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Background: Throwing injuries of the shoulder and elbow are common among youth baseball players. Hypothesis: A prevention program will reduce the incidence of throwing injuries of the shoulder and elbow by 50% among youth baseball players. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: The authors block randomized 16 youth baseball teams consisting of 237 players aged 9 to 11 years into an intervention group (8 teams, 117 players) and a control group (8 teams, 120 players). The intervention program consisted of 5 stretching, 2 dynamic mobility, and 2 balance training exercises performed during warm-up. Both groups were followed up for 12 months, during which the incidence of shoulder and elbow injuries was recorded. In addition, ball speed during pitching as a performance-related factor and variables of physical function (passive range of motion of the elbow, shoulder and hip, dynamic balance, and thoracic kyphosis angle) were assessed during the pre- and postintervention periods. Results: The incidence of shoulder and elbow injuries in the intervention group (1.7 per 1000 athlete-exposures) was significantly lower than that in the control group (3.1 per 1000 athlete-exposures) (hazard ratio, 1.940; 95% CI, 1.175-3.205; P =.010). The factors related to pitching performance, as assessed by ball speed, tended to increase in the intervention group as compared with the control group (P =.010). The program also improved shoulder horizontal adduction deficits on the dominant side, hip internal rotation on the nondominant side, and the thoracic kyphosis angle. Conclusion: A prevention program decreases throwing injuries of the shoulder and elbow and enhances the parameter of pitching performance in youth baseball players. [ABSTRACT FROM AUTHOR]

Objective: To investigate the concomitant effects of two patient-directed interventions for post-stroke depressive symptoms on caregivers' well-being. Design: Secondary analyses of the results of a randomized controlled trial. Subjects: Fifty caregivers of stroke patients receiving outpatient rehabilitation. Interventions: Stroke patients and their caregivers were randomly allocated to either cognitive-behavioural therapy augmented with movement or occupational therapy (n = 23) or computerized cognitive training (n = 27) to alleviate depressive symptoms in patients. Main measures: Emotional burden (Involvement Evaluation Questionnaire), practical burden (Caregiver Strain Index), mental health (General Health Questionnaire) and emotional complaints (Hospital Anxiety and Depression Scale). Results: Caregivers of patients who received cognitive-behavioural therapy reported significantly higher mental health levels (mean difference (MD) = 1.78, 95% confidence interval (CI) = 0.43–3.13, P = 0.01) and less worrying about patients' well-being (MD = 1.9, 95% CI = 0.56–3.24, P < 0.01). In addition, there were positive time effects on the Involvement Evaluation Questionnaire for Brain Injury, particularly the subscales Worrying, Supervision and Tension. Conclusion: The results suggest that augmented cognitive-behavioural therapy aimed at improving patients' emotional, behavioural and social functioning positively affects some aspects of caregivers' well-being. [ABSTRACT FROM AUTHOR]

The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children (UP-C) is an intervention for children aged 7 to 13 targeting high negative emotion, emotional reactivity, and emotion regulation deficits common across emotional disorders. Our objective was to collect pilot randomized controlled trial (RCT) data on the efficacy of the UP-C, comparing UP-C with an active, anxiety-focused intervention. Participants were 47 children with at least one primary anxiety disorder; approximately one half had elevated depression symptoms. Participants received either UP-C or the anxiety-focused control treatment. No condition-related differences were found with respect to diagnostic remission and anxiety symptoms. However, differences in favor of UP-C were observed with respect to treatment response at follow-up, depression symptoms, sadness dysregulation, and cognitive reappraisal. Results provide preliminary evidence that the UP-C may be at least as efficacious in treating anxiety as well-supported anxiety-specific treatment protocols and may produce greater gains in certain emotion reactivity and regulation variables. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effectiveness of acupuncture in patients with vascular cognitive impairment no dementia (VCIND) in comparison with citicoline, an agent for cognitive disturbances associated with chronic cerebral disorders. Design: A randomized controlled multicenter trial. Setting: In three hospitals in Beijing, China. Subjects: A total of 216 patients with VCIND were recruited. Interventions: Patients with VCIND (mean age of 65.4 years) were randomized to receive acupuncture (two sessions per week) or oral citicoline (100 mg three times daily) over three months. Main measures: The primary outcome was the change from baseline to three months in cognitive symptom, measured by Alzheimer's disease Assessment Scale, cognitive subscale (ADAS-cog). Secondary outcomes included changes from baseline to six months in ADAS-cog, executive function measured by the Clock Drawing Test (CDT), and functional disability measured by the Ability of Daily Living (ADL) scale at three and six months. Results: At three months, the acupuncture group had a greater decrease in mean ADAS-cog score (−2.33 ± 0.31) than the citicoline group (−1.38 ± 0.34) with a mean difference of −0.95 (95% CI, −1.84 to −0.07, P = 0.035). The mean change from baseline to six months in ADAS-cog also significantly favored acupuncture treatments (acupuncture change −2.61 vs citicoline −1.25, difference: −1.36 points; 95% CI, −2.20 to −0.51; P = 0.002). There was no difference between the two groups on CDT and ADL scores at either time point. Conclusion: Compared with citicoline, acupuncture has comparable and even superior efficacy with improved cognitive and daily living performance as a complementary and alternative medicine treatment for VCIND. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to assess if external focus instructions result in greater improvements in motor skill and automaticity compared to internal focus instructions in stroke patients. Design: Double-blind randomized controlled trial. Setting: Inpatient stroke rehabilitation unit. Subjects: A total of 63 stroke patients (Meanage = 59.6 ± 10.7 years; Meandays since stroke = 28.5 ± 16.6; MedianFunctional Ambulation Categories = 4). Interventions: Patients were randomly assigned to an internal (N = 31) or external (N = 32) focus instruction group. Both groups practiced a balance board stabilization task, three times per week, for three weeks. Balance performance was assessed at baseline, and after one and three weeks of practice. Main measures: Primary outcome was the threshold stiffness (Nm/rad) at which patients could stay balanced. Secondary outcomes were patients' sway (root-mean-square error in degrees) at the baseline threshold stiffness under single- and dual-task conditions, and their performance on the Timed Up and Go Test and Utrecht Scale for Evaluation of Rehabilitation. Results: Both groups achieved similar improvements in threshold stiffness (∆= 27.1 ± 21.1 Nm/rad), and single- (∆= 1.8 ± 2.3° root-mean-square error) and dual-task sway (∆= 1.7 ± 2.1° root-mean-square error) after three weeks of practice. No differences were found in improvements in clinical tests of balance and mobility. Patients with comparatively good balance and sensory function, and low attention capacity showed greatest improvements with external focus instructions. Conclusion: External focus instructions did not result in greater improvement in balance skill in stroke patients compared to internal focus instructions. Results suggest that tailoring instructions to the individual stroke patient may result in optimal improvements in motor skill. [ABSTRACT FROM AUTHOR]

Objective: This pre-planned secondary analysis of geriatric interdisciplinary home rehabilitation, which was initially found to shorten the postoperative length of stay in hospital for older individuals following hip fracture, investigated whether such rehabilitation reduced the numbers of complications, readmissions, and total days spent in hospital after discharge during a 12-month follow-up period compared with conventional geriatric care and rehabilitation. Design: Randomized controlled trial. Setting: Geriatric department, participants' residential care facilities, and ordinary housing. Subjects: Individuals aged ⩾70 years with acute hip fracture (n = 205) were included. Intervention: Geriatric interdisciplinary home rehabilitation was individually designed and aimed at early discharge with the intention to prevent, detect, and treat complications after discharge. Main measures: Complications, readmissions, and days spent in hospital were registered from patients' digital records and interviews conducted during hospitalization and at 3- and 12-month follow-up visits. Results: No significant difference in outcomes was observed. Between discharge and the 12-month follow-up, among participants in the geriatric interdisciplinary home rehabilitation group (n = 106) and control group (n = 93), 57 (53.8%) and 44 (47.3%) had complications (P = 0.443), 46 (43.4%) and 38 (40.9%) fell (P = 0.828), and 38 (35.8%) and 27 (29.0%) were readmitted to hospital (P = 0.383); the median total days spent in hospital were 11.5 and 11.0 (P = 0.353), respectively. Conclusion: Geriatric interdisciplinary home rehabilitation for older individuals following hip fracture resulted in similar proportions of complications, readmissions, and total days spent in hospital after discharge compared with conventional geriatric care and rehabilitation. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effectiveness of acupuncture for pain relief and function improvement in patients with knee osteoarthritis and to determine the feasibility of an eight-week acupuncture intervention. Design: Pilot randomized controlled trial. Setting: Three teaching hospitals in China. Subjects: Patients with knee osteoarthritis (Kellgren grade II or III). Interventions: Patients were randomly assigned to an eight-week (three sessions per week) intervention of either traditional Chinese acupuncture or sham acupuncture. Main measures: The primary outcome was response rate—the proportion of patients achieving score ⩾36% decrease in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function at week 8 compared with baseline. Secondary outcomes included pain, function and quality of life. Results: Of 42 patients randomized, 36 (85.7%) completed the study. There was no significant difference in response rate between the traditional Chinese acupuncture and control groups: 61.9% (13 of 21) versus 42.9% (9 of 21) achieved score ⩾36% decrease in WOMAC pain and function at week 8 (P = 0.217). The sum of WOMAC pain and function scores at week 8 was 11.6 (9.1) in the traditional Chinese acupuncture group compared with 16.3 (10.9) in the control group (P = 0.183). There was no significant difference between groups. Three adverse events were recorded and were classified as mild. Conclusion: It showed that three sessions per week acupuncture intervention of knee osteoarthritis was feasible and safe. No difference was observed between groups due to small sample size. Larger (sample size ⩾ 296) randomized controlled trials of this intervention appear justified. [ABSTRACT FROM AUTHOR]

Little is known about the effects of distraction techniques when undertaking medical procedures with hospitalized pediatric patients in Asian countries. This study examined the effects of distraction interventions on behavioral distress related to venipuncture procedures in Taiwanese children aged 3 to 7 years. Using concealed randomization, eligible children were allocated to receive a picture book (n = 92), or animated cartoon (n = 92) compared with routine oral instructions (n = 92), when being injected with an intravenous cannula. Two trained observers independently scored the responses of each child using the Observational Scale of Behavioral Distress–Revised before, during, and after the procedure. All children experienced distress during needle insertion, but distress was less in the distraction-based intervention groups. Moreover, distraction interventions were more effective for children aged 4 to 5 years. Our culturally tailored intervention engaged child participants, was age-appropriate, and could be adapted for use in other Chinese cultures. [ABSTRACT FROM AUTHOR]

Objective: Aim of this trial was to compare efficacy of activated platelet-rich plasma against hyaluronic acid as intra-articular injections to people with osteoarthritis of the knee. Design: Phase-2 randomized controlled trial, with blind patients and outcome assessors. Setting: Outpatient rehabilitation service; years 2011-2013. Subjects: Patients with knee osteoarthritis grades 2-3 at magnetic resonance imaging (MRI) were included after consent and randomized. Target sample size was 25 patients per group. Interventions: Patients received three activated platelet-rich plasma (intervention group) or hyaluronic acid (controls) intra-articular injections at 4-week intervals. Main measures: Main outcome measure was proportion of patients with >1 grade improvement at six months from last injection, as assessed by a radiologist blind to study group. Patients were evaluated over time clinically and with functional scales (Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lysholm, Tegner, American Knee Society Score (AKSS), Lequesne, visual analogue scale (VAS) for pain). Results: Overall, 30 patients were randomized to intervention and 28 to control group. For primary outcome, 28 patients (29 knees) in the intervention and 22 (25 knees) in the control group were available. Patients with at least 1 grade improvement at repeat MRI were 14 (48.3%) in the intervention and 2 (8%) in the control group (P < 0.003). Improvement in symptoms and functional scales was consistently higher in the intervention group. No side-effects were observed in either group. Conclusion: Activated platelet-rich plasma reduces articular damage as evident at MRI, as soon as six months after treatment; it reduces pain and improves patient's function and overall quality of life. [ABSTRACT FROM AUTHOR]

Background: The recommended initial treatment for multidirectional instability (MDI) of the shoulder is a rehabilitation program, yet there is very low-quality evidence to support this approach. Purpose/Hypothesis: The purpose was to compare the Watson MDI program and Rockwood Instability program among patients with nontraumatic, nonstructural MDI. The hypothesis was that the Watson MDI program would produce clinically and statistically superior outcomes over the Rockwood Instability program. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: Forty-one participants with MDI were randomly allocated to the Watson MDI or Rockwood Instability program. Participants attended 12 weekly physiotherapy sessions for exercise prescription. Outcomes were assessed at baseline and 6, 12, and 24 weeks after randomization. Primary outcomes were the Melbourne Instability Shoulder Score (MISS) and the Western Ontario Shoulder Index (WOSI). Secondary outcomes included the Orebro Musculoskeletal Pain Questionnaire, pain, muscle strength, scapular upward rotation, scapular coordinates, global rating of change, satisfaction scales, limiting angle in abduction range, limiting factor in abduction range, and incidence of dislocation. Primary analysis was by intention to treat based on linear mixed models. Results: Between-group differences showed significant effects favoring the Watson program for the WOSI (effect size [ES], 11.1; 95% CI, 1.9-20.2; P = .018) and for the limiting factor in abduction (ES, 0.1; 95% CI, 0.0-1.6; P = .023) at 12 weeks, and for the WOSI (ES, 12.6; 95% CI, 3.4-21.9; P =. 008), MISS (ES, 15.4; 95% CI, 5.9-24.8; P = .002), and pain (ES, -2.0; CI: -2.3 to -0.7, P = .003) at 24 weeks. Conclusion: For people with MDI, 12 sessions of the Watson MDI program were more effective than the Rockwood program at 12- and 24-week follow-up. Registration: ACTRN12613001240730 (Australian New Zealand Clinical Trials Registry). [ABSTRACT FROM AUTHOR]

Background: Barbotage (needling and lavage) is often applied in the treatment of calcific tendinitis of the rotator cuff (RCCT). In a previously published randomized controlled trial, we reported superior clinical and radiological 1-year outcomes for barbotage combined with a corticosteroid injection in the subacromial bursa (SAIC) compared with an isolated SAIC. There are no trials with a midterm or long-term follow-up of barbotage available. Purpose: To compare the 5-year results of 2 regularly applied treatments of RCCT: ultrasound (US)–guided barbotage combined with a SAIC (group 1) versus an isolated US-guided SAIC (group 2). Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients were randomly assigned to group 1 or 2 and evaluated before and after treatment at regular time points until 12 months and also at 5 years using the Constant score (CS), the Western Ontario Rotator Cuff Index (WORC), and the Disabilities of the Arm, Shoulder and Hand (DASH). The calcification location and size and Gärtner classification were assessed on radiographs. The rotator cuff condition was evaluated with US. Results were analyzed using t tests, linear regression, and a mixed model for repeated measures. Results: Forty-eight patients were included (mean age, 52.0 ± 7.3 years; 25 [52%] female) with a mean baseline CS of 68.7 ± 11.9. After a mean follow-up of 5.1 ± 0.5 years, the mean CS was 90 (95% CI, 83.0-95.9) in group 1 versus 87 (95% CI, 80.5-93.5) in group 2 (P = .58). The mean improvement in the CS in group 1 was 18 (95% CI, 12.3-23.0) versus 21 (95% CI, 16.2-26.2) in group 2 (P = .32). There was total resorption in 62% of group 1 and 73% of group 2 (P = .45). The US evaluation of the rotator cuff condition showed no significant differences between the groups. With the mixed model for repeated measures, taking into account the baseline CS and Gärtner classification, the mean treatment effect for barbotage was 6 (95% CI, –8.9 to 21.5), but without statistical significance. Follow-up scores were significantly associated with baseline scores and the duration of follow-up. Results for the DASH and WORC were similar. There were no significant complications, but 4 patients in group 1 and 16 in group 2 underwent additional treatment during the follow-up period (P < .001). Conclusion: No more significant differences were found in the clinical and radiological outcomes between barbotage combined with a SAIC versus an isolated SAIC after 5 years of follow-up. Registration: NTR2282 (Dutch Trial Registry). [ABSTRACT FROM AUTHOR]

Two blinded single-dose studies randomized children 6 months to 11 years old with fever to receive ibuprofen (IBU) pediatric suspension 7.5 mg/kg or acetaminophen (APAP) suspension 10 to 15 mg/kg. The primary efficacy parameter was time-weighted sum of temperature differences (TWSTD) from baseline through 8 hours for each study. Secondary end points included TWSTD from baseline through 6 hours, time to onset and duration of temperature control, and proportion with temperature control. Studies were pooled for post hoc analyses of efficacy and adverse event end points. The primary efficacy parameter significantly favored IBU over APAP in study 1 and the pooled analysis (both P < .001), but was not significant in study 2. Onset of temperature control significantly favored IBU in study 2 (P = .007). Individual and pooled secondary efficacy outcomes supported significant advantages (P < .05) of IBU over APAP. IBU pediatric suspension provided greater temperature reduction versus acetaminophen in febrile children, with a comparable safety profile. [ABSTRACT FROM AUTHOR]

Objective: To identify the extent to which exercise intervention studies in multiple sclerosis rehabilitation are addressing comorbidities and if researchers consider comorbidities as possible moderators or mediators of exercise outcomes. Methods: Five databases were searched from inception to January 8, 2016, for exercise-related terms in combination with multiple sclerosis. Studies were screened and limited to randomized control trials, full text, and English language. We assessed whether comorbidities were excluded or included, how they were reported and described, and if they were examined as possible moderators or mediators of exercise outcomes. Results: We reviewed 99 articles that included various exercise interventions, where the most common were general multi-faceted exercise training (n=34), cardiovascular training (n=18), progressive- resistance training (n=12), and balance and gait training (n=12). In total, 77 of 99 studies reported one or more comorbidities as an exclusion criterion. The most commonly excluded comorbidities were cardiovascular diseases, cognitive impairments or psychiatric disorders, and unspecified conditions or contraindications. Only nine studies reported details on excluded participants with comorbidities. Across studies that reported comorbidities of included participants (n=8), none examined comorbidities as possible moderators or mediators of exercise outcomes. Conclusion: Although a variety of exercise interventions have positive outcomes, there is limited evidence that these interventions are generalizable to people with multiple sclerosis who have comorbid conditions. [ABSTRACT FROM AUTHOR]

Objective: To compare efficacy of a web-based multimodal training programme, ‘Move it to improve it’ (MitiiTM), to usual care on gross motor capacity and performance for children with an acquired brain injury. Design: Randomized waitlist controlled trial. Setting: Home environment. Participants: A total of 60 independently ambulant children (30 in each group), minimum 12 months post-acquired brain injury were recruited and randomly allocated to receive either 20 weeks of MitiiTM training (30 minutes/day, six days/week, total 60 hours) immediately, or waitlisted (usual care control group) for 20 weeks. A total of 58 children completed baseline assessments (32 males; age 11 years 11 months ± 2 years 6 months; Gross Motor Function Classification System equivalent I = 29, II = 29). Intervention: The MitiiTM program comprised of gross motor, upper limb and visual perception/cognitive activities. Main measures: The primary outcome was 30-second, repetition maximum functional strength tests for the lower limb (sit-to-stand, step-ups, half-kneel to stand). Secondary outcomes were the 6-minute walk test, High-level Mobility Assessment Tool, Timed Up and Go Test and habitual physical activity as captured by four-day accelerometry. Results: Groups were equivalent at baseline on demographic and clinical measures. The MitiiTM group demonstrated significantly greater improvements on combined score of functional strength tests (mean difference 10.19 repetitions; 95% confidence interval, 3.26–17.11; p = 0.006) compared with the control group. There were no other between-group differences on secondary outcomes. Conclusion: Although the MitiiTM programme demonstrated statistically significant improvements in the functional strength tests of the lower limb, results did not exceed the minimum detectable change and cannot be considered clinically relevant for children with an acquired brain injury. Clinical Trial Registration: Australian New Zealand Clinical Trials Registration Number, ANZCTR12613000403730. [ABSTRACT FROM AUTHOR]

Background: The Canadian Network for Mood and Anxiety Treatments (CANMAT) conducted a revision of the 2009 guidelines by updating the evidence and recommendations. The scope of the 2016 guidelines remains the management of major depressive disorder (MDD) in adults, with a target audience of psychiatrists and other mental health professionals.Methods: Using the question-answer format, we conducted a systematic literature search focusing on systematic reviews and meta-analyses. Evidence was graded using CANMAT-defined criteria for level of evidence. Recommendations for lines of treatment were based on the quality of evidence and clinical expert consensus. "Pharmacological Treatments" is the third of six sections of the 2016 guidelines. With little new information on older medications, treatment recommendations focus on second-generation antidepressants.Results: Evidence-informed responses are given for 21 questions under 4 broad categories: 1) principles of pharmacological management, including individualized assessment of patient and medication factors for antidepressant selection, regular and frequent monitoring, and assessing clinical and functional outcomes with measurement-based care; 2) comparative aspects of antidepressant medications based on efficacy, tolerability, and safety, including summaries of newly approved drugs since 2009; 3) practical approaches to pharmacological management, including drug-drug interactions and maintenance recommendations; and 4) managing inadequate response and treatment resistance, with a focus on switching antidepressants, applying adjunctive treatments, and new and emerging agents.Conclusions: Evidence-based pharmacological treatments are available for first-line treatment of MDD and for management of inadequate response. However, given the limitations of the evidence base, pharmacological management of MDD still depends on tailoring treatments to the patient. [ABSTRACT FROM AUTHOR]

Background: Achilles tendinopathy (AT) is a common and difficult to treat musculoskeletal disorder. Purpose: To examine whether 1 injection of platelet-rich plasma (PRP) would improve outcomes more effectively than placebo (saline) after 3 months in patients with AT. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 24 patients with chronic AT (median disease duration, 33 months) were randomized (1:1) to receive either a blinded injection of PRP (n = 12) or saline (n = 12). The primary endpoint was improvement in Victorian Institute of Sports Assessment–Achilles (VISA-A) score at 3 months. Secondary outcomes were pain at rest, pain while walking, pain when tendon was squeezed, ultrasonographic changes in tendon thickness, and color Doppler activity. Patients were informed that they could drop out after 3 months if they were dissatisfied with the treatment. Results: After 3 months, all 24 patients were reassessed (no dropouts). No difference between the PRP and the saline group could be observed with regard to the primary outcome (VISA-A score: mean difference [MD], –1.3; 95% CI, −17.8 to 15.2; P = .868). Secondary outcomes were pain at rest (MD, 1.6; 95% CI, −0.5 to 3.7; P = .137), pain while walking (MD, 0.8; 95% CI, −1.8 to 3.3; P = .544), pain when tendon was squeezed (MD, 0.3; 95% CI, −0.2 to 0.9; P = .208), color Doppler activity (MD, 0.3; 95% CI, −0.2 to 0.8; P = .260), and tendon thickness (MD, 0.8 mm; 95% CI, 0.1 to 1.6 mm; P = .030). After the 3-month follow-up, a large dropout was observed: 75% of patients in the PRP group and 33% in the saline group. Conclusion: PRP injection did not result in an improved VISA-A score over a 3-month period in patients with chronic AT compared with placebo. The only secondary outcome demonstrating a statistically significant difference between the groups was change in tendon thickness; this difference indicates that a PRP injection could increase tendon thickness compared with saline injection. The conclusions are limited to the 3 months after treatment owing to the large dropout rate. [ABSTRACT FROM AUTHOR]

Background: The aim of this prospective randomized study was to compare the outcomes of the anatomic double-bundle (DB) and anatomic single-bundle (SB) techniques 5 years after anterior cruciate ligament (ACL) reconstruction. Since more effective restoration of rotational laxity is considered the main advantage of the DB technique, the pivot-shift test was the primary outcome variable of the study. Hypothesis: Double-bundle ACL reconstruction will result in a better outcome in terms of the pivot-shift test. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 105 patients (33 women, 72 men; median age, 27 years; range, 18-52 years) were randomized and underwent ACL reconstruction (DB group, n = 53; SB group, n = 52). All reconstructions were performed anatomically by identifying the ACL footprints, using the anteromedial portal for the femoral tunnel drilling, and utilizing interference screw for tibial and femoral fixation. A single blinded observer examined the patients preoperatively and at follow-up (median, 64 months; range, 55-75 months). Multiple subjective and objective clinical evaluation tests and radiographic assessments of osteoarthritis (OA) were performed using the Ahlbäck, Kellgren-Lawrence, and Fairbank grading systems at 6 weeks postoperatively and at the final follow-up evaluation. Results: Preoperatively, no differences were found between the study groups, apart from the preinjury Tegner activity level, which was lower in the DB group (SB: mean, 7.8 [range, 3-9]; DB: mean, 7.3 [range, 0-9]; P = .02). Eighty-seven patients (83%) were available for examination at the 5-year follow-up. Statistical differences could not be found between the groups in terms of the pivot-shift test, KT-1000 arthrometer laxity measurements, manual Lachman test, single-legged-hop test, square-hop test, range of motion, Lysholm knee scoring scale, Tegner activity scale, or Knee injury and Osteoarthritis Outcome Score. Correspondingly, no differences were found between the groups regarding the presence of OA at follow-up. However, a significant increase of OA was found within the DB group at the 5-year follow-up. Both groups improved at follow-up compared with the preoperative assessment in terms of the laxity tests, hop tests, and scoring scales. Conclusion: At the 5-year follow-up of an unselected group of patients, anatomic DB reconstruction was not superior to anatomic SB reconstruction in terms of the pivot-shift test. [ABSTRACT FROM AUTHOR]

Background: Evidence from preclinical and human studies indicates the presence of reduced dopamine-1 receptor (D1R) signaling in the cortex, where D1Rs predominate, in patients with schizophrenia (SCZ), which may contribute to their cognitive deficits. Furthermore, studies in nonhuman primates (NHP) have suggested that intermittent administration of low doses of D1R agonists produce long-lasting reversals in cognitive deficits. The purpose of this trial was to test whether a similar design, involving subacute intermittent administration of low doses of a full, selective agonist at D1Rs, DAR-0100A, would improve cognitive deficits in SCZ.Methods: We randomized 49 clinically stable individuals with SCZ to three weeks of intermittent treatment with 0.5 mg or 15 mg of DAR-0100A, or placebo (normal saline). Functional magnetic resonance imaging (fMRI) BOLD was used to evaluate the effects of drug administration on brain activity during a working memory (WM) task. Effects on cognition were also assessed using the MATRICS and the N-back task as primary endpoints. The CogState battery was used as a secondary endpoint.Results: There were no observed treatment effects on either the BOLD fMRI signal during WM tasks or the WM domains of the MATRICS. Moderate improvement was detected on the CogState battery and on the attention domain of the MATRICS.Conclusion: These results suggest that low doses of D1 agonists that do not result in measureable occupancy of the D1R do not reliably improve cognition in SCZ, unlike the observations in NHP. As this drug is limited by its pharmacokinetic profile, better D1R agonists that can achieve adequate levels of D1R occupancy are needed to test the efficacy of this mechanism for cognitive enhancement in SCZ. [ABSTRACT FROM AUTHOR]

Background. Benefits associated with probiotic administration to children seeking emergency department care with diarrheal disease are unknown. Methods. In this 3-site, double-blind, placebo-controlled study, children aged 4 to 48 months with gastroenteritis were randomized to receive 5 days of placebo, low-dose (4 × 109 colony forming units per day), or high-dose (8 × 109 colony forming units per day) probiotic (Lactobacillus helveticus and Lactobacillus rhamnosus) in a 2:1:1 ratio. The primary outcome was day care absenteeism. Results. The proportion of children missing a day of day care was 63% (39/62) and 61% (37/61) in the placebo and probiotic arms, respectively (95%CI −14.6% to 18.9%). The proportions experiencing unscheduled health care provider visits and intravenous fluid rehydration were 24% (15/62), 7% (4/62), and 30% (18/61), 5% (3/61) in the placebo and probiotic study arms, respectively (P = .52 and P = .65). None of the results differed based on probiotic dose. Conclusions. The probiotic evaluated did not reduce absenteeism. Since power was suboptimal, further evaluation is required. [ABSTRACT FROM AUTHOR]

Statins have been shown to decrease depressive symptoms in certain groups of patients, an effect that is mostly attributed to their anti-inflammatory and neurotransmitter modulatory potentials. We aimed to investigate the antidepressant effects of simvastatin as an adjuvant therapy in patients with moderate to severe depression. In this double-blind placebo-controlled clinical trial, 48 patients were randomly allocated to receive simvastatin or placebo as an adjunct to fluoxetine for six weeks. Patients were evaluated with the Hamilton Depression Rating Scale (HDRS) at baseline and weeks 2, 4 and 6. Probable clinical and laboratory adverse events were also monitored and compared between the two groups. Simvastatin-treated patients experienced significantly more reductions in HDRS scores compared to the placebo group by the end of the trial (p=0.02). Early improvement and response rates were significantly greater in the simvastatin group than the placebo group (p=0.02 and p=0.01, respectively) but remission rate was not significantly different between the two groups (p=0.36). No serious adverse event was reported during this trial. In conclusion, simvastatin seems to be a safe and effective adjuvant therapy for patients suffering from major depressive disorder. However, more confirmatory studies are warranted. [ABSTRACT FROM AUTHOR]

The article focuses on a randomized, single-blind study which investigates the effectiveness of Wii Sports Resort™ training and if they possess benefits. Topics include consideration of hemiplegic children with cerebral palsy for study, health benefits of regular participation in physical activity, people with cerebral palsy and virtual reality as a training tool that encourages ability to prescribe the dose of exercise.

The article focuses on the study which aims to evaluate the effectiveness and efficiency between the robot-assisted arm group therapy (RAGT) and individual arm therapy (IAT) to restore motor function in severely affected patients after stroke. It states that patients improved their upper limb motor function over time. It mentions that the RAGT in combination with IAT was effective in restoring upper limb motor functions.

The role of cholinergic abnormalities in autism was recently evidenced and there is a growing interest in cholinergic modulation, emerging for targeting autistic symptoms. Galantamine is an acetylcholinesterase inhibitor and an allosteric potentiator of nicotinic receptors. This study aimed to evaluate the possible effects of galantamine as an augmentative therapy to risperidone, in autistic children. In this randomized, double-blind, placebo-controlled, parallel-group study, 40 outpatients aged 4–12 years whom had a diagnosis of autism (DSM IV-TR) and a score of 12 or higher on the Aberrant Behavior Checklist-Community (ABC-C) Irritability subscale were equally randomized to receive either galantamine (up to 24 mg/day) or placebo, in addition to risperidone (up to 2 mg/day), for 10 weeks. We rated participants by ABC-C and a side effects checklist, at baseline and at weeks 5 and 10. By the study endpoint, the galantamine-treated patients showed significantly greater improvement in the Irritability (P = 0.017) and Lethargy/Social Withdrawal (P = 0.005) subscales than the placebo group. The difference between the two groups in the frequency of side effects was not significant. In conclusion, galantamine augmentation was shown to be a relatively effective and safe augmentative strategy for alleviating some of the autism-related symptoms. [ABSTRACT FROM PUBLISHER]

The article presents a study which determines the eligibility of EMG-triggered electrical stimulation as an intervention for muscle stimulation among patients after stroke. A prospective, randomized controlled trial with blinded assessment was done in thirty-tree patients within four weeks of stroke and with less Grade 3 strength in shoulder flexors, elbow extensors, and wrist and finger extensors. Results indicate no difference between the groups for strength and the activity group.

The article presents the study which examined the effectiveness of platelet-rich plasma (PRP) as a treatment for patellar tendinopathy. Among the measures used in the study are the Victorian Institute of Sports Assessment (VISA) score for patellar tendinopathy, the visual analog scale (VAS) for pain, and the Tegner activity scale. Based on the results, the apparent benefits of PRP as treatment dissipate over time.

Multiple sclerosis (MS) has a significant impact on health-related quality of life (HRQoL) with symptoms adversely affecting many aspects of everyday living. BG-12 (dimethyl fumarate) demonstrated significant efficacy in the phase III studies DEFINE and CONFIRM in patients with relapsing–remitting MS. In CONFIRM, HRQoL was worse in patients with greater disability at baseline, and who relapsed during the study, and improved with BG-12 treatment. Mean Short Form-36 Physical Component Summary scores for BG-12 increased over 2 years and scores for placebo decreased. Coupled with clinical and neuroradiological benefits, these HRQoL results further support BG-12 as an effective oral treatment for relapsing MS. [ABSTRACT FROM PUBLISHER]

The article reports a study which evaluated behavioral therapy as a treatment for low mood in people with aphasia after stroke. The results revealed that at 3 months, behavioral therapy significantly improved self-reported mood, self-esteem, and observer-rated Mood and at 6 months a significant benefit for observer-rated mood was seen. This indicates that behavioral therapy improves the mood of people with aphasia.

The article reports a study which evaluated the feasibility and safety of a home-based exercise programme for people with Alzheimer's disease. The results revealed that an individualized home-based balance, strengthening and walking exercise programme delivered by a physiotherapist appears to be safe and feasible for people with mild to moderate Alzheimer's disease. The programme may improve balance and mobility performance and reduce risk of fall in people with Alzheimer's disease.

The article reports a study which investigated the feasibility and effectiveness of an active exercise program for cervical dystonia patients. It mentions that the feasibility of the intervention was assessed by recording adherence, muscle soreness, and adverse events. The results revealed that the active exercise program was feasible and safe for people with cervical dystonia.

The article reports a study to evaluate whether a single injection of platelet-rich plasma (PRP) is more effective than placebo (saline) or glucocorticoid in reducing pain in adults with lateral epicondylitis (LE) after 3 months. The results proved that neither PRP nor glucocorticoid was superior to saline in pain reduction in LE at the primary end point at 3 months. However, injection of glucocorticoid had a short-term pain reducing effect at 1 month in contrast to the other therapies.

The article discusses a study to determine the effectiveness and safety of aerobic physical training with spinal cord injury for the for treatment of chronic asymptomatic bacteriuria. An aerobic physical conditioning was carried out by the intervention group while control group carried out daily life activities. The physical activities carried out during training period produced no adverse effects and so activity of moderate intensity proved to be a safe method for its treatment.

The article discusses a study which investigates the effects of lumbar extension traction inm patients with unilateral lumbosacral radiculopathy as a result of L5-SI disc herniation.Study done by Ibrahim M Moustafa and Aliaa A Diab found major differences between the traction group and the control group. A randomized control trial is carried out where a tractio group recieved lumbar extension traction in addition to hot packs and interferential therepy had better effect than the control group.

The article discusses a study conducted to examine the safety and efficacy of onabotulinumtoxinA (Botox) for plantarflexor overactivity following stroke. It highlights that Botulinum toxin type A (BoNT-A) is treatment of choice to reduce the neurogenic component of focal hypertonia; and leads to muscle overactivity causing equinovarus ankle deformity after stroke. The result suggests that its injection for ankle flexor overactivity after stroke was safe but did not alter local spasticity.

Background: The authors developed a novel technique to improve tendon-bone healing by hybridizing calcium phosphate (CaP) with a tendon graft using an alternating soaking process. Hypothesis: Anterior cruciate ligament (ACL) reconstruction using the CaP-hybridized tendon graft would have a better clinical outcome and reduce the percentage of bone tunnel enlargement compared with a conventional method because of the enhanced anchoring between the tendon graft and the bone. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients (N = 64) with unilateral ACL rupture underwent arthroscopically assisted single-bundle ACL reconstruction using a 4-strand semitendinosus tendon or 4-strand semitendinosus and gracilis tendons with EndoButton femoral fixation and screw washer tibial fixation. These patients were equally randomized to undergo the CaP (n = 32) or conventional (n = 32) method using a transtibial tunnel approach according to the closed envelope method. In the CaP group, the tendon graft was hybridized with the CaP at both ends of the graft. One surgeon performed all reconstructions without knowing which graft was prepared. Patients’ backgrounds regarding age at surgery, gender, period before surgery, and associated meniscal injuries were similar in the 2 groups. All patients followed the same postoperative protocol. At 1 and 2 years after surgery, they were evaluated with the manual knee laxity test, KT-1000 arthrometry, International Knee Documentation Committee (IKDC) examination form, Tegner scale, and Lysholm scale. Also, 1 year postoperatively, bone tunnel enlargement was analyzed using computed tomography, intensity of the tendon graft by magnetic resonance imaging (MRI), and tendon graft appearance by arthroscopic examination. All the examinations were performed blindly. Results: All patients underwent a minimum 2-year follow-up. KT-1000 arthrometry data indicated statistically significant decreased average anterior tibial translation in the CaP group compared with the conventional method group: 1.0 6 2.0 mm versus 1.9 6 1.6 mm (P\.05), respectively, at 1 year; 1.6 6 2.1 mm versus 2.6 6 2.4 mm (P\.05), respectively, at 2 years. The Lysholm score was higher in the CaP group than in the conventional method group at 2 years (96.9 6 4.3 vs 91.7 6 13.3, P\.05). The CaP-hybridized tendon graft reduced the percentage of bone tunnel enlargement of the anteroposterior diameter at the main joint aperture site 1 year postoperatively (femoral side: 15.5% 6 13.4% vs 22.1% 6 16.4%, P\.05; tibial side: 19.3% 6 17.1% vs 26.1% 6 13.7%, P\.05). The results of the pivot-shift test, IKDC grade, and Tegner score; the intensity of the tendon graft (MRI); and arthroscopic appearance were not significantly different at both follow-up periods in the 2 groups. Conclusion: The CaP-hybridized tendon graft improved anterior knee stability and Lysholm scores at the 2-year follow-up and improved anterior knee stability and reduced the percentage of bone tunnel enlargement in both tunnels at the 1-year follow-up compared with the conventional method for single-bundle ACL reconstruction. However, longer follow-up is needed to investigate the appearance of any increased instability. [ABSTRACT FROM AUTHOR]

Objective: To examine the effects of foot orthosis intervention during a 60-minute running test in pronated-foot runners with overuse knee or foot pain during running.Design: A randomized, controlled design.Setting: Sports gym.Participants: Twenty-four runners with pronated foot who experienced pain over anterior knee or foot region during running were recruited and randomized into the treatment, or the control, group.Interventions: A soft insole with a semi-rigid rearfoot medial wedge was given to the treatment group, and a soft insole without corrective posting was applied to the control group.Outcome measures: The immediate and short-term effects of orthosis application on incidence of pain, pain intensity and onset time were evaluated using the 60-minutes treadmill test.Results: Immediately after wearing the foot orthosis, pain incidence reduced in the treatment group but not in the control group (P = 0.04). After two weeks, seven (58%) subjects in the treatment group and one (8%) in the control group were free of pain during the test (P = 0.01). The pain intensity score decreased significantly after orthosis application, from 35.5 to 17.2 (immediate effect, P = 0.014), then to 12.3 (short-term effect, P < 0.001).Conclusion: The rearfoot medially-wedged insole was a useful intervention for preventing or reducing painful knee or foot symptoms during running in runners with pronated foot. [ABSTRACT FROM PUBLISHER]

Objective: Adults with long-term neurological conditions have low levels of participation in physical activities and report many barriers to participation in exercise. This study examines the feasibility and safety of supporting community exercise for people with long-term neurological conditions using a physical activity support system.Design: A phase II randomized controlled trial using computer-generated block randomization, allocation concealment and single blind outcome assessment.Setting: Oxfordshire and Birmingham community Inclusive Fitness Initiative gyms.Subjects: Patients with a long-term neurological condition.Interventions: The intervention group (n = 51) received a 12-week, supported exercise programme. The control group (n = 48) participants received standard care for 12 weeks and were then offered the intervention.Main measures: Physical activity, adherence to exercise, measures of mobility, health and well-being.Results: Forty-eight patients (n = 51) completed the intervention, achieving 14 gym attendances (range 0–39) over the 12 weeks. Overall activity did not increase as measured by the Physical Activity Scale for the Elderly (change score mean 14.31; 95% confidence interval (CI) −8.27 to 36.89) and there were no statistically significant changes in body function and health and well-being measures.Conclusions: People with long-term neurological conditions can safely exercise in community gyms when supported and achieve similar attendance to standard exercise referral schemes, but may reduce other life activities in order to participate at a gym. [ABSTRACT FROM PUBLISHER]

Objective: To test the efficacy of calcium dobesilate (CaD) in chronic venous insufficiency (CVI). Method: Double-blind, parallel groups, placebo-controlled, multicentre trial in adult patients with symptomatic CVI and pitting oedema. Wearing of compression stockings Class II was admitted. During treatment period of eight weeks, the patients received CaD 3 x 500 mg/day or placebo. The leg volume calculation was based on a truncated cone model. Results: A total of 256 patients was randomized to treatment (dobesilate: n = 132, placebo: n = 124); the demographic and anamnestic data at admission were comparable in the two therapeutic groups. The volume of the lower calf diminished in the dobesilate group at the end of the active treatment period by -64.72 ± 111.93 cm³ (mean ± SD), independent of the concomitant usage of compression stockings versus placebo +0.8 ± 152.98 cm³ (P = 0.0002). The symptoms of pain, discomfort, heavy legs, tired legs, tingling, itching and cramps, as well as the global assessments by investigators and patients, also improved significantly (P < 0.05) better in the dobesilate group at the end of the treatment. The observed adverse events correspond to the known profile. Conclusion: Dobesilate reduces leg oedema and improves the symptoms of objectively diagnosed CVI, independent of the concomitant usage of compression stockings. [ABSTRACT FROM AUTHOR]

Background: Compression stockings are the cornerstone of the treatment of chronic venous disorders, but practical acceptability is an important limitation in the elderly. Objective: To evaluate the practicability of compression stockings in elderly patients. Methods: Twenty women aged 68-85 years without major disability were asked to put on, wear for three hours and take off Solegg® and Solegg® Fine compressive stockings (15-20 mmHg) in random order on different days, and to rate through questionnaires the difficulties and discomfort they experienced in comparison with their usual non-compressive stockings (controls). Results: Foot and heel insertions of the compression stockings, as well as their removal, were found significantly more difficult, whereas comfort when they were on was higher. In the whole, the compression stockings were found to be more agreeable than the controls. Conclusion: Difficulties regarding putting on and removal of the compression stockings remain significant but are counterbalanced by a better comfort when they are on. [ABSTRACT FROM AUTHOR]

This study investigated changes in the urine dihydroxyphenylglycol to norepinephrine ratio in patients with attention-deficit hyperactivity disorder (ADHD) treated with atomoxetine. The possible relationship with clinical response was also explored. Newly ADHD diagnosed, treatment-naïve children or adolescents were double-blindly randomized (2:1) to atomoxetine (n = 28) or placebo (n = 13). The dihydroxyphenylglycol to norepinephrine ratio decreased in both groups, showing significantly greater changes with atomoxetine than with placebo at week 6 (-42% versus -14%; P = .001), when dosed at 1.2 mg/kg/day, than at week 2 (-20% versus -2%; P = .118) with a dose of 0.5 mg/kg/day. Although the significant dihydroxyphenylglycol to norepinephrine ratio decrease with atomoxetine indicated norepinephrine transporter blockade, no association with ADHD clinical response (ADHD Rating Scale-IV-Parent:Investigator) was found. Therefore, dihydroxyphenylglycol to norepinephrine ratio might be a useful pharmacodynamic/pharmacokinetic biomarker, although not sufficiently sensitive to predict clinical efficacy. It remains a possibility that this ratio might have value to facilitate personalized atomoxetine pharmacotherapy in ADHD patients. [ABSTRACT FROM AUTHOR]

Objective: The present study (Shyness 7) has two aims: Firstly, to replicate an earlier trial showing that a self-guided Internet treatment for social phobia is efficacious, and secondly, to examine whether the addition of self-guided motivational enhancement strategies improves completion rates and clinical outcomes. Method: Randomized controlled trial (RCT) of self-guided Internet-based cognitive behavioural treatment (iCBT), or iCBT plus self-guided motivational enhancement strategies (iCBT+MS), was conducted. An intention-to-treat and last observation carried forward model was used for data analyses. The participants consisted of 108 volunteers with social phobia. The iCBT intervention consisted of two online lessons about symptoms and treatment of anxiety disorders and six lessons about management of social phobia (the Shyness programme) with complex automated reminders. The motivational intervention was based on traditional techniques including understanding and exploring ambivalence about change using a cost-benefit analysis, developing and resolving discrepancy between values and symptoms, and enhancing self-efficacy for change. The main outcome measures were the Social Interaction Anxiety Scale and Social Phobia Scale. Results: More iCBT+MS group participants completed the eight lessons than iCBT group participants (75% versus 56%, respectively), but there were no between-group differences in outcome measures at post-treatment or at 3 month follow up. Large mean within-groups effect sizes (Cohen's d) for the two social phobia measures were found for both the iCBT and iCBT+ MS groups (1.1 and 0.95, respectively), which were sustained at 3 month follow up (1.06 and 1.07, respectively). Both iCBT and iCBT+MS group participants reported that the procedures were highly acceptable. Conclusions: Both self-guided versions of the Shyness programme were reliably efficacious, confirming that people with social phobia may significantly benefit from a highly structured self-guided intervention. The addition of motivational techniques increased completion rates but did not improve clinical outcomes or acceptability. [ABSTRACT FROM AUTHOR]

This exploratory randomized, double-blind, doubledummy, 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 ⩾ 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 < .005); PSE alone (-1.8) was not significantly different from placebo. 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 ? 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 effect in the treatment of PNE compared to placebo, whereas PSE did not. The addition of PSE to IBU did not enhance or diminish the efficacy of IBU. All treatments were well tolerated. [ABSTRACT FROM AUTHOR]

Objective: In two randomized controlled trials Titov et al. demonstrated significant benefit from an Internet- and email-based treatment programme for social phobia: the Shyness programme. Data are presented about the longer term outcomes (6 months after treatment), cost-effectiveness relative to face-to-face treatment, and the acceptability of the programme to participants. Method: Participants completed outcome and acceptability questionnaires at 6 months after treatment. Repeated measures analyses of variance were calculated using an intention-to-treat design. Cost-effectiveness in years lived with disability averted were calculated based on between-group effect sizes. Results: A total of 59% of treatment group participants completed the 6 month follow-up questionnaires. Between post-treatment and 6 month follow up participants continued to make improvements in symptoms of social phobia, while maintaining improvements in mood, psychological distress, and disability. At 6 month follow up the mean within-group effect size (Cohen's d) for the two social phobia measures increased from 1.2 to 1.4. Cost-effectiveness in years lived with disability (YLD) averted was calculated as one-quarter that of face-to-face group treatment, or $AUD1495 for one YLD gained, compared to $AUD5686/YLD gained. Participants rated the Internet treatment to be as effective and helpful as face-to-face treatment. Conclusions: The present results confirm the reliability of the short-term findings reported in the first two Shyness programmes. The procedure appears to be very cost-effective, and acceptable to participants. These data provide further support for the development of Internet-based virtual clinics for common mental disorders. [ABSTRACT FROM AUTHOR]

The incidence of heart failure (HF) is increasing as the population ages. Pharmacotherapy is an important component of treatment and yields significant improvements in survival and quality of life. In recent decades, exercise has gradually become accepted as an intervention beneficial to patients with HF, but more information is needed to clarify the effects of exercise and optimize interventions. Therefore, a systematic review of randomized controlled trials published from 1966 to October 2006 was carried out via PubMed. About 69 trials were reviewed, which used as main outcome measures: (a) central hemodynamic parameters, (b) peripheral blood flow, (c) endothelial function, (d) activation of neurohormones and cytokine systems, (e) structure of and metabolism in skeletal muscles, and/or (f) quality of life. Study findings suggest that the favorable physiological responses to exercise might slow some of the pathophysiological progression of HF. However, most of the trials reviewed here were based on relatively small samples and selected participant groups, and the exercise programs varied widely. These limitations and inconsistencies need to be addressed through further studies. Furthermore, reliable strategies for maintaining the positive effects of exercise and extending them to patients' daily life and quality of life are scarce in these trials. These domains need further exploration through rationally designed, large-scale randomized controlled trials. [ABSTRACT FROM AUTHOR]

Objective: The purpose of the present study was to examine the effectiveness of an Internet-based clinician-assisted computerized cognitive behavioural therapy programme for social phobia. Method: A total of 105 individuals with social phobia were randomly assigned to a six-lesson cognitive behavioural treatment programme or to a waitlist control group. Treatment consisted of four components: six online lessons; homework assignments; participation in an online discussion forum; and regular email contact with a therapist. An intention-to-treat model was used for data analyses. Results: A total of 78% of treatment group participants completed all lessons, and post-treatment data were obtained from 93/105 participants. Significant post-treatment differences between treatment and waitlist participants were found on two measures of symptoms of social phobia. Mean within- and between-group effect sizes (Cohen's d) for the primary social phobia outcome measures were 1.15, and 0.95, respectively. Conclusions: These results were comparable with those obtained in exemplary face-to-face treatment programmes. They provide further positive data about the utility of Internet-based guided self-help programmes for people with common mental disorders. [ABSTRACT FROM AUTHOR]

Objective: In a randomized controlled trial Titov et al. (2008) demonstrated significant benefit from an Internet- and email-based treatment programme for social phobia. The present study (Shyness 2) seeks to replicate that finding and compares results with benchmark data. Method: Eighty-eight individuals with social phobia were randomly assigned to a clinician-assisted computerized cognitive behavioural treatment programme or to a waitlist control group. Participants completed the same treatment programme used in Shyness 1, consisting of six online lessons, cognitive behavioural homework assignments, email contact with a therapist, and participation in an online discussion forum. An intention-to-treat model was used for data analyses. Results: A total of 80% of treatment group participants completed all lessons, and post-treatment data were obtained from 78/81 participants. Treatment group participants each had an average of 127 min of therapist contact over the 10 week programme, including an average of 22 email contacts plus therapist responses to forum postings. Pre- to post-treatment differences were seen between treatment and waitlist participants across two measures of symptoms of social phobia, and across a measure of disability. Mean within- and between-group effect sizes (Cohen's d) across the two primary outcome measures were 1.18, and 1.20, respectively. Quantitative and qualitative data indicate that the procedure is very acceptable to participants. Conclusions: These results closely replicate those obtained in Shyness 1, indicating that the treatment procedure is reliable. These results compare favourably with outcomes reported in benchmarking studies from high-quality face-to-face treatment programmes for social phobia. These results provide further positive data about the utility of Internet-based guided self-help programmes for people with social phobia. [ABSTRACT FROM AUTHOR]

Prostanoids, which promote vasodilation and reduce platelet aggregation, have been proposed as candidate therapies for intermittent claudication due to peripheral arterial disease (PAD). However, studies of these medications have yielded inconsistent results. This study tested the hypothesis that iloprost, an oral prostacyclin analogue, would improve walking distance and quality of life in patients with intermittent claudication. The study was a multi-center, randomized, double-blind, placebo-controlled trial comparing three doses of oral iloprost (50 μg, 100 μg, or 150 μg twice daily), pentoxifylline, or placebo in 430 patients with intermittent claudication. The primary outcome measure was improvement in absolute claudication distance (ACD) after 6 months. Secondary outcomes included initial claudication distance and quality of life assessment. Placebo increased ACD by 3.3%, and iloprost increased peak ACD by 7.7%, 8.8% and 11.2% at the 50 μg, 100 μg, and 150 μg twice-daily doses, respectively (all insignificant relative to placebo). Pentoxifylline increased ACD by 13.9% relative to placebo (p = 0.039). Neither iloprost nor pentoxifylline enhanced quality of life. These results indicate that oral iloprost is not effective in improving exercise performance or quality of life in patients with PAD who have intermittent claudication. [ABSTRACT FROM AUTHOR]

Background: Tennis elbow is a common complaint. Several treatment strategies, such as corticosteroid injections and physical therapy and braces, have been described. Hypothesis: The extensor grip test has predictive value in assessing the effectiveness of bracing in tennis elbow. Study Design: Cohort study (prognosis); Level of evidence, 1. Methods: Patients with tennis elbow complaints were randomized into 3 groups: brace only, physical therapy, and combination brace and physical therapy. The extensor grip test was performed before randomization on all patients. Outcome measures at 6-week follow-up were success rate, severity of complaints, pain, disability, inconvenience during daily life, and satisfaction. Results: In the brace-only group, significant differences were identified between patients with a positive test result and patients with a negative test result for 3 outcome measures. The success rate in the test-negative group was 23% (5/22) compared to 47% (21/45) in the test-positive group. Mean decrease in pain was 23 (95% confidence interval, -3 to 49) in the test-positive group compared to 11(95% confidence interval, -6 to 28) in the test-negative group, and mean satisfaction in the test-positive group was 71(95% confidence interval, 48 to 94) compared to 51(95% confidence interval, 24 to 78) in the test-negative group. In the physical therapy and combination groups, no differences were identified between test-positive and test-negative patients. Conclusion: The extensor grip test seems valuable as a predictive factor for the effectiveness of bracing as treatment for tennis elbow over the short term. [ABSTRACT FROM AUTHOR]

Glutamatergic hyperactivity is implicated migraine pathogenesis. Also, LY293558, an a-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA)/kainate (KA) receptor antagonist, is effective in preclinical models of migraine. We therefore tested LY293558 in acute migraine. We conducted a randomized, triple-blind, parallel-group, double-dummy, multicentre trial of 1.2 mg/kg intravenous (IV) LY293558, 6 mg subcutaneous (SC) sumatriptan, or placebo in the treatment of acute migraine. The primary efficacy variable was the headache response rate, i.e. headache score improvement from moderate/severe at baseline to mild/none at 2 h. Of 45 enrolled patients, 44 patients (20M:24F; mean age ± SD = 40 ± 9 years) completed the study. Response rates were 69% for LY293558 (P = 0.017 vs. placebo), 86% for sumatriptan (P < 0.01 vs. placebo) and 25% for placebo. LY293558 and sumatriptan were superior to placebo (P < 0.01 for all comparisons) on all other measures of improvement in pain and migraine associated symptoms. Fifteen percent of patients who took LY293558 reported adverse events (AEs) (n = 2; one mild, one severe). Fifty-three percent of patients who took sumatriptan (n = 8; seven mild, one moderate) and 31% of those who received placebo reported AEs (n = 5; four mild, one severe). The efficacy and safety results of LY293558 in this small migraine proof of concept trial, together with supportive preclinical data, provide evidence for a potential role of nonvasoactive AMPA/KA antagonists in treating migraine. Larger trials are needed to further test the hypothesis. [ABSTRACT FROM AUTHOR]

Most people with episodic tension-type headache (TTH) treat themselves with over-the-counter analgesics. In the absence of clear evidence of dose-related efficacy of the two most commonly used analgesics, aspirin (acetylsalicylic acid) and paracetamol (acetaminophen), this study compared two doses of each with placebo. In a double-blind, double-dummy, randomized parallel-groups comparative trial, 638 consenting subjects aged 16-65 years with episodic TTH (but not migraine) by IHS criteria were recruited from the UK general population by advertisement. They treated one episode of moderate or severe TTH with a single dose of 500 or 1000 mg aspirin, 500 or 1000 mg paracetamol or placebo. The primary objective was to compare aspirin 1000 mg with placebo, and the primary end-point was subjective pain relief (total or worthwhile) 2 h after treatment ('response'). Additionally, pain intensity on a 100-mm visual analogue scale and functional impairment were monitored regularly for 4 h and at 24 h, although rescue medication was allowed after 2 h. The analysis was of the intention-to-treat population of 542 who took treatment (all providing outcome data). Treatment groups were matched at baseline. Aspirin 1000 mg (75.7% response rate; P = 0.0009) and to a lesser extent aspirin 500 mg (70.3%; P = 0.011) and paracetamol 1000 mg (71.2%; P = 0.007), but not paracetamol 500 mg (63.8%; P = 0.104), were statistically more effective than placebo despite a high placebo-response rate (54.5%). Outcome was not affected by headache intensity at baseline. Secondary end-points including functional recovery (by median times of 4.0-13.5 h) were consistent with these findings, although a minority of subjects recorded long-duration functional impairment (37-54 h). Adverse events reported by 13.4-18.9% of subjects were mild or moderate, and transient. No safety concerns arose. [ABSTRACT FROM AUTHOR]

S-fluoxetine is the long-acting enantiomer of the racemic antidepressant serotonin reuptake inhibitor. Sixty-five patients needing migraine prophylaxis were recruited into a phase II, double-blind, placebo-controlled trial. After a 1-month placebo run-in, 53 patients met entry criteria with regard to attack frequency and were randomized, 27 to S-fluoxetine and 26 to matching placebo. Three failed to start treatment and there were 17 early discontinuations, 9 from S-fluoxetine, 8 from placebo, at similar times and for similar reasons. The primary efficacy variable was attack frequency and analysis compared decline-from-baseline in the two groups. This was earlier and greater (1.7 attacks/28 days, or 52%) on active therapy than on placebo (1.1 attacks/28 days, or 27%), and statistically significant in month 2 (F = 4.93; p = 0.033) and month 4 (F = 4.55; p = 0.041). As secondary measures of efficacy, migraine-days per month and Patient's Global Impression of Disease Severity coherently reflected the changes in attack frequency. Mean attack severity and acute medication use (doses per attack) were unaltered by either treatment. There were no serious adverse events. Withdrawals for adverse events were four from each group but none was considered causally related. The finding of greater efficacy of S-fluoxetine than of placebo should be interpreted conservatively, since the analysis in the final month was made on only half of the entered patients. It supports progression to phase III evaluation, which was the purpose of the study. [ABSTRACT FROM AUTHOR]