Chewing Gum Cannot Reduce Postoperative Abdominal Pain and Nausea After Posterior Spinal Fusions in Patients With Adolescent Idiopathic Scoliosis: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

STUDY DESIGN: A systematic review and meta-analysis of randomized controlled trials. OBJECTIVE: The aim of this study was to determine the effect of chewing gum on postoperative abdominal pain, nausea, and hospital stays after posterior spinal fusions (PSFs) in patients with adolescent idiopathic scoliosis (AIS). SUMMARY OF BACKGROUND DATA: Chewing gum had been extensively reported to improve bowel motility and is recommended to hasten bowel recovery following gastrointestinal surgery. However, there is no conclusive evidence regarding the effect of chewing gum on postoperative abdominal pain, nausea, and hospital stays after PSFs in AIS patients. METHODS: A comprehensive literature search was performed for relevant randomized controlled trials using PubMed, Cochrane Central Register of Controlled Trials, Web of Science, and Embase. Studies were selected to compare the use of chewing gum versus standard care in the management of postoperative abdominal pain and nausea in AIS patients undergoing PSFs. Hospital stays were also investigated. The study was conducted using the checklist for PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses). RESULTS: Three randomized controlled trials were included in the systematic review and the meta-analysis. No significant effect of chewing gum was highlighted concerning the postoperative abdominal pain scores at 24 and 48 hours [24 h: mean difference (MD)=0.45, 95% CI=-0.97 to 0.07, P =0.09; 48 h: MD=-0.24, 95% CI=-0.79 to 0.32, P =0.41]. No significant difference regarding the postoperative nausea scores was found at 24 and 48 hours (24 h: MD=0.26, 95% CI=-0.27 to 0.79, P =0.34; 48 h: MD=0.06, 95% CI=-0.36 to 0.48, P =0.77). No significant difference regarding hospital stays was found (MD=0.13, 95% CI=-0.02 to 0.28, P =0.09). CONCLUSIONS: Based on the current studies, chewing gum does not have a significant effect on postoperative abdominal pain, nausea, or hospital stays after PSFs in AIS patients. As the effect of chewing gum in reducing postoperative abdominal pain exhibits a tendency towards statistical significance ( P =0.09), the effect of chewing gum in spinal surgery merits further studies with larger sample size.

Geriatric mortality risk factors in emergency department for non-traumatic abdominal pain.

OBJECTIVES: The study aimed to determine the factors affecting the mortality of geriatric patients presenting to the emergency department with non-traumatic abdominal pain, as well as the associations of these factors with mortality. BACKGROUND: With the increasing number of elderly patients, early recognition of patients with risk-bearing diagnoses is crucial. METHODS: This prospective cross-sectional study included 466 patients over 65 years of age who were admitted to THE emergency department of a tertiary hospital and consented to participate. Data was collected on patient demographics, vital signs, chronic diseases, laboratory investigations, diagnoses, disposition, and 30-day mortality. RESULTS: The results showed that the mean patient age was 74.42 years, with 47.4 % being male and 52.6 % female. 15.6 % of the patients had nonspecific causes. The risk of mortality within one month was 5.797 times higher in patients with neurological diseases and 5.183 times higher in those with a history of surgery. A one-unit decrease in hemoglobin increased the mortality risk by 0.656 times. CONCLUSION: This study highlights the importance of careful evaluation of elderly patients with neurological diseases, previous surgical history, and anemia in the emergency department with non-traumatic abdominal pain (Tab. 5, Ref. 18).

Modified Lamaze Breathing Reduces Abdominal Pain in Patients during Colonoscopy.

Objective: To study the effects of modified Lamaze breathing on abdominal pain experienced during colonoscopy. Methods: Eighty-five patients who underwent common colonoscopy at our hospital between March 2021 and May 2021 were selected and randomly divided into the Lamaze group (n = 40) and a control group (n = 45). Their basic clinical information was collected, and the bowel cleanliness, the time for the endoscope to reach the ileocecal junction, and the degree of abdominal pain of the two groups were compared. Results: No significant difference was observed in age, gender, bowel cleanliness, and time of endoscope to reach the ileocecal junction between the two groups. However, the degree of abdominal pain (anal region, descending sigmoid colon junction, splenic flexure, and hepatic flexure) was significantly lower in the Lamaze group compared with the control group. Conclusion: Modified Lamaze breathing demonstrated promising effectiveness in reducing abdominal pain during colonoscopy and improving the quality of the examination.

The effect of a probiotic on gastrointestinal symptoms due to menstruation in healthy adult women on oral contraceptives: randomized, double-blind, placebo-controlled trial protocol.

INTRODUCTION: For many women, uncomfortable and stressful symptoms accompany the menstrual cycle each month, sometimes in a debilitating manner. Previous studies have reported that gastrointestinal symptoms in healthy women significantly differ by the day of the menstrual cycle, but few studies have assessed interventions intended to minimize these symptoms. Probiotics supplements have been shown to attenuate gastrointestinal symptom severity as well as self-reported feelings of stress in various populations. This study evaluates the effect of a probiotic on abdominal pain and gastrointestinal symptoms in healthy women who take an oral contraceptive, have regular menses, and typically experience these symptoms during menstruation with the primary aim being change in abdominal pain intensity related to the menstrual cycle with probiotic versus placebo supplementation. METHODS AND ANALYSIS: In this randomized, double-blind, placebo-controlled parallel study, participants will receive either a probiotic or placebo supplement. Participants will begin answering questionnaires approximately 7 days before the start of menstruation (i.e., active bleeding), and 3 days later, they will begin consuming the study supplement for 8 weeks. The questionnaires administered will collect data about abdominal pain severity (primary outcome) and duration related to the menstrual cycle, digestive health, dietary intake, stress, and digestion-associated quality-of-life. A subgroup of women will provide weekly vaginal swabs and stool samples to examine the effect of the probiotic supplement on microbiota composition and diversity for exploratory purposes. Two-sided tests using a linear model and a type I error rate of α = 0.05 will be employed to test all hypotheses. Continuous variables will be presented as means with standard errors and categorical variables, as counts or proportions. ETHICS AND DISSEMINATION: This study was reviewed and approved by the University of Florida Institutional Review Board 01. Written informed consent will be obtained from all participants prior to any study activities. Study findings will be disseminated at scientific conferences and publication in the trial registry or in a peer-reviewed journal. Any protocol amendments will be reported in the final manuscript of this study. TRIAL REGISTRATION: ClinicalTrials.gov NCT04457401 . Registered prospectively on 07 July 2020. The trial was completed in December of 2021. PROTOCOL VERSION: V4.0 (11-04-2020) TRIAL STATUS: Currently recruiting. Recruitment began in November 2020 and extend until December 2021.

Post Laparoscopy Pain Reduction Project I (POLYPREP I): intraperitoneal normal saline instillation-a randomised controlled trial.

OBJECTIVES: To evaluate the effect of intraperitoneal normal saline instillation (INSI) of 15 mL/kg body weight on postoperative pain after a gynaecological laparoscopic procedure. DESIGN: Randomised controlled trial. SETTING: University Hospital in Kuala Lumpur, Malaysia. PARTICIPANTS: Patients aged 18-55 years, with American Society of Anaesthesiologists (ASA) classification I-II, scheduled for an elective gynaecological laparoscopic procedure for a benign cause. INTERVENTION: The patients were randomly allocated to two groups. In the intervention group, 15 mL/kg body weight of normal saline was instilled intraperitoneally, while the control group received the conventional combination of open laparoscopic trocar valves with gentle abdominal pressure to remove the retained carbon dioxide. MAIN OUTCOME MEASURES: The outcomes measured were the mean pain scores for shoulder and upper abdominal pain at 24 h, 48 h, and 72 h postoperatively. RESULTS: A total of 68 women completed the study, including 34 women in each group. There was no difference in the shoulder pain score at 24 h, 48 h, and 72 h postoperatively. However, a significant improvement in the upper abdominal pain score after 48 h (95% confidence interval [CI] 0.34-1.52, p = 0.019) and 72 h (95% CI 0.19-0.26, p = 0.007) postoperatively were observed. CONCLUSIONS: INSI of 15 mL/kg body weight does not lower postoperative shoulder pain compared to no fluid instillation. A modest pain score improvement was observed in the upper abdominal area at 48 h and 72 h after surgery. An INSI of up to 30 mL/kg body weight may be required to eliminate shoulder pain. Care must be taken before administering a higher amount of INSI, considering the potential risk of peritoneal adhesions. Clinical registration ISRCTN Identifier: 87898051 (Date: 26 June 2019) https://doi.org/10.1186/ISRCTN87898051.

Effects of Bifidobacterium animalis subspecies lactis supplementation on gastrointestinal symptoms: systematic review with meta-analysis.

CONTEXT: The effects of probiotics on gastrointestinal (GI) symptoms have been increasingly investigated, particularly that of Bifidobacterium animalis. Clinical trials so far have shown differing evidence regarding these effects in healthy adults. OBJECTIVE: To synthesize the published evidence on the effects of B. animalis subspecies lactis on GI symptoms (GIS) in healthy adults. DATA SOURCE: A search of the Medline, Embase, Lilacs, Scopus, Web of Science, ProQuest, and Google Scholar databases was conducted for reports on randomized controlled trials published up to October 2021. DATA EXTRACTION: Population characteristics and data on colonic transit time (CTT), stool consistency, defecation frequency, abdominal pain, bloating, flatulence, volunteer compliance, and adverse events were extracted. A random-effects model was used to estimate the effect of probiotic treatment on these variables. DATA SYNTHESIS: In total, 1551 studies were identified, of which 14 were included in the qualitative synthesis and 13 in the meta-analysis. Overall, probiotic supplementation increased defecation frequency (standardized mean difference [SMD], 0.26; 95%CI, 0.13-0.39). Subgroup analysis revealed a decrease in CTT (SMD, -0.34; 95%CI, -0.62 to -0.07) in short-term treatment (≤14 d) and an improvement in stool consistency (SMD, 0.76; 95%CI, 0.44-1.08) in individuals without GIS. No improvement in abdominal pain and bloating was found. CONCLUSIONS: B. animalis subspecies lactis supplementation may increase defecation frequency and, in short-term treatment, may reduce CTT in healthy adults and improve stool consistency in individuals without GIS. More high-quality randomized controlled trials are needed to develop a clinical protocol for the use of this strain to improve these symptoms. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration no. CRD42020154060.

Governor Vessel Moxibustion Therapy Improves Microbiota Structure in Ankylosing Spondylitis Patients.

BACKGROUND: Clinical studies have shown that ankylosing spondylitis (AS) could be significantly improved by Governor Vessel moxibustion (GVM) therapy. OBJECTIVE: Study whether GVM therapy alleviates the clinical symptoms of AS by modulating intestinal microbiota. METHODS: A total of 9 AS patients and 9 paired healthy individuals were enrolled, and GVM therapy was provided to the AS patients. Stool, urine, and saliva samples from the healthy individuals and the AS patients before and after GVM therapy were collected, and 16S rRNA gene sequencing was performed for microbiota analysis. RESULTS: We found that GVM therapy can significantly alleviate the symptoms of AS, such as diarrhea, abdominal pain, and bloating. GVM therapy also decreased the abundances of Bacteroides and Prevotella while increasing the abundances of beneficial bacteria, such as Lactobacillus, in the gut microbiota of the AS patients. The analyses for AS clinical data and microbial abundances in AS patients revealed their multiple significant correlations (P < 0.01); for example, an unclassified crystal was positively correlated with AF12 and Delftia, monocyte had a negative correlation with Scardovia, and human leukocyte antigen-B27 was negatively correlated with Catenibacterium, Coprococcus, and Oscillospira. CONCLUSIONS: Overall, these findings demonstrate that GVM therapy can alleviate AS clinical symptoms, and at the same time, it improves the microbial structure of microbiota in AS patients. This trial is registered with Chinese Clinical Trial Registry ChiCTR2100051907.

Aggressive hydration with lactated ringer solution in prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: A systematic review and meta-analysis.

BACKGROUND: Acute pancreatitis is the most common complication of Endoscopic Retrograde Cholangiopancreatography (ERCP). There was no conclusion on the prevention of Post-ERCP Pancreatitis (PEP) by Lactated Ringer Solution. AIM: The purpose of this meta analyses is to determine whether aggressive hydration with Lactated Ringer Solution reduced the incidence of PEP. METHODS: We retrieved randomized clinical trials comparing the preventive effects of aggressive hydration with Lactated Ringer Solution and standard hydration on PEP from PubMed, the Cochrane Library, Embase, the Web of Science, Clinical Trial.gov, Scopus database, CNKI, CQVIP and WanFang Data. Primary outcome was incidence of PEP. Secondary outcomes included incidence of hyperamylasemia, abdominal pain and adverse events. RESULTS: Ten randomized controlled trials with 2200 patients were included in this meta-analysis. Meta-analysis showed that compared with standard hydration, aggressive hydration reduced the incidence of PEP (odds ratio [OR], 0.40; 95% confidence intervals [CI], 0.26-0.63; P < .0001). Compared with standard hydration, aggressive hydration also reduced the incidence of hyperamylasemia after ERCP (OR, 0.48; 95% CI, 0.38-0.60; P < .0001). There was significant difference between aggressive hydration and standard hydration in the incidence of abdominal pain (OR, 0.29; 95% CI, 0.11-0.73; P = .008). There was no difference in adverse events between aggressive hydration and standard hydration (OR, 0.93; 95% CI, 0.21-4.13; P = .93). Sensitivity analyses showed that neither alternative effect measures nor statistical models regarding heterogeneity affected the conclusions of this meta-analysis. CONCLUSION: Aggressive hydration with Lactated Ringer Solution during perioperative period of ERCP can prevent PEP.

Do Children With Functional Abdominal Pain Benefit More From a Pain-Specific Cognitive-Behavioral Intervention Than From an Unspecific Attention Control Intervention? Results of a Randomized Controlled Trial.

INTRODUCTION: We aimed to compare the efficacy of cognitive-behavioral therapy (CBT) among children with functional abdominal pain with an attention control (AC), hypothesizing the superiority of CBT group intervention regarding pain intensity (primary outcome), pain duration and frequency (further primary outcomes), functional disability, and quality of life and coping strategies (key secondary outcomes). METHODS: We conducted a prospective, multicenter, randomized controlled efficacy trial (RCT) with 4 time points (before intervention, after intervention, 3-month follow-up, and 12-month follow-up). One hundred twenty-seven children aged 7-12 years were randomized to either the CBT (n = 63; 55.6% girls) or the AC (n = 64; 57.8% girls). RESULTS: Primary endpoint analysis of the logarithmized area under the pain intensity curve showed no significant difference between groups (mean reduction = 49.04%, 95% confidence interval [CI] -19.98%-78.36%). Treatment success rates were comparable (adjusted odds ratio = 0.53, 95% CI 0.21-1.34, number needed to treat = 16). However, time trend analyses over the course of 1 year revealed a significantly greater reduction in pain intensity (40.9%, 95% CI 2.7%-64.1%) and pain duration (43.6%, 95% CI 6.2%-66.1%) in the CBT compared with the AC, but not in pain frequency per day (1.2, 95% CI -2.7 to 5.2). In the long term, children in the CBT benefitted slightly more than those in the AC with respect to functional disability, quality of life, and coping strategies. DISCUSSION: Both interventions were effective, which underlines the role of time and attention for treatment efficacy. However, in the longer term, CBT yielded more favorable results.

Recurrent and acute abdominal pain as the main clinical manifestation in patients with hereditary angioedema.

Background: Hereditary angioedema (HAE) is a rare disease that often leads to misdiagnosis. The delay of diagnosis is > 10 years in China. Recurrent and acute abdominal pain is one of the common symptoms of HAE. Because of the high misdiagnosis rate, it usually results in unnecessary surgical procedures. This study focused on the clinical symptoms and management of HAE-related abdominal attacks in Chinese patients to provide some new insight for the emergency department (ED) physicians and gastroenterologists. Methods: A Web-based survey was conducted among 107 patients with HAE from 94 unrelated families. Detailed questions with respect to the abdominal attacks were asked, including the frequency, symptoms, and duration before and after confirmed diagnosis. The demographic characteristics, diagnosis process, and treatment outcomes were also included. Results: Approximately 70% of the patients with HAE presented with abdominal symptoms during the onset of edema, mostly characterized by pain (94.8%), nausea (83.1%), vomiting (83.1%), diarrhea (59.7%), and constipation (23.4%). The patients were easily misdiagnosed as having gastroenteritis (35.1%) and appendicitis (10.4%), and 24.7% of them received unnecessary appendectomy or laparotomy. Danazol, a widely used drug for long-term prophylaxis of HAE in China, can reduce the attack frequency and alleviate the abdominal symptoms, but the adverse effects are also significant and more severe in women. Conclusions: Abdominal symptoms are common and important clinical features of HAE but are easily confused with other gastrointestinal diseases. ED physicians and gastroenterologists should consider HAE when patients experience recurrent and unexplained abdominal pain. Proper medical treatment should be administered in a timely manner if an HAE diagnosis is confirmed and efforts are required to increase access in China to medications both for on-demand treatment and long-term prophylaxis.

Aggressive hydration compared to standard hydration with lactated ringer's solution for prevention of post endoscopic retrograde cholangiopancreatography pancreatitis.

BACKGROUND AND AIMS: Previous studies have suggested that aggressive hydration with lactated ringer solution are one of the protective factors in preventing post endoscopic retrograde cholangiopancreatography (post-ERCP). We conducted a systematic review and meta-analysis to examine the efficacy aggressive hydration with lactated Ringer solution in preventing PEP. METHODS: All published and unpublished articles on aggressive hydration with lactated ringer solution in those underwent ERCP procedure for any reasons were screened for eligibility. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed. This paper doesn't need the IRB approval. RESULTS: Seven RCTs met the inclusion criteria. Meta-analysis indicates that aggressive hydration with lactated Ringer solution were associated with lower PEP rate.[odds ratio (OR) 0.29; 95% confidence interval (CI) 0.18-0.48]; lower incidence of hyperamylasemia (OR 0.49; 95% CI 0.35, 0.69) and lower risk of pain (OR 0.28; 95% CI 0.10-0.81). The association between aggressive hydration with lactated Ringer solution and incidence of moderate severity PEP were unclear (OR 0.57; 95% CI 0.22, 1.45). Sensitivity analyses also showed that omitting 1 study from analysis of PEP rate could reduce the heterogeneity but did not change the conclusion of this meta-analysis. A cumulating meta-analysis was performed statistically which showed a stable result of overall incidence of PEP. CONCLUSIONS: Aggressive hydration with lactated Ringer solution was a protective factor in reducing the overall incidence of PEP, hyperamylasemia and risk of abdominal pain.

Fecal Microbiota Transplantation Reduces Symptoms in Some Patients With Irritable Bowel Syndrome With Predominant Abdominal Bloating: Short- and Long-term Results From a Placebo-Controlled Randomized Trial.

BACKGROUND & AIMS: Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder associated with intestinal dysbiosis. Given the reported promising results of open-label fecal microbiota transplantation (FMT) therapy in patients with predominant abdominal bloating, we studied efficacy of this treatment in a randomized, placebo-controlled trial. METHODS: Patients with refractory IBS, defined as failure of ≥3 conventional therapies, were randomly assigned to single-dose nasojejunal administration of donor stools (n = 43) or autologous stools (n = 19) in a double-blind study, performed from December 2015 through October 2017, and were followed up for 1 year. IBS-related symptoms were assessed by using a daily symptom diary to determine general abdominal discomfort, abdominal bloating, abdominal pain, and flatulence on a scale of 1-6. Number of daily bowel movements, consistency of the stools, and abdominal circumference were also recorded. Patients completed the IBS-specific quality of life questionnaire. Primary endpoints were improvement of IBS symptoms and bloating at 12 weeks (response). Secondary endpoints were changes in IBS symptom scores and quality of life. Stool samples were collected for microbiota amplicon sequencing. Open-label retransplantation was offered after the trial. RESULTS: At week 12, 56% of patients given donor stool reported improvement in both primary endpoints compared with 26% of patients given placebo (P = .03). Patients given donor stool had significant improvements in level of discomfort (mean reduction, 19%; median score before FMT, 3.98; range, 2.13-6.00; median score after FMT, 3.1; range, 951.29-5.90), stool frequency (mean reduction, 13%; median score before FMT, 2.10; range, 0.57-14.29; median score after FMT 1.7; range, 0.71-4.29), urgency (mean reduction, 38%; median score before FMT, 0.61; range, 0.00-1.00; median score after FMT, 0.37; range, 0.00-1.00), abdominal pain (mean reduction, 26%; median score before FMT, 3.88; range, 1.57-5.17; median score after FMT, 2.80; range, 1.14-4.94), flatulence (mean reduction, 10%; median score before FMT, 3.42; range, 0.71-6.00; median score after FMT, 3.07; range, 0.79-4.23), and quality of life (mean increase, 16%; median score before FMT 32.6; range, 11-119; median score after FMT, 43.1; range, 32.25-99). A significantly higher proportion of women given donor stool (69%) had a response than men (29%) (P = .01). Fecal samples from responders had higher diversity of microbiomes before administration of donor material than fecal samples from nonresponders (P = .04) and distinct baseline composition (P = .04), but no specific marker taxa were associated with response. After single FMT, 21% of patients given donor stool reported effects that lasted for longer than 1 year compared with 5% of patients given placebo stool. A second FMT reduced symptoms in 67% of patients with an initial response to donor stool but not in patients with a prior nonresponse. CONCLUSIONS: In a randomized trial of patients with treatment-refractory IBS with predominant bloating, FMT relieved symptoms compared with placebo (autologous transplant), although the effects decreased over 1 year. A second FMT restored the response patients with a prior response. Response was associated with composition of the fecal microbiomes before FMT; this might be used to as a biomarker to select patients for this treatment. ClinicalTrials.gov, Number: NCT02299973.

Primary Conservative Therapy for Symptomatic Isolated Mesenteric Artery Dissection with Severely Compressed True Lumen or Large Dissecting Aneurysm.

PURPOSE: To investigate the safety and effectiveness of primary conservative therapy for patients with symptomatic isolated mesenteric artery dissection (IMAD) with a severely compressed true lumen and/or a large dissecting aneurysm. MATERIALS AND METHODS: A total of 35 consecutive patients (all men; median age, 53 y) with symptomatic IMAD with a severely compressed true lumen and/or a large dissecting aneurysm but without intestinal necrosis or arterial rupture who were treated with primary conservative therapy between November 2018 and February 2020 were assessed. A severely compressed true lumen was defined as luminal stenosis > 70%. A large dissecting aneurysm was defined as dissecting aneurysm diameter ≥ 1.5 times larger than the normal mesenteric artery diameter. RESULTS: There was a strong positive relationship among abdominal pain, degree of luminal stenosis, and length of dissection (R = 0.811; P < .001). Conservative treatment was successful in all patients. Abdominal pain was eliminated within 4.7 d ± 4.8 (range, 2-31 d) in all patients, within 3.6 d ± 1.2 (range, 2-6) in the 31 patients with minor or moderate abdominal pain, and within 13.3 d ± 11.9 (range, 6-31 d) in the 4 patients with severe abdominal pain. Complete or partial remodeling of the mesenteric artery was achieved in 6 (17.1%) and 29 (82.9%) patients, respectively, during 8.6 mo ± 4.3 of follow-up. CONCLUSIONS: Primary conservative therapy can be used safely and effectively in patients with symptomatic IMAD with a severely compressed true lumen and/or a large dissecting aneurysm but without intestinal necrosis or arterial rupture.

Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 26-Week, Placebo-Controlled Phase 3 Trial (T3MPO-2).

INTRODUCTION: Tenapanor is a first-in-class, minimally absorbed, small-molecule inhibitor of the gastrointestinal sodium/hydrogen exchanger isoform 3. This phase 3 trial assessed the long-term efficacy and safety of tenapanor 50 mg b.i.d. for the treatment of patients with irritable bowel syndrome with constipation (IBS-C). METHODS: In this randomized double-blind study (ClinicalTrials.gov identifier: NCT02686138), patients with IBS-C received tenapanor 50 mg b.i.d. or placebo b.i.d. for 26 weeks. The primary endpoint was the proportion of patients who had a reduction of ≥30.0% in average weekly worst abdominal pain and an increase of ≥1 weekly complete spontaneous bowel movement from baseline, both in the same week, for ≥6 of the first 12 treatment weeks (6/12-week combined responder). RESULTS: Of the 620 randomized patients with IBS-C, 593 (95.6%) were included in the intention-to-treat analysis set (tenapanor: n = 293; placebo: n = 300) and 481 patients (77.6%) completed the 26-week treatment period. In the intention-to-treat analysis set (mean age: 45.4 years; 82.1% women), a significantly greater proportion of patients treated with tenapanor were 6/12-week combined responders than those treated with placebo (36.5% vs 23.7%; P < 0.001). Abdominal symptoms and global symptoms of IBS were significantly improved with tenapanor compared with placebo. Diarrhea, the most common adverse event, was typically transient and mild to moderate in severity. Diarrhea led to study drug discontinuation for 19 (6.5%) and 2 patients (0.7%) receiving tenapanor and placebo, respectively. DISCUSSION: Tenapanor 50 mg b.i.d. improved IBS-C symptoms over 26 weeks and was generally well tolerated, offering a potential new long-term treatment option for patients with IBS-C (see Visual abstract, Supplementary Digital Content 1, http://links.lww.com/AJG/B797).

Calcium channels blockers toxins attenuate abdominal hyperalgesia and inflammatory response associated with the cerulein-induced acute pancreatitis in rats.

Agents that modulate the activity of high-voltage gated calcium channels (HVCCs) exhibit experimentally and clinically significant effect by relieving visceral pain. Among these agents, the toxins Phα1ß and ω-conotoxin MVIIA effectively reduce chronic pain in rodent models. The molecular mechanisms underlying the chronic pain associated with acute pancreatitis (AP) are poorly understood. Hypercalcemia is a risk factor; the role of cytosolic calcium is considered to be a modulator of pancreatitis. Blockade of Ca2+ signals may be useful as a prophylactic treatment of pancreatitis. We explored the pathophysiological roles of three peptide toxins: Phα1ß and its recombinant form CTK 01512-2-blockers of TRPA1 receptor and HVCCs and ω-conotoxin MVIIA, a specific blocker of N-type calcium channels in cerulein-induced AP. Cerulein injection elicits AP in rats, evidenced by an increase in hyperalgesic pain, inflammatory infiltration, amylase and lipase secretion, and reactive oxygen species, TNF-α, and p65 NF-κB levels. These effects of cerulein-induced AP were abolished by Phα1ß and its recombinant form CTK 01512-2, whereas ω-conotoxin MVIIA had no effect on the induced increase in pancreatic enzyme secretion. Our results demonstrate that Phα1ß and CTK 01512-2 toxins-antagonists of HVCCs and TRPA1 receptor presented an effective response profile, in the control of nociception and inflammatory process in the AP model in rats, without causing changes in spontaneous locomotion of the rats.

Dexamethasone prevents TACE-induced adverse events: A meta-analysis.

BACKGROUND: While dexamethasone has been applied following transcatheter arterial chemoembolization (TACE) for years, its clinical effects have not been determined. In the current study, we aimed to evaluate the efficacy of dexamethasone in preventing adverse events induced by TACE. METHODS: Literature retrieval was conducted using globally recognized online databases, namely MEDLINE, EMBASE, and Cochrane Central, to identify randomized controlled trials (RCTs) of dexamethasone application in patients undergoing TACE. The relative odds ratios (ORs) of incidence rates of three adverse events, namely, fever, abdominal pain and nausea/vomiting, were calculated. The value of I was applied to evaluate the heterogeneity of the trials, and the overall publication bias was assessed with Egger test. RESULTS: Four RCTs containing 350 subjects were included for the pooled estimation. Dexamethasone significantly reduced the incidence rate of TACE-induced adverse events (OR = 1.237, 95% CI: 1.170-1.308, P < .001) with moderate heterogeneity (I = 46.0%). The result of Egger test revealed a publication bias for the included studies. CONCLUSION: The current meta-analysis confirmed the efficacy of dexamethasone in preventing TACE-induced adverse events. To confirm the practicality of dexamethasone use with TACE, further studies with large sample sizes are warranted to update the evidence-based analyses.

Randomised Controlled Trial: Partial Hydrolysation of Casein Protein in Milk Decreases Gastrointestinal Symptoms in Subjects with Functional Gastrointestinal Disorders.

Unspecific gastrointestinal symptoms associated with milk consumption are common. In addition to lactose, also other components of milk may be involved. We studied whether the partial hydrolysation of milk proteins would affect gastrointestinal symptoms in subjects with functional gastrointestinal disorders. In a randomised, placebo-controlled crossover intervention, subjects (n = 41) were given ordinary or hydrolysed high-protein, lactose-free milkshakes (500 mL, 50 g protein) to be consumed daily for ten days. After a washout period of ten days, the other product was consumed for another ten days. Gastrointestinal symptoms were recorded daily during the study periods, and a validated irritable bowel syndrome-symptom severity scale (IBS-SSS) questionnaire was completed at the beginning of the study and at the end of both study periods. Blood and urine samples were analysed for markers of inflammation, intestinal permeability and immune activation. Both the IBS-SSS score (p = 0.001) and total symptom score reported daily (p = 0.002) were significantly reduced when participants consumed the hydrolysed product. Less bloating was reported during both study periods when compared with the baseline (p < 0.01 for both groups). Flatulence (p = 0.01) and heartburn (p = 0.03) decreased when consuming the hydrolysed product but not when drinking the control product. No significant differences in the levels of inflammatory markers (tumor necrosis factor alpha, TNF-α and interleukin 6, IL-6), intestinal permeability (fatty acid binding protein 2, FABP2) or immune activation (1-methylhistamine) were detected between the treatment periods. The results suggest that the partial hydrolysation of milk proteins (mainly casein) reduces subjective symptoms to some extent in subjects with functional gastrointestinal disorders. The mechanism remains to be resolved.

Effects of Daikenchuto on postoperative gastrointestinal motility in colorectal carcinoma patients with abdominal pain and distension: a prospective, randomized trial.

PURPOSE: To investigate the efficacy and safety of Daikenchuto (DKT) for colorectal cancer patients undergoing surgery with the potential risk of postoperative ileus (POI). METHODS: Colorectal cancer patients with abdominal pain and distention, scheduled for surgery, were randomly assigned to a DKT group or a control group. Patients assigned to the DKT group were given 15 g of DKT per day during the perioperative period. We then compared the perioperative gastrointestinal symptoms between the two groups. RESULTS: The aim for a sample size of 30 patients per group was not reached in time, so we conducted an analysis on 16 patients in each group. The visual Analogue Scale scores for abdominal pain and distention were similar in the two groups. The number of bowel movements per day on postoperative days (PODs) 1, 2, and 6 were significantly lower in the DKT group. The incidence of a sensation of incomplete bowel evacuation on PODs 3 and 28 was also significantly lower in the DKT group. There were no adverse events thought to be related to DKT. CONCLUSIONS: DKT could potentially inhibit diarrhea and reduce the number of bowel movements per day and the sensation of incomplete bowel evacuation after colorectal surgery. Thus, the perioperative use of DKT may be safe for colorectal cancer patients with abdominal pain and distention, who undergo surgery.