METHODS: This was a quasi-experimental study conducted in two sub-urban communities in Seremban, Malaysia. A total of 268 participants with prediabetes aged between 18 to 65 years old were assigned to either the community-based lifestyle intervention (Co-HELP) (n = 122) or the usual care (n = 146) groups. The Co-HELP program was delivered in partnership with the existing community volunteers to incorporate diet, physical activity, and behaviour modification strategies. Participants in the Co-HELP group received twelve group-based sessions and two individual counselling to reinforce behavioural change. Participants in the usual care group received standard health education from primary health providers in the clinic setting. Primary outcomes were fasting blood glucose, 2-hour plasma glucose, and HbA1C. Secondary outcomes included weight, BMI, waist circumference, total cholesterol, triglyceride, LDL cholesterol, HDL cholesterol, systolic and diastolic blood pressure, physical activity, diet, and health-related quality of life (HRQOL).
RESULTS: An intention-to-treat analysis of between-groups at 12-month (mean difference, 95% CI) revealed that the Co-HELP participants' mean fasting plasma glucose reduced by -0.40 mmol/l (-0.51 to -0.28, p<0.001), 2-hour post glucose by -0.58 mmol/l (-0.91 to -0.24, p<0.001), HbA1C by -0.24% (-0.34 to -0.15, p<0.001), diastolic blood pressure by -2.63 mmHg (-3.79 to -1.48, p<0.01), and waist circumference by -2.44 cm (-4.75 to -0.12, p<0.05) whereas HDL cholesterol increased by 0.12 mmol/l (0.05 to 0.13, p<0.01), compared to the usual care group. Significant improvements were also found in HRQOL for both physical component (PCS) by 6.51 points (5.21 to 7.80, p<0.001) and mental component (MCS) by 7.79 points (6.44 to 9.14, p<0.001). Greater proportion of participants from the Co-HELP group met the clinical recommended target of 5% or more weight loss from the initial weight (24.6% vs 3.4%, p<0.001) and physical activity of >600 METS/min/wk (60.7% vs 32.2%, p<0.001) compared to the usual care group.
CONCLUSIONS: This study provides evidence that a culturally adapted diabetes prevention program can be implemented in the community setting, with reduction of several diabetes risk factors and improvement of HRQOL. Collaboration with existing community partners demonstrated a promising channel for the wide-scale dissemination of diabetes prevention at the community level. Further studies are required to determine whether similar outcomes could be achieved in communities with different socioeconomic backgrounds and geographical areas.
TRIAL REGISTRATION: IRCT201104106163N1.
METHODS: In three double-blind phase 3 studies, patients receiving HEC or MEC were randomized 1:1 to receive oral rolapitant 180 mg or placebo prior to chemotherapy plus 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone therapy. Patients completed the FLIE questionnaire on day 6 of cycle 1. Endpoints included FLIE total score, nausea and vomiting domain scores, and the proportion of patients with no impact on daily life (total score >108 [range 18-126]). We performed a prespecified analysis of the MEC/anthracycline-cyclophosphamide (AC) study and a post hoc analysis of two pooled cisplatin-based HEC studies.
RESULTS: In the pooled HEC studies, rolapitant significantly improved the FLIE total score (114.5 vs 109.3, p life with rolapitant than with control in the MEC/AC study (73.2 vs 67.4, p = 0.027).
CONCLUSIONS: Compared with control, rolapitant improved quality of life in patients receiving HEC or MEC.
MATERIAL AND METHODS: Eighty-nine previously treated patients with AgP were re-examined. Clinical and radiographic parameters before treatment discontinuation and at re-examination were compared. OHRQoL at re-call was assessed with the short-form Oral Health Impact Profile (OHIP-14S).
RESULTS: None of the subjects adhered to suggested periodontal therapy and maintenance after discharge. Mean percentage of sites with probing pocket depth (PPD) ≥6 mm at re-examination was 4.5 ± 5.9%. A total of 182 teeth had been lost over time. Tooth loss rate was 0.14/patient/year. From 68 subjects with documented favorable treatment outcomes, higher percentage of sites with PPD ≥6 mm at re-examination and higher radiographic proximal bone loss was associated with current smoking status. Patients with AgP with <20 teeth at re-call had worse OHRQoL than those with ≥20 teeth. Patients with higher full-mouth mean PPD also reported poorer OHRQoL.
CONCLUSION: Treatment in patients with AgP who smoke and neglect proper supportive care, risk periodontal disease progression. Substantial tooth loss and higher full-mouth mean PPD led to poorer OHRQoL in this cohort.
METHODS: In this randomized, double-blind, time-to-event trial, 143 adults were randomly assigned in a 2:1 ratio to receive either intravenous eculizumab (at a dose of 900 mg weekly for the first four doses starting on day 1, followed by 1200 mg every 2 weeks starting at week 4) or matched placebo. The continued use of stable-dose immunosuppressive therapy was permitted. The primary end point was the first adjudicated relapse. Secondary outcomes included the adjudicated annualized relapse rate, quality-of-life measures, and the score on the Expanded Disability Status Scale (EDSS), which ranges from 0 (no disability) to 10 (death).
RESULTS: The trial was stopped after 23 of the 24 prespecified adjudicated relapses, given the uncertainty in estimating when the final event would occur. The mean (±SD) annualized relapse rate in the 24 months before enrollment was 1.99±0.94; 76% of the patients continued to receive their previous immunosuppressive therapy during the trial. Adjudicated relapses occurred in 3 of 96 patients (3%) in the eculizumab group and 20 of 47 (43%) in the placebo group (hazard ratio, 0.06; 95% confidence interval [CI], 0.02 to 0.20; P<0.001). The adjudicated annualized relapse rate was 0.02 in the eculizumab group and 0.35 in the placebo group (rate ratio, 0.04; 95% CI, 0.01 to 0.15; P<0.001). The mean change in the EDSS score was -0.18 in the eculizumab group and 0.12 in the placebo group (least-squares mean difference, -0.29; 95% CI, -0.59 to 0.01). Upper respiratory tract infections and headaches were more common in the eculizumab group. There was one death from pulmonary empyema in the eculizumab group.
CONCLUSIONS: Among patients with AQP4-IgG-positive NMOSD, those who received eculizumab had a significantly lower risk of relapse than those who received placebo. There was no significant between-group difference in measures of disability progression. (Funded by Alexion Pharmaceuticals; PREVENT ClinicalTrials.gov number, NCT01892345; EudraCT number, 2013-001150-10.).
METHODS: This multicenter, parallel, open-label, randomized controlled trial investigated the clinical efficacy of WPS in 126 malnourished CAPD patients with serum albumin <40 g/L and body mass index (BMI) <24 kg/m2. Patients randomized to the intervention group (IG, n = 65) received protein powder (27.4 g) for 6 months plus dietary counseling (DC) while the control group (CG, n = 61) received DC only. Anthropometry, biochemistry, malnutrition-inflammation-score (MIS), dietary intake inclusive of dialysate calories, handgrip strength (HGS) and quality of life (QOL) were assessed at baseline and 6 months. Clinical outcomes were assessed by effect size (Cohen's d) comparisons within and between groups.
RESULTS: Seventy-four patients (n = 37 per group) completed the study. Significantly more IG patients (59.5%) achieved dietary protein intake (DPI) adequacy of 1.2 g/kg per ideal body weight (p 0.05). A higher DPI paralleled significant increases in serum urea (mean Δ: IG = +2.39 ± 4.36 mmol/L, p = 0.002, d = 0.57 vs CG = -0.39 ± 4.59 mmol/L, p > 0.05, d = 0.07) and normalized protein catabolic rate, nPCR (mean Δ: IG = +0.11 ± 0.14 g/kg/day, p 0.05, d = 0.09) for IG compared to CG patients. Although not significant, comparison for changes in post-dialysis weight (mean Δ: +0.64 ± 1.16 kg vs +0.02 ± 1.36 kg, p = 0.076, d = 0.58) and mid-arm circumference (mean Δ: +0.29 ± 0.93 cm vs -0.12 ± 0.71 cm, p = 0.079, d = 0.24) indicated trends favoring IG vs CG. Other parameters remained unaffected by treatment comparisons. CG patients had a significant decline in QOL physical component (mean Δ = -6.62 ± 16.63, p = 0.020, d = 0.47). Using changes in nPCR level as a marker of WPS intake within IG, 'positive responders' achieved significant improvement in weight, BMI, skinfold measures and serum urea (all p 0.05).
CONCLUSION: A single macronutrient approach with WPS in malnourished CAPD patients was shown to achieve DPI adequacy and improvements in weight, BMI, skin fold measures, serum urea and nPCR level. CLINICAL TRIAL REGISTRY: www.clinicaltrials.gov (NCT03367000).