Measurement of fasted state gastric antral motility before and after a standard bioavailability and bioequivalence 240 mL drink of water: Validation of MRI method against concomitant perfused manometry in healthy participants.

OBJECTIVE: The gastrointestinal environment in which drug products need to disintegrate before the drug can dissolve and be absorbed has not been studied in detail due to limitations, especially invasiveness of existing techniques. Minimal in vivo data is available on undisturbed gastrointestinal motility to improve relevance of predictive dissolution models and in silico tools such as physiologically-based pharmacokinetic models. Recent advances in magnetic resonance imaging methods could provide novel data and insights that can be used as a reference to validate and, if necessary, optimize these models. The conventional method for measuring gastrointestinal motility is via a manometric technique involving intubation. Nevertheless, it is feasible to measure gastrointestinal motility with magnetic resonance imaging. The aim of this study was is to develop and validate a magnetic resonance imaging method using the most recent semi-automated analysis method against concomitant perfused manometry method. MATERIAL AND METHODS: Eighteen healthy fasted participants were recruited for this study. The participants were intubated with a water-perfused manometry catheter. Subsequently, stomach motility was assessed by cine-MRI acquired at intervals, of 3.5min sets, at coronal oblique planes through the abdomen and by simultaneous water perfused manometry, before and after administration of a standard bioavailability / bioequivalence 8 ounces (~240mL) drink of water. The magnetic resonance imaging motility images were analysed using Spatio-Temporal Motility analysis STMM techniques. The area under the curve of the gastric motility contractions was calculated for each set and compared between techniques. The study visit was then repeated one week later. RESULTS: Data from 15 participants was analysed. There was a good correlation between the MRI antral motility plots area under the curve and corresponding perfused manometry motility area under the curve (r = 0.860) during both antral contractions and quiescence. CONCLUSION: Non-invasive dynamic magnetic resonance imaging of gastric antral motility coupled with recently developed, semi-automated magnetic resonance imaging data processing techniques correlated well with simultaneous, 'gold standard' water perfused manometry. This will be particularly helpful for research purposes related to oral absorption where the absorption of a drug is highly depending on the underlying gastrointestinal processes such as gastric emptying, gastrointestinal motility and availability of residual fluid volumes. CLINICAL TRIAL: This trial was registered at ClinicalTrials.gov as NCT03191045.

Glycaemic, gastrointestinal, hormonal and appetitive responses to pearl millet or oats porridge breakfasts: a randomised, crossover trial in healthy humans.

Whole-grain cereal breakfast consumption has been associated with beneficial effects on glucose and insulin metabolism as well as satiety. Pearl millet is a popular ancient grain variety that can be grown in hot, dry regions. However, little is known about its health effects. The present study investigated the effect of a pearl millet porridge (PMP) compared with a well-known Scottish oats porridge (SOP) on glycaemic, gastrointestinal, hormonal and appetitive responses. In a randomised, two-way crossover trial, twenty-six healthy participants consumed two isoenergetic/isovolumetric PMP or SOP breakfast meals, served with a drink of water. Blood samples for glucose, insulin, glucagon-like peptide 1, glucose-dependent insulinotropic polypeptide (GIP), peptide YY, gastric volumes and appetite ratings were collected 2 h postprandially, followed by an ad libitum meal and food intake records for the remainder of the day. The incremental AUC (iAUC2h) for blood glucose was not significantly different between the porridges (P > 0·05). The iAUC2h for gastric volume was larger for PMP compared with SOP (P = 0·045). The iAUC2h for GIP concentration was significantly lower for PMP compared with SOP (P = 0·001). Other hormones and appetite responses were similar between meals. In conclusion, the present study reports, for the first time, data on glycaemic and physiological responses to a pearl millet breakfast, showing that this ancient grain could represent a sustainable alternative with health-promoting characteristics comparable with oats. GIP is an incretin hormone linked to TAG absorption in adipose tissue; therefore, the lower GIP response for PMP may be an added health benefit.

Magnetic Resonance Imaging Quantification of Fasted State Colonic Liquid Pockets in Healthy Humans.

The rate and extent of drug dissolution and absorption from solid oral dosage forms is highly dependent on the volume of liquid in the gastrointestinal tract (GIT). However, little is known about the time course of GIT liquid volumes after drinking a glass of water (8 oz), particularly in the colon, which is a targeted site for both locally and systemically acting drug products. Previous magnetic resonance imaging (MRI) studies offered novel insights on GIT liquid distribution in fasted humans in the stomach and small intestine, and showed that freely mobile liquid in the intestine collects in fairly distinct regions or "pockets". Based on this previous pilot data, we hypothesized that (1) it is possible to quantify the time course of the volume and number of liquid pockets in the undisturbed colon of fasted healthy humans following ingestion of 240 mL, using noninvasive MRI methods; (2) the amount of freely mobile water in the fasted human colon is of the order of only a few milliliters. Twelve healthy volunteers fasted overnight and underwent fasted abdominal MRI scans before drinking 240 mL (∼8 fluid ounces) of water. After ingesting the water they were scanned at frequent intervals for 2 h. The images were processed to quantify freely mobile water in the total and regional colon: ascending, transverse, and descending. The fasted colon contained (mean ± SEM) 11 ± 5 pockets of resting liquid with a total volume of 2 ± 1 mL (average). The colonic fluid peaked at 7 ± 4 mL 30 min after the water drink. This peak fluid was distributed in 17 ± 7 separate liquid pockets in the colon. The regional analysis showed that pockets of free fluid were found primarily in the ascending colon. The interindividual variability was very high; the subjects showed a range of number of colonic fluid pockets from 0 to 89 and total colonic freely mobile fluid volume from 0 to 49 mL. This is the first study measuring the time course of the number, regional location, and volume of pockets of freely mobile liquid in the undisturbed colon of fasted humans after ingestion of a glass of water. Novel insights into the colonic fluid environment will be particularly relevant to improve our understanding and design of the in vivo performance of controlled release formulations targeted to the colon. The in vivo quantitative information presented here can be input into physiologically based mechanistic models of dissolution and absorption, and can be used in the design and set up of novel in vitro performance tools predictive of the in vivo environment.

Patterns and obstacles to oral antidiabetic medications adherence among type 2 diabetics in Ismailia, Egypt: a cross section study.

INTRODUCTION: Diabetes is a costly and increasingly common chronic disease. Effective management of diabetes to achieve glycemic control improves patient quality of life. Adherence rates to drug regimens in patients with type 2 diabetes are relatively low and vary widely between populations. There are many factors that could affect patient adherence to drug therapy. The aim of the present study was assessing patterns and obstacles to adherence of type 2 diabetic patients to their oral hypoglycemic drugs. METHODS: The present work is a descriptive cross section study, carried on type 2 diabetic patients who were on oral hypoglycemic drugs. Data concerning adherence to drugs was assessed using measure treatment adherence scale (MTA). RESULTS: A total of 372 (55.59% males and 44.41% females) patients with type-2 diabetes fulfilled the inclusion criteria and included in the study. Among the participants, 26.1% were found to have good adherence, 47.9% had a fair adherence, and 26% had poor adherence. CONCLUSION: The overall rate of medication adherence among the diabetic patients population was suboptimal and non-acceptable. Evaluation of adherence is vital for patients with diabetes in order to determine factors and barriers affecting the adherence and to manage them.

The effect of lifestyle modification on severity of constipation and quality of life of elders in nursing homes at Ismailia city, Egypt.

BACKGROUND: Constipation has a significant impact on the quality of life (QOL). Lifestyle modification is widely accepted and recommended by experts as first-line therapy. AIM: This study aimed at using education on lifestyle modification to improve the QOL of the elderly in nursing homes suffering from functional constipation (FC). MATERIALS AND METHODS: This study was conducted in nursing homes in Ismailia city, Egypt. It involved 23 elderly patients suffering from FC, who were randomly selected according to the sample equation. They fulfilled the inclusion criteria of being ≥60 years age and according to Rome II criteria. Participants completed personal characteristics and lifestyle questionnaire, the Patient Assessment of Constipation Symptom questionnaire (PAC-SYM) to assess the severity of symptoms, and the Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) to assess pre- and post-intervention. The intervention was conducted in three sessions, of 30 min each, 2 weeks apart using group discussions to educate the sample about dietary pattern, fluid intake, regular physical activity, and the use of laxatives. STATISTICAL ANALYSIS: Data were analyzed using a statistical package for social sciences (SPSS version 20). RESULTS: The lifestyle modification education on constipation significantly reduced the severity of symptoms as measured by PAC-SYM, including its total score and subscores (P < 0.001). It also improved the QOL of elderly suffering from constipation as measured by PAC-QOL and reduced total scores of dissatisfaction (P = 0.001) with the exception of the psychosocial subscale. It also significantly increased the satisfaction subscale of PAC-SYM (P < 0.001). CONCLUSION: Education on lifestyle modification leads to an improvement in the severity of the symptoms of constipation and the QOL of the elderly in nursing homes.

Patterns and Obstacles of Provision of Minor Orthopedic Procedures among Primary Care Physicians in Saudi Arabia.

INTRODUCTION: Musculoskeletal disorders are common reasons for consultation with the primary care provider (PCP). For many of these disorders, treatment with minor procedures can bring about rapid and effective response with a very low complication rate. In reality, not many of these procedures are carried out in the primary care facilities in Saudi Arabia and in many other countries around. MATERIALS AND METHODS: A cross sectional study design was chosen. The questionnaire aimed to quantify the number and different types of injections performed by PCPs; to evaluate the level of training and to identify barriers to PCPs performing joint and soft tissue injections in the primary care facilities. This questionnaire was distributed on 298 physicians working in primary care setting in Riyadh. The absolute frequency and percentages were calculated, and Chi square and ANOVA analyses were calculated and correlation test was done to procedures obstacles and their patterns. RESULTS: One hundred and thirty physicians (43.6%) of the respondents have taken orthopedic training during their residency program. Among the respondents who have taken a training period during their residency 115 (88.5%) had orthopedic training for 4 weeks. Only 69 (53.1%) of them -who had training- had performed joint and soft tissue injections during their family medicine residency program. The top reasons cited for not performing the procedures were "Lack of up to date skills" and "limited consultation time" because of work overload. CONCLUSION: Many physicians working in primary care settings in Saudi Arabia refer patients requiring minor office procedures for specialist consultation. Treating patients at the primary care level can be more time and cost effective. These results uncover that there is a big need for improvement in orthopedic and rheumatology training during undergraduate medical vocational training and family medicine residency program.

Laparoscopic elective cholecystectomy with and without drain: A controlled randomised trial.

BACKGROUND: Laparoscopic cholecystectomy is the main method of treatment of symptomatic gallstones. Routine drainage after laparoscopic cholecystectomy is an issue of considerable debate. Therefore, a controlled randomised trial was designed to assess the value of drains in elective laparoscopic cholecystectomy. MATERIALS AND METHODS: During a two-year period (From April 2008 to January 2010), 80 patients were simply randomised to have a drain placed (group A), an 8-mm pentose tube drain was retained below the liver bed, whereas 80 patients were randomised not to have a drain (group B) placed in the subhepatic space. End points of this trial were to detect any differences in morbidity, postoperative pain, wound infection and hospital stay between the two groups. RESULTS: There was no mortality in either group and no statistically significant difference in postoperative pain, nausea and vomiting, wound infection or abdominal collection between the two groups. However, hospital stay was longer in the drain group than in group without drain and it is appearing that the use of drain delays hospital discharge. CONCLUSION: The routine use of a drain in non-complicated laparoscopic cholecystectomy has nothing to offer; in contrast, it is associated with longer hospital stay.

Intraincisional vs intraperitoneal infiltration of local anaesthetic for controlling early post-laparoscopic cholecystectomy pain.

BACKGROUND: The study was designed to compare the effect of intraincisional vs intraperitoneal infiltration of levobupivacaine 0.25% on post-operative pain in laparoscopic cholecystectomy. MATERIALS AND METHODS: This randomised controlled study was carried out on 189 patients who underwent laparoscopic cholecystectomy. Group 1 was the control group and did not receive either intraperitoneal or intraincisional levobupivacaine. Group 2 was assigned to receive local infiltration (intraincisional) of 20 ml solution of levobupivacaine 0.25%, while Group 3 received 20 ml solution of levobupivacaine 0.25% intraperitoneally. Post-operative pain was recorded for 24 hours post-operatively. RESULTS: Post-operative abdominal pain was significantly lower with intraincisional infiltration of levobupivacaine 0.25% in group 2. This difference was reported from 30 minutes till 24 hours post-operatively. Right shoulder pain showed significantly lower incidence in group 2 and group 3 compared to control group. Although statistically insignificant, shoulder pain was less in group 3 than group 2. CONCLUSION: Intraincisional infiltration of levobupivacaine is more effective than intraperitoneal route in controlling post-operative abdominal pain. It decreases the need for rescue analgesia.