Efficacy and Safety of Morning Versus Evening Dose of Controlled-Release Simvastatin Tablets in Patients With Hyperlipidemia: A Randomized,Double-Blind,Multicenter Phase III Trial

Background

Flexibility in the recommended dosing time for a statin may improve patient compliance.

Objective

This study was designed to compare the efficacy and tolerability of morning and evening doses of controlled-release simvastatin in Korean adults with dyslipidemia. It was carried out as a requirement to obtain authorization from the Korean regulatory agency to market the product.

Methods

In this prospective, randomized, double-blind, multicenter, placebo-controlled Phase III study, we randomly assigned 132 patients with hypercholesterolemia to a morning-dose group or an evening-dose group. Patients in the morning-dose group received 20 mg controlled-release simvastatin in the morning and a placebo in the evening, and those in the evening-dose group received a placebo in the morning and 20 mg controlled-release simvastatin in the evening.

Results

After 8 weeks of the treatment, the difference in the mean change of LDL-C between the morning-dose and evening-dose groups was −2.78% (95% confidence interval, −7.65 to 2.10). The changes in total cholesterol, triglycerides, HDL-C, apolipoprotein A1, apolipoprotein B, and lipoprotein (a) after treatment did not differ between groups. Also, the achievement rates of the target LDL-C goal suggested by the dyslipidemia treatment guideline of the Korean Society of Lipidology and Atherosclerosis were not different. No serious adverse event was observed in either group. Mild and moderate adverse events were observed similarly in both groups.

Conclusions

Although controlled-release simvastatin significantly reduces LDL-C levels with good tolerability in Korean adults with dyslipidemia, the time of administration does not affect its efficacy.     

A Multicenter, Randomized Trial Comparing an Active Can Implantable Defibrillator with a Passive Can System

Replacing one defibrillation electrode lead by the defibrillator can may simplify implantation of the ICD. In this multicenter study, 304 patients were randomized to receive either the biphasic active can (AC) (model 7219C system, Medtronic, Inc.) or the passive can (PC) (model 7219D system). The AC and PC systems were compared with respect to their ability to meet the implant defibrillation criterion and to defibrillate VF, and to DFTs, implant time, patient adverse events, and survival rates. A higher percentage fulfilled the implant defibrillation criterion on the first configuration with the AC (86.3% vs 75.9% for PC; P = 0.023), and the first shock success for terminating induced VF was 94% for AC compared to 89% for PC (P = 0.026). DFTs were significantly lower (10.9 vs 12.7 J; P = 0.031), and implant time was significantly shorter for the AC patients (99.2 vs 112.0 min; P = 0.002). The two groups showed no significant differences in 3-month adverse event rates, 3-month survival, and hospital stay.     

Written Pain Neuroscience Education in Fibromyalgia: A Multicenter Randomized Controlled Trial

Mounting evidence supports the use of face‐to‐face pain neuroscience education for the treatment of chronic pain patients. This study aimed at examining whether written education about pain neuroscience improves illness perceptions, catastrophizing, and health status in patients with fibromyalgia. A double‐blind, multicenter randomized controlled clinical trial with 6‐month follow‐up was conducted. Patients with FM (n = 114) that consented to participate were randomly allocated to receive either written pain neuroscience education or written relaxation training. Written pain neuroscience education comprised of a booklet with pain neuroscience education plus a telephone call to clarify any difficulties; the relaxation group received a booklet with relaxation education and a telephone call. The revised illness perception questionnaire, Pain Catastrophizing Scale, and fibromyalgia impact questionnaire were used as outcome measures. Both patients and assessors were blinded. Repeated‐measures analyses with last observation carried forward principle were performed. Cohen's d effect sizes (ES) were calculated for all within‐group changes and between‐group differences. The results reveal that written pain neuroscience education does not change the impact of FM on daily life, catastrophizing, or perceived symptoms of patients with FM. Compared with written relaxation training, written pain neuroscience education improved beliefs in a chronic timeline of FM (P = 0.03; ES = 0.50), but it does not impact upon other domains of illness perceptions. Compared with written relaxation training, written pain neuroscience education slightly improved illness perceptions of patients with FM, but it did not impart clinically meaningful effects on pain, catastrophizing, or the impact of FM on daily life. Face‐to‐face sessions of pain neuroscience education are required to change inappropriate cognitions and perceived health in patients with FM.     

Efficacy and Tolerability of Tratinterol Hydrochloride Tablets in Bronchial Asthma: A Multicenter,Randomized, Double-blind,Dose-finding Clinical Trial

Purpose

The aims of this study were to determine the efficacy and tolerability of different dosages of, and to identify the best dosage of, tratinterol hydrochloride tablets in the treatment of bronchial asthma.

Methods

This multicenter, randomized, double-blind, dose-finding clinical research study was completed at 3 centers in the People’s Republic of China from March 2008 to February 2009. Each center selected patients with bronchial asthma whose forced expiratory volume in 1 second (FEV₁) values were <80% of predicted normal (pretreatment). Patients were assigned to 1 of 3 groups, based on daily dosage: low, 50 μg/d; intermediate, 100 μg/d; and high, 150 μg/d. Doses were administered orally twice daily for 10 days. The primary end points were the changes from baseline (0 minutes) in peak expiratory flow (PEF) and FEV₁ at 30 minutes and 1, 2, 4, 6, and 12 hours after administration. Secondary end points were changes from baseline in forced vital capacity and asthma scores. Tolerability was monitored throughout the study period using physical examinations, laboratory testing, and spontaneous reporting.

Findings

A total of 72 patients were selected in this study (24 per group; 40 men; 32 women; mean age, 43.48 years). The efficacy analysis (per-protocol set) included 20, 20, and 22 patients in the low-, intermediate-, and high-dosage groups, respectively. In terms of the primary and secondary end points, the intermediate dosage was most efficacious, followed by the high and low dosages, respectively. All 3 dosages were well-tolerated.

Implications

In these patients with bronchial asthma, 100 μg/d was the dosage of tratinterol hydrochloride tablets most efficacious in terms of improvement in lung function. All 3 dosages were well-tolerated.     

Multicenter,Randomized Clinical Trial To Compare the Safety and Efficacy of LFF571 and Vancomycin for Clostridium difficile Infections

Clostridium difficile infection causes serious diarrheal disease. Although several drugs are available for treatment, including vancomycin, recurrences remain a problem. LFF571 is a semisynthetic thiopeptide with potency against C. difficile in vitro. In this phase 2 exploratory study, we compared the safety and efficacy (based on a noninferiority analysis) of LFF571 to those of vancomycin used in adults with primary episodes or first recurrences of moderate C. difficile infection. Patients were randomized to receive 200 mg of LFF571 or 125 mg of vancomycin four times daily for 10 days. The primary endpoint was the proportion of clinical cures at the end of therapy in the per-protocol population. Secondary endpoints included clinical cures at the end of therapy in the modified intent-to-treat (mITT) population, the time to diarrhea resolution, and the recurrence rate. Seventy-two patients were randomized, with 46 assigned to receive LFF571. Based on the protocol-specified definition, the rate of clinical cure for LFF571 (90.6%) was noninferior to that of vancomycin (78.3%). The 30-day sustained cure rates for LFF571 and vancomycin were 56.7% and 65.0%, respectively, in the per-protocol population and 58.7% and 60.0%, respectively, in the modified intent-to-treat population. Using toxin-confirmed cases only, the recurrence rates were lower for LFF571 (19% versus 25% for vancomycin in the per-protocol population). LFF571 was generally safe and well tolerated. The incidence of adverse events (AEs) was higher for LFF571 (76.1% versus 69.2% for vancomycin), although more AEs in the vancomycin group were suspected to be related to the study drug (38.5% versus 32.6% for LFF571). One patient receiving LFF571 discontinued the study due to an AE. (This study has been registered at ClinicalTrials.gov under registration no. {"type":"clinical-trial","attrs":{"text":"NCT01232595","term_id":"NCT01232595"}}NCT01232595.)     

Fenoldopam, a Dopamine Agonist, for Hypertensive Emergency: A Multicenter Randomized Trial

Despite successful therapies for chronic hypertension, hospital admissions for hypertensive emergency more than tripled between 1983 and 1992. OBJECTIVE: To examine the safety and efficacy of fenoldopam, the first antihypertensive with selective and specific action on vascular dopamine (DA1) receptors, in a clinical trial involving emergency department patients with true hypertensive emergencies. METHODS: Patients with a sustained diastolic blood pressure (DBP) of > or =120 mm Hg and evidence of target organ compromise were randomized in a double-blinded manner to one of four fixed doses of intravenous fenoldopam (0.01, 0.03, 0.1, or 0.3 microg/kg/min) for 24 hours. The primary endpoint was the magnitude of DBP reduction in each of the three higher-dose groups after four hours of fenoldopam treatment compared with the lowest-dose group. RESULTS: One hundred seven participants from 21 centers were enrolled, and 94 patients received fenoldopam. Evidence of acute target-organ damage included new renal dysfunction or hematuria (50%), acute congestive heart failure or myocardial ischemia (48%), and papilledema or grade III-IV hypertensive retinopathy (34%). The DBP decreased in a dose-dependent fashion, with significant differences between the 0.1- and 0.3-microg/kg/min groups compared with the lowest-dose group. Treatment was well tolerated, and there were no deaths or serious adverse events during follow-up, up to 48 hours. All patients were successfully transitioned to oral or transdermal antihypertensives with maintenance of blood pressure control. CONCLUSIONS: Fenoldopam safely and effectively lowers blood pressure in a dose-dependent manner in patients with hypertensive emergencies. Observations supporting potential risk factors for hypertensive emergency are discussed.     

A Randomized Controlled Trial Comparing Manipulation With Mobilization for Recent Onset Neck Pain

Leaver AM, Maher CG, Herbert RD, Latimer J, McAuley JH, Jull G, Refshauge KM. A randomized controlled trial comparing manipulation with mobilization for recent onset neck pain.

Objective

To determine whether neck manipulation is more effective for neck pain than mobilization.

Design

Randomized controlled trial with blind assessment of outcome.

Setting

Primary care physiotherapy, chiropractic, and osteopathy clinics in Sydney, Australia.

Participants

Patients (N=182) with nonspecific neck pain less than 3 months in duration and deemed suitable for treatment with manipulation by the treating practitioner.

Interventions

Participants were randomly assigned to receive treatment with neck manipulation (n=91) or mobilization (n=91). Patients in both groups received 4 treatments over 2 weeks.

Main Outcome Measure

The number of days taken to recover from the episode of neck pain.

Results

The median number of days to recovery of pain was 47 in the manipulation group and 43 in the mobilization group. Participants treated with neck manipulation did not experience more rapid recovery than those treated with neck mobilization (hazard ratio=.98; 95% confidence interval, .66-1.46).

Conclusions

Neck manipulation is not appreciably more effective than mobilization. The use of neck manipulation therefore cannot be justified on the basis of superior effectiveness.     

国产扎来普隆治疗失眠症的多中心随机双盲对照研究

目的：评价国产扎来普隆胶囊治疗失眠症的有效性和安全性。方法：多中心、随机、双盲、双模拟、阳性药平行对照研究，209例失眠症患者随机分为扎来普隆组（105例）与唑吡坦组（104例）,分别口服扎来普隆胶囊10mg&#8226;d-1或唑吡坦片10mg&#8226;d-1，疗程14天。结果：睡眠障碍量表总评分在治疗结束时两组较基线均显著减少(p<0.01)；有效率扎来普隆组为62.7%与唑吡坦组为61.0%，差异无显著性 (p>0.05)。扎来普隆较常见的不良反应为：头晕、头昏、口苦，未出现严重的不良反应。结论：国产扎来普隆胶囊治疗失眠症安全、有效。     

A Qualitative Analysis of a Randomized Controlled Trial Comparing a Cognitive-Behavioral Treatment With Education

Cognitive behavioral therapy (CBT) is a widely accepted psychosocial treatment for chronic pain. However, the efficacy of CBT has not been investigated within a rural setting. Furthermore, few studies have utilized first-person accounts to qualitatively investigate the key treatment elements and processes of change underlying the well-documented quantitative improvements associated with CBT. To address these gaps, we conducted a randomized controlled trial (RCT) investigating the efficacy of group CBT compared to an active education condition (EDU) within a rural, low-literacy population. Posttreatment semistructured interviews of 28 CBT and 24 EDU treatment completers were qualitatively analyzed. Emerging themes were collated to depict a set of finalized thematic maps to visually represent the patterns inherent in the data. Patterns were separated into procedural elements and presumed change processes of treatment. Key themes, subthemes, and example extracts for CBT and EDU are presented; unique and shared aspects pertaining to the thematic maps are discussed. Results indicate that while both groups benefited from the program, the CBT group described more breadth and depth of change as compared to the EDU group. Importantly, this study identified key treatment elements and explored possible processes of change from the patients’ perspective.

Perspective

This qualitative article describes patient-identified key procedural elements and change process factors associated with psychosocial approaches for chronic pain management. Results may guide further adaptations to existing treatment protocols for use within unique, underserved chronic pain populations. Continued development of patient-centered approaches may help reduce health, treatment, and ethnicity disparities.     

甲磺酸帕珠沙星注射液治疗急性呼吸道感染的多中心随机对照试验

目的评价国产甲磺酸帕珠沙星注射液治疗急性呼吸道细菌感染的有效性与安全性。方法试验采用多中心、随机、阳性药物平行对照、非盲法试验设计,共纳入134例受试者,随机分为试验组68例和对照组66例,试验组与对照组分别接受甲磺酸帕珠沙星500mg与左氧氟沙星300mg,每12h静脉滴注1次,每日两次治疗,疗程均为7~10天,病情重者可延长至14天。结果试验组与对照组的急性呼吸道感染的临床痊愈率分别为52.9%、57.6%(FAS分析集)和57.1%、61.3%(PPS分析集);临床有效率分别为86.8%、87.9%(FAS分析集)和93.7%、93.6%(PPS分析集),两组比较差异无统计学意义,表明两药疗效相当。两组的细菌阴转率分别为92.5%和94.3%,两组差异无统计学意义(P>0.05)。安全性评价结果显示,两组临床不良反应发生率分别为16.2%和16.7%,均以局部刺激及消化道反应为主,但大多轻微,无需特殊处理。结论甲磺酸帕珠沙星注射液治疗急性呼吸道细菌感染疗效确切,不良反应少,安全性较好,适合敏感菌所致的中重度呼吸道细菌感染及不能口服给药的患者使用。     

A Randomized Trial Comparing Two Cuffed Emergency Cricothyrotomy Devices Using a Wire-Guided and a Catheter-Over-Needle Technique

Background: According to different algorithms of airway management, emergency cricothyrotomy is the final step in managing the otherwise inaccessible airway. As an alternative to an open surgical procedure, minimally invasive approaches exist. Various sets for different methods are commercially available. QuickTrach™ (VBM Medizintechnik GmbH, Sulz am Neckar, Germany) contains a plastic cannula over a metal needle for direct placement in the trachea, whereas a guide-wire is used for the actual placement of the cannula in the Melker Set™ (Cook Group Incorporated, Bloomington, IN). Objective: We hypothesize that the direct puncture involving less discrete steps is faster to perform. However, it will lead to more complications due to the higher force needed to place the relatively thick needle. Method: After approval of the local ethics committee, the study was performed on cadavers of 16 adult sheep. A wire-guided cricothyrotomy was compared with a catheter-over-needle technique. Successful placement and performance time were compared. Complication rate and maximal achieved airway pressure were evaluated. Data is given as mean and interquartile range, and Mann-Whitney U-test (p < 0.05) for significant differences. Results: With the wire-guided technique, successful placement was possible in all attempts. The catheter-over-needle method was successful in 63% and had a higher complication rate (75% vs. 13%). The cannula-over-needle method allowed a faster cricothyrotomy (32 [2–34] vs. 53 [52–56] s). Both methods allowed the delivery of similar maximal airway pressures (50 [44–51] vs. 48 [43–53] mbar). Conclusion: The wire-guided method proved to be the more reliable technique, leading to fewer complications. However, the direct puncture was faster to perform. Placed accurately, both devices allowed sufficient ventilation.     

Comparing Occupation-Based and Repetitive Task Practice Interventions for Optimal Stroke Recovery: A Pilot Randomized Trial

Aims: This pilot randomized comparative study investigated changes in motor performance and indices of neuroplasticity associated with occupation-based intervention and repetitive task practice in the recovery of occupational performance following stroke. Method: Sixteen participants received either occupation-based intervention or repetitive task practice for eight 55-minute sessions. Motor performance was measured by the Fugl Meyer Assessment (FMA), Stroke Impact Scale (SIS), the Canadian Occupational Performance Measure (COPM) and the Goal Attainment Scale (GAS). Indices of neuroplastic change were assessed by transcranial magnetic stimulation (TMS). Results: Both occupation-based intervention and repetitive task practice groups demonstrated significant changes on the FMA and the occupation-based group demonstrated significant changes on the GAS goals. Neurophysiological measures showed enlargement in TMS volume maps in the affected hemisphere for both groups. Conclusion: Occupation-based and repetitive task practice interventions can yield similar improvements in chronic stroke.     

A Randomized Controlled Clinical Trial Comparing Ventricular Fibrillation Detection Time Between Two Transvenous Defibrillator Models

The Ventak AV is an implantable cardioverter defibrillator with dual chamber pacing capability. Features include detection and treatment of ventricular arrhythmias, detection of atrial arrhythmias, as well as dual chamber pacing. The objective of the investigation was to verify the efficacy of the Ventak AV in detecting ventricular fibrillation in the presence of dual chamber pacing. Thirty-three patients, who were to receive an implantable defibrillator were randomized (1:1) in a paired comparison study to the Ventak AV (study device) and the Ventak Mini (control) during defibrillation threshold testing. In order to create a "worst case scenario" for sensing of ventricular fibrillation, pacing was performed at high lower rate limit values (Ventak AV DDD pacing at 150/min, Ventak Mini at VVI 100/min). Ventricularfibrillation was induced and the randomized device was allowed to detect and treat the arrhythmia. This test was repeated for each patient using the alternate device in a randomized order, such that all patients were tested with both devices. The mean ventricular fibrillation detection time for the Ventak AV was 2.0+/-0.11 seconds and for the control device the detection time was 1.8+/-0.11 seconds (P = 0.26). Appropriate tachyarrhythmia therapy decision was documented in all episodes for both devices. The study patient population demonstrated equivalent ventricular fibrillation detection time between the Ventak AV and the Ventak Mini. The Ventak AV demonstrated effectiveness in detecting ventricular fibrillation in the presence of high rate dual chamber pacing.     

医用透明质酸钠预防甲状腺术后切口粘连的有效性和安全性

目的:观察医用透明质酸钠预防甲状腺术后切口粘连的有效性和安全性。方法:用前瞻性临床随机对照研究的方法,入选2007年2-9月间我院与温州医学院附属第一医院肿瘤外科所做的各类甲状腺手术335例。其中,实验组166例,于切除甲状腺病灶后,取医用透明质酸钠3～5mL均匀涂抹于甲状腺创面、颈前肌群深面以及颈阔肌深面;对照组169例,创面未涂抹医用透明质酸钠。结果:实验组术后发生皮下积液18例(10.8%),对照组发生皮下积液13例(7.7%),两组间差异无显著性(P=0.32)。实验组无一例发生对该药物的过敏或异物排斥反应。实验组术后6个月发生各类颈部粘连19例(11.4%),对照组43例(25.4%),术后6个月颈部B超检查,实验组同步移动27例,不同步移动138例;对照组同步移动76例,不同步移动91例,两组间差异均有统计学意义(P<0.01)。结论:医用透明质酸钠能有效地降低甲状腺手术后颈部粘连,并不增加手术并发症。     

Acceptance and Commitment Therapy for Primary Headache Sufferers: A Randomized Controlled Trial of Efficacy

Prevention of headaches via avoidance of triggers remains the main behavioral treatment suggestion for headache management despite trigger avoidance resulting in increases in potency, lifestyle restrictions, internal locus of control decreases, pain exacerbation and maintenance. New approaches, such as Acceptance and Commitment Therapy (ACT), instead emphasize acceptance and valued living as alternatives to avoidance. Though ACT is an empirically supported treatment for chronic pain, there is limited evidence for headache management while preliminary outcome studies are afflicted with methodological limitations. This study compared an ACT-based group headache-specific intervention to wait-list control, in a randomized clinical trial, on disability, distress, medical utilization, functioning, and quality of life. Ninety-four individuals with primary headache (84% women; Mage = 43 years; 87.35% migraine diagnosis) were randomized into 2 groups (47 in each). Assessments occurred: before, immediately after, and at 3 months following treatment end. Only the ACT group was additionally assessed at 6- and 12-month follow-up. Results (intent to treat analyses corroborated by linear mixed model analyses) showed substantial improvements in favor of ACT compared to control, on disability, quality of life, functional status, and depression at 3-, 6-, and 12-month follow-up. Improvements were maintained in the ACT group at 6- and 12-month follow-up. At 3-month follow-up, clinical improvement occurred in headache-related disability (63%) and 65% in quality of life in ACT versus 37% and 35% in control. These findings offer new evidence for the utility and efficacy of ACT in localized pain conditions and yields evidence for both statistical and clinical improvements over a years’ period.PerspectiveAn Acceptance and Commitment Therapy approach focusing on acceptance and values-based activities was found to improve disability, functioning, and quality of life among patients with primary headaches.     

Efficacy of Cartoon Viewing Devices During Phlebotomy in Children: A Randomized Controlled Trial

PurposeThe purpose of this study was to examine the efficacy of different cartoon viewing devices during phlebotomy in children.DesignThis study was a prospective, randomized controlled trial.MethodsThe study included inpatients from the Biochemical Laboratory of a private university hospital in Turkey and was conducted between September 2017 and April 2018. A computer-based random number generator was used to randomly assign the patients into three groups (virtual reality [VR], tablet, and control) with 40 children each. Data were collected using the Wong-Baker FACES Pain Rating Scale and the Children's Fear Scale. Pain and anxiety scores were reported by children, parents, and observers in tablet and control groups. In the VR group, pain and anxiety were determined only by children's reports.FindingsAccording to the children reports, the VR group reported significantly less pain and anxiety than those in the tablet and control groups (P < .05).ConclusionsThe cartoon distraction performed using a VR device reduced the perception of pain and anxiety during phlebotomy in school-age children.     

Spa Therapy for the Treatment of Fibromyalgia: An Open,Randomized Multicenter Trial

Fibromyalgia is a common chronic pain pathology with an incidence of 4.3 per 1,000 person-years. An open, randomized clinical trial of patients with fibromyalgia comparing an immediate vs. delayed 18-day spa therapy in five spa therapy care facilities in France enrolled 220 patients. Randomization was in blocks of four, stratified by center, severity of fibromyalgia and previous spa therapy. Patients continued usual treatment. The main endpoint was the number of patients achieving minimal clinically important difference at 6 months, defined as 14% change in their baseline fibromyalgia impact questionnaire score. The intention-to-treat analysis included 100 and 106 patients in the intervention and control groups, respectively. At 6 months, 45/100 (45.0%) and 30/106 (28.3%) patients in the intervention and control groups, respectively, achieved a minimal clinically important difference (P= .013). There was also a significant improvement in pain, fatigue, and symptom severity (secondary outcomes) in the intervention group but not for generic quality of life (QOL), sleep or physical activity. None of the 33 serious adverse events reported by 25 patients were related to the spa therapy. Our results demonstrate the benefit of spa treatment in patients with fibromyalgia.PerspectiveA 12-month, open, randomized clinical trial of 220 patients with fibromyalgia compared an immediate versus delayed (ie, after 6 months) 18-day spa therapy. The results showed a clinically significant improvement at 6 months for those who received immediate therapy which was maintained up to 12 months.Trial registration numberClinicalTrials.gov: NCT02265029     

Intravenous Propafenone for Converting Recent onset Atrial Fibrillation in Emergency Departments: A Randomized Placebo-Controlled Multicenter Trial

Atrial fibrillation (AF) is one of the most frequent dysrhythmias in patients coming to emergency departments (EDs), and pharmacological treatment is frequently performed. The aim of this randomized placebo-controlled multicenter trial was to compare propafenone (a class 1C antidysrhythmic agent), administered i.v. in the ED, with placebo in the treatment of recent-onset AF (<72 h). We randomly allocated 156 patients (88 males; 68 females) from 18 to 80 years old, with recent-onset AF, to receive i.v. propafenone (2 mg/kg for 10 min) or the matching placebo. The patients were followed for 2 h. Exclusion criteria were the presence of one of the following: lack of informed consent, clinical evidence of heart failure, clinical hyperthyroidism, recent acute myocardial infarction, atrioventricular block, cardiac valve dysfunction, a history of bronchial asthma, and current treatment with antidysrhythmic agents including digitalis. The two groups did not differ significantly in terms of sex, age, body weight, or estimated time elapsed since the beginning of atrial fibrillation. Conversion to sinus rhythm occurred in 13 of the 75 patients who received the placebo (17.3%) and in 57 of the 81 patients who were given propafenone (70.3%). In conclusion, intravenous propafenone administration in the ED can be considered a safe and effective approach for converting AF to sinus rhythm.