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.

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

Eradication of helicobacter pylori in Iran: a review

Helicobacter pylori [H. pylori] infection is one of the most common bacterial infections, affecting almost half of the world's population. It is associated with peptic ulcer disease, gastric adenocarcinoma, and lymphoma. In Iran, the prevalence of H. pylori infection has been reported to be between 36% and 90% in different geographic regions. Several studies have assessed the efficacy of different therapeutic options for first line and second-line H. pylori eradication in Iran; however, the results are conflicting. Therefore, we conducted a review to evaluate different studies in order to select the best options and to provide recommendations for H. pylori eradication in Iran. Accordingly, we searched through PubMed to obtain relevant randomized clinical trials published in English language up to June 2017. According to our study, among first-line eradication regimens, bismuth-based furazolidone-or clarithromycin-containing quadruple therapies, hybrid regimen, and concomitant therapy seem to be appropriate options. Also, 10- or 14-day clarithromycin-containing triple therapy can be used if local H. pylori resistance to clarithromycin is known to be less than 15%. For second-line H. pylori eradication, bismuth-based quadruple therapies and 14-day levofloxacin-based triple therapy can be used, provided that antibiotics other than those used in the first-line regimen are used. Third-line H. pylori eradication regimens have not been addressed in Iranian studies. However, most guidelines recommend treatment according to the results of culture and susceptibility testing. Although we limited our investigation to H. pylori eradication regimens in Iran, the results are transferrable to any region as long as the patterns of antibiotic resistance are the same

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

Role of upper and lower gastrointestinal endoscopy in investigating the etiologies of iron deficiency anemia in postmenopausal women

Background: iron deficiency anemia has been considered as an alarming sign of the possible presence of malignancy in the digestive tract. Inadequate assessment of such affected patients can lead to delay in the diagnosis of gastrointestinal [GI] tumors especially colorectal cancers. Therefore the present study examined the upper and lower GI tract of postmenopausal women with iron deficiency anemia by GI endoscopy

Materials and Methods: women aged over 45 years referred to Gastroenterology Clinic of Imam Khomeini Hospital were asked about their menstruation. Postmenopausal women with the anemia were enrolled. A list of laboratory studies was performed for all included patients. These laboratory studies included complete blood count [CBC], iron profile and stool examination for occult blood. 103 postmenopausal women with iron deficiency anemia according to laboratory tests were interviewed and their clinical and biochemical variables were recorded. All of the study patients underwent esophagogastroduodenoscopy and colonoscopy. The endoscopic findings were recorded regarding the presence of GI lesions causing iron deficiency anemia or the lack of them

Results: a total of 103 patients participated in this study. Endoscopy revealed a source of iron deficiency anemia in 90.3% of the study population. Upper and lower GI tract lesions were found in 73.8% and 51.5% of the patients, respectively. The most frequent lesions in the upper GI endoscopy were severe gastroesophageal reflux disease involving 34 patients [33%] followed by gastric erosions in 31 cases [30.1%] and duodenal ulcer in 15 cases [14.6%]

Conclusion: in postmenopausal women with iron deficiency anemia as in men, it is necessary to examine the GI tract

comparison between hybrid therapy and standard triple therapy for helicobacter pylori eradication in patients with uremia: a randomized clinical trial

Background: The prevalence of peptic ulcer disease in hemodialysis patients is more than the general population. They are also more prone to complications including upper gastrointestinal bleeding. The aim of this study was to compare the efficacy of 14 days hybrid regimen with 14 days triple therapy for Helicobacter pylori [H. pylori] eradication in hemodialysis patients

Methods: Forty hemodialysis patients with naïve H.pylori infection were randomized to receive either hybrid regimen [pantoprazole 40 mg + amoxicillin 500 mg, both twice a day during the first 7 days, followed by pantoprazole 40 mg + amoxicillin 500 mg + clarithromycin 500 mg + tinidazole 500 mg, all twice a day, for the second 7 days, or standard triple therapy including pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 500 mg, all twice a day for 14 days. H.pylori eradication was assessed by fecal H.pylori antigen test 8 weeks after the treatment

Results: All the patients completed the study. According to both intention to treat and per-protocol analyses, H.pylori eradication rates were 100% [95% confidence interval [CI]: 100] in those who received hybrid therapy and 70% [95% CI: 69.4 - 70.8] in those who were treated by standard triple therapy [p=0.02]. Severe adverse effects were not reported by any patient; however, mild adverse effects were more frequent in those who received standard triple therapy [p<0.05]

Conclusion: Hybrid regimen could achieve ideal H.pylori eradication rates with low rates of adverse effects

Effects of clarithromycin-containing quadruple therapy on helicobacter pylori eradication after nitroimidazole-containing quadruple therapy failure

Background: Several large clinical trials and meta-analyses have shown about 20% failure to eradicate Helicobacter pylori [H.pylori], necessitating investigations for second-line treatments. The aim of this study was to evaluate the effects of clarithromycin-containing quadruple regimen after nitroimidazole-containing quadruple therapy failure

Methods: Thirty two patients who had failed 10-day H.pylori treatment with omeprazole, amoxicillin, bismuth subcitrate, and metronidazole [OABM] regimen and 31 patients who had failed 10-day treatment with omeprazole, amoxicillin, bismuth subcitrate, and furazolidone [OAMF] regimen entered the study. They all received omeprazole [20 mg], amoxicillin [1 gr], bismuth subcitrate [240 mg] and clarithromycin [500 mg] twice a day for 10 days. Eight weeks after treatment, H. pylori eradication was assessed by 14C-urea breath test

Results: Totally 61 patients completed the study. According to intention to treat [ITT] analysis, eradication rates by second-line OABC regimen were 84.37% [95% CI= 71.7-96.9%] in OABM group and 77.41% [95% CI= 62.71-92.11%] in OABF group [p=0.756]. Per-protocol [pp] eradication rates were 87.09% [95% CI= 75.2-98.8%] and 82.75% [95% CI= 79.4-96%], respectively [p=0.638]. Also the cumulative eradication rates by OABC regimen were 80.9% [95% CI= 71.2-90.6%] and 85% [95% CI= 75.9-94%] according to ITT and PP analyses, respectively. Severe side effects were reported in 3.1% of the patients

Conclusion: Regarding ideal eradication rate [>80%] and very low adverse effects, it seems that clarithromycin-containing quadruple therapy can be an encouraging regimen after nitroimidazole-containing regimen failure

Large bowel obstruction after colonoscopy; a case report

Postpolypectomy bleeding and perforation are the major complications of colonoscopy. This report presents a rare case of colon obstruction immediately after colonoscopy. A 56-year-old man underwent colonoscopy because of 6 months lower abdominal pain. Colonoscopy revealed diverticulosis and multiple small sessile polyps in sigmoid colon. Biopsy samples were taken from the polyps and the procedure was continued up to cecum. Soon after the procedure, the patient complained of colicky abdominal pain accompanied by diaphoresis. In physical examination, the abdomen seemed distended and bowel sounds were high-pitched. There was no abdominal tenderness or guarding. Plain and upright abdominal radiography showed multiple colonic air-fluid levels. Immediately, the patient underwent second colonoscopy, but passage of scope through sigmoid colon [at the site of biopsies] was somewhat hard because of edema and spasm. The colonoscope proceeded gently up to cecum and decompressed the entire colon by suctioning the air that was entrapped in proximal parts. By second colonoscopy and further conservative treatments, the patient's condition improved without any surgical procedure and was discharged after 24 hours

Efficacy of clarithromycin containing bismuth-based regimen as a second-line therapy in helicobacter pylori eradication

The eradication of Helicobacter pylori infection, commonly prevailing in the stomach, has been important since its introduction. Adequate preparations should be made in finding alternatives when faced with first-line treatment failures. Currently, ideal second-line treatments are indistinct and varied among countries as result of different antibiotic resistance patterns. We aimed to evaluate the safety and efficacy of a clarithromycin-containing bismuth-based quadruple regimen as a second-line treatment. Forty-eight H.pylori-positive patients with proven gastric or duodenal ulcers and/or erosions who had previously failed to respond to furazolidone-containing regimens were enrolled. They received pantoprazole [40 mg-bid], amoxicillin [1gr-bid], bismuth subcitrate [240 mg-bid], and clarithromycin [500mg-bid] for 10 days. Eight weeks after treatment, a 14C-urea breath test was performed for the re-evaluation of H. pylori eradication. Forty-three patients completed the study. H.pylori eradication rates were 79.2% [95% CI=65.00-89.53] and 88.4% [95% CI=74.91-96.11] according to intention-to-treat and per-protocol analyses, respectively. All patients had excellent compliance to treatment and one did not continue therapy because of adverse effects. In developing countries such as Iran, a ten-day clarithromycin-containing bismuth-based quadruple regimen is encouraged as a second-line treatment because of the acceptable rate of eradication and low adverse effects

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

incidence and outcome of pregnancy-related biliary sludge/stones and potential risk factors

Diseases of the gall bladder have been reported to be the most common cause for non-obstetrical hospitalizations during the first year postpartum. Therefore we designed a prospective study to evaluate the incidence and natural outcome of pregnancy-related biliary sludge and stones, and to define the potential risk factors in a population of pregnant women in Sari, Iran. A total of 380 pregnant women were scheduled for three ultrasound assessments: 1] during the first trimester of pregnancy [9 - 12 weeks], 2] during the early third trimester [26 - 32 weeks], and 3] during the fourth to sixth weeks postpartum. The incidence of biliary sludge, new stones and progression from sludge to stones in addition to the probable risk factors were analyzed with the t-test and chi-square test as appropriate [SPSS software, version 15]. According to the first ultrasonography, 14 [3.7%] participants had evidence of biliary sludge and 3 [0.7%] had gallstones. Among those with normal baseline ultrasound findings, 28 [7.7%] developed biliary sludge and 7 [1.9%] formed stones by their second ultrasound examination [P < 0.05]. Among the 14 participants with biliary sludge in their first ultrasound assessment, 1 [7.1%] developed gall stone and sludge remained in the other 13 as seen on the third trimester ultrasound results. According to the third ultrasound [performed postpartum], out of 41 participants with prior biliary sludge, 16 [39%] had no evidence of sludge, 22 [53.7%] had persistent sludge, and 3 [7.3%] developed stones. Out of 11 participants with prior gallstones, 1 had a normal ultrasound postpartum, but stones persisted in the other 10 [P < 0.05]. In those with stones, 9.1% underwent cholecystectomies postpartum. The incidence of sludge and stones significantly correlated with the number of pregnancies and higher age at pregnancy. Since the annual rate of pregnancy is high in Iran, pregnancy-related biliary disorders are important in this country. According to our results, the number of parities and age at pregnancy are potentially modifiable risk factors for lowering pregnancy-related biliary disorders

Familial aspects of colorectal cancers in southern littoral of Caspian sea

About 50,000 new cancer cases occur annually in Iran, of which gastrointestinal [GI] cancers are the most common Colorectal cancers [CRC] account for the third and fourth most prevalent cancers amongst Iranian men and women, respectively. Since CRC has some well-known hereditary forms with differences in their prevalence according to regional heterogeneity, we designed a study to assess familial aspects of this cancer in subjects who reside in Mazandaran Province, Iran. We interviewed all CRC patients who attended a private GI clinic during 1999-2007, with histologically confirmed diagnoses of colorectal adenocarcinoma, about their family histories of CRC and age at diagnosis. Pedigrees were drawn up to second-degree relatives. A total of 293 CRC cases were enrolled in the study, of which 152 were male and 141 were female. The mean age of patients was 52.6 +/- 15.2 years. Of these, 98 patients [33.5%] were under the age of 45. A total of 66 cases [22.5%] had familial histories of CRC, being significantly more prevalent in younger subjects [11.2% vs. 44.9%, P<0.0001]. Thirty-two patients [10.9%] fulfilled the criteria for hereditary non-polyposis colon cancer. In addition, right-sided colon cancers were more prevalent in those with positive familial histories [P<0.05]. Due to the frequency of early-onset CRC and familial syndromes, a more intense screening protocol for early detection of CRC should be developed for this population

[Acute pancreatitis in severe leptospirosis infection]

Leptospirosis is a Zoonotic disease that rarely manifests in a severe manner, [Weil's syndrome]. Regarding epidemiology of this disease, in some rural areas of Mazandaran Province we encountered a rare case of acute pancreatitis during progression of severe Leptosprosis is presented herein. Patient is a 50 year old male farmer who was admitted to the hospital due to experiencing 10 days of fever, myalgia, vomiting, jaundice and abdominal pain. He underwent haemo-dialysis due to acute renal failure only once. Direct bilirubin was 31.7 mg/dl with serum amylase, while lipase was three times more than normal levels. The CT-Scan demonstrated diffuse pancreatic enlargement. The IgM titer fourfold which was more than normal level against leptospirosis [ELISA] confirmed the diagnosis. Patient was cured completely through supportive care and antibiotic therapy, thus, this case was reported in drawing attention to Leptospira infections, which should be considered in the differential diagnosis of patients with jaundice and pancreatitis

[ epidemiologic and clinical-pathologic characteristics of coloretal cancers from 1999 to 2007 in Sari, Iran]

Each year, about 50,000 new cases of cancer occur in Iran and the most common being the gastrointestinal [GI] tract [38%]. Colorectal cancers account for the 3[rd] and 4[th] most prevalent cancers in Iranian men and women, respectively. Since genetic and environmental factors lead to differences in colorectal cancer occurrence in different geographic regions and races, we designed a study to assess characteristics of this cancer, in the Guilak race of Mazandaranian people. The records of all colorectal cancer patients who were referred to in a private GI clinic or admitted in hospitals and were studied during 1999 to 2007. Data was analyzed using SPSS software, Chi- Square and T-Tests. 296 cases of colorectal cancers [CRCs] were enrolled in the study. There were 2 cases of colon lymphoma and 1 case of cervical cancer with metastasis to colon. The remaining 293 patients had colorectal Aden carcinoma, of which 152 were males and 141 were females. The mean age of patients was 52.6 +/- 15.2 years. 98 patients [33.5%] were under 45 years of age. A total of 70 cases [24%] had familial history of CRC. Moreover, 47% of patients under 45 years had positive familial history for CRC, of whom 43 patients [14.6%] were classified as having Hereditary Non- Polyposis Colorectal Cancer [HNPCC]. 125 patients had rectal, while 168 cases had colon cancers. Right- sided colon cancers were 2 times more prevalent than the left- sided involvements. In addition, right- sided colon cancers were relatively more prevalent in those with positive familial history of CRC. Importantly, about half of all patients showed advanced stages of the disease [Lymph node involvement or distal metastases] at the time of diagnosis. Regarding the younger age of involvement, the significant positive familial history, the more prevalent proximal colon cancers and advanced stages of the disease at the time of diagnosis, we recommend to design screening programs for earlier detection of CRCS in this geographic region