A clinician's guide to gallstones and common bile duct (CBD): A study protocol for a systematic review and evidence-based recommendations.

Background and Aims: Gallstones are one of the most common and costly diseases of the gastrointestinal tract and occur when a combination of deposits consisting of fat or minerals accumulate in the gallbladder or common bile duct (CBD). This paper provides a comprehensive review of gallstone epidemiology, diagnosis, and management, focusing on current clinical guidelines and evidence-based approaches. Methods: A systematic literature review gathered information from various sources, including PubMed, Trip, Google Scholar, Clinical Key, and reputable medical association websites. Keywords related to gallstones, CBD stones, cholelithiasis, choledocholithiasis, and guidelines were used to extract relevant recommendations. Expert consultations and consensus meetings localized the recommendations based on the target population and available resources. Results: The paper discusses demographic factors, dietary habits, and lifestyle influences contributing to gallstone formation. Gallstones are categorized into cholesterol and pigment types, with varying prevalences across regions. Many individuals with gallstones remain asymptomatic, but complications can lead to serious and potentially life-threatening conditions. Diagnosis relies on history, physical examination, laboratory tests, and transabdominal ultrasound. Specific predictive factors help categorize patients into high, moderate, or low probability groups for CBD stones. Conclusion: Evidence-based recommendations for gallstone diagnosis and management are presented, emphasizing individualized treatment plans. Surgical interventions, nonsurgical treatments like oral litholysis with UDCA, and stenting are discussed. The management of gallstones in pregnant women is also addressed, considering the potential risks and appropriate treatment options during pregnancy.

Endoscopic clipping of a complicated esophageal perforation following pneumatic dilation for achalasia: A case study and literature review.

A transmural esophageal tear complicated by large size and unusual location was diagnosed in a 59-year-old man after undergoing pneumatic balloon dilation for achalasia. It was closed with six endo-clips. The patient recovered and was discharged with ordinary diet 8 days later, after receiving supportive care for a week.

The combination of sofosbuvir and daclatasvir is effective and safe in treating patients with hepatitis C and severe renal impairment.

BACKGROUND AND AIM: Many of the treatment regimens available for hepatitis C include sofosbuvir. Unfortunately, sofosbuvir has not been recommended for use in patients with severe renal impairment leaving these group of patients with very few options. Nevertheless, there are many reports in which these patients have been treated with sofosbuvir-containing regiments without important adverse events. This study aims at determining the safety and effectiveness of a sofosbuvir-based treatment in patients with severe renal impairment, including those on hemodialysis. METHOD: We enrolled subjects with hepatitis C and estimated glomerular filtration rate under ml/min/1.73m2 from 13 centers in Iran. Patients were treated for 12 weeks with a single daily pill containing 400-mg sofosbuvir and 60-mg daclatasvir. Patients with cirrhosis were treated for 24 weeks. Response to treatment was evaluated 12 weeks after end of treatment (sustained viral response [SVR]). ClinicalTrials.gov identifier: NCT03063879. RESULTS: A total of 103 patients were enrolled from 13 centers. Seventy-five patients were on hemodialysis. Thirty-nine had cirrhosis and eight were decompensated. Fifty-three were Genotype 1, and 27 Genotype 3. Twenty-seven patients had history of previous failed interferon-based treatment. Three patients died in which cause of death was not related to treatment. Six patients were lost to follow-up. The remaining 94 patients all achieved SVR. No adverse events leading to discontinuation of medicine was observed. CONCLUSIONS: The combination of sofosbuvir and daclatasvir is an effective and safe treatment for patients infected with all genotypes of hepatitis C who have severe renal impairment, including patients on hemodialysis.

Correlation of Treatment of Peptic Ulcer Bleeding by Argon Plasma Coagulation (APC) via Contact Heat Probe Method (heater probe) with Epinephrine Injection.

BACKGROUND This clinical investigation aimed to compare the efficacy of treatment of peptic ulcer hemorrhage by argon plasma coagulation (APC) via contact heat probe method (heater probe) along with epinephrine injection. METHODS 100 patients who underwent endoscopic treatment, were randomly divided into two groups consisting of 50 patients each. In the first group, an intervention was performed using foot pedal and 2.3 mm and 3.2 mm argon probes placed in a 2 to 8 mm distance of delivery place leading to plasma coagulation, sufficient necrosis and hemostasis. In the second group, wound press contact probe was used for wound healing with 15 watts of heat for about 25 degrees, causing coagulation and hemostasis. To evaluate and compare the ulcer treatment in both groups, the patient progress results were monitored for a period of one month from the day of discharge. Statistical analyses of data were performed using SPSS software version 22 along with Chi-square test and T-test. RESULTS No significant difference observed in two groups in term of age, sex and clinical symptoms, but patients treated with APC method had higher hemoglobin levels (p < 0.001). The duration of intervention and abdominal bloating in APC group was significantly higher with two cases of re-admission. In HP group, 3 cases (6.3%) had treatment failure and an average transfused blood was significantly higher in the HP group (p < 0.001). CONCLUSION Endoscopy treatment duration was significantly lower in patients treated with the HP method due to separate washing route. HP method seems to be more appropriate for treatment of cases with abdominal bloating, distal gastric lesion and HP bulbs.

Comparison of the Bile Reflux Frequency in One Anastomosis Gastric Bypass and Roux-en-Y Gastric Bypass: a Cohort Study.

INTRODUCTION: One of the most acceptable procedures in bariatric surgery is laparoscopic gastric bypass. Laparoscopic Roux-en-Y gastric bypass (RYGB) is a common technique used in bariatric surgery. Recently, one anastomosis gastric bypass (OAGB) has been suggested as a simple, fast, and effective technique for obesity treatment. This study aims to compare the frequency of histologically proven bile reflux in OAGB and RYGB among patients with morbid obesity. METHODS: This prospective cohort study was performed from 2015 to 2017 in the Department of Bariatric Surgery of Isfahan University of Medical Sciences, Isfahan, Iran. Patients who had undergone RYGB or OAGB surgery were enrolled. Patients who had undergone revisional surgery were excluded. Data on demographics, symptoms, fasting blood sugar, lipid profile, endoscopic, and histologic findings (based on the Sydney bile reflux index) of bile reflux and postoperative complications were collected and compared for the two techniques. RESULTS: A total of 122 obese patients (22 males) who had undergone RYGB or OAGB surgery were included. The Sydney bile reflux index showed no statistically significant difference between RYGB and OAGB groups. Similarly, no statistically significant difference was found in the self-reported history of bile reflux-related symptoms, bile reflux markers in esophagogastroduodenoscopy, and postoperative complications between groups. CONCLUSIONS: OAGB and RYGB appear to be equal with respect to postoperative complications, bile reflux frequency, bile reflux index, and the Sydney system score.

Novel Variants and Copy Number Variation in CDH1 Gene in Iranian Patients with Sporadic Diffuse Gastric Cancer.

INTRODUCTION: The aim of this study was to survey the nucleotide changes and copy number variations (CNV) in the CDH1 gene in Iranian patients with sporadic diffuse gastric cancer (SDGC). MATERIALS AND METHODS: In this study, 28 patients were examined who upon gastrectomy had been diagnosed with SDGC according to the familial history and histopathological criteria which was confirmed by the pathologist. DNA extraction was performed from formalin-fixed paraffin-embedded tissues using a phenol-chloroform method following xylene deparaffinization. Determination of DNA sequence by Sanger was performed using PCR amplification of 16 exons and boundaries of intron/exon of CDH1 gene. Multiplex ligation-dependent probe amplification (MLPA) was performed on patients with pathogenic disorders in the sequence. RESULTS: In total, patients included 20 males and 8 females. Of all patients, 12 patients were under 45 years old (early onset gastric cancer, EODC) and 16 patients were older. The tumor was diagnosed in the early TNM stage (I, II) in six patients and in late stages (III, IV) in 19 cases. Altogether, 16 variants (three exonic with one new variant and 13 intronic with nine new variants) were found in DNA sequencing of the CDH1 gene in five samples. Also, using MLPA, a new duplication in exon 9 and one deletion in exon 2 were detected in two other patients. Altogether, CDH1 variants were identified in seven out of 28 patients (25%). CONCLUSION: Our study revealed several novel somatic variants in the CDH1 gene in Iranian patients with sporadic diffuse GC. Our data supports the hypothesis that mutations in CDH1 gene, and particularly the mutations we describe, should be considered, even in sporadic cases of gastric cancer. The presence of these mutations in patients raises important issues regarding genetic counseling and diagnostic test in DGC patients.

Serum amylase and lipase levels for prediction of postendoscopic retrograde cholangiopancreatography pancreatitis.

BACKGROUND: The aim of the present study was to assess 2- and 4-h postendoscopic retrograde cholangiopancreatography (ERCP) serum amylase and lipase levels for prediction of post-ERCP, pancreatitis (PEP), and their predictive cutoff values. MATERIALS AND METHODS: In this cross-sectional study, we evaluated serum amylase and lipase levels before the procedure, 2 h and 4 h after the procedure, and in patients with persisting abdominal pain, 24 h afterward. A total of 300 adult patients who underwent ERCP procedures from March 2014 to June 2015 in referral hospital in Isfahan were studied. The receiver operating characteristic analysis was applied to determine the predictive score of amylase and lipase levels for PEP 2 and 4 h after ERCP. RESULTS: The 2-h serum amylase cutoff values of 241 IU/L (normal range: 28-100 IU/L) had a very high negative predictive value (NPV) (98.7%) but a poor positive predictive value (49.2%) for prediction of PEP (area under curve [AUC]: 0.947; 95% confidence interval [CI]: 0.914-0.979). Based on our results, the patients might be considered for supportive therapy of PEP with the 4-h serum amylase above the cut point of 839.5 IU/L with a specificity of 95.1% (AUC: 0.978; 95% CI: 0.964-0.992). In addition, the 2- and 4-h serum lipase levels at cut points of 216 IU/L (AUC: 0.954; 95% CI: 0.931-0.977) and 656.5 IU/L (AUC: 0.966; 95% CI: 0.945-0.986) (normal value <60 IU/L), respectively, had the best sensitivity (97.1%) and high NPVs (99.6%) for exclusion of PEP. CONCLUSION: Measurements of serum amylase and lipase 2- and 4-h post-ERCP might be useful in prediction of PEP.

Is There a Correlation between Helicobacter Pylori and Enterohepatic Helicobacter Species and Gallstone Cholecystitis?

BACKGROUND Cholecystitis is a common surgical condition. Recently, several authors have reported that DNA of bile tolerant Helicobacter spp. has been found in the human bile colonizing the biliary tract. The aim of this study was to evaluate the association between the presence of Helicobacter spp. and gallstone cholecystitis. METHODS In this case-control study, gallstones, bile, and gallbladder mucosa were collected from 25 patients without gallstone disease, 24 with acute cholecystitis, and 28 with chronic cholecystitis. The presence of Helicobacter pylori (H. pylori), Helicobacter bilis (H. bilis), Helicobacter hepaticus (H. hepaticus) , and Helicobacter pullorum (H. pullorum) were investigated by polymerase chain reaction (PCR) using species-specific primers. RESULTS In this study, 77 subjects with acute and chronic cholecystitis and control groups with a mean age of 46.85 ± 14.53 years, including 58 (67.25%) women and 19 (32.75%) men were included. DNA of 10 Helicobacter spp. was detected in the bile of the patients with cholecystitis including eight H. pylori and two H. bilis. However, we could not detect H. hepaticus and H. pullorum DNA in the samples. Moreover, there was an association between H. pylori and acute cholecystitis (p = 0.048), which was found to be stronger in 31-40-year-olds group (p = 0.003). CONCLUSION We found an association between the presence of H. pylori DNA and acute gallstone cholecystitis. There is not statistically significant correlation between three enterohepatic Helicobacter spp. ( H. bilis, H. hepaticus , and H. pullorum) and cholelithiasis. Given the low sample size of the patients, more studies are required to clear the clinical role of Helicobacter spp. in the gallstone disease and cholecystitis.

The Relationship between the Time of Endoscopy and Morbidity and Mortality Rates in Patients with Upper Gastrointestinal Bleeding.

BACKGROUND: This study was done to evaluate the relationship between the time of endoscopy in patients with upper gastrointestinal bleeding with morbidity and mortality rates of patients at the Al Zahra Hospital emergency room. MATERIALS AND METHODS: In a cohort study, 1152 patients at 2014 and 2015 have been hospitalized due to gastrointestinal bleeding in Al Zahra Hospital, were selected and demographic and clinical information and day and time of endoscopy and hospital mortality and fewer deaths than a month after discharge were studied, and prognosis was analyzed in terms of day and time of endoscopy. RESULTS: Nine hundred and seventy-three cases (84.5%) of endoscopy were performed during the working days and 179 (15.5%) were performed on holidays. Moreover, 801 cases (69.5%) of endoscopy were done in the morning and 351 cases (30.5%) were performed in the evening and night shifts. The day and time of endoscopy had no significant effect on mortality in hospital and less than a month after but hospital death in whom underwent endoscopy by fellowship was significantly higher (P = 0.004). CONCLUSION: Endoscopy in nonholiday and holiday days and the time of endoscopy has no significant effect on hospital mortality 1 month after discharge. However, other factors such as endoscopy by attendant or fellowship, time between admission to endoscopy, age and sex of the patients, etc., were significantly effective on in-hospital mortality and death 1 months after discharge. Also faster and sooner endoscopy cannot reduce rate of blood transfusions or reduce the length of hospital stay but faster endoscopy of patients can reduce the risk of in-hospital death.

Comparing the Effects of Hydroxyethyl Starch and Albumin in Cirrhotic Patients with Tense Ascites; a Randomized Clinical Trial.

INTRODUCTION: Large-volume paracentesis is one of the usual treatments for cirrhotic patients with tense ascites, which may cause different complications including decreased cardiac preload, suppressed renin angiotensin system, inactivation of sympathetic nervous system, electrolyte imbalances, etc. OBJECTIVE: The aim of this study was to compare the effects of administrating hydroxyethyl starch (HES) and albumin in cirrhotic patients with tense ascites in order to reduce the paracentesis complications. METHODS: In the present randomized clinical trial, 108 cirrhotic patients with tense ascites were enrolled. The patients were randomly divided into 3 groups. In group A, albumin 20% with 5 g/L dose of paracentesis fluid, in group B, HES 6% dissolved in saline were administered, and in group C, a combination of albumin 20% and HES 6% with half the dosage administrated to two other groups were prescribed. Then biochemical panel, and liver function tests and renal and electrolyte complications were compared between the groups. RESULTS: The results obtained after intervention did not show significant differences between the groups regarding weight (p=0.102), heart rate and platelet count (both p=0.094), hematocrit (p=0.09), creatinine (p=0.421), serum sodium (p=0.743) and potassium (p=0.147), total bilirubin (p=0.375) and urine volume (p=0.421). Additionally, we concluded that mean arterial pressure of patients who had received albumin was higher than the other 2 groups (p < 0.001). CONCLUSION: The results of the present study showed the similar effects of HES and albumin in cirrhotic patients with tense ascites undergoing large-volume paracentesis.

Premedication with benzodiazepines for upper gastrointestinal endoscopy: Comparison between oral midazolam and sublingual alprazolam.

BACKGROUND: Premedication with orally administered benzodiazepines is effective in reducing anxiety and discomfort related to endoscopic procedures. We evaluated the efficacy and safety of oral midazolam in comparison to sublingual alprazolam as premedication for esophagogastroduodenoscopy (EGD). MATERIALS AND METHODS: Adult candidates for diagnostic EGD received either oral midazolam (7.5 mg in 15 cc apple juice) or sublingual alprazolam (0.5 mg) 30 min before EGD. Procedural anxiety and pain/discomfort were assessed using 11-point numerical rating scales. Patients' overall tolerance (using a four-point Likert scale) and willingness to repeat the EGD, if necessary, were also assessed. Blood pressure, heart rate, and arterial oxygen saturation were monitored from medication to 30 min after the procedure. RESULTS: Patients experienced a similar reduction in procedural anxiety after medication with oral midazolam and sublingual alprazolam; mean (standard deviation [SD] of 1.86 [1.63] and 2.02 [1.99] points, respectively, P = 0.91). Compared to oral midazolam, pain/discomfort scores were lower with sublingual alprazolam; mean (SD) of 4.80 (3.01) versus 3.68 (3.28), P = 0.024. There was no significant difference between the two groups in patients' tolerance, willingness to repeat the procedure, or hemodynamic events. CONCLUSION: Oral midazolam and sublingual alprazolam are equally effective in reducing EGD-related anxiety; however, EGD-related pain/discomfort is lower with alprazolam. Both benzodiazepines are equally safe and can be used as premedication for patients undergoing diagnostic EGD.

Etiology and outcome in patients with upper gastrointestinal bleeding: Study on 4747 patients in the central region of Iran.

BACKGROUND AND AIM: Upper gastrointestinal bleeding (UGIB) is a threatening condition leading to urgent hospitalization. This study aims to investigate etiology and outcome in UGIB patients in Iran. METHODS: Medical records of GIB patients admitted to Alzahra referral hospital (in Isfahan) during 2010-2015 were retrospectively reviewed for demographic data, comorbidities, history of smoking and taking non-steroidal anti-inflammatory drugs (NSAIDs), presenting symptoms, endoscopic findings, therapeutic endoscopy, blood products' infusion, surgical intervention, rebleeding, and mortality. RESULTS: A total of 4747 patients were enrolled in the study (69.2% men, mean age = 55.46 ± 21.98 years). Hematemesis was the most frequent presenting symptom (63.5%). Peptic ulcer (duodenal ulcer in most cases) was seen as the main reason for UGIB (42.4%). Rebleeding (present in 16.5% of patients) was found to be more frequent in patients with older age, presenting sign of hematochezia and hypotension, history of taking NSAIDs and smoking, presence of comorbidities, history of bleeding because of UGI tract neoplasm and esophageal varices, history of needing blood products' infusion, and history of therapeutic endoscopy or surgical intervention (P < 0.005). We found that mortality (5.5% in total) was also higher in the same group of patients that were seen to have a higher tendency for rebleeding (P < 0.005). CONCLUSION: Peptic ulcers are the most common cause of UGIB. Comorbidities, hemodynamic instability, high-risk endoscopic stigmata, history of smoking and taking NSAIDs, gastric and esophageal malignancies, may be important predisposing factors for rebleeding and mortality in patients with UGIB.

Prevalence of interleukin-28B single nucleotide polymorphism genotypes in patients with hepatitis C infection in Isfahan, Iran.

BACKGROUND: Hepatitis C infection is one of the most common causes of liver-related morbidity and mortality. Due to limited efficacy and side-effects of treatment, identification of the determinants of response to treatment is an important issue. Nowadays, genotyping of interleukin (IL)-28B is one of the strongest tests used for prediction of sustained virological response. The prevalence of IL28B genotypes varies across different ethnicities. This study presents data on IL28B single nucleotide polymorphism (SNP) (rs12979860) in a group of Iranian hepatitis C virus (HCV)-infected patients in Isfahan. MATERIALS AND METHODS: One hundred patients already diagnosed for hepatitis C enrolled the study. Genomic DNA was extracted from whole blood samples. Specific primers were used to amplify IL28B gene (rs12979860). The rs129679860 SNP was genotyped by real-time polymerase chain reaction using TaqMan(®) probes. RESULTS: The mean age of patients was 33.16 years (25-42 years). Ninety-nine subjects were male and 1 was female. The frequency of HCV genotypes was as follows: Genotype 3a: 53%, genotype 1a: 42%, genotype 1b: 2%, mixed genotype (1a + 3a): 1% and 2%: Nontypable. IL28B rs12979860 genotypes were TT in 17 patients (17%), CT in 41 patients (41%), and CC in the remaining 42 patients (42%). CONCLUSION: The prevalence of C allele is much higher in our population study than in African American HCV patients (62.5% and 40% respectively), which can explain better response to treatment in our patients.

A comparative study of one minute versus five seconds endoscopic biliary balloon dilation after small sphincterotomy in choleducolithiasis.

BACKGROUND: Limited sphincterotomy and endoscopic papillary balloon dilation (EPBD) is a low-risk method for the treatment of choleducolithiasis. Traditionally one minute ballooning time (BT) is applied; however, the effective BT is not clear. In this study, we compare five seconds and one minute ballooning time. MATERIALS AND METHODS: In this single-blind, randomized, clinical trial 60 patients with common bile duct (CBD) stones documented in ultrasonography or magnetic resonance cholangiopancreatography (MRCP), with no severe hepatic, biliary or systemic diseases, enrolled in the study. The patients were randomly assigned to receive EPBD with either five seconds (n = 31) or one minute (n = 29) ballooning time (BT) after endoscopic retrograde cholangiopancreatography (ERCP) and small sphincterotomy. Then stones were retrieved with an extractor balloon. The patients were followed for 48 hours to check the possible complications. RESULTS: Successful CBD stone removal was the same in the five-second and one-minute BT groups (93.5% vs. 96.6%; P = 0.594). Pancreatitis occurred in three (9.7%) patients in the five-second BT group and in six (20.7%) patients in the one-minute BT group (P = 0.233). No hemorrhage or perforation was noted. CONCLUSIONS: After a small sphincterotomy, EPBD in the five-second and one-minute BT groups had a similar efficacy. Small sphincterotomy combined with very short BT is a safe and effective method for CBD stone removal.

Multistrain probiotic and lactulose in the treatment of minimal hepatic encephalopathy.

BACKGROUND: Some evidence has shown benefits of probiotics in the management of minimal hepatic encephalopathy (MHE). We evaluated the efficacy of a multistrain probiotic compound, alone and in combination with lactulose, in the treatment of MHE. MATERIALS AND METHODS: This study has two parts. First, consecutive adult patients with MHE were randomized to receive lactulose (30-60 mL/day) + probiotic (200 million colony forming units of seven bacteria species/day) (Gp-LPr) or lactulose + placebo (Gp-L). In second part, a non-randomized group of patients received probiotic alone (Gp-Pr). Medication duration was for 2 weeks and patients were followed-up for another 8 weeks. Improvement in MHE status was assessed by psychometric hepatic encephalopathy score (PHES). Development of overt encephalopathy, hospitalization, and death were considered as secondary outcomes. RESULTS: Sixty patients (80% male, mean age 38.4 ± 9.6 years) completed the intervention. PHES significantly improved after medication in all the three groups (Gp-LPr: -3.8 ± 3.9 to -1.6 ± 3.0; Gp-L: -4.8 ± 4.1 to -1.6 ± 2.9; and Gp-Pr: -4.9 ± 3.7 to -2.1 ± 2.5, P < 0.001). After 8 weeks follow-up, improvement was maintained in Gp-LPr and Gp-Pr, but there was deterioration in those who did not receive probiotics (Gp-L: PHES score reversed to -4.8 ± 4.2). Two patients (one each in Gp-L and Gp-Pr) experienced overt encephalopathy. One patient was hospitalized due to worsening of ascites (Gp-LPr) and one due to spontaneous bacterial peritonitis (Gp-L). Side effects were mild and not significantly different among the groups. CONCLUSION: Lactulose and probiotics are effective for the treatment of MHE; however, probiotics, but not lactulose, have long-term effects. More studies are required before suggesting probiotics for the standard treatment of MHE.

The effects of multi-strain probiotic compound on symptoms and quality-of-life in patients with irritable bowel syndrome: A randomized placebo-controlled trial.

BACKGROUND: Evidence has shown beneficial effects of probiotics in the treatment of irritable bowel syndrome (IBS); however, there is still a lack of data in this regard. We evaluated the efficacy of a multi-strain probiotic compound on IBS symptoms and quality-of-life (QOL). MATERIALS AND METHODS: Adult IBS patients (n = 132) were randomized to receive a probiotic compound containing seven bacteria species including Lactobacillus strains, Bifidobacterium strains and Streptococcus thermophiles or similar placebo, twice daily after a meal for 14 consecutive days. Improvement of IBS symptoms was assessed in categories of abdominal pain and distension and improvement of bowel habit. Improvement in patients QOL was assessed by the IBS-QOL instrument. Patients were evaluated for symptoms and QOL at baseline and then 1 month after completion of the treatment. RESULTS: After treatment, there was a decrease in abdominal pain and distension severity in both probiotic and the placebo groups (P<0.001), but there was no difference between the two groups in this regard (P>0.05). Improvement in bowel habit was observed in 33.3% of the probiotic and 36.5% of the placebo group (P = 0.910). There was no significant difference between the two groups in QOL after the treatment (P >0.05). CONCLUSIONS: We found no beneficial effects over placebo for a 2-week treatment with the above mentioned multi-strain probiotic compound in the treatment of IBS. Further, trials are yet required before a clear conclusion in this regards.

Premedication with sublingual or oral alprazolam in adults undergoing diagnostic upper gastrointestinal endoscopy.

BACKGROUND AND STUDY AIM: Diagnostic esophagogastroduodenoscopy (EGD) is uncomfortable for most patients. We determined the efficacy of alprazolam, administered orally or sublingually, as premedication for sedation during EGD. PATIENTS AND METHODS: Adult EGD candidates were randomly allocated to four groups (n = 55, each group) and received alprazolam (0.5 mg) sublingually or orally, placebo sublingually or orally at 30 minutes before EGD. Main outcome measures included procedure-related anxiety and pain/discomfort (assessed using 11-point numeric scales), patient overall tolerance (assessed using a 4-point Likert scale), need for intravenous sedation, and willingness to repeat the EGD if necessary. RESULTS: Patients experienced greater reduction in anxiety score after medication with sublingual alprazolam (mean 2.25, standard deviation [SD] 1.73) compared with sublingual placebo (mean 0.10, standard error [SE] 0.15]; P < 0.001) and oral alprazolam (0.63, SE 0.14; P < 0.001). Also, pain/discomfort scores were lower with sublingual alprazolam compared with sublingual placebo (3.29, SE 0.29 vs. 4.16, SD 1.86; P = 0.024), and with oral alprazolam compared with oral placebo (3.48, SD 1.69 vs. 5.13, SD 2.39; P  < 0.001). Patient overall tolerance was better with sublingual alprazolam than with sublingual placebo (P = 0.005) or with oral alprazolam (P = 0.009). Regarding intravenous sedation, there was no difference between sublingual alprazolam and sublingual placebo (10.9 % vs. 10.9 %; P = 0.619) or between oral alprazolam and oral placebo (9.0 % vs. 12.7 %; P = 0.381). Willingness to repeat the procedure was greater with sublingual alprazolam than with sublingual placebo (50.9 % vs. 30.9 %; P = 0.026). CONCLUSIONS: Sublingual alprazolam is an effective premedication for sedation during EGD. It reduces anxiety and pain/discomfort related to EGD and increases patient tolerance and willingness to repeat the EGD if necessary. CLINICAL TRIAL REGISTRATION: NCT01949038 ClinicalTrials.gov.

The effect of Helicobacter pylori eradication on liver enzymes in patients referring with unexplained hypertransaminasemia.

BACKGROUND: Evidence has shown an association of Helicobacter pylori infection with liver dysfunction and damage. We investigated if H. pylori eradication affects liver enzymes in patients referring with unexplained hypertransaminasemia. MATERIALS AND METHODS: Patients with mild unexplained hypertransaminasemia accompanied with dyspepsia and confirmed H. pylori infection were studied. Viral, metabolic, autoimmune, and drug/toxin induced hepatitis as well as fatty liver were all ruled-out by appropriate tests. Patients received bismuth-containing quadruple-therapy for 2 weeks. Serum levels of liver enzymes (alanine transaminase (ALT) and aspartate transaminase (AST)) and successful eradication (with stool antigen test) were evaluated 4 weeks after the medication. RESULTS: A total number of 107 patients (55 males, mean age = 35.0 ± 8.4 years) were studied. Eradication was successful in 93 patients (86.9%). Serum levels of AST (6.3 ± 19.6 IU/L, P = 0.002) and ALT (7.8 ± 24.9 IU/L, P = 0.001) were significantly decreased after eradication. Levels of AST and ALT decreased to normal range respectively in 46.6% and 45.7% of the cases who had baseline levels above the normal range. CONCLUSION: This study showed a decrease in liver enzymes after receiving eradication regimen of H. pylori, suggesting a role for H. pylori infection in at least some of patients with mild unexplained hypertransaminasemia. Further studies are warranted to find the underlying mechanisms by which H. pylori infection affects the liver and clinical importance of such effects.

Efficacy of double dose recombinant hepatitis B vaccination in chronic hepatitis C patients, compared to standard dose vaccination.

BACKGROUND: Hepatitis B virus (HBV) vaccination is a well-known, safe and effective way for protection against HBV infection; however, non-responders remain susceptible to infection with HBV. This is so important in patients with any kind of chronic liver disease, especially chronic hepatitis C virus (HCV) patients in whom acute HBV infection may lead to decompensation of liver disease. Some of the studies have shown that immunogenicity of HBV vaccination is decreased in these patients. The aim of this study was to evaluate the efficacy and safety of double dose vaccination of HBV in these patients, compared with standard dose vaccination in similar patients and healthy adults. METHODS: A total of 64 patients with chronic HCV infection were randomized into 2 groups of 32. Group A received standard dose HBV vaccine, at 0, 1, 6 months, whereas group B received double dose HBV vaccine. Group C consisted of 32 healthy adults who also received standard dose vaccination. At 1 month after the end of vaccination, Hepatitis B surface antibody (HBsAb) titer was checked in all participants and the results were compared. RESULTS: There was no significant difference in age or sex among three groups. The response rate in groups B and C was 100% (all had HBsAb titer >10 mIU/mL), while in group A, 4 patients (12.5%) were non-responders (HBsAb titer < 10 mIU/mL). The difference in response rate was statistically significant between Group A and the other two groups (P < 0.05). CONCLUSIONS: The efficacy of standard dose HBV vaccination in patients with chronic HCV infection was suboptimal. Using double dose vaccination in these patients was an effective way to increase the antibody response.