlled trial, pts with fatigue score = 4 on a 0 to 10 scale (10 = worst fatigue) for > 1 week, hemoglobin = 10g/dl for = 4 weeks, and no major contraindication to D were randomized to receive D 5 mg or P orally every morning for 7 days. All pts were offered open-label D during week 2. Assessment included: research nurse daily phone call for fatigue and toxicity evaluation, Edmonton Symptom Assessment System (ESAS), Functional Assessment for Chronic Illness Therapy-Fatigue (FACIT-F), Sleeping Pattern Assessment, and overall effectiveness of the treatment. The FACIT-F fatigue subscale score on day 8 was considered the primary endpoint. Results: 103 pts were evaluable for final analysis. Mean difference in scores for symptoms intensity between baseline and day 8 are shown in Table 1 . FACIT-F fatigue subscale score at day 8 decreased a mean of 6 (10.6 SD) in the D arm (p < 0.001) and 7.2 (9.5 SD) in the P arm (p < 0.001). There was no significant difference in fatigue improvement between both arms according to the FACIT-F subscale (p = 0.57) and ESAS fatigue (p = 0.18) scores, and no significant difference in sleep quality score between D and P. On day 15 of the open-label phase, mean fatigue intensity remained significantly improved as compared to baseline on FACIT-F fatigue subscale (p < 0.001) and ESAS fatigue (p < 0.001) scores. No significant toxicities were observed. Conclusions: Both donepezil and placebo resulted in significant fatigue improvement. Donepezil was not significantly superior to placebo after one week. Our pilot findings are probably due to placebo effect. No significant financial relationships to disclose. [Table: see text]

scholarly journals Achieving remission in psoriatic arthritis by early initiation of TNF inhibition: a double-blind, randomised, placebo-controlled trial of golimumab plus methotrexate versus placebo plus methotrexate

2019 ◽  
Vol 78 (5) ◽  
pp. 610-616 ◽  
Author(s):  
Leonieke J J van Mens ◽  
Henriëtte M de Jong ◽  
Inka Fluri ◽  
Michael T Nurmohamed ◽  
Marleen G H van de Sande ◽  
...  
Keyword(s):  
Adverse Event ◽  
Psoriatic Arthritis ◽  
Controlled Trial ◽  
Early Initiation ◽  
Controlled Study ◽  
Tender Joint Count ◽  
Tender Joint ◽  
Double Blind ◽  
Significant Difference ◽  
Patient Reported

ObjectivesEarly initiation of effective treatment favours remission in rheumatoid arthritis, but it remains unknown if the same concept applies to psoriatic arthritis (PsA). Therefore, this study investigated whether the combination of golimumab plus methotrexate (MTX) as a first-line treatment is superior to MTX alone in inducing remission in PsA.MethodsThis investigator-initiated, multicentre, double-blind, randomised, placebo-controlled trial included 51 MTX and bDMARD-naive patients with PsA fulfilling the CASPAR criteria and with active disease at baseline (≥3 swollen joint count/tender joint count). Patients were randomised to golimumab (50 mg SC monthly)+MTX (n=26) (TNFi arm) or matched placebo+MTX (n=25) (MTX arm). MTX was started 15 mg/week and increased to 25 mg/week over 8 weeks. The primary endpoint was percentage of patients achieving Disease Activity Score (DAS) remission (<1.6) at week 22. Safety was assessed throughout the study.ResultsThe primary efficacy endpoint was achieved by 81% in the TNFi arm versus 42 % in the MTX arm (p=0.004). This difference in DAS remission was already observed at week 8. A significant difference in favour of the golimumab+MTX arm at week 22 was also observed for other response criteria such as MDA, ACR20/50/70, disease measures and patient-reported outcomes. The occurrence rates of adverse event and treatment-emergent adverse event were similar in both arms.ConclusionsIn patients with early PsA, DAS remission at week 22 was almost doubled with golimumab+MTX versus MTX alone. This double-blind, randomised, placebo-controlled study supports the concept that early initiation of TNFi in patients with PsA favours remission.Trial registration numberNCT01871649.

Double-blind placebo-controlled trial of etanercept in the prevention of work disability in ankylosing spondylitis: Table 1

2010 ◽  
Vol 69 (11) ◽  
pp. 1926-1928 ◽  
Author(s):  
Nick Barkham ◽  
Laura C Coates ◽  
Helen Keen ◽  
Elizabeth Hensor ◽  
Alexander Fraser ◽  
...  
Keyword(s):  
Placebo Group ◽  
Ankylosing Spondylitis ◽  
Clinical Outcomes ◽  
Job Loss ◽  
Controlled Trial ◽  
Controlled Study ◽  
Double Blind ◽  
Treatment Groups ◽  
Gait Parameters ◽  
Significant Difference

ObjectivesEtanercept has been shown to be rapidly effective in suppressing disease activity in ankylosing spondylitis (AS). The aim of this study was to determine whether etanercept improves work instability as measured by the Ankylosing Spondylitis Work Instability Scale (AS-WIS).MethodForty patients with active AS who were in work but were work unstable were recruited. Patients were randomised to receive 25 mg etanercept or placebo twice weekly for 12 weeks. The primary outcome was change in AS-WIS at week 12. The AS-WIS is a patient-derived outcome measure which allows stratification of the risk of job loss. Secondary outcomes included clinical outcomes and gait parameters.ResultsThe mean improvement in AS-WIS score at week 12 was 2.75 in the etanercept group and 0.68 in the placebo group (p=0.125). The risk of job loss decreased for 11 (55%) of the etanercept group compared with 7 (35%) in the placebo group. Conversely, the risk of job loss increased in 3 (15%) of the placebo group compared with 1 (5%) in the etanercept group. There was no statistically significant difference between treatment groups in change in WIS categories (Mann–Whitney U test=0.153, p=0.160). Significant improvement with etanercept was seen at week 12 in clinical outcomes and gait parameters. Etanercept was well tolerated, with no dropouts due to adverse events.ConclusionThis small study confirms the efficacy of etanercept on clinical outcome measures in patients with AS and suggests an effect on work instability which needs to be replicated in a larger controlled study.

scholarly journals Occupational Traumatic Amputation of Distal Part of Thumb Caused by Constriction Effect of Nylon Rope: A Case Report with Review of Literature

2011 ◽  
Vol 2011 ◽  
pp. 1-4
Author(s):  
M. Kalra ◽  
A. Mahmood ◽  
M. Patralekh
Keyword(s):  
Emergency Department ◽  
Distal Part ◽  
Distal Phalanx ◽  
Skin Closure ◽  
Mechanism Of Injury ◽  
Review Of Literature ◽  
Traumatic Amputation ◽  
Accident And Emergency ◽  
Accident And Emergency Department ◽  
Neurovascular Bundles

A 60-year-old farmer came to the accident and emergency department complaining of traumatic amputation of distal part of right thumb. On examination, there was a circumferential wound located at the base of right thumbnail with injury to both neurovascular bundles and fracture of distal part of distal phalanx with the distal part hanging by volar skin only. The wound was irrigated and the distal part terminalised with direct loose skin closure. Discussion with the patient about the scenario of trauma revealed a mechanism of injury which may appear unique.

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