Comparison of calculations to estimate gastric emptying half-time of solids in humans.
ABSTRACT Background Measuring solid gastric emptying (GE) at 4 h is used to identify gastroparesis. GE half-time (GE T(1/2) ) is useful to assess overall and early GE. Aim To examine the validity of hourly imaging as a measurement of GE T(1/2) compared with estimates from more detailed imaging. Methods 155 human subjects (99 female, 56 male) underwent scintigraphic GE of a solid-liquid meal. We calculated the GE T(1/2) using linear interpolation based on a full set of abdominal images obtained over 4 h, and the GE T(1/2) based on images at 1, 2, 3, and 4 h after the meal with interpolation of data. Key Results Differences in GE T(1/2) values (entire set of scan times compared with just the hourly scans) were small [overall median (5th, 95th percentiles) = -0.2[-7.5, 4.6] min] with slightly greater differences in males compared with females. The agreement between the two methods was very high [concordance correlation coefficient (CCC) (95% CI) = 0.993 (0.990, 0.995)] and a Bland-Altman plot indicated the variation in the results between the two methods did not change appreciably across the range of GE studied (within ±10 min for all but four subjects). Calculated GE T(1/2) values, omitting the 3-h data from the hourly measurements, were associated with similar high accuracy overall and for fast GE, but were less accurate with slow GE. Conclusions & Inferences Results of GE T(1/2) solids, using hourly imaging over 4 h, are accurate in the range 75-235 min which reflects the typical range of GE of solids in health and disease.
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ABSTRACT: BACKGROUND: Daikenchuto, a Japanese herbal medicine used for post-operative ileus and constipation, dose dependently stimulates gastrointestinal (GI) motility and decreases rectal compliance and sensation. Effects of TU-100 (commercial form of daikenchuto) in adults with constipation are unknown. AIM: To compare the effects of oral TU-100, 2.5 g t.d.s. or 5 g t.d.s. and placebo t.d.s. on GI and colonic transit (CT), rectal compliance (RC) and sensation thresholds (RST), anal sphincter pressures (ASP) and bowel function in female patients with functional constipation (FC). METHODS: We conducted a single-centre, randomised, parallel-group, double-blind, pharmacodynamic study; 45 female patients with FC without evidence of rectal evacuation disorder were assigned to 28 days' treatment with oral placebo or TU-100 (Tsumura USA, Princeton, NJ, USA). Demographic data and CT were measured at baseline and randomisation stratified by baseline CT (GC> or <1.9) and by BMI (<25 or ≥25 kg/m2 ). At the end of treatment period, we measured GI and CT by scintigraphy, RST and RC by barostat, ASP by manometry, psychosensory sensations, bowel function by daily diary and quality of life (QOL). The study had power to detect effect sizes of 33% (CT), 40% (RC) and 46% (RST). Statistical analysis included BMI as covariate. RESULTS: TU-100 had no significant effects on GI or CT, RC, ASP, recto-anal pressure difference, or RST. The 5 g t.d.s./day dose was associated with lower RST for first sensation and gas (unadjusted P: 0.045 and 0.024 respectively). There were no treatment effects on psychosensory symptoms, stool frequency, stool consistency or QOL. CONCLUSION: Mechanisms underlying the observed clinical benefit of TU-100 remain unclear (ClinicalTrials.gov NCT01139216).Alimentary Pharmacology & Therapeutics 03/2013; · 4.55 Impact Factor