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Background: Many people with aphasia have word‐finding difficulties, with some showing particular difficulties with verbs. Picture‐naming therapy is often used to improve naming, but gains are usually limited to therapy items and do not transfer to conversation. Therapy where words are produced in sentences and in real‐life activities may be more effective. Aims: The current pilot study investigated whether an activity‐oriented therapy approach would be accepted and viable if implemented in a community setting, and whether communicating whilst cooking was more beneficial than using paper‐based activities. If successful, it would be expected that verb production would improve in structured and unstructured tasks in both naming and narrative tasks. Methods & Procedures: The study employed a case‐series repeated‐measures design, with testing of treated and control items. Seven adults with anomia participated, although only five completed the full programme. Participants were divided into two groups and each group completed both treatments, but in different orders. Each treatment was employed for six 2‐h sessions over a 3‐week period. Outcomes & Results: Naming of both treated and untreated verbs showed a statistically significant improvement following both treatments and this continued into the maintenance phase. There was a numerical but not statistically significant gain in the variety of verbs used in spoken narratives. Participants predominantly chose positive terms to describe their experience of the programme, but did not prefer one therapy over the other. Conclusions & Implications: Preliminary findings suggest that an activity‐oriented therapy approach, whether it involves carrying out tasks or paper‐based activities, can result in clinically meaningful improvements for people with chronic aphasia. Further research using a randomized control trial is required to determine whether cooking therapy alone is effective. [ABSTRACT FROM AUTHOR]

Background The primary goals in conducting clinical trials of treatments for alcohol use disorders ( AUDs) are to identify efficacious treatments and determine which treatments are most efficacious for which patients. Accurate reporting of study design features and results is imperative to enable readers of research reports to evaluate to what extent a study has achieved these goals. Guidance on quality of clinical trial reporting has evolved substantially over the past 2 decades, primarily through the publication and widespread adoption of the Consolidated Standards of Reporting Trials statement. However, there is room to improve the adoption of those standards in reporting the design and findings of treatment trials for AUD. Methods This paper provides a narrative review of guidance on reporting quality in AUD treatment trials. Results Despite improvements in the reporting of results of treatment trials for AUD over the past 2 decades, many published reports provide insufficient information on design or methods. Conclusions The reporting of alcohol treatment trial design, analysis, and results requires improvement in 4 primary areas: (i) trial registration, (ii) procedures for recruitment and retention, (iii) procedures for randomization and intervention design considerations, and (iv) statistical methods used to assess treatment efficacy. Improvements in these areas and the adoption of reporting standards by authors, reviewers, and editors are critical to an accurate assessment of the reliability and validity of treatment effects. Continued developments in this area are needed to move AUD treatment research forward via systematic reviews and meta-analyses that maximize the utility of completed studies. [ABSTRACT FROM AUTHOR]

Background Over the past 60 years, the view that 'alcoholism' is a disease for which the only acceptable goal of treatment is abstinence has given way to the recognition that alcohol use disorders ( AUDs) occur on a continuum of severity, for which a variety of treatment options are appropriate. However, because the available treatments for AUDs are not effective for everyone, more research is needed to develop novel and more efficacious treatments to address the range of AUD severity in diverse populations. Here we offer recommendations for the design and analysis of alcohol treatment trials, with a specific focus on the careful conduct of randomized clinical trials of medications and nonpharmacological interventions for AUDs. Methods This paper provides a narrative review of the quality of published clinical trials and recommendations for the optimal design and analysis of treatment trials for AUDs. Results Despite considerable improvements in the design of alcohol clinical trials over the past 2 decades, many studies of AUD treatments have used faulty design features and statistical methods that are known to produce biased estimates of treatment efficacy. Conclusions The published statistical and methodological literatures provide clear guidance on methods to improve clinical trial design and analysis. Consistent use of state-of-the-art design features and analytic approaches will enhance the internal and external validity of treatment trials for AUDs across the spectrum of severity. The ultimate result of this attention to methodological rigor is that better treatment options will be identified for patients with an AUD. [ABSTRACT FROM AUTHOR]

Objectives: To compare 3 mouthwashes: 0.20% chlorhexidine (CHX) with Anti‐Discoloration System (ADS), 0.20% CHX and 0.12% CHX with 0.05% cetylpyridinium chloride (CPC), in terms of reduction of plaque and gingival bleeding and side effects. Methods: Mild gingivitis patients were randomly divided into three Groups: they underwent professional oral hygiene and received instructions: oral rinse with 10 mL for 1', twice a day, 30' after tooth brushing, for 14 days. Primary outcomes were plaque and gingival bleeding, assessed with Plaque Control Record and Gingival Bleeding Index. Feedback questionnaire and spectrophotometer evaluated secondary outcomes: adverse events. Timing of the study was T0 (baseline), T1 (professional oral hygiene) and T2 (14th day after mouthwash use). Results: Sixty‐six patients were recruited, two patients dropped out, and 64 patients completed the study. PCR T1‐T2 mean variation was 30.67 (SD = 15.22; 95% CI 23.55 to 37.80; P = 0.000), 19.93 (SD = 11.03; 95% CI 14.90 to 24.95; P = 0.000) and 16.24 (SD = 15.35; 95% CI 9.60 to 22.88; P = 0.000) respectively in Groups 0.2% CHX + ADS, 0.2% CHX and 0.12% CHX + CPC. GBI mean variation (T0‐T2) was −9.82 (SD = 9.27; 95% CI −5.48 to 14.16; P = 0.000), −19.31 (SD = 11.33; 95% CI −14.15 to −24.47; P = 0.000) and −21.13 (SD = 12.56; 95% CI −15.70 to −26.56; P = 0.000) respectively in Groups 0.2% CHX + ADS, 0.2% CHX and 0.12% CHX + CPC. Statistical significance was found in lower efficacy of 0.2% CHX + ADS Group. Patients tolerated 0.12% CHX + CPC mouthwash better in bleeding perception (95.5%; P = 0.046), burning sensation (13.6%; P = 0.006), and mouthwash taste (100%; P = 0.000). Results on staining were no statistically significant (P = 0.106). Conclusions: Addition of CPC allows reduction of CHX percentage in mouthwash formulation while keeping equal efficacy and less side effects. ADS addition decreases CHX efficacy in reducing plaque and bleeding, while resulting more tolerated than CHX. [ABSTRACT FROM AUTHOR]

Background: Effortful swallowing training (EST) is a remedial method for the training of swallowing‐related muscles in the oropharyngeal phase. However, clinical evidence of its effectiveness is insufficient. Aims: To investigate the effects of EST on tongue strength and swallowing function in patients with stroke. Methods & Procedures: Stroke patients with dysphagia were randomly assigned to one of two groups: an experimental group (n = 12) and a control group (n = 12). The experimental group underwent EST, while the control group performed saliva swallowing. Training was conducted 5 days per week for 4 weeks. Both groups underwent conventional dysphagia treatment for 30 min/day, 5 days/week for 4 weeks. Outcomes & Results: Tongue strength was assessed using the Iowa Oral Performance Instrument. The Videofluoroscopic Dysphagia Scale (VDS), based on a videofluoroscopic swallowing study, was used to analyze oropharyngeal swallowing function. The experimental group showed greater improvements in anterior and posterior tongue strength compared with the control group (p = 0.046 and 0.042, respectively), and greater improvement in the oral phases of the VDS (p = 0.017). Conclusions & Implications: We recommend EST as a remedial strategy for improving tongue strength and oral swallowing function in patients with stroke. [ABSTRACT FROM AUTHOR]

Background: Electropalatography (EPG) records details of the location and timing of tongue contacts with the hard palate during speech. It has been effective in treating articulation disorders that have failed to respond to conventional therapy approaches but, until now, its use with children and adolescents with intellectual/learning disabilities and speech disorders has been limited. Aims: To evaluate the usefulness of EPG in the treatment of speech production difficulties in children and adolescents with Down syndrome (DS) aged 8–18 years. Methods & Procedures: A total of 27 children with DS were assessed on a range of cognitive and speech and language measures and underwent additional EPG assessment. Participants were randomly allocated to one of three age‐matched groups receiving either EPG therapy, EPG‐informed conventional therapy or 'treatment as usual' over a 12‐week period. The speech of all children was assessed before therapy using the Diagnostic Evaluation of Articulation and Phonology (DEAP) and reassessed immediately post‐ and 3 and 6 months post‐intervention to measure percentage consonants correct (PCC). EPG recordings were made of the DEAP assessment items at all time points. Per cent intelligibility was also calculated using the Children's Speech Intelligibility Measure (CSIM). Outcomes & Results: Gains in accuracy of production immediately post‐therapy, as measured by PCC, were seen for all groups. Reassessment at 3 and 6 months post‐therapy revealed that those who had received therapy based directly on EPG visual feedback were more likely to maintain and improve on these gains compared with the other groups. Statistical testing showed significant differences between groups in DEAP scores across time points, although the majority did not survive post‐hoc evaluation. Intelligibility across time points, as measured by CSIM, was also highly variable within and between the three groups, but despite significant correlations between DEAP and CSIM at all time points, no statistically significant group differences emerged. Conclusions & Implications: EPG was an effective intervention tool for improving speech production in many participants. This may be because it capitalizes on the relative strength of visual over auditory processing in this client group. The findings would seem to warrant an increased focus on addressing speech production difficulties in current therapy. [ABSTRACT FROM AUTHOR]

Background: Migraine has a substantial impact on daily living, affecting productivity and quality of life for patients and their families. Patients frequently discontinue preventive medications in part because of a delay in headache and symptom relief due to the long dose titration procedures necessary for some migraine preventives. Objective: To evaluate the efficacy of fremanezumab, a selective monoclonal CGRP ligand antibody, during the first 3 weeks of therapy in patients with high‐frequency episodic migraine (HFEM) to relieve migraine headaches and associated symptoms and to reduce use of acute migraine medications. Methods: In a multicenter, randomized, double‐blind, placebo‐controlled, phase 2 study, patients with HFEM who met inclusion criteria and were 80% compliant with daily headache diary entry were randomized and treated once every 28 days for 3 months with either placebo or fremanezumab 225 or 675 mg. Compared to placebo, both doses of fremanezumab significantly reduced the primary endpoint of the HFEM study, change in the number of migraine days in month 3 relative to baseline. Herein, we performed post‐hoc analyses to assess the efficacy of each dose during the first 3 weeks of treatment to reduce migraine headache parameters, associated migraine symptoms, and the consumption of acute migraine medications. Results: The sample consisted of 297 study participants. Compared to placebo, decreases in migraine days were seen during the first week of therapy for both fremanezumab doses with least square mean (LSM) differences between fremanezumab 225 mg and placebo of −0.93 (95% CI: −1.36, −0.49) and between 675 mg dose and placebo of −1.02 (95% CI: −1.46, −0.58), both P < .0001. This benefit was maintained through the second week of therapy for the 225 and 675 mg doses, respectively, (−0.76 (95% CI: −1.11, −0.40) P < .0001, −.79 (95% CI: −1.15, −0.44) P < .0001) and the third week of therapy (−0.64 (95% CI: −0.97, −0.30) P = .0003 and −0.64 (95% CI: −0.98, −0.30) P = .0003). Likewise in the first week, patients recorded reductions in associated migraine symptoms such as nausea, vomiting, photophobia, and phonophobia, which continued through weeks 2 and 3. There were also reductions in days with acute medication use to treat migraine for the 225 and 675 mg fremanezumab doses compared to placebo. In the first week, LSM differences between 225 mg and placebo were −1.02 (95% CI: −1.39, −0.64) and between 675 mg and placebo were −1.06 (95% CI: −1.39, −0.64) P < .0001); for the second and third weeks (−1.01 (95% CI: −1.14, −0.55) P < .0001; −.90 (95% CI: −1.04, −0.44) P < .0001; −.91 (95% CI: −0.92, −0.34) P < .0001; and −.83 (95% CI: −0.84, −0.26) P = .0002), respectively. Conclusion: Fremanezumab treatment resulted in a rapid preventive response in patients with HFEM, with reductions seen in several headache parameters and migraine symptoms within the first week after therapy initiation and continuing during the second and third weeks. Patients also were able to rapidly reduce their use of acute medications to treat migraine attacks. The trial is registered at Clinicaltrials.gov as NCT02025556. [ABSTRACT FROM AUTHOR]

Aims To investigate clinical, radiographic and microbiological outcome over 12 months following open flap debridement of peri-implantitis with or without antibiotics. Materials and methods Peri-implantitis was surgically treated with or without Zithromax® in 19 control and 20 test individuals. Probing pocket depth ( PPD), gingival inflammation ( BOP), intra-oral radiographs and microbial samples were studied. Per protocol and intent-to-treat analyses were performed. Results The mean difference (reduction) in PPD values between baseline and month 12 in the test and control groups was 1.7 mm ( SD ± 1.1, 95% CI: 1.1, 2.3, p < .001) and 1.6 mm ( SD ± 1.5, 95% CI: 0.8, 2,4, p < .001), respectively. Data analysis failed to show study group differences for BOP, PPD, radiographic bone level and microbial load. Successful treatment (per protocol: PPD ≤ 5 mm, no BOP, no suppuration and no bone loss ≥0.5 mm) at 12 months in test and control groups was 7/15 (46.7%) and 4/16 (25.0%). Bacterial load reduction was similar in study groups with a temporary reduction following treatment. Conclusions Surgical treatment of peri-implantitis with adjunctive systemic azithromycin did not provide 1-year clinical benefits in comparison with those only receiving open flap debridement. [ABSTRACT FROM AUTHOR]

Study design This single-masked, randomized and six-month clinical intervention trial including two study groups was planned to evaluate the efficacy of maintenance treatment with glycine powder on the periodontal health of peri-implant tissues. Methods A total of 46 patients with partial or total edentulism, carrying a total of 88 implants, were assigned either to an air abrasive with the glycine powder treatment group ( AAD) or to a manual debridement and clorexidine administration treatment group ( MDA). Clinical data were collected before treatment and at 3 and 6 months after the treatment. Plaque index ( PI), bleeding index ( BOP), probing depth ( PD), clinical attachment level ( CAL) and bleeding score ( BS) were analysed. Results After 3 months, AAD treatment statistically significantly improved BS ( P < 0.05); at 6 months, AAD treatment statistically significantly improved indexes PD, PI, BOP and BS ( P < 0.05). In addition, the AAD treatment proved to be more effective than MDA in maintaining the peri-implant health of PD at three and 6 months, and of PI at 6 months ( P < 0.05). There were no significant changes of CAL in both groups, and all the indexes remained within the physiological levels. Conclusions Within the limits of the study, treatment with glycine seems appropriate in the maintenance of peri-implant health and more effective than the traditional treatment with plastic curette and chlorhexidine. [ABSTRACT FROM AUTHOR]

Background and Objective This study aimed to investigate the effects of low-level laser therapy (LLLT) as an adjunct to scaling and root planing (SRP) on smoking and non-smoking patients with chronic periodontitis. Material and Methods The study was conducted using a split-mouth design with 30 patients with chronic periodontitis (15 smokers, 15 non-smokers) and 30 healthy individuals matched for age, sex and smoking status as controls. Groups were constituted as follows: Cp+SRP+Sham: non-smokers with chronic periodontitis treated with SRP; Cp+SRP+LLLT: non-smokers with chronic periodontitis treated with SRP+LLLT; SCp+SRP+Sham: smokers with chronic periodontitis treated with SRP; SCp+SRP+LLLT: smokers with chronic periodontitis treated with SRP+LLLT; C: control group comprised of periodontally healthy non-smokers; SC: control group comprised of periodontally healthy smokers. LLLT was first applied on the same day as SRP and again on days 2 and 7 after SRP treatment. Clinical parameters were recorded before non-surgical periodontal treatment (baseline) and on day 30. Gingival crevicular fluid samples were collected before periodontal treatment (baseline) and during follow-up visits on days 7, 14 and 30. Gingival crevicular fluid transforming growth factor (TGF)-β1, tissue plasminogen activator (tPA) and plasminogen activator inhibitor 1 (PAI-1) levels were measured using enzyme-linked immunosorbent assay. Results All clinical parameters showed significant reductions between baseline and day 30 following SRP treatment in both the LLLT and sham groups ( P<.001). No significant differences were observed between the LLLT and sham groups of either the smokers or non-smokers ( P>.05). Gingival crevicular fluid PAI-1 levels decreased significantly in the SCp+SRP+sham and SCp+SRP+LLLT groups ( P<.05), and gingival crevicular fluid tPA levels decreased significantly in the Cp+SRP+sham, Cp+SRP+LLLT and SCp+SRP+LLLT groups ( P<.05). Gingival crevicular fluid TGF-β1 levels decreased significantly in all treatment groups ( P<.05). Although no significant differences were found between the gingival crevicular fluid PAI-1, tPA and TGF-β1 levels of the LLLT versus sham groups ( P>.05) at any of the time points measured, both LLLT groups showed significant reductions in tPA/PAI-1 ratios over time. Conclusion Within the limits of this study, LLLT may be understood to play a role in the modulation of periodontal tissue tPA and PAI-1 gingival crevicular fluid levels, particularly in smoking patients with chronic periodontitis, and may thus be recommended as an adjunct to non-surgical periodontal treatment. [ABSTRACT FROM AUTHOR]

ABSTRACT Background Maintaining endotracheal tube patency is critical for neonates receiving mechanical ventilation. Endotracheal tube suctioning removes accumulated secretions preventing potential adverse events, however is also potentially hazardous to the patient. Objective To compare respiratory rate, arterial blood oxygen saturation, heart rate and pain in newborns undergoing endotracheal tube suctioning with closed ( CS) and open ( OS) systems. Methods Randomized crossover trial with 13 newborns from two Brazilian hospitals. The respiratory rate, arterial blood oxygen saturation, heart rate and pain (Premature Infant Pain Profile) were analysed: immediately before ( T1), during ( T2), immediately after ( T3), 10 min after ( T4) and 30 min ( T5) after endotracheal suctioning. Results The majority (11/85·0%) of the newborns were premature and 45% weighed less than 1000 g. No statistically significant difference was identified according to the use of CS or OS to all the parameters investigated. The main results demonstrated that in T2 arterial blood oxygen saturation was higher with CS ( CS 93·0%; OS 89 · 0%; p = 0·561). In T3 there was an increase in respiratory rate average only with the use of OS ( T1 50·0; T3 56·0). The pain score in T2 and heart rate in T3 were higher with OS without significant differences ( p = 0·114; p = 0·479, respectively). Conclusion There was no significant difference in the studied clinical parameters or presence and intensity of pain according to the two investigated techniques of endotracheal tube suctioning. Relevance to clinical practice This research can provide support for clinical practice regarding endotracheal tube suctioning of newborns describing that the use of closed systems was similar to the open system regarding pain presence and intensity, as well as, in the clinical effects analysed, in accordance with other studies produced in this field. [ABSTRACT FROM AUTHOR]

Objective The aim was to evaluate the effect of a chlorhexidine-containing brush-on gel when used as supplement to oral hygiene instructions and mechanical debridement, on peri-implant mucositis in adults. Materials and methods The study group consisted of 38 adults (48-87 years.) with peri-implant mucositis that were consecutively enrolled in three private clinics after informed consent. The study employed a double-blind controlled design with two parallel arms. After baseline registrations, oral hygiene reinforcement and mechanical debridement, the patients were randomly allocated to either a test group with once daily tooth brushing with an oral care brush-on gel containing 0.2% chlorhexidine digluconate (Cervitec Gel) or a control gel group. The duration of the intervention was 12 weeks. The primary outcome was bleeding on probing ( BOP) and secondary endpoints were local plaque score ( LPS) and pocket probing depth ( PPD). Results The groups were balanced at baseline. The daily use of the chlorhexidine-containing gel resulted in reduced BOP after 4 and 12 weeks compared with the control group ( P < 0.05). The PPD was significantly reduced ( P < 0.05) after 12 weeks compared to baseline in the test group, but not in the control group. No side effects or adverse events were reported. Conclusion The present findings indicated moderate but significant improvements of clinical parameters when mechanical debridement was combined with a self-applied oral care brush-on gel for the management of peri-implant mucositis. [ABSTRACT FROM AUTHOR]

Objectives Mental ill-health has become a large health problem and it is important for caregivers to provide effective treatment alternatives. REGASSA is a randomized controlled study performed in primary care to study the effects of 12 weeks of Internet-based cognitive behaviour therapy ( ICBT) and physical exercise ( PE) compared with treatment as usual ( TAU) in patients with mild-to-moderate mental ill-health. The present study aimed to examine the results of these treatment alternatives on psychological functioning, stress, and sleep disturbances. Methods The study comprised 879 patients with mental ill-health taking part in the REGASSA study. Data were collected by Interactive Voice Response ( IVR), a computerized, automated telephone technique. The treatments were compared at baseline, twice during treatment, at the end of treatment and at three follow-ups after treatment. Measures used were the Outcome Questionnaire-45, the short versions of the Perceived Stress Scale, and the Karolinska Sleep Questionnaire. Results Linear mixed models showed that the patients in ICBT and PE had better results than in TAU on psychological functioning and sleep disturbances, p < .001 , with weak-to-moderate effect sizes. On stress there were no differences; all groups made improvements. Women had stronger effects than men. More patients recovered on psychological functioning ( OQ-45) in ICBT and PE than in TAU. Conclusions Internet-based cognitive behaviour therapy and PE proved to be effective treatment alternatives for patients with mild-to-moderate mental ill-health in improving psychological functioning, stress, and sleep disturbances and could be useful alternatives in primary care. Practitioner points Internet-based cognitive behaviour therapy and physical exercise proved to be effective treatment alternatives for mental ill-health patients in primary care., Automated techniques (Interactive Voice Response) could be useful for following treatment course in large groups of patients in the health care., It is important to use measures that capture different aspects of patients' health problems., The recruitment of participants was based on patients' interest and inclusion criteria which may have affect the generalizability. [ABSTRACT FROM AUTHOR]

Aim To investigate the clinical and microbiological effects of local disinfection with 0.5% sodium hypochlorite (NaOCl) with or without systemic antimicrobials (amoxicillin and metronidazole, AM) during basic periodontal therapy (BPT). Material and Methods In a randomized clinical trial (four groups), 110 chronic periodontitis patients received BPT plus local irrigation with saline (BPT + S), local disinfection with NaOCl (BPT + DIS), BPT + DIS + AM or BPT + S + AM. The outcome was analysed at baseline, 3, 6 and 12 months. Results There was no difference in clinical attachment level gain at 12 months between the four groups. BPT + DIS showed no additional improvement compared to BPT + S; BPT + DIS + AM showed fewer sites with probing pocket depth (PPD) ≥7 mm versus BPT + S only up to 6 months ( p = 0.037). In factorial analyses, additional clinical reduction for PPD ( p = 0.023) and number of sites with PPD ≥5 ( p = 0.007), ≥6 ( p = 0.002) and ≥7 mm ( p < 0.001) were found when AM was added to BPT, but not when DIS was applied. In all groups, a comparable decrease in targeted bacteria was found. AM caused adverse events in 22% of the patients. Conclusion Local disinfection with NaOCl, also in combination with AM, showed, after 1-year follow-up, no additional clinical and microbiological effects compared to BPT alone. [ABSTRACT FROM AUTHOR]

Aims To examine the safety and effectiveness of buprenorphine + naloxone sublingual tablets (BUP, as Suboxone®) provided after administration of extended-release injectable naltrexone (XR-NTX, as Vivitrol®) to reduce cocaine use in participants who met DSM-IV criteria for cocaine dependence and past or current opioid dependence or abuse. Methods This multi-centered, double-blind, placebo-controlled study, conducted under the auspices of the National Drug Abuse Treatment Clinical Trials Network, randomly assigned 302 participants at sites in California, Oregon, Washington, Colorado, Texas, Georgia, Ohio, New York and Washington DC, USA to one of three conditions provided with XR-NTX: 4 mg/day BUP (BUP4, n = 100), 16 mg/day BUP (BUP16, n = 100, or no buprenorphine (placebo; PLB, n = 102). Participants received pharmacotherapy for 8 weeks, with three clinic visits per week. Cognitive behavioral therapy was provided weekly. Follow-up assessments occurred at 1 and 3 months post-intervention. The planned primary outcome was urine drug screen (UDS)-corrected, self-reported cocaine use during the last 4 weeks of treatment. Planned secondary analyses assessed cocaine use by UDS, medication adherence, retention and adverse events. Results No group differences were found between groups for the primary outcome (BUP4 versus PLB, P = 0.262; BUP16 versus PLB, P = 0.185). Longitudinal analysis of UDS data during the evaluation period using generalized linear mixed equations found a statistically significant difference between BUP16 and PLB [ P = 0.022, odds ratio (OR) = 1.71] but not for BUP4 ( P = 0.105, OR = 1.05). No secondary outcome differences across groups were found for adherence, retention or adverse events. Conclusions Buprenorphine + naloxone, used in combination with naltrexone, may be associated with reductions in cocaine use among people who meet DSM-IV criteria for cocaine dependence and past or current opioid dependence or abuse. [ABSTRACT FROM AUTHOR]

The RELAX trial studied the efficacy of intra‐detrusor onabotulinum toxin A (onaBoNTA) for the treatment of detrusor overactivity (DO) in women. Our objectives in this study were to explore patients' experience and understanding of taking part in a randomised controlled trial (RCT) and their experience of the treatment itself. In addition we explored how patients felt about their bladder problem prior to treatment, conservative management strategies they had been offered, and anti‐muscarinic treatment. Purposive sampling was used to interview patients who had successful and unsuccessful outcomes. Interviewers were blinded to this sampling. Semi‐structured telephone interviews were conducted with all recruited women. Analysis was using a grounded theory approach. Transcripts were analysed thematically based on a constant comparative method until the point of data saturation, that is no new themes were identified. Fifteen women in total were interviewed. There were eight global themes identified. These were: quality of life, conservative management, study awareness, reasons for participation, role of the media, the extension study, intervention and experience of a RCT. The impact of overactive bladder (OAB) symptoms was a strong theme leading to feelings of anxiety. All of the women interviewed perceived pelvic floor exercises as a short term plan. Compliance was sporadic and most discontinued because of lack of efficacy. All women had been counselled about the risk of voiding dysfunction after onaBoNTA treatment and women found the actual process of being taught clean intermittent self‐catheterisation by another woman difficult, Patients stated they felt embarrassed and traumatised by the experience. OnaBoNTA is an effective treatment for patients with DO whose disease burden is considerable. This work highlights the value of incorporating qualitative research methods into the design of RCTs particularly when dealing with surgical procedures. [ABSTRACT FROM AUTHOR]

Aims To investigate the effectiveness of a diabetes virtual clinic to enhance diabetes in primary care by developing clinical management plans for patients with suboptimal metabolic control and/or case complexity. Methods A prospective study with randomized allocation to virtual clinic or usual care. Patients with Type 2 diabetes ( n = 208) were recruited from six general practices in South London. The primary outcome for the study was glycaemic control, secondary outcomes included: lipids, blood pressure, weight (kg and BMI) and renal function ( eGFR). Data were collected from participants' records at baseline and 12 months. We also considered process measures including therapy optimization. Results The 12-month data show equivalence between the virtual clinic and control groups for glycaemic control with both achieving clinically significant reductions in HbA1c of 8 mmol/mol (0.6 ± 1.7%) and 10 mmol/mol (0.8 ± 1.9%), respectively ( P = 0.4). The virtual clinic group showed superiority over the intervention group for blood pressure control with a mean reduction in systolic blood pressure of 6 ± 16 mmHg compared with an increased of 2 ± 18 mmHg in the control group ( P = 0.008). There were no significant differences between the groups in terms of cholesterol, weight and renal function. Process measures showed an increased level of therapy adjustment in the virtual clinic group. Conclusion The virtual clinic model explored in this study showed a clinically important improvement in glycaemic control. Although this improvement was not superior to that observed in the control participants, this might be attributable to the systemic impact of the virtual clinic on the practice as a whole. [ABSTRACT FROM AUTHOR]

Aim To evaluate the effect of self-performed mechanical plaque control ( SPC) frequency on gingival health. Methods Thirty-nine subjects exhibiting limited gingival inflammation and minimal clinical attachment loss were enrolled in a single-blind, parallel group, randomized clinical trial. The subjects that were divided into three groups were tasked to perform SPC (using tooth brush and dental floss) at 12, 24 or 48 h intervals. Gingival index ( GI), plaque index (PlI), and gingival crevicular fluid ( GCF) volume were evaluated at baseline and 30 days follow-up. Groups were compared using anova and Tukey. Results No significant differences in mean GI change were observed between the 12 and 24 h SPC intervals from baseline to 30 days (−0.06 ± 0.13 versus 0.05 ± 0.09; p = 0.11). In contrast, the 48 h interval had significantly higher mean GI change than the 12 and 24 h intervals (0.33 ± 0.17; p = 0.001). Similarly, mean PlI change was not significantly different between the 12 and 24 h SPC intervals (0.11 versus 0.28; p = 0.15), whereas SPC at 48 h-intervals yielded a significantly increased PlI (0.39; p = 0.001). Conclusions Self-performed mechanical plaque control performed at 12 h or 24 h intervals appears sufficient to maintain gingival health in subjects with no or limited clinical attachment loss. [ABSTRACT FROM AUTHOR]

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. Copyright © 2014 John Wiley & Sons, Ltd. Key Practitioner Message 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. [ABSTRACT FROM AUTHOR]

Objective Evaluate the immediate and cumulative optical whitening efficacy of a blue covarine toothpaste. Materials and Methods 180 bovine tooth specimens with similar shade (Δ E < 3.5) were staining of different beverage: black tea(BT), green tea (GT), red wine (RW), orange soda (OS), and brazilian açai juice (AJ), and then submitted to tooth brushing with a blue covarine toothpaste (Op) or a control abrasive toothpaste (Ab). The whitening effect was evaluated at baseline (B), after staining (S), after 1 day (1D) and 7 days of cumulative use of toothpastes (7D). The color shade chances were assessment by Vita Easyshade reflectance spectroscope and the data of CIELab color coordinates (L*, a*, and b*), color difference (Δ E) and the whiteness index optimized (WIO), were analyzed by two-way mixed analysis of variance (ANOVA) for repeated measures and Bonferroni-corrected t-tests (α = 0.05). Results The analysis showed statistically significant differences before and after staining by colored beverages ( p < 0.05), but no differences were found due to the action of toothpaste ( p > 0.05), in the CIELab coordinates, Δ E and WIO index. Conclusions The use of toothpastes (Op or Ab) reduced the dental staining caused by different colored beverage, but the whitening effect of blue covarine toothpaste could not be confirmed ( p > 0.05). [ABSTRACT FROM AUTHOR]

Background In clinical practice as well as research situations, it is of great importance to get reliable information about a patient's alcohol consumption. The aim of the study was to investigate the correlation of alcohol biomarkers (phosphatidylethanol [PEth], carbohydrate-deficient transferrin [ CDT], γ-glutamyltransferase, aspartate aminotransferase, and alanine aminotransferase) to retrospective as well as diary-based alcohol self-reports and to examine whether it is possible to correlate a biomarker result to a more precise level of alcohol consumption. Methods One hundred and sixty alcohol-dependent patients were included in a randomized, placebo-controlled clinical trial of pharmacotherapy for alcohol dependence, of which 115 (76 men and 39 women) completed the study. Retrospective alcohol consumption data were collected at baseline, and alcohol diaries were used during the study. Blood samples for determination of alcohol biomarkers were collected on 5 occasions during the study. Results PEth and CDT showed a better correlation with alcohol consumption documented in the diary ( PEth rs = 0.56 and CDT rs = 0.35) than with retrospective consumption data ( PEth rs = 0.23 and CDT rs = 0.22). An even higher correlation ( rs = 0.63) was seen between the 2 alcohol biomarkers PEth and CDT. At all consumption levels, PEth had the highest sensitivity of all biomarkers studied. Conclusions PEth was the biomarker with the best correlation to self-reported alcohol consumption. PEth was superior to CDT owing to its substantially higher sensitivity but also due to its closer correlation to self-report. PEth values can be translated into an approximate level of alcohol consumption and PEth appears to be a more reliable measure of alcohol consumption than self-reports. [ABSTRACT FROM AUTHOR]

Background: Plasma is commonly used for vitamin K antagonist (VKA) reversal, but observational studies suggest that it is associated with transfusion-related adverse reactions (e.g., volume overload). However, this issue has not previously been addressed in a randomized controlled trial (RCT).Study Design and Methods: Factors associated with volume overload were examined using data from two Phase IIIb RCTs comparing plasma with four-factor prothrombin complex concentrate (4F-PCC, Beriplex/Kcentra, CSL Behring) for urgent VKA reversal. VKA-treated patients with major bleeding (NCT00708435) or requiring an urgent surgical or invasive procedure (NCT00803101) were randomly assigned (1:1) to receive either plasma or 4F-PCC, concomitant with vitamin K. Adverse events (AEs) and serious AEs were prospectively captured up to Day 10 and 45, respectively. Volume overload predictors were evaluated on a univariate and multivariate basis.Results: A total of 388 patients (4F-PCC, n = 191; plasma, n = 197) were enrolled. Volume overload occurred in 34 (9%) patients (4F-PCC, n = 9; plasma, n = 25). In univariate analyses, use of plasma (vs. 4F-PCC), use of nonstudy plasma and/or platelets, race, history of congestive heart failure (CHF), and history of renal disease were associated with volume overload. In multivariate analyses, use of plasma (vs. 4F-PCC), history of CHF, and history of renal disease were independent volume overload predictors. In an additional analysis restricted to volume overload events recorded up to Day 7, only use of plasma (vs. 4F-PCC) was an independent volume overload predictor.Conclusions: After adjusting for other potential risk factors, plasma use was independently associated with a greater risk of volume overload than 4F-PCC in patients requiring urgent VKA reversal. [ABSTRACT FROM AUTHOR]

Aim To evaluate the clinical treatment effects of a glycine powder air-polishing or ultrasonic device on peri-implant mucositis. Materials and methods Thirty-seven patients with one implant diagnosed with peri-implant mucositis (probing depth ≥4 mm (0.2N) and bleeding on probing ( BOP) (primary outcome)) were randomly assigned to treatment with either glycine powder air-polishing ( GPAP) or ultrasonic ( US) debridement. Treatment was performed at baseline and at 3 and 6 months. Professional supra gingival cleaning was performed at 9 and 12 months. Oral hygiene instructions were reinforced at each visit. Results At 12 months there was a statistically significant reduction in mean plaque score, bleeding on probing and number of periodontal pockets ≥4 mm within the treatment groups compared to baseline. The percentages of diseased sites were significantly reduced for both groups. Conclusions Treatment with a glycine powder air-polishing or an ultrasonic device is effective in non-surgical treatment of peri-implant mucositis. [ABSTRACT FROM AUTHOR]

Objectives The objective was to assess adverse outcomes in relation to the simplified Pulmonary Embolism Severity Index ( PESI) score in patients treated with rivaroxaban or standard therapy in the phase III EINSTEIN PE study and to evaluate the utility of the simplified PESI score to identify low-risk pulmonary embolism ( PE) patients. Methods A post hoc analysis of EINSTEIN PE data was performed to assess the efficacy and safety of rivaroxaban in patients with a range of simplified PESI scores. Recurrent venous thromboembolism, fatal PE, all-cause mortality, and major bleeding were stratified by simplified PESI scores of 0, 1, or ≥2 and according to treatment period at 7, 14, 30, and 90 days and at the end of the full intended treatment period. Results Simplified PESI scores could be calculated in 4,831 of the 4,832 randomized patients; of those, 53.6, 36.7, and 9.7% had PESI scores of 0, 1, and ≥2, respectively. Among patients with simplified PESI scores of 0 or 1, fatal PE, all-cause mortality, and other adverse outcomes were uncommon within the first 7, 14, and 30 days. Patients with simplified PESI scores of ≥2 had more frequent adverse outcomes. Major bleeding was lower in the rivaroxaban group, particularly in those with simplified PESI scores of 1 or ≥2. Conclusions The findings support using risk stratification with the simplified PESI score to identify low-risk patients with PE. [ABSTRACT FROM AUTHOR]

Xanthine oxidase (XO), a free radical-generating enzyme, is involved in tissue damage produced during exhaustive exercise. Our aim was to test whether allopurinol, a powerful inhibitor of XO, may be effective in preventing exercise-induced tissue damage in soccer players. Twelve soccer players were randomized into two experimental groups. One received allopurinol, before a match of the premier Spanish Football League, and the other placebo. Allopurinol prevented the exercise-induced increase in all the markers of skeletal muscle damage analyzed: creatine kinase, lactate dehydrogenase, aspartate aminotransferase, and myoglobin. Creatine kinase-MB isoenzyme and highly sensitive troponin T, specific biomarkers of myocardial injury, increased significantly in the placebo but not in the allopurinol-treated group after the football match. We also found that the exercise-induced lipid peroxidation, as reflected by malondialdehyde measurements, was prevented after allopurinol administration. However, inhibition of XO did not prevent the increment in the activity of alanine aminotransferase found after the match. No changes in the serum gamma glutamyltransferase activity was found after the match on either the placebo and the allopurinol groups. These two enzymes were determined as biomarkers of liver injury. Allopurinol represents an effective and inexpensive pharmacological agent to prevent tissue damage in soccer players. [ABSTRACT FROM AUTHOR]

Background This study examined the effects of atomoxetine ( ATX) and OROS methylphenidate ( MPH) on laboratory measures of inhibitory control and attention in youth with attention-deficit/hyperactivity disorder ( ADHD). It was hypothesized that performance would be improved by both treatments, but response profiles would differ because the medications work via different mechanisms. Methods One hundred and two youth (77 male; mean age = 10.5 ± 2.7 years) with ADHD received ATX (1.4 ± 0.5 mg/kg) and MPH (52.4 ± 16.6 mg) in a randomized, double-blind, crossover design. Medication was titrated in 4-6-week blocks separated by a 2-week placebo washout. Inhibitory control and attention measures were obtained at baseline, following washout, and at the end of each treatment using Conners' Continuous Performance Test II ( CPT- II), which provided age-adjusted T-scores for reaction time ( RT), reaction time variability ( RT variability), and errors. Repeated-measures analyses of variance were performed, with Time (premedication, postmedication) and Treatment type ( ATX, MPH) entered as within-subject factors. Data from the two treatment blocks were checked for order effects and combined if order effects were not present. Clinical trial registration: Clinicaltrials.gov: NCT00183391. Results Main effects for Time on RT ( p = .03), RTSD ( p = .001), and omission errors ( p = .01) were significant. A significant Drug × Time interaction indicated that MPH improved RT, RTSD, and omission errors more than ATX ( p < .05). Changes in performance with treatment did not correlate with changes in ADHD symptoms. Conclusions MPH has greater effects than ATX on CPT measures of sustained attention in youth with ADHD. However, the dissociation of cognitive and behavioral change with treatment indicates that CPT measures cannot be considered proxies for symptomatic improvement. Further research on the dissociation of cognitive and behavioral endpoints for ADHD is indicated. [ABSTRACT FROM AUTHOR]

ABSTRACT Benign prostatic hyperplasia ( BPH) is a common problem of the elderly population. This study was conducted to investigate the effect of Urtica dioica on the clinical symptoms of BPH. This double-blind clinical trial included 248 patients with symptomatic BPH in Shohada Ashayer Hospital of Khorramabad. The patients were randomly divided into four groups of treatment with U. dioica 3 g, U. dioica 5 g, U. dioica 7 g and treatment with prazosin 1 mg alone as the control group. The clinical symptoms, patients' quality of life and level of serum prostate-specific antigen ( PSA) were measured before and 2 months after the intervention. The results of the study showed significant differences between the four groups after the intervention for the scores of clinical symptoms and patients' quality of life, while no significant differences were found for serum PSA levels. Sheffe post hoc comparisons showed significant improvements in the scores of the patients' clinical symptom in the U. dioica 5 g/d and U. dioica 7 g/d groups. The results of the study showed that simultaneous consumption of higher doses of U. dioica, up to 7 g/d, plus prazosin, compared with the consumption of prazosin alone, resulted in significant improvements in the clinical symptoms of BPH. [ABSTRACT FROM AUTHOR]

The authors comment on a study comparing Mindfulness Based Interventions (MBIs) with Cognitive Behavioural Therapy (CBT) for the patients with depression, anxiety and stress disorders. Topics discussed include cost effectiveness of mindfulness based group, maintenance of the long term effect of the treatment after intervention and increasing prevalence of depression and anxiety.