Opioid Analgesics Do Not Improve Abdominal Pain or Quality of Life in Crohn's Disease.

BACKGROUND: Abdominal pain and opioid analgesic use are common in Crohn's disease (CD). AIMS: We sought to identify factors associated with abdominal pain in CD and evaluate the impact of opioid analgesics on pain and quality-of-life scores in this setting. METHODS: We performed a longitudinal cohort study using a prospective, consented IBD natural history registry from a single academic center between 2009 and 2013. Consecutive CD patients were followed for at least 1 year after an index visit. Data were abstracted regarding pain experience (from validated surveys), inflammatory activity (using endoscopic/histologic findings), laboratory studies, coexistent psychiatric disorders, medical therapy, opioid analgesic, and tobacco use. RESULTS: Of 542 CD patients (56.6% women), 232 (42.8%) described abdominal pain. Individuals with pain were more likely to undergo surgery and were more frequently prescribed analgesics and/or antidepressants/anxiolytics. Elevated ESR (OR 1.79; 95%CI 1.11-2.87), coexistent anxiety/depression (OR 1.87; 95%CI 1.13-3.09), smoking (OR 2.08; 95%CI 1.27-3.40), and opioid use (OR 2.46; 95%CI 1.33-4.57) were independently associated with abdominal pain. Eighty patients (14.8%) were prescribed opioids, while 31 began taking them at or after the index visit. Patients started on opioids demonstrated no improvement in abdominal pain or quality-of-life scores on follow-up compared to patients not taking opioids. CONCLUSIONS: Abdominal pain is common in CD and is associated with significant opioid analgesic utilization and increased incidence of anxiety/depression, smoking, and elevated inflammatory markers. Importantly, opioid use in CD was not associated with improvement in pain or quality-of-life scores. These findings reinforce the limitations of currently available analgesics in IBD and support exploration of alternative therapies.

A randomized single-blind trial of standard diet versus fiber-free diet with polyethylene glycol electrolyte solution for colonoscopy preparation.

BACKGROUND AND STUDY AIMS: Colonoscopy preparation usually involves the intake of large volumes of polyethylene glycol electrolyte solution (PEG-ES) in combination with a clear-liquid diet (CLD). Liberalization of the diet might enhance the tolerance to PEG-ES without compromising the quality of the preparation. The primary aims of this study were to evaluate the efficacy and tolerability of PEG-ES given with a CLD compared with a fiber-free diet (FFD) for colonoscopy preparation. The incidence of adverse events among patients in the two diet groups was also assessed as a secondary outcome. METHODS: This was a single-center randomized, prospective, single-blind study. A total of 200 patients undergoing colonoscopy were randomized to either CLD or FFD in addition to PEG-ES. RESULTS: Patients in the FFD group were able to drink more PEG-ES (mean +/- SD, 3.9 +/- 0.3 L) compared with those in the CLD group (3.3 +/- 0.7 L) ( P < 0.01). The quality of the preparation was significantly better in the FFD group, with more patients having satisfactory preparations than those in the CLD group (81.4 % vs. 52.0 %; P < 0.001). Tolerance to the preparation was higher in the FFD group compared with the CLD group, with significantly more patients adhering to the FFD regimen ( P < 0.001). There were more adverse events experienced in the CLD group, with odds ratios of 1.9 for nausea (95 % confidence interval [CI] 1.0 - 3.6), 3.8 for vomiting (95 % CI 1.3 - 11.3), and 3.0 for headache (95 % CI 1.5 - 5.9). CONCLUSION: FFD given with PEG-ES on the day before colonoscopy is a more effective regimen than the standard CLD regimen, and is better tolerated by patients.

Clinical trial: a randomized controlled cross-over study of flupenthixol + melitracen in functional dyspepsia.

BACKGROUND: Functional dyspepsia is a prevalent condition associated with diminished quality of life (QoL) and high economic burden. AIM: To study the efficacy of a combination of flupenthixol and melitracen (F + M) with anxiolytic and antidepressant properties in functional dyspepsia using a randomized controlled cross-over design. METHODS: Patients met the Rome III criteria for functional dyspepsia and a validated questionnaire was used to exclude those with anxiety or depression. Moreover, patients had to have failed a trial of acid-suppressive therapy and Helicobacter pylori eradication when positive. End points included subjective global symptom relief and QoL assessed by the Nepean Dyspepsia Index (NDI). RESULTS: Twenty-five patients (14 females, 11 males; mean age = 34.3 +/- 9.9 years) were enrolled and 24 completed the 8-week study. There was a significant improvement in subjective global symptom relief with F + M vs. placebo (ITT: 73.9% vs. 26.1%, P = 0.001) and a significant drop in the NDI score vs. placebo (ITT: -9.0 +/- 11.9 vs. -2.4 +/- 8.9, P = 0.03). No difference was noted whether the initial treatment was F + M or placebo. No significant side effects were noted. CONCLUSIONS: A combination of F and M is safe and effective in the short-term treatment of functional dyspepsia. F + M is associated with significant improvement in QoL independent of the presence of anxiety or depression.

Association of gastroduodenal disease phenotype with ABO blood group and Helicobacter pylori virulence-specific serotypes.

AIMS: To investigate the prevalence of Helicobacter pylori infection in Lebanon and the association between virulence factors (cytotoxin-associated gene A and vacuolating cytotoxin gene A), ABO blood groups, and disease phenotype. METHODS: One hundred and thirty symptomatic patients with H. pylori-associated endoscopic findings and 104 healthy male donors (age range 18-55) were evaluated. Both, patients and donors underwent ABO blood typing and Western blot for cytotoxin-associated gene A and vacuolating cytotoxin gene A. RESULTS: The prevalence of H. pylori infection in healthy donors is 68.3%. Type I (cytotoxin-associated gene A- and vacuolating cytotoxin gene A-positive) was the predominant phenotype in all groups, though significantly less common in the asymptomatic population (46.5%) than in patients with benign disease (71.4%, p<0.01) or malignancy (71.6%, p<0.05). Type II (cytotoxin-associated gene A- and vacuolating cytotoxin gene A-negative) and vacuolating cytotoxin gene A-only strains were more common in the asymptomatic cohort. Overall, 35.2% of asymptomatic individuals and 10.8% of patients with benign disease were cytotoxin-associated gene A-negative (p<0.01). There was no significant association between immunoserotypes, ABO groups or benign gastroduodenal disease. All gastric malignancies (lymphoma and adenocarcinoma) were cytotoxin-associated gene A-positive but this was not significantly different from patients with benign disease. We found a higher prevalence of blood group A in patients with gastric malignancy than in the general population [47.6% versus 25%, p=0.037; RR=2.73 (1.04-7.16; 95% CI)]. CONCLUSIONS: The seroprevalence of H. pylori is moderately high in Lebanon. Phenotypic classification identifies a higher prevalence of Type I in symptomatic patients. A significant relationship between infection with a cytotoxin-associated gene A-positive strain in blood type A patients and the risk of gastric malignancy was noted.