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BackgroundThe Saudi Food and Drug Authority (SFDA) has approved the subcutaneous (SC) administration of infliximab, presenting a more convenient alternative with reduced outpatient visits and diminished expenses compared to the intravenous (IV) administration. However, the financial implications of this formulation have not been examined from the perspective of Saudi payers.Methods and materialsA prevalence-based budget impact model was developed to evaluate the financial effects of introducing "environment without" versus "with infliximab SC." The model's time horizon spanned over 2 years (2021-2023), aligning with the biennial national pharmaceutical procurement cycle. The comparison focused on infliximab SC versus all available formulations of infliximab IV in the Saudi market for two inflammatory bowel diseases (IBD): Ulcerative Colitis (UC) and Crohn's Disease (CD). Treatment comparators' comparability and dose escalations were substantiated by published studies, utilizing dosing information from the summary of product characteristics. Drug acquisition costs were derived from SFDA registered prices, with IV formulation administration costs included. Scenario analysis assessed the budget impact of infliximab SC introduction at uptake rates ranging from 0% to 100%.ResultsIntroducing infliximab SC demonstrated cost-saving potential in the treatment of IBD. At 100% uptake with UC patients for 2 years, infliximab SC resulted in savings of -SAR-31.9 million (-SAR29,145 per patient). Similarly, for CD, introducing infliximab SC at 100% uptake over 2 years yielded savings of -SAR106.2 million (-SAR36,585 per patient).ConclusionThis study reveals that infliximab SC is associated with cost-saving potential when compared to infliximab IV formulations available in Saudi Arabia. Future research should address uncertainties related to real-world comparative effectiveness, the convenience of administration, patient tolerability, and physician acceptance of the SC formulation of infliximab, alongside comparisons with other TNF-alpha inhibitors.

Background: Clinical guidelines recommend that patients with long-standing ulcerative colitis (UC) should undergo periodic surveillance colonoscopy. However, the cost and clinical value of performing annual colonoscopy among high-risk patient populations is largely unknown in the Middle East. Therefore, this study aimed to examine the cost and consequence of annual colonoscopy among high-risk UC patients in Saudi Arabia. Methods: A retrospective cohort study was conducted on UC patients who had UC for ≥ 8 years or had primary sclerosing cholangitis (PSC) at any time during their disease,and underwent colonoscopy surveillance between 2010 and 2021 at a university-affiliated tertiary care center. Patients who underwent annual screening were considered adherent, and those who did not were considered non-adherent. The dysplasia detection rate (%) and the costs were expressed in United States Dollars (USD). To generate the 95 % confidence intervals for annual cost and clinical consequence, nonparametric bias-corrected accelerated bootstrapping with 10,000 simulations were conducted. Results: Two-hundred and sixty-one UC patients met the inclusion criteria and were included. Most of the patients 54 % (141 patients), were non-adherent to annual screening, and the patients’ mean age and duration of illness were 45 years and 15 years, respectively. The mean annual direct medical costs were USD 10,210.6 for patients who adhered to the annual screening program and USD 6,191.77 for those who did not adhere. The mean rates of dysplasia detection were 1.66 % and 7.09 % for patients who adhered and patients who did not adhere to annual colonoscopy, respectively. The difference in costs and rates of dysplasia detections between those who adhered to the annual screening and those who did not were USD 4,018.88 (95 % CI: 3097.46 – 6,798.06) and −5.43 % (95 % CI: −10.019 – −1.58730), respectively, resulting in an incremental cost-effectiveness ratio (ICER) of USD 740.125 per 1 % reduction in the rates of dysplasia. According to the bootstrap cost effectiveness distributions, adherence to the annual screening for UC patients would result in higher cost and lower rates of dysplasia development with more than 99 % confidence level. Conclusion: Adherence to annual colonoscopy screening detects more dysplasia in UC patients but with an increased cost. Considering the low rate of progression to colorectal cancer among UC patients, the annual screening might not be cost effective.

The quality and safety of gastrointestinal endoscopy varies considerably across regions and facilities worldwide. In this field, quality management has traditionally focused on individual performance of endoscopists, with most indicators addressing process measures and limited evidence of improvement in health outcomes. Indicators of quality can be classified according to their nature and sequence. The various professional societies and organizations have proposed many systems of indicators, but a universal system is necessary so that healthcare professionals are not overburdened and confused with a variety of quality improvement approaches. In this paper, we propose guidelines by the Saudi Gastroenterology Association pertaining to quality in endoscopic procedures aiming to improve the awareness of endoscopy unit staff toward important quality indications to enhance and standardize quality of care provided to our patients.

Background: The use of complementary and alternative medicines (CAMs) has been embedded in populations for decades. In this study, we aimed to determine the rate of their usage among inflammatory bowel disease (IBD) patients and their association with adherence to conventional therapies. Methods: In this cross sectional, survey-based study, IBD patients' (n=226) adherence and compliance were evaluated using the Morisky Medication Adherence Scale-8. A control sample of 227 patients with other gastrointestinal diseases was included to compare trends of CAM use. Results: Crohn's disease represented 66.4% of those with IBD, with a mean age of 35 ± 13.0 years (54% males). The control group had either chronic viral hepatitis B, gastroesophageal reflux disease, Celiac disease, or other non-IBD diseases, with a mean age of 43.5 ± 16.8 years (55% males). Overall, 49% of patients reported using CAMs (54% in IBD group and 43% in the non-IBD group, P =0.024). Across both groups, the most used CAMs were honey (28%) and Zamzam water (19%). There was no significant association between the severity of the illness and use of CAMs. Patients who used CAMs had a lower adherence to conventional therapies vs. those who did not use CAMs (39% vs. 23%, P =0.038). Using the Morisky Medication Adherence Scale-8, low adherence to medications was reported in 35% of the IBD group vs. 11% of non-IBD group (P = 0.01). Conclusion: In our population, patients with IBD are more likely to use CAMs and are less adherent to medications. Furthermore, the use of CAMs was associated with a lower adherence rate to conventional therapies. Consequently, further studies assessing the causes associated with the use of CAMs and nonadherence to conventional therapies should be explored and interventions designed to mitigate nonadherence.

The eradication rates for Helicobacter pylori globally are decreasing with a dramatic increase in the prevalence of antibiotic resistant bacteria all over the world, including Saudi Arabia. There is no current consensus on the management of H. pylori in Saudi Arabia. The Saudi Gastroenterology Association developed these practice guidelines after reviewing the local and regional studies on the management of H. pylori. The aim was to establish recommendations to guide healthcare providers in managing H. pylori in Saudi Arabia. Experts in the areas of H. pylori management and microbiology were invited to write these guidelines. A literature search was performed, and all authors participated in writing and reviewing the guidelines. In addition, international guidelines and consensus reports were reviewed to bridge the gap in knowledge when local and regional data were unavailable. There is limited local data on treatment of H. pylori. The rate of clarithromycin and metronidazole resistance is high; therefore, standard triple therapy for 10–14 days is no longer recommended in the treatment of H. pylori unless antimicrobial susceptibility testing was performed. Based on the available data, bismuth quadruple therapy for 10–14 days is considered the best first-line and second-line therapy. Culture and antimicrobial susceptibility testing should be considered following two treatment failures. These recommendations are intended to provide the most relevant evidence-based guidelines for the management of H. pylori infection in Saudi Arabia. The working group recommends further studies to explore more therapeutic options to eradicate H. pylori.

Background and study aims Novel topical hemostatic agents have shown promising results in treating patients with non-variceal upper gastrointestinal bleeding (NVUGIB). However, data are limited even in published meta-analyses as to their role, especially compared to conventional endoscopic approaches. The aim of this study was to perform a highly comprehensive systematic review assessing the effectiveness of topical hemostatic agents in UGIB in different clinical settings. Methods We performed a literature search of OVID MEDLINE, EMBASE, and ISI Web of Knowledge databases through September 2021. Studies assessing the efficacy of topical hemostatic agents in UGIB were included. Main outcomes were immediate hemostasis and overall rebleeding. Results A total of 980 citations were identified and 59 studies with a total of 3,417 patients were included in the analysis. Immediate hemostasis was achieved in 93 % (91 %; 94 %), with similar results according to etiology (NVUGIB vs. variceal), topical agent used, or treatment strategy (primary vs. rescue). The overall rebleeding rate was 18 % (15%; 21 %) with the majority of rebleeds occurring in the first 7 days. Among comparative studies, topical agents achieved immediate hemostasis more often than standard endoscopic modalities (OR 3.94 [1.73; 8.96), with non-different overall rebleeding odds (OR 1.06 [0.65; 1.74]). Adverse events occurred in 2 % (1 %; 3 %). Study quality was overall low to very low. Conclusions Topical hemostatic agents are effective and safe in the management of UGIB with favorable outcomes when compared to conventional endoscopic modalities across a variety of bleeding etiologies. This is especially true in novel subgroup analyses that assessed immediate hemostasis and rebleeding among RCTs and in malignant bleeding. Due to methodological limitations of available data, additional studies are needed to ascertain their effectiveness more confidently in the management of patients with UGIB.

Background: Crohn's disease (CD) frequently recurs after intestinal resection. Azathioprine (AZA) and biological therapies have shown efficacy in preventing postoperative recurrence (POR). Data on POR from Middle Eastern populations is lacking. This study aimed to evaluate the rate of endoscopic POR in a cohort of CD patients who underwent ileocecal resection (ICR), and to assess the effectiveness of AZA and biological therapies in reducing the risk of disease recurrence. Methods: We performed a retrospective cohort study on 105 CD patients followed at our center, who underwent ileal resection and were at moderate to high risk for POR. Clinical and laboratory data were collected; the primary endpoint was post ICR endoscopic recurrence at 24 months defined by Rutgeerts' score of i2 or more despite treatment. Results: In total, 105 patients with Crohn's disease met our inclusion criteria; 76.2% were in remission and did not have endoscopic POR at 24 months. Further, 41.9% were on biological therapy, and 34.3% were mainly on AZA. Out of the 28.2% who had POR, approximately 15% were on biological therapies. Penetrating phenotype was the only predictive factor for decreasing POR (OR = 0.19, 95% CI: 0.04–0.98, P = 0.04) as identified in multiple logistic regression analysis. Conclusions: The use of biological therapies post-surgery was not superior than AZA in reducing the endoscopic POR for mod- high risk CD patients. Only penetrating behavior of the CD was associated with significantly lower risk of endoscopic recurrence. This finding is worth further investigation in more robust study designs and among larger samples of patients.

Background/Aims: This study aimed to design a structured simulation training curriculum for upper endoscopy and validate a new assessment checklist. Materials and Methods: A proficiency-based progression stepwise curriculum was developed consisting of didactic, technical and non-technical components using a virtual reality simulator (VRS). It focused on: scope navigation, anatomical landmarks identification, mucosal inspection, retro-flexion, pathology identification, and targeting biopsy. A total of 5 experienced and 10 novice endoscopists were recruited. All participants performed each of the selected modules twice, and mean and median performance were compared between the two groups. Novices pre-set level of proficiency was set as 2 standard deviations below the mean of experts. Performance was assessed using multiple-choice questions for knowledge, while validated simulator parameters incorporated into a novel checklist; Simulation Endoscopic Skill Assessment Score (SESAS) were used for technical skills. Results: The following VRS outcome measures have shown expert vs novice baseline discriminative ability: total procedure time, number of attempts for esophageal intubation and time in red-out. All novice trainees achieved the preset level of proficiency by the end of training. There were no statistically significant differences between experts' and trainees' rate of complications, landmarks identification and patient discomfort. SESAS checklist showed high degree of agreement with the VRS metrices (kappa = 0.83) and the previously validated direct observation of procedural skills tool (kappa = 0.90). Conclusion: The Fundamentals of Gastrointestinal Endoscopy simulation training curriculum and its SESAS global assessment tool have been primarily validated and can serve as a valuable addition to the gastroenterology fellowship programs. Follow up study of trainee performance in workplaces is recommended for consequences validation.

Background/Aim: The treatment efficacy of Helicobacter pylori (H. pylori) has been decreasing over time due to resistance to multiple antimicrobial therapies. The most effective treatment regimen for Saudi Arabian patients infected with H. pylori is still unknown. We aimed to study the eradication rate of 10 days of quadruple therapy; bismuth subcitrate potassium 140 mg, metronidazole 125 mg, and tetracycline 125 mg for H. pylori infection in a Saudi population. Patients and Methods: This was a prospective, open-label, non-randomized controlled trial. Patients with H. pylori infection were diagnosed by upper gastrointestinal (GI) endoscopy and rapid urease test (RUT) or histology. Patients who tested positive were recruited. Eligible patients were prescribed a 10-day course of quadruple therapy and received three capsules 4 times daily for 10 days along with omeprazole 20 mg twice daily. H. pylori was considered eradicated if the urea breath test (UBT) was negative after 6 weeks of completing the treatment. Results: Ninety-two patients with H. pylori infection were recruited. Three patients withdrew from the trial and another seven patients lost follow-up. We analyzed 82 patient's data as per-protocol analysis, of whom 66 (80%) were naive to H. pylori treatment. Four patients had failed previous treatment with the sequential regimen and 12 patients had treatment with clarithromycin-based triple therapy. The post-treatment UBT for H. pylori infection was negative by per-protocol analysis in 72/82 patients (87.8%), and 72/92 (78.3%) by intention-to-treat analysis. There was no correlation between previous treatment failure and treatment response to the bismuth-based quadruple therapy (P value = 0.28). Conclusions: Treatment with a bismuth-based quadruple therapy was effective in eradicating H. pylori infection in 78.3% of Saudi patients with an ITT analysis and in 87.8% as per-protocol analysis.

Background/Aim: Early diagnosis of chronic illnesses and cancers mainly occurs at primary health care centers (PHCs) by primary health care physicians (PHPs). The incidence of colorectal cancer (CRC) in the Kingdom of Saudi Arabia (KSA) is rising and this has been attributed to many factors. The increasing incidence of CRC is compounded by nonadherence to screening recommendations. Therefore, evaluating PHPs knowledge, attitudes, and practices of screening for CRC is clinically important. We aimed to evaluate the knowledge, attitudes, and practices of PHPs regarding CRC screening and to identify the factors associated with nonadherence of PHPs to screening recommendations. Materials and Methods: PHPs working at three tertiary care centers and PHCs across the city of Jeddah were randomly recruited. Participants were surveyed using a comprehensive questionnaire that recorded data on demographics, qualifications, and knowledge of various modalities and guidelines related to CRC screening. Perspectives about effectiveness of, or adherence to, factors that influence physicians' perspectives or recommendations for CRC screening were also assessed. Logistic regression analysis was used to identify physician characteristics associated with PHPs perspectives and nonadherence to CRC screening. Results: A total of 127 PHPs were recruited. The average age of participants was 34 (±8.4) years, 86.6% were native Saudi's and 56.7% were females. The majority of surveys (66.9%) were completed at 24 PHCs and the remaining at hospital-based family medicine clinics. Most of the PHPs (55%) had a bachelor's degree and 31.5% were board-certified or carried a PhD in family medicine; 95% of participants believed that CRC screening in general was effective, but as much as 55% reported that they did not practice screening. The male physicians [odds ratio (OR) = 0.44, 95% confidence interval (CI) = 0.19–0.99, P = 0.048)] and PHPs with only a bachelor degree or less (OR = 0.72, 95% CI = 0.55–0.93, P = 0.011) were less likely to recommend screening for CRC. Conclusions: A considerable proportion of PHPs do not adhere to CRC screening recommendations despite a wide belief that screening is effective. Male PHPs with lower qualifications appear to be less likely to recommend screening.

BACKGROUND:Colorectal cancer is the leading cause of cancer-related deaths in Saudi Arabia. Cancer has a multifactorial nature and can be described as a disease of altered gene expression. The profiling of gene expression has been used to identify cancer subtypes and to predict patients' responsiveness. Telomere-associated proteins that regulate telomere biology are essential molecules in cancer development. Thus, the present study examined their contributions to colorectal cancer progression in Saudi patients. METHODS:The expression of hTERT, TRF1, TRF2, POT1, ATR, ATM, Chk1 and Chk2 were measured via real-time PCR in matched cancerous and adjacent tissues of CRC patients. The protein level of hTERT, TRF1, TRF2, ATR, ATM, Chk1 and Chk2 were measured using immunohistochemistry. A region of hTERT core promoter was sequenced via Sanger sequencing. Methylation of CTCF binding site was examined via methylation-specific PCR. Finally, the length of telomere was estimated using q-PCR. RESULTS:Our results showed that POT1, ATR, Chk1 and Chk2 show increased expression in CRC relative to the adjacent mucosa. The expression levels of each gene were associated with clinicopathological characteristics of patients with CRC. There was a positive correlation between the age of the patients and hTERT expression. Regarding tumor site, telomere length, ATR, ATM and Chk1 were shown to be altered. No somatic mutation was detected in hTERT core promoter, and no differences in methylation patterns at CTCF binding site in the promoter between normal and cancer tissues. CONCLUSION:Analysis of targeted genes expression in colorectal cancer based on the clinical variables revealed that tumor location and age could have a role in gene expression and telomere length variations and this could be taken under consideration during CRC diagnosis and therapy. Other epigenetic mechanisms could influence hTERT expression in cancers. Our findings warrant further validation through experiments involving a larger number of patients.

Over the past two decades, several advances have been made in the management of patients with inflammatory bowel disease (IBD) from both evaluative and therapeutic perspectives. This review discusses the medical advancements that have recently been made as the standard of care for managing patients with ulcerative colitis (UC) and Crohn′s Disease (CD) and to identify the challenges associated with implementing their use in clinical practice. A comprehensive literature search of the major databases (PubMed and Embase) was conducted for all recent scientific papers (1990-2013) giving the recent updates on the management of IBD and the data were extracted. The reported advancements in managing IBD range from diagnostic and evaluative tools, such as genetic tests, biochemical surrogate markers of activity, endoscopic techniques, and radiological modalities, to therapeutic advances, which encompass medical, endoscopic, and surgical interventions. There are limited studies addressing the cost-effectiveness and the impact that these advances have had on medical practice. The majority of the advances developed for managing IBD, while considered instrumental by some IBD experts in improving patient care, have questionable applications due to constraints of cost, lack of availability, and most importantly, insufficient evidence that supports their role in improving important long-term health-related outcomes.

Background/Aim: Bleeding from Gastric Varices (GV) is not only life threatening, but also leads to many hospitalizations, contributes to morbidity and is resource intensive. GV are difficult to diagnose and their treatment can be challenging due to their location and complex structure. To assess the safety and efficacy of endoscopic gastric fundal variceal gluing using periodic endoscopic injections of N-butyl-2-cyanoacylate (NBCA) and to assess the utility of endoscopic ultrasound (EUS) in assessing for the eradication of GV post-NBCA treatment. Materials and Methods: Analysis of prospectively collected data of a cohort of patients with GV who underwent periodic endoscopic variceal gluing from 2005 to 2011. Outcomes included success of GV obliteration, incidence of rebleeding, complications from the procedure, and analysis of factors that might predict GV rebleeding. The success of GV eradication was assessed by both EUS and direct endoscopy. Results: The cohort consisted of 29 consecutive patients that had undergone NBCA injection for GV. The mean age was 60.8 years standard deviations (SD 13.3, range 20-81). The average follow-up was 28 months (SD 19.61, range 1-64) and the most common cause for GV was alcoholic liver cirrhosis (34.48%). A total of 91 sessions of NBCA injections were carried out for 29 patients (average of 3.14 sessions/patient, SD 1.79, range 1-8) with a total of 124 injections applied (average of 4.28 injections/patient, SD 3.09, range 1-13). 24 patients were treated for previously documented GV bleeding while five were treated for primary prevention. Overall, 79% of patients were free of rebleeding once three sessions of histoacryl ® injection were completed. None of the patients treated for primary prevention developed bleeding during follow-up. 11 of the 24 patients (46%) with previous bleeding however had rebleeding. 4/11 (36%) patients had GV rebleeding while awaiting scheduled additional NBCA sessions. 19/29 (60%) patients had complete eradication of GV, 11/19 (58%) documented by endoscopic assessment alone, 4/19 (21%) by EUS alone and 4/19 (21%) by both techniques. Two of the 11 (18%) patients that had rebleeding had recurrence of GV bleeding after documented eradication by EUS compared to 5/11 (45%) patients documented eradication by endoscopic assessment and 2/11 (18%) patients that had rebleeding after documented eradication by both modalities. Twenty five patients in total had documented residual GV by EUS (14, 56%), direct endoscopic assessment (18, 72%) or both modalities (9, 36%), two of which developed recurrent bleeding (13%). No immediate or long-term complications of NBCA injection occurred, nor any related endoscopic complications were reported in any of these cases during the time of follow-up. Conclusion: NBCA injection of GV is a safe and successful therapeutic intervention. A minimum of three endoscopic sessions is required to significantly decrease the risk of bleeding/rebleeding. In this small sample of patients, neither EUS nor direct endoscopic assessment was reliable in predicting the recurrence of GV bleeding.

BACKGROUND: Patients with upper gastrointestinal bleeding (UGIB) require an early, tailored approach best guided by knowledge of the bleeding lesion, especially a variceal versus a nonvariceal source.

The present article describes three difficult cases of recurrent bleeding from obscure causes, followed by a review of the pitfalls and pharmacological management of obscure gastrointestinal bleeding. All three patients underwent multiple investigations. An intervening complicating diagnosis or antiplatelet drugs may have compounded long-term bleeding in two of the cases. A bleeding angiodysplasia was confirmed in one case but was aggravated by the need for anticoagulation. After multiple transfusions and several attempts at endoscopic management in some cases, long-acting octreotide was associated with decreased transfusion requirements and increased hemoglobin levels in all three cases, although other factors may have contributed in some. In the third case, however, the addition of low-dose thalidomide stopped bleeding for a period of at least 23 months.