Is There a Real Relationship between the Presence of Helicobacter pylori in Dental Plaque and Gastric Infection? A Genotyping and Restriction Fragment Length Polymorphism Study on Patient Specimens with Dyspepsia in Southwest Iran.

Background: The oral cavity can act as an extra gastric reservoir for H. pylori, and the presence of the bacteria in the oral cavity is associated with a higher risk of dental caries development. This study aimed to determine the genotype and evaluate the association between the presence of H. pylori in dental plaque and gastric biopsy specimens in dyspeptic patients in Ahvaz, Southwest Iran. Methods: In this study, 106 patients with recruited dyspeptic complaints were selected, and from each patient, two gastric antral biopsy specimens and two dental plagues were examined. The presence of H. pylori was identified by the rapid urease test (RUT) and the amplification of ureAB and 16S rRNA genes. Also, to verify a hypothetical mouth-to-stomach infection route, the enzymatic digestions of three genes of cagA, vacA, and ureAB in H. pylori strains isolated from dental plaques and stomach samples were compared for each same case. Results: H. pylori was found in the stomach of 52.8% (56/106) and the dental plaques of 17.9% (19/106) of the studied cases. On the other hand, H. pylori was recognized in the stomach of all 19 cases with oral colonization. Following a combination of restriction fragment lengths 21 polymorphism (RFLP) patterns of these three known genes on stomach and dental plague samples, 14 and 11 unique patterns were seen, respectively. However, for all H. pylori-positive cases (19), the comparison of RLFP patterns of these genes in dental plaque and gastric biopsy specimens was different for the same case. Conclusions: In this study, it seems that there is no significant association between the presence of H. pylori in dental plaque and the stomach of the same case.

Levofloxacin+Tetracycline Quadruple Regimen for Eradication of Helicobacter pylori: A Multicenter Multinational Randomized Controlled Trial.

Background: The ideal combination regimen for Helicobacter pylori (HP) eradication has not yet been determined and the success rate of HP eradication has been extensively reduced worldwide due to increasing antibiotic resistance. So this multinational multi-center randomized controlled trial was designed to evaluate the efficacy of tetracycline +levofloxacin for HP eradication. Methods: During a 6-month period, all of the cases with HP infection in eight referral tertiary centers of three countries were included and randomly allocated to receive either tetracycline + levofloxacin or clarithromycin plus amoxicillin quadruple regimen for two weeks. For all of the participants, pantoprazole was continued for 4 more weeks and after one to two weeks of off-therapy, they underwent urea breath test C13 to prove eradication. Results: Overall 788 patients were included (358 male (45.4%), average age 44.2 years). They were diagnosed as having non-ulcer dyspepsia (516 cases, 65.5%), peptic ulcer disease (PUD) (234 cases, 29.69%), and intestinal metaplasia (38 cases, 4.8%). Racially 63.1% were Caucasian, 14.5% Arab, 15.6% African, and 6.1% Asian. The participants were randomly allocated to groups A and B to receive either tetracycline + levofloxacin or clarithromycin. Among groups A and B in intention to treat (ITT) and per protocol (PP) analysis, 75.2% & 82.1% (285 cases) and 67.5% & 70.1% (276 cases) of participants achieved eradication, respectively (P = 0.0001). The complete compliance rate in groups A and B were 84.4% and 83.6%, respectively. During the study, 33.5% of the participants in group A (127 cases) reported side effects while the complication rate among group B was 27.9% (114 cases, P = 0.041). The most common complaints among groups A and B were nausea and vomiting (12.6% & 9.3%) and abdominal pain (4.48% & 2.68%), respectively. The rate of severe complications that caused discontinuation of medication in groups A and B were 2.1% and 1.46%, respectively (P = 679). In subgroup analysis, the eradication rates of tetracycline+levofloxacin among patients with non-ulcer dyspepsia, PUD, and intestinal metaplasia were 79.4%, 88.1%, and 73.9%, respectively. These figures in group B (clarithromycin base) were 71.3%, 67.6%, and 61.5% respectively (P = 0.0001, 0.0001, and 0.043). Conclusion: Overall, the combination of tetracycline+levofloxacin is more efficient for HP eradication in comparison with clarithromycin+amoxicillin despite more complication rate. In areas with a high rate of resistance to clarithromycin, this therapeutic regimen could be an ideal choice for HP eradication, especially among those who were diagnosed with PUD.

Effect of Helicobacter pylori eradication on metabolic profile: an international, multicenter, case-control study.

BACKGROUND: As a gram-negative and microaerophilic bacterium, Helicobacter pylori (HP) is the main cause of chronic gastritis. Therefore, considering the high prevalence of HP infection worldwide, as well as the increasing prevalence of metabolic disorders, the present study aimed to investigate the relationship between HP infection eradication and metabolic profile. METHODS: This prospective case-control study was performed on patients with HP infection whom referred to 7 medical centers in 3 countries (Iran, Egypt, and Vietnam) in 2020-2021. The metabolic profile of all of the participants evaluated before starting of treatment for HP eradication and 3 months after the treatment. Then changes of metabolic profile compared between those with successful HP eradication (group A) and subjects who failed to eradicate (group B). RESULTS: Overall, 199 patients, including 93 male (46.7%) with the mean age of 44.5 years (18-93 years) included. Based on response to treatment, the participants allocate into group A (those who respond to HP eradication): 164 cases (82.42%); or group B as those who failed to achieve eradication (35 cases, 17.58%). Racially 86.9% of participants were Caucasian and 89% diagnosed as non-ulcer dyspepsia (NUD). The most prevalent comorbidity include hypertension (11.5%) and hyperlipidemia (10%) which were more prevalent in group B (P = 0.002). Three months after therapy, average weight of participants among those who achieved eradication (group A) decreased from 73.1 to 71.4 kg (P = 0.01), but in comparison with group B, was non-significant (P = 0.171). The BMI of patients before and after treatment did not show any significant differences. The biochemical parameters of patients before and after treatment were not significantly different regardless of treatment success (P > 0.05). The levels of total cholesterol and VLDL cholesterol after treatment were not significantly different from baseline values in two groups. HDL and LDL cholesterol levels before and after treatment in the resistant group were significantly higher than the responding group. Average serum TG level decreased significantly after treatment in the group A (P < 0.0001), in contrast to the resistant group (P = 0.356). The liver transaminases (AST and ALT) before and after treatment were not significantly different between the two groups (P > 0.05). The results of logistic regression showed that the eradication of infection has no significant affect any of the metabolic profile parameters. CONCLUSION: HP infection treatment in individuals without significant metabolic disorders does not affect metabolic parameters up to 3 months after eradication. HP eradication among subjects with several comorbidities mandates eradication protocol intensification to avoid treatment failure.

Liver stiffness and liver function index in liver fibrosis patients afflicted with electrocardiographic abnormalities.

Introduction: Heart disorders are one of the causes of death in cirrhotic patients. Objectives: This study aimed to investigate liver stiffness and liver function indices in liver fibrosis patients afflicted with electrocardiographic abnormalities. Patients and Methods: wo hundred patients entered this cross-sectional study. First, all of the patients underwent liver elastography. They were then divided into four groups based on the results obtained. Patients in three of the total groups (I-III) had fibrosis and those in the fourth group (IV) had cirrhosis. Afterward, electrocardiograms were taken from the patients, and based on the existence of electrocardiographic abnormalities, the patients were divided into two groups (group 1, consisting of liver fibrosis patients with a heart disease and group 2, consisting of those without a heart disease). Finally, liver function index, liver stiffness, frequency of variables, and their relationship with the presence or absence of electrocardiographic (ECG) abnormalities were analyzed. Results: Forty-eight percent of the patients were afflicted with ECG abnormalities. The majority of the patients in each of the two groups were male. The differences between patients with and without electrocardiographic abnormalities as regards to liver stiffness, liver function index, and platelet count were found to be statistically significant (P < 0.05). However, the differences between the two groups with regard to serum transaminase levels did not appear to be statistically significant (P > 0.05). Conclusion: It seems that liver stiffness and liver function index are non-invasive factors for predicting the presence of accompanying heart disorders in patients suffering from liver fibrosis.

Association between high-sensitivity-CRP and liver elastography and cardiac ischemic diseases in patients with fatty liver.

Objective: Inflammatory markers are among the possible contributing factors with a proposed role in hepatic and ischemic heart disease. The present study aimed to determine the association between high-sensitivity-C-reactive protein (hs-CRP), liver elastography, and cardiac ischemic diseases in patients with fatty liver. Methods: In this cross-sectional comparative study, 103 consecutive patients with fatty liver were enrolled to undergo angiography. They were divided into groups with and without cardiac ischemia. Results: The results demonstrated that the mean hs-CRP was 2.3 and 10.9 mg/L in normal and ischemic angiography groups, respectively (P = 0.001). According to the receiver operating characteristic (ROC) analysis, the predictive role for hs-CRP was 94.5% that had sensitivity and specificity of 95.2% and 90%, respectively, with a cut-off point of 3.1. Conclusion: This study showed that there is an association between the fatty liver, cardiac ischemia, and hs-CRP level.

Cisteína oral N-Acetyl versus indometacina retal para prevenção de pancreatite pós-CPRE: um ensaio controlado randomizado multinacional multicêntrico / Oral n-acetyl cysteine versus rectal indomethacin for prevention of post ercp pancreatitis: a multicenter multinational randomized controlled trial

ABSTRACT Background This multicenter multinational RCT designed to compare the efficacy of suppository indomethacin and NAC for prevention of PEP. Methods: During a 6-month period, all of the ERCP cases in seven referral centers were randomly assigned to receive either 1200 mg oral NAC, indomethacin suppository 100 mg, 1200 mg oral NAC plus indomethacin suppository 100 mg or placebo 2 hours before ERCP. The primary outcomes were the rate and severity of any PEP. Results: A total of 432 patients included (41.4% male). They were originally citizens of 6 countries (60.87% Caucasian). They were randomly allocated to receive either NAC (group A, 84 cases), rectal indomethacin (group B, 138 cases), NAC + rectal indomethacin (group C, 115 cases) or placebo (group D, 95 cases). The rate of PEP in groups A, B and C in comparison with placebo were 10.7%, 17.4%, 7.8% vs 20% (P=0.08, 0.614 & 0.01 respectively). The NNT for NAC, indomethacin and NAC + indomethacin was 11, 38 and 8 respectively. Conclusion: Oral NAC is more effective than rectal indomethacin when compared to placebo for prevention of PEP and the combination of NAC and Indomethacin had the lowest incidence of PEP and may have synergistic effect in preventing of PEP (IRCT20201222049798N1; 29/12/2020).

RESUMO Contexto: Este estudo randomizado, controlado multicêntrico e multinacional foi projetado para comparar a eficácia da indometacina supositório e N-acetil cisteína (NAC) para prevenção de pancreatite pós colangiografia endoscópica. Métodos: Durante um período de 6 meses, todos os pacientes submetidos à CPRE em sete centros de referência foram aleatoriamente atribuídos para receber 1200 mg de NAC oral, supositório de indometacina 100 mg, 1200 mg de NAC oral mais supositório de indometacina 100 mg ou placebo 2 horas antes do procedimento. Os resultados primários foram a taxa e a gravidade de qualquer pancreatite pós procedimento (PPP). Resultados: Um total de 432 pacientes foram incluídos (41,4% do sexo masculino). Eram originalmente cidadãos de seis países (60,87% caucasianos). Foram alocados aleatoriamente para receber NAC (grupo A, 84 casos), indometacina retal (grupo B, 138 casos), NAC + indometacina retal (grupo C, 115 casos) ou placebo (grupo D, 95 casos). A taxa de PPP nos grupos A, B e C em comparação com o placebo foi de 10,7%, 17,4%, 7,8% vs 20% (P=0,08, 0,614 e 0,01, respectivamente). Conclusão A NAC oral é mais eficaz do que a indometacina retal quando comparado ao placebo para prevenção de PPP e a combinação de NAC e indometacina teve a menor incidência de PPP e pode ter efeito sinérgico na sua prevenção de PPP. (IRCT20201222049798N1; 29/12/2020).

ORAL N-ACETYL CYSTEINE VERSUS RECTAL INDOMETHACIN FOR PREVENTION OF POST ERCP PANCREATITIS: A MULTICENTER MULTINATIONAL RANDOMIZED CONTROLLED TRIAL.

BACKGROUND: This multicenter multinational RCT designed to compare the efficacy of suppository indomethacin and NAC for prevention of PEP. METHODS: During a 6-month period, all of the ERCP cases in seven referral centers were randomly assigned to receive either 1200 mg oral NAC, indomethacin suppository 100 mg, 1200 mg oral NAC plus indomethacin suppository 100 mg or placebo 2 hours before ERCP. The primary outcomes were the rate and severity of any PEP. RESULTS: A total of 432 patients included (41.4% male). They were originally citizens of 6 countries (60.87% Caucasian). They were randomly allocated to receive either NAC (group A, 84 cases), rectal indomethacin (group B, 138 cases), NAC + rectal indomethacin (group C, 115 cases) or placebo (group D, 95 cases). The rate of PEP in groups A, B and C in comparison with placebo were 10.7%, 17.4%, 7.8% vs 20% (P=0.08, 0.614 & 0.01 respectively). The NNT for NAC, indomethacin and NAC + indomethacin was 11, 38 and 8 respectively. CONCLUSION: Oral NAC is more effective than rectal indomethacin when compared to placebo for prevention of PEP and the combination of NAC and Indomethacin had the lowest incidence of PEP and may have synergistic effect in preventing of PEP (IRCT20201222049798N1; 29/12/2020).

IS DAIRY FOODS RESTRICTION MANDATORY FOR INFLAMMATORY BOWEL DISEASE PATIENTS: A MULTINATIONAL CROSS-SECTIONAL STUDY.

BACKGROUND: The role of dairy foods in inflammatory bowel disease (IBD) has been controversial and it is debatable if patients with IBD should avoid milk and dairy products or not, as well as the relationship between these foods and symptoms among those population. OBJECTIVE: This multi centric cross-sectional study designed to evaluate if it is really necessary to deprive IBD patients from consumption of dairy foods. METHODS: A multicenter study with 12 gastroenterology referral centers in four countries was designed to evaluate gastrointestinal (GI) symptoms after consumption of dairy foods from all outpatients with IBD during 6 months and to compare patients treated at the same centers without IBD (non IBD cases). RESULTS: Overall 1888 cases included (872 IBD patients and 1016 non IBD cases). 56.6% of participants were female with average age of 40.1 years. Racially 79.8% participants were Caucasians and originally they were citizens of 10 countries. Relative prevalence of IBD was higher in Africans and Indians and the most frequent prevalence of dairy foods intolerance was seen in Asians. Among IBD patients, 571 cases diagnosed as ulcerative colitis and 189 participants as Crohn's disease. Average duration of diagnosis as IBD was 6.8 years (from 2 months to 35 years). The most prevalent GI symptoms after consumption of all the dairy foods were bloating and abdominal pain. Totally, intolerance of dairy foods and lactase deficiency was more prevalent among IBD patients in comparison with non IBD cases (65.5% vs 46.1%, P=0.0001). But the rate of GI complains among IBD patients who had not any family history of lactase deficiency, history of food sensitivity or both were 59.91%, 52.87% & 50.33% respectively and similar to non IBD cases (P=0.68, 0.98 & 0.99 respectively). CONCLUSION: The rate of dairy foods intolerance among IBD patients without family history of lactase deficiency or history of food sensitivity is similar to non IBD cases and probably there is no reason to deprive them from this important source of dietary calcium, vitamin D and other nutrients.

A restrição de alimentos lácteos é obrigatória para pacientes com doença inflamatória intestinal? Estudo transversal multinacional / Is dairy foods restriction mandatory for inflammatory bowel disease patients: a multinational cross-sectional study

ABSTRACT Background: The role of dairy foods in inflammatory bowel disease (IBD) has been controversial and it is debatable if patients with IBD should avoid milk and dairy products or not, as well as the relationship between these foods and symptoms among those population. Objective: This multi centric cross-sectional study designed to evaluate if it is really necessary to deprive IBD patients from consumption of dairy foods. Methods: A multicenter study with 12 gastroenterology referral centers in four countries was designed to evaluate gastrointestinal (GI) symptoms after consumption of dairy foods from all outpatients with IBD during 6 months and to compare patients treated at the same centers without IBD (non IBD cases). Results: Overall 1888 cases included (872 IBD patients and 1016 non IBD cases). 56.6% of participants were female with average age of 40.1 years. Racially 79.8% participants were Caucasians and originally they were citizens of 10 countries. Relative prevalence of IBD was higher in Africans and Indians and the most frequent prevalence of dairy foods intolerance was seen in Asians. Among IBD patients, 571 cases diagnosed as ulcerative colitis and 189 participants as Crohn's disease. Average duration of diagnosis as IBD was 6.8 years (from 2 months to 35 years). The most prevalent GI symptoms after consumption of all the dairy foods were bloating and abdominal pain. Totally, intolerance of dairy foods and lactase deficiency was more prevalent among IBD patients in comparison with non IBD cases (65.5% vs 46.1%, P=0.0001). But the rate of GI complains among IBD patients who had not any family history of lactase deficiency, history of food sensitivity or both were 59.91%, 52.87% & 50.33% respectively and similar to non IBD cases (P=0.68, 0.98 & 0.99 respectively). Conclusion: The rate of dairy foods intolerance among IBD patients without family history of lactase deficiency or history of food sensitivity is similar to non IBD cases and probably there is no reason to deprive them from this important source of dietary calcium, vitamin D and other nutrients.

RESUMO Contexto: O papel dos alimentos lácteos na doença inflamatória intestinal (DII) tem sido controverso e é discutível se os pacientes com DII devem ou não evitar leite e laticínios, bem como a relação entre esses alimentos e sintomas nesta população. Objetivo: Estudo transversal multicêntrico foi projetado para avaliar se é realmente necessário privar os pacientes com DII do consumo desta classe de alimentos. Métodos: Um estudo multicêntrico com 12 centros de referência em gastroenterologia de quatro países foi projetado para avaliar sintomas gastrointestinais após o consumo de alimentos lácteos em todos os ambulatórios de DII durante seis meses e comparar pacientes tratados nos mesmos centros sem DII. Resultados: No total, foram incluídos 1888 casos (872 pacientes com DII e 1016 casos sem DII. 56,6% dos participantes eram do sexo feminino com idade média de 40,1 anos. 79,8% dos participantes eram caucasianos e originalmente eram cidadãos de 10 países. A prevalência relativa de DII foi maior em africanos e indianos e a prevalência mais frequente de intolerância a alimentos lácteos observada nos asiáticos. Entre os pacientes com DII, 571 casos foram diagnosticados como colite ulcerativa e 189 participantes como doença de Crohn. A duração média do diagnóstico como DII foi de 6,8 anos (de 2 meses a 35 anos). Os sintomas de gastrointestinais mais prevalentes após o consumo de todos os alimentos lácteos foram inchaço e dor abdominal. No total, a intolerância aos alimentos lácteos e a deficiência de lactase foi mais prevalente entre os pacientes com DII em comparação com os casos sem DII (65,5% vs 46,1%, P=0,0001). A taxa de queixas gastrointestinais entre os pacientes com DII que não tinham histórico familiar de deficiência de lactase, histórico de sensibilidade alimentar ou ambos foram de 59,91%, 52,87% e 50,33% respectivamente e semelhantes aos casos sem DII (P=0,68, 0,98 e 0,99, respectivamente). Conclusão: A taxa de intolerância de alimentos lácteos entre pacientes com DII sem histórico familiar de deficiência de lactase ou histórico de sensibilidade alimentar é semelhante aos casos sem DII e provavelmente não há razão para privá-los dessa importante fonte de cálcio dietético, vitamina D e outros nutrientes.

Loop mediated isothermal amplification of Clostridioides difficile isolates in gastrointestinal patients.

This study investigated the prevalence of Clostridioides difficile by culture, multiplex polymerase chain reaction (M-PCR), and loop mediated isothermal amplification (LAMP) in patients with suspected C. difficile infections (CDIs). Also, the results of three methods were compared. All stool specimens collected from CDI suspected patients were cultured on selective C. difficile cycloserine-cefoxitin fructose agar and incubated in an anaerobic jar up to 7 days. The bacterial isolates were identified using standard tests. Multiplex-PCR (M-PCR) was performed for detection of tcdA, tcdB, and tpi genes. The LAMP assay was performed to detect the tcdB gene of C. difficile. C. difficile was isolated from 20.0% (n = 10/50) of samples by culture. M-PCR showed that 34.0% (n = 17/50) of the specimens were positive for C. difficile based on the presence of tpi gene. Out of the 17 C. difficile, 13 strains (76.0%) were positive for tcdB gene using M-PCR. However, the LAMP assay showed that 30.0% (15/50) of specimens were positive for the presence of tcdB gene. M-PCR and LAMP methods showed 100.0% sensitivity compared to the culture method. However, the specificity of the LAMP (87.5%) was relatively higher than the M-PCR (82.5%) compared to the culture. Based on the results of this study, the prevalence of toxigenic C. difficile strains was high in suspected CDI patients. So, the differentiation between toxigenic and non-toxigenic strains is necessary. Our data showed that the LAMP assay is a good method for direct detection of toxigenic C. difficile strains from stool specimens.

Irritable Bowel Syndrome Demographics: A Middle Eastern Multinational Cross-sectional Study.

BACKGROUND: Irritable bowel syndrome (IBS) is the most frequent functional gastrointestinal (GI) disorder. In this study, we aimed to evaluate the different aspects of IBS among Middle Eastern residents. METHODS: During the study period, patients attending gastroenterology clinics of nine tertiary referral centers in four Middle Eastern couturiers (Iran, Egypt, Kuwait, and Turkey) were evaluated by Rome IV diagnostic criteria, and those who fulfilled the diagnostic criteria of IBS were asked to fill in a questionnaire covering different demographics and clinical aspects. RESULTS: Overall, during a 6-month period, 509 patients with IBS were included. 41.3% of the participants were male (210 patients), and 37.4% of them had academic education. 50% of the participants were Caucasian, and 34% were Arab, and originally, they were citizens of 18 countries. 77.4% of the participants were residents of subtropical areas, while 22.2% were living in temperate regions. The average age of the participants during the first presentation in subtropical and temperate areas were 38.4 ± 12.19 and 38.06 ± 12.18 years, respectively (P = 0.726). The most common subtypes of IBS in subtropical areas were unclassified (IBS-U, 44.4%), constipation dominant (IBS-C, 27.6%), mixed pattern (IBS-M, 21%), and diarrhea dominant (IBS-D, 6.8%) in descending order while in temperate areas the most common subtypes were IBS-U (43.3%), and IBS-D (22.1%), respectively (P < 0.001). Besides abdominal pain, the most common symptom of patients in each region was bloating (62.2% and 68.1%, respectively, P = 0.246). The rate of depression and anxiety were significantly higher among the residents of temperate areas in comparison with subtropical regions (41.6% vs. 16.5% and 80.5% vs. 58.4%, respectively, P < 0.001). CONCLUSION: Although the average age of IBS presentation is the same in subtropical and temperate areas, it seems that in temperate areas, the rate of IBS-D is more prevalent than in subtropical regions. The rate of anxiety and depression are significantly higher among those who searched social media and the internet to get information about their problems.

Eradication efficacy of high-dose amoxicillin and proton pump inhibitor compared with quadruple therapy contained bismuth in the treatment of Helicobacter pylori.

Background: Helicobacter pylorus is one of the most common bacterial infections affecting the world's population. Peptic ulcer disease is caused by H. pylori and the use of nonsteroidal anti-inflammatory drugs. The aim of this study was to assessment of two antibiotic regimens in the treatment of H. pylori. Methods: A total of 220 H. pylori infected patients were enrolled in the randomized clinical trial that referred to Imam Khomeini Hospital gasterointestinal clinic, Ahvaz. Patients were allocated into two groups randomly. Group 1 received the 14-day proton pump inhibitor (PPI) amoxicillin-containing high-dose therapy and group II received the bismuth-containing quadruple therapy. Basic characteristics, adverse events, and eradication rates were compared between two groups. Results: The PPI-amoxicillin-containing high-dose therapy group achieved eradication rates of 73.6% and 72.4% as determined by the intention-to-treat and per-protocol analyses, respectively (P > 0.05). The eradication rates at bismuth-containing quadruple therapy group were 77.2% and 76.1%, respectively, (P > 0.05). Also, there were no significant differences in the compliance rates and adverse effects between two groups (P > 0.05). Furthermore, the cost of medications in the PPI-amoxicillin-containing high-dose therapy was significantly lower compared with that in the quadruple therapy contained bismuth. Conclusion: PPI-amoxicillin-containing high-dose treatment regimen can be used especially in the pregnancy and lactating patient or low-economic patient because safer and less costly compared with bismuth-containing quadruple therapy.

Effect of Ginger Powder Supplementation in Patients with Non-Alcoholic Fatty Liver Disease: A Randomized Clinical Trial.

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is one of the most common chronic liver disorders. The main causes of NAFLD are associated with insulin resistance, severe lipid metabolism disorders, oxidative stress and inflammation. Previous studies have reported that ginger has positive metabolic results. AIM: The aim of this study was to determine the effect of ginger powder supplement on lipid profiles, insulin resistance, liver enzymes, inflammatory cytokines and antioxidant status in patients with NAFLD. METHODS: In this randomized clinical trial, 46 people with NAFLD were parted into two groups and subjected to the ginger or placebo capsules (3 capsules daily, each containing 500 mg of ginger or wheat flour) over 12 weeks. All patients received a diet with balanced energy and physical activity during the intervention period. Liver ultrasonography, anthropometric indices and biochemical parameters were measured before and after intervention. RESULTS: No significant difference was found between the two groups in the baseline variables at the beginning of the study. At the end of the study, serum levels of alanine aminotransferase (ALT), total cholesterol, low-density lipoprotein (LDL-C), fasting blood glucose, and insulin resistance index (HOMA), C-reactive protein (hs-CRP), and fetuin-A in the group receiving a ginger supplement significantly decreased compared to placebo. However, there was no significant difference between the two groups in body weight, fasting insulin, HDL-C, triglyceride, adiponectin, alpha-tumor necrosis factor (TNF-α), total antioxidant capacity (TAC), gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST), fatty liver index (FLI), fatty liver grade and blood pressure. CONCLUSION: The ginger supplement may be used as a complementary therapy along with existing therapies to reduce insulin resistance, liver enzymes and inflammation in patients with non-alcoholic fatty liver.

Comparison between gluten-free regime and regime with gluten in symptoms of patients with irritable bowel syndrome (IBS).

BACKGROUND AND OBJECTIVE: Irritable bowel syndrome (IBS) is the most common gastrointestinal disorder and accounts for most of the referrals of patients to gastroenterologists. Given the high prevalence of this syndrome and its significant effect on the reduced quality of life of patients, the present study aimed to investigate the effect of using gluten-containing or gluten-free diet on symptoms of patients with irritable bowel syndrome. MATERIALS AND METHODS: In this trial, 140 patients with irritable bowel syndrome who referred to Imam Khomeini Hospital (2006) were randomly divided into two groups based on Rome III criteria. Seventy patients received a gluten-free diet and rest patent received a regular diet as control group for 12 weeks. In order to compare the quantitative characteristics, independent samples T-test was used, while Mann-Whitney and Z-tests were used to compare the qualitative characteristics. FINDINGS: There was no significant difference between the control group (9.8 ± 37 years) and the group with gluten-free diet (0.2 ± 37 years) in terms of mean age. The effect of gluten-free diet on intestinal gas, fecal consistency, urgent need for expulsion, and insufficient defecation were higher than in control group. Although abdominal pain and reduced frequency of bowel movements were higher in the control group than gluten-free diet group (P < 0.05). The positive response to general improvement in the gluten-free group and in the control group was 67% and 52%, respectively. CONCLUSION: According to present results, providing gluten-free diet could be improved patient treatment's symptoms. Also, it seemed that the duration of treatment can lead to better therapeutic outcomes.

The effect of nutritional education and continuous monitoring on clinical symptoms, knowledge, and quality of life in patients with cirrhosis.

AIM: In this study, we aimed to evaluate the effectiveness of an educational intervention in patients with liver cirrhosis. BACKGROUND: Liver cirrhosis is end stage of liver diseases with many complications that affects quality of life and nutritional status in cirrhotic patients. Today, educational intervention and nutritional counseling is a key factor for preventing disease process and improving quality of life in patients with chronic diseases. METHODS: This quasi-experimental, non-randomized, pre and post intervention were conducted as a pilot study on cirrhotic patients. Educational intervention and nutritional counseling were performed in clinical visits and via guide booklet. Chronic liver disease questionnaire (CLDQ) and knowledge questionnaire were used to assess patients' quality of life and knowledge. Blood samples were taken before and after intervention for assessment of laboratory outcomes. RESULTS: One hundred and seven patients referred to Research Center for enrolling in the trial. Twenty-eight did not meet inclusion criteria and seven patients were excluded from the study for lack of proper follow-up. Final analyses were done on 72 patients. Quality of life and knowledge of cirrhotic patients improved significantly after educational intervention (P < 0.0001). Biochemical characteristics were not changed significantly. Ascites and edema were improved significantly (P = 0.005 and P = 0.002, respectively). There was significant difference before and after intervention in the days of hospitalization (P = 0.001). CONCLUSION: We concluded a simple educational intervention and continuous monitoring for 6 months can affect clinical outcomes, quality of life, hospital admissions days, and knowledge of patients with cirrhosis.

Comparison of the effects and side-effects of sedation with propofol versus midazolam plus pethidine in patients undergoing endoscopy in Imam Khomeini Hospital, Ahvaz.

INTRODUCTION: Gastrointestinal endoscopy is an invasive and diagnostic procedure that causes the patients considerable pain, discomfort, and anxiety. Therefore, various types of sedation and analgesia techniques have been used during the procedure. AIM: To compare the effects and side-effects of sedation with propofol versus midazolam plus pethidine in patients undergoing endoscopy. MATERIAL AND METHODS: This is a randomised controlled double-blind clinical trial study conducted on 272 patients undergoing diagnostic and treatment endoscopy and colonoscopy in Imam Khomeini Hospital in Ahvaz between 2017 and 2018. The patients were randomly assigned to two groups. Patients in the first group (n = 136) received propofol with midazolam and ketamine, and the second group (n = 136) received pethidine and midazolam. Study outcome measures included the recovery time, patient satisfaction, quality of sedation, and adverse events. RESULTS: The occurrence of complications was higher in the propofol group (25% vs. 0%; p = 0.0001). No serious adverse events were observed in the study groups. Overall patient satisfaction and quality of sedation assessment scores in the propofol group were significantly better than those seen in the pethidine-midazolam group (p = 0.012 and p = 0.001, respectively). Recovery time was statistically shorter in the propofol-midazolam group (6.05 ±1.62 min) compared to the pethidine-midazolam group (6.72 ±2.21 min) (p = 0.006). CONCLUSIONS: Propofol-midazolam can provide better sedation, patient satisfaction, and recovery than pethidine-midazolam during endoscopy. Therefore, it can be recommended in patients scheduled for diagnostic and treatment endoscopy.

Vitamin D3 Induced Decrease in IL-17 and Malondialdehyde, and Increase in IL-10 and Total Antioxidant Capacity Levels in Patients with Irritable Bowel Syndrome.

BACKGROUND: Given the variations in clinical presentation and physiopathological mechanisms in irritable bowel syndrome (IBS) subtypes, it is an acknowledged fact that the response to treatments can be disparate. OBJECTIVE: To assess the effect of vitamin D on inflammatory cytokines (IL-17, IL-10, TNF-α), and biomarkers of oxidative stress (total antioxidant capacity (TAC), and malondialdehyde (MDA)) among IBS patients. METHODS: A double-blind, randomized, placebo-controlled 6-month intervention study was carried out on 90 IBS patients (85 were analyzed), as defined by the Rome III criteria. Study participants were randomly assigned to receive either 50,000 IU vitamin D3 or a placebo fortnightly. RESULTS: Vitamin D supplementation significantly reduced the IL-17 and MDA serum levels (P<0.05) and observably increased the TAC and IL-10 serum levels (P<0.05), compared with the placebo group. Comparing different bowel habit subtypes, we observed that it was only in diarrhea predominant IBS (IBS-D) that vitamin D supplementation was able to significantly reduce the serum levels of TNF-α and IL-17 (P<0.05). However, in all subtypes, IL-10 and TAC increased, while MDA decreased (P<0.05) in vitamin D group, compared to the placebo group. CONCLUSION: Vitamin D3 supplementation reduces the serum IL-17 and MDA levels, and augments the serum IL-10 and TAC levels in IBS patients, particularly in IBS-D subtype. Thus, the present study demonstrates the beneficial effects of vitamin D on patients with IBS-D.

Comparison of Levofloxacin-Based, 10-day Sequential Therapy with 14-day Quadruple Therapy for Helicobacter Pylori Eradication: A Randomized Clinical Trial.

BACKGROUND Considering the importance of Helicobacter pylori (H. pylori) eradication, this clinical trial was designed to prospectively evaluate the efficacy of levofloxacin-based, sequential therapy in comparison with quadruple therapy for eradicating H. pylori. METHODS Overall 156 patients with dyspepsia and H. pylori infection were included in this study and were randomly allocated to either 10-day sequential therapy group (group A) to receive pantoprazole (40 mg twice daily), amoxicillin (1 gr twice daily), levofloxacin (500 mg twice daily), and tinidazole (500 mg twice daily) (PALT) or 14-day quadruple therapy group (group B) to receive pantoprazole, clarithromycin, bismuth subcitrate, and amoxicillin (PABC). At the end of the study the eradication rate in each group was assessed by urea breath test (UBT). RESULTS Age range of the participants was 18-65 years (average 36.9 years) and 50% of them (78 patients) were men. 78 patients were allocated to group A and 78 patients to groupe B. After antibiotic therapy, all the patients received acid suppression therapy with Proton Pump Inhibitor (PPI) for 4 weeks and then the eradication rate was confirmed by UBT (Heli FAN plus 13C, Germany). Before performing UBT, all the participants were requested to halt consumption of PPI for at least 1 week. During the treatment there was not any major complication but in group A (sequential therapy), two patients complained of minor complications including musculoskeletal pain. None of the patients in group B had any complaint or side effect. The rate of H. pylori eradication in group A was 78.2% (61 patients) while this rate in group B was 83.3% (65 patients) with no significant difference between the two groups (p = 0.42). In subgroup analysis, the rate of eradication among men in group A and B were 76.9% and 89.7%, respectively (p = 0.22) while the eradication rate among women were 79.4% and 76.9%, respectively (p = 1.00). CONCLUSION It seems that levofloxacin base sequential therapy does not have any advantage in comparison with quadruple regimen and until finding any more effective short course therapy for H. Pylori eradication; we encourage quadruple regimen to be used as the first line therapy.

Evaluation of argon plasma coagulation in healing of a solitary rectal ulcer in comparison with conventional therapy: a randomised controlled trial.

INTRODUCTION: Argon plasma coagulation (APC) has been reported to be effective in the treatment of solitary rectal ulcer syndrome (SRUS). However, it has not appeared to be effective in healing ulcers. AIM: This study aimed at assessing the effectiveness of APC in controlling rectal ulcer-induced bleeding, and at examining the ultimate effect of this approach in healing these lesions. MATERIAL AND METHODS: This randomised, controlled trial was conducted on 99 patients with SRUS. Patients were randomly enrolled into two groups of APC therapy (intervention) and conventional therapy (control). The control group (n = 58) received a high-fibre diet, laxatives, behaviour therapy, and sucralfate enemas, and the intervention group (n = 41) were treated with APC plus conventional therapy; in fact they received directed and focused argon gas in addition to a high-fibre diet and laxatives. RESULTS: Responses to treatment in the control group and in the APC-receiving group were 29.3% and 75.6%, respectively. The continuation of ulcer healing after 3 months in the control group was 10.3%, and it was 70.7% in the APC-treated group. There was a significant statistical difference between the two groups (p < 0.004), i.e. bleeding was controlled more frequently in the group receiving APC plus conventional therapies than in the group receiving only the conventional therapies. However, the results showed no statistically significant difference between the two groups in terms of pain relief (p < 0.36). CONCLUSIONS: Argon plasma coagulation not only controlled bleeding in patients with SRUS, but also, in comparison with the conventional methods of treating SRUS, led to healing and continuation of healing of rectal ulcers.