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Mastectomy serves as the main surgical treatment for both invasive and in situ breast carcinoma and large phyllodes tumors. It is associated with skin necrosis, seroma, and surgical site infection in up to 30% of patients. In the present trial, we compared the complications in patients undergoing skin flap elevation by one of the 4 techniques: thick skin flap raised by scalpel(group1), thin skin flap raised with scalpel (group 2), thick skin flap raised with diathermy (group 3), and thin skin flap raised with diathermy (group 4). A randomized trial with superiority hypothesis and 2 × 2 factorial design was conducted at All India Institute of Medical Sciences New Delhi. Mastectomy skin flap necrosis (MSN) was recorded as the main outcome of interest. MSN was noted in 2.5% in group1, 10% in group 2, 7.5% in group 3, and 30% in group 4. MSN was observed in 5% cases with thick flap compared to 20% cases with a thin skin flap (p = 0.007). Raising the flap with scalpel was associated with MSN in 6.25% compared to 18.75% in the diathermy group (p = 0.029). We conclude that raising a thick flap with scalpel is associated with lowest risk of skin flap necrosis. Trial Registration: Clinical Trial Registry- India CTRI/2014/09/004978 [ABSTRACT FROM AUTHOR]

Acne scarring results from a common inflammatory condition present in many people. These scars can have an impact on quality of life by influencing self-esteem and social acceptance. Current acne scarring treatments, such as chemical peels and laser treatments, often have limited success due to their time-consuming nature and the variability of acne scar types. The subcision technique has shown promise for the treatment of rolling acne scars. There are few studies to date that examine the effects of multiple subcision treatments on rolling acne scars. We evaluated whether the use of multiple subcision treatments improved the appearance of rolling acne scars compared to no treatment. Five patients with rolling acne scars on both sides of their face who met inclusion and exclusion criteria were enrolled in the study. One side of the face was randomized to receive treatment, while the contralateral side of the face received no treatment. Subjects underwent five sequential subcision treatments, spaced 4 weeks apart, with two follow-up visits at weeks 20 and 36 from the 1st treatment. Photographs were taken before and after the initial treatment visit and at each subsequent visit. Acne scar appearance was evaluated by the subject, a blinded live rater, and two double-blinded dermatologist raters. Evaluations of treatment outcomes involved overall acne scar appearance on a 5-point scale, acne scar improvement on a percentage scale, a modified quantitative global scarring grading system, and potential treatment side effects. There was a greater decrease in global scarring scores in the multiple subcision side compared to the control side. There was a greater difference in the average acne scar appearance scores between the Week 36 follow-up visit and baseline for the multiple subcision side compared to that of the control side. 50% of patients reported being more satisfied with the treatment side compared to the control side in regard to overall improvement. The study results suggest that multiple subcision treatments may improve the appearance of rolling acne scars compared to no treatment. [ABSTRACT FROM AUTHOR]

Depression in early childhood increases risk of psychopathology and impairment across the lifespan. Parent–Child Interaction Therapy-Emotion Development (PCIT-ED) effectively treats depression and improves functioning in preschoolers. Parental depression has been associated with inconsistent parenting, depression onset and maintenance in offspring, and decreased treatment efficacy for youth. Given the intensity of parent involvement in PCIT-ED, this secondary data analysis aimed to evaluate parental depression severity (i.e., Beck Depression Inventory-II Total Score; BDI-II) as a moderator and predictor of child, parenting, and engagement outcomes, within the context of a randomized trial. Children (N = 229; ages 3–6.11) with early childhood depression and a consenting caregiver were randomly assigned to receive PCIT-ED or Waitlist (WL). Moderation results supported the superiority of PCIT-ED over WL on child and parenting outcomes, independent of parent-reported BDI-II at baseline (p ≥ 0.684 and p ≥ 0.476, respectively). BDI-II did not significantly predict child (p ≥ 0.836), parenting (p ≥ 0.114) or engagement (p ≥ 0.114) outcomes. Finally, BDI-II did not surpass chance in predicting whether children would maintain a depression diagnosis after PCIT-ED (AUC = 0.530) or prematurely terminate treatment (AUC = 0.545). Our results suggest that PCIT-ED is not contraindicated by minimal-to-moderate symptoms of depression in parents. Taken together with previous reports, PCIT-ED may indeed be a particularly beneficial treatment choice for this population. Further research in samples with more severe parental depression is needed. ClinicalTrials.gov identifier: NCT02076425. [ABSTRACT FROM AUTHOR]

This was a randomized controlled trial, conducted to determine the effectiveness of CBT for depression delivered by trained therapists with an adapted Bengali CBT (BaCBT) manual, as compared to a control group. A total of 148 patients with a diagnosis of depression and attending psychiatry departments of three hospitals in Dhaka, Bangladesh, were assessed for eligibility, and 107 were randomly allocated to either treatment (n = 54) or a waitlist (n = 53). Assessments of outcome were completed at 3 time points (pre-test, post-test, and 1-month follow-up). The results revealed significant reductions in depression severity, anxiety, perceived stress, and suicidal ideation in the group that received the intervention, but modest to no significant changes in the control group. This is the first report of the results of an adapted CBT program for depression from Bangladesh. Although several limitations of the study are noted, and further studies are needed to generalize these current results, they indicate that CBT is an efficacious treatment option for depression in varied cultures. [ABSTRACT FROM AUTHOR]

The exact aetiology of pityriasis lichenoides chronica (PLC) remains unknown. While phototherapy is the most investigated therapeutic modality, azithromycin has been used scarcely. The aim of this study is to evaluate the therapeutic efficacy of azithromycin in the treatment of PLC compared to NB-UVB and evaluating the presence of streptococcal infection as a possible etiological factor in PLC patients. The study was designed as a randomised controlled trial. Twenty-four patients with PLC were randomly allocated into either azithromycin (n = 13, standard dose every 10 days) or NB-UVB (n = 11, thrice weekly) groups. End of study (EOS) was either complete clearance of lesions or a maximum of 8 weeks. Therapeutic efficacy was defined as percent reduction in lesions and was calculated for the rash as a whole, erythematous papules alone, and hypopigmented lesions alone and graded into complete, very-good, good, poor or no response. Anti-streptolysin O titre (ASOT), anti-deoxyribonuclease B titre (anti-DNaseB) and throat culture were evaluated at day 0. No significant difference existed between both groups as regards therapeutic efficacy. At EOS, NB-UVB achieved significantly more percent reduction in the extent of hypopigmented lesions and consequently in the rash as a whole (p = 0.001, p = 0.034, respectively). The extent of the rash as a whole was significantly less in the NB-UVB at EOS (p = 0.029, respectively). The effect of NB-UVB on hypopigmented lesions appeared early at week 4 of treatment. Only two patients, one from each group, relapsed during the 3 month follow-up. Evidence of recent streptococcal infection was present in 79% of the cases, mainly in the form of elevated ASOT (94.7%). It was significantly more encountered in young children (< 13 years) (p = 0.03) and was associated with more extent of erythematous papules and consequently with more extent of the rash as a whole (p = 0.05 and p = 0.01, respectively). It did not affect outcome of therapy at EOS. Azithromycin did not show more favorable response in patients with recent streptococcal infection. Therapeutic efficacy of azithromycin is comparable to NB-UVB in treatment of PLC; however, NB-UVB is superior in management of hypopigmented lesions. It is highly suggested that PLC could be a post streptococcal immune mediated disorder. Registration number: ClinicalTrials.gov, NCT03831269. [ABSTRACT FROM AUTHOR]

Introduction: Bimekizumab treatment resulted in improved clinical outcomes in patients with moderate-to-severe plaque psoriasis in BE VIVID, a 52-week, phase 3, randomized, ustekinumab and placebo-controlled study. We present data from the BE VIVID Japan patient subpopulation. Methods: Globally, patients were randomized to receive bimekizumab 320 mg every 4 weeks (Q4W), ustekinumab (45/90 mg weight-based at baseline and week 4, then every 12 weeks), or placebo (Q4W through week 16, then bimekizumab 320 mg Q4W). Efficacy endpoints included week 16 Psoriasis Area and Severity Index (PASI) 90 and Investigator's Global Assessment (IGA) 0/1, and other outcomes [PASI 100, PASI 75, IGA 0, Dermatology Life Quality Index (DLQI) 0/1, absolute PASI, scalp IGA, Psoriasis Symptoms and Impacts Measure (P-SIM) responses]. Safety analyses were conducted. Results: There were 108 Japanese randomized patients (bimekizumab: 62; ustekinumab: 29; placebo: 17). At week 16, bimekizumab-treated patients had a higher clinical response versus ustekinumab and placebo (PASI 90: 85.5% versus 51.7% and 5.9%; IGA 0/1: 82.3% versus 48.3% and 0.0%). Over 52 weeks, improved clinical response was maintained with bimekizumab, including patients switching from placebo at week 16. Overall, the safety profile in Japanese patients was consistent with that observed in the global population. Conclusion: Bimekizumab resulted in improved clinical response versus ustekinumab and placebo, and was well-tolerated in Japanese patients. Trial registration: NCT03370133. [ABSTRACT FROM AUTHOR]

Lactational breast abscess results from inadequate or partially treated mastitis. Recently, needle aspiration or catheter suction drainage is being adopted in place of incision and drainage. We planned to evaluate the effectiveness of needle aspiration versus vacuum suction drainage in resolution of puerperal breast abscess. One-hundred-twelve mothers with lactational breast abscess were randomized to either ultrasound-guided needle aspiration or vacuum suction drainage. These patients were followed up on alternate days and assessed for complete resolution of breast abscess, pain in the breast on Visual Analog Scale (VAS) of 0–10, day of return to normal breast feeding, number of aspirations needed, recurrence of abscess and total cost of care. In the suction drain group, 98% of mothers enjoyed complete resolution within 10 days as compared to 87% of mothers treated with needle aspiration. Mean VAS at first follow-up was 2.89 in aspiration group and 2.62 in suction group. The VAS reduced to 0.74 in aspiration group and 0.53 in suction drainage group, at the last follow-up. The mean day of recovery was 7 days for aspiration and 5.73 days for suction. Most patients required 3 aspirations. The mean drainage time was 4.5 days. Vacuum suction drainage is the more effective method for achieving resolution of lactational breast abscess and offers greater patient satisfaction compared to needle aspiration. [ABSTRACT FROM AUTHOR]

Several studies have demonstrated the benefits of thalidomide as a treatment for patients with ankylosing spondylitis (AS); however, published literature reported controversial results. We conducted a meta-analysis to systematically evaluate the efficacy of thalidomide in AS patients. PubMed, Embase, Cochrane Library, Web of Science, Wanfang Data, and China National Knowledge Infrastructure (CNKI) were searched for relevant studies. The Q test and I2 statistic were used to examine between-study heterogeneity. Fixed- or random-effects models were selected based on study heterogeneity. The risk difference (RD), absolute risk reduction (ARR), and weighted mean difference (WMD) with 95% confidence intervals (CI) were pooled for dichotomous or continuous data, as appropriate. Sensitivity analyses, funnel plots, and the Begg's tests were also performed. Overall, 19 trials with 1471 patients were included. The effectiveness of thalidomide alone and combined with other drugs was significantly higher than the control group, and the pooled RDs were 0.15 (95% CI: 0.10–0.20, I2 = 0%) and 0.20 (95% CI: 0.14–0.25, I2 = 13.4%), respectively. Thalidomide treatment yielded significant improvements in secondary outcomes for patients with AS. The adverse reaction rate for thalidomide alone was low than that for the control group (ARR = 0.08, 95% CI: 0.01–0.15, I2 = 0.0%), while there was no significant difference in the safety between the group in which thalidomide was combined with other drugs and the control (ARR = 0.03, 95% CI: − 0.04–0.10, I2 = 41.1%). The findings suggest that thalidomide improves the effectiveness of AS treatment, which should be considered by physicians. However, owing to the inclusion of several low-quality and Chinese studies, additional rigorous randomized controlled trials (RCTs) are needed in the future to confirm the results of this meta‑analysis. [ABSTRACT FROM AUTHOR]

Background: Women veterans experience higher levels of stress-related symptoms than their civilian counterparts. Psychological stress is associated with greater inflammation and may increase risk for cardiovascular disease (CVD). Mindfulness-based stress reduction (MBSR) has been found to improve psychological well-being in other populations but no randomized controlled trials (RCT) have been conducted examining the impact of MBSR on well-being and inflammation in women veterans at risk for CVD.Objective: Determine the effectiveness of MBSR in improving psychological well-being, cortisol, and inflammation associated with CVD in women veterans.Design: The design is a RCT comparing MBSR to an active control condition (ACC) consisting of a health education program.Participants: Women veterans (N=164) with risk factors for CVD from the Chicagoland area participated in the study.Intervention: An 8-week MBSR program with weekly 2.5-h classes was compared to an ACC consisting of an 8-week health promotion education program with weekly 2.5-h classes.Main Measures: The outcomes were psychological well-being [perceived stress, depressive symptoms, loneliness, and post-traumatic stress disorder (PTSD)] symptoms and stress-related markers, including diurnal salivary cortisol and cytokines interleukin-6 (IL-6) and interferon gamma (IFN-γ). Data were collected at baseline, 4 weeks (mid-point of intervention), 8 weeks (completion of intervention), and 6 months after completion of MBSR or ACC.Key Results: Compared to the ACC, women who participated in MBSR reported less perceived stress, loneliness, and symptoms of PTSD. Although there were no significant differences between groups or changes over time in IL-6 or IFN-γ, participants in the MBSR program demonstrated a more rapid decline in diurnal salivary cortisol as compared to those in the ACC.Conclusions: MBSR was found to improve psychological well-being and decrease diurnal salivary cortisol in women veterans at risk for CVD. Health care providers may consider MBSR for women veterans as a means by which to improve their psychological well-being. [ABSTRACT FROM AUTHOR]

Background: Erenumab, a fully human monoclonal antibody that targets the calcitonin gene-related peptide receptor, has demonstrated efficacy and safety in the prevention of episodic and chronic migraine. There exists an unmet need to establish the safety of erenumab in older individuals, in view of existing multiple comorbidities, polypharmacy, and age-related physiological changes. This pooled analysis of five large migraine-prevention studies examined the safety of erenumab stratified across age groups, particularly in older populations. Methods: Pooled and age-stratified analysis of safety data from the 12-week double-blind treatment phase (DBTP) of five randomized, placebo-controlled Phase 2 and 3 studies of erenumab in participants with episodic or chronic migraine across the age groups < 40 years, 40–49 years, 50–59 years, and ≥ 60 years was completed. The safety of erenumab across age groups was determined by assessing safety endpoints including treatment-emergent adverse events (AEs), serious AEs, and events leading to study drug discontinuation. Results: Overall, 3345 participants across five studies were randomized to receive either placebo (n = 1359), erenumab 70 mg (n = 1132) or erenumab 140 mg (n = 854); 3176 (94.9%) completed the DBTP, and 169 (5.1%) discontinued, mainly due to participant decision (110; 3.3%). Overall, 1349 (40.6%), 1122 (33.8%), and 850 (25.6%) participants received at least one dose of placebo, erenumab 70 mg, and erenumab 140 mg, respectively. Incidence of treatment-emergent AEs was similar across all age groups for both doses of erenumab (70 mg or 140 mg) and placebo (< 40 years, 44.0% vs 44.4%; 40–49 years, 42.5% vs 49.2%; 50–59 years, 46.5% vs 41.6%; ≥ 60 years, 43.8% vs 59.4%). Incidence of treatment-emergent serious AEs overall, and stratified by age groups for both doses and placebo was low (< 40 years, 0.9% vs 1.2%; 40–49 years, 1.7% vs 1.9%; and 50–59 years, 1.6% vs 1.1%), with no serious AEs reported in participants aged ≥ 60 years. No deaths were reported. Conclusions: Erenumab (70 mg or 140 mg) exhibited a similar safety profile compared with placebo across age groups in individuals with episodic or chronic migraine, with no increased emergence of events due to age. Erenumab was well tolerated in older participants with multiple comorbidities, polypharmacy, and age-related physiological changes. Trial registration number: ClinicalTrials.gov Identifiers: NCT02066415, NCT02456740, NCT02483585, NCT03096834, NCT03333109. [ABSTRACT FROM AUTHOR]

In a randomized controlled trial, we tested the efficacy of Baby Triple P in a community sample of first-time parent couples. The intervention was developed to promote better mental health, a positive couple relationship, positive parenting, and a better parent-infant relationship. One hundred and fifty six couples were randomly allocated to intervention (n = 78) or care as usual (n = 78) conditions. The intervention was delivered in four antenatal face-to-face group sessions followed by four early postnatal individual telephone sessions. Couples completed self-report assessments at baseline, immediately postintervention and at 12 and 24 months. The study had one primary (the Depression, Anxiety and Stress Scale) and 11 secondary outcomes. Over half of the intervention and care as usual participants remained in the study for the full 24 months. Intention to treat analysis of the full sample yielded positive results in some mental health domains for mothers and fathers, but this was not evident when follow up sensitivity analysis was conducted on a subsample of the data. There was limited support for the intervention in relation to secondary outcomes such as the couple relationship, social support and parenting. However, the parent couples were positive about the intervention and described it as providing the support that they wanted. This trial provides some evidence in support of Baby Triple P as an early intervention for new parent couples. High levels of satisfaction with the intervention are promising, especially in relation to the engagement of fathers. Trial Registration: ISRCTN31955576 Highlights: This randomized controlled trial provides some evidence that the mental health of new parents is amenable to intervention. This randomized controlled trial provides some evidence in support of Baby Triple P as an early intervention. Evidence from this study demonstrates that engagement and retention of fathers is possible and fathers value involvement. Initial engagement is a critical point in the delivery of early interventions; couples who are engaged are more likely to complete the intervention. [ABSTRACT FROM AUTHOR]

Purpose: Anterior cervical discectomy and fusion (ACDF) surgery is commonly performed to treat cervical degenerative disc disease (CDDD). The lost of range of motion (ROM) is also found after ACDF, which contributes to degenerate in adjacent segment disease (ASD). Artificial cervical disc replacement (ACDR), an alternative to ACDF, is developed to preserve the ROM and reduce ASD. This article aims to compare the outcomes between ACDR and ACDF in the short-, mid-, and long-term.Methods: Databases including Cochrane, Embase, PubMed, and Web of Science were searched. Only RCTs were included in this meta-analysis, and the search strategy followed the requirements of the Cochrane Handbook. The strength of evidence was assessed using GRADE. Two reviewers independently assessed the methodological quality of each included study and extracted the relevant data.Results: Thirty prospective RCTs were included. Prolonged operative duration, better overall success, neurological success, and NDI success rates were found in ACDR group in all follow-up periods, with lower dysphagia/dysphonia during short-term follow-up. Moreover, a lower ASD was found in ACDR group during long-term follow-up and overall analysis, with lower reoperation rates in all follow-up periods. Comparable length of hospital stay and blood loss were found in both groups. Moreover, ASD was similar in short- and mid-term follow-ups, while dysphagia/dysphonia incidence was similar in mid- and long-term follow-ups. The incidence of implant events was comparable in all follow-up periods (p > 0.05).Conclusions: ACDR is as effective as ACDF and superior for some success rates. Disc replacement can reduce the risk of dysphagia/dysphonia, ASD, and re-operation. [ABSTRACT FROM AUTHOR]

Purpose: The present study aimed to investigate fish oil plus vitamin D3 (FO + D) supplementation on biomarkers of non-alcoholic fatty liver disease (NAFLD). Methods: In a 3-month randomized controlled trial, 111 subjects with NAFLD, aged 56.0 ± 15.9 y, were randomized into FO + D group (n = 37), fish oil group (FO, n = 37) or corn oil group (CO, n = 37). The subjects consumed the following capsules (3 g/day), which provided 2.34 g/day of eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) + 1680 IU vitamin D3 (FO + D group), or 2.34 g/day of EPA + DHA (FO group), or 1.70 g/d linoleic acid (CO group). Results: Using multivariable-adjusted general linear model, there were significant net reductions in serum alanine aminotransferase (ALT), and triacylglycerol (TAG) and TNF-α levels in the FO + D and FO groups, compared with the control group (P < 0.05). The supplemental FO + D also showed significant reductions in insulin (− 1.58 ± 2.00 mU/L vs. − 0.63 ± 1.55 mU/L, P = 0.050) and IL-1β (− 6.92 ± 7.29 ng/L vs. 1.06 ± 5.83 ng/L, P < 0.001) in comparison with control group. Although there were no significant differences between FO + D and FO groups regarding biochemical parameters, supplemental FO + D showed decreases in ALT (from 26.2 ± 13.5 U/L to 21.4 ± 9.6 U/L, P = 0.007), aspartate aminotransferase (AST, from 22.5 ± 7.0 U/L to 20.2 ± 4.0 U/L, P = 0.029), HOMA-IR (from 3.69 ± 1.22 to 3.38 ± 1.10, P = 0.047), and TNF-α (from 0.43 ± 0.38 ng/L to 0.25 ± 0.42 ng/L, P < 0.001) levels following the intervention. Conclusion: The present study demonstrated that groups supplemented with FO + D and FO had similar beneficial effects on biomarkers of hepatocellular damage and plasma TAG levels in subjects with NAFLD, while in the FO + D group, there were some suggestive additional benefits compared with FO group on insulin levels and inflammation. Trial registration: ChiCTR1900024866. [ABSTRACT FROM AUTHOR]

Cognitive-Behavioral Therapy for Insomnia (CBT-I) is the gold-standard treatment for insomnia, which is common among breast cancer survivors (BCS). This pilot randomized controlled trial tested the first CBT-I intervention for Spanish-speaking BCS delivered using eHealth. Participants (N = 30) were Spanish-speaking BCS with insomnia symptoms recruited in Puerto Rico and randomized to a 6-week eHealth CBT-I group intervention or a waitlist control. Primary outcomes were acceptability (recruitment, treatment satisfaction) and feasibility (retention, attendance). Secondary outcomes were group differences in sleep outcomes post-treatment (i.e., insomnia symptoms, sleep disturbance, sleep efficiency). Recruitment (95%) and retention (97%) were excellent. All CBT-I participants (100%) attended ≥ 3 of 6 sessions. Satisfaction with CBT-I was acceptable. Post-intervention, there were medium to large group differences for average insomnia symptoms (d = 1.02), sleep disturbance (d = 1.25), and sleep efficiency (d = 0.77) favoring CBT-I. There were small/medium to medium/large group differences for the proportion of participants with clinically significant insomnia symptoms (d = 0.52), sleep disturbance (d = 0.67), and low sleep efficiency (d = 0.33) favoring CBT-I. Spanish-language eHealth CBT-I for BCS was acceptable and feasible and showed preliminary efficacy. ClinicalTrials.gov TRN: NCT04101526 (Posted September 24, 2019). [ABSTRACT FROM AUTHOR]

Robust clinical evidence has not been available for melatonin, a drug commonly administered for treating sleep problems of children with autism spectrum disorder (ASD). In a phase 3 randomized, placebo-controlled clinical trial, we administered 1-mg melatonin (n = 65), 4-mg melatonin (n = 65), or placebo (n = 66) to196 children with ASD once daily before bedtime under adequate sleep hygiene interventions. The primary outcome was sleep onset latency (SOL) assessed with the electronic sleep diary. SOL shortened significantly in the 1- and 4-mg melatonin groups compared to the placebo group (− 22.0, − 28.0, and − 5.0 min, respectively; p < 0.0001 each). This therapeutic regimen of melatonin is a reasonable clinical approach to cope with ASD-emergent difficulties in children with ASD. [ABSTRACT FROM AUTHOR]

Endovascular coiling has revolutionized intracranial aneurysm treatment; however, recurrence continues to represent a major limitation. The hydrogel coil was developed to increase packing density and improve neck healing and therefore decrease recurrence rates. In this paper, we review treatment outcomes of first- (1HCs) and second-generation (2HCs) hydrogel coils and compare them to those of bare platinum coils (BPC). A query of multiple databases was performed. Articles with at least 10 aneurysms treated with either 1HC or 2HC were selected for analysis. Collected data included aneurysm size, rupture status, initial occlusion, initial residual neck/aneurysm, packing density, mortality, morbidity, recurrence, and retreatment rates. The primary endpoint was recurrence at final follow-up. Secondary endpoints included residual neck and dome rates as well as procedure-related complications and functional dependence at final follow-up. Studies that compared 1HC to BPC showed significant lower recurrence (24% vs. 30.8%, p = 0.02) and higher packing density (58.5% vs. 24.1%, p < 0.001) in 1HC but no significant difference in initial occlusion rate (p = 0.08). Studies that compared 2HC to BPC showed lower recurrence (6.3% vs. 14.3%, p = 0.007) and retreatment rates (3.4% vs. 7.7%, p = 0.010) as well as higher packing density (36.4% vs. 29.2%, p = 0.002) in 2HC, with similar initial occlusion rate (p = 0.86). The rate of complications was not statistically different between HC (25.5%) and BPC (22.6%, p = 0.06). Based on our review, the 1HC and 2HC achieved higher packing density and lower recurrence rates compared to BPC. The safety profile was similar between both groups. [ABSTRACT FROM AUTHOR]

Behavioral activation (BA) is a beneficial and relatively cost-effective treatment option for depression. This study utilized a pragmatic randomized controlled research design to investigate whether BA, as compared with treatment as usual (TAU), led to superior treatment effects, when delivered in community mental health settings by retrained community mental health professionals. Patients with depressive disorders (n = 64) were randomly assigned to a 10-session BA (n = 31) or TAU (n = 33) group. The depressive symptoms and behavioral engagement were assessed at the baseline, post-treatment, and a six-month follow-up. Results showed that, as compared to the TAU group, the BA group had: (1) a reduction in depression severity, as evidenced by large effect sizes and greater response rates, and (2) an increase in behavioral engagement. However, the post-treatment gains were not maintained at the six-month follow-up. The implications and limitations of the study are also discussed (KCT0004098, June 27, 2019, retrospectively registered). [ABSTRACT FROM AUTHOR]

Introduction: Currently, the best and simplest way that used to select the distal femoral valgus cut (DFVC) angle in total knee arthroplasty (TKA) is standing long leg radiograph. However, this kind of film is still not available in all hospitals. The purpose of this study is to compare the accuracy of different empirical DFVC angles in the restoration of the neutral mechanical alignment of the femoral component after TKA. Method: 125 patients who diagnosed primary osteoarthritic knee and underwent unilateral TKA were randomly assigned into three groups: A, B, and C, according to the use of an intramedullary guide with the DFVC angle of 4°, 5°, and 6°, respectively. At three months after surgery, anteroposterior hip-to-ankle computed tomography (CT) scanograms were evaluated. Mechanical axis angle (MAA), mechanical lateral distal femoral angle (LDFA), femoral bowing, femoral neck-shaft angle (FNSA), and outliers of femoral component position were measured and compared among three groups. Independent influencing factors for the outliers > ±3° were determined using binary logistic regression analysis. Results: Group B was older than group A. There were no significant differences of postoperative MAA, LDFA, femoral bowing, and FNSA among three groups. Outliers > ±3° of femoral component position in each group were 14.6%, 19.0%, and 16.7%, respectively (p = 0.865). When considering the outliers > ±2°, group C (35.7%) had a trend to have fewer outliers than groups A and B (41.5 and 42.9%). However, this finding was not reached the statistical significance (p = 0.778). Femoral bowing was only significantly influencing factors that related to the outliers > ±3° (p = 0.003). Conclusion: This study demonstrates that there are no significant differences in coronal femoral component alignment among using the DFVC angle of 4°, 5°, and 6°. The use of the DFVC angle of 6° had a trend to reduce the outliers. Nevertheless, femoral bowing is the crucial influencing factor for selecting the degree of DFVC angle. [ABSTRACT FROM AUTHOR]

Pivotal Response Treatment (PRT) is promising for children with Autism Spectrum Disorder (ASD), but more methodologically robust designed studies are needed. In this randomized controlled trial, forty-four children with ASD, aged 9–15 years, were randomly allocated to PRT (n = 22) or treatment-as-usual (TAU; n = 22). Measurements were obtained after 12- and 20-weeks treatment, and 2-month follow-up. PRT resulted in significant greater improvements on parent-rated social-communicative skills after 12 weeks treatment (p =.004, partial η2 = 0.22), compared to TAU. Furthermore, larger gains in PRT compared to TAU were observed on blindly rated global functioning, and parent-rated adaptive socialization skills and attention problems. Implications for clinical practice and suggestions for future research are discussed. [ABSTRACT FROM AUTHOR]

Introduction: To investigate the effects of structured moderate-intensity aerobic exercise on blood glucose, insulin, and pregnancy outcomes in patients with gestational diabetes mellitus (GDM). Methods: One hundred one patients with GDM were randomly divided into a control group (50 cases) and an experimental group (51 cases) in a class 3 first-level general hospital. GDM patients in the control group received a personalized diabetes diet intervention, online education, and routine prenatal care. The experimental group added 6 weeks of moderate-intensity aerobic exercise in addition to the identical conditions given to the control group. The differences of fasting and 2-h postprandial blood glucose, insulin use, and adverse pregnancy outcomes were evaluated between the experimental and control group after intervention. Results: Outcomes were available from 89 participants. Compared with before intervention, there were statistically significant differences in fasting blood glucose and 2-h blood glucose after three meals in both groups (P < 0.05). There were statistically significant differences in the average fasting blood glucose, the average 2-h postprandial blood glucose, the insulin dosage, and the utilization rate between the experimental and control group after the intervention (P < 0.05). Parameters in the experimental group were all lower than in the control group. Compared with the control group, the incidence of adverse pregnancy outcomes in the experimental group after intervention was not statistically significant (P > 0.05). Conclusion: Moderate-intensity aerobic exercise can help improve blood glucose control and insulin use in patients with GDM. In the future, long-term follow-up can be conducted for maternal and neonatal infants to evaluate the impact of exercise intervention on the risk of type 2 diabetes. Clinical Trial Registration: The trial was approved by the registration of the Chinese Clinical Trial Registry. Registration number: ChiCTR1900027929. [ABSTRACT FROM AUTHOR]

Callous-unemotional (CU) traits and effortful control (EC) are two early dispositions that play a key role in developmental pathways of childhood-onset conduct problems (CP). Recently, a randomized controlled trial of an early parenting intervention (PI) with parents of preschoolers with CP, called Hitkashrut, indicated that these dispositions are interrelated, and can be improved following treatment. The objective of the current study was to use Hitkashrut's 2-wave dataset to test a temperamentally-driven mechanism in which EC is hypothesized to mediate PI's effect on CU traits. Parents of 209 preschoolers (163 boys; 46 girls), with subclinical-clinical range CP were assigned to 14-session co-parent training groups (n = 140 couples), or to minimal intervention control groups (n = 69 couples). All participants were Jewish ranging from ultra-orthodox to secular. We employed averaged indices of pre- and post-intervention questionnaires completed by both parents. An intent-to-treat analysis showed that EC partially mediated treatment effect on CU traits, while controlling for treatment effect on CP. A nonsignificant alternative model in which CU traits mediate effect on children's EC further supported the hypothesis that change in EC preceded change in CU traits. This is the first demonstration of EC mediated treatment effect on CU traits in a randomized controlled study conducted in everyday practice settings. Overall, the results suggested that CU traits are malleable following appropriate treatment and affected by improvement in temperamental self-regulatory capacity as indicated by EC. The results suggest that preschoolers' CU traits can be improved by incorporating intervention that enhance self-regulation capabilities. Highlights: Effortful control (EC) mediated parenting intervention's effect on callous-unemotional (CU) traits in real-world settings. Preschoolers' CU traits can be improved by enhancing self-regulation capabilities. EC partially mediated treatment effect on CU traits, while controlling for CP. [ABSTRACT FROM AUTHOR]

To study the efficacy of breast nodule lysis (BNL) for the treatment of mammary gland hyperplasia (MGH). A total of 304 patients with MGH and breast pain were randomly divided into a BNL group and an oral tamoxifen (OT) group. In the BNL group (n = 156), patients were treated with BNL technique once a day for 7 consecutive days. BNL is a novel technique developed by our department, by which breast nodules can be released and breast duct can be cleared via external force and manipulation. In the OT group (n = 148), patients took oral tamoxifen 10 mg once a day for 15 consecutive days beginning 5 days after termination of the menstrual period for 3 menstrual cycles. The McGill Pain Questionnaire (MPQ) score, number and size of breast nodules pre- and post-treatment, efficacy, time to response, total treatment expenses, recurrence rate, and side effects were compared across groups. The MPQ score was significantly better in the BNL than the OT on day 7, and the total effective rate (86.54%) was significantly higher in the BNL than the OT (43.92%) on day 15. The number and size of breast nodules were decreased in the BNL compared with the OT 15 days, 3 months, and 6 months after treatment. The total treatment expenses were higher in the BNL than the OT. The recurrence rate within 6 months was lower in the BNL than the OT. There was no difference in side effects (nausea, vomiting, diarrhea, or dizziness) across groups. BNL can effectively alleviate pain and reduce the number and size of nodules with quick effect and a low recurrence rate, making it an enticing treatment for MGH. [ABSTRACT FROM AUTHOR]

Breast cancer, which is the most common cancer in women, results to moderate to severe acute postoperative pain. Pectoral nerve block I and II, relatively new regional techniques, were introduced for perioperative and postoperative postmastectomy pain by Blanco in 2011 and 2012, respectively. The aim of this study is to evaluate the efficacy of combined pectoral nerve block I and pectoral nerve block II blocks for perioperative opioid consumption and postoperative analgesia and also contribute to new topic in anaesthesia: "Opioid-free anaesthesia is possible with combination of pectoral blocks in breast cancer surgery". Sixty women patients of American Society of Anesthesiologists status I–III, aged ≥ 18 years undergoing breast surgeries, were included to study. Cases were randomly allocated to two groups: Group I, opioid-based general anaesthesia, and Group II, non-opioid general anaesthesia except induction of anaesthesia with pectoral nerve block I and pectoral nerve block II blocks. Patients demographic characteristics, intraoperative total remifentanil consumption, duration of surgery, first analgesic demand after surgery, nausea and vomiting, surgeon and patient satisfaction were recorded. Two groups were similar in terms of demographic features, surgery time, surgery type and vomiting. The mean remifentanil consumption in Group I was 8.63 mL (SD = 3.18) compared to mean = 1.73 mL (SD = 1.04) in Group II. Statistically lower remifentanil consumption was recorded in Group II than Group I. No patient developed nausea after surgery in Group II. Time for first analgesic demand after surgery for Group I and II were 35.00 (SD = 19.60) and 124.5 (SD = 99.00) minutes respectively. Time for first analgesic demand after surgery was statistically significant between the groups. Satisfaction scores were higher in Group II for both surgeon and patient. General anaesthesia combined with pectoral nerve block I and pectoral nerve block II blocks which is gaining acceptance over the world is safe and effective for breast surgery. We thought that further studies are necessary to investigate timing of blocks and combinations of blocks. [ABSTRACT FROM AUTHOR]

This study investigated the effects of a parent-implemented dialogic reading approach—Reading to Engage Children with Autism in Language and Learning (RECALL)—on the engagement in reading and inference-making ability for preschoolers with autism spectrum disorder (ASD). Thirty-one preschoolers (mean age = 5.90 years, SD = 0.69; 26 boys, 5 girls) were randomly assigned to a treatment or control group. Six weeks of RECALL significantly enhanced story comprehension, emotion knowledge, and reading engagement among preschoolers in the treatment group. This might be the first randomized controlled trial testing the effects of RECALL on children with ASD. Our findings suggest that additional instructional support such as the application of a prompting hierarchy during dialogic reading might help children with ASD reap greater benefits from shared book reading. [ABSTRACT FROM AUTHOR]

Introduction: Palmoplantar pustulosis (PPP) is a chronic, inflammatory skin disease, with high disease burden, that is often refractory to treatment. There is a high unmet clinical need for the treatment of patients with PPP. The objectives of this study were to evaluate the safety and efficacy of spesolimab, a novel anti-interleukin-36 receptor antibody, in patients with PPP. Methods: This was a phase IIa, multicenter, double-blind, randomized, placebo-controlled pilot study comparing 900 mg spesolimab (n = 19), 300 mg spesolimab (n = 19), and placebo (n = 21) administered intravenously every 4 weeks until week 12 in patients with PPP. The primary efficacy endpoint was the achievement of Palmoplantar Pustulosis Area and Severity Index 50 (PPP ASI50) at week 16, defined as achieving an ≥ 50% decrease from baseline PPP ASI. Results: At week 16, 31.6% of patients in both spesolimab dose groups achieved PPP ASI50 versus 23.8% receiving placebo (risk difference 0.078; 95% confidence interval –0.190, 0.338). Thus, the primary endpoint was not met. Spesolimab was well tolerated with no clinically relevant treatment-emergent safety signals observed. Conclusions: PPP severity declined over time in all treatment groups after the start of treatment, with a faster decline in the spesolimab arms than in the placebo arm, indicating a potential treatment effect for spesolimab. Limitations to the study included a small sample size and lower overall disease severity than expected at baseline. It is possible that the primary efficacy endpoint may have coincided with natural disease resolution in some patients. Further effects of the efficacy of spesolimab in PPP are being explored in a phase IIb trial. [ABSTRACT FROM AUTHOR]

The aim of this study was comparing different lasers with conventional non-surgical treatment (CNT) for the management of peri-implantitis, regarding probing depth (PD), plaque index (PLI), clinical attachment level (CAL), and sulcus bleeding index (SBI). Randomized controlled trials (RCTs) on different lasers and CNT for peri-implantitis were searched. Pairwise and network meta-analyses were performed to analyze the PD, PLI, CAL, and SBI outcomes. The risk of bias, evidence quality, statistical heterogeneity, and ranking probability were also evaluated. Eleven studies were included in this study, involving three types of lasers. Diode + CNT had significantly superior efficacy to CNT alone, regarding PD reduction, while Er:YAG + CNT had significantly superior efficacy than CNT in terms of the PLI, CAL, and SBI. The highest probability of being most effective for PD was diode + CNT (49%), while Er:YAG + CNT had the highest probability of improving the PLI, CAL, and SBI (66%, 53%, and 79%, respectively). Diode + CNT was significantly superior for PD management in peri-implantitis compared with CNT alone, while Er:YAG + CNT significantly improved the PLI, CAL, and SBI. Therefore, Er:YAG + CNT might be recommended methods considered for management of peri-implantitis. [ABSTRACT FROM AUTHOR]

While some RCTs have observed efficacy for omega-3 supplementation in reducing antisocial behavior, the role of psychopathic personality and gender in moderating treatment outcome has not been examined. This study examines whether omega-3 supplementation reduces antisocial behavior, and whether any treatment effects are a function of gender and psychopathy. Three hundred and twenty-four schoolchildren with a mean age of 11.9 years were randomized into 3 groups: omega-3 (N = 108), placebo (N = 110), and no-treatment controls (N = 106). Parent and child reports of child antisocial and aggressive behavior and psychopathic-like personality were collected at 0 months (baseline), 6 months (end of treatment), and 12 months (6 months post-treatment). A group × time × gender interaction (p =.016) indicated that only females in the omega-3 group showed a significant reduction in antisocial behavior 6 months post-treatment compared to baseline (d =.35), whereas the females in the two control groups showed no change over time. A group x time x psychopathy interaction (p <.006) was also observed, with psychopathic personality levels moderating treatment outcome. Children in the omega-3 group with high (but not low) psychopathic-like personality showed significant improvements in child-reported antisocial behavior at the end of treatment (d =.19) Results suggest that omega-3 supplementation may be helpful in reducing childhood antisocial and aggressive behavior in females, and those with psychopathic-like personalities. [ABSTRACT FROM AUTHOR]

Purpose: Time of drug administration may significantly influence its effect. The aim of the present study was to investigate the effect of ASA (administrated in the morning or in the evening) on the anti-hypertensive effect and diurnal blood pressure profile in the high-risk group of cardiovascular patients. Methods: All patients (n = 114) had been diagnosed with coronary heart disease and arterial hypertension prior to the enrolment and had been treated with 75 mg per day of ASA in the morning. The patients were randomly assigned to one of the two study groups receiving 75 mg of ASA per day in a single antiplatelet therapy for 3 months in the morning (n = 58) or in the evening (n = 56). The control group (n = 61) consisted of patients with arterial hypertension but without coronary heart disease, not receiving ASA. In all the patients, during each visit, clinical blood pressure (BP) and ambulatory blood pressure measurements (ABPM) were performed. Results: There was a significant reduction in 24-h BP and blood pressure at night in the ASA group evening group compared with the ASA morning group and the control group. Conclusions: The present study demonstrated that compared with the use of ASA in the morning, its administration in the evening may lead to favourable drop in the ABPM and an improvement of the diurnal profile in the high-risk group of cardiovascular patients who are not naïve to ASA. [ABSTRACT FROM AUTHOR]

Purpose: To investigate the effect of consuming quinoa biscuits on markers of CVD risk over 4 weeks in free-living older adults. Methods: A randomized-controlled, double-blind crossover trial was conducted in which consenting healthy adults aged 50–75 years (n = 40) consumed 15 g quinoa biscuits (60 g quinoa flour/100 g) or control iso–energetic biscuits (made using wheat flour) daily for 28 consecutive days (4 weeks), in addition to their normal diet. Following a 6-week washout, participants consumed the alternate biscuit for a final 4 weeks. Anthropometry and fasted blood samples were obtained before and after each intervention period. Results: At the beginning of the trial, mean ± SD total cholesterol concentrations were 6.02 ± 1.22 mmol/L (3.7–9.2 mmol/L); 33 participants (82.5%) had high cholesterol (> 5 mmol/L). No participants were lost to follow-up and there were no changes in habitual dietary intakes or levels of physical activity between each 4-week intervention period. Significantly greater decreases in total and LDL cholesterol concentrations (− 0.30 ± 0.58 and − 0.25 ± 0.38 mmol/L, respectively), TC: HDL ratio (− 0.11 ± 0.30), weight (− 0.61 ± 0.89 kg) and BMI (− 0.22 ± 0.34 kg/m2) were apparent following consumption of the quinoa versus control biscuits (all P < 0.05). Changes in triglycerides, HDL cholesterol, or PUFA or CRP concentrations were not significant between treatment groups. Conclusion: Consumption of novel quinoa biscuits produced small, but favorable changes in body weight, BMI, and circulating cholesterol concentrations, all of which may contribute to lowered CVD risk in older adults. [ABSTRACT FROM AUTHOR]

Objective: We aimed to evaluate to what extent the results of registered randomized controlled trials (RCTs) assessing transarterial chemoembolization (TACE) for treating hepatocellular carcinoma (HCC) are publicly available.Methods: We searched the Cochrane Central Register of Controlled Trials, the International Clinical Trials Registry Platform, and primary registries for RCTs assessing TACE for treating HCC, registered between January 2008 and August 2018, that had exceeded their completion date by more than 1 year. We systematically searched PubMed, EMBASE, and Google Scholar for a publication as well as the registry for results. The main outcomes were the availability of results, and the time to the first availability of results (i.e., posted on the registry or published). Secondary outcomes were the proportion of results available at 12 and 36 months after completion.Results: Among 67 identified RCTs, including a total target number to 11,599 participants, 26 had publicly available results (39%; i.e., 42% of total target number of participants). Results of 25 RCTs (37%) were published, with only 3 having results posted on the registry and 2 with both published and posted results. The median (Q1-Q3) time from completion to the first public availability of results was 18 months (11-29). The cumulative percentages of RCTs with results available were 10% (95% CI, 3-17%) and 29% (95% CI, 17-39%) at 12 and 36 months, respectively, after completion.Conclusions: Despite the ethical commitments and societal expectations for disclosure of results, the availability of results of RCTs on TACE for treating HCC is very limited.Key Points: • Underreporting of trial results is a major cause of wasted medical research since inaccessible research results fail to help both patients and clinicians. • Transarterial chemoembolization (TACE) is the most common treatment for hepatocellular carcinoma (HCC) and has called for considerable research efforts. • Yet, almost two-thirds of randomized controlled trials assessing TACE for treating HCC did not yield any public results, either on the registry platform or in scientific journals. [ABSTRACT FROM AUTHOR]

Background: Anxiety and depressive disorders are often characterized by perceived social disconnection, yet evidence-based treatments produce only modest improvements in this domain. The well-established link between positive affect (PA) and social connectedness suggests that directly targeting PA in treatment may be valuable. Method: A secondary analysis of a waitlist-controlled trial (N = 29) was conducted to evaluate treatment response and process of change in social connectedness within a 10-session positive activity intervention protocol—Amplification of Positivity (AMP)—designed to increase PA in individuals seeking treatment for anxiety or depression (ClinicalTrials.gov Identifier: NCT02330627). Perceived social connectedness and PA/negative affect (NA) were assessed throughout treatment. Time-lagged multilevel mediation models examined the process of change in affect and connectedness throughout treatment. Results: The AMP group displayed significantly larger improvements in social connectedness from pre- to post-treatment compared to waitlist; improvements were maintained through 6-month follow-up. Within the AMP group, increases in PA and decreases in NA both uniquely predicted subsequent increases in connectedness throughout treatment. However, experiencing heightened NA throughout treatment attenuated the effect of changes in PA on connectedness. Improvements in connectedness predicted subsequent increases in PA, but not changes in NA. Conclusions: These preliminary findings suggest that positive activity interventions may be valuable for enhancing social connectedness in individuals with clinically impairing anxiety or depression, possibly through both increasing positive emotions and decreasing negative emotions. [ABSTRACT FROM AUTHOR]

Cognitive behavioral therapy for psychosis (CBT) is an effective treatment in adult patients with schizophrenia. However, no randomized controlled and blinded trial in adolescents with early-onset psychosis (EOP) has been conducted. Therefore, the present pilot study explores the acceptance, tolerability, feasibility, and safety of a modified CBT in adolescents with EOP. Twenty-five adolescents with EOP were randomized to either 9 months (20 sessions) of CBT + treatment as usual (TAU) or TAU alone. The primary endpoint was the PANSS-positive subscale (P1-7). Secondary endpoints included psychopathology, global functioning, and quality of life (QoL). Acceptance, tolerability, feasibility, and safety were assessed. Blinded assessments took place by the end of the treatment (9 months) and at 24-month follow-up. Despite improvements in both groups and lack of statistical significance between CBT + TAU and TAU regarding the primary endpoint, we observed between-group effect sizes of at least d = 0.39 in favor of CBT + TAU at post-treatment for delusions, negative symptoms, functioning and QoL after the intervention and effect sizes of at least d = 0.35 after 24 months. CBT in EOP was highly acceptable (73.5% agreed to randomization), well-tolerated (83.1% attendance rate, no drop-outs), and safe (one serious adverse event (SAE) in CBT + TAU in comparison with six SAEs in TAU). These findings suggest that CBT adapted to the needs of adolescents with EOP is a promising approach regarding negative symptoms, functioning, and QoL. CBT is a safe and tolerable treatment. However, due to the small sample size and the pilot character of the study, these conclusions are limited, and should be tested in a larger, adequately powered randomized controlled trial. [ABSTRACT FROM AUTHOR]

Objective: Alzheimer's disease (AD) is a common type of dementia, which has caused heavy global economic and health burden, and the using of statins to treat AD has caused widely debated. The purpose of this meta-analysis is to explore the effect of statins in the treatment of Alzheimer's disease.Methods: Studies were retrieved by searching PubMed, Embase, Cochrane library, OvisdSP, Web of Science, Chinese Nation Knowledge Infrastructure (CNKI) and Chinese Biomedical Database (CBM) databases before March 31, 2019. We extracted the Mini-Mental State Examination (MMSE), Alzheimer's Disease Assessment Scale-cognitive (ADAS-Cog), Neuropsychiatric Inventory (NPI), Activities of Daily Living (ADL) scale score, and other information. The pooled Weighted Mean Difference (WMD) and their 95% confidence intervals (95% CI) were calculated with random effect model or fixed random effect model.Results: A total of nine randomized controlled trials were included that contained 1489 patients; of them, 742 patients in the statins group, 747 patients in the control group. There were nine studies used the MMSE scale, five studies used the ADAS-Cog scale, four studies used the NPI scale, and six studies used the ADL scale. Meta-analysis of the nine studies that reported the MMSE scale scores indicated that there is no significant effect of statins as compared with control group (the pooled WMD = 1.09, 95% CI, - 0.00, 2.18, p = 0.05, I2 = 87.9%). Meta-analysis of the five studies that reported the ADAS-Cog scale scores also indicated that there is no significant effect of statins as compared with control group (the pooled WMD = - 0.16, 95% CI, - 2.67, 2.36, p = 0.90, I2 = 80.1%). Meta-analysis of the four studies that reported the NPI scale scores indicated that treatment with statins could slow the rise in the NPI scale scores (the pooled WMD = - 1.16, 95% CI, - 1.88, - 0.44, p = 0.002, I2 = 45.4%). Meta-analysis of the six studies that reported the ADL scale scores indicated that treatment with statins could improve patients' daily living ability (the pooled WMD = - 4.06, 95% CI, - 6.88, - 1.24, p = 0.005, I2 = 86.7%). Results of subgroup analysis indicated that the use of statins in the short term (≤ 12 months) associated with the change of the MMSE scale scores (the pooled WMD = 1.78, 95% CI, 0.53, 3.04, p = 0.005, I2 = 79.6%). Sensitivity analysis and publication bias test were both negative, and the results were relatively reliable and stable.Conclusion: Statins used in AD patients had beneficial effects on the scores of MMSE scale in the short term (≤ 12 months), and statins could slow the deterioration of neuropsychiatric status and significantly improve activities of daily living ability in AD patients, but statins did not show an advantage in the change of the ADAS-Cog scale scores. [ABSTRACT FROM AUTHOR]

Objectives: This network meta-analysis compares different lasers, placebo, and no treatment in terms of their effects on dentine hypersensitivity (DH) immediately after treatment and over the long term (1 month). Methods: A systematic electronic literature search of four databases and a manual search were performed to identify randomized controlled trials (RCTs) examining different laser treatments for the treatment of DH. Pairwise and network meta-analyses were performed to analyze the desensitization effect immediately after treatment and over the long term. The risk of bias was assessed based on the Cochrane guidelines and funnel plots. The quality of the evidence, statistical heterogeneity, inconsistencies, and ranking probability were also evaluated. Results: A total of 11 RCTs were included in the network meta-analysis; 11 and 9 of these studies analyzed immediate and long-term effects, respectively. All four types of laser had a better desensitizing effect than controls immediately after treatment and over the long term, but there were no significant differences among the four different lasers. There was a significant placebo effect immediately after treatment. The laser with the highest probability of being the most effective treatment for DH was Er,Cr:YSGG immediately after treatment and over the long term (73% and 47%, respectively). Conclusions: All four types of laser had significantly better effects than no treatment on DH immediately after treatment and in the long term, but there were no significant differences among the four lasers. In addition, there was a significant placebo effect, supporting the importance of including a placebo group in future studies. Furthermore, Er,Cr:YSGG may be the most effective laser for the treatment of DH immediately and over the long term. Clinical relevance: This study used network meta-analyses to compare different lasers, placebo, and no treatment over different time periods, which is to provide guidance for selecting an appropriate laser treatment in patients with DH. [ABSTRACT FROM AUTHOR]

Background: The purpose of this study was to examine demographic, psychological, military, and deployment variables that might predict posttraumatic stress disorder (PTSD) symptom improvement in a sample of active duty service members who received either group or individual cognitive processing therapy (CPT). Methods: Data were analyzed from 165 active duty service members with pre- and posttreatment data participating in a randomized controlled trial comparing group with individual CPT. Pretreatment variables were examined as predictors of change in PTSD severity from baseline to posttreatment, assessed using the PTSD Symptom Scale-Interview Version (PSS-I). Predictors of PSS-I change were first evaluated using Pearson correlations, followed by partial and multiple correlations to clarify which associations remained when effects of other predictors were controlled. Multiple regression analyses were used to test for interactions between pretreatment variables and treatment format. Results: Only age was a significant predictor of PTSD symptom change after controlling for other variables and statisitically correcting for testing multiple variables. There was also an interaction between age and treatment format. Conclusions: Younger participants had greater symptom improvement, particularly if they received individual treatment. Other pretreatment variables did not predict outcome. CPT appears to be robust across most pretreatment variables, such that comorbid disorders, baseline symptom severity, and suicidal ideation do not interfere with application of CPT. However, individual CPT may be a better option particularly for younger service members. [ABSTRACT FROM AUTHOR]

Objective: This meta-analysis aimed at evaluating and comparing the efficacy of noninvasive brain stimulation (NIBS) techniques on the behavioral and psychological symptoms of dementia (BPSD).Methods: An exhaustive literature retrieval was performed on PubMed, Embase, Cochrane Library, and Web of Science until October 2019. The primary outcome was the relative changes in BPSD severity scores immediately after NIBS and at the last follow-up visit. Subgroup analyses were conducted to compare the efficacy of repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS). Changes in the severity scores after NIBS were also analyzed with restriction to patients with Alzheimer's disease (AD).Results: Ten studies with 324 patients were included, out of which 7 studies involved patients with AD. The analysis results indicated that NIBS significantly improved the BPSD outcome immediately after stimulation (SMD, 0.31; 95% CI, 0.10-0.52; P = 0.005), but not at the last follow-up visit (0.15; - 0.11-0.41; 0.25). Our subgroup analyses suggested that the favorable effects of rTMS remained significant at the last follow-up visit (0.57; 0.18-0.96; 0.004). This discrepancy maybe caused by the continuously insignificant outcomes of tDCS on the whole data. The results for AD patients immediately after stimulation (0.37; 0.12-0.61; 0.003) and at the last follow-up visit (0.29; - 0.19-0.76; 0.24) were both largely similar to those in the whole patient group with dementia.Conclusions: rTMS, rather than tDCS, was capable of persistently improving the BPSD at an early stage after treatment. More trials are warranted to confirm our results before the establishment of final conclusions. [ABSTRACT FROM AUTHOR]

The objective is to investigate the effectiveness of home-based behavioral parent training for school-aged children with attention-deficit/hyperactivity disorder (ADHD) and behavior problems with remaining impairing disruptive behaviors after routinely offered treatments in clinical practice. In a randomized controlled study including 73 referred children with ADHD and impairing disruptive symptoms after routine clinical pharmacotherapy and/or clinic-based parent training had been tried or, at least, offered, home-based behavioral parent training (n = 26) was compared to a waiting list (n = 23) and a care-as-usual home-based treatment (n = 24). It was unknown to families which of the home-based treatments that they received. Using mixed models for repeated measures, we examined the effectiveness on the primary outcome measure of children's severity of disruptive behaviors and on a number of secondary outcome measures [the degree to which parents experienced the disruptive behaviors as troublesome, ADHD symptoms, oppositional-defiant disorder (ODD) symptoms, and internalizing problems]. Compared to the waiting list, children receiving home-based parent training improved significantly more regarding severity of disruptive behaviors (ES = 0.75), ADHD symptoms (ES = 0.89), ODD symptoms (ES = 0.65), and internalizing problems (ES = 0.60). Compared to care-as-usual, home-based parent training was more effective in reducing disruptive behaviors (ES = 0.57), ADHD symptoms (ES = 0.89), and ODD symptoms (ES = 0.88). Significantly more reduction of children's internalizing problems was not found. In conclusion, children with ADHD and residual behavioral problems after routine treatment may benefit from home-based behavioral parent training. [ABSTRACT FROM AUTHOR]

Background: Vedolizumab is a gut-selective humanized antibody that binds the α4β7 integrin. We evaluated efficacy and safety of vedolizumab in Japanese patients with moderate-to-severe Crohn's disease (CD).Methods: In this Phase 3, double-blind study (NCT02038920), 157 patients were randomized to receive intravenous vedolizumab 300 mg (n = 79) or placebo (n = 78) at Weeks 0, 2, and 6 (induction phase). Patients with CD activity index (CDAI)-70 response at Week 10 were randomized to receive vedolizumab 300 mg (n = 12) or placebo (n = 12) at Week 14, then every 8 weeks until Week 54 (maintenance phase). Primary endpoints were ≥ 100-point reduction in CDAI (CDAI-100 response) at Week 10 for induction, and clinical remission (CR: CDAI ≤ 150) at Week 60 for maintenance.Results: At Week 10, 26.6% of patients who received vedolizumab and 16.7% who received placebo achieved CDAI-100 response (odds ratio [OR] [95% confidence interval (CI)] 1.80 [0.82-3.96]; p = 0.145). At Week 60, 41.7% of vedolizumab-treated patients and 16.7% of placebo-treated patients achieved CR (OR [95% CI] 3.57 [0.53-23.95]; p = 0.178). The incidence of adverse events was similar in both treatment groups in both induction and maintenance phases. In patients without prior anti-TNFα exposure or with inadequate response to anti-TNFα, vedolizumab showed improved outcomes over placebo in the induction phase. Age might be a possible predictive factor of CR for future research.Conclusion: Vedolizumab showed a numerically greater efficacy versus placebo as induction therapy, but the difference was not statistically significant. Vedolizumab also showed a numerically greater efficacy in maintenance therapy, and was well tolerated. [ABSTRACT FROM AUTHOR]

To determine whether a gluten-free diet (GFD) compared with a gluten-containing diet (GD) influences functioning of children with autism spectrum disorders (ASD), we performed a randomized, controlled, single-blinded trial. Sixty-six children (36–69 months) with ASD, within the normal IQ (> 70) range, who had been on a GFD for at least 8 weeks before enrollment were eligible for inclusion. After an 8-week run-in period on a GFD, the GFD group continued this diet and the GD group consumed at least one normal meal containing gluten per day for 6 months. There were no differences between groups in autistic symptoms, maladaptive behaviors, or intellectual abilities after the intervention. A GFD compared with a GD did not affect functioning of children with ASD. Trial registration ClinicalTrials.gov, number NCT02280746. [ABSTRACT FROM AUTHOR]

This study aimed to compare the effectiveness of two different cognitive-behavioural therapy programs in patients with schizophrenia and clarify which techniques are more effective on psychotic symptoms. With this purpose, 39 schizophrenia outpatients—assessed by independent assessors using Scale for the Assessment of Positive Symptoms, Scale for the Assessment of Negative Symptoms and by researchers using Psychotic Symptoms Rating Scales-were randomly assigned to routine care (RC), RC plus COPE-CBT or RC plus CBT groups. The repeated measures ANOVA results show that there was a significant reduction in the severity and frequency of hallucinations in CBT group and delusions in COPE-CBT group. Both CBT programs were found to be superior to RC group on some measures at post-treatment, as well as 3 months follow-up. [ABSTRACT FROM AUTHOR]

Background and Aims: Despite advances in pharmacological and endoscopic management of non-variceal upper gastrointestinal bleeding (NVUGIB), mortality is still relevant. TC-325 (Hemospray-Cook Medical) is a mineral powder with adsorptive properties, designed for endoscopic hemostasis. There are still no comparative trials studying this new hemostatic modality. The objective of this research was to compare the use of TC-325 (associated with epinephrine injection) with the combined technique of endoscopic clipping and epinephrine injection for the treatment of patients with NVUGIB.Methods: We conducted a pilot randomized controlled trial with patients that presented NVUGIB with an actively bleeding lesion at the endoscopic evaluation. Patients were randomized either to the Hemospray or Hemoclip group. The randomization list was generated by a computer program and remained unknown throughout the entire trial. All patients underwent second-look endoscopy.Results: Thirty-nine patients were enrolled. Peptic ulcer was the most frequent etiology. Primary hemostasis was achieved in all Hemospray cases and in 90% of Hemoclip group (p = 0.487). Five patients in Hemospray group underwent an additional hemostatic procedure during second-look endoscopy, while no patient in the Hemoclip group needed it (p = 0.04). Rebleeding, emergency surgery and mortality rates were similar in both groups. No toxicity, allergy events, or gastrointestinal obstruction signs were observed in Hemospray group.Conclusions: TC-325 presents similar hemostatic results when compared with conventional dual therapy for patients with NVUGIB. Hemospray's excellent primary hemostasis rate certifies it as a valuable tool in arduous situations of severe bleeding or difficult location site. [ABSTRACT FROM AUTHOR]

Purpose: It has been hypothesized that vitamin D is associated with androgen levels in men. We, therefore, aimed to evaluate whether vitamin D supplementation increases serum total testosterone (TT) levels in men with low TT levels at baseline. Methods: The Graz Vitamin D&TT-RCT is a single-center, double-blind, randomized placebo-controlled trial conducted between March 2013 and November 2017 at the endocrine outpatient clinic at the Medical University of Graz, Austria. One-hundred healthy men with serum TT levels < 10.4 nmol/l and 25-hydroxyvitamin D [25(OH)D] levels < 75 nmol/l participated in the trial. Subjects were randomized to receive 20,000 IU of vitamin D3/week (n = 50) or placebo (n = 50) for 12 weeks. Primary outcome was TT measured using mass spectrometry. Secondary outcomes were free testosterone, free androgen index, sex hormone-binding globulin, estradiol, follicle-stimulating hormone, luteinizing hormone, metabolic characteristics, and body composition. Results: Ninety-four men [mean age and 25(OH)D: 47 (± 12) years and 56.3 (± 18.3) nmol/l, respectively] completed the study. We found no significant treatment effect on serum TT or on the remaining secondary outcome variables. Conclusion: Vitamin D treatment had no effect on serum TT levels in middle-aged healthy men with low TT levels. [ABSTRACT FROM AUTHOR]

Summary: A 48-week, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial (the TWICE study) conducted in Japanese primary osteoporosis patients with a high risk of fractures demonstrated that a 28.2-μg twice-weekly regimen of teriparatide can provide comparable efficacy to a 56.5-μg once-weekly regimen of teriparatide, while also improving safety. Introduction: While a 56.5-μg once-weekly regimen of teriparatide has high efficacy for osteoporosis, treatment continuation rates are low, with one of the major causes being adverse drug reactions such as nausea or vomiting. The TWICE study was therefore conducted to investigate whether a twice-weekly regimen with 28.2-μg teriparatide can provide comparable efficacy to the 56.5-μg once-weekly regimen while improving safety. Methods: A 48-week, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial was conducted in Japan. Patients with primary osteoporosis aged ≥ 65 years at high risk of fractures (n = 553) were randomly allocated to the 28.2-μg twice-weekly group (n = 277) or the 56.5-μg once-weekly group (n = 276). The primary endpoint was the percentage change in lumbar spine (L2–L4) bone mineral density (BMD) at final follow-up. Results: The percentage changes in lumbar spine (L2–L4) BMD at final follow-up in the 28.2-μg twice-weekly and 56.5-μg once-weekly groups were 7.3% and 5.9%, respectively; the difference (95% confidence interval [CI]) in percentage change was 1.3% (0.400–2.283%). Since the lower limit of the 95% CI was above the pre-specified non-inferiority margin (− 1.6%), non-inferiority of the 28.2-μg twice-weekly group was demonstrated. Adverse drug reactions were significantly less frequent in the 28.2-μg twice-weekly group (39.7% vs 56.2%; p < 0.01); the incidence of major adverse drug reactions was lower, and the number of subjects who discontinued due to adverse drug reactions was less in the 28.2-μg twice-weekly group. Conclusions: A 28.2-μg twice-weekly regimen of teriparatide can provide comparable efficacy to a 56.5-μg once-weekly regimen while improving safety. Clinical trial registration: JapicCTI-163477. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the exposure-overall survival (OS) relationship in patients with advanced pancreatic cancer treated with galunisertib plus gemcitabine (GG) or gemcitabine plus placebo (GP).Methods: Galunisertib 300 mg/day was given orally as intermittent dosing and gemcitabine as per label. Galunisertib exposure metrics for each patient in the GG arm (n = 99) of a phase 2 study of pancreatic cancer were calculated. Parametric survival models were used to identify influential baseline and response covariates on OS.Results: The population pharmacokinetics dataset included data from 297 patients/healthy subjects (age: 22-84 years, weight: 39-126 kg) across multiple studies, including this pancreatic cancer study. Galunisertib was rapidly absorbed with peak concentrations attained within 0.5-2 h and had an elimination half-life of 8 h. Between-subject variance on apparent clearance was estimated to be 47%. Age was the only characteristic to have a statistically significant effect on apparent clearance. A parametric Weibull survival model with treatment effect (dose) estimated a hazard ratio of 0.796, after adjusting for patient baseline factors that were significantly associated with OS. There was also a flat daily exposure-OS relationship within the observed exposure range, once all significant baseline covariates were included. Response covariates, such as reduction in CA19-9, time on treatment, and cumulative exposure over treatment cycles were also identified as significant factors for OS for patients with pancreatic cancer.Conclusions: This analysis suggests that 300 mg/day galunisertib administered as 150 mg twice daily for 14 days on/14 days off treatment is an appropriate dosing regimen for patients with pancreatic cancer. [ABSTRACT FROM AUTHOR]

This randomized controlled non-inferiority trial explored the effectiveness of Seeking Safety (SS) delivered by peer providers compared to its delivery by licensed behavioral health clinicians. The study enrolled 291 adults with PTSD and/or substance use disorders. Data were collected at 3 and 6-months post start of treatment. With respect to long-term outcomes, at 6 months PTSD symptoms decreased by 5.1 points [95% CI (− 9.0, − 1.1)] and by 4.9 points [95% CI (− 8.6, − 1.1)] and coping skills increased by 5.5 points [95% CI (0.4, 10.6)] and by 5.6 points [95% CI (0.8, 10.4)], in the peer- and clinician-led groups, respectively. This study demonstrated non-inferiority of peer-delivered SS compared to clinician-delivered SS for reducing PTSD symptoms and similar outcomes for both groups with respect to coping skills. A confirmatory study on the effectiveness of peer-delivered trauma-specific services is warranted, especially given the potential for increasing access to such treatment in underserved rural communities. [ABSTRACT FROM AUTHOR]

Summary: Treatment effects of combining teriparatide and whole-body vibration exercise (WBV) vs teriparatide alone in twelve months were compared using bone mineral density (BMD), bone microarchitecture, and bone turnover markers. We found an increased effect in lumbar spine BMD by adding WBV to teriparatide in postmenopausal osteoporotic women. Introduction: The parathyroid hormone (PTH) analogue teriparatide is an effective but expensive anabolic treatment for osteoporosis. Whole-body vibration exercise (WBV) has been found to stimulate muscle and bone strength in some studies. Animal data demonstrate a beneficial effect on bone when combining PTH with mechanical loading. The aim of this study was to investigate if combining WBV exercise and teriparatide treatment gives additional beneficial effects on bone compared to teriparatide alone in postmenopausal women with osteoporosis. Methods: The PaVOS study is a randomized controlled trial where postmenopausal osteoporotic women starting teriparatide 20 μg/day were randomized to WBV + teriparatide or teriparatide alone. WBV consisted of three sessions a week (12 min, including 1:1 ratio of exercise:rest). Bone mineral density (BMD) and bone microarchitecture, bone turnover markers, and sclerostin measurements were obtained. Data were analyzed using a linear mixed regression model with adjustment for baseline values or robust cluster regression in an intention-to-treat (ITT) analysis. Results: Thirty-five women were randomized (17 in teriparatide + WBV group and 18 in teriparatide group). At 12 months, both groups increased significantly in BMD at the lumbar spine. The teriparatide + WBV group increased by (mean ± SD) 8.90% ± 5.47 and the teriparatide group by 6.65% ± 5.51. The adjusted treatment effect of adding WBV to teriparatide was statistically significant at 2.95% [95% CI = 0.14–5.77; P = 0.040]. Markers of bone turnover increased significantly in both groups at three and six months with no significant difference between groups. No other treatment effects were observed in hip BMD, bone microarchitecture parameters, or sclerostin levels in either group. Conclusion: Twelve months of WBV and teriparatide had a significant clinically relevant treatment effect in lumbar spine BMD compared to teriparatide alone in postmenopausal osteoporotic women. ClinicalTrials.gov:(NCT02563353). [ABSTRACT FROM AUTHOR]

The systematic use of feedback from patients on treatment progress and treatment satisfaction is a promising method to increase treatment effectiveness. The extent to which this also applies to the treatment of children with severe psychiatric problems is not clear. We conducted a Randomized Controlled Trial (RCT) to study the effect of adding Feedback Informed Treatment (FIT) to care as usual in a child psychiatric sample. Quality of Life (QoL) was used as the primary outcome measure and symptom severity as the second. Fifty-one therapists from eight Autism Care Teams in a multi-center facility for Child and Adolescent Psychiatry (Karakter) participated and were cluster randomized to the FIT condition (n = 4 teams) or the Care as Usual (CAU) condition (n = 4 teams). Children aged 6–18 years, mainly with an Autism Spectrum Disorder (ASD) and treated in one of the Autism Care Teams were allocated to the FIT condition (n = 86) or the CAU condition (n = 80). Results indicated that adding FIT leads to an increased QoL [F (2,165) = 3.16, p = 0.045]. No additional effects were observed for symptom severity decrease [F (2,158) = 0.19, p = 0.825]. No interaction with time was found for QoL nor symptom severity. Adding FIT in a child psychiatric setting may increase QoL, but does not appear to decrease symptom severity as compared with CAU. It is suggested that FIT positively changes parents' expectations. Results should be replicated in other child psychiatric samples and with an extended theoretical model. [ABSTRACT FROM AUTHOR]

Background: Persistent proteinuria seems to be a risk factor for progression of renal disease. Its reduction by angiotensin-converting inhibitors (ACEIs) or angiotensin II receptor blockers (ARBs) is renoprotective. Our previous pilot study showed that 2-year lisinopril therapy is effective and safe for children with mild IgA nephropathy. When combined with ACEI and ARB, reported results are of greater decrease in proteinuria than monotherapy in chronic glomerulonephritis, including IgA nephropathy. To date, however, there have been no randomized controlled trials in children.Methods: This is an open-label, multicenter, prospective, and randomized phase II controlled trial of 63 children with biopsy-proven proteinuric mild IgA nephropathy. We compared efficacy and safety between patients undergoing lisinopril monotherapy and patients undergoing combination therapy of lisinopril and losartan to determine better treatment for childhood proteinuric mild IgA nephropathy.Results: There was no difference in proteinuria disappearance rate (primary endpoint) between the two groups (cumulative disappearance rate of proteinuria at 24 months: 89.3% vs 89% [combination vs monotherapy]). Moreover, there were no significant differences in side effects between the two groups.Conclusions: We propose lisinopril monotherapy as treatment for childhood proteinuric mild IgA nephropathy as there are no advantages of combination therapy.Clinical trial registration: Clinical trial registry, UMIN ID C000000006, https://www.umin.ac.jp. [ABSTRACT FROM AUTHOR]

Purpose: Vena cava syndrome (VCS) from stenosis of the superior vena cava or inferior vena cava caused by compression from a malignant tumor is one of the typical clinical conditions in patients with advanced stage malignant disease. VCS is difficult to manage and painful, reducing patients' quality of life. Although several reports have investigated stent placement for VCS, this treatment has never been established as the standard because of the lack of evidence of the safety and efficacy. We conducted a phase II trial and a phase III randomized controlled trial to clarify the role of stent placement in managing patients with VCS.Methods: In the phase II trial, 28 eligible patients were treated with stent placement. The efficacy of stent placement for VCS was evaluated based on the reduction of patients' symptom scores during 14 days following treatment. Technical success, technical feasibility, overall survival, recurrence of symptoms, and adverse events were evaluated. In the phase III trial, 32 patients were enrolled and randomly assigned to the test (n = 16) and control groups (n = 16). The area under the symptom score curve was compared between the groups. The EQ-5D, SF-8, and adverse events were evaluated until discontinuation of the protocol treatment or 28 days after enrollment.Results: In the phase II trial, the median patients' symptom scores significantly decreased from 10.50 before the procedure to 3.00 after the procedure. Technical success and technical feasibility rates were 96.4% and 100%, respectively. The incidence of treatment-related grade 3 or higher adverse events was 14.3%. In the phase III trial, significant superiority of stent placement was observed in the test, compared to that in the control, group. There was no significant difference in most other evaluations between the groups.Conclusions: Stent placement significantly improved the symptoms of VCS; thus, it might be accepted as the standard treatment to manage the symptoms of VCS.Trial Registration: JIVROSG-0402, JIVROSG-0807. [ABSTRACT FROM AUTHOR]

The mechanisms of change are rarely investigated in the field of gamified interventions for preventing emotional disorders in children and adolescents despite the wide recognition for the advantages they offer as prevention tool. Therefore, the aim of the present study was to investigate the mechanisms of change of a therapeutic game (REThink), specifically mediators and moderators of its efficacy. We conducted a randomized controlled trial, involving 165 children (age range 10-16 years), who were randomly distributed across three groups: the REThink group (N = 54), the Rational Emotive Behavior Education group (N = 55) and the Waitlist condition (N = 56). Results indicated that changes in irrational beliefs were significant mediators for the REThink intervention on depressive mood and overall negative emotions. Age did not moderate the effect of REThink, which indicates that the program was equally effective for children and adolescents.Trial Registration ClinicalTrials.gov NCT03308981. [ABSTRACT FROM AUTHOR]