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1.
Benefit-Risk Assessment of Plecanatide in the Treatment of Chronic Idiopathic Constipation.
Miner, PB
Drug safety. 2019;(5):603-615
Abstract
Plecanatide, a uroguanylin analog, activates the guanylate cyclase C receptors in the epithelial lining of the gastrointestinal tract in a pH-dependent fashion initiating (1) the conversion of intracellular guanosine triphosphate to cyclic guanosine monophosphate, which increases the activity of the cystic fibrosis transmembrane conductance regulator to increase chloride and bicarbonate secretion into the intestinal lumen and (2) a decrease in activity of the sodium-hydrogen ion exchanger. The resulting ionic shifts cause an increase in lumenal fluid to facilitate digestion. Plecanatide has been approved by the FDA for use in chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation. This manuscript is a critical assessment of the therapeutic efficacy and potential risks associated with the use of plecanatide in CIC. The discussion of CIC as a clinical and investigative disorder focuses on the importance of this problem as well and the difficulties involved in clinical management and scholarly investigation of a symptom arising from multiple pathophysiologic mechanisms. Clinical data from studies of recently approved drugs for CIC are utilized to construct a platform for thoughtful understanding of CIC and of how changes in investigation guidelines influence the interpretation of study data and guide symptom management. Plecanatide is a safe and effective medication for the management of adults with CIC.
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PEG 3350 Versus Lactulose for Treatment of Functional Constipation in Children: Randomized Study.
Jarzebicka, D, Sieczkowska-Golub, J, Kierkus, J, Czubkowski, P, Kowalczuk-Kryston, M, Pelc, M, Lebensztejn, D, Korczowski, B, Socha, P, Oracz, G
Journal of pediatric gastroenterology and nutrition. 2019;(3):318-324
Abstract
OBJECTIVES The aim of this study was to compare the clinical efficacy and tolerance of polyethylene glycol 3350 (PEG) and lactulose for the treatment of functional constipation in infants and children. METHODS This randomized, multicenter study covered 12 weeks of treatment and 4 weeks of follow-up of patients with functional constipation. Patients were randomized (central randomization) to receive either PEG or lactulose. The primary end points were the number of defecations per week after 12 weeks of treatment and improvement in stool consistency of at least 2 points in the Bristol scale. The secondary end point was the presence of adverse events. Bowel movements ≥3 per week and stool consistency ≥2 (Bristol scale) were considered as successful treatment. RESULTS We enrolled 102 patients (M 57, F 45) aged 3.62 ± 1.42 years and 88 completed the study. At week 12, good clinical outcome was achieved in 98% (PEG) and 90% (lactulose). The PEG group had more defecations per week compared with the lactulose group (7.9 ± 0.6 vs 5.7 ± 0.5, P = 0.008) and both groups had similar frequency of defecation with pain (5% vs 5%, P = 0.9), stool retention (7% vs 10%, P = 057), large volume of stools (30% vs 31%, P = 0.9) and hard stools (7% vs 13%, P = 0.58). There were more patients with side effects in the lactulose group (15 vs 23, P = 0.02), mostly bloating and abdominal pain. CONCLUSIONS PEG 3350 is more effective and causes fewer side effects than lactulose in the treatment of constipation in infants and children.
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Obesity, Motility, Diet, and Intestinal Microbiota-Connecting the Dots.
Fayfman, M, Flint, K, Srinivasan, S
Current gastroenterology reports. 2019;(4):15
Abstract
PURPOSE OF REVIEW The goal of the present review is to explore the relationship between dietary changes and alterations in gut microbiota that contribute to disorders of gut motility and obesity. RECENT FINDINGS We review the microbiota changes that are seen in obesity, diarrhea, and constipation and look at potential mechanisms of how dysbiosis can predispose to these. We find that microbial metabolites, particularly short chain fatty acids, can lead to signaling changes in the host enterocytes. Microbial alteration leading to both motility disorders and obesity may be mediated by the release of hormones including glucagon-like peptides 1 and 2 (GLP-1, GLP-2) and polypeptide YY (PYY). These pathways provide avenues for microbiota-targeted interventions that can treat both disorders of motility and obesity. In summary, multiple mechanisms contribute to the interplay between the microbial dysbiosis, obesity, and dysmotility.
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4.
Effect of Ubiquinol Intake on Defecation Frequency and Stool Form: A Prospective, Double-Blinded, Randomized Control Study.
Suzuki, S, Gotoda, T, Kusano, C, Ikehara, H, Miyakoshi, Y, Fujii, K
Journal of medicinal food. 2019;(1):81-86
Abstract
Bowel habits affect the quality of life (QOL) of patients with functional gastrointestinal disorders. This study evaluated the effects of reduced form coenzyme Q 10 (ubiquinol) intake on defecation frequency and stool form in patients with daily abdominal symptoms. This was a single-center, prospective, double-blind, randomized control study. Forty-one patients who had the daily symptom of constipation or diarrhea were randomly assigned at a 1:1 ratio to receive either ubiquinol (150 mg/day) or placebo for 12 weeks. Patients completed a daily diary to collect information regarding their numbers of defecations and stool forms according to the Bristol Stool Form (BSF) Scale for 7 days at baseline and 12 weeks. QOL was assessed using the 36-item short-form (SF-36) at baseline and 12 weeks. Twenty-one patients were assigned to the ubiquinol group, and 20 were assigned to the placebo group. At 12 weeks, the mean defecation frequency, compared to baseline, significantly decreased in the ubiquinol group (-0.1 times/day, P = .034) and increased in the placebo group (+0.3 times/day, P = .004). There was no significant change in the 12-week BSF Scale score of the ubiquinol group (+0.2, P = .123), whereas that of the placebo group was increased (+0.5, P < .001). The 12-week general health perception SF-36 score was significantly increased in the ubiquinol group (+3.5, P = .045), whereas there was no significant difference in that score in the placebo group (+1.2, P = .178). In conclusion, taking ubiquinol for 12 weeks decreased defecation frequencies and increased the QOL score, suggesting that ubiquinol may change the bowel habits and improve QOL in patients with abdominal distress.
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Efficacy and safety of Gelidium elegans intake on bowel symptoms in obese adults: A 12-week randomized double-blind placebo-controlled trial.
Choi, HI, Cha, JM, Jeong, IK, Cho, IJ, Yoon, JY, Kwak, MS, Jeon, JW, Kim, SJ
Medicine. 2019;(17):e14981
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Abstract
BACKGROUND/AIMS: Gelidium elegans (GE) is known to have antiobesity effects and beneficial effects on functional bowel symptoms in preclinical studies. The aim of this study was to determine the efficacy and safety of GE intake on bowel symptoms in obese human adults. METHODS This 12-week single-center randomized double-blind placebo-controlled study was performed from September 2016 to May 2017. Consecutive obese subjects were randomly assigned (1:1) to either GE (1 g) or placebo (1 g) once daily group for 12 weeks. Patients' bowel symptoms were evaluated using the Bristol Stool Form Scale, Constipation Scoring System (CSS), and Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire. RESULTS The stool symptom score of PAC-SYM significantly improved in the GE group compared with the placebo group after the 12-week treatment (P = .041). Abdominal discomfort score of CSS significantly decreased at 12 weeks compared to that at baseline in the GE group (P = .003), but not in the placebo group (P = .398). In addition, abdominal discomfort score of CSS slightly decreased in the GE group compared with the placebo group after the 12-week treatment (P = .060). However, stool consistency, total CSS score, and PAC-SYM score did not change significantly in both GE group and the placebo group over the 12-week treatment period. CONCLUSIONS GE treatment for 12 weeks improved the stool symptom score on the PAC-SYM and abdominal discomfort score on the CSS in obese adults. However, further research is needed in large-scale human studies.
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Effect of flaxseed or psyllium vs. placebo on management of constipation, weight, glycemia, and lipids: A randomized trial in constipated patients with type 2 diabetes.
Soltanian, N, Janghorbani, M
Clinical nutrition ESPEN. 2019;:41-48
Abstract
BACKGROUND Both flaxseed and psyllium have previously been shown to reduce constipation symptoms, weight, glycemic and lipid levels, and we postulate that treatment with flaxseed and psyllium may have similar benefits. OBJECTIVE To compare constipation symptoms, weight, glycemia, and lipids in constipated patients with type 2 diabetes (T2D) who received baked flaxseed or psyllium versus those who received a placebo. METHODS In a single-blinded, randomized controlled trial, 77 constipated patients with T2D were randomized into three groups. Patients received either 10 g flaxseed or psyllium pre-mixed in cookies or placebo cookies twice per day for a total of 12 weeks. The constipation symptoms, body mass index (BMI), fasting plasma glucose (FPG), glycosylated hemoglobin (HbA1c), and lipid profile were determined at the beginning and end of 4, 8, and 12-week period. Constipation was assessed with the ROME III criteria score. RESULTS The flaxseed appear to be superior to psyllium for improving constipation symptoms, weight, glycemic, and lipid control. The change from baseline of constipation symptoms (P = 0.002), stool consistency (P < 0.001), weight (P < 0.001), BMI (P < 0.001), FPG (P = 0.004), cholesterol (P = 0.010), LDLC (P = 0.031), and cholesterol/HDLC ratio (P = 0.019), was significantly improved in both flaxseed and psyllium groups than in the placebo group. The compliance was good and no adverse effects were observed. CONCLUSION Although both flaxseed and psyllium may decrease constipation symptoms, weight, glycemic and lipid levels, treatment with flaxseed appear to be superior to psyllium. TRIAL REGISTRATION Registered under Iranian Clinical Trials Identifier no. IRCT20110416006202N2.
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The effect of 'Zesy002' kiwifruit (Actinidia chinensis var. chinensis) on gut health function: a randomised cross-over clinical trial.
Eady, SL, Wallace, AJ, Butts, CA, Hedderley, D, Drummond, L, Ansell, J, Gearry, RB
Journal of nutritional science. 2019;:e18
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Abstract
Functional gastrointestinal disorders including constipation affect up to 14 % of the world's population. Treatment is difficult and challenging resulting in a need for alternative safe and effective therapies. The present study investigated whether daily consumption of three gold-fleshed kiwifruit could alleviate constipation and improve gastrointestinal discomfort in mildly constipated individuals with and without pain. A total of thirty-two participants were enrolled in a 16-week randomised, single-blind, crossover study. Participants received either three 'Zesy002' kiwifruit or 14·75 g Metamucil® (5 g dietary fibre/d (a positive control)) for 4 weeks each with a 4-week washout between treatments. A 2-week washout period was included at the beginning and end of the study. Daily bowel habit diaries were kept throughout the study. The primary outcome measure was differences in the number of complete spontaneous bowel movements (CSBM). Secondary outcome measures were bowel movement frequency and stool form as well as digestive symptoms and comfort. The number of CSBM per week was significantly greater during daily consumption of three kiwifruit compared with the baseline (6·3 v. 3·3; P < 0·05) and the Metamucil® treatment (6·3 v. 4·5; P < 0·05). Stool consistency was also improved, with kiwifruit producing softer stools and less straining (P < 0·05). Gastrointestinal discomfort was also improved compared with baseline for abdominal pain, constipation and indigestion (P < 0·05) during the kiwifruit intervention and constipation during the Metamucil® intervention (P < 0·05). This randomised controlled trial demonstrates that daily consumption of three gold-fleshed kiwifruit is associated with a significant increase of two CSBM per week and reduction in gastrointestinal discomfort in mildly constipated adults.
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Comparison and Assessment of Flixweed and Fig Effects on Irritable Bowel Syndrome with Predominant Constipation: A Single-Blind Randomized Clinical Trial.
Pourmasoumi, M, Ghiasvand, R, Darvishi, L, Hadi, A, Bahreini, N, Keshavarzpour, Z
Explore (New York, N.Y.). 2019;(3):198-205
Abstract
BACKGROUND Irritable bowel syndrome with predominant constipation (IBS-C) is a common digestive disorder. The current therapy is inadequate and evidence regarding the effect of herbal therapies on the relief of affected individuals is insufficient. The aim of this study was to investigate the beneficial effects of flixweed and fig consumption on IBS-C symptoms. METHODS 150 patients with IBS-C were enrolled in this randomized, controlled trial. All patients were randomly assigned to three groups and received an intervention for four months. The IBS severity score system and quality-of-life questionnaires were used for evaluating IBS-C symptoms. C-reactive protein levels, frequency of defecation and hard stool were also assessed. RESULTS Consumption of flixweed or fig, compared to a control group, caused a significant improvement in IBS symptoms including frequency of pain, distention, frequency of defecation and hard stool. Also, the findings showed a significant increase in quality of life, as well as satisfaction with overall bowel habits. However, flixweed and fig intake had no significant effects on abdominal pain severity and C-reactive protein levels. CONCLUSIONS In conclusion, consumption of flixweed or fig for four months would be a useful therapy for alleviating IBS-C symptoms and can be a beneficial option for first-line treatment.
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Neurogenic bowel dysfunction.
Emmanuel, A
F1000Research. 2019
Abstract
The symptoms of neurogenic bowel dysfunction (NBD) comprise constipation and fecal incontinence. These have a major impact on quality of life and dignity. Bowel symptoms occur in the majority of patients with chronic neurological diseases like multiple sclerosis, spinal cord injury, and Parkinson's disease. Management relies on obtaining a careful bowel history, including assessment of bowel function prior to the onset of neurological symptoms. Objective measures of NBD are available and important in terms of monitoring response for what are often intensely personal and difficult-to-elicit symptoms. Conservative management begins by establishing an effective and regular bowel regime by optimizing diet and laxative use. If this is insufficient, as seen in about half of patients, transanal irrigation has been shown to reduce NBD symptoms and improve quality of life. Failing that, there are more invasive surgical options available. This review aims to provide practical guidance for the clinician who encounters these patients, focusing on a stepwise approach to assessment, interventions, and monitoring.
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The Impact of Alvimopan on Return of Bowel Function After Major Spine Surgery - A Prospective, Randomized, Double-Blind Study.
Dunn, LK, Thiele, RH, Lin, MC, Nemergut, EC, Durieux, ME, Tsang, S, Shaffrey, ME, Smith, JS, Shaffrey, CI, Naik, BI
Neurosurgery. 2019;(2):E233-E239
Abstract
BACKGROUND Pain management following major spine surgery requires high doses of opioids and is associated with a risk of opioid-induced constipation. Peripheral mu-receptor antagonists decrease the gastrointestinal complications of perioperative systemic opioid administration without antagonizing the analgesic benefits of these drugs. OBJECTIVE To investigate the impact of alvimopan in opioid-naive patients undergoing major spine surgery. METHODS Patients undergoing >3 levels of thoracic and/or lumbar spine surgery were enrolled in this prospective, randomized, double-blind study to receive either alvimopan or placebo prior to and following surgery. Opioid consumption; pain scores; and time of first oral intake, flatus, and bowel movement were recorded. RESULTS A total of 24 patients were assigned to the active group and 25 were assigned to the placebo group. There was no significant difference in demographics between the groups. Postoperatively, the alvimopan group reported earlier time to first solid intake [median (range): alvimopan: 15 h (3-25) vs placebo: 17 h (3-46), P < .001], passing of flatus [median (range): alvimopan: 22 h (7-63) vs placebo: 28 h (10-58), P < .001], and first bowel movement [median (range): alvimopan: 50 h (22-80) vs placebo: 64 h (40-114), P < .001]. The alvimopan group had higher pain scores (maximum, minimum, and median); however, there was no significant difference between the groups with postoperative opioid use. CONCLUSION This study shows that the perioperative use of alvimopan significantly reduced the time to return of bowel function with no increase in postoperative opioid use despite a slight increase in pain scores.