Acetyl-l-carnitine versus placebo for migraine prophylaxis: A randomized, triple-blind, crossover study

Cephalalgia ◽  
2015 ◽  
Vol 35 (11) ◽  
pp. 987-995 ◽  
Author(s):  
Knut Hagen ◽  
Eiliv Brenner ◽  
Mattias Linde ◽  
Gøril Bruvik Gravdahl ◽  
Erling Andreas Tronvik ◽  
...  
Keyword(s):  
Crossover Study ◽  
Primary Outcome ◽  
Prophylactic Treatment ◽  
Episodic Migraine ◽  
Secondary Outcome ◽  
Complete Case ◽  
Preventive Medication ◽  
Prophylactic Drug ◽  
To Receive ◽  
Blind Crossover Study

Background Preventive medication is indicated for many migraine patients, but is used in relatively few. The aim of the present study was to evaluate the efficacy of acetyl-l-carnitine as a prophylactic drug in migraine patients. Methods A single-center, randomized, triple-blind, placebo-controlled, crossover study was carried out. Men and women, age 18–65 years, with episodic migraine but otherwise healthy, were recruited mostly through advertisements. After a four-week run-in-phase, 72 participants were randomized to receive either placebo or 3 g acetyl-l-carnitine for 12 weeks. After a four-week washout, treatment was switched. The primary outcome was days with moderate or severe headache per four weeks. Secondary outcomes were days with headache, hours with headache, proportion of responders (>50% reduction in migraine days from baseline) and adverse events. Results In the complete case analyses, no statistically significant differences were found between acetyl-l-carnitine and placebo in severe or moderate headache days per month (3.0 versus 3.1, p = 0.80), headache days per month (5.1 versus 5.2, p = 0.73) or for the other secondary outcome measures. Conclusion In this triple-blind crossover study no differences were found in headache outcomes between acetyl-l-carnitine and placebo. Our results do not provide evidence of benefit for efficacy of acetyl-l-carnitine as prophylactic treatment for migraine. Trial registration: EUDRACT (2012-001624-36), ClinicalTrials.gov (NCT01695317).

Extended infusion compared to standard infusion cefepime as empiric treatment of febrile neutropenia

2017 ◽  
Vol 24 (3) ◽  
pp. 170-175 ◽  
Author(s):  
Rebekah H Wrenn ◽  
David Cluck ◽  
LeAnne Kennedy ◽  
Christopher Ohl ◽  
John C Williamson
Keyword(s):  
Febrile Neutropenia ◽  
Creatinine Clearance ◽  
Primary Outcome ◽  
Clinical Success ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Secondary Outcome ◽  
Cell Transplant ◽  
To Receive ◽  
Extended Infusion

Background Extended infusion (EI) dosing provides a longer time above the minimum inhibitory concentration, which is important for the clinical success of β-lactam antibiotics, especially for patients with impaired immunity. The aim of this study was to determine the feasibility and clinical impact of administering cefepime by EI as treatment of febrile neutropenia. Methods This was a prospective, randomized, comparative pilot study. All patients received cefepime 2 g IV every 8 h, with the first dose administered using a 30-min infusion. After the first dose, patients were randomized to receive cefepime over 30 min as a standard infusion (SI) or 3 h (EI). Patients were >18 years old with febrile neutropenia (neutrophil count <500 cells/mm3 and temperature >38.0ºC) and received chemotherapy or stem cell transplant as treatment for malignancy. Patients were excluded for the following: allergy to a cephalosporin, creatinine clearance (CrCl) < 50 mL/min, receipt of concurrent Gram-negative antimicrobial, sepsis, or solid tumor malignancy. The primary outcome was defervescence by 72 h. Secondary outcomes included time to defervescence, clinical success, in-hospital mortality, hospital length of stay, and need for additional antimicrobials. Main results Sixty-three patients were enrolled: 33 in the SI arm and 30 in the EI arm. The groups were similar with regard to age, gender, weight, estimated creatinine clearance, and duration of neutropenia. None of the patients in the EI arm withdrew due to practical complications of receiving EI cefepime. Twenty-three patients in the SI arm and 20 patients in the EI arm defervesced by 72 h ( p = 0.99). There were no differences in secondary outcome measures; however, patients in the EI arm appeared to have defervesced more rapidly (median 19 vs. 41 h, p = 0.305). Conclusion Administration of cefepime by EI for the treatment of febrile neutropenia is feasible. Larger clinical trials are necessary to determine if EI cefepime imparts a clinical benefit in the treatment of febrile neutropenia.

Aspirin Use and Post-operative Bleeding from Dental Extractions

2008 ◽  
Vol 87 (8) ◽  
pp. 740-744 ◽  
Author(s):  
M.T. Brennan ◽  
M.A. Valerin ◽  
J.L. Noll ◽  
J.J. Napeñas ◽  
M.L. Kent ◽  
...  
Keyword(s):  
Tooth Extraction ◽  
Primary Outcome ◽  
Preventive Treatment ◽  
Primary Outcome Measure ◽  
Bleeding Complications ◽  
Secondary Outcome ◽  
Dental Procedures ◽  
Secondary Bleeding ◽  
Single Tooth ◽  
To Receive

Aspirin is a common, chronically administered preventive treatment for cardiovascular disease, but is often discontinued prior to invasive dental procedures because of concern for bleeding complications. We hypothesized that aspirin does not cause increased bleeding following a single tooth extraction. Thirty-six healthy persons requiring a tooth extraction were randomized to receive 325 mg/day aspirin or placebo for 4 days. Cutaneous bleeding time (BT) and platelet aggregation tests were obtained prior to extraction. The primary outcome measure, oral BT, and secondary bleeding outcomes were evaluated during and following extraction. No significant baseline differences, except for diastolic blood pressure, were found between groups. There were no differences in oral BT, cutaneous BT, secondary outcome measures, or compliance. Whole-blood aggregation results were significantly different between the aspirin and placebo groups. These findings suggest that there is no indication to discontinue aspirin for persons requiring single-tooth extraction.

Low Bacterial Diet in Patients with Cytopenia after Intensive Chemotherapy for Hematological Malignancy: A Study of Efficacy and Costs.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 5548-5548
Author(s):  
Harry C. Schouten ◽  
Peter Terporten ◽  
Maartje Harbers ◽  
Riette van Boxtel ◽  
Alphons Kessels ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Preventive Measure ◽  
Secondary Outcome ◽  
Control Group ◽  
Study Group ◽  
Risk Of Infection ◽  
Outcome Parameter ◽  
Societal Costs ◽  
Gram Negative ◽  
To Receive

Abstract Patients with hematological malignancies who receive intensive chemotherapy usually develop a period of cytopenia, during which there is an increased risk of infection. In order to reduce the risk of infection several preventive measures have been adopted. Fundamentally, all of these measures were designed to prevent either acquisition of Gram negative rods or fungal pathogens from the environment, or the translocation of these potential pathogens across the mucosal barrier of the gut. The evidence for the necessity of low bacterial diet as an infection preventive measure is weak. Therefore, in this randomized, controlled study the question whether normal hospital diet is equivalent in efficacy to low bacterial diets, given as an infection preventive measure during treatment of cytopenic patients, was addressed. Intestinal colonization by aerobic Gram negative rods and yeasts has been chosen as primary endpoint. In addition, the occurrence of infections and the total costs of hospital care have been documented, in order to identify potential cost savings by the use of either diet. The patients were randomized into two groups: one group (Study group) to receive antimicrobial prophylaxis (AP) and low-bacterial diet, the other (Control group) to receive the same AP and normal hospital diet. The primary outcome parameter is colonization of faeces with Gram-negative rods or Candida species. Degree of colonization was calculated as [∑ 10log (CFU/g feces)] x [duration of episode] /[number of days on which feces culture were taken]. Next, an analysis of variance was performed taking several factors into account, such as the use of antibiotics. As secondary outcome parameters all infections, and therapeutic use of antibiotics were registered; moreover, total societal costs were calculated for each patient starting at first hospitalization until 28 days after the last discharge. In the study group 10 patients were included and evaluable, in the control group 10 patients were included and 9 evaluable. The number of cycles studied, defined as the period from starting antibiotic prophylaxis until leukocyte counts had recovered to 1000 /mm3 or higher, was 21 in the study group, and 18 in the control group. The median number of days per cycle was 28 (range 17–43) days for the study group, and 34 (range 19–60) days for the control group (NS). Regarding the primary outcome parameter, gut colonization by yeasts or Gram negative rods, no statistically significant differences between treatment groups were observed. With respect to infections as secondary outcome parameter, neither the number of days with fever nor the number of days, during which antibiotics were administered therapeutically, was different between the study and control group of patients. The numbers of fungal infections were no cases of invasive aspergillosis (IA) in the study group, 2 episodes of possible aspergillosis in the control group, and in both groups one episode of candidemia. Regarding the total societal costs no statistically significant differences were measured between normal diet and low-bacterial diet. The results indicate that low-bacterial diet and normal hospital diet are equivalent regarding colonization with yeasts and Gram negative rods, infections and total societal costs.

Co-Phenylcaine Spray: can we improve the taste? A randomised, double-blind, crossover study

2017 ◽  
Vol 132 (2) ◽  
pp. 138-142
Author(s):  
S Bailey ◽  
B Panizza ◽  
P Cabot ◽  
B Wallwork
Keyword(s):  
Crossover Study ◽  
Nasal Spray ◽  
Patient Experience ◽  
Washout Period ◽  
Sensory Attributes ◽  
Satisfaction Score ◽  
Double Blind ◽  
To Receive ◽  
Blind Crossover Study ◽  
Double Blind Crossover Study

AbstractObjective:Co-Phenylcaine Forte is a nasal spray routinely prescribed by otolaryngologists in Australia. The taste of Co-Phenylcaine Forte is typically described as unpleasant. This study sought to improve the overall patient experience associated with Co-Phenylcaine Forte by generating a Co-Phenylcaine Forte formulation, referred to as Co-Phenylcaine Zest, which contains an added vanilla flavour and masking agent.Methods:Participants were randomised to receive two actuations of Co-Phenylcaine Forte in each nostril followed by two actuations of Co-Phenylcaine Zest, or vice versa. There was a 6–36-hour washout period between each treatment. After the administration of each spray, participants completed a questionnaire to rate various sensory attributes of each formulation on seven-point ordinal scales. Patients reported their overall formulation preference after receiving both treatments.Results:A total of 86 participants completed the trial. Seventy-four per cent of patients preferred Co-Phenylcaine Zest, 21 per cent preferred Co-Phenylcaine Forte and 5 per cent had no preference (p < 0.001). The satisfaction score associated with Co-Phenylcaine Zest was 1.22 points greater than with Co-Phenylcaine Forte (p < 0.001).Conclusion:A novel formulation of Co-Phenylcaine Forte was created by adding a flavour and a masking agent; this formulation was preferred by most patients.

scholarly journals Reversal of Vecuronium-induced Neuromuscular Blockade with Low-dose Sugammadex at Train-of-four Count of Four

2017 ◽  
Vol 127 (3) ◽  
pp. 441-449 ◽  
Author(s):  
László Asztalos ◽  
Zoltán Szabó-Maák ◽  
András Gajdos ◽  
Réka Nemes ◽  
Adrienn Pongrácz ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Low Dose ◽  
Neuromuscular Block ◽  
Study Drug ◽  
Neuromuscular Function ◽  
Secondary Outcome ◽  
Drug Injection ◽  
Train Of Four ◽  
Study Participants ◽  
To Receive

Abstract Background Rocuronium-induced neuromuscular block that spontaneously recovered to a train-of-four count of four can be reversed with sugammadex 0.5 or 1.0 mg/kg. We investigated whether these doses of sugammadex can also reverse vecuronium at a similar level of block. Methods Sixty-five patients were randomly assigned, and 64 were analyzed in this controlled, superiority study. Participants received general anesthesia with propofol, sevoflurane, fentanyl, and vecuronium. Measurement of neuromuscular function was performed with acceleromyography (TOF-Watch-SX, Organon Teknika B.V., The Netherlands ). Once the block recovered spontaneously to four twitches in response to train-of-four stimulation, patients were randomly assigned to receive sugammadex 0.5, 1.0, or 2.0 mg/kg; neostigmine 0.05 mg/kg; or placebo. Time from study drug injection to normalized train-of-four ratio 0.9 and the incidence of incomplete reversal within 30 min were the primary outcome variables. Secondary outcome was the incidence of reparalysis (normalized train-of-four ratio less than 0.9). Results Sugammadex, in doses of 1.0 and 2.0 mg/kg, reversed a threshold train-of-four count of four to normalized train-of-four ratio of 0.9 or higher in all patients in 4.4 ± 2.3 min (mean ± SD) and 2.6 ± 1.6 min, respectively. Sugammadex 0.5 mg/kg reversed the block in 6.8 ± 4.1 min in 70% of patients (P &lt; 0.0001 vs. 1.0 and 2.0 mg/kg), whereas neostigmine produced reversal in 11.3 ± 9.7 min in 77% of patients (P &gt; 0.05 vs. sugammadex 0.5 mg/kg). The overall frequency of reparalysis was 18.7%, but this incidence varied from group to group. Conclusions Sugammadex 1.0 mg/kg, unlike 0.5 mg/kg, properly reversed a threshold train-of-four count of four vecuronium-induced block but did not prevent reparalysis.

scholarly journals Short email with attachment versus long email without attachment when contacting authors to request unpublished data for a systematic review: a nested randomised trial

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e025273 ◽  
Author(s):  
Peter J Godolphin ◽  
Philip M Bath ◽  
Alan A Montgomery
Keyword(s):  
Systematic Review ◽  
Primary Outcome ◽  
Additional Data ◽  
Response Rate ◽  
Randomised Trial ◽  
Secondary Outcome ◽  
Unit Of Analysis ◽  
Secondary Outcomes ◽  
To Receive ◽  
Contacting Authors

ObjectiveSystematic reviews often rely on the acquisition of unpublished analyses or data. We carried out a nested randomised trial comparing two different approaches for contacting authors to request additional data for a systematic review.ParticipantsParticipants were authors of published reports of prevention or treatment trials in stroke in which there was central adjudication of events. A primary and secondary research active author were selected as contacts for each trial.InterventionsAuthors were randomised to be sent either a short email with a protocol of the systematic review attached (‘Short’) or a longer email that contained detailed information and without the protocol attached (‘Long’). A maximum of two emails were sent to each author to obtain a response. The unit of analysis was trial, accounting for clustering by author.Primary and secondary outcome measuresThe primary outcome was whether a response was received from authors. Secondary outcomes included time to response, number of reminders needed before a response was received and whether authors agreed to collaborate.Results88 trials with 76 primary authors were identified in the systematic review, and of these, 36 authors were randomised to Short (trials=45) and 40 to Long (trials=43). Responses were received for 69 trials. There was no evidence of a difference in response rate between trial arms (Short vs Long, OR 1.10, 95% CI 0.36 to 3.33). There was no evidence of a difference in time to response between trial arms (Short vs Long, HR 0.91, 95% CI 0.55 to 1.51). In total, 27% of authors responded within a day and 22% of authors never responded.ConclusionsThere was no evidence to suggest that email format had an impact on the number of responses received when acquiring data for a systematic review involving stroke trials or the time taken to receive these responses.

scholarly journals Randomized Controlled Trial Comparing the Efficacy and Safety of Epidural Infiltration of Particulate Versus Nonparticulate Steroids in the Treatment of Patients with Sciatic Pain

2021 ◽  
Vol 6 (12) ◽  
pp. 911-914
Author(s):  
Nazia Nazir ◽  
Savita Gupta ◽  
Vikas Saxena
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Radicular Pain ◽  
Functional Improvement ◽  
Secondary Outcome ◽  
Methylprednisolone Acetate ◽  
Dexamethasone Phosphate ◽  
To Receive ◽  
Corticosteroid Injections

Introduction: Epidural corticosteroid injections are widely used to treat low back pain, but doubts exist about the relative efficacy of particulate versus non-particulate corticosteroids. Epidural corticosteroid injections were performed in 75 patients with chronic radicular pain were evaluated for epidural corticosteroid injections to determine if there was a difference in the efficacy of triamcilone acetate, methylprednisolone acetate, and dexamethasone. Methods: 75 patients presenting with debilitating radicular pain were randomized to receive an injection of triamcilone acetate 40 mg/ml, methylprednisolone acetate 40 mg/ml, and dexamethasone phosphate 7.5 mg/ml at equal doses. Data were collected at 1-month and 3-month follow-up. The primary outcome of the present study was reduction in pain on a visual analog scale (VAS) at 3 months, while the secondary outcome was the type and number of complications in the study group. Results: Regardless of baseline score VAS, pain score decreased in all patients at one and three months. The patients with VAS of very severe also showed a statistically significant success rate at one and three month follow-up [p= 0.043]. No serious complications occurred in all three groups. Conclusion: According to this study, pain relief and functional improvement are similar among all three methylprednisolone acetate, triamcilone acetate and dexamethasone phosphate at 3 months.

scholarly journals 2253. Comparison of Outcomes Between Patients with and without Cystic Fibrosis Treated with Ceftolozane–Tazobactam for Pseudomonas aeruginosa Infections

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S771-S771
Author(s):  
Michael J Trisler ◽  
Pranita Tamma ◽  
Pranita Tamma ◽  
Edina Avdic
Keyword(s):  
Cystic Fibrosis ◽  
Primary Outcome ◽  
Resistant Isolate ◽  
Secondary Outcome ◽  
Receive Combination Therapy ◽  
Multicenter Cohort Study ◽  
Multicenter Cohort ◽  
Definitive Therapy ◽  
Emergence Of Resistance ◽  
To Receive

Abstract Background Ceftolozane–tazobactam (C/T) was designed to have enhanced activity against P. aeruginosa and has been shown to retain activity against many isolates that are resistant to other antipseudomonal β-lactams. However, there are no data comparing outcomes in patients with and without cystic fibrosis (CF). Methods Retrospective, multicenter cohort study conducted at 5 hospitals that included all patients with P. aeruginosa infections who received C/T as definitive therapy between November 2016 and December 2018. The primary outcome at 90 days was a composite of mortality, recurrence, readmission, and inappropriate response at end of therapy (EOT). The secondary outcome was to describe baseline C/T susceptibility and emergence of resistance. All outcomes were adjudicated by 2 infectious diseases specialists. Results Thirty-five, 27 non-CF and 8 CF, patients were included. CF patients were younger, had greater baseline C/T resistance (50.0% vs. 8.3%, P = 0.02) and were more likely to receive combination therapy. The most common site of infection was pulmonary (71.4%) followed by intra-abdominal (14.3%) and osteomyelitis (5.7%). Overall, 54.3% of patients had an unsuccessful outcome with no difference between CF and non-CF patients (62.5% vs. 51.9%, P = 0.70). There was also no difference between each component of the primary outcome. All 4 CF patients with a baseline-resistant isolate had an appropriate response at EOT, while neither of the 2 non-CF patients did. The C/T MIC distribution in CF and non-CF patients was ≤ 2 μg/mL (0.0%, 64.2%), 4 μg/mL (50.0%, 25%) ≥ 8 μg/mL (50.0%, 8.4%). The median duration of C/T in CF and non-CF patients was 18.5 days (interquartile range [IQR], 14–37.5 days) and 15 days (IQR, 10–25 days). Ten, 7 non-CF and 3 CF, patients had a P. aeruginosa isolate cultured and tested for C/T susceptibility within 90 days of index culture with 80% having an MIC increase. Non-CF patients treated for > 14 days were more likely to have an MIC increase (P = 0.047). All CF patients had an MIC increase. Conclusion We did not observe a difference in the rate of unsuccessful outcome between CF and non-CF patients; however, our sample size was small. CF patients were more likely to be resistant to C/T at baseline. Resistance emerged frequently in both groups following exposure to C/T. Disclosures All authors: No reported disclosures.

Venlafaxine versus amitriptyline in the prophylactic treatment of migraine: randomized, double-blind, crossover study

2004 ◽  
Vol 107 (1) ◽  
pp. 44-48 ◽  
Author(s):  
Serpil Bulut ◽  
M.Said Berilgen ◽  
Aslihan Baran ◽  
Aslan Tekatas ◽  
Murad Atmaca ◽  
...  
Keyword(s):  
Crossover Study ◽  
Prophylactic Treatment ◽  
Double Blind ◽  
Blind Crossover Study ◽  
Double Blind Crossover Study
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