Swallowability of Minitablets among Children Aged 6–23 Months: An Exploratory, Randomized Crossover Study

Minitablets have garnered interest as a new paediatric formulation that is easier to swallow than liquid formulations. In Japan, besides the latter, fine granules are frequently used for children. We examined the swallowability of multiple drug-free minitablets and compared it with that of fine granules and liquid formulations in 40 children of two age groups (n = 20 each, aged 6–11 and 12–23 months). We compared the percentage of children who could swallow minitablets without chewing with that of children who could swallow fine granules or liquid formulations without leftover. The children who visited the paediatric department of Showa University Hospital were enrolled. Their caregivers were allowed to choose the administration method. In total, 37 out of 40 caregivers dispersed the fine granules in water. Significantly more children (80%, 95% CI: 56–94%) aged 6–11 months could swallow the minitablets than those who could swallow all the dispersed fine granules and liquid formulations (22%, 95% CI: 6–47% and 35%, 95% CI: 15–59%, respectively). No significant differences were observed in children aged 12–23 months. Hence, minitablets may be easier to swallow than dispersed fine granules and liquid formulations in children aged 6–11 months.

The Effects of Heatwaves on Human Morbidity in Primary Care Settings: A Case-Crossover Study

Purpose: This study assesses the potential acute effects of heatwaves on human morbidities in primary care settings. Methods: We performed a time-stratified case-crossover study to assess the acute effects of heatwaves on selected morbidities in primary care settings in Flanders, Belgium, between 2000 and 2015. We used conditional logistic regression models. We assessed the effect of heatwaves on the day of the event (lag 0) and X days earlier (lags 1 to X). The associations are presented as Incidence Density Ratios (IDR). Results: We included 22,344 events. Heatwaves are associated with increased heat-related morbidities such as heat stroke IDR 3.93 [2.94–5.26] at lag 0, dehydration IDR 3.93 [2.94–5.26] at lag 1, and orthostatic hypotension IDR 2.06 [1.37–3.10] at lag 1. For cardiovascular morbidities studied, there was only an increased risk of stroke at lag 3 IDR 1.45 [1.04–2.03]. There is no significant association with myocardial ischemia/infarction or arrhythmia. Heatwaves are associated with decreased respiratory infection risk. The IDR for upper respiratory infections is 0.82 [0.78–0.87] lag 1 and lower respiratory infections (LRI) is 0.82 [0.74–0.91] at lag 1. There was no significant effect modification by age or premorbid chronic disease (diabetes, hypertesnsion). Conclusion: Heatwaves are associated with increased heat-related morbidities and decreased respiratory infection risk. The study of heatwaves’ effects in primary care settings helps evaluate the impact of heatwaves on the general population. Primary care settings might be not suitable to study acute life-threatening morbidities.

Antiplaque Efficacy of a Novel Moringa oleifera Dentifrice: A Randomized Clinical Crossover Study

Objectives The use of herbal dentifrices has grown exponentially over the years. They are categorically referred to as ethnomedicines. Various agents have been tried with contradicting findings based on phytopharmacological analysis. Miswak is one agent which has been used over the years. A novel Moringa oleifera-based dentifrice has shown promising results in terms of its cytotoxicity, biocompatibility, and as a potent anti-inflammatory agent. Therefore, the present study aims to compare the efficacy of two commercially available miswak- and moringa-based herbal dentifrices on the reduction of plaque and gingivitis scores. Materials and Methods This randomized clinical crossover study included 20 subjects with mild to moderate gingivitis. The study was conducted over a total examination period of 20 days with a wash-out period of 2 weeks between the use of both the toothpastes. The plaque index and gingival index of the study subjects were recorded at the designated time intervals throughout the study period. Statistical Analysis The data collected were entered on Microsoft Excel, and statistical analysis using SPSS software (SPSS version 28, IBM Corp, Armonk, New York, United States) was done. The statistical test used was the Wilcoxon signed-rank test. Moreover, p ≤0.05 was considered significant. Results The results showed that the reduction in mean gingival index scores from baseline to day 3 was more statistically significant in the moringa-based dentifrice. Similarly, the plaque index scores showed statistically significant reduction following the use of the moringa-based dentifrice when compared with the miswak dentifrice. This study reveals that the moringa dentifrice is a safe and effective agent in reducing plaque accumulation and treating gingival inflammation. Conclusion The current study aims to provide an insight into the possible role of moringa dentifrice as a possible adjunctive oral hygiene aid.

Comparison between 20 and 30 meters in walkway length affecting the 6-minute walk test in patients with chronic obstructive pulmonary disease: A randomized crossover study

Background A 30-m walkway length for the 6-minute walk test (6MWT) is the standard recommendation established by the American Thoracic Society to assess patients with chronic obstructive pulmonary disease (COPD). This study aimed to compare between the distances of 20 and 30 m long corridor affecting 6MWT in COPD patients. Methods A randomized crossover study was conducted with patients. COPD patients were randomized 1:1 to either a 20-m or a 30-m walkway in the first test, then switched to the other in the second test. Physiologic parameters and 6-minute walking distance (6MWD) were recorded. Results Fifty subjects (92% men) were included: age 69.1±7.4 years, body mass index 22.9±5.5 kg/m2, FEV1 63.0±21.3%, and 50% having cardiovascular disease. The 6MWD in a 20-m and a 30-m walkway were 337.82±71.80 m and 359.85±77.25 m, respectively (P<0.001). Mean distance difference was 22.03 m (95% CI -28.29 to -15.76, P<0.001). Patients with a 20-m walkway had more turns than those with a 30-m walkway (mean difference of 4.88 turns, 95% CI 4.48 to 5.28, P<0.001). Also, higher systolic blood pressure was found in patients with a 20-m walkway after 6MWT (4.62 mmHg, P = 0.019). Other parameters and Borg dyspnea scale did not differ. Conclusions The walkway length had significant effect on walking distance in COPD patients. A 30-m walkway length should still be recommended in 6MWT for COPD assessment. Clinical trial registration Clinicaltrials.in.th number: TCTR20200206003.

Effects of Short-Term Phosphate Loading on Aerobic Capacity under Acute Hypoxia in Cyclists: A Randomized, Placebo-Controlled, Crossover Study

The aim of this study was to evaluate the effects of sodium phosphate (SP) supplementation on aerobic capacity in hypoxia. Twenty-four trained male cyclists received SP (50 mg·kg−1 of FFM/day) or placebo for six days in a randomized, crossover study, with a three-week washout period between supplementation phases. Before and after each supplementation phase, the subjects performed an incremental exercise test to exhaustion in hypoxia (FiO2 = 16%). Additionally, the levels of 2,3-diphosphoglycerate (2,3-DPG), hypoxia-inducible factor 1 alpha (HIF-1α), inorganic phosphate (Pi), calcium (Ca), parathyroid hormone (PTH) and acid-base balance were determined. The results showed that phosphate loading significantly increased the Pi level by 9.0%, whereas 2,3-DPG levels, hemoglobin oxygen affinity, buffering capacity and myocardial efficiency remained unchanged. The aerobic capacity in hypoxia was not improved following SP. Additionally, our data revealed high inter-individual variability in response to SP. Therefore, the participants were grouped as Responders and Non-Responders. In the Responders, a significant increase in aerobic performance in the range of 3–5% was observed. In conclusion, SP supplementation is not an ergogenic aid for aerobic capacity in hypoxia. However, in certain individuals, some benefits can be expected, but mainly in athletes with less training-induced central and/or peripheral adaptation.