Therapeutic Advances in Gastroenterology最新文献

Background: Endoscopic ultrasonography is crucial for diagnosing solid pancreatic lesions. Tissue acquisition using rapid on-site evaluation (ROSE) significantly improves diagnostic efficiency.

Objectives: This study evaluates the efficacy of tissue acquisition from pancreatic tumors with and without ROSE.

Design: Systematic review and meta-analysis.

Data sources and methods: A search was conducted in PubMed and other databases covering the period up to February 2024. Eligible randomized control trials (RCTs) reporting data on comparing the efficacy of ROSE and no ROSE were included in this study. We compare the two groups using odd ratios (OR) and mean difference approach.

Results: This meta-analysis included seven RCTs, including 1723 patients (909 in the ROSE and 814 in the no-ROSE group) with pancreatic masses. The fundamental characteristics of the studies were almost identical in both groups. There was no significant difference (p > 0.05) in the mean procedure time (1.49 min, 95% CI: -2.76, 5.75), needle passes (-0.34 passes, 95% CI: -1.00, 0.32), The OR of sample adequacy 1.34 (95% CI: 0.29, 6.25), diagnostic sensitivity 1.95 (95% CI: -0.79, 4.82), accuracy 1.28 (95% CI 0.54, 3.00), negative predictive value 1.05 (95% CI 0.54, 2.06), and adverse events 0.87 (95% CI 0.16, 4.87) with significant higher heterogeneity. Subgroup analysis also showed no difference between the FNA + ROSE versus FNA and FNB.

Conclusion: The ROSE and non-ROSE approaches showed similar outcomes regarding mean needle passes, sample adequacy, diagnostic accuracy, and adverse event rates.

Trial registration: This systematic review and meta-analysis was registered at PROSPERO (https://www.crd.york.ac.uk/PROSPERO/) with PROSPERO Number CRD42024520977.

Background: Music has been shown to reduce pain and anxiety in patients undergoing colonoscopy. Distraction, a newer technique with less available evidence, has shown similar effective outcomes.

Objectives: This systematic review and meta-analysis evaluate the current evidence available on music and task distraction and its potential to reduce pain in colonoscopy.

Design: The study was performed within PRISMA guidelines and registered with PROSPERO. Inclusion criteria comprised peer-reviewed randomised controlled trial publications in English. Exclusion criteria comprised duplicate studies, non-peer-reviewed and non-English studies.

Methods: A literature search was conducted with Medline, Embase, Cochrane and Google. Two independent clinicians reviewed the studies to avoid inclusion bias. Visual analogue score mean pain and Spielberger State-Trait Anxiety Inventory (STAI) mean anxiety were collected. Inverse variance DerSimonian-led meta-analytical approach was conducted using a random effects model and statistical software STATA.

Results: Music intervention reported a significant (p < 0.05) weighted mean reduction of 1.50 for pain scores (95% CI 0.69-2.31) and a significant weighted mean reduction of 3.56 for anxiety scores (95% CI 0.86-6.27).Distraction intervention reported a significant weighted mean reduction of 1.59 for pain scores (95% CI 0.79-2.39) and a significant weighted mean reduction of 7.49 for anxiety scores (95% CI 3.64-11.35). There was high heterogeneity recorded for both pain and anxiety studies (I² >90%).

Conclusion: Music and distraction intervention has the ability to be introduced at minimal cost. Furthermore, no changes to endoscopy infrastructure are required. This allows a clinical real-world option that is immediately implementable for patients. This meta-analysis has demonstrated that there is a potential role for music and task distraction to reduce pain and anxiety for patients undergoing a colonoscopy. It supports a low cost and safe option for patients who may not be eligible for sedation. Whilst the body of evidence is growing, it is plausible to claim these interventions can be implemented and established into daily clinical practice.

Background: As no direct comparison is available between drugs to prevent endoscopic postoperative recurrence (POR) in Crohn's disease (CD), hierarchizing these therapeutic options remains challenging.

Objectives: We aimed to compare the effectiveness of treatments to prevent CD endoscopic POR.

Design: Systematic review and network meta-analysis using a random-effects model.

Data sources and methods: We include studies comparing treatments to prevent CD POR according to PRISMA guidelines. The primary endpoint was endoscopic POR (Rutgeerts score ⩾i2). Surface under the cumulative ranking (SUCRA) was used to hierarchize the treatments.

Results: Twenty studies were included (2414 patients). Overall heterogeneity was moderate (τ = 0.34). Ustekinumab (odds ratio (OR) = 0.23 (0.07-0.70); OR = 0.29 (0.08-0.99)), vedolizumab (OR = 0.17 (0.05-0.59); OR = 0.22 (0.06-0.85)), infliximab (OR = 0.18 (0.36-0.88); OR = 0.23 (0.09-0.54)), and adalimumab (OR = 0.17 (0.07-0.42); OR = 0.22 (0.08-0.59)) were more effective to prevent endoscopic POR than placebo or 5-ASA, respectively, contrary to thiopurines (OR = 0.52 (0.22-1.24); OR = 0.66 (0.25-1.76)). Adalimumab (OR = 0.33 (0.15-0.74)) and infliximab (OR = 0.34 (0.13-0.87)) were more effective than thiopurines. While no difference was observed between the four biologics, adalimumab (SUCRA = 0.81), infliximab (SUCRA = 0.80), vedolizumab (SUCRA = 0.79), and ustekinumab (SUCRA = 0.72) had the highest likelihood of being the most effective drug, contrary to thiopurines (SUCRA = 0.41), 5-ASA (SUCRA = 0.24), or placebo (SUCRA = 0.16).

Conclusion: This network meta-analysis confirms the efficacy of anti-TNF agents, vedolizumab, and ustekinumab in preventing endoscopic CD POR without any difference between them. When a prophylactic therapy is needed, biologics should be preferred to 5-ASA or thiopurines.

Trial registration: PROSPERO registration number CRD42024555528.

Background: A reliable approach to predict the response to Ustekinumab (UST) in patients with Crohn's disease (CD) is lacking.

Objectives: This study aims to develop and validate machine learning (ML) models to predict the response to UST and further achieve personalized therapy.

Design: Retrospective multi-center study.

Methods: This study included 162 CD patients treated with UST between May 2022 and May 2024. Four ML algorithms (extreme gradient boosting, random forest, logistic regression, and support vector machine) were integrated to identify the optimal model, and Shapley Additive exPlanations (SHAP) interpretation was used for visual explainability. Two models were established to forecast the response to UST, with the outcomes of the response situation at week 26 and secondary loss of response (sLOR) status at week 52, respectively. Eighty-two CD patients from the other five centers were applied for the week-26 model's external validation.

Results: XGBoost performed excellently among the four ML algorithms. The week-26 model exhibited good performances of 0.88 area under the receiver operating characteristic curve (AUC), 0.92 area under the precision-recall curve, and 0.86 F1 score. The sLOR model demonstrated acceptable predictive performance with 0.74 AUC.

Conclusion: We developed and validated models to predict UST response for CD patients and interpreted related factors by the SHAP method. We hope that the models can assist physicians in identifying patients who are suitable for UST at baseline and further explore who are at high risk for sLOR.

Background: Gut-directed hypnotherapy is effective for treating children with disorders of gut-brain interaction, but is currently unavailable in Sweden.

Objectives: To evaluate the within-group effect and feasibility of a Swedish adaptation of an audio-based gut-directed hypnotherapy program.

Design: Uncontrolled within-group feasibility study.

Methods: Children and adolescents (aged 8-17) diagnosed with irritable bowel syndrome, functional abdominal pain, or functional dyspepsia (per Rome IV criteria) participated in a 12-week online hypnotherapy program. The program used audio files that were translated and adapted from a validated Dutch protocol. Data were collected at baseline, during treatment, and post-treatment. The primary outcome was gastrointestinal symptoms, measured by the PedsQL Gastrointestinal Symptoms Short Scale. Secondary outcomes included pain intensity and frequency, quality of life, stress, depression, anxiety, school absenteeism, and treatment credibility and satisfaction. Analyses with linear mixed models were used to estimate means, standard deviations, and effect sizes (Cohen's d).

Results: Of the 32 patients included in the study, 25 (78%) completed the program and provided post-treatment data. Significant improvements in PedsQL gastro score were observed, with moderate effect size in child reports (d = 0.63, p < .001) and large effect size in parent reports (d = 0.81, p < .001). Clinically significant improvement (>30%) in gastrointestinal symptoms was achieved by 40% of completers. Pain intensity showed a modest decrease, with small effect sizes in both child (d = 0.24, p < .005) and parent reports (d = 0.28, p < .005).

Conclusion: The Swedish version of audio-based gut-directed hypnotherapy appears feasible and acceptable, with promising symptom improvements in children with functional gastrointestinal disorders. A randomized controlled trial should be conducted to confirm efficacy and identify predictors of treatment response.

Background: High-volume polyethylene glycol (PEG) solutions are commonly used for bowel preparation but are often poorly tolerated, reducing patient compliance. Shouhui Tongbian Capsules (SHTBC), a traditional Chinese medicine known to promote gastrointestinal motility, may offer an alternative approach. However, its role in bowel preparation remains unclear.

Objectives: To evaluate the efficacy, safety, and tolerability of a novel bowel preparation regimen combining SHTBC with low-volume PEG (2L) compared to conventional high-volume PEG (3L).

Design: Multicenter, randomized, single-blind, parallel-controlled trial.

Methods: A total of 404 participants scheduled for colonoscopy across 34 medical centers in China were randomized into two groups: the experimental group (SHTBC + 2L PEG, n = 202) and the control group (3L PEG, n = 202). Bowel preparation quality was assessed using the Boston Bowel Preparation Scale (BBPS), with successful cleansing defined as a total BBPS score ⩾6. The secondary outcomes included time to adequate bowel movement, number of bowel movements, patient tolerance, acceptance, and incidence of adverse drug reactions (ADRs).

Results: The success rate of bowel preparation was comparable between groups (p = 0.7454). The experimental group had a slightly longer time to first adequate bowel movement on the day of colonoscopy (p = 0.0013) but experienced fewer bowel movements the day before (p < 0.0001). The experimental group reported significantly fewer ADRs (p = 0.0311) and better tolerance, including reduced bloating, nausea, and sleep disturbance (p < 0.01 for all). Patient acceptance was higher in the experimental group (92.89% vs 88.32%), although the difference was not statistically significant (p = 0.4170).

Conclusion: SHTBC combined with 2L PEG is a safe, effective, and better-tolerated alternative to 3L PEG for bowel preparation before colonoscopy, offering a promising strategy to improve patient compliance.

Trial registration: Chinese Clinical Trial Registry: ChiCTR2300069962.

Background: The increasing availability of biological drugs (originators and biosimilars) in the last decade for inflammatory bowel diseases (IBD), such as Crohn's disease (CD) and ulcerative colitis (UC), has led to complex switching patterns in real-world settings.

Objectives: To describe the switching/swapping patterns of biological drugs in IBD patients in Italy over the last decade.

Design: A retrospective cohort study was conducted using administrative data from 14 Italian regions (2010-2023) in the VALORE distributed database network.

Methods: Patients with at least 1 year of look-back and follow-up, who initiated biological therapy with ⩾2 dispensations for IBD, were included. Switches, swaps (between biologic classes), multiple switches (⩾2), switch-backs, and re-transitioning (biosimilar to originator) were described. Predictors of multiple switches at 3 years were identified through COX regression analysis.

Results: Among 28,073 first-ever users (55.8% Crohn's disease and 44.2% ulcerative colitis), most started with adalimumab (45.3%) or infliximab (39.6%). The F/M ratio was 0.79, with a median age of 41.0 years (IQR: 27.0-54.0). At 1, 3, and 5 years, switch/swap rates were 12.0%, 35.6%, and 52.6%, respectively, while multiple switches occurred in 18.7% at 5 years. Re-transitioning from biosimilar to originator occurred in 10% of patients who initially switched from originator to biosimilar of the same molecule. Tumor necrosis factor alpha (TNF-α) inhibitors switched more frequently and more rapidly than ustekinumab or vedolizumab. Depression and corticosteroid use were identified as predictors of multiple switches at 3 years of follow-up.

Conclusion: About half of first-ever users of biological drugs who were treated because of IBDs switched or swapped within 5 years from treatment start. TNF-α drugs were more likely to switch or swap. They also swapped or switched more rapidly than vedolizumab and ustekinumab. Notably, 1 out of 5 had changed biologic therapy more than once at 5 years and, among those who switched to a biosimilar, 1 out of 10 re-transitioned to the originator.

Background: Crohn's disease (CD) remains a challenging condition, especially in patients with moderate-to-severe disease. Risankizumab (RZB), an anti-IL-23p19 monoclonal antibody, has shown efficacy in clinical trials. However, real-world data (RWD) in Asian populations are limited.

Objectives: To assess the effectiveness and safety of Risankizumab in Asian patients with CD.

Design: Multicenter cohort study.

Methods: This study enrolled adult patients with moderate-to-severe CD who received Risankizumab between September 2024 and May 2025 in Taiwan. Efficacy was assessed at weeks 4, 8, and 12 using CD Activity Index (CDAI), patient-reported outcomes-2 (PRO2), and inflammatory bowel disease (IBD)-disk scores. Safety outcomes and treatment response by prior biologic exposure, including Ustekinumab (UST), were evaluated.

Results: Forty-nine patients (mean age 41.5 years, 69.4% male) were included. Clinical response rates were 53.1%, 75.5%, and 91.8% at weeks 4, 8, and 12, respectively; clinical remission was achieved in 12.2%, 22.4%, and 42.9%. PRO2 remission reached 53.5% by week 12. Both CDAI and IBD-Disk scores improved at weeks 4, 8, and 12 with statistical significance (p < 0.0001). Transmural healing was observed in 16.3% of patients at week 12. Clinical remission at week 12 was consistent regardless of prior Ustekinumab exposure (exposed 36.36% vs naïve 44.74%, p = 0.630) or biologic-naïve status (exposed 36.84% vs naïve 63.63%, p = 0.119). No severe adverse events were reported, but mild events included headache and transient liver enzyme elevation (each 2.04%).

Conclusion: Risankizumab may demonstrate significant short-term efficacy and favorable safety in real-world treatment of moderate-to-severe CD in an Asian cohort. Long-term data are needed to confirm sustained outcomes and guide their optimal use across diverse CD populations.

Background: Effective Helicobacter pylori (H. pylori) eradication depends on maintaining intragastric pH >6 and overcoming antibiotic resistance. High-dose dual therapy (HDDT) with a proton pump inhibitor (PPI) and amoxicillin has shown promising results.

Objectives: To compare the efficacy of 14-day vonoprazan-based (VA) and esomeprazole-based (EA) HDDT for H. pylori eradication and evaluate the impact of antibiotic resistance.

Design: Randomized controlled trial (RCT).

Methods: A total of 121 patients with confirmed H. pylori infection were randomized to receive either VA therapy (vonoprazan 20 mg twice daily plus amoxicillin 750 mg four times daily (QID)) or EA therapy (esomeprazole 40 mg three times daily plus amoxicillin 750 mg QID) for 14 days. Eradication was assessed by the ¹³C-urea breath test at week 8. Antibiotic susceptibility testing was performed on cultured isolates.

Results: Baseline demographic and clinical characteristics were comparable between the VA and EA groups. In the intention-to-treat analysis, eradication rates were 86.9% (95% confidence interval (CI): 78.4%-95.4%) in the VA group and 81.7% (95% CI: 71.3%-89.4%) in the EA group (p = 0.430). Per-protocol (PP) analysis showed eradication rates of 93.0% (95% CI: 86.4%-99.6%) for VA and 84.5% (95% CI: 73.8%-92.1%) for EA (p = 0.150), indicating no statistically significant difference. Adverse events (AEs) were mild and similar between groups (5.3% in VA vs 5.2% in EA, p = 0.983), with constipation and diarrhea being the most reported. Both groups achieved 100% compliance. Antibiotic resistance patterns did not significantly affect outcomes.

Conclusion: Both VA and EA-HDDT regimens demonstrated comparable efficacy, excellent compliance, and minimal AEs. Although VA therapy achieved a >90% eradication rate in the PP analysis, our study was underpowered to confirm superiority. Therefore, larger, adequately powered RCTs are warranted to validate the potential superiority of VA.

Trial registration: ClinicalTrials.gov: NCT06811207.

Background: Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using lumen apposing metal stent (LAMS) has emerged as a treatment option in patients with acute cholecystitis (AC) deemed unfit for surgery. Prior to this technique, percutaneous transhepatic gallbladder drainage (PT-GBD) was the only drainage modality available for these patients.

Objectives: This study compares clinical outcomes of EUS-GBD versus PT-GBD in high-risk surgical patients with AC.

Design: From July 2019 to October 2023, all consecutive patients with AC undergoing EUS-GBD (using LAMS) and PT-GBD at a single academic medical center were retrospectively reviewed and analyzed.

Methods: A propensity score-matched analysis using age, sex, and Charlson Comorbidity Index was performed. This was used to obtain a 1:1 ratio of PT-GBD:EUS-GBD patients. Technical success was defined as successful placement of LAMS or percutaneous cholecystostomy tube in the gallbladder. Clinical success was defined as resolution of patients' symptoms and normalization of white cell count within 96 h post procedure without recurrence of AC. Outcomes were analyzed using Fisher's exact test and Student's t test.

Results: Following propensity score matching, 57 EUS-GBD patients were matched with 57 PT-GBD patients. Technical success was seen in 96% (55/57) in the EUS-GBD group and 98% (56/57) in the PT-GBD group (p > 0.99). Clinical success was observed in 93% (52/56) in EUS-GBD group and 80% (45/56) in PT-GBD group (p = 0.093). PT-GBD patients underwent more procedures than the EUS-GBD group (median 3 vs 2, p < 0.0001) and had more complications (44% vs 16%, p = 0.0010). The median survival was 573 days for EUS-GBD and 452 days for PT-GBD (p = 0.77).

Conclusion: EUS-GBD is superior to PT-GBD, requiring fewer gallbladder-related procedures and lower rates of adverse events. Given these benefits, it has emerged as the preferred non-surgical alternative in the management of patients with AC who are poor surgical candidates.