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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]

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Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

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]

Background The effectiveness of two treatment approaches (phonological therapy and articulation therapy) for treatment of 14 children, aged 4;0-6;7 years, with phonologically based speech-sound disorder (SSD) has been previously analysed with severity outcome measures (percentage of consonants correct score, percentage occurrence of phonological processes and phonetic inventory). Considering that the ultimate goal of intervention for children with phonologically based SSD is to improve intelligibility, it is curious that intervention studies focusing on children's phonology do not routinely use intelligibility as an outcome measure. It is therefore important that the impact of interventions on speech intelligibility is explored. Aims This paper investigates the effectiveness of the two treatment approaches (phonological therapy and articulation therapy) using intelligibility measures, both in single words and in continuous speech, as the primary outcome. Methods & Procedures Fourteen children with phonologically based SSD participated in the intervention. The children were randomly assigned to phonological therapy or articulation therapy (seven children in each group). Two assessment methods were used for measuring intelligibility: a word identification task (for single words) and a rating scale (for continuous speech). Twenty-one unfamiliar adults listened and judged the children's intelligibility. Reliability analyses showed overall high agreement between listeners across both methods. Outcomes & Results Significant improvements were noted in intelligibility in both single words (paired t(6) = 4.409, p = 0.005) and continuous speech (asymptotic Z = 2.371, p = 0.018) for the group receiving phonology therapy pre- to post-treatment, but no differences in intelligibility were found for those receiving the articulation therapy pre- to post-treatment, either for single words (paired t(6) = 1.763, p = 0.128) or continuous speech (asymptotic Z = 1.442, p = 0.149). Conclusions & Implications Intelligibility measures were sensitive enough to show changes in the phonological therapy group but not in the articulation therapy group. These findings emphasize the importance of using intelligibility as an outcome measure to complement the results obtained with other severity measures when exploring the effectiveness of speech interventions. This study presents new evidence for the effectiveness of phonological therapy in improving intelligibility with children with SSD. [ABSTRACT FROM AUTHOR]

Background: The short dating period of room temperature-stored platelets (PLTs; 5-7 days) limits their availability at far-forward combat facilities and at remote civilian sites in the United States. PLT cryopreservation in 6% DMSO and storage for up to 2 years may improve timely availability for bleeding patients.Study Design and Methods: A dose escalation trial of DMSO-cryopreserved PLTs (CPPs) compared to standard liquid-stored PLTs (LSPs) was performed in bleeding patients with thrombocytopenia. Within each of four cohorts, six patients received escalating doses of CPP (0.5 unit, 1 unit, and sequential transfusions of 2 and 3 units) and one received a LSP transfusion. Patients were monitored for adverse events (AEs), coagulation markers, PLT responses, and hemostatic efficacy.Results: Patients with a World Health Organization bleeding score of 2 or more received from 0.5 to 3 units of CPP (n = 24) or 1 unit of LSP (n = 4). There were no related thrombotic or other serious AEs experienced. Mild transfusion-related AEs of chills and fever (n = 1), transient increased respiratory rate (n = 1), DMSO-related skin odor (n = 2), and headache (n = 1) were observed after CPP transfusion. Among CPP recipients 14 of 24 (58%) had improved bleeding scores, including three of seven (43%) patients who had intracerebral bleeding. CPP posttransfusion PLT increments were significantly less than those of LSPs; however, days to next transfusion were the same. After transfusion, the CPP recipients had improvements in some variables of thrombin generation tests and thromboelastography.Conclusion: Cryopreserved PLT transfusions appear to be safe and effective when given to bleeding patients with thrombocytopenia. [ABSTRACT FROM AUTHOR]

Background: Fluid treatment in sepsis is a challenge and clinical equipoise exists regarding intravenous (IV) volumes. We aimed to determine whether a 24‐h protocol restricting IV fluid was feasible in adult patients with sepsis without shock presenting to the emergency department (ED). Methods: The REFACED Sepsis trial is an investigator‐initiated, multicenter, randomized, open‐label, feasibility trial, assigning sepsis patients without shock to 24 h of restrictive, crystal IV fluid administration or standard care. In the IV fluid restriction group fluid boluses were only permitted if predefined criteria for hypoperfusion occurred. Standard care was at the discretion of the treating team. The primary outcome was total IV crystalloid fluid volumes at 24 h after randomization. Secondary outcomes included total fluid volumes, feasibility measures, and patient‐centered outcomes. Results: We included 123 patients (restrictive 61 patients and standard care 62 patients) in the primary analysis. A total of 32% (95% confidence interval [CI] 28%–37%) of eligible patients meeting all inclusion criteria and no exclusion criteria were included. At 24 h, the mean (±SD) IV crystalloid fluid volumes were 562 (±1076) ml versus 1370 (±1438) ml in the restrictive versus standard care group (mean difference –801 ml, 95% CI −1257 to −345 ml, p = 0.001). Protocol violations occurred in 21 (34%) patients in the fluid‐restrictive group. There were no differences between groups in adverse events, use of mechanical ventilation or vasopressors, acute kidney failure, length of stay, or mortality. Conclusions: A protocol restricting IV crystalloid fluids in ED patients with sepsis reduced 24‐h fluid volumes compared to standard care. A future trial powered toward patient‐centered outcomes appears feasible. [ABSTRACT FROM AUTHOR]

Background: Metacognitive training for depression (D‐MCT) is a novel low‐intensity group training for economic treatment of depression. Previous studies demonstrate its efficacy in moderately depressed outpatients. The present study evaluated efficacy and patients' perspective of the D‐MCT in severely depressed psychiatric inpatients. Methods: In a randomized‐controlled trial, 75 individuals with a major depressive disorder (MDD) were allocated to D‐MCT versus euthymic therapy as add‐on (twice a week) to cognitive‐behavioural‐based (CBT) inpatient‐care. Depressive symptoms (HDRS, BDI), dysfunctional (meta)cognition (DAS, MCQ‐30) and subjective appraisal were assessed at baseline, 4 weeks (post) and 3 months (follow‐up). Results: Participants in both conditions showed a large decline in depression at post and follow‐up‐assessment. No superior add‐effect of D‐MCT versus active control emerged for depression severity on top of the inpatient care. However, among patients with a diagnosis of MDD with no (vs. at least one) comorbidity, D‐MCT participants showed a larger decline in depressive (meta‐)cognition at follow‐up with medium‐to‐large effect sizes. D‐MCT was evaluated as superior in overall appraisal, treatment preference, motivation and satisfaction. Limitations: The follow‐up time interval of 3 months may have been too short to detect long‐term effects. There is emerging evidence that modification of (meta)cognition unfolds its full effects only with time. Effects of CBT inpatient‐care on outcome parameters cannot be differentiated. Conclusions: Although D‐MCT as an add‐on was not superior in complete case analyses, results suggest greater benefit for patients with MDD and no comorbidity. D‐MCT proved feasible in acute‐psychiatric inpatient‐care and was highly accepted by patients. Future studies should investigate the role of modified (meta)cognition on long‐term treatment outcome, including dropout and relapse rates. [ABSTRACT FROM AUTHOR]

Buprenorphine was registered in Australia as a maintenance and detoxification agent for the management of opioid dependence in November, 2000, and became widely available in August, 2001. This paper provides an overview of key developments in the introduction of buprenorphine treatment in Australia, with an emphasis upon the delivery of services in community-based (primary care) settings. A central study in this work was the Buprenorphine Implementation Trial (BIT), a randomized, controlled trial comparing buprenorphine and methadone maintenance treatment delivered under naturalistic conditions by specialist and community-based service providers (general practitioners and community pharmacists) in 139 subjects across nineteen treatment sites. In addition to conventional patient outcome measures (treatment retention, drug use, psychosocial functioning, and cost effectiveness), the BIT study also involved the development and evaluation of clinical guidelines, training programs for clinicians, and client literature, which are described here. Integration of treatment systems (methadone with buprenorphine, specialist and primary-care programs) and factors thought to be important in the uptake of buprenorphine treatment in Australia since registration are discussed. [ABSTRACT FROM AUTHOR]

Background and aims: Evidence for efficacy of brief alcohol interventions (BAIs) is mainly limited to primary care and at‐risk drinkers. The aim was to test the efficacy of a BAI addressing the full spectrum of alcohol use in a general population sample and across alcohol risk groups. Design Two‐parallel‐group randomized controlled trial (allocation ratio 1:1) with post‐baseline assessments at months 3, 6 and 12. Setting: One municipal registry office in Germany responsible for registration, passport and vehicle admission issues. Participants: A total of 1646 proactively recruited 18–64‐year‐old adults with past year alcohol use (56% women, 66% low‐risk drinkers) were randomized to intervention (n = 815) or control (n = 831). Intervention and comparator: The intervention consisted of assessment plus computer‐generated individualized feedback letters at baseline and months 3 and 6. Comparator was assessment only. Measurements Primary outcome was change in the self‐reported number of drinks/week from baseline to 12 months. Changes at 3 and 6 months were secondary outcomes. Moderator was alcohol risk group (low‐risk versus at‐risk drinking) according to the Alcohol Use Disorders Identification Test–Consumption, with scores from 1‐3 (women) and from 1‐4 (men) indicating low‐risk drinking. Findings For the whole sample, significant group differences were observed neither at 12‐month follow‐up [incidence rate ratio (IRR) = 1.01, 95% confidence interval (CI) = 0.87–1.17, Bayes factor (BE) = 0.52] nor at previous assessments (month 3: IRR = 1.01, 95% CI = 0.92–1.12, BE = 0.41; month 6: IRR = 0.93, 95% CI = 0.81–1.07, BE = 1.10). Moderator analyses revealed that low‐risk drinkers were more likely to benefit from BAI only at month 6 than at‐risk drinkers (IRR = 0.77, 95% CI = 0.70–0.86). Conclusions: In a randomized controlled trial, there was no clear evidence for efficacy of a computer‐based brief alcohol intervention in a general population sample, but there was some evidence of medium‐term benefits in the large but understudied group of low‐risk drinkers. [ABSTRACT FROM AUTHOR]

Ready‐to‐use therapeutic foods (RUTF) used to treat children with severe acute malnutrition (SAM) are costly, and the prescribed dosage has not been optimized. The MANGO trial, implemented by Action Contre la Faim in Burkina Faso, proved the non‐inferiority of a reduced RUTF dosage in community‐based treatment of uncomplicated SAM. We performed a cost‐minimization analysis to assess the economic impact of transitioning from the standard to the reduced RUTF dose. We used a decision‐analytic model to simulate a cohort of 399 children/arm, aged 6–59 months and receiving SAM treatment. We adopted a societal perspective: direct medical costs (drugs, materials and staff time), non‐medical costs (caregiver expenses) and indirect costs (productivity loss) in 2017 international US dollar were included. Data were collected through interviews with 35 caregivers and 20 informants selected through deliberate sampling and the review trial financial documents. The overall treatment cost for 399 children/arm was $36,550 with the standard and $30,411 with the reduced dose, leading to $6,140 (16.8%) in cost savings ($15.43 saved/child treated). The cost/consultation was $11.6 and $9.6 in the standard and reduced arms, respectively, with RUTF accounting for 56.2% and 47.0% of the total. The savings/child treated was $11.4 in a scenario simulating the Burkinabè routine SAM treatment outside clinical trial settings. The reduced RUTF dose tested in the MANGO trial resulted in significant cost savings for SAM treatment. These results are useful for decision makers to estimate potential economic gains from an optimized SAM treatment protocol in Burkina Faso and similar contexts. [ABSTRACT FROM AUTHOR]

Explosive strength and balance training are commonly applied to enhance explosive strength and balance performance. Even though both training methods are frequently implemented, ordering effects have largely been neglected. Therefore, the present study aimed to investigate ordering effects of balance and explosive strength training on explosive strength and balance performance as well as changes in short‐interval intracortical inhibition (SICI). Two groups of subjects either participated in 4 weeks of balance training followed by 4 weeks of explosive strength training (BT‐ET) or vice versa (ET‐BT). Before, after 4 and 8 weeks, balance performance, as well as explosive strength, was tested. Additionally, SICI was tested during rest as well as during balance perturbations and explosive contractions. The results show a training specific increase in performance with an increase in balance control followed by an increase in explosive strength in the BT‐ET, while the ET‐BT increased its balance and explosive strength in the opposite order. There were no significant ordering effects. Both groups showed a significant decrease in SICI during the explosive contractions after the eight weeks of training. When SICI was tested during the balance perturbations, SICI initially increased after the first 4 weeks of training but returned to baseline until the end of the eight weeks. It is suggested that the decrease in SICI with prolonged training might show a disengagement of the motor cortex during the balance task. During the explosive contractions, the low SICI levels are beneficial to provide the necessary level of excitatory cortical drive. [ABSTRACT FROM AUTHOR]

Background: Computer‐based delivery of cognitive behavioral therapy (CBT) may be a less costly approach to increase dissemination and implementation of evidence‐based treatments for alcohol use disorder (AUD). However, comprehensive evaluations of costs, cost‐effectiveness, and cost–benefit of computer‐delivered interventions are rare. Methods: This study used data from a completed randomized clinical trial to evaluate the cost‐effectiveness and cost–benefit of a computer‐based version of CBT (CBT4CBT) for AUD. Sixty‐three participants were randomized to receive one of the following treatments at an outpatient treatment facility and attended at least one session: (1) treatment as usual (TAU), (2) CBT4CBT plus treatment as usual (CBT4CBT+TAU), or (3) CBT4CBT plus brief monitoring. Results: Median protocol treatment costs per participant differed significantly between conditions, Kruskal‐Wallis H(2) = 8.40, p = 0.02, such that CBT4CBT+TAU and CBT4CBT+monitoring each cost significantly more per participant than TAU. However, when nonprotocol treatment costs were included, total treatment costs per participant did not differ significantly between conditions. Median incremental cost‐effective ratios (ICERs) revealed that CBT4CBT+TAU was more costly and more effective than TAU. It cost $35.08 to add CBT4CBT to TAU to produce a reduction of one additional drinking day per month between baseline and the end of the 8‐week treatment protocol: CBT4CBT+monitoring cost $33.70 less to produce a reduction of one additional drinking day per month because CBT4CBT+monitoring was less costly than TAU and more effective at treatment termination, though not significantly so. Net benefit analyses suggested that costs of treatment, regardless of condition, did not offset monthly costs related to healthcare utilization, criminal justice involvement, and employment disruption between baseline and 6‐month follow‐up. Benefit–cost ratios were similar for each condition. Conclusions: Results of this pilot economic evaluation suggest that an 8‐week course of CBT4CBT may be a cost‐effective addition and potential alternative to standard outpatient treatment for AUD. Additional research is needed to generate conclusions about the cost–benefit of providing CBT4CBT to treatment‐seeking individuals participating in standard outpatient treatment. [ABSTRACT FROM AUTHOR]

The purpose of the study was to compare treatment of chronic rhinosinusitis (CRS) with topical glucocorticoids and saline irrigation versus aerosol inhalation therapy. Patients diagnosed with CRS were randomly divided into 2 groups. In the first group, patients were treated with topical glucocorticoids (mometasone furoate, 100 µg in each nostril once daily) and saline irrigation (150 mL twice a day) for 2 weeks. In the second group, patients were treated with inhalation aerosol therapy composed of essential oils, saline, glucocorticoids, and antibiotics, once daily 5 times per week (Monday through Friday), for 2 weeks. The effect of the treatments was compared between the 2 groups. In the first group there was no significant improvement in the Glasgow Health Status Inventory (GHSI) (P =.29). In the second group the improvement in GHSI score was significant (P =.037). It was shown that in the first group the Glasgow Benefit Inventory score was significantly lower than in the second group (P =.002), which means that the improvement in the health status after the therapy was better in the second group. A Lund‐Kennedy score showed statistical improvement in both groups (both P <.001). Improvement was also compared between the groups. The results were not significant (P =.11). The authors concluded that, in this preliminary research, inhalation aerosol therapy composed of essential oils, saline, glucocorticoids, and antibiotics led to better subjective results than intranasal glucocorticoid therapy and saline irrigation in the treatment of CRS. Further investigations with more participants, longer periods of treatment, and different validation tools are needed to confirm our results. [ABSTRACT FROM AUTHOR]

Background: Conventional infiltration anaesthesia (CIA) is the most frequently used in paediatric oral health care. However, other techniques are available, such as intraosseous anaesthesia (IOA), that can beneficiate from newly developed technologies. Aim: To compare the pain caused by CIA and IOA delivered by the computerized system (QuickSleeper™) in children. Design: We used an innovative design consisting in simultaneously conducting a multicentre split‐mouth and parallel‐arm randomized controlled trial (RCT) to allow for increased power. The primary outcome was pain reported by the patient on a visual analogue scale (0‐10 cm) concerning the insertion of the needle and injection. Results: A total of 30 children were included in the split‐mouth RCT and 128 in the parallel‐arm RCT. We combined treatment effect estimates by using an inverse‐variance weighting meta‐analysis approach. Pain scores were significantly decreased with IOA vs CIA (mean difference −0.69 cm, 95% confidence intervals −1.13 to −0.25 cm). For each patient enrolled in the split‐mouth RCT, about five were enrolled in the parallel‐arm RCT, which allowed for not losing any eligible patients. Conclusion: Pain during the insertion of the needle and injection was less with IOA vs CIA in children. The design of this study allowed for increasing statistical power and using all generated evidence. (ClinicalTrials.gov NCT02084433). [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]

Objectives: The aim of this double-blinded randomised placebo-controlled trial was to investigate the efficacy of clonidine for delirium in medical inpatients greater than 65 years.Methods: Acutely admitted medical patients greater than 65 years with delirium or subsyndromal delirium were eligible for inclusion. Included patients were given a loading dose of either placebo or clonidine; 75 μg every third hour up to a maximum of four doses to reach steady state and further 75 μg twice daily until delirium free for 2 days, discharge or a maximum of 7 days of treatment. The primary endpoint was the trajectory of the Memorial Delirium Assessment Scale (MDAS) for the 7 days of treatment. Presence of delirium according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria and severity measured by MDAS were assessed daily until discharge or a maximum of 7 days after end of treatment.Results: Because of slower enrolment than anticipated, the study was halted early. Ten patients in each group were studied. The low recruitment rate was mainly due to the presence of multiple patient exclusion criteria for patient safety. There was no significant difference between the treatment group in the primary endpoint comparing the trajectory of MDAS for the 7 days of treatment using mixed linear models with log transformation, (P = .60). The treatment group did not have increased adverse effects.Conclusions: No effect of clonidine for delirium was found, although the study was under powered. Further studies in less frail populations are now required. [ABSTRACT FROM AUTHOR]

Objective: Clinical trial results have shown that, in glucocorticoid‐treated patients, treatment with denosumab 60 mg subcutaneously once every 6 months (Q6M) increased spine and hip bone mineral density (BMD) at month 12 significantly more than treatment with risedronate 5 mg orally once daily (QD). The present analysis was performed to compare efficacy and characterize safety through month 24. Methods: This phase III study enrolled men and women ≥18 years old who had received ≥7.5 mg daily prednisone or equivalent for <3 months (glucocorticoid‐initiating) or for ≥3 months (glucocorticoid‐continuing) before screening. All patients <50 years old had a history of osteoporotic fracture. Glucocorticoid‐continuing patients ≥50 years old had T scores of −2.0 or less (or −1.0 or less with fracture history). Patients were randomized (1:1) to receive denosumab 60 mg subcutaneously Q6M or risedronate 5 mg orally QD for 24 months, with daily calcium and vitamin D. Results: Of 795 patients, 590 (74.2%) completed the study (in the glucocorticoid‐initiating group, 109 of 145 patients treated with denosumab and 117 of 145 patients treated with risedronate; in the glucocorticoid‐continuing group, 186 of 253 patients treated with denosumab and 178 of 252 patients treated with risedronate). Denosumab was superior to risedronate in increasing lumbar spine and total hip BMD at all time points assessed, among glucocorticoid‐initiating patients (24‐month lumbar spine: BMD increase of 6.2% versus 1.7%, respectively [P < 0.001]; 24‐month total hip: BMD increase of 3.1% versus 0.0% [P < 0.001]) and among glucocorticoid‐continuing patients (24‐month lumbar spine: BMD increase of 6.4% versus 3.2% [P < 0.001]; 24‐month total hip: BMD increase of 2.9% versus 0.5% [P < 0.001]). Adverse events, serious adverse events (including infections), and fractures were similar between treatment groups. Conclusion: Denosumab was superior to risedronate in terms of increases in spine and hip BMD through month 24, and the safety profile was similar between treatment groups. Denosumab may offer a new osteoporosis treatment option for glucocorticoid‐treated patients. [ABSTRACT FROM AUTHOR]

Background: Currently, comparison studies on glycaemic control by originator versus generic fixed‐dose antidiabetic drugs are limited. Aim: This study assessed the efficacy, adherence and adverse effects between originator and generic fixed‐dose glibenclamide/metformin after switching from gliclazide coadministered with metformin, and after interchanging the originator and generic fixed‐dose tablets between the study groups. Methods: A prospective randomised cross‐over study was conducted among type 2 diabetes mellitus patients treated with stable doses of at least 240 mg gliclazide plus 1000 mg metformin in the Out‐Patient Clinic, Penang Hospital. Patients were randomised to receive either originator (Group A) or generic (Group B) glibenclamide/metformin 2.5/500 mg, two tablets twice daily for 12 weeks. After 12 weeks, Group A and Group B were switched to generic and originator, respectively, for another 12 weeks. HbA1c, pill count and hypoglycaemic episodes were measured at baseline and at 12 and 24 weeks. Results: The mean (±SD) age of the 84 patients in the study was 58.01 ± 7.87 years, and the median duration of diabetes was 10.00 years (interquartile range 7.00–16.75 years). Baseline characteristics were similar between the two groups. Mean HbA1c decreased significantly from 0 to 12 weeks in Groups A and B (−0.76% and −0.56%, respectively), but increased significantly from 12 to 24 weeks (+0.39% and +0.33%, respectively). There was no significant difference in the mean change in HbA1c between the two groups. Adherence improved significantly by 11% when patients were switched to fixed‐dose glibenclamide/metformin regardless of whether it was originator or generic. There was no significant difference between originator and generic in the number of hypoglycaemic episodes (11 vs 32; p = 0.825) after switching to fixed‐dose glibenclamide/metformin. Conclusion: Generic glibenclamide/metformin was therapeutically equivalent to its originator. [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]

Aim: To determine the effect of vaginal tablet of Salvia officinalis, alone and in combination with Clotrimazole, on the recovery of Vulvovaginal candidiasis. Methods: In this triple‐blind randomized controlled trial, 111 participants were randomly assigned into three groups of 37 patients using block randomization with block sizes of 6 and 9, and allocation ratio of 1:1:1: 100 mg vaginal tablet of Clotrimazole and Placebo (CP), 400 mg vaginal tablet of S. officinalis and Placebo (SP), and vaginal tablet of S. officinalis and Clotrimazole (SC), once daily for 7 days. On the seventh day after the treatment was ended up, Vulvovaginal candidiasis were examined by vaginal symptoms and wet test, and if positive, they were examined by culture in chrome agar Candida medium. Results: Socio‐demographic characteristics was similar (P > 0.05). Thirty‐six, 36 and 35 patients, respectively in CP, SC and SP groups recruited in the study. The frequency of a positive wet test confirmed by Sabrodextrose agar medium 7 days after treatment was significantly lower in SC group than the reference group of CP (adjusted odds ratio = 0.09, 95% confidence interval: 0.93–0.932, P = 0.043). There was no significant difference between SP and CP group (P = 0.071, 95% confidence interval: 0.032–1.151, adjusted odds ratio = 0.192). Also, there was no significant difference between the three groups in terms of vaginal symptoms at the baseline (P > 0.05), however the statistical differences were indicated after the intervention in cheesy discharge, pruritus and Vulvovaginal edema (P < 0.05.(. Conclusion: S. officinalis in the form of vaginal tablet, alone and when combined with Clotrimazole, can treat the Vulvovaginal Candidiasis. [ABSTRACT FROM AUTHOR]

Aim: The aim of this study was to evaluate immediate pain control in patients who underwent laparoscopic myomectomy (LM) by intraoperative injection of ropivacaine into both uterosacral ligaments. Methods: The study was a prospective, double‐blind, randomized study. We analyzed 46 cases of LM performed between July 2015 and November 2016 by a single surgeon. We randomized the enrolled patients into either a ropivacaine or a saline injection group. Before the surgeon closed the abdominal wall, each 7.5% ropivacaine (5 mL) or saline (5 mL) was administered into both uterosacral ligaments through laparoscopic injection needle. We compared the pain intensity scores 2, 6, 12, and 24 h after injection between the two groups. Results: The pain intensity scores were not significantly different. However, the ropivacaine group requested less of the analgesic than the placebo‐injected group requested (P = 0.035). No patient in the ropivacaine group reported any side effects. Conclusion: Intraoperative ropivacaine injection into both uterosacral ligaments during LM can reduce the dosage of opioid analgesics. [ABSTRACT FROM AUTHOR]

Objectives: To assess the effects of Xerostom® toothpaste and mouthwash in primary Sjögren's syndrome (pSS) patients with xerostomia. Subjects and Methods: A double‐blinded, randomized study where patients were assigned at baseline test or control products. Patients used the products 3 times/day/28 days. We used a visual analogue scale (VAS) for xerostomia and an Oral Health Impact Profile‐14 (OHIP‐14), baseline and after treatment, to assess possible improvement. Results: A total of 28 patients with pSS were included in this study, but only 24 finished it (all women, mean age 55.21 ± 11.87), and 13 patients received the test and 11 the control. VAS and OHIP‐14 scores decreased in both groups after treatment but significant differences between groups were not found. We do not detect VAS intragroup significant differences before and after treatment in test and control groups. A significant improvement in OHIP‐14 was identified in the treatment group, while no significant differences were observed in the control group. No adverse effects were present. Conclusions: Xerostom® toothpaste and mouthrinse may alleviate and improve quality of life without associated side effects, but further research with a larger number of participants and follow‐up are necessary to establish the positive efficacy of these topical products in pSS patients. [ABSTRACT FROM AUTHOR]

Adjustment disorder (AD) and complicated grief (CG) are serious mental conditions that have a high prevalence and are associated with significant impairments in social and work functioning. Recently, these categories have been better specified in the new ICD‐11 proposal. Empirical research on the efficacy of treatments for these problems is scarce. This study aims to offer long‐term efficacy data from a between‐groups controlled study that compares two treatment conditions (AD‐protocol applied in a traditional way: N = 18 and the same protocol supported by virtual reality (VR); VR‐protocol applied in a traditional way: N = 18) and a waiting list (WL) control group (N = 18). Both treatment conditions resulted in statistically significant improvements on both primary and secondary outcome measures, with large effect sizes, and this improvement did not occur in the WL. These changes were maintained in both treatment conditions in the medium (6‐month) and long‐term (12‐month follow‐up). Larger effect sizes were achieved in the VR condition in the long term. Furthermore, clinically significant change estimations on the primary outcome measures showed an advantage for the VR condition This is the first controlled study to compare a traditional face‐to‐face protocol for the treatment of stress‐related disorders with the same protocol supported by VR and a WL control group. [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: Fluent word reading is a key characteristic of skilled reading, yet most children with reading disorders have impaired word‐reading skills. Previous research has demonstrated that multi‐component interventions targeting phonemic awareness and the alphabetic principle are effective for children with reading disorders. However, about 25% of children fail to respond to these interventions. While it has been difficult to isolate the active ingredient, the findings of some studies suggest that tasks targeting phonological recoding and orthographic processing are essential elements in improving decoding. Aims: To develop and evaluate an intervention that specifically targets phonological recoding and orthographic processing (a decoding intervention) for children with persistent word‐reading impairment. Methods & Procedures: A single‐subject crossover design with multiple treatments was used to examine the efficacy of the decoding intervention (15 × 20‐min sessions) compared with a language intervention that controlled for individual therapy time. Eight children (aged 7:6–8:11 years) with persistent word‐reading impairment were randomly assigned to one of two intervention sequences. The effect of the decoding intervention was evaluated by (1) changes in decoding accuracy measured by performance on researcher‐developed non‐word lists; and (2) generalization to other standardized measures of reading. Outcomes & Results: The results showed that all participants demonstrated significant gains in non‐word reading on researcher‐developed non‐word lists and standardized measures of non‐word‐reading accuracy and efficiency. Trends for improvement on standardized measures of word‐reading efficiency, text‐reading accuracy and reading comprehension were observed. Conclusions & Implications: This decoding intervention significantly improved non‐word decoding skills in all participants who had not responded to previous reading interventions. As such, it may be an efficient adjunct to the first stage of reading interventions for this population. The relative lack of generalization to other word‐reading skills may have been due to the nature of the outcome measures, the short intervention time and/or additional delays in participant orthographic processing skills. [ABSTRACT FROM AUTHOR]

Dental anxiety causes patients to refuse or delay treatment, which may exacerbate oral diseases. The aim of the current randomized controlled trial was to determine whether progressive muscle relaxation therapy could relieve dental anxiety. The trial included 68 periodontal patients with dental anxiety scores of ≥13 who were randomly assigned to either an intervention group or a control group (n = 34 per group). The intervention group was administered progressive muscle relaxation therapy for 20 min and oral health education for 15 min before periodontal treatment once per week for 4 wk. The control group was provided with oral health education only, for the same duration. Changes in dental anxiety, depression symptoms, blood pressure, heart rate, and salivary cortisol were evaluated 4 wk and 3 months after the intervention. The intervention group exhibited statistically significantly greater reductions in dental anxiety scores than did the control group at the 4‐wk (−3.82 vs. −0.89) and 3‐month (−4.22 vs. −0.28) assessments. They also exhibited significantly greater reductions in depression symptoms, systolic and diastolic blood pressure, pulse rate, and salivary cortisol levels at both time‐points. Progressive muscle relaxation therapy relieves tension and anxiety in dental patients. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the impact of a transcutaneous electrical nerve stimulation (TENS) program for hemodialysis on patients' dry mouth and salivary flow rates. Subjects and Methods: A single‐blinded repeated measures study design was used. A total of 80 subjects were randomly assigned to a treatment group receiving a 250 µs; 50 Hz TENS program and a control group receiving a 50 µs; 2 Hz TENS program at acupoints ST 6 and TE17 three times a week for 3 weeks. Whole salivary flow rate and dry mouth intensity were measured totally five times for both groups, at pretreatment, after three, six, nineTENS sessions, and 1 week after the treatment was completed. Results: After six TENS sessions were completed, whole salivary flow rates increased stably until the end of nine TENS sessions for the treatment group. In the follow‐up week after treatment, there was significant increase as well. However, significant improvement in dry mouth intensity was observed at all post‐tests than that at pretreatment in both groups. Conclusion: Whole salivary flow rates and improvement in dry mouth intensity were only observed during and 1 week after the TENS sessions. Further studies are needed to evaluate whether this method can offer a long‐term effective nonpharmacological therapy for dry mouth‐disturbed hemodialysis patients. [ABSTRACT FROM AUTHOR]

Background: Transient tachypnea of the newborn (TTN) is a respiratory disorder that results from inadequate or delayed clearance of fetal lung fluid following delivery. At present, supportive care is generally practiced for the treatment of TTN. In this study, we focused on inhaled beta‐agonists for the treatment of TTN, and the aim was to verify the efficacy and the safety of inhaled procaterol for the treatment of TTN. Methods: Inhaled procaterol or normal saline solution was administered to infants. Respiratory rate and mixed venous carbon dioxide (PvCO2) were evaluated as the primary outcomes. The duration of hospitalization, duration of oxygen therapy, and changes in respiratory support were evaluated as secondary outcomes. Results: Thirty‐seven neonates diagnosed with TTN were randomly assigned to the procaterol group (n = 18) or the placebo group (n = 19). There were no differences in PvCO2 or respiratory rate between the two groups before and after intervention. Median duration of oxygen therapy (3 days; IQR, 3–6.5 days vs 2 days, IQR, 2–4.75 days; P = 0.13) and of hospitalization (15 days; IQR, 11.25–20 days vs 11 days, IQR, 8–15.5 days; P = 0.14) were not significantly different. Conclusions: Inhaled procaterol was not effective for the treatment of TTN. [ABSTRACT FROM AUTHOR]

Objective: To determine whether oral clindamycin reduces the risk of preterm birth (PTB) in women with abnormal vaginal microflora as evidenced by a vaginal pH ≥5.0.Design: Randomised double-blind placebo-controlled trial.Setting: Rural southern India.Population: Pregnant women with a singleton fetus between 13+0/7 weeks and 20+6/7 weeks.Methods: Pregnant women were recruited during prenatal visits in Karnataka, India, from October 2013 to July 2015. Women were required to have a singleton fetus between 13+0/7 weeks and 20+6/7 weeks and an elevated vaginal pH (≥5.0) by colorimetric assessment. Participants were randomised to either oral clindamycin 300 mg twice daily for 5 days or an identical-appearing placebo.Main Outcome Measures: The primary outcome was the incidence of PTB, defined as delivery before 37+0/7 weeks.Results: Of the 6476 screened women, 1727 women were randomised (block randomised in groups of six; clindamycin n = 866, placebo n = 861). The demographic, reproductive, and anthropomorphometric characteristics of the study groups were similar. Compliance was high, with over 94% of capsules being taken. The rate of PTB before 37 weeks was comparable between the two groups [clindamycin 115/826 (13.9%) versus placebo 111/806 (13.8%), between-group difference 0.2% (95% CI -3.2 to 3.5%, P = 0.93)], as was PTB at less than 34 weeks [clindamycin 40/826 (4.8%) versus placebo group 37/806 (4.6%), between-group difference 0.3% (95% CI -1.8 to 2.3%, P = 0.81)]. No differences were detected in the incidence of birthweight of<2500 g, <1500 g, miscarriage, stillbirth or neonatal death.Conclusion: In this setting, oral clindamycin did not decrease PTB among women with vaginal pH ≥5.0.Tweetable Abstract: Oral clindamycin between 13+0/7 and 20+6/7 weeks does not prevent preterm birth in women with a vaginal pH ≥5.0. [ABSTRACT FROM AUTHOR]

We report the rationale and design of a community PHARMacy-based prospective randomized controlled interdisciplinary study for ambulatory patients with Chronic Heart Failure (PHARM-CHF) and results of its pilot study. The pilot study randomized 50 patients to a pharmacy-based intervention or usual care for 12 months. It demonstrated the feasibility of the design and showed reduced systolic blood pressure in the intervention group as indicator for improved medication adherence. The main study will randomize patients ≥60 years on stable pharmacotherapy including at least one diuretic and a history of heart failure hospitalization within 12 months. The intervention group will receive a medication review at baseline followed by regular dose dispensing of the medication, counselling regarding medication use and symptoms of heart failure. The control patients are unknown to the pharmacy and receive usual care. The primary efficacy endpoint is medication adherence, pre-specified as a significant difference of the proportion of days covered between the intervention and control group within 365 days following randomization using pharmacy claims data for three CHF medications (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, beta-blockers, and mineralocorticoid receptor antagonists). The primary composite safety endpoint is days lost due to blindly adjudicated unplanned cardiovascular hospitalizations or death. Overall, 248 patients shall be randomized. The minimum follow-up is 12 months with an expected mean of 24 months. Based on the feasibility demonstrated in the pilot study, the randomized PHARM-CHF trial will test whether an interdisciplinary pharmacy-based intervention can safely improve medication adherence and will estimate the potential impact on clinical endpoints. ClinicalTrials.gov Identifier: NCT01692119. [ABSTRACT FROM AUTHOR]

Background and Objective: Glycine powder air‐polishing (GPAP) is an alternative approach to removing subgingival plaque biofilms for effective periodontal therapy. This study aimed to investigate the effect of subgingival GPAP as an additional approach to nonsurgical periodontal treatment in subjects with chronic periodontitis. Material and Methods: Twenty‐seven nonsmoking subjects were recruited. Two quadrants in each subject were randomly assigned, according to a split‐mouth design, to receive scaling and root planing (SRP) and GPAP (Test group) or SRP and air flushing with water (Control group) at sites with probing depth ≥5 mm. Clinical parameters, gingival crevicular fluid volumes and the concentrations of interleukin‐1β and interleukin‐1ra in gingival crevicular fluid were measured at baseline and 1, 3 and 6 months after the treatments. Results: At baseline, no statistically significant difference in periodontal and gingival crevicular fluid parameters was found between the Test and Control groups. Overall, the periodontal conditions of all subjects showed significant improvement after the treatments. Notably, the Test group showed greater reduction in gingival crevicular fluid volume (0.37 ± 0.26 μL) than the Control group (0.23 ± 0.30 μL) at 3 months (P < .05). The gingival crevicular fluid levels of interleukin‐1β and interleukin‐1ra showed a significant decrease in both groups at 6 months, and no significant difference was found between the groups. Conclusion: These preliminary results suggest that GPAP, as an additional approach to nonsurgical periodontal treatment, may be beneficial for the short‐term improvement of subclinical inflammation when measured by gingival crevicular fluid volume. Further longitudinal studies with larger sample sizes are required to clarify the exact benefits of GPAP treatment for controlling inflammation and maintaining long‐term periodontal health. [ABSTRACT FROM AUTHOR]

Abstract: Background and Objective: Oral probiotics appear to improve the treatment of periodontal diseases but there is limited evidence on their efficacy in the treatment of peri‐implant diseases. The objective of the present study was to evaluate, clinically and microbiologically, the effect of the oral probiotic, Lactobacillus reuteri Prodentis, as adjuvant to non‐surgical mechanical therapy in implants with mucositis or peri‐implantitis, placed in patients with a history of periodontal disease. Material and Methods: A randomized, controlled, parallel‐design, triple‐blind prospective clinical study was designed. Patients included in the study were partially edentulous and had implants with mucositis or peri‐implantitis. Implants with radiographic bone loss of ≥5 mm and/or ≥50% of the implant length were excluded, and only one implant per patient was included. After non‐surgical mechanical therapy, subjects were randomly assigned to take either 1 probiotic lozenge or 1 placebo lozenge every day for 30 days. Clinical measurements were taken in the whole mouth (general plaque index and general bleeding on probing) and at the implant site (probing pocket depth, plaque index and bleeding on probing) at baseline and 30 and 90 days Microbiological examination (to identify Aggregatibacter actinomycetemcomitans, Tannerella forsythia, Porphyromonas gingivalis, Treponema denticola, Prevotella intermedia, Peptostreptococcus micros, Fusobacterium nucleatum, Campylobacter rectus and Eikenella corrodens) was performed at the same study time points that clinical measurements were made. Results: A total of 44 patients – 22 with mucositis and 22 with peri‐implantitis – randomly received treatment with either probiotic or placebo. The probiotic L. reuteri, together with mechanical therapy, produced an additional improvement over treatment with mechanical therapy alone, both in the general clinical parameters of patients with mucositis (bleeding on probing) and at the level of implants with mucositis (probing pocket depth) or peri‐implantitis (bleeding on probing and probing pocket depth). However, L. reuteri had a very limited effect on the peri‐implant microbiota because the only parameter in which a significant decrease was found was the bacterial load of P. gingivalis in implants with mucositis (P = .031). Conclusion: The administration of a daily lozenge of L. reuteri for 30 days, together with mechanical debridement of the whole mouth, improved the clinical parameters of implants with mucositis or peri‐implantitis over a period of at least 90 days, but the microbiological effect was much more limited. Probiotics provide an alternative therapeutic approach to consider in the prevention and treatment of peri‐implant diseases, but further long‐term prospective studies with standardized variables are needed. [ABSTRACT FROM AUTHOR]

Background: Nucleic acid-targeted pathogen inactivation technology using amustaline (S-303) and glutathione (GSH) was developed to reduce the risk of transfusion-transmitted infectious disease and transfusion-associated graft-versus-host disease with red blood cell (RBC) transfusion.Study Design and Methods: A randomized, double-blind, controlled study was performed to assess the in vitro characteristics of amustaline-treated RBCs (test) compared with conventional (control) RBCs and to evaluate safety and efficacy of transfusion during and after cardiac surgery. The primary device efficacy endpoint was the postproduction hemoglobin (Hb) content of RBCs. Exploratory clinical outcomes included renal and hepatic failure, the 6-minute walk test (a surrogate for cardiopulmonary function), adverse events (AEs), and the immune response to amustaline-treated RBCs.Results: A total of 774 RBC unis were produced. Mean treatment difference in Hb content was -2.27 g/unit (95% confidence interval, -2.61 to -1.92 g/unit), within the prespecified equivalence margins (±5 g/unit) to declare noninferiority. Amustaline-treated RBCs met European guidelines for Hb content, hematocrit, and hemolysis. Fifty-one (25 test and 26 control) patients received study RBCs. There were no significant differences in RBC usage or other clinical outcomes. Observed AEs were within the spectrum expected for patients of similar age undergoing cardiovascular surgery requiring RBCs transfusion. No patients exhibited an immune response specific to amustaline-treated RBCs.Conclusion: Amustaline-treated RBCs demonstrated equivalence to control RBCs for Hb content, have appropriate characteristics for transfusion, and were well tolerated when transfused in support of acute anemia. Renal impairment was characterized as a potential efficacy endpoint for pivotal studies of RBC transfusion in cardiac surgery. [ABSTRACT FROM AUTHOR]

Objective: The ketones d-β-hydroxybutyrate (BHB) and acetoacetate are elevated during prolonged fasting or during a "ketogenic" diet. Although weight loss on a ketogenic diet may be associated with decreased appetite and altered gut hormone levels, it is unknown whether such changes are caused by elevated blood ketones. This study investigated the effects of an exogenous ketone ester (KE) on appetite.Methods: Following an overnight fast, subjects with normal weight (n = 15) consumed 1.9 kcal/kg of KE, or isocaloric dextrose (DEXT), in drinks matched for volume, taste, tonicity, and color. Blood samples were analyzed for BHB, glucose, insulin, ghrelin, glucagon-like peptide 1 (GLP-1), and peptide tyrosine tyrosine (PYY), and a three-measure visual analogue scale was used to measure hunger, fullness, and desire to eat.Results: KE consumption increased blood BHB levels from 0.2 to 3.3 mM after 60 minutes. DEXT consumption increased plasma glucose levels between 30 and 60 minutes. Postprandial plasma insulin, ghrelin, GLP-1, and PYY levels were significantly lower 2 to 4 hours after KE consumption, compared with DEXT consumption. Temporally related to the observed suppression of ghrelin, reported hunger and desire to eat were also significantly suppressed 1.5 hours after consumption of KE, compared with consumption of DEXT.Conclusions: Increased blood ketone levels may directly suppress appetite, as KE drinks lowered plasma ghrelin levels, perceived hunger, and desire to eat. [ABSTRACT FROM AUTHOR]

While continuing care for substance use treatment has been associated with reduced involvement in the criminal justice system, much of this research lacks random assignment to continuing care and so is limited by self-selection bias. This study sought to determine the impact of adding telephone-based continuing care to intensive outpatient programs on criminal justice outcomes for people with cocaine dependence. In three continuing care studies, spanning 1998-2008, participants were randomly assigned to an intensive outpatient program or an intensive outpatient program plus a telephone-based continuing care intervention. Cocaine-dependent participants from these three studies were included in the analyses, with outcomes derived from a dataset of jurisdiction-wide criminal sentences from a state sentencing agency. Multiple logistic regression was employed to examine the odds of a criminal conviction occurring in the 4 years after enrollment in a continuing care study. The results showed that, controlling for a criminal sentence in the previous year, gender, age, and continuing care study, people with cocaine dependence randomized to an intensive outpatient program plus a telephone-based continuing care intervention had 54% lower odds (p = 0.05, odds ratio = 0.46, 95% CI: 0.20-1.02) of a criminal sentence in the 4 years after enrollment in the continuing care study, compared with those randomized to an intensive outpatient program alone. We can conclude that adding telephone monitoring and counseling to intensive outpatient programs is associated with fewer criminal convictions over a 4-year follow-up period compared with intensive outpatient programs alone. [ABSTRACT FROM AUTHOR]

Objective: The present investigation was intended to test the hypothesis that the elderly provided with the frequent consumption of fishes marinated in essential oil of Perilla frutescens (EOPF) or not would experience fewer depressive symptoms after 6 months.Methods: A total of 180 participants were recruited from Sina Hospital, Mashhad, Iran, who were diagnosed with depression based on Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision and Beck Depression Inventory. Participants (n = 180) were randomly assigned in a 1:1:1 ratio to Groups A, B, and C. The last two were provided with an instruction to consume Caspian white fish marinated in the presence or absence of EOPF (434 g each week or four meals per week). Group A served as the control with the common diet. The outcome measures were performed using the Beck Depression Inventory and the General Health Questionnaire.Results: There were no statistically significant differences in depressive symptom scores between groups with frequent fish consumption as compared with the control (p > 0.05). Yet adjustment for covariates showed that there was a significant reduction in depression among them (p < 0.05). Moreover, consumption of fish and EOPF was associated with more considerable improvements than Groups A and B (p < 0.05).Conclusions: It could be concluded that high intakes of unsaturated fatty acids can afford to diminish likelihood of late-life depression. Copyright © 2017 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Objective: Most investigations of pharmacotherapy for treating Alzheimer's disease focus on patients with mild-to-moderate symptoms, with little evidence to guide clinical decisions when symptoms become severe. We examined whether continuing donepezil, or commencing memantine, is cost-effective for community-dwelling, moderate-to-severe Alzheimer's disease patients.Methods: Cost-effectiveness analysis was based on a 52-week, multicentre, double-blind, placebo-controlled, factorial clinical trial. A total of 295 community-dwelling patients with moderate/severe Alzheimer's disease, already treated with donepezil, were randomised to: (i) continue donepezil; (ii) discontinue donepezil; (iii) discontinue donepezil and start memantine; or (iv) continue donepezil and start memantine.Results: Continuing donepezil for 52 weeks was more cost-effective than discontinuation, considering cognition, activities of daily living and health-related quality of life. Starting memantine was more cost-effective than donepezil discontinuation. Donepezil-memantine combined is not more cost-effective than donepezil alone.Conclusions: Robust evidence is now available to inform clinical decisions and commissioning strategies so as to improve patients' lives whilst making efficient use of available resources. Clinical guidelines for treating moderate/severe Alzheimer's disease, such as those issued by NICE in England and Wales, should be revisited. © 2016 The Authors. International Journal of Geriatric Psychiatry published by John Wiley & Sons Ltd. [ABSTRACT FROM AUTHOR]

This study aimed to examine the effects of hesperidin supplement on the glycemic parameters, oxidative DNA damage, and lipid peroxidation in patients with type 2 diabetes. Sixty-four patients were randomly allocated to receive 500 mg/day hesperidin or placebo capsules for 6 weeks. Data on glycemic parameters, total antioxidant capacity (TAC), 8-hydroxydeoxyguanosine (8-OHDG), and malondialdehyde (MDA) were collected at the baseline and at the end of the study. In hesperidin group, TAC increased (0.74 ± 0.16 vs. 0.82 ± 0.18), while serum froctoseamin (5.79 ± 5.86 vs. 5.01 ± 4.95; p = 0.001), 8-OHDG (14.32 ± 6.4 vs. 11.00 ± 7.0; p = 0.000), and MDA (5.78 ± 1.76 vs. 4.60 ± 0.75; p = 0.000) decreased in comparison with the baseline values. There was a significant difference in percent change of TAC (13.35 ± 19.21 vs. 3.13 ± 10.02; p = 0.043), froctoseamin (-10.10 ± 16.84 vs. 4.27 ± 34.646), 8-OHDG (-25.11 ± 28.23 vs. 8.69 ± 35.41; p = 0.000), and MDA (-16.46 ± 18.04 vs. -1.82 ± 22.63; p = 0.007) between hesperidin and control groups following intervention in adjusted models. These results suggest that hesperidin may improve TAC and alleviate serum froctoseamin, 8-OHDG, and MDA levels in type 2 diabetes. Copyright © 2017 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Background: To examine whether SMOFlipid prevents progression of intestinal failure-associated liver disease (IFALD) in parenteral nutrition (PN)-dependent infants with early IFALD (conjugated bilirubin 17-50 µmol/L, 1-3 mg/dL).Study Design: Pilot multicenter blinded randomized controlled trial comparing SMOFlipid with Intralipid. Patients received the trial lipid for up to 12 weeks, unless they achieved full enteral tolerance sooner. The primary clinical outcome was the serum conjugated bilirubin.Results: Twenty-four infants (mean age, 6 weeks) participated in the trial (13 Intralipid and 11 SMOFlipid). At the time of trial enrollment, patients in both groups were receiving 90% of their calories by PN. Mean duration on trial was 8 weeks and did not differ according to treatment ( P = .99). At trial conclusion, patients who received SMOFlipid had a lower conjugated bilirubin than those who received Intralipid (mean difference, -59 µmol/L; P = .03). Patients receiving SMOFlipid were also more likely to have a decrease in serum conjugated bilirubin to 0 µmol/L than those in the Intralipid group over the entire observation period (hazard ratio, 10.6; 95%; P = .03). The time to achievement of full enteral tolerance did not differ statistically (hazard ratio, 1.3; P = .59) between the groups. There was no significant difference in safety outcomes between the groups.Conclusions: Compared with Intralipid, SMOFlipid reduces the risk of progressive IFALD in children with intestinal failure. This trial was registered at clinicaltrials.gov as NCT00793195. [ABSTRACT FROM AUTHOR]

Background Aspects of impulsivity have been implicated in the development, or maintenance, of alcohol use disorder ( AUD). The brain dopamine system is implicated in both reward processing/memory (typically subcortical) and in brain inhibitory control mechanisms (typically cortical). Using a validated clinical laboratory paradigm, the dopamine/serotonin 'stabilizing' drug, aripiprazole was evaluated in non-treatment-seeking AUD individuals based on their level of impulsivity/self-control. Methods Ninety-nine individuals (77% male; mean age 27; 7.5 drinks per day; 83% heavy drinking days) meeting DSM- IV criteria for alcohol dependence were randomized to aripiprazole ( N = 47 evaluable) or placebo ( N = 48 evaluable) based on their Barratt Impulsiveness Scale ( BIS-11) score (above or below 68). Aripiprazole, or similar placebo, was titrated to 15 mg over 8 days. Drinking was recorded over 6 days under natural conditions. On Day 8, after 1 day of required abstinence, individuals participated in a bar laboratory paradigm that included a priming drink (breath alcohol concentration [ BAC] target 0.02 to 0.03 g/dl) and free-choice consumption of up to 8 drinks (max BAC 0.1 g/dl) in exchange for a 'bar credit' of $2 per drink (max $16). End points were drinks per day under natural conditions and drinks consumed in the bar laboratory after the priming drink. Results There was no significant main effect of aripiprazole or interaction with BIS-11 score during the natural drinking period. However, there was a main effect of aripiprazole on bar laboratory drinking ( p = 0.04) and aripiprazole reduced the total number of drinks consumed more among individuals with low self-control ( p = 0.034) and increased latency to consume those drinks ( p = 0.045) more among those with high impulsivity. Relative to placebo, aripiprazole caused more side effects and increased alcohol-induced sedation, but neither significantly influenced its interaction with impulsivity/self-control scores on drinking. Conclusions This paradigm forced a choice between immediate drinking reward and delayed monetary reward. In those with high impulsivity and/or low self-control, aripiprazole shifts the balance away from immediate drinking toward a later reward. Medications targeting cortical dopamine/serotonin balance might show clinical benefit of reduced drinking, among individuals with impulsivity/low self-control. [ABSTRACT FROM AUTHOR]

Objective To compare mycophenolate mofetil (MMF) with placebo for the treatment of systemic sclerosis (SSc)-related interstitial lung disease (ILD). Methods We included participants enrolled in the placebo arm of Scleroderma Lung Study (SLS) I and the MMF arm of SLS II. SLS I randomized participants to receive either oral cyclophosphamide (CYC) or placebo for 1 year, while SLS II randomized participants to receive either MMF for 2 years or oral CYC for 1 year followed by 1 year of placebo. Eligibility criteria for SLS I and SLS II were nearly identical. The primary outcome was % predicted forced vital capacity (FVC), and key secondary outcomes included % predicted diffusing capacity for carbon monoxide (DL co), the modified Rodnan skin thickness score (MRSS), and dyspnea. Joint models were created to evaluate the treatment effect on the course of these outcomes over 2 years. Results At baseline, the MMF-treated group in SLS II (n = 69) and the placebo-treated group in SLS I (n = 79) had similar percentages of men and women and similar disease duration, SSc subtype, extent of skin disease, and % predicted FVC. MMF-treated patients in SLS II were slightly older (mean ± SD age 52.6 ± 9.7 years versus 48.1 ± 12.4 years; P = 0.0152) and had higher % predicted DL co (mean ± SD 54.0 ± 11.1 versus 46.2 ± 13.3; P = 0.0002) than placebo-treated patients in SLS I. After adjustment for baseline disease severity, treatment with MMF in comparison with placebo was associated with improved % predicted FVC ( P < 0.0001), % predicted DL co ( P < 0.0001), MRSS ( P < 0.0001), and dyspnea ( P = 0.0112) over 2 years. Conclusion Although there are inherent limitations in comparing participants from different trials, treatment with MMF was associated with improvements in physiologic outcomes and dyspnea compared with placebo, even after accounting for baseline disease severity. These results further substantiate the use of MMF for the treatment of SSc-related ILD. [ABSTRACT FROM AUTHOR]

Aim: Optimal duration of parenteral antibiotics for treating neonatal sepsis ranges from 7-14 days. We compared the efficacy of 7 versus 10 days duration of intravenous antibiotics for neonatal septicaemia.Methods: We randomised blood culture-proven septic neonates (≥32 weeks and birth weight ≥1.5 kg) to receive either 7 or 10 days duration of intravenous antibiotics. We followed up neonates upto 28 days after stopping antibiotics for treatment failure defined by reappearance of clinical sepsis with a blood culture growing the same organism as cultured earlier, or in the absence of a positive culture, the presence of C-reactive protein and as adjudicated by an expert committee.Results: A total of 132 neonates were randomised to receive either 7 (n = 66) or 10 (n = 66) days duration of antibiotic therapy. Out of 128 neonates (64 per group) followed up, two (one per group) were regarded as 'treatment failure', and two were labelled as fresh episodes of sepsis (both in 10-day group). The risk (95% confidence interval) for treatment failure in the 7-day group was (1.0 (0.064-15.644) was not significantly higher. Neonates in both groups had comparable need for oxygen, inotropic support and blood products, duration of oxygen therapy and time to attainment of full feeds. The duration of hospitalisation was significantly longer in the 10-day group.Conclusion: A 7-day course of intravenous antibiotics may be sufficient to treat neonatal sepsis with the advantage of shorter hospital stay, but a larger meta-analysis would be required to state this with a degree of certainty. [ABSTRACT FROM AUTHOR]

Exploration of the patient-therapist relationship (transference work) is considered a core active ingredient in dynamic psychotherapy. However, there are contradictory findings as for whom and under what circumstances these interventions are beneficial. This study investigates long-term effects of transference work in the context of patients' quality of object relations (QOR) and therapists' self-reported disengaged feelings. Therapists' disengaged feelings may negatively influence the therapeutic process, especially while working explicitly with the transference since discussing feelings that are present in the session is an essential aspect of transference work. One hundred outpatients seeking psychotherapy for depression, anxiety and personality disorders were randomly assigned to one year of dynamic psychotherapy with transference work or to the same type and duration of treatment, but without transference work. Patients' QOR-lifelong pattern was evaluated before treatment and therapists' feelings were assessed using the Feeling Word Checklist-58 after each session. Outcome was measured with self-reports and interviews at pre-treatment, mid-treatment, post-treatment, one year and three years after treatment termination. A significant interaction of treatment group (transference work versus no transference work) by QOR by disengaged therapist feelings was present, indicating that disengaged feelings, even small amounts, were associated with negative long-term effects of transference work, depending on QOR Scale scores. The strengths of the negative association increased significantly with lower levels of QOR. The negative association between even a small increase in disengaged therapist feelings and long-term effects of transference interpretation was substantial for patients with poor QOR, but small among patients with good QOR. Copyright © 2016 John Wiley & Sons, Ltd. Key Practitioner Message Therapists' emotional reactions to their patients (countertransference) seem to have a significant impact on both the treatment process and outcome of psychotherapy., Therapists' heightened level of disengaged feelings over a treatment period shows an adverse impact on the effect of transference work for all patients, and especially so for patients with a history of poor, non-mutual and complicated relationships., For patients with a history of reciprocal, sound relationships the negative influence of therapists' disengaged countertransference is minimal., Higher therapist disengagement is strongly related to inferior therapists' skill for patients with a history of poor relationships and/or more personality disorder pathology., Training and supervision should provide direct feedback and focus on therapists' internal thought processes and emotional reactions., Therapists need to recognize and understand their feelings and attitudes in order to use the countertransference as a tool to understand the interpersonal process in therapy. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives Our aim was to evaluate the effectiveness of a Post-it® note to increase response rates and shorten response times to a 4-month postal follow-up questionnaire sent to participants taking part in the Collaborative Care in Screen-Positive Elders (CASPER) trials. Method Our trial was a two-arm randomized controlled trial comparing response rates to questionnaires with a printed Post-it® note (intervention) and without (control), nested in multi centred randomized controlled trials of older people with varying levels of depressive symptoms; the CASPER+ and CASPER Self Help for those At Risk of Depression (SHARD) trials. A total of 611 participants were eligible and randomized. The primary outcome was response rates, secondary outcomes were time to response and need for a reminder. Results Of 297 participants, 266 (89.6%) returned their 4-month questionnaire in the post-it note arm, compared with 282 of 314 participants (89.8%) in the control arm (OR = 0.97, 95% CI: 0.57, 1.65, P = 0.913). There were no statistically significant differences in time to respond or the need to be sent a reminder. Patients with a major depressive episode were more likely to return questionnaires with post-it notes ( P of interaction = .019). Conclusion There was no significant difference in response rates, time to response, or the need for a reminder between the intervention and control at 4-month follow up for older people with depressive symptoms. However, there was a significant interaction between the Post-it® note group and level of depression. [ABSTRACT FROM AUTHOR]

Objectives To compared outcomes of regional nerve blocks with those of standard analgesics after hip fracture. Design Multisite randomized controlled trial from April 2009 to March 2013. Setting Three New York hospitals. Participants Individuals with hip fracture (N = 161). Intervention Participants were randomized to receive an ultrasound-guided, single-injection, femoral nerve block administered by emergency physicians at emergency department ( ED) admission followed by placement of a continuous fascia iliaca block by anesthesiologists within 24 hours (n = 79) or conventional analgesics (n = 82). Measurements Pain (0-10 scale), distance walked on Postoperative Day ( POD) 3, walking ability 6 weeks after discharge, opioid side effects. Results Pain scores 2 hours after ED presentation favored the intervention group over controls (3.5 vs 5.3, P = .002). Pain scores on POD 3 were significantly better for the intervention than the control group for pain at rest (2.9 vs 3.8, P = .005), with transfers out of bed (4.7 vs 5.9, P = .005), and with walking (4.1 vs 4.8, P = .002). Intervention participants walked significantly further than controls in 2 minutes on POD 3 (170.6 feet, 95% confidence interval ( CI) = 109.3-232 vs 100.0 feet, 95% CI = 65.1-134.9; P = .04). At 6 weeks, intervention participants reported better walking and stair climbing ability (mean Functional Independence Measure locomotion score of 10.3 (95% CI = 9.6-11.0) vs 9.1 (95% CI = 8.2-10.0), P = .04). Intervention participants were significantly less likely to report opioid side effects (3% vs 12.4%, P = .03) and required 33% to 40% fewer parenteral morphine sulfate equivalents. Conclusion Femoral nerve blocks performed by emergency physicians followed by continuous fascia iliaca blocks placed by anesthesiologists are feasible and result in superior outcomes. [ABSTRACT FROM AUTHOR]

Background Numerous studies have demonstrated the benefit of devices delivering altered auditory feedback (AAF) as a therapeutic alternative for those who stutter. Aims The effectiveness of a device delivering AAF (SpeechEasy®) was compared with behavioural techniques in the treatment of stuttering in a randomized clinical trial. Methods & Procedures Two groups of adults who stutter participated: group 1 consisted of 10 men and one woman aged 21-42 years (mean = 30.0). Group 2 consisted of six men and one woman aged 20-50 years (mean = 35.6). Participants in group 1 were fit with a SpeechEasy® device and were not given any additional training (i.e., supplementary fluency enhancing techniques). Participants used the device daily for 6 months. Participants in group 2 received treatment in the form of a 12-week fluency promotion protocol with techniques based on both fluency shaping and stuttering modification. Outcomes & Results There were no statistically significant differences ( p > .05) between groups in participants' stuttered syllables following treatment. That is, both therapeutic protocols achieved approximately 40% reduction in number of stuttered syllables from baseline measures, with no significant relapse after 3 or 6 months post-treatment. Conclusions & Implications The results suggest that the SpeechEasy® device can be a viable option for the treatment of stuttering. [ABSTRACT FROM AUTHOR]

Background Pain after hysteroscopy is usually minimal but some women need additional analgesia while in the recovery ward and some require overnight hospital admission to control pain. Intrauterine installation of an anaesthetic after hysteroscopy may reduce pain. Aims To see if intrauterine levobupivacaine reduces post-procedure pain, need for analgesia and allow earlier return to normal activity. Materials and methods This was a double-blind randomised controlled trial. Women having hysteroscopy under general anaesthesia were allocated to receive intrauterine instillation of levubupivacaine or normal saline at the end of the procedure. Women were assessed in the recovery ward by a verbal descriptor pain scale and need for additional analgesia and followed up on day 3 to further assess pain and return to normal activity. Results There were no significant differences in demographic characteristics or indication for surgery between the 224 women in the study group or the 214 women in the control group. At two hours post-procedure, 156/224 (70%) study women versus 119/214 (56%) control women had no pain; (relative risk (RR) 0.68 and 95% confidence interval (CI) 0.53-0.87). There were 182/224 (81%) study women versus 154/214 (72%) control women with a pain score < 5 ( RR 0.67; 95% CI 0.47-0.95). Fewer women in the study group required additional analgesia 54/224 (24%) versus 88/214 (41%) (RR 0.58; 95% CI 0.44-0.78). There was no significant difference between groups with regards to pain at 24 h post-procedure or return to activity. Conclusion Intrauterine instillation of levobupivacaine reduced post-procedure pain and need for additional pain relief. [ABSTRACT FROM AUTHOR]

Background: Minocycline microspheres (MMs) are being used to treat residual inflamed periodontal pockets during periodontal maintenance therapy (PMT), but evidence for efficacy from randomized clinical trials is lacking. The purpose of this study is to evaluate the effect of MMs plus scaling and root planing (SRP) on these sites.Methods: Sixty patients with chronic periodontitis on 6-month PMT intervals to be followed for 1 year were randomized (51 completed the study) into two statistically similar groups, SRP + MM (aged 66.8 years) and SRP alone (aged 67 years), to treat a ≥5 mm posterior interproximal pocket during PMT with a history of bleeding on probing (BOP). Group treatments were applied to the site at baseline and 6 months. Clinical attachment levels (CALs; primary outcome), probing depths (PDs), plaque, and BOP also were recorded at baseline and 6 and 12 months. In addition, gingival crevicular fluid was analyzed for an inflammation index ratio of interleukin (IL)-1β/IL-1 receptor antagonist (ra) using enzyme-linked immunosorbent assays.Results: All clinical parameters improved significantly (P <0.005) from baseline in both groups with no differences between groups at any time point. CAL decreased 17% (0.9 ± 0.8 mm) and 13% (0.7 ± 0.9 mm) in SRP + MM and 11% (0.7 ± 1.1 mm) and 21% (1.2 ± 0.9 mm) in SRP at 6 and 12 months, respectively. The odds of having BOP decreased 90% (down to 38% of patients) and 95% (26%) in SRP + MM and 82% (42%) and 82% (41%) in SRP at 6 and 12 months, respectively. IL-1β/IL-1ra decreased a significant 61% (P = 0.009) only in SRP + MM at 6 months.Conclusions: SRP of inflamed moderate pockets during 6-month PMT, with or without MMs, improves CALs, along with PDs and BOP over a 1-year period. The use of MMs did not result in an additional benefit over SRP alone. [ABSTRACT FROM AUTHOR]