OBJECTIVE: To establish whether tranexamic acid compared with placebo increased the prevalence or number of remote cerebral DWIHLs within 2 weeks of ICH onset.
DESIGN, SETTING, AND PARTICIPANTS: This prospective nested magnetic resonance imaging (MRI) substudy of a randomized clinical trial (RCT) recruited participants from the multicenter, double-blind, placebo-controlled, phase 3 RCT (Tranexamic Acid for Hyperacute Primary Intracerebral Hemorrhage [TICH-2]) from July 1, 2015, to September 30, 2017, and conducted follow-up to 90 days after participants were randomized to either the tranexamic acid or placebo group. Participants had acute spontaneous ICH and included TICH-2 participants who provided consent to undergo additional MRI scans for the MRI substudy and those who had clinical MRI data that were compatible with the brain MRI protocol of the substudy. Data analyses were performed on an intention-to-treat basis on January 20, 2020.
INTERVENTIONS: The tranexamic acid group received 1 g in 100-mL intravenous bolus loading dose, followed by 1 g in 250-mL infusion within 8 hours of ICH onset. The placebo group received 0.9% saline within 8 hours of ICH onset. Brain MRI scans, including DWI, were performed within 2 weeks.
MAIN OUTCOMES AND MEASURES: Prevalence and number of remote DWIHLs were compared between the treatment groups using binary logistic regression adjusted for baseline covariates.
RESULTS: A total of 219 participants (mean [SD] age, 65.1 [13.8] years; 126 men [57.5%]) who had brain MRI data were included. Of these participants, 96 (43.8%) were randomized to receive tranexamic acid and 123 (56.2%) were randomized to receive placebo. No baseline differences in demographic characteristics and clinical or imaging features were found between the groups. There was no increase for the tranexamic acid group compared with the placebo group in DWIHL prevalence (20 of 96 [20.8%] vs 28 of 123 [22.8%]; odds ratio [OR], 0.71; 95% CI, 0.33-1.53; P = .39) or mean (SD) number of DWIHLs (1.75 [1.45] vs 1.81 [1.71]; mean difference [MD], -0.08; 95% CI, -0.36 to 0.20; P = .59). In an exploratory analysis, participants who were randomized within 3 hours of ICH onset or those with chronic infarcts appeared less likely to have DWIHLs if they received tranexamic acid. Participants with probable cerebral amyloid angiopathy appeared more likely to have DWIHLs if they received tranexamic acid.
CONCLUSIONS AND RELEVANCE: This substudy of an RCT found no evidence of increased prevalence or number of remote DWIHLs after tranexamic acid treatment in acute ICH. These findings provide reassurance for ongoing and future trials that tranexamic acid for acute ICH is unlikely to induce cerebral ischemic events.
TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN93732214.
SETTING: Departments of Ophthalmology, University of Malaya, Kuala Lumpur, Malaysia, and Tan Tock Seng Hospital, Singapore.
METHODS: In a randomized, double-blind study performed at two centers, 51 patients received an HSM PMMA lens and 48, an unmodified PMMA IOL. Cell and pigment deposits were evaluated by slitlamp at 1 to 6 days, 2 to 3 weeks, and 3 to 6 months postoperatively.
RESULTS: Significantly more eyes with unmodified IOLs had inflammatory cell deposits than those with HSM IOLs at 3 to 6 months (P < .001) and 12 to 14 months (P = .018) postoperatively. The HSM group also had significantly fewer cell deposits per patient at these two follow-ups. Significantly more eyes in the non-HSM group had pigment deposits 3 to 6 months after surgery (P = .049). One year postoperatively, about 85% of patients in both groups had a best corrected visual acuity of 0.5 or better.
CONCLUSION: Heparin surface modification significantly reduced the inflammatory response to PMMA IOLs in an Asian population for at least 12 to 14 months.
DESIGN: A randomized, double-blind, parallel-group, controlled clinical trial.
SETTING: Diabetes clinic of a teaching hospital in Kuala Lumpur, Malaysia.
PARTICIPANTS: A total of 136 participants with type 2 diabetes, aged 30-70 years, were recruited and randomly assigned to receive either probiotics (n = 68) or placebo (n = 68) for 12 weeks.
OUTCOMES: Primary outcomes were glycemic control-related parameters, and secondary outcomes were anthropomorphic variables, lipid profile, blood pressure and high-sensitivity C-reactive protein. The Lactobacillus and Bifidobacterium quantities were measured before and after intervention as an indicator of successful passage of the supplement through gastrointestinal tract.
STATISTICAL ANALYSIS: Intention-to-treat (ITT) analysis was performed on all participants, while per-protocol (PP) analysis was performed on those participants who had successfully completed the trial with good compliance rate.
RESULTS: With respect to primary outcomes, glycated hemoglobin decreased by 0.14 % in the probiotics and increased by 0.02 % in the placebo group in PP analysis (p
METHODOLOGY: The trial is reported according to the Preferred Reporting Items for RAndomized Trials in Endodontics (PRIRATE) 2020 guidelines. The protocol was registered at the clinical trial registry (India) (CTRI/2019/06/019818). In total, 160 patients, assigned to four groups, received orally either 20 mg piroxicam, 20 mg prednisolone, 4 mg dexamethasone or a placebo 60 min before root canal treatment. Patients recorded their postoperative pain intensity at 6, 12, 24, 48 and 72 h using a 10-cm visual analogue scale. Intergroup comparison was performed using Kruskal-Wallis tests with post hoc analysis using Dunns test. Incidence of pain was analysed using chi-square tests. A P value 0.05). One patient in the piroxicam group reported gastritis, whereas no adverse effects were recorded in other groups.
CONCLUSION: Preoperative oral administration of a single dose of 4 mg dexamethasone, 20 mg piroxicam or 20 mg prednisolone reduced the incidence and severity of postoperative pain following single-visit root canal treatment compared to a placebo in patients with symptomatic irreversible pulpitis and symptomatic apical periodontitis up to 24 h. The odds of postoperative pain at 24 h for patients premedicated with 4 mg dexamethasone or 20 mg piroxicam or 20 mg prednisolone were 5.3 times, 3.4 times and 2.5 times less compared to the placebo, respectively.
METHODS: Sixty patients were randomised to receive IV dexmedetomidine 0.5 μg.kg-1 (Group DEX, n = 30) or IV saline (Group P, n = 30). General anaesthesia was maintained with Sevoflurane: oxygen: air, titrated to BIS 40-60. Pain intensity, sedation, rescue analgesics, nausea/vomiting and resumption of daily activities were recorded at 1 h, and postoperative day (POD) 1-5.
RESULTS: Group DEX patients had significant reduction in sevoflurane minimum alveolar concentration (MAC), mean (SD) DEX vs. Placebo 0.6 (0.2) vs. 0.9 (0.1), p = 0.037; reduced postoperative resting pain at 1 h (VAS 0-10) (mean (SD) 1.00 (1.84) vs. 2.63 (2.78), p = 0.004), POD 1 (mean (SD) 1.50 (1.48) vs. 2.87 (2.72), p = 0.002), POD 2 (0.53 (0.97) vs. 1.73 (1.96), p = 0.001) and POD 3 (0.30 (0.75) vs. 0.89 (1.49), p = 0.001). DEX patients also had less pain on movement POD 1 (3.00 (2.12) vs. 4.30 (3.10), p = 0.043) and POD 2 (2.10 (1.98) vs. 3.10 (2.46), p = 0.040), with higher resumption of daily activities by 48 h compared to placebo, 87% vs. 63%, p = 0.04.
CONCLUSIONS: We conclude that a single dose of dexmedetomidine was a useful adjuvant in reducing MAC and postoperative pain (at 1 h and POD 1-3), facilitating faster return to daily activities by 48 h.
TRIAL REGISTRATION: The Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12617001120369 , 31st July 2017, retrospectively registered.
INTRODUCTION: SCF has been reported to improve calcium absorption. We investigated the long-term effect of SCF and calcium on bone indices of healthy preadolescent children aged 9-11 years old.
METHODS: In a double-blind, randomised, parallel arm study, 243 participants were randomised into four groups: placebo, 12-g SCF, 600-mg calcium lactate gluconate (Ca) and 12-g SCF + 600-mg calcium lactate gluconate (SCF + Ca). Total body bone mineral content (TBBMC) and total body bone mineral density (TBBMD) were measured using dual-energy X-ray absorptiometry at baseline, 6 and 12 months.
RESULTS: At 6 months, SCF + Ca had a significant increase in TBBMC from baseline (27.14 ± 6.10 g, p = 0.001). At 12 months, there was a significant increase in TBBMC from baseline in the SCF + Ca (40.28 ± 9.03 g, p = 0.001) and SCF groups (27.34 ± 7.93 g, p = 0.037). At 6 months, the change in TBBMD in the SCF + Ca (0.019 ± 0.003 g/cm2) and Ca (0.014 ± 0.003 g/cm2) groups was significantly different (p
MATERIALS AND METHODS: Eighty patients for laparoscopic surgery with at least one of the determined risks (nonsmoker, female, previous PONV/motion sickness, or postoperative opioid use) were randomized into either an active or sham group. At the end of surgery, Reletex electrical acustimulation was placed at the P6 acupoint. The active group had grade 3 strength and the sham group had inactivated electrodes covered by silicone. It was worn for 24 h following surgery. PONV scores were recorded.
RESULTS: The active group had significantly shorter durations of surgery and lower PONV incidence over 24 h (35.1% versus 64.9%, P = 0.024) and this was attributed to the lower incidence of nausea (31.4% versus 68.6%, P = 0.006). The overall incidence of vomiting was not significantly different between the groups, but it was higher in the sham group of patients with PONV risk score 3 (23.9%, P = 0.049).
CONCLUSION: In patients at high risk for PONV, P6 acupoint electrical stimulation lowers the PONV incidence by reducing the nausea component. However, this reduction in nausea is not related to increasing PONV risk scores.
METHODS: A total of 163 patients were randomized into two groups: Group A to consume 350 mL of sterilized probiotic with 5.85 g polydextrose daily for 1 week and Group B without polydextrose. Intestinal transit time, fecal pH, fecal weight, and modified Garrigues questionnaires for pre- and post-consumption were assessed.
RESULTS: Median intestinal transit time was significantly reduced from 58 (IQR 43-72) to 45 (IQR 24-59) hours and 48 (IQR 31-72) to 30 (IQR 24-49) hours for Groups A and B, respectively (p
OBJECTIVE: The aim of this study was to evaluate the effectiveness of a Web-based continuing professional development (CPD) program on "general intention" of the health carers to perform daily mouth cleaning for stroke patients using the theory of planned behavior (TPB).
METHODS: A double-blind cluster randomized controlled trial was conducted among 547 stroke care providers across 10 hospitals in Malaysia. The centers were block randomized to receive either (1) test intervention (a Web-based CPD program on providing oral hygiene care to stroke patients using TPB) or (2) control intervention (a Web-based CPD program not specific to oral hygiene). Domains of TPB: "attitude," "subjective norm" (SN), "perceived behavior control" (PBC), "general intention" (GI), and "knowledge" related to providing oral hygiene care were assessed preintervention and at 1 month and 6 months postintervention.
RESULTS: The overall response rate was 68.2% (373/547). At 1 month, between the test and control groups, there was a significant difference in changes in scores of attitude (P=.004) and subjective norm (P=.01), but not in other TPB domains (GI, P=.11; PBC, P=.51; or knowledge, P=.08). At 6 months, there were significant differences in changes in scores of GI (P=.003), attitude (P=.009), SN (P
BACKGROUND: CKD is associated with fluid excess that can be estimated by bioimpedance spectroscopy. We aimed to assess effects of sodium glucose co-transporter 2 inhibition on bioimpedance-derived "Fluid Overload" and adiposity in a CKD population.
METHODS: EMPA-KIDNEY was a double-blind placebo-controlled trial of empagliflozin 10 mg once daily in patients with CKD at risk of progression. In a substudy, bioimpedance measurements were added to the main trial procedures at randomization and at 2- and 18-month follow-up visits. The substudy's primary outcome was the study-average difference in absolute "Fluid Overload" (an estimate of excess extracellular water) analyzed using a mixed model repeated measures approach.
RESULTS: The 660 substudy participants were broadly representative of the 6609-participant trial population. Substudy mean baseline absolute "Fluid Overload" was 0.4±1.7 L. Compared with placebo, the overall mean absolute "Fluid Overload" difference among those allocated empagliflozin was -0.24 L (95% confidence interval [CI], -0.38 to -0.11), with similar sized differences at 2 and 18 months, and in prespecified subgroups. Total body water differences comprised between-group differences in extracellular water of -0.49 L (95% CI, -0.69 to -0.30, including the -0.24 L "Fluid Overload" difference) and a -0.30 L (95% CI, -0.57 to -0.03) difference in intracellular water. There was no significant effect of empagliflozin on bioimpedance-derived adipose tissue mass (-0.28 kg [95% CI, -1.41 to 0.85]). The between-group difference in weight was -0.7 kg (95% CI, -1.3 to -0.1).
CONCLUSIONS: In a broad range of patients with CKD, empagliflozin resulted in a sustained reduction in a bioimpedance-derived estimate of fluid overload, with no statistically significant effect on fat mass.
TRIAL REGISTRATION: Clinicaltrials.gov: NCT03594110 ; EuDRACT: 2017-002971-24 ( https://eudract.ema.europa.eu/ ).