WorldWideScience

Sample records for randomized treatment assignment

  1. A Search for Alternatives to Random Assignment to Treatment Groups.

    Science.gov (United States)

    Halasa, Ofelia

    In a public school setting administrators are frequently under local pressure to make a new project service available to all eligible children. However, comparable control groups for project evaluation are often absent, and although random assignment to treatment groups remains the most systematic method of providing controls, this is not often…

  2. Random Cell Identifiers Assignment

    Directory of Open Access Journals (Sweden)

    Robert Bestak

    2012-01-01

    Full Text Available Despite integration of advanced functions that enable Femto Access Points (FAPs to be deployed in a plug-and-play manner, the femtocell concept still cause several opened issues to be resolved. One of them represents an assignment of Physical Cell Identifiers (PCIs to FAPs. This paper analyses a random based assignment algorithm in LTE systems operating in diverse femtocell scenarios. The performance of the algorithm is evaluated by comparing the number of confusions for various femtocell densities, PCI ranges and knowledge of vicinity. Simulation results show that better knowledge of vicinity can significantly reduce the number of confusions events.

  3. Comparing cluster-level dynamic treatment regimens using sequential, multiple assignment, randomized trials: Regression estimation and sample size considerations.

    Science.gov (United States)

    NeCamp, Timothy; Kilbourne, Amy; Almirall, Daniel

    2017-08-01

    Cluster-level dynamic treatment regimens can be used to guide sequential treatment decision-making at the cluster level in order to improve outcomes at the individual or patient-level. In a cluster-level dynamic treatment regimen, the treatment is potentially adapted and re-adapted over time based on changes in the cluster that could be impacted by prior intervention, including aggregate measures of the individuals or patients that compose it. Cluster-randomized sequential multiple assignment randomized trials can be used to answer multiple open questions preventing scientists from developing high-quality cluster-level dynamic treatment regimens. In a cluster-randomized sequential multiple assignment randomized trial, sequential randomizations occur at the cluster level and outcomes are observed at the individual level. This manuscript makes two contributions to the design and analysis of cluster-randomized sequential multiple assignment randomized trials. First, a weighted least squares regression approach is proposed for comparing the mean of a patient-level outcome between the cluster-level dynamic treatment regimens embedded in a sequential multiple assignment randomized trial. The regression approach facilitates the use of baseline covariates which is often critical in the analysis of cluster-level trials. Second, sample size calculators are derived for two common cluster-randomized sequential multiple assignment randomized trial designs for use when the primary aim is a between-dynamic treatment regimen comparison of the mean of a continuous patient-level outcome. The methods are motivated by the Adaptive Implementation of Effective Programs Trial which is, to our knowledge, the first-ever cluster-randomized sequential multiple assignment randomized trial in psychiatry.

  4. The Random Quadratic Assignment Problem

    Science.gov (United States)

    Paul, Gerald; Shao, Jia; Stanley, H. Eugene

    2011-11-01

    The quadratic assignment problem, QAP, is one of the most difficult of all combinatorial optimization problems. Here, we use an abbreviated application of the statistical mechanics replica method to study the asymptotic behavior of instances in which the entries of at least one of the two matrices that specify the problem are chosen from a random distribution P. Surprisingly, the QAP has not been studied before using the replica method despite the fact that the QAP was first proposed over 50 years ago and the replica method was developed over 30 years ago. We find simple forms for C min and C max , the costs of the minimal and maximum solutions respectively. Notable features of our results are the symmetry of the results for C min and C max and their dependence on P only through its mean and standard deviation, independent of the details of P.

  5. Comparing cluster-level dynamic treatment regimens using sequential, multiple assignment, randomized trials: Regression estimation and sample size considerations

    OpenAIRE

    NeCamp, Timothy; Kilbourne, Amy; Almirall, Daniel

    2016-01-01

    Cluster-level dynamic treatment regimens can be used to guide sequential, intervention or treatment decision-making at the cluster level in order to improve outcomes at the individual or patient-level. In a cluster-level DTR, the intervention or treatment is potentially adapted and re-adapted over time based on changes in the cluster that could be impacted by prior intervention, including based on aggregate measures of the individuals or patients that comprise it. Cluster-randomized sequentia...

  6. Assignment refusal and its relation to outcome in a randomized controlled trial comparing Cognitive Therapy and Fluvoxamine in treatment-resistant patients with obsessive compulsive disorder.

    Science.gov (United States)

    Landsheer, Johannes A; Smit, Johannes H; van Oppen, Patricia; van Balkom, Anton J L M

    2015-03-30

    The effectiveness of Fluvoxamine was compared to that of Cognitive Therapy (CT) in a 12-week randomized controlled trial (RCT) in 48 patients with obsessive-compulsive disorder (OCD), who were treatment-resistant to a previous behavior therapy (BT). A considerable amount of patients did not comply with the assigned treatment and switched treatments. The aim of this study was to identify patient characteristics predictive of assignment compliance and to study whether these characteristics were related to outcome. A logistic model, based on psychological and social patient characteristics, in addition to or in interaction with the assignment, was used for the explanation of compliance with treatment assignment. Especially patients who have a higher score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) tend to comply with the effective Fluvoxamine treatment. The same set of variables was related to both compliance and outcome of therapy received. Therefore, the logistic model of compliance could be used to reduce the positive bias of As-Treated analysis (AT). The difference between the results of Fluvoxamine and Cognitive Therapy remained statistically significant after correcting for the positive bias as the result of assignment refusal and after applying the assumption that two drop-out patients needed imputation of lesser results. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  7. Adolescent Substance Use in the Multimodal Treatment Study of Attention-Deficit/Hyperactivity Disorder (ADHD) (MTA) as a Function of Childhood ADHD, Random Assignment to Childhood Treatments, and Subsequent Medication

    Science.gov (United States)

    Molina, Brooke S. G.; Hinshaw, Stephen P.; Arnold, L. Eugene; Swanson, James M.; Pelham, William E.; Hechtman, Lily; Hoza, Betsy; Epstein, Jeffery N.; Wigal, Timothy; Abikoff, Howard B.; Greenhill, Laurence L.; Jensen, Peter S.; Wells, Karen C.; Vitiello, Benedetto; Gibbons, Robert D.; Howard, Andrea; Houck, Patricia R.; Hur, Kwan; Lu, Bo; Marcus, Sue

    2013-01-01

    Objective: To determine long-term effects on substance use and substance use disorder (SUD), up to 8 years after childhood enrollment, of the randomly assigned 14-month treatments in the multisite Multimodal Treatment Study of Children with Attention-Deficit/Hyperactivity Disorder (MTA; n = 436); to test whether medication at follow-up, cumulative…

  8. Sequential multiple assignment randomization trials with enrichment design.

    Science.gov (United States)

    Liu, Ying; Wang, Yuanjia; Zeng, Donglin

    2017-06-01

    Sequential multiple assignment randomization trial (SMART) is a powerful design to study Dynamic Treatment Regimes (DTRs) and allows causal comparisons of DTRs. To handle practical challenges of SMART, we propose a SMART with Enrichment (SMARTER) design, which performs stage-wise enrichment for SMART. SMARTER can improve design efficiency, shorten the recruitment period, and partially reduce trial duration to make SMART more practical with limited time and resource. Specifically, at each subsequent stage of a SMART, we enrich the study sample with new patients who have received previous stages' treatments in a naturalistic fashion without randomization, and only randomize them among the current stage treatment options. One extreme case of the SMARTER is to synthesize separate independent single-stage randomized trials with patients who have received previous stage treatments. We show data from SMARTER allows for unbiased estimation of DTRs as SMART does under certain assumptions. Furthermore, we show analytically that the efficiency gain of the new design over SMART can be significant especially when the dropout rate is high. Lastly, extensive simulation studies are performed to demonstrate performance of SMARTER design, and sample size estimation in a scenario informed by real data from a SMART study is presented. © 2016, The International Biometric Society.

  9. Assignment refusal and its relation to outcome in a randomized controlled trial comparing Cognitive Therapy and Fluvoxamine in treatment-resistant patients with obsessive compulsive disorder

    NARCIS (Netherlands)

    Landsheer, J.A.; Smit, J.H.; van Oppen, P.C.; van Balkom, A.J.L.M.

    2015-01-01

    The effectiveness of Fluvoxamine was compared to that of Cognitive Therapy (CT) in a 12-week randomized controlled trial (RCT) in 48 patients with obsessive-compulsive disorder (OCD), who were treatment-resistant to a previous behavior therapy (BT). A considerable amount of patients did not comply

  10. Long-term risk of carotid restenosis in patients randomly assigned to endovascular treatment or endarterectomy in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS): long-term follow-up of a randomised trial.

    LENUS (Irish Health Repository)

    Bonati, Leo H

    2009-10-01

    In the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS), early recurrent carotid stenosis was more common in patients assigned to endovascular treatment than it was in patients assigned to endarterectomy (CEA), raising concerns about the long-term effectiveness of endovascular treatment. We aimed to investigate the long-term risks of restenosis in patients included in CAVATAS.

  11. Treatment Assignment Guesses by Study Participants in a Double-Blind Dose Escalation Clinical Trial of Saw Palmetto

    OpenAIRE

    Lee, Jeannette Y.; Moore, Page; Kusek, John; Barry, Michael

    2014-01-01

    Objectives: This report assesses participant perception of treatment assignment in a randomized, double-blind, placebo-controlled trial of saw palmetto for the treatment of benign prostatic hyperplasia (BCM).

  12. Error treatment in students' written assignments in Discourse Analysis

    African Journals Online (AJOL)

    ... is generally no consensus on how lecturers should treat students' errors in written assignments, observations in this study enabled the researcher to provide certain strategies that lecturers can adopt. Key words: Error treatment; error handling; corrective feedback, positive cognitive feedback; negative cognitive feedback; ...

  13. Randomized Assignments for Barter Exchanges: Fairness vs Efficiency

    DEFF Research Database (Denmark)

    Fang, Wenyi; Filos-Ratsikas, Aris; Frederiksen, Søren Kristoffer Stiil

    2015-01-01

    often restrict the maximum allowed cycle-length of the exchange and for randomized algorithms, this imposes constraints of the cycle-length of every realized exchange in their decomposition. We prove that standard fairness properties such as envy-freeness or symmetry are incompatible with even...... the weakest notion of economic efficiency in this setting. On the plus side, we adapt some well-known matching mechanisms to incorporate the restricted cycle constraint and evaluate their performance experimentally on instances of the kidney exchange problem, showing tradeoffs between fairness and efficiency....

  14. Algorithm for generation pseudo-random series with arbitrarily assigned distribution law

    Directory of Open Access Journals (Sweden)

    В.С. Єременко

    2005-04-01

    Full Text Available  Method for generation pseudo-random series with arbitrarily assigned distribution law has been proposed. The praxis of using proposed method for generation pseudo-random series with anti-modal and approximate to Gaussian distribution law has been investigated.

  15. Effects and cost of glycyrrhizin in the treatment of upper respiratory tract infections in members of the Japanese maritime self-defense force: Preliminary report of a prospective, randomized, double-blind, controlled, parallel-group, alternate-day treatment assignment clinical trial.

    Science.gov (United States)

    Yanagawa, Youichi; Ogura, Masatsune; Fujimoto, Eita; Shono, Satoshi; Okuda, Eriya

    2004-01-01

    Upper respiratory tract infections (URTIs) account for at least half of all acute illnesses. Specific antiviral therapy has not been developed against most respiratory viruses thought to cause URTIs. The pharmacologic action of glycyrrhizin has been shown to produce anti-inflammatory activity, modulation of the immune system, inhibition of virus growth, and inactivation of viruses. The aim of this study was to assess the tolerability, efficacy, and cost of glycyrrhizin in improving the severity and duration of signs and symptoms of URTIs. The primary end point was tolerability, and the secondary and points included improvement in signs and symptoms of URTI and cost. Members of the Japanese Maritime Self-Defense Force (SDF) treated for URTIs from January 2002 to May 2002 in the SDF Etajima Hospital (Hiroshima, Japan) were eligible for this prospective, randomized, double-blind, controlled, parallel-group, alternate-day treatment assignment study. All patients in this study fulfilled the following enrollment criteria: admitted to the hospital on the first arrival day as an outpatient; fever (body temperature women; mean [SD] age, 25.2 [1.5] years) were assigned to the glycyrrhizin group and 269 patients (24 men, 2 women; mean [SD] age, 22.6 [0.9] years) were assigned to the control group. The 2 groups were similar in terms of baseline characteristics. The mean duration of hospitalization was shorter (P = 0.01), the mean maximum body temperature 24 to 48 hours after admission was less (P = 0.05), and the cost of therapy (P = 0.03) was less in the glycyrrhizin group than the control group. No AEs were reported. In this study of hospitalized patients with URTIs, glycyrrhizin therapy was associated with a shorter hospitalization, lower-grade fever, and lower cost of therapy compared with controls, showing that it may be beneficial to patients with URTIs without acute bacterial infections.

  16. Practice Makes Progress? Homework Assignments and Outcome in Treatment of Cocaine Dependence

    Science.gov (United States)

    Carroll, Kathleen M.; Nich, Charla; Ball, Samuel A.

    2005-01-01

    The relationship between treatment outcome and the extent to which participants completed homework assignments was evaluated among 60 cocaine-dependent individuals assigned to cognitive-behavioral therapy (CBT). Homework was assigned in 72% of all sessions and initiated by participants in 48% of the sessions in which it was assigned. Completion of…

  17. Study on MAX-MIN Ant System with Random Selection in Quadratic Assignment Problem

    Science.gov (United States)

    Iimura, Ichiro; Yoshida, Kenji; Ishibashi, Ken; Nakayama, Shigeru

    Ant Colony Optimization (ACO), which is a type of swarm intelligence inspired by ants' foraging behavior, has been studied extensively and its effectiveness has been shown by many researchers. The previous studies have reported that MAX-MIN Ant System (MMAS) is one of effective ACO algorithms. The MMAS maintains the balance of intensification and diversification concerning pheromone by limiting the quantity of pheromone to the range of minimum and maximum values. In this paper, we propose MAX-MIN Ant System with Random Selection (MMASRS) for improving the search performance even further. The MMASRS is a new ACO algorithm that is MMAS into which random selection was newly introduced. The random selection is one of the edgechoosing methods by agents (ants). In our experimental evaluation using ten quadratic assignment problems, we have proved that the proposed MMASRS with the random selection is superior to the conventional MMAS without the random selection in the viewpoint of the search performance.

  18. Practice Makes Progress? Homework Assignments and Outcome in Treatment of Cocaine Dependence

    OpenAIRE

    Carroll, Kathleen M.; Nich, Charla; Ball, Samuel A.

    2005-01-01

    The relationship between treatment outcome and the extent to which participants completed homework assignments was evaluated among 60 cocaine-dependent individuals assigned to cognitive–behavioral therapy (CBT). Homework was assigned in 72% of all sessions and initiated by participants in 48% of the sessions in which it was assigned. Completion of homework was unrelated to participants' baseline characteristics and several indicators of treatment compliance. Participants who completed more ho...

  19. Assignment of Dental School Patients Using Periodontal Treatment Need Indices.

    Science.gov (United States)

    Mubarak, Ala

    1990-01-01

    The validity of the Periodontal Treatment Need System and the Community Periodontal Index for Treatment Need as screening tests for allocation of patients to dental students was assessed and compared. Sixty-one patients reporting to the Department of Periodontology at the University of Oslo were studied. (MLW)

  20. Practice Makes Progress? Homework Assignments and Outcome in Treatment of Cocaine Dependence

    Science.gov (United States)

    Carroll, Kathleen M.; Nich, Charla; Ball, Samuel A.

    2008-01-01

    The relationship between treatment outcome and the extent to which participants completed homework assignments was evaluated among 60 cocaine-dependent individuals assigned to cognitive–behavioral therapy (CBT). Homework was assigned in 72% of all sessions and initiated by participants in 48% of the sessions in which it was assigned. Completion of homework was unrelated to participants' baseline characteristics and several indicators of treatment compliance. Participants who completed more homework assignments demonstrated significantly greater increases in the quantity and quality of their coping skills and used significantly less cocaine during treatment and through a 1-year follow-up. These data suggest that the extent to which participants are willing to complete extrasession assignments may be an important mediator of response to CBT. PMID:16173864

  1. Teacher-Child Interaction Training: A Pilot Study With Random Assignment.

    Science.gov (United States)

    Fernandez, Melanie A; Adelstein, Jonathan S; Miller, Samantha P; Areizaga, Margaret J; Gold, Dylann C; Sanchez, Amanda L; Rothschild, Sara A; Hirsch, Emily; Gudiño, Omar G

    2015-07-01

    Teacher-Child Interaction Training (TCIT), adapted from Parent-Child Interaction Therapy (PCIT), is a classroom-based program designed to provide teachers with behavior management skills that foster positive teacher-student relationships and to improve student behavior by creating a more constructive classroom environment. The purpose of this pilot study was to evaluate TCIT in more classrooms than previously reported in the literature, with older children than previously reported, using random assignment of classrooms to TCIT or to a no-TCIT control condition and conducting all but two sessions within the classroom to enhance feasibility. Participants included 11 kindergarten and first grade classroom teachers and their 118 students from three urban, public schools in Manhattan, with five classrooms randomly assigned to receive TCIT and six to the no-TCIT control condition. Observations of teacher skill acquisition were conducted before, during, and after TCIT for all 11 teachers, and teacher reports of student behavior were obtained at these same time points. Teacher satisfaction with TCIT was assessed following training. Results suggested that after receiving TCIT, teachers increased rates of positive attention to students' appropriate behavior, decreased rates of negative attention to misbehavior, reported significantly less distress related to student disruptive behavior, and reported high satisfaction with the training program. Our study supports the growing evidence-base suggesting that TCIT is a promising approach for training teachers in positive behavior management strategies and for improving student disruptive behavior in the classroom. Copyright © 2015. Published by Elsevier Ltd.

  2. Causal Effects of Single-Sex Schools on College Entrance Exams and College Attendance: Random Assignment in Seoul High Schools

    OpenAIRE

    Park, Hyunjoon; Behrman, Jere R.; Choi, Jaesung

    2013-01-01

    Despite the voluminous literature on the potentials of single-sex schools, there is no consensus on the effects of single-sex schools because of student selection of school types. We exploit a unique feature of schooling in Seoul—the random assignment of students into single-sex versus coeducational high schools—to assess causal effects of single-sex schools on college entrance exam scores and college attendance. Our validation of the random assignment shows comparable socioeconomic backgroun...

  3. Treatment assignment guesses by study participants in a double-blind dose escalation clinical trial of saw palmetto.

    Science.gov (United States)

    Lee, Jeannette Y; Moore, Page; Kusek, John; Barry, Michael

    2014-01-01

    This report assesses participant perception of treatment assignment in a randomized, double-blind, placebo-controlled trial of saw palmetto for the treatment of benign prostatic hyperplasia (BCM). Participants randomized to receive saw palmetto were instructed to take one 320 mg gelcap daily for the first 24 weeks, two 320 mg gelcaps daily for the second 24 weeks, and three 320 mg gelcaps daily for the third 24 weeks. Study participants assigned to placebo were instructed to take the same number of matching placebo gelcaps in each time period. At 24, 48, and 72 weeks postrandomization, the American Urological Association Symptom Index (AUA-SI) was administered and participants were asked to guess their treatment assignment. The study was conducted at 11 clinical centers in North America. Study participants were men, 45 years and older, with moderate to low severe BPH symptoms, randomized to saw palmetto (N=151) or placebo (N=155). Treatment arms were compared with respect to the distribution of participant guesses of treatment assignment. For participants assigned to saw palmetto, 22.5%, 24.7%, and 29.8% correctly thought they were taking saw palmetto, and 37.3%, 40.0%, and 44.4% incorrectly thought they were on placebo at 24, 48, and 72 weeks, respectively. For placebo participants, 21.8%, 27.4%, and 25.2% incorrectly thought they were on saw palmetto, and 41.6%, 39.9%, and 42.6% correctly thought they were on placebo at 24, 48, and 72 weeks, respectively. The treatment arms did not vary with respect to the distributions of participants who guessed they were on saw palmetto (p=0.823) or placebo (p=0.893). Participants who experienced an improvement in AUA-SI were 2.16 times more likely to think they were on saw palmetto. Blinding of treatment assignment was successful in this study. Improvement in BPH-related symptoms was associated with the perception that participants were taking saw palmetto.

  4. Fourth graders' reports of fruit and vegetable intake at school lunch: does treatment assignment affect accuracy?

    Science.gov (United States)

    Harrington, Kathleen Fleege; Kohler, Connie L; McClure, Leslie A; Franklin, Frank A

    2009-01-01

    Dietary interventions with children often use self-reported data to assess efficacy despite that objective methods rarely support self-report findings in validation studies. This study compared fourth graders' self-reported to observed lunch fruit and vegetable intake to determine if the accuracy of self-reported intake varied by treatment condition. Matched randomized follow-up design examined three treatment groups (high and low intensity interventions and control) post-intervention. Three hundred seventy-nine middle-school children participating in a randomized controlled trial of a school-based fruit and vegetable intervention were observed during school lunch one day and asked to recall intake the following day. Food items were coded as: "match," "omission," or "intrusion." Students were classified as accurate if all food items matched, otherwise inaccurate. Matched foods' portions were compared for accuracy. Servings were computed for total fruit and vegetable intake. Accuracy for fruits and vegetables were compared in separate analyses and tested for multiple potential associates: treatment condition, sex, race, body mass index, subsidized meal eligibility, school district, fruit/vegetable availability, age, and test scores. Fitted multivariable regression models included variables found to be significant in univariate or chi(2) analyses. Variables found to be significant for fruit item accuracy were availability at lunch, body mass index, and subsidized lunch eligibility. For vegetable item accuracy, availability at lunch was significant. No differences were found for food portions or for efficacy of the intervention between the two methods of dietary data collection: observation and self-report. Condition assignment did not bias recalled fruit and vegetable intakes among fourth graders.

  5. TEO: an online emotional therapy system to apply homework assignments in the Treatment of adjustment disorders

    OpenAIRE

    Quero Castellano, Soledad; Botella Arbona, Cristina; Pérez Ara, María Ángeles; Andreu Mateu, Maria Sabrina; Baños Rivera, Rosa María; Castilla López, Diana Virginia

    2011-01-01

    Adjustment Disorders (AD) are a very important public health problem. Regarding its treatment, only a series of general guidelines are available. Our research team has developed a cognitive-behavioral treatment (CBT) supported by Virtual Reality (VR) that has shown its utility in the treatment of AD. A CBT approach gives a crucial role to homework assignments. So far, studies that use Information and Communication Technologies (ICT) for psychological treatments have been ...

  6. Sleep improvement for restless legs syndrome patients. Part III: effect of treatment assignment belief on sleep improvement in restless legs syndrome patients. A mediation analysis

    Directory of Open Access Journals (Sweden)

    Burbank F

    2013-04-01

    Full Text Available Fred Burbank Director, Salt Creek International Women's Health Foundation, San Clemente, CA, USA Purpose: Two parallel-design, randomized, sham-controlled clinical trials were conducted to study the safety and efficacy of vibratory stimulation (VS on restless legs syndrome (RLS patients (Part I of this series of articles. Pooled data from the two studies was retroactively analyzed to compare the relative effects of actual pad assignment with therapeutic pad assignment belief on sleep improvement for patients with RLS. Patients and methods: One hundred fifty-eight patients with at least moderately severe RLS, as measured by a score of 15 points or greater on the International Restless Legs Syndrome Study Group rating scale (IRLS, were enrolled in the study. Patients were randomly assigned to treatment (patient-controlled vibration or sham (patient-controlled sound or light-emitting pads. Patients and clinicians were blinded to pad assignment. The pad was placed under the patient's legs while in bed at night and activated during an RLS episode. Improvements in Medical Outcomes Study Sleep Problems Index II (MOS-II scores from baseline to week 4 were examined as a function of pad assignment (independent variable and therapeutic pad assignment belief held by each patient (mediator variable through mediation analysis. Results: Therapeutic pad assignment belief influenced change in MOS-II scores more than actual pad assignment. Patients who believed they had been assigned a therapeutic pad had substantially greater sleep improvement than those who concluded the opposite. When a patient believed that a therapeutic pad had been assigned, sleep improvement was comparable in magnitude, independent of the type of pad assigned (vibrating or sham. Patients assigned vibrating pads believed that they had been assigned a therapeutic pad 2.6 times more frequently than patients assigned sham pads. Consequently, vibrating pads were more efficient at improving

  7. Treatment noncompliance in randomized experiments: statistical approaches and design issues.

    Science.gov (United States)

    Sagarin, Brad J; West, Stephen G; Ratnikov, Alexander; Homan, William K; Ritchie, Timothy D; Hansen, Edward J

    2014-09-01

    Treatment noncompliance in randomized experiments threatens the validity of causal inference and the interpretability of treatment effects. This article provides a nontechnical review of 7 approaches: 3 traditional and 4 newer statistical analysis strategies. Traditional approaches include (a) intention-to-treat analysis (which estimates the effects of treatment assignment irrespective of treatment received), (b) as-treated analysis (which reassigns participants to groups reflecting the treatment they actually received), and (c) per-protocol analysis (which drops participants who did not comply with their assigned treatment). Newer approaches include (d) the complier average causal effect (which estimates the effect of treatment on the subpopulation of those who would comply with their assigned treatment), (e) dose-response estimation (which uses degree of compliance to stratify participants, producing an estimate of a dose-response relationship), (f) propensity score analysis (which uses covariates to estimate the probability that individual participants will comply, enabling estimates of treatment effects at different propensities), and (g) treatment effect bounding (which calculates a range of possible treatment effects applicable to both compliers and noncompliers). The discussion considers the areas of application, the quantity estimated, the underlying assumptions, and the strengths and weaknesses of each approach. PsycINFO Database Record (c) 2014 APA, all rights reserved.

  8. Communication Interventions for Minimally Verbal Children With Autism: Sequential Multiple Assignment Randomized Trial

    Science.gov (United States)

    Kasari, Connie; Kaiser, Ann; Goods, Kelly; Nietfeld, Jennifer; Mathy, Pamela; Landa, Rebecca; Murphy, Susan; Almirall, Daniel

    2014-01-01

    Objective This study tested the effect of beginning treatment with a speech-generating device in the context of a blended, adaptive treatment design for improving spontaneous, communicative utterances in school-aged, minimally verbal children with autism. Method Sixty-one minimally verbal children with autism, aged 5 to 8 years, were randomized to a blended developmental/behavioral intervention (JASP+EMT) with or without the augmentation of a speech-generating device (SGD) for 6 months with a 3-month follow-up. The intervention consisted of two stages. In Stage 1 all children received two sessions per week for 3 months. Stage 2 intervention was adapted (increased sessions or adding the SGD) based on the child’s early response. The primary outcome was the total number of spontaneous communicative utterances; secondary measures were total number of novel words and total comments from a natural language sample. Results Primary aim results found improvements in spontaneous communicative utterances, novel words, and comments that all favored the blended behavioral intervention that began by including an SGD (JASP+EMT+SGD) as opposed to spoken words alone (JASP+EMT). Secondary aim results suggest that the adaptive intervention beginning with JASP+EMT+SGD and intensifying JASP+EMT+SGD for children who were slow responders led to better post-treatment outcomes. Conclusion Minimally verbal school-aged children can make significant and rapid gains in spoken spontaneous language with a novel, blended intervention that focuses on joint engagement and play skills and incorporates an SGD. Future studies should further explore the tailoring design used in this study to better understand children’s response to treatment. Clinical trial registration information—Developmental and Augmented Intervention for Facilitating Expressive Language (CCNIA); http://clinicaltrials.gov/; NCT01013545. PMID:24839882

  9. The Thoc1 Ribonucleoprotein as a Novel Biomarker for Prostate Cancer Treatment Assignment

    Science.gov (United States)

    2017-10-01

    AWARD NUMBER: W81XWH-14-1-0475 TITLE: The Thoc1 Ribonucleoprotein as a Novel Biomarker for Prostate Cancer Treatment Assignment PRINCIPAL...provision of law , no person shall be subject to any penalty for failing to comply with a collection of information if it does not display a currently...15Sept 2016 - 14Sep2017 4. TITLE AND SUBTITLE The Thoc1 Ribonucleoprotein as a Novel Biomarker for Prostate 5a. CONTRACT NUMBER Cancer Treatment

  10. Communication interventions for minimally verbal children with autism: a sequential multiple assignment randomized trial.

    Science.gov (United States)

    Kasari, Connie; Kaiser, Ann; Goods, Kelly; Nietfeld, Jennifer; Mathy, Pamela; Landa, Rebecca; Murphy, Susan; Almirall, Daniel

    2014-06-01

    This study tested the effect of beginning treatment with a speech-generating device (SGD) in the context of a blended, adaptive treatment design for improving spontaneous, communicative utterances in school-aged, minimally verbal children with autism. A total of 61 minimally verbal children with autism, aged 5 to 8 years, were randomized to a blended developmental/behavioral intervention (JASP+EMT) with or without the augmentation of a SGD for 6 months with a 3-month follow-up. The intervention consisted of 2 stages. In stage 1, all children received 2 sessions per week for 3 months. Stage 2 intervention was adapted (by increased sessions or adding the SGD) based on the child's early response. The primary outcome was the total number of spontaneous communicative utterances; secondary measures were the total number of novel words and total comments from a natural language sample. Primary aim results found improvements in spontaneous communicative utterances, novel words, and comments that all favored the blended behavioral intervention that began by including an SGD (JASP+EMT+SGD) as opposed to spoken words alone (JASP+EMT). Secondary aim results suggest that the adaptive intervention beginning with JASP+EMT+SGD and intensifying JASP+EMT+SGD for children who were slow responders led to better posttreatment outcomes. Minimally verbal school-aged children can make significant and rapid gains in spoken spontaneous language with a novel, blended intervention that focuses on joint engagement and play skills and incorporates an SGD. Future studies should further explore the tailoring design used in this study to better understand children's response to treatment. Clinical trial registration information-Developmental and Augmented Intervention for Facilitating Expressive Language (CCNIA); http://clinicaltrials.gov/; NCT01013545. Copyright © 2014 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

  11. Random Assignment of Schools to Groups in the Drug Resistance Strategies Rural Project: Some New Methodological Twists

    Science.gov (United States)

    Pettigrew, Jonathan; Miller-Day, Michelle; Krieger, Janice L.; Zhou, Jiangxiu; Hecht, Michael L.

    2014-01-01

    Random assignment to groups is the foundation for scientifically rigorous clinical trials. But assignment is challenging in group randomized trials when only a few units (schools) are assigned to each condition. In the DRSR project, we assigned 39 rural Pennsylvania and Ohio schools to three conditions (rural, classic, control). But even with 13 schools per condition, achieving pretest equivalence on important variables is not guaranteed. We collected data on six important school-level variables: rurality, number of grades in the school, enrollment per grade, percent white, percent receiving free/assisted lunch, and test scores. Key to our procedure was the inclusion of school-level drug use data, available for a subset of the schools. Also, key was that we handled the partial data with modern missing data techniques. We chose to create one composite stratifying variable based on the seven school-level variables available. Principal components analysis with the seven variables yielded two factors, which were averaged to form the composite inflate-suppress (CIS) score which was the basis of stratification. The CIS score was broken into three strata within each state; schools were assigned at random to the three program conditions from within each stratum, within each state. Results showed that program group membership was unrelated to the CIS score, the two factors making up the CIS score, and the seven items making up the factors. Program group membership was not significantly related to pretest measures of drug use (alcohol, cigarettes, marijuana, chewing tobacco; smallest p>.15), thus verifying that pretest equivalence was achieved. PMID:23722619

  12. It Takes Two Shining Lights to Brighten the Room: Peer Effects with Random Roommate Assignments

    Science.gov (United States)

    Zhang, Liang; Pu, Shi

    2017-01-01

    We used housing assignment data from a college in China to investigate peer effects on college grades. Study results provided some evidence for peer effects in college housing units. First, peer effects through means occurred during both fall and spring semester of the first year in college, with estimated effect much larger than that in previous…

  13. Teaching reading to children with neurofibromatosis type 1: a clinical trial with random assignment to different approaches.

    Science.gov (United States)

    Barquero, Laura A; Sefcik, Angela M; Cutting, Laurie E; Rimrodt, Sheryl L

    2015-12-01

    Neurofibromatosis type 1 (NF1) is a genetic disorder with a cognitive profile that includes visual-spatial perception deficits and a high incidence of reading disability. There is a paucity of information about how this cognitively complex population responds to mainstream reading interventions. The clinical trial goals were to determine whether children and adolescents with NF1 and reading deficits (NF+RD) benefit from mainstream remedial reading programs and whether responsiveness varies with differences in program-related visual-spatial demands. Forty-nine participants (28 males, 21 females; aged 8-14y) with either NF+RD (n=17, 11 males, six females) or idiopathic reading deficit (IRD) (n=32, 17 males, 15 females) were randomly assigned to intensive remedial teaching using one of two multisensory reading programs: one with greater kinesthetic demands and the other with greater visual-spatial demands. Two control groups - wait-list IRD (n=14, 11 males, three females) and typically developing readers (n=26, 13 males, 13 females) - received no treatment. Repeated measures and multivariate ANOVA analyses compared each group's growth in reading achievement from pre- to post-testing. Treated groups showed significant growth whereas untreated groups did not. Comparing treated groups, the IRD group responded equally well to both interventions, whereas the NF+RD group showed a better response to the more kinesthetic approach. Results suggest that multisensory remedial reading teaching that emphasizes kinesthetic demands more than visual-spatial demands is suitable for students with NF+RD. © 2015 Mac Keith Press.

  14. An assessment of health behavior peer effects in Peking University dormitories: a randomized cluster-assignment design for interference.

    Science.gov (United States)

    Yuan, Changzheng; Lv, Jun; VanderWeele, Tyler J

    2013-01-01

    Relatively little is known about the peer influence in health behaviors within university dormitory rooms. Moreover, in China, the problem of unhealthy behaviors among university students has not yet been sufficiently recognized. We thus investigated health behavior peer influence in Peking University dormitories utilizing a randomized cluster-assignment design. Cross-sectional in-dormitory survey. Current students from Peking University Health Science Center from April to June, 2009. Self-reported questionnaire on health behaviors: physical activity (including bicycling), dietary intake and tobacco use. Use of bicycle, moderate-intensity exercise, frequency of sweet food and soybean milk intake, frequency of roasted/baked/toasted food intake were behaviors significantly or marginally significantly affected by peer influence. Health behavior peer effects exist within dormitory rooms among university students. This could provide guidance on room assignment, or inform intervention programs. Examining these may demand attention from university administrators and policy makers.

  15. Cluster Randomized Trials with Treatment Noncompliance

    Science.gov (United States)

    Jo, Booil; Asparouhov, Tihomir; Muthen, Bengt O.; Ialongo, Nicholas S.; Brown, C. Hendricks

    2008-01-01

    Cluster randomized trials (CRTs) have been widely used in field experiments treating a cluster of individuals as the unit of randomization. This study focused particularly on situations where CRTs are accompanied by a common complication, namely, treatment noncompliance or, more generally, intervention nonadherence. In CRTs, compliance may be…

  16. Effects of contact with treatment users on mental illness stigma: evidence from university roommate assignments.

    Science.gov (United States)

    Eisenberg, Daniel; Downs, Marilyn F; Golberstein, Ezra

    2012-09-01

    Mental illness stigma refers to negative stereotypes and prejudices about people with mental illness, and is a widespread phenomenon with damaging social, psychological, and economic consequences. Despite considerable policy attention, mental illness stigma does not appear to have declined significantly in recent years. Interpersonal contact with persons with mental illness has been identified as a promising approach to reducing mental illness stigma. This study investigates the effect of contact with mental health treatment users on stigma using an observational research design that is free of self-selection bias. The research design is based on the quasi-experiment in which university students are assigned to live together as roommates. Survey data were collected from first-year undergraduates at two large universities in the United States (N = 1605). Multivariable regressions were used to estimate the effect of assignment to a roommate with a history of mental health treatment on a brief measure of stigmatizing attitudes. Contact with a treatment user caused a modest increase in stigma (standardized effect size = 0.15, p = 0.03). This effect was present among students without a prior treatment history of their own, but not among those with a prior history. The findings indicate that naturalistic contact alone does not necessarily yield a reduction in mental illness stigma. This may help explain why stigma has not declined in societies such as the United States even as treatment use has risen substantially. The findings also highlight the importance of isolating the specific components, beyond contact per se, that are necessary to reduce stigma in contact-based interventions. Copyright © 2012 Elsevier Ltd. All rights reserved.

  17. Causal effects of single-sex schools on college entrance exams and college attendance: random assignment in Seoul high schools.

    Science.gov (United States)

    Park, Hyunjoon; Behrman, Jere R; Choi, Jaesung

    2013-04-01

    Despite the voluminous literature on the potentials of single-sex schools, there is no consensus on the effects of single-sex schools because of student selection of school types. We exploit a unique feature of schooling in Seoul-the random assignment of students into single-sex versus coeducational high schools-to assess causal effects of single-sex schools on college entrance exam scores and college attendance. Our validation of the random assignment shows comparable socioeconomic backgrounds and prior academic achievement of students attending single-sex schools and coeducational schools, which increases the credibility of our causal estimates of single-sex school effects. The three-level hierarchical model shows that attending all-boys schools or all-girls schools, rather than coeducational schools, is significantly associated with higher average scores on Korean and English test scores. Applying the school district fixed-effects models, we find that single-sex schools produce a higher percentage of graduates who attended four-year colleges and a lower percentage of graduates who attended two-year junior colleges than do coeducational schools. The positive effects of single-sex schools remain substantial, even after we take into account various school-level variables, such as teacher quality, the student-teacher ratio, the proportion of students receiving lunch support, and whether the schools are public or private.

  18. Causal Effects of Single-Sex Schools on College Entrance Exams and College Attendance: Random Assignment in Seoul High Schools

    Science.gov (United States)

    Park, Hyunjoon; Behrman, Jere R.; Choi, Jaesung

    2012-01-01

    Despite the voluminous literature on the potentials of single-sex schools, there is no consensus on the effects of single-sex schools because of student selection of school types. We exploit a unique feature of schooling in Seoul—the random assignment of students into single-sex versus coeducational high schools—to assess causal effects of single-sex schools on college entrance exam scores and college attendance. Our validation of the random assignment shows comparable socioeconomic backgrounds and prior academic achievement of students attending single-sex schools and coeducational schools, which increases the credibility of our causal estimates of single-sex school effects. The three-level hierarchical model shows that attending all-boys schools or all-girls schools, rather than coeducational schools, is significantly associated with higher average scores on Korean and English test scores. Applying the school district fixed-effects models, we find that single-sex schools produce a higher percentage of graduates who attended four-year colleges and a lower percentage of graduates who attended two-year junior colleges than do coeducational schools. The positive effects of single-sex schools remain substantial, even after we take into account various school-level variables, such as teacher quality, the student-teacher ratio, the proportion of students receiving lunch support, and whether the schools are public or private. PMID:23073751

  19. Optimal Design for Two-Level Random Assignment and Regression Discontinuity Studies

    Science.gov (United States)

    Rhoads, Christopher H.; Dye, Charles

    2016-01-01

    An important concern when planning research studies is to obtain maximum precision of an estimate of a treatment effect given a budget constraint. When research designs have a "multilevel" or "hierarchical" structure changes in sample size at different levels of the design will impact precision differently. Furthermore, there…

  20. Peer Influence on Aggressive Behavior, Smoking, and Sexual Behavior: A Study of Randomly-assigned College Roommates.

    Science.gov (United States)

    Li, Yi; Guo, Guang

    2016-09-01

    Identifying casual peer influence is a long-standing challenge to social scientists. Using data from a natural experiment of randomly-assigned college roommates (N = 2,059), which removes the threat of friend selection, we investigate peer effects on aggressive behavior, smoking, and concurrent sexual partnering. The findings suggest that the magnitude and direction of peer influence depend on predisposition, gender, and the nature of the behavior. Peer effects on individuals predisposed toward a given behavior tend to be larger than peer effects on individuals without such a predisposition. We find that the influence of roommates on aggressive behavior is more pronounced among male students than among female students; roommate effects on smoking are negative among female students and male students who did not smoke before college. For concurrent sexual partnering, a highly private behavior, we find no evidence of peer effects. © American Sociological Association 2016.

  1. Separating boys and girls and increasing weight? Assessing the impacts of single-sex schools through random assignment in Seoul.

    Science.gov (United States)

    Choi, Jaesung; Park, Hyunjoon; Behrman, Jere R

    2015-06-01

    A growing body of research reports associations of school contexts with adolescents' weight and weight-related behaviors. One interesting, but under-researched, dimension of school context that potentially matters for adolescents' weight is the gender composition. If boys and girls are separated into single-sex schools, they might be less concerned about physical appearance, which may result in increased weight. Utilizing a unique setting in Seoul, Korea where students are randomly assigned to single-sex and coeducational schools within school districts, we estimate causal effects of single-sex schools on weight and weight-related behaviors. Our results show that students attending single-sex schools are more likely to be overweight, and that the effects are more pronounced for girls. We also find that girls in single-sex schools are less likely to engage in strenuous activities than their coeducational counterparts. Copyright © 2015 Elsevier Ltd. All rights reserved.

  2. Random search for shared chromosomal regions in four affected individuals: the assignment of a new hereditary ataxia locus

    Energy Technology Data Exchange (ETDEWEB)

    Nikali, K.; Suomalainen, A.; Koskinen, T.; Peltonen, L. [Univ. of Helsinki (Finland); Terwilliger, J. [Univ. of Oxford (United Kingdom); Weissenbach, J. [Genethon, Evry (France)

    1995-05-01

    Infantile-onset spinocerebellar ataxia (IOSCA) is an autosomal recessively inherited progressive neurological disorder of unknown etiology. This ataxia, identified so far only in the genetically isolated Finnish population, does not share gene locus with any of the previously identified hereditary ataxias, and a random mapping approach was adopted to assign the IOSCA locus. Based on the assumption of one founder mutation, a primary screening of the genome was performed using samples from just four affected individuals in two consanguineous pedigrees. The identification of a shared chromosomal region in these four patients provided the first evidence that the IOSCA gene locus is on chromosome 10q23.3-q24.1, which was confirmed by conventional linkage analysis in the complete family material. Strong linkage disequilibrium observed between IOSCA and the linked markers was utilized to define accurately the critical chromosomal region. The results showed the power of linkage disequilibrium in the locus assignment of diseases with very limited family materials. 30 refs., 3 figs., 2 tabs.

  3. An assessment of health behavior peer effects in Peking University dormitories: a randomized cluster-assignment design for interference.

    Directory of Open Access Journals (Sweden)

    Changzheng Yuan

    Full Text Available BACKGROUND: Relatively little is known about the peer influence in health behaviors within university dormitory rooms. Moreover, in China, the problem of unhealthy behaviors among university students has not yet been sufficiently recognized. We thus investigated health behavior peer influence in Peking University dormitories utilizing a randomized cluster-assignment design. METHODS: STUDY DESIGN: Cross-sectional in-dormitory survey. STUDY POPULATION: Current students from Peking University Health Science Center from April to June, 2009. MEASUREMENT: Self-reported questionnaire on health behaviors: physical activity (including bicycling, dietary intake and tobacco use. RESULTS: Use of bicycle, moderate-intensity exercise, frequency of sweet food and soybean milk intake, frequency of roasted/baked/toasted food intake were behaviors significantly or marginally significantly affected by peer influence. CONCLUSION: Health behavior peer effects exist within dormitory rooms among university students. This could provide guidance on room assignment, or inform intervention programs. Examining these may demand attention from university administrators and policy makers.

  4. Assertive community treatment in the Netherlands: a randomized controlled trial.

    Science.gov (United States)

    Sytema, S; Wunderink, L; Bloemers, W; Roorda, L; Wiersma, D

    2007-08-01

    Assertive community treatment is rapidly implemented by many European mental health services, but recently the evidence base has been questioned. Positive results of randomized trials in the USA were not replicated in the UK. The question is whether the UK findings are representative for other European countries with modern mental health services. Open randomized controlled trial of long-term severely mentally ill patients [Health of the Nation Outcome Scales (HoNOS) total score >or=15], assigned to assertive community treatment (n = 59) or to standard community mental health care (n = 59). sustained contact; housing stability and admission days. This trial is registered as an International Standard Randomized Clinical Trial, number ISRCTN 11281756. Assertive community treatment was significantly better in sustaining contact with patients, but not in reducing admission days. No differences in housing stability, psychopathology, social functioning or quality of life were found. The results are in agreement with UK studies. However, the sustained contact potential of assertive community treatment is important, as too many patients are lost in standard care.

  5. Cognitive-Behavioral Treatment for Panic Disorder with Agoraphobia: A Randomized, Controlled Trial and Cost-Effectiveness Analysis

    Science.gov (United States)

    Roberge, Pasquale; Marchand, Andre; Reinharz, Daniel; Savard, Pierre

    2008-01-01

    A randomized, controlled trial was conducted to examine the cost-effectiveness of cognitive-behavioral treatment (CBT) for panic disorder with agoraphobia. A total of 100 participants were randomly assigned to standard (n = 33), group (n = 35), and brief (n = 32) treatment conditions. Results show significant clinical and statistical improvement…

  6. Hypnotic Taper with or without Self-Help Treatment of Insomnia: A Randomized Clinical Trial

    Science.gov (United States)

    Belleville, Genevieve; Guay, Catherine; Guay, Bernard; Morin, Charles M.

    2007-01-01

    This study aimed to assess the efficacy of a minimal intervention focusing on hypnotic discontinuation and cognitive-behavioral treatment (CBT) for insomnia. Fifty-three adult chronic users of hypnotics were randomly assigned to an 8-week hypnotic taper program, used alone or combined with a self-help CBT. Weekly hypnotic use decreased in both…

  7. Do Treatment Improvements in PTSD Severity Affect Substance Use Outcomes? A Secondary Analysis From a Randomized Clinical Trial in NIDA's Clinical Trials Network

    National Research Council Canada - National Science Library

    Hien, Denise A; Jiang, Huiping; Campbell, Aimee N.C; Hu, Mei-Chen; Miele, Gloria M; Cohen, Lisa R; Brigham, Gregory S; Capstick, Carrie; Kulaga, Agatha; Robinson, James; Suarez-Morales, Lourdes; Nunes, Edward V

    2010-01-01

    ...) and substance use disorder among women in outpatient substance abuse treatment. MethodParticipants were 353 women randomly assigned to 12 sessions of either trauma-focused or health education group treatment...

  8. A pilot randomized controlled trial of pioglitazone for the treatment of poorly controlled asthma in obesity.

    Science.gov (United States)

    Dixon, Anne E; Subramanian, Meenakumari; DeSarno, Michael; Black, Kendall; Lane, Lisa; Holguin, Fernando

    2015-11-26

    Obese asthmatics tend to have poorly controlled asthma, and resistance to standard asthma controller medications. The purpose of this study was to determine the efficacy of pioglitazone, an anti-diabetic medication which can alter circulating adipokines and have direct effects on asthmatic inflammation, in the treatment of asthma in obesity. A two-center, 12-week, randomized, placebo-controlled, double-blinded trial. Treatments were randomly assigned with concealment of allocation. The primary outcome was difference in change in airway reactivity between participants assigned to pioglitazone versus placebo at 12 weeks. Twenty-three participants were randomized to treatment, 19 completed the study. Median airway reactivity, measured by PC20 to methacholine was 1.99 (IQR 3.08) and 1.60 (5.91) mg/ml in placebo and pioglitazone group at baseline, and 2.37 (15.22) and 5.08 (7.42) mg/ml after 12 weeks, p = 0.38. There was no difference in exhaled nitric oxide, asthma control or lung function between treatment groups over the 12 week trial. Participants assigned to pioglitazone gained a significant amount more weight than those assigned to placebo (pioglitazone group mean weight 113.6, CI 94.5-132.7 kg at randomization and 115.9, CI 96.9-135.1 at 12 weeks; placebo mean weight 127.5, CI 108.4 - 146.6 kg at randomization and 124.5, CI 105.4 - 143.6 kg at 12 weeks; p = 0.04). This pilot study suggests limited efficacy for pioglitazone in the treatment of poorly controlled asthma in obesity, and also the potential for harm, given the weight gain in those assigned to active treatment, and the association between increased weight and worse outcomes in asthma. Clinicaltrials.gov (NCT00634036).

  9. Transdiagnostic Internet treatment for anxiety disorders: A randomized controlled trial.

    Science.gov (United States)

    Titov, Nickolai; Andrews, Gavin; Johnston, Luke; Robinson, Emma; Spence, Jay

    2010-09-01

    Clinician-guided Internet-based cognitive behavioural therapy (iCBT) programs are clinically effective at treating specific anxiety disorders. The present study examined the efficacy of a transdiagnostic Internet-based cognitive behavioural treatment (iCBT) program to treat more than one anxiety disorder within the same program (the Anxiety Program). Eighty six individuals meeting diagnostic criteria for generalized anxiety disorder (GAD), panic disorder, and/or social phobia were randomly assigned to a treatment group, or to a waitlist control group. Treatment consisted of CBT based online educational lessons and homework assignments, weekly email or telephone contact from a clinical psychologist, access to a moderated online discussion forum, and automated emails. An intention-to-treat model using the baseline-observation-carried-forward principle was employed for data analyses. Seventy-five percent of treatment group participants completed all 6 lessons within the 8 week program. Post-treatment data was collected from 38/40 treatment group and 38/38 control group participants, and 3-month follow-up data was collected from 32/40 treatment group participants. Relative to controls, treatment group participants reported significantly reduced symptoms of anxiety as measured by the Generalized Anxiety Disorder - 7 Item, Social Phobia Screening Questionnaire, and the Panic Disorder Severity Rating Scale - Self Report Scale, but not on the Penn State Worry Questionnaire, with corresponding between-groups effect sizes (Cohen's d) at post-treatment of 0.78, 0.43, 0.43, and 0.20, respectively. The clinician spent a total mean time of 46min per person over the program, participants rated the procedure as moderately acceptable, and gains were sustained at follow-up. Modifications to the Anxiety program, based on post-treatment feedback from treatment group participants, were associated with improved outcomes in the control group. These results indicate that transdiagnostic

  10. Peripheral Defocus and Myopia Progression in Myopic Children Randomly Assigned to Wear Single Vision and Progressive Addition Lenses

    Science.gov (United States)

    Berntsen, David A.; Barr, Christopher D.; Mutti, Donald O.; Zadnik, Karla

    2013-01-01

    Purpose. To determine the effect of progressive addition lenses (PALs) and single vision lenses (SVLs) on peripheral defocus in myopic children, and to compare the effect of myopic versus hyperopic peripheral defocus on foveal myopia progression. Methods. Eighty-four myopic children aged 6 to 11 years with spherical equivalent (SE) cycloplegic autorefraction between −0.75 diopters (D) and −4.50 D were randomly assigned to wear SVLs or PALs. Aberrometry measurements of the eye and spectacles were made centrally, 30° nasally, temporally, and superiorly, and 20° inferiorly on the retina using a Complete Ophthalmic Analysis System for Vision Research (COAS-VR). The association between peripheral defocus and the 1-year change in central myopia was investigated. Results. SVLs caused a hyperopic shift in peripheral defocus at all locations (all P ≤ 0.0003). PALs caused a myopic shift in peripheral defocus in three of four locations measured (all P ≤ 0.01) with the greatest shift superiorly due to the PAL addition (−1.04 ± 0.30 D). Superior retinal defocus when wearing either SVLs or PALs was associated with the 1-year change in central myopia. The adjusted 1-year change in central SE myopia was −0.38 D for children with absolute superior myopic defocus (n = 67) and −0.65 D for children with absolute superior hyperopic defocus (n = 17; difference = 0.27 D; P = 0.002). Conclusions. PALs caused a myopic shift in peripheral defocus. Superior myopic defocus was associated with less central myopia progression. These data support the continued investigation of optical designs that result in peripheral myopic defocus as a potential way to slow myopia progression. (ClinicalTrials.gov number, NCT00335049.) PMID:23838771

  11. The Effects of Therapist Competence in Assigning Homework in Cognitive Therapy with Cluster C Personality Disorders: Results from a Randomized Controlled Trial

    Science.gov (United States)

    Ryum, Truls; Stiles, Tore C.; Svartberg, Martin; McCullough, Leigh

    2010-01-01

    Therapist competence in assigning homework was used to predict mid- and posttreatment outcome for patients with Cluster C personality disorders in cognitive therapy (CT). Twenty-five patients that underwent 40 sessions of CT were taken from a randomized controlled trial (Svartberg, Stiles, & Seltzer, 2004). Therapist competence in assigning…

  12. Unpacking the Treatment Contrast in the Head Start Impact Study: To What Extent Does Assignment to Treatment Affect Quality of Care?

    Science.gov (United States)

    Friedman-Krauss, Allison H.; Connors, Maia C.; Morris, Pamela A.

    2017-01-01

    Attending high-quality early childhood care and education (ECCE) is associated with higher cognitive and social-emotional skills, especially for children growing up in poverty, but access to high-quality ECCE is limited. This study capitalizes on the random assignment design of the Head Start Impact Study to better understand whether the…

  13. Randomized Trial of MST and ARC in a Two-Level Evidence-Based Treatment Implementation Strategy

    Science.gov (United States)

    Glisson, Charles; Schoenwald, Sonja K.; Hemmelgarn, Anthony; Green, Philip; Dukes, Denzel; Armstrong, Kevin S.; Chapman, Jason E.

    2010-01-01

    Objective: A randomized trial assessed the effectiveness of a 2-level strategy for implementing evidence-based mental health treatments for delinquent youth. Method: A 2 x 2 design encompassing 14 rural Appalachian counties included 2 factors: (a) the random assignment of delinquent youth within each county to a multisystemic therapy (MST) program…

  14. Attachment as Moderator of Treatment Outcome in Major Depression: A Randomized Control Trial of Interpersonal Psychotherapy versus Cognitive Behavior Therapy

    Science.gov (United States)

    McBride, Carolina; Atkinson, Leslie; Quilty, Lena C.; Bagby, R. Michael

    2006-01-01

    Anxiety and avoidance dimensions of adult attachment insecurity were tested as moderators of treatment outcome for interpersonal psychotherapy (IPT) and cognitive-behavioral therapy (CBT). Fifty-six participants with major depression were randomly assigned to these treatment conditions. Beck Depression Inventory-II, Six-Item Hamilton Rating Scale…

  15. Chiropractor interaction and treatment equivalence in a pilot randomized controlled trial

    DEFF Research Database (Denmark)

    Salsbury, Stacie A; DeVocht, James W; Hondras, Maria

    2014-01-01

    and study participants regarding treatment group assignment. METHODS: We conducted an observational analysis of digital video-recordings derived from study visits conducted during a pilot randomized trial of conservative therapies for temporomandibular pain. A theory-based, iterative process developed...... the 13-item Chiropractor Interaction and Treatment Equivalence Instrument. A trained evaluator masked to treatment assignment coded video-recordings of clinical encounters between one chiropractor and multiple visits of 26 participants allocated to active or sham chiropractic treatment groups. Non......-parametric statistics were calculated. RESULTS: The trial ran from January 2010 to October 2011. We analyzed 111 complete video-recordings (54 active, 57 sham). Chiropractor interactions differed between the treatment groups in 7 categories. Active participants received more interactions with clinical information (8 vs...

  16. Cardiovascular disease risk by assigned treatment using the 2013 and 1998 obesity guidelines.

    Science.gov (United States)

    Stevens, June; Erber-Oakkar, Eva; Cui, Zhaohui; Cai, Jianwen; Virani, Salim S; Di Angelantonio, Emanuele; Wormser, David

    2016-07-01

    The 1998 and the 2013 guidelines on management of overweight and obesity in adults provided algorithms for identification of patients to be treated with weight loss. To date, the cardiovascular disease (CVD) risk in the groups recommended or not recommended for weight loss treatment has not been estimated and compared. Baseline data for the Atherosclerosis Risk in Communities study were collected between 1987 and 1989 from adults aged 45 to 64 years. Black and White men and women free of CVD were followed over 22.8 years (median), and 2,907 incident CVD events were recorded. The hazard ratios adjusted for demographic variables in adults not recommended for treatment versus adults recommended for treatment were 0.54 (95% CI: 0.50-0.59) for the 1998 algorithm and 0.63 (95% CI: 0.58-0.69) for the 2013 algorithm, respectively. No gender or race differences were detected when the 2013 algorithm was applied, but using the 1998 algorithm, CVD risk between the groups recommended or not recommended for treatment was more pronounced in Black women than in Black men. The 2013 algorithm performed similarly in Black and White men and women but did not improve upon the 1998 algorithm in terms of discriminating risk of CVD. © 2016 The Obesity Society.

  17. The Thoc1 Ribonucleoprotein as a Novel Biomarker for Prostate Cancer Treatment Assignment

    Science.gov (United States)

    2016-10-01

    stage and Gleason score to distinguish between prostate cancers that can be observed safely from those that require immediate treatment could help...autoantibodies is underway. A three gene panel constituting PMP22, CDKN1A and FGFR1 has been shown to stratify low gleason score prostate cancers into...indolent and aggressive cancer (Irshad et al., 2013). This panel of genes has been shown to have increased expression in low Gleason score prostate cancers

  18. Soft-assignment random-forest with an application to discriminative representation of human actions in videos

    NARCIS (Netherlands)

    Burghouts, G.J.

    2013-01-01

    The bag-of-features model is a distinctive and robust approach to detect human actions in videos. The discriminative power of this model relies heavily on the quantization of the video features into visual words. The quantization determines how well the visual words describe the human action. Random

  19. A randomized controlled clinical trial of a hypnosis-based treatment for patients with conversion disorder, motor type

    NARCIS (Netherlands)

    Moene, F.C.; Spinhoven, P.; Hoogduin, C.A.L.; Dyck, R. van

    2003-01-01

    This study tested whether a hypnosis-based intervention showed promise as a treatment for patients with conversion disorder, motor type. Forty-four outpatients with conversion disorder, motor type, or somatization disorder with motor conversion symptoms, were randomly assigned to a hypnosis or a

  20. Acceptance and Commitment Therapy and Cognitive-Behavioral Therapy as Treatments for Academic Procrastination: A Randomized Controlled Group Session

    Science.gov (United States)

    Wang, Shuo; Zhou, Ya; Yu, Shi; Ran, Li-Wen; Liu, Xiang-Ping; Chen, Yu-Fei

    2017-01-01

    Objective: This study tested the efficacy of Acceptance and Commitment Therapy (ACT), compared with Cognitive-Behavioral Therapy (CBT), in alleviating academic procrastination. Method: A total of 60 (53.3% male) undergraduates suffering from academic procrastination were randomly assigned to two treatment groups (ACT and CBT) and a control group.…

  1. Neurodynamic treatment for patients with nerve-related leg pain: Protocol for a randomized controlled trial.

    Science.gov (United States)

    Ferreira, Giovanni E; Stieven, Fábio F; Araújo, Francisco X; Wiebusch, Matheus; Rosa, Carolina G; Plentz, Rodrigo Della Méa; Silva, Marcelo F

    2016-10-01

    To investigate if neurodynamic treatment is more effective than advice to remain active in patients with nerve-related leg pain. Parallel-group randomized controlled trial blinded to the outcome assessor conducted in Porto Alegre, Brazil. Sixty patients recruited from the community and private practices. Patients will be randomly assigned to receive four sessions of neurodynamic treatment over two weeks comprising passive lumbar foramen opening and neurodynamic sliders plus home exercises or advice to remain active. Leg pain intensity, disability, low back pain intensity, functional ability, symptoms distribution and global impression of recovery will be assessed at two and four weeks after randomization. A linear mixed model will be employed for each outcome following intention to treat principles. Copyright © 2016 Elsevier Ltd. All rights reserved.

  2. A randomized clinical trial of treatment for lumbar segmental rigidity.

    Science.gov (United States)

    Mayer, Tom G; Gatchel, Robert J; Keeley, Janice; McGeary, Don; Dersh, Jeffrey; Anagnostis, Christopher

    2004-10-15

    A randomized single-blind clinical trial of facet injections plus exercise, versus exercise alone, in chronic disabling work-related lumbar spinal disorders (CDWRLSD), accompanied by pilot interrater reliability and facet syndrome prevalence studies. To systematically investigate the use of facet injections as an adjunct to supervised lumbar stretching exercises in regaining lumbar range of motion (ROM) following prolonged deconditioning after work-related lumbar injuries. To assess interrater reliability of visual assessment of segmental rigidity (SR), and to evaluate the prevalence of facet syndrome in cases of lumbar SR. Corticosteroid joint injections have often been used to reduce musculoskeletal inflammation to facilitate joint mobilization in the presence of degenerative arthritis. Lumbar segmental rigidity is a recently described entity usually associated with painful chronic spinal disorders and postoperative spine surgery. Previous work has shown that SR and lumbar ROM improves with a brief intervention consisting of facet injections followed by specific stretching exercises. No systematic study has investigated the potential benefits of a combination of facet injections and exercise over supervised exercises alone to treat lumbar SR. Similarly, no study has assessed the association between SR and the facet syndrome. From a group of consecutive patients (n = 421) with CDWRLSD referred for tertiary rehabilitation between November 1999 and January 2001, 70 were noted to have SR on intake physical examination. The first part of this study assessed interrater reliability for detecting SR, and intrarater reliability for 3-segment true lumbar ROM measurements. Patients randomly assigned to participate in supervised stretching exercises with the addition of fluoroscopically guided bilateral facet injections at the involved levels (Group A, n = 36) also underwent facet syndrome prevalence assessment at the time of injection. They were compared to a randomly

  3. A Randomized Trial to Measure the Efficacy of Applying Task Oriented Role Assignment to Improve Neonatal Resuscitation

    Science.gov (United States)

    2017-05-06

    DEPARTMENT OF THE AIR FORCE 59TH MEDICAL W ING (AETC) JOINT BASE SAN ANTONIO - LACKLAND TEXAS MEMORANOUMFORSGVT ATTN: MAJ CARRIE LITKE-WAGER...Author Litke· Wager, Carrie 0-4/Major 959/CSPS/ 59MDW/SGVT b. Mu, Thornton 0-5/LTC MCH E-ZDP-N SA MMC c. Delaney, Heather 0-4/ MAJ MCHE-ZDP-N SA MMC d...78234-2715 15 June 2016 Maj Carrie Litke-Wager, MD Brooke Army Medical Center Institutional Review Board A Randomized Trial to Measure the

  4. A multicenter, randomized, controlled trial of osteopathic manipulative treatment on preterms.

    Directory of Open Access Journals (Sweden)

    Francesco Cerritelli

    Full Text Available Despite some preliminary evidence, it is still largely unknown whether osteopathic manipulative treatment improves preterm clinical outcomes.The present multi-center randomized single blind parallel group clinical trial enrolled newborns who met the criteria for gestational age between 29 and 37 weeks, without any congenital complication from 3 different public neonatal intensive care units. Preterm infants were randomly assigned to usual prenatal care (control group or osteopathic manipulative treatment (study group. The primary outcome was the mean difference in length of hospital stay between groups.A total of 695 newborns were randomly assigned to either the study group (n= 352 or the control group (n=343. A statistical significant difference was observed between the two groups for the primary outcome (13.8 and 17.5 days for the study and control group respectively, p<0.001, effect size: 0.31. Multivariate analysis showed a reduction of the length of stay of 3.9 days (95% CI -5.5 to -2.3, p<0.001. Furthermore, there were significant reductions with treatment as compared to usual care in cost (difference between study and control group: 1,586.01€; 95% CI 1,087.18 to 6,277.28; p<0.001 but not in daily weight gain. There were no complications associated to the intervention.Osteopathic treatment reduced significantly the number of days of hospitalization and is cost-effective on a large cohort of preterm infants.

  5. A multicenter, randomized, controlled trial of osteopathic manipulative treatment on preterms.

    Science.gov (United States)

    Cerritelli, Francesco; Pizzolorusso, Gianfranco; Renzetti, Cinzia; Cozzolino, Vincenzo; D'Orazio, Marianna; Lupacchini, Mariacristina; Marinelli, Benedetta; Accorsi, Alessandro; Lucci, Chiara; Lancellotti, Jenny; Ballabio, Silvia; Castelli, Carola; Molteni, Daniela; Besana, Roberto; Tubaldi, Lucia; Perri, Francesco Paolo; Fusilli, Paola; D'Incecco, Carmine; Barlafante, Gina

    2015-01-01

    Despite some preliminary evidence, it is still largely unknown whether osteopathic manipulative treatment improves preterm clinical outcomes. The present multi-center randomized single blind parallel group clinical trial enrolled newborns who met the criteria for gestational age between 29 and 37 weeks, without any congenital complication from 3 different public neonatal intensive care units. Preterm infants were randomly assigned to usual prenatal care (control group) or osteopathic manipulative treatment (study group). The primary outcome was the mean difference in length of hospital stay between groups. A total of 695 newborns were randomly assigned to either the study group (n= 352) or the control group (n=343). A statistical significant difference was observed between the two groups for the primary outcome (13.8 and 17.5 days for the study and control group respectively, ptreatment as compared to usual care in cost (difference between study and control group: 1,586.01€; 95% CI 1,087.18 to 6,277.28; pOsteopathic treatment reduced significantly the number of days of hospitalization and is cost-effective on a large cohort of preterm infants.

  6. Block urn design - a new randomization algorithm for sequential trials with two or more treatments and balanced or unbalanced allocation

    Science.gov (United States)

    Zhao, Wenle; Weng, Yanqiu

    2011-01-01

    Permuted block design is the most popular randomization method used in clinical trials, especially for trials with more than two treatments and unbalanced allocation, because of its consistent imbalance control and simplicity in implementation. However, the risk of selection biases caused by high proportion of deterministic assignments is a cause of concern. Efron’s biased coin design and Wei’s urn design provide better allocation randomness without deterministic assignments, but they do not consistently control treatment imbalances. Alternative randomization designs with improved performances have been proposed over the past few decades, including Soares and Wu’s big stick design, which has high allocation randomness, but is limited to two-treatment balanced allocation scenarios only, and Berger’s maximal procedure design which has a high allocation randomness and a potential for more general trial scenarios, but lacks the explicit function for the conditional allocation probability and is more complex to implement than most other designs. The block urn design proposed in this paper combines the advantages of existing randomization designs while overcoming their limitations. Statistical properties of the new algorithm are assessed and compared to currently available designs via analytical and computer simulation approaches. The results suggest that the block urn design simultaneously provides consistent imbalance control and high allocation randomness. It can be easily implemented for sequential clinical trials with two or more treatments and balanced or unbalanced allocation. PMID:21893215

  7. Promoting supportive parenting in new mothers with substance-use problems: a pilot randomized trial of residential treatment plus an attachment-based parenting program.

    Science.gov (United States)

    Berlin, Lisa J; Shanahan, Meghan; Appleyard Carmody, Karen

    2014-01-01

    This pilot randomized trial tested the feasibility and efficacy of supplementing residential substance-abuse treatment for new mothers with a brief, yet rigorous, attachment-based parenting program. Twenty-one predominantly (86%) White mothers and their infants living together in residential substance-abuse treatment were randomly assigned to the program (n = 11) or control (n = 10) group. Program mothers received 10 home-based sessions of Dozier's Attachment and Biobehavioral Catch-up (ABC) intervention. Postintervention observations revealed more supportive parenting behaviors among the randomly assigned ABC mothers. © 2013 Michigan Association for Infant Mental Health.

  8. Hallucination focused integrative treatment : A randomized controlled trial

    NARCIS (Netherlands)

    Jenner, JA; Nienhuis, FJ; Wiersma, D; van de Willige, G

    2004-01-01

    Improvements in psychopathology, subjective burden, and coping with voices after hallucination focused integrative treatment (HIT) were studied in chronic schizophrenic patients with persistent (> 10 years), drug-refractory auditory hallucinations. In a randomized controlled trial, routine care was

  9. Behavioral and cognitive group treatment for fear of flying: a randomized controlled trial.

    Science.gov (United States)

    Van Gerwen, Lucas J; Spinhoven, Philip; Van Dyck, Richard

    2006-12-01

    In a long-standing fear-of-flying program, persons with fear of flying (N=150) were after a diagnostic assessment and individual preparation phase randomly assigned to either a 1-day behavioral group treatment (BGT) program, a 2-day cognitive-behavioral group treatment (CBGT) program or a waiting list (WL) control group. A post-treatment flight on a commercial airline measured participants' ability to fly. Different self-report flight anxiety questionnaires were completed before, during and after treatment at 3-, 6- and 12-month follow-up. Results indicated that both treatments were superior to the WL, and equally effective on the flying test and later independent flying, but also that the 2-day CBGT program was significantly more effective than the 1-day BGT program on subjective measures of fear and self-efficacy.

  10. Treatment comparison in randomized clinical trials with nonignorable missingness: A reverse regression approach.

    Science.gov (United States)

    Zhang, Zhiwei; Cheon, Kyeongmi

    2017-04-01

    A common problem in randomized clinical trials is nonignorable missingness, namely that the clinical outcome(s) of interest can be missing in a way that is not fully explained by the observed quantities. This happens when the continued participation of patients depends on the current outcome after adjusting for the observed history. Standard methods for handling nonignorable missingness typically require specification of the response mechanism, which can be difficult in practice. This article proposes a reverse regression approach that does not require a model for the response mechanism. Instead, the proposed approach relies on the assumption that missingness is independent of treatment assignment upon conditioning on the relevant outcome(s). This conditional independence assumption is motivated by the observation that, when patients are effectively masked to the assigned treatment, their decision to either stay in the trial or drop out cannot depend on the assigned treatment directly. Under this assumption, one can estimate parameters in the reverse regression model, test for the presence of a treatment effect, and in some cases estimate the outcome distributions. The methodology can be extended to longitudinal outcomes under natural conditions. The proposed approach is illustrated with real data from a cardiovascular study.

  11. A Randomized Controlled Trial of Cognitive-Behavioral Treatment of Posttraumatic Stress Disorder in Severe Mental Illness

    OpenAIRE

    Mueser, Kim T.; Rosenberg, Stanley D.; Xie, Haiyi; Jankowski, M. Kay; Bolton, Elisa E.; Lu, Weili; Jessica L Hamblen; Rosenberg, Harriet J.; McHugo, Gregory J.; Wolfe, Rosemarie

    2008-01-01

    A cognitive-behavioral therapy (CBT) program for PTSD was developed to address its high prevalence in persons with severe mental illness receiving treatment at community mental health centers. CBT was compared to treatment as usual (TAU) in a randomized controlled trial with 108 clients with PTSD and either major mood disorder (85%) or schizophrenia or schizoaffective disorder (15%), of whom 25% also had borderline personality disorder. Eighty-one percent of clients assigned to CBT participat...

  12. SU-F-J-162: Is Bulky Electron Density Assignment Appropriatefor MRI-Only Based Treatment Planning for Lung Cancer?

    Energy Technology Data Exchange (ETDEWEB)

    Prior, P; Chen, X; Johnstone, C; Gore, E; Li, X [Medical College of Wisconsin, Milwaukee, WI (United States)

    2016-06-15

    Purpose: To assess the appropriateness of bulky electron density assisment for MRI-only treatment planning for lung cancer via comparing dosimetric difference between MRI- and CT-based plans. Methods: Planning 4DCTs acquired for six representative lung cancer patients were used to generate CT-based IMRT plans. To avoid the effect of anatomic difference between CT and MRI, MRI-based plans were generated using CTs by forcing the relative electron density (rED) of organ specific values from ICRU report 46 and using the mean rED value of the internal target volume (ITV) of the patient for the ITV. Both CT and “MRI” plans were generated using a research planning system (Monaco, Elekta) employing Monte Carlo dose calculation the following dose-volume-parameters (DVPs): D99 – dose delivered to 99% of the ITV/PTV volume; D95; D5; D1; Vpd –volume receiving the prescription dose; V5 – volume of normal lung irradiated > 5 Gy; and V20. The percent point difference and dose difference was used for comparison for Vpd-V5-V20 and D99-D1, respectively. Four additional plans per patient were calculated with rEDITV = 0.6 and 1.0 and rEDlung = 0.1 and 0.5. Results: Noticeable differences in the ITV and PTV point doses and DVPs were observed. Variations in Vpd ranged from 0.0–6.4% and 0.32–18.3% for the ITV and PTV, respectively. The ITV and PTV variations in D99, D95, D5 and D1 were 0.15–3.2 Gy. The normal lung V5 & V20 variations were no larger than 1.9%. In some instances, varying the rEDITV between rEDmean, 0.6 and 1.0 resulted in D95 increases ranging from 3.9–6.3%. Uniform rED assignment on normal lung affected DVPs of ITV and PTV by 4.0–9.8% and 0.3–19.6%, respectively. Conclusion: The commonly-used uniform rED assignment in MRI-only based planning may not be appropriate for lung-cancer. A voxel based method, e.g. synthetic CT generated from MRI data, is required. This work was partially funded by Elekta, Inc.

  13. Image similarity evaluation of the bulk-density-assigned synthetic CT derived from MRI of intracranial regions for radiation treatment.

    Directory of Open Access Journals (Sweden)

    Shin-Wook Kim

    Full Text Available Various methods for radiation-dose calculation have been investigated over previous decades, focusing on the use of magnetic resonance imaging (MRI only. The bulk-density-assignment method based on manual segmentation has exhibited promising results compared to dose-calculation with computed tomography (CT. However, this method cannot be easily implemented in clinical practice due to its time-consuming nature. Therefore, we investigated an automatic anatomy segmentation method with the intention of providing the proper methodology to evaluate synthetic CT images for a radiation-dose calculation based on MR images.CT images of 20 brain cancer patients were selected, and their MR images including T1-weighted, T2-weighted, and PETRA were retrospectively collected. Eight anatomies of the patients, such as the body, air, eyeball, lens, cavity, ventricle, brainstem, and bone, were segmented for bulk-density-assigned CT image (BCT generation. In addition, water-equivalent CT images (WCT with only two anatomies-body and air-were generated for a comparison with BCT. Histogram comparison and gamma analysis were performed by comparison with the original CT images, after the evaluation of automatic segmentation performance with the dice similarity coefficient (DSC, false negative dice (FND coefficient, and false positive dice (FPD coefficient.The highest DSC value was 99.34 for air segmentation, and the lowest DSC value was 73.50 for bone segmentation. For lens segmentation, relatively high FND and FPD values were measured. The cavity and bone were measured as over-segmented anatomies having higher FPD values than FND. The measured histogram comparison results of BCT were better than those of WCT in all cases. In gamma analysis, the averaged improvement of BCT compared to WCT was measured. All the measured results of BCT were better than those of WCT. Therefore, the results of this study show that the introduced methods, such as histogram comparison and

  14. Randomized Trial of a Hypnosis Intervention for Treatment of Hot Flashes Among Breast Cancer Survivors

    Science.gov (United States)

    Elkins, Gary; Marcus, Joel; Stearns, Vered; Perfect, Michelle; Rajab, M. Hasan; Ruud, Christopher; Palamara, Lynne; Keith, Timothy

    2008-01-01

    Purpose Hot flashes are a significant problem for many breast cancer survivors. Hot flashes can cause discomfort, disrupted sleep, anxiety, and decreased quality of life. A well-tolerated and effective mind-body treatment for hot flashes would be of great value. On the basis of previous case studies, this study was developed to evaluate the effect of a hypnosis intervention for hot flashes. Patients and Methods Sixty female breast cancer survivors with hot flashes were randomly assigned to receive hypnosis intervention (five weekly sessions) or no treatment. Eligible patients had to have a history of primary breast cancer without evidence of detectable disease and 14 or more weekly hot flashes for at least 1 month. The major outcome measure was a bivariate construct that represented hot flash frequency and hot flash score, which was analyzed by a classic sums and differences comparison. Secondary outcome measures were self-reports of interference of hot flashes on daily activities. Results Fifty-one randomly assigned women completed the study. By the end of the treatment period, hot flash scores (frequency × average severity) decreased 68% from baseline to end point in the hypnosis arm (P hypnosis intervention (P Hypnosis appears to reduce perceived hot flashes in breast cancer survivors and may have additional benefits such as reduced anxiety and depression, and improved sleep. PMID:18809612

  15. Technical Note: Is bulk electron density assignment appropriate for MRI-only based treatment planning for lung cancer?

    Science.gov (United States)

    Prior, Phil; Chen, Xinfeng; Gore, Elizabeth; Johnstone, Candice; Li, X Allen

    2017-07-01

    MRI-based treatment planning in radiation therapy (RT) is prohibitive, in part, due to the lack of electron density (ED) information within the image. The dosimetric differences between MRI- and CT-based planning for intensity modulated RT (IMRT) of lung cancer were investigated to assess the appropriateness of bulk ED assignment. Planning CTs acquired for six representative lung cancer patients were used to generate bulk ED IMRT plans. To avoid the effect of anatomic differences between CT and MRI, "simulated MRI-based plans" were generated by forcing the relative ED (rED) to water on CT-delineated structures using organ specific values from the ICRU Report 46 and using the mean rED value of the internal target volume (ITV) from the planning CT. The "simulated MRI-based plans" were generated using a research planning system (Monaco v5.09.07a, Elekta, AB) and employing Monte Carlo dose calculation. The following dose-volume-parameters (DVPs) were collected from both the "simulated MRI-based plans" and the original planning CT: D95 , the dose delivered to 95% of the ITV & planning target volume (PTV), D5 and V5 , the volume of normal lung irradiated ≥5 Gy. The percent point difference and relative dose difference were used for comparison with the CT based plan for V5 and D95 respectively. A total of five plans per patient were generated; three with the ITV rED (rEDITV ) = 1.06, 1.0 and the mean value from the planning CT while the lung rED (rEDlung ) was fixed at the ICRU value of 0.26 and two with rEDlung = 0.1 and 0.5 while the rEDITV was fixed to the mean value from the planning CT. Noticeable differences in the ITV and PTV DVPs were observed. Variations of the normal lung V5 can be as large as 9.6%. In some instances, varying the rEDITV between rEDmean and 1.06 resulted in D95 increases ranging from 3.9% to 6.3%. Bulk rED assignment on normal lung affected the DVPs of the ITV and PTV by 4.0-9.8% and 0.3-19.6% respectively. Dose volume histograms were presented

  16. Radiographic Healing after a Root Canal Treatment Performed in Single-rooted Teeth with and without Ultrasonic Activation of the Irrigant : A Randomized Controlled Trial

    NARCIS (Netherlands)

    Liang, Yu-Hong; Jiang, Lei-Meng; Jiang, Lan; Chen, Xiao-Bo; Liu, Ying-Yi; Tian, Fu-Cong; Bao, Xu-Dong; Gao, Xue-Jun; Versluis, Michel; Wu, Min-Kai; van der Sluis, Luc

    2013-01-01

    Introduction: The aim of this study was to compare the outcome of a root canal treatment with and without additional ultrasonic activation of the irrigant. Methods: Single-rooted teeth with radiographic evidence of periapical bone loss were randomly assigned to 2 treatment groups. In both groups

  17. Comparison of 2 Dosages of Stretching Treatment in Infants with Congenital Muscular Torticollis: A Randomized Trial.

    Science.gov (United States)

    He, Lu; Yan, Xiaohua; Li, Jinling; Guan, Buyun; Ma, Liying; Chen, Ying; Mai, Jianning; Xu, Kaishou

    2017-05-01

    To compare the short-term efficacy of 2 dosages of stretching treatment on the clinical outcomes in infants with congenital muscular torticollis. This was a prospective randomized controlled study. Fifty infants with congenital muscular torticollis who were randomly assigned to 100-times stretching group and 50-times stretching group received stretching treatment for the affected sternocleidomastoid muscle. The outcomes including the head tilt, the cervical passive range of motion, and the muscle function of cervical lateral flexors determined by the muscle function scale were assessed at baseline and at 4 and 8 weeks after treatment. The sternocleidomastoid muscle growth analyzed by the thickness ratio of sternocleidomastoid muscles was measured using ultrasonography at baseline and 8 weeks after treatment. Except the ratio of muscle function scale scores, the postintervention outcomes were all significantly improved in both groups compared with baseline (P stretching group showed greater improvement compared with 50-times stretching group in head tilt and cervical passive range of motion at 4 and 8 weeks after treatment (P Stretching treatment of 2 dosages may effectively improve head tilt, cervical passive range of motion, and sternocleidomastoid muscle growth in infants with congenital muscular torticollis. The stretching treatment of 100 times per day is likely to associate with greater improvement in head tilt and cervical passive range of motion.

  18. Less wound complications of a sinus tarsi approach compared to an extended lateral approach for the treatment of displaced intraarticular calcaneal fracture: A randomized clinical trial in 64 patients

    National Research Council Canada - National Science Library

    Li, Lian-Hua; Guo, Yong-Zhi; Wang, Hao; Sang, Qing-Hua; Zhang, Jian-Zheng; Liu, Zhi; Sun, Tian-Sheng

    2016-01-01

    ... intraarticular calcaneal fractures. Between January 2009 and January 2014, patients with displaced intraarticular calcaneal fracture were randomly assigned to receive surgical treatment by the sinus tarsi approach or the extended...

  19. A randomized controlled trial of intensive sleep retraining (ISR): a brief conditioning treatment for chronic insomnia.

    Science.gov (United States)

    Harris, Jodie; Lack, Leon; Kemp, Kristyn; Wright, Helen; Bootzin, Richard

    2012-01-01

    To investigate the effectiveness of intensive sleep retraining in comparison and combination with traditional behavioral intervention for chronic primary insomnia. Seventy-nine volunteers with chronic sleep-onset insomnia (with or without sleep maintenance difficulties) were randomly assigned either to intensive sleep retraining (ISR), stimulus control therapy (SCT), ISR plus SCT, or the control (sleep hygiene) treatment condition. ISR treatment consisted of 50 sleep onset trials over a 25-h sleep deprivation period. Treatment response was assessed with sleep diary, activity monitoring, and questionnaire measures. The active treatment groups (ISR, SCT, ISR+SCT) all resulted in significant improvements in sleep onset latency and sleep efficiency, with moderate to large effect sizes from pre- to post-treatment. Wake time after sleep onset decreased significantly in the SCT and ISR+SCT groups. Total sleep time increased significantly in the ISR and ISR+SCT treatment groups. Participants receiving ISR (ISR, ISR+SCT) experienced rapidly improved SOL and TST during treatment, suggesting an advantage of rapid improvements in sleep in response to ISR. Although there were few statistically significant differences between groups on individual variables, ISR+SCT resulted in consistently larger effect sizes of change than other treatments, including questionnaire measures of sleep quality, sleep self-efficacy, and daytime functioning. The combination treatment group (ISR+SCT) showed trends to outperform other active treatment groups with fewer treatment dropouts, and a greater proportion of treatment responders with 61% reaching "good sleeper" status. Treatment gains achieved at post-treatment in the active treatment groups were largely maintained throughout follow-up periods to 6 months. This 25-hour intensive conditioning treatment for chronic insomnia can produce rapid improvements in sleep, daytime functioning, and psychological variables. Adding ISR to traditional

  20. Assertive community treatment in the Netherlands : a randomized controlled trial

    NARCIS (Netherlands)

    Sytema, S.; Wunderink, L.; Bloemers, W.; Roorda, L.; Wiersma, D.

    Objective: Assertive community treatment is rapidly implemented by many European mental health services, but recently the evidence base has been questioned. Positive results of randomized trials in the USA were not replicated in the UK. The question is whether the UK findings are representative for

  1. Coping and health-related quality of life in men with prostate cancer randomly assigned to hormonal medication or close monitoring.

    Science.gov (United States)

    Green, Heather J; Pakenham, Kenneth I; Headley, Betty C; Gardiner, Robert A

    2002-01-01

    Prostatic carcinoma and its treatment have been associated with adverse effects on health-related quality of life (HRQoL). Individual differences in appraisal and coping have been suggested to mediate these HRQoL outcomes. A randomized trial of 65 men with non-localized prostate cancer compared several treatments and tested associations between appraisal, coping, and HRQoL. These patients, and 16 community volunteers matched for age and general health, undertook psychosocial assessments before treatment and after 6 months of treatment. Compared with baseline assessments, men on hormonal treatments reported impaired sexual function. Groups did not differ on emotional distress, existential satisfaction, subjective cognitive function, physical symptoms, or social and role functioning. For individuals, hormonal treatments were more frequently associated with decreased sexual, social and role functioning, but were also associated with improved physical symptoms. In hierarchical regression analysis, HRQoL was lower for men who had more comorbid illnesses, a history of neurological dysfunction, higher threat appraisals, or higher use of coping strategies at baseline. These results showed that pharmacological hormonal ablation for prostate cancer can improve or decrease HRQoL in different domains. HRQoL in men with prostate cancer was associated more strongly with appraisal and coping than with medical variables. Copyright 2002 John Wiley & Sons, Ltd.

  2. Effects of acupuncture treatment on depression insomnia: a study protocol of a multicenter randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Chen Yuan-Fang

    2013-01-01

    Full Text Available Abstract Background More than 70% of patients with depression who see their doctors experience insomnia. Insomnia treatment is a very important link for depression treatment. Furthermore, antidepression treatment is also important for depression insomnia. In acupuncture, LU-7 (Lie Que and KID-6 (Zhao Hai, which are two of the eight confluence points in meridian theory, are used as main points. An embedded needle technique is used, alternately, at two groups of points to consolidate the treatment effect. These two groups of points are BL-15 (Xin Shu with BL-23 (Shen Shu and BL-19 (Dan Shu with N-HN-54 (An Mian. The effectiveness of these optimized acupuncture formulas is well proven in the practice by our senior acupuncturists in Guangdong Provincial Hospital of TCM. This study has been designed to examine whether this set of optimized clinical formulas is able to increase the clinical efficacy of depression insomnia treatment. Methods/design In this randomized controlled multicenter trial, all the eligible participants are diagnosed with depression insomnia. All participants are randomly assigned to one of two groups in a ratio of 1:1 and receive either conventional acupuncture treatment or optimized acupuncture treatment. Patients are evaluated using the Pittsburgh Sleep Quality Index(PSQIand the Hamilton rating scale(HAMD for depression. The use of antidepression and hypnotics drugs is also considered. Results are obtained at the start of treatment, 1 and 2 months after treatment has begun, and at the end of treatment. The entire duration of the study will be approximately 36 months. Discussion A high quality of trial methodologies is utilized in the study, and the results may provide better evidence for the effectiveness of acupuncture as a treatment for depression insomnia. The optimized acupuncture formula has potential benefits in increasing the efficacy of treating depression insomnia. Trial registration The trial was registered in

  3. Do billing codes accurately capture intravenous tissue plasminogen activator treatment rates? Justified concern for clinical performance measures based on billing code assignment.

    Science.gov (United States)

    Palazzo, Paola; Alexandrov, Andrei V; Alexandrov, Anne W

    2015-02-01

    International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes are commonly used to determine US national stroke volume and intravenous (IV) tissue plasminogen activator (tPA) treatment rates; however, this method is often criticized because of assumed poor validity and reliability of coding assignment. We sought to understand the validity of IV tPA ICD-9-CM code assignments within a comprehensive stroke center in the southeastern United States. Confirmed stroke registry IV tPA cases were retrieved from 2009 to 2011; tPA drip and ship cases were eliminated from the analysis. Retained clinical data included admission National Institutes of Health Stroke Scale (NIHSS) scores, hemorrhagic transformation, diffusion positive magnetic resonance imaging (MRI) results, and discharge modified Rankin Scale (mRS) score. A total of 247 IV tPA cases were assembled, of which 78% were appropriately assigned the IV tPA billing code. ICD-9 code 434.91 (cerebral artery occlusion with infarct) was used for 72% of the sample, 434.11 (cerebral emboli with infarct) was used for 9% of cases, and 433.11 (carotid occlusion with infarct) was assigned to 2% of cases. Interestingly, 435 (transient cerebral ischemia) was assigned to 2% (n = 7) with all of these cases having NIHSS score more than 2 at time of treatment, diffusion MRI documentation of infarction in 29%, and 43% having a discharge mRS score more than 2. Our findings support the concern that billing codes may significantly underestimate actual IV tPA treatment volume in the United States and suggest the need for regular audit of billing codes by Stroke Center leaders, with provision of feedback and education to coders, aimed at improving code assignment. Copyright © 2015 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  4. Bispectoral index scores of pediatric patients under dental treatment and recovery conditions: Study of children assigned for general anesthesia under propofol and isofloran regimes

    OpenAIRE

    Tahririan, Dana; Kaviani, Naser; Nourbakhsh, Nosrat

    2016-01-01

    Background: This study was planned to determine the relationship between bispectoral index (BIS) during dental treatment and recovery conditions in children undergoing two regimes of anesthesia of propofol and isoflurane. Materials and Methods: In this single-blind clinical trial study, 57 4-7-year-old healthy children who had been referred for dental treatment under general anesthesia between 60 and 90 min were selected by convenience sampling and assigned to two groups, after obtaining ...

  5. Acupuncture in alcoholism treatment: a randomized out-patient study.

    Science.gov (United States)

    Sapir-Weise, R; Berglund, M; Frank, A; Kristenson, H

    1999-01-01

    Seventy-two alcoholics were treated with acupuncture to the ear in a randomized single-blind controlled design over 10 weeks. Orthodox points and incorrect points 3-5 mm from orthodox points were used. No initial differences were found regarding social characteristics, the responses to the Swedish version of the Alcohol Use Inventory and the Three-dimensional Personality Questionnaire, indicating a successful randomization. There were non-significant tendencies towards gender differential response after acupuncture treatment (P = 0.07). There was no difference in the number of drinking days or level of craving between treatment and control patients. Among females, those in the treatment group reported reduction of anxiety after 1 month, more often than those in the control group (P < 0.05). Response to acupuncture was not related to personality or drinking pattern. Patients' experience of needle placement was similar in the study and control groups. The effects of acupuncture were less pronounced than those previously reported.

  6. Assignment of adverse event indexing terms in randomized clinical trials involving spinal manipulative therapy: an audit of records in MEDLINE and EMBASE databases.

    Science.gov (United States)

    Gorrell, Lindsay M; Engel, Roger M; Lystad, Reidar P; Brown, Benjamin T

    2017-03-14

    Reporting of adverse events in randomized clinical trials (RCTs) is encouraged by the authors of The Consolidated Standards of Reporting Trials (CONSORT) statement. With robust methodological design and adequate reporting, RCTs have the potential to provide useful evidence on the incidence of adverse events associated with spinal manipulative therapy (SMT). During a previous investigation, it became apparent that comprehensive search strategies combining text words with indexing terms was not sufficiently sensitive for retrieving records that were known to contain reports on adverse events. The aim of this analysis was to compare the proportion of articles containing data on adverse events associated with SMT that were indexed in MEDLINE and/or EMBASE and the proportion of those that included adverse event-related words in their title or abstract. A sample of 140 RCT articles previously identified as containing data on adverse events associated with SMT was used. Articles were checked to determine if: (1) they had been indexed with relevant terms describing adverse events in the MEDLINE and EMBASE databases; and (2) they mentioned adverse events (or any related terms) in the title or abstract. Of the 140 papers, 91% were MEDLINE records, 85% were EMBASE records, 81% were found in both MEDLINE and EMBASE records, and 4% were not in either database. Only 19% mentioned adverse event-related text words in the title or abstract. There was no significant difference between MEDLINE and EMBASE records in the proportion of available papers (p = 0.078). Of the 113 papers that were found in both MEDLINE and EMBASE records, only 3% had adverse event-related indexing terms assigned to them in both databases, while 81% were not assigned an adverse event-related indexing term in either database. While there was effective indexing of RCTs involving SMT in the MEDLINE and EMBASE databases, there was a failure of allocation of adverse event indexing terms in both databases. We

  7. Assignment of adverse event indexing terms in randomized clinical trials involving spinal manipulative therapy: an audit of records in MEDLINE and EMBASE databases

    Directory of Open Access Journals (Sweden)

    Lindsay M. Gorrell

    2017-03-01

    Full Text Available Abstract Background Reporting of adverse events in randomized clinical trials (RCTs is encouraged by the authors of The Consolidated Standards of Reporting Trials (CONSORT statement. With robust methodological design and adequate reporting, RCTs have the potential to provide useful evidence on the incidence of adverse events associated with spinal manipulative therapy (SMT. During a previous investigation, it became apparent that comprehensive search strategies combining text words with indexing terms was not sufficiently sensitive for retrieving records that were known to contain reports on adverse events. The aim of this analysis was to compare the proportion of articles containing data on adverse events associated with SMT that were indexed in MEDLINE and/or EMBASE and the proportion of those that included adverse event-related words in their title or abstract. Methods A sample of 140 RCT articles previously identified as containing data on adverse events associated with SMT was used. Articles were checked to determine if: (1 they had been indexed with relevant terms describing adverse events in the MEDLINE and EMBASE databases; and (2 they mentioned adverse events (or any related terms in the title or abstract. Results Of the 140 papers, 91% were MEDLINE records, 85% were EMBASE records, 81% were found in both MEDLINE and EMBASE records, and 4% were not in either database. Only 19% mentioned adverse event-related text words in the title or abstract. There was no significant difference between MEDLINE and EMBASE records in the proportion of available papers (p = 0.078. Of the 113 papers that were found in both MEDLINE and EMBASE records, only 3% had adverse event-related indexing terms assigned to them in both databases, while 81% were not assigned an adverse event-related indexing term in either database. Conclusions While there was effective indexing of RCTs involving SMT in the MEDLINE and EMBASE databases, there was a failure of

  8. Efficacy and safety of acupuncture treatment on primary insomnia: a randomized controlled trial.

    Science.gov (United States)

    Yin, Xuan; Gou, Minghui; Xu, Jian; Dong, Bo; Yin, Ping; Masquelin, Fernand; Wu, Junyi; Lao, Lixing; Xu, Shifen

    2017-09-01

    The objective of this study was to evaluate the efficacy and safety of acupuncture treatment for primary insomnia. We conducted a single-center, single-blinded, and randomized controlled clinical trial. Seventy-two patients with primary insomnia were randomly assigned into two groups - the acupuncture group, who received acupuncture treatment, and the control group, who received sham acupuncture treatment. The treatment was given three times a week for four weeks. Patients were asked to wear sleep monitors and complete questionnaires every two weeks for a total of eight weeks. The primary outcome was the Insomnia Severity Index (ISI). The secondary outcomes were sleep parameters including sleep efficiency (SE), sleep awakenings (SA) and total sleep time (TST) recorded by the Actigraphy, as well as scores of the Self-Rating Anxiety Scale (SAS) and the Self-Rating Depression Scale (SDS). Compared with pretreatment baseline, patients in both groups had varying degrees of improvements in their sleep conditions. Paired t-test showed that there was a significant difference in all indicators in the acupuncture group before and after acupuncture treatment. One-way analysis of covariance adjusted for baseline scores indicated that the ISI improved dramatically in the acupuncture group at two weeks post-treatment (F = 11.3, p = 0.001), four weeks post-treatment (F = 33.6, p acupuncture treatment group after the two-week and four-week follow-ups. Acupuncture treatment is more effective than sham acupuncture treatment in increasing insomnia patients' sleep quality and improving their psychological health. Chinese Clinical Trial Registry: Chi CTR-TRC-14004859. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

  9. Strategy-Proof Stochastic Assignment

    OpenAIRE

    Erdil, A.

    2013-01-01

    I study strategy-proof assignment mechanisms where the agents reveal their preference rankings over the available objects. A stochastic mechanism returns lotteries over deterministic assignments, and mechanisms are compared according to first-order stochastic dominance. I show that non-wasteful strategy-proof mechanisms are not dominated by strategy-proof mechanisms, however nonwastefulness is highly restrictive when the mechanism involves randomization. In fact, the Random Priority mechanism...

  10. A randomized clinical trial of a standard versus vegetarian diet for weight loss: the impact of treatment preference.

    Science.gov (United States)

    Burke, L E; Warziski, M; Styn, M A; Music, E; Hudson, A G; Sereika, S M

    2008-01-01

    With obesity rampant, methods to achieve sustained weight loss remain elusive. To compare the long-term weight-loss efficacy of 2 cal and fat-restricted diets, standard (omnivorous) versus lacto-ovo-vegetarian, and to determine the effect of a chosen diet versus an assigned diet. A randomized clinical trial was conducted with 176 adults who were sedentary and overweight (mean body mass index, 34.0 kg/m(2)). Participants were first randomly assigned to either receive their preferred diet or be assigned to a diet group and second, were given their diet of preference or randomly assigned to a standard weight-loss diet or a lacto-ovo-vegetarian diet. Participants underwent a university-based weight-control program consisting of daily dietary and exercise goals plus 12 months of behavioral counseling followed by a 6-month maintenance phase. Percentage change in body weight, body mass index, waist circumference, low- and high-density lipoprotein, glucose, insulin and macronutrient intake. The program was completed by 132 (75%) of the participants. At 18 months, mean percentage weight loss was greater (P=0.01) in the two groups that were assigned a diet (standard, 8.0% (s.d., 7.8%); vegetarian, 7.9% (s.d., 8.1%)) than in those provided the diet of their choice (standard, 3.9% (s.d., 6.1%); vegetarian, 5.3% (s.d., 6.2%)). No difference was observed in weight loss between the two types of diet. Over the 18-month program, all groups showed significant weight loss. Participants assigned to their dietary preference did not have enhanced treatment outcomes. However, all groups lost weight with losses ranging from 4 to 8% at 18 months.

  11. Study and treatment of post Lyme disease (STOP-LD): a randomized double masked clinical trial.

    Science.gov (United States)

    Krupp, L B; Hyman, L G; Grimson, R; Coyle, P K; Melville, P; Ahnn, S; Dattwyler, R; Chandler, B

    2003-06-24

    To determine whether post Lyme syndrome (PLS) is antibiotic responsive. The authors conducted a single-center randomized double-masked placebo-controlled trial on 55 patients with Lyme disease with persistent severe fatigue at least 6 or more months after antibiotic therapy. Patients were randomly assigned to receive 28 days of IV ceftriaxone or placebo. The primary clinical outcomes were improvement in fatigue, defined by a change of 0.7 points or more on an 11-item fatigue questionnaire, and improvement in cognitive function (mental speed), defined by a change of 25% or more on a test of reaction time. The primary laboratory outcome was an experimental measure of CSF infection, outer surface protein A (OspA). Outcome data were collected at the 6-month visit. Patients assigned to ceftriaxone showed improvement in disabling fatigue compared to the placebo group (rate ratio, 3.5; 95% CI, 1.50 to 8.03; p = 0.001). No beneficial treatment effect was observed for cognitive function or the laboratory measure of persistent infection. Four patients, three of whom were on placebo, had adverse events associated with treatment, which required hospitalization. Ceftriaxone therapy in patients with PLS with severe fatigue was associated with an improvement in fatigue but not with cognitive function or an experimental laboratory measure of infection in this study. Because fatigue (a nonspecific symptom) was the only outcome that improved and because treatment was associated with adverse events, this study does not support the use of additional antibiotic therapy with parenteral ceftriaxone in post-treatment, persistently fatigued patients with PLS.

  12. A randomized factorial trial comparing 4 treatment regimens in treatment-naive HIV-infected persons with AIDS and/or a CD4 cell count Africa.

    Science.gov (United States)

    Ratsela, Andrew; Polis, Michael; Dhlomo, Sibongiseni; Emery, Sean; Grandits, Greg; Khabo, Paul; Khanyile, Thandeka; Komati, Stephanus; Neaton, James D; Naidoo, Lionel Chris David; Magongoa, Daphne; Qolohle, Duma

    2010-11-15

    Few randomized trials comparing antiretroviral therapy (ART) regimens have been conducted in resource-limited settings. In the Republic of South Africa, antiretroviral-naive human immunodeficiency virus (HIV)-infected individuals >14 years old with a CD4 cell count AIDS diagnosis were randomized to receive efavirenz (EFV) or lopinavir/ritonavir (LPV/r) with either zidovudine (ZDV) plus didanosine (ddI) or stavudine (d4T) plus lamivudine (3TC) in an open-label, 2-by-2 factorial study and followed up for the primary outcome of AIDS or death and prespecified secondary outcomes, including CD4 cell count and viral load changes, treatment discontinuation, and grade 4 events. In total, 1771 persons were randomized and followed up for a median of 24.7 months. AIDS or death occurred in (1) 163 participants assigned EFV and 157 assigned LPV/r (hazard ratio [HR], 1.04 [95% confidence interval {CI}, 0.84-1.30]) and in (2) 170 participants assigned ZDV+ddI and 150 assigned d4T+3TC (HR, 1.15 [95% CI, 0.93-1.44]). HIV RNA levels were lower (P < .001) and CD4 cell counts were greater (P < .01) over follow-up for d4T+3TC versus ZDV+ddI. Rates of potentially life-threatening adverse events and overall treatment discontinuation were similar for d4T+3TC and ZDV+ddI; however, more participants discontinued d4T because of toxicity (12.6%) than other treatments (<5%). EFV and LPV/r are effective components of first-line ART. The poorer viral and immune responses with ZDV+ddI and the greater toxicity-associated discontinuation rate with d4T+3TC suggest that these treatments be used cautiously as initial therapy. ClinicalTrials.gov identifier: NCT00342355.

  13. Contribution of Dry Needling to Individualized Physical Therapy Treatment of Shoulder Pain: A Randomized Clinical Trial.

    Science.gov (United States)

    Pérez-Palomares, Sara; Oliván-Blázquez, Bárbara; Pérez-Palomares, Ana; Gaspar-Calvo, Elena; Pérez-Benito, Marina; López-Lapeña, Elena; de la Torre-Beldarraín, Maria Luisa; Magallón-Botaya, Rosa

    2017-01-01

    Study Design Multicenter, parallel randomized clinical trial. Background Myofascial trigger points (MTrPs) are implicated in shoulder pain and functional limitations. An intervention intended to treat MTrPs is dry needling. Objectives To investigate the effectiveness of dry needling in addition to evidence-based personalized physical therapy treatment in the treatment of shoulder pain. Methods One hundred twenty patients with nonspecific shoulder pain were randomly allocated into 2 parallel groups: (1) personalized, evidencebased physical therapy treatment; and (2) trigger point dry needling in addition to personalized, evidence-based physical therapy treatment. Patients were assessed at baseline, posttreatment, and 3-month follow-up. The primary outcome measure was pain assessed by a visual analog scale at 3 months, and secondary variables were joint range-of-motion limitations, Constant-Murley score for pain and function, and number of active MTrPs. Clinical efficacy was assessed using intention-to-treat analysis. Results Of the 120 enrolled patients, 63 were randomly assigned to the control group and 57 to the intervention group. There were no significant differences in outcome between the 2 treatment groups. Both groups showed improvement over time. Conclusion Dry needling did not offer benefits in addition to personalized, evidencebased physical therapy treatment for patients with nonspecific shoulder pain. Level of Evidence Therapy, level 1b. Registered February 11, 2009 at www.isrctn.com (ISRCTN30907460). J Orthop Sports Phys Ther 2017;47(1):11-20. Epub 9 Dec 2016. doi:10.2519/jospt.2017.6698.

  14. A Randomized Controlled Trial of Intensive Sleep Retraining (ISR): A Brief Conditioning Treatment for Chronic Insomnia

    Science.gov (United States)

    Harris, Jodie; Lack, Leon; Kemp, Kristyn; Wright, Helen; Bootzin, Richard

    2012-01-01

    Study Objective: To investigate the effectiveness of intensive sleep retraining in comparison and combination with traditional behavioral intervention for chronic primary insomnia. Participants: Seventy-nine volunteers with chronic sleep-onset insomnia (with or without sleep maintenance difficulties) were randomly assigned either to intensive sleep retraining (ISR), stimulus control therapy (SCT), ISR plus SCT, or the control (sleep hygiene) treatment condition. Intervention: ISR treatment consisted of 50 sleep onset trials over a 25-h sleep deprivation period. Measurements and Results: Treatment response was assessed with sleep diary, activity monitoring, and questionnaire measures. The active treatment groups (ISR, SCT, ISR+SCT) all resulted in significant improvements in sleep onset latency and sleep efficiency, with moderate to large effect sizes from pre- to post-treatment. Wake time after sleep onset decreased significantly in the SCT and ISR+SCT groups. Total sleep time increased significantly in the ISR and ISR+SCT treatment groups. Participants receiving ISR (ISR, ISR+SCT) experienced rapidly improved SOL and TST during treatment, suggesting an advantage of rapid improvements in sleep in response to ISR. Although there were few statistically significant differences between groups on individual variables, ISR+SCT resulted in consistently larger effect sizes of change than other treatments, including questionnaire measures of sleep quality, sleep self-efficacy, and daytime functioning. The combination treatment group (ISR+SCT) showed trends to outperform other active treatment groups with fewer treatment dropouts, and a greater proportion of treatment responders with 61% reaching “good sleeper” status. Treatment gains achieved at post-treatment in the active treatment groups were largely maintained throughout follow-up periods to 6 months. Conclusion: This 25-hour intensive conditioning treatment for chronic insomnia can produce rapid improvements in

  15. Measles virus antibody responses in children randomly assigned to receive standard-titer edmonston-zagreb measles vaccine at 4.5 and 9 months of age, 9 months of age, or 9 and 18 months of age

    DEFF Research Database (Denmark)

    Martins, Cesario; Garly, May-Lill; Bale, Carlitos

    2014-01-01

    The World Health Organization recommends administration of measles vaccine (MV) at age 9 months in low-income countries. We tested the measles virus antibody response at 4.5, 9, 18, and 24 months of age for children randomly assigned to receive standard-titer Edmonston-Zagreb MV at 4.5 and 9 months...

  16. Using instrumental variables to disentangle treatment and placebo effects in blinded and unblinded randomized clinical trials influenced by unmeasured confounders

    Science.gov (United States)

    Chaibub Neto, Elias

    2016-11-01

    Clinical trials traditionally employ blinding as a design mechanism to reduce the influence of placebo effects. In practice, however, it can be difficult or impossible to blind study participants and unblinded trials are common in medical research. Here we show how instrumental variables can be used to quantify and disentangle treatment and placebo effects in randomized clinical trials comparing control and active treatments in the presence of confounders. The key idea is to use randomization to separately manipulate treatment assignment and psychological encouragement conversations/interactions that increase the participants’ desire for improved symptoms. The proposed approach is able to improve the estimation of treatment effects in blinded studies and, most importantly, opens the doors to account for placebo effects in unblinded trials.

  17. Pilot Randomized Controlled Trial of Internet-Delivered Cognitive-Behavioral Treatment for Pediatric Headache.

    Science.gov (United States)

    Law, Emily F; Beals-Erickson, Sarah E; Noel, Melanie; Claar, Robyn; Palermo, Tonya M

    2015-01-01

    To evaluate the feasibility and preliminary effectiveness of an Internet-delivered cognitive-behavioral therapy (CBT) intervention for adolescents with chronic headache. Headache is among the most common pain complaints of childhood. Cognitive-behavioral interventions are efficacious for improving pain among youth with headache. However, many youth do not receive psychological treatment for headache due to poor access, which has led to consideration of alternative delivery modalities such as the Internet. We used a parallel arm randomized controlled trial design to evaluate the feasibility and preliminary effectiveness of an Internet-delivered family-based CBT intervention, Web-based management of adolescent pain. Adolescents were eligible for the trial if they were a new patient being evaluated in a specialized headache clinic, between 11 and 17 years of age, and had recurrent headache for 3 months or more as diagnosed by a pediatric neurologist. Eighty-three youths were enrolled in the trial. An online random number generator was used to randomly assign participants to receive Internet CBT adjunctive to specialized headache treatment (n = 44) or specialized headache treatment alone (n = 39). The primary treatment outcome was headache days. Youth and parents in the Internet CBT group demonstrated high levels of engagement with the web program and reported satisfaction with the intervention. Multilevel modelling (MLM) was used to conduct hypothesis testing for continuous outcomes. For our primary treatment outcome of headache days, adolescents reported a statistically significant reduction in headache days from baseline to post-treatment and baseline to 3-month follow-up in both treatment conditions (main effect for time F(2, 136) = 19.70, P headache treatment group at post-treatment or follow-up (group × time interaction F(2, 134) = 0.94, P = .395). For our secondary treatment outcomes, findings from MLM showed that adolescents in both

  18. Reiki for the treatment of fibromyalgia: a randomized controlled trial.

    Science.gov (United States)

    Assefi, Nassim; Bogart, Andy; Goldberg, Jack; Buchwald, Dedra

    2008-11-01

    Fibromyalgia is a common, chronic pain condition for which patients frequently use complementary and alternative medicine, including Reiki. Our objective was to determine whether Reiki is beneficial as an adjunctive fibromyalgia treatment. This was a factorial designed, randomized, sham-controlled trial in which participants, data collection staff, and data analysts were blinded to treatment group. The study setting was private medical offices in the Seattle, Washington metropolitan area. The subjects were comprised 100 adults with fibromyalgia. Four (4) groups received twice-weekly treatment for 8 weeks by either a Reiki master or actor randomized to use direct touch or no touch (distant therapy). The primary outcome was subjective pain as measured by visual analog scale at weeks 4, 8, and 20 (3 months following end of treatment). Secondary outcomes were physical and mental functioning, medication use, and health provider visits. Participant blinding and adverse effects were ascertained by self-report. Improvement between groups was examined in an intention-to-treat analysis. Neither Reiki nor touch had any effect on pain or any of the secondary outcomes. All outcome measures were nearly identical among the 4 treatment groups during the course of the trial. Neither Reiki nor touch improved the symptoms of fibromyalgia. Energy medicine modalities such as Reiki should be rigorously studied before being recommended to patients with chronic pain symptoms.

  19. Randomized trial of aromatherapy. Successful treatment for alopecia areata.

    Science.gov (United States)

    Hay, I C; Jamieson, M; Ormerod, A D

    1998-11-01

    To investigate the efficacy of aromatherapy in the treatment of patients with alopecia areata. A randomized, double-blind, controlled trial of 7 months' duration, with follow-up at 3 and 7 months. Dermatology outpatient department. Eighty-six patients diagnosed as having alopecia areata. Eighty-six patients were randomized into 2 groups. The active group massaged essential oils (thyme, rosemary, lavender, and cedarwood) in a mixture of carrier oils (jojoba and grapeseed) into their scalp daily. The control group used only carrier oils for their massage, also daily. Treatment success was evaluated on sequential photographs by 2 dermatologists (I.C.H. and A.D.O.) independently. Similarly, the degree of improvement was measured by 2 methods: a 6-point scale and computerized analysis of traced areas of alopecia. Nineteen (44%) of 43 patients in the active group showed improvement compared with 6 (15%) of 41 patients in the control group (P = .008). An alopecia scale was applied by blinded observers on sequential photographs and was shown to be reproducible with good interobserver agreement (kappa = 0.84). The degree of improvement on photographic assessment was significant (P = .05). Demographic analysis showed that the 2 groups were well matched for prognostic factors. The results show aromatherapy to be a safe and effective treatment for alopecia areata. Treatment with these essential oils was significantly more effective than treatment with the carrier oil alone (P = .008 for the primary outcome measure). We also successfully applied an evidence-based method to an alternative therapy.

  20. N-Acetylcysteine in the Treatment of Pediatric Trichotillomania: A Randomized, Double-Blind, Placebo-Controlled Add-On Trial

    Science.gov (United States)

    Bloch, Michael H.; Panza, Kaitlyn E.; Grant, Jon E.; Pittenger, Christopher; Leckman, James F.

    2013-01-01

    Objective: To examine the efficacy of N-acetylcysteine (NAC) for the treatment of pediatric trichotillomania (TTM) in a double-blind, placebo-controlled, add-on study. Method: A total of 39 children and adolescents aged 8 to 17 years with pediatric trichotillomania were randomly assigned to receive NAC or matching placebo for 12 weeks. Our primary…

  1. Varying Treatment Intensity in a Home-Based Parent and Child Therapy Program for Families Living in Poverty: A Randomized Clinic Trial

    Science.gov (United States)

    Carrasco, Jennifer M.; Fox, Robert A.

    2012-01-01

    This study addressed the question of whether increasing the intensity of a parent and child therapy program would improve results for young children with significant behavior problems from families living in poverty. Children were randomly assigned to either a standard condition or an intensity condition that provided 50% more treatment over a…

  2. Effectiveness of a Treatment for Impairments in Social Cognition and Emotion Regulation (T-ScEmo) after traumatic brain injury : A randomized controlled trial

    NARCIS (Netherlands)

    Westerhof-Evers, Herma J.; Visser-Keizer, Annemarie C.; Fasotti, Luciano; Schönherr, Marleen C.; Vink, Martie; van der Naalt, Joukje; Spikman, Jacoba M.

    OBJECTIVE: To evaluate the effects of a multifaceted Treatment for Social cognition and Emotion regulation (T-ScEmo) in patients with a traumatic brain injury. PARTICIPANTS: Sixty-one patients with moderate to severe traumatic brain injury randomly assigned to an experimental T-ScEmo intervention or

  3. Efficacy and safety of various repeat treatment dosing regimens of rituximab in patients with active rheumatoid arthritis: results of a Phase III randomized study (MIRROR)

    NARCIS (Netherlands)

    Rubbert-Roth, Andrea; Tak, Paul P.; Zerbini, Cristiano; Tremblay, Jean-Luc; Carreño, Luis; Armstrong, Gillian; Collinson, Neil; Shaw, Tim M.

    2010-01-01

    Methods. Patients with active RA despite stable MTX (10-25 mg/week) were randomly assigned to one of the three treatment regimens comprising two courses of RTX given 24 weeks apart: 2 x 500 and 2 x 500 mg; 2 x 500 and 2 x 1000 mg (dose escalation); and 2 x 1000 and 2 x 1000 mg. The primary endpoint

  4. Microbiota-based Signature of Gingivitis Treatments: A Randomized Study.

    Science.gov (United States)

    Huang, Shi; Li, Zhen; He, Tao; Bo, Cunpei; Chang, Jinlan; Li, Lin; He, Yanyan; Liu, Jiquan; Charbonneau, Duane; Li, Rui; Xu, Jian

    2016-04-20

    Plaque-induced gingivitis can be alleviated by various treatment regimens. To probe the impacts of various anti-gingivitis treatments on plaque microflora, here a double blinded, randomized controlled trial of 91 adults with moderate gingivitis was designed with two anti-gingivitis regimens: the brush-alone treatment and the brush-plus-rinse treatment. In the later group, more reduction in both Plaque Index (TMQHI) and Gingival Index (mean MGI) at Day 3, Day 11 and Day 27 was evident, and more dramatic changes were found between baseline and other time points for both supragingival plaque microbiota structure and salivary metabonomic profiles. A comparison of plaque microbiota changes was also performed between these two treatments and a third dataset where 50 subjects received regimen of dental scaling. Only Actinobaculum, TM7 and Leptotrichia were consistently reduced by all the three treatments, whereas the different microbial signatures of the three treatments during gingivitis relieve indicate distinct mechanisms of action. Our study suggests that microbiota based signatures can serve as a valuable approach for understanding and potentially comparing the modes of action for clinical treatments and oral-care products in the future.

  5. Comparing a stratified treatment strategy with the standard treatment in randomized clinical trials

    DEFF Research Database (Denmark)

    Sun, Hong; Bretz, Frank; Gerke, Oke

    2016-01-01

    The increasing emergence of predictive markers for different treatments in the same patient population allows us to define stratified treatment strategies. We consider randomized clinical trials that compare a standard treatment with a new stratified treatment strategy that divides the study...... population into subgroups receiving different treatments. Because the new strategy may not be beneficial in all subgroups, we consider in this paper an intermediate approach that establishes a treatment effect in a subset of patients built by joining several subgroups. The approach is based on the simple...

  6. Benzodiazepine loading versus symptom-triggered treatment of alcohol withdrawal: a prospective, randomized clinical trial.

    Science.gov (United States)

    Maldonado, José R; Nguyen, Long H; Schader, E Merritt; Brooks, John O

    2012-01-01

    The objectives were to compare the efficacy of a benzodiazepine loading versus a symptom-triggered protocol in the management of alcohol withdrawal. We conducted a prospective, randomized, controlled trial including 47 consecutive patients admitted to one of two tertiary care medical centers who developed alcohol withdrawal syndrome. Patients were randomly assigned to either a benzodiazepine loading protocol or a symptom-triggered treatment protocol. The Clinical Institute Withdrawal Assessment for Alcohol-Revised scale (CIWA-Ar) was recorded throughout the length of stay, along with measures of autonomic system functioning. The average rate of change of CIWA-Ar scores was -1.5 ± 1.3 for the symptom-triggered group and -2.3 ± 2.5 for the loading group. Average rate of change for systolic blood pressure was -2.7 ± 5.3 for the symptom-triggered group and -2.3 ± 6.4 for the loading group. There was no significant difference between the rates of change for either group on either measure. Similarly, there was no significant difference in total benzodiazepine use between groups. Within 72 h of treatment, 69.6% of patients in the loading group were free of withdrawal symptoms versus 41.7% in the symptom-triggered group, a difference not reaching statistical significance. This study did not reveal clear evidence of a clinical advantage for choosing either treatment method. Copyright © 2012 Elsevier Inc. All rights reserved.

  7. Albendazole versus metronidazole in the treatment of adult giardiasis: a randomized, double-blind, clinical trial.

    Science.gov (United States)

    Cañete, Roberto; Rodríguez, Pablo; Mesa, Lumey; Brito, Katia; Prior, Ada; Guilhem, Dirce; Novaes, M R C G

    2012-01-01

    Albendazole (ABZ) is a benzimidazole carbamate compound currently in use for human medical practice against enterobiasis and soil-transmitted helminthiasis (STH); However, its spectrum of activity is broad and goes beyond these infections. This study compares the efficacy and safety of ABZ versus metronidazole (MTZ) in human giardiasis. A randomized, double-blind, clinical trial was carried out at the Centre of Hygiene, Epidemiology and Microbiology in Matanzas City, Cuba. Adult patients with confirmed symptomatic G. duodenalis mono-infection were randomly assigned to receive either ABZ [400 mg daily (n = 75)] or MTZ [250 mg t.i.d. (n = 75)], both for 5 days. Follow-up fecal samples were obtained at 3, 5, 7 days after treatment end. The efficacy was similar for both treatment groups: ABZ (82.6%) and MTZ (85.3%); p > 0.05. Side-effects including bitter taste, headache, vomiting and dizziness were significantly higher in the MTZ group. Abdominal pain was significantly higher in ABZ group. ABZ was found as effective as MTZ in the treatment of G. duodenalis infections in adult patients from Cuba and could be a useful drug in areas where co-infection with STH infections is common.

  8. Extension traction treatment for patients with discogenic lumbosacral radiculopathy: a randomized controlled trial.

    Science.gov (United States)

    Moustafa, Ibrahim M; Diab, Aliaa A

    2013-01-01

    To investigate the effects of lumbar extension traction in patients with unilateral lumbosacral radiculopathy due to L5-S1 disc herniation. A randomized controlled study with six-month follow-up. University research laboratory. Sixty-four patients with confirmed unilateral lumbosacral radiculopathy due to L5-S1 disc herniation and a lumbar lordotic angle less than 39°, randomly assigned to traction or control group. The control group (n = 32) received hot packs and interferential therapy, whereas the traction group (n = 32) received lumbar extension traction in addition to hot packs and interferential therapy. Absolute rotatory angle, back and leg pain rating scale, Oswestry Disability Index, Modified Schober test, H-reflex (latency and amplitude) and intervertebral movements were measured for all patients three times (before treatment, after 10 weeks of treatment and at six-month follow-up). There was a significant difference between the traction group and the control group adjusted to baseline values at 10 weeks post treatment with respect to: absolute rotatory angle (P traction group receiving lumbar extension traction in addition to hot packs and interferential therapy had better effects than the control group with regard to pain, disability, H-reflex parameters and segmental intervertebral movements.

  9. Dismantling multicomponent behavioral treatment for insomnia in older adults: a randomized controlled trial.

    Science.gov (United States)

    Epstein, Dana R; Sidani, Souraya; Bootzin, Richard R; Belyea, Michael J

    2012-06-01

    Recently, the use of multicomponent insomnia treatment has increased. This study compares the effect of single component and multicomponent behavioral treatments for insomnia in older adults after intervention and at 3 months and 1 yr posttreatment. A randomized, controlled study. Veterans Affairs medical center. 179 older adults (mean age, 68.9 yr ± 8.0; 115 women [64.2%]) with chronic primary insomnia. Participants were randomly assigned to 6 wk of stimulus control therapy (SCT), sleep restriction therapy (SRT), the 2 therapies combined into a multicomponent intervention (MCI), or a wait-list control group. Primary outcomes were subjective (daily sleep diary) and objective (actigraphy) measures of sleep-onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), time in bed (TIB), and sleep efficiency (SE). Secondary outcomes were clinical measures including response and remission rates. There were no differences between the single and multicomponent interventions on primary sleep outcomes measured by diary and actigraphy. All treatments produced significant improvement in diary-reported sleep in comparison with the control group. Effect sizes for sleep diary outcomes were medium to large. Treatment gains were maintained at follow-up for diary and actigraph measured SOL, WASO, and SE. The MCI group had the largest proportion of treatment remitters. For older adults with chronic primary insomnia, the findings provide initial evidence that SCT, SRT, and MCI are equally efficacious and produce sustainable treatment gains on diary, actigraphy, and clinical outcomes. From a clinical perspective, MCI may be a preferred treatment due to its higher remission rate. Behavioral Intervention for Insomnia in Older Adults. NCT01154023. URL: http://clinicaltrials.gov/ct2/show/NCT01154023?term=Behavioral+Intervention+for+Insomnia+in+Older+Adults&rank=1.

  10. A Randomized Controlled Trial of Two Syntactic Treatment Procedures With Cantonese-Speaking, School-Age Children With Language Disorders.

    Science.gov (United States)

    To, Carol K S; Lui, Hoi Ming; Li, Xin Xin; Lam, Gary Y H

    2015-08-01

    In this study, we aimed to evaluate the efficacy of sentence-combining (SC) and narrative-based (NAR) intervention approaches to syntax intervention using a randomized-controlled-trial design. Fifty-two Cantonese-speaking, school-age children with language impairment were assigned randomly to either the SC or the NAR treatment arm. Seven children did not receive treatment as assigned. Intervention in both arms targeted the same complex syntactical structures. The SC group focused on sentence combination training, whereas the NAR group made use of narratives in which the target structures were embedded. Pretest and posttest performances measured using a standardized language assessment were subjected to analyses of covariance mixed-effect-model analyses of variance. Children in both treatment arms demonstrated significant growth after 4 months of intervention. The main effect between treatment arms and time was not significant after controlling the pretest performance, suggesting that both treatment approaches showed similar effects. The main effect of time was significant. This study provided evidence to support language intervention in the school years in Cantonese-speaking children. However, neither approach was shown to be more efficacious than the other. Future researchers could examine the effects of a longer treatment period and include functional outcome measures.

  11. Biases in Estimating Treatment Effects Due to Attrition in Randomized Controlled Trials and Cluster Randomized Controlled Trials: A Simulation Study

    Science.gov (United States)

    Dong, Nianbo; Lipsey, Mark W.

    2011-01-01

    Attrition occurs when study participants who were assigned to the treatment and control conditions do not provide outcome data and thus do not contribute to the estimation of the treatment effects. It is very common in experimental studies in education as illustrated, for instance, in a meta-analysis studying "the effects of attrition on baseline…

  12. Intense pulsed light vs. long-pulsed dye laser treatment of telangiectasia after radiotherapy for breast cancer: a randomized split-lesion trial of two different treatments

    DEFF Research Database (Denmark)

    Nymann, P.; Hedelund, L.; Hædersdal, Merete

    2009-01-01

    ); the interventions were randomly assigned to left/right or upper/lower halves. Primary end-points were reduction in telangiectasia, patient satisfaction and preferred treatment. Secondary end-points were pain and adverse effects. Efficacy was registered by blinded photographic evaluations 3 months after the final......Background Chronic radiodermatitis is a common sequela of treatment for breast cancer and potentially a psychologically distressing factor for the affected women. Objectives To evaluate the efficacy and adverse effects of treatments with a long-pulsed dye laser (LPDL) vs. intense pulsed light (IPL...... treatment. Results Eleven patients completed the study. Telangiectasia cleared with both treatments but the efficacy of LPDL was superior. Blinded photographic evaluations showed median vessel clearances of 90% (LPDL) and 50% (IPL) (P = 0.01). LPDL treatments were associated with lower pain scores than IPL...

  13. Treadmill training as an augmentation treatment for Alzheimer?s disease: a pilot randomized controlled study

    Directory of Open Access Journals (Sweden)

    Cynthia Arcoverde

    2014-03-01

    Full Text Available Objective To assess the effect of aerobic exercise on the cognition and functional capacity in Alzheimer’s disease (AD patients. Method Elderly (n=20 with mild dementia (NINCDS-ADRDA/CDR1 were randomly assigned to an exercise group (EG on a treadmill (30 minutes, twice a week and moderate intensity of 60% VO2max and control group (GC 10 patients. The primary outcome measure was the cognitive function using Cambridge Cognitive Examination (CAMCOG. Specifics instruments were also applied to evaluate executive function, memory, attention and concentration, cognitive flexibility, inhibitory control and functional capacity. Results After 16 weeks, the EG showed improvement in cognition CAMCOG whereas the CG declined. Compared to the CG, the EG presented significant improvement on the functional capacity. The analysis of the effect size has shown a favorable response to the physical exercise in all dependent variables. Conclusion Walking on treadmill may be recommended as an augmentation treatment for patients with AD.

  14. Antisepsis regimen in the surgical treatment of HPV generated cervical lesions: polyhexamethylene biguanide vs chlorhexidine. A randomized, double blind study.

    Science.gov (United States)

    Gerli, S; Bavetta, F; Di Renzo, G C

    2012-12-01

    To reduce the risk of local infections after surgical treatments for HPV infected cervical lesions, the post-operative regimen is generally based on the use of vaginal antimicrobial agents. The efficacy and safety of polyhexamethylene biguanide-based vaginal suppositories was compared to a similar chlorhexidine-based treatment, in the post recovery regimen after surgical treatment of cervical lesions. 50 women who underwent to CO2 laser therapy for cervical lesions were randomly assigned to receive 10 days of antiseptic treatment with chlorhexidine digluconate vaginal suppositories, or polyhexamethylene biguanide vaginal suppositories (Monogin®/Biguanelle® ovuli, Lo.Li. Pharma, Italy). A weekly follow-up check was performed for 6 weeks. Polyhexamethylene biguanide-based treatment showed improved efficacy compared to chlorhexidine, in terms of healing process and prevention of bacterial infections. Due to its safety and effectiveness, the vaginal treatment with polyhexamethylene biguanide is preferred to chlorexidine, in accordance with previously reported in vitro evidences.

  15. Magnesium treatment in alcoholics: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Poikolainen Kari

    2008-01-01

    Full Text Available Abstract Background Magnesium (Mg deficiency is common among alcoholics. Earlier research suggests that Mg treatment may help to normalize elevated enzyme activities and some other clinically relevant parameters among alcoholics but the evidence is weak. Methods The effect of Mg was studied in a randomized, parallel group, double-blind trial. The patients were first treated for alcohol withdrawal symptoms and then received for 8 weeks either 500 mg of Mg divided into two tablets or matching placebo. Measurements were made at the beginning and in the end of the Mg treatment period. The primary outcome was serum gamma-glutamyltransferase (S-GGT activity; secondary outcomes included aspartate-aminotransferase (S-AST and alanine-aminotransferase (S-ALT activity. Results The number of randomized patients (completers was 64 (27 in the treatment and 54 (31 in the control group. In intention-to-treat-analyses and in most analyses of study completers, there were no significant differences between the Mg-treated and placebo groups in the outcome variables. When baseline serum Mg level, coffee intake, and the number of unused Mg tablets were controlled for in a multivariate regression model, after-treatment serum Mg levels were found to be higher among the Mg-treated group than in the placebo group (t-test 3.334, df = 53, p = 0.002. After controlling for age, body weight, baseline alcohol intake, subsequent change in alcohol intake and baseline S-AST, the after-treatment S-AST levels were found to be lower among the Mg-treated group than in the placebo group (t-test 2.061, df = 49, p = 0.045. Conclusion Mg treatment may speed up the S-AST decrease in compliant patients. This might decrease the risk of death from alcoholic liver disease. Trial Registration ClinicalTrials.gov ID NCT00325299

  16. Reporting methods of blinding in randomized trials assessing nonpharmacological treatments.

    Directory of Open Access Journals (Sweden)

    Isabelle Boutron

    2007-02-01

    Full Text Available BACKGROUND: Blinding is a cornerstone of treatment evaluation. Blinding is more difficult to obtain in trials assessing nonpharmacological treatment and frequently relies on "creative" (nonstandard methods. The purpose of this study was to systematically describe the strategies used to obtain blinding in a sample of randomized controlled trials of nonpharmacological treatment. METHODS AND FINDINGS: We systematically searched in Medline and the Cochrane Methodology Register for randomized controlled trials (RCTs assessing nonpharmacological treatment with blinding, published during 2004 in high-impact-factor journals. Data were extracted using a standardized extraction form. We identified 145 articles, with the method of blinding described in 123 of the reports. Methods of blinding of participants and/or health care providers and/or other caregivers concerned mainly use of sham procedures such as simulation of surgical procedures, similar attention-control interventions, or a placebo with a different mode of administration for rehabilitation or psychotherapy. Trials assessing devices reported various placebo interventions such as use of sham prosthesis, identical apparatus (e.g., identical but inactivated machine or use of activated machine with a barrier to block the treatment, or simulation of using a device. Blinding participants to the study hypothesis was also an important method of blinding. The methods reported for blinding outcome assessors relied mainly on centralized assessment of paraclinical examinations, clinical examinations (i.e., use of video, audiotape, photography, or adjudications of clinical events. CONCLUSIONS: This study classifies blinding methods and provides a detailed description of methods that could overcome some barriers of blinding in clinical trials assessing nonpharmacological treatment, and provides information for readers assessing the quality of results of such trials.

  17. CANDIS treatment program for cannabis use disorders: findings from a randomized multi-site translational trial.

    Science.gov (United States)

    Hoch, E; Bühringer, G; Pixa, A; Dittmer, K; Henker, J; Seifert, A; Wittchen, H U

    2014-01-01

    In a recent paper, we reported the efficacy of a modular cognitive-behavioral intervention for treating adolescents and adults with cannabis use disorders (CUD). In this study, we examine the outcome of this intervention after translating it into clinical practice. A multi-site, randomized controlled trial of 279 treatment seekers with ICD-10 cannabis use disorders aged 16- 63 years was conducted in 11 outpatient addiction treatment centers in Germany. Patients were randomly assigned to an Active Treatment (AT, n=149) or Delayed Treatment Control (DTC, n=130). Treatment consisted of 10 sessions of fully manualized individual psychotherapy that combined Cognitive-Behavioral Therapy, Motivational EnhancementTherapy and problem-solving training. Assessments were conducted at baseline, during each therapy session, at post-treatment and at three and six month follow-ups. At post assessment 53.3% of AT patients reported abstinence (46.3% negative urine screenings) compared to 22% of DTC patients (17.7% negative drug screenings) (pcannabis use, number of cannabis dependence criteria, severity of dependence, as well as number and severity of cannabis-related problems. Effect sizes were moderate to high. While abstinence rates in the AT group decreased over the 3-month (negative urine screenings: 32.4%) and 6-month (negative urine screenings: 35.7%) follow-up periods, the effects in secondary outcomes were maintained. The intervention can successfully be translated to and applied in clinical practice. It has the potential to improve access to evidence-based care for chronic CUD patients. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  18. Pain Reduction After Laser Acupuncture Treatment in Geriatric Patients with Knee Osteoarthritis: a Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Dwi R Helianthi

    2016-09-01

    Full Text Available Aim: to compare the effectiveness of active laser acupuncture with placebo on reducing pain intensity and improving functional outcome in geriatric patients with knee osteoarthritis (OA. Methods: a double-blind randomized controlled trial was conducted in geriatrics with knee OA at Medical Acupuncture Outpatient Clinic, Integrated Geriatric Outpatient Clinic, Rheumatology Outpatient Clinic of Cipto Mangunkusumo Hospital, Jakarta, during May to October 2015. Sixty two patients with knee OA  were randomly assigned into two groups: active laser acupuncture group or placebo laser acupuncture group. Interventions were carried out using a gallium aluminum arsenide laser device at the ST35 Dubi, ST36 Zusanli, SP9 Yinlingquan, GB34 Yanglingquan and EX - LE - 4 Neixiyan acupuncture points on the affected knee for ten sessions of treatment, i.e. twice a week. Patients were assessed using a visual analogue scale (VAS and Lequesne index at baseline, after four sessions, after nine sessions and at 2 weeks after the treatment had been stopped. Results: the VAS scores were significantly improved in the active laser acupuncture group compared to the placebo group. The evaluation of VAS scores was carried out after four treatment sessions (mean difference: 0.39; p<0.001, after nine treatment sessions (mean difference: 37.48; p<0.001 and at 2 weeks post intervention (mean difference: 39.15; p<0.001. The evaluation also showed significant improvement of Lequesne index after four treatment sessions (mean difference: 4.68; p<0.001, after nine treatment sessions (mean difference: 5.90; p<0.001 and at 2 weeks post intervention (mean difference: 6.48; p<0.001. Conclusion: active laser acupuncture is effective in reducing pain.

  19. Early control treatment with montelukast in preschool children with asthma: A randomized controlled trial.

    Science.gov (United States)

    Nagao, Mizuho; Ikeda, Masanori; Fukuda, Norimasa; Habukawa, Chizu; Kitamura, Tetsuro; Katsunuma, Toshio; Fujisawa, Takao

    2017-05-16

    While Japanese guideline recommends initial control treatment for preschool children with asthma symptoms more than once a month, Western guidelines do not. To determine whether control treatment with montelukast was more effective than as-needed β2-agonists in this population, we conducted a randomized controlled trial. Eligible patients were children aged 1-5 years who had asthma symptoms more than once a month but less than once a week. Patients were randomly assigned in a 1:1 ratio to receive montelukast 4 mg daily for 48 weeks or as-needed β2-agonists. The primary endpoint was the number of acute asthma exacerbations before starting step-up treatment with inhaled corticosteroids. This study is registered with the University Hospital Medical Information Network clinical trials registry, number UMIN000002219. From September 2009 to November 2012, 93 patients (47 in the montelukast group and 46 in the no-controller group) were enrolled into the study. All patients were included in the analysis. During the study, 13 patients (28%) in the montelukast group and 23 patients (50%) in the no-controller group had acute exacerbations with the mean numbers of 0.9 and 1.9/year, respectively (P = 0.027). In addition, 10 (21%) and 19 (41%) patients received step-up treatment, respectively. Cumulative incidence of step-up treatment was significantly lower in the montelukast group (hazard ratio 0.45, 95% confidence interval 0.21 to 0.92; P = 0.033). Montelukast is an effective control treatment for preschool children who had asthma symptoms more than once a month but less than once a week. Copyright © 2017 Japanese Society of Allergology. Production and hosting by Elsevier B.V. All rights reserved.

  20. A randomized controlled trial to influence client language in substance use disorder treatment.

    Science.gov (United States)

    Moyers, Theresa B; Houck, Jon; Glynn, Lisa H; Hallgren, Kevin A; Manuel, Jennifer K

    2017-03-01

    Client language is hypothesized to be a mechanism of action in motivational interviewing (MI). Despite the association of change and sustain talk with substance treatment outcomes, it not known whether providers can intentionally influence this language as hypothesized. This is a randomized controlled trial to investigate whether substance use providers can be trained to influence client language. Treatment providers specializing in substance use disorders (n=190) were randomly assigned to standard training in MI (MI-AU) or training emphasizing an influence of client language (MI-LEAF). Treatment sessions with actual clients were evaluated 3, 6 and 12 months after training by masked raters. Frequencies of client change and sustain talk were the outcome variables. Sustain talk, but not change talk, was significantly lower in clients whose providers had received the specialized training (b=-0.175, SE=0.087, p=0.046, CI[-0.348 to 0.002], d=-0.325). Mediation analyses supported a causal chain between a) training, b) providers' attempts to minimize sustain talk in treatment sessions via directive reflective listening and c) client sustain talk in the treatment session (κ 2 =0.0833, bootstrap SE=0.0394, 95% CI [0.0148, 0.1691]). With specialized training, providers can reduce the amount of opposition language their clients offer when considering a change in their substance use. Demonstrating that client language is under partial control of the provider supports the feasibility of clinical trials to investigate the impact of shaping client language on treatment outcomes. Copyright © 2017 Elsevier B.V. All rights reserved.

  1. Effect of integrated treatment on the use of coercive measures in first-episode schizophrenia-spectrum disorder. A randomized clinical trial

    DEFF Research Database (Denmark)

    Ohlenschlæger, Johan; Nordentoft, Merete; Thorup, Anne

    2008-01-01

    of assertive community treatment, psycho-educational multi-family groups, and social skills training. Data on coercion were extracted from the register from the National Board of Health, and data on continuity from medical records. Even though the level of continuity seemed higher in integrated treatment......The effect of integrated treatment on the use of coercive measures in first-episode schizophrenia-spectrum disorder in Denmark is not known. A total of 328 patients were randomly assigned to integrated treatment (167 patients) or standard treatment (161 patients). Integrated treatment consisted...

  2. Hydrotherapy for the Treatment of Pain in People with Multiple Sclerosis: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Adelaida María Castro-Sánchez

    2012-01-01

    Full Text Available Background. Multiple sclerosis (MS is a chronic demyelinating neurological disease. Several studies have reported that complementary and alternative therapies can have positive effects against pain in these patients. Objective. The objective was to investigate the effectiveness of an Ai-Chi aquatic exercise program against pain and other symptoms in MS patients. Methods. In this randomized controlled trial, 73 MS patients were randomly assigned to an experimental or control group for a 20-week treatment program. The experimental group underwent 40 sessions of Ai-Chi exercise in swimming pool and the control group 40 sessions of abdominal breathing and contraction-relaxation exercises in therapy room. Outcome variables were pain, disability, spasm, depression, fatigue, and autonomy, which were assessed before the intervention and immediately and at 4 and 10 weeks after the last treatment session. Results. The experimental group showed a significant (P<0.028 and clinically relevant decrease in pain intensity versus baseline, with an immediate posttreatment reduction in median visual analogue scale scores of 50% that was maintained for up to 10 weeks. Significant improvements were also observed in spasm, fatigue, disability, and autonomy. Conclusion. According to these findings, an Ai-Chi aquatic exercise program improves pain, spasms, disability, fatigue, depression, and autonomy in MS patients.

  3. Dynamic splinting after treatment with botulinum toxin type-A: a randomized controlled pilot study.

    Science.gov (United States)

    Lai, Jenny M; Francisco, Gerard E; Willis, F Buck

    2009-02-01

    Over 1.5 million Americans are diagnosed with a stroke each year, and excessive flexion or extension (hypertonia) of upper extremity joints are common secondary conditions. The purpose of this study was to compare the efficacy of botulinum toxin type-A and manual therapy, with the adjunct treatment of dynamic splinting on range of motion, spasticity, and elbow flexor hypertonia, in a randomized trial. Thirty-six subjects were recruited for this pilot study and all exhibited hypertonia in elbow flexion. Six patients were excluded due to noncompliance. Testing was done with pre/post active range of motion in elbow extension, and the Modified Ashworth Scale (extension) for spasticity. All patients received the current standard of care: botulinum toxin type-A injections and manual therapy. Experimental patients were randomly assigned adjunct treatment with Elbow Extension Dynasplint. Thirty patients completed the study (mean age [SD] 52+/-17 years). The percentage of change in active range of motion in elbow extension was greater for the experimental than for control subjects (33.5% vs. 18.7%). The Modified Ashworth Scale (extension) scores showed comparable changes of a mean 9.3% improvement for experimental versus 8.6% for the control subjects. This study confirmed the efficacy of botulinum toxin type-A in tone management and occupational therapy in contracture reduction. It also showed the value of dynamic splinting in maintaining gains in range of motion.

  4. Transarterial RAdioembolization versus ChemoEmbolization for the treatment of hepatocellular carcinoma (TRACE: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Seinstra Beatrijs A

    2012-08-01

    Full Text Available Abstract Background Hepatocellular carcinoma is a primary malignant tumor of the liver that accounts for an important health problem worldwide. Only 10 to 15% of hepatocellular carcinoma patients are suitable candidates for treatment with curative intent, such as hepatic resection and liver transplantation. A majority of patients have locally advanced, liver restricted disease (Barcelona Clinic Liver Cancer (BCLC staging system intermediate stage. Transarterial loco regional treatment modalities offer palliative treatment options for these patients; transarterial chemoembolization (TACE is the current standard treatment. During TACE, a catheter is advanced into the branches of the hepatic artery supplying the tumor, and a combination of embolic material and chemotherapeutics is delivered through the catheter directly into the tumor. Yttrium-90 radioembolization (90Y-RE involves the transarterial administration of minimally embolic microspheres loaded with Yttrium-90, a β-emitting isotope, delivering selective internal radiation to the tumor. 90Y-RE is increasingly used in clinical practice for treatment of intermediate stage hepatocellular carcinoma, but its efficacy has never been prospectively compared to that of the standard treatment (TACE. In this study, we describe the protocol of a multicenter randomized controlled trial aimed at comparing the effectiveness of TACE and 90Y-RE for treatment of patients with unresectable (BCLC intermediate stage hepatocellular carcinoma. Methods/design In this pragmatic randomized controlled trial, 140 patients with unresectable (BCLC intermediate stage hepatocellular carcinoma, with Eastern Cooperative Oncology Group performance status 0 to 1 and Child-Pugh A to B will be randomly assigned to either 90Y-RE or TACE with drug eluting beads. Patients assigned to 90Y-RE will first receive a diagnostic angiography, followed by the actual transarterial treatment, which can be divided into two sessions in case

  5. Remote treatment of panic disorder: a randomized trial of internet-based cognitive behavior therapy supplemented with telephone calls.

    Science.gov (United States)

    Carlbring, Per; Bohman, Susanna; Brunt, Sara; Buhrman, Monica; Westling, Bengt E; Ekselius, Lisa; Andersson, Gerhard

    2006-12-01

    This study evaluated a 10-week Internet-based bibliotherapy self-help program with short weekly telephone calls for people suffering from panic disorder with or without agoraphobia. After the authors confirmed the diagnosis by administering the Structured Clinical Interview for DSM-IV by telephone, 60 participants were randomly assigned to either a wait-listed control group or a multimodal treatment package based on cognitive behavior therapy plus minimal therapist contact via e-mail. A 10-minute telephone call was made each week to support each participant. Total mean time spent on each participant during the 10 weeks was 3.9 hours. The participants were required to send in homework assignments before receiving the next treatment module. Analyses were conducted on an intention-to-treat basis, which included all randomly assigned participants. From pretreatment to posttreatment, all treated participants improved significantly on all measured dimensions (bodily interpretations, maladaptive cognitions, avoidance, general anxiety and depression levels, and quality of life). Treatment gains on self-report measures were maintained at the 9-month follow-up. A blind telephone interview after the end of treatment revealed that 77% of the treated patients no longer fulfilled the criteria for panic disorder, whereas all of the wait-listed subjects still suffered from it. This study provides evidence to support the use of treatment distributed via the Internet with the addition of short weekly telephone calls to treat panic disorder. Replication should be made to compare self-help and telephone treatment based on cognitive behavior methods with nonspecific interventions.

  6. Randomized controlled trial of vertebroplasty versus kyphoplasty in the treatment of vertebral compression fractures.

    Science.gov (United States)

    Evans, Avery J; Kip, Kevin E; Brinjikji, Waleed; Layton, Kennith F; Jensen, Mary L; Gaughen, John R; Kallmes, David F

    2016-07-01

    We present the results of a randomized controlled trial evaluating the efficacy of vertebroplasty versus kyphoplasty in treating vertebral body compression fractures. Patients with vertebral body compression fractures were randomly assigned to treatment with kyphoplasty or vertebroplasty. Primary endpoints were pain (0-10 scale) and disability assessed using the Roland-Morris Disability Questionnaire (RMDQ). Outcomes were assessed at 3 days, 1 month, 6 months, and 1 year following the procedure. 115 subjects were enrolled in the trial with 59 (51.3%) randomly assigned to kyphoplasty and 56 (48.7%) assigned to vertebroplasty. Mean (SD) pain scores at baseline, 3 days, 30 days, and 1 year for kyphoplasty versus vertebroplasty were 7.4 (1.9) vs 7.9 (2.0), 4.1 (2.8) vs 3.7 (3.0), 3.4 (2.5) vs 3.6 (2.9), and 3.0 (2.8) vs 2.3 (2.6), respectively (p>0.05 at all time points). Mean (SD) RMDQ scores at baseline, 3 days, 30 days, 180 days, and 1 year were 17.3 (6.6) vs 16.3 (7.4), 11.8 (7.9) vs 10.9 (8.2), 8.6 (7.2) vs 8.8 (8.5), 7.9 (7.4) vs 7.3 (7.7), 7.5 (7.2) vs 6.7 (8.0), respectively (p>0.05 at all time points). For baseline to 12-month assessment in average pain and RMDQ scores, the standardized effect size between kyphoplasty and vertebroplasty was small at -0.36 (95% CI -1.02 to 0.31) and -0.04 (95% CI -1.68 to 1.60), respectively. Our study indicates that vertebroplasty and kyphoplasty appear to be equally effective in substantially reducing pain and disability in patients with vertebral body compression fractures. NCT00279877. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  7. Internet treatment for generalized anxiety disorder: a randomized controlled trial comparing clinician vs. technician assistance.

    Directory of Open Access Journals (Sweden)

    Emma Robinson

    Full Text Available BACKGROUND: Internet-based cognitive behavioural therapy (iCBT for generalized anxiety disorder (GAD has been shown to be effective when guided by a clinician. The present study sought to replicate this finding, and determine whether support from a technician is as effective as guidance from a clinician. METHOD: Randomized controlled non-inferiority trial comparing three groups: Clinician-assisted vs. technician-assisted vs. delayed treatment. Community-based volunteers applied to the VirtualClinic (www.virtualclinic.org.au research program and 150 participants with GAD were randomized. Participants in the clinician- and technician-assisted groups received access to an iCBT program for GAD comprising six online lessons, weekly homework assignments, and weekly supportive contact over a treatment period of 10 weeks. Participants in the clinician-assisted group also received access to a moderated online discussion forum. The main outcome measures were the Penn State Worry Questionnaire (PSWQ and the Generalized Anxiety Disorder-7 Item (GAD-7. Completion rates were high, and both treatment groups reduced scores on the PSWQ (p<0.001 and GAD-7 (p<0.001 compared to the delayed treatment group, but did not differ from each other. Within group effect sizes on the PSWQ were 1.16 and 1.07 for the clinician- and technician-assisted groups, respectively, and on the GAD-7 were 1.55 and 1.73, respectively. At 3 month follow-up participants in both treatment groups had sustained the gains made at post-treatment. Participants in the clinician-assisted group had made further gains on the PSWQ. Approximately 81 minutes of clinician time and 75 minutes of technician time were required per participant during the 10 week treatment program. CONCLUSIONS: Both clinician- and technician-assisted treatment resulted in large effect sizes and clinically significant improvements comparable to those associated with face-to-face treatment, while a delayed treatment

  8. Nonoperative Treatment of Thoracic and Lumbar Spine Fractures : A Prospective Randomized Study of Different Treatment Options

    NARCIS (Netherlands)

    Stadhouder, Agnita; Buskens, Erik; Vergroesen, Diederik A.; Fidler, Malcolm W.; de Nies, Frank; Oner, F. C.

    Objectives: To evaluate and compare nonoperative treatment methods for traumatic thoracic and lumbar compression fractures and burst fractures. Design: Prospective randomized controlled trial with long-term follow-up. Setting: Two general hospitals in the Netherlands. Patients/Participants: Patients

  9. Aromatherapy as treatment for postoperative nausea: a randomized trial.

    Science.gov (United States)

    Hunt, Ronald; Dienemann, Jacqueline; Norton, H James; Hartley, Wendy; Hudgens, Amanda; Stern, Thomas; Divine, George

    2013-09-01

    Postoperative nausea (PON) is a common complication of anesthesia and surgery. Antiemetic medication for higher-risk patients may reduce but does not reliably prevent PON. We examined aromatherapy as a treatment for patients experiencing PON after ambulatory surgery. Our primary hypothesis was that in comparison with inhaling a placebo, PON will be reduced significantly by aromatherapy with (1) essential oil of ginger, (2) a blend of essential oils of ginger, spearmint, peppermint, and cardamom, or (3) isopropyl alcohol. Our secondary hypothesis was that the effectiveness of aromatherapy will depend upon the agent used. A randomized trial of aromatherapy with patients who reported nausea in the postanesthesia care unit was conducted at one ambulatory surgical center. Eligibility criteria were adult, able to give consent, and no history of coagulation problems or allergy to the aromatherapy agents. Before surgery, demographic and risk factors were collected. Patients with a nausea level of 1 to 3 on a verbal descriptive scale (0-3) received a gauze pad saturated with a randomly chosen aromatherapy agent and were told to inhale deeply 3 times; nausea (0-3) was then measured again in 5 minutes. Prophylactic and postnausea antiemetics were given as ordered by physicians or as requested by the patient. A total of 1151 subjects were screened for inclusion; 303 subjects reporting nausea were enrolled (26.3%), and 301 meeting protocol were analyzed (26.2%). The change in nausea level was significant for the blend (P aromatherapy was also significantly reduced with ginger or blend aromatherapy versus saline (P = 0.002 and P aromatherapy would be effective as a treatment for PON was supported. On the basis of our results, future research further evaluating aromatherapy is warranted. Aromatherapy is promising as an inexpensive, noninvasive treatment for PON that can be administered and controlled by patients as needed.

  10. Randomized controlled trial of outpatient mentalization-based treatment versus structured clinical management for borderline personality disorder.

    Science.gov (United States)

    Bateman, Anthony; Fonagy, Peter

    2009-12-01

    This randomized controlled trial tested the effectiveness of an 18-month mentalization-based treatment (MBT) approach in an outpatient context against a structured clinical management (SCM) outpatient approach for treatment of borderline personality disorder. Patients (N=134) consecutively referred to a specialist personality disorder treatment center and meeting selection criteria were randomly allocated to MBT or SCM. Eleven mental health professionals equal in years of experience and training served as therapists. Independent evaluators blind to treatment allocation conducted assessments every 6 months. The primary outcome was the occurrence of crisis events, a composite of suicidal and severe self-injurious behaviors and hospitalization. Secondary outcomes included social and interpersonal functioning and self-reported symptoms. Outcome measures, assessed at 6-month intervals, were analyzed using mixed effects logistic regressions for binary data, Poisson regression models for count data, and mixed effects linear growth curve models for self-report variables. Substantial improvements were observed in both conditions across all outcome variables. Patients randomly assigned to MBT showed a steeper decline of both self-reported and clinically significant problems, including suicide attempts and hospitalization. Structured treatments improve outcomes for individuals with borderline personality disorder. A focus on specific psychological processes brings additional benefits to structured clinical support. Mentalization-based treatment is relatively undemanding in terms of training so it may be useful for implementation into general mental health services. Further evaluations by independent research groups are now required.

  11. Internet treatment for depression: a randomized controlled trial comparing clinician vs. technician assistance.

    Directory of Open Access Journals (Sweden)

    Nickolai Titov

    Full Text Available BACKGROUND: Internet-based cognitive behavioural therapy (iCBT for depression is effective when guided by a clinician, less so if unguided. QUESTION: Would guidance from a technician be as effective as guidance from a clinician? METHOD: Randomized controlled non-inferiority trial comparing three groups: Clinician-assisted vs. technician-assisted vs. delayed treatment. Community-based volunteers applied to the VirtualClinic (www.virtualclinic.org.au research program, and 141 participants with major depressive disorder were randomized. Participants in the clinician- and technician-assisted groups received access to an iCBT program for depression comprising 6 online lessons, weekly homework assignments, and weekly supportive contact over a treatment period of 8 weeks. Participants in the clinician-assisted group also received access to a moderated online discussion forum. The main outcome measures were the Beck Depression Inventory (BDI-II and the Patient Health QUESTIONnaire-9 Item (PHQ-9. Completion rates were high, and at post-treatment, both treatment groups reduced scores on the BDI-II (p<0.001 and PHQ-9 (p<0.001 compared to the delayed treatment group but did not differ from each other. Within group effect sizes on the BDI-II were 1.27 and 1.20 for the clinician- and technician-assisted groups respectively, and on the PHQ-9, were 1.54 and 1.60 respectively. At 4-month follow-up participants in the technician group had made further improvements and had significantly lower scores on the PHQ-9 than those in the clinician group. A total of approximately 60 minutes of clinician or technician time was required per participant during the 8-week treatment program. CONCLUSIONS: Both clinician- and technician-assisted treatment resulted in large effect sizes and clinically significant improvements comparable to those associated with face-to-face treatment, while a delayed treatment control group did not improve. These results provide support for large

  12. A Randomized Controlled Trial of Cognitive Debiasing Improves Assessment and Treatment Selection for Pediatric Bipolar Disorder

    Science.gov (United States)

    Jenkins, Melissa M.; Youngstrom, Eric A.

    2015-01-01

    Objective This study examined the efficacy of a new cognitive debiasing intervention in reducing decision-making errors in the assessment of pediatric bipolar disorder (PBD). Method The study was a randomized controlled trial using case vignette methodology. Participants were 137 mental health professionals working in different regions of the US (M=8.6±7.5 years of experience). Participants were randomly assigned to a (1) brief overview of PBD (control condition), or (2) the same brief overview plus a cognitive debiasing intervention (treatment condition) that educated participants about common cognitive pitfalls (e.g., base-rate neglect; search satisficing) and taught corrective strategies (e.g., mnemonics, Bayesian tools). Both groups evaluated four identical case vignettes. Primary outcome measures were clinicians’ diagnoses and treatment decisions. The vignette characters’ race/ethnicity was experimentally manipulated. Results Participants in the treatment group showed better overall judgment accuracy, p < .001, and committed significantly fewer decision-making errors, p < .001. Inaccurate and somewhat accurate diagnostic decisions were significantly associated with different treatment and clinical recommendations, particularly in cases where participants missed comorbid conditions, failed to detect the possibility of hypomania or mania in depressed youths, and misdiagnosed classic manic symptoms. In contrast, effects of patient race were negligible. Conclusions The cognitive debiasing intervention outperformed the control condition. Examining specific heuristics in cases of PBD may identify especially problematic mismatches between typical habits of thought and characteristics of the disorder. The debiasing intervention was brief and delivered via the Web; it has the potential to generalize and extend to other diagnoses as well as to various practice and training settings. PMID:26727411

  13. Internet-based mindfulness treatment for anxiety disorders: a randomized controlled trial.

    Science.gov (United States)

    Boettcher, Johanna; Aström, Viktor; Påhlsson, Daniel; Schenström, Ola; Andersson, Gerhard; Carlbring, Per

    2014-03-01

    Mindfulness-based interventions have proven effective for the transdiagnostic treatment of heterogeneous anxiety disorders. So far, no study has investigated the potential of mindfulness-based treatments when delivered remotely via the Internet. The current trial aims at evaluating the efficacy of a stand-alone, unguided, Internet-based mindfulness treatment program for anxiety. Ninety-one participants diagnosed with social anxiety disorder, generalized anxiety disorder, panic disorder, or anxiety disorder not otherwise specified were randomly assigned to a mindfulness treatment group (MTG) or to an online discussion forum control group (CG). Mindfulness treatment consisted of 96 audio files with instructions for various mindfulness meditation exercises. Primary and secondary outcome measures were assessed at pre-, posttreatment, and at 6-months follow-up. Participants of the MTG showed a larger decrease of symptoms of anxiety, depression, and insomnia from pre- to postassessment than participants of the CG (Cohen's d(between)=0.36-0.99). Within effect sizes were large in the MTG (d=0.82-1.58) and small to moderate in the CG (d=0.45-0.76). In contrast to participants of the CG, participants of the MTG also achieved a moderate improvement in their quality of life. The study provided encouraging results for an Internet-based mindfulness protocol in the treatment of primary anxiety disorders. Future replications of these results will show whether Web-based mindfulness meditation can constitute a valid alternative to existing, evidence-based cognitive-behavioural Internet treatments. The trial was registered at ClinicalTrials.gov (NCT01577290). Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.

  14. Efficacy and safety of adding mizoribine to standard treatment in patients with immunoglobulin A nephropathy: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Keiji Hirai

    2017-06-01

    Full Text Available Background: Mizoribine (MZR is an immunosuppressive drug used in Japan for treating patients with lupus nephritis and nephrotic syndrome and has been also reportedly effective in patients with immunoglobulin A (IgA nephropathy. However, to date, few randomized control studies of MZR are performed in patients with IgA nephropathy. Therefore, this prospective, open-label, randomized, controlled trial aimed to investigate the efficacy and safety of adding MZR to standard treatment in these patients, and was conducted between April 1, 2009, and March 31, 2016, as a multicenter study. Methods: Patients were randomly assigned (1:1 to receiving standard treatment plus MZR (MZR group or standard treatment (control group. MZR was administered orally at a dose of 150 mg once daily for 12 months. Results: Primary outcomes were the percentage reduction in urinary protein excretion from baseline and the rate of patients with hematuria disappearance 36 months after study initiation. Secondary outcomes were the rate of patients with proteinuria disappearance, clinical remission rate, absolute changes in estimated glomerular filtration rate from baseline, and the change in daily dose of prednisolone. Forty-two patients were randomly assigned to MZR (n = 21 and control groups (n = 21. Nine patients in MZR group and 15 patients in the control group completed the study. No significant differences were observed between the two groups with respect to primary and secondary outcomes. Conclusion: The addition of MZR to standard treatment has no beneficial effect on reducing urinary protein excretion and hematuria when treating patients with IgA nephropathy.

  15. Curcuminoid treatment for knee osteoarthritis: a randomized double-blind placebo-controlled trial.

    Science.gov (United States)

    Panahi, Yunes; Rahimnia, Ali-Reza; Sharafi, Mojtaba; Alishiri, Gholamhossein; Saburi, Amin; Sahebkar, Amirhossein

    2014-11-01

    Treatment of osteoarthritis (OA) is challenging owing to the inefficacy and long-term adverse events of currently available medications including non-steroidal anti-inflammatory drugs. Curcuminoids are polyphenolic phytochemicals with established anti-inflammatory properties and protective effects on chondrocytes. The aim of this study is to investigate the clinical efficacy of curcuminoids in patients suffering from knee OA. A pilot randomized double-blind placebo-control parallel-group clinical trial was conducted among patients with mild-to-moderate knee OA. Patients were assigned to curcuminoids (1500 mg/day in 3 divided doses; n = 19) or matched placebo (n = 21) for 6 weeks. Efficacy measures were changes in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), visual analogue scale (VAS) and Lequesne's pain functional index (LPFI) scores during the study. There was no significant difference in age, gender, body mass index, and VAS, WOMAC and LPFI scores between the study groups at baseline (p > 0.05). Treatment with curcuminoids was associated with significantly greater reductions in WOMAC (p = 0.001), VAS (p  0.05). There was no considerable adverse effect in both groups. To conclude, curcuminoids represent an effective and safe alternative treatment for OA. Copyright © 2014 John Wiley & Sons, Ltd.

  16. Minimal treatment approaches for concerned significant others of problem gamblers: a randomized controlled trial.

    Science.gov (United States)

    Hodgins, David C; Toneatto, Tony; Makarchuk, Karyn; Skinner, Wayne; Vincent, Susan

    2007-06-01

    The goal of this study was to examine the efficacy of minimal treatment interventions for concerned significant others (CSOs) of problem gamblers. One hundred and eighty-six participants (82% females, 56% spouses) were randomly assigned to one of three groups: the first minimal intervention group received a self-help workbook [based on behavioral principles, modified from the Community Reinforcement and Family Therapy (CRAFT) model] and the second minimal intervention group received the workbook plus telephone support. The control condition received a treatment resource information package. Overall, all participants reported significant improvement in personal and relationship functioning and gambling behavior and consequences at the 3- and 6-month follow-up. The data demonstrated differences in favor of the interventions in three areas: days gambling, satisfaction with the program, and number who had their needs met. There was no difference in the number who had entered treatment. It may be that CSOs require more guidance and follow-up support to achieve these goals using the CRAFT procedures and strategies.

  17. Propranolol versus captopril in the treatment of infantile hemangioma (IH): A randomized controlled trial.

    Science.gov (United States)

    Zaher, Hesham; Rasheed, Hoda; El-Komy, Mohamed M; Hegazy, Rehab A; Gawdat, Heba I; Abdel Halim, Dalia M; Abdel Hay, Rania M; Hegazy, Ranya A; Mohy, Abeer M

    2016-03-01

    Renin-angiotensin system components have been demonstrated in the biology of infantile hemangioma (IH). Captopril, an angiotensin-converting enzyme inhibitor, is proposed as a therapeutic alternative to oral propranolol. We sought to compare the benefit of propranolol and captopril in the treatment of IH, and to assess angiotensin-converting enzyme gene polymorphism in patients with IH and in control subjects. Thirty patients with IH and 35 healthy control subjects were enrolled in this study. Patients were randomly assigned to treatment with either propranolol or captopril. Assessment was done clinically and by measurement of serum vascular endothelial growth factor and angiotensin II in patients and control subjects. Angiotensin-converting enzyme gene polymorphism was also studied. Clinical improvement was significantly better and faster in the patients treated with propranolol. Both groups showed reduced vascular endothelial growth factor and angiotensin II levels posttreatment, with a significantly higher percentage reduction in the propranolol-treated group. Cardiac side effects were reported only in the captopril-treated group. Baseline vascular endothelial growth factor level was significantly higher, and baseline angiotensin II level was significantly lower, in patients than control subjects. We studied a relatively small number of patients and control subjects. Propranolol shows greater benefit than captopril in the treatment of IH. Copyright © 2015 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  18. Art therapy as an adjuvant treatment for depression in elderly women: a randomized controlled trial.

    Science.gov (United States)

    Ciasca, Eliana C; Ferreira, Rita C; Santana, Carmen L A; Forlenza, Orestes V; Dos Santos, Glenda D; Brum, Paula S; Nunes, Paula V

    2018-02-01

    There are few quantitative studies on art therapy for the treatment of depression. The objective of this study was to evaluate if art therapy is beneficial as an adjuvant treatment for depression in the elderly. A randomized, controlled, single-blind study was carried out in a sample of elderly women with major depressive disorder (MDD) stable on pharmacotherapy. The experimental group (EG) was assigned to 20 weekly art therapy sessions (90 min/session). The control group (CG) was not subjected to any adjuvant intervention. Patients were evaluated at baseline and after 20 weeks, using the Geriatric Depression Scale (GDS), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), and cognitive measures. Logistic regression analysis adjusted for age revealed that women in EG (n=31) had significant improvement in GDS (p = 0.007), BDI (p = 0.025), and BAI (p = 0.032) scores as compared with controls (n=25). No difference was found in the cognitive measures. Art therapy as an adjunctive treatment for MDD in the elderly can improve depressive and anxiety symptoms. RBR-2YXY7Z.

  19. Art therapy as an adjuvant treatment for depression in elderly women: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Eliana C. Ciasca

    2018-02-01

    Full Text Available Objective: There are few quantitative studies on art therapy for the treatment of depression. The objective of this study was to evaluate if art therapy is beneficial as an adjuvant treatment for depression in the elderly. Methods: A randomized, controlled, single-blind study was carried out in a sample of elderly women with major depressive disorder (MDD stable on pharmacotherapy. The experimental group (EG was assigned to 20 weekly art therapy sessions (90 min/session. The control group (CG was not subjected to any adjuvant intervention. Patients were evaluated at baseline and after 20 weeks, using the Geriatric Depression Scale (GDS, Beck Depression Inventory (BDI, Beck Anxiety Inventory (BAI, and cognitive measures. Results: Logistic regression analysis adjusted for age revealed that women in EG (n=31 had significant improvement in GDS (p = 0.007, BDI (p = 0.025, and BAI (p = 0.032 scores as compared with controls (n=25. No difference was found in the cognitive measures. Conclusion: Art therapy as an adjunctive treatment for MDD in the elderly can improve depressive and anxiety symptoms. Clinical trial registration: RBR-2YXY7Z

  20. Astym treatment vs. eccentric exercise for lateral elbow tendinopathy: a randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Thomas L. Sevier

    2015-05-01

    Full Text Available Introduction. Patients with chronic lateral elbow (LE tendinopathy, commonly known as tennis elbow, often experience prolonged symptoms and frequent relapses. Astym treatment, evidenced in animal studies to promote the healing and regeneration of soft tissues, is hypothesized to improve outcomes in LE tendinopathy patients. This study had two objectives: (1 to compare the efficacy of Astym treatment to an evidence-based eccentric exercise program (EE for patients with chronic LE tendinopathy, and (2 to quantify outcomes of subjects non-responsive to EE who were subsequently treated with Astym treatment.Study Design. Prospective, two group, parallel, randomized controlled trial completed at a large orthopedic center in Indiana. Inclusion criteria: age range of 18–65 years old, with clinical indications of LE tendinopathy greater than 12 weeks, with no recent corticosteriod injection or disease altering comorbidities.Methods. Subjects with chronic LE tendinopathy (107 subjects with 113 affected elbows were randomly assigned using computer-generated random number tables to 4 weeks of Astym treatment (57 elbows or EE treatment (56 elbows. Data collected at baseline, 4, 8, 12 weeks, 6 and 12 months. Primary outcome measure: DASH; secondary outcome measures: pain with activity, maximum grip strength and function. The treating physicians and the rater were blinded; subjects and treating clinicians could not be blinded due to the nature of the treatments.Results. Resolution response rates were 78.3% for the Astym group and 40.9% for the EE group. Astym subjects showed greater gains in DASH scores (p = 0.047 and in maximum grip strength (p = 0.008 than EE subjects. Astym therapy also resolved 20/21 (95.7% of the EE non-responders, who showed improvements in DASH scores (p < 0.005, pain with activity (p = 0.002, and function (p = 0.004 following Astym treatment. Gains continued at 6 and 12 months. No adverse effects were reported.Conclusion. This study

  1. A randomized controlled study for the treatment of acne vulgaris using high-intensity 414 nm solid state diode arrays.

    Science.gov (United States)

    Ash, Caerwyn; Harrison, Anna; Drew, Samantha; Whittall, Rebecca

    2015-01-01

    The treatment of acne vulgaris poses a challenge to the dermatologist, and the disease causes emotional anxiety for the patient. The treatment of acne vulgaris may be well-suited to home-use applications, where sufferers may be too embarrassed to seek medical treatment. This randomized controlled study is designed to quantify the effectiveness of using a blue light device in a therapy combined with proprietary creams, in the investigation of a self-treatment regimen. A total of 41 adults with mild-to-moderate facial inflammatory acne were recruited. The subjects were randomly assigned to combination blue light therapy (n = 26) or control (n = 15). Photography was used for qualitative assessment of lesion counts, at weeks 1, 2, 4, 8, and 12. All subjects in the treatment cohort achieved a reduction in their inflammatory lesion counts after 12 weeks. The mean inflammatory lesion counts reduced by 50.02% in the treatment cohort, and increased by 2.45% in the control cohort. The reduction in inflammatory lesions was typically observable at week-3, and maximal between weeks 8 and 12. The treatment is free of pain and side-effects. The blue light device offers a valuable alternative to antibiotics and potentially irritating topical treatments. Blue light phototherapy, using a narrow-band LED light source, appears to be a safe and effective additional therapy for mild to moderate acne.

  2. Perturbation treatment of symmetry breaking within random matrix theory

    Energy Technology Data Exchange (ETDEWEB)

    Carvalho, J.X. de [Max-Planck-Institut fuer Physik komplexer Systeme, Noethnitzer Strasse 38, D-01187 Dresden (Germany); Instituto de Fisica, Universidade de Sao Paulo, C.P. 66318, 05315-970 Sao Paulo, S.P. (Brazil); Hussein, M.S. [Max-Planck-Institut fuer Physik komplexer Systeme, Noethnitzer Strasse 38, D-01187 Dresden (Germany); Instituto de Fisica, Universidade de Sao Paulo, C.P. 66318, 05315-970 Sao Paulo, S.P. (Brazil)], E-mail: mhussein@mpipks-dresden.mpg.de; Pato, M.P.; Sargeant, A.J. [Instituto de Fisica, Universidade de Sao Paulo, C.P. 66318, 05315-970 Sao Paulo, S.P. (Brazil)

    2008-07-07

    We discuss the applicability, within the random matrix theory, of perturbative treatment of symmetry breaking to the experimental data on the flip symmetry breaking in quartz crystal. We found that the values of the parameter that measures this breaking are different for the spacing distribution as compared to those for the spectral rigidity. We consider both two-fold and three-fold symmetries. The latter was found to account better for the spectral rigidity than the former. Both cases, however, underestimate the experimental spectral rigidity at large L. This discrepancy can be resolved if an appropriate number of eigenfrequencies is considered to be missing in the sample. Our findings are relevant for symmetry violation studies in general.

  3. A randomized trial investigating a chiropractic manual placebo: a novel design using standardized forces in the delivery of active and control treatments.

    Science.gov (United States)

    Hawk, Cheryl; Long, Cynthia R; Rowell, Robert M; Gudavalli, M Ram; Jedlicka, James

    2005-02-01

    To evaluate the proposed manual placebo in terms of success in blinding patients to treatment group assignment and outcomes between the treatment groups. Randomized controlled trial. A chiropractic college research clinic in the midwestern United States. One hundred and eleven (111) individuals aged 18 years and over with subacute or chronic lowback pain. The active treatment consisted of flexion-distraction chiropractic manipulation and trigger point therapy and the control treatment of sham manipulation and effleurage; both groups received eight treatments over a 3-week period. The application of prescribed ranges of biomechanical forces for each treatment was standardized using specialized computerized equipment. "Nontreatment" aspects of the clinical encounter were to be standardized across groups. A primary clinician blinded to treatment assignment provided interpersonal interactions and treating clinicians delivered treatments with a minimum of interaction. The accuracy of the patient's perception of group assignment at visit 4 and the mean change in the Pain Disability Index (PDI) over the treatment period were the primary outcome variables. Patients in the control group were more likely to perceive their treatment assignment accurately than those in the active group (78% versus 54%, respectively). Patients in both treatment groups improved on the PDI and the Roland-Morris Questionnaire; there were no significant differences in improvement between the groups. Age, gender, prior chiropractic experience and expectation of treatment at baseline had no effect on outcomes. Patients in the control group were not successfully blinded; however, patients' perceptions of treatment group assignment did not significantly affect outcomes. The clinically significant improvement in both groups, independent of patient or clinician expectations, suggests the presence of therapeutic factors common to both groups, other than biomechanical force. Further studies examining other

  4. Brief relaxation versus music distraction in the treatment of dental anxiety: a randomized controlled clinical trial.

    Science.gov (United States)

    Lahmann, Claas; Schoen, Rainer; Henningsen, Peter; Ronel, Joram; Muehlbacher, Moritz; Loew, Thomas; Tritt, Karin; Nickel, Marius; Doering, Stephan

    2008-03-01

    Dental anxiety is a significant cause of poor dental health. Because patients often prefer nonpharmacological interventions, the clinical effectiveness of clearly structured approaches is of particular interest. This prospective randomized controlled study compares a brief relaxation method (BR) with music distraction (MD) and with a control group (C). The authors randomly assigned 90 patients with dental anxiety to BR, MD or C groups. They assessed the outcomes by means of the state anxiety subscale of the State-Trait Anxiety Inventory. Both BR and MD reduced dental anxiety significantly. In contrast, patients in the C group did not exhibit a significant change in their anxiety level. BR was significantly superior to MD. Stratification according to the patient's general level of dental anxiety revealed that BR also was particularly effective in highly anxious subjects, whereas MD did not have a clinically relevant effect on these subjects. BR appears to be a safe, economically sound and effective nonpharmacological approach to the short-term reduction of dental anxiety. Additional investigations are needed to validate these findings in a larger clinical trial and to determine the long-term effects of this intervention. Relaxation techniques are a pragmatic, effective and cost-saving method of facilitating dental treatment in anxious patients.

  5. The treatment of painful temporomandibular joint clicking with oral splints: a randomized clinical trial.

    Science.gov (United States)

    Conti, Paulo César Rodrigues; dos Santos, Carlos Neanes; Kogawa, Evelyn Mikaela; de Castro Ferreira Conti, Ana Claudia; de Araujo, Carlos dos Reis Pereira

    2006-08-01

    The authors compared the efficacy of bilateral balanced and canine guidance (occlusal) splints in the treatment of temporomandibular joint (TMJ) pain in subjects who experienced joint clicking with a nonoccluding splint in a double-blind, controlled randomized clinical trial. The authors randomly assigned 57 people with signs of disk displacement and TMJ pain into three groups according to the type of splint: bilateral balanced, canine guidance and nonoccluding. The authors followed the groups for six months using analysis of a visual analog scale (VAS), palpation of the TMJ and masticatory muscles, mandibular movements and joint sounds. They used repeated analysis of variance and a chi(2) test to test the hypothesis. The type of guidance used did not influence the pain reduction, yet both occlusal splints were superior to the nonoccluding splint, on the basis of the VAS. Despite similar outcomes in relation to opening, left lateral and protrusive movements, TMJ and muscle pain on palpation, subjects who used the occlusal splints had improved clinical outcomes. The frequency of joint noises decreased over time, with no significant differences among groups. Subjects in the groups using the occlusal splints reported more comfort. The type of lateral guidance did not influence the subjects' improvement. All of the subjects had a general improvement on the VAS, though subjects in the occlusal splint groups had better results that did subjects in the nonoccluding splint group.

  6. Exposure to virtual social interactions in the treatment of social anxiety disorder: A randomized controlled trial.

    Science.gov (United States)

    Kampmann, Isabel L; Emmelkamp, Paul M G; Hartanto, Dwi; Brinkman, Willem-Paul; Zijlstra, Bonne J H; Morina, Nexhmedin

    2016-02-01

    This randomized controlled trial investigated the efficacy of a stand-alone virtual reality exposure intervention comprising verbal interaction with virtual humans to target heterogeneous social fears in participants with social anxiety disorder. Sixty participants (Mage = 36.9 years; 63.3% women) diagnosed with social anxiety disorder were randomly assigned to individual virtual reality exposure therapy (VRET), individual in vivo exposure therapy (iVET), or waiting-list. Multilevel regression analyses revealed that both treatment groups improved from pre-to postassessment on social anxiety symptoms, speech duration, perceived stress, and avoidant personality disorder related beliefs when compared to the waiting-list. Participants receiving iVET, but not VRET, improved on fear of negative evaluation, speech performance, general anxiety, depression, and quality of life relative to those on waiting-list. The iVET condition was further superior to the VRET condition regarding decreases in social anxiety symptoms at post- and follow-up assessments, and avoidant personality disorder related beliefs at follow-up. At follow-up, all improvements were significant for iVET. For VRET, only the effect for perceived stress was significant. VRET containing extensive verbal interaction without any cognitive components can effectively reduce complaints of generalized social anxiety disorder. Future technological and psychological improvements of virtual social interactions might further enhance the efficacy of VRET for social anxiety disorder. Copyright © 2015 Elsevier Ltd. All rights reserved.

  7. Acupuncture Treatment for Plantar Fasciitis: A Randomized Controlled Trial with Six Months Follow-Up

    Directory of Open Access Journals (Sweden)

    Shi Ping Zhang

    2011-01-01

    Full Text Available Plantar fasciitis is a common cause of heel pain. It has been suggested that some acupoints have a specific effect on heel pain. The aim of this study was to determine the efficacy and specificity of acupuncture treatment for plantar fasciitis. Subjects were randomly assigned to the treatment group (n = 28 or control group (n = 25. The treatment group received needling at the acupoint PC 7, which is purported to have a specific effect for heel pain. The control group received needling at the acupoint Hegu (LI 4, which has analgesic properties. Treatment was administered five times a week for 2 weeks, with an identical method of manual needling applied to the two acupoints. The primary outcome measure was morning pain on a 100-point visual analog scale (VAS at one month post-treatment. Secondary outcome measures included a VAS for activity pain, overall pain rating as well as pressure pain threshold using algometry. Significant differences in reduction in pain scores, favoring the treatment group, were seen at one month for morning pain (22.6 ± 4.0 versus 12.0 ± 3.0, mean ± SEM, overall pain (20.3 ± 3.7 versus 9.5 ± 3.6 and pressure pain threshold (145.5 ± 32.9 versus −15.5 ± 39.4. No serious adverse event was observed in either group. The results indicate that acupuncture can provide pain relief to patient with plantar fasciitis, and that PC 7 is a relatively specific acupoint for heel pain.

  8. Anal self-massage in the treatment of acute anal fissure: a randomized prospective study.

    Science.gov (United States)

    Gaj, Fabio; Biviano, Ivano; Candeloro, Laura; Andreuccetti, Jacopo

    2017-01-01

    An anal fissure (AF) is a tear in the epithelial lining of the anal canal. This is a very common condition, but the choice of treatment is unclear. The use of anal dilators is effective, economic, and safe. The aim of the study was to compare the efficacy of two conservative treatments, the use of anal dilators or a finger for anal dilatation, in reducing anal pressure and resolving anal fissures. Fifty patients with a clinical diagnosis of AF were randomly assigned to one of the treatments, self-massage of the anal sphincter (group A, 25 patients) or passive dilatation using dilators (group B, 25 patients). All patients were evaluated at baseline, at the end of treatment, and after 12 weeks and 6 months. Pain was measured using a visual analog scale. After the treatment, 60% of patients treated with dilators and 80% of patients treated with anal self-massage using a finger showed disappearance of their anal fissures. A comparison between signs and symptoms reported by the patients in the two groups showed a statistically significant reduction in anal pain (group A, P=0.0001; group B, P=0.0001) and bleeding after defecation (group A, P=0.001, group B, P=0.001). At 6 months after treatment, a significantly greater reduction in anal pain was observed in Group A compared to Group B (P=0.02). The use of anal self-massage with a finger appears to induce a better resolution of acute anal fissure than do anal dilators, and in a shorter time.

  9. Internet-based treatment for depression in multiple sclerosis: A randomized controlled trial.

    Science.gov (United States)

    Boeschoten, Rosa E; Dekker, Joost; Uitdehaag, Bernard Mj; Beekman, Aartjan Tf; Hoogendoorn, Adriaan W; Collette, Emma H; Cuijpers, Pim; Nieuwenhuis, Magdalena M; van Oppen, Patricia

    2017-07-01

    Depression in multiple sclerosis (MS) patients is common but may stay untreated. Physical limitations impede face-to-face treatment. Internet-based treatment is therefore a promising tool for treating depression in MS. To investigate effectiveness of a guided Internet-based problem-solving treatment (IPST) for depressed MS patients. MS patients with moderate or severe depressive symptoms were randomly assigned to IPST or a wait list control. Primary outcome was the change in depressive symptoms defined by a change in sum score on the Beck Depression Inventory Second Edition (BDI-II). Assessments took place at baseline (T0), within a week after the intervention (T1), and at 4 months follow-up (T2). Analyses were based on the intention-to-treat principle. A total of 171 patients were randomized to IPST ( n = 85) or a wait list control ( n = 86). T1 was completed by 152 (89%) and T2 by 131 patients (77%). The IPST group and wait list control showed large significant improvements in depressive symptoms, but no differences were found between groups at T1 ( d = 0.23; 95% confidence interval (CI) = (-4.03, 1.08); p = 0.259) and T2 ( d = 0.01; 95% CI = (-2.80, 2.98); p = 0.953). We found no indication that IPST for MS patients with moderate or severe depression is effective in reducing depressive symptoms compared to a waiting list. Large improvements in the wait list control were unexpected and are discussed.

  10. Postprison release HIV-risk behaviors in a randomized trial of methadone treatment for prisoners.

    Science.gov (United States)

    Wilson, Monique E; Kinlock, Timothy W; Gordon, Michael S; O'Grady, Kevin E; Schwartz, Robert P

    2012-01-01

    This secondary analysis examined the impact of methadone initiated in prison on postrelease HIV risk behaviors. The parent study was a three-group randomized clinical trial in which participants received drug abuse counseling in prison and were randomly assigned to: (1) passive referral to substance abuse treatment upon release; (2) guaranteed methadone treatment admission upon release; and (3) methadone in prison and guaranteed continuation of methadone upon release. Participants were 211 adult males with preincarceration histories of opiate dependence. The AIDS Risk Assessment was administered at baseline (in prison) and at 1-, 3-, 6-, and 12-month postrelease. Data were analyzed for the entire sample (N = 211) as well as the subsamples who reported injecting drugs in the 30 days prior to incarceration (n = 131) and who reported having unprotected sex in that time frame (n = 144) using generalized linear mixed model on an intent-to-treat basis. There were no significant changes in sex- or drug-risk by Condition over Time. There were significant Time and Condition main effects for the total sample as well as the injector subsample for drug-risk behaviors. There were no significant Condition main effects for HIV sex-risk behaviors, but there were significant Time main effects. Methadone initiated in prison or immediately postrelease is associated with reduced HIV drug-risk compared to counseling in prison without methadone and passive referral to treatment at release. Participation in several drug- and sex-risk behaviors also showed significant declines during the postrelease time periods. Copyright © American Academy of Addiction Psychiatry.

  11. Pentoxifylline as a rescue treatment for DMD: a randomized double-blind clinical trial.

    Science.gov (United States)

    Escolar, D M; Zimmerman, A; Bertorini, T; Clemens, P R; Connolly, A M; Mesa, L; Gorni, K; Kornberg, A; Kolski, H; Kuntz, N; Nevo, Y; Tesi-Rocha, C; Nagaraju, K; Rayavarapu, S; Hache, L P; Mayhew, J E; Florence, J; Hu, F; Arrieta, A; Henricson, E; Leshner, R T; Mah, J K

    2012-03-20

    To determine whether pentoxifylline (PTX) slows the decline of muscle strength and function in ambulatory boys with Duchenne muscular dystrophy (DMD). This was a multicenter, randomized, double-blinded, controlled trial comparing 12 months of daily treatment with PTX or placebo in corticosteroid-treated boys with DMD using a slow-release PTX formulation (~20 mg/kg/day). The primary outcome was the change in mean total quantitative muscle testing (QMT) score. Secondary outcomes included changes in QMT subscales, manual muscle strength, pulmonary function, and timed function tests. Outcomes were compared using Student t tests and a linear mixed-effects model. Adverse events (AEs) were compared using the Fisher exact test. A total of 64 boys with DMD with a mean age of 9.9 ± 2.9 years were randomly assigned to PTX or placebo in 11 participating Cooperative International Neuromuscular Research Group centers. There was no significant difference between PTX and the placebo group in total QMT scores (p = 0.14) or in most of the secondary outcomes after a 12-month treatment. The use of PTX was associated with mild to moderate gastrointestinal or hematologic AEs. The addition of PTX to corticosteroid-treated boys with DMD at a moderate to late ambulatory stage of disease did not improve or halt the deterioration of muscle strength and function over a 12-month study period. This study provides Class I evidence that treatment with PTX does not prevent deterioration in muscle function or strength in corticosteroid-treated boys with DMD.

  12. Treatment of ADHD in children with tics: a randomized controlled trial.

    Science.gov (United States)

    2002-02-26

    The treatment of children with attention deficit hyperactivity disorder (ADHD) and Tourette syndrome (TS) has been problematic because methylphenidate (MPH)--the most commonly used drug to treat ADHD--has been reported to worsen tics and because clonidine (CLON)--the most commonly prescribed alternative--has unproven efficacy. The authors conducted a multicenter, randomized, double-blind clinical trial in which 136 children with ADHD and a chronic tic disorder were randomly administered CLON alone, MPH alone, combined CLON + MPH, or placebo (2 x 2 factorial design). Each subject participated for 16 weeks (weeks 1-4 CLON/placebo dose titration, weeks 5-8 added MPH/placebo dose titration, weeks 9-16 maintenance therapy). Thirty-seven children were administered MPH alone, 34 were administered CLON alone, 33 were administered CLON + MPH, and 32 were administered placebo. For our primary outcome measure of ADHD (Conners Abbreviated Symptom Questionnaire--Teacher), significant improvement occurred for subjects assigned to CLON (p tics as an adverse effect was no higher in those treated with MPH (20%) than those being administered CLON alone (26%) or placebo (22%). Compared with placebo, measured tic severity lessened in all active treatment groups in the following order: CLON + MPH, CLON alone, MPH alone. Sedation was common with CLON treatment (28% reported moderate or severe sedation), but otherwise the drugs were tolerated well, including absence of any evident cardiac toxicity. Methylphenidate and clonidine (particularly in combination) are effective for ADHD in children with comorbid tics. Prior recommendations to avoid methylphenidate in these children because of concerns of worsening tics are unsupported by this trial.

  13. Economic evaluation of antibiotic therapy versus appendicectomy for the treatment of uncomplicated acute appendicitis from the APPAC randomized clinical trial.

    Science.gov (United States)

    Sippola, S; Grönroos, J; Tuominen, R; Paajanen, H; Rautio, T; Nordström, P; Aarnio, M; Rantanen, T; Hurme, S; Salminen, P

    2017-09-01

    An increasing amount of evidence supports antibiotic therapy for treating uncomplicated acute appendicitis. The objective of this study was to compare the costs of antibiotics alone versus appendicectomy in treating uncomplicated acute appendicitis within the randomized controlled APPAC (APPendicitis ACuta) trial. The APPAC multicentre, non-inferiority RCT was conducted on patients with CT-confirmed uncomplicated acute appendicitis. Patients were assigned randomly to appendicectomy or antibiotic treatment. All costs were recorded, whether generated by the initial visit and subsequent treatment or possible recurrent appendicitis during the 1-year follow-up. The cost estimates were based on cost levels for the year 2012. Some 273 patients were assigned to the appendicectomy group and 257 to antibiotic treatment. Most patients randomized to antibiotic treatment did not require appendicectomy during the 1-year follow-up. In the operative group, overall societal costs (€5989·2, 95 per cent c.i. 5787·3 to 6191·1) were 1·6 times higher (€2244·8, 1940·5 to 2549·1) than those in the antibiotic group (€3744·4, 3514·6 to 3974·2). In both groups, productivity losses represented a slightly higher proportion of overall societal costs than all treatment costs together, with diagnostics and medicines having a minor role. Those in the operative group were prescribed significantly more sick leave than those in the antibiotic group (mean(s.d.) 17·0(8·3) (95 per cent c.i. 16·0 to 18·0) versus 9·2(6·9) (8·3 to 10·0) days respectively; P appendicitis incurred lower costs than those who had surgery. © 2017 BJS Society Ltd Published by John Wiley & Sons Ltd.

  14. Prospective, randomized trial of epinephrine, metaproterenol, and both in the prehospital treatment of asthma in the adult patient.

    Science.gov (United States)

    Quadrel, M; Lavery, R F; Jaker, M; Atkin, S; Tortella, B J; Cody, R P

    1995-10-01

    To compare the effectiveness and incidence of adverse reactions with three treatment regimens for asthma in adults in the prehospital setting. Prospective, randomized clinical study. Inner-city emergency medical service system providing basic and advanced life support and transport to 14 urban area hospital emergency departments. One hundred fifty-four adult asthmatic patients, 18 to 50 years old, who presented to paramedics with shortness of breath and wheezing. Eligible patients were randomly assigned by the base station physician to one of three treatment groups: subcutaneous epinephrine, nebulized metaproterenol, or subcutaneous epinephrine and nebulized metaproterenol. Peak expiratory flow rate (PEFR), blood pressure, heart rate, and respiratory rate were measured before and after treatment in each patient. During a 9-month period (October 1992 through June 1993), 154 patients were enrolled in the study; 53 (34%) received epinephrine, 49 (32%) received metaproterenol, and 52 (34%) received both. There were no significant differences in patient demographics, initial vital signs, or pretreatment PEFR among the three groups. The mean difference between pretreatment and posttreatment PEFR was 73 L/min and did not significantly differ among the treatment groups. Significant changes in vital signs were seen in no treatment group. Nebulized metaproterenol is as effective as subcutaneous epinephrine in the prehospital treatment of adult patients with acute asthma. The combination of these two treatments offered no additional clinical benefit in the patients we studied.

  15. Biomarker-based strategy for early discontinuation of empirical antifungal treatment in critically ill patients: a randomized controlled trial.

    Science.gov (United States)

    Rouzé, Anahita; Loridant, Séverine; Poissy, Julien; Dervaux, Benoit; Sendid, Boualem; Cornu, Marjorie; Nseir, Saad

    2017-11-01

    The aim of this study was to determine the impact of a biomarker-based strategy on early discontinuation of empirical antifungal treatment. Prospective randomized controlled single-center unblinded study, performed in a mixed ICU. A total of 110 patients were randomly assigned to a strategy in which empirical antifungal treatment duration was determined by (1,3)-β-D-glucan, mannan, and anti-mannan serum assays, performed on day 0 and day 4; or to a routine care strategy, based on international guidelines, which recommend 14 days of treatment. In the biomarker group, early stop recommendation was determined using an algorithm based on the results of biomarkers. The primary outcome was the percentage of survivors discontinuing empirical antifungal treatment early, defined as a discontinuation strictly before day 7. A total of 109 patients were analyzed (one patient withdraw consent). Empirical antifungal treatment was discontinued early in 29 out of 54 patients in the biomarker strategy group, compared with one patient out of 55 in the routine strategy group [54% vs 2%, p empirical antifungal treatment among critically ill patients with suspected invasive Candida infection. These results confirm previous findings suggesting that early discontinuation of empirical antifungal treatment had no negative impact on outcome. However, further studies are needed to confirm the safety of this strategy. This trial was registered at ClinicalTrials.gov, NCT02154178.

  16. Assigning agents to a line

    DEFF Research Database (Denmark)

    Hougaard, Jens Leth; Moreno-Ternero, Juan D.; Østerdal, Lars Peter Raahave

    2014-01-01

    minimizing modification of the classic random priority method to solve this class of problems. We also provide some logical relations in our setting among standard axioms in the literature on assignment problems, and explore the robustness of our results to several extensions of our setting....

  17. Pain Reduction in Myofascial Pain Syndrome by Anodal Transcranial Direct Current Stimulation Combined with Standard Treatment: A Randomized Controlled Study

    Science.gov (United States)

    Sakrajai, Piyaraid; Janyacharoen, Taweesak; Jensen, Mark P.; Sawanyawisuth, Kittisak; Auvichayapat, Narong; Tunkamnerdthai, Orathai; Keeratitanont, Keattichai; Auvichayapat, Paradee

    2014-01-01

    Background Myofascial pain syndrome (MPS) in the shoulder is among the most prevalent pain problems in the middle-aged population worldwide. Evidence suggests that peripheral and central sensitization may play an important role in the development and maintenance of shoulder MPS. Given previous research supporting the potential efficacy of anodal transcranial direct current stimulation (tDCS) for modulating pain-related brain activity in individuals with refractory central pain, we hypothesized that anodal tDCS when applied over the primary motor cortex (M1) combined with standard treatment will be more effective for reducing pain in patients with MPS than standard treatment alone. Method Study participants were randomized to receive either (1) standard treatment with 5-consecutive days of 1 mA anodal tDCS over M1 for 20 min or (2) standard treatment plus sham tDCS. Measures of pain intensity, shoulder passive range of motion, analgesic medication use, and self-reported physical functioning were administered before treatment and again at post-treatment and 1-, 2-, 3-and 4-week follow-up. Results Thirty-one patients with MPS were enrolled. Participants assigned to the active tDCS condition reported significantly more pre- to post-treatment reductions in pain intensity that were maintained at 1-week post-treatment, and significant improvement in shoulder adduction PROM at 1-week follow-up than participants assigned to the sham tDCS condition. Conclusion 5 consecutive days of anodal tDCS over M1 combined with standard treatment appears to reduce pain intensity, and may improve PROM, faster than standard treatment alone. Further tests of the efficacy and duration of effects of tDCS in the treatment of MPS are warranted. PMID:25373724

  18. Is radiofrequency treatment effective for shoulder impingement syndrome? A prospective randomized controlled study.

    Science.gov (United States)

    Lu, Yi; Zhang, Qiang; Zhu, Yiming; Jiang, Chunyan

    2013-11-01

    To determine whether radiofrequency based plasma microtenotomy has a positive effective in the treatment of shoulder impingement syndrome with cuff tendinosis. Eighty patients with impingement syndrome and cuff tendinosis that were treated arthroscopically were enrolled in the study. The patients were randomly assigned to receive either arthroscopic subacromial decompression (ASD) alone (ASD group, n = 40) or arthroscopic subacromial decompression combined with radiofrequency (RF) based plasma microtenotomy (RF group, n = 40). Clinical outcome data including VAS pain score, shoulder range of motion (ROM), ASES, UCLA, Constant-Murley, and SST score were recorded preoperatively and at 3 weeks, 6 weeks, 3 months, 6 months, and 1 year postoperatively. Sixty-five out of eighty patients (81.3%) were available for the final follow-up at 1 year postoperation. There were 32 patients in the ASD group and 33 in the RF group. Both treatment groups showed significantly (P = .031 in the ASD group vs P = .017 in the RF group) reduced pain 3 weeks postoperatively. Both treatment groups showed significantly improved functional scores 3 months postoperatively. Both treatment groups showed significantly improved flexion elevation (FE) and external rotation (ER) 1 year postoperatively and internal rotation (IR) 6 months postoperatively. No significant difference between the 2 groups was found in any of the outcome measurements at any time point postoperatively. Arthroscopic subacromial decompression is a reliable treatment for refractory impingement syndrome. The additional radiofrequency based plasma microtenotomy did not show any significant positive effects regarding pain relief, ROM, or functional recovery. Copyright © 2013 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.

  19. Efficacy of Esomeprazole for Treatment of Poorly Controlled Asthma; a Randomized Controlled Trial

    Science.gov (United States)

    Mastronarde, John G.; Anthonisen, Nicholas R.; Castro, Mario; Holbrook, Janet T.; Leone, Frank T.; Teague, W. Gerald; Wise, Robert A.

    2010-01-01

    Background Gastroesophageal reflux (GER) is common in asthma patients but often has mild or no symptoms. It is not known whether treatment of GER with proton pump inhibitors (PPIs) in poorly-controlled asthmatics without GER symptoms can substantially improve asthma control. Methods 402 asthmatics with inadequate asthma control despite inhaled corticosteroids and absent or minimal GER symptoms were randomly assigned to either esomeprazole 40mg b.i.d. or matching placebo in a parallel-group double-masked clinical trial. Participants were followed for 24 weeks with daily asthma diaries, every 4-week spirometry, and asthma symptom questionnaires. Participants were classified with respect to GER status with ambulatory pH probe monitoring. The primary outcome was the rate of episodes of poor asthma control (EPACs) based on asthma diaries. Results Episodes of poor asthma control occurred with similar frequency in the placebo and esomeprazole treatment groups (2.3 vs 2.5 events/person-year, respectively, P=0.66). There was no treatment effect with respect to components of the EPACs, or secondary outcomes including pulmonary function, airways reactivity, asthma control, symptom scores, nocturnal awakenings, or quality of life. GER documented by pH probe studies in 40% of participants with absent or minimal symptoms did not identify a subgroup benefitting from PPI treatment. Conclusion Despite a high prevalence of asymptomatic GER in patients with poorly controlled asthma, treatment with proton pump inhibitors does not improve control. Silent GER is not a likely cause of poorly controlled asthma. PMID:19357404

  20. Executive function predicts response to antiaggression treatment in schizophrenia: a randomized controlled trial.

    Science.gov (United States)

    Krakowski, Menahem I; Czobor, Pal

    2012-01-01

    Despite extensive experience with antipsychotic medications, we have limited capacity to predict which patients will benefit from which medications and for what symptoms. Such prediction is of particular importance for the proper treatment of violence. Our goal was to determine whether executive function predicts outcome of treatment for aggressive behavior and whether such prediction varies across medication groups. Ninety-nine physically aggressive inpatients (aged 18-60 years) with schizophrenia or schizoaffective disorder (diagnosed according to DSM-IV) who completed tests of executive function were randomly assigned in a double-blind, parallel-group, 12-week trial to clozapine (n = 32), olanzapine (n = 32), or haloperidol (n = 35). The number and severity of aggressive events as measured by the Modified Overt Aggression Scale (MOAS) were the outcome measures. Psychopathology and medication side effects were also assessed. The study was conducted from 1999 to 2004. Poor executive function predicted higher levels of aggression, as measured by MOAS scores over the 12-week period, in all 3 medication groups (F(1,98) = 222.2, P aggression in patients with schizophrenia. clinicaltrials.gov Identifier: NCT01123408. © Copyright 2012 Physicians Postgraduate Press, Inc.

  1. Tailored versus Triple plus Bismuth or Concomitant Therapy as Initial Helicobacter pylori Treatment: A Randomized Trial.

    Science.gov (United States)

    Zhou, Liya; Zhang, Jianzhong; Song, Zhiqiang; He, Lihua; Li, Yanqing; Qian, Jiaming; Bai, Peng; Xue, Yan; Wang, Ye; Lin, Sanren

    2016-04-01

    With markedly increased antibiotic resistance and unsatisfactory efficacies of common empiric eradication regimens in the mainland of China, tailored therapy may be the best choice to achieve good efficacy. This study compared the eradication rates, safety, and compliance of tailored therapy to those of triple therapy plus bismuth and concomitant therapy in the naïve patients with Helicobacter pylori infection. Between September 2013 and April 2014, 1050 patients with H. pylori infection at three tertiary hospitals were randomly assigned to 10-day treatment with tailored, triple plus bismuth, or concomitant regimens. In tailored therapy, medications were adjusted according to clarithromycin sensitivity and cytochrome P450 isoenzyme 2C19 genotype. The antimicrobial susceptibility testing (E test) was performed. Eradication status was assessed 4-12 weeks after treatment. The eradication rate was significantly higher in tailored group than in triple plus bismuth and concomitant groups in both intention-to-treat (88.7 vs 77.4 vs 78.3%, p bismuth and 75.9, 87.2, 92.9, and 95.2% in concomitant therapy, respectively. First-line tailored therapy achieves significantly higher eradication rates and fewer side effects, compared to triple therapy plus bismuth and concomitant therapy in a setting with high rates of clarithromycin and metronidazole resistance. © 2015 John Wiley & Sons Ltd.

  2. [Diltiazem versus intravenous nitroglycerin in the treatment of unstable angina pectoris. A randomized study].

    Science.gov (United States)

    Castro, P; Corbalán, R; Vergara, I; Kunstmann, S

    1995-07-01

    Prognosis of unstable angina pectoris is related to admission EKG changes and prompt symptom control. The aim of this study was to compare the clinical effects of intravenous diltiazem (DTZ) or nitroglycerin (NTG) in patients with unstable angina pectoris. We studied 43 patients admitted to the hospital with a history of rest angina within the last 48 hours, associated with EKG evidence of ischemia. All subjects received intravenous heparin and oral aspirin, 23 were randomly assigned to receive intravenous DTZ and 20 to receive intravenous NTG. Both groups had similar baseline features and the endpoints of treatment were recurrence of angina, myocardial infarction, death during hospitalization and secondary side effects. Treatment with DTZ, when compared to NTG, resulted in a significant reduction of recurrent angina (8.7 and 59% respectively; p bradicardia with DTZ (28% of patients). In each group, one patient had a myocardial infarction and one patient died. It is concluded that intravenous DTZ reduces myocardial ischemia to a greater extent than NTG and can be safely used in patients with unstable angina pectoris.

  3. Randomized trial of three phototherapy methods for the treatment of acne vulgaris in Chinese patients.

    Science.gov (United States)

    Liu, Li-Hong; Fan, Xin; An, Yu-Xi; Zhang, Jin; Wang, Cong-Min; Yang, Rong-Ya

    2014-10-01

    Acne vulgaris is common in Asian populations. We compared three methods of phototherapy for the treatment of moderate to severe facial acne vulgaris in Chinese patients. Patients were randomly assigned to receive photodynamic therapy (PDT), intense pulsed light (IPL) or blue-red light-emitting diode (LED) phototherapy to the right side of the face until the inflammatory lesion count reduced by ≥ 90%. Patients were examined at 1 and 3 months after the final treatment. We enrolled 150 patients (92 males; mean age, 28 years). At 1 month, ≥90% clearance or moderate improvement occurred in 46/50 (92%), 29/50 (58%) and 22/50 (44%) patients in the PDT, IPL and LED groups, respectively (mean number of sessions required, PDT: 3 ± 1.52; IPL: 6 ± 2.15; LED: 9 ± 3.34). Forty-six (92%) patients experienced mild to moderate pain, erythema and edema after PDT, which resolved within 5-7 days. Slight erythema and stinging were reported immediately after IPL and LED, resolving within 2 h. After 3 months, minimal papules and pustules were observed in 4 patients in the PDT group, 7 in the IPL group and 12 in the LED group, but no nodular pustules recurred. Phototherapy is efficacious for moderate to severe facial acne vulgaris. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  4. Study Protocol for a Randomized Double Blind, Treatment Control Trial Comparing the Efficacy of a Micronutrient Formula to a Single Vitamin Supplement in the Treatment of Premenstrual Syndrome

    Directory of Open Access Journals (Sweden)

    Hannah Retallick-Brown

    2016-12-01

    Full Text Available Background: The recent addition of Premenstrual Dysphoric Disorder (PMDD to the Diagnostic and Statistical Manual (5th ed. has highlighted the seriousness of this disorder. Many alternatives to psychoactive medication in the form of vitamins, minerals, and plant extracts have been trialled by women seeking a natural treatment approach. We plan to explore whether a well validated micronutrient formula, EMPowerplus Advanced, can outperform a recognized single nutrient treatment, vitamin B6, for the treatment of Premenstrual Syndrome (PMS. Methods: This will be a randomized treatment control study. Eighty women will be recruited and assigned to one of two treatment groups; EMPowerplus Advanced or vitamin B6. Baseline daily data will be collected for an initial two cycles, followed by three months of active treatment. A natural follow up will take place three cycles post treatment. Results: The primary outcome measure will be PMS change scores as based on results from the Daily Record of Severity of Problems (DRSP. The number of treatment responders for each of the two groups will yield a comparison score between the two treatments, with participants deemed as a responder if they show a total PMS score improvement of 50% from their baseline scores on the DRSP. Conclusion: If a micronutrient formula proves more effective for treating PMS, not only does it give women suffering from the condition a viable treatment option, but it may also suggest one cause of PMS; that is insufficient minerals and vitamins.

  5. Treatment of acute posttraumatic stress disorder with brief cognitive behavioral therapy: a randomized controlled trial

    NARCIS (Netherlands)

    Sijbrandij, Marit; Olff, Miranda; Reitsma, Johannes B.; Carlier, Ingrid V. E.; de Vries, Mirjam H.; Gersons, Berthold P. R.

    2007-01-01

    OBJECTIVE: The purpose of this study was to evaluate the efficacy of brief cognitive behavioral therapy for patients with acute posttraumatic stress disorder (PTSD) resulting from various types of psychological trauma. METHOD: The authors randomly assigned 143 patients with acute PTSD (irrespective

  6. Labetalol Versus Nifedipine as Antihypertensive Treatment for Chronic Hypertension in Pregnancy: A Randomized Controlled Trial.

    Science.gov (United States)

    Webster, Louise M; Myers, Jenny E; Nelson-Piercy, Catherine; Harding, Kate; Cruickshank, J Kennedy; Watt-Coote, Ingrid; Khalil, Asma; Wiesender, Cornelia; Seed, Paul T; Chappell, Lucy C

    2017-11-01

    Data from randomized controlled trials to guide antihypertensive agent choice for chronic hypertension in pregnancy are limited; this study aimed to compare labetalol and nifedipine, additionally assessing the impact of ethnicity on treatment efficacy. Pregnant women with chronic hypertension (12 +0 -27 +6 weeks' gestation) were enrolled at 4 UK centers (August 2014 to October 2015). Open-label first-line antihypertensive treatment was randomly assigned: labetalol- (200-1800 mg/d) or nifedipine-modified release (20-80 mg/d). Analysis included 112 women (98%) who completed the study (labetalol n=55, nifedipine n=57). Maximum blood pressure after randomization was 161/101 mm Hg with labetalol versus 163/105 mm Hg with nifedipine (mean difference systolic: 1.2 mm Hg [-4.9 to 7.2 mm Hg], diastolic: 3.3 mm Hg [-0.6 to 7.3 mm Hg]). Mean blood pressure was 134/84 mm Hg with labetalol and 134/85 mm Hg with nifedipine (mean difference systolic: 0.3 mm Hg [-2.8 to 3.4 mm Hg], and diastolic: -1.9 mm Hg [-4.1 to 0.3 mm Hg]). Nifedipine use was associated with a 7.4-mm Hg reduction (-14.4 to -0.4 mm Hg) in central aortic pressure, measured by pulse wave analysis. No difference in treatment effect was observed in black women (n=63), but a mean 4 mm Hg reduction (-6.6 to -0.8 mm Hg; P =0.015) in brachial diastolic blood pressure was observed with labetalol compared with nifedipine in non-black women (n=49). Labetalol and nifedipine control mean blood pressure to target in pregnant women with chronic hypertension. This study provides support for a larger definitive trial scrutinizing the benefits and side effects of first-line antihypertensive treatment. URL: https://www.isrctn.com. Unique identifier: ISRCTN40973936. © 2017 American Heart Association, Inc.

  7. Efficacy and safety of oral tinidazole and metronidazole in treatment of bacterial vaginosis: a randomized control trial

    Directory of Open Access Journals (Sweden)

    Zahra Abbaspoor

    2014-05-01

    Full Text Available Aims: Oral metronidazole 500 mg twice a day for one week is currently the treatment of choice for bacterial vaginosis (BV. Complete treatment by this regimen takes time and occurs less often. This drug has significant side effects too. Using a drug in the shortest treatment course may increases the success of treatment. To evaluate the effectiveness and safety of oral tinidazole compare to metronidazole in treatment of BV.Methods: In this randomized, controlled, double-blind, comparative, clinical trial, 110 non-pregnant women aged between 15-45 years with confirmed diagnosis of BV by Amsels criteria were randomly assigned to receive either 2 g tinidazole tablet once daily for 2 days (n=55 or 500 mg metronidazole table twice daily for 7 days (n=55.The cure and recurrence rate were evaluated in both groups after 2 and 4 weeks follow up visits. For statistical analysis t-test,   test, fisher's exact test and Mann-Whitney test were used.Results: The results showed that cure rate after 2 weeks in tinidazole tablet group was 84.6٪ and in metronidazole group was 85.4٪ (p=0.9, and after 4 weeks recurrence rate in tinidazole and metronidazole groups was 6.9٪and 12.1٪respectively (P=0.3.Conclusions: Tinidazole table 2 g once daily for 2 days is as effective as metronidazole tablet 500 mg twice a day for 7 days in treatment of BV.

  8. Acupuncture versus paroxetine for the treatment of premature ejaculation: a randomized, placebo-controlled clinical trial.

    Science.gov (United States)

    Sunay, Didem; Sunay, Melih; Aydoğmuş, Yasin; Bağbancı, Sahin; Arslan, Hüseyin; Karabulut, Ayhan; Emir, Levent

    2011-05-01

    Acupuncture therapy has been used by many researchers in both male and female sexual dysfunction studies. To determine whether acupuncture is effective as a premature ejaculation (PE) treatment compared with paroxetine and placebo. The study was conducted with methodologic rigor based on Consolidated Standards of Reporting Trials (CONSORT) criteria. Ninety patients referred to the urology clinic at a tertiary training and research hospital with PE were included in this randomized controlled trial and randomly assigned into paroxetine, acupuncture, and placebo groups. Heterosexual, sexually active men aged between 28 and 50 yr were included. Men with other sexual disorders, including erectile dysfunction; with chronic psychiatric or systemic diseases; with alcohol or substance abuse; or who used any medications were excluded. The medicated group received paroxetine 20 mg/d; the acupuncture or sham-acupuncture (placebo) groups were treated twice a week for 4 wk. Intravaginal ejaculation latency times (IELTs) and the Premature Ejaculation Diagnostic Tool (PEDT) were used to assess PE. IELTs were calculated by using a partner-held stopwatch. Data were analyzed statistically. Median PEDT scores of paroxetine, acupuncture, and placebo groups were 17.0, 16.0, and 15.5 before treatment, and 10.5, 11.0, and 16.0 after treatment, respectively (p=0.001, p=0.001, and p=0.314, respectively). Subscores after treatment were significantly lower than subscores before treatment in the paroxetine and acupuncture groups but remained the same in the placebo group. Significant differences were found between mean-rank IELTs of the paroxetine and placebo groups (p=0.001) and the acupuncture and placebo groups (p=0.001) after treatment. Increases of IELTs with paroxetine, acupuncture, and placebo acupuncture were 82.7, 65.7, and 33.1 s, respectively. Extent of ejaculation delay induced by paroxetine was significantly higher than that of acupuncture (p=0.001). The most important limitation

  9. Treatment of chronic lumbosacral radicular pain using adjuvant pulsed radiofrequency: a randomized controlled study.

    Science.gov (United States)

    Koh, Wonuk; Choi, Seong-Soo; Karm, Myong Hwan; Suh, Jeong Hun; Leem, Jeong Gil; Lee, Jae Do; Kim, Young Ki; Shin, Jinwoo

    2015-03-01

    The objective of this study was to determine the effects of combining pulsed radiofrequency (PRF) treatment and transforaminal epidural injection (TFEI) to treat patients with chronic refractory lumbar radicular pain caused by lumbar spinal stenosis. Randomized control trial. Interventional pain management practice. Sixty-two patients were assigned to the study groups (PRF group = 31; control group = 31). Under fluoroscopic guidance, the RF needle was positioned close to the lumbar dorsal root ganglion. The PRF group received 3 cycles of PRF treatment, and sensory stimulation without RF lesioning was applied to the control group. After PRF or sham lesioning, a local anesthetic with steroid was injected. The primary outcome of a successful response was defined as: 1) ≥50% or 4-point pain reduction in the numerical rating scale (NRS) without an increase in the Oswestry disability index (ODI) or medication quantification scale (MQS), or mean score <4 in the global perceived effect (GPE) scale; or 2) ≥30% or 2-point pain reduction in NRS with a simultaneous decrease in ODI, MQS, or ≥6 points in the GPE scale. The number of patients with successful treatment results was higher in the PRF group at 2 months (P = 0.032) and 3 months (P = 0.018). No significant differences were observed in terms of the secondary outcome variables between the 2 groups. The TFEI provided significant short-term pain relief and PRF can be applied in conjunction with TFEI to achieve higher treatment efficacy compared with TFEI alone. Wiley Periodicals, Inc.

  10. Esomeprazole treatment of frequent heartburn: two randomized, double-blind, placebo-controlled trials.

    Science.gov (United States)

    Peura, David A; Traxler, Barry; Kocun, Christopher; Lind, Tore

    2014-07-01

    To determine the efficacy of a 14-day regimen of esomeprazole 20 mg for the treatment of frequent heartburn in subjects who are likely to self-treat with over-the-counter medications without consulting a health care provider. Adults with frequent heartburn ≥ 2 days per week in the past 4 weeks were randomly assigned to 14-day double-blind treatment with esomeprazole 20 mg once daily or placebo in 2 identical multicenter studies (ClinicalTrials.gov identifiers: NCT01370525, NCT01370538). The primary efficacy outcome was percentage of heartburn-free 24-hour days across 14 days. Secondary efficacy outcomes included heartburn resolution, defined as heartburn ≤ 2 days over 14 days, and percentages of subjects reporting ≤ 1 day with heartburn in the first and final weeks of treatment. Subjects recorded data in daily self-assessment diaries. The percentage of heartburn-free 24-hour days over 14 days was significantly higher (P esomeprazole 20 mg compared with placebo in study 1 (N = 331; 46.13% vs. 33.07%, respectively) and study 2 (N = 320; 48.00% vs 32.75%, respectively). Significantly more subjects treated with esomeprazole 20 mg had heartburn resolution over 14 days and in the first and final weeks compared with placebo. Within the first 4 days, the proportion of subjects with heartburn-free days was significantly greater with esomeprazole 20 mg versus placebo. Treatment was generally well tolerated, with a safety pattern consistent with the known profile for esomeprazole. A 14-day regimen of esomeprazole 20 mg once daily was effective for treating frequent heartburn in subjects who are likely to self-treat with over-the-counter medications.

  11. Effects of an integrated Yoga Program on Self-reported Depression Scores in Breast Cancer Patients Undergoing Conventional Treatment: A Randomized Controlled Trial

    OpenAIRE

    Raghavendra Mohan Rao; Nagarathna Raghuram; H.R. Nagendra; M R Usharani; Gopinath, K. S.; Diwakar, Ravi B; Shekar Patil; Bilimagga, Ramesh S.; Nalini Rao

    2015-01-01

    Aim: To compare the effects of yoga program with supportive therapy on self-reported symptoms of depression in breast cancer patients undergoing conventional treatment. Patients and Methods: Ninety-eight breast cancer patients with stage II and III disease from a cancer center were randomly assigned to receive yoga (n = 45) and supportive therapy (n = 53) over a 24-week period during which they underwent surgery followed by adjuvant radiotherapy (RT) or chemotherapy (CT) or both. The stud...

  12. Effects of Mild Curvature on ANCOVA and Randomized Blocks.

    Science.gov (United States)

    Klockars, Alan J.; Potter, Nina Salcedo

    The type I error control and power of a number of analysis of covariance (ANCOVA) and randomized block (RB) designs with curvilinear data were studied for tests of the additive treatment effect and interaction. For tests of additive effects, the analysis was also conducted using systematic assignment to treatments and using random assignment with…

  13. Effect of sanhuangwuji powder, anti-rheumatic drugs, and ginger-partitioned acupoint stimulation on the treatment of rheumatoid arthritis with peptic ulcer: a randomized controlled study.

    Science.gov (United States)

    Liu, Defang; Guo, Mingyang; Hu, Yonghe; Liu, Taihua; Yan, Jiao; Luo, Yong; Yun, Mingdong; Yang, Min; Zhang, Jun; Guo, Linglin

    2015-06-01

    To observe the efficacy and safety of oral sanhuangwuji powder, anti-rheumatic drugs (ARDs), and ginger-partitioned acupoint stimulation at zusanli (ST 36) on the treatment of rheumatoid arthritis (RA) complicated by peptic ulcer. This prospective randomized controlled study included 180 eligible inpatients and outpatients randomly assigned to an ARD treatment (n.= 60), ginger-partitioned stimulation (n = 60), or combination treatment (n = 60). Patients assigned to the ARD group were given oral celecoxib, methotrexate, and esomeprazole. Patients assigned to the ginger-partitioned stimulation group were given ginger-partitioned acupoint stimulation at zusanli (ST 36) in addition to the ARDs. Patients in the combination treatment group were given oral sanhuangwuji powder, ginger-partitioned acupoint stimulation at susanli (ST 36), and ARDs. All patients were followed up for 2 months to evaluate clinical effects and safety. The study was registered in the World Health Organization database at the General Hospital of Chengdu Military Area Command Chinese People's Liberation Army (ChiCTR-TCC12002824). The combination treatment group had significantly greater improvements in RA symptoms, laboratory outcomes, and gastrointestinal symptom scores, compared with the other groups (P ginger-partitioned stimulation group (χ2= 6.171, P ginger-partitioned acupoint stimulation at zusanli (ST 36), oral sanhuangwuji powder, and ARDs had a better clinical effect for RA with complicated peptic ulcer, compared with ARD treatmentalone or in combination with ginger-partitioned acupoint stimulation.

  14. The effectiveness of anxiety treatment on alcohol-dependent patients with a comorbid phobic disorder: a randomized controlled trial.

    Science.gov (United States)

    Schadé, Annemiek; Marquenie, Loes A; van Balkom, Anton J L M; Koeter, Maarten W J; de Beurs, Edwin; van den Brink, Wim; van Dyck, Richard

    2005-05-01

    Evidence has emerged which indicates that the post-treatment relapse rate for alcohol-dependent patients with a comorbid anxiety disorder is higher than for alcohol-dependent patients without a comorbid anxiety disorder. The question raised by this evidence is whether the relapse rate in these dually diagnosed patients could be reduced if they were given additional treatment for the comorbid anxiety disorder. We attempted to answer this question by conducting a trial among patients with a double diagnosis of alcohol dependence and agoraphobia or social phobia. We conducted a 32-week randomized controlled trial among 96 abstinent patients with a primary diagnosis of alcohol dependence and a comorbid anxiety disorder involving agoraphobia or social phobia. The patients were randomly assigned to an intensive psychosocial relapse-prevention program on its own (n = 49) or in combination with an anxiety treatment program comprising cognitive behavioral therapy (CBT) and optional pharmacotherapy consisting of an SSRI (n = 47). The primary outcome measure was the percentage of patients who suffered an alcohol relapse during a 32-week period. The secondary outcome measures were total abstinence, a reduction in the days of heavy drinking, and less severe anxiety symptoms. Although the additional therapy clearly reduced the anxiety symptoms, it had no significant effect on the alcohol relapse rates. Anxiety treatment for alcohol-dependent patients with a comorbid anxiety disorder can alleviate anxiety symptoms, but it has no significant effect on the outcome of alcohol treatment programs.

  15. Maintaining Treatment Fidelity of Mindfulness-Based Relapse Prevention Intervention for Alcohol Dependence: A Randomized Controlled Trial Experience

    Directory of Open Access Journals (Sweden)

    Aleksandra E. Zgierska

    2017-01-01

    Full Text Available Background. Treatment fidelity is essential to methodological rigor of clinical trials evaluating behavioral interventions such as Mindfulness Meditation (MM. However, procedures for monitoring and maintenance of treatment fidelity are inconsistently applied, limiting the strength of such research. Objective. To describe the implementation and findings related to fidelity monitoring of the Mindfulness-Based Relapse Prevention for Alcohol Dependence (MBRP-A intervention in a 26-week randomized controlled trial. Methods. 123 alcohol dependent adults were randomly assigned to MM (MBRP-A and home practice, adjunctive to usual care; N=64 or control (usual care alone; N=59. Treatment fidelity assessment strategies recommended by the National Institutes of Health Behavior Change Consortium for study/intervention design, therapist training, intervention delivery, and treatment receipt and enactment were applied. Results. Ten 8-session interventions were delivered. Therapist adherence and competence, assessed using the modified MBRP Adherence and Competence Scale, were high. Among the MM group participants, 46 attended ≥4 sessions; over 90% reported at-home MM practice at 8 weeks and 72% at 26 weeks. They also reported satisfaction with and usefulness of MM for maintaining sobriety. No adverse events were reported. Conclusions. A systematic approach to assessment of treatment fidelity in behavioral clinical trials allows determination of the degree of consistency between intended and actual delivery and receipt of intervention.

  16. Health outcomes of continuous positive airway pressure versus oral appliance treatment for obstructive sleep apnea: a randomized controlled trial.

    Science.gov (United States)

    Phillips, Craig L; Grunstein, Ronald R; Darendeliler, M Ali; Mihailidou, Anastasia S; Srinivasan, Vasantha K; Yee, Brendon J; Marks, Guy B; Cistulli, Peter A

    2013-04-15

    Continuous positive airway pressure (CPAP) and mandibular advancement device (MAD) therapy are commonly used to treat obstructive sleep apnea (OSA). Differences in efficacy and compliance of these treatments are likely to influence improvements in health outcomes. To compare health effects after 1 month of optimal CPAP and MAD therapy in OSA. In this randomized crossover trial, we compared the effects of 1 month each of CPAP and MAD treatment on cardiovascular and neurobehavioral outcomes. Cardiovascular (24-h blood pressure, arterial stiffness), neurobehavioral (subjective sleepiness, driving simulator performance), and quality of life (Functional Outcomes of Sleep Questionnaire, Short Form-36) were compared between treatments. Our primary outcome was 24-hour mean arterial pressure. A total of 126 patients with moderate-severe OSA (apnea hypopnea index [AHI], 25.6 [SD 12.3]) were randomly assigned to a treatment order and 108 completed the trial with both devices. CPAP was more efficacious than MAD in reducing AHI (CPAP AHI, 4.5 ± 6.6/h; MAD AHI, 11.1 ± 12.1/h; P health outcomes were similar after 1 month of optimal MAD and CPAP treatment in patients with moderate-severe OSA. The results may be explained by greater efficacy of CPAP being offset by inferior compliance relative to MAD, resulting in similar effectiveness. Clinical trial registered with https://www.anzctr.org.au (ACTRN 12607000289415).

  17. A randomized clinical trial comparing general exercise, McKenzie treatment and a control group in patients with neck pain.

    Science.gov (United States)

    Kjellman, Görel; Oberg, Birgitta

    2002-07-01

    Seventy-seven patients with neck pain in the primary health care were included in a prospective, randomized clinical trial and randomly assigned to general exercise, McKenzie treatment, or a control group. Seventy patients completed the treatment; response rate 93% at 12-month follow-up. All three groups showed significant improvement regarding the main outcomes, pain intensity and Neck Disability Index, even at 12-month follow-up, but there was no significant difference between the groups. In all, 79% reported that they were better or completely restored after treatment, although 51% reported constant/daily pain. In the McKenzie group compared with the control group, a tendency toward greater improvement was noted for pain intensity at 3 weeks and at 6-month follow-up, and for post-treatment Neck Disability Index. Significant improvement in Distress and Risk Assessment Method scores was shown in the McKenzie group only. The three groups had similar recurrence rates, although after 12 months the McKenzie group showed a tendency toward fewer visits for additional health care. The study did not provide a definite evidence of treatment efficacy in patients with neck pain, however, there was a tendency toward a better outcome with the two active alternatives compared with the control group.

  18. Topical cyclosporine a 0.05% eyedrops in the treatment of vernal keratoconjunctivitis - randomized placebo-controlled trial.

    Science.gov (United States)

    Keklikci, Ugur; Dursun, Birgul; Cingu, Abdullah Kursat

    2014-01-01

    Vernal keratoconjunctivitis (VKC) is a chronic, bilateral inflammation of the conjunctiva that mostly affects children and young adult males. Management of VKC is primarily aimed at reducing symptoms and preventing serious vision threatening sequelae. To assess the efficacy of topical cyclosporine A (CsA) 0.05% on the signs and symtomps in the management of VKC. This is a placebo-controlled, randomized prospective study. Sixty-two patients with VKC were included in this study. Patients were randomly assigned (1 : 1) to treatment with topical 0.05% CsA eyedrops or a placebo (artificial tears) for a period of 4 weeks, 4 times daily. Ocular signs and symptoms were in all patients scored at entry and at the end of 4 weeks. When pre-treatment mean signs and symptoms scores were compared in both groups, there was no significant difference (p > 0.05). However, mean post-treatment scores as regards signs and symptoms were found to be lower in cyclosporine group than those in placebo group (p < 0.001). No side effects of the treatment with CsA 0.05% eyedrops were observed. It was found that topical CsA 0.05% eyedrops were safe and effective in the treatment of patients with VKC.

  19. Randomized clinical trial of multimodal physiotherapy treatment compared to overnight lidocaine ointment in women with provoked vestibulodynia: Design and methods.

    Science.gov (United States)

    Morin, Mélanie; Dumoulin, Chantale; Bergeron, Sophie; Mayrand, Marie-Hélène; Khalifé, Samir; Waddell, Guy; Dubois, Marie-France

    2016-01-01

    Provoked vestibulodynia (PVD) is a highly prevalent and debilitating condition yet its management relies mainly on non-empirically validated interventions. Among the many causes of PVD, there is growing evidence that pelvic floor muscle (PFM) dysfunctions play an important role in its pathophysiology. Multimodal physiotherapy, which addresses these dysfunctions, is judged by experts to be highly effective and is recommended as a first-line treatment. However, the effectiveness of this promising intervention has been evaluated through only two small uncontrolled trials. The proposed bi-center, single-blind, parallel group, randomized controlled trial (RCT) aims to evaluate the efficacy of multimodal physiotherapy and compare it to a frequently used first-line treatment, topical overnight application of lidocaine, in women with PVD. A total of 212 women diagnosed with PVD according to a standardized protocol were eligible for the study and were randomly assigned to either multimodal physiotherapy or lidocaine treatment for 10weeks. The primary outcome measure is pain during intercourse (assessed with a numerical rating scale). Secondary measures include sexual function, pain quality, psychological factors (including pain catastrophizing, anxiety, depression and fear of pain), PFM morphology and function, and patients' global impression of change. Assessments are made at baseline, post-treatment and at the 6-month follow-up. This manuscript presents and discusses the rationale, design and methodology of the first RCT investigating physiotherapy in comparison to a commonly prescribed first-line treatment, overnight topical lidocaine, for women with PVD. Copyright © 2015 Elsevier Inc. All rights reserved.

  20. Prophylactic nimodipine treatment for cochlear and facial nerve preservation after vestibular schwannoma surgery: a randomized multicenter Phase III trial.

    Science.gov (United States)

    Scheller, Christian; Wienke, Andreas; Tatagiba, Marcos; Gharabaghi, Alireza; Ramina, Kristofer F; Ganslandt, Oliver; Bischoff, Barbara; Zenk, Johannes; Engelhorn, Tobias; Matthies, Cordula; Westermaier, Thomas; Antoniadis, Gregor; Pedro, Maria Teresa; Rohde, Veit; von Eckardstein, Kajetan; Kretschmer, Thomas; Kornhuber, Malte; Steighardt, Jörg; Richter, Michael; Barker, Fred G; Strauss, Christian

    2016-03-01

    A pilot study of prophylactic nimodipine and hydroxyethyl starch treatment showed a beneficial effect on facial and cochlear nerve preservation following vestibular schwannoma (VS) surgery. A prospective Phase III trial was undertaken to confirm these results. An open-label, 2-arm, randomized parallel group and multicenter Phase III trial with blinded expert review was performed and included 112 patients who underwent VS surgery between January 2010 and February 2013 at 7 departments of neurosurgery to investigate the efficacy and safety of the prophylaxis. The surgery was performed after the patients were randomly assigned to one of 2 groups using online randomization. The treatment group (n = 56) received parenteral nimodipine (1-2 mg/hr) and hydroxyethyl starch (hematocrit 30%-35%) from the day before surgery until the 7th postoperative day. The control group (n = 56) was not treated prophylactically. Intent-to-treat analysis showed no statistically significant effects of the treatment on either preservation of facial nerve function (35 [67.3%] of 52 [treatment group] compared with 34 [72.3%] of 47 [control group]) (p = 0.745) or hearing preservation (11 [23.4%] of 47 [treatment group] compared with 15 [31.2%] of 48 [control group]) (p = 0.530) 12 months after surgery. Since tumor sizes were significantly larger in the treatment group than in the control group, logistic regression analysis was required. The risk for deterioration of facial nerve function was adjusted nearly the same in both groups (OR 1.07 [95% CI 0.34-3.43], p = 0.91). In contrast, the risk for postoperative hearing loss was adjusted 2 times lower in the treatment group compared with the control group (OR 0.49 [95% CI 0.18-1.30], p = 0.15). Apart from dose-dependent hypotension (p nimodipine can be recommended in VS surgery.

  1. Acupuncture treatment of shoulder impingement syndrome: A randomized controlled trial.

    Science.gov (United States)

    Rueda Garrido, Juan Carlos; Vas, Jorge; Lopez, D Rafael

    2016-04-01

    Shoulder pain or omalgia is one of the main types of osteoarticular pain that can be observed in every-day clinical practice, frequently causing significant functional impairment. The most common cause of shoulder pain is impingement syndrome. To decrease the intensity of short- and mid-term pain in the injured shoulder by means of acupuncture. Randomized controlled trial with two groups of participants: one group received true acupuncture (TA) and the other received acupuncture at sham points (SA). The treatment was carried out over 4 weeks, with the participants receiving a session every week. The results were measured immediately after the treatment (T1) and 3 months later (T2). To evaluate the results, we used the 100 mm Visual Analogue Scale (VAS), and to assess the functionality of the shoulder we employed the UCLA questionnaire (0-35 points). A total of 68 participants were included in the analysis (TA, n=35; SA, n=33), with a mean age of 33.4 years (SD 12.53). We found significant differences in the analyzed results between the two groups, as we observed a decrease on the intensity of pain for the TA group of 44.13 mm at T1 (CI 95% 36.7; 51.5) and 87.58 mm at T2 (CI 95% 28.32; 46.81), while the decrease in the FA group was of 19.84 mm at T1 (CI 95% 12.2; 27.4) and 20 mm at T2 (CI 95% 10.9; 29.09). When the UCLA scores were analyzed, the results were clinically meaningful in support of TA in terms of functional assessment of the shoulder. No adverse effects were reported. The use of acupuncture to treat impingement syndrome seems to be a safe and reliable technique to achieve clinically significant results and could be implemented in the therapy options offered by the health services. Copyright © 2016 Elsevier Ltd. All rights reserved.

  2. Acupuncture for the treatment of phantom limb pain in lower limb amputees: study protocol for a randomized controlled feasibility trial.

    Science.gov (United States)

    Trevelyan, Esmé G; Turner, Warren A; Robinson, Nicola

    2015-04-12

    Phantom limb pain is a prevalent condition that is difficult to manage, with a lack of robust evidence to support the use of many adjunctive treatments. Acupuncture can be effective in the management of many painful conditions but little is known about its effectiveness in treating phantom limb pain. The aim of this study is to explore the feasibility of conducting a randomized controlled trial comparing acupuncture and routine care in a group of lower limb amputees with phantom limb pain. An unstratified, pragmatic, randomized, two-armed, controlled trial of parallel design comparing acupuncture and usual care control will be conducted. A total of 20 participants will be randomly assigned to receive either usual care or usual care plus acupuncture. Acupuncture will include eight 1 hour treatments delivered pragmatically over 4 weeks by practitioners trained in traditional Chinese medicine. As outcome measures, the Numerical Pain Rating Scale, short-form McGill Pain Questionnaire 2, EQ-5D-5 L, Hospital Anxiety and Depression Scale, 10-Item Perceived Stress Scale, Insomnia Severity Index, and Patient Global Impression of Change will be completed at baseline, weekly for the duration of the study and at 1 month after completion of the study. After completion of the trial, participants will provide feedback though semi-structured interviews. Feasibility will be determined through the ability to recruit to the study, success of the randomization process, completion of acupuncture intervention, acceptability of random allocation and completion of outcome measures. Acceptability of the acupuncture intervention will be determined through semi-structured interviews with participants. The appropriateness of outcome measures for a future trial will be addressed through completion rates of questionnaires and participant feedback. Data generated on effect size will be used for future sample size calculations and will inform the development of an appropriate and feasible

  3. Finite-sample corrected generalized estimating equation of population average treatment effects in stepped wedge cluster randomized trials.

    Science.gov (United States)

    Scott, JoAnna M; deCamp, Allan; Juraska, Michal; Fay, Michael P; Gilbert, Peter B

    2017-04-01

    Stepped wedge designs are increasingly commonplace and advantageous for cluster randomized trials when it is both unethical to assign placebo, and it is logistically difficult to allocate an intervention simultaneously to many clusters. We study marginal mean models fit with generalized estimating equations for assessing treatment effectiveness in stepped wedge cluster randomized trials. This approach has advantages over the more commonly used mixed models that (1) the population-average parameters have an important interpretation for public health applications and (2) they avoid untestable assumptions on latent variable distributions and avoid parametric assumptions about error distributions, therefore, providing more robust evidence on treatment effects. However, cluster randomized trials typically have a small number of clusters, rendering the standard generalized estimating equation sandwich variance estimator biased and highly variable and hence yielding incorrect inferences. We study the usual asymptotic generalized estimating equation inferences (i.e., using sandwich variance estimators and asymptotic normality) and four small-sample corrections to generalized estimating equation for stepped wedge cluster randomized trials and for parallel cluster randomized trials as a comparison. We show by simulation that the small-sample corrections provide improvement, with one correction appearing to provide at least nominal coverage even with only 10 clusters per group. These results demonstrate the viability of the marginal mean approach for both stepped wedge and parallel cluster randomized trials. We also study the comparative performance of the corrected methods for stepped wedge and parallel designs, and describe how the methods can accommodate interval censoring of individual failure times and incorporate semiparametric efficient estimators.

  4. Assessment of alternative emergency treatments for symptomatic irreversible pulpitis: a randomized clinical trial.

    Science.gov (United States)

    Eren, B; Onay, E O; Ungor, M

    2017-08-30

    To evaluate three emergency procedures for their ability to alleviate clinical symptoms associated with symptomatic teeth having signs of (at least) partial irreversible pulpitis. Sixty-six maxillary and mandibular molars were randomly assigned to a total pulpectomy group (TP; n = 22), partial pulpectomy group (PP; n = 22) or pulpotomy group (P; n = 22). Procedure durations were recorded. Patients answered a questionnaire on daily analgesic requirements and about clinical symptoms (pain intensity, chewing sensitivity and thermal sensitivity) after the anaesthetic effect had disappeared (Day 0) and on Days 1, 3 and 7 post-treatment. The total pulpectomy group was associated with the longest procedures (median, 24 min), followed by the partial pulpectomy and pulpotomy groups (P pulpectomy group reported greater reductions in pain intensity than the pulpotomy group between Days 0 and 7, Days 1 and 3, and Days 1 and 7 (P pulpectomy and total pulpectomy were comparable with respect to relieving clinical symptoms. Pulpotomy may be preferred because it requires significantly less time and is a simple technique that relieves symptoms quickly and effectively. © 2017 International Endodontic Journal. Published by John Wiley & Sons Ltd.

  5. A double blind randomized trial of ketofol versus propofol for endodontic treatment of anxious pediatric patients.

    Science.gov (United States)

    Mittal, N; Goyal, A; Gauba, K; Kapur, A; Jain, K

    2013-01-01

    To find out the safe and efficient sedative agent for primary molar pulpectomy in uncooperative pediatric patients. This double blind randomized trial enrolled 40 anxious and healthy 2-6 year olds. All subjects received IV propofol (1-1.5 mg/kg) or ketofol (1-1.5 mg/kg propofol with 0.25 mg/kg ketamine) as per group assignment after oral midazolam premedication (0.5 mg/kg). Sedation maintenance was done with propofol infusion at 25-75 microg/kg/min titrated to a predefined Worse level as per Houpt's sedation rating scale. Additional bolus/es was/were administered in the dosage similar to induction dose in case of inadequate sedation. Primary outcomes were intraoperative and postoperative adverse events. Secondary outcomes were vital signs, success of procedure, operator satisfaction, sedation quality, treatment time, recovery time and total propofol dose. Significantly greater incidence of respiratory depression was reported for ketofol group (11/20; 55%) when compared to propofol group (3/20; 15%) (p = 0.008). Desaturation was the most common adverse respiratory event with significantly greater incidence in ketofol group (9/20; 45%) when compared to propofol only group (3/20; 15%) (p = 0.033). No significant differences regarding secondary outcomes were reported in two groups. Both the regimen exhibited similar sedation profile while propofol alone emerged as a safer option.

  6. Echinacea purpurea and osteopathic manipulative treatment in children with recurrent otitis media: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Worden Katherine A

    2008-10-01

    Full Text Available Abstract Background Recurrent otitis media is a common problem in young children. Echinacea and osteopathic manipulative treatment have been proposed as preventive measures, but have been inadequately studied. This study was designed to assess the efficacy of Echinacea purpurea and/or osteopathic manipulative treatment (OMT for prevention of acute otitis media in otitis-prone children. Methods A randomized, placebo-controlled, two-by-two factorial trial with 6-month follow-up, conducted 1999 – 2002 in Tucson, Arizona. Patients were aged 12–60 months with recurrent otitis media, defined as three or more separate episodes of acute otitis media within six months, or at least four episodes in one year. Ninety children (44% white non-Hispanic, 39% Hispanic, 57% male were enrolled, of which 84 had follow-up for at least 3 months. Children were randomly assigned to one of four protocol groups: double placebo, echinacea plus sham OMT, true OMT (including cranial manipulation plus placebo echinacea, or true echinacea plus OMT. An alcohol extract of Echinacea purpurea roots and seeds (or placebo was administered for 10 days at the first sign of each common cold. Five OMT visits (or sham treatments were offered over 3 months. Results No interaction was found between echinacea and OMT. Echinacea was associated with a borderline increased risk of having at least one episode of acute otitis media during 6-month follow-up compared to placebo (65% versus 41%; relative risk, 1.59, 95% CI 1.04, 2.42. OMT did not significantly affect risk compared to sham (44% versus 61%; relative risk, 0.72, 95% CI 0.48, 1.10. Conclusion In otitis-prone young children, treating colds with this form of echinacea does not decrease the risk of acute otitis media, and may in fact increase risk. A regimen of up to five osteopathic manipulative treatments does not significantly decrease the risk of acute otitis media. Trial registration ClinicalTrials.gov Identifier: NCT00010465

  7. Echinacea purpurea and osteopathic manipulative treatment in children with recurrent otitis media: a randomized controlled trial

    Science.gov (United States)

    Wahl, Richard A; Aldous, Michael B; Worden, Katherine A; Grant, Kathryn L

    2008-01-01

    Background Recurrent otitis media is a common problem in young children. Echinacea and osteopathic manipulative treatment have been proposed as preventive measures, but have been inadequately studied. This study was designed to assess the efficacy of Echinacea purpurea and/or osteopathic manipulative treatment (OMT) for prevention of acute otitis media in otitis-prone children. Methods A randomized, placebo-controlled, two-by-two factorial trial with 6-month follow-up, conducted 1999 – 2002 in Tucson, Arizona. Patients were aged 12–60 months with recurrent otitis media, defined as three or more separate episodes of acute otitis media within six months, or at least four episodes in one year. Ninety children (44% white non-Hispanic, 39% Hispanic, 57% male) were enrolled, of which 84 had follow-up for at least 3 months. Children were randomly assigned to one of four protocol groups: double placebo, echinacea plus sham OMT, true OMT (including cranial manipulation) plus placebo echinacea, or true echinacea plus OMT. An alcohol extract of Echinacea purpurea roots and seeds (or placebo) was administered for 10 days at the first sign of each common cold. Five OMT visits (or sham treatments) were offered over 3 months. Results No interaction was found between echinacea and OMT. Echinacea was associated with a borderline increased risk of having at least one episode of acute otitis media during 6-month follow-up compared to placebo (65% versus 41%; relative risk, 1.59, 95% CI 1.04, 2.42). OMT did not significantly affect risk compared to sham (44% versus 61%; relative risk, 0.72, 95% CI 0.48, 1.10). Conclusion In otitis-prone young children, treating colds with this form of echinacea does not decrease the risk of acute otitis media, and may in fact increase risk. A regimen of up to five osteopathic manipulative treatments does not significantly decrease the risk of acute otitis media. Trial registration ClinicalTrials.gov Identifier: NCT00010465 PMID:18831749

  8. Continuous vs episodic prophylactic treatment with amiodarone for the prevention of atrial fibrillation : a randomized trial

    NARCIS (Netherlands)

    Ahmed, Sheba; Rienstra, Michiel; Crijns, Harry J. G. M.; Links, Thera P.; Wiesfeld, Ans C. P.; Hillege, Hans L.; Bosker, Hans A.; Lok, Dirk J. A.; Van Veldhuisen, Dirk J.; Van Gelder, Isabelle C.

    2008-01-01

    Context Amiodarone effectively suppresses atrial fibrillation but causes many adverse events. Objective To compare major events in patients randomized to receive episodic amiodarone treatment with those who received continuous amiodarone treatment while still aiming to prevent atrial fibrillation.

  9. Treatment of tympanic membrane perforation using bacterial cellulose: a randomized controlled trial.

    Science.gov (United States)

    Silveira, Fábio Coelho Alves; Pinto, Flávia Cristina Morone; Caldas Neto, Sílvio da Silva; Leal, Mariana de Carvalho; Cesário, Jéssica; Aguiar, José Lamartine de Andrade

    2016-01-01

    Promising treatments for tympanic membrane perforation closure have been studied. Therapies derived from tissue engineering probably eliminate the need for conventional surgery. Bacterial cellulose is presented as an alternative that is safe, biocompatible, and has low toxicity. To investigate the effect on healing of direct application of a bacterial cellulose graft on the tympanic membrane compared to the conventional approach with autologous fascia. Randomized controlled trial. Forty patients with tympanic membrane perforations secondary to chronic otitis media were included, and were randomly assigned to an experimental group (20), treated with a bacterial cellulose graft (BC) and control group (20), treated with autologous temporal fascia (fascia). We evaluated the surgical time, hospital stay, time of epithelialization and the rate of tympanic perforation closure. Hospital costs were compared. The statistical significance level accepted was established at p<0.05. The closure of perforations was similar in both groups. The average operation time in the fascia group was 76.50 min versus 14.06 min bacterial cellulose in the group (p=0.0001). The hospital cost by the Brazilian public health system was R$ 600.00 for the bacterial cellulose group, and R$ 7778.00 for the fascia group (p=0.0001). Bacterial cellulose grafts promoted the closure of the tympanic membrane perforations, and were demonstrated to be innovative, effective, safe, minimally invasive, efficacious and to have a very low cost. Copyright © 2015 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. Published by Elsevier Editora Ltda. All rights reserved.

  10. [Hydrocortisone for the treatment of refractory hypotension: a randomized controlled trial].

    Science.gov (United States)

    Salas, G; Travaglianti, M; Leone, A; Couceiro, C; Rodríguez, S; Fariña, D

    2014-06-01

    Systemic hypotension is a common sign in critically sick infants. Several studies have suggested that the use of short series of corticosteroids increases arterial blood pressure and reduces the inotropic support needs in preterm neonates with hypotension. There are a small number of reports on the use of hydrocortisone (HC) for the treatment of refractory hypotension in infants. To assess the effectiveness of hydrocortisone in the reduction of inotropic support in infants with refractory hypotension. infants who required dopamine ≥ 14 μg/kg/min and/or epinephrine. prospective, controlled, randomized, double blind trial with placebo. 2.5mg/kg every 12 hours, for 48 hours intravenously (intervention group [IG]); placebo: isotonic saline 1.25 ml/kg/doses intravenously (placebo group [PG]) every 12 hours, for 48 hours. Randomization was performed in blocks with blind assignment. A total of 50 infants with refractory systemic hypotension were prospectively recruited. Patient characteristics were similar in both groups. Requirements for inotropic support at 48 hrs were achieved in 60%, of the IG versus 24% of the PG (P=.009, RR: 2.5, 95% CI, 1.16-5.38). A significant association was observed between the administration of HC in infants treated with epinephrine and the presence of hyperglycemia (P =.008). In patients with refractory hypotension hydrocortisone administration reduced the need for inotropic support. Further studies with a greater number of patients are needed to confirm the effectiveness of HC as a therapeutic tool in these infants. Copyright © 2013 Asociación Española de Pediatría. Published by Elsevier Espana. All rights reserved.

  11. Randomized Controlled Pilot Trial of Behavioral Insomnia Treatment for Chronic Migraine With Comorbid Insomnia.

    Science.gov (United States)

    Smitherman, Todd A; Walters, A Brooke; Davis, Rachel E; Ambrose, Carrie E; Roland, Malcolm; Houle, Timothy T; Rains, Jeanetta C

    2016-02-01

    Migraine frequently co-occurs with and is triggered by sleep disturbance, particularly insomnia, and the large majority of patients with chronic migraine (CM) have comorbid insomnia. Limited evidence suggests that behavioral regulation of sleep may reduce migraine frequency, but studies to date have not assessed the viability of stimulus control and sleep restriction interventions or included objective measurement of sleep parameters. The aim of this study, thus, was to pilot-test the efficacy of a brief behavioral insomnia intervention for adults with CM and comorbid insomnia; headache diaries and actigraphy were included to assess outcomes throughout the trial. This randomized parallel-arm pilot trial recruited adults with both CM and comorbid insomnia. Participants were randomly assigned to three 30-minute biweekly sessions of cognitive-behavioral therapy for insomnia (CBTi) or control treatment. Participants were blinded to treatment and control conditions to control for outcome expectations. Each treatment condition involved training in and daily practice in 5 instructions/skills. The CBTi group learned and practiced skills pertaining to stimulus control and sleep restriction. The control intervention was the same as used by Calhoun and Ford (2007) and involved training in and daily practice of skills pertaining to keeping a consistent food/liquid intake, range of motion exercises, and acupressure. Participants provided outcome data via daily headache diaries, actigraphy, and self-report measures. The primary outcome was reduction in headache frequency at 2 weeks post-treatment and 6-week follow-up; secondary outcomes included other headache parameters, objective actigraphic and subjective changes in sleep, and treatment effect sizes and perceived credibility. Generalized estimating equations with a binomial logit link and inverse probability weights were used to assess the primary outcome among the intent-to-treat sample, and repeated measures generalized

  12. Predictive impact of RRM1 protein expression on vinorelbine efficacy in NSCLC patients randomly assigned in a chemotherapy phase III trial

    DEFF Research Database (Denmark)

    Vilmar, A C; Santoni-Rugiu, E; Sørensen, Jens Benn

    2013-01-01

    Platinum-based doublets (PBDs) remain the cornerstone of treatment in non-small-cell lung cancer (NSCLC) and may include gemcitabine. A biomarker predicting sensitivity to this antimetabolite would represent a major step forward. Accordingly, we explored the predictive role of ribonucleotide...

  13. Efficacy of Internet-Based Guided Treatment for Genito-Pelvic Pain/Penetration Disorder: Rationale, Treatment Protocol, and Design of a Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Anna-Carlotta Zarski

    2018-01-01

    Full Text Available IntroductionGenito-pelvic pain/penetration disorder (GPPPD not only adversely affects women’s sexuality and sexual satisfaction but is also associated with a wide range of psychosocial consequences such as reduced quality of life and well-being, mental health comorbidities, and relationship distress. Evidence for effective treatment options is scarce.AimThis article describes the rationale, treatment protocol, and study design for a randomized controlled trial examining the efficacy of an Internet-based guided intervention for GPPPD.MethodTwo hundred women who meet the criteria for GPPPD and have not been able to experience sexual intercourse for at least the last 6 months will be recruited and randomly assigned either to the intervention group (IG or a 6-month waitlist control group. Assessments take place at baseline (T1, peritreatment after completion of Session 5 in IG (T2, after completion of Session 8 or 12 weeks after randomization (T3, and after 6 months (T4. Data will be analyzed on an intention-to-treat and a completer basis.Main outcome measuresThe primary outcome will be sexual intercourse involving the insertion of the partner’s penis at posttreatment. Secondary outcomes include, e.g., improved non-intercourse penetration, sexual functioning, dyadic stress coping, reduced fear of sexuality and negative penetration-related cognitions. Fear of sexuality, penetration-related cognitions, and exercise intensity will be assessed as mediators of intercourse in the IG. Sexual dysfunctions of partners will be measured at baseline (T1 and investigated as a potential moderator of the primary treatment outcome.DiscussionGiven the burden associated with GPPPD and the need for specialized treatment, there is a surprising lack of evidence-based treatment options. This study aims to assess whether Internet-based interventions could contribute to closing this treatment gap.Clinical Trial RegistrationGerman Register of Clinical Studies (DRKS

  14. Randomization-based adjustment of multiple treatment hazard ratios for covariates with missing data.

    Science.gov (United States)

    Lam, Diana; Koch, Gary G; Preisser, John S; Saville, Benjamin R; Hussey, Michael A

    2017-01-01

    Clinical trials are designed to compare treatment effects when applied to samples from the same population. Randomization is used so that the samples are not biased with respect to baseline covariates that may influence the efficacy of the treatment. We develop randomization-based covariance adjustment methodology to estimate the log hazard ratios and their confidence intervals of multiple treatments in a randomized clinical trial with time-to-event outcomes and missingness among the baseline covariates. The randomization-based covariance adjustment method is a computationally straight-forward method for handling missing baseline covariate values.

  15. The impact of text message reminders on adherence to antimalarial treatment in northern Ghana: a randomized trial.

    Directory of Open Access Journals (Sweden)

    Julia R G Raifman

    Full Text Available BACKGROUND: Low rates of adherence to artemisinin-based combination therapy (ACT regimens increase the risk of treatment failure and may lead to drug resistance, threatening the sustainability of current anti-malarial efforts. We assessed the impact of text message reminders on adherence to ACT regimens. METHODS: Health workers at hospitals, clinics, pharmacies, and other stationary ACT distributors in Tamale, Ghana provided flyers advertising free mobile health information to individuals receiving malaria treatment. The messaging system automatically randomized self-enrolled individuals to the control group or the treatment group with equal probability; those in the treatment group were further randomly assigned to receive a simple text message reminder or the simple reminder plus an additional statement about adherence in 12-hour intervals. The main outcome was self-reported adherence based on follow-up interviews occurring three days after treatment initiation. We estimated the impact of the messages on treatment completion using logistic regression. RESULTS: 1140 individuals enrolled in both the study and the text reminder system. Among individuals in the control group, 61.5% took the full course of treatment. The simple text message reminders increased the odds of adherence (adjusted OR 1.45, 95% CI [1.03 to 2.04], p-value 0.028. Receiving an additional message did not result in a significant change in adherence (adjusted OR 0.77, 95% CI [0.50 to 1.20], p-value 0.252. CONCLUSION: The results of this study suggest that a simple text message reminder can increase adherence to antimalarial treatment and that additional information included in messages does not have a significant impact on completion of ACT treatment. Further research is needed to develop the most effective text message content and frequency. TRIAL REGISTRATION: ClinicalTrials.gov NCT01722734.

  16. Voice Quality After Treatment of Early Vocal Cord Cancer: A Randomized Trial Comparing Laser Surgery With Radiation Therapy

    Energy Technology Data Exchange (ETDEWEB)

    Aaltonen, Leena-Maija, E-mail: leena-maija.aaltonen@hus.fi [Department of Otorhinolaryngology–Head and Neck Surgery, Helsinki University Central Hospital, and University of Helsinki, Helsinki (Finland); Rautiainen, Noora; Sellman, Jaana [Institute of Behavioural Sciences, University of Helsinki, Helsinki (Finland); Saarilahti, Kauko [Department of Oncology, Helsinki University Central Hospital, and University of Helsinki, Helsinki (Finland); Mäkitie, Antti; Rihkanen, Heikki [Department of Otorhinolaryngology–Head and Neck Surgery, Helsinki University Central Hospital, and University of Helsinki, Helsinki (Finland); Laranne, Jussi; Kleemola, Leenamaija [Department of Otorhinolaryngology–Head and Neck Surgery, Tampere University Hospital, and University of Tampere, Tampere (Finland); Wigren, Tuija [Department of Oncology, Tampere University Hospital, and University of Tampere, Tampere (Finland); Sala, Eeva [Department of Otorhinolaryngology–Head and Neck Surgery, Turku University Hospital, and University of Turku, Turku (Finland); Lindholm, Paula [Department of Oncology, Turku University Hospital, and University of Turku, Turku (Finland); Grenman, Reidar [Department of Otorhinolaryngology–Head and Neck Surgery, Turku University Hospital, and University of Turku, Turku (Finland); Joensuu, Heikki [Department of Oncology, Helsinki University Central Hospital, and University of Helsinki, Helsinki (Finland)

    2014-10-01

    Objective: Early laryngeal cancer is usually treated with either transoral laser surgery or radiation therapy. The quality of voice achieved with these treatments has not been compared in a randomized trial. Methods and Materials: Male patients with carcinoma limited to 1 mobile vocal cord (T1aN0M0) were randomly assigned to receive either laser surgery (n=32) or external beam radiation therapy (n=28). Surgery consisted of tumor excision with a CO{sub 2} laser with the patient under general anaesthesia. External beam radiation therapy to the larynx was delivered to a cumulative dose of 66 Gy in 2-Gy daily fractions over 6.5 weeks. Voice quality was assessed at baseline and 6 and 24 months after treatment. The main outcome measures were expert-rated voice quality on a grade, roughness, breathiness, asthenia, and strain (GRBAS) scale, videolaryngostroboscopic findings, and the patients' self-rated voice quality and its impact on activities of daily living. Results: Overall voice quality between the groups was rated similar, but voice was more breathy and the glottal gap was wider in patients treated with laser surgery than in those who received radiation therapy. Patients treated with radiation therapy reported less hoarseness-related inconvenience in daily living 2 years after treatment. Three patients in each group had local cancer recurrence within 2 years from randomization. Conclusions: Radiation therapy may be the treatment of choice for patients whose requirements for voice quality are demanding. Overall voice quality was similar in both treatment groups, however, indicating a need for careful consideration of patient-related factors in the choice of a treatment option.

  17. Comparison of clinical efficacy and safety of thermotherapy versus cryotherapy in treatment of skin warts: A randomized controlled trial.

    Science.gov (United States)

    Izadi Firouzabadi, Leila; Khamesipour, Ali; Ghandi, Narges; Hosseini, Hamed; Teymourpour, Amir; Firooz, Alireza

    2018-01-01

    The effect of thermotherapy in the treatment of skin warts in comparison to cryotherapy, as the standard conventional method, has remained uncertain. This study aimed to assess the clinical efficacy and safety of thermotherapy and cryotherapy in removing skin warts. This randomized controlled trial was conducted on 52 patients aged 18 years and over with ≤ 10 skin warts. The participants were randomly assigned into two groups to receive cryotherapy (every 2 to 3 weeks up to six sessions if required) or thermotherapy (one session). The patients in both groups were followed every 2 to 3 weeks for the first three months, and then three months after the last treatment session. The clearance rate was 79.2% in the thermotherapy group and 58.3% in the cryotherapy group with no significant difference (p = 0.212). The rate of scarring in the thermotherapy group was 20% (p = .018). A higher clearance rate was achieved in the thermotherapy group. However, this result was not statistically significant. There were some minimal post-treatment complications. Patients needed only one session of thermotherapy. Due to the risk of scarring, we suggest thermotherapy only as a suitable treatment method for palmoplantar warts. © 2017 Wiley Periodicals, Inc.

  18. Treatment Effectiveness of PMTO for Children's Behavior Problems in Iceland: Child Outcomes in a Nationwide Randomized Controlled Trial.

    Science.gov (United States)

    Sigmarsdóttir, Margrét; Thorlacius, Örnólfur; Guðmundsdóttir, Edda Vikar; DeGarmo, David S

    2015-09-01

    Well-documented treatment methods must be tested following their implementation in community service agencies and across different cultures to ensure continuing effectiveness. This study was a randomized controlled trial (RCT) of Parent Management Training-the Oregon model (PMTO), conducted within a nationwide implementation in Iceland. Families of 102 clinically referred children with behavior problems were recruited from five municipalities throughout Iceland. Child age ranged from 5 to 12; 73% were boys. Families were randomly assigned to either PMTO or services usually offered in the communities (SAU). Child adjustment was measured with a latent construct based on parent, child, and teacher reports of externalizing and internalizing problems and social skills. Prepost intent-to-treat analyses showed that PMTO treatment led to greater reductions in child adjustment problems relative to the comparison group, obtaining a modest to medium effect size based on the construct score. Only one indicator (parent-rated Social Skills) showed significant change independently and information on amount and kind of treatment in the SAU was limited. Overall, findings indicate that PMTO is an effective method to treat children's behavior problems in a Northern European culture and supply evidence for the method's successful implementation in community settings in Iceland. This is one of few nationwide implementation studies of PMTO outside the United States and the first RCT in Iceland to test a treatment model for children's behavior problems. © 2014 Family Process Institute.

  19. Psychological treatment of late-life depression:a meta-analysis of randomized controlled trials

    NARCIS (Netherlands)

    Cuijpers, P.; van Straten, A.; Smit, H.F.E.

    2006-01-01

    Background: Older meta-analyses of the effects of psychological treatments for depression in older adults have found that these treatments have large effects. However, these earlier meta-analyses also included non-randomized studies, and did not include newer high-quality randomized controlled

  20. Acupuncture As an Integrative Approach for the Treatment of Hot Flashes in Women With Breast Cancer: A Prospective Multicenter Randomized Controlled Trial (AcCliMaT).

    Science.gov (United States)

    Lesi, Grazia; Razzini, Giorgia; Musti, Muriel Assunta; Stivanello, Elisa; Petrucci, Chiara; Benedetti, Benedetta; Rondini, Ermanno; Ligabue, Maria Bernadette; Scaltriti, Laura; Botti, Alberto; Artioli, Fabrizio; Mancuso, Pamela; Cardini, Francesco; Pandolfi, Paolo

    2016-05-20

    To determine the effectiveness of acupuncture for the management of hot flashes in women with breast cancer. We conducted a pragmatic, randomized controlled trial comparing acupuncture plus enhanced self-care versus enhanced self-care alone. A total of 190 women with breast cancer were randomly assigned. Random assignment was performed with stratification for hormonal therapy; the allocation ratio was 1:1. Both groups received a booklet with information about climacteric syndrome and its management to be followed for at least 12 weeks. In addition, the acupuncture group received 10 traditional acupuncture treatment sessions involving needling of predefined acupoints. The primary outcome was hot flash score at the end of treatment (week 12), calculated as the frequency multiplied by the average severity of hot flashes. The secondary outcomes were climacteric symptoms and quality of life, measured by the Greene Climacteric and Menopause Quality of Life scales. Health outcomes were measured for up to 6 months after treatment. Expectation and satisfaction of treatment effect and safety were also evaluated. We used intention-to-treat analyses. Of the participants, 105 were randomly assigned to enhanced self-care and 85 to acupuncture plus enhanced self-care. Acupuncture plus enhanced self-care was associated with a significantly lower hot flash score than enhanced self-care at the end of treatment (P Acupuncture was also associated with fewer climacteric symptoms and higher quality of life in the vasomotor, physical, and psychosocial dimensions (P Acupuncture in association with enhanced self-care is an effective integrative intervention for managing hot flashes and improving quality of life in women with breast cancer. © 2016 by American Society of Clinical Oncology.

  1. Vision-Related Quality-of-Life Outcomes in the Mycotic Ulcer Treatment Trial I: A Randomized Clinical Trial.

    Science.gov (United States)

    Rose-Nussbaumer, Jennifer; Prajna, N Venkatesh; Krishnan, K Tiruvengada; Mascarenhas, Jeena; Rajaraman, Revathi; Srinivasan, Muthiah; Raghavan, Anita; Oldenburg, Catherine E; O'Brien, Kieran S; Ray, Kathryn J; McLeod, Stephen D; Porco, Travis C; Lietman, Thomas M; Acharya, Nisha R; Keenan, Jeremy D

    2015-06-01

    Given the limitations in health care resources, quality-of-life measures for interventions have gained importance. To determine whether vision-related quality-of-life outcomes were different between the natamycin and voriconazole treatment arms in the Mycotic Ulcer Treatment Trial I, as measured by an Indian Vision Function Questionnaire. Secondary analysis (performed October 11-25, 2014) of a double-masked, multicenter, randomized, active comparator-controlled, clinical trial at multiple locations of the Aravind Eye Care System in South India that enrolled patients with culture- or smear-positive filamentous fungal corneal ulcers who had a baseline visual acuity of 20/40 to 20/400 (logMAR of 0.3-1.3). Study participants were randomly assigned to topical voriconazole, 1%, or topical natamycin, 5%. Subscale score on the Indian Vision Function Questionnaire from each of the 4 subscales (mobility, activity limitation, psychosocial impact, and visual function) at 3 months. A total of 323 patients were enrolled in the trial, and 292 (90.4%) completed the Indian Vision Function Questionnaire at 3 months. The majority of study participants had subscale scores consistent with excellent function. After adjusting for baseline visual acuity and organism, we found that study participants in the natamycin-treated group scored, on average, 4.3 points (95% CI, 0.1-8.5) higher than study participants in the voriconazole-treated group (P = .046). In subgroup analyses looking at ulcers caused by Fusarium species and adjusting for baseline best spectacle-corrected visual acuity, the natamycin-treated group scored 8.4 points (95% CI, 1.9-14.9) higher than the voriconazole-treated group (P = .01). Differences in quality of life were not detected for patients with Aspergillus or other non-Fusarium species as the causative organism (1.5 points [95% CI, -3.9 to 6.9]; P = .52). We found evidence of improvement in vision-related quality of life among patients with fungal ulcers

  2. Effectiveness of a self-guided web-based cannabis treatment program: randomized controlled trial.

    Science.gov (United States)

    Rooke, Sally; Copeland, Jan; Norberg, Melissa; Hine, Donald; McCambridge, Jim

    2013-02-15

    Self-help strategies offer a promising way to address problems with access to and stigma associated with face-to-face drug and alcohol treatment, and the Internet provides an excellent delivery mode for such strategies. To date, no study has tested the effectiveness of a fully self-guided web-based treatment for cannabis use and related problems. The current study was a two-armed randomized controlled trial aimed at testing the effectiveness of Reduce Your Use, a fully self-guided web-based treatment program for cannabis use disorder consisting of 6 modules based on cognitive, motivational, and behavioral principles. 225 individuals who wanted to cease or reduce their cannabis use were recruited using both online and offline advertising methods and were randomly assigned to receive: (1) the web-based intervention, or (2) a control condition consisting of 6 modules of web-based educational information on cannabis. Assessments of cannabis use, dependence symptoms, and abuse symptoms were conducted through online questionnaires at baseline, and at 6-week and 3-month follow-ups. Two sets of data analyses were undertaken--complier average causal effect (CACE) modeling and intention to treat (ITT). Two thirds (149) of the participants completed the 6-week postintervention assessment, while 122 (54%) completed the 3-month follow-up assessment. Participants in the intervention group completed an average of 3.5 of the 6 modules. The CACE analysis revealed that at 6 weeks, the experimental group reported significantly fewer days of cannabis use during the past month (P=.02), significantly lower past-month quantity of cannabis use (P=.01), and significantly fewer symptoms of cannabis abuse (P=.047) relative to controls. Cannabis dependence symptoms (number and severity) and past-month abstinence did not differ significantly between groups (Ps>.05). Findings at 3 months were similar, except that the experimental group reported significantly fewer and less severe cannabis

  3. Defining Success: Insights From a Random Assignment, Multisite Study of Implementing HIV Prevention, Testing, and Linkage to Care in U.S. Jails and Prisons.

    Science.gov (United States)

    Mitchell, Shannon Gwin; Willett, Jennifer; Swan, Holly; Monico, Laura B; Yang, Yang; Patterson, Yvonne O; Belenko, Steven; Schwartz, Robert P; Visher, Christy A

    2015-10-01

    In the emerging field of implementation science, measuring the extent to which a new or modified healthcare program or practice is successfully implemented following an intervention is a critical component in understanding how evidence-based treatments become part of regular practice. This paper is intended to expand our understanding of factors that influence the successful adoption of new or modified HIV services in correctional settings. The nine-site project developed and directed an organization-level intervention designed to implement improvements in preventing, detecting, and treating HIV for persons under correctional supervision. Using semi-structured interviews to elicit perceptions from Senior Researchers and Executive Sponsors at each of the nine sites, this paper presents their views and observations regarding the success of the experimental intervention in their criminal justice setting. Within the areas of focus for implementation (either HIV prevention, testing, or linkage to community treatment) the complexity of programmatic needs was very influential with regards to perceptions of success. An organization's pre-existing characteristics, staffing, funding, and interorganizational relationships contributed to either the ease or difficulty of programmatic implementation. Results are discussed pertaining to furthering our understanding of why new or modified healthcare interventions achieve success, including whether the intervention is a modification of existing practice or is a new intervention, and the choice of implementation strategy.

  4. Ototoxicity of artemether/lumefantrine in the treatment of falciparum malaria: a randomized trial

    Directory of Open Access Journals (Sweden)

    Krause Eike

    2008-09-01

    Full Text Available Abstract Background Due to increasing drug resistance, artemisinin-based combination chemotherapy (ACT has become the first-line treatment of falciparum malaria in many endemic countries. However, irreversible ototoxicity associated with artemether/lumefantrine (AL has been reported recently and suggested to be a serious limitation in the use of ACT. The aim of the study was to compare ototoxicity, tolerability, and efficacy of ACT with that of quinine and atovaquone/proguanil in the treatment of uncomplicated falciparum malaria. Methods Ninety-seven patients in south-west Ethiopia with slide-confirmed malaria were randomly assigned to receive either artemether/lumefantrine or quinine or atovaquone/proguanil and followed-up for 90 days. Comprehensive audiovestibular testing by pure tone audiometry (PTA, transitory evoked (TE and distortion product (DP otoacoustic emissions (OAE and brain stem evoked response audiometry (BERA was done before enrolment and after seven, 28 and 90 days. Results PTA and DP-OAE levels revealed transient significant cochlear hearing loss in patients treated with quinine but not in those treated with artemether/lumefantrine or atovaquone/proguanil. TE-OAE could be elicited in all examinations, except for three patients in the Q group on day 7, who suffered a transient hearing loss greater than 30 dB. There was no evidence of drug-induced brain stem lesions by BERA measurements. Conclusion There was no detrimental effect of a standard oral regimen of artemether/lumefantrine on peripheral hearing or brainstem auditory pathways in patients with uncomplicated falciparum malaria. In contrast, transient hearing loss is common after quinine therapy and due to temporary outer hair cell dysfunction.

  5. Computer-Assisted Delivery of Cognitive-Behavioral Therapy for Addiction: A Randomized Trial of CBT4CBT

    National Research Council Canada - National Science Library

    Gordon, Melissa A; Nuro, Kathryn F; Ball, Samuel A; Rounsaville, Bruce J; Martino, Steve; Carroll, Kathleen M; Babuscio, Theresa A; Nich, Charla; Portnoy, Galina A

    2008-01-01

    ...) for substance dependence. Method: This was a randomized clinical trial in which 77 individuals seeking treatment for substance dependence at an outpatient community setting were randomly assigned to standard treatment or standard...

  6. Misoprostol in addition to routine treatment of postpartum hemorrhage: A hospital-based randomized-controlled trial in Karachi, Pakistan

    Directory of Open Access Journals (Sweden)

    Blum Jennifer

    2008-08-01

    Full Text Available Abstract Background Postpartum hemorrhage (PPH remains a major killer of women worldwide. Standard uterotonic treatments used to control postpartum bleeding do not always work and are not always available. Misoprostol's potential as a treatment option for PPH is increasingly known, but its use remains ad hoc and available evidence does not support the safety or efficacy of one particular regimen. This study aimed to determine the adjunct benefit of misoprostol when combined with standard oxytocics for PPH treatment. Methods A randomized controlled trial was conducted in four Karachi hospitals from December 2005 – April 2007 to assess the benefit of a 600 mcg dose of misoprostol given sublingually in addition to standard oxytocics for postpartum hemorrhage treatment. Consenting women had their blood loss measured after normal vaginal delivery and were enrolled in the study after losing more than 500 ml of blood. Women were randomly assigned to receive either 600 mcg sublingual misoprostol or matching placebo in addition to standard PPH treatment with injectable oxytocics. Both women and providers were blinded to the treatment assignment. Blood loss was collected until active bleeding stopped and for a minimum of one hour after PPH diagnosis. Total blood loss, hemoglobin measures, and treatment outcomes were recorded for all participants. Results Due to a much lower rate of PPH than expected (1.2%, only sixty-one patients were diagnosed and treated for their PPH in this study, and we were therefore unable to measure statistical significance in any of the primary endpoints. The addition of 600 mcg sublingual misoprostol to standard PPH treatments does, however, suggest a trend in reduced postpartum blood loss, a smaller drop in postpartum hemoglobin, and need for fewer additional interventions. Women who bled less overall had a significantly smaller drop in hemoglobin and received fewer additional interventions. There were no hysterectomies or

  7. Modafinil for the treatment of fatigue in lung cancer: results of a placebo-controlled, double-blind, randomized trial.

    Science.gov (United States)

    Spathis, Anna; Fife, Kate; Blackhall, Fiona; Dutton, Susan; Bahadori, Ronja; Wharton, Rose; O'Brien, Mary; Stone, Patrick; Benepal, Tim; Bates, Nick; Wee, Bee

    2014-06-20

    Fatigue is a distressing symptom occurring in more than 60% of patients with cancer. The CNS stimulants modafinil and methylphenidate are recommended for the treatment of cancer-related fatigue, despite a limited evidence base. We aimed to evaluate the efficacy and tolerability of modafinil in the management of fatigue in patients with non-small-cell lung cancer (NSCLC). Adults with advanced NSCLC and performance status of 0 to 2, who were not treated with chemotherapy or radiotherapy within the last 4 weeks, were randomly assigned to daily modafinil (100 mg on days 1 to 14; 200 mg on days 15 to 28) or matched placebo. The primary outcome was change in Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue score from baseline to 28 days, adjusted for baseline fatigue and performance status. Secondary outcomes included safety and patient-reported measures of depression, daytime sleepiness, and quality of life. A total of 208 patients were randomly assigned, and 160 patients (modafinil, n = 75; placebo, n = 85) completed questionnaires at both baseline and day 28 and were included in the modified intention-to-treat analysis. FACIT-Fatigue scores improved from baseline to day 28 (mean score change: modafinil, 5.29; 95% CI, 2.57 to 8.02; placebo, 5.09; 95% CI, 2.54 to 7.65), but there was no difference between treatments (0.20; 95% CI, -3.56 to 3.97). There was also no difference between treatments for the secondary outcomes; 47% of the modafinil group and 23% of the placebo group stated that the intervention was not helpful. Modafinil had no effect on cancer-related fatigue and should not be prescribed outside a clinical trial setting. Its use was associated with a clinically significant placebo effect. © 2014 by American Society of Clinical Oncology.

  8. Bispectoral index scores of pediatric patients under dental treatment and recovery conditions: Study of children assigned for general anesthesia under propofol and isofloran regimes

    Directory of Open Access Journals (Sweden)

    Dana Tahririan

    2016-01-01

    Full Text Available Background: This study was planned to determine the relationship between bispectoral index (BIS during dental treatment and recovery conditions in children undergoing two regimes of anesthesia of propofol and isoflurane. Materials and Methods: In this single-blind clinical trial study, 57 4-7-year-old healthy children who had been referred for dental treatment under general anesthesia between 60 and 90 min were selected by convenience sampling and assigned to two groups, after obtaining their parents′ written consent. The anesthesia was induced by inhalation. For the first group, the anesthesia was preserved by a mixture of oxygen (50%, nitrous oxide (50%, and isoflurane (1%. For the second group, the anesthesia was preserved by a mixture of oxygen (50%, nitrous oxide (50%, and propofol was administered intravenously at a dose of 100 Ng/kg/min. The patients′ vital signs, BIS, and agitation scores were recorded every 10 min. The data were analyzed by repeated measure ANOVA and t-tests at a significance level of α = 0.05 using SPSS version 20. Results: The results of independent t-test for anesthesia time showed no statistically significant difference between isoflurane and propofol (P = 0.87. Controlling age, the BIS difference between the two anesthetic agents was not significant (P > 0.05; however, it was negatively correlated with the duration of anesthesia and the discharge time (P = 0.001, r = -0.308 and (P < 0.001, r = -0.55. Conclusion: The same depth of anesthesia is produced by propofol and isoflurane, but lower recovery complications from anesthesia are observed with isoflurane.

  9. Bispectoral index scores of pediatric patients under dental treatment and recovery conditions: Study of children assigned for general anesthesia under propofol and isofloran regimes.

    Science.gov (United States)

    Tahririan, Dana; Kaviani, Naser; Nourbakhsh, Nosrat

    2016-01-01

    This study was planned to determine the relationship between bispectoral index (BIS) during dental treatment and recovery conditions in children undergoing two regimes of anesthesia of propofol and isoflurane. In this single-blind clinical trial study, 57 4-7-year-old healthy children who had been referred for dental treatment under general anesthesia between 60 and 90 min were selected by convenience sampling and assigned to two groups, after obtaining their parents' written consent. The anesthesia was induced by inhalation. For the first group, the anesthesia was preserved by a mixture of oxygen (50%), nitrous oxide (50%), and isoflurane (1%). For the second group, the anesthesia was preserved by a mixture of oxygen (50%), nitrous oxide (50%), and propofol was administered intravenously at a dose of 100 Ng/kg/min. The patients' vital signs, BIS, and agitation scores were recorded every 10 min. The data were analyzed by repeated measure ANOVA and t-tests at a significance level of α = 0.05 using SPSS version 20. The results of independent t-test for anesthesia time showed no statistically significant difference between isoflurane and propofol (P = 0.87). Controlling age, the BIS difference between the two anesthetic agents was not significant (P > 0.05); however, it was negatively correlated with the duration of anesthesia and the discharge time (P = 0.001, r = -0.308) and (P < 0.001, r = -0.55). The same depth of anesthesia is produced by propofol and isoflurane, but lower recovery complications from anesthesia are observed with isoflurane.

  10. The Effect of Active Treatment and Visit Compared to Conventional Treatment, on Preventing Recurrent Suicidal Attempts: A Randomized Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Seyed Ghafur Mousavi

    2017-01-01

    Full Text Available Background: Suicide is a major problem, and its prevention is a global priority. In many cases, suicide attempter attempts to do it again after the rescue. In current study we aimed to compare active visit and treatment of patients in a periodic manner with treatment as usual, in the prevention of recurrent suicidal attempts. Materials and Methods: This study was a randomized controlled clinical trial which was conducted in Isfahan Noor Hospital's Emergency Center on 60 patients in 2013-2014. The samples were selected using simple random sampling and they were assigned into two groups: The conventional treatment group (treatment as usual (30 patients, and visit and active treatment (30 patients. In the intervention group, there were ten follow-ups by a face-to-face visit over 12 months, and six follow-ups by phone call in control group. Through the completion of the initial and follow-up questionnaire evaluation was performed. The data were analyzed using Cochran test, and repeated measure (ANOVA. Results: During the 12-month follow-up visit and active treatment, significant difference in reducing suicidal thoughts (P = 0.003 was observed and an increase in the life expectancy (P = 0.001, interest and motivation in life (P = 0.001 was found in the intervention group, and also nonsignificant reduction was found in the rate of suicidal attempts. Conclusion: Visit and active treatment is useful in suicide attempters and it can helps in preventing recurrent suicide attempt as a preventive program by increasing hope and reducing suicidal thoughts.

  11. The treatment of medial tibial stress syndrome in athletes; a randomized clinical trial

    OpenAIRE

    Moen, Maarten Hendrik; Holtslag, Leonoor; Bakker, Eric; Barten, Carl; Weir, Adam; Tol, Johannes L; Backx, Frank

    2012-01-01

    Abstract Background The only three randomized trials on the treatment of MTSS were all performed in military populations. The treatment options investigated in this study were not previously examined in athletes. This study investigated if functional outcome of three common treatment options for medial tibial stress syndrome (MTSS) in athletes in a non-military setting was the same. Methods The study design was randomized and multi-centered. Physical therapists and sports physicians referred ...

  12. The comparative effectiveness of Integrated treatment for Substance abuse and Partner violence (I-StoP) and substance abuse treatment alone: a randomized controlled trial.

    Science.gov (United States)

    Kraanen, Fleur L; Vedel, Ellen; Scholing, Agnes; Emmelkamp, Paul M G

    2013-07-16

    Research has shown that treatments that solely addressed intimate partner violence (IPV) perpetration were not very effective in reducing IPV, possibly due to neglecting individual differences between IPV perpetrators. A large proportion of IPV perpetrators is diagnosed with co-occurring substance use disorders and it has been demonstrated that successful treatment of alcohol dependence among alcohol dependent IPV perpetrators also led to less IPV. The current study investigated the relative effectiveness of Integrated treatment for Substance abuse and Partner violence (I-StoP) to cognitive behavioral treatment addressing substance use disorders including only one session addressing partner violence (CBT-SUD+) among patients in substance abuse treatment who repeatedly committed IPV. Substance use and IPV perpetration were primary outcome measures. Patients who entered substance abuse treatment were screened for IPV. Patients who disclosed at least 7 acts of physical IPV in the past year (N = 52) were randomly assigned to either I-StoP or CBT-SUD+. Patients in both conditions received 16 treatment sessions. Substance use and IPV perpetration were assessed at pretreatment, halfway treatment and posttreatment in blocks of 8 weeks. Both completers and intention-to-treat (ITT) analyses were performed. Patients (completers and ITT) in both conditions significantly improved regarding substance use and IPV perpetration at posttreatment compared with pretreatment. There were no differences in outcome between conditions. Completers in both conditions almost fully abstained from IPV in 8 weeks before the end of treatment. Both I-StoP and CBT-SUD+ were effective in reducing substance use and IPV perpetration among patients in substance abuse treatment who repeatedly committed IPV and self-disclosed IPV perpetration. Since it is more cost and time-effective to implement CBT-SUD+ than I-StoP, it is suggested to treat IPV perpetrators in substance abuse treatment with CBT-SUD+.

  13. Bupropion in the treatment of pathological gambling: a randomized, double-blind, placebo-controlled, flexible-dose study.

    Science.gov (United States)

    Black, Donald W; Arndt, Stephan; Coryell, William H; Argo, Tami; Forbush, Kelsie T; Shaw, Martha C; Perry, Paul; Allen, Jeff

    2007-04-01

    We tested the efficacy of bupropion in the treatment of persons with pathological gambling (PG). Nondepressed, healthy subjects with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition PG were randomly assigned to placebo or flexibly dosed bupropion in a 12-week double-blind trial. Outcome measures included the Yale-Brown Obsessive-Compulsive Scale modified for PG, the Gambling Severity Assessment Scale, the Clinical Global Impression Improvement and Severity Scales, the Global Assessment Scale, the Timeline Follow Back, the Attention-Deficit/Hyperactivity Disorder Rating Scale, and the Sheehan Disability Scale. Thirty-nine subjects (28 men, 11 women) were randomized to bupropion (n = 18) or placebo (n = 21). The 2 groups were similar on demographic and clinical measures. There were few differences between the treatment groups on any primary or secondary outcome measure, although subjects in each cell experienced significant improvement. Of subjects with at least 1 postrandomization visit, 35.7% of bupropion and 47.1% of placebo recipients experienced "much" or "very much" improvement on the Clinical Global Impression Improvement Scale. The trial was complicated by a high noncompletion rate (43.6%). Bupropion was well tolerated. Bupropion and placebo recipients did equally well in a short-term trial, with improvement seen as early as the first week of treatment. The high placebo response rate and the high noncompletion rate each reflect the challenge inherent in treating persons with PG.

  14. Lactoferrin versus ferrous sulphate for the treatment of iron deficiency anemia during pregnancy: a randomized clinical trial.

    Science.gov (United States)

    Rezk, Mohamed; Dawood, Ragab; Abo-Elnasr, Mohamed; Al Halaby, Alaa; Marawan, Hala

    2016-01-01

    This study was conducted to evaluate the efficacy and safety of lactoferrin in comparison to ferrous sulphate for the treatment of iron deficiency anemia (IDA) during pregnancy. This prospective, randomized, parallel-group, single-center study was conducted in the Department of Obstetrics and Gynecology at Menoufia University Hospital, Egypt and included a total of 200 pregnant women in the second trimester with IDA who were enrolled and randomly assigned either to receive 150 mg of dried ferrous sulphate capsules or lactoferrin 250 mg capsules once daily for eight consecutive weeks. The primary efficacy parameter was the amount of increase in hemoglobin concentration by 4 and 8 weeks, the adverse effects related to iron therapy and the patient compliance to the treatment. Total increase in Hb after 2 months with lactoferrin was higher (2.26 ± 0.51 g/dL) compared to ferrous sulfate (1.11 ± 0.22 g/dL) (p lactoferrin group (p Lactoferrin was more effective than ferrous sulfate over a two-month period in pregnant women with IDA, with fewer gastrointestinal adverse events and better treatment acceptability.

  15. Long-term results of RTOG trial 8911 (USA Intergroup 113): a random assignment trial comparison of chemotherapy followed by surgery compared with surgery alone for esophageal cancer.

    Science.gov (United States)

    Kelsen, David P; Winter, Katryn A; Gunderson, Leonard L; Mortimer, Joanne; Estes, Norman C; Haller, Daniel G; Ajani, Jaffer A; Kocha, Walter; Minsky, Bruce D; Roth, Jack A; Willett, Christopher G

    2007-08-20

    We update Radiation Therapy Oncology Group trial 8911 (USA Intergroup 113), a comparison of chemotherapy plus surgery versus surgery alone for patients with localized esophageal cancer. The relationship between resection type and between tumor response and outcome were also analyzed. The chemotherapy group received preoperative cisplatin plus fluorouracil. Outcome based on the type of resection (R0, R1, R2, or no resection) was evaluated. The main end point was overall survival. Disease-free survival, relapse pattern, the influence of postoperative treatment, and the relationship between response to preoperative chemotherapy and outcome were also evaluated. Two hundred sixteen patients received preoperative chemotherapy, 227 underwent immediate surgery. Fifty-nine percent of surgery only and 63% of chemotherapy plus surgery patients underwent R0 resections (P = .5137). Patients undergoing less than an R0 resection had an ominous prognosis; 32% of patients with R0 resections were alive and free of disease at 5 years, only 5% of patients undergoing an R1 resection survived for longer than 5 years. The median survival rates for patients with R1, R2, or no resections were not significantly different. While, as initially reported, there was no difference in overall survival for patients receiving perioperative chemotherapy compared with the surgery only group, patients with objective tumor regression after preoperative chemotherapy had improved survival. For patients with localized esophageal cancer, whether or not preoperative chemotherapy is administered, only an R0 resection results in substantial long-term survival. Even microscopically positive margins are an ominous prognostic factor. After a R1 resection, postoperative chemoradiotherapy therapy offers the possibility of long-term disease-free survival to a small percentage of patients.

  16. Oral hygiene compliance in orthodontic patients: a randomized controlled study on the effects of a post-treatment communication

    Directory of Open Access Journals (Sweden)

    Mauro Cozzani

    2016-12-01

    Full Text Available Abstract Background Several studies have recently demonstrated that a post-treatment communication to explain the importance of an oral hygiene can improve the orthodontic patients’ compliance over a period of 66 days. The main goal of this study is to evaluate the effects of a structured follow-up communication after orthodontic appliance application on oral hygiene compliance after 30–40 days. Methods Eighty-four orthodontic participants enrolled from patients who were beginning fixed orthodontic treatment at the Orthodontic Department, Gaslini Hospital, Genova, between July and October 2014 were randomly assigned to one of three trial arms. Before the bonding, all patients underwent a session of oral hygiene aimed at obtaining an plaque index of “zero.” At the following orthodontic appointment, the plaque index was calculated for each patient in order to assess oral hygiene compliance. The first group served as control and did not receive any post-procedure communication, the second group received a structured text message giving reassurance, and the third group received a structured telephone call. Participants were blinded to group assignment and were not made aware that the text message or the telephone call was part of the study. (The research protocol was approved by the Italian Comitato Etico Regionale della Liguria-sezione 3^ c/o IRCCS-Istituto G. Gaslini 845/2014, and it is not registered in the trial’s register. Results Thirty patients were randomly assigned to the control group, 28 participants to the text message group, and 26 to the telephone group. Participants who received a post-treatment communication reported higher level of oral hygiene compliance than participants in the control group. The plaque index was 0.3 (interquartile range (Iqr, 0.60 and 0.75 (Iqr, 1.30, respectively, with a significant difference (P = 0.0205. Conclusions A follow-up procedure after orthodontic treatment may be an effective tool to

  17. The Power of the Test for Treatment Effects in Three-Level Block Randomized Designs

    Science.gov (United States)

    Konstantopoulos, Spyros

    2008-01-01

    Experiments that involve nested structures may assign treatment conditions either to subgroups (such as classrooms) or individuals within subgroups (such as students). The design of such experiments requires knowledge of the intraclass correlation structure to compute the sample sizes necessary to achieve adequate power to detect the treatment…

  18. Blocked Randomization with Randomly Selected Block Sizes

    Directory of Open Access Journals (Sweden)

    Jimmy Efird

    2010-12-01

    Full Text Available When planning a randomized clinical trial, careful consideration must be given to how participants are selected for various arms of a study. Selection and accidental bias may occur when participants are not assigned to study groups with equal probability. A simple random allocation scheme is a process by which each participant has equal likelihood of being assigned to treatment versus referent groups. However, by chance an unequal number of individuals may be assigned to each arm of the study and thus decrease the power to detect statistically significant differences between groups. Block randomization is a commonly used technique in clinical trial design to reduce bias and achieve balance in the allocation of participants to treatment arms, especially when the sample size is small. This method increases the probability that each arm will contain an equal number of individuals by sequencing participant assignments by block. Yet still, the allocation process may be predictable, for example, when the investigator is not blind and the block size is fixed. This paper provides an overview of blocked randomization and illustrates how to avoid selection bias by using random block sizes.

  19. Blocked randomization with randomly selected block sizes.

    Science.gov (United States)

    Efird, Jimmy

    2011-01-01

    When planning a randomized clinical trial, careful consideration must be given to how participants are selected for various arms of a study. Selection and accidental bias may occur when participants are not assigned to study groups with equal probability. A simple random allocation scheme is a process by which each participant has equal likelihood of being assigned to treatment versus referent groups. However, by chance an unequal number of individuals may be assigned to each arm of the study and thus decrease the power to detect statistically significant differences between groups. Block randomization is a commonly used technique in clinical trial design to reduce bias and achieve balance in the allocation of participants to treatment arms, especially when the sample size is small. This method increases the probability that each arm will contain an equal number of individuals by sequencing participant assignments by block. Yet still, the allocation process may be predictable, for example, when the investigator is not blind and the block size is fixed. This paper provides an overview of blocked randomization and illustrates how to avoid selection bias by using random block sizes.

  20. Biofeedback-based cognitive-behavioral treatment compared with occlusal splint for temporomandibular disorder: a randomized controlled trial.

    Science.gov (United States)

    Shedden Mora, Meike C; Weber, Daniel; Neff, Andreas; Rief, Winfried

    2013-12-01

    Cognitive-behavioral treatment has proven efficacy for chronic temporomandibular disorder (TMD). However, most patients receive dental treatment that may not address psychological comorbidities often present in TMD. The aim of the present study was to evaluate the efficacy of biofeedback-based cognitive-behavioral treatment (BFB-CBT) versus dental treatment with occlusal splint (OS). Moreover, changes in nocturnal masseter muscle activity (NMMA) were investigated. Fifty-eight patients with chronic TMD were randomly assigned to receive either 8 weekly sessions of BFB-CBT or 8 weeks of OS treatment. Diagnoses were established using Research Diagnostic Criteria for TMD. Pain intensity and disability were defined as primary outcomes. Secondary outcomes included emotional functioning, pain coping, somatoform symptoms, treatment satisfaction, and adverse events. NMMA was assessed during 3 nights pretreatment and posttreatment with portable devices. Follow-up assessment took place 6 months after the treatment. Both treatments resulted in significant reductions in pain intensity and disability, with similar amounts of clinically meaningful improvement (45% for BFB-CBT and 48% for OS). Patients receiving BFB-CBT showed significantly larger improvements in pain coping skills. Satisfaction with treatment and ratings of improvement were higher for BFB-CBT. Effects were stable over 6 months, and tended to be larger in the BFB-CBT group for all outcomes. No significant changes were observed in NMMA. The fact that BFB-CBT resulted in larger improvements in pain coping skills, and was well accepted by the patients, underlines the importance and feasibility of psychological treatments in the clinical management of TMD.

  1. Exploring Outcomes Related to Anxiety and Depression in Completers of a Randomized Controlled Trial of Complicated Grief Treatment.

    Science.gov (United States)

    Glickman, Kim; Shear, M Katherine; Wall, Melanie

    2016-01-01

    The present study examines a more fine-grained analysis of anxiety-related and depression-related outcomes amongst a sample of treatment completers who were assigned to complicated grief treatment (CGT) (n = 35) or interpersonal psychotherapy (IPT) (n = 34) in a previously reported randomized controlled trial. We examined effects of antidepressant use and measures of anxiety and depression, focusing especially on guilt related to the death or deceased and grief-related avoidance in order to further understand the differential effectiveness of CGT and IPT amongst participants who received the full course of treatment. Analyses showed that CGT produced greater reductions in anxiety and depressive symptoms including negative thoughts about the future and grief-related avoidance. CGT's advantage over IPT in lowering depression was most pronounced amongst those not taking antidepressants. Our results further elucidate CGT effects and support the idea that CG and major depressive disorder are distinct conditions. Targeted treatment for complicated grief (CG) produces benefits in associated mood and anxiety symptoms and CG symptoms. Amongst patients with CG, interpersonal psychotherapy seems relatively ineffective in ameliorating depressive symptoms. Grief-related depressive symptoms may not respond to standard treatments unless CG symptoms are also addressed. Reducing grief-related symptoms, such as anxieties about the future, guilt related to the death or deceased and avoidance of reminders of the loss may be important aspects in reducing CG. Copyright © 2014 John Wiley & Sons, Ltd.

  2. Baclofen for maintenance treatment of opioid dependence: A randomized double-blind placebo-controlled clinical trial [ISRCTN32121581

    Directory of Open Access Journals (Sweden)

    Ahmadi-Abhari Seyed Ali

    2003-11-01

    Full Text Available Abstract Background Results of preclinical studies suggest that the GABAB receptor agonist baclofen may be useful in treatment of opioid dependence. This study was aimed at assessing the possible efficacy of baclofen for maintenance treatment of opioid dependence. Methods A total of 40 opioid-dependent patients were detoxified and randomly assigned to receive baclofen (60 mg/day or placebo in a 12-week, double blind, parallel-group trial. Primary outcome measure was retention in treatment. Secondary outcome measures included opioids and alcohol use according to urinalysis and self-report ratings, intensity of opioid craving assessed with a visual analogue scale, opioid withdrawal symptoms as measured by the Short Opiate Withdrawal Scale and depression scores on the Hamilton inventory. Results Treatment retention was significantly higher in the baclofen group. Baclofen also showed a significant superiority over placebo in terms of opiate withdrawal syndrome and depressive symptoms. Non-significant, but generally favorable responses were seen in the baclofen group with other outcome measures including intensity of opioid craving and self-reported opioid and alcohol use. However, no significant difference was seen in the rates of opioid-positive urine tests. Additionally, the drug side effects of the two groups were not significantly different. Conclusion The results support further study of baclofen in the maintenance treatment of opioid dependence.

  3. Effect of treatment of temporomandibular disorders (TMD) in patients with cervicogenic headache: a single-blind, randomized controlled study.

    Science.gov (United States)

    von Piekartz, Harry; Lüdtke, Kerstin

    2011-01-01

    The present study was comprised of 43 patients (16 men) with cervicogenic headaches for over three months, diagnosed according to the International Classification of Diagnostic Criteria of Headaches (ICDH-II). The patients were randomly assigned to receive either manual therapy for the cervical region (usual care group) or additional manual therapy techniques to the temporomandibular region to additionally influence temporomandibular disorders (TMD). All patients were assessed prior to treatment, after six sessions of treatment, and at a six-month follow-up. The outcome criteria were: intensity of headaches measured on a colored analog scale, the Neck Disability Index (Dutch version), the Conti Anamnestic Questionnaire, noise registration at the mandibular joint using a stethoscope, the Graded Chronic Pain Status (Dutch version), mandibular deviation, range of mouth opening, and pressure/pain threshold of the masticatory muscles. The results indicate in the studied sample of cervicogenic headache patients, 44.1% had TMD. The group that received additional temporomandibular manual therapy techniques showed significantly decreased headache intensities and increased neck function after the treatment period. These improvements persisted during the treatment-free period (follow-up) and were not observed in the usual care group. This trend was also reflected on the questionnaires and the clinical temporomandibular signs. Based on these observations, we strongly believe that treatment of the temporomandibular region has beneficial effects for patients with cervicogenic headaches, even in the long-term.

  4. Demonstrating treatment efficacy using the single subject randomization design: A tutorial and demonstration.

    Science.gov (United States)

    Rvachew, Susan; Matthews, Tanya

    2017-05-01

    Single case research refers to the broader category of research designs in which each case serves as his or her own control. A single subject randomization design is a specific form in which sessions are randomly allocated to treatment conditions within subjects. Two tutorials on the application of these designs are provided. In the single subject randomized phase design, baseline probes are administered repeatedly during a no-treatment or usual care phase; subsequently probes are administered repeatedly during the treatment phase of the experiment; the starting point for the treatment phase is determined by random selection. In the single subject randomized alternation design, any session can be randomly allocated to any treatment condition. In either case, the test statistic can be the mean of probe performance during the treatment sessions after subtracting the baseline mean. The significance of the obtained test statistic is determined by resampling test. Specifically, the obtained test statistic is interpreted relative to a distribution of test statistics generated by all possible random allocations. This distribution yields a P value which represents the probability of obtaining a test statistic as large as that obtained by the selected allocation. In addition to the tutorials, two experiments using these designs with a single 8-year-old participant with Childhood Apraxia of Speech are presented to demonstrate the utility of these designs and the application of the associated statistical analysis procedures. Copyright © 2017 Elsevier Inc. All rights reserved.

  5. Multidisciplinary rehabilitation treatment versus cognitive behavioural therapy for patients with chronic fatigue syndrome: a randomized controlled trial.

    Science.gov (United States)

    Vos-Vromans, D C W M; Smeets, R J E M; Huijnen, I P J; Köke, A J A; Hitters, W M G C; Rijnders, L J M; Pont, M; Winkens, B; Knottnerus, J A

    2016-03-01

    The aim of this trial was to evaluate the difference in treatment effect, at 26 and 52 weeks after the start of treatment, between cognitive behavioural therapy (CBT) and multidisciplinary rehabilitation treatment (MRT) for patients with chronic fatigue syndrome (CFS). Multicentre, randomized controlled trial of patients with CFS. Participants were randomly assigned to MRT or CBT. Four rehabilitation centres in the Netherlands. A total of 122 patients participated in the trial. Primary outcomes were fatigue measured by the fatigue subscale of the Checklist Individual Strength and health-related quality of life measured by the Short-Form 36. Outcomes were assessed prior to treatment and at 26 and 52 weeks after treatment initiation. A total of 114 participants completed the assessment at 26 weeks, and 112 completed the assessment at 52 weeks. MRT was significantly more effective than CBT in reducing fatigue at 52 weeks. The estimated difference in fatigue between the two treatments was -3.02 [95% confidence interval (CI) -8.07 to 2.03; P = 0.24] at 26 weeks and -5.69 (95% CI -10.62 to -0.76; P = 0.02) at 52 weeks. Patients showed an improvement in quality of life over time, but between-group differences were not significant. This study provides evidence that MRT is more effective in reducing long-term fatigue severity than CBT in patients with CFS. Although implementation in comparable populations can be recommended based on clinical effectiveness, it is advisable to analyse the cost-effectiveness and replicate these findings in another multicentre trial. © 2015 The Association for the Publication of the Journal of Internal Medicine.

  6. Behavioral activation treatment for major depression: A randomized trial of the efficacy of augmentation with cognitive control training.

    Science.gov (United States)

    Moshier, Samantha J; Otto, Michael W

    2017-03-01

    Major depressive disorder (MDD) is associated with hypoactivation of the dorsolateral prefrontal cortex, a brain region involved in emotion regulation and basic cognitive control processes. Recent studies have indicated that computerized interventions designed to activate this region may reduce depressive and ruminative symptoms. In this double-blind randomized controlled trial, we tested whether one such program, called Cognitive Control Training (CCT), enhanced treatment outcomes when used in adjunct to brief behavior therapy for MDD. Thirty-four adults with MDD were randomly assigned to complete four sessions of either computerized CCT or a control task, concurrently with four sessions of Brief Behavioral Activation Therapy for Depression (BATD). Post-treatment and one-month follow-up assessments were conducted, with self-reported depressive symptoms as the primary outcome and clinician-rated depressive symptoms and self-reported rumination as secondary outcomes. In both intent-to-treat and completer analyses, depressive symptoms and rumination decreased significantly over the course of treatment in both treatment conditions. There were no significant differences in treatment outcome depending on the augmentation condition. The sample size was small, hindering secondary analyses and identification of potential predictors or moderators of treatment effect. Results demonstrate substantial clinical benefit following four sessions of BATD; however, adjunctive CCT did not enhance outcomes. This study and other recent research suggest that the effects of CCT may not be as robust as previously indicated, highlighting the need for continued investigation of the conditions under which CCT may be effective. Published by Elsevier B.V.

  7. Treatment effectiveness of PMTO for children's behavior problems in Iceland: assessing parenting practices in a randomized controlled trial.

    Science.gov (United States)

    Sigmarsdóttir, Margrét; Degarmo, David S; Forgatch, Marion S; Guðmundsdóttir, Edda Vikar

    2013-12-01

    Findings are presented from an Icelandic randomized control trial (RCT) evaluating parent management training - Oregon model (PMTO™), a parent training intervention designed to improve parenting practices and reduce child behavior problems. In a prior report from this effectiveness study that focused on child outcomes, children in the PMTO condition showed greater reductions in reported child adjustment problems relative to the comparison group. The present report focuses on observed parenting practices as the targeted outcome, with risk by treatment moderators also tested. It was hypothesized that mothers assigned to the PMTO condition would show greater gains in pre-post parenting practices relative to controls. The sample was recruited from five municipalities throughout Iceland and included 102 participating families of children with behavior problems. Cases were referred by community professionals and randomly assigned to either PMTO (n = 51) or community services usually offered (n = 51). Child age ranged from 5 to 12 years; 73% were boys. Contrary to expectations, findings showed no main effects for changes in maternal parenting. However, evaluation of risk by treatment moderators showed greater gains in parenting practices for mothers who increased in depressed mood within the PMTO group relative to their counterparts in the comparison group. This finding suggests that PMTO prevented the expected damaging effects of depression on maternal parenting. Failure to find hypothesized main effects may indicate that there were some unobserved factors regarding the measurement and a need to further adapt the global observational procedures to Icelandic culture. © 2013 The Scandinavian Psychological Associations.

  8. Is ginger effective for the treatment of irritable bowel syndrome? A double blind randomized controlled pilot trial.

    Science.gov (United States)

    van Tilburg, Miranda A L; Palsson, Olafur S; Ringel, Yehuda; Whitehead, William E

    2014-02-01

    Ginger is one of the most commonly used herbal medicines for irritable bowel syndrome (IBS) but no data exists about its effectiveness. Double blind randomized controlled trial. University of North Carolina, Chapel Hill, North Carolina, USA. Forty-five IBS patients were randomly assigned to three groups: placebo, 1g of ginger, and 2g of ginger daily for 28 days. The IBS severity scale (IBS-SS) was administered, as well as adequate relief of symptoms scale. A responder was defined as having at least 25% reduction in IBS-SS post-treatment. There were 57.1% responders to placebo, 46.7% to 1g and 33.3% to 2g of ginger. Adequate relief was reported by 53.3% on placebo and 53.3% in both ginger groups combined. Side effects were mild and reported by 35.7% in the placebo and 16.7% in the ginger groups. This double blind randomized controlled pilot study suggests ginger is well tolerated but did not perform better than placebo. Larger trials are needed before any definitive conclusions can be drawn. Copyright © 2014 Elsevier Ltd. All rights reserved.

  9. Scaffolding students’ assignments

    DEFF Research Database (Denmark)

    Slot, Marie Falkesgaard

    2013-01-01

    This article discusses scaffolding in typical student assignments in mother tongue learning materials in upper secondary education in Denmark and the United Kingdom. It has been determined that assignments do not have sufficient scaffolding end features to help pupils understand concepts and build...

  10. Evaluation of injection techniques in the treatment of lateral epicondylitis: a prospective randomized clinical trial.

    Science.gov (United States)

    Okçu, Güvenir; Erkan, Serkan; Sentürk, Mehmet; Ozalp, R Taçkın; Yercan, H Serhat

    2012-01-01

    We aimed to compare the efficacy of two different injection techniques of local corticosteroid and local anesthetic in the management of lateral epicondylitis. This prospective study followed 80 consecutive patients who were diagnosed with lateral epicondylitis at our hospital outpatient clinic between 2005 and 2006. Patients were randomly assigned into two equal groups. Group 1 received a single injection of 1 ml betamethasone and 1 ml prilocaine on the lateral epicondyle at the point of maximum tenderness. Group 2 patients received an injection of the same drug mixture. Following the initial injection, the needle tip was redirected and reinserted down the bone approximately 30 to 40 times without emerging from the skin, creating a hematoma. Patients were evaluated with the Turkish version of the Disabilities of the Arm, Shoulder and Hand questionnaire before injection and at the final follow-up. The unpaired t-test and chi-square tests were used to compare results. Sixteen patients in Group 1 and 15 patients in Group 2 were lost during follow-up. The average follow-up period of the remaining 49 patients was 21.6 months. There were no significant differences between the two groups with regard to gender, age, follow-up period, symptom duration, involvement side and number of dominant limbs. The Turkish DASH scores of Group 2 were significantly lower than those of Group 1 (p=0.017). Long-term clinical success in the treatment of lateral epicondylitis depends on the injection method. The peppering technique appears to be more effective than the single injection technique in the long-term.

  11. A prospective, randomized multicenter study comparing APD and CAPD treatment

    DEFF Research Database (Denmark)

    Bro, S; Bjorner, J B; Tofte-Jensen, P

    2000-01-01

    , dialysis-related complications, dialysis-related expenses. RESULTS: The quality-of-life studies showed that significantly more time for work, family, and social activities was available to patients on APD compared to those on CAPD (p .... With larger patient samples, it is possible, however, that a significant difference might have been achieved. The running costs for APD treatment were US $75 per day and for CAPD treatment US $61 per day. CONCLUSION: If APD treatment can help to keep selected patients vocationally or socially active, paying...

  12. Randomized Controlled Trial of an Internet-Based Cognitive-Behavioral Treatment Program for Binge-Eating Disorder.

    Science.gov (United States)

    Wagner, Birgit; Nagl, Michaela; Dölemeyer, Ruth; Klinitzke, Grit; Steinig, Jana; Hilbert, Anja; Kersting, Anette

    2016-07-01

    Binge-eating disorder (BED) is a prevalent health condition associated with obesity. Few people with BED receive appropriate treatment. Personal barriers include shame, fear of stigma, geographic distance to mental health services, and long wait-lists. The aims of this study were to examine the efficacy of an Internet-based cognitive-behavioral intervention for adults with threshold BED (DSM-IV) and to examine the stability of treatment effects over 12months. Participants were randomly assigned to a 16-week Internet-based cognitive-behavioral intervention (n=69) or a wait-list condition (n=70). Binge-eating frequency and eating disorder psychopathology were measured with the Eating Disorder Examination-Questionnaire and the Eating Disorder Examination administered over the telephone. Additionally, body weight and body mass index, depression, and anxiety were assessed before and immediately after treatment. Three-, 6-, and 12-month follow-up data were recorded in the treatment group. Immediately after the treatment the number of binge-eating episodes showed significant improvement (d=1.02, between group) in the treatment group relative to the wait-list condition. The treatment group had also significantly reduced symptoms of all eating psychopathology outcomes relative to the wait-list condition (0.82≤d≤1.11). In the treatment group significant improvement was still observed for all measures 1year after the intervention relative to pretreatment levels. The Internet-based intervention proved to be efficacious, significantly reducing the number of binge-eating episodes and eating disorder pathology long term. Low-threshold e-health interventions should be further evaluated to improve treatment access for patients suffering from BED. Copyright © 2016. Published by Elsevier Ltd.

  13. Additional effect of pulsed electromagnetic field therapy on knee osteoarthritis treatment: a randomized, placebo-controlled study.

    Science.gov (United States)

    Ozgüçlü, Erkan; Cetin, Alp; Cetin, Meral; Calp, Emel

    2010-08-01

    The aim of this study was to evaluate if pulsed electromagnetic field therapy (PEMF) has additional effect on the classical physical treatment of knee osteoarthritis (OA) composed of hot pack, therapeutic ultrasound, and terminal isometric exercises. Forty patients (29 women and 11 men), ages 44 to 78 (mean age was 61.3 +/- 7.8 years) were included in our study. Patients with knee osteoarthritis [Kellgren-Lawrence criteria grade 2 and above and an average pain intensity of 40 or more on a 100-mm visual analog scale (VAS)] recruited from outpatient physical medicine and rehabilitation clinic were randomly assigned to receive PEMF or sham PEMF treatment in addition to their physical therapy. Both the PEMF and sham PEMF treatments being evaluated were 55 min/session, five sessions per week for 2 weeks. Each session comprise 20-min hot pack, 5-min therapeutic ultrasound, and 30-min PEMF or sham PEMF treatment applied to the knee of the patients. Patients were evaluated by the Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Index and VAS at the baseline and at the end of treatment. Both PEMF and sham PEMF treatment groups showed statistically significant improvement in WOMAC pain and functional scores at the end of treatment (p < 0.001 in both groups). There were no statistically significant differences between groups in WOMAC pain, stiffness, and physical function scores after treatment (p = 0.906, p = 0.855, p = 0.809, respectively). There was neither difference in concomitant used acetaminophen dose in both groups (p = 0.289). The results of this study show that PEMF does not have additional effect on the classical physical treatment in reducing symptoms of knee OA.

  14. Neurocognition and quality of life after reinitiating antiretroviral therapy in children randomized to planned treatment interruption

    NARCIS (Netherlands)

    Ananworanich, Jintanat; Melvin, Diane; Amador, Jose T. R.; Childs, Tristan; Medin, Gabriela; Boscolo, Valentina; Compagnucci, Alexandra; Kanjanavanit, Suparat; Montero, Samuel; Gibb, Diana M.; Aboulker, J. -P.; Babiker, A.; Belfrage, E.; Bernardi, S.; Bologna, R.; Burger, D.; Butler, K.; Castelli-Gattinara, G.; Castro, H.; Clayden, P.; Compagnucci, A.; Cressey, T.; Darbyshire, J. H.; Debré, M.; de Groot, R.; della Negra, M.; Di Biagio, A.; de Rossi, A.; Duicelescu, D.; Faye, A.; Giaquinto, C.; Giacomet, V.; Gibb, D. M.; Grosch-Wörner, I.; Hainault, M.; Klein, N.; Lallemant, M.; Levy, J.; Lyall, H.; Marczynska, M.; Marques, L.; Mardarescu, M.; Mellado Peña, M. J.; Nadal, D.; Nastouli, E.; Naver, L.; Niehues, T.; Peckham, C.; Pillay, D.; Popieska, J.; Ramos Amador, J. T.; Rojo Conejo, P.; Rosado, L.; Rosso, R.; Rudin, C.; Scherpbier, H. J.; Sharland, M.; Stevanovic, M.; Thorne, C.; Tovo, P. A.; Tudor-Williams, G.; Turkova, A.; Valerius, N.; Volokha, A.; Walker, A. S.; Welch, S.; Wintergerst, U.; Aboulker, J. P.; Burger, D. M.; Green, H.; Harper, L.; Mofenson, L.; Moye, J.; Saïdi, Y.; Cressey, T. R.; Jacqz-Aigrain, E.; Khoo, S.; Regazzi, M.; Tréluyer, J. M.; Ngo-Giang-Huong, N.; Muñoz Fernandez, M. A.; Hill, C.; Lepage, P.; Pozniak, A.; Vella, S.; Chêne, G.; Vesikari, T.; Hadjou, G.; Léonardo, S.; Riault, Y.; Bleier, J.; Buck, L.; Duong, T.; Farrelly, L.; Forcat, S.; Harrison, L.; Horton, J.; Johnson, D.; Montero, S.; Taylor, C.; Chalermpantmetagul, S.; Peongjakta, R.; Khamjakkaew, W.; Than-in-at, K.; Chailert, S.; Jourdain, G.; Le Coeur, S.; Floret, D.; Costanzo, P.; Le Thi, T. T.; Monpoux, F.; Mellul, S.; Caranta, I.; Boudjoudi, N.; Firtion, G.; Denon, M.; Charlemaine, E.; Picard, F.; Hellier, E.; Heuninck, C.; Damond, F.; Alexandre, G.; Tricoire, J.; Antras, M.; Lachendowier, C.; Nicot, F.; Krivine, A.; Rivaux, D.; Notheis, G.; Strotmann, G.; Schlieben, S.; Rampon, O.; Boscolo, V.; Zanchetta, M.; Ginocchio, F.; Viscoli, C.; Martino, A.; Pontrelli, G.; Baldassar, S.; Concato, C.; Mazza, A.; Rossetti, G.; Dobosz, S.; Oldakowska, A.; Popielska, J.; Kaflik, M.; Stanczak, J.; Stanczack, G.; Dyda, T.; Kruk, M.; González Tomé, M. I.; Delgado García, R.; Fernandez Gonzalez, M. T.; Medin, G.; Mellado Peña, M. José; Martín Fontelos, P.; Garcia Mellado, M. I.; Medina, A. F.; Ascencion, B.; Garcia Bermejo, I.; Navarro Gomez, D. M. L.; Saavedra, J.; Prieto, C.; Jimenez, J. L.; Muñoz-Fernandez, M. A.; Garcia Torre, A.; de José Gómez, M. I.; García Rodriguez, M. C.; Moreno Pérez, D.; Núñez Cuadros, E.; Asensi-Botet, F.; Otero Reigada, C.; Pérez Tamarit, M. D.; Vilalta, R.; Molina Moreno, J. M.; Rainer, Truninger; Schupbach, J.; Rutishauser, M.; Bunupuradah, T.; Butterworth, O.; Phasomsap, C.; Prasitsuebsai, W.; Chuanjaroen, T.; Jupimai, T.; Ubolyam, S.; Phanuphak, P.; Puthanakit, T.; Pancharoen, C.; Mai, Chaing; Kanjanavanit, S.; Namwong, T.; Punsakoon, W.; Payakachat, S.; Chutima, D.; Raksasang, M.; Foster, C.; Hamadache, D.; Campbell, S.; Newbould, C.; Monrose, C.; Abdulla, A.; Walley, A.; Melvin, D.; Patel, D.; Kaye, S.; Seery, P.; Rankin, A.; Wildfire, A.; Novelli, V.; Shingadia, D.; Moshal, K.; Flynn, J.; Clapson, M.; Allen, A.; Spencer, L.; Rackstraw, C.; Ward, B.; Parkes, K.; Depala, M.; Jacobsen, M.; Poulsom, H.; Barkley, L.; Miah, J.; Lurie, P.; Keane, C.; McMaster, P.; Phipps, M.; Orendi, J.; Farmer, C.; Liebeschuetz, S.; Sodeinde, O.; Wong, S.; Bostock, V.; Heath, Y.; Scott, S.; Gandhi, K.; Lewis, P.; Daglish, J.; Miles, K.; Summerhill, L.; Subramaniam, B.; Weiner, L.; Famiglietti, M.; Rana, S.; Yu, P.; Roa, J.; Puga, A.; Haerry, A.

    2016-01-01

    Objective: Understanding the effects of antiretroviral treatment (ART) interruption on neurocognition and quality of life (QoL) are important for managing unplanned interruptions and planned interruptions in HIV cure research. Design: Children previously randomized to continuous (continuous ART, n =

  15. The morbidity of treatment for patients with stage I endometrial cancer : Results from a randomized trial

    NARCIS (Netherlands)

    Creutzberg, CL; van Putten, WLJ; Koper, PC; Lybeert, MLM; Jobsen, JJ; Warlam-Rodenhuis, CC; De Winter, KAJ; Lutgens, LCHW; van den Bergh, ACM; van der Steen-Banasik, E; Beerman, H; van Lent, M

    2001-01-01

    Purpose: To compare the treatment complications for patients with Stage I endometrial cancer treated with surgery and pelvic radiotherapy (RT) or surgery alone in a multicenter randomized trial. Methods and Materials: The Postoperative Radiation Therapy in Endometrial Carcinoma (PORTEC) trial

  16. Efficacy of bacterial cellulose membrane for the treatment of lower limbs chronic varicose ulcers: a randomized and controlled trial

    Directory of Open Access Journals (Sweden)

    LUCIANA MARINS CAVALCANTI

    Full Text Available ABSTRACT Objective: to evaluate the efficacy of Bacterial Cellulose (BC membrane dressings in the treatment of lower limb venous ulcers. Methods: we carried out a prospective, randomized, controlled study of 25 patients with chronic venous ulcer disease in the lower limbs from the Angiology and Vascular Surgery Service of the Federal University of Pernambuco Hospital and from the Salgado Polyclinic of the County Health Department, Caruaru, Pernambuco. We randomly assigned patients to two groups: control group, receiving dressings with triglyceride oil (11 patients and experimental group, treated with BC membrane (14 patients. We followed the patients for a period of 120 days. Results: There was a reduction in the wound area in both groups. There were no infections or reactions to the product in any of the groups. Patients in the BC group showed decreased pain and earlier discontinuation of analgesic use. Conclusion: BC membrane can be used as a dressing for the treatment of varicose ulcers of the lower limbs.

  17. Cognitive behavioral therapy for insomnia outcomes in women after primary breast cancer treatment: a randomized, controlled trial.

    Science.gov (United States)

    Matthews, Ellyn E; Berger, Ann M; Schmiege, Sarah J; Cook, Paul F; McCarthy, Michaela S; Moore, Camille M; Aloia, Mark S

    2014-05-01

    To examine the effect of cognitive-behavioral therapy for insomnia (CBTI) on sleep improvement, daytime symptoms, and quality of life (QOL) in breast cancer survivors (BCSs) after cancer treatment. A prospective, longitudinal, randomized, controlled trial. Oncology clinics, breast cancer support groups, and communities in Colorado. 56 middle-aged BCSs with chronic insomnia. Women were randomly assigned to CBTI or behavioral placebo treatment (BPT) and completed measures of sleep, QOL, functioning, fatigue, and mood at baseline, postintervention, and at three- and six-month follow-ups. Sleep outcomes (e.g., sleep efficiency, sleep latency, total sleep time, wake after sleep onset, number of nightly awakenings); secondary variables included sleep medication use, insomnia severity, QOL, physical function, cognitive function, fatigue, depression, anxiety, and sleep attitudes or knowledge. Sleep efficiency and latency improved more in the CBTI group than the BPT group; this difference was maintained during follow-up. Women in the CBTI group had less subjective insomnia, greater improvements in physical and cognitive functioning, positive sleep attitudes, and increased sleep hygiene knowledge. No group differences in improvement were noted relative to QOL, fatigue, or mood. Nurse-delivered CBTI appears to be beneficial for BCSs' sleep latency/efficiency, insomnia severity, functioning, sleep knowledge, and attitudes more than active placebo, with sustained benefit over time. Oncology nurses are in a unique position to identify insomnia in cancer survivors. When sleep disturbances become chronic, nurses need to make recommendations and referrals.

  18. [Treatment of vascular dementia by Chinese herbal medicine: a systematic review of randomized controlled trials of clinical studies].

    Science.gov (United States)

    Jian, Wen-Jia; Shi, Jing; Tian, Jin-Zhou; Ni, Jing-Nian

    2015-01-01

    Chinese herbal medicine has been extensively used in the treatment of vascular dementia (VaD), but lacked systematic review on its efficacy and safety. So we conducted a systematic review to assess the efficacy and safety of Chinese herbal medicine in treating VaD. CNKI, CBM, PubMed, and Wiley Online Library were retrieved for randomized trials (RCTs) on Chinese herbal medicine treating VaD patients. Randomized parallel control trials by taking Chinese herbal medicine as one treatment method and placebos/cholinesterase inhibitors/Memantine hydrochloride as the control were included. Quality rating and data extraction were performed. RevMan5.2.0 Software was used for meta-analysis. Standardized mean difference (SMD) at 95% confidence interval (CI) was used to indicate effect indicators of results. Seven RCTs met the inclusive criteria. Totally 677 VaD patients were randomly assigned to the treatment group and the control group. Descriptive analyses were performed in inclusive trials. The cognitive function was assessed in all trials. Results showed Mini-Mental state examination (MMSE) score was better in the Chinese herbal medicine group than in the placebo group, but with no significant difference when compared with the donepezil group (P > 0.05). Adverse reactions were mainly manifested as gastrointestinal symptoms such as abdominal pain in the Chinese herbal medicine group. But they occurred more in the donepezil group than in the Chinese herbal medicine group. The methodological quality of included trials was poor with less samples. Results of different trials were lack of consistency. Present evidence is not sufficient to prove or disapprove the role of Chinese herbal medicine in improving clinical symptoms and outcome indicators of VaD patients. Their clinical efficacy and safety need to be supported by more higher quality RCTs.

  19. The treatment of medial tibial stress syndrome in athletes; a randomized clinical trial.

    Science.gov (United States)

    Moen, Maarten Hendrik; Holtslag, Leonoor; Bakker, Eric; Barten, Carl; Weir, Adam; Tol, Johannes L; Backx, Frank

    2012-03-30

    The only three randomized trials on the treatment of MTSS were all performed in military populations. The treatment options investigated in this study were not previously examined in athletes. This study investigated if functional outcome of three common treatment options for medial tibial stress syndrome (MTSS) in athletes in a non-military setting was the same. The study design was randomized and multi-centered. Physical therapists and sports physicians referred athletes with MTSS to the hospital for inclusion. 81 athletes were assessed for eligibility of which 74 athletes were included and randomized to three treatment groups. Group one performed a graded running program, group two performed a graded running program with additional stretching and strengthening exercises for the calves, while group three performed a graded running program with an additional sports compression stocking. The primary outcome measure was: time to complete a running program (able to run 18 minutes with high intensity) and secondary outcome was: general satisfaction with treatment. 74 Athletes were randomized and included of which 14 did not complete the study due a lack of progress (18.9%). The data was analyzed on an intention-to-treat basis. Time to complete a running program and general satisfaction with the treatment were not significantly different between the three treatment groups. This was the first randomized trial on the treatment of MTSS in athletes in a non-military setting. No differences were found between the groups for the time to complete a running program. CCMO; NL23471.098.08.

  20. Buspirone versus methylphenidate in the treatment of children with attention- deficit/ hyperactivity disorder: randomized double-blind study.

    Science.gov (United States)

    Mohammadi, Mohammad-Reza; Hafezi, Poopak; Galeiha, Ali; Hajiaghaee, Reza; Akhondzadeh, Shahin

    2012-01-01

    A recent randomized clinical trial showed buspirone efficacy in the treatment of attention-deficit/hyperactivity disorder (ADHD) in children. However, results from a recent multi-site controlled clinical trial of transdermal buspirone failed to separate it from placebo in a large sample of children with ADHD. Therefore, due to these inconsistent findings, this study was designed to assess the efficacy of buspirone in the treatment of children with ADHD compared to methylphenidate in a double blind randomized clinical trial. Forty outpatients with a DSM-IV-TR diagnosis of ADHD were study population of this trial. Subjects were recruited from an outpatient child and adolescent clinic for a 6 week double blind, randomized clinical trial. All study subjects were randomly assigned to receive treatment using tablet of buspirone at a dose of 20-30 mg/day depending on weight (20 mg/day for 30kg) (group 1) or methylphenidate at a dose of 20-30 mg/day depending on weight (20 mg/day for 30kg (group 2) for a 6 week double blind, randomized clinical trial. The principal measure of outcome was the Teacher and Parent ADHD Rating Scale IV. Patients were assessed at baseline and at 21 and 42 days after the medication started. Significant differences were observed between the two groups on the Parent and Teacher Rating Scale scores. The changes at the endpoint compared to baseline were: -8.95±8.73 (mean±SD) and -15.60±7.81 (mean±SD) for buspirone and methyphenidate, for Parent ADHD Rating Scale. The changes at the endpoint compared to baseline were: -9.80 ±7.06 (mean±SD) and -22.40±9.90 (mean±SD) for buspirone and methyphenidate, respectively for Teacher ADHD Rating Scale. The difference between the buspirone and methylphenidate groups in the frequency of side effects was not significant except for decreased appetite, headache and insomnia that were observed more frequently in the methylphenidate group. The results of this study suggest that administration of buspirone was

  1. Buspirone Versus Methylphenidate in the Treatment of Children with Attention- Deficit/ Hyperactivity Disorder: Randomized Double-Blind Study

    Directory of Open Access Journals (Sweden)

    Shahin Akhondzadeh

    2012-11-01

    Full Text Available A recent randomized clinical trial showed buspirone efficacy in the treatment of attention-deficit/hyperactivity disorder (ADHD in children. However, results from a recent multi-site controlled clinical trial of transdermal buspirone failed to separate it from placebo in a large sample of children with ADHD. Therefore, due to these inconsistent findings, this study was designed to assess the efficacy of buspirone in the treatment of children with ADHD compared to methylphenidate in a double blind randomized clinical trial. Forty outpatients with a DSM-IV-TR diagnosis of ADHD were study population of this trial. Subjects were recruited from an outpatient child and adolescent clinic for a 6 week double blind, randomized clinical trial. All study subjects were randomly assigned to receive treatment using tablet of buspirone at a dose of 20-30 mg/day depending on weight (20 mg/day for 30kg (group 1 or methylphenidate at a dose of 20-30 mg/day depending on weight (20 mg/day for 30kg (group 2 for a 6 week double blind, randomized clinical trial. The principal measure of outcome was the Teacher and Parent ADHD Rating Scale IV. Patients were assessed at baseline and at 21 and 42 days after the medication started. Significant differences were observed between the two groups on the Parent and Teacher Rating Scale scores. The changes at the endpoint compared to baseline were: -8.95±8.73 (mean±SD and -15.60±7.81 (mean±SD for buspirone and methyphenidate, for Parent ADHD Rating Scale. The changes at the endpoint compared to baseline were: -9.80 ±7.06 (mean±SD and -22.40±9.90 (mean±SD for buspirone and methyphenidate, respectively for Teacher ADHD Rating Scale. The difference between the buspirone and methylphenidate groups in the frequency of side effects was not significant except for decreased appetite, headache and insomnia that were observed more frequently in the methylphenidate group. The results of this study suggest that administration of

  2. False Safety Behavior Elimination Therapy: A randomized study of a brief individual transdiagnostic treatment for anxiety disorders.

    Science.gov (United States)

    Riccardi, Christina J; Korte, Kristina J; Schmidt, Norman B

    2017-03-01

    In response to the ever-growing number of CBT based therapy protocols, transdiagnostic approaches to anxiety treatment, based on models of anxiety emphasizing common elements across anxiety disorders, have been increasingly explored. The aim of the current study was to test the efficacy of an individually administered, brief (5-session) transdiagnostic treatment for anxiety disorders. The current treatment (called F-SET) focuses chiefly on the elimination of anxiety maintaining behaviors and cognitive strategies (so-called "safety" aids) among individuals suffering from a range of anxiety disorders including generalized anxiety disorder (GAD), social anxiety disorder (SAD) and panic disorder (PD). Patients (N=28; mean age=28.5years; 75% female; 71% White) were randomly assigned to F-SET or waitlist control conditions. Participants were assessed prior to, immediately after, and 1-month following treatment. In addition to independent assessments of diagnostic status, standardized self-report measures and assessor ratings of severity and distress associated with anxiety symptoms were used. Participants in the F-SET condition experienced significantly less anxiety (Cohen's d=2.01) and depression (Cohen's d=2.16) than those in the WL condition. Mediational analysis showed that change in avoidance strategies mediated the group changes in anxiety symptoms. The results from the current study are an important first step in identifying a simpler, focused form of CBT that can be delivered with minimal therapist training, at a low cost and with minimal client contact time. Copyright © 2016 Elsevier Ltd. All rights reserved.

  3. Pharmacological treatment of the pathogenetic defects in type 2 diabetes: the randomized multicenter South Danish Diabetes Study.

    Science.gov (United States)

    Gram, Jeppe; Henriksen, Jan Erik; Grodum, Ellen; Juhl, Henning; Hansen, Tony Bill; Christiansen, Christian; Yderstræde, Knud; Gjessing, Hans; Hansen, Henrik M; Vestergaard, Vibe; Hangaard, Jørgen; Beck-Nielsen, Henning

    2011-01-01

    To determine the effect of treatment with insulin aspart compared with NPH insulin, together with metformin/placebo and rosiglitazone/placebo. The hypothesis was that combined correction of major pathogenetic defects in type 2 diabetes would result in optimal glycemic control. This study was a 2-year investigator-driven randomized partly placebo-controlled multicenter trial in 371 patients with type 2 diabetes on at least oral antiglycemic treatment. Patients were assigned to one of eight treatment groups in a factorial design with insulin aspart at mealtimes versus NPH insulin once daily at bedtime, metformin twice daily versus placebo, and rosiglitazone twice daily versus placebo. The main outcome measurement was change in A1C. A1C decreased more in patients treated with insulin aspart compared with NPH (-0.41 ± 0.10%, P weight (1.6 ± 0.6 kg, P weight and hypoglycemic episodes. However, insulin therapy has to be combined with treatment of both peripheral and liver insulin resistance to normalize blood glucose, and in this case, the insulin regimen is less important.

  4. An Internet-based treatment for flying phobia (NO-FEAR Airlines): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Campos, Daniel; Bretón-López, Juana; Botella, Cristina; Mira, Adriana; Castilla, Diana; Baños, Rosa; Tortella-Feliu, Miquel; Quero, Soledad

    2016-08-20

    Flying phobia (FP) is a common and disabling mental disorder. Although in vivo exposure is the treatment of choice, it is linked to a number of limitations in its implementation. Particularly important, is the limited access to the feared stimulus (i.e., plane). Moreover, the economic cost of in vivo exposure should be specially considered as well as the difficulty of applying the exposure technique in an appropriate way; controlling important variables such as the duration of the exposure or the number of sessions. ICTs could help to reduce these limitations. Computer-assisted treatments have remarkable advantages in treating FP. Furthermore, they can be delivered through the Internet, increasing their advantages and reaching more people in need. The Internet has been established as an effective way to treat a wide range of mental disorders. However, as far as we know, no controlled studies exist on FP treatment via the Internet. This study aims to evaluate the efficacy of an Internet-based treatment for FP (NO-FEAR Airlines) versus a waiting list control group. Secondary objectives will be to explore two ways of delivering NO-FEAR Airlines, with or without therapist guidance, and study the patients' acceptance of the program. This paper presents the study protocol. The study is a randomized controlled trial. A minimum of 57 participants will be randomly assigned to three conditions: a) NO-FEAR Airlines totally self-applied, b) NO-FEAR Airlines with therapist guidance, or c) a waiting list control group (6 weeks). Primary outcomes measures will be the Fear of Flying Questionnaire-II and the Fear of Flying Scale. Secondary outcomes will be included to assess other relevant clinical measures, such as the Fear and Avoidance Scales, Clinician Severity Scale, and Patient's Improvement scale. Analyses of post-treatment flights will be conducted. Treatment acceptance and preference measures will also be included. Intention-to-treat and per protocol analyses will be

  5. Exercise during and after neoadjuvant rectal cancer treatment (the EXERT trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Morielli, Andria R; Usmani, Nawaid; Boulé, Normand G; Severin, Diane; Tankel, Keith; Nijjar, Tirath; Joseph, Kurian; Fairchild, Alysa; Courneya, Kerry S

    2018-01-12

    Standard treatment for locally advanced rectal cancer includes 5-6 weeks of neoadjuvant chemoradiotherapy (NACRT) followed by total mesorectal excision 6-8 weeks later. NACRT improves local disease control and surgical outcomes but also causes side effects including fatigue, diarrhea, hand-foot syndrome, and physical deconditioning that may impede quality of life (QoL), treatment completion, treatment response, and long-term prognosis. Interventions to improve treatment outcomes and manage side effects that are safe, tolerable and low-cost are highly desirable. Exercise has been shown to improve some of these outcomes in other cancer patient groups but no study to date has examined the potential benefits (and harms) of exercise training during and after NACRT for rectal cancer. The Exercise During and After Neoadjuvant Rectal Cancer Treatment (EXERT) trial is a single-center, prospective, two-armed, phase II randomized controlled trial designed to test the preliminary efficacy of exercise training in this clinical setting and to further evaluate its feasibility and safety. Participants will be 60 rectal cancer patients scheduled to receive long-course NACRT followed by total mesorectal excision. Participants will be randomly assigned to exercise training or usual care. Participants in the exercise training group will be asked to complete three supervised, high-intensity interval training sessions/week during NACRT and ≥ 150 min/week of unsupervised, moderate-to-vigorous-intensity, continuous exercise training after NACRT prior to surgery. Participants in the usual care group will be asked not to increase their exercise from baseline. Assessments will be completed pre NACRT, post NACRT, and pre surgery. The primary endpoint will be cardiorespiratory fitness (VO 2 peak) at the post-NACRT time point assessed by a graded exercise test. Secondary endpoints will include functional fitness assessed by the Senior's Fitness Test, QoL assessed by the European

  6. Childhood Resiliency Effects from Schoolwide Treatment: A Cluster Randomized Trial

    Science.gov (United States)

    Hinerman, Krystal M.; Hull, Darrell M.; Hayes, DeMarquis; Powell, Marvin G.; Ferguson, Sarah; Naslund-Hadley, Emma I.

    2014-01-01

    The purpose of the Childhood Resiliency Effects from Schoolwide Treatment (CREST) Pilot was to implement a comprehensive school wide social and character development program aimed at decreasing violence among students and assisting students exposed to violence in Belize City. This one-year pilot program implemented portions of the Positive Action…

  7. Osteopathic manipulative treatment in conjunction with medication relieves pain associated with fibromyalgia syndrome: results of a randomized clinical pilot project.

    Science.gov (United States)

    Gamber, Russell G; Shores, Jay H; Russo, David P; Jimenez, Cynthia; Rubin, Benard R

    2002-06-01

    Osteopathic physicians caring for patients with fibromyalgia syndrome (FM) often use osteopathic manipulative treatment (OMT) in conjunction with other forms of standard medical care. Despite a growing body of evidence on the efficacy of manual therapy for the treatment of selected acute musculoskeletal conditions, the role of OMT in treating patients with chronic conditions such as FM remains largely unknown. Twenty-four female patients meeting American College of Rheumatology criteria for FM were randomly assigned to one of four treatment groups: (1) manipulation group, (2) manipulation and teaching group, (3) moist heat group, and (4) control group, which received no additional treatment other than current medication. Participants' pain perceptions were assessed by use of pain thresholds measured at each of 10 bilateral tender points using a 9-kg dolorimeter, the Chronic Pain Experience Inventory, and the Present Pain Intensity Rating Scale. Patients' affective response to treatment was assessed using the Self-Evaluation Questionnaire. Activities of daily living were assessed using the Stanford Arthritis Center Disability and Discomfort Scales: Health Assessment Questionnaire. Depression was assessed using the Center for Epidemiological Studies Depression Scale. Significant findings between the four treatment groups on measures of pain threshold, perceived pain, attitude toward treatment, activities of daily living, and perceived functional ability were found. All of these findings favored use of OMT. This study found OMT combined with standard medical care was more efficacious in treating FM than standard care alone. These findings need to be replicated to determine if cost savings are incurred when treatments for FM incorporate nonpharmacologic approaches such as OMT.

  8. Historical WBAN ID Assignments

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — 4"x6" index cards represent the first written assignments of Weather Bureau Army Navy (WBAN) station identifier numbers by the National Climatic Data Center....

  9. My Favorite Assignment.

    Science.gov (United States)

    Post, Robert E.; Johnson, Jack E.

    1982-01-01

    Presents two assignments that show (1) how George Orwell's "Politics and the English Language" can be applied to business writing and (2) how structured student-teacher conferences can generate enthusiasm for oral expression in a business communication course. (AEA)

  10. Predictors of treatment response for depression and inadequate social support--the ENRICHD randomized clinical trial.

    Science.gov (United States)

    Cowan, Marie J; Freedland, Kenneth E; Burg, Matthew M; Saab, Patrice G; Youngblood, Marston E; Cornell, Carol E; Powell, Lynda H; Czajkowski, Susan M

    2008-01-01

    To determine whether the 'dose' of treatment exposure, delivery of specific components of cognitive behavior therapy (CBT), patient adherence and/or use of antidepressants predict favorable depression and social support outcomes after 6 months of cognitive behavioral treatment. Secondary analyses of the intervention arm of the Enhancing Recovery in Coronary Heart Disease (ENRICHD) clinical trial involving persons with acute myocardial infarction (MI): n = 641 for the depression outcomes and n = 523 for the social support outcomes. The outcome measures were, for depression: the Beck Depression Inventory (BDI) and Hamilton Rating Scale for Depression (HAM-D); for social support: the ENRICHD Social Support Instrument (ESSI) and Perceived Social Support Scale (PSSS). Better depression outcomes (measured by the BDI) were receiving a high number of depression-specific intervention components, p homework assignments, p homework assignments, p homework assignments, p homework assignments is important for both outcomes. Other components of the ENRICHD intervention that were designed to improve social support had no discernible effects on outcomes. Intervention refinements may be needed in order to achieve better results in future post-MI clinical trials. A greater emphasis on CBT homework adherence could improve both depression and social support outcomes. 2008 S. Karger AG, Basel

  11. Caffeine for treatment of Parkinson disease: a randomized controlled trial.

    Science.gov (United States)

    Postuma, Ronald B; Lang, Anthony E; Munhoz, Renato P; Charland, Katia; Pelletier, Amelie; Moscovich, Mariana; Filla, Luciane; Zanatta, Debora; Rios Romenets, Silvia; Altman, Robert; Chuang, Rosa; Shah, Binit

    2012-08-14

    Epidemiologic studies consistently link caffeine, a nonselective adenosine antagonist, to lower risk of Parkinson disease (PD). However, the symptomatic effects of caffeine in PD have not been adequately evaluated. We conducted a 6-week randomized controlled trial of caffeine in PD to assess effects upon daytime somnolence, motor severity, and other nonmotor features. Patients with PD with daytime somnolence (Epworth >10) were given caffeine 100 mg twice daily ×3 weeks, then 200 mg twice daily ×3 weeks, or matching placebo. The primary outcome was the Epworth Sleepiness Scale score. Secondary outcomes included motor severity, sleep markers, fatigue, depression, and quality of life. Effects of caffeine were analyzed with Bayesian hierarchical models, adjusting for study site, baseline scores, age, and sex. Of 61 patients, 31 were randomized to placebo and 30 to caffeine. On the primary intention-to-treat analysis, caffeine resulted in a nonsignificant reduction in Epworth Sleepiness Scale score (-1.71 points; 95% confidence interval [CI] -3.57, 0.13). However, somnolence improved on the Clinical Global Impression of Change (+0.64; 0.16, 1.13, intention-to-treat), with significant reduction in Epworth Sleepiness Scale score on per-protocol analysis (-1.97; -3.87, -0.05). Caffeine reduced the total Unified Parkinson's Disease Rating Scale score (-4.69 points; -7.7, -1.6) and the objective motor component (-3.15 points; -5.50, -0.83). Other than modest improvement in global health measures, there were no changes in quality of life, depression, or sleep quality. Adverse events were comparable in caffeine and placebo groups. Caffeine provided only equivocal borderline improvement in excessive somnolence in PD, but improved objective motor measures. These potential motor benefits suggest that a larger long-term trial of caffeine is warranted. This study provides Class I evidence that caffeine, up to 200 mg BID for 6 weeks, had no significant benefit on excessive daytime

  12. Radonexposure with the treatment of rheumatic diseases - randomized controlled trials

    Energy Technology Data Exchange (ETDEWEB)

    Falkenbach, A. [Krankenanstalt Gasteiner Heilstollen, Bad Gastein-Boeckstein (Austria)]|[Forschungsinstitut Gastein, Bad Gastein (Austria); Kovac, J.; Brandmaier, P. [Krankenanstalt Gasteiner Heilstollen, Bad Gastein-Boeckstein (Austria); Soto, J. [Dept. of Medical Physics, Univ. of Cantabria (Spain)

    2001-07-01

    The objective was to investigate whether there is evidence for the effectiveness of radon therapy in the treatment of rheumatic diseases. Method: Medline and MedKur databases were searched for randomised controlled clinical trials. Radon therapy centres and experts in the field were contacted, proceedings were hand-searched and bibliographies were checked for references of potential impact. Four clinical trials evaluating the effect of radon in patients suffering from rheumatic diseases with no or only a small number of drop-outs met the inclusion criteria. In patients with degenerative disease of the spine and large joints, two trials [1,2] reported less pain on pressure of painful paraspinal muscle points after a series of radon baths at a concentration of 0.8 kBq/L and 3 kBq/L, respectively. The alleviation of pain was most pronounced in the weeks following the treatment period. [3]. At six months follow-up serial immersion in combined radon and CO{sub 2} baths reduced pain and functional restrictions in patients with rheumatoid arthritis (n=60) more effectively than bathing in CO{sub 2} only. [4] In 130 patients with ankylosing spondylitis a complex rehabilitation program at a health resort (group 1 and 2) showed greater and longer-lasting differences to a control group staying at home (group 3), if speleotherapeutic radon exposure (group 1) was added (as compared to an added sauna treatment, group 2). Conclusion: The four trials meeting the inclusion criteria showed beneficial effects of radon therapy compared to interventions without radon exposure. Up to nine months after the treatment period significantly better results were observed, if radon therapy is added. (orig.)

  13. Music therapy as an adjunct to standard treatment for obsessive compulsive disorder and co-morbid anxiety and depression: A randomized clinical trial.

    Science.gov (United States)

    Shirani Bidabadi, Shahrzad; Mehryar, Amirhooshang

    2015-09-15

    Previous studies have highlighted the potential therapeutic benefits of music therapy as an adjunct to standard care, in a variety of psychiatric ailments including mood and anxiety disorders. However, the role of music in the treatment of obsessive-compulsive disorder (OCD) have not been investigated to date. In a single-center, parallel-group, randomized clinical trial (NCT02314195) 30 patients with OCD were randomly assigned to standard treatment (pharmacotherapy and cognitive-behavior therapy) plus 12 sessions of individual music therapy (n = 15) or standard treatment only (n = 15) for one month. Maudsley Obsessive-Compulsive Inventory, Beck Anxiety Inventory, and Beck Depression Inventory-Short Form were administered baseline and after one month. Thirty patients completed the study. Music therapy resulted in a greater decrease in total obsessive score (post-intervention score: music therapy+standard treatment: 12.4 ± 1.9 vs standard treatment only: 15.1 ± 1.7, p Music therapy was significantly more effective in reducing anxiety (post-intervention score: music therapy + standard treatment: 16.9 ± 7.4 vs standard treatment only: 22.9 ± 4.6, p music therapy + standard treatment: 10.8 ± 3.8 vs standard treatment: 17.1 ± 3.7, p music therapy, as an adjunct to standard care, seems to be effective in reducing obsessions, as well as co-morbid anxiety and depressive symptoms. Copyright © 2015. Published by Elsevier B.V.

  14. Impulsive lifestyle counseling to prevent dropout from treatment for substance use disorders in people with antisocial personality disorder: A randomized study.

    Science.gov (United States)

    Thylstrup, Birgitte; Hesse, Morten

    2016-06-01

    Patients with antisocial personality disorder in outpatient treatment for substance use disorders are at high risk of drop-out. Using a randomized design, this study tested the impact of adding a brief psycho-educational program, the Impulsive Lifestyle Counseling program, to outpatient substance abuse treatment in order to prevent treatment dropout. Patients (N=175) were recruited from 13 municipal treatment centers in Denmark, and assigned to treatment as usual or to the experimental condition. In all, 172 patients could be included in the analyses. In the intent-to-treat analysis, the risk of treatment dropout was reduced among patients randomized to the experimental program (hazard ratio=0.63, p=.031), after controlling for age, gender, and substitution treatment status. The study supported the efficacy of the Impulsive Lifestyle Counseling program as a method for preventing treatment dropout for patients with comorbid antisocial personality disorder in substance abuse treatment. Trial registration #ISRCTN67266318. Copyright © 2016 Elsevier Ltd. All rights reserved.

  15. Antiplatelet treatments: recent evidence from randomized controlled trials.

    Science.gov (United States)

    Vogel, Birgit; Baber, Usman

    2017-07-01

    To provide an overview of selected randomized studies reported over the last 2 years evaluating antiplatelet therapies in patients with either acute or stable manifestations of atherosclerosis. From large outcome trials included evidence for reduced risk of ischemic events associated with use of ticagrelor and aspirin versus aspirin alone, albeit with an increased bleeding risk in patients with stable coronary artery disease and history of myocardial infarction. No benefit regarding ischemic outcomes could be demonstrated for ticagrelor monotherapy compared with aspirin or clopidogrel in patients with stroke or peripheral vascular disease, respectively. Results from pharmacokinetic/pharmacodynamic studies suggest that switching from prasugrel to ticagrelor is safe, regardless of the use of a loading dose, and that loading with prasugrel or ticagrelor compared with clopidogrel leads to more prompt and potent platelet inhibition in patients undergoing ad hoc percoutaneous coronary intervention. No evidence could be demonstrated for the prognostic value of routine platelet function monitoring to adjust antiplatelet therapy. Large outcome trials demonstrated various effects of antithrombotic strategies including ticagrelor on clinical outcomes across patient populations. Pharmacokinetic/pharmacodynamic studies confirmed a more prompt and potent platelet inhibition after loading with the new P2Y12 inhibitors versus clopidogrel, and suggested the safety of switching from prasugrel to ticagrelor.

  16. A randomized, placebo-controlled, exploratory trial of Ibuprofen and pseudoephedrine in the treatment of primary nocturnal enuresis in children.

    Science.gov (United States)

    Gelotte, Cathy K; Prior, Mary Jane; Gu, Joan

    2009-05-01

    This exploratory randomized, double-blind, double-dummy, placebo-controlled trial of 14 days duration conducted in 22 primary care practices in the United States was used to compare the efficacy of ibuprofen and pseudoephedrine, administered alone or in combination, to placebo for the treatment of primary nocturnal enuresis (PNE) in children aged 6 to 11 years. Ibuprofen (IBU) and pseudoephedrine (PSE) are not approved for the treatment of PNE. Three hundred eighteen children with PNE were enrolled. Eligible children had >or= 8 wet nights during a 14-day baseline. Each child was randomly assigned to 1 of 4 treatment groups: IBU 12.5 mg/kg and PSE HCl 15 or 30 mg (depending on weight) (n = 82), IBU 12.5 mg/kg (n = 78), PSE HCl 15 or 30 mg (n = 76), or placebo (n = 82). Treatment was administered orally at bedtime for 14 days. Caregivers recorded whether the child was wet or dry each night in a daily diary. Children in the IBU alone and IBU and PSE combined groups had greater mean reductions from baseline in the number of wet nights (primary end point) compared to children receiving placebo (-2.9, -2.9, and -1.4, respectively, P Children in these groups also had greater mean percentage reductions in the number of wet nights compared to placebo-treated children (26%, 28%, and 12%, respectively). Although not always statistically significant, secondary end points improved in the IBU alone and IBU and PSE combined treatment groups, which included decreases in mean number of wet nights and decreases in the number and percentage of children with >or= 50%, 40%, 30%, or 25% reductions in number of wet nights. Children responding to treatment had larger mean bladder capacities and larger mean percentage of predicted bladder capacities than children who did not respond in each treatment group. No significant differences in adverse events were found among treatment groups. In conclusion, in this exploratory study in children aged 6 through 11 years, IBU provided a beneficial

  17. Internet-delivered cognitive-behavioral treatment for adolescents with chronic pain and their parents: a randomized controlled multicenter trial

    Science.gov (United States)

    Palermo, Tonya M.; Law, Emily F.; Fales, Jessica; Bromberg, Maggie H.; Jessen-Fiddick, Tricia; Tai, Gabrielle

    2016-01-01

    Internet-delivered interventions are emerging as a strategy to address barriers to care for individuals with chronic pain. This is the first large multicenter randomized controlled trial of Internet-delivered cognitive-behavioral therapy (CBT) for pediatric chronic pain. Participants included were 273 adolescents (205 females and 68 males), aged 11 to 17 years with mixed chronic pain conditions and their parents, who were randomly assigned in a parallel-group design to Internet-delivered CBT (n = 138) or Internet-delivered Education (n = 135). Assessments were completed before treatment, immediately after treatment, and at 6-month follow-up. All data collection and procedures took place online. The primary analysis used linear growth models. Results demonstrated significantly greater reduction on the primary outcome of activity limitations from baseline to 6-month follow-up for Internet CBT compared with Internet education (b = −1.13, P = 0.03). On secondary outcomes, significant beneficial effects of Internet CBT were found on sleep quality (b = 0.14, P = 0.04), on reducing parent miscarried helping (b = −2.66, P = 0.007) and protective behaviors (b = −0.19, P = 0.001), and on treatment satisfaction (P values Internet CBT were found for parent-perceived impact (ie, reductions in depression, anxiety, self-blame about their adolescent’s pain, and improvement in parent behavioral responses to pain). In conclusion, our Internet-delivered CBT intervention produced a number of beneficial effects on adolescent and parent outcomes, and could ultimately lead to wide dissemination of evidence-based psychological pain treatment for youth and their families. PMID:26335910

  18. Adjuvant treatment with dexamethasone plus anti-C5 antibodies improves outcome of experimental pneumococcal meningitis: a randomized controlled trial.

    Science.gov (United States)

    Kasanmoentalib, E Soemirien; Valls Seron, Mercedes; Morgan, B Paul; Brouwer, Matthijs C; van de Beek, Diederik

    2015-08-15

    We compared adjunctive treatment with placebo, dexamethasone, anti-C5 antibodies, and the combination of dexamethasone plus anti-C5 antibodies in experimental pneumococcal meningitis. In this prospective, investigator-blinded, randomized trial, 96 mice were infected intracisternally with 10(7) CFU/ml Streptococcus pneumoniae serotype 3, treated with intraperitoneal ceftriaxone at 20 h, and randomly assigned to intraperitoneal adjunctive treatment with placebo (saline), dexamethasone, anti-C5 antibodies, or dexamethasone plus anti-C5 antibodies. The primary outcome was survival during a 72-h observational period that was analyzed with the log-rank test. Secondary outcome was clinical severity, scored on a validated scale using a linear mixed model. Mortality rates were 16 of 16 mice (100%) in the placebo group, 12 of 15 mice (80%) in the dexamethasone group, 25 of 31 mice (80%) in the anti-C5 antibody group, and 18 of 30 mice (60%) in the dexamethasone plus anti-C5 antibody group (Fisher's exact test for overall difference, P = .012). Mortality of mice treated with dexamethasone plus anti-C5 antibodies was lower compared to the anti-C5 antibody-treated mice (log-rank P = .039) and dexamethasone-treated mice (log-rank P = .040). Clinical severity scores for the dexamethasone plus anti-C5 antibody-treated mice increased more slowly (0.199 points/h) as compared to the anti-C5 antibody-treated mice (0.243 points/h, P = .009) and dexamethasone-treated mice (0.249 points/h, P = .012). Modeling of severity data suggested an additive effect of dexamethasone and anti-C5 antibodies. Adjunctive treatment with dexamethasone plus anti-C5 antibodies improves survival in severe experimental meningitis caused by S. pneumoniae serotype 3, posing an important new treatment strategy for patients with pneumococcal meningitis.

  19. [Acupuncture therapy for the improvement of sleep quality of outpatients receiving methadone maintenance treatment: a randomized controlled trial].

    Science.gov (United States)

    Li, Yi; Liu, Xue-bing; Zhang, Yao

    2012-08-01

    To study the efficacy and safety of acupuncture therapy for the improvement of sleep quality of outpatients receiving methadone maintenance treatment (MMT). Using randomized double-blinded controlled design, seventy-five MMT outpatients with low sleep quality [score of Pittsburgh sleep quality index (PSQI) > or = 8], were randomly assigned to the acupuncture group (38 cases) and the sham-acupuncture group (37 cases). All patients maintained previous MMT. Acupuncture was applied to Baihui (GV20), Shenmen (bilateral, TF4), Shenting (GV24), Sanyinjiao (bilateral, SP6), and Sishencong (EX-HN1) in the acupuncture group. The same procedures were performed in the sham-acupuncture group, but not to the acupoints (5 mm lateral to the acupoints selected in the acupuncture group) with shallow needling technique. The treatment was performed 5 times each week for 8 successive weeks. The PSQI was assessed before treatment, at the end of the 2nd, 4th, 6th, and 8th week of the treatment. The detection ratio of low sleep quality and the incidence of adverse acupuncture reactions were compared between the two groups at the end of the 8th week. The overall PSQI score was obviously higher in the acupuncture group than in the sham-acupuncture group with statistical difference (P acupuncture group (60.53%, 23/38 cases) than in the sham-acupuncture group (83.78%, 31/37 cases) with statistical difference (P acupuncture reaction was 5.26% (2/38 cases) in the acupuncture group and 2.70% (1/37 cases) in the sham-acupuncture group respectively, showing no statistical difference (P > 0.05). Acupuncture therapy could effectively and safely improve the sleep quality of outpatients receiving MMT.

  20. A randomized, controlled trial of osteopathic manipulative treatment for acute low back pain in active duty military personnel

    Science.gov (United States)

    Cruser, des Anges; Maurer, Douglas; Hensel, Kendi; Brown, Sarah K; White, Kathryn; Stoll, Scott T

    2012-01-01

    Objective Acute low back pain (ALBP) may limit mobility and impose functional limitations in active duty military personnel. Although some manual therapies have been reported effective for ALBP in military personnel, there have been no published randomized controlled trials (RCTs) of osteopathic manipulative treatment (OMT) in the military. Furthermore, current military ALBP guidelines do not specifically include OMT. Methods This RCT examined the efficacy of OMT in relieving ALBP and improving functioning in military personnel at Fort Lewis, Washington. Sixty-three male and female soldiers ages 18 to 35 were randomly assigned to a group receiving OMT plus usual care or a group receiving usual care only (UCO). Results The primary outcome measures were pain on the quadruple visual analog scale, and functioning on the Roland Morris Disability Questionnaire. Outcomes were measured immediately preceding each of four treatment sessions and at four weeks post-trial. Intention to treat analysis found significantly greater post-trial improvement in ‘Pain Now’ for OMT compared to UCO (P = 0·026). Furthermore, the OMT group reported less ‘Pain Now’ and ‘Pain Typical’ at all visits (P = 0·025 and P = 0·020 respectively). Osteopathic manipulative treatment subjects also tended to achieve a clinically meaningful improvement from baseline on ‘Pain at Best’ sooner than the UCO subjects. With similar baseline expectations, OMT subjects reported significantly greater satisfaction with treatment and overall self-reported improvement (P<0·01). Conclusion This study supports the effectiveness of OMT in reducing ALBP pain in active duty military personnel. PMID:23372389

  1. Augmentation vs Nonaugmentation Techniques for Open Repairs of Achilles Tendon Ruptures with Early Functional Treatment: A Prospective Randomized Study.

    Science.gov (United States)

    Tezeren, Gündüz; Kuru, Ilhami

    2006-01-01

    A prospective randomized study was conducted in order to compare augmentation technique versus nonaugmentation technique, followed by early functional postoperative treatment, for operative repair of Achilles tendon ruptures. Twenty-four consecutive patients were assigned to two groups. Group I included 12 patients treated with Lindholm augmentation technique, whereas group II included 12 patients treated with modified Kessler end-to-end repair. Thereafter, these patients had postoperative management with a below-knee-cast for three weeks. The physioteraphy was initiated immediately after the cast was removed. Full weight bearing was allowed after five weeks postoperatively in the both groups. Two patients had reruptures in group II, whereas group I had prolonged operative time significantly. The patients with reruptures underwent reoperations and at the most final follow-up, it was observed that they could not resume to sporting activities. The other objective and subjective results were similar between two groups. Because of quite high rerupture rate in the group of patients treated with nonaugmentation technique, we favor functional postoperative treatment with early ankle movement in the patients treated with augmentation technique for the management of acute rupture of the Achilles tendon. Key PointsA prospective randomized study was conducted in order to compare augmentation technique versus nonaugmentation technique, followed by early functional postoperative treatment, for operative repair of Achilles tendon ruptures.Group I included 12 patients treated with Lindholm augmentation technique, whereas group II included 12 patients treated with modified Kessler end-to-end repair.Functional postoperative treatment with early ankle movement in the patients treated with augmentation for the management of acute rupture of the Achilles tendon is recommended.

  2. A randomized, controlled trial of osteopathic manipulative treatment for acute low back pain in active duty military personnel.

    Science.gov (United States)

    Cruser, des Anges; Maurer, Douglas; Hensel, Kendi; Brown, Sarah K; White, Kathryn; Stoll, Scott T

    2012-02-01

    Acute low back pain (ALBP) may limit mobility and impose functional limitations in active duty military personnel. Although some manual therapies have been reported effective for ALBP in military personnel, there have been no published randomized controlled trials (RCTs) of osteopathic manipulative treatment (OMT) in the military. Furthermore, current military ALBP guidelines do not specifically include OMT. This RCT examined the efficacy of OMT in relieving ALBP and improving functioning in military personnel at Fort Lewis, Washington. Sixty-three male and female soldiers ages 18 to 35 were randomly assigned to a group receiving OMT plus usual care or a group receiving usual care only (UCO). The primary outcome measures were pain on the quadruple visual analog scale, and functioning on the Roland Morris Disability Questionnaire. Outcomes were measured immediately preceding each of four treatment sessions and at four weeks post-trial. Intention to treat analysis found significantly greater post-trial improvement in 'Pain Now' for OMT compared to UCO (P = 0·026). Furthermore, the OMT group reported less 'Pain Now' and 'Pain Typical' at all visits (P = 0·025 and P = 0·020 respectively). Osteopathic manipulative treatment subjects also tended to achieve a clinically meaningful improvement from baseline on 'Pain at Best' sooner than the UCO subjects. With similar baseline expectations, OMT subjects reported significantly greater satisfaction with treatment and overall self-reported improvement (P<0·01). This study supports the effectiveness of OMT in reducing ALBP pain in active duty military personnel.

  3. Dry Needling Versus Cortisone Injection in the Treatment of Greater Trochanteric Pain Syndrome: A Noninferiority Randomized Clinical Trial.

    Science.gov (United States)

    Brennan, Kindyle L; Allen, Bryce C; Maldonado, Yolanda Munoz

    2017-04-01

    Study Design Prospective, randomized, partially blinded. Background Greater trochanteric pain syndrome (GTPS) is the current terminology for what was once called greater trochanteric or subgluteal bursitis. Cortisone (corticosteroid) injection into the lateral hip has traditionally been the accepted treatment for this condition; however, the effectiveness of injecting the bursa with steroids is increasingly being questioned. An equally effective treatment with fewer adverse side effects would be beneficial. Objective To investigate whether administration of dry needling (DN) is noninferior to cortisone injection in reducing lateral hip pain and improving function in patients with GTPS. Methods Forty-three participants (50 hips observed), all with GTPS, were randomly assigned to a group receiving cortisone injection or DN. Treatments were administered over 6 weeks, and clinical outcomes were collected at baseline and at 1, 3, and 6 weeks. The primary outcome measure was the numeric pain-rating scale (0-10). The secondary outcome measure was the Patient-Specific Functional Scale (0-10). Medication intake for pain was collected as a tertiary outcome. Results Baseline characteristics were similar between groups. A noninferiority test for a repeated-measures design for pain and averaged function scores at 6 weeks (with a noninferiority margin of 1.5 for both outcomes) indicated noninferiority of DN versus cortisone injection (both, P<.01). Medication usage (P = .74) was not different between groups at the same time point. No adverse side effects were reported. Conclusion Cortisone injections for GTPS did not provide greater pain relief or reduction in functional limitations than DN. Our data suggest that DN is a noninferior treatment alternative to cortisone injections in this patient population. Level of Evidence Therapy, level 1b. Registered December 2, 2015 at www.clinicaltrials.gov (NCT02639039). J Orthop Sports Phys Ther 2017;47(4):232-239. Epub 3 Mar 2017. doi:10

  4. Raloxifene hydrochloride is an adjuvant antiviral treatment of postmenopausal women with chronic hepatitis C: a randomized trial.

    Science.gov (United States)

    Furusyo, Norihiro; Ogawa, Eiichi; Sudoh, Masayuki; Murata, Masayuki; Ihara, Takeshi; Hayashi, Takeo; Ikezaki, Hiroaki; Hiramine, Satoshi; Mukae, Haru; Toyoda, Kazuhiro; Taniai, Hiroaki; Okada, Kyoko; Kainuma, Mosaburo; Kajiwara, Eiji; Hayashi, Jun

    2012-12-01

    Early menopause in women with chronic hepatitis C virus (HCV) infection is associated with a low likelihood of a sustained virological response (SVR) in conjunction with their antiviral treatment. This is potentially related to their reduced estrogen secretion. The study was done to determine whether selective estrogen receptor modulator administration might improve the efficacy of the current standard of care (SOC) treatment, pegylated interferon (PegIFN) α2a plus ribavirin (RBV), for postmenopausal women. One hundred and twenty-three postmenopausal women with genotype 1b chronic hepatitis C were randomly assigned to one of two treatment groups: raloxifene hydrochloride (RLX) (60 mg/day) plus SOC (PegIFNα2a 180 μg/week and RBV 600-1,000 mg/day) (n=62) or SOC only (n=61). Genotyping was performed of the polymorphism in the interleukin-28B (IL28B) gene region (rs8099917) of DNA collected from each patient. One RLX-treated patient discontinued RLX because of a systemic rash following 2 weeks of treatment. Twenty-four weeks after treatment, the SVR rate was significantly higher for RLX plus SOC patients (61.3%) than for SOC only patients (34.4%) (p=0.0051). Further, the SVR rate was significantly higher for RLX plus SOC patients with IL28B TT (72.5%) than for SOC only patients with IL28B TT (39.2%) (p=0.0014), but no such relationship was observed in patients carrying the minor IL28B allele. RLX improved the efficacy of SOC in the treatment of postmenopausal women with chronic hepatitis C. RLX shows promise as an adjuvant to the standard antiviral treatment of such patients. Copyright © 2012 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

  5. 1-Hz rTMS in the treatment of tinnitus: A sham-controlled, randomized multicenter trial.

    Science.gov (United States)

    Landgrebe, Michael; Hajak, Göran; Wolf, Stefan; Padberg, Frank; Klupp, Philipp; Fallgatter, Andreas J; Polak, Thomas; Höppner, Jacqueline; Haker, Rene; Cordes, Joachim; Klenzner, Thomas; Schönfeldt-Lecuona, Carlos; Kammer, Thomas; Graf, Erika; Koller, Michael; Kleinjung, Tobias; Lehner, Astrid; Schecklmann, Martin; Pöppl, Timm B; Kreuzer, Peter; Frank, Elmar; Langguth, Berthold

    Chronic tinnitus is a frequent, difficult to treat disease with high morbidity. This multicenter randomized, sham-controlled trial investigated the efficacy and safety of 1-Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left temporal cortex in patients with chronic tinnitus. Tinnitus patients were randomized to receive 10 sessions of either real or sham 1-Hz-rTMS (2000 stimuli, 110% motor threshold) to the left temporal cortex. The primary outcome was the change in the sum score of the tinnitus questionnaire (TQ) of Goebel and Hiller from baseline to end of treatment. A total of 163 patients were enrolled in the study (real rTMS: 75; sham rTMS: 78). At day 12, the baseline mean of 43.1 TQ points in 71 patients assigned to real rTMS changed by -0.5 points; it changed by 0.5 points from a baseline of 42.1 in 75 patients randomized to sham rTMS (adjusted mean difference between groups: -1.0; 95.19% confidence interval: -3.2 to 1.2; p = 0.36). All secondary outcome measures including measures of depression and quality of life showed no significant differences either (p > 0.11). The number of participants with side-effects or adverse events did not differ between groups. Real 1-Hz-rTMS over the left temporal cortex was well tolerated but not superior compared with sham rTMS in improving tinnitus severity. These findings are in contrast to results from studies with smaller sample sizes and put the efficacy of this rTMS protocol for treatment of chronic tinnitus into question. Controlled Trials: http://www.isrctn.com/ISRCTN89848288. Copyright © 2017 Elsevier Inc. All rights reserved.

  6. A randomized clinical trial of treatment of clomiphene citrate-resistant anovulation with the use of oral contraceptive pill suppression and repeat clomiphene citrate treatment.

    Science.gov (United States)

    Branigan, Emmett F; Estes, M Antoinette

    2003-06-01

    The purpose of this study was to evaluate the effectiveness and endocrine response of oral contraceptive ovarian suppression followed by clomiphene citrate in patients who previously were clomiphene citrate resistant. Forty-eight patients from a private tertiary infertility clinic were assigned randomly prospectively to either group 1 (oral contraceptive/clomiphene citrate), which received continuous oral contraceptives followed by clomiphene citrate, or to group 2 (control) received no treatment in the cycle before clomiphene citrate treatment. On day 3, 17 beta-estradiol, follicle-stimulating hormone, luteinizing hormone, and androgens were assayed before and after treatment. Follicle growth, ovulation, and pregnancy were evaluated. The Student t test and analysis of variance were used for statistical significance. The oral contraceptive/clomiphene citrate group had a significantly higher percentage of patients who ovulated and of ovulatory cycles and pregnancies. Significantly lower levels of 17 beta-estradiol, luteinizing hormone, and androgen levels were seen in the oral contraceptive/clomiphene citrate group, with no significant changes in group 2. Suppression of the ovary with oral contraceptives results in excellent rates of ovulation and pregnancy in patients who previously were resistant to clomiphene citrate. The decreases in ovarian androgens, luteinizing hormone, and 17 beta-estradiol may be responsible for the improved response.

  7. Treatment Preferences Affect the Therapeutic Alliance: Implications for Randomized Controlled Trials

    Science.gov (United States)

    Iacoviello, Brian M.; McCarthy, Kevin Scott; Barrett, Marna S.; Rynn, Moira; Gallop, Robert; Barber, Jacques P.

    2007-01-01

    The influence of treatment preferences on the development of the therapeutic alliance was investigated. Seventy-five patients were followed while participating in a randomized controlled trial comparing supportive-expressive psychotherapy with sertraline or pill placebo in the treatment of major depressive disorder. Therapeutic alliance was…

  8. Cost effectiveness of arthrocentesis as initial treatment for temporomandibular joint arthralgia: A randomized controlled trial

    NARCIS (Netherlands)

    Vos, L.M.; Stant, A.D.; Quik, E.H.; Huddleston Slater, J.J.R.; Stegenga, B.

    2013-01-01

    Objective: To determine the cost effectiveness of arthrocentesis as initial treatment compared to care as usual (CAU) for temporomandibular joint (TMJ) arthralgia. Materials and methods: 80 patients were randomly allocated to arthrocentesis as initial treatment (n = 40) or CAU (n = 40).

  9. Randomized clinical trial of ascorbic acid in the treatment of pressure ulcers

    NARCIS (Netherlands)

    ter Riet, G.; Kessels, A. G.; Knipschild, P. G.

    1995-01-01

    The objective of this study was to assess the effects of ascorbic acid supplementation, 500 mg twice daily in the treatment of pressure ulcers as an adjunct to standardized treatment. The design consisted of a multicenter blinded randomized trial. The control group received 10 mg of ascorbic acid

  10. Mentalization-Based Treatment for Self-Harm in Adolescents: A Randomized Controlled Trial

    Science.gov (United States)

    Rossouw, Trudie I.; Fonagy, Peter

    2012-01-01

    Objective: We examined whether mentalization-based treatment for adolescents (MBT-A) is more effective than treatment as usual (TAU) for adolescents who self-harm. Method: A total of 80 adolescents (85% female) consecutively presenting to mental health services with self-harm and comorbid depression were randomly allocated to either MBT-A or TAU.…

  11. Randomized Controlled Trial of Video Self-Modeling Following Speech Restructuring Treatment for Stuttering

    Science.gov (United States)

    Cream, Angela; O'Brian, Sue; Jones, Mark; Block, Susan; Harrison, Elisabeth; Lincoln, Michelle; Hewat, Sally; Packman, Ann; Menzies, Ross; Onslow, Mark

    2010-01-01

    Purpose: In this study, the authors investigated the efficacy of video self-modeling (VSM) following speech restructuring treatment to improve the maintenance of treatment effects. Method: The design was an open-plan, parallel-group, randomized controlled trial. Participants were 89 adults and adolescents who undertook intensive speech…

  12. Pseudo cluster randomization: a treatment allocation method to minimize contamination and selection bias.

    NARCIS (Netherlands)

    Borm, G.F.; Melis, R.J.F.; Teerenstra, S.; Peer, P.G.M.

    2005-01-01

    In some clinical trials, treatment allocation on a patient level is not feasible, and whole groups or clusters of patients are allocated to the same treatment. If, for example, a clinical trial is investigating the efficacy of various patient coaching methods and randomization is done on a patient

  13. A randomized clinical trial of a therapeutic community treatment for female inmates: outcomes at 6 and 12 months after prison release.

    Science.gov (United States)

    Sacks, JoAnn Y; McKendrick, Karen; Hamilton, Zachary

    2012-01-01

    This random assignment study compared female offenders (n = 468) with substance use disorders in a prison therapeutic community program with those in a cognitive-behavioral intervention. The study demonstrates that all women benefitted from gender-sensitive prison treatment, but the therapeutic community was more effective in reducing drug use, criminal activity, and exposure to trauma and increasing mental health functioning and time until reincarceration during the year after prison. In addition, the ability to sustain and even improve behavior change after the women leave prison highlights the importance of providing accessible community-based continuity of mental health and substance abuse services during reentry.

  14. Late treatment-related morbidity in breast cancer patients randomized to postmastectomy radiotherapy and systemic treatment versus systemic treatment alone

    Energy Technology Data Exchange (ETDEWEB)

    Hoejris, I.; Andersen, J.; Overgaard, M.; Overgaard, J. [Aarhus Univ. Hospital (Denmark). Dept. of Oncology

    2000-07-01

    Late treatment-related morbidity after mastectomy and adjuvant systemic treatment with and without postoperative irradiation was assessed in 84 patients randomized in the Danish Breast Cancer Cooperative Group Trials 82b and c. A structured interview and physical examination, using a standardized assessment sheet, constructed on the basis of the late effects normal tissues (LENT) scoring system, was used. The median length of follow-up from mastectomy was 9 years (range 6-13 years). Lymphedema was measured in 14%, of the irradiated patients versus 3% of the non-irradiated patients (NS). Slightly decreased shoulder morbidity was measured in 45% of the irradiated women versus 15% of the non-irradiated patients, but moderate or more severe impairment was seen in only 5% of the irradiated patients and in none of the non-irradiated patients (p = 0.004). Seventeen percent of the irradiated patients and 2% of the non-irradiated patients found that impairment of shoulder movement caused symptoms (p = 0.001)

  15. Randomized comparative clinical trial of artemisia sieberi 5% lotion and clotrimazole 1% lotion for the treatment of pityriasis versicolor

    Directory of Open Access Journals (Sweden)

    Rad Farrokh

    2008-01-01

    Full Text Available Aims: To compare the therapeutic effects of topical Artremisia sieberi 5% lotion with topical clotrimazole 1% lotion in the treatment of pityriasis versicolor. Materials and Methods: 100 patients with pityriasis versicolor and microscopic identification of Malassezia furfur were randomly assigned to treatment with either topical Artemisia sieberi 5% lotion (group 1 or topical clotrimazole 1% lotion (group 2 for 2 weeks. Group 1 and group 2 consisted of 51 and 49 patients respectively. The patients were evaluated both clinically and mycologically at baseline and every 2 weeks for a period of 4 weeks. Results: At the end of the second week, clinical cure rates were 86.3% and 65.3% for group 1 and group 2 respectively ( P < 0.01, but at the same time mycological cure rate was 92.2% for group 1 and 73.5% for group 2 ( P < 0.05. At the end of the fourth week, clinical cure rates were 86.3% and 59.2% for group 1 and group 2 respectively ( P < 0.01, and at the same time mycologic cure rate was 96.1% for group 1 and 65.3% for group 2 ( P < 0.01. Conclusions: The results of this study demonstrated that Artemisia sieberi 5% lotion was more effective than clotrimazole 1% lotion in the treatment of pityriasis versicolor.

  16. Efficacy of high intensity diode laser as an adjunct to non-surgical periodontal treatment: a randomized controlled trial.

    Science.gov (United States)

    De Micheli, Giorgio; de Andrade, Ana Karina Pinto; Alves, Vanessa Tubero Euzebio; Seto, Marcio; Pannuti, Cláudio Mendes; Cai, Silvana

    2011-01-01

    The high intensity diode laser has been studied in periodontics for the reduction of subgingival bacteria in non-surgical treatment. Our study evaluated the bacterial effect as well as changes in periodontal clinical parameters promoted by root scaling and planing associated with this wavelength. Twenty-seven patients randomly assigned in two groups underwent root scaling and planing on the tested sites, and only the experimental group received the diode laser irradiation. Among the clinical parameters studied, the clinical probing depth (CPD) and the clinical attachment level (CAL) resulted in significant enhancement in the control group when compared with the experimental group (P = 0.014 and P = 0.039, respectively). The results were similar for both groups regarding the plaque index (PI) and bleeding on probing (BP). No significant difference in the microbiological parameters was observed between the control and experimental groups. It was possible to conclude that the high power diode laser adjunct to the non-surgical periodontal treatment did not promote additional effects to the conventional periodontal treatment.

  17. Single-dose versus two-dose administration of methotrexate for the treatment of ectopic pregnancy: a randomized controlled trial.

    Science.gov (United States)

    Song, Taejong; Kim, Mi Kyoung; Kim, Mi-La; Jung, Yong Wook; Yun, Bo Seong; Seong, Seok Ju

    2016-02-01

    Can a two-dose methotrexate treatment protocol improve the treatment success rate compared with a single-dose protocol in women with an ectopic pregnancy? The two-dose protocol was not superior to the single-dose protocol for the treatment of ectopic pregnancy. Although the two-dose methotrexate protocol for ectopic pregnancy was recently introduced to combine the efficacy and convenience of the fixed multi-dose and single-dose protocols, studies comparing the success rates, treatment satisfaction and acceptability of the single-dose and two-dose treatment protocols for ectopic pregnancy are currently lacking. A randomized trial was conducted on 92 participants with tubal ectopic pregnancy, between May 2013 and April 2015. Patients who were diagnosed with tubal ectopic pregnancy and who elected to undergo systemic methotrexate treatment were randomly assigned to follow either the single-dose (n = 46) or two-dose protocol (n = 46). The primary outcome measure was treatment success without surgical intervention. The secondary outcome measures were the incidence of methotrexate-associated side effects, β-human chorionic gonadotrophin (β-hCG) resolution time, cost of care received and treatment satisfaction. There were no differences in baseline characteristics between the groups. The success rates between the single-dose and two-dose groups did not show a significant difference [82.6 versus 87.0%; relative risk (RR) 0.95; 95% confidence interval (CI) 0.80-1.13]. However, the success rate in a subgroup of participants with a pretreatment β-hCG level of >5000 mIU/ml appeared to be higher in the two-dose group than in the single-dose group (80.0 versus 58.8%), although the difference was not statistically significant. No significant differences in methotrexate-associated side effects, cost or treatment satisfaction were observed between the groups. The two-dose group required a lower number of days for the β-hCG level to decrease to ectopic pregnancy. None. www

  18. FLEET ASSIGNMENT MODELLING

    Directory of Open Access Journals (Sweden)

    2016-01-01

    Full Text Available The article is devoted to the airline scheduling process and methods of its modeling. This article describes the main stages of airline scheduling process (scheduling, fleet assignment, revenue management, operations, their features and interactions. The main part of scheduling process is fleet assignment. The optimal solution of the fleet assignment problem enables airlines to increase their incomes up to 3 % due to quality improving of connections and execution of the planned number of flights operated by less number of aircraft than usual or planned earlier. Fleet assignment of scheduling process is examined and Conventional Leg-Based Fleet Assignment Model is analyzed. Finally strong and weak aspects of the model (SWOT are released and applied. The article gives a critical analysis of FAM model, with the purpose of identi- fying possible options and constraints of its use (for example, in cases of short-term and long-term planning, changing the schedule or replacing the aircraft, as well as possible ways to improve the model.

  19. Effect of RME and headgear treatment on the eruption of palatally displaced canines: a randomized clinical study.

    Science.gov (United States)

    Armi, Pamela; Cozza, Paola; Baccetti, Tiziano

    2011-05-01

    To determine the effectiveness of orthodontic treatment finalized on the maintenance/improvement the upper arch perimeter to assist in the successful eruption of palatally displaced maxillary canines (PDCs). The randomized prospective design comprised 64 subjects with PDCs who were randomly assigned to one of three groups: cervical pull headgear (HG); rapid maxillary expansion and cervical pull headgear (RME/HG); or untreated control group (CG). Panoramic radiographs and lateral cephalograms were evaluated at the time of initial observation (T1) and after an average period of 18 months (T2). At T2 the success of canine eruption was evaluated. A superimposition study on lateral cephalograms was undertaken to evaluate the T1-T2 changes in the sagittal position of the upper molars in the three groups. The prevalence of successful eruption was 85.7% in the RME/HG group and 82.3% in the HG group. Both these prevalence rates were significantly greater than the success rate in untreated control subjects (36%). The cephalometric superimposition study showed a significant mesial movement of the upper first molars in the CG compared with the HG and RME/HG groups. The use of rapid maxillary expansion and headgear (or headgear alone) in PDC cases increases the success rate of eruption of the canine significantly (almost three times more than in untreated controls).

  20. Efficacy of Manual Therapy Including Neurodynamic Techniques for the Treatment of Carpal Tunnel Syndrome: A Randomized Controlled Trial.

    Science.gov (United States)

    Wolny, Tomasz; Saulicz, Edward; Linek, Paweł; Shacklock, Michael; Myśliwiec, Andrzej

    2017-05-01

    The purpose of this randomized trial was to compare the efficacy of manual therapy, including the use of neurodynamic techniques, with electrophysical modalities on patients with mild and moderate carpal tunnel syndrome (CTS). The study included 140 CTS patients who were randomly assigned to the manual therapy (MT) group, which included the use of neurodynamic techniques, functional massage, and carpal bone mobilizations techniques, or to the electrophysical modalities (EM) group, which included laser and ultrasound therapy. Nerve conduction, pain severity, symptom severity, and functional status measured by the Boston Carpal Tunnel Questionnaire were assessed before and after treatment. Therapy was conducted twice weekly and both groups received 20 therapy sessions. A baseline assessment revealed group differences in sensory conduction of the median nerve (P therapy, analysis of variance revealed group differences in pain severity (P therapies had a positive effect on nerve conduction, pain reduction, functional status, and subjective symptoms in individuals with CTS. However, the results regarding pain reduction, subjective symptoms, and functional status were better in the MT group. Copyright © 2017. Published by Elsevier Inc.

  1. Effect of curettage after segmental phenolization in the treatment of onychocryptosis: a randomized double-blind clinical trial.

    Science.gov (United States)

    Álvarez-Jiménez, Jesús; Córdoba-Fernández, Antonio; Munuera, Pedro V

    2012-03-01

    Segmental phenolization for the treatment of onychocryptosis has a number of disadvantages, resulting from the cauterization of the tissue, including delayed healing and prolonged drainage. Although one may expect excision or curettage of the cauterized tissue after phenolization to benefit the healing process, these simple procedures have not been suitably studied. To examine the effect of curettage primarily on cicatrization or healing time and secondarily on postoperative bleeding. Fifty-one patients (80 feet) with stage I or IIa onychocryptosis according to the classification of Mozena were enrolled in this randomized, double-blind, parallel-group, controlled clinical trial. A total of 137 phenolizations were performed on affected folds of ingrowing hallux nails. Each hallux was randomly assigned to one of two groups (experimental [phenolization with curettage]; control [phenolization alone]). Curettage reduced healing time (7.49 ± 1.76 days vs 12.38 ± 3.01 days; p = .001), increased postoperative bleeding (p Surgery, Inc. Published by Wiley Periodicals, Inc.

  2. A randomized controlled trial of prison-initiated buprenorphine: prison outcomes and community treatment entry.

    Science.gov (United States)

    Gordon, Michael S; Kinlock, Timothy W; Schwartz, Robert P; Fitzgerald, Terrence T; O'Grady, Kevin E; Vocci, Frank J

    2014-09-01

    Buprenorphine is a promising treatment for heroin addiction. However, little is known regarding its provision to pre-release prisoners with heroin dependence histories who were not opioid-tolerant, the relative effectiveness of the post-release setting in which it is provided, and gender differences in treatment outcome in this population. This is the first randomized clinical trial of prison-initiated buprenorphine provided to male and female inmates in the US who were previously heroin-dependent prior to incarceration. A total of 211 participants with 3-9 months remaining in prison were randomized to one of four conditions formed by crossing In-Prison Treatment Condition (received buprenorphine vs. counseling only) and Post-release Service Setting (at an opioid treatment center vs. a community health center). Outcome measures were: entered prison treatment; completed prison treatment; and entered community treatment 10 days post-release. There was a significant main effect (p=.006) for entering prison treatment favoring the In-Prison buprenorphine Treatment Condition (99.0% vs. 80.4%). Regarding completing prison treatment, the only significant effect was Gender, with women significantly (pPrison buprenorphine Treatment Condition (47.5% vs. 33.7%). Buprenorphine appears feasible and acceptable to prisoners who were not opioid-tolerant and can facilitate community treatment entry. However, concerns remain with in-prison treatment termination due to attempted diversion of medication. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  3. A Randomized Controlled Trial of Prison-Initiated Buprenorphine: Prison Outcomes and Community Treatment Entry

    Science.gov (United States)

    Gordon, Michael S.; Kinlock, Timothy W.; Schwartz, Robert P.; Fitzgerald, Terrence; O’Grady, Kevin E.; Vocci, Frank J.

    2014-01-01

    Background Buprenorphine is a promising treatment for heroin addiction. However, little is known regarding its provision to pre-release prisoners with heroin dependence histories who were not opioid-tolerant, the relative effectiveness of the post-release setting in which it is provided, and gender differences in treatment outcome in this population. Methods This is the first randomized clinical trial of prison-initiated buprenorphine provided to male and female inmates in the US who were previously heroin-dependent prior to incarceration. A total of 211 participants with 3–9 months remaining in prison were randomized to one of four conditions formed by crossing In-Prison Treatment Condition (received buprenorphine vs. counseling only) and Post-release Service Setting (at an opioid treatment center vs. a community health center). Outcome measures were: entered prison treatment; completed prison treatment; and entered community treatment 10 days post-release. Results There was a significant main effect (p=.006) for entering prison treatment favoring the In-Prison buprenorphine Treatment Condition (99.0% vs. 80.4%). Regarding completing prison treatment, the only significant effect was Gender, with women significantly (pbuprenorphine Treatment Condition (47.5% vs. 33.7%). Conclusions Buprenorphine appears feasible and acceptable to prisoners who were not opioid-tolerant and can facilitate community treatment entry. However, concerns remain with in-prison treatment termination due to attempted diversion of medication. PMID:24962326

  4. Initiation of GnRH agonist treatment on 3-5 days postoperatively in endometriosis patients: a randomized controlled trial.

    Science.gov (United States)

    Gong, Lili; Zhang, Shaofen; Han, Yi; Long, Qiqi; Zou, Shien; Cao, Yuankui

    2015-08-01

    Seventy patients with stage III or IV endometriosis were randomly assigned to 2 groups after conservative surgery. Group O (n = 35) received 3 cycles of a 28-day gonadotropin-releasing hormone agonist (GnRH-a) treatment (goserelin, 3.6 mg) starting 3-5 days postoperatively. Group M (n = 35) received the same treatment starting on days 1-5 of menstruation. Groups were further subdivided according to add-back treatment. Pre- and posttreated levels of estradiol (E2 ), follicle stimulating hormone (FSH), and luteinizing hormone (LH) and visual analog scale (VAS), Kupperman menopausal index (KMI), and bone mineral density (BMD) scores were recorded. The incidence of uterine bleeding was assessed. In both groups, serum levels of E2 , FSH, and LH and VAS scores decreased significantly after treatment. Spotting was the most frequent bleeding pattern. During cycle 1, the bleeding time in group M was much longer that than that in group O (P =.001), and the bleeding rate in group M was significantly higher than that in group O (P =.024, RR = 1.185). In patients with stage III or IV endometriosis, the efficacy of GnRH-a initiated 3-5 days postoperatively was equivalent to that of GnRH-a initiated on days 1-5 of menstruation. Female patients who initiated GnRH-a treatment 3-5 days postoperatively experienced less uterine bleeding during the first cycle of treatment. © 2015, The American College of Clinical Pharmacology.

  5. A multicentre, randomized, controlled trial of oseltamivir in the treatment of influenza in a high-risk Chinese population.

    Science.gov (United States)

    Lin, Jiang-Tao; Yu, Xue-Zhong; Cui, De-Jian; Chen, Xu-Yan; Zhu, Ji-Hong; Wang, Yu-Zhen; Wu, Xiao-di

    2006-01-01

    To evaluate the efficacy and safety of oseltamivir treatment in a population at high risk for influenza. This was a randomized, open-label, controlled trial involving Chinese patients with chronic respiratory diseases (chronic bronchitis, obstructive emphysema, bronchial asthma or bronchiectasis) or chronic cardiac disease. Patients showing symptoms of influenza were randomly assigned to receive oral oseltamivir 75 mg twice daily for 5 days (oseltamivir group), or symptomatic treatment (control group) within 48 h after symptom onset. The main outcome measures were duration and severity of illness in influenza-infected patients. Other outcome measures included incidence of complications, antibiotic use, hospitalization and total medical cost. Of the 118 recruited patients, 56 were identified as influenza-infected through laboratory tests (oseltamivir, N = 27; control, N = 29). Relative to symptomatic treatment, oseltamivir significantly reduced the duration of influenza symptoms by 36.8% (p = 0.0479), and the severity by 43.1% (p = 0.0002). In addition, oseltamivir significantly reduced the duration of fever by 45.2% (p = 0.0051), and the time to return to baseline health status by 5 days (p = 0.0011). The incidence of complications (11% vs. 45%, p = 0.0053) and antibiotic use (37% vs. 69%, p = 0.0167) were also significantly lower in the oseltamivir group compared with the control group. The cost of treating influenza and its complications was comparable between the two groups (p = 0.2462). Oseltamivir is effective and well tolerated in high-risk patients with chronic respiratory or cardiac diseases. It can reduce the duration and severity of influenza symptoms and decrease the incidence of secondary complications and antibiotic use, without increasing the total medical cost.

  6. Randomized trial of distance-based treatment for young children with discipline problems seen in primary health care.

    Science.gov (United States)

    Reid, Graham J; Stewart, Moira; Vingilis, Evelyn; Dozois, David J A; Wetmore, Stephen; Jordan, John; Dickie, Gordon; Osmun, W E; Wade, Terrance J; Brown, Judith B; Zaric, Gregory S

    2013-02-01

    Many parents of preschool-age children have concerns about how to discipline their child but few receive help. We examined the effects of a brief treatment along with usual care, compared with receiving usual care alone. Patients. Parents (N = 178) with concerns about their 2- to 5-year olds' discipline were recruited when they visited their family physician at 1 of 24 practices. After completing mailed baseline measures, parents were randomly assigned to receive usual care or the Parenting Matters intervention along with usual care. Parenting Matters combined a self-help booklet with two calls from a telephone coach during a 6-week treatment period. Follow-up assessments were completed at 7 weeks post-randomization, and 3 and 6 months later. Behaviour problems (Eyberg Child Behaviour Inventory) decreased significantly more in the Parenting Matters condition compared with Usual Care alone, based on a significant time by treatment group effect in intent-to-treat, growth curve analyses (P = 0.033). The Parenting Matters group also demonstrated greater and more rapid improvement than in usual care alone in terms of overall psychopathology (Child Behaviour Checklist, P = 0.02), but there were no group differences in parenting. The overall magnitude of group differences was small (d = 0.15 or less). A brief early intervention combining a self-help booklet and telephone coaching is an effective way to treat mild behaviour problems among young children. This minimal-contact approach addresses the need for interventions in primary health care settings and may be a useful component in step-care models of mental health.

  7. Dermal scarification versus intramuscular diclofenac sodium injection for the treatment of renal colic: a prospective randomized clinical trial.

    Science.gov (United States)

    Ioannidis, Stavros; Kampantais, Spyridon; Ioannidis, Anastasios; Gkagkalidis, Konstantinos; Vakalopoulos, Ioannis; Toutziaris, Chrysovalantis; Patsialas, Christos; Laskaridis, Leonidas; Dimopoulos, Panagiotis; Dimitriadis, Georgios

    2014-12-01

    The aim of the study is to determine whether dermal scarification is equally effective for treating acute renal colic compared to diclofenac sodium intramuscular therapy. A prospective, randomized controlled study was conducted with methodologic rigor based on CONSORT criteria. A total of 291 patients, aged ≥ 18 years, suffering from acute renal colic were included in this trial and randomly assigned in two groups. Patients in the first group (A) received endodermal injection (dermal scarification) of 1 ml normal saline at the area of intensity of pain. The second group (B) received 75 mg diclofenac sodium by intramuscular injection. The success of each method defined the primary end point. Pain intensity before and after treatment was assessed using a visual analog scale. The time onset and the duration of analgesia were also recorded. There was no significant difference between the two groups regarding hematuria (p = 0.158), stone identification at KUB (p = 0.751) and mean pain intensity (p = 0.609) before treatment initiation. The method was successful in 75.5 % of patients in group A and 74.3 % of patients in group B (p = 0.812). Mean pain reduction was comparable, 5.65 ± 3.05 in group A and 5.34 ± 2.99 in group B (p = 0.379), with dermal scarification eliciting its effect considerably faster, whereas the duration of analgesia was longer in the diclofenac group (p < 0.05). In conclusion, dermal scarification could constitute an alternative method for treating renal colic as it is equally effective compared to the standard treatment of diclofenac sodium.

  8. The effect of Frankincense in the treatment of moderate plaque-induced gingivitis: a double blinded randomized clinical trial

    Directory of Open Access Journals (Sweden)

    M Chitsazan

    2011-10-01

    Full Text Available "n  Background and the purpose of the Study: Extract of Boswellia Serrata species has been used in the Indian traditional medicine in the treatment of various inflammatory diseases. The present study was designed to evaluate anti-inflammatory effects of Frankincense in the treatment of gingivitis, which is a periodontal tissue inflammatory disease. "n  Methods: This double blind randomized placebo controlled trial was carried out among high school female students with moderate plaque-induced gingivitis. Based on either administration of 0.1 gram of Frankincense extract or 0.2 gram of its powder or placebo and whether the patients undergone scaling and root planning (SRP or not, they were randomly assigned to 6 groups. The primary efficacy outcome was changes in Gingival Index (Loe & Sillness and the secondary outcomes were alteration in plaque index (Sillness & Loe, bleeding index (Cowell and probing pocket depth (WHO probe. All indices were measured in the 0, 7th and 14th days of the study. "n  Results: Seventy five patients ranged of 15-18 years old were enrolled. At the end of the study, the indices in all groups showed significant decreases in comparison to the first day (p< 0.05, except for the bleeding index in the group without SRP and drug therapy (p=0.111. More precise analysis of data revealed that SRP in association with Frankincense application (either extract or powder can lead to remarkable decrease in inflammatory indices in comparison to the groups without SRP and drug therapy (p<0.001. In addition, no significant difference was observed between powder or extract therapy (p >0.05 and between patients received either SRP or treatment alone (p=0.169. "n  Conclusion: Frankincense, a safe and low-cost herbal medicine, may be feasibly applied to improve inflammation based disease of gingival as an adjunct to the conventional mechanical therapy.

  9. The effect of Frankincense in the treatment of moderate plaque-induced gingivitis: a double blinded randomized clinical trial

    Science.gov (United States)

    Khosravi Samani, M.; Mahmoodian, H.; Moghadamnia, AA.; Poorsattar Bejeh Mir, A.; Chitsazan, M.

    2011-01-01

    Background and the purpose of the study Extract of Boswellia Serrata species has been used in the Indian traditional medicine in the treatment of various inflammatory diseases. The present study was designed to evaluate anti-inflammatory effects of Frankincense in the treatment of gingivitis, which is a periodontal tissue inflammatory disease. Methods This double blind randomized placebo controlled trial was carried out among high school female students with moderate plaque-induced gingivitis. Based on either administration of 0.1 gram of Frankincense extract or 0.2 gram of its powder or placebo and whether the patients undergone scaling and root planning (SRP) or not, they were randomly assigned to 6 groups. The primary efficacy outcome was changes in Gingival Index (Loe & Sillness) and the secondary outcomes were alteration in plaque index (Sillness & Loe), bleeding index (Cowell) and probing pocket depth (WHO probe). All indices were measured in the 0, 7th and 14th days of the study. Results Seventy five patients ranged of 15–18 years old were enrolled. At the end of the study, the indices in all groups showed significant decreases in comparison to the first day (pFrankincense application (either extract or powder) can lead to remarkable decrease in inflammatory indices in comparison to the groups without SRP and drug therapy (p0.05) and between patients received either SRP or treatment alone (p=0.169). Conclusion Frankincense, a safe and low-cost herbal medicine, may be feasibly applied to improve inflammation based disease of gingival as an adjunct to the conventional mechanical therapy. PMID:22615671

  10. Shockwave treatment for medial tibial stress syndrome in military cadets: A single-blind randomized controlled trial.

    Science.gov (United States)

    Gomez Garcia, Santiago; Ramon Rona, Silvia; Gomez Tinoco, Martha Claudia; Benet Rodriguez, Mikhail; Chaustre Ruiz, Diego Mauricio; Cardenas Letrado, Francia Piedad; Lopez-Illescas Ruiz, África; Alarcon Garcia, Juan Maria

    2017-10-01

    Medial tibial stress syndrome (MTSS) is a common injury in athletes and soldiers. Several studies have demonstrated the effectiveness of extracorporeal shockwave treatment (ESWT) in athletes with MTSS. To assess whether one session of focused ESWT is effective in the treatment of military cadets with MTSS. A randomized, prospective, controlled, single-blind, parallel-group clinical study. Ib. Military School of Cadets of the Colombian Army. Forty-two military cadets with unilateral chronic MTSS were randomly assigned to either one session of focused electromagnetic ESWT (1500 pulses at 0.20 mJ/mm2) plus a specific exercise programme (muscle stretching and strengthening exercises) or the exercise programme alone. The primary endpoint was change in asymptomatic running test (RT) duration at four weeks from baseline. Secondary endpoints were changes in the visual analogue scale (VAS) after running and modified Roles and Maudsley (RM) score also at four weeks from baseline. ESWT patients were able to run longer. Mean RT after four weeks was 17 min 33 s (SE: 2.36) compared to 4 min 48 s (SE: 1.03) in the exercise-only group (p = 0.000). Mean VAS after running was 2.17 (SE: 0.44) in the ESWT group versus 4.26 (SE: 0.36) in the exercise-only group (p = 0.001). The ESWT group had a significantly higher RM score, with excellent or good results for 82.6% of patients vs. 36.8% in the exercise-only group (p = 0.002). No significant adverse effects of ESWT were observed. A single application of focused shockwave treatment in combination with a specific exercise programme accelerates clinical and functional recovery in military cadets with MTSS. Copyright © 2017 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

  11. Tai Chi Chih Compared With Cognitive Behavioral Therapy for the Treatment of Insomnia in Survivors of Breast Cancer: A Randomized, Partially Blinded, Noninferiority Trial.

    Science.gov (United States)

    Irwin, Michael R; Olmstead, Richard; Carrillo, Carmen; Sadeghi, Nina; Nicassio, Perry; Ganz, Patricia A; Bower, Julienne E

    2017-08-10

    Purpose Cognitive behavioral therapy for insomnia (CBT-I) and Tai Chi Chih (TCC), a movement meditation, improve insomnia symptoms. Here, we evaluated whether TCC is noninferior to CBT-I for the treatment of insomnia in survivors of breast cancer. Patients and Methods This was a randomized, partially blinded, noninferiority trial that involved survivors of breast cancer with insomnia who were recruited from the Los Angeles community from April 2008 to July 2012. After a 2-month phase-in period with repeated baseline assessment, participants were randomly assigned to 3 months of CBT-I or TCC and evaluated at months 2, 3 (post-treatment), 6, and 15 (follow-up). Primary outcome was insomnia treatment response-that is, marked clinical improvement of symptoms by the Pittsburgh Sleep Quality Index-at 15 months. Secondary outcomes were clinician-assessed remission of insomnia; sleep quality; total sleep time, sleep onset latency, sleep efficiency, and awake after sleep onset, derived from sleep diaries; polysomnography; and symptoms of fatigue, sleepiness, and depression. Results Of 145 participants who were screened, 90 were randomly assigned (CBT-I: n = 45; TCC: n = 45). The proportion of participants who showed insomnia treatment response at 15 months was 43.7% and 46.7% in CBT-I and TCC, respectively. Tests of noninferiority showed that TCC was noninferior to CBT-I at 15 months ( P = .02) and at months 3 ( P = .02) and 6 ( P TCC, respectively. CBT-I and TCC groups showed robust improvements in sleep quality, sleep diary measures, and related symptoms (all P TCC produce clinically meaningful improvements in insomnia. TCC, a mindful movement meditation, was found to be statistically noninferior to CBT-I, the gold standard for behavioral treatment of insomnia.

  12. Matching of treatment-resistant heroin-dependent patients to medical prescription of heroin or oral methadone treatment: results from two randomized controlled trials

    NARCIS (Netherlands)

    Blanken, Peter; Hendriks, Vincent M.; Koeter, Maarten W. J.; van Ree, Jan M.; van den Brink, Wim

    2005-01-01

    AIMS: To investigate which baseline patient characteristics of treatment-resistant heroin addicts differentially predicted treatment response to medical heroin prescription compared to standard methadone maintenance treatment. DESIGN: Two open-label randomized controlled trials; pooled data.

  13. Paroxetine, Cognitive Therapy or Their Combination in the Treatment of Social Anxiety Disorder with and without Avoidant Personality Disorder: A Randomized Clinical Trial.

    Science.gov (United States)

    Nordahl, Hans M; Vogel, Patrick A; Morken, Gunnar; Stiles, Tore C; Sandvik, Pål; Wells, Adrian

    2016-01-01

    The most efficacious treatments for social anxiety disorder (SAD) are the SSRIs and cognitive therapy (CT). Combined treatment is advocated for SAD but has not been evaluated in randomized trials using CT and SSRI. Our aim was to evaluate whether one treatment is more effective than the other and whether combined treatment is more effective than the single treatments. A total of 102 patients were randomly assigned to paroxetine, CT, the combination of CT and paroxetine, or pill placebo. The medication treatment lasted 26 weeks. Of the 102 patients, 54% fulfilled the criteria for an additional diagnosis of avoidant personality disorder. Outcomes were measured at posttreatment and 12-month follow-up assessments. CT was superior to paroxetine alone and to pill placebo at the end of treatment, but it was not superior to the combination treatment. At the 12-month follow-up, the CT group maintained benefits and was significantly better than placebo and paroxetine alone, whereas there were no significant differences among combination treatment, paroxetine alone, and placebo. Recovery rates at 12 months were much higher in the CT group (68%) compared to 40% in the combination group, 24% in the paroxetine group, and 4% in the pill placebo group. CT was the most effective treatment for SAD at both posttreatment and follow-up compared to paroxetine and better than combined treatment at the 12-month follow-up on the Liebowitz Social Anxiety Scale. Combined treatment provided no advantage over single treatments; rather there was less effect of the combined treatment compared to CT alone. © 2016 The Author(s) Published by S. Karger AG, Basel.

  14. A cosmetic evaluation of breast cancer treatment: a randomized study of radiotherapy boost technique.

    Science.gov (United States)

    Vass, Sylvie; Bairati, Isabelle

    2005-08-01

    To compare cosmetic results of two different radiotherapy (RT) boost techniques used in the treatment of breast cancer after whole breast radiotherapy and to identify factors affecting cosmetic outcomes. Between 1996 and 1998, 142 patients with Stage I and II breast cancer were treated with breast conservative surgery and adjuvant RT. Patients were then randomly assigned to receive a boost dose of 15 Gy delivered to the tumor bed either by iridium 192, or a combination of photons and electrons. Cosmetic evaluations were done on a 6-month basis, with a final evaluation at 36 months after RT. The evaluations were done using a panel of global and specific subjective scores, a digitized scoring system using the breast retraction assessment (BRA) measurement, and a patient's self-assessment evaluation. As cosmetic results were graded according to severity, the comparison of boost techniques was done using the ordinal logistic regression model. Adjusted odds ratios (OR) and their 95% confidence intervals (CI) are presented. At 36 months of follow-up, there was no significant difference between the two groups with respect to the global subjective cosmetic outcome (OR = 1.40; 95%CI = 0.69-2.85, p = 0.35). Good to excellent scores were observed in 65% of implant patients and 62% of photon/electron patients. At 24 months and beyond, telangiectasia was more severe in the implant group with an OR of 9.64 (95%CI = 4.05-22.92, p cosmetic outcome was the presence of concomitant chemotherapy (OR = 3.87; 95%CI = 1.74-8.62). The BRA value once adjusted for age, concomitant chemotherapy, and boost volume showed a positive association with the boost technique. The BRA value was significantly greater in the implant group (p = 0.03). There was no difference in the patient's final self-assessment score between the two groups. Three variables were statistically associated with an adverse self-evaluation: an inferior quadrant tumor localization, postoperative hematoma, and concomitant

  15. Task assignment and coaching

    NARCIS (Netherlands)

    Dominguez-Martinez, S.

    2009-01-01

    An important task of a manager is to motivate her subordinates. One way in which a manager can give incentives to junior employees is through the assignment of tasks. How a manager allocates tasks in an organization, provides information to the junior employees about his ability. Without coaching

  16. A randomized controlled trial of duloxetine versus placebo in the treatment of nonmajor chronic depression.

    Science.gov (United States)

    Hellerstein, David J; Stewart, Jonathan W; McGrath, Patrick J; Deliyannides, Deborah A; Batchelder, Sarai T; Black, Sarah R; Withers, Amy; O'Shea, Donna; Chen, Ying

    2012-07-01

    Numerous double-blind studies have assessed the efficacy of antidepressants in treating chronic depressive disorder, including dysthymic disorder, low-grade chronic depression. However, there are no double-blind, placebo-controlled studies of serotonin-norepinephrine reuptake inhibitors in chronic depressive disorder. Outpatients with chronic depressive disorder, but without concurrent major depressive disorder (MDD), were randomly assigned to prospective double-blind duloxetine (beginning at 30 mg/d, increased to a maximum dose of 120 mg/d) versus placebo for 10 weeks. Inclusion criteria were current DSM-IV-TR diagnosis of dysthymic disorder or depression not otherwise specified, age 18-75 years, and a Hamilton Depression Rating Scale (HDRS) score ≥ 12. Exclusion criteria included current major depression. The study was conducted between August 2006 and December 2011. HDRS, Cornell Dysthymia Rating Scale (CDRS), Clinical Global Impressions (CGI), Beck Depression Inventory (BDI), Global Assessment of Functioning (GAF), Social Adjustment Scale (SAS), and other assessments were administered at each visit. We hypothesized that duloxetine would be superior to placebo in (1) 24-item HDRS total score, (2) the percentage of subjects classified as responders and remitters, and (3) secondary measures (CDRS, BDI, CGI). Response was defined as > 50% decrease in 24-item HDRS and CGI-Improvement scale score of 1 or 2 ("very much improved" or "much improved"). Remission was defined as HDRS-17 item score ≤ 4 and 0 on item 1 of the HDRS (depressed mood). 65 subjects were enrolled, of whom 57 began medication. They ranged in age from 19 to 70 years (mean ± SD = 41.63 ± 11.22) and included 24 women and 33 men. Baseline 24-item HDRS score (mean ± SD) for both groups was 20.75 ± 4.92. After 10 weeks, duloxetine-treated subjects had significantly lower 24-item HDRS scores than placebo-treated subjects (time-by-drug group effect on analysis of variance: F1,55 = 9.43, P = .003

  17. Switch Rates During Acute Treatment for Bipolar II Depression With Lithium, Sertraline, or the Two Combined: A Randomized Double-Blind Comparison.

    Science.gov (United States)

    Altshuler, Lori L; Sugar, Catherine A; McElroy, Susan L; Calimlim, Brian; Gitlin, Michael; Keck, Paul E; Aquino-Elias, Ana; Martens, Brian E; Fischer, E Grace; English, Teri L; Roach, Janine; Suppes, Trisha

    2017-03-01

    The authors compared medication-induced mood switch risk (primary outcome), as well as treatment response and side effects (secondary outcomes) with three acute-phase treatments for bipolar II depression. In a 16-week, double-blind, multisite comparison study, 142 participants with bipolar II depression were randomly assigned to receive lithium monotherapy (N=49), sertraline monotherapy (N=45), or combination treatment with lithium and sertraline (N=48). At each visit, mood was assessed using standardized rating scales. Rates of switch were compared, as were rates of treatment response and the presence and severity of treatment-emergent side effects. Twenty participants (14%) experienced a switch during the study period (hypomania, N=17; severe hypomania, N=3). Switch rates did not differ among the three treatment groups, even after accounting for dropout. No patient had a manic switch or was hospitalized for a switch. Most switches occurred within the first 5 weeks of treatment. The treatment response rate for the overall sample was 62.7% (N=89), without significant differences between groups after accounting for dropout. The lithium/sertraline combination group had a significantly higher overall dropout rate than the monotherapy groups but did not have an accelerated time to response. Lithium monotherapy, sertraline monotherapy, and lithium/sertraline combination therapy were associated with similar switch and treatment response rates in participants with bipolar II depression. The dropout rate was higher in the lithium/sertraline combination treatment group, without any treatment acceleration advantage.

  18. The treatment of medial tibial stress syndrome in athletes; a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Moen Maarten

    2012-03-01

    Full Text Available Abstract Background The only three randomized trials on the treatment of MTSS were all performed in military populations. The treatment options investigated in this study were not previously examined in athletes. This study investigated if functional outcome of three common treatment options for medial tibial stress syndrome (MTSS in athletes in a non-military setting was the same. Methods The study design was randomized and multi-centered. Physical therapists and sports physicians referred athletes with MTSS to the hospital for inclusion. 81 athletes were assessed for eligibility of which 74 athletes were included and randomized to three treatment groups. Group one performed a graded running program, group two performed a graded running program with additional stretching and strengthening exercises for the calves, while group three performed a graded running program with an additional sports compression stocking. The primary outcome measure was: time to complete a running program (able to run 18 minutes with high intensity and secondary outcome was: general satisfaction with treatment. Results 74 Athletes were randomized and included of which 14 did not complete the study due a lack of progress (18.9%. The data was analyzed on an intention-to-treat basis. Time to complete a running program and general satisfaction with the treatment were not significantly different between the three treatment groups. Conclusion This was the first randomized trial on the treatment of MTSS in athletes in a non-military setting. No differences were found between the groups for the time to complete a running program. Trial registration CCMO; NL23471.098.08

  19. Upregulating Positive Affectivity in the Transdiagnostic Treatment of Emotional Disorders: A Randomized Pilot Study.

    Science.gov (United States)

    González-Robles, Alberto; García-Palacios, Azucena; Baños, Rosa; Quero, Soledad; Botella, Cristina

    2017-10-01

    Transdiagnostic cognitive-behavioral therapy for emotional disorders (ED) has proven to be effective. However, current transdiagnostic treatment protocols address only the regulation of negative affectivity, and they do not include treatment components to more directly target the regulation of positive affectivity. In this study, we propose to evaluate the preliminary efficacy and acceptability of a transdiagnostic treatment protocol for ED that includes, as an innovative feature, a specific treatment component to directly upregulate positive affectivity based on positive psychology interventions. A total of 24 participants were randomized to either a transdiagnostic treatment protocol ( n = 12) or a transdiagnostic treatment protocol with an additional component designed to regulate positive affectivity ( n = 12). Participants completed measures of anxiety, depression, positive and negative affectivity, and quality of life, as well as treatment acceptability at pre- and posttreatment and at the 3-month follow-up. Both interventions led to improvements in all measures at posttreatment, and these outcomes were maintained at the 3-month follow-up, with large effect sizes for all measures. The effect sizes for positive affect were larger in the condition that included the component to upregulate positive affectivity. Attrition rate was low, and both treatment protocols were well accepted by participants. The results obtained in this study indicate the feasibility of testing the treatment protocol in a larger, randomized, controlled trial, and they suggest the potential of including treatment components for directly upregulating positive affectivity in future research on transdiagnostic treatment protocols for ED.

  20. Uterine artery embolization vs hysterectomy in the treatment of symptomatic uterine fibroids : 10-year outcomes from the randomized EMMY trial

    NARCIS (Netherlands)

    de Bruijn, Annefleur M.; Ankum, Willem M.; Reekers, Jim A.; Birnie, Erwin; van der Kooij, Sanne M.; Volkers, Nicole A.; Hehenkamp, Wouter J. K.

    2016-01-01

    BACKGROUND: Since 1995 uterine artery embolization has been described as an alternative for hysterectomy in patients with symptomatic fibroids. Many studies including several randomized controlled trials established uterine artery embolization as a valuable treatment. These randomized controlled

  1. Directly administered antiretroviral therapy for HIV-infected individuals in opioid treatment programs: results from a randomized clinical trial.

    Directory of Open Access Journals (Sweden)

    Gregory M Lucas

    Full Text Available Data regarding the efficacy of directly administered antiretroviral therapy (DAART are mixed. Opioid treatment programs (OTPs provide a convenient framework for DAART. In a randomized controlled trial, we compared DAART and self-administered therapy (SAT among HIV-infected subjects attending five OTPs in Baltimore, MD.HIV-infected individuals attending OTPs were eligible if they were not taking antiretroviral therapy (ART or were virologically failing ART at last clinical assessment. In subjects assigned to DAART, we observed one ART dose per weekday at the OTP for up to 12 months. SAT subjects administered ART at home. The primary efficacy comparison was the between-arm difference in the average proportions with HIV RNA <50 copies/mL during the intervention phase (3-, 6-, and 12-month study visits, using a logistic regression model accounting for intra-person correlation due to repeated observations. Adherence was measured with electronic monitors in both arms.We randomized 55 and 52 subjects from five Baltimore OTPs to DAART and SAT, respectively. The average proportions with HIV RNA <50 copies/mL during the intervention phase were 0.51 in DAART and 0.40 in SAT (difference 0.11, 95% CI: -0.020 to 0.24. There were no significant differences between arms in electronically-measured adherence, average CD4 cell increase from baseline, average change in log10 HIV RNA from baseline, opportunistic conditions, hospitalizations, mortality, or the development of new drug resistance mutations.In this randomized trial, we found little evidence that DAART provided clinical benefits compared to SAT among HIV-infected subjects attending OTPs.ClinicalTrials.gov NCT00279110 NCT00279110?term = NCT00279110&rank = 1.

  2. The effect of emotion and physician communication behaviors on surrogates' life-sustaining treatment decisions: a randomized simulation experiment.

    Science.gov (United States)

    Barnato, Amber E; Arnold, Robert M

    2013-07-01

    Surrogate decision makers for critically ill patients experience strong negative emotional states. Emotions influence risk perception, risk preferences, and decision making. We sought to explore the effect of emotional state and physician communication behaviors on surrogates' life-sustaining treatment decisions. 5 × 2 between-subject randomized factorial experiment. Web-based simulated interactive video meeting with an intensivist to discuss code status. Community-based participants 35 and older who self-identified as the surrogate for a parent or spouse recruited from eight U.S. cities through public advertisements. Block random assignment to emotion arousal manipulation and each of the four physician communication behaviors. Surrogate's code status decision (cardiopulmonary resuscitation vs do not resuscitate/allow natural death). Two hundred fifty-six of 373 respondents (69%) logged-in and were randomized: average age was 50; 70% were surrogates for a parent; 63.5% were women; 76% were white, 11% black, and 9% Asian; and 81% were college educated. When asked about code status, 56% chose cardiopulmonary resuscitation. The emotion arousal manipulation increased the score on depression-dejection scale (β = 1.76 [0.58 - 2.94]) but did not influence cardiopulmonary resuscitation choice. Physician attending to emotion and framing the decision as the patient's rather than the surrogate's did not influence cardiopulmonary resuscitation choice. Framing no cardiopulmonary resuscitation as the norm rather than cardiopulmonary resuscitation resulted in fewer surrogates choosing cardiopulmonary resuscitation (48% vs 64%, odds ratio, 0.52 [95% CI, 0.32-0.87]), as did framing the alternative to cardiopulmonary resuscitation as "allow natural death" rather than do not resuscitate (49% vs 61%, odds ratio, 0.58 [95% CI, 0.35-0.96]). Experimentally induced emotional state did not influence code status decisions, although small changes in physician communication behaviors

  3. Topical 5% tranexamic acid for the treatment of melasma in Asians: a double-blind randomized controlled clinical trial.

    Science.gov (United States)

    Kanechorn Na Ayuthaya, Pinyapat; Niumphradit, Nucha; Manosroi, Aranya; Nakakes, Artit

    2012-06-01

    Topical tranexamic acid has been claimed to lighten melasma without serious adverse effects. However, controlled studies assessing the efficacy and safety of topical tranexamic acid (TA) for the treatment of melasma is limited. To assess in a double blind, randomized, prospective study, the efficacy of topical 5% tranexamic acid versus vehicle for treatment of melasma. Twenty-three women with bilateral epidermal melasma enrolled in a split-face trial lasting 12 weeks. Patients blindly applied topical 5% tranexamic acid and its vehicle, to the designated sides of the face twice daily in addition to the assigned sunscreen each morning. Pigmentation and erythema were measured objectively using a mexameter and Melasma Area and Severity Index (MASI), in addition to physician and patient global assessments. Twenty-one patients completed the study. Eighteen out of twenty-three patients (78.2%) showed decrease in the melanin index on either or both sides of the face by the end of 12 weeks compared to baseline. The MASI scores were also significantly reduced on both tested sides. However, lightening of pigmentation induced by TA gel was neither superior nor different (p > 0.05) compared to its vehicle although erythema was significant on the TA-applied site (p < 0.05). Although lightening of pigmentation was obtained, the results were not significant between the two regimens. However, topical TA produced erythema.

  4. Efficacy of tip cryotherapy in the treatment of idiopathic guttate hypomelanosis (IGH): a randomized, controlled, evaluator-blinded study.

    Science.gov (United States)

    Laosakul, Kulwadee; Juntongjin, Premjit

    2017-05-01

    Idiopathic guttate hypomelanosis (IGH) is a common hypopigmentation affecting a large amount of older population. However, there is no standard treatment. Cryotherapy has been reported as an alternative therapy for years; nevertheless, there is no randomized controlled study to determine its efficacy. To evaluate the efficacy and side effects of tip cryotherapy in IGH treatment. Total 101 lesions were included. Forty-three lesions were treated with cryotherapy and 58 lesions were assigned as control. A single session of tip cryotherapy was delivered and remained for 5 s. Colorimeter was used to measure lesional luminosity at baseline and then monthly until 4 months. Digital photographs were evaluated by two blinded dermatologists. In addition, patients' assessments and side effects were assessed. Mean luminosity scale gradually decreased from baseline. Also, the score of the treated lesions has been significantly lower than that of the control lesions since week 8 (p = .005). At the fourth month, dermatologists' assessment revealed that 82.3% of the treated lesions comparing to only 2% of the control showed more than 75% improvement (p cryotherapy appears to be an effective therapy with minimal adverse effect for IGH.

  5. AUGMENTATION VS NONAUGMENTATION TECHNIQUES FOR OPEN REPAIRS OF ACHILLES TENDON RUPTURES WITH EARLY FUNCTIONAL TREATMENT: A PROSPECTIVE RANDOMIZED STUDY

    Directory of Open Access Journals (Sweden)

    Gündüz Tezeren

    2006-12-01

    Full Text Available A prospective randomized study was conducted in order to compare augmentation technique versus nonaugmentation technique, followed by early functional postoperative treatment, for operative repair of Achilles tendon ruptures. Twenty-four consecutive patients were assigned to two groups. Group I included 12 patients treated with Lindholm augmentation technique, whereas group II included 12 patients treated with modified Kessler end-to-end repair. Thereafter, these patients had postoperative management with a below-knee-cast for three weeks. The physioteraphy was initiated immediately after the cast was removed. Full weight bearing was allowed after five weeks postoperatively in the both groups. Two patients had reruptures in group II, whereas group I had prolonged operative time significantly. The patients with reruptures underwent reoperations and at the most final follow-up, it was observed that they could not resume to sporting activities. The other objective and subjective results were similar between two groups. Because of quite high rerupture rate in the group of patients treated with nonaugmentation technique, we favor functional postoperative treatment with early ankle movement in the patients treated with augmentation technique for the management of acute rupture of the Achilles tendon

  6. Single- versus two-visit pulpectomy treatment in primary teeth with apical periodontitis: A double-blind, parallel group, randomized controlled trial.

    Science.gov (United States)

    Bharuka, Sneha Bharatkumar; Mandroli, Praveenkumar S

    2016-01-01

    Reduction of the bacterial populations to levels compatible with periradicular tissue healing is the primary microbiological goal of the endodontic treatment of teeth with apical periodontitis. The number of visits required to treat teeth with apical periodontitis represents one of the most debatable issues in endodontics. The objective of this study was to compare and evaluate the clinical and radiographic outcome of single- versus two-visit pulpectomy treatment in primary teeth with apical periodontitis at the end of 6-month healing period. A parallel group, double-blind, randomized controlled trial was carried out in 64 children aged 4-8 years. Nonvital primary teeth with apical periodontitis with enough coronal structure were selected. Sixty-four children were assigned randomly into two groups (32 children each) by block randomization, and allocation concealment was done with closed envelop method. Group I underwent single-visit pulpectomy followed by obturation with zinc oxide eugenol (ZOE). Group II underwent conventional two-visit pulpectomy with intracanal calcium hydroxide, followed by obturation with ZOE. Postoperative clinical and radiographic evaluation was carried out at 1, 3, and 6 months after the end of the treatment. The data were analyzed by Wilcoxon's signed rank test, Mann-Whitney U-test, and Friedman test. There was no statistically significant difference in clinical and radiographic outcomes in both the groups at the end of 6-month healing period. Single-visit pulpectomy can be considered as a viable option for the treatment of primary teeth with apical periodontitis.

  7. Reducing HIV-Risk Behavior Among Adults Receiving Outpatient Psychiatric Treatment: Results From a Randomized Controlled Trial

    Science.gov (United States)

    Carey, Michael P.; Carey, Kate B.; Maisto, Stephen A.; Gordon, Christopher M.; Schroder, Kerstin E. E.; Vanable, Peter A.

    2004-01-01

    This study investigated the efficacy of a 10-session, HIV-risk-reduction intervention with 221 women and 187 men receiving outpatient psychiatric care for a mental illness. Patients were randomly assigned to the HIV intervention, a structurally equivalent substance use reduction (SUR) intervention, or standard care; they were assessed pre- and…

  8. Sequential causal inference: application to randomized trials of adaptive treatment strategies.

    Science.gov (United States)

    Dawson, Ree; Lavori, Philip W

    2008-05-10

    Clinical trials that randomize subjects to decision algorithms, which adapt treatments over time according to individual response, have gained considerable interest as investigators seek designs that directly inform clinical decision making. We consider designs in which subjects are randomized sequentially at decision points, among adaptive treatment options under evaluation. We present a sequential method to estimate the comparative effects of the randomized adaptive treatments, which are formalized as adaptive treatment strategies. Our causal estimators are derived using Bayesian predictive inference. We use analytical and empirical calculations to compare the predictive estimators to (i) the 'standard' approach that allocates the sequentially obtained data to separate strategy-specific groups as would arise from randomizing subjects at baseline; (ii) the semi-parametric approach of marginal mean models that, under appropriate experimental conditions, provides the same sequential estimator of causal differences as the proposed approach. Simulation studies demonstrate that sequential causal inference offers substantial efficiency gains over the standard approach to comparing treatments, because the predictive estimators can take advantage of the monotone structure of shared data among adaptive strategies. We further demonstrate that the semi-parametric asymptotic variances, which are marginal 'one-step' estimators, may exhibit significant bias, in contrast to the predictive variances. We show that the conditions under which the sequential method is attractive relative to the other two approaches are those most likely to occur in real studies.

  9. Cumulative Hazard Ratio Estimation for Treatment Regimes in Sequentially Randomized Clinical Trials.

    Science.gov (United States)

    Tang, Xinyu; Wahed, Abdus S

    2015-05-01

    The proportional hazards model is widely used in survival analysis to allow adjustment for baseline covariates. The proportional hazard assumption may not be valid for treatment regimes that depend on intermediate responses to prior treatments received, and it is not clear how such a model can be adapted to clinical trials employing more than one randomization. Besides, since treatment is modified post-baseline, the hazards are unlikely to be proportional across treatment regimes. Although Lokhnygina and Helterbrand (Biometrics 63: 422-428, 2007) introduced the Cox regression method for two-stage randomization designs, their method can only be applied to test the equality of two treatment regimes that share the same maintenance therapy. Moreover, their method does not allow auxiliary variables to be included in the model nor does it account for treatment effects that are not constant over time. In this article, we propose a model that assumes proportionality across covariates within each treatment regime but not across treatment regimes. Comparisons among treatment regimes are performed by testing the log ratio of the estimated cumulative hazards. The ratio of the cumulative hazard across treatment regimes is estimated using a weighted Breslow-type statistic. A simulation study was conducted to evaluate the performance of the estimators and proposed tests.

  10. Motivational enhancement therapy in addition to physical therapy improves motivational factors and treatment outcomes in people with low back pain: a randomized controlled trial.

    Science.gov (United States)

    Vong, Sinfia K; Cheing, Gladys L; Chan, Fong; So, Eric M; Chan, Chetwyn C

    2011-02-01

    To examine whether the addition of motivational enhancement treatment (MET) to conventional physical therapy (PT) produces better outcomes than PT alone in people with chronic low back pain (LBP). A double-blinded, prospective, randomized, controlled trial. PT outpatient department. Participants (N=76) with chronic LBP were randomly assigned to receive 10 sessions of either MET plus PT or PT alone. MET included motivational interviewing strategies and motivation-enhancing factors. The PT program consisted of interferential therapy and back exercises. Motivational-enhancing factors, pain intensity, physical functions, and exercise compliance. The MET-plus-PT group produced significantly greater improvements than the PT group in 3 motivation-enhancing factors; proxy efficacy (Pmotivation and exercise compliance and show better improvement in physical function in patients with chronic LBP compared with PT alone. Copyright © 2011 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  11. Gain weighted eigenspace assignment

    Science.gov (United States)

    Davidson, John B.; Andrisani, Dominick, II

    1994-01-01

    This report presents the development of the gain weighted eigenspace assignment methodology. This provides a designer with a systematic methodology for trading off eigenvector placement versus gain magnitudes, while still maintaining desired closed-loop eigenvalue locations. This is accomplished by forming a cost function composed of a scalar measure of error between desired and achievable eigenvectors and a scalar measure of gain magnitude, determining analytical expressions for the gradients, and solving for the optimal solution by numerical iteration. For this development the scalar measure of gain magnitude is chosen to be a weighted sum of the squares of all the individual elements of the feedback gain matrix. An example is presented to demonstrate the method. In this example, solutions yielding achievable eigenvectors close to the desired eigenvectors are obtained with significant reductions in gain magnitude compared to a solution obtained using a previously developed eigenspace (eigenstructure) assignment method.

  12. Evaluation of pretreatment with gelofen and novafen on pain relief after endodontic treatment; A double-blind randomized clinical trial study

    Directory of Open Access Journals (Sweden)

    Seyed Mehdi Dejkam

    2015-03-01

    Full Text Available Introduction: Feeling pain after root canal therapy has always been a major problem for patients and dentists. One of the suggested methods to manage the pain is using the prophylactic medication before treatment process. This study aimed at investigating the comparison of pretreatment with novafen versus gelofen on reducing the pain after root canal therapy. Materials &Methods: This double-blind randomized clinical trial study was conducted on 60 patients aged 18-65 who were indicated for root canal therapy. Patients were randomly assigned to receive gelofen capsules (400mg, novafen capsules (200mg and placebo two capsules by every patient of these groups one hour prior to sampling. Pre/post-treatment pain was measured using Visual Analog Scale (VAS before treatment and 4, 8, 12, 24 and 48 hours after treatment. Results: Both novafen and gelofen indicated significant analgesic effect during the study period (p<0.001. Pain severity within 8 hours after treatment was significantly lower in novafen group than two other groups (p=0.03. The difference between the severity of pain did not show any association to their place of life and gender in any groups. Conclusion: Our findings revealed that the prophylactic novafen in comparison to gelofen had a better analgesic effect in short-term and could be a good candidate for the management of post-endodontic treatment pain.

  13. The Effects of Tai Chi and Neck Exercises in the Treatment of Chronic Nonspecific Neck Pain: A Randomized Controlled Trial.

    Science.gov (United States)

    Lauche, Romy; Stumpe, Christoph; Fehr, Johannes; Cramer, Holger; Cheng, Ying Wu; Wayne, Peter M; Rampp, Thomas; Langhorst, Jost; Dobos, Gustav

    2016-09-01

    This study aimed to test the efficacy of Tai Chi for treating chronic neck pain. Subjects with chronic nonspecific neck pain were randomly assigned to 12 weeks of group Tai Chi or conventional neck exercises with weekly sessions of 75 to 90 minutes, or a wait-list control. The primary outcome measure was pain intensity (visual analogue scale). Secondary outcomes included pain on movement, functional disability, quality of life, well-being and perceived stress, postural and interoceptive awareness, satisfaction, and safety. Altogether, 114 participants were included (91 women, 49.4 ± 11.7 years of age). After 12 weeks Tai Chi participants reported significantly less pain compared with the wait list group (average difference in mm on the visual analogue scale: -10.5; 95% confidence interval, -20.3 to -.9; P = .033). Group differences were also found for pain on movement, functional disability, and quality of life compared with the wait list group. No differences were found for Tai Chi compared with neck exercises. Patients' satisfaction with both exercise interventions was high, and only minor side effects were observed. Tai Chi was more effective than no treatment in improving pain in subjects with chronic nonspecific neck pain. Because Tai Chi is probably as effective as neck exercises it may be considered a suitable alternative to conventional exercises for those with a preference toward Tai Chi. This article presents results of a randomized controlled trial comparing Tai Chi, conventional neck exercises, and no treatment for chronic nonspecific neck pain. Results indicate that Tai Chi exercises and conventional neck exercises are equally effective in improving pain and quality of life therefore representing beneficial interventions for neck pain. Copyright © 2016 American Pain Society. Published by Elsevier Inc. All rights reserved.

  14. Community treatment of posttraumatic stress disorder for children exposed to intimate partner violence: a randomized controlled trial.

    Science.gov (United States)

    Cohen, Judith A; Mannarino, Anthony P; Iyengar, Satish

    2011-01-01

    To evaluate community-provided trauma-focused cognitive behavior therapy (TF-CBT) compared with usual community treatment for children with intimate partner violence (IPV)-related posttraumatic stress disorder (PTSD) symptoms. Randomized controlled trial conducted using blinded evaluators. Recruitment, screening, and treatment were conducted at a community IPV center between September 1, 2004, and June 30, 2009. Of 140 consecutively referred 7- to 14-year-old children, 124 participated. Children and mothers were randomly assigned to receive 8 sessions of TF-CBT or usual care (child-centered therapy). Total child PTSD symptoms assessed using child and parent structured interview (Kiddie Schedule for Affective Disorders and Schizophrenia, Present and Lifetime Version [K-SADS-PL]) and self-report (University of California at Los Angeles PTSD Reaction Index [RI]). Secondary child outcomes were scores on the K-SADS-PL (PTSD symptom clusters), Screen for Child Anxiety Related Emotional Disorders (SCARED) (anxiety), Children's Depression Inventory (depression), Kaufman Brief Intelligence Test (cognitive functioning), and Child Behavior Checklist (total behavior problems). Intent-to-treat analysis using last observation carried forward showed superior outcomes for TF-CBT on the total K-SADS-PL (mean difference, 1.63; 95% confidence interval [CI], 0.44-2.82), RI (mean difference, 5.5; 95% CI, 1.37-9.63), K-SADS-PL hyperarousal (mean difference, 0.71; 95% CI, 0.22-1.20), K-SADS-PL avoidance (0.55; 0.07-1.03), and SCARED (mean difference, 5.13; 95% CI, 1.31-8.96). Multiple imputation analyses confirmed most of these findings. The TF-CBT completers experienced significantly greater PTSD diagnostic remission (χ(2) = 4.67, P = .03) and had significantly fewer serious adverse events. Community TF-CBT effectively improves children's IPV-related PTSD and anxiety. clinicaltrials.gov Identifier: NCT00183326.

  15. TITRATION: A Randomized Study to Assess 2 Treatment Algorithms with New Insulin Glargine 300 units/mL.

    Science.gov (United States)

    Yale, Jean-François; Berard, Lori; Groleau, Mélanie; Javadi, Pasha; Stewart, John; Harris, Stewart B

    2017-10-01

    It was uncertain whether an algorithm that involves increasing insulin dosages by 1 unit/day may cause more hypoglycemia with the longer-acting insulin glargine 300 units/mL (GLA-300). The objective of this study was to compare safety and efficacy of 2 titration algorithms, INSIGHT and EDITION, for GLA-300 in people with uncontrolled type 2 diabetes mellitus, mainly in a primary care setting. This was a 12-week, open-label, randomized, multicentre pilot study. Participants were randomly assigned to 1 of 2 algorithms: they either increased their dosage by 1 unit/day (INSIGHT, n=108) or the dose was adjusted by the investigator at least once weekly, but no more often than every 3 days (EDITION, n=104). The target fasting self-monitored blood glucose was in the range of 4.4 to 5.6 mmol/L. The percentages of participants reaching the primary endpoint of fasting self-monitored blood glucose ≤5.6 mmol/L without nocturnal hypoglycemia were 19.4% (INSIGHT) and 18.3% (EDITION). At week 12, 26.9% (INSIGHT) and 28.8% (EDITION) of participants achieved a glycated hemoglobin value of ≤7%. No differences in the incidence of hypoglycemia of any category were noted between algorithms. Participants in both arms of the study were much more satisfied with their new treatment as assessed by the Diabetes Treatment Satisfaction Questionnaire. Most health-care professionals (86%) preferred the INSIGHT over the EDITION algorithm. The frequency of adverse events was similar between algorithms. A patient-driven titration algorithm of 1 unit/day with GLA-300 is effective and comparable to the previously tested EDITION algorithm and is preferred by health-care professionals. Copyright © 2017 Diabetes Canada. Published by Elsevier Inc. All rights reserved.

  16. Assignment Tracking Android Application

    OpenAIRE

    Akanni, Feranmi Timothy

    2016-01-01

    One of the common ways of checking that knowledge is impacted into students at every level of education is by giving various tasks to students and part of the responsibilities of the teacher is to give assignments to students and check the solution provided by the students. Increase in technology development involves a number of mobile applications that are being developed and released on a daily basis, out of which Android operating application is one of the dominant mobile application. T...

  17. Task assignment and coaching

    OpenAIRE

    Dominguez-Martinez, S.

    2009-01-01

    An important task of a manager is to motivate her subordinates. One way in which a manager can give incentives to junior employees is through the assignment of tasks. How a manager allocates tasks in an organization, provides information to the junior employees about his ability. Without coaching from a manager, the junior employee only has information about his past performance. Based on his past performance, a talented junior who has performed a difficult task sometimes decides to leave the...

  18. A new interdisciplinary treatment strategy versus usual medical care for the treatment of subacromial impingement syndrome: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    van der Meer Klaas

    2007-02-01

    Full Text Available Abstract Background Subacromial impingement syndrome (SIS is the most frequently recorded shoulder disorder. When conservative treatment of SIS fails, a subacromial decompression is warranted. However, the best moment of referral for surgery is not well defined. Both early and late referrals have disadvantages – unnecessary operations and smaller improvements in shoulder function, respectively. This paper describes the design of a new interdisciplinary treatment strategy for SIS (TRANSIT, which comprises rules to treat SIS in primary care and a well-defined moment of referral for surgery. Methods/Design The effectiveness of an arthroscopic subacromial decompression versus usual medical care will be evaluated in a randomized controlled trial (RCT. Patients are eligible for inclusion when experiencing a recurrence of SIS within one year after a first episode of SIS which was successfully treated with a subacromial corticosteroid injection. After inclusion they will receive injection treatment again by their general practitioner. When, after this treatment, there is a second recurrence within a year post-injection, the participants will be randomized to either an arthroscopic subacromial decompression (intervention group or continuation of usual medical care (control group. The latter will be performed by a general practitioner according to the Dutch National Guidelines for Shoulder Problems. At inclusion, at randomization and three, six and 12 months post-randomization an outcome assessment will take place. The primary outcome measure is the patient-reported Shoulder Disability Questionnaire. The secondary outcome measures include both disease-specific and generic measures, and an economic evaluation. Treatment effects will be compared for all measurement points by using a GLM repeated measures analyses. Discussion The rationale and design of an RCT comparing arthroscopic subacromial decompression with usual medical care for subacromial

  19. Treatment of traumatic thoracolumbar spine fractures : A multicenter prospective randomized study of operative versus nonsurgical treatment

    NARCIS (Netherlands)

    Siebenga, Jan; Leferink, Vincent J. M.; Segers, Michiel J. M.; Elzinga, Matthijs J.; Bakker, Fred C.; Haarman, Henk J. Th. M.; Rommens, Pol M.; ten Duis, Henk-Jan; Patka, Peter

    2006-01-01

    Study Design. Multicenter prospective randomized trial. Objective. To test the hypotheses that thoracolumbar AO Type A spine fractures without neurologic deficit, managed with short-segment posterior stabilization will show an improved radiographic outcome and at least the same functional outcome as

  20. A Statistical Programme Assignment Model

    DEFF Research Database (Denmark)

    Rosholm, Michael; Staghøj, Jonas; Svarer, Michael

    When treatment effects of active labour market programmes are heterogeneous in an observable way  across the population, the allocation of the unemployed into different programmes becomes a particularly  important issue. In this paper, we present a statistical model designed to improve the present...... duration of unemployment spells may result if a statistical programme assignment model is introduced. We discuss several issues regarding the  plementation of such a system, especially the interplay between the statistical model and  case workers....

  1. Treatment duration of febrile urinary tract infection (FUTIRST trial): a randomized placebo-controlled multicenter trial comparing short (7 days) antibiotic treatment with conventional treatment (14 days)

    OpenAIRE

    Kuijper Ed J; Ablij Hans C; Delfos Nathalie M; Wattel-Louis G Hanke; Koster Ted; Leyten Eliane MS; Elzevier Henk W; Assendelft Willem JJ; van't Wout Jan W; van Nieuwkoop Cees; Pander Jan; Blom Jeanet W; Spelt Ida C; van Dissel Jaap T

    2009-01-01

    Abstract Background Current guidelines on the management of urinary tract infection recommend treating febrile urinary tract infection or acute pyelonephritis with antimicrobials for at least 14 days. Few randomized trials showed the effectiveness of treatment durations of 5 to 7 days but this has only been studied in young previously healthy women. Methods/Design A randomized placebo-controlled double-blind multicenter non-inferiority trial in which 400 patients with community acquired febri...

  2. Prediction of Treatment Response at 5-year Follow-up in a Randomized Clinical Trial of Behaviorally Based Couple Therapies

    Science.gov (United States)

    Baucom, Brian R.; Atkins, David C.; Rowe, Lorelei Simpson; Doss, Brian D.; Christensen, Andrew

    2014-01-01

    Objective Building on earlier work examining predictors of short- and moderate-term treatment response, demographic, intrapersonal, communication, and interpersonal variables were examined as predictors of clinically significant outcomes five years after couples completed one of two behaviorally based couple therapies. Method One hundred and thirty-four couples were randomly assigned to Integrative Behavioral Couple Therapy (IBCT; Jacobson & Christensen, 1998) or Traditional Behavioral Couple Therapy (TBCT; Jacobson & Margolin, 1979) and followed for 5 years after treatment. Outcomes include clinically significant change categories of relationship satisfaction and marital status at 5-year follow-up. Optimal subsets of predictors were selected using an automated, bootstrapped selection procedure based on Bayesian Information Criterion. Results Higher levels of commitment and being married for a longer period of time were associated with decreased likelihood of divorce/separation (Odds Ratio [OR] = 1.39, p = .004; OR = 0.91, p = .015). Being married for a longer period of time was also associated with increased likelihood of positive, clinically significant change (OR = 1.12, p = .029). Finally, higher levels of wife desired closeness were associated with increased odds of positive, clinically significant change and decreased odds of divorce for moderately distressed, IBCT couples (OR = 1.16, p = 0.002; OR = 0.85, p = 0.007, respectively) whereas the opposite was true for moderately distressed, TBCT couples (OR = 0.77, p divorced and most likely to report improvements in relationship satisfaction five years after ending treatment. In addition, it appears that the impact of wives’ desired closeness depended on the type of treatment moderately distressed couple received. PMID:25265544

  3. A multicentre randomized controlled clinical trial on the treatment of intrabony defects with enamel matrix derivatives/synthetic bone graft or enamel matrix derivatives alone?Results after 12 months

    OpenAIRE

    Meyle, Joerg; Hoffmann, Thomas; Topoll, Heinz; Heinz, Bernd; Al-Machot, Eli; Jervøe-Storm, Pia-Merete; Jepsen, Søren; Eickholz, Peter; Meiss, Christian

    2011-01-01

    Abstract Objectives: Comparison of clinical and radiographic outcomes of a combination of enamel matrix derivatives (EMD) and a synthetic bone graft (SBG) with EMD alone in wide and deep 1- and 2- wall intrabony defects 12 months after treatment. Method: In 73 patients with chronic periodontitis and one intrabony lesion, defects were randomly assigned to EMD/SBG (test) or EMD (control). Bone sounding, attachment levels, probing pocket depths, bleeding on probing and recessions w...

  4. Escitalopram in the Treatment of Adolescent Depression: A Randomized Placebo-Controlled Multisite Trial

    Science.gov (United States)

    Emslie, Graham J.; Ventura, Daniel; Korotzer, Andrew; Tourkodimitris, Stavros

    2009-01-01

    A randomized, double-blind, placebo-controlled trial that involves 312 male and female patients aged 12-17 reveal the effectiveness of escitalopram in the treatment of depressed adolescents. Eighty-three percent of the participants or 259 participants completed the 8 weeks therapy period.

  5. Treatment of Co-Occurring Substance Abuse and Suicidality among Adolescents: A Randomized Trial

    Science.gov (United States)

    Esposito-Smythers, Christianne; Spirito, Anthony; Kahler, Christopher W.; Hunt, Jeffrey; Monti, Peter

    2011-01-01

    Objective: This study tested a cognitive-behavioral treatment protocol for adolescents with a co-occurring alcohol or other drug use disorder (AOD) and suicidality in a randomized clinical trial. Method: Forty adolescents (M[subscript age] = 15 years; 68% female, 89% White) and their families recruited from an inpatient psychiatric hospital were…

  6. Melatonin Treatment in Individuals with Intellectual Disability and Chronic Insomnia: A Randomized Placebo-Controlled Study

    Science.gov (United States)

    Braam, W.; Didden, R.; Smits, M.; Curfs, L.

    2008-01-01

    Background: While several small-number or open-label studies suggest that melatonin improves sleep in individuals with intellectual disabilities (ID) with chronic sleep disturbance, a larger randomized control trial is necessary to validate these promising results. Methods: The effectiveness of melatonin for the treatment of chronic sleep…

  7. The Effectiveness of Two Grammar Treatment Procedures for Children with SLI: A Randomized Clinical Trial

    Science.gov (United States)

    Smith-Lock, Karen M.; Leitão, Suze; Prior, Polly; Nickels, Lyndsey

    2015-01-01

    Purpose: This study compared the effectiveness of two grammar treatment procedures for children with specific language impairment. Method: A double-blind superiority trial with cluster randomization was used to compare a cueing procedure, designed to elicit a correct production following an initial error, to a recasting procedure, which required…

  8. Mindfulness-Based Stress Reduction for the Treatment of Adolescent Psychiatric Outpatients: A Randomized Clinical Trial

    Science.gov (United States)

    Biegel, Gina M.; Brown, Kirk Warren; Shapiro, Shauna L.; Schubert, Christine M.

    2009-01-01

    Research has shown that mindfulness-based treatment interventions may be effective for a range of mental and physical health disorders in adult populations, but little is known about the effectiveness of such interventions for treating adolescent conditions. The present randomized clinical trial was designed to assess the effect of the…

  9. Surgical treatment of hidradenitis suppurativa with gentamicin sulfate: a prospective randomized study

    NARCIS (Netherlands)

    Buimer, Mathijs G.; Ankersmit, Miriam F. P.; Wobbes, Theo; Klinkenbijl, Jean H. G.

    2008-01-01

    This article describes and discusses a prospective randomized study with gentamicin sulfate in the surgical treatment of hidradenitis suppurativa. The purpose of the study was to investigate whether enclosure of antibiotics after primary excision and closure reduces the number of postoperative

  10. Psychological treatment of depression: A meta-analytic database of randomized studies

    NARCIS (Netherlands)

    Cuijpers, P.; Straten, van A.; Warmerdam, E.H.; Andersson, G.

    2008-01-01

    Abstract Background A large number of randomized controlled studies have clearly demonstrated that psychological interventions are effective in the treatment of depression. The number of studies in this area is increasing rapidly. In this paper, we present a database of controlled and comparative

  11. OPEN, RANDOMIZED COMPARISON OF PEFLOXACIN AND CEFOTAXIME IN THE TREATMENT OF COMPLICATED URINARY-TRACT INFECTIONS

    NARCIS (Netherlands)

    TIMMERMAN, C; HOEPELMAN, [No Value; DEHOND, J; SCHREINEMACHERS, L; MENSINK, H; VERHOEF, J

    1992-01-01

    In an open, randomized study, the effect of pefloxacin (400 mg b.i.d.) was compared with that of cefotaxime (1 g t.i.d.) in the treatment of complicated urinary tract infections. In total 87 patients entered the study under the clinical diagnosis of complicated urinary tract infection, of whom 49

  12. Randomized Clinical Trial: The Use of SpeechEasy® in Stuttering Treatment

    Science.gov (United States)

    Ritto, Ana Paula; Juste, Fabiola Staróbole; Stuart, Andrew; Kalinowski, Joseph; de Andrade, Claudia Regina Furquim

    2016-01-01

    Background: Numerous studies have demonstrated the benefit of devices delivering altered auditory feedback (AAF) as a therapeutic alternative for those who stutter. Aims: The effectiveness of a device delivering AAF (SpeechEasy®) was compared with behavioural techniques in the treatment of stuttering in a randomized clinical trial. Methods &…

  13. Power for Detecting Treatment by Moderator Effects in Two- and Three-Level Cluster Randomized Trials

    Science.gov (United States)

    Spybrook, Jessaca; Kelcey, Benjamin; Dong, Nianbo

    2016-01-01

    Recently, there has been an increase in the number of cluster randomized trials (CRTs) to evaluate the impact of educational programs and interventions. These studies are often powered for the main effect of treatment to address the "what works" question. However, program effects may vary by individual characteristics or by context,…

  14. [Randomized controlled trails for "equilibrium-acupuncture" treatment of lumbar pain in patients with lumbar intervertebral disc prolapse].

    Science.gov (United States)

    Han, Xiao; Ma, Wen-Zhu; Wang, Wen-Yuan

    2013-02-01

    To observe the effect of "equilibrium-acupuncture" intervention on lumbar pain in lumbar intervertebral disc prolapse patients. A total of 287 patients with lumbar intervertebral disc prolapse syndrome were randomly assigned to equilibrium acupuncture group (n = 143) and routine acupuncture group (n = 144) using SAS (Statistical Analysis System) Software. Patients of the equilibrium acupuncture group were treated by acupuncture stimulation of bilateral "Yaotong" point (at the middle site of the forehead) and those of the routine acupuncture group treated by acupuncture stimulation of Ashi-points, Weizhong (BL 40), Jiaji (EX-B 2), Shenshu (BL 23), etc. The treatment was conducted once daily for 20 days, then, 3 months' follow-up was given. Pain scores including pain rating index (PRI) and visual analogue scale (VAS) were given to the patients before and after the treatment using Chinese version of Short-Form of McGill Pain Questionnaire. Present pain intensity (PPI) was evaluated after the treatment. Before the treatment, no significant differences were found between the equilibrium acupuncture group and the routine acupuncture group in PRI and VAS scores (P > 0.05). Following the treatment, the pain symptom was apparently improved in both groups, and the rates of pain improvement (including excellent, good and moderate improvement rates) of the equilibrium acupuncture group were significantly higher than those of the routine acupuncture group from the 1st to the 4th treatment sessions, in the 20th treatment session and the 2nd follow-up (P equilibrium acupuncture group were significantly lower than those of the routine acupuncture group after the 18th and 20th sessions of treatment and the 3 months' follow-up (P equilibrium acupuncture group than in the routine acupuncture group in the 18th and 20th treatment sessions and the 2nd follow-up (P equilibrium-acupuncture" is relatively superior to routine acupuncture in the instant effect and long-term effect

  15. Computer-based psychological treatment for comorbid depression and problematic alcohol and/or cannabis use: a randomized controlled trial of clinical efficacy.

    Science.gov (United States)

    Kay-Lambkin, Frances J; Baker, Amanda L; Lewin, Terry J; Carr, Vaughan J

    2009-03-01

    To evaluate computer- versus therapist-delivered psychological treatment for people with comorbid depression and alcohol/cannabis use problems. Randomized controlled trial. Community-based participants in the Hunter Region of New South Wales, Australia. Ninety-seven people with comorbid major depression and alcohol/cannabis misuse. All participants received a brief intervention (BI) for depressive symptoms and substance misuse, followed by random assignment to: no further treatment (BI alone); or nine sessions of motivational interviewing and cognitive behaviour therapy (intensive MI/CBT). Participants allocated to the intensive MI/CBT condition were selected at random to receive their treatment 'live' (i.e. delivered by a psychologist) or via a computer-based program (with brief weekly input from a psychologist). Depression, alcohol/cannabis use and hazardous substance use index scores measured at baseline, and 3, 6 and 12 months post-baseline assessment. (i) Depression responded better to intensive MI/CBT compared to BI alone, with 'live' treatment demonstrating a strong short-term beneficial effect which was matched by computer-based treatment at 12-month follow-up; (ii) problematic alcohol use responded well to BI alone and even better to the intensive MI/CBT intervention; (iii) intensive MI/CBT was significantly better than BI alone in reducing cannabis use and hazardous substance use, with computer-based therapy showing the largest treatment effect. Computer-based treatment, targeting both depression and substance use simultaneously, results in at least equivalent 12-month outcomes relative to a 'live' intervention. For clinicians treating people with comorbid depression and alcohol problems, BIs addressing both issues appear to be an appropriate and efficacious treatment option. Primary care of those with comorbid depression and cannabis use problems could involve computer-based integrated interventions for depression and cannabis use, with brief regular

  16. [Effectiveness of microcurrent therapy as a constituent of post-hospital rehabilitative treatment in patients after total knee alloarthroplasty - a randomized clinical trial].

    Science.gov (United States)

    Rockstroh, G; Schleicher, W; Krummenauer, F

    2010-06-01

    This trial compared the clinical effectiveness of a combination of microcurrent therapy (M) with conventional postoperative physiotherapy treatment versus the combination of the latter with a sham (S) treatment after total knee arthroplasty (TKA) in terms of patient-related functional outcome parameters. A total of 78 inpatients after TKA was randomized into the active versus the sham treatment samples; all patients received ten applications of their respective therapy assignment. The primary clinical endpoint of the investigation was defined as the three-months intraindividual change (%) in a patient's OSWESTRY total function score after start of treatment. Secondary endpoints were the WOMAC osteoarthritis index as well as a patient's pain profile as assessed by a visual analogue scale before start of treatment, after five and ten therapeutic applications, and three months after discharge from hospital. The M sample showed a median increase of 31% (22-38%) in the OSWESTRY total score from 53% before start of treatment to 91% three months afterwards; the control sample showed an increase of 18% (3-31%) in median from 56 % to 78%; the samples differed significantly in this three-months increase (pmicrocurrent therapy embedded in conventional postoperative rehabilitation treatment after TKA versus the combination with a sham treatment. The results indicate an early introduction of microcurrent therapy concepts into postoperative treatment. Georg Thieme Verlag KG Stuttgart New York.

  17. Protocol for a proof of concept randomized controlled trial of cognitive-behavioural therapy for adult ADHD as a supplement to treatment as usual, compared with treatment as usual alone.

    Science.gov (United States)

    Dittner, Antonia J; Rimes, Katharine A; Russell, Ailsa J; Chalder, Trudie

    2014-09-03

    ADHD is prevalent in adults and frequently associated with impairment and distress. While medication is often the first line of treatment a high proportion of people with the condition are not fully treated by medication alone, cannot tolerate medication or do not wish to take it. Preliminary studies suggest that psychosocial approaches are a promising adjunctive or alternative treatment option. To date, individual cognitive-behaviour therapy (CBT) has been found to be efficacious in three randomized controlled trials (RCTs). There is a need for more RCTs to be carried out in order to replicate these results in different sites, to further investigate the acceptability and feasibility of CBT in this population and to further develop CBT approaches based on a psychological model. This randomized controlled trial investigates the efficacy of individual, formulation-based CBT when added to treatment-as-usual as compared with treatment as usual alone. Sixty patients with a diagnosis of adult ADHD attending a specialist clinic are randomly allocated to 1 of 2 treatments, 'Treatment as Usual' (TAU) or TAU plus 16 sessions individual CBT (TAU + CBT). In the TAU + CBT, the first 15 sessions take place over 30 weeks with a 16th 'follow-up' session at 42 weeks. Outcomes are assessed at 30 weeks and 42 weeks following randomization. The two primary outcomes are self-rated ADHD symptoms and functioning (occupational and social). Secondary outcomes include distress, mood, ADHD-related cognitions, ADHD-related behaviours and informant-rated ADHD symptoms. The primary analysis will include all participants for whom data is available and will use longitudinal regression models to compare treatments. Secondary outcomes will be analysed similarly. The results of the study will provide information about a) whether CBT adds benefit over and above TAU for ADHD and, b) if CBT is found to be efficacious, potential mechanisms of change and predictors of efficacy. Current Controlled Trials

  18. Intranasal sedation using ketamine and midazolam for pediatric dental treatment (NASO): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Gomes, Heloisa Sousa; Miranda, Analya Rodrigues; Viana, Karolline Alves; Batista, Aline Carvalho; Costa, Paulo Sucasas; Daher, Anelise; Machado, Geovanna de Castro Morais; Sado-Filho, Joji; Vieira, Liliani Aires Candido; Corrêa-Faria, Patrícia; Hosey, Marie Therese; Costa, Luciane Rezende

    2017-04-11

    Uncooperative children may need to receive dental treatment under sedation, which is indicated when nonpharmacological behavior guidance is unsuccessful. There are randomized controlled trials (RCTs) comparing different sedative protocols for dental procedures; however, the evidence for superiority of one form over another is weak. The primary aim of this study is to investigate the efficacy of intranasally administered ketamine plus midazolam for the dental treatment of children. We have designed a three-armed, parallel RCT to assess intranasal sedation using ketamine/midazolam in terms of the following measures: efficacy, safety, and cost-effectiveness. Two- to 6-year-old healthy children, referred for dental treatment in a dental sedation center in Brazil due to uncooperative behavior and requiring restorative dental procedures, will be recruited. Each child will be randomly assigned to one of the three groups: A - Intranasal administration of ketamine (4.0 mg/kg, maximum 100 mg) and midazolam (0.2 mg/kg, maximum 5.0 mg); B - Oral administration of ketamine (4.0 mg/kg, maximum 100 mg) and midazolam (0.5 mg/kg, maximum 20 mg); and C - Oral administration of midazolam (1.0 mg/kg, maximum 20 mg). The primary outcome is the child's behavior assessed through an observational scale using digital videos of the restorative dental treatment under sedation. The secondary outcomes are as follows: acceptance of sedative administration; memory of intraoperative events; the child's stress; adverse events; the child's pain during the procedure; the parent's, dentists', and child's perceptions of sedation; and economic analysis. Measures will be taken at baseline and drug administration and during and after the dental procedure. The necessary sample size was estimated to be 84 children after a blinded interim analysis of the first 30 cases. This study will provide data that can substantially add to science and pediatric dentistry as it examines the effect of sedative

  19. Using "warm handoffs" to link hospitalized smokers with tobacco treatment after discharge: study protocol of a randomized controlled trial.

    Science.gov (United States)

    Richter, Kimber P; Faseru, Babalola; Mussulman, Laura M; Ellerbeck, Edward F; Shireman, Theresa I; Hunt, Jamie J; Carlini, Beatriz H; Preacher, Kristopher J; Ayars, Candace L; Cook, David J

    2012-08-01

    Post-discharge support is a key component of effective treatment for hospitalized smokers, but few hospitals provide it. Many hospitals and care settings fax-refer smokers to quitlines for follow-up; however, less than half of fax-referred smokers are successfully contacted and enrolled in quitline services. "Warm handoff" is a novel approach to care transitions in which health care providers directly link patients with substance abuse problems with specialists, using face-to-face or phone transfer. Warm handoff achieves very high rates of treatment enrollment for these vulnerable groups. The aim of this study-"EQUIP" (Enhancing Quitline Utilization among In-Patients)-is to determine the effectiveness, and cost-effectiveness, of warm handoff versus fax referral for linking hospitalized smokers with tobacco quitlines. This study employs a two-arm, individually randomized design. It is set in two large Kansas hospitals that have dedicated tobacco treatment interventionists on staff. At each site, smokers who wish to remain abstinent after discharge will be randomly assigned to groups. For patients in the fax group, staff will provide standard in-hospital intervention and will fax-refer patients to the state tobacco quitline for counseling post-discharge. For patients in the warm handoff group, staff will provide brief in-hospital intervention and immediate warm handoff: staff will call the state quitline, notify them that a warm handoff inpatient from Kansas is on the line, then transfer the call to the patients' mobile or bedside hospital phone for quitline enrollment and an initial counseling session. Following the quitline session, hospital staff provides a brief check-back visit. Outcome measures will be assessed at 1, 6, and 12 months post enrollment. Costs are measured to support cost-effectiveness analyses. We hypothesize that warm handoff, compared to fax referral, will improve care transitions for tobacco treatment, enroll more participants in quitline

  20. Increasing adherence to obstructive sleep apnea treatment with a group social cognitive therapy treatment intervention: a randomized trial.

    Science.gov (United States)

    Bartlett, Delwyn; Wong, Keith; Richards, Dianne; Moy, Emma; Espie, Colin A; Cistulli, Peter A; Grunstein, Ronald

    2013-11-01

    To examine whether a social cognitive therapy (SCT) intervention increases continuous positive airway pressure (CPAP) use compared to equivalent social interaction (SI) time. Individuals with obstructive sleep apnea (OSA) referred for CPAP therapy. Participants received a 30-min group education session regarding OSA and CPAP. Groups of three to four participants were then randomly assigned to an SCT session or social interaction. CPAP usage was assessed at 7 nights, then 1, 3, and 6 months. The two primary outcomes were adherence, usage ≥ 4 h per night at 6 months, and uptake of CPAP. Questionnaires were given pretreatment and posttreatment. Two hundred six individuals were randomized to SI (n = 97) or SCT (n = 109). CPAP uptake was not different between groups (82% in SI, 88% in SCT groups, P = 0.35). There were no differences between groups in adherence: 63-66% at 1 week, and at 6 months 55-47% (P = 0.36). Higher pretreatment apnea-hypopnea index, higher baseline self-efficacy, and use of CPAP (≥ 4 h) at 1 week were independent predictors of CPAP adherence at 6 months. CPAP adherence increased by a factor of 1.8 (odds ratio = 1.8, 95% confidence interval 1.1-3.0) for every one-unit increase in self-efficacy. There was no difference between groups postintervention in self-efficacy scores, sleepiness, mood, or sleep quality. In this randomized trial, a single SCT application did not increase adherence when compared with SI time. Although self-efficacy scores prior to CPAP predicted adherence, self-efficacy was not increased by the interventions. Increasing intensity and understanding of SCT interventions may be needed to improve CPAP adherence. Australian New Zealand Clinical Trials Registry, ACTRN12607000424404.

  1. Treatment of panic disorder with agoraphobia: randomized placebo-controlled trial of four psychosocial treatments combined with imipramine or placebo.

    Science.gov (United States)

    Marchand, Andre; Coutu, Marie-France; Dupuis, Gilles; Fleet, Richard; Borgeat, Francois; Todorov, Christo; Mainguy, Nicole

    2008-01-01

    Few randomized controlled trials have included panic disorder patients with moderate to severe agoraphobia. Therefore, this population was studied using pharmacotherapy as well as psychotherapy. At the time of the study, imipramine was widely used as a pharmacological treatment. Also, current practice guidelines for patients with panic disorder find selective serotonin reuptake inhibitors and tricyclic antidepressants roughly comparable in terms of efficacy. Therefore, the main objective of this study is to compare four psychosocial treatments-cognitive and graded in vivo exposure treatments, graded in vivo exposure, cognitive treatment, and supportive therapy-to evaluate the benefits of combining cognitive therapy with exposure in vivo. These treatments were combined with imipramine or placebo for a total of eight experimental conditions. Participants presented moderate to severe agoraphobia. The method involved a randomized, double-blind, placebo-controlled trial with 137 participants who completed a 14-session protocol involving the treatments just mentioned. Measures were taken at baseline and posttreatment and at 3-, 6-, and 12-month follow-up. All treatment conditions were statistically and clinically effective in reducing self-reported panic-agoraphobia symptoms over the 1-year follow-up. No statistical differences were observed between imipramine and placebo conditions. This study found that all treatment modalities helped reduce panic and agoraphobic symptomatology over a 1-year follow-up period. These surprising results support the need to document the relations among the various components of an intervention. This would make it possible to assess the relative efficacy of the treatment components rather than of the intervention as a whole.

  2. Internet Treatment Addressing either Insomnia or Depression, for Patients with both Diagnoses: A Randomized Trial

    Science.gov (United States)

    Blom, Kerstin; Jernelöv, Susanna; Kraepelien, Martin; Bergdahl, Malin Olséni; Jungmarker, Kristina; Ankartjärn, Linda; Lindefors, Nils; Kaldo, Viktor

    2015-01-01

    Study Objectives: To compare treatment effects when patients with insomnia and depression receive treatment for either insomnia or depression. Design: A 9-w randomized controlled trial with 6- and 12-mo follow-up. Setting: Internet Psychiatry Clinic, Stockholm, Sweden. Participants: Forty-three adults in whom comorbid insomnia and depression were diagnosed, recruited via media and assessed by psychiatrists. Interventions: Guided Internet-delivered cognitive behavior therapy (ICBT) for either insomnia or depression. Measurements and Results: Primary outcome measures were symptom self-rating scales (Insomnia Severity Index [ISI] and the Montgomery Åsberg Depression Rating Scale [MADRS-S]), assessed before and after treatment with follow-up after 6 and 12 mo. The participants' use of sleep medication and need for further treatment after completion of ICBT was also investigated. The insomnia treatment was more effective than the depression treatment in reducing insomnia severity during treatment (P = 0.05), and equally effective in reducing depression severity. Group differences in insomnia severity were maintained during the 12-mo follow-up period. Post treatment, participants receiving treatment for insomnia had significantly less self-rated need for further insomnia treatment (P Internet-delivered treatment with cognitive behavior therapy (ICBT) for insomnia was more effective than ICBT for depression for patients with both diagnoses. This indicates, in line with previous research, that insomnia when comorbid with depression is not merely a symptom of depression, but needs specific treatment. Trial Registration: The trial was registered at Clinicaltrials.gov, registration ID: NCT01256099. Citation: Blom K, Jernelöv S, Kraepelien M, Bergdahl MO, Jungmarker K, Ankartjärn L, Lindefors N, Kaldo V. Internet treatment addressing either insomnia or depression, for patients with both diagnoses: a randomized trial. SLEEP 2015;38(2):267–277. PMID:25337948

  3. Randomized controlled trial of modafinil for the treatment of fatigue in postpolio patients.

    Science.gov (United States)

    Chan, K Ming; Strohschein, Fay J; Rydz, David; Allidina, Amyn; Shuaib, Ashfaq; Westbury, Chris F

    2006-01-01

    The purpose of this study was to test whether modafinil is effective in alleviating the symptoms of fatigue in postpolio patients, because it has been helpful for such symptoms in other neurologic disorders. Using a double-blind, randomized, placebo-controlled cross-over design, 14 postpolio patients with moderate to severe fatigue were assigned to receive modafinil or placebo first. Piper Fatigue Scale, Epworth Sleepiness Scale, digit span, and reaction time tests were done at baseline and then at weekly intervals. The Piper Fatigue Scale scores improved by 27 +/- 40% (mean +/- SD) following modafinil and by 43 +/- 36% following placebo. Scores for most of the other tests did not change during the study. Therefore, we conclude that modafinil was not effective in alleviating the symptoms of fatigue in postpolio patients.

  4. A single-blinded, randomized pilot study of botulinum toxin type A combined with non-pharmacological treatment for spastic foot.

    Science.gov (United States)

    Baricich, Alessio; Carda, Stefano; Bertoni, Michele; Maderna, Luca; Cisari, Carlo

    2008-11-01

    To explore the effect of treatment after botulinum toxin type A combined with treatments for the spastic foot. Single-blind, randomized trial, with 3-month follow-up. Twenty-three chronic hemiplegic adult patients with spastic equinus foot. Following botulinum toxin type A injection at the medial and lateral gastrocnemius, patients were assigned randomly to 3 groups, and treated with taping, electrical stimulation or stretching. They were evaluated before treatment (t0), and at 10 (t1), 20 (t2) and 90 (t3) days after treatment. Outcome measures were: Modified Ashworth Scale; passive range of motion at the ankle; measurement of muscle action potential at the gastrocnemius medialis; and measurement of maximum ankle dorsiflexion angle in stance using gait analysis. The group treated with electrical stimulation performed better at t1 on the Modified Ashworth Scale. The taping and electrical stimulation groups performed better in all outcome measures at t3. The taping group performed better mainly for maximum ankle dorsiflexion angle in stance. The stretching group showed a less durable result, with some worsening at the t3 evaluation compared with the assessment performed before treatment. This pilot study indicates that combining botulinum toxin type A administration for the ankle plantar flexors with taping and electrical stimulation might be beneficial.

  5. Outcomes are not different for patient-matched vs. non-matched treatment in subjects with chronic, recurrent low back pain: a randomized clinical trial

    Science.gov (United States)

    Henry, Sharon M.; Van Dillen, Linda; Ouellette-Morton, Rebecca H.; Hitt, Juvena R.; Lomond, Karen V.; DeSarno, Michael J.; Bunn, Janice Y.

    2014-01-01

    Background Classification schemas for low back pain (LBP), such as the Treatment Based Classification and the Movement System Impairment schemas, use common clinical features to subgroup patients with LBP and are purported to improve treatment outcomes. Purpose To assess if providing matched treatments based on patient specific clinical features led to superior treatment outcomes compared to an unmatched treatment for subjects with chronic, recurrent LBP. Study Design A randomized controlled trial. Patient Sample Subjects (n=124) with LBP (≥ 12 months) with or without recurrences underwent a standardized clinical exam to group them into one of 2 strata: (1) ineligible or (2) eligible for stabilization exercises based on the Treatment Based Classification schema. Subjects underwent additional clinical tests to assign them to one of the 5 possible Movement System Impairment categories. Outcome Measures Questionnaires were collected electronically at: Week 0, prior to treatment; Week 7 (following the 6 weekly, one hour treatment sessions); and 12 months. Using the Oswestry Disability Index (0-100) and the Numeric Pain Rating Scale (0-10), the primary analysis was performed using the intention-to-treat principle. Secondary outcomes included fear-avoidance beliefs as well as psychosocial, work related and general health status. Methods After subjects were categorized based on their particular clinical features using both the Treatment Based Classification and Movement System Impairment schemas, they were randomized into one of two treatments using a 3:1 ratio for matched or unmatched treatments. The treatments were (1) trunk stabilization exercise, or (2) Movement System Impairment-directed exercises. The study was funded by National Institutes of Health (NCMRR/R01HD040909; $1,485,000). There are no study specific conflicts of interest to report. Results Of the patients allocated to treatment for this study, 76 received a matched treatment and 25 received an unmatched

  6. One-Session treatment of specific phobias in youths: a randomized clinical trial.

    Science.gov (United States)

    Ost, L G; Svensson, L; Hellström, K; Lindwall, R

    2001-10-01

    Sixty children, ages 7-17 years, who fulfilled Diagnostic and Statistical Manual of Mental Disorders (4th ed.; American Psychiatric Association, 1994) diagnosis for various specific phobias were randomized to (a) 1-session exposure treatment alone, (b) 1-session treatment with a parent present, or (c) wait-list control group for 4 weeks. After the waiting period, the wait-list patients were rerandomized to the active treatments. The patients' phobias were assessed with behavioral approach tests (approach behavior, experienced anxiety, and physiological reactions), whereas general anxiety, depression, phobic tendencies, and anxiety sensitivity were assessed with self-report inventories. Assessments were done pre-, post-, and 1-year following treatment. Results showed that both treatment conditions did significantly better than the control condition, whereas the treatment groups did equally well on most measures, and the effects were maintained at follow-up. The implications of these results are discussed.

  7. Aripiprazole for the treatment of methamphetamine dependence: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Coffin, Phillip Oliver; Santos, Glenn-Milo; Das, Moupali; Santos, Deirdre M; Huffaker, Shannon; Matheson, Tim; Gasper, James; Vittinghoff, Eric; Colfax, Grant N

    2013-04-01

    To test aripiprazole for efficacy in decreasing use in methamphetamine-dependent adults, compared to placebo. Participants were randomized to receive 12 weeks of aripiprazole or placebo, with a 3-month follow-up and a platform of weekly 30-minute substance abuse counseling. The trial was conducted from January 2009 to March 2012 at the San Francisco Department of Public Health. Ninety actively using, methamphetamine-dependent, sexually active adults were recruited from community venues. The primary outcome was regression estimated reductions in weekly methamphetamine-positive urines. Secondary outcomes were study medication adherence [by self-report and medication event monitoring systems (MEMS)], sexual risk behavior and abstinence from methamphetamine. Participant mean age was 38.7 years, 87.8% were male, 50.0% white, 18.9% African American, and 16.7% Latino. Eighty-three per cent of follow-up visits and final visits were completed. By intent-to-treat, participants assigned to aripiprazole had similar reductions in methamphetamine-positive urines as participants assigned to placebo [risk ratio (RR) 0.88, 95% confidence interval (CI): 0.66-1.19, P = 0.41]. Urine positivity declined from 73% (33 of 45 participants) to 45% (18 of 40) in the placebo arm and from 77% (34 of 44) to 44% (20 of 35) in the aripiprazole arm. Adherence by MEMS and self-report was 42 and 74%, respectively, with no significant difference between arms (MEMS P = 0.31; self-report P = 0.17). Most sexual risk behaviors declined similarly among participants in both arms (all P > 0.05). There were no serious adverse events related to study drug, although participants randomized to aripiprazole reported more akathisia, fatigue and drowsiness (P methamphetamine use significantly among actively using, dependent adults. Published 2012. This article is a U.S. Government work and is in the public domain in the USA.

  8. Does addition of `mud-pack and hot pool treatment' to patient education make a difference in fibromyalgia patients? A randomized controlled single blind study

    Science.gov (United States)

    Bağdatlı, Ali Osman; Donmez, Arif; Eröksüz, Rıza; Bahadır, Güler; Turan, Mustafa; Erdoğan, Nergis

    2015-12-01

    The aim of this randomized controlled single-blind study is to explore whether addition of mud-pack and hot pool treatments to patient education make a significant difference in short and mild term outcomes of the patients with fibromyalgia. Seventy women with fibromyalgia syndrome were randomly assigned to either balneotherapy with mud-pack and hot pool treatments (35) or control (35) groups. After randomization, five patients from balneotherapy group and five patients from control group were dropped out from the study with different excuses. All patients had 6-h patient education programme about fibromyalgia syndrome and were given a home exercise programme. The patients in balneotherapy group had heated pool treatment at 38 °C for 20 min a day, and mud-pack treatment afterwards on back region at 45 °C. Balneotherapy was applied on weekdays for 2 weeks. All patients continued to take their medical treatment. An investigator who was blinded to the intervention assessed all the patients before and after the treatment, at the first and the third months of follow-up. Outcome measures were FIQ, BDI and both patient's and physician's global assessments. Balneotherapy group was significantly better than control group at after the treatment and at the end of the first month follow-up assessments in terms of patient's and physician's global assessment, total FIQ score, and pain intensity, fatigue, non-refreshed awaking, stiffness, anxiety and depression subscales of FIQ. No significant difference was found between the groups in terms of BDI scores. It is concluded that patient education combined with 2 weeks balneotherapy application has more beneficial effects in patients with fibromyalgia syndrome as compared to patient education alone.

  9. Does addition of 'mud-pack and hot pool treatment' to patient education make a difference in fibromyalgia patients? A randomized controlled single blind study.

    Science.gov (United States)

    Bağdatlı, Ali Osman; Donmez, Arif; Eröksüz, Rıza; Bahadır, Güler; Turan, Mustafa; Erdoğan, Nergis

    2015-12-01

    The aim of this randomized controlled single-blind study is to explore whether addition of mud-pack and hot pool treatments to patient education make a significant difference in short and mild term outcomes of the patients with fibromyalgia. Seventy women with fibromyalgia syndrome were randomly assigned to either balneotherapy with mud-pack and hot pool treatments (35) or control (35) groups. After randomization, five patients from balneotherapy group and five patients from control group were dropped out from the study with different excuses. All patients had 6-h patient education programme about fibromyalgia syndrome and were given a home exercise programme. The patients in balneotherapy group had heated pool treatment at 38 °C for 20 min a day, and mud-pack treatment afterwards on back region at 45 °C. Balneotherapy was applied on weekdays for 2 weeks. All patients continued to take their medical treatment. An investigator who was blinded to the intervention assessed all the patients before and after the treatment, at the first and the third months of follow-up. Outcome measures were FIQ, BDI and both patient's and physician's global assessments. Balneotherapy group was significantly better than control group at after the treatment and at the end of the first month follow-up assessments in terms of patient's and physician's global assessment, total FIQ score, and pain intensity, fatigue, non-refreshed awaking, stiffness, anxiety and depression subscales of FIQ. No significant difference was found between the groups in terms of BDI scores. It is concluded that patient education combined with 2 weeks balneotherapy application has more beneficial effects in patients with fibromyalgia syndrome as compared to patient education alone.

  10. Direct versus Indirect Treatment for Preschool Children who Stutter: The RESTART Randomized Trial.

    Directory of Open Access Journals (Sweden)

    Caroline de Sonneville-Koedoot

    Full Text Available Stuttering is a common childhood disorder. There is limited high quality evidence regarding options for best treatment. The aim of the study was to compare the effectiveness of direct treatment with indirect treatment in preschool children who stutter.In this multicenter randomized controlled trial with an 18 month follow-up, preschool children who stutter who were referred for treatment were randomized to direct treatment (Lidcombe Program; n = 99 or indirect treatment (RESTART-DCM treatment; n = 100. Main inclusion criteria were age 3-6 years, ≥3% syllables stuttered (%SS, and time since onset ≥6 months. The primary outcome was the percentage of non-stuttering children at 18 months. Secondary outcomes included stuttering frequency (%SS, stuttering severity ratings by the parents and therapist, severity rating by the child, health-related quality of life, emotional and behavioral problems, and speech attitude.Percentage of non-stuttering children for direct treatment was 76.5% (65/85 versus 71.4% (65/91 for indirect treatment (Odds Ratio (OR, 0.6; 95% CI, 0.1-2.4, p = .42. At 3 months, children treated by direct treatment showed a greater decline in %SS (significant interaction time x therapy: β = -1.89; t(282.82 = -2.807, p = .005. At 18 months, stuttering frequency was 1.2% (SD 2.1 for direct treatment and 1.5% (SD 2.1 for indirect treatment. Direct treatment had slightly better scores on most other secondary outcome measures, but no differences between treatment approaches were significant.Direct treatment decreased stuttering more quickly during the first three months of treatment. At 18 months, however, clinical outcomes for direct and indirect treatment were comparable. These results imply that at 18 months post treatment onset, both treatments are roughly equal in treating developmental stuttering in ways that surpass expectations of natural recovery. Follow-up data are needed to confirm these findings in the longer term

  11. Randomized clinical study for comparative evaluation of fourth-generation fluoroquinolones with the combination of fortified antibiotics in the treatment of bacterial corneal ulcers.

    Science.gov (United States)

    Shah, Vinit Mahendra; Tandon, Radhika; Satpathy, Gita; Nayak, Niranjan; Chawla, Bhavna; Agarwal, Tushar; Sharma, Namrata; Titiyal, Jeewan S; Vajpayee, Rasik B

    2010-07-01

    Comparative evaluation of efficacy of monotherapy with moxifloxacin (0.5%) or gatifloxacin (0.3%) with combination therapy of cefazolin (5%) and tobramycin (1.3%) in treatment of bacterial corneal ulcers. Patients diagnosed with bacterial keratitis (ulcer diameter 2-8 mm) were randomized to 1 of the 3 treatment groups (tobramycin 1.3% and cefazolin 5%, gatifloxacin 0.3%, or moxifloxacin 0.5%). After obtaining corneal scrapings, assigned study medication was instilled hourly for 48 hours and tapered as per clinical response. Healing of ulcer, duration to cure, adverse reactions, antibiogram profile, treatment failures, final visual acuity, and corneal opacity size were evaluated. A total of 61 patients were enrolled [cefazolin and tobramycin (n = 20), gatifloxacin (n = 21), and moxifloxacin (n = 20)]. Overall, 57 patients (93%) healed on treatment. On comparison of the mean time taken to heal, no statistically significant difference was found among all the 3 treatment groups (P = 0.98). Positive bacterial culture was obtained in only 38 patients (62%). There was no significant difference in the bacterial isolates in each treatment group. There were 4 (7%) treatment failures (perforation or nonhealing ulcer): 1 (5%) each in moxifloxacin and gatifloxacin group and 2 (10%) in fortified antibiotics group. All regimens were well tolerated. The study failed to find a difference in the efficacy of monotherapy with fourth-generation fluoroquinolones in the treatment of bacterial corneal ulcers of 2-8 mm size when compared with combination therapy of fortified antibiotics.

  12. Homework assignments in couple and family therapy.

    Science.gov (United States)

    Dattilio, Frank M

    2002-05-01

    Homework has been cited as an integral part of a number of theoretical orientations and therapy formats; unfortunately, very little has been written about its use with couples and families. This is despite the fact that many couple and family therapists espouse the use of homework or out-of-session assignments in order to help the effects of therapy jell. This article reviews some of the empirical literature on homework assignments and their effectiveness in the domain of therapy for families and couples. It also highlights the effectiveness of and the need for out-of-session assignments in treatment. A case illustration is used to demonstrate how homework assignments may be used as a significant change agent in couple and family treatment. Copyright 2002 Wiley Periodicals, Inc.

  13. Combined treatment with oral finasteride and topical minoxidil in male androgenetic alopecia: a randomized and comparative study in Chinese patients.

    Science.gov (United States)

    Hu, Ruiming; Xu, Feng; Sheng, Youyu; Qi, Sisi; Han, Yumei; Miao, Ying; Rui, Wenlong; Yang, Qinping

    2015-01-01

    Finasteride at 1 mg/day and 5% topical minoxidil are effective in male androgenetic alopecia (MAGA). However, studies describing their effects in Chinese individuals are scarce. 450 Chinese MAGA patients were randomly assigned to receive finasteride (n = 160), minoxidil (n = 130) and combined medication (n = 160) for 12 months. The patients returned to the clinic every 3 months for efficacy evaluation. And efficacy was evaluated in 428 men at treatment end, including 154, 122, and 152 in the finasteride, 5% minoxidil, and combination groups, respectively. All groups showed similar baseline characteristics, including age at enrollment, and duration and severity of alopecia (p > 0.05). At 12 months, 80.5, 59, and 94.1% men treated with finasteride, 5% minoxidil and the combination therapy showed improvement, respectively. Adverse reactions were rare (finasteride, 1.8%; minoxidil, 6.1%), and disappeared right after drug withdrawal. In conclusion, finasteride is superior to 5% minoxidil, while the combined medication showed the best efficacy. © 2015 Wiley Periodicals, Inc.

  14. Effectiveness of dry needling for the treatment of temporomandibular myofascial pain: a double-blind, randomized, placebo controlled study.

    Science.gov (United States)

    Dıraçoğlu, Demirhan; Vural, Meltem; Karan, Ayşe; Aksoy, Cihan

    2012-01-01

    To test the hypothesis that dry needling is more effective than sham dry needling in relieving myofascial pain of the temporomandibular muscles. Fifty-two subjects with established myofascial trigger points were randomized into two groups; study group (N: 26) and placebo group (N: 26). Dry needling was applied using acupuncture needles. Sham dry needling was applied to the placebo group. Pain pressure threshold was measured with pressure algometry, pain intensity was rated using a 10-cm visual analog scale (VAS) and the unassisted jaw opening without pain measurement was performed. Evaluations were done by a physician blinded to the data. Of 52 patients assigned, 50 completed the study. Mean algometric values were significantly higher in the study group when compared to the placebo group (p values being less than 0.05). There were no differences between the two groups in terms of VAS and unassisted jaw-opening without pain values. Dry needling appears to be an effective treatment method in relieving the pain and tenderness of myofascial trigger points.

  15. Ziprasidone in the treatment of borderline personality disorder: a double-blind, placebo-controlled, randomized study.

    Science.gov (United States)

    Pascual, Juan Carlos; Soler, Joaquim; Puigdemont, Dolors; Pérez-Egea, Rosario; Tiana, Thais; Alvarez, Enrique; Pérez, Víctor

    2008-04-01

    The aim of this double-blind, placebo-controlled study was to evaluate the efficacy and tolerability of ziprasidone in the treatment of adult patients with borderline personality disorder. Sixty DSM-IV borderline personality disorder patients were included from March 2004 to April 2006 in a 12-week, single-center, double-blind, placebo-controlled study. The subjects were randomly assigned to ziprasidone or placebo in a 1:1 ratio following a 2-week baseline period. The Clinical Global Impressions scale for use in borderline personality disorder patients (CGI-BPD) was the primary outcome measure, and other scales and self-reports related to affect, behavior, psychosis, general psychopathology domains, and clinical safety were included. Analysis of variance indicated no statistically significant differences between ziprasidone and placebo in the CGI-BPD. Nor were significant differences observed between groups in depressive, anxiety, psychotic, or impulsive symptoms. The mean daily dose of ziprasidone was 84.1 mg/day (SD = 54.8; range, 40-200). The drug was seen to be safe, and no serious adverse effects were observed. This trial failed to show a significant effect of ziprasidone in patients with borderline personality disorder. clinicaltrials.gov Identifier: NCT00635921.

  16. Cognitive-Behavioral Treatment of Posttraumatic Stress in Patients With Implantable Cardioverter Defibrillators: Results From a Randomized Controlled Trial.

    Science.gov (United States)

    Ford, Jessica; Rosman, Lindsey; Wuensch, Karl; Irvine, Jane; Sears, Samuel F

    2016-08-01

    Approximately 20% of patients with implantable cardioverter defibrillators (ICDs) suffer from posttraumatic stress disorder (PTSD) due to a history of cardiac arrest, device implantation, and ICD shock. There has been very little examination of treatment of PTSD symptoms in these patients. This study evaluated the effect of a specific cognitive-behavioral therapy (CBT) intervention for ICD patients with high levels of PTSD symptoms: a manualized program consisting of 8 telephone sessions with a trained counselor, a patient education book, and a stress management procedure on compact disc. Participants were 193 ICD patients, who were randomized to CBT or usual cardiac care (UCC) who completed self-report surveys at the time of recruitment and 6 and 12 months after initial measurement. Previous publication on the primary research evaluation questions reported that the CBT condition resulted in greater improvement on PTSD and depression symptoms than the UCC for the general population of ICD patients, but did not evaluate the effect on those with elevated symptoms of PTSD. The authors conducted secondary analyses of the effect of treatment on high and low PTSD symptom groups based on a cutoff for the Impact of Event Scale-Revised (Weiss & Marmar, 1997). Participants in the CBT group who had high symptoms experienced significantly greater symptom reduction from baseline to 12 months (d = 2.44, p = .021) than the UCC group (d = 1.12). Participants with low symptoms had small reductions regardless of group assignment (d = 0.16, p = .031). ICD-focused CBT was sufficient to produce a large, statistically significant reduction in PTSD symptoms in ICD patients with indications for treatment. Copyright © 2016 International Society for Traumatic Stress Studies.

  17. Duloxetine-bupropion combination for treatment-resistant atypical depression: a double-blind, randomized, placebo-controlled trial.

    Science.gov (United States)

    Fornaro, Michele; Martino, Matteo; Mattei, Chiara; Prestia, Davide; Vinciguerra, Valentina; De Berardis, Domenico; De Pasquale, Concetta; Iasevoli, Felice; Mungo, Sergio; Fornaro, Pantaleo

    2014-08-01

    The efficacy, safety, and tolerability of combined bupropion versus placebo using duloxetine as active reference drug, in patients with a DSM-IV diagnosis of major depression with atypical features and a history of treatment resistance, were evaluated in this preliminary six-week study. Patients (n=46) had a baseline Hamilton Depression Scale (HAM-D) ≥14 and were randomly assigned to 150/300 mg/day bupropion vs. placebo, which was added to 60 to 120 mg/day duloxetine depending on baseline depression severity. Atypical features of depression were assessed using the additional eight-item module of the Structured Interview Guide for the HAM-D with the Atypical Depression Supplement. By week 6, only five (21.7%) patients receiving duloxetine+placebo vs. six (26.1%) patients on the bupropion combination achieved response. No significant difference in final HAM-D scores between the two groups was observed between those patients achieving response. The presence of a higher number of atypical features significantly predicted non-response, with the relevant binary logistic regression model correctly classifying 17 out 22 (77.3%) of non-responders [Exp(B)=0.294; p=0.016] vs. 17 out 23 (73.9%) [Exp(B)=0.353; p=0.028] non-responder cases in the "+placebo" and "+bupropion" groups, respectively. In those patients receiving bupropion, treatment-emergent adverse events leading to withdrawal were more common among those receiving lower doses of the combination drug, and no life-threating dangers were noted. Additional studies, including an adequate course of duloxetine trial, are nonetheless aimed to allow a firm conclusion about the usefulness of the combination of duloxetine and bupropion for treatment-resistant cases of major depression with atypical features. Copyright © 2014 Elsevier B.V. and ECNP. All rights reserved.

  18. A randomized prospective study of rehabilitation therapy in the treatment of radiation-induced dysphagia and trismus.

    Science.gov (United States)

    Tang, Y; Shen, Q; Wang, Y; Lu, K; Wang, Y; Peng, Y

    2011-01-01

    To evaluate the therapeutic effect of rehabilitation therapy on radiation-induced dysphagia and trismus in nasopharyngeal carcinoma (NPC) patients after radiotherapy. 43 NPC patients after radiotherapy were included. Patients were randomly assigned to either the rehabilitation group or a control group. Both groups were subjected to routine treatment, while the rehabilitation group also received rehabilitation therapy for 3 months. The severity of dysphagia was assessed using the water swallow test, while trismus was evaluated with the LENT/SOMA score and the interincisor distance (IID). The water swallow test, the LENT/SOMA score, as well as IID for both groups before and after treatment were analyzed and compared. After treatment, the rehabilitation group displayed a significant improvement in swallowing function, while the control group did not. The efficacy rate (percentage of patients with excellent or effective results) of rehabilitation group was higher than that of control group (77% vs. 43%), and the difference was statistically significant (ϰ(2) = 5.32, p = 0.02). IID pretreatment and posttreatment did not show much difference in the rehabilitation group, while in the control group IID significantly decreased posttreatment (1.1 ± 0.36 cm vs.1.8 ± 0.56 cm, p = 0.001). Although the mean IID in patients of both groups decreased after the 3 month follow-up, the decrease in the rehabilitation group was less than that of the control group (0.19 ± 0.5 cm vs. 0.69 ± 0.56 cm, p = 0.004 ). The efficacy rate of trismus in the rehabilitation group was significantly higher than that of the control group (64% vs. 28%, ϰ(2) = 5.31, p = 0.02). Rehabilitation training can improve swallow function and slow down the progress of trismus in NPC patients following radiotherapy.

  19. The Comparison of Topiramate and Placebo in the Treatment of Posttraumatic Stress Disorder: A Randomized, Double- Blind Study

    Directory of Open Access Journals (Sweden)

    Sh Akuchekian

    2004-10-01

    Full Text Available Background: Posttraumatic stress disorder (PTSD is a chronic illness and a difficult – to – treat condition. The Hypothesis that exposure to Traumatic events may sensitize or kindle limbic nuclei has led to efforts to treat PTSD with anticonvulsants. Based on the kindling hypothesis of PTSD, this clinical trial was designed to assess the clinical response to topiramate (a new anticonvulsant as a potential Treatment for PTSD. Methods: Sixty seven combat veterans with PTSD (range 30-50 years old; SD: 39.5 ± 4.19 randomly assigned in a double – blind design. They were Treated for 12 weeks with topiramat (N=34, 50-500 mg/day as add – on therapy or placebo (N=33. Patients were monthly assessed for three consecutive months using Clinician – Administered PTSD Scale (CAPS. Results:Two patients were withdrawn from the study because of topiramate side effects.In reminders, the mean Score of topiramate group, in the first visit was 50.70 ± 7.7 and the mean score of placebo group was 48.9 ± 9.13. After finishing the treatment period, the mean score of the topiramate group was 32.75 ± 8.2 and of the placebo group was 46.62 ± 8.8. The analysis of these scores showed a significant difference between the two groups (P=0.00. Frequency and intensity of re-experience criteria (intrusive memory, night mare, and flash back, sleep problem, irritability, anger, frequency of difficulty to recall, and intensity of startle reaction in topiramate group was significantly less than placebo group (P < 0.05. Conclusion: The results of this study suggest that topiramate is a safe, well – tolerated, and significantly effective Treatment for PTSD. Keywords: PTSD, Topiramate, Anticonvulsant.

  20. Ursodeoxycholic acid in the treatment of cholestasis of pregnancy: a randomized, double-blind study controlled with placebo.

    Science.gov (United States)

    Palma, J; Reyes, H; Ribalta, J; Hernández, I; Sandoval, L; Almuna, R; Liepins, J; Lira, F; Sedano, M; Silva, O; Tohá, D; Silva, J J

    1997-12-01

    Intense pruritus and the risk of stillbirths and premature deliveries justify the search for an effective pharmacologic treatment of intrahepatic cholestasis of pregnancy. This study was designed to test the efficacy of ursodeoxycholic acid in maternal pruritus, the biochemical abnormalities and the outcome of pregnancy, in patients with intrahepatic cholestasis of pregnancy of early onset. Pregnant patients hospitalized in a secondary case-referral center with intense pruritus and abnormal serum levels of bile salts and aminotransferases, detected before week 33 of pregnancy, were randomly assigned to receive ursodeoxycholic acid, 1 g per day orally, or an identical placebo, until delivery, in a double-blind study. A 3-week trial period was chosen to compare drug and placebo effects. The follow-up was extended for 3 months after delivery. Twenty-four patients entered the trial; eight had deliveries before 2 weeks of treatment and one dropped out. The study was then completed in 15 patients: eight received ursodeoxycholic acid and seven placebo. No adverse effects were detected in the mothers or in their babies. After 3 weeks of treatment, patients receiving ursodeoxycholic acid (mean daily dose 16 mg/kg body weight) had a significant improvement in pruritus (pursodeoxycholic acid (26.3+/-33.7 micromol/l vs 55.0+/-44.8, p N.S.). Deliveries occurred at or near term in all mothers who received ursodeoxycholic acid (mean week of pregnancy: 38), while they occurred before week 36 of pregnancy in five patients who received placebo, including one stillbirth. All babies born alive had birth weights adequate for gestational age and they were thriving normally 3 months after delivery. Ursodeoxycholic acid is effective and safe in patients with intrahepatic cholestasis of pregnancy of early onset, attenuating pruritus and correcting some biochemical abnormalities in the mothers. Relevant aspects of fetal outcome were also improved in patients receiving ursodeoxycholic acid

  1. A randomized prospective study of rehabilitation therapy in the treatment of radiation-induced dysphagia and trismus

    Energy Technology Data Exchange (ETDEWEB)

    Tang, Y.; Shen, Q.; Lu, K.; Peng, Y. [Sun Yat-sen Univ., Guangzhou (China). Dept. of Neurology; Wang, Y. [Sun Yat-sen Univ., Guangzhou (China). Dept. of Internal Medicine; Wang, Y. [Sun Yat-sen Univ., Guangzhou (China). Dept. of Neurosurgery

    2011-01-15

    Purpose: To evaluate the therapeutic effect of rehabilitation therapy on radiation-induced dysphagia and trismus in nasopharyngeal carcinoma (NPC) patients after radiotherapy. Patients and Methods: 43 NPC patients after radiotherapy were included. Patients were randomly assigned to either the rehabilitation group or a control group. Both groups were subjected to routine treatment, while the rehabilitation group also received rehabilitation therapy for 3 months. The severity of dysphagia was assessed using the water swallow test, while trismus was evaluated with the LENT/SOMA score and the interincisor distance (IID). The water swallow test, the LENT/SOMA score, as well as IID for both groups before and after treatment were analyzed and compared. Results: After treatment, the rehabilitation group displayed a significant improvement in swallowing function, while the control group did not. The efficacy rate (percentage of patients with excellent or effective results) of rehabilitation group was higher than that of control group (77% vs. 43%), and the difference was statistically significant ({chi}{sup 2} = 5.32, p = 0.02). IID pretreatment and posttreatment did not show much difference in the rehabilitation group, while in the control group IID significantly decreased posttreatment (1.1 {+-} 0.36 cm vs.1.8 {+-} 0.56 cm, p = 0.001). Although the mean IID in patients of both groups decreased after the 3 month follow-up, the decrease in the rehabilitation group was less than that of the control group (0.19 {+-} 0.5 cm vs. 0.69 {+-} 0.56 cm, p = 0.004). The efficacy rate of trismus in the rehabilitation group was significantly higher than that of the control group (64% vs. 28%, {chi}{sup 2} = 5.31, p = 0.02). Conclusions: Rehabilitation training can improve swallow function and slow down the progress of trismus in NPC patients following radiotherapy. (orig.)

  2. Serum proteomic changes after randomized prolonged erythropoietin treatment and/or endurance training: detection of novel biomarkers.

    Directory of Open Access Journals (Sweden)

    Britt Christensen

    Full Text Available Despite implementation of the biological passport to detect erythropoietin abuse, a need for additional biomarkers remains. We used a proteomic approach to identify novel serum biomarkers of prolonged erythropoiesis-stimulating agent (ESA exposure (Darbepoietin-α and/or aerobic training.Thirty-six healthy young males were randomly assigned to the following groups: Sedentary-placebo (n = 9, Sedentary-ESA (n = 9, Training-placebo (n = 10, or Training-ESA (n = 8. They were treated with placebo/Darbepoietin-α subcutaneously once/week for 10 weeks followed by a 3-week washout period. Training consisted of supervised biking 3/week for 13 weeks at the highest possible intensity. Serum was collected at baseline, week 3 (high dose Darbepoietin-α, week 10 (reduced dose Darbepoietin-α, and after a 3-week washout period.Serum proteins were separated according to charge and molecular mass (2D-gel electrophoresis. The identity of proteins from spots exhibiting altered intensity was determined by mass spectrometry.Six protein spots changed in response to Darbepoietin-α treatment. Comparing all 4 experimental groups, two protein spots (serotransferrin and haptoglobin/haptoglobin related protein showed a significant response to Darbepoietin-α treatment. The haptoglobin/haptoglobin related protein spot showed a significantly lower intensity in all subjects in the training-ESA group during the treatment period and increased during the washout period.An isoform of haptoglobin/haptoglobin related protein could be a new anti-doping marker and merits further research.ClinicalTrials.gov NCT01320449.

  3. A comparison of orthoses in the treatment of idiopathic toe walking: A randomized controlled trial.

    Science.gov (United States)

    Herrin, Kinsey; Geil, Mark

    2016-04-01

    Orthotic treatment of idiopathic toe walking is complicated by the lack of a known etiology. This study compared control of toe walking using an articulated ankle-foot orthosis versus a rigid carbon fiber footplate attached to a foot orthosis. Ascertain differences between two orthoses in the control of idiopathic toe walking. Randomized controlled trial. A total of 18 children with idiopathic toe walking were randomized to either the ankle-foot orthosis or foot orthosis treatment group in a Parallel Randomized Controlled Trial with no blinding. Prior to and after 6 weeks of treatment, participants completed three-dimensional gait assessment and the L-test of Functional Mobility. Parents completed a satisfaction survey and a subset of the Orthotic and Prosthetic User Survey after treatment. Nine participants were analyzed in each group. Both groups showed significant improvement in kinematics versus baseline with orthoses; however, when the orthoses were removed, the ankle-foot orthosis group did not immediately sustain this improvement, while the foot orthosis group did. Parents preferred the foot orthosis for donning and appearance. The ankle-foot orthosis controls idiopathic toe walking, but subjects may revert to earlier patterns following treatment. The foot orthosis does not control idiopathic toe walking as well but is less restrictive and more accepted by children and their parents, with similar out-of-brace effects. This study suggests that sequential orthotic treatment for children with idiopathic toe walking (ITW) may be beneficial. Initial treatment could include a less restrictive orthosis like a foot orthosis (FO); if this is unsuccessful within a set time frame, then the patient may require a more restrictive form of treatment such as an ankle-foot orthosis (AFO). © The International Society for Prosthetics and Orthotics 2015.

  4. Adverse Effects of Outcome Monitoring Feedback in Patients With Personality Disorders: A Randomized Controlled Trial in Day Treatment and Inpatient Settings.

    Science.gov (United States)

    de Jong, Kim; Segaar, Jaap; Ingenhoven, Theo; van Busschbach, Jan; Timman, Reinier

    2017-06-08

    This study aimed to evaluate the differential effect of outcome monitoring feedback to therapists and to patients on outcomes in cluster B, cluster C, and personality disorder not otherwise specified (PD-NOS) patients. Day treatment patients (n = 112) and inpatients (n = 94) were randomly assigned to a feedback to therapist (FbT), feedback to therapist and patient (FbTP), or no feedback (NFb) condition. Feedback was based on weekly administrations of the Outcome Questionnaire-45 (OQ-45). In cluster B and PD-NOS patients FbTP resulted in increased OQ-45 scores during the first 6 months of therapy for not on track (NOT) patients. In cluster C patients, no adverse effects of feedback were found. These results suggest that for certain personality disorder patient groups, providing feedback during treatment may not always be beneficial, although more research is needed to further assess these effects.

  5. Disease management in the treatment of patients with chronic heart failure who have universal access to health care: a randomized controlled trial.

    Science.gov (United States)

    Kalter-Leibovici, Ofra; Freimark, Dov; Freedman, Laurence S; Kaufman, Galit; Ziv, Arnona; Murad, Havi; Benderly, Michal; Silverman, Barbara G; Friedman, Nurit; Cukierman-Yaffe, Tali; Asher, Elad; Grupper, Avishay; Goldman, Dorit; Amitai, Miriam; Matetzky, Shlomi; Shani, Mordechai; Silber, Haim

    2017-05-01

    The efficacy of disease management programs in improving the outcome of heart failure patients remains uncertain and may vary across health systems. This study explores whether a countrywide disease management program is superior to usual care in reducing adverse health outcomes and improving well-being among community-dwelling adult patients with moderate-to-severe chronic heart failure who have universal access to advanced health-care services and technologies. In this multicenter open-label trial, 1,360 patients recruited after hospitalization for heart failure exacerbation (38%) or from the community (62%) were randomly assigned to either disease management or usual care. Disease management, delivered by multi-disciplinary teams, included coordination of care, patient education, monitoring disease symptoms and patient adherence to medication regimen, titration of drug therapy, and home tele-monitoring of body weight, blood pressure and heart rate. Patients assigned to usual care were treated by primary care practitioners and consultant cardiologists. The primary composite endpoint was the time elapsed till first hospital admission for heart failure exacerbation or death from any cause. Secondary endpoints included the number of all hospital admissions, health-related quality of life and depression during follow-up. Intention-to-treat comparisons between treatments were adjusted for baseline patient data and study center. During the follow-up, 388 (56.9%) patients assigned to disease management and 387 (57.1%) assigned to usual care had a primary endpoint event. The median (range) time elapsed until the primary endpoint event or end of study was 2.0 (0-5.0) years among patients assigned to disease management, and 1.8 (0-5.0) years among patients assigned to usual care (adjusted hazard ratio, 0.908; 95% confidence interval, 0.788 to 1.047). Hospital admissions were mostly (70%) unrelated to heart failure. Patients assigned to disease management had a better

  6. The ANTOP study: focal psychodynamic psychotherapy, cognitive-behavioural therapy, and treatment-as-usual in outpatients with anorexia nervosa - a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Schauenburg Henning

    2009-04-01

    Full Text Available Abstract Background Anorexia nervosa is a serious eating disorder leading to high morbidity and mortality as a result of both malnutrition and suicide. The seriousness of the disorder requires extensive knowledge of effective treatment options. However, evidence for treatment efficacy in this area is remarkably weak. A recent Cochrane review states that there is an urgent need for large, well-designed treatment studies for patients with anorexia nervosa. The aim of this particular multi-centre study is to evaluate the efficacy of two standardized outpatient treatments for patients with anorexia nervosa: focal psychodynamic (FPT and cognitive behavioural therapy (CBT. Each therapeutic approach is compared to a "treatment-as-usual" control group. Methods/Design 237 patients meeting eligibility criteria are randomly and evenly assigned to the three groups – two intervention groups (CBT and FPT and one control group. The treatment period for each intervention group is 10 months, consisting of 40 sessions respectively. Body weight, eating disorder related symptoms, and variables of therapeutic alliance are measured during the course of treatment. Psychotherapy sessions are audiotaped for adherence monitoring. The treatment in the control group, both the dosage and type of therapy, is not regulated in the study protocol, but rather reflects the current practice of established outpatient care. The primary outcome measure is the body mass index (BMI at the end of the treatment (10 months after randomization. Discussion The study design surmounts the disadvantages of previous studies in that it provides a randomized controlled design, a large sample size, adequate inclusion criteria, an adequate treatment protocol, and a clear separation of the treatment conditions in order to avoid contamination. Nevertheless, the study has to deal with difficulties specific to the psychopathology of anorexia nervosa. The treatment protocol allows for dealing with the

  7. Effect of occupational therapy on functional and emotional outcomes after hip fracture treatment: a randomized controlled trial.

    Science.gov (United States)

    Martín-Martín, Lydia M; Valenza-Demet, Gerald; Jiménez-Moleón, José Juan; Cabrera-Martos, Irene; Revelles-Moyano, Francisco Javier; Valenza, Marie Carmen

    2014-06-01

    To explore whether an occupational therapy intervention combined with physiotherapy rehabilitation improved hip fracture patient outcomes regarding emotional distress, fatigue, independence and function. Randomized controlled trial. Inpatient trauma ward in a rehabilitation and trauma hospital. One hundred and twenty-two patients admitted into hospital for hip fracture. Patients were randomly assigned to a standard care group (SC, n = 61) or a combined treatment group (CT, n = 61). The SC group received conventional hospital care for hip fracture patients and the CT group underwent occupational therapy as well. Patients' emotional distress (GHQ-28), perceived fatigue (the first item of the BASDAI using a 0-100 visual analogue scale scale), level of independence (Modified Barthel Index) and function (Harris Hip Score) were measured at baseline and one, three and six months after the intervention. Patients in the CT group experienced a considerable decrease of emotional distress at three and six months (p = 0.005 and p < 0.001, respectively). A between-group analysis showed significant differences in emotional distress at one, three and six months (p < 0.001). Although fatigue levels decreased in the SC group, the most significant decline was reported by the CT group at six months (p < 0.001, mean difference = 14 points). Regarding independence level, significant differences were found within groups at each stage, but also between groups at one month in favor of the CT group. Function improved in both groups compared with baseline (p < 0.001), but no significant differences were found in functionality between groups. Although both groups reported significant improvements, patients in the CT group had better scores in emotional distress and dependence throughout follow-up and better scores in all measures at six months. © The Author(s) 2013.

  8. Long-term clinical effect of adjunctive antimicrobial photodynamic therapy in periodontal treatment: a randomized clinical trial.

    Science.gov (United States)

    Alwaeli, Haider A; Al-Khateeb, Susan N; Al-Sadi, Amani

    2015-02-01

    Mechanical removal of microbial biofilm dental plaque from tooth surfaces is important for treatment of periodontal diseases. However, the effectiveness of conventional scaling and root planing (SRP) is affected by the local conditions and residual bacteria which may affect the healing process. We performed a randomized clinical trial to test our hypothesis that adjunctive antimicrobial photodynamic therapy (aPDT) plus SRP has significant effect compared with SRP alone, which can last for 1 year. The study included 136 sites in 16 patients with previously untreated chronic periodontitis, at least one premolar and one molar in every quadrant (minimum, four teeth/quadrant) and at least one tooth with attachment loss of ≥4 mm in every quadrant. In all patients, two randomly assigned quadrants were treated with SRP and the other two were treated with SRP + aPDT. The clinical parameters of probing pocket depth (PPD), bleeding on probing (BOP), and clinical attachment level (CAL) were evaluated at baseline and after 3, 6, and 12 months. There were no significant differences between the two groups at baseline. PPD and BOP showed significant reduction, and CAL showed significant gain from baseline for all three time points in both groups. In addition, there were significantly greater reduction and gain for SRP + aPDT than for SRP at all three time points. No adverse effects of aPDT were observed. These data demonstrate significant improvement in all evaluated clinical parameters for at least 1 year and suggest that aPDT as an adjunctive therapy to SRP represents a promising therapeutic concept for persistent periodontitis.

  9. A Randomized, Controlled Proof-of-Concept Trial of an Internet-Based, Therapist-Assisted Self-Management Treatment for Posttraumatic Stress Disorder

    National Research Council Canada - National Science Library

    Bryant, Richard A; Engel, Charles C; Litz, Brett T; Papa, Anthony

    2007-01-01

    ... counseling for posttraumatic stress disorder (PTSD). Method: Service members with PTSD from the attack on the Pentagon on September 11th or the Iraq War were randomly assigned to self-management cognitive behavior therapy (N=24...

  10. Pilot randomized double-blind trial of treatment of Mycobacterium ulcerans disease (Buruli ulcer) with topical nitrogen oxides.

    Science.gov (United States)

    Phillips, R; Adjei, O; Lucas, S; Benjamin, N; Wansbrough-Jones, M

    2004-08-01

    Mycobacterium ulcerans disease (Buruli ulcer) is a serious ulcerating skin disease which is common in many tropical countries. Standard treatment, by extensive excision and skin grafting, is not available in rural communities where the disease is common. We evaluated the efficacy and safety of treatment with topical nitrogen oxides. Thirty-seven patients with a clinical diagnosis of Buruli ulcer caused by M. ulcerans disease were randomly assigned to one of two groups. In one group, two creams containing sodium nitrite (6%, wt/wt) or citric acid monohydrate (9%, wt/wt) were applied daily for 6 weeks, while the other group received a placebo. In the second 6 weeks, both groups received the nitrogen oxide-generating combination of creams. Treatment was continued for another 4 weeks for patients whose ulcers were not healed after 12 weeks. The ulcer surface area was monitored by weekly tracings made by assessors blinded to the treatment. In the first 6 weeks, patients on sodium nitrite and citric acid monohydrate (group I, active treatment) showed a rapid decrease in ulcer size from 28.6 +/- 5.6 cm2 (mean +/- standard error) to 12.6 +/- 3.2 cm2, a decrease significantly greater than that in group II (from 15.3 +/- 3.1 to 11.7 +/- 3.7 cm2; P = 0.03). Five ulcers in the placebo group enlarged during this period, compared with one in the active group. In the second 6 weeks (both groups on active treatment), the rates of healing were similar for the two groups and there was a significant reduction in ulcer size in group II (previously on placebo) compared to the first 6 weeks. Yellow pigmentation of the skin, which disappeared 3 days after treatment was stopped, was the only side effect to date. We conclude that creams releasing nitrogen oxides increase the healing rate of ulcers caused by M. ulcerans infection with minimal adverse events. This is the first controlled trial of any form of therapy which demonstrates efficacy in treating this disease.

  11. Quality of life and costs of levonorgestrel-releasing intrauterine system or hysterectomy in the treatment of menorrhagia: a 10-year randomized controlled trial.

    Science.gov (United States)

    Heliövaara-Peippo, Satu; Hurskainen, Ritva; Teperi, Juha; Aalto, Anna-Mari; Grénman, Seija; Halmesmäki, Karoliina; Jokela, Markus; Kivelä, Aarre; Tomás, Eija; Tuppurainen, Marjo; Paavonen, Jorma

    2013-12-01

    Menorrhagia is a common problem impairing the quality of life (QOL) of many women. Both levonorgestrel-releasing intrauterine system (LNG-IUS) and hysterectomy are effective treatment modalities but no long-term comparative studies of QOL and costs exist. The objective of this study was to compare QOL and costs of LNG-IUS or hysterectomy in the treatment of menorrhagia during 10-year follow-up. A total of 236 women, aged 35-49 years, referred for menorrhagia to 5 university hospitals in Finland were randomly assigned to treatment with LNG-IUS (n = 119) or hysterectomy (n = 117) and were monitored for 10 years. The main outcome measures were health-related QOL (HRQOL), psychosocial well-being, and cost-effectiveness. A total of 221 (94%) women were followed for 10 years. Although 55 (46%) women assigned to the LNG-IUS subsequently underwent hysterectomy, the overall costs in the LNG-IUS group ($3423) were substantially lower than in the hysterectomy group ($4937). Overall, levels of HRQOL and psychosocial well-being improved during first 5 years but diminished between 5 years and 10 years and the improved HRQOL returned close to the baseline level. There were no significant differences between LNG-IUS and hysterectomy groups. Both LNG-IUS and hysterectomy improved HRQOL. The improvement was most striking during the first 5 years. Although many women eventually had hysterectomy, LNG-IUS remained cost-effective. Copyright © 2013 Mosby, Inc. All rights reserved.

  12. Testing the leadership and organizational change for implementation (LOCI) intervention in substance abuse treatment: a cluster randomized trial study protocol.

    Science.gov (United States)

    Aarons, Gregory A; Ehrhart, Mark G; Moullin, Joanna C; Torres, Elisa M; Green, Amy E

    2017-03-03

    Evidence-based practice (EBP) implementation represents a strategic change in organizations that requires effective leadership and alignment of leadership and organizational support across organizational levels. As such, there is a need for combining leadership development with organizational strategies to support organizational climate conducive to EBP implementation. The leadership and organizational change for implementation (LOCI) intervention includes leadership training for workgroup leaders, ongoing implementation leadership coaching, 360° assessment, and strategic planning with top and middle management regarding how they can support workgroup leaders in developing a positive EBP implementation climate. This test of the LOCI intervention will take place in conjunction with the implementation of motivational interviewing (MI) in 60 substance use disorder treatment programs in California, USA. Participants will include agency executives, 60 program leaders, and approximately 360 treatment staff. LOCI will be tested using a multiple cohort, cluster randomized trial that randomizes workgroups (i.e., programs) within agency to either LOCI or a webinar leadership training control condition in three consecutive cohorts. The LOCI intervention is 12 months, and the webinar control intervention takes place in months 1, 5, and 8, for each cohort. Web-based surveys of staff and supervisors will be used to collect data on leadership, implementation climate, provider attitudes, and citizenship. Audio recordings of counseling sessions will be coded for MI fidelity. The unit of analysis will be the workgroup, randomized by site within agency and with care taken that co-located workgroups are assigned to the same condition to avoid contamination. Hierarchical linear modeling (HLM) will be used to analyze the data to account for the nested data structure. LOCI has been developed to be a feasible and effective approach for organizations to create a positive climate and

  13. Adjunctive treatment with transcranial magnetic stimulation in treatment resistant depression: a randomized, double-blind, sham-controlled study

    Directory of Open Access Journals (Sweden)

    Qiang LIU

    2011-02-01

    Full Text Available Background: High-frequency repetitive transcranial magnetic stimulation (rTMS to the left prefrontal cortex is a promising antidepressant treatment but the appropriate duration of treatment andits effect on cognitive symptoms in treatment resistant patients is uncertain.Hypotheis: Patients with treatment resistant depression on standard antidepressant medication who receive four weeks of adjunctive treatment with high-frequency rTMS to the left prefrontal cortex will have better clinical outcomes and better cognitive functioning than those who receive sham rTMS treatments.Methods: Thirty patients with treatment resistant depression (defined as failure to respond to two or more antidepressants of different classes administered for at least 6 weeks at or above two-thirds of the recommended maximum dose receiving selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors wererandomly assigned to receive adjundive treatment with either real rTMS (n=15 or sham rTMS (n=15 5 times a week for 4 conseculive weeks. Blinded pre-post evaluations were conducted using the 17-item Hamilton Depression Rating Scale (HAMD, the Montgomery-Asberg Depression Rating Scale (MADRS, the severity of illness measure from the Clinical Global Impression Rating scale(CGI-S, the Wechsler Adult Intelligence ScaIe (WAIS, the Wechsler Memory Scale (WMS, and the Wisconsjn Card Sorting Test(WC5T.Results:14 subjects from each group completed the study. There was no significant difference in the HAMD total scores between the two groups after 2 weeks of treatment but after 4 weeks of treatment the mean percentage drop in the HAMD total score was significantly greater in the real rTMS group (49%, SD=19% than in the sham rTMS group(29%, SD=25%, with a mean difference of 20% [95%CI=3%-37%;t26=2.42; P=0.023]. At 4 weeks the mean (SD reduction in the MADRS total score was also greater in the real rTMS group [47%(23% vs 16%(40

  14. A randomized controlled trial of Minnesota day clinic treatment of alcoholics

    DEFF Research Database (Denmark)

    Grønbaek, Morten; Nielsen, Bent

    2007-01-01

    dependence were included in a 1-year clinical trial. MEASUREMENTS: Self-reported drinking pattern and the seven composite scores from the addiction severity index (ASI). FINDINGS: A total of 42 (57%) and 45 (61%) patients (P > 0.05) completed the Minnesota treatment and public treatment, respectively......AIM: To compare the Minnesota day clinic treatment with the traditional public psychosocial treatment. DESIGN: Randomized controlled trial. SETTING: Public out-patient alcohol clinic and privately funded Minnesota day clinic in Denmark. PARTICIPANTS: A total of 148 individuals with alcohol......% of the patients treated according to the Minnesota model were abstainers, while this was the case for 43% of the patients treated in the public out-patient alcohol clinic (P = 0.249). There were insignificant differences in the seven ASI scores. CONCLUSIONS: Twelve months after onset of treatment, the Minnesota...

  15. A practical guide and power analysis for GLMMs: detecting among treatment variation in random effects.

    Science.gov (United States)

    Kain, Morgan P; Bolker, Ben M; McCoy, Michael W

    2015-01-01

    In ecology and evolution generalized linear mixed models (GLMMs) are becoming increasingly used to test for differences in variation by treatment at multiple hierarchical levels. Yet, the specific sampling schemes that optimize the power of an experiment to detect differences in random effects by treatment/group remain unknown. In this paper we develop a blueprint for conducting power analyses for GLMMs focusing on detecting differences in variance by treatment. We present parameterization and power analyses for random-intercepts and random-slopes GLMMs because of their generality as focal parameters for most applications and because of their immediate applicability to emerging questions in the field of behavioral ecology. We focus on the extreme case of hierarchically structured binomial data, though the framework presented here generalizes easily to any error distribution model. First, we determine the optimal ratio of individuals to repeated measures within individuals that maximizes power to detect differences by treatment in among-individual variation in intercept, among-individual variation in slope, and within-individual variation in intercept. Second, we explore how power to detect differences in target variance parameters is affected by total variation. Our results indicate heterogeneity in power across ratios of individuals to repeated measures with an optimal ratio determined by both the target variance parameter and total sample size. Additionally, power to detect each variance parameter was low overall (in most cases >1,000 total observations per treatment needed to achieve 80% power) and decreased with increasing variance in non-target random effects. With growing interest in variance as the parameter of inquiry, these power analyses provide a crucial component for designing experiments focused on detecting differences in variance. We hope to inspire novel experimental designs in ecology and evolution investigating the causes and implications of

  16. Improving insomnia in primary care patients: A randomized controlled trial of nurse-led group treatment.

    Science.gov (United States)

    Sandlund, Christina; Hetta, Jerker; Nilsson, Gunnar H; Ekstedt, Mirjam; Westman, Jeanette

    2017-07-01

    Insomnia is a common health problem, and most people who seek help for insomnia consult primary care. In primary care, insomnia treatment typically consists of hypnotic drugs, although cognitive behavioral therapy for insomnia is the recommended treatment. However, such treatment is currently available to few primary care patients. To evaluate the effects of a group treatment program for insomnia led by nurses in primary care. were the Insomnia Severity Index, a 2-week sleep diary, and a questionnaire on frequency of hypnotic drug use. A randomized controlled trial with pre- and post-treatment assessment and a 1-year post-treatment follow-up of the intervention group. Routine primary health care; 7 primary care centers in Stockholm, Sweden. Patients consulting primary care for insomnia were assessed for eligibility. To be included, patients had to have insomnia disorder and be 18 years or older. Patients were excluded if they if they worked night shifts or had severe untreated somatic and/or mental illness, bipolar disorder, or untreated sleep disorder other than insomnia. One-hundred and sixty-five patients 20 to 90 years were included. Most were women, and many had co-existing somatic and/or mental health problems. The post-treatment dropout rate was 20%. The intervention was a nurse-led group treatment for insomnia based on the techniques of cognitive behavioral therapy for insomnia. The nurses had 2days of training in how to deliver the program. Ninety patients were randomized to the intervention and 75 to the control group (treatment as usual). Data from 82 in the intervention and 71 in the control group were analyzed in accordance with intention-to-treat principles. Fifty-four of the 72 in the intervention group who participated in the group treatment program were followed up after 1year. Mean Insomnia Severity Index score decreased significantly from 18.4 to 10.7 after group treatment but remained unchanged after treatment as usual (17.0 to 16.6). The effect

  17. A double-blind, randomized trial of IV immunoglobulin treatment in acute optic neuritis

    DEFF Research Database (Denmark)

    Roed, H.G; Langkilde, Annika Reynberg; Sellebjerg, F

    2005-01-01

    -four patients were randomized to IVIG 0.4 g/kg body wt, and 34 patients were randomized to placebo. Infusions were given at days 0, 1, 2, 30, and 60. Contrast sensitivity, visual acuity, and color vision were measured at baseline and after 1 week, 1 month, and 6 months. Pattern reversal visual evoked potential......OBJECTIVE: To investigate if IV immunoglobulin (IVIG) treatment in the acute phase of optic neuritis (ON) could improve visual outcome and reduce MRI disease activity 6 months after onset of ON. METHODS: Sixty-eight patients with ON were randomized within 4 weeks from onset of symptoms. Thirty....... In addition, there was no significant difference in the secondary outcome measures, improvement in the visual function measures and MRI, at any time during follow-up. At baseline, a significantly higher number of patients in the IVIG group had one or more enhancing lesions on MRI and IVIG-treated patients had...

  18. Symptomatic treatment of the common cold with a fixed-dose combination of paracetamol, chlorphenamine and phenylephrine: a randomized, placebo-controlled trial.

    Science.gov (United States)

    Picon, Paulo Dornelles; Costa, Marisa Boff; da Veiga Picon, Rafael; Fendt, Lucia Costa Cabral; Suksteris, Maurício Leichter; Saccilotto, Indara Carmanim; Dornelles, Alicia Dorneles; Schmidt, Luis Felipe Carissimi

    2013-11-22

    The common cold and other viral airway infections are highly prevalent in the population, and their treatment often requires the use of medications for symptomatic relief. Paracetamol is as an analgesic and antipyretic; chlorphenamine is an antihistamine; and phenylephrine, a vasoconstrictor and decongestant. This randomized, double-blind, placebo-controlled trial sought to evaluate the efficacy and safety of a fixed-dose combination of paracetamol, chlorphenamine and phenylephrine in the symptomatic treatment of the common cold and flu-like syndrome in adults. This study enrolled 146 individuals aged 18 to 60 years who had moderate to severe flu-like syndrome or common cold. After clinical examination and laboratory tests, individuals were randomly assigned to receive the fixed-dose combination (73) or placebo (73), five capsules per day for 48 to 72 hours. The primary efficacy endpoint was the sum of the scores of 10 symptoms on a four-point Likert-type scale. To evaluate treatment safety, the occurrence of adverse events was also measured. Mean age was 33.5 (±9.5) years in the placebo group and 33.8 (±11.5) in the treatment group. There were 55 women and 18 men in the placebo group, and 46 women and 27 men in the treatment group. Comparison of overall symptom scores in the two groups revealed a significantly greater reduction in the treatment group than in the placebo group (p = 0.015). Analysis at the first 13 dose intervals (± 66 h of treatment) showed a greater reduction of symptom scores in the treatment group than in the placebo group (p paracetamol, chlorphenamine and phenylephrine was safe and more effective than placebo in the symptomatic treatment of the common cold or flu-like syndrome in adults. NCT01389518.

  19. The effect of three-monthly albendazole treatment on malarial parasitemia and allergy: a household-based cluster-randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Wiria, Aprilianto E; Hamid, Firdaus; Wammes, Linda J; Kaisar, Maria M M; May, Linda; Prasetyani, Margaretta A; Wahyuni, Sitti; Djuardi, Yenny; Ariawan, Iwan; Wibowo, Heri; Lell, Bertrand; Sauerwein, Robert; Brice, Gary T; Sutanto, Inge; van Lieshout, Lisette; de Craen, Anton J M; van Ree, Ronald; Verweij, Jaco J; Tsonaka, Roula; Houwing-Duistermaat, Jeanine J; Luty, Adrian J F; Sartono, Erliyani; Supali, Taniawati; Yazdanbakhsh, Maria

    2013-01-01

    Helminth infections are proposed to have immunomodulatory activities affecting health outcomes either detrimentally or beneficially. We evaluated the effects of albendazole treatment, every three months for 21 months, on STH, malarial parasitemia and allergy. A household-based cluster-randomized, double-blind, placebo-controlled trial was conducted in an area in Indonesia endemic for STH. Using computer-aided block randomization, 481 households (2022 subjects) and 473 households (1982 subjects) were assigned to receive placebo and albendazole, respectively, every three months. The treatment code was concealed from trial investigators and participants. Malarial parasitemia and malaria-like symptoms were assessed in participants older than four years of age while skin prick test (SPT) to allergens as well as reported symptoms of allergy in children aged 5-15 years. The general impact of treatment on STH prevalence and body mass index (BMI) was evaluated. Primary outcomes were prevalence of malarial parasitemia and SPT to any allergen. Analysis was by intention to treat. At 9 and 21 months post-treatment 80.8% and 80.1% of the study subjects were retained, respectively. The intensive treatment regiment resulted in a reduction in the prevalence of STH by 48% in albendazole and 9% in placebo group. Albendazole treatment led to a transient increase in malarial parasitemia at 6 months post treatment (OR 4.16(1.35-12.80)) and no statistically significant increase in SPT reactivity (OR 1.18(0.74-1.86) at 9 months or 1.37 (0.93-2.01) 21 months). No effect of anthelminthic treatment was found on BMI, reported malaria-like- and allergy symptoms. No adverse effects were reported. The study indicates that intensive community treatment of 3 monthly albendazole administration for 21 months over two years leads to a reduction in STH. This degree of reduction appears safe without any increased risk of malaria or allergies. Controlled-Trials.com ISRCTN83830814.

  20. Guided internet cognitive behavioral therapy for insomnia compared to a control treatment - A randomized trial.

    Science.gov (United States)

    Kaldo, Viktor; Jernelöv, Susanna; Blom, Kerstin; Ljótsson, Brjánn; Brodin, Maria; Jörgensen, Mia; Kraepelien, Martin; Rück, Christian; Lindefors, Nils

    2015-08-01

    To evaluate if internet-delivered Cognitive Behavioral Therapy for insomnia (ICBT-i) with brief therapist support outperforms an active control treatment. Adults diagnosed with insomnia were recruited via media (n = 148) and randomized to either eight weeks of ICBT-i or an active internet-based control treatment. Primary outcome was the insomnia severity index (ISI) assessed before and after treatment, with follow-ups after 6 and 12 months. Secondary outcomes were use of sleep medication, sleep parameters (sleep diary), perceived stress, and a screening of negative treatment effects. Hierarchical Linear Mixed Models were used for intent-to-treat analyses and handling of missing data. ICBT-i was significantly more effective than the control treatment in reducing ISI (Cohen's d = 0.85), sleep medication, sleep efficiency, sleep latency, and sleep quality at post-treatment. The positive effects were sustained. However, after 12 months the difference was no longer significant due to a continuous decrease in ISI among controls, possibly due to their significantly higher utilization of insomnia relevant care after treatment. Forty-six negative effects were reported but did not differ between interventions. Supported ICBT-i is more effective than an active control treatment in reducing insomnia severity and treatment gains remain stable one year after treatment. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

  1. Non-invasive treatment to grade 1 essential hypertension by percutaneous laser and electric pulse to acupoint with music: A randomized controlled trial.

    Science.gov (United States)

    Zhan, Hong-Rui; Hong, Zhong-Si; Chen, Yi-Shen; Hong, Hai-Yu; Weng, Ze-Bin; Yang, Zhang-Bin; Shi, Jing-Li; Chen, Zhong-Ben

    2016-09-01

    To study a non-drug therapy for hypertension disease by combining percutaneous laser and electric pulse stimulation to acupoint with music, and to test the efficiency of the combining treatment to grade 1 essential hypertension. A total of 174 patients with grade 1 essential hypertension were randomly assigned to 3 groups with a random number table after Chinese medicine (CM) syndrome differentiation: the photoelectric and musical treatment group (Group 1, with a self-developed multi-mode audio frequency pulse photoelectric therapeutic apparatus), acupuncture group (Group 2), and oral placebo group (Group 3), 58 cases per group. The curative effect of each group was evaluated by the changes of blood pressure and CM syndrome integral before and after treatment. Compared with Group 3, there were significant decrease of blood pressure and CM syndrome integral in Group 1 and Group 2 (P0.05). The multi-mode audio frequency pulse photoelectric therapeutic apparatus, combining music, laser and electric pulse stimulation, is clinically useful for grade 1 essential hypertension. This "three in one" therapy method is non-invasive, easy and simple to handle. It is expected to be popularized as a new alternative treatment.

  2. Comparative Evaluation of Tacrolimus Versus Interferon Alpha-2b Eye Drops in the Treatment of Vernal Keratoconjunctivitis: A Randomized, Double-Masked Study.

    Science.gov (United States)

    Zanjani, Habibollah; Aminifard, Mohammad Naim; Ghafourian, Abdolhossein; Pourazizi, Mohsen; Maleki, Alireza; Arish, Mohammed; Shahrakipoor, Mahnaz; Rohani, Mohammad Reza; Abrishami, Mojtaba; Khafri Zare, Ehsan; Barzegar Jalali, Farhad

    2017-06-01

    Vernal keratoconjunctivitis (VKC) is a bilateral, chronic, external ocular inflammatory disorder that mainly affects patients in their first or second decade. This study was designed to compare tacrolimus and interferon alpha-2b (IFN alpha-2b) eye drops in the treatment of VKC. In this randomized, double-masked clinical trial, 40 consecutive patients with VKC were sent to a referral eye hospital in a tropical region southeast of Iran. Patients were randomly assigned to receive either 0.005% tacrolimus or IFN alpha-2b (1,000,000 units/cc). Chi-square and t tests were used for comparison of outcomes between both groups. Mean ± SD age was 11.1 ± 5.2 years. Thirty-one patients (77.5%) were male. The mean duration of disease was 3.4 ± 2.9 years. In this study, the signs and symptoms were significantly reduced in patients after treatment in both groups (P = 0.0001). In the tacrolimus group, all patients responded to treatment whereas only one subject in the IFN group failed to respond (P = 0.99). Side effects in both groups were mild and tolerable. This study indicated that both 0.005% tacrolimus and IFN alpha-2b are effective and appear to be safe in treatment of recalcitrant VKC.

  3. A European multicenter randomized double-blind placebo-controlled monotherapy clinical trial of milnacipran in treatment of fibromyalgia

    DEFF Research Database (Denmark)

    Branco, Jaime C; Zachrisson, Olof; Perrot, Serge

    2010-01-01

    This randomized, double-blind, placebo-controlled, multicenter study investigated the efficacy and safety of milnacipran in the treatment of fibromyalgia (FM) in a European population.......This randomized, double-blind, placebo-controlled, multicenter study investigated the efficacy and safety of milnacipran in the treatment of fibromyalgia (FM) in a European population....

  4. Impact of attention-deficit/hyperactivity disorder (ADHD) treatment on smoking cessation intervention in ADHD smokers: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Winhusen, Theresa M; Somoza, Eugene C; Brigham, Gregory S; Liu, David S; Green, Carla A; Covey, Lirio S; Croghan, Ivana T; Adler, Lenard A; Weiss, Roger D; Leimberger, Jeffrey D; Lewis, Daniel F; Dorer, Emily M

    2010-12-01

    High smoking rates in adults with attention-deficit/hyperactivity disorder (ADHD) and nicotine's amelioration of ADHD suggest that effective ADHD treatment might facilitate abstinence in smokers with ADHD. The present study evaluated if using osmotic-release oral system methylphenidate (OROS-MPH) to treat ADHD enhances response to smoking cessation treatment in smokers with ADHD. A randomized, double-blind, placebo-controlled, 11-week trial with a 1-month follow-up was conducted at 6 clinical sites between December 2005 and January 2008. Adults (aged 18-55 years) meeting DSM-IV criteria for ADHD and interested in quitting smoking were randomly assigned to OROS-MPH titrated to 72 mg/d (n = 127) or placebo (n = 128). All participants received brief weekly individual smoking cessation counseling for 11 weeks and 21 mg/d nicotine patches starting on the smoking quit day (day 27) through study week 11. Outcome measures included prolonged smoking abstinence and DSM-IV ADHD Rating Scale (ADHD-RS) score. Of 255 randomly assigned participants, 204 (80%) completed the trial. Prolonged abstinence rates, 43.3% and 42.2%, for the OROS-MPH and placebo groups, respectively, did not differ significantly (OR = 1.1; 95% CI, 0.63-1.79; P = .81). Relative to placebo, OROS-MPH evidenced a greater reduction in DSM-IV ADHD-RS score (P ADHD did not improve smoking cessation success; OROS-MPH, relative to placebo, effectively treated ADHD and was safe and generally well tolerated in this healthy sample of adult ADHD smokers. clinical trials.gov Identifier: NCT00253747. © Copyright 2010 Physicians Postgraduate Press, Inc.

  5. Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects: The PROMOTE Study A Randomized Controlled Trial

    Science.gov (United States)

    HENSEL, Kendi L.; BUCHANAN, Steve; BROWN, Sarah K.; RODRIGUEZ, Mayra; CRUSER, des Anges

    2014-01-01

    Objective To evaluate the efficacy of Osteopathic Manipulative Treatment (OMT) to reduce low back pain and improve functioning during the third trimester in pregnancy and improve selected outcomes of labor and delivery. Study Design PROMOTE was a randomized, placebo-controlled trial of 400 women in their third trimester. Women were randomized to usual care only (UCO), usual care plus OMT (OMT), or usual care plus placebo ultrasound treatment (PUT). The study included seven treatments over nine weeks. The OMT protocol included specific techniques administered by board-certified OMT specialists. Outcomes were assessed using self-report measures for pain and back-related functioning, and medical records for delivery outcomes. Results There were 136 women in the OMT group, 131 in PUT, and 133 in UCO. Characteristics at baseline were similar across groups. Findings indicate significant treatment effects for pain and back related functioning (P<.001 for both), with outcomes for the OMT group similar to that of the PUT, but both groups were significantly improved compared to UCO. For secondary outcome of meconium- stained amniotic fluid there were no differences between the groups. Conclusion OMT was effective for mitigating pain and functional deterioration compared to the UCO group; however OMT did not differ significantly from PUT. This may be attributed to PUT being a more active treatment than intended. There was no higher likelihood of conversion to high risk status based on treatment group. Therefore, OMT is a safe, effective adjunctive modality to improve pain and functioning during their third trimester. PMID:25068560

  6. Robustness and Optimal Design Issues for Cluster Randomized Trials

    NARCIS (Netherlands)

    Korendijk, E.|info:eu-repo/dai/nl/072035463

    2012-01-01

    Cluster randomized trials (CRT), in which whole clusters instead of individuals are assigned to conditions, are not uncommon in the social, behavioral, educational, medical and organizational sciences. Though the assignment of individuals to treatment conditions is more efficient, this may not

  7. Effects of a manualized short-term treatment of internet and computer game addiction (STICA): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Jäger, Susanne; Müller, Kai W; Ruckes, Christian; Wittig, Tobias; Batra, Anil; Musalek, Michael; Mann, Karl; Wölfling, Klaus; Beutel, Manfred E

    2012-04-27

    In the last few years, excessive internet use and computer gaming have increased dramatically. Salience, mood modification, tolerance, withdrawal symptoms, conflict, and relapse have been defined as diagnostic criteria for internet addiction (IA) and computer addiction (CA) in the scientific community. Despite a growing number of individuals seeking help, there are no specific treatments of established efficacy. This clinical trial aims to determine the effect of the disorder-specific manualized short-term treatment of IA/CA (STICA). The cognitive behavioural treatment combines individual and group interventions with a total duration of 4 months. Patients will be randomly assigned to STICA treatment or to a wait list control group. Reliable and valid measures of IA/CA and co-morbid mental symptoms (for example social anxiety, depression) will be assessed prior to the beginning, in the middle, at the end, and 6 months after completion of treatment. A treatment of IA/CA will establish efficacy and is desperately needed. As this is the first trial to determine efficacy of a disorder specific treatment, a wait list control group will be implemented. Pros and cons of the design were discussed. ClinicalTrials (NCT01434589).

  8. Effects of a manualized short-term treatment of internet and computer game addiction (STICA: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Jäger Susanne

    2012-04-01

    Full Text Available Abstract Background In the last few years, excessive internet use and computer gaming have increased dramatically. Salience, mood modification, tolerance, withdrawal symptoms, conflict, and relapse have been defined as diagnostic criteria for internet addiction (IA and computer addiction (CA in the scientific community. Despite a growing number of individuals seeking help, there are no specific treatments of established efficacy. Methods/design This clinical trial aims to determine the effect of the disorder-specific manualized short-term treatment of IA/CA (STICA. The cognitive behavioural treatment combines individual and group interventions with a total duration of 4 months. Patients will be randomly assigned to STICA treatment or to a wait list control group. Reliable and valid measures of IA/CA and co-morbid mental symptoms (for example social anxiety, depression will be assessed prior to the beginning, in the middle, at the end, and 6 months after completion of treatment. Discussion A treatment of IA/CA will establish efficacy and is desperately needed. As this is the first trial to determine efficacy of a disorder specific treatment, a wait list control group will be implemented. Pros and cons of the design were discussed. Trial Registration ClinicalTrials (NCT01434589

  9. Conservative treatment, plate fixation, or prosthesis for proximal humeral fracture. A prospective randomized study

    Directory of Open Access Journals (Sweden)

    Launonen Antti P

    2012-09-01

    Full Text Available Abstract Background Proximal humerus fracture is the third most common fracture type after hip and distal radius fracture in elderly patients. A comprehensive study by Palvanen et al. demonstrated an increase in the annual fracture rate of 13.7% per year over the past 33 years. Should this trend continue, the fracture rate would triple over the next three decades. The increasing incidence of low-energy fractures raises questions about the optimal treatment in terms of functional outcome, pain, and rehabilitation time, as well as the economical impact. Despite the high incidence and costs of proximal humerus fractures, there is currently no valid scientific evidence for the best treatment method. Several publications, including a Cochrane review outline the need for high-quality, well-designed randomized controlled trials. Methods/Design The study is a prospective, randomized, national multi-center trial. The hypothesis of the trial is that surgical treatment of displaced proximal humerus fractures achieves better functional outcome, pain relief, and patient satisfaction compared to conservative treatment. The trial is designed to compare conservative and surgical treatment of proximal humerus fractures in patients 60 years and older. The trial includes two strata. Stratum I compares surgical treatment with locking plates to conservative treatment for two-part fractures. Stratum II compares multi-fragmented fractures, including three- and four-part fractures. The aim of Stratum II is to compare conservative treatment, surgical treatment with the Philos locking plate, and hemiarthroplasty with an Epoca prosthesis. The primary outcome measure will be the Disabilities of the Arm, Shoulder and Hand (DASH score and the secondary outcome measures will be the EuroQol-5D (EQ-5D value, OSS, Constant-Murley Score, VAS, and 15D. Recruiting time will be 3 years. The results will be analyzed after the 2-year follow-up period. Discussion This publication

  10. Parents' and Adolescents' Preferences for Intensified or Reduced Treatment in Randomized Lymphoblastic Leukemia Trials

    DEFF Research Database (Denmark)

    Tulstrup, Morten; Larsen, Hanne Bækgaard; Castor, Anders

    2015-01-01

    BACKGROUND: When offered participation in clinical trials, families of children with cancer face a delicate balance between cure and toxicity. Since parents and children may perceive this balance differently, this paper explores whether adolescent patients have different enrollment patterns...... compared to younger children in trials with different toxicity profiles. PROCEDURE: Age-dependent participation rates in three consecutive, randomized childhood leukemia trials conducted by the Nordic Society of Paediatric Haematology and Oncology were evaluated. The ALL2000 dexamethasone/vincristine (Dx....../VCR) trial tested treatment intensifications to improve cure, and the back-to-back ALL2008 6-mercaptopurine (6MP) and ALL2008 PEG-asparaginase (ASP) trials tested treatment intensifications (6MP) and toxicity reduction without compromising survival (ASP). Patient randomization and toxicity data were...

  11. Vasopressin vs Dopamine for Treatment of Hypotension in ELBW Infants: A Randomized, Blinded Pilot Study

    Science.gov (United States)

    Rios, Danielle R.; Kaiser, Jeffrey R.

    2015-01-01

    Objective To evaluate vasopressin vs dopamine as initial therapy in ELBW infants with hypotension during the first 24 hours of life. Study design Hypotensive ELBW infants ≤ 30 weeks’ gestation and ≤ 24 hours old randomly received treatment with vasopressin or dopamine in a blinded fashion. Normotensive infants not receiving vasopressor support served as a comparison group. Results Twenty hypotensive ELBW infants received vasopressin (n=10) or dopamine (n=10), and 50 were enrolled for comparison. Mean gestational age was 25.6 ± 1.4 weeks and birth weight 705 ± 154 g. Response to vasopressin paralleled that of dopamine in time to adequate mean BP (Kaplan-Meier curve, p=0.986); 90% of infants in each treatment group responded with adequate BP. The vasopressin group received fewer doses of surfactant (phypotension appeared safe. This pilot study supports a larger randomized controlled trial of vasopressin vs dopamine therapy in ELBW infants with hypotension. PMID:25641242

  12. The pursuit of balance: An overview of covariate-adaptive randomization techniques in clinical trials.

    Science.gov (United States)

    Lin, Yunzhi; Zhu, Ming; Su, Zheng

    2015-11-01

    Randomization is fundamental to the design and conduct of clinical trials. Simple randomization ensures independence among subject treatment assignments and prevents potential selection biases, yet it does not guarantee balance in covariate distributions across treatment groups. Ensuring balance in important prognostic covariates across treatment groups is desirable for many reasons. A broad class of randomization methods for achieving balance are reviewed in this paper; these include block randomization, stratified randomization, minimization, and dynamic hierarchical randomization. Practical considerations arising from experience with using the techniques are described. A review of randomization methods used in practice in recent randomized clinical trials is also provided. Copyright © 2015 Elsevier Inc. All rights reserved.

  13. An Integrated Clinic-Community Partnership for Child Obesity Treatment: A Randomized Pilot Trial.

    Science.gov (United States)

    Hoffman, Jessica; Frerichs, Leah; Story, Mary; Jones, Jason; Gaskin, Kiah; Apple, Annie; Skinner, Asheley; Armstrong, Sarah

    2018-01-01

    Effective treatment of childhood obesity remains elusive. Integration of clinical and community systems may achieve effective and sustainable treatment. However, the feasibility and effectiveness of this integrated model are unknown. We conducted a randomized clinical trial among children aged 5 to 11 presenting for obesity treatment. We randomized participants to clinical care or clinical care plus community-based programming at a local parks and recreation facility. Primary outcomes were the change in child BMI at 6 months and the intensity of the program in treatment hours. Secondary outcomes included health behaviors, fitness, attrition, and quality of life. We enrolled 97 children with obesity, and retention at 6 months was 70%. Participants had a mean age of 9.1 years and a mean baseline BMI z score of 2.28, and 70% were living in poverty. Intervention participants achieved more treatment hours than controls (11.4 vs 4.4, SD: 15.3 and 1.6, respectively). We did not observe differences in child BMI z score or percent of the 95th percentile at 6 months. Intervention participants had significantly greater improvements in physical activity (P = .010) and quality of life (P = .008). An integrated clinic-community model of child obesity treatment is feasible to deliver in a low-income and racially diverse population. As compared with multidisciplinary treatment, the integrated model provides more treatment hours, improves physical activity, and increases quality of life. Parks and recreation departments hold significant promise as a partner agency to deliver child obesity treatment. Copyright © 2018 by the American Academy of Pediatrics.

  14. Intermittent claudication--surgical reconstruction or physical training? A prospective randomized trial of treatment efficiency.

    Science.gov (United States)

    Lundgren, F; Dahllöf, A G; Lundholm, K; Scherstén, T; Volkmann, R

    1989-01-01

    This study reports the initial evaluation of treatment efficiency in 75 patients with intermittent claudication who were randomized to three treatment groups: 1) reconstructive surgery, 2) reconstructive surgery with subsequent physical training, and 3) physical training alone. Before treatment, there were no statistically significant differences between the groups in age, sex, smoking habits, symptom duration of claudication, ankle-arm blood pressure quotient (ankle-index), maximal plethysmographic calf blood flow, symptom-free and maximal walking distance, the history of other atherosclerotic manifestations or in the medical treatment. The walking performance was improved in all three groups at follow-up 13 +/- 0.5 months after randomization. Surgery was most effective, but the addition of training to surgery improved the symptom-free walking distance even further. In pooled observations of the three groups, age, symptom duration, and a history of myocardial ischemic disease correlated negatively with walking performance after treatment. In the operated group, the duration of claudication and a history of myocardial ischemic disease correlated negatively with the walking performance. This was not the case when patients were censored if limited by other symptoms than intermittent claudication after treatment. In the trained group, the duration of claudication correlated negatively to symptom-free and maximal walking distance. Ankle-index and maximal plethysmographic calf blood flow after treatment and the change of these variables with treatment correlated positively with both symptom-free and maximal walking distance when results were pooled for all patients. Although this mainly was a consequence of the improved blood flow after surgery, the change of maximal plethysmographic calf blood flow also correlated with symptom-free but not with maximal walking distance in the trained group. The results demonstrate that, compared with physical training alone, operation

  15. Intrathecal ziconotide in the treatment of refractory pain in patients with cancer or AIDS: a randomized controlled trial.

    Science.gov (United States)

    Staats, Peter S; Yearwood, Thomas; Charapata, Steven G; Presley, Robert W; Wallace, Mark S; Byas-Smith, Michael; Fisher, Robert; Bryce, David A; Mangieri, Eugene A; Luther, Robert R; Mayo, Martha; McGuire, Dawn; Ellis, David

    2004-01-07

    Ziconotide (formerly SNX-111) selectively blocks N-type voltage-sensitive calcium channels and may be effective in patients with pain that is refractory to opioid therapy or those with intolerable opioid-related adverse effects. To assess the safety and efficacy of intrathecal ziconotide in patients with pain that is refractory to conventional treatment. Double-blind, placebo-controlled, randomized trial conducted from March 12, 1996, to July 11, 1998, at 32 study centers in the United States, Australia, and the Netherlands. Patients were 111 individuals ages 24 to 85 years with cancer or AIDS and a mean Visual Analog Scale of Pain Intensity (VASPI) score of 50 mm or greater. Patients were randomly assigned in a 2:1 ratio to receive ziconotide or placebo treatment. Intrathecal ziconotide was titrated over 5 to 6 days, followed by a 5-day maintenance phase for responders and crossover of nonresponders to the opposite treatment group. Mean percentage change in VASPI score from baseline to the end of the initial titration period. Of the evaluable population, 67 (98.5%) of 68 patients receiving ziconotide and 38 (95%) of 40 patients receiving placebo were taking opioids at baseline (median morphine equivalent dosage of 300 mg/d for the ziconotide group and 600 mg/d for the placebo group; P =.63, based on mean values), and 36 had used intrathecal morphine. Mean (SD) VASPI scores were 73.6 (1.8) mm in the ziconotide group and 77.9 (2.3) mm in the placebo group (P =.18). Mean VASPI scores improved 53.1% (95% confidence interval [CI], 44.0%-62.2%) in the ziconotide group and 18.1% (95% CI, 4.8%-31.4%) in the placebo group (Pziconotide in the maintenance phase. Pain relief was moderate to complete in 52.9% of patients in the ziconotide group compared with 17.5% in the placebo group (Pziconotide achieved complete pain relief, and 50.0% of patients receiving ziconotide responded to therapy compared with 17.5% of those receiving placebo (P =.001). Intrathecal ziconotide

  16. Treatment of neonatal jaundice with filtered sunlight in Nigerian neonates: study protocol of a non-inferiority, randomized controlled trial.

    Science.gov (United States)

    Slusher, Tina M; Olusanya, Bolajoko O; Vreman, Hendrik J; Wong, Ronald J; Brearley, Ann M; Vaucher, Yvonne E; Stevenson, David K

    2013-12-28

    Severe neonatal jaundice and its progression to kernicterus is a leading cause of death and disability among newborns in poorly-resourced countries, particularly in sub-Saharan Africa. The standard treatment for jaundice using conventional phototherapy (CPT) with electric artificial blue light sources is often hampered by the lack of (functional) CPT devices due either to financial constraints or erratic electrical power. In an attempt to make phototherapy (PT) more readily available for the treatment of pathologic jaundice in underserved tropical regions, we set out to test the hypothesis that filtered sunlight phototherapy (FS-PT), in which potentially harmful ultraviolet and infrared rays are appropriately screened, will be as efficacious as CPT. This prospective, non-blinded randomized controlled non-inferiority trial seeks to enroll infants with elevated total serum/plasma bilirubin (TSB, defined as 3 mg/dl below the level recommended by the American Academy of Pediatrics for high-risk infants requiring PT) who will be randomly and equally assigned to receive FS-PT or CPT for a total of 616 days at an inner-city maternity hospital in Lagos, Nigeria. Two FS-PT canopies with pre-tested films will be used. One canopy with a film that transmits roughly 33% blue light (wavelength range: 400 to 520 nm) will be used during sunny periods of a day. Another canopy with a film that transmits about 79% blue light will be used during overcast periods of the day. The infants will be moved from one canopy to the other as needed during the day with the goal of keeping the blue light irradiance level above 8 μW/cm²/nm. FS-PT will be as efficacious as CPT in reducing the rate of rise in bilirubin levels. Secondary outcome: The number of infants requiring exchange transfusion under FS-PT will not be more than those under CPT. This novel study offers the prospect of an effective treatment for infants at risk of severe neonatal jaundice and avoidable exchange transfusion in

  17. Treatment of Chronic Plantar Fasciitis with Noninvasive Interactive Neurostimulation: A Prospective Randomized Controlled Study.

    Science.gov (United States)

    Razzano, Cristina; Carbone, Stefano; Mangone, Massimiliano; Iannotta, M Raffaella; Battaglia, Alessandro; Santilli, Valter

    The initial treatment of plantar fasciitis should be conservative, with most cases responding to standard physiotherapy, nonsteroidal anti-inflammatory drugs (NSAIDs), heel pads, and stretching. In cases of chronic refractory symptoms, more invasive treatment could be necessary. Noninvasive interactive neurostimulation (NIN) is a form of electric therapy that works by locating areas of lower skin impedance. The objective of the present prospective randomized controlled study was to evaluate whether the use of NIN for chronic plantar fasciitis could result in greater improvement in a foot functional score, lower levels of reported pain, reduced patient consumption of NSAIDs, and greater patient satisfaction compared with electric shockwave therapy in patients without a response to standard conservative treatment. The patients were randomized using random blocks to the NIN program (group 1) or electric shockwave therapy (group 2). The outcome measurements were the pain subscale of the validated Foot Function Index (PS-FFI), patient-reported subjective assessment of the level of pain using a standard visual analog scale, and daily intake of NSAID tablets (etoricoxib 60 mg). The study group was evaluated at baseline (time 0), week 4 (time 1), and week 12 (final follow-up point). Group 1 (55 patients) experienced significantly better results compared with group 2 (49 patients) in term of the PS-FFI score, visual analog scale score, and daily intake of etoricoxib 60 mg. NIN was an effective treatment of chronic resistant plantar fasciitis, with full patient satisfaction in >90% of cases. The present prospective randomized controlled study showed superior results for noninvasive neurostimulation compared with electric shockwave therapy, in terms of the functional score, pain improvement, and use of NSAIDs. Copyright © 2017 American College of Foot and Ankle Surgeons. Published by Elsevier Inc. All rights reserved.

  18. Treatment of myofascial trigger points in patients with chronic shoulder pain: a randomized, controlled trial

    OpenAIRE

    Stegenga Boudewijn; Dommerholt Jan; de Gast Arthur; Bron Carel; Wensing Michel; Oostendorp Rob AB

    2011-01-01

    Abstract Background Shoulder pain is a common musculoskeletal problem that is often chronic or recurrent. Myofascial trigger points (MTrPs) cause shoulder pain and are prevalent in patients with shoulder pain. However, few studies have focused on MTrP therapy. The aim of this study was to assess the effectiveness of multimodal treatment of MTrPs in patients with chronic shoulder pain. Methods A single-assessor, blinded, randomized, controlled trial was conducted. The intervention group receiv...

  19. Cognitive-Behavioral Treatment of Insomnia and Depression in Adolescents: A Pilot Randomized Trial

    OpenAIRE

    Clarke, Greg; McGlinchey, Eleanor L.; Hein, Kerrie; Gullion, Christina M; Dickerson, John F.; Leo, Michael C.; Harvey, Allison G.

    2015-01-01

    We tested whether augmenting conventional depression treatment in youth by treating sleep issues with cognitive behavioral therapy for insomnia (CBT-I) improved depression outcomes. We randomized youth 12–20 years of age to 10 weekly sessions of a sleep hygiene control condition (SH) combined with CBT for depression (CBT-D) (n=20), or an experimental condition consisting of CBT-I combined with CBT-D (n=21).

  20. Surgical or nonoperative treatment for lumbar spinal stenosis? A randomized controlled trial.

    Science.gov (United States)

    Malmivaara, Antti; Slätis, Pär; Heliövaara, Markku; Sainio, Päivi; Kinnunen, Heikki; Kankare, Jyrki; Dalin-Hirvonen, Nina; Seitsalo, Seppo; Herno, Arto; Kortekangas, Pirkko; Niinimäki, Timo; Rönty, Hannu; Tallroth, Kaj; Turunen, Veli; Knekt, Paul; Härkänen, Tommi; Hurri, Heikki

    2007-01-01

    A randomized controlled trial. To assess the effectiveness of decompressive surgery as compared with nonoperative measures in the treatment of patients with lumbar spinal stenosis. No previous randomized trial has assessed the effectiveness of surgery in comparison with conservative treatment for spinal stenosis. Four university hospitals agreed on the classification of the disease, inclusion and exclusion criteria, radiographic routines, surgical principles, nonoperative treatment options, and follow-up protocols. A total of 94 patients were randomized into a surgical or nonoperative treatment group: 50 and 44 patients, respectively. Surgery comprised undercutting laminectomy of the stenotic segments in 10 patients augmented with transpedicular fusion. The primary outcome was based on assessment of functional disability using the Oswestry Disability Index (scale, 0-100). Data on the intensity of leg and back pain (scales, 0-10), as well as self-reported and measured walking ability were compiled at randomization and at follow-up examinations at 6, 12, and 24 months. Both treatment groups showed improvement during follow-up. At 1 year, the mean difference in favor of surgery was 11.3 in disability (95% confidence interval [CI], 4.3-18.4), 1.7 in leg pain (95% CI, 0.4-3.0), and 2.3(95% CI, 1.1-3.6) in back pain. At the 2-year follow-up, the mean differences were slightly less: 7.8 in disability (95% CI, 0.8-14.9) 1.5 in leg pain (95% CI, 0.3-2.8), and 2.1 in back pain (95% CI, 1.0-3.3). Walking ability, either reported or measured, did not differ between the two treatment groups. Although patients improved over the 2-year follow-up regardless of initial treatment, those undergoing decompressive surgery reported greater improvement regarding leg pain, back pain, and overall disability. The relative benefit of initial surgical treatment diminished over time, but outcomes of surgery remained favorable at 2 years. Longer follow-up is needed to determine if these

  1. Systematic and Random errors in prostate treatments; Errores sistematicos y aleatorios en los tratamientos de prostata

    Energy Technology Data Exchange (ETDEWEB)

    Quinones Rodriguez, L. A.; Salas Buzon, M. C.; Castro Ramirez, I. J.; Iborra Oquendo, M. A.; Urena Llinares, A.; Angulo Pain, E.; Ramos Caballero, L. J.; Seguro Fernandez, A.; Mora Melendez, R.

    2013-07-01

    Prostate treatments, the largest sources of geometric uncertainty are given by the tumor inter-fraction movements and those associated with the daily patient positioning. One of the solutions that have been taken to eliminate the sources of uncertainty, is the implantation of fiducials marks in the prostate. The objective of this work is the analysis of the data of displacements carried out according to those marks and use these results to calculate what would be the value of systematic and random uncertainty in treatments in which these fiducials marks are not used. (Author)

  2. Effects of craniosacral therapy as adjunct to standard treatment for pelvic girdle pain in pregnant women: a multicenter, single blind, randomized controlled trial.

    Science.gov (United States)

    Elden, Helen; Östgaard, Hans-Christian; Glantz, Anna; Marciniak, Pia; Linnér, Ann-Charlotte; Olsén, Monika Fagevik

    2013-07-01

    Pelvic girdle pain (PGP) is a disabling condition affecting 30% of pregnant women. The aim of this study was to investigate the efficacy of craniosacral therapy as an adjunct to standard treatment compared with standard treatment alone for PGP during pregnancy. Randomized, multicenter, single blind, controlled trial. University hospital, a private clinic and 26 maternity care centers in Gothenburg, Sweden. A total of 123 pregnant women with PGP. Participants were randomly assigned to standard treatment (control group, n = 60) or standard treatment plus craniosacral therapy (intervention group, n = 63). pain intensity (visual analog scale 0-100 mm) and sick leave. function (Oswestry Disability Index), health-related quality of life (European Quality of Life measure), unpleasantness of pain (visual analog scale), and assessment of the severity of PGP by an independent examiner. Between-group differences for morning pain, symptom-free women and function in the last treatment week were in favor of the intervention group. Visual analog scale median was 27 mm (95% confidence interval 24.6-35.9) vs. 35 mm (95% confidence interval 33.5-45.7) (p = 0.017) and the function disability index was 40 (range 34-46) vs. 48 (range 40-56) (p = 0.016). Lower morning pain intensity and less deteriorated function was seen after craniosacral therapy in conjunction with standard treatment compared with standard treatment alone, but no effects regarding evening pain and sick-leave. Treatment effects were small and clinically questionable and conclusions should be drawn carefully. Further studies are warranted before recommending craniosacral therapy for PGP. © 2013 Nordic Federation of Societies of Obstetrics and Gynecology.

  3. Treatment of intra-oral injection phobia: a randomized delayed intervention controlled trial among Norwegian 10- to 16-year-olds.

    Science.gov (United States)

    Berge, Karin G; Agdal, Maren Lillehaug; Vika, Margrethe; Skeie, Marit Slåttelid

    2017-05-01

    To evaluate the effect of five sessions of cognitive behavioural therapy (CBT) for 10- to 16-year-olds with intra-oral injection phobia. This was a randomized delayed intervention controlled trial in 67 patients, fulfilling the DSM-5 criteria for specific phobia. All patients received the same CBT performed by dentists specially trained in CBT. The patients were randomly assigned to either an immediate treatment group (ITG) (34 patients) or a waitlist-control group (WCG) (33 patients). The WCG was put on a waitlist for 5 weeks. After treatment, all patients were combined for post-treatment analyses. Assessments including the psychometric self-report scales Intra-oral injection fear scale (IOIF-s), Children's Fear Survey Schedule-Dental Subscale (CFSS-DS), Injection Phobia Scale for children (IS-c) and Mutilation Questionnaire for children (MQ-c) and a behavioural avoidance test (BAT) followed by a questionnaire on cognitions during the BAT, occurred pre-, post-treatment/waitlist and at a 1-year follow-up. CBT had a significant effect compared to no treatment (WCG). After treatment, the scores on the psychometric self-report scales were significantly reduced and higher levels in the BAT were achieved. The results were maintained at 1-year follow-up. Of the 67 patients, 70.1% received intra-oral injections during CBT treatment, whereas 69.4% of those completing the CBT, in need for further dental treatment, managed to receive the necessary intra-oral injections at their regular dentist. The 10- to 16-year-olds diagnosed with intra-oral injection phobia benefitted positively on CBT performed by specially trained dentists.

  4. Efficacy of low-frequency low-intensity electrotherapy in the treatment of breast cancer-related lymphoedema: a cross-over randomized trial.

    Science.gov (United States)

    Belmonte, Roser; Tejero, Marta; Ferrer, Montse; Muniesa, Josep Maria; Duarte, Esther; Cunillera, Oriol; Escalada, Ferran

    2012-07-01

    To compare the efficacy of low-frequency low-intensity electrotherapy and manual lymphatic drainage in the treatment of chronic upper limb breast cancer-related lymphoedema. Cross-over single-blind random clinical trial. Rehabilitation service. Thirty-six women with chronic upper limb breast cancer-related lymphoedema. Patients were randomized to undergo 10 sessions of manual lymphatic drainage followed by 10 sessions of low-frequency low-intensity electrotherapy or to undergo first low-frequency low-intensity electrotherapy followed by manual lymphatic drainage. There was a month of washout time between treatments. Each patient was examined just before and after each treatment. Researchers and outcome assessors were blinded for assigned treatment. Outcomes were lymphoedema volume, pain, heaviness and tightness, and health-related quality of life measured with the Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer version 4 (FACT-B+4). Carry-over, period and treatment effects were analysed. Treatment effect was assessed using paired t-test. Thirty patients finalized treatment. Comparing the changes in low-frequency low-intensity electrotherapy with manual lymphatic drainage changes, there were no significant differences. Low-frequency low-intensity electrotherapy did not reduce lymphoedema volume (mean of change = 19.77 mL, P = 0.36), but significant reductions were observed in pain, heaviness and tightness (mean of change = 13.1, 16.2 and 6.4 mm, respectively), and FACT-B+4 summaries improved significantly (Trial Outcome Index mean of change = 5.4, P = 0.015). Manual lymphatic drainage showed no significant changes in any of the outcomes Although there are no significant differences between treatment changes, the observed trend towards a better health-related quality of life is remarkable in low-frequency low-intensity electrotherapy.

  5. Comparing treatments for children with ADHD and word reading difficulties: A randomized clinical trial.

    Science.gov (United States)

    Tamm, Leanne; Denton, Carolyn A; Epstein, Jeffery N; Schatschneider, Christopher; Taylor, Heather; Arnold, L Eugene; Bukstein, Oscar; Anixt, Julia; Koshy, Anson; Newman, Nicholas C; Maltinsky, Jan; Brinson, Patricia; Loren, Richard E A; Prasad, Mary R; Ewing-Cobbs, Linda; Vaughn, Aaron

    2017-05-01

    This trial compared attention-deficit/hyperactivity disorder (ADHD) treatment alone, intensive reading intervention alone, and their combination for children with ADHD and word reading difficulties and disabilities (RD). Children (n = 216; predominantly African American males) in Grades 2-5 with ADHD and word reading/decoding deficits were randomized to ADHD treatment (medication + parent training), reading treatment (reading instruction), or combined ADHD + reading treatment. Outcomes were parent and teacher ADHD ratings and measures of word reading/decoding. Analyses utilized a mixed models covariate-adjusted gain score approach with posttest regressed onto pretest. Inattention and hyperactivity/impulsivity outcomes were significantly better in the ADHD (parent Hedges's g = .87/.75; teacher g = .67/.50) and combined (parent g = 1.06/.95; teacher g = .36/41) treatment groups than reading treatment alone; the ADHD and Combined groups did not differ significantly (parent g = .19/.20; teacher g = .31/.09). Word reading and decoding outcomes were significantly better in the reading (word reading g = .23; decoding g = .39) and combined (word reading g = .32; decoding g = .39) treatment groups than ADHD treatment alone; reading and combined groups did not differ (word reading g = .09; decoding g = .00). Significant group differences were maintained at the 3- to 5-month follow-up on all outcomes except word reading. Children with ADHD and RD benefit from specific treatment of each disorder. ADHD treatment is associated with more improvement in ADHD symptoms than RD treatment, and reading instruction is associated with better word reading and decoding outcomes than ADHD treatment. The additive value of combining treatments was not significant within disorder, but the combination allows treating both disorders simultaneously. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  6. Depression treatment for impoverished mothers by point-of-care providers: A randomized controlled trial.

    Science.gov (United States)

    Segre, Lisa S; Brock, Rebecca L; O'Hara, Michael W

    2015-04-01

    Depression in low-income, ethnic-minority women of childbearing age is prevalent and compromises infant and child development. Yet numerous barriers prevent treatment delivery. Listening Visits (LV), an empirically supported intervention developed for delivery by British home-visiting nurses, could address this unmet mental health need. This randomized controlled trial (RCT) evaluated the effectiveness of LV delivered at a woman's usual point-of-care, including home visits or an ob-gyn office. Listening Visits were delivered to depressed pregnant women or mothers of young children by their point-of-care provider (e.g., home visitor or physician's assistant), all of whom had low levels of prior counseling experience. Three quarters of the study's participants were low-income. Of those who reported ethnicity, all identified themselves as minorities. Participants from 4 study sites (N = 66) were randomized in a 2:1 ratio, to LV or a wait-list control group (WLC). Assessments, conducted at baseline and 8 weeks, evaluated depression, quality of life, and treatment satisfaction. Depressive severity, depressive symptoms, and quality of life significantly improved among LV recipients as compared with women receiving standard social/health services. Women valued LV as evidenced by their high attendance rates and treatment satisfaction ratings. In a stepped model of depression care, LV can provide an accessible, acceptable, and effective first-line treatment option for at-risk women who otherwise are unlikely to receive treatment. (PsycINFO Database Record (c) 2015 APA, all rights reserved).

  7. Ursodeoxycholic acid in the treatment of intrahepatic cholestasis of pregnancy: a randomized controlled trial.

    Science.gov (United States)

    Joutsiniemi, Titta; Timonen, Susanna; Leino, Riitta; Palo, Pertti; Ekblad, Ulla

    2014-03-01

    To test the efficacy and safety of ursodeoxycholic acid (UDCA) in the treatment of patients with intrahepatic cholestasis of pregnancy (ICP). In the randomized (double-blind, placebo-controlled) study 20 pregnant women with ICP received (random allocation of) either 450 mg/day UDCA or placebo for 14 days during the third trimester of pregnancy. The severity of pruritus was registered and itching scores were assessed before the treatment and weekly thereafter. The effects of UDCA on liver function and fetoplacental hormone production were measured with covering laboratory testing: serum levels of alanine aminotransferase (ALAT), total bile acids (TBA), estradiol, progesterone, prolactin, cholesterol, HDL-cholesterol, triglycerides, activated partial thromboplastin time, fibrinogen D-dimers (FIDD) and platelet count were assessed before the treatment and weekly thereafter. Data on pregnancy and delivery outcome were recorded and analyzed. UDCA was well tolerated. A significant improvement in itching scores was detected in 2 weeks in the group receiving UDCA. Serum levels of ALAT and TBA fell after 2 weeks treatment. The other laboratory values were not modified by the treatment. UDCA improves maternal itching scores and liver function tests without interfering with the fetoplacental estrogen production in patients with ICP. UDCA is well tolerated by pregnant women. No fetal or neonatal side-effects could be detected.

  8. Neuronox versus BOTOX in the Treatment of Post-Stroke Upper Limb Spasticity: A Multicenter Randomized Controlled Trial

    Science.gov (United States)

    Seo, Han Gil; Paik, Nam-Jong; Lee, Shi-Uk; Oh, Byung-Mo; Chun, Min Ho; Kwon, Bum Sun; Bang, Moon Suk

    2015-01-01

    Background Botulinum toxin type A is widely used for treating spasticity. Neuronox (Neu-BoNT/A), a newly manufactured botulinum toxin a, has not yet been investigated for its efficacy and safety in the treatment of post-stroke upper limb spasticity. Objective We evaluated the efficacy and safety of Neuronox (Neu-BoNT/A) compared with BOTOX (onabotulinum toxin A) for treating post-stroke upper limb spasticity. Methods In total, 196 stroke patients with moderate to severe upper limb spasticity were randomly assigned to either Neuronox or BOTOX intervention. The wrist flexors were mandatory and elbow, finger, and thumb flexors were optional muscles to be injected. Assessments were performed at baseline and 4, 8, and 12 weeks after the intervention. The primary outcome measure was the change from baseline of the Modified Ashworth Scale (MAS) at the wrist flexors at week 4. Secondary outcome measures included the change of MAS at each visit, response rate, Disability Assessment Scale (DAS), Carer Burden Scale, and Global Assessment of treatment benefit. Results Primary outcome measures were -1.39±0.79 and -1.56±0.81 in the Neuronox and BOTOX groups, respectively. The difference was within the noninferiority margin of 0.45 (95% upper limit=0.40). There were no significant differences between the groups in the secondary outcome and safety measures, except the change of the MAS at the elbow flexors at week 12 (-0.88±0.75 in the Neuronox group, -0.65±0.74 in the BOTOX group; P=0.0429). Both groups showed significant improvements in the MAS, DAS, and Carer Burden Scale at weeks 4, 8, and 12. Conclusion Neuronox showed equivalent efficacy and safety compared with BOTOX for treating post-stroke upper limb spasticity. Trial Registration ClinicalTrials.gov NCT01313767 PMID:26030192

  9. Neuronox versus BOTOX in the Treatment of Post-Stroke Upper Limb Spasticity: A Multicenter Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Han Gil Seo

    Full Text Available Botulinum toxin type A is widely used for treating spasticity. Neuronox (Neu-BoNT/A, a newly manufactured botulinum toxin a, has not yet been investigated for its efficacy and safety in the treatment of post-stroke upper limb spasticity.We evaluated the efficacy and safety of Neuronox (Neu-BoNT/A compared with BOTOX (onabotulinum toxin A for treating post-stroke upper limb spasticity.In total, 196 stroke patients with moderate to severe upper limb spasticity were randomly assigned to either Neuronox or BOTOX intervention. The wrist flexors were mandatory and elbow, finger, and thumb flexors were optional muscles to be injected. Assessments were performed at baseline and 4, 8, and 12 weeks after the intervention. The primary outcome measure was the change from baseline of the Modified Ashworth Scale (MAS at the wrist flexors at week 4. Secondary outcome measures included the change of MAS at each visit, response rate, Disability Assessment Scale (DAS, Carer Burden Scale, and Global Assessment of treatment benefit.Primary outcome measures were -1.39±0.79 and -1.56±0.81 in the Neuronox and BOTOX groups, respectively. The difference was within the noninferiority margin of 0.45 (95% upper limit=0.40. There were no significant differences between the groups in the secondary outcome and safety measures, except the change of the MAS at the elbow flexors at week 12 (-0.88±0.75 in the Neuronox group, -0.65±0.74 in the BOTOX group; P=0.0429. Both groups showed significant improvements in the MAS, DAS, and Carer Burden Scale at weeks 4, 8, and 12.Neuronox showed equivalent efficacy and safety compared with BOTOX for treating post-stroke upper limb spasticity.ClinicalTrials.gov NCT01313767.

  10. Prediction of treatment response at 5-year follow-up in a randomized clinical trial of behaviorally based couple therapies.

    Science.gov (United States)

    Baucom, Brian R; Atkins, David C; Rowe, Lorelei Simpson; Doss, Brian D; Christensen, Andrew

    2015-02-01

    Building on earlier work examining predictors of short- and moderate-term treatment response, demographic, intrapersonal, communication, and interpersonal variables were examined as predictors of clinically significant outcomes 5 years after couples completed 1 of 2 behaviorally based couple therapies. One hundred and thirty-four couples were randomly assigned to Integrative Behavioral Couple Therapy (IBCT; Jacobson & Christensen, 1998) or Traditional Behavioral Couple Therapy (TBCT; Jacobson & Margolin, 1979) and followed for 5 years after treatment. Outcomes include clinically significant change categories of relationship satisfaction and marital status at 5-year follow-up. Optimal subsets of predictors were selected using an automated, bootstrapped selection procedure based on Bayesian information criterion. Higher levels of commitment and being married for a longer period of time were associated with decreased likelihood of divorce or separation (odds ratio [OR] = 1.39, p = .004; OR = 0.91, p = .015). Being married for a longer period of time was also associated with increased likelihood of positive, clinically significant change (OR = 1.12, p = .029). Finally, higher levels of wife-desired closeness were associated with increased odds of positive, clinically significant change and decreased odds of divorce for moderately distressed, IBCT couples (OR = 1.16, p = .002; OR = 0.85, p = .007, respectively), whereas the opposite was true for moderately distressed, TBCT couples (OR = 0.77, p < .001; OR = 1.17, p = .002, respectively). Commitment-related variables are associated with clinically significant outcomes at 5-year follow-up as well as at termination and moderate-term follow-up. (PsycINFO Database Record (c) 2015 APA, all rights reserved).

  11. Preemptive Treatment of Nausea and Vomiting of Pregnancy: Results of a Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Caroline Maltepe

    2013-01-01

    Full Text Available Objectives. To determine whether the initiation of treatment (preemptive treatment before the symptoms of nausea and vomiting of pregnancy (NVP versus when the symptoms begin can improve the outcome in patients at a high risk for recurrence of severe NVP. Study Design. Prospective, randomized controlled trial. Results. Preemptive therapy conferred a significant reduction in HG as compared to the previous pregnancy (P=0.047. In the preemptive arm, there were 2.5-fold fewer cases of moderate-severe cases of NVP than those in the control group (15.4% versus 39.13% in the first 3 weeks of NVP (P=0.05. In the preemptive group, significantly more women had their NVP resolved before giving birth (78.2% versus 50% (P<0.002. Conclusions. Preemptive treatment with antiemetics is superior to the treatment that starts only when the symptoms have already occurred in decreasing the risk of severe forms of NVP.

  12. Job Assignments under Moral Hazard

    DEFF Research Database (Denmark)

    Koch, Alexander; Nafziger, Julia

    Inefficient job assignments are usually explained with incomplete information about employees' abilities or contractual imperfections. We show that inefficient assignments arise even without uncertainty about the employee's ability and with complete contracts. Building on this result we provide...

  13. Cortisol augmentation of a psychological treatment for warfighters with posttraumatic stress disorder: Randomized trial showing improved treatment retention and outcome.

    Science.gov (United States)

    Yehuda, Rachel; Bierer, Linda M; Pratchett, Laura C; Lehrner, Amy; Koch, Erin C; Van Manen, Jaklyn A; Flory, Janine D; Makotkine, Iouri; Hildebrandt, Tom

    2015-01-01

    Prolonged exposure (PE) therapy for post-traumatic stress disorder (PTSD) in military veterans has established efficacy, but is ineffective for a substantial number of patients. PE is also associated with high dropout rates. We hypothesized that hydrocortisone augmentation would enhance symptom improvement and reduce drop-out rates by diminishing the distressing effects of traumatic memories retrieved during imaginal exposure. We also hypothesized that in responders, hydrocortisone augmentation would be more effective in reversing glucocorticoid indices associated with PTSD than placebo augmentation. Twenty-four veterans were randomized to receive either 30 mg oral hydrocortisone or placebo prior to PE sessions 3-10 in a double-blind protocol. Glucocorticoid receptor sensitivity was assessed in cultured peripheral blood mononuclear cells (PBMC) using the in vitro lysozyme inhibition test and was determined before and after treatment. Intent-to-treat analysis was performed using latent growth curve modeling of treatment effects on change in PTSD severity over time. Veterans who no longer met diagnostic criteria for PTSD at post-treatment were designated as responders. Veterans randomized to hydrocortisone or placebo augmentation did not differ significantly in clinical severity or glucocorticoid sensitivity at pre-treatment. Hydrocortisone augmentation was associated with greater reduction in total PTSD symptoms compared to placebo, a finding that was explained by significantly greater patient retention in the hydrocortisone augmentation condition. A significant treatment condition by responder status interaction for glucocorticoid sensitivity indicated that responders to hydrocortisone augmentation had the highest pre-treatment glucocorticoid sensitivity (lowest lysozyme IC50-DEX) that diminished over the course of treatment. There was a significant association between decline in glucocorticoid responsiveness and improvement in PTSD symptoms among hydrocortisone

  14. Bath thermal waters in the treatment of knee osteoarthritis: a randomized controlled clinical trial.

    Science.gov (United States)

    Branco, Marcelo; Rêgo, Neiva N; Silva, Paulo H; Archanjo, Ingrid E; Ribeiro, Mirian C; Trevisani, Virgínia F

    2016-08-01

    Osteoarthritis is a degenerative disease associated with pain, reduced range of motion, and impaired function. Balneotherapy or bathing in thermal or mineral waters is used as a non-invasive treatment for various rheumatic diseases. To evaluate the effectiveness of hot sulfurous and non-sulfurous waters in the treatment of knee osteoarthritis. A randomized, assessor-blind, controlled trial. A spa resort. One hundred and forty patients of both genders, mean age of 64.8±8.9 years, with knee osteoarthritis and chronic knee pain. Patients were randomized into three groups: the sulfurous water (SW) group (N.=47), non-sulfurous water (NSW) group (N.=50), or control group (N.=43) who received no treatment. Patients were not blinded to treatment allocation. Treatment groups received 30 individual thermal baths (three 20-minute baths a week for 10 weeks) at 37-39 °C. The outcome measures were pain (visual analog scale, VAS), physical function (Western Ontario and McMaster Universities Osteoarthritis Index, WOMAC; Lequesne Algofunctional Index, LAFI; Stanford Health Assessment Questionnaire, HAQ), and use of pain medication. Patients were assessed before treatment (T1), at treatment endpoint (T2), and two months post-intervention (T3). Intra- and intergroup comparisons were performed at a significance level of 0.05 (Ptreatment groups (Ptreatment groups at T2 and T3 (Ptreatment groups at T2, but patients in the SW group reported less pain and better functional status than those in the NSW group at T3, showing a lasting effect of sulfurous water baths. Both therapeutic methods were effective in the treatment of knee osteoarthritis; however, sulfurous baths yielded longer-lasting effects than non-sulfurous water baths. Baths in thermal waters, especially those in sulfurous waters, are effective in reducing pain and improving physical function in patients with knee osteoarthritis.

  15. Did you get any help? A post-hoc secondary analysis of a randomized controlled trial of psychoeducation for patients with antisocial personality disorder in outpatient substance abuse treatment programs.

    Science.gov (United States)

    Thylstrup, Birgitte; Schrøder, Sidsel; Fridell, Mats; Hesse, Morten

    2017-01-09

    People in treatment for substance use disorder commonly have comorbid personality disorders, including antisocial personality disorder. Little is known about treatments that specifically address comorbid antisocial personality disorder. Self-rated help received for antisocial personality disorder was assessed during follow-ups at 3, 9 and 15 months post-randomization of a randomized trial of psychoeducation for people with comorbid substance use and antisocial personality disorder (n = 175). Randomization to psychoeducation was associated with increased perceived help for antisocial personality disorder. Perceived help for antisocial personality disorder was in turn associated with more days abstinent and higher treatment satisfaction at the 3-month follow-up, and reduced risk of dropping out of treatment after the 3-month follow-up, and perceived help mediated the effects of random assignment on days abstinent at 3-month. Brief psychoeducation for antisocial personality disorder increased patients' self-rated help for antisocial personality disorder in substance abuse treatment, and reporting having received help for antisocial personality disorder was in turn associated with better short-term outcomes, e.g., days abstinent, dropout from treatment and treatment satisfaction. ISRCTN registry, ISRCTN67266318 , retrospectively registered 17/7/2012.

  16. Dresden PTSD treatment study: randomized controlled trial of motor vehicle accident survivors

    Directory of Open Access Journals (Sweden)

    Menning Hans

    2006-07-01

    Full Text Available Abstract Background We translated, modified, and extended a cognitive behavioral treatment (CBT protocol by Blanchard and Hickling (2003 for the purpose of treating survivors of MVA with full or subsyndromal posttraumatic stress disorder (PTSD whose native language is German. The treatment manual included some additional elements, e. g. cognitive procedures, imaginal reliving, and facilitating of posttraumatic growth. The current study was conducted in order to test the efficacy of the modified manual by administering randomized controlled trial in which a CBT was compared to a wait-list control condition. Methods Forty-two motor vehicle accident survivors with chronic or severe subsyndromal posttraumatic stress disorder (PTSD completed the treatment trial with two or three detailed assessments (pre, post, and 3-month follow-up. Results CAPS-scores showed significantly greater improvement in the CBT condition as compared to the wait list condition (group × time interaction effect size d = 1.61. Intent-to-treat analysis supported the outcome (d = 1.34. Categorical diagnostic data indicated clinical recovery of 67% (post-treatment and 76% (3 months FU in the treatment group. Additionally, patients of the CBT condition showed significantly greater reductions in co-morbid major depression than the control condition. At follow-up the improvements were stable in the active treatment condition. Conclusion The degree of improvement in our treatment group was comparable to that in previously reported treatment trials of PTSD with cognitive behavioral therapy. Trial registration ISRCTN66456536

  17. Online cognitive-behavioural treatment of bulimic symptoms: a randomized controlled trial.

    Science.gov (United States)

    Ruwaard, Jeroen; Lange, Alfred; Broeksteeg, Janneke; Renteria-Agirre, Aitziber; Schrieken, Bart; Dolan, Conor V; Emmelkamp, Paul

    2013-01-01

    Manualized cognitive-behavioural treatment (CBT) is underutilized in the treatment of bulimic symptoms. Internet-delivered treatment may reduce current barriers. This study aimed to assess the efficacy of a new online CBT of bulimic symptoms. Participants with bulimic symptoms (n = 105) were randomly allocated to online CBT, bibliotherapy or waiting list/delayed treatment condition. Data were gathered at pre-treatment, post-treatment and 1-year follow-up. The primary outcome measures were the Eating Disorder Examination Questionnaire (EDE-Q) and the frequency of binge eating and purging episodes. The secondary outcome measure was the Body Attitude Test. Dropout from Internet treatment was 26%. Intention-to-treat ANCOVAs of post-test data revealed that the EDE-Q scores and the frequency of binging and purging reduced more in the online CBT group compared with the bibliotherapy and waiting list groups (pooled between-group effect size: d = 0.9). At 1-year follow-up, improvements in the online CBT group had sustained. This study identifies online CBT as a viable alternative in the treatment of bulimic symptoms. Copyright © 2012 John Wiley & Sons, Ltd.

  18. Osteopathic manipulative treatment of back pain and related symptoms during pregnancy: a randomized controlled trial.

    Science.gov (United States)

    Licciardone, John C; Buchanan, Steve; Hensel, Kendi L; King, Hollis H; Fulda, Kimberly G; Stoll, Scott T

    2010-01-01

    To study osteopathic manipulative treatment of back pain and related symptoms during the third trimester of pregnancy. A randomized, placebo-controlled trial was conducted to compare usual obstetric care and osteopathic manipulative treatment, usual obstetric care and sham ultrasound treatment, and usual obstetric care only. Outcomes included average pain levels and the Roland-Morris Disability Questionnaire to assess back-specific functioning. Intention-to-treat analyses included 144 subjects. The Roland-Morris Disability Questionnaire scores worsened during pregnancy; however, back-specific functioning deteriorated significantly less in the usual obstetric care and osteopathic manipulative treatment group (effect size, 0.72; 95% confidence interval, 0.31-1.14; P = .001 vs usual obstetric care only; and effect size, 0.35; 95% confidence interval, -0.06 to 0.76; P = .09 vs usual obstetric care and sham ultrasound treatment). During pregnancy, back pain decreased in the usual obstetric care and osteopathic manipulative treatment group, remained unchanged in the usual obstetric care and sham ultrasound treatment group, and increased in the usual obstetric care only group, although no between-group difference achieved statistical significance. Osteopathic manipulative treatment slows or halts the deterioration of back-specific functioning during the third trimester of pregnancy. 2010 Mosby, Inc.

  19. Prospective randomized study on the efficacy of blue light in the treatment of psoriasis vulgaris.

    Science.gov (United States)

    Weinstabl, Antonia; Hoff-Lesch, Susanne; Merk, Hans F; von Felbert, Verena

    2011-01-01

    Blue light has no known toxic effects on human skin, but reduces the proliferative capacity of keratinocytes in vitro. We therefore investigated the efficacy of blue light in the treatment of psoriasis vulgaris (PV). Forty patients with mild to moderate PV and bilateral plaques were assigned to two groups. Group 1 (n = 20) received irradiation at home with blue light (light-emitting diode, LED, emission maximum: 420 nm) once daily for 4 weeks. In parallel, group 2 (n = 20) performed irradiations with another blue light device (LED emission maximum: 453 nm). The contralateral control plaques remained untreated in both groups. Thirty-seven patients completed the trial. The main study parameter, the difference of Local Psoriasis Severity Index (LPSI) scores of the irradiated plaques compared to the control plaques, showed statistically significant improvement after 4 weeks of treatment in both groups [group 1 (420 nm): n = 17, p = 0.04; group 2 (453 nm): n = 20, p = 0.04]. Accordingly, plaque status as assessed by both the physicians and the patients improved continuously during the 4 weeks of treatment and steadily declined thereafter. Blue light appears to be a promising treatment modality in PV that warrants further evaluation in larger studies. Copyright © 2011 S. Karger AG, Basel.

  20. Patient navigation for breast and colorectal cancer treatment: a randomized trial.

    Science.gov (United States)

    Fiscella, Kevin; Whitley, Elizabeth; Hendren, Samantha; Raich, Peter; Humiston, Sharon; Winters, Paul; Jean-Pierre, Pascal; Valverde, Patricia; Thorland, William; Epstein, Ronald

    2012-10-01

    There is limited high-quality evidence about the impact of patient navigation (PN) on outcomes for patients with diagnosed cancer. We pooled data from two sites from the national Patient Navigation Research Program. Patients (n = 438) with newly diagnosed breast (n = 353) or colorectal cancer (n = 85) were randomized to PN or usual care. Trained lay navigators met with patients randomized to PN to help them assess treatment barriers and identify resources to overcome barriers. We used intent-to-treat analysis to assess time to completion of primary treatment, psychologic distress (impact of events scale), and satisfaction (patient satisfaction with cancer-related care) within 3 months after initiation of cancer treatment. The sample was predominantly middle-aged (mean age = 57) and female (90%); 44% were race-ethnic minorities (44%), 46% reported lower education levels, 18% were uninsured, and 9% reported a non-English primary language. The randomized groups were comparable in baseline characteristics. Primary analysis showed no statistically significant group differences in time to completion of primary cancer treatment, satisfaction with cancer-related care, or psychologic distress. Subgroup analysis showed that socially disadvantaged patients (i.e., uninsured, low English proficiency, and non-English primary language) who received PN reported higher satisfaction than those receiving usual care (all P < 0.05). Navigated patients living alone reported greater distress than those receiving usual care. Although the primary analysis showed no overall benefit, the subgroup analysis suggests that PN may improve satisfaction with care for certain disadvantaged individuals. PN for cancer patients may not necessarily reduce treatment time nor distress. 2012 AACR

  1. Multicenter Randomized Clinical Trial of Nonoperative Versus Operative Treatment of Acute Acromio-Clavicular Joint Dislocation.

    Science.gov (United States)

    2015-11-01

    To perform a randomized clinical trial of operative versus nonoperative treatment of acute acromio-clavicular (AC) joint dislocations using modern surgical fixation and both patient-based and surgeon-based outcome measures to determine which treatment method was superior. Prospective, randomized. Multicenter. Eight-three patients with acute (dislocations of the AC joint. Patients were randomized to operative repair with hook plate fixation versus nonoperative treatment (operative repair, 40; nonoperative treatment, 43). Disabilities of the Arm, Shoulder and Hand (DASH) score at 1 year after injury. Assessment also included a complete clinical assessment, evaluation of the constant score, and a radiographic evaluation at 6 weeks, and at 3, 6, 12, and 24 months. There were no demographic differences between the 2 groups, and the mechanisms of injury were similar between the 2 groups. The DASH scores (a disability score, lower score is better) were significantly better in the nonoperative group at 6 weeks (operative, 45; nonoperative, 31; P = 0.014) and 3 months (operative, 29; nonoperative, 16; P = 0.005). There were no significant differences between the groups at 6 months (operative, 14; nonoperative, 12; P = 0.442), 1 year (operative, 9; nonoperative, 9; P = 0.997), or 2 years (operative, 5; nonoperative, 6; P = 0.439) after injury. Constant scores were similar (better scores in the nonoperative group at 6 weeks, 3 months, and 6 months; P = 0.0001; and no difference thereafter). Although radiographic results were better in the operative group, the reoperation rate was significantly lower in the nonoperative group (P dislocations of the AC joint. The nonoperative group had better early scores, although both groups improved from a significant level of initial disability to a good or excellent result (mean DASH score, 5-6; mean constant score, 91-95) at 2 years. At present, there is no clear evidence that operative treatment with the currently available hook plate

  2. Utility of inline milk fat and protein ratio to diagnose subclinical ketosis and to assign propylene glycol treatment in lactating dairy cows.

    Science.gov (United States)

    Jenkins, Nicholas T; Peña, Gustavo; Risco, Carlos; Barbosa, Carolina C; Vieira-Neto, Achilles; Galvão, Klibs N

    2015-08-01

    The objective was to identify a fat-to-protein ratio (FPR) cut-off to diagnose subclinical ketosis (SCK) and to evaluate the effect of propylene glycol (PPG) treatment of cows with high FPR. The optimized cut-off was > 1.42; sensitivity (Se) = 92%; specificity (Sp) = 65%. A cut-off > 1.5 was selected for the PPG trial for balanced Se-Sp. Fat-to-protein ratio cut-offs > 1.25, 1.35, 1.50, 1.60, and 1.70 resulted in Se-Sp of 100% to 49%, 96% to 59%, 75% to 78%, 33% to 90%, and 8% to 96%, respectively. The proportions of cows with FPR > 1.25, 1.35, 1.42, 1.50, 1.60, and 1.70 were 60%, 50%, 44%, 30%, 14%, and 6%, respectively. Incidences of clinical ketosis and milk yield were similar between cows that received 400 mL of PPG (n = 34) and control cows (n = 38). Prevalence of SCK at enrollment was 29.2%; therefore, FPR > 1.5 is not indicated for treatment. Lower cut-offs should be used for screening.

  3. Clinical and biochemical effects of diode laser as an adjunct to nonsurgical treatment of chronic periodontitis: a randomized, controlled clinical trial.

    Science.gov (United States)

    Saglam, Mehmet; Kantarci, Alpdogan; Dundar, Niyazi; Hakki, Sema S

    2014-01-01

    The aim of this randomized, parallel, controlled clinical trial was to examine the clinical and biochemical efficacy of diode laser as an adjunct to scaling and root planing (SRP). Thirty chronic periodontitis patients were randomly assigned into two groups to receive SRP alone (control) or SRP followed by diode laser (test). Plaque index, gingival index, bleeding on probing, probing depth, and clinical attachment level were measured at baseline and at 1, 3, and 6 months after treatment. The gingival crevicular fluid levels of interleukin-1β (IL-1β), interleukin-6 (IL-6), interleukin-8 (IL-8), matrix metalloproteinase-1 (MMP-1), matrix metalloproteinase-8 (MMP-8) and tissue inhibitor matrix metalloproteinase-1 (TIMP-1) were analyzed by enzyme-linked immunosorbent assay. Test group showed significantly a better outcome compared to the control group in full-mouth clinical parameters. MMP-1, MMP-8, and TIMP-1 showed significant differences between groups after treatment compared to baseline (p laser provided significant improvements in clinical parameters and MMP-8 was significantly impacted by the adjunctive laser treatment at first month providing an insight to how lasers can enhance the outcomes of the nonsurgical periodontal therapy.

  4. Effectiveness of Topical Curcumin for Treatment of Mastitis in Breastfeeding Women: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Raha Afshariani

    2014-09-01

    Full Text Available Objective: To determine the efficacy of topical curcumin in reducing breast inflammation in women suffering from lactational mastitis. Methods: A randomized double-blind, placebo-controlled study including 63 breastfeeding women with lactational mastitis were randomly assigned to receive curcumin topical cream, one pump every 8 hours for 3 days (n=32 or topical moisturizer as placebo (n=31. Using an index for severity of breast inflammation, all of the patients had moderate breast inflammation before entering the study. The outcome of treatment was evaluated using the same index at 24, 48 and 72 hours of starting the treatment. Results: There was no significant difference between two study groups regarding the baseline characteristics such as age (p=0.361 and duration of lactation (p=0.551. After 72-hour of therapy, patients in curcumin groups had significantly lower rate of moderate (p=0.019 and mild (p=0.002 mastitis. Patients in curcumin group had significantly lower scores for tension (p<0.001, erythema (p<0.001 and pain (p<0.001, after 72-hour of treatment. Conclusion: The results of the current study indicate that topical preparation of curcumin successfully decrease the markers of lactational mastitis such as pain, breast tension and erythema within 72 hours of administration without side effects. Thus, topical preparation of curcumin could be safely administered for those suffering from lactational mastitis after excluding infectious etiologies.

  5. Prolonged exposure, paroxetine and the combination in the treatment of PTSD following a motor vehicle accident. A randomized clinical trial - The "TRAKT" study.

    Science.gov (United States)

    Popiel, Agnieszka; Zawadzki, Bogdan; Pragłowska, Ewa; Teichman, Yona

    2015-09-01

    Little is known about direct comparisons of the efficacy of trauma-focused psychotherapies and SSRIs. This is the first randomized clinical trial comparing the efficacy of prolonged exposure (PE), paroxetine (Ph) and their combination (Comb) in a sample of adults diagnosed with PTSD following motor vehicle accidents (MVA). A total of 228 people were randomly assigned to a twelve-week treatment of PE (N = 114), Ph (N = 57) or Comb (N = 57). The ITT analyses showed that the remission rate of PTSD was significantly greater after PE (65.5%) compared with Ph (43.3%), whereas Comb (51.2%) did not differ from either. The differences in dropout rates were not significant between treatments (18.4% - PE; 12.2% - Ph; 22.8% - Comb), while the differences in numbers of refusers were significant (3.5% PE paroxetine and combination treatment in PTSD PE was more effective than Ph in achieving remission of PTSD. The additive effect of Comb over any monotherapy was not shown. Copyright © 2015 Elsevier Ltd. All rights reserved.

  6. Effect of pulsed Nd:YAG laser in the treatment of neuropathic foot ulcers in children with spina bifida: a randomized controlled study.

    Science.gov (United States)

    Ebid, Anwar Abdelgayed; El-Kafy, Ehab Mohame Abd; Alayat, Mohamed Salaheldien Mohamed

    2013-12-01

    This study assessed the effects of pulsed Nd:YAG laser treatment of neuropathic foot ulcers in children with spina bifida. Children with spina bifida face increased risk for developing neuropathic foot ulcers. In a randomized controlled trial, 39 children and adolescents (ages 6-15 years) with spina bifida and stage III neuropathic foot ulcers were randomly assigned to the laser group or the placebo laser group. The former received pulsed Nd:YAG laser treatments (i.e., total energy of 300-350 J during three sessions/week) plus standard wound care, and the latter received sham laser treatments plus standard wound care. Wound size and wound appearance were assessed for all patients at the beginning of the treatment, after 5 weeks, and after 10 weeks. The decrease in wound surface area at 5 and 10 weeks post- treatment was significantly greater in the laser group (i.e., 2.44 ± 0.33 and 0.29 ± 0.25 cm(2), respectively) than in the placebo group (i.e., 3.81 ± 0.18 and 3.24 ± 0.44 cm(2), respectively). Also, the decrease in the total score for the Pressure Sore Status Tool (PSST) at 5 and 10 weeks post-treatment was significantly different for the laser group (i.e., 32.76 ± 2.30 and 17.52 ± 1.66, respectively) than for the placebo group (i.e., 46.50 ± 2.12 and 38.11 ± 3.17, respectively). Treatment with pulsed neodymium:yttrium aluminum garnet (Nd:YAG) laser combined with standard wound care decreases wound size and improves wound appearance for stage III neuropathic foot ulcers in children with spina bifida.

  7. The clinical impact and cost-effectiveness of essential oils and aromatherapy for the treatment of acne vulgaris: a protocol for a randomized controlled trial.

    Science.gov (United States)

    Agnew, Tamara; Leach, Matthew; Segal, Leonie

    2014-05-01

    Acne is a prevalent, chronic, and sometimes severe skin disorder affecting an estimated 85% of adolescents and 50% of adults older than age 20 years. The psychosocial implications of acne can be considerable, often continuing long after physical symptoms resolve. Although effective acne medications are available, most exhibit adverse-effect profiles that can leave the patient with few effective treatment options. Emerging evidence indicates that plant-derived essential oils may be a biologically plausible treatment for acne, although high-quality evidence of effectiveness and safety is lacking. To examine the clinical effectiveness and cost-effectiveness of essential oils and aromatherapy for the treatment of acne. This randomized, wait-list controlled trial will have three parallel groups; 192 participants with acne vulgaris, aged 16-45 years, will be recruited primarily through eight Technical and Further Education campuses across Adelaide, South Australia. Participants will be randomly assigned to standard essential oil blend, customized aromatherapy treatment, or wait-list control. Changes in the physical and psychosocial symptoms of acne will be assessed at baseline and 6 and 12 weeks by using the Leeds Acne Grading System, Assessment of Quality of Life-8 Dimension instrument, and Acne-Specific Quality of Life instrument. Costs of treatment will be measured on the basis of resource inputs and unit costs and will be limited to acne treatment. The clinical effectiveness and cost-effectiveness will be compared between each intervention and against usual care, using standard health economic techniques. The provision of high-quality evidence of the effectiveness of essential oils and aromatherapy in the treatment of acne may help consumers make better-informed choices about acne management. Insights gained from this research will also contribute to the academic field of complementary medicine, specifically aromatherapy, for which the evidence base is extremely

  8. Acceptability, efficacy and safety of two treatment protocols for dental fluorosis: a randomized clinical trial.

    Science.gov (United States)

    Castro, Kaline Silva; Ferreira, Ana Cláudia de Araújo; Duarte, Rosângela Marques; Sampaio, Fábio Correia; Meireles, Sônia Saeger

    2014-08-01

    This parallel randomized clinical trial evaluated the efficacy of two treatments for removing fluorosis stains. Seventy individuals living in an area endemic for fluorosis, with at least four maxillary anterior teeth presenting fluorosis with a Thylstrup and Fejerskov index from 1 to 7, were randomized into two treatment groups (n=35): GI - enamel microabrasion or GII - microabrasion associated with at-home bleaching. Microabrasion was performed using 37% phosphoric acid and pumice and, at-home tooth bleaching was performed with 10% carbamide peroxide. Areas of enamel opacities were recorded by digital camera at baseline and 1-month (1M) after treatment. Two blinded examiners evaluated the reduction in the area (mm(2)) of opacity using software. Two visual analogue scales were used: one for recording tooth sensitivity and/or gingival irritation ranging from 1 (none) to 5 (severe) and the other to evaluate participant satisfaction with the treatment used ranging from 1 (no improvement) to 7 (exceptional improvement). 1M after treatment, both groups showed a significant reduction in the area of enamel opacity (p=0.0001) and there was no difference between groups (p=0.1). Most of the participants from both treatment groups reported no or mild tooth sensitivity and gingival irritation (p>0.05). Participants reported that they were happy with the improvement in dental appearance, however, individuals from GII reported that they were happier than those from GI (p=0.004). Both treatment protocols were effective in reducing fluoride stains, however, when home bleaching was associated to enamel microabrasion, patients reported a major satisfaction with dental appearance. Copyright © 2014 Elsevier Ltd. All rights reserved.

  9. Exercise as an augmentation treatment for nonremitted major depressive disorder: a randomized, parallel dose comparison.

    Science.gov (United States)

    Trivedi, Madhukar H; Greer, Tracy L; Church, Timothy S; Carmody, Thomas J; Grannemann, Bruce D; Galper, Daniel I; Dunn, Andrea L; Earnest, Conrad P; Sunderajan, Prabha; Henley, Steven S; Blair, Steven N

    2011-05-01

    Most patients with major depressive disorder (MDD) require second-step treatments to achieve remission. The Treatment with Exercise Augmentation for Depression (TREAD) study was designed to test the efficacy of aerobic exercise as an augmentation treatment for MDD patients who had not remitted with antidepressant treatment. Eligible participants in this randomized controlled trial were sedentary individuals (men and women aged 18-70 years) diagnosed with DSM-IV nonpsychotic MDD who had not remitted with selective serotonin reuptake inhibitor (SSRI) treatment. Participants were recruited through physician referrals and advertisements. A total of 126 participants were randomized to augmentation treatment with either 16 kcal per kg per week (KKW) or 4 KKW of exercise expenditure for 12 weeks while SSRI treatment was held constant. Supervised sessions were conducted at The Cooper Institute, Dallas, Texas, with additional home-based sessions as needed to fulfill the weekly exercise prescription. The primary outcome was remission (as determined by a score ≤ 12 on the Inventory of Depressive Symptomatology, Clinician-Rated). The study took place between August 2003 and August 2007. There were significant improvements over time for both groups combined (F₁,₁₂₁ = 39.9, P exercise (women, 5.6%; men, 0.1%) (women: t₉₅ = 2.1, P = .04; men: t₈₈ = 5.4, P exercise group (P exercise dose. Significant differences between groups were found when the moderating effects of gender and family history of mental illness were taken into account and suggest that higher-dose exercise may be better for all men and for women without a family history of mental illness. clinicaltrials.gov Identifier: NCT00076258. © Copyright 2011 Physicians Postgraduate Press, Inc.

  10. Internet treatment for social anxiety disorder in Romania: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Tulbure Bogdan Tudor

    2012-10-01

    Full Text Available Abstract Background Social anxiety disorder (SAD is one of the most common anxiety disorders and is associated with marked impairments. However, a small proportion of individuals with SAD seek and receive treatment. Internet-administrated cognitive behavior therapy (iCBT has been found to be an effective treatment for SAD. This trial will be the first Internet-delivered guided self-help intervention for SAD in Romania. Methods Participants with social anxiety disorder (N = 96 will be recruited via newspapers, online banners and Facebook. Participants will be randomized to either: a an active treatment, or b a waiting list control group. The treatment will have a guided iCBT format and will last for nine weeks. Self-report questionnaires on social phobia, anxiety, depression, treatment credibility and irrational thinking will be used. All assessments will be collected pre, post and at follow-up (six months after intervention. Liebowitz Social Anxiety Scale – Self-Report version (LSAS-SR will be the primary outcome measure and will be administrated on a weekly basis in both conditions. Discussion The present randomized controlled trial investigates the efficacy of an Internet-administered intervention in reducing social anxiety symptoms in a culture where this form of treatment has not been tested. This trial will add to the body of knowledge on the efficacy of iCBT, and the results might lead to an increase of the accessibility of evidence-based psychological treatment in Romania. Trial registration ClinicalTrials.gov: NCT01557894

  11. A randomized, controlled pilot study of acupuncture treatment for menopausal hot flashes.

    Science.gov (United States)

    Avis, Nancy E; Legault, Claudine; Coeytaux, Remy R; Pian-Smith, May; Shifren, Jan L; Chen, Wunian; Valaskatgis, Peter

    2008-01-01

    To investigate the feasibility of conducting a randomized trial of the effect of acupuncture in decreasing hot flashes in peri- and postmenopausal women. Fifty-six women ages 44 to 55 with no menses in the past 3 months and at least four hot flashes per day were recruited from two clinical centers and randomized to one of three treatment groups: usual care (n = 19), sham acupuncture (n = 18), or Traditional Chinese Medicine acupuncture (n = 19). Acupuncture treatments were scheduled twice weekly for 8 consecutive weeks. The sham acupuncture group received shallow needling in nontherapeutic sites. The Traditional Chinese Medicine acupuncture group received one of four treatments based on a Traditional Chinese Medicine diagnosis. Usual care participants were instructed to not initiate any new treatments for hot flashes during the study. Daily diaries were used to track frequency and severity of hot flashes. The mean daily index score was based on the number of mild, moderate, and severe hot flashes. Follow-up analyses were adjusted for baseline values, clinical center, age, and body mass index. There was a significant decrease in mean frequency of hot flashes between weeks 1 and 8 across all groups (P = 0.01), although the differences between the three study groups were not significant. However, the two acupuncture groups showed a significantly greater decrease than the usual care group (P acupuncture significantly reduce hot flash frequency.

  12. Shoe Orthotics for the Treatment of Chronic Low Back Pain: A Randomized Controlled Trial.

    Science.gov (United States)

    Cambron, Jerrilyn A; Dexheimer, Jennifer M; Duarte, Manuel; Freels, Sally

    2017-09-01

    To investigate the efficacy of shoe orthotics with and without chiropractic treatment for chronic low back pain compared with no treatment. Randomized controlled trial. Integrative medicine teaching clinic at a university. Adult subjects (N=225) with symptomatic low back pain of ≥3 months were recruited from a volunteer sample. Subjects were randomized into 1 of 3 treatment groups (shoe orthotic, plus, and waitlist groups). The shoe orthotic group received custom-made shoe orthotics. The plus group received custom-made orthotics plus chiropractic manipulation, hot or cold packs, and manual soft tissue massage. The waitlist group received no care. The primary outcome measures were change in perceived back pain (numerical pain rating scale) and functional health status (Oswestry Disability Index) after 6 weeks of study participation. Outcomes were also assessed after 12 weeks and then after an additional 3, 6, and 12 months. After 6 weeks, all 3 groups demonstrated significant within-group improvement in average back pain, but only the shoe orthotic and plus groups had significant within-group improvement in function. When compared with the waitlist group, the shoe orthotic group demonstrated significantly greater improvements in pain (Ppain (P=.3431). Group differences at 12 weeks and later were not significant. Six weeks of prescription shoe orthotics significantly improved back pain and dysfunction compared with no treatment. The addition of chiropractic care led to higher improvements in function. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  13. A randomized pilot trial of a full subsidy vs. a partial subsidy for obesity treatment.

    Science.gov (United States)

    Tsai, Adam G; Felton, Sue; Hill, James O; Atherly, Adam J

    2012-09-01

    Intensive obesity treatment is mandated by federal health care reform but is costly. A partial subsidy for obesity treatment could lower the cost of treatment, without reducing its efficacy. This study sought to test whether a partial subsidy for obesity treatment would be feasible, as compared to a fully subsidized intervention. The study was a pilot randomized trial. Participants (n = 50) were primary care patients with obesity and at least one comorbid condition (diabetes, hypertension, dyslipidemia, or obstructive sleep apnea). Each participant received eight weight loss counseling visits as well as portion-controlled foods for weight loss. Participants were randomized to full subsidy or partial subsidy (2 vs. 1 meal per day provided). The primary outcome was weight change after 4 months. Secondary outcomes included changes in blood pressure, waist circumference, and health-related quality of life. Participants in the full and partial subsidy groups lost 5.9 and 5.3 kg, equivalent to 5.3% and 5.1% of initial weight, respectively (P = 0.71). Changes in secondary outcomes were similar in the two groups. A partial subsidy was feasible and induced a clinically similar amount of weight loss, compared to a full subsidy. Large-scale testing of economic incentives for weight control is merited given the federal mandate to offer weight loss counseling to obese patients.

  14. A randomized placebo-controlled clinical trial of phonophoresis for the treatment of chronic neck pain.

    Science.gov (United States)

    Durmus, Dilek; Alayli, Gamze; Tufekci, Tugce; Kuru, Omer

    2014-05-01

    The aim of this trial was to investigate and compare the effects of phonophoresis (PP), placebo PP and exercise therapies on pain, disability, sleep quality, and depression in the patients with chronic neck pain (CNP). This is a randomized, single-blind, placebo-controlled study. A total of 61 patients with definite CNP were included in this study. The patients were randomized into three groups. Group 1 (n = 21) received PP with capsaicin treatment and exercises. Group 2 (n = 20) received placebo PP with capsaicin and exercises. Group 3 (n = 20) was given only exercises. All of the programs were performed 3 days a week, for 6 weeks. The pain (visual analog scale), disability (the neck pain disability index), depression (Beck Depression Inventory scores), and sleep quality (Pittsburgh Sleep Quality Index) of all participants were evaluated. Measurements were taken before and after treatment. All of the groups showed statistically significant improvements in pain, disability, sleep quality, and depression. While there was no difference between groups regarding depression and sleep quality, intergroup comparison showed significant differences in pain and disability among three groups. These differences were statistically significant in group 1 and 2 compared to group 3, and also in group 1 compared to group 2. We observed that PP treatment was effective in the treatment for patients with CNP. A combination of PP with exercises can be used to obtain optimal clinical results.

  15. Interactive Assignments for Online Students

    Directory of Open Access Journals (Sweden)

    Pam Lowry

    2009-04-01

    Full Text Available Students can experience first hand through interactive assignments what is involved in teaching an online course. Most students develop a whole new appreciation for the student learning process. Faculty are beginning to realize that online instruction is more than a series of readings posted to a course management system. This paper summarizes the faculty member's instructional strategies involved when creating student interaction assignments. The paper also summarizes the assignments, discussion board, and trends in education from the student's perspective. In summary, it concludes with the faculty's overall perspective concerning these assignments and how the assignments could be more effective for the student.

  16. Efficacy of bacterial cellulose membrane for the treatment of lower limbs chronic varicose ulcers: a randomized and controlled trial.

    Science.gov (United States)

    Cavalcanti, Luciana Marins; Pinto, Flávia Cristina Morone; Oliveira, Glícia Maria DE; Lima, Salvador Vilar Correia; Aguiar, José Lamartine DE Andrade; Lins, Esdras Marques

    2017-01-01

    to evaluate the efficacy of Bacterial Cellulose (BC) membrane dressings in the treatment of lower limb venous ulcers. we carried out a prospective, randomized, controlled study of 25 patients with chronic venous ulcer disease in the lower limbs from the Angiology and Vascular Surgery Service of the Federal University of Pernambuco Hospital and from the Salgado Polyclinic of the County Health Department, Caruaru, Pernambuco. We randomly assigned patients to two groups: control group, receiving dressings with triglyceride oil (11 patients) and experimental group, treated with BC membrane (14 patients). We followed the patients for a period of 120 days. There was a reduction in the wound area in both groups. There were no infections or reactions to the product in any of the groups. Patients in the BC group showed decreased pain and earlier discontinuation of analgesic use. BC membrane can be used as a dressing for the treatment of varicose ulcers of the lower limbs. avaliar a eficácia de curativos com membrana de Celulose Bacteriana (CB) no tratamento de úlceras venosas de membros inferiores. estudo prospectivo, randomizado e controlado de 25 pacientes com úlceras decorrentes de doença venosa crônica nos membros inferiores provenientes do Serviço de Angiologia e Cirurgia Vascular do Hospital de Clínicas da Universidade Federal de Pernambuco e da Policlínica do Salgado da Secretaria Municipal de Saúde, Caruaru, Pernambuco. Os pacientes foram distribuídos aleatoriamente em dois grupos: grupo controle, que recebeu curativos com óleo de triglicerídeos (11 pacientes) e grupo experimental, tratado com membrana de CB (14 pacientes). Os pacientes foram acompanhados por um período de 120 dias. houve uma redução na área de ferida em ambos os grupos. Não houve infecção ou reações ao produto em nenhum dos grupos. Pacientes do grupo CB mostraram diminuição da dor e interrupção mais precoce do uso de analgésicos. a membrana de CB pode ser usada como

  17. Depression beliefs, treatment preference, and outcomes in a randomized trial for major depressive disorder.

    Science.gov (United States)

    Dunlop, Boadie W; Kelley, Mary E; Mletzko, Tanja C; Velasquez, Cristina M; Craighead, W Edward; Mayberg, Helen S

    2012-03-01

    Previous studies suggest that individual preferences for medication- or psychotherapy-based treatments for depression may affect outcomes in clinical trials that compare these two forms of treatment. We assessed patients' beliefs about the causes of their depression, their preferred treatment, and strength of that preference in 80 patients participating in a 12-week clinical trial evaluating neuroimaging predictors of response to cognitive behavior therapy (CBT) or escitalopram. Forty-five patients expressed a preference for one of the 2 treatments, but being matched to preference did not influence remission or completion rates. Medication-preferring patients were more likely to terminate the trial early, regardless of treatment received. CBT-preferring patients rarely endorsed unknown causes for their depression, and medication-preferring patients were highly unlikely to identify pessimistic attitudes as a source of their depression. Among patients willing to be randomized to treatment, preference does not appear to strongly influence outcome. Specific preferences for CBT or medication may reflect differing conceptualizations about depressive illness, knowledge of which may enhance treatment retention and efficacy. Copyright © 2011 Elsevier Ltd. All rights reserved.

  18. Lactobacillus GG for treatment of acute childhood diarrhoea: an open labelled, randomized controlled trial.

    Science.gov (United States)

    Aggarwal, Sunny; Upadhyay, Amit; Shah, Dheeraj; Teotia, Neeraj; Agarwal, Astha; Jaiswal, Vijay

    2014-03-01

    Randomized controlled trials in developed countries have reported benefits of Lactobacillus GG (LGG) in the treatment of acute watery diarrhoea, but there is paucity of such data from India. The study was aimed to evaluate the efficacy and safety of Lactobacillus GG in the treatment of acute diarrhoea in children from a semi-urban city in north India. In this open labelled, randomized controlled trial 2000 children with acute watery diarrhoea, aged between 6 months to 5 years visiting outpatient department and emergency room of a teaching hospital in north India were enrolled. The children were randomized into receiving either Lactobacillus GG in dose of 10 billion cfu/day for five days or no probiotic medication in addition to standard WHO management of diarrhoea. Primary outcomes were duration of diarrhoea and time to change in consistency of stools. Median (inter quartile range) duration of diarrhoea was significantly shorter in children in LGG group [60 (54-72) h vs. 78 (72-90) h; PLactobacillus GG than control group [36 (30-36) h vs. 42 (36-48) h; PLactobacillus GG in children with acute diarrhoea resulted in shorter duration and faster improvement in stool consistency as compared to the control group.

  19. assignments in Discourse Analysis

    African Journals Online (AJOL)

    Key words: Error treatment; error handling; corrective feedback, positive cognitive feedback; ... English as a second language need to attend to is “error correction”. .... teaching. Some of these will be discussed below. Gaeis (1983: 21 l) observes that teachers seem to. ”have abandoned an “all out” global approach to error ...

  20. A Randomized Controlled Trial of Adjunctive Family Therapy and Treatment as Usual Following Inpatient Treatment for Anorexia Nervosa Adolescents

    Science.gov (United States)

    Godart, Nathalie; Berthoz, Sylvie; Curt, Florence; Perdereau, Fabienne; Rein, Zoé; Wallier, Jenny; Horreard, Anne-Sophie; Kaganski, Irène; Lucet, Réjane; Atger, Frédéric; Corcos, Maurice; Fermanian, Jacques; Falissard, Bruno; Flament, Martine; Eisler, Ivan; Jeammet, Philippe

    2012-01-01

    Research on treatments in anorexia nervosa (AN) is scarce. Although most of the therapeutic programs used in ‘real world practice’ in AN treatment resort to multidisciplinary approaches, they have rarely been evaluated. Objective To compare two multidimensional post-hospitalization outpatients treatment programs for adolescents with severe AN: Treatment as Usual (TAU) versus this treatment plus family therapy (TAU+FT). Method Sixty female AN adolescents, aged 13 to 19 years, were included in a randomized parallel controlled trial conducted from 1999 to 2002 for the recruitment, and until 2004 for the 18 months follow-up. Allocation to one of the two treatment groups (30 in each arm) was randomised. The TAU program included sessions for the patient alone as well as sessions with a psychiatrist for the patient and her parents. The TAU+FT program was identical to the usual one but also included family therapy sessions targeting intra-familial dynamics, but not eating disorder symptoms. The main Outcome Measure was the Morgan and Russell outcome category (Good or Intermediate versus Poor outcome). Secondary outcome indicators included AN symptoms or their consequences (eating symptoms, body mass index, amenorrhea, number of hospitalizations in the course of follow-up, social adjustment). The evaluators, but not participants, were blind to randomization. Results At 18 months follow-up, we found a significant group effect for the Morgan and Russell outcome category in favor of the program with family therapy (Intention-to-treat: TAU+FT :12/30 (40%); TAU : 5/29 (17.2%) p = 0.05; Per Protocol analysis: respectively 12/26 (46.2%); 4/27 (14.8%), p = 0.01). Similar group effects were observed in terms of achievement of a healthy weight (i.e., BMI≥10th percentile) and menstrual status. Conclusions Adding family therapy sessions, focusing on intra-familial dynamics rather than eating symptomatology, to a multidimensional program improves treatment effectiveness in

  1. A randomized controlled trial of adjunctive family therapy and treatment as usual following inpatient treatment for anorexia nervosa adolescents.

    Directory of Open Access Journals (Sweden)

    Nathalie Godart

    Full Text Available UNLABELLED: Research on treatments in anorexia nervosa (AN is scarce. Although most of the therapeutic programs used in 'real world practice' in AN treatment resort to multidisciplinary approaches, they have rarely been evaluated. OBJECTIVE: To compare two multidimensional post-hospitalization outpatients treatment programs for adolescents with severe AN: Treatment as Usual (TAU versus this treatment plus family therapy (TAU+FT. METHOD: Sixty female AN adolescents, aged 13 to 19 years, were included in a randomized parallel controlled trial conducted from 1999 to 2002 for the recruitment, and until 2004 for the 18 months follow-up. Allocation to one of the two treatment groups (30 in each arm was randomised. The TAU program included sessions for the patient alone as well as sessions with a psychiatrist for the patient and her parents. The TAU+FT program was identical to the usual one but also included family therapy sessions targeting intra-familial dynamics, but not eating disorder symptoms. The main Outcome Measure was the Morgan and Russell outcome category (Good or Intermediate versus Poor outcome. Secondary outcome indicators included AN symptoms or their consequences (eating symptoms, body mass index, amenorrhea, number of hospitalizations in the course of follow-up, social adjustment. The evaluators, but not participants, were blind to randomization. RESULTS: At 18 months follow-up, we found a significant group effect for the Morgan and Russell outcome category in favor of the program with family therapy (Intention-to-treat: TAU+FT :12/30 (40%; TAU : 5/29 (17.2% p = 0.05; Per Protocol analysis: respectively 12/26 (46.2%; 4/27 (14.8%, p = 0.01. Similar group effects were observed in terms of achievement of a healthy weight (i.e., BMI≥10(th percentile and menstrual status. CONCLUSIONS: Adding family therapy sessions, focusing on intra-familial dynamics rather than eating symptomatology, to a multidimensional program improves

  2. Functional treatment versus plaster for simple elbow dislocations (FuncSiE: a randomized trial

    Directory of Open Access Journals (Sweden)

    Verleisdonk Egbert JMM

    2010-11-01

    Full Text Available Abstract Background Elbow dislocations can be classified as simple or complex. Simple dislocations are characterized by the absence of fractures, whi