Evaluation of the additive effect of domperidone on patients with refractory gastroesophageal reflux disease; a randomized double blind clinical trial

Background: Gastroesophageal reflux disease [GERD] is a common problem with annoying symptoms. It is associated with negative impact on quality of life. Prokinetic agents may be used in combination with acid suppression agents as an adjunctive in patients with GERD refractory to proton pump inhibitors [PPI] therapy, rather than as sole treatment. This study aimed to evaluate the efficacy of combination of PPI with domperidone [a prokinetic agent] compared with PPI alone in the treatment of patients with refractory GERD

Methods: This study was a double blind clinical trial on 29 patients with GERD refractory to PPI during the period of one month. By randomization, the patients were divided into two groups. Group A was treated by pantoprazole 40 mg twice daily and domperidone three times a day for a month, while group B was treated by pantoprazole 40 mg twice daily and placebo three times a day. In this study endoscopy was performed to evaluate the prevalence of erosive esophagitis, non-erosive reflux, and hiatal hernia. Manometry was conducted to study the prevalence of dysmotility. GERD symptom questionnaires including the Gastrointestinal Symptom Rating Scale [GSRS], Carlson Dennett, and the Medical Outcomes Study Short Form-36 health survey [SF36] were used before and after treatment for screening GERD and assessing treatment response

Results: There were 17 [58.62%] women and 12 [41.37%] men. The prevalence of erosive esophagitis and non-erosive reflux, was 10.34% and 89.66%, respectively. There was a significant difference comparing reflux symptoms before and after treatment between the two groups according to reflux and Carlson Dennett questionnaires. At the end of the study, symptoms of reflux significantly improved by treatment. Although, the quality of life questionnaire scores improved by treatment, there was no statistically significant difference in response to treatment between the two groups

Conclusion: In this research, we showed that adding domperidone to PPI could not make any improvement in patients with refractory reflux regarding the quality of life and improving the symptoms

Iranian Registry of Crohn's and Colitis: study profile of first nation-wide inflammatory bowel disease registry in Middle East

BACKGROUND/AIMS: A recent study revealed increasing incidence and prevalence of inflammatory bowel disease (IBD) in Iran. The Iranian Registry of Crohn's and Colitis (IRCC) was designed recently to answer the needs. We reported the design, methods of data collection, and aims of IRCC in this paper. METHODS: IRCC is a multicenter prospective registry, which is established with collaboration of more than 100 gastroenterologists from different provinces of Iran. Minimum data set for IRCC was defined according to an international consensus on standard set of outcomes for IBD. A pilot feasibility study was performed on 553 IBD patients with a web-based questionnaire. The reliability of questionnaire evaluated by Cronbach's α. RESULTS: All sections of questionnaire had Cronbach's α of more than 0.6. In pilot study, 312 of participants (56.4%) were male and mean age was 38 years (standard deviation=12.8) and 378 patients (68.35%) had ulcerative colitis, 303 subjects (54,7%) had college education and 358 patients (64.74%) were of Fars ethnicity. We found that 68 (12.3%), 44 (7.9%), and 13 (2.3%) of participants were smokers, hookah and opium users, respectively. History of appendectomy was reported in 58 of patients (10.48%). The most common medication was 5-aminosalicylate (94.39%). CONCLUSIONS: To the best of our knowledge, IRCC is the first national IBD registry in the Middle East and could become a reliable infrastructure for national and international research on IBD. IRCC will improve the quality of care of IBD patients and provide national information for policy makers to better plan for controlling IBD in Iran.

efficacy of levofloxacin-based triple therapy for helicobacter pylori eradication after failure with clarithromycin-containing regimens

Background: Clinical trials and meta-analyses have reported about 20% failure rates in first-line Helicobacter pylori [H. pylori] eradication. This reflects the need for effective second-line eradication regimens

Materials and Methods: 61 patients with H. pylori infection who had failed previous non-bismuth clarithromycin-containing first line therapies entered the study. They were given a 14-day levofloxacin-containing triple regimen consisted of pantoprazole 40 mg, amoxicillin 1gr, and levofloxacin 500mg, each given twice daily. Eight weeks after the treatment, H. pylori eradication was assessed by 14C-urea breath test

Results: All patients completed the study. The eradication rate was 91.8% [95% confidence interval = 84.9% - 98.6%] by both intention to treat and per-protocol analyses. Side effects of therapy were reported by eight patients [13.1%], but they were severe in only two patients [3.2%]

Conclusion: According to the high H. pylori eradication rate and the very low rate of severe adverse effects, levofloxacin-containing triple therapy seems to be a suitable second-line option in case of previous failure by clarithromycin-containing therapies. We suggest further studies with shorter duration of treatment or lower dose of levofloxacin

Comparison of oral versus intravenous proton pump inhibitors in preventing re-bleeding from peptic ulcer after successful endoscopic therapy

Background: Proton pump inhibitors [PPIs] are now widely prescribed for the management of patients with acute upper gastrointestinal bleeding; although its optimal dose and route of administration has remained a controversial issue. The aim of this study was to assess the clinical effectiveness of high dose oral versus intravenous [IV] PPI after successful endoscopic therapy in patients with bleeding peptic ulcer disease

Methods: 178 patients with active upper gastrointestinal bleeding due to a peptic ulcer with stigmata of high risk for re-bleeding entered the study. After successful endoscopic hemostasis, they were randomized to receive either high dose oral pantoprazole [80 mg stat and 80 mg twice daily for 3 days] or high dose intravenous pantoprazole [80 mg IV infusion within 30 minutes and 8 mg per hour for 3 days]. After the 3rd day, the patients in both groups received oral pantoprazole 40 mg twice daily for one month. The end points were comparing the rate of re-bleeding or mortality, and the need for blood transfusion or surgery during the first month between the two groups

Results: There were not significant statistical differences between the two groups in the volume of blood transfusion, mean duration of hospital stay, need to surgery, or mortality rates. However, the rates of re-bleeding were 2.3% [2:88] in the IV group and 3.3% [3:90] in the oral group [p = 0.6]

Conclusion: According to our findings, it seems that high dose oral PPI can be a good alternative to high dose IV PPI in patients with bleeding peptic ulcer who are at high risk of re-bleeding. Due to the lower cost and the availability of oral PPIs, their use can be economically much more affordable

Cancer stem cells CD133 and CD24 in colorectal cancers in Northern Iran

Aim: We aimed to study the expression of CD24 and CD133 in colorectal cancer and normal adjacent tissues to assess a relationship between these markers and clinic-pathological characteristics and patient's survival

Background: Cancer stem cells are a group of tumor cells that have regeneration and multi-order differentiation capabilities

Patients and methods: Expression of CD24 and CD133 was studied in a paraffin block of colorectal cancer and normal tissues near tumors with the immuneohistochemical method in patients who were referred to Imam Khomeini Hospital in Sari

Results: A total of 50 samples [25 males and 25 females] with a mean age of 67.57 +/- 13.9 years old with range 28-93 years, included 3 mucinous carcinoma and 47 adenocarcinoma. Expression of CD133 marker was negative in 29 cases and positive in 21 cases. Expression of CD24 in tissue near tumor cells was found in 30% of available samples. The relationship between expressing CD24 with treatment [surgery and chemotherapy] was significant and its relationship with patient's survival was insignificant statistically. However, there was a clear difference as mean survival age of patients based on CD24 expression was 26.64 +/- 18.15 for negative cases and 41.75 +/- 28.76 months for positive cases. CD24 and CD133 expressions and their co-expression with other clinic-pathological factors were not significant

Conclusion: During this study, the relationship between CD24 and treatment type was significant. To confirm this result, various studies with high sample numbers and other stem cell markers are recommended

comparison between hybrid and concomitant regimens for helicobacter pylori eradication: a randomized clinical trial

Background: Helicobacter pylori [H. pylori] is one of the most common bacterial infections worldwide. We designed a study to compare the efficacy of 14-day hybrid regimen with 10-day concomitant therapy for H. pylori eradication in Iran

Methods: 252 patients with naive H. pylori infection were randomly divided to receive either hybrid regimen [pantoprazole 40 mg, and amoxicillin 1 gr twice daily for 14 days, accompanied by clarithromycin 500 mg, and metronidazole 500 mg, twice daily just during the last 7 days] or concomitant regimen [pantoprazole 40 mg, amoxicillin 1 gr, clarithromycin 500 mg, and metronidazole 500 mg, all twice daily for 10 days]. 8 weeks after therapy, 14C- urease breath test was performed to confirm eradication

Results: According to intention to treat analysis, the eradication rates were 87.3% [95% CI: 81.4-93.1] and 80.9% [95% CI: 74-87.8] in hybrid and concomitant groups, respectively [p=0.38]. Per-protocol eradication rates were 89.3% [95% CI: 83.8-94.7] and 83.1% [95% CI: 76.3-89.8], respectively [p=0.19]. The rates of severe side effects were not statistically different between the two groups [4% vs. 8.7%]

Conclusion: 14-day hybrid therapy can be considered as a nearly acceptable regimen with few severe side effects in Iran. However, it seems that the efficacy of this therapy is decreasing as the resistance rates to antibiotics are increasing. We suggest further studies to assess the efficacy of a more prolonged concomitant therapy for H. pylori eradication in Iran

[Correlation of changes in serum pepsinogen 1, pepsinogen 2 with helicobacter pylori eradication]

H.pylori infection in the stomach was the first major cause of gastritis and peptic ulcer disease and gastric adenocarcinoma and lymphoma [MALT]. Evaluation of the infection eradication is important. H.pylori infection was associated with gastric glands dysfunction such as increased serum gastrin and increased secretion of Pepsinogen. In recent years the measurement of serum gastrin and pepsinogen were considered to evaluation of Helicobacter pylori eradication.In a case - control study, we evaluated the changes of serum pepsinogen type 1 and 2 in H.pylori-positive patients after eradication therapy, and we assessed the correlation of serum pepsinogen type 1 and 2 and with successful eradication therapy. Pepsinogen type 1 and 2 serum levels significantly decreased after successful eradication in comparison with unsuccessful eradication. The both 2 markers decreased after 8 weeks of therapy. Pepsinogen 1 by a 41.1% decrease in 8 weeks after eradication had 95% sensitivity and 100% specificity for successful eradication. 64.1% reduction in pepsinogen 2, 8 weeks after treatment had 97.5% sensitivity and specificity for successful eradication. According to the findings of this study and other previous studies, changes in the type 2 pepsinogen serum levels, can be a reliable indicator of successful eradication of H.pylori infection. Although our study showed that changes in pepsinogen1 levels have a sufficient sensitivity and specificity of treatment, but in our study some factors including atrophic gastritis and age that affected on type 1 pepsinogen serum levels, did not considered

Simultaneous esophageal squamous cell carcinoma and adenocarcinoma: a case report

Esophageal squamous cell carcinoma is a rather common cancer in northern Iran. Incidence of adenocarcinoma of esophagus has an increasing trend in Iran. Co-existence of both cancers in one patient is very rare. We report a middle age woman from northern Iran with a typical presentation of esopha-geal cancer, who was found to have a dual esophageal cancer. The disease was found in the advanced stage with pulmonary metastasis at the presentation. Palliative chemo-radiotherapy induced partial clinical response

Comparison of half-dose and full-dose triple therapy regimens for Helicobacter pylori eradication in patients with end-stage renal disease

The aim of this study was to compare the half-dose and full-dose triple therapy regimens for Helicobacter pylori [Hp] eradication in patients with end-stage renal disease. H. Pylori is one the most important causes of dyspepsia in patients with end-stage renal disease [ESRD]. Sixty-six patients with ESRD were enrolled in the study with Hp infection and peptic disease with a need of Hperadication. Patients were randomly assigned to full-dose [A=35 patients] or half-dose group [B=31 patients]. Patients received clarithromycin 500 mg, amoxicillin 1000 mg and omeprazole 20 mg twice daily in group A and clarithromycin 250 mg and amoxicillin 500 mg twice daily and omeprazole 20 mg once daily in group B for two weeks. Patients provided stool samples 4 weeks of completing study to assess the success of Hp eradication by Hp-specific stool antigen. Finally, the rate of eradication and complications were compared between two groups. The successful Hp eradication was achieved in 26 patients [74%] in group A and in 22 patients [74%] in group B. The difference between 2 groups was not statistically significant [p=0.973] [per protocol analysis]. Half-dose triple-therapy with clarithromycin, amoxicillin and omeprazole is as effective as full-dose triple-therapy to eradicate the Hp in patients with ESRD. According to lower toxicity level, complications and cost in half-dose regimen in this subset of patients, this protocol is advised

comparison between moderate- and high-dose furazolidone in triple regimens for Helicobacter pylori eradication in Iran

Furazolidone has been used as an alternative for clarithromycin or metronidazole in Helicobacterpylori [H. pylori] eradication regimens. In Iran, 14-day Furazolidone-containing quadruple regimens have shown promising eradication rates, but short-course, low dose therapies are always attractive. Therefore, we designed a study to compare the efficacy of two 10-day triple regimens containing moderate and high dose furazolidone for H. pylori eradication. Two hundred and ten patients with peptic ulcer disease who were naive to H. pylori treatment were included. They were randomized into 2 groups: 105 patients received omeprazole 20mg, amoxicillin 1000mg, and furazolidone 200mg [OAF-400], all twice a day for ten days. And the remaining 105 patients received omeprazole 20mg twice a day, amoxicillin 1000mg twice a day and furazolidone 200mg three times a day for ten days [OAF-600]. Urease breath test was performed 8 weeks after the treatment to confirm H. pylori eradication. The intention-to-treat eradication rate was 76.19% in group OAF-400 and 80.95% in group OAF-600 [p=0.38]. Per protocol eradication rates were 81.63% and 89.47%, respectively [p= 0.11]. Severe adverse effects were reported by 8.6% of the patients in group OAF-400 and 5.7% of the patient in group OAF-600 [p=0.1]. However, the total side effects [including mild, moderate, and severe ones] were significantly more prevalent in the OAF-600 group [p=0.001]. None of our triple furazolidone-based regimens [moderate- and high-dose] could achieve the standard eradication rate, and therefore, cannot be considered as a suitable option for first-line treatment

Quality of life in patients with gastroesophageal reflux disease in an Iranian population

The study was designed to evaluate quality of life [QOL] for Iranian patients with gastroesophageal reflux disease [GERD]. GERD is a common and chronic world-wide disease. Impact of GERD on QOL has been studied in many countries, but it has not been studied in Iranian population. Fifty five patients suffering from GERD and fifty five age and sex matched controls were enrolled. Patient inclusion criteria were based on clinical and endoscopic findings. All other major diseases having an impact on QOL had been excluded. All the subjects were asked to fill the validated translation of SF-36 and GHQ-28 questionnaires. Results of the SF-36 questionnaire was analyzed directly and after correction for the results obtained from the GHQ-28 tool. GERD patients had lower QOL scores than controls. Correction of the results based the findings of GHQ-28 questionnaire did not change the results. QOL in GERD patients is impaired and should be considered in clinical practice and implementing research studies upon GERD patients

Jejunal intussusception caused by a huge Vanek's tumor: a case report

Inflammatory fibroid polyp [known also as Vanek's tumor] is a type of localized, non-neoplastic inflammatory pseudotumor or inflammatory myofibroblastic tumor that occurs most commonly in the stomach but also in the small and large bowel. It is a documented cause of intussusception in adults. We report a case of a 40-year-old woman who presented with severe, postprandial abdominal pain followed by projectile vomiting over a period of three days. Ultrasonography demonstrated a solid and echogenic mass surrounded by the typical mural layers of an invaginated jejunum. She underwent urgent laparotomy and resection of an 18 cm tumor from the distal jejunum. The immuno-histopathological diagnosis after segmental jejunal resection was a jejunal inflammatory fibroid polyp. Although inflammatory fibroid polyps are seen very rarely in adults, they are among the probable diagnoses that should be considered in obstructive tumors of the small bowel causing intussusceptions

Novel Mutations of ATP7B gene in Iranian patients with Wilson's disease

Wilson's disease is a rare autosomal recessive disorder characterized by toxic accumulation of copper in liver and brain. The disorder is caused by mutations in the ATP7B gene, encoding a copper transporting P-type ATPase. Characterization of the spectrum of mutations in this gene is important both for diagnosis and genetic counseling of the families. We enrolled 30 definitely diagnosed patients [ages ranging from 3 to 33]. Genomic DNA was extracted from peripheral blood samples. All the exons of the gene were amplified by polymerase chain reaction using specified primers for each exon. The amplification products were then analyzed by direct automated sequencing. 87% of our patients had liver problems while 47% of suffered from neurological problems. In this study we will report the spectrum of mutation found among Iranian families, which are mainly different from other reports. By performing the present study, some new mutations in ATP7B gene, Del C 3696[1232] and S1369L were identified for the first time in Wilson's disease patients

rare cause of small bowel obstruction in adults: left paraduodenal internal hernia

A 47 years old lady presented with repeated intermittent, colicky, left upper, and periumblical abdominal pain associated with nausea and vomiting since two years prior to admission. Each episode of the pain spontaneously subsided after bilious vomiting. The patient had no history of surgery, abdominal trauma or intra-abdominal infection, weight loss or previous history for small bowel obstruction [SBO]. MRI enterography was suggestive of internal hernia and surgery documented left paraduodenal [mesocolic] internal hernia [LPDIH]. After surgery the patient was followed for three months without any abdominal symptoms

[Severe lower gastrointestinal bleeding, small intestine lymphoma: a case report]

The patient was a 67-year-old female who presented with severe rectal bleeding since three days prior to hospital admission. She complained of mild abdominal pain. Rectal examination revealed the presence of fresh blood and a clot. She had a normal upper endoscopy. A colonoscopy showed a large clot with bloody secretions up to the cecum, with no obvious origin. Because of the severity of bleeding, a laparotomy was performed. Resection included large areas of the ileum and jejunum which were involved. Pathology report was remarkable for diffuse large B cell lymphoma.