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Meta-analysis of Magnetic Marker Monitoring Data to Characterize the Movement of Single Unit Dosage Forms Though the Gastrointestinal Tract Under Fed and Fasting Conditions.
Hénin, E, Bergstrand, M, Weitschies, W, Karlsson, MO
Pharmaceutical research. 2016;(3):751-62
Abstract
PURPOSE To develop a model predicting movement of non-disintegrating single unit dosage forms (or "tablet") through the gastrointestinal tract and characterizing the effect of food intake, based on Magnetic Marker Monitoring data, allowing real-time location of a magnetically labeled formulation. METHODS Five studies including 30 individuals in 94 occasions under 3 food status were considered. The mean residence time (MRT) of the tablet and the effect of food intake in proximal (PS) and distal stomach (DS), small intestine (SI), ascending (AC), transverse (TC) and descending colon (DC) were estimated using a Markov model for probabilities of movement. RESULTS Under fasting conditions, tablet MRTs were 9.4 min in PS, 10.4 in DS, 246 in SI, 545 in AC, 135 in TC, and 286 in DC. A meal taken simultaneous to tablet intake prolonged tablet MRT to 99 min in PS and to 232 in DS; probability of gastric emptying increased of 89% each hour from 2.25 h after meal. The effect of a gastroileac reflex, caused by a secondary meal, accelerated the transit from terminal SI to AC. CONCLUSION This model-based knowledge can be used as a part of mechanism-based models for drug absorption, applied for bottom-up predictions and/or top-down estimation.
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Acute exercise and gastric emptying: a meta-analysis and implications for appetite control.
Horner, KM, Schubert, MM, Desbrow, B, Byrne, NM, King, NA
Sports medicine (Auckland, N.Z.). 2015;(5):659-78
Abstract
BACKGROUND Gastric emptying (GE) could influence exercise-induced changes in appetite and energy intake. GE also could contribute to changes in gastric symptoms and the availability of nutrients during exercise, which will subsequently affect performance. OBJECTIVE The objective of this review was to determine the effects of acute exercise on GE using a systematic review and meta-analysis. The most common parameters to determine GE were selected, consisting of half-emptying time and volume emptied. Oral-caecal transit time (OCTT) was also examined. DATA SOURCES Research databases (PubMed, Scopus, Google Scholar, EBSCOhost, SPORTDiscus) were searched through November 2013 for original studies, abstracts, theses and dissertations that examined the influence of acute exercise on GE. STUDY SELECTION Studies were included if they evaluated GE or OCTT during and/or after exercise and involved a resting control trial. STUDY APPRAISAL AND SYNTHESIS Initially, 195 studies were identified. After evaluation of study characteristics and quality and validity, data from 20 studies (35 trials) involving 221 participants (157 men; 52 women; 12 unknown) were extracted for meta-analysis. Random-effects meta-analyses were utilised for the three main outcome variables, and effect sizes (ES) are reported as Hedge's g due to numerous small sample sizes. RESULTS Random-effects modelling revealed non-significant and small/null main effect sizes for volume emptied (ES = 0.195; 95% CI -0.25 to 0.64), half-time (ES = -0.109, 95% CI -0.66 to 0.44) and OCTT (ES = 0.089; 95% CI -0.64 to 0.82). All analyses exhibited significant heterogeneity and numerous variables moderated the results. There was a dose response of exercise intensity; at lower intensities GE was faster, and at high exercise intensities GE was slower. Walking was associated with faster GE and cycling with slower GE. Greater volume of meal/fluid ingested, higher osmolality of beverage and longer exercise duration were also associated with slower GE with exercise. LIMITATIONS The major limitation is that the majority of studies utilised a liquid bolus administered pre-exercise to determine GE; the relationship to post-exercise appetite and energy intake remains unknown. Study populations were also generally active or trained individuals. Furthermore, our review was limited to English language studies and studies that utilised resting control conditions. CONCLUSIONS These results suggest that exercise intensity, mode, duration and the nature of meal/fluid ingested all influence GE during and after acute exercise. The relationship of GE parameters with appetite regulation after exercise remains largely unexplored. Further integrative studies combining GE and alterations in gut hormones, as well as in populations such as overweight and obese individuals are needed.
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Does age affect gastric emptying time? A model-based meta-analysis of data from premature neonates through to adults.
Bonner, JJ, Vajjah, P, Abduljalil, K, Jamei, M, Rostami-Hodjegan, A, Tucker, GT, Johnson, TN
Biopharmaceutics & drug disposition. 2015;(4):245-57
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Abstract
PURPOSE Gastric emptying (GE) is often reported to be slower and more irregular in premature neonates than in older children and adults. The aim of this study was to investigate the impact of age and other covariates on the rate of GE. METHODS The effect of age on the mean gastric residence times (MGRT) of liquid and solid food was assessed by analysing 49 published studies of 1457 individuals, aged from 28 weeks gestation to adults. The data were modelled using the nonlinear mixed-effects approach within NONMEM version 7.2 (ICON, Dublin, Ireland), with evaluation of postnatal age, gestational age and meal type as covariates. A double Weibull function was selected as a suitable model since it could account for the typical biphasic nature of GE. RESULTS Age was not a significant covariate for GE but meal type was. Aqueous solutions were associated with the fastest emptying time (mean simulated gastric residence time of 45 min) and solid food was associated with the slowest (98 min). CONCLUSIONS These findings challenge the assertion that GE is different in neonates, as compared with older children and adults due to age, and they reinforce the significance of food type in modulating GE.
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Xiangshaliujunzi Decoction for the treatment of diabetic gastroparesis: a systematic review.
Tian, JX, Li, M, Liao, JQ, Liu, WK, Tong, XL
World journal of gastroenterology. 2014;(2):561-8
Abstract
AIM: To assess the current clinical evidence of the effectiveness of Xiangshaliujunzi Decoction (XSLJZD) for the treatment of diabetic gastroparesis (DGP). METHODS Randomized controlled trials (RCTs) were retrieved from seven major electronic databases including Medline, the Cochrane Library, Embase, Chinese Biomedical Literature Database (CBM), Chinese National Knowledge Infrastructure, Chinese Scientific Journal Database (VIP), and Wanfang Databases, using search dates from the beginning of the databases to May 2013. No language limitations were applied. We included RCTs that used XSLJZD or a modified XSLJZD compared with a control group for the treatment of DGP. The control groups included conventional treatment (Western medicinal treatment), placebo, and no treatment (blank), but not acupuncture. The main outcome index was clinical effectiveness, which was based on the gastric emptying test and variations in the gastrointestinal (GI) symptoms between the treatment and control groups after intervention. Data extraction, analysis, and quality assessment were conducted according to the Cochrane Handbook for Systematic Review of Interventions, Version 5.1.0. RESULTS Ten RCTs involving 867 patients (441 in the experimental groups, and 426 in the control groups) were identified, and the overall methodological quality was evaluated as generally low. In the treatment groups, all 10 trials used herbs alone as the treatment, whereas all control groups used prokinetic medicine. The period of intervention ranged from 2 to 8 wk. Three classes were used to evaluate treatment efficacy: significant effective, effective, and ineffective, and all trials used the clinical effective rate (based on the gastric emptying test and changes in GI symptoms) to evaluate efficacy. The data showed that the effects of XSLJZD for the treatment of DGP were superior to the control group (n = 867, RR =1.33, 95%CI: 1.24-1.42, Z = 8.11, P < 0.00001). Two trials recorded adverse events, and one trial reported follow-up. CONCLUSION XSLJZD could restore the gastric emptying rate and improve symptoms. However, the evidence remains weak due to the poor methodological quality of the included studies.